Bill C-393 (Historical)

An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act

This enactment amends the Patent Act and the Food and Drugs Act to make it easier to manufacture and export pharmaceutical products to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.

Opposition Motion—Passage of Bill C-234 by the Senate

[Alistair MacGregor, NDP, Cowichan—Malahat—Langford, BC]

Mr. Speaker, we do have selective amnesia in this place. I thank the member for Courtenay—Alberni for referencing that, because we lose sight of our history in this place.

The member for Carleton has been an MP for 19 very long years. I know the Conservatives have spent millions of dollars on burnishing up his image, but he has a long history in this House of Commons. If we do some digging, there are a lot of comments, a lot of questions and a lot of speeches from the member for Carleton that will give truth to who he really is.

However, it gets better, because the Conservatives have stood in this place accusing Liberals of bullying senators and imposing their will, when the Conservative Party is the only party in this House that still has 15 senators at caucus every Wednesday. Fifteen Conservative senators join their MP counterparts for every Wednesday meeting, and they get their marching orders from the member for Carleton on how to play games in the Senate. This has been the case for several Parliaments and we have seen it in the past.

Conservative senators have taken their marching orders from former prime minister Harper and have done the very thing that Conservatives are mad about today with Bill C-234. Senators took their marching orders from the Conservative Party in the House of Commons and used their procedural shenanigans in the red chamber to block multiple bills on multiple occasions that were passed by the democratic House. Again, it is rank hypocrisy from the Conservatives.

I will outline a few notable examples.

Our former beloved leader Jack Layton, several Parliaments ago, had a bill that was passed by the House called the climate change accountability act. My God, how things would be different now if we had actually paid attention back then and passed that law. However, right now in 2023, we are dealing with the consequences of years of inaction from both Liberal and Conservative governments. That bill was held up. It died in the Senate because of procedural shenanigans instigated by Conservative senators.

We have also had other cases. Former NDP member of Parliament Paul Dewar, who represented Ottawa Centre, introduced Bill C-393. It was a bill to permit the shipment and provision of generic drugs to Africa, a worthy cause, but it died in the Senate because of Conservative senator procedural shenanigans.

Then of course, in the 42nd Parliament, there was the bill that brought us to where we are today. It was the bill introduced to fully implement the United Nations Declaration on the Rights of Indigenous Peoples, a groundbreaking piece of legislation, Bill C-262. It was ahead of its time, ahead of where the puck was going, and it directly led to the government introducing its own legislation in the subsequent Parliament to make sure Canada's federal laws were in harmony with the United Nations Declaration on the Rights of Indigenous Peoples. That bill, which was duly passed by the House of Commons in the 42nd Parliament, was held up because of procedural shenanigans and games by Conservative senators at the request of their leader.

This is the amazing thing about the Senate. We cannot do that here in the House. With the rules there, one senator can throw in a wrench and jam up the entire works for days on end, and this tactic is used again and again. Conservative senators, under orders from their leader, have been doing precisely the same thing that Conservatives are mad about today when it comes to their own legislation.

These are the things we have to highlight. They are incredibly important because we have short memories in this place.

I am coming down to my final three minutes, and I very much look forward to the questions that will come. However, it does us well to understand that, first of all, Bill C-234 would not have passed in this place if it were not for all opposition parties working together to pass it because they saw merit in the bill. That is number one. Number two, we fundamentally agree with the principle that the Senate, as an unelected body, needs to respect the will of the House. The only party that has been consistent on that position through several parliaments is the NDP. We are the only party that comes out squeaky clean in a debate about the Senate, and all members would do well to acknowledge that fact.

Consistent with our third reading vote on Bill C-234, we will be voting in favour of today's motion, because that is consistent with the approach we have always taken. Had there been motions on our own private members' bills from several previous parliaments, we would have done the same thing. It is important to remind senators that we are the ones who have to face the electorate. We are the ones conveying the wishes of the people of Canada. Every seat in this place represents a distinct geographic area of Canada. We are the ones bringing the voice of the people here, and senators need to be reminded of that fact.

I will end by again highlighting the hypocrisy. I like serving with many of my Conservative colleagues, but as a party, we cannot take any moral lessons from them on the Senate given their history with appointing failed candidates, with party bagmen and with the instructions they give to their 15 caucus members who are members of the Senate. With the entire history they have of blocking bills, Canadians who are listening to today's debate need to understand that the last place we would ever go for a moral lesson on the problems with the Senate is the Conservative Party of Canada. I just want to make that very clear.

I will end my remarks there. I thank everyone for taking the time to listen, and I look forward to any questions or comments.

Patent Act

[Brian Masse, NDP, Windsor West, ON]

Mr. Speaker, I rise today to speak to the bill that my colleague has brought forth. I rise with a sense of regret and shame for a country that has failed to deliver on a promise that it made nearly 10 years ago. As a result of that failure and that promise that was never kept, we have witnessed children, men and women suffer and die because we did not get a chance to provide medications.

We built the system. This is important to recognize when we go back and look at the past. Bill C-56 was the original bill. It was nicknamed Jean Chrétien's aid to Africa act. We said at that time that we would put a system in place that would be the envy of the world. It would allow generic drugs to get to those who were suffering, whether it be from HIV-AIDS, tuberculosis or malaria. We promised.

When Parliament recessed Bill C-56 came back to the House as Bill C-9 in 2004. We made another promise. Experts appeared at committee a couple of times. We brought in witnesses. We had expert testimony from many people from around the world. People testified to make sure that we were WTO and TRIPS compliant, that we were within the mandate with regard to allowing the patented drugs to be generically created and distributed, and that we would follow certain rules. Basically, we wanted to create an open and accountable process. Instead we built a monster that really has only been exercised once in all of these years. It really is a monster, because it is preventing us from stopping death and suffering.

Why is it important? Lots of numbers get thrown out and there have been some improvements over the years. The reality is that many people are still suffering. I cannot understand it when I look at the problems being faced in sub-Saharan Africa. What are we doing when children are becoming the heads of households because their parents are dying? We are taking out the capacity for the family unit to be effective. These children are losing the knowledge of how to raise themselves, how to become successful, how to get an education and work co-operatively with others. We are undermining people because we are not providing the resources that are there.

There is a will out there. I want to read some comments from organizations that are in favour of the legislation, because it needs to be noted that they did their part. They did their part for many years on the Hill as we have moved this issue forward.

When we moved Bill C-393, the previous legislation, it ended up dying in the Senate. Unfortunately, we are back here today. It is important to move this legislation again to committee because it does have a few changes, some improvements and some compromise. It is not like we did not compromise along the way. At one point I submitted over 100 amendments to the original bill at industry committee because we knew the legislation was so badly constructed. The Canadian access to medicines regime was built to defeat itself.

The organizations that did their part include the Canadian HIV/AIDS Legal Network, Grandmothers Advocacy Network, Results Canada, the Federation of Medical Women of Canada, the Canadian Federation of University Women, the Ontario Nurses' Association, UNICEF, Bracelet of Hope, World Vision, the United Church of Canada. A whole coalition, a rainbow of organizations have come together and worked together.

There have been some important changes and there is some hope. We were fighting with the brand name drug companies along the way. We have gone through a whole range of issues about certain countries being listed and certain drugs being listed, and fought back and forth on all of those things.

However, now there has been a shift in their position. In a letter dated November 19 from research-based pharmaceutical companies to my leader, the hon. member for Outremont, it says they are open to looking at a more constructive approach. They list a series of concerns. Some I do not think are as valid as others, but there are important ones to note. They talk about transparency, amount and term, anti-diversion, eligible countries, eligible medicines and safety appeal mechanisms.

The good news is that there is no reason for any member now to vote against the bill. If a member is voting against the bill, he or she is voting directly against the pharmaceutical companies, the generics, and all the organizations I mentioned, that want to see this move forward. I thank them for coming to the table this time. In the past, we have witnessed a relationship that has been rocky at best. However, at this moment in time there has been a change in position. We are going to hopefully see this legislation move to committee so we can start to deal with some of the issues they raised to improve the legislation.

It is important. We have set an example internationally with this legislation. If we can get the changes here, other countries can also get some changes. We have a situation where some of the global funds are diminishing, so we have an issue with supply and management right now, and the costs.

I will conclude that I have come here today speaking out of frustration and disappointment, but there is a glimmer of hope this time. I am hoping all the members understand that there is nobody else out there against moving forward, so let us do it together with all members' support.

Access to Medicines

[Mauril Bélanger, Liberal, Ottawa—Vanier, ON]

Mr. Speaker, I would like to table a petition on behalf of hundreds of Canadians, many of them from Ottawa but also from the western provinces, B.C. and Manitoba in particular. The petition is by the Grandmothers Advocacy Network encouraging members of this House and the government in particular to support Bill C-398, a bill to amend Canada's access to medicine regime to allow people in Africa, principally but not only there, who suffer from treatable diseases such as HIV-AIDS, malaria and tuberculosis to receive medicines that are not priced exorbitantly. The petition also encourages those members who voted in the past for Bill C-393, which passed the House but did not get through the Senate, to consider supporting Bill C-398.

Patent Act

[Bradley Trost, Conservative, Saskatoon—Humboldt, SK]

Mr. Speaker, I have a petition from constituents concerning Canada's Access to Medicines Regime. The petitioners are in support of Bill C-393.

[Frank Valeriote, Liberal, Guelph, ON]

Mr. Speaker, from time to time we have an opportunity to discuss an issue that is so fundamentally important that the question of action is not if, but how.

Before us today is a bill that will address the ongoing and terribly destructive crisis with access to medicines in developing and least developed countries across the world. While this bill is not perfect, there is a balance to be struck between maintaining our country's commitment to intellectual property protection while ensuring that we do not build unnecessary barriers limiting access to the medicines that are much needed in developing countries. That is why it is important to get this legislation to committee for closer examination.

We have no excuse for inaction. The House already passed a version of this bill in the last Parliament and the problem is not going away. It has been eight years since the Liberal government of the day put forward a bill that established a legal framework for Canada's access to medicine regime. The bill, otherwise known as Jean Chrétien's pledge to Africa act, was meant to create a balance between addressing our commitment to combat HIV and AIDS and simultaneously honouring intellectual property rights and trade obligations. The bill passed unanimously. Through that legislation, parliamentarians of all stripes signalled that it was a priority that there be timely access to affordable generic versions of patented drugs meant to fight HIV-AIDS, malaria, tuberculosis and other diseases that are killing thousands of vulnerable men, women and children every day. As an international leader, we could not stand idly by and watch others suffer without trying to help.

It has since become clear that the bill, well-intentioned as it was, proved ineffective in accomplishing its main role. Whether it has been overly complex or onerous or unresponsive to the urgent needs of countries in need, Canada's access to medicines regime has simply not lived up to its intended purpose. That is not to say that we should throw the baby out with the bathwater. There are solutions and we must move forward to implement them and reach these noble goals.

The bill before us today contains workable solutions to the administrative burdens that have made CAMR frustratingly inaccessible. In fact, we saw this legislation before the last Parliament as Bill C-393, and the House of Commons passed it before it died in the Senate when Parliament was dissolved for a general election.

I remember its passage from the House as one of the proudest moments in my time here, standing with a majority of fellow members, Liberals, NDP, the Bloc and several Conservatives alike saying to the world that we would help. At that time I argued that we could, and I still firmly believe that we can, pass this legislation and prolong lives while preventing the transmission of insidious diseases like HIV-AIDS. We can renew a lease on life for ailing parents, confident in the knowledge that they can live to provide for their loved ones, secure in knowing that they will not transmit the disease to their children. It is not enough to wish it were so, and words certainly will not make it true. Action is necessary. We can act now and finally address this head on.

Mr. Speaker, I will defer to you, understanding that I will have six minutes remaining when called upon again.

[Ted Hsu, Liberal, Kingston and the Islands, ON]

Mr. Speaker, I would like to begin by thanking the hon. member for Laurier—Sainte-Marie for bringing this matter before us again by introducing this bill.

I thank the hon. member for Laurier—Sainte-Marie for bringing forward Bill C-398, which would amend the Canadian access to medicines regime. It is my pleasure to speak today in support of the bill and to move it to committee stage by voting for it at second reading. It is time to move the bill to committee and move on the legislative process, which was interrupted in the last election after it passed this House with support from all parties.

We are very fortunate in Canada that we live in a country where we are able to benefit from medication and as a country we have the infrastructure and the know-how to produce medicines. As Canadians, we also feel that we have an obligation to help those around the planet who are less fortunate, who are sick or dying and could be helped if they had access to medicines that exist today.

That was the motivation for Bill C-9, the original Canada access to medicines regime, also known as the Jean Chrétien Pledge to Africa Act.

Some medicines are expensive and the point of CAMR is to make available to developing countries safe, generic versions of medicines manufactured in Canada and to do it within international rules on trade and on intellectual property rights. It is intended to provide the competitive pressure to reduce the cost barrier to those countries that would never be able to afford the medicine but would greatly benefit from it and where people are in dire need of the medicine. We know that other countries can produce generic drugs but the Canadian product is produced with higher standards in quality control and it will provide competition on that basis.

CAMR came into force in 2005 but, as people have noticed, since that time this regime has only been used to provide one shipment of medicine to one country so far, which is why we believe there are barriers. One of the barriers that has been identified is the cumbersome licensing process.

The core of Bill C-398 is to provide the so-called one licence solution, which would remove the need for each individual country to make a request for a compulsory licence to produce generic drugs that are needed for serious health problems in these countries. It would remove the need for individual countries to apply and, instead, a Canadian generic pharmaceutical manufacturer would apply for the licence for all countries.

This reform has been sought for several years now, and in the previous Parliament, Bill C-393, upon which Bill C-398 is based, passed this House with support from all parties and probably would have come into force had the May 2011 election not been called.

I want to expand a little bit on the remarks that my colleague from Laurier—Sainte-Marie made and I want to talk a little bit about intellectual property issues, which were the subject of the speech by my hon. colleague from the Conservative benches.

Advocates for reforming CAMR do not wish to jeopardize pharmaceutical R and D in Canada. They have said that an I think they do believe in the importance of the knowledge economy , and one of its pillars, the value of intellectual property.

I think we all agree that Canada's future will depend very much on its participation in the knowledge economy and nobody wants our kids to be competing in the world on the basis of providing the lowest cost labour. I believe that the drafters of Bill C-398 recognize some of these concerns.

For example, Bill C-398 improves upon Bill C-393 in that respect by specifying that Canadian generic manufacturers must post online the quantities of medicine being exported to each country. They must also put online the notification that each WTO country gave to the WTO trade related aspects of intellectual property rights council, or, for a non-WTO country, the notice that country gave to the Government of Canada.

The old bill, Bill C-393 from the last Parliament, at first removed a two-year time limit on licences before a renewal was required. In the last Parliament this was amended in committee to restore that time limit. Bill C-398 keeps that two-year time limit in the current draft. Drafters of the bill have responded to concerns about an open-ended licence in time.

In the spirit of the changes that the drafters of Bill C-398 have made, compared to Bill C-393 that already passed the House in the last Parliament, we could make some amendments to emphasize that it is not the intent of the bill to negatively impact any R and D investment in Canada. It is not the intent of the bill to devalue intellectual property that is a pillar of a knowledge economy.

People have asked me, for example, why Qatar is on the list of countries in the bill. It is a country with a per capita income of $90,000 per annum. I believe that no one wants that distraction. It really is distracting from the fact that people are sick and dying and need medicines that they cannot afford. Therefore, this is something we could look at in committee, the list of countries in schedule 2 of the bill, to remove these distractions that may lead people to question some aspects of the bill.

My colleague from the Conservative Party is worrying about safety issues. Some critics have worried that the generic drugs would not be subjected to safety reviews. However, section 21.04(3)(b) in the current legislation remains unchanged under Bill C-398 and affirms that any generic product must meet the requirements of the Food and Drugs Act and its regulations. Therefore, my hon. colleague is incorrect when he makes that point. It is an old point that was made in the past but this bill is slightly different and that point is covered. In fact, the advantage of importing drugs from Canada is that products are manufactured with higher standards and with better quality control.

I will be voting in favour of the bill. It is time to move toward reforming Canada's access to medicines regime, a process that was accidentally interrupted at the last election, but which had already passed the House. We must not delay in sending the bill to the next stage of the legislative process, to committee where we can examine it and related issues in detail, as we should examine every bill. We must move this bill to committee and I urge my colleagues to vote for the bill at second reading.

Motion in Amendment

[Brian Masse, NDP, Windsor West, ON]

Mr. Speaker, it is a pleasure to rise here today on Bill S-5 and the amendments that the NDP has put forward with regard to creating more transparency and accountability in this bill.

We do support the bill. However, we see this as a missed opportunity because there are so many issues relating to the banking industry right now that affect Canadian consumers, and also Canadian companies. I was at committee today and so I do not know if this has been discussed a great deal here, but small and medium size businesses have been hurt exponentially by the banking system in recent years. I will get into more detail on that later, but it is important to put that as part of the equation as we talk about this missed opportunity here.

First, as my colleague from the Liberal Party noted, the bill comes from the Senate. That is a concern for us. Why would the government table a bill in the Senate and then have it come to the House of Commons? A Conservative called the Senate equally capable. That is an interesting description for the Senate coming from the Alliance/Reform Party base out there when senators are unelected, unaccountable individuals.

While there are some very good people in the Senate who do some good work, at the same time they are not elected and not accountable to the Canadian people. Therefore, I do not think the Senate is equal to the House in any sense whatsoever. I am shocked that a Conservative/Reform/Alliance person would call the Senate that, because senators are political patronage appointments made by the Prime Minister, whether that be Joe Clark at the time, Pierre Trudeau, Jean Chrétien, Paul Martin or now our current Prime Minister.

Senators do not have to go to the electorate and earn their seat. Once again, there are some very good people there whom I have worked with on a lot of good issues and I respect them a great deal, but there is a big difference between them and having to go to the person checking out groceries and selling cars. They are our bosses. They are the ones who decide whether we get to this place or not.

Having said that, I am a little concerned that the bill is from the Senate. I say this because in the past I worked on Bill C-393, a bill on providing generic drugs to developing countries for tuberculosis, AIDS and malaria. The House of Commons passed it, but it actually died in the Senate. Thus the elected body here passed a bill, sent it to the Senate, but it never made it through, even though it should be Canadian law right now so that we could provide medicines to those who are suffering from tuberculosis, malaria and AIDS in developing countries. There was also the bill from Jack Layton, the climate change bill, that was passed in this House of Commons, but, again, did not make it out the door of the Senate.

Now we have the reverse coming back here and what we see is a very scoped bill on the banking industry. However, I am glad that the Conservatives are dealing with this. The government is actually addressing some component of it, but let us take a step back in history, which I think is very important.

It is interesting that representatives of the banking industry came into my office a year ago and said that I should be thanking them for the work they had done and the fact they had propped up the Canadian financial system because of the way banks were structured and had done business. At that point, I asked if they wanted me to go to my computer or to my filing system and pull out all of the presentation decks and summaries they had previously provided me saying that they had to become like the American banks.

It was the New Democrat members in the House of Commons who fought against that. I will admit there were some Liberals who did so too, because I have been corrected in the past on this, and quite sincerely, by some of my Liberal friends. However, it was John Manley under Paul Martin who was trying to move our banks towards the American model. We voted against that and stopped it and it did not pass the House of Common, as there were some others who supported that notion to keep our banks the way they were. However, it was certainly the Conservatives, the right wing members, who got up day after day to complain about how Canadian banks would be swallowed up by U.S. institutions if we did not act at that particular time. That took on—

Senate Reform Act

[Élaine Michaud, NDP, Portneuf—Jacques-Cartier, QC]

Madam Speaker, I rise today to speak to Bill C-7, An Act respecting the selection of senators and amending the Constitution Act, 1867 in respect of Senate term limits.

I am pleased to have this opportunity today. I have a degree in political science and I am very interested in all matters pertaining to parliamentary process, especially Senate reform. It is a subject that I studied a number of times while in university. This is the third time that the Conservatives have introduced a bill dealing with either the election of senators or Senate terms. Thus, we have had a great deal of material to examine and analyze in recent years.

The purpose of the bill before us today is to reform the Senate in two main ways. The first limits the tenure of senators to a maximum of nine years for all senators appointed after October 14, 2008. The second allows the provinces and territories to hold elections, at their own expense, to decide the names to be submitted to the Prime Minister for consideration for future Senate appointments. The provinces could thus choose any system they liked for electing senators, provided that the system adhered to basic democratic principles.

The Conservatives say the measures they have introduced are intended to modernize the aging institution that is the Senate. For once, I agree with my Conservative colleagues on part of what they say: the upper chamber does in fact present major problems, and measures need to be taken to remedy the situation.

However, the solution the NDP has been proposing for several years is quite different. In fact, we are calling for the complete abolition of the Senate. The reasons why we are calling for the abolition of the upper chamber are very simple. First, the institution is not democratic, and it is composed of unelected members appointed by the Prime Minister. More often than not, those appointments are partisan and are made to reward friends of the Prime Minister. As well, he sometimes adds insult to injury by appointing candidates, and even ministers, who were rejected by the public in a general election, as we saw after the last election on May 2. The people living in the greater Quebec City region can attest to that as well.

In addition, the Senate is also used for partisan purposes by the government, whether to guarantee the speedy passage of government bills or to kill bills that have actually been approved by the House of Commons. I am thinking in particular of the Climate Change Accountability Act and the bill to provide generic drugs for Africa.

Since 1900, there have been 13 attempts to reform the Senate, and they have all failed. Bill C-7 is no different from all those other failed attempts. It does not solve the problems that already exist in the upper chamber, and on top of that it creates new problems that simply worsen the present situation. First, limiting senators’ tenure to nine years does not make them more accountable to Canadians; quite the contrary. In fact, the bill eliminates any form of accountability to the public, since senators would never have to face the public at the end of their tenure. Once senators were elected, they would never have to account for their decisions, their actions and their broken election promises, because they could never stand in another election. As well, they would be automatically entitled to a pension, regardless of their record.

I cannot see how having the Prime Minister give a senator a nine year non-renewable term increases democracy in the Senate. Nor do the measures proposed by the Conservatives in Bill C-7 prevent partisan appointments. The bill does not really change the way senators are appointed, and the Prime Minister remains entirely responsible for choosing senators. The Prime Minister is not obliged by this bill to select senators from the lists submitted by the provinces or territories, and he can continue to choose whomever he wants and ignore each and every list he receives. He can, therefore, continue to fill the Senate with senators who are loyal to the government rather than to Canadians. This is a major problem.

Canadians elect the members of the House of Commons and place their trust in them to be their voices in Parliament. The Prime Minister, on the other hand, appoints senators, as a reward, and they serve the governing party.

I shall now read a letter written by Senator Bert Brown to the members of the Conservative Senate caucus. It is dated June 15, 2001, which, in my opinion, perfectly illustrates a situation. I am going to read the first and last paragraphs, which I think are the most relevant . The letter reads,“Yesterday, in Senate caucus [the minister] was showered with complaints about Senate elections and a nine year term. ... Every Senator in this caucus needs to decide where their loyalty should be and must be. The answer is simple; our loyalty is to the man who brought us here, the man who has wanted Senate reform since he entered politics, the Rt. Hon. [Prime Minister].

The message to senators is very clear: their loyalty lies not with the regions that they represent, nor with Canadians; their loyalty is to the Prime Minister. Canadians, too, have heard this message loud and clear.

Another consequence of this bill would be the creation of a two-tiered Senate with elected and unelected senators in the same upper house, which may be worse than what we currently have.

Bill C-7, if passed in its present form, will fundamentally change the nature of Canadian politics as we know it today. We will end up with senators elected at the provincial level who believe that they are more legitimate than the unelected senators. We will then have a Senate with different degrees of legitimacy based on the method by which senators are selected.

However, the most negative effect of this bill will be evident once we have an entirely elected Senate. According to the Canadian Constitution, the Senate currently has more or less the same powers as the House of Commons. However, since senators are unelected, they cannot indefinitely block legislation with financial implications because they have no direct mandate from Canadians but are appointed by the Prime Minister.

Once we have an elected upper house, it will be a whole different story. Senators will have greater legitimacy to introduce bills and block House bills. That could result in American-style impasses pitting two houses of elected representatives with essentially the same decision-making powers against one another in legislative conflicts with no apparent solution.

Ultimately, such impasses will force us to redefine the framework of Parliament, including the rights and responsibilities of both the House of Commons and the Senate. Major changes will require nothing less than a constitutional amendment. There is no other option, because that is the existing legislative framework.

The Conservatives claim that their bill will sidestep a constitutional debate on Senate reform, but I do not see how such a debate can be avoided.

Before passing a bill that will inevitably lead to interminable constitutional debates and discussions, we have to let Canadians weigh in on the issue of the Senate's very existence. All the provinces have done quite well without their upper houses since 1968, so it is high time we thought seriously about getting rid of the federal Senate. That is why, for years, the NDP has been calling for a referendum to find out if Canadians want to get rid of the Senate. Before setting in motion any major reforms of the Senate or abolishing it entirely, we need a clear mandate from Canadians, from the people of this country, and the only way to get a clear, legitimate mandate is to hold a referendum.

The changes that the Conservatives have proposed in Bill C-7 are inadequate and will not solve the Senate-related problems. That is why I oppose this bill. If the Senate cannot be abolished outright, the status quo is better than the constitutional chaos into which the Conservatives apparently wish to lead us. Serious consideration is in order before passing Bill C-7. The government will find itself embroiled in constitutional debates that it would rather avoid. That deserves some thought.

Patent Act

[Hélène Laverdière, NDP, Laurier—Sainte-Marie, QC]

moved for leave to introduce Bill C-398, An Act to amend the Patent Act (drugs for international humanitarian purposes).

Mr. Speaker, today, I am proud to introduce my bill entitled An Act to amend the Patent Act.

This bill will modify the provisions of the current access to medicines regime, which allows Canada to export generic versions of drugs for HIV-AIDS, tuberculosis, malaria and other illnesses to developing countries, and it will make the regime easier to use.

This will enable Canadian manufacturers to send potentially life-saving medicines to those who desperately need them.

This bill is an improved version of Bill C-393, which the House passed by a comfortable margin last March but which, unfortunately, died on the order paper in the Senate.

When drafting this bill, I worked closely with the Grandmothers Advocacy Network and the Canadian HIV/AIDS Legal Network. I would like to thank Pat Evans and Richard Elliott for their help.

The bill has already received significant support from all parties in the House. Over the coming months I will be encouraging my fellow parliamentarians to take this opportunity to support lifesaving legislation.

Together, with hope, love and optimism, we can make a difference.

(Motions deemed adopted, read the first time and printed)

Senate Reform Act

[Jasbir Sandhu, NDP, Surrey North, BC]

Madam Speaker, I rise to speak to Bill C-7, An Act respecting the selection of senators and amending the Constitution Act, 1867 in respect of Senate term limits.

If only we could be so fortunate as to have the government amend the bill so that the Senate would be abolished, then this could be our last time to rise and speak about Senate reform. My NDP colleagues and I believe that the Senate needs to be abolished. Any attempt to reform the Senate would simply be window dressing to this very seriously undemocratic institution. As things currently stand, Bill C-7 introduces ineffective measures that will do nothing to fix the Senate.

What is currently wrong with the Senate? We often describe the Senate as a romantic place of sober second thought. However, we know the Senate is no such a place. Last year, rather than respecting the will of this House, as my colleagues have pointed out, the Senate killed Bill C-311, the climate change accountability act. The bill was passed in the House of Commons and voted for by elected members of this House. The Senate killed it and the government called a snap election.

In the words of our former leader, the hon. Jack Layton:

This was one of the most undemocratic acts that we have ever seen in the Parliament of Canada. To take power that doesn't rightfully belong to them to kill a bill that has been adopted by a majority of the House of Commons representing a majority of Canadians is as wrong as it gets when it comes to democracy in this country.

This spring the Senate killed another bill which was very important. Bill C-393 would have made it easier for people in developing countries to obtain more affordable life-saving medicines. It was a bill that would have saved lives. It was voted for by members of this House and killed by an unelected Senate.

To suggest amendments and return a bill to the House is one thing, but to kill a bill in this way, using sneaky tactics, is just plain wrong. It is disrespectful to the decision-making power of this democratically elected House.

Right now the Senate is basically full of political appointments, friends and failed candidates. That is what the Senate is right now. For instance, our Prime Minister appointed to the Senate three failed Conservative candidates from the last federal election. All three failed to win a seat in the election. Canadians decided on May 2 that they did not want to have these people representing them. Yet, here they are; they are in the Senate.

There are a number of things in the bill that do not fix anything at all. For example, the Conservatives make excuses for their appointments saying that they will use them to reform the Senate. This is clearly laughable.

Every day in this House the Conservatives trample on democracy. They ram bills through the House and committees without debate or examination, sometimes without even costing these bills. Then the Conservatives want members to believe that they actually want a more democratic Senate. They do not.

The reforms the Conservatives are proposing in this bill are completely inadequate.

First, under the proposed legislation, the Senate would become a two-tiered system with some elected senators and some unelected senators.

Second, the limit of one nine-year term means that senators, even elected ones, would not be held accountable for their actions in a subsequent democratic race.

Third, because the actual appointment process would not change at all, despite talk of increased democratic accountability, the bill does not actually introduce any check on the Prime Minister in the appointment process. Basically, it could be business as usual.

Fourth, because the bill would do nothing to address the distribution of seats in the Senate, the increase in power of an elected Senate would mean an unbalanced increase in the power in Quebec and Ontario. I come from British Columbia and that is not fair.

Fifth, perhaps the most important intended role of the Senate is its ability to represent women and minority interests. By making it an elected Senate and forcing any candidate that runs to do so under a party banner would only tighten the partisan stranglehold on the legislative process. Parties will drown out minority representation, like we have seen in Australia. There are examples in Australia where this has happened.

Sixth, the introduction of increased democratic legitimacy would give the Senate even more leeway to assert its own decision-making power, which could result in gridlock. We have seen that in the United States. This is counter to the productivity Canadians expect from their government.

There are solutions, and New Democrats and others have proposed them. The best solution to this democratic black hole, that is the Senate, is to basically abolish it. The Conservatives have been wishy-washy in the past and unable to decide what they want when it comes to the Senate. For instance, previous Conservative bills have called for a federally regulated electoral process while another bill called for eight year term limits. We can see clearly that what the Conservatives want is the appearance of reforming the Senate when, in reality, they stack it with their cronies and use it to kill legislation passed by democratically elected members of the House.

Unlike the Conservatives, New Democrats have unwaveringly supported the abolition of the Senate since the 1930s, and many Canadians agree that we need to abolish it and move on from this undemocratically elected institution. At the provincial level, both Liberal Premier Dalton McGuinty in Ontario and NDP provincial Premier Darrell Dexter have called for the abolition of the Senate. In my province, Premier Christy Clark has said that the Senate no longer plays a role in Confederation.

We have seen from history that all provincial legislatures have abolished their provincial senates. The last one was done in 1968. Even the Prime Minister himself once said that the unelected Senate is a relic of the 19th century.

Unlike the Conservatives who have not consulted the provinces, New Democrats believe it is the responsibility of the government to consult all Canadians. To that end, New Democrats believe that the issue of Senate reform cannot be solved by this piecemeal bill. The issue of Senate reform needs to be put in a referendum, so Canadians themselves can decide how they want to deal with it.

The majority of Canadians support New Democrats in this proposal as well. There have been a number of polls done and I will mention one that was done in July 2001 by Angus Reid, which said that 71% of Canadians supported having a referendum on this issue.

In closing, I would therefore urge my Conservative colleagues to heed their small c conservative roots. We know how the House of Commons works, but we have no idea what would happen with an elected Senate. It would no doubt completely change the Canadian political system, but to what end we cannot be sure. The best solution to Senate reform is abolition.

[Glenn Thibeault, NDP, Sudbury, ON]

Where do I begin on that, Mr. Speaker? We have conversations in the House and we debate policy on many issues that affect all Canadians and costs that are associated with that. Some of the things we have been saying is that many of the decisions that are made in the House we need to flip on their heads.

If I could go to the one bill that was defeated in the Senate, which was Bill C-393, the cost associated with providing anti-viral drugs to children and adults in Africa suffering from HIV and AIDS would have been minimal and we could have eased the suffering of people. Instead, we are spending money on, as the hon. member said, travel and everything else.

The decisions that are being made in the Senate are affecting the decisions that we have made in this House. We make these decisions in the House based on what we think is in the best interests of Canadians.

We need to ensure those best interests continue to be brought forward and we need the Senate to actually support these bills until they are no longer around.

[Glenn Thibeault, NDP, Sudbury, ON]

Mr. Speaker, I am pleased to rise in the House today to speak to the bill entitled “An act respecting the selection of senators and amending the Constitution Act, 1867 in respect of Senate term limits”.

Although the bill may appear to address one of Canada's most egregious democratic deficits, I am afraid that the approach being taken leaves much to be desired.

Essentially, Bill C-7 restricts all senators appointed to the Senate after October 14, 2008, to a single nine-year term. Provinces and territories would then be given the opportunity to hold elections at their own expense to determine which names would be submitted to the Prime Minister for consideration, and only consideration.

While on the surface this approach might appear to bring heightened accountability to an unelected institution of the Crown, restricting Senate term limits while holding non-binding Senate elections fails to consider the most logical option for improving Canadian democracy, namely the abolishment of Canada's Senate.

I recall one of my constituents, Craig, telling me that he did not support a triple-E Senate. He supported a single-E Senate, and that single E stands for empty.

Before I get into why New Democrats believe that the Senate has outlived its raison d'être, I would like to highlight some specific criticisms of the bill as it currently has been presented to Parliament.

First, it appears that, as it is currently written, Bill C-7 contains a glaring loophole which would completely undermine the spirit of what the government is proposing. This is because the government is clearly attempting to pass legislation which should require a constitutional amendment and making unclear how much force the bill would actually carry.

For instance, by taking an approach which fails to crystallize the changes in Canada's Constitution, the Prime Minister would not be constitutionally required to appoint anyone elected by the provinces. Therefore, the bill does not actually change the way senators are currently appointed as the Prime Minister would still be free to appoint whomever he or she chooses.

We have seen previous examples of the Prime Minister acting in contravention of existing democratic reform legislation which has passed through the House. Specifically, I can point to the fixed election date legislation. Why then should Canadians trust that the government would actually abide by the legislation that we have in front of us today? Call me a pessimist, but this is certainly one concern that I have with Bill C-7.

Let me make this clear. We know how the House of Commons works, but we have no idea what would happen with an elected Senate. That brings me to another major concern arising from Bill C-7, which is the inevitable gridlock which would arise from having two separately duly elected Houses of Parliament.

Since the Senate would have virtually the same powers as the House under Bill C-7, an elected Senate would have greater legitimacy to introduce legislation or oppose bills sent to it from the House of Commons. On the surface this seems like a good idea. However, when we dig deeper into those proposals, it would illicit the real fear that we could end up with the kind of gridlock we see in the U.S., something which no Canadian wants to see our Parliament descend into.

This brings me to my final point that the best approach to take in order to reduce Canada's democratic deficit is the complete abolishment of the Senate. Personally, I am of the belief that when it comes to the Senate, Canadians do not need it. It is expensive. It has been packed with party insiders and we cannot trust what the leaders are going to do with the Senate.

The Prime Minister has repeatedly used the unaccountable and undemocratic Senate to kill legislation that had been passed in the House of Commons, twice killing Bill C-311, the climate change accountability act and, this spring, killing Bill C-393, a very important bill which would have facilitated the movement of generic antiviral drugs to Africa to help people living with HIV-AIDS.

These pieces of legislation, supported by wide swaths of the Canadian public, were killed by the Prime Minister's appointed senators in the Senate with no sober second thought. How can we have sober second thought when we have a bunch of Conservative Party organizers and fundraisers with obvious conflicts of interest? It makes a mockery of our democratic system.

As I noted earlier, even should the bill pass during the 41st Parliament, there is no guarantee that the government would actually abide by the rules it has put in place. Thus, we could end up with a patchwork Senate filled with a mix of elected and unelected senators.

I will put forward a hypothetical situation. What if the government refuses to appoint a senator who has been elected by residents of a province because it disagrees with the party banner under which that senator was elected? After all, the prime minister would not be constitutionally obliged to actually appoint them to the Senate. That is why I firmly believe the safest and most obviously beneficial approach to the Senate is to abolish it.

I will conclude my statement today by drawing attention to what the provinces, our partners in Confederation, have been saying about the Senate, both in terms of the status quo and the proposals in front of us. Both the Ontario premier, Dalton McGuinty, and the Nova Scotia premier, Darrel Dexter, have openly called for the abolition of the Senate. The B.C. premier, Christy Clark, has said that the Senate no longer plays a useful role in Confederation, while Manitoba maintains its position of eliminating the Senate. Even more worrisome is that Quebec has called this legislation unconstitutional and has said that it will launch a provincial court appeal if this bill proceeds without the consultation of the provinces.

Why, then, is the government moving ahead with a plan that is not supported by the federal government's partners in Confederation? It seems that without the full support of the provinces this proposal will merely be a paper tiger dressed up as a solution to bring Canada's democracy into the 21st century.

What happens if certain provinces refuse to participate in the system? Citizens of those provinces would certainly be shortchanged. Even more dire is the thought that this bill would lead to a constitutional crisis with multiple provinces taking action at the Supreme Court to challenge the constitutionality of this legislation. Without proper provincial consultation, which I fear has not taken place, this is an inevitability and something that should be avoided at all costs.

Therefore, I ask that the government reconsider its position on the bill until such a time as the provinces are properly consulted and sign on to these proposals.

[Pierre Dionne Labelle, NDP, Rivière-du-Nord, QC]

Madam Speaker, my colleagues, as elected members, have a duty to be accountable, but members of the archaic Senate do not have this moral duty.

This relic is a home for numerous defeated politicians who are appointed for partisan purposes, which was the case for some Conservatives who lost the election and were still rewarded by the Prime Minister. I am not the first person to use the word “relic”. In fact, the Prime Minister himself described the Senate as a relic of the 19th century. Now that he is no longer talking about abolishing it, as he used to do, he wants to reform it based on equally outdated values. Why not donate this relic to the Museum of Civilization?

You do not have to be able to predict the future to know that this bill will fail, as did the 13 other attempts at reform before it. The NDP's long-standing belief in abolishing the Senate dates back to the 1930s, and it has constantly been reaffirmed by the party. Yes, the New Democratic Party will vote against the bill and will voice its desire to abolish the Senate, pure and simple. If the government is wondering about the public's opinion on this, we invite it to ask Canadians to voice their opinion through a referendum.

Here is why this bill is going to end up in the dustbin of history. It is undemocratic. The government wants to limit the tenure of all senators summoned after October 14, 2008 to a maximum of nine years. Considering that these individuals are accountable only to the Prime Minister, this is an invitation to hit and run. Moreover, they are entitled to a pension when they leave the Senate. While elected members must face voters at each election to get their verdict, senators are free to completely reject the opinion of Canadians.

The nine-year term set out in the bill confirms this situation, because even if senators were appointed after being elected, they would have the luxury of behaving as they please, without any obligation to go back before voters. The term “election” thus becomes devoid of any moral compass that is part of democratic duty. Since senators will not be allowed to run twice, how can they be accountable to the public? In this regard, the bill does not change anything in the undemocratic basis of the Senate, whose members are accountable only to the Prime Minister. A senator will only be accountable to the Prime Minister, as has always been the case. The bill only provides that a list be submitted to the Prime Minister. It does not in any way affect his discretionary powers.

Some may argue that the Prime Minister will never dare oppose the public's choice, but recent history has shown that the Prime Minister can violate this principle, as he did on the issue of fixed election dates.

I am going to digress a bit and talk about my thoughts while listening to hon. members and what the majority of people think of the Senate. To most people, the Senate is not a big concern. Except for the fact that it costs a lot of money, people do not wake up in the morning thinking about the Senate. For years, I too did not think about those individuals sitting over there and quietly passing the time while waiting for a well-deserved retirement. I did not think about the Senate until Ms. Verner was appointed there. To me, that was a fundamental violation of the democratic process. Someone who had lost all authority through a democratic process was promoted to the Senate with a golden pension for the rest of her life, this for services rendered to the Conservative government. There is a problem there.

There is a second problem. The Senate blocked two bills passed by a majority of members in a Parliament that required the agreement of all parties in order to make a firm decision. I am referring to Bill C-311, An Act to ensure Canada assumes its responsibilities in preventing dangerous climate change, which the Senate killed, and Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act.

In addition to posing a problem of legitimacy, the people appointed to the Senate have begun to kill bills duly passed by a democratically elected assembly. This is starting to get serious. Do we want to continue down that road? The Conservative government is going down a path that is fraught with danger for the future and for democracy.

It has been said the Prime Minister will take into consideration the provincial nominees or the list submitted when elections are held. I am the first to doubt this, and I am convinced that my colleagues and my friends in the NDP and other parties also have serious doubts about that.

Let us imagine for a moment that cross-Canada elections are held for senators. The list of new senators includes Amir Khadr, a symbol of the new Quebec left. This man is a leading light. His views could lead to social progress in Canada. Would the Prime Minister agree to appoint him to the Senate? Never, that is clear.

François Saillant, a champion of Quebec's homeless people, has been involved in every fight to increase social housing in the past 25 years. Would the Prime Minister appoint him if he were on the list? Never.

If Steven Guilbeault were on the list submitted by Canadians, would he be appointed as a senator by the Prime Minister? Of course not. I am convinced that members of the Green Party share my belief. Steven Guilbeault would never be appointed, nor would Laure Waridel of the organization Équiterre. The government does not want supporters of fair trade. We know that trade is unfair in the House. We have to leave it alone.

Would David Suzuki be appointed if he were on the list? I am convinced that the Conservatives would not want to appoint David Suzuki to the Senate.

Would astrophysicist Hubert Reeves be appointed? Would the Prime Minister appoint an astrophysicist, when this party denies scientific facts and scientific actions? Never.

Vivian Labrie founded the Collectif pour un Québec sans pauvreté, which fights to try to get the government to take the reality facing those most in need into account when making decisions. It fights to prevent decisions that will affect the poorest one-fifth of the population. Would this government appoint Ms. Labrie to the Senate? Never.

So this shatters the illusion and the fantasy that the Prime Minister would definitely appoint all of the senators proposed. That is not true. I would like to come back to my speech, which does not necessarily address that, but this raises a question. Basically, is it not dishonest to claim such things, when we all know the political stripes of the people appointed to the Senate?

The Prime Minister is under no obligation to appoint someone who has been elected by a province or territory. This bill therefore does not change how senators are appointed, since the Prime Minister is still free to choose whomever he wants to appoint to the position of senator. How can anyone believe that he will respect the democratic will of the people? He clearly does not understand the notion of democratic accountability. The Conservatives say that the provinces would be able to choose any system they like to elect senators, as long as the system complies with basic democratic principles. The facts show that this government knows very little about basic democratic rules. We cannot help but be cynical, since the government acts as though it was elected by 100% of the population when, clearly, that is not the case.

Quebec has called this bill unconstitutional. The provincial government said that it would go to court if this bill were passed without prior consultation with the provinces. What do the Conservatives want to do, reopen a constitutional debate? What a great way to be put through the wringer.

In closing, I wish I could find the words that would bring this government back to its senses and make it see that this issue must be resolved by the people.

We invite the government to hold a referendum if it is certain about the reform it wants to propose. I remain convinced that all Canadians would like to do away with this relic and relegate the Senate to the Canadian history museum.

[Hélène Laverdière, NDP, Laurier—Sainte-Marie, QC]

Very quickly, I was wondering also if you've heard about Bill C-393, which is intended to improve our access to medicine within the TRIPS context and improve on the law we already have, which is an established mechanism that is not used very much.

Do you think it would be useful for Canada to become a more important player in this provision of generic drugs?

[Claude Gravelle, NDP, Nickel Belt, ON]

Mr. Speaker, since this is my first speech in the House of Commons in the 41st Parliament, I would like to thank the people of Nickel Belt for returning me to this House of Commons. I am grateful to the people from as far west as Foleyet, to the east of Garden Village, from the south in Killarney, and to the north of Capreol and River Valley, for returning me to this House.

One of their reasons for returning me to this House of Commons is due to the fine work that my staff is doing in Nickel Belt. I would like to thank them in this House, including Carmen McMurray in Nickel Belt and Val Caron, Ghislaine Millette in Val Caron, and Mona Noël and Don Pitre in Sturgeon Falls. I would like to thank them for the fine work they are doing.

Some of the reasons why we were re-elected to this House of Commons are because the people of Nickel Belt are more concerned about unemployment, health care, education and about their mothers, fathers and grandfathers. They are not too concerned about Senate reform. They are concerned about the things that affect them and Senate reform certainly does not affect them.

I am happy to rise in the House today to speak about the important principles of democratic reform and accountability.

I know the citizens of my riding of Nickel Belt want an electoral system where people are made to feel their vote counts. They want to feel good about government again, to see it as truly representative of them, and to feel they have a choice.

Five years ago, our Prime Minister was opposition leader. He recognized how wrong the unelected Senate was. He called it unfair and undemocratic. He called an appointed Senate a relic of the 19th century. Then, as opposition leader, he clearly did not like how the Prime Minister held a virtual free hand in the selection of senators and he made a promise that, as Prime Minister he would not name appointed people to the Senate. Sadly, we have seen another broken promise. Instead of fixing the problem with the Senate, the Conservative government has made the problem worse.

Consider the evidence. The Prime Minister now holds the all-time record for appointing the largest number of senators in one day. He has appointed Conservative Party faithful, spin doctors, fundraisers and insiders, his former Conservative Party president, his former national campaign director, and several defeated Conservative candidates. What more evidence do we need than seeing the architect of the Conservative notorious in and out scheme currently sitting in the Senate? Unnecessary Conservative senators spend their time voting down laws passed by elected members of the House of Commons, while burning through taxpayers' dollars to travel the country fundraising for the Conservative Party of Canada. Talk about doing politics differently; it is more of the same old, same old as we saw with the previous Liberal government.

Last fall, we watched in shame as the Conservative-dominated Senate was used to veto legislation that the Prime Minister simply did not like. The Climate Change Accountability Act, introduced by my colleague from northern Ontario, the hon. member for Thunder Bay—Superior North, was passed twice in a minority Parliament. Elected members representing Canadians passed the bill. A majority of elected MPs supported that legislation twice. Tragically, on November 16, 2010, the Senate, with its Conservative appointees, defeated Bill C-311 on second reading. There was no community discussion in the Senate and no witnesses. It was killed by unelected friends of the Prime Minister.

Unfortunately, the government's legislation related to the Senate is not about real democratic reform or delivering on commitments of accountability. New Democrats are talking about real democratic reform. We are calling for the abolition of the Senate. Canadians have had enough. The Senate has to go. Most Canadians would not miss it. Recent polling shows that only 18% approve of the actions of the Senate. Unfortunately, today's senators are too often partisan, working for their parties while being paid with public money. No sober second thought can come from unelected appointees with such obvious conflicts of interest.

Then there is the waste of money in the unelected Senate because Canadians are paying more and more for a discredited institution that does less and less at a time when people are dealing with slow economic recovery and the Conservative government is contemplating billions in cutbacks. Maintaining the Senate costs Canadians around $19 million a year. While folks are looking for jobs, trying to make ends meet when their EI runs out and scraping by on pensions that do not even cover basic necessities, senators are earning $132,000 a year for a three-day work week. Travel and expenses for senators cost $859,000 a year for an institution that will not play any relevant role in the lives of most Canadians.

I can think of a lot of things that matter to people, like creating family-supporting jobs, improving public health care, and building a decent future for our kids. Lining the pockets of party insiders probably is not high on anyone's list. I repeat that New Democrats want the Senate abolished. That has been the position of the New Democratic Party and its predecessors since 1930, and we are not alone.

The Premier of Ontario, Dalton McGuinty, and the Premier of Nova Scotia, Darrell Dexter, have publicly called for the Senate to be abolished. The Premier of British Columbia, Christy Clark, has said she does not think it serves a useful purpose within Confederation. Manitoba also maintains its position in favour of abolishing the Senate. Quebec has called this bill unconstitutional. The provincial government has said it would appeal the matter in court if this bill passes without prior consultation with the provinces.

We know real democratic reform is not achieved by tinkering with how senators are appointed or chosen from the provinces. We will need to introduce fair voting and proportional representation where the franchise of every voter is respected. We are calling on government to hold a referendum asking the Canadian public whether they support abolishing the Senate.

Today, I am asking the Prime Minister to start with two modest but vital first steps. First, I am asking the Prime Minister to stop appointing failed candidates and party insiders to the Senate. I am asking him to reach out to Canadians by making that a firm commitment.

Second, I am asking the Prime Minister to work with me to ensure all senators are banned from fundraising for political parties. No sober second thought can come from unelected appointees with such an august conflict of interest. It makes a joke of our democratic system, and it is not fair to Canadians.

In the long run, New Democrats remain firmly committed to following other modern democracies, as well as Canada's provinces, by abolishing the upper house and continuing to call for a pan-Canadian referendum to allow Canadians to provide a mandate on how to proceed.

We, as New Democrats, want Canadians to feel good about government again, to see it as the embodiment of their collective capacities as citizens, and to feel they have a voice. Let our elected members of Parliament, and only our elected MPs, speak on behalf of Canadians.

Second, let us stop wasting money on the undemocratic parts of our country that are not benefiting Canadians.

I want to bring out some key facts on this Senate reform. All provincial Senates were abolished by 1960, and provinces have continued to function properly. For those from the opposition who think we cannot work without a Senate, the proof is in the pudding. The provinces got rid of all Senates in 1968, and they are still functioning.

Public support for a referendum on the Senate is growing. An Angus Reid survey from July 2011 showed that 71% of Canadians were in favour of holding a referendum to decide the future of the Senate; and 36% of Canadians supported abolishing the Senate, up from 25% one year earlier.

If we really want to hear what Canadians have to say about the Senate, maybe we should have a referendum and let Canadians tell us what they want. With this Angus Reid survey, we know what Canadians want. They want the Senate abolished.

The Conservatives have said that they do not want to tear the other place down, they want to rebuild it. They are accusing us of wanting to tear the other place down. There have been 13 attempts to reform the Senate since the 1900s, 13 times Canadians wanted to remodel the Senate and failed every time. We are not going to accomplish anything this time either.

The government has been all over the map when it comes to Senate reform. A previous Conservative bill called for a federally regulated electoral process, while another bill called for eight year term limits.

The Conservatives have not properly consulted with the provinces about whether or not they agree with the content of this bill. When this bill was first introduced in June 2011, Conservative senators, even those appointed by the Prime Minister, pushed back against any plan for Senate term limits.

Senators will remain unaccountable to the Canadian people by only being allowed by law to serve one term as senators. They will never have to face the public to account for the promises they made to get elected or the decisions they made in the previous nine years, and they will get a pension when they leave office.

The safest, small c conservative approach to the Senate is to abolish it. We know how the House of Commons works, but we have no idea what will happen with an elected Senate.

The Prime Minister has called the Senate a relic of the 19th century. In 2006, the Conservative Party platform stated:

The Conservatives...believe that the current Senate must be either reformed or abolished. An unelected Senate should not be able to block the will of the elected House in the 21st century.

That is exactly what happened to Bill C-311.

The government has used the Senate as a dumping ground for party operatives and fundraisers who are using public money to campaign for the Conservatives. We are seeing that right now with the provincial elections going on across the country. We are seeing senators going from province to province and riding to riding campaigning for the Conservatives at a cost to public money.

The Prime Minister has used the unaccountable and undemocratic Senate to kill legislation that had been passed by the House of Commons twice. As I mentioned previously, Bill C-311 and, this past spring, killing Bill C-393, generic drugs to Africa.

We have Alberta senator, Bert Brown, whose name has been mentioned quite often by Conservative members today making him the god from Alberta. Bert Brown made it very clear in his letter to the Senate dated June 15, when he stated:

...our loyalty is to the man who brought us here, the man who has wanted Senate reform since he entered politics....

It was not to their regions or constituents.

What a shame that an appointed senator would say something like that. He is not there to represent the regions or his constituents. Who is he there to represent if he is not there to represent Canadians? It is a shame.

Health

[Megan Leslie, NDP, Halifax, NS]

Mr. Speaker, the Minister of Industry wrote to the unelected Conservative senators and directed them to kill the medicine for all or drugs for Africa bill despite the fact that Bill C-393 was passed by the majority of elected members of this House, including 26 Conservatives. The minister's contempt for democracy is appalling.

The Conservatives may be in the pockets of big pharma but Canadians did not elect big pharma. They also did not elect the Senate.

Why is the minister putting the interests of Conservative insiders and big pharma ahead of saving lives?

[Paul Dewar, NDP, Ottawa Centre, ON]

Mr. Speaker, elected members of Parliament, including 26 Conservatives, voted to save lives by passing Bill C-393, the medicines for all bill.

However we have obtained an email drafted by the industry minister directing Conservative senators to kill the bill. Conservatives are again using the Senate, a relic of the 19th century according to the Prime Minister, to kill a bill this House passed. Conservatives are putting profits for the big drug companies against saving lives.

Do the Conservatives understand democracy, or do they just not like it?

Freezing Assets of Corrupt Foreign Officials Act

[Paul Dewar, NDP, Ottawa Centre, ON]

Mr. Speaker, I join with my colleagues in supporting the fast-tracking of this bill. I also want to mention the importance of having this review. From the beginning, it was our party's position that this needed a review. We are talking about significant changes, albeit ones that are needed. When we are moving rapidly to make changes like these, it is important that Parliament have an opportunity for review.

I also want to recognize the public servants who worked on this matter. Often they are not given the accolades they deserve. When these things happen, we all know who does the detailed work. I want to thank the officials at the Department of Justice and the Department of Foreign Affairs, those who were willing and able to brief us and appear at committee.

There is no doubt this is a phenomenon we will have to deal with in a different way in terms of legislative tools. This is important. We also have to acknowledge that assets exist here from questionable regimes. In particular, we are seeing a kind of strong-arm phenomenon, in that individuals who are using the profits from ill-gotten gains are often supported by companies from the west. These have to be scrutinized more closely. FINTRAC is one means, but we need something that is a lot more precise.

I would note that the government did bring in measures on arms restrictions banning exports to Libya. It is important to note that to date, the government has not brought forward to Parliament, and therefore Canadians, a report on our arms exports as a country. That has to happen.

I would also mention that this bill has to go through the Senate quickly. I would hope that would be done with Bill C-393 as well.

Patent Act

[The Deputy Speaker, Conservative, Andrew Scheer]

The House will now proceed to the deferred recorded division on the amendment to Motion No. 3 at report stage of Bill C-393 under private members' business.

The question is on the amendment to Motion No. 3.

The House resumed from March 3 consideration of Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, as reported (with amendment) from the committee, and of the amendment to Motion No. 3.

Access to Medicines

[Megan Leslie, NDP, Halifax, NS]

Mr. Speaker, women and girls continue to be affected disproportionately by HIV and AIDS in sub-Saharan Africa. Better access to life-saving medicines would greatly benefit mothers and children living with HIV and AIDS, as well as help family members, particularly grandmothers caring for their grandchildren.

Bill C-393 proposes a one-licence solution that would greatly simplify the licensing process to export lower-cost generic medicines to developing countries.

I would like to recognize the support of this bill by the strong national network of grandmothers groups which seek to build solidarity, raise awareness and mobilize support in Canada for Africa's grandmothers. These women have built a strong two-way relationship that has proven to be a powerful challenge to a pharmaceutical industry that prioritizes profits over human rights, health, social and economic justice.

I hope that the actions of these grandmothers and of all women and girls working in solidarity with each other around the world will inspire the members of this House to pass Bill C-393.

Patent Act

[Jim Maloway, NDP, Elmwood—Transcona, MB]

Mr. Speaker, I am very pleased to be speaking once again to Bill C-393. I want to recognize Judy Wasylycia-Leis, the former member for Winnipeg North, who did a terrific job in this House for the whole 12 years she was here, particularly with respect to this bill.

It seems so typical that when we find issues like this, we always seem to be up against the Conservatives who are finding ways to oppose bills like this, seemingly always taking the side of big business and the drug companies, trying to put up roadblocks to the good work that was done by the member. Now I recognize there are a few members across the way who have supported the bill, but in a general sense, we predictably find the Conservatives supporting the corporate agenda.

I want to also thank the Bloc because it has made some amendments that actually change the bill in an extremely substantial way. Prior to this, we were looking at a five-year sunset clause. Five years is a very short period of time for something like this, particularly when we recognize how long it takes Parliament to get anything done in terms of legislation. Amending it to deal with a 10-year review seems a much more reasonable approach, and I want to thank the Bloc for that.

There are a number of issues that we can deal with on the bill. I know I do not have a lot of time, but we are talking about over 16,000 lives lost per day in the world to HIV, tuberculosis, malaria and other treatable infectious diseases, according to the Global Fund. In 2009, 33.3 million people around the world were living with HIV-AIDS; 1.8 million of them died from the infection and 260,000 of them were children. Ninety-seven per cent of the people infected with HIV-AIDS live in low- to middle-income countries. Almost 15 million people infected with these diseases were in need of antiviral drugs and only 5.2 million were treated.

It is significant that we have seen in the last three or four years, Warren Buffet and Bill Gates in the United States make a commitment while they are still alive to give away half of their $50 billion fortunes and challenging other billionaires in the United States and, I believe, even around the world to participate with them. But the foundation of Bill and Melinda Gates, supplemented by half of Warren Buffet's money, showed some very good direction. They could have picked many different causes in the world, but they chose Africa and the AIDS issue as a point to concentrate on when other groups and other governments were not interested in that. Thus I want to compliment them.

I also want to compliment all of the people who were involved in the development of this bill and getting it to this stage.

[John Rafferty, NDP, Thunder Bay—Rainy River, ON]

Mr. Speaker, I am pleased to stand today to talk about Bill C-393. In fact, I am pleased that my friend from Ottawa Centre put his name to the bill and is giving me the opportunity to do just that.

As I listened to the various debaters today, it occurred to me there were some myths that perhaps I might have an opportunity to debunk today. I hope everyone is listening carefully as I do that.

The bill was first introduced almost two years ago in the House. The intention was to address deficiencies and limitations in Canada's access to medicines regime that have rendered it cumbersome and very user-unfriendly.

Parliament can and must deliver on its promise to people in developing countries struggling with the burden of such public health problems as AIDS, tuberculosis and malaria.

I will deal with myth number one. The myth is that Bill C-393 would weaken current safeguards aimed at ensuring medicines are not diverted and illegally resold. Critics of Bill C-393 have previously claimed that it would weaken Canada's medicines regime and the existing measures to prevent the diversion and illegal resale of medicines, or that it would allow substandard medicines to be exported to developing countries. These claims were never accurate. In any event, such objections can no longer stand since the relevant clauses were removed at committee and are no longer part of Bill C-393.

All of the requirements to disclose quantities of a medicine being shipped and to which countries are being preserved. These safeguards were already deemed satisfactory by Parliament when it first created Canada's medicines regime.

Myth number two is that Bill C-393 would remove measures to ensure the quality of medicines being supplied to developing countries. This claim is simply not true. Under Bill C-393 as it now stands, a Health Canada review would continue to be required for all drugs exported.

Myth number three is that the amendments in Bill C-393 would violate Canada's obligations under the World Trade Organization's treaty on intellectual property rights. In detailed analysis, including by some of the world's leading legal experts on the subject, have shown that this is not correct. All countries at the World Trade Organization, including Canada, have repeatedly and explicitly agreed that issuing compulsory licences on patented medicines to facilitate exports of lower priced generic medicines is entirely consistent with World Trade Organization rules.

The next myth is that Bill C-393 and the one licence solution would authorize unfair competition for brand name pharmaceutical companies. We heard my friend from Ottawa Centre and a number of other speakers today mention the one licence solution. The claim makes no sense. The proposed one licence solution would not, as some inaccurately claim, create unfair competition for brand name pharmaceutical companies.

To be clear, nothing in Bill C-393 prevents brand name pharmaceutical companies from competing to supply their patented products to developing countries. Rather, Bill C-393 simply aims to enable competition by generics to supply those eligible countries and preserves the requirement that generic manufacturers pay royalties to patent holding pharmaceutical companies in the event of any compulsory licence being issued.

Bill C-393 is about making workable something already endorsed by Parliament.

Another myth is that Canadian generic manufacturers will not be able to supply medicines at prices that are competitive with generic manufacturers elsewhere. This claim is simplistic and unfounded. The goal is not to get business for Canadian companies. The goal is to get quality medicines at the lowest possible price for as many patients in developing countries as possible. However, it makes no sense to simply assume that Canadian companies cannot compete globally because they already do.

My friend from Edmonton—Mill Woods—Beaumont was talking about the inability of countries to actually deal with the issue and to work with the drugs. That is a another myth that I will debunk.

The barrier to greater access is not the price of medicines but rather widespread poverty and inadequate health systems. The myth is that widespread poverty, inadequate health systems and not enough doctors, clinics, nurses and so on are the barriers to delivering these.

I spent almost six years living in west and southern Africa working for a Canadian aid organization and I can tell the House that there are multiple barriers to accessing medicines in the developing world which vary from country to country and even community to community. However, major progress has been made in increasing access to treatment, including by strengthening health systems. It is simply inaccurate to claim that the quality of health or physical infrastructure in some developing countries presents an insurmountable challenge to delivering affordable medicines.

For example, with determination and innovative approaches, AIDS treatment is being delivered effectively in some of the most resource limited settings imaginable. In just a few years, millions of people have been put on life-saving AIDS drugs in developing countries, thanks to both effective global investments in health systems, for example through the global fund to fight AIDS, tuberculosis and malaria, and the use of generic medicines purchased at dramatically lower prices.

Every credible organization and expert recognizes the obvious fact that the price of medicines is a key factor affecting access to those medicines and that the price of medicines prevent many patients with HIV or numerous other conditions from accessing life-saving treatments. Prices are higher when medicines are only available from brand name pharmaceutical companies that hold patents on those medicines. Instead of the word patents we could use monopolies if we wish.

Making medicines affordable, strengthening health systems and other initiatives to tackle poverty and improve health in developing countries are not mutually exclusive. Rather, they are complementary and all are necessary. All the clinics, doctors and nurses in the world will not be able to help patients if medicines are priced out of reach, and that is the bottom line, and that is why we have this bill before us today.

[Raymonde Folco, Liberal, Laval—Les Îles, QC]

Mr. Speaker, unlike the hon. member across the way, I am supporting Bill C-393, which aims to correct the major issues with Canada's Access to Medicines Regime, or CAMR.

It is true that the regime is not currently operating, but reforms could change that. CAMR has provided only one drug to one country since it was created by Parliament more than six years ago. We cannot expect the regime to be used again if it is not effectively reformed.

Doctors Without Borders told the committee that it had tried many times to use the regime to get drugs to patients, but that it had given up because of pointless hurdles in the legislation. Developing countries have said that CAMR is not flexible enough, that it contains too many restrictions and that it is not compatible with their procurement processes. Only one Canadian generic drug manufacturer used the regime, and it then said that it would not use the complex process again. But it is important to note that the manufacturer publicly committed to using the regime again if it were simplified, for example, to export a long-awaited pediatric formulation of an anti-AIDS drug that is not currently available from any other source.

Canadians want Parliament to take action to fix CAMR. According to a national poll, 80% of Canadians support reforming Canada's Access to Medicines Regime to make it more workable and to help developing countries get access to more affordable life-saving medicine. So do dozens of prominent Canadians, including our former prime minister whose government enacted CAMR, and many leading Canadian organizations, including all those that recently issued an open letter on World AIDS Day to our colleagues in the House of Commons.

We need to make sure that competition makes these drugs affordable. This is critical for developing countries and has already been recognized by Canada and all the other member countries of the World Trade Organization, the WTO. The ability to procure lower-cost generic versions of expensive patented drugs is the most important factor in making it possible to treat and save the lives of 5 million HIV-positive people in low- and middle-income countries. Another 10 million people living with HIV also need these drugs. There is an urgent need for competition in order to obtain and increase access to affordable generic drugs, and this need will continue in developing countries.

At the core of Bill C-393 was, and should be, a proposal to streamline CAMR with a simplified one licence solution. This approach would eliminate the regime's current requirement for separate negotiations with patent-holding pharmaceutical companies for individual licences for each purchasing country and each order of medicines. It would also remove the requirement to determine and disclose in advance of even being able to apply for a licence to export to a single recipient country and a fixed maximum quantity of medicines. These unnecessary requirements have proven to be the major stumbling blocks to the use of CAMR.

Independent legal experts have repeatedly confirmed that the reforms in Bill C-393, including the one-licence solution, are compliant with Canada's obligations as a member of the WTO, unlike what my colleague across the floor said. This includes a world-renowned expert who appeared before the Standing Committee on Industry, Science and Technology, as well as experts brought together last year by the United Nations Development Program in order to examine Bill C-393 in relation to Canada's WTO obligations.

The proposed reforms in Bill C-393 offer value for money and its proposed changes to CAMR would cost taxpayers nothing. In fact, the one licence solution in Bill C-393 would make Canadian foreign aid more effective because limited resources could purchase more medicines and would also free up scarce resources to invest in making health systems stronger.

Scaling up access to treatment also means greater opportunities for producing and distributing good quality, Canadian made generic medicines, meaning more business and more jobs in addressing oppressing global health needs.

CAMR is not working rapidly and easily precisely because it requires one specific country and a fixed quantity of medicines to be determined and disclosed in advance before seeking a licence is even possible. It took years to get to the point of getting even one licence issued because of this. Claiming that it only took 68 days for the process to work is misleading because it ignores the entire process that was and is required. The one licence solution would streamline the process so that it can work.

Bill C-393 does not weaken measures aimed at ensuring the delivery of quality medicines to patients. The amendment to restore the one-licence solution will ensure that all medicines exported under the regime would still be reviewed by Health Canada. Furthermore, all of the regime's existing safeguards against diversion of medicines would remain unchanged.

Streamlining CAMR does not jeopardize pharmaceutical research and development, including those carried out in Canada. CAMR authorizes exports of generic versions of patented medicines to certain eligible countries only. These countries were already agreed upon by Canada and all WTO members in 2003 and are already reflected in the current CAMR, as created unanimously by Parliament in 2004. These countries represent a small portion of total global pharmaceutical sales and the profits of brand name pharmaceutical companies. Furthermore, the brand name drug companies are entitled to receive royalties on sales of generic medicines supplied to these countries under CAMR.

As for the amendment to include a sunset clause, there is no valid reason to include such a clause, which would automatically kill the crucial improvements needed for the CAMR after they have been in effect for just a few years. On the one hand, the need for more affordable medicines in developing countries could unfortunately remain a reality for many more years to come. On the other hand, it is no secret that the regime is flawed and, as a result, there is almost zero chance that it will ever be used again unless it is simplified.

So why would Parliament bother making improvements to the regime to make it more effective, only to turn around and put an expiry date on those improvements through a sunset clause, to return to the current system, which has proven untenable?

I support Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, and I invite my hon. colleagues to also vote to support it.

[Mike Lake, Conservative, Parliamentary Secretary to the Minister of Industry]

Mr. Speaker, I thank my hon. colleague from the NDP for his passion on this issue, for his interest in picking this bill up. I thank all hon. colleagues in the House, regardless of how they feel about this legislation, for voting unanimously to allow the member to pick up the bill so we could continue this important debate.

Bill C-393 is drafted to deal with the many challenges associated with access to medicines in the developing world.

Before I begin, I commend the Grandmothers to Grandmothers campaign for their continued perseverance to keep this issue at the top of public debate. Although we may not agree on the legislation, I share with the grandmothers a commitment to bringing real and meaningful improvements to the health issues plaguing the people of the developing world, especially those who are most vulnerable, children and mothers.

The House of Commons Standing Committee on Industry, Science and Technology recently completed an extensive review of Bill C-393. The committee heard that Canada's Access to Medicines Regime, in its current form, enabled Canada to deliver two shipments of approximately 15 million tablets of an HIV-AIDS drug to Rwanda in 2008 and 2009.

This makes Canada the only country to have successfully exported generic versions of patented drugs to a developing country using a system like Canada's access to Medicines Regime, a significant achievement to be sure.

The committee also heard testimony that made the following point very clear. African countries depend on medicines from countries such as India, not Canada as some have suggested. The rationale is basic economics: they cost less. They cost less to produce and ship and systems are already in place that see millions of generic copies of patented drugs shipped from countries like India to the developing world.

This is why our government's primary effort to combat the shortage of drugs in the developing world has been focused on direct support to NGOs in Africa or to the global fund to fight AIDS, tuberculosis and malaria. Supporting these worthwhile initiatives is the most effective means to help those in need.

However, that is not all that our government has done. In budget 2010 the government reaffirmed its commitment to double international assistance, bringing Canada's total international assistance to approximately $5 billion

. Working with the Bill and Melinda Gates Foundation, our government is at the forefront of the effort to develop an HIV vaccine, possibly one of the greatest medical breakthroughs of our time.

The committee heard from Dr. Frank Plummer, a world-leading HIV-AIDS researcher and specialist in infectious diseases, who said that to address this issue “we need multiple mechanisms, and the Government of Canada is doing that”.

We will continue to do just that by focusing our efforts on worthwhile results-based initiatives worldwide. Our government's concerns with Bill C-393's proposal to water down Canadian patent laws are shared by members of the opposition, too.

To quote the Liberal member of Parliament for Esquimalt—Juan de Fuca, I would note the following. He says:

Patents are not an obstacle to accessing medicines in developing countries. In the words of Uganda's President Yoweri Museveni, the debate about changing patent rules for drugs is a "red herring.

The notion that patent laws stand in the way of shipping drugs to Africa is simply false.

At the conclusion of the review by the Standing Committee on Industry, Science and Technology, committee members voted to substantially amend Bill C-393.

These amendments were considered necessary by some members of the committee to ensure that the bill would both respect Canada's international trade obligations and maintain the integrity of Canada's framework for encouraging innovation and access to medicines for Canadians.

However, I still have reservations with the amended Bill C-393, which is why I cannot support it. In particular, I am concerned that, unlike the existing Access to Medicines Regime, the amended Bill C-393 does not include sufficient safeguards to ensure that drugs authorized for export are used for humanitarian purposes only and cannot be sold on the black market.

As well, the amended Bill C-393 does not have the necessary components to respect Canada's international trade obligations.

I, and I am sure other hon. members as well, am committed to improving the poor health conditions of people living in the developing world. In my opinion, the most effective way to do this is to improve the basic health infrastructure in the developing world. Low-income countries lack the trained medical staff, access to clean water, accurate diagnostic equipment, and reliable power that are crucial to improving health outcomes.

Canada needs to help these countries by continuing to support funds that assist countries to procure essential medicines, by providing technical assistance to help those countries navigate the drug procurement process and by helping to train qualified health professionals. All of this is in an effort to ensure that the primary health care needs of the world's most vulnerable citizens are being met. We need to focus on what works.

We heard before the committee that in 2003, 400,000 Africans were being treated for HIV-AIDS. In 2010, that 400,000 will grow to 5.2 million people. We need to continue to focus on what makes a difference in the lives of those people.

The testimony provided to the committee was essential to getting to the heart of Bill C-393 and its well-intentioned but flawed reform of Canada's Access to Medicines Regime. Access to health care in developing countries is a multifaceted issue. Neither Canada's Access to Medicines Regime nor the changes proposed by the bill currently before us will provide the additional health care professionals, infrastructure and other tools necessary to effectively administer life-saving drugs in Africa.

As our colleague, the member of Parliament for Esquimalt—Juan de Fuca, so succinctly stated recently:

Changing [Canada’s Access to Medicines Regime] will have no effect on the ability of [Low Income Countries] to acquire medicines and medical supplies that are beyond their means to purchase or administer in the first place.

Bill C-393 is not the answer to solving the access to medicines issue. It is for this reason that I urge members to not support Bill C-393.

The House resumed consideration of Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, as reported (with amendment) from the committee, and of the motions in Group No. 1.

[Paul Dewar, NDP, Ottawa Centre, ON]

Mr. Speaker, I want to thank my colleagues from the Bloc for that amendment. We see it as a friendly and constructive amendment.

Bill C-393 has been debated at great length in this House. We have heard the reasons for it. I would remind members of the House that this is an urgent call to help and that we are talking about 2.3 million children under the age of 15 who are infected right now with HIV. We can help those who are in need of help right now.

One in two children with HIV in the developing world dies before reaching his or her second birthday. Let us think about that. Many of us in this House have children. Fifty per cent of those who contract the virus die, not because they cannot be helped, but because we are not able to help them right now.

That is what the bill is about. It is about life and death, and this House can decide to help save lives. It is that simple.

When we look at the numbers, there is despair, but there is hope. The despair is what the virus does. The hope is what we can do in the House today. What I just saw from my colleagues in the Bloc, what I have heard from my colleagues in the Conservative Party who support the bill and what I heard from my colleagues in the Liberal Party show that the will is there. It is goodwill. It is about people living up to their principles. It is about people putting aside their partisan differences. It is about people listening to the people who need our help. We have heard those voices loud and clear, some of us who have been to Africa.

When I went to the Democratic Republic of the Congo, I saw a warehouse for medicines that could help save children and that warehouse was half empty. They want to see a supply of medicines and by passing this legislation, as amended, we can fill that warehouse to ensure those medicines get to the people who need it.

On another visit after I went to see that warehouse in the Congo a couple of years ago, was to some of the clinics where huge progress has been made to identify the HIV-AIDS virus.

However, if they do not have the medicines to help those who have been identified, then they will perish.

We are here today to look at the bill to ensure it can be amended and improve what the House passed previously.

I want to address, very directly, the amendments. If we are not able to get the one licence solution back in, as my colleagues know, then this bill is not worthy of going ahead. We cannot pretend. If the one licence solution is not put back in, the bill will not be worth the paper it is written on, and my colleagues know that.

To those who have concerns about compliance with WTO regulations, they will know it has been analyzed by experts and it is compliant. So, that argument does not hold weight. They know there are provisions and the amendments in the bill that would ensure standards are kept. We have ensured in the bill and the amendments that have been made that there are no concerns around leakage, in other words, that drugs would go to other countries. It is very precise. These drugs would go to the countries that have been put in the legislation.

We have an opportunity to put forward an innovative solution to help the millions of children who need it. We have an opportunity to improve something that this country has innovated. We have an opportunity, which excites me, to work together as parliamentarians to do something to help save lives.

I salute the people who have worked on this. I have been blessed with the opportunity to take the bill at this point. Many people have referenced my colleague from Winnipeg who started this, but it is because of every member in this House that I stand here today able to debate this bill.

Another thing happened in this place that was unusual and was welcomed. I put aside the bill I had and because of unanimity in the House, I was allowed to pick this bill up at the stage it was at. That means each party had to oblige.

I thank every member in the House for that. If members of the NDP did not get that support, we would have been unable to debate the bill. It does not matter whether members are in favour of the bill or not. I, the NDP members and the people who have worked on the bill thank each and every member of Parliament for that.

It is important to note that what we are talking about is, yes, saving lives. However, it also addresses what is happening in the world in terms of the disease itself. As we know, it is an HIV virus, which is mutating and changing, and we need medical regimes and medicines to change along with the virus. That is happening.

However, another thing is happening. As we know, countries like India have been trying since 2000 to become compliant with the WTO. They are unable to provide the same generic regimes they had in the past, so it requires innovation. We just do not have the drugs to support the people who need them now. The bill would help deal with that challenge.

For those who wonder what the bill can do, it can show the way forward to deal with not only the changes required in the regime of medicines needed, because of the change in the virus, but it will ensure that the progress made, with over five million lives saved in the last number of years, will continue. If we do not, make absolutely no mistake about it, we will potentially be going backward. Why? Because the drugs, which have worked so successfully, have to respond to the way in which the HIV virus and others are changing and mutating.

We cannot stand still. We have to continue to move ahead, and the bill is all about that. There are no concerns about WTO compliance. There are no concerns about quality controls. There are no concerns about leakage to other jurisdictions in terms of the drugs being sent somewhere else. They are in the bill and we would have oversight.

The only challenge is for the House to pass the bill, as amended. If we can do that, if we can put aside our differences, as we have before, and let our partisan shields down and ask what is the best for the people on the receiving end of these drugs, then we can show what Parliament is about. It is about working together from time to time. We have done that on a couple of occasions.

One of the proudest moments for all of us was witnessing, for instance, the apology to first nations. I will never forget that day and I hope we can do that again with this bill.

People are watching. I want to ask all of us to acknowledge the work that has been done by activists and civil society members. The grandmothers have been tireless and vigilant and have understood the importance of Canada working in solidarity with people in other countries. It is the finest example of what Canada and other activists, particularly from the coalition for HIV-AIDS, can do.

At the end of the day, it is very simple. I ask my colleagues to support the bill, as amended, so we can do what we can to help the people who need it. That is what I hope we will do. I hope next week all my colleagues will see fit to pass the bill. I look forward to them supporting it.

[Monique Guay, Bloc, Rivière-du-Nord, QC]

Mr. Speaker, I am pleased to take part in this evening's debate at the report stage of Bill C-393. The purpose of this bill is to amend the Canadian Access to Medicines Regime, which was created to facilitate the development and sale of low-cost generic medicines to developing countries.

Bill C-393 was introduced in the House on May 25, 2009, by the former member for Winnipeg North so that this regime, which has been used only once so far, would be more flexible and therefore used more often. In fact, these changes were called for by the only generic pharmaceutical company to have ever used the regime. It sent a clear message that if the changes are not made, it would never use the regime again. However, we have been advised that, if Bill C-393 passes, it has promised to create and distribute a drug for the treatment of HIV infection among children in Africa.

Since we began examining the bill, the Bloc Québécois has always remained completely open and carefully studied the impact of the changes that Bill C-393 would bring to the Canadian Access to Medicines Regime. We have made it very clear from the beginning that we did not want the House of Commons to limit itself only to the study of Bill C-393. One of our biggest concerns was the importance of seeing more low-cost medicines distributed to some of the world's most needy populations.

Once again, we believe that other solutions, no doubt more consensual, could have been considered. For that to happen, Parliament would have had to clearly express its desire to reflect on this very important question without any partisan agendas. However, as he himself indicated on January 31, 2011, my colleague from Verchères—Les Patriotes was unable to convince the members of the Standing Committee on Industry, Science and Technology to take an interest in studying the regime as a whole.

How can we balance the objectives of Bill C-393 with the concerns that have been raised, such as respect for the requirements of our participation in the World Trade Organization, the need to encourage research and innovation of pharmaceutical products and respect for the altruistic spirit of the act that created the regime in 2004—the objective of which was not to create a tool to export medication for commercial purposes? We can do so simply by more closely monitoring its application to ensure that these irritants are simple concerns and not real problems. Today, the real problem is that there are entire segments of poor societies that are struggling with infectious and communicable diseases. This has reached proportions so high that it is impossible to turn a blind eye and do nothing. Today, we have the only option before us here, which is the passing of Bill C-393.

Of course, when the bill came out of committee some amendments were needed to bring out the essence of the bill. That is why the member for Halifax moved two motions that were then amended by the member for Windsor West. As we have said before, we are in favour of their adoption.

However, a third motion was moved by the member for Verchères—Les Patriotes, which is pragmatic, something that is more than necessary in this case. Since it is impossible to eliminate all of the potential irritants of passing Bill C-393 by studying the information available, without any concrete examples, we believe that we must create some examples.

Need I remind members that one single global transaction took place through Canada's access to medicines regime? This was the sale of antiretrovirals to Rwanda by Canadian company Apotex. We must experiment and use the modified regime to prove that all of the concerns were unfounded, while assuming our responsibilities as legislators and not disregarding the concerns raised by experts. This inspired my colleague from Verchères—Les Patriotes to propose this sunset clause. He wants to create a sort of pilot project.

Pilot projects are strong tools to test and evaluate programs. They must not prevent decisions from being made. On the contrary, they should make decisions easier. That is why we agree that a fundamental part of the clause proposed by the Bloc Québécois is missing, which is feedback. What will we do, as parliamentarians, at the end of the pilot project?

Motion No. 3 is silent on this issue. That is why in a few moments I will be proposing a major amendment that will require hon. members to re-evaluate the plan in order, if possible, not to interrupt a plan that has contributed significantly to making a difference in getting drugs to countries that struggle, despite poverty, to bring relief to their sick.

I also propose making another major change resulting from the fact that in this matter, as in all matters brought to our attention, we have continued to listen to the people. When we were asked why we proposed a pilot project for four years, the answer was easy. It seemed and continues to seem clear to us that at the end of that period of time we would have seen concrete results from the changes made. If, at the end of four years, nothing has happened, then we will have to admit that the officials who told us that Bill C-393 would not change anything were right. However, one argument made us stop and think. What would happen to a drug being distributed at the very moment that the four years were over?

To prevent a drug from being withheld for that reason and to truly give Parliament enough time to study this new plan with access to real examples provided by the manufacturers and exporters of these new generic drugs, and, if possible, to make permanent the changes suggested by Bill C-393 before the sunset clause takes effect, we agree with the proposal made by a stakeholder we have encountered many times, to extend the trial period from four years to ten years. Therefore, there is every reason to adopt Motions No. 1 and No. 2, and Motion No. 3, as amended, in order to allow the desired changes to the plan to be made while ensuring that the plan remains consistent with the spirit of the legislation adopted in 2004.

Therefore, seconded by the hon. member for Compton—Stanstead, I move that motion No. 3 of January 31, 2010, be amended by replacing the words following “The provisions of this Act that amend the Patent Act” with the following:

“shall cease to apply on the day that is the tenth anniversary of the day on which this Act comes into force unless, before that day, the application of those provisions is subject to a comprehensive review by the standing committee designated by the House of Commons for that purpose, that committee recommends that they be maintained and the House of Commons approves that recommendation.”

[Frank Valeriote, Liberal, Guelph, ON]

Mr. Speaker, I rise in the House this evening to speak in support of Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act.

I strongly urge all members to support the bill and the amendments put forward by my hon. colleagues from Halifax and from Windsor West, calling for a one license solution to cut the red tape currently preventing the sale of generic drugs overseas and to also restore the definition of pharmaceutical products to protect the knowledge developed by name brand drug manufacturers. Accepting these amendments will simultaneously help those in the developing world and will also protect the investment and the knowledge developed by pharmaceutical companies.

On May 14, 2004, the Martin Liberal government passed Bill C-9, An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa). This act established the legal framework for Canada's Access to Medicine Regime, or CAMR, which sought to balance Canada's trade and intellectual property obligations with the humanitarian objectives set out in Bill C-9 and help us honour our commitment to realize the sixth millennium development goal to combat HIV and AIDS.

Despite this act's best intentions, CAMR was unsuccessful in its objective to facilitate timely access to generic versions of patented drugs for people in the least developed or developing countries to fight HIV-AIDS, malaria, tuberculosis and other diseases. This act's complexities are blamed for the daunting inability and serious obstacles to the supply of generic drugs to fight HIV-AIDS in the developing world. As a result, drugs have only been delivered to one country on one single occasion, Rwanda.

Parliamentarians have made a number of attempts to fix the obstacles preventing the shipment of generic drugs to those who need it. Now we have another opportunity to meaningfully help those in need. The opportunity is right now. We have the chance to pass Bill C-393, which will help to clear these obstacles and reduce the complexity of the current CAMR regime, so we can begin to deliver on our pledge to improve the health of the world's poorest people. It is absolutely imperative that we do so, to stop people from dying when they could be living and to alleviate suffering when they could be blessed with an extension of their lives for their own well-being and the well-being of their entire family.

The statistics are alarming. There are more than 33 million people living with HIV-AIDS globally, 22.5 million of whom live in sub-Saharan Africa. Three-quarters of all AIDS related deaths since 2008 occurred in Africa. There are 2.3 million children infected with HIV. One in two children with HIV in the developing world dies before their second birthday. Less than 15% of the children who need treatment are getting it. More than half a million children die of AIDS every year. Every day 7,100 people become infected with AIDS.

Yet statistics themselves can be desensitizing, thrown around at random to make a point. I have a hard time conceptualizing what 2.3 million children infected with HIV really means, so I thought I would put this into perspective.

I recall a documentary called Paper Clips, where children in a middle school in Tennessee, attempting to grasp the enormity of just how big the number six million really was, gathered six million paper clips, one for each life. If we did the same and placed the clips in boxes of 100, just like the ones we have in our offices, the number of children with HIV in developing countries would equal the number of paper clips contained in 23,000 of these boxes.

Let me give the House another comparison. Thirty-three million people in the world are living with HIV-AIDS globally. That is the entire population of Canada. Imagine attempting to treat this many people in a meaningful way, with our hands tied because of ineffective and cumbersome legislation that we can now change.

Developing countries in Africa are already suffering from the government's withdrawal of foreign aid dollars, which in part resulted in our loss of a seat at the United Nations Security Council. We must not allow this ambivalence to prevail.

If we do not vote for this bill, we will wake tomorrow and we as a country will be no better able to help the 7,100 newly-infected people with HIV tomorrow. Nor will we be in a position to prevent another 7,100 people from becoming infected two days from now. Today we have to make a choice and there is only one right decision. I am voting for Bill C-393. I am voting for helping people in need and for doing what is right. I implore everyone in the House to do the same.

I am acutely aware of the way HIV-AIDS destroys the lives of people, having personally witnessed this epidemic while doing international aid work in San Pedro Sula, Honduras, the city with the highest incidents of AIDS in Central America at the time I was there. As part of my continuing international aid work in central and South America, I have helped build schools in the hope that knowledge and health education can keep children safe and help prevent the infection of HIV.

A 2008 UN report estimated that seven million cases of AIDS could be prevented in the next decade if every child received a primary education.

I am also aware of the impact that AIDS can have through my work with Anne-Marie Zajdlik and the Masai Centre for the treatment of AIDS in Guelph while on the Bracelets of Hope Campaign, where we raised over $1 million selling red and white beaded bracelets made by the women of Lesotho in southern Africa to fund AIDS treatment centres in that country.

In discussing this bill, Dr. Zajdlik said:

In the last 5 years I have treated hundreds of HIV positive children...Despite our best attempts, many, many of these children died.

In our world of unprecedented wealth, information and technology, no child should die of a preventable disease. The life saving miracle of medicine and medical technology is part of the intellectual property of the world and should be made available to all.

Prevention has to be taken seriously. This can be achieved in several ways. Building schools, improving educational programming, increasing HIV testing and treatment sites are but some. We must also facilitate the provision of antiretroviral drugs, or ARVs, that actually prevent the transmission of AIDS from a pregnant woman to her newborn. Providing these drugs will prevent infant deaths and will save hundreds of thousands of children from suffering from HIV-AIDS.

In 2009, 370,000 children were infected with HIV during the perinatal and breast-feeding period of growth. That is 370,000 children who could have been saved through the use of ARVs and other HIV-AIDS drugs that would have prevented the transmission of this virus. That is another 370,000 children who would not have grown into adulthood with the risk of passing HIV onto others.

While resources need to be devoted to preventing HIV-AIDS, we must also acknowledge that we need to do our part to help treat HIV-AIDS in the developing world until it is eradicated. That means developing the best legislation and regulatory system possible to ensure that generic and affordable medication is available for those who need it.

According to a 2010 UN report, access to antiretroviral drugs has resulted in a gain of 14.2 million life years worldwide. In Botswana, AIDS-related deaths fell from 18,000 deaths in 2002 to 9,100 deaths in 2009 as a result of antiretroviral drug use. Accordingly the rate of children orphaned by AIDS fell by 40%. This is not only a matter of life and death; it is also an enormous moral and social issue.

The House should be grateful for the efforts of the Guelph GoGo Grandmothers who have nobly and passionately worked towards the passage of this legislation. I can feel the impact that its members have had on the House. I sincerely hope its efforts have not been in vain.

If we pass this bill and embrace this noble strategy, we can prolong lives and prevent the transmission of this insidious disease. Imagine a world without AIDS, where people could live and thrive knowing that they would live to be able to provide for their loved ones and raise their children with the knowledge that they could have a child without transmitting HIV to them, a world where their energy could be spent productively contributing to their families, communities and economies.

Wishing this to be true will not make this happen. We must be intentional in our efforts to pass legislation so it will happen. I implore the members to vote with me in favour of Bill C-393 and make it happen.

The House resumed from January 31 consideration of Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, as reported (with amendment) from the committee, and of the motions in Group No. 1.

Motions in Amendment

[Kelly Block, Conservative, Saskatoon—Rosetown—Biggar, SK]

Mr. Speaker, I echo the comments of my colleagues here this morning in welcoming everybody back. It is good to be here and to be participating in such an important debate.

I too have had many opportunities in the past number of months to meet with representatives from Grandmothers to Grandmothers in my riding and to appreciate the commitment and compassion that they come to me with in sharing their concerns for providing this kind of aid to folks in Africa. I am thankful for the opportunity to provide my views on Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act as well as on the motions to amend Bill C-393 that are being discussed today at report stage.

Given that Bill C-393 has been under discussion in Parliament since 2009, I will begin my comments with a short review of the bill's history as well as the goals of the Access to Medicines Regime, which the bill seeks to substantially revise.

Canada's Access to Medicines Regime was developed in 2005 with three key principles in mind. The first was to provide a mechanism for developing and least developed countries to access the drugs and medical devices they need to treat HIV/AIDS, malaria, tuberculosis and other public health epidemics. The second was to ensure that Canada's intellectual property regime for patents continues to respect international obligations. The third principle was to maintain the integrity of Canada's business environment and ensure that Canadians continue to have access to the latest pharmaceutical products and innovations.

In my view, years might have passed since the regime's development, but all three of these objectives are still relevant today and must be kept in mind when considering next steps on Bill C-393. I would urge my fellow members of Parliament to also keep in mind that Canada's Access to Medicines Regime is the only one of its kind worldwide to have successfully authorized an export of drugs to a country in need. Thanks to the regime, in 2008 and 2009 over 15 million tablets of an HIV/AIDS drug were successfully delivered to Rwanda. This demonstrates that Canada's Access to Medicines Regime works as it was intended to support public health objectives.

As we may recall, Bill C-393 recently underwent an extensive review by members of the Standing Committee on Industry, Science and Technology. During this review, the committee heard from a wide array of witnesses, including technical experts in the government, representatives of several non-governmental organizations focused on HIV/AIDS initiatives, members of the pharmaceutical industry and concerned citizens. This extensive testimony thoroughly informed the committee about the health challenges facing people living in the developing world, which go beyond the issue of drug patent protection.

It is my understanding that after this extensive testimony was carefully reviewed by members of the House of Commons standing committee, the committee decided to eliminate many of the proposed changes in Bill C-393. In particular, it voted to remove clauses from the bill that would have expanded the definition of an eligible product for export under Canada's Access to Medicines Regime to any drug, and that would have allowed the regime to export any amount of any drug to almost any country for an unlimited period of time. This is sometimes referred to as “the one-licence solution”.

The trouble with this is that if the one-licence approach is applied to Canada's Access to Medicines Regime, it would allow drugs to be sent to high-income countries like Singapore, obviously counter to the original principles of the regime.

[Brian Masse, NDP, Windsor West, ON]

Mr. Speaker, I want to thank the member for Halifax for her great work on the bill. I also want to thank the members who spoke in favour of the bill. The bill is very important. Since 2003 I have been trying to get the law amended or fixed properly. It was Bill C-56 originally.

I want to impress on members that we can make a difference. We can choose to make it happen. We have proposed under Bill C-393 WTO and TRIPS agreement compliance. By that I mean that it abides by all international laws. There can be no other excuse used during this debate. If members do not believe me, they can believe the Library of Parliament's independent research which shows that what we are proposing here today is legal internationally. If we want to make a difference, we can do it now.

Back in 2004 I spoke in this chamber about the law that we passed and my fear that it was built to fail. It has failed. There has been one application. Apotex got one drug into Africa, despite the obstacles of the bill.

We told the world something. We told the world that we would help, that Canada would stand front and centre, show respect and help people. We said that we would make sure that women, men and children would get drugs that we have on our shelves and in our plants, that they could not get because of the cost. We told that to the world. We promised the world that we would lead the way. However, the way that we did it is despicable. We made a law that does not work, which others replicated, which gave an excuse. Right now people are suffering. People are dying. That does not have to happen. Not only have we chosen to turn our backs on them, but we have given them a phony law and literally slapped them in the face. Canada, the country to which I belong, has done that.

That is a shame. I have seen that over the years as a member of Parliament. I have tried to fix it four times. I feel strongly about it. I thought about that on the way to Ottawa. I used to belong to the AIDS Committee of Windsor. Before that, I had friends in Toronto who were gay, who had AIDS, who suffered. I have seen friends die, and they had medication. It is horrible to witness the disintegration of a human being, and that is in the best of circumstances.

We have an opportunity to make a difference. We continue to hear that it is a great idea and the laurels of the bill are applauded but that it cannot work. It does work, and we need to try. We need to move the bill to the next stage. It has to go to the Senate. Let those excuses resurface there and let us find solutions. As New Democrats, that is what we have done along the way.

I have a brief time to speak today, and I have two amendments that I will propose.

We have agreed to compromise continually in this process, not only with the Conservatives, but with the Liberals and now with the Bloc. There has been an attempt, one way or another, to either gut the bill or pretend that we are doing something and then say that we are doing all these other things. That is not the point. The point is this is one tool that could end the suffering of millions of people. This is one tool in the kit that Canada could use to help people.

Even if members' worst fears occur, we could bring the bill back to this chamber and fix it again. We could bring it back right away. We do not want intellectual property stolen. It will not happen with this bill, but that is one of the excuses that has been given. We have actually included the components of criticism that members have put. Even though we did not think they were warranted, we have agreed to them. Even under the worst scenario, we could bring the bill back to the chamber and fix it right away. New Democrats are prepared to participate every single day to do that. We are here today to do that.

I want to thank some people. I want to thank Richard Elliot and the grandmothers across this country, people who care for people and understand the connection, the values and principles with which this country could lead the world.

We have told them that we have a phony law that does not give them the drugs they deserve, that they could get to actually have good health and take care of other types of problems, as opposed to a solution.

There is no other excuse. The bill is WTO and TRIPS compliant. I have heard that. Witness after witness came to the committee. The same excuses were brought forward against this bill. They were not verified. At the very least, we could try with this bill. The people who are opposed to this are worried that affordable medicines will get to people rather quickly, and even more important, will get to the types of diseases that we need to get to. If that becomes a problem because it is happening too often and too fast, then we could revisit that. The excuses we have heard make no sense whatsoever.

The drug industry has blatantly said that if we do this it is going to cost us research and development and the industry will not invest in Canada. Despite the generous corporate tax cuts, despite all the grants and subsidies the industry is getting for research development and all the other incentives that have been thrown in the mix, the industry would throw the country under the bus just because a bill could pass that would, ironically, give the industry money. The pharmaceutical companies would get money for the drugs. They would get a percentage.

Again, I want to thank every member for participating in this debate. I hope that everybody thinks about this as the bill, hopefully, goes forward.

I would like to amend Motions No. 1 and 2. Mr. Speaker, I move:

That the motion proposing to restore Clause 2 of Bill C-393 be amended by replacing the definition of “pharmaceutical product” with the following:

“pharmaceutical product” means any patented product listed in Schedule 1 in, if applicable, the dosage form, the strength and the route of administration specified in that Schedule in relation to the product and any other patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics, and includes active ingredients necessary for its manufacture and diagnostic kits needed for its use.

The second amendment is long, and it is also WTO and TRIPS compliant. Mr. Speaker, I move:

That the Motion proposing to restore Clause 4 of Bill C-393 be amended by replacing the text after “4.(1) Subsection 21.04(1) of the Act is replaced by the following:” with the following:

21.04 (1) Subject to subsection (3), the Commissioner shall, on the application of any person and on the payment of the prescribed fee, authorize the person to make, construct and use a patented invention solely for purposes directly related to the manufacture of the pharmaceutical product named in the application and to sell it for export to any country listed in Schedule 2.

(2) Paragraph 21.04(2)(c) of the Act is repealed.

(3) Paragraph 21.04(2)(e) and (f) of the Act are repealed.

(4) Subparagraph 21.04(3)(c)(i) and (ii) of the Act are replaced by the following:

(i) sought from the patentee or, if there is more than one, from each of the patentees, by certified or registered mail, a licence to manufacture and sell the pharmaceutical product for export to one or more of the countries listed in Schedule 2 on reasonable terms and conditions and that such efforts have not been successful; and

(ii) provided the patentee, or each of the patentees, as the case may be, by certified or registered mail, in the written request for a licence, with the information that is in all material respects identical to the information referred to in subsection (2).

(5) Paragraph 21.04(3)(d) of the Act is repealed.

(6) Section 21.04 is amended by the following after subsection (3):

(4) The solemn or statutory declaration referred to in paragraph 3(c) is not required in the case of an application to the Commissioner for an authorization to supply the product named in the application to an eligible importing country for purposes of addressing a national emergency or other circumstances of extreme urgency in that country or for purposes of public non-commercial use, but in such cases, the Commissioner shall notify the patentee or patentees of the issuance of the compulsory licence as soon as reasonably practicable after it has been issued.

That is all about compromise by the New Democrats for those who are opposed to the bill.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Mr. Speaker, I am pleased to be back in the House today and would like to welcome all members back to this first day of the 2011 session.

I am also very pleased to debate this topic again. I spoke to it last in November 2009. Since then there has been considerable work done on Bill C-393, a bill that proposes to amend Canada's access to medicines regime. However, I would like to touch again on the reason this matters.

I was born in South Africa and spent much of my childhood there. I went back in 2002, and visited Soweto and people there knowing full well that 50 per cent of the people in Soweto at that time were infected with the HIV-AIDS virus. That meant that of every child born to an infected mother, one out of two was infected with the AIDS virus, and of every baby born who was infected with the virus, one out of two, or half, would not live past their second birthday. This is also a humanitarian tragedy in Africa.

I visited with a cousin who was a manager in an important industry in South Africa. I asked how the economy was doing, and he said that one of the key challenges was that with the prevalence of AIDS in South Africa, people were being trained to be managers, technicians, professionals, and workers but then leaving and dying early because of the AIDS scourge. Therefore, it is also an economic tragedy in South Africa.

In Africa approximately five million people have access to AIDS treatments comparable to what we have in Canada, but 10 million people in Africa do not. That is why the bill for CAMR was put forward in 2004 by a Liberal government to provide access to such medicines and to enable Canadian companies to export low-cost, generic drug cocktails to help lessen those tragedies.

Although the hope was that there would be a flow of royalties to Canadian companies and a flow of life-giving medication to Africans who required it, that bill just did not work. The legislation was flawed with bureaucratic and institutional barriers that made it unworkable. Essentially, only one contract was signed and implemented under that law. Therefore, Bill C-393 was put forward as a solution to address those problems and make it easier accomplish the objectives of CAMR.

There are members in the House who believe that Bill C-393 is imperfect and does not do enough to address systemic problems in providing access to affordable AIDS medication in Africa. I understand that reasonable people can sometimes disagree on the means to a common end: supporting Canadian businesses and those people in Africa who need medication for AIDS.

To those MPs, I would say that the motion for the one-licence solution that is at the core of the bill must reinstate the latter for Bill C-393 to become meaningful, and that it will help. There have been many credible witnesses before the committee who said that Bill C-393 , while perhaps not being the full solution to AIDS in Africa, would improve access to affordable AIDS medication for people who are dying without it, as well as protecting the interests of the patent owners of those medications. Let us help the Africans and support Bill C-393 and its one-licence solution.

I would like to make a few comments beyond the direct implications of the bill.

Imagine if the 10 million people in Africa currently carrying the HIV-AIDS virus and suffering and dying from AIDS were receiving the drug cocktails that turn this dreadful killer of a disease into a chronic yet manageable one, as we are doing in Canada. Imagine the well-being that would result in Africa and the economic and human implications of doing so.

Another piece that is starting to become clearer is drug cocktails. These medications prevent the transmission of AIDS. This is a very important point and an important underpinning for passing Bill C-393 with the one licence solution intact.

Drug cocktails lower the viral load of an AIDS patient to undetectable levels, which means they do not allow the disease to be transmitted. These cocktails are proving to be an almost 100% prevention mechanism. Treatment equals prevention. With access to these medicines people will no longer suffer the way they do without treatment and transmission of the disease will be prevented. If people who have contracted HIV-AIDS are fully treated, millions of others will be prevented from contracting AIDS each year. It is even more urgent that Canada support making affordable drugs available in Africa.

Unfortunately, the Conservative government is ignoring this prevention aspect of HIV-AIDS treatment. It has provided absolutely no support for pilot projects in Canada. There is a provincially funded pilot project in my province of British Columbia which seeks out AIDS sufferers who are not aware they have contracted the virus, or are incapable of managing their own treatment, so that they can be treated and the transmission of AIDS in Canada can be reduced. Six thousand people a year contract AIDS in Canada unnecessarily. With proper treatment, AIDS would no longer be transferable.

I would urge Conservative MPs to recognize the importance of AIDS medications as being not only treatment but prevention too. I would urge my colleagues to support prevention funding and projects here in Canada and abroad, which is what we are talking about with Bill C-393.

One member referred to Dr. James Orbinski, head of Doctors Without Borders. He has led this organization through some of the worst and most wrenching conflicts in Africa: Somalia, Rwanda and Darfur. Dr. Orbinski received a Nobel Prize on behalf of Doctors Without Borders. He has a great deal of credibility both as a medical professional and as someone who has worked in Africa on this issue. Dr. Orbinski commented that the possible failure of Bill C-393 with its one licence solution reinstated would be as unconscionable as leaving a room full of AIDS patients to die simply because they are poor and African.

Members on all sides of the House have big hearts. We want to see improvements in AIDS treatment in Africa and affordable medicines as part of that. I would urge all members to think about the foundational reasons of the importance that this bill go forward and soon. Lives are at risk every day that we wait.

We cannot let our brothers and sisters in Africa down. We must fix CAMR so these treatments can be provided affordably and soon. Humanity depends on it. I urge all members of Parliament to support Bill C-393 with its one licence solution.

[Mike Wallace, Conservative, Burlington, ON]

Mr. Speaker, Canada will provide support to improve maternal and child health care to several developing countries as part of its five-year commitment to the Muskoka initiative. As part of this initiative, Canada will provide support to improve the nutrition and health of three million pregnant and nursing women and their children in Ethiopia.

In addition, the government will strengthen the national health system in Mozambique to develop health services for mothers and children, providing life-saving HIV treatment to 38,000 children, treating 94,000 pregnant women and preventing HIV infections, and immunizing 2.8 million children over the age of five against measles.

Canada's support will also help to strengthen maternal and neonatal health services in Bangladesh through the purchase of essential drugs and equipment; the recruiting and training of health care professionals, including 2,000 new skilled community birth attendants; the upgrading of existing treatment centres; and by helping to purchase enough oral polio vaccine for 250,000 children annually.

I will now turn to discussing my concerns with Bill C-393, followed by the motions before us today at report stage.

I would like to remind the House that this is not the first time I have stood up to speak to this bill. I spoke to it before it went to committee. I actually supported it going to committee so we could hear the discussions. I want to thank my colleague from the Bloc, who attended those meetings and provided valuable input.

In October 2010, as we all recall, Bill C-393 underwent an extensive review by the House of Commons Standing Committee on Industry, Science and Technology, a committee of which I am a member. I would like to congratulate the members of the committee for their commitment to hearing testimony from a wide array of witnesses. Among those who shared their views on the access to medicines initiative for the developing world were experts in the field of international trade and patent law, representatives of non-governmental organizations with experience working in Africa, and government officials with knowledge of the historical background and technical implications of Canada's access to medicines regime.

Through this extensive testimony, the committee was well informed of the international drug procurement framework and trade obligations within which Canada's access to medicines regime must operate.

The committee also heard that Canada's access to medicines regime is only one element of the government's plan to improve health outcomes in developing countries, and that Canada is active in supporting programs like the Muskoka initiative on maternal and child health, which will have a significant effect on improving health conditions in poor countries.

The committee also heard evidence that there is a large economic context to providing affordable health care, including drugs, to low income countries, and that poverty, not patents, is the major obstacle to health access in developing countries.

Finally, the committee heard that Canada's access to medicines regime is working in its current form. The two shipments of 15,600,000 tablets of HIV-AIDS drugs to Rwanda in 2008 and 2009, after the country made a request for the drugs, is proof that it does work. It may not work to the efficiency and effectiveness of many we have heard from, but in its present form it does work. If it is compared with the access to medicines regimes in other countries, Canada is the only country around the world that has actually been able to use the system to deliver drugs to a third world country, a country in need.

In my view, along with what my colleague from the Bloc has said, that tells me that the regimes as set up now are not working to people's satisfaction. However, that does not mean that the regime we have is not set up in a proper, legal, and effective form. Maybe we should be looking at a broader review of what we can do to make sure we provide HIV drugs to those countries in need.

At the conclusion of the committee's review, members voted to substantially amend Bill C-393. One of the changes the committee considered necessary was the removal of the clauses that would allow Canada's access to medicines regime to be used by generic companies to export any amount of any drug to almost any country, including some that are relatively well off. This is sometimes known as the one-licence solution.

It is my understanding that the committee considered the elimination of the one-licence solution and the other changes to Bill C-393 necessary to ensure that the bill respects Canada's international trade obligations and maintains the integrity of Canada's framework for encouraging innovation and to ensure access to medicines for Canadians.

My key concern with the motions before us today is that they seek to undo all of the good work of the committee and they undermine the conclusions our fellow members of Parliament reached after careful review of Bill C-393.

In addition, I have particular concerns with Motion No. 3. The motion is original, in that it proposes to implement changes to Canada's access to medicines regime on a trial basis; first, for an initial period of four years, and then for a further five years, if both Houses agree.

As I have said, during the committee's review of Bill C-393, several witnesses noted that Canada's access to medicines regime works to send drugs to developing countries in need. It is the only regime, as I have said, of its kind in the world to have had this kind of success. As a result, it is our view that Canada's access to medicines regime does not need the changes that Bill C-393 proposes on a temporary basis.

I am also concerned that allowing provisions of Bill C-393 to have a temporary effect would be harmful because it would do nothing to improve primary health in developing countries. In our government's opinion, the best way to improve primary health care is through programs such as the Muskoka initiative that actively work to improve poor health conditions in African countries.

For all of these reasons, I am of the view that none of the motions to amend Bill C-393 should be accepted today by members of Parliament and that at third reading this bill should be defeated. Canada's access to medicines regime works and does not requiring changing.

In reviewing Canada's initiatives on access to medicines, the needs of developing countries must be balanced with the needs of Canadians. In sending over 15 million tablets of HIV-AIDS drugs to Rwanda, the current access to medicines regime has demonstrated that it achieves this balance; and the regime would not be improved by Bill C-393 or the motions put forward today. Therefore, I ask my colleagues not to support the report stage motions to amend Bill C-393.

Finally, Mr. Speaker, I want to thank Elizabeth Rennie and her team of grandmothers. Grandmothers to Grandmothers has come to see me many times. I have been very clear to this organization that I think the bill needs changes and that it would not have any effect on our being able to provide the drugs the organization would seek for African countries. This was passed by all parties. I think all parties should look at what we can do to continue to provide support for those countries, but I do not think it is through changes to this regime.

[Mike Wallace, Conservative, Burlington, ON]

Mr. Speaker, I want to welcome back everybody to the House after the Christmas break. I am very happy to back.

I am pleased to have the opportunity to discuss Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, and to address the motions that some of my colleagues have put forward to amend the bill at report stage. However, before I discuss Bill C-393 and the motions, I will take a few minutes to highlight Canada's commitment to improving the health conditions of people living in the developing world. This will provide important context given that the laudable goal behind Bill C-393 is to improve the access to medicines in developing countries.

I am sure I can speak for all hon. members in expressing support for this excellent humanitarian goal. However, in my opinion, the most effective way to improve the poor health conditions of people living in the developing world is not by changing Canada's Access to Medicines Regime, as Bill C-393 and other motions today propose to do, but by helping to ensure that primary health care for the world's most vulnerable citizens, the mothers and their children, are being met.

As a result, I stand proudly behind the recent announcement by Prime Minister Harper—

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Mr. Speaker, it is my turn, after the member for Halifax, to speak to Bill C-393, which would amend Canada's access to medicines regime. Before I speak directly about Motions Nos. 1 and 2 moved by the member for Halifax and Motion No. 3, which I moved, I would like to talk about the study we did in parliamentary committee.

When the parliamentary committee was studying this bill, I informed the committee chair that it would be important to take a closer look at Canada's access to medicines regime because it had been used only one time. We wondered why this regime, which was meant to provide ongoing access to medicines, particularly antiretrovirals, for African countries and all disadvantaged countries, was used only once and what kinds of changes would have to be made to it. More generally, how could we change how the different partners involved in this regime acted so that it was used more? Some witnesses told us that the regime worked, yet many people had used it only once. My colleague spoke about groups that had written to her and that came to tell us in committee that they would like to see the regime used more.

I told the committee chair that we needed to hear as many witnesses as possible and that the study needed to be broadened to include the entire regime, not just the bill that had been introduced by the former member for Winnipeg North. The study began and we heard from many witnesses. Unfortunately, I did not get the feeling that my colleagues around the table wanted to go beyond the bill and study Canada's access to medicines regime in its entirety.

When it comes down to it, all members of the House should hope that a regime put in place by Parliament in 2004 is used and that countries in need of low-cost medications have greater access to them, especially when witnesses told the committee that, in the case of antiretroviral drugs, many of these disadvantaged countries need access to second- or even third-generation drugs, which are not currently available in generic form.

This is why it was important to go beyond the bill and study the regime. However, because other members clearly refused to do so, we had to stick to Bill C-393 and study its merits, hence the analysis of the various motions before us.

As the member for Halifax mentioned, the Bloc members who sit on the committee voted in favour of all of Bill C-393's clauses, including those that referred to the one-licence solution.

Basically, when examining a bill like Bill C-393, we need to look at what it is all about and what is at the core of the bill. When we looked at Bill C-393, it was clear that its key element was the one-licence solution, which is why the hon. member for Halifax had to reintroduce that element. Motions Nos. 1 and 2 reintroduce clauses that the Bloc Québécois has already voted to support.

Now I would like to move Motion No. 3, which I had placed on the order paper on December 15, 2010, and which is in fact a sunset clause. I will not take the time to reread the motion, since the Speaker already read it when introducing the motions under consideration.

Why do we feel that a sunset clause is necessary? Quite simply, to sum everything up and to connect, in a way, all of the testimony we heard in committee. Many witnesses said they wanted to improve access to medications, that is, facilitate the sale and production of drugs in order to make them more accessible, which is what Bill C-393 is all about. Keeping this bill intact would serve to address the concerns expressed by this group of witnesses, since the sunset clause would not affect the other clauses of the bill.

Witnesses also pointed out that by changing Canada's access to medicines regime, Bill C-393 might be in violation of WTO rules. No one in the House would want to introduce or enact legislation that would violate WTO rules. In fact, Canada is calling on its trade partners around the world to comply with these very rules; we therefore would not want the legislation we are passing to violate those rules.

What is more, some fear that the changes made to the regime will simply make it a vehicle for exporting drugs on a large scale, which is inconsistent with the very spirit of this humanitarian regime. They fear that the fundamental purpose of the regime—to provide help—will be lost, and they want the regime's core purpose, namely to aid countries in need of inexpensive drugs, to be preserved.

Officials told us that nothing would change and that even amending the regime through Bill C-393 would change nothing. There need to be concrete examples and facts proving that Bill C-393 can indeed work and that the regime it is amending is an effective regime that is not breaking any rules.

The purpose of the sunset clause is simply to reassure everyone and to ensure that when the four years are up, we have solid examples and can resume the debate calmly with much more on the table than just the example of Rwanda with the current regime. Then in the House and in committee, we can base our discussions on reality, on concrete evidence and on the advances that will have been made through the changes Bill C-393 is making to Canada's access to medicines regime.

[Megan Leslie, NDP, Halifax, NS]

Mr. Speaker, every day, over 16,000 lives are lost in the world to HIV, tuberculosis, malaria and other treatable infectious diseases, according to the Global Fund.

In 2009, 33.3 million people around the world were living with HIV-AIDS, 1.8 million of them died from the infection and 260,000 of those people were children. Ninety-seven percent of people infected with HIV-AIDS live in low to middle wealth countries, and while almost 15 million infected in these countries were in need of antiviral drugs, only 5.2 million were treated.

I am pleased to speak to Bill C-393, which would fix key flaws in Canada's Access to Medicine Regime, CAMR. I have eagerly been awaiting this opportunity because Bill C-393 is a bill that I talk about a lot with my constituents in Halifax. I get letters and phone calls about CAMR. I have been to events around Nova Scotia, like the grandmothers' event, Good Words for Africa-A Scrabble Afternoon, which is a scrabble fundraiser to raise money for HIV-AIDS and to raise awareness of Bill C-393.

I get postcards from the grandmothers to grandmothers campaign. I have received letters from the HIV-AIDS Legal Network. I am a member of the all party HIV-AIDS and TB caucus, or the HAT caucus, where I have listened to Stephen Lewis and James Orbinski talk about Bill C-393. I have received Facebook messages and tweets. I have been stopped on the streets. I have talked to students, doctors, community activists, retired politicians, health policy experts and grandmother after grandmother about this legislation. They have all said the same thing, which is to support Bill C-393 in its original form.

One letter I received was from the international NGO, OXFAM. I would like to read this letter to my colleagues in the House because it effectively communicates everything we need to know about this bill. It reads:

Dear Member of Parliament,

You have an amazing opportunity right 2at would save lives around the world, without costing Canadian taxpayers a dime.

In many places in the world, countless people are dying every day of AIDS, Tuberculosis, Malaria and a host of other diseases.

But these deaths are preventable. What these countries need is access to generic medications.

The good news is: The political will exists to ensure this access. In 2004, Parliament unanimously passed legislation creating Canada’s Access to Medicines Regime (CAMR).

The bad news is: CAMR is broken.

As the legislation functions now, generic drug manufacturers are required to negotiate with patent holders on a country-by-country and drug-by-drug basis, before they are able to distribute affordable life saving medicines. Due to this complexity and difficulty of use, CAMR has been deemed unworkable in its present form.

In more than six years, CAMR has resulted in only one order of one AIDS drug to one country.

But wait! There is more good news: Bill C-393--in its original form--would solve this problem. It contains a one-licence-solution, which would eliminate the need for separate negotiations with patent-holders for each purchasing country and each order of medicines. It would provide a more workable process to get affordable medicines for people in developing countries. And it would do all of this while meeting every one of Canada’s international legal obligations, including WTO rules.

Please commit to voting to restore the “one-licence” solution to Bill C-393.

You will be directly responsible for saving lives.

Thank you.

As I said, this is a letter that many of my colleagues in the House would have received from OXFAM. It does not get any simpler than that. As members of Parliament, as representatives of our communities, we could be directly responsible for saving lives. Or, we could all be implicated in Canada's refusal to help and watch by the sidelines as more and more people die. It is up to each and every one of us in this House to make a decision about what side of this issue we are on.

CAMR is not working now but reforms can make it work. As we have heard, CAMR has only delivered one medicine to one country since Parliament created it more than six years ago. There is no expectation that CAMR will be used again, unless it gets fixed.

Médecins sans frontières, Doctors Without Borders, testified before committee that it tried for months to make use of CAMR to get medicines for patients but, ultimately, it abandoned this effort because of unnecessary hurdles in the law. Only one generic drug manufacturer has been willing to use CAMR and said that it would not try this process again. However, it has publicly committed to using the system again if it were simplified to make a version of an AIDS drug that is needed to treat children with HIV, a drug that is not currently available from any other source.

Streamlining CAMR does not jeopardize pharmaceutical research and development, including here in Canada. CAMR only authorizes exports of generic versions of patented medicines to certain eligible countries and these countries were already agreed upon by Canada and all WTO members in 2003 and are already reflected in the current CAMR as it was created by Parliament in 2004.

These countries represent a very small portion of the total global pharmaceutical sales and profits of brand name pharmaceutical companies. Further, the brand name drug companies are entitled to receive royalties on sales of generic medicines supplied to these countries under CAMR.

Bill C-393's proposed reforms offer value for money for Canadians. These changes cost taxpayers nothing. In fact, Bill C-393's one-licence solution would make Canadian foreign aid more effective because limited resources could be used to purchase more medicines and would also free up scarce resources to invest in making health systems stronger. Scaling up access to treatment also means greater opportunities for producing and distributing good quality, Canadian-made generic medicines, meaning more business and more jobs in addressing a pressing global health need.

We are here today debating amendments that I have introduced at report stage. We have had to introduce these amendments because Conservative and Liberal members of the industry committee worked together to strip some of the most critical aspects from the CAMR legislation, like the one-licence solution.

We have heard criticism about this bill and we are willing to compromise. We are willing to work with parties to reach across the House and work together to ensure this important legislation passes. We have brought forward only two amendments in an effort to make Parliament work and get this legislation passed.

However, at the core of Bill C-393 is and should continue to be the one-licence solution. This approach would eliminate CAMR's current requirement for separate negotiations with patent-holding pharmaceutical companies for individual licences for each country and each order of medicines.

It would also remove the requirement to determine and disclose in advance of even being able to apply for a licence to export a single recipient country and a fixed maximum quantity of medicines. These unnecessary requirements have been proven to be the major stumbling blocks to the use of CAMR. The one-licence solution was removed by committee by a slim majority when it deleted clause 4 of Bill C-393 in spite of the fact that it had clear support at second reading.

Canadians want Parliament to take action on the Canadian access to medicines regime. According to a national poll, 80% of Canadians support reforming Canada's Access to Medicines Regime to make it more workable so that we can help developing countries get access to affordable and life-saving medicines. Dozens of prominent Canadians have come on board to say that this is the way we should be moving, including the former prime minister whose government enacted CAMR.

In honour of World AIDS Day, a group of prominent Canadians wrote a letter to members of Parliament asking them to support Bill C-393. Some of the signatories to this letter included: the right hon. Paul Martin, the former prime minister of Canada; Janice Alton, national co-chair, Canadian Voice of Women for Peace; Richard Bedell, medical advisor for Dignitas; Nigel Fisher, president and CEO of UNICEF; Robert Fox, executive director of Oxfam; Michael Geist, Canada Research chair of Internet and E-commerce Law at the University of Ottawa; Karen Kain, artistic director at the National Ballet of Canada; Alexa McDonough, former member of Parliament; Steve Morgan, researcher at the University of British Columbia; and David Suzuki, Companion of the Order of Canada. As members can see, there are pages and pages of signatories.

Canadians want this legislation to pass and they want all parliamentarians to work together to ensure it passes. I hope every member will stand and vote for these amendments and support Bill C-393.

Speaker's Ruling

[The Speaker, Liberal, Peter Milliken]

There are three motions in amendment standing on the notice paper for the report stage of Bill C-393. Motions Nos. 1 to 3 will be grouped for debate and voted upon according to the voting pattern available at the table.

I will now put Motions Nos. 1 to 3 to the House.

The House proceeded to the consideration of Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, as reported (with amendment) from the committee.

[Dave Van Kesteren, Conservative, Chatham-Kent—Essex, ON]

Thank you, Mr. Chair, and thank you, witnesses, for coming.

I want to go on from where Ms. Sgro left off. In this whole debate there's a disturbing element of “them against us”. Earlier this week we heard from some of the witnesses from Nortel that this bill could become retroactive and that there was a court ruling in B.C. We on this side and, I think, most people would disagree with that. It shows how the whole drift of the bill is heading in the wrong direction.

We just talked about Bill C-393, and I'll get to that in just a second. I remember being challenged by the grandmothers when I walked out the door, and they told me to do the right thing. I said at one point in this committee as well that we passed legislation in 2006, the Federal Accountability Act, that stopped every one of us in this room and everybody in the House from taking any funds from anybody except from private individuals, and then only to the amount of $1,000. That was a significant bill, because we're no longer tied to any one person or any one group. We can say as parliamentarians, “I want to do the right thing. I don't have a bank or something that bankrolls my campaign”.

There was a time not too long ago.... It was before my time, but if you go back in the records, you can see members who had almost their entire bankroll funded by one group or one individual. Those days are gone.

As a government we try to keep the ship afloat, and I've got to dump on my friend John again.

I like our member across the way. I think he's a great guy, but the NDP consistently comes up with bills that are mischievous. This is another example, and I could give you more. It all sounds good. Affordable housing is an example: we're going to save the housing crisis in this country. We're struggling with that. I say we need to keep the ship afloat. Affordable housing.... There was Bill C-393, the grandmothers' bill. Who would disagree with grandmothers trying to save people in Africa from dying of AIDS? Who would disagree with that? But the fundamental principle, again, is wrong.

Bill C-501 is one of these bills.

Today we have an NDP motion in the House to stop oil tankers from floating down the west coast. There's been one accident. Correct me if I'm wrong, though not at this point, because it's my time. One ferry has sunk, and it's leaking oil, and that's tragic. Again, I could go on.

The NDP constantly wants to shut down the oil sands. They like to call them the “tar sands”. In the end, when everything is said and done, we have to realize that the hallmark of a free and open society is a free and open marketplace.

I think Ms. Sgro was absolutely right. We have to make sure that when we move legislation forward, it's not them against us. We, as a group of parliamentarians and as the government, want to make sure we have a healthy and transparent society that allows the free flow of goods. This bill seriously undermines that. It more than undermines it; it threatens it.

I often say I've seen societies that have attempted this, and it's not pretty. I've been to Cuba. They have everything in common, but it's common misery. I know everybody here doesn't want to see that; I certainly don't.

I had to give my rant because I, like everyone else, feel terrible about what's happened to Nortel. I feel bad when these things happen, but we don't want to do something as a knee-jerk reaction that's going to cause even more grief.

My time is almost up, but I think I've got 30 seconds. If anybody wants to comment, go ahead.

Access to Medicines

[Chris Charlton, NDP, Hamilton Mountain, ON]

Mr. Speaker, today is World AIDS Day, and in communities such as Hamilton, grandmothers are gathering in support of Bill C-393. The purpose of this bill is to ensure that life-saving medicines reach those who need them most. By simplifying the export of cheap, generic, antiretroviral drugs to the countries of sub-Saharan Africa, this bill literally could turn the tide of HIV-AIDS.

Sadly, a few weeks ago, the Liberal opposition teamed up with the Conservative government to gut Bill C-393. In committee, the Liberal-Tory coalition stripped the most critical element, the one-licence provision, from the bill.

While I try to avoid excessive partisanship, this is a profoundly partisan matter. There is no sugaring the pill: across Africa, people are dying from preventable diseases. Children are dying from treatable illness. They desperately need the medicines we have and they need them now.

I urge my Liberal and Conservative colleagues to do the right thing. There is no downside. By restoring the one-licence solution and passing the bill immediately, millions of lives can be saved. Brand-name companies will receive royalties for their intellectual property, and generic drug companies will increase their capacity and employment, all without costing Canadian taxpayers a dime.

Rarely do we as MPs have such personal power to save millions of lives. Let us use that power wisely.

Industry, Science and Technology

[David Sweet, Conservative, Ancaster—Dundas—Flamborough—Westdale, ON]

Mr. Speaker, I have the honour to present, in both official languages, the ninth report of the Standing Committee on Industry, Science and Technology, in accordance with its order of reference on Wednesday, March 3, 2010.

Your committee has considered Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act and agreed on Monday, November 1, 2010, to report it, with amendments.

[Mike MacPherson]

Right now, the bill as amended by the committee leaves schedule 1 of the Patent Act intact, and the schedule that was found in Bill C-393 now becomes schedule 2. There are two schedules. The first schedule, schedule 1, was the list of pharmaceutical products or drugs or--

[Mona Frendo]

Certainly, there were a number of safeguards built into the Patent Act to ensure that the regime would be used and applied in accordance with the WTO decision and the objectives by which it was implemented in Canada. Bill C-393 does remove a number of those amendments. I'm not going to go through it now that we've had various changes and amendments, but Bill C-393 does remove a number of those safeguards.

[Peter Braid, Conservative, Kitchener—Waterloo, ON]

Thank you, Mr. Chair.

Quickly cutting to the chase, then, are you saying--and I will get you to confirm--that the reason to address Mr. Masse's point that there hasn't been abuse is that there are safeguards in place, those safeguards have helped to prevent abuse, and Bill C-393 removes many of the safeguards?

[Mona Frendo]

Section 21.16 of the Patent Act presently describes the obligation on the authorization holder to provide the patentee or patentees, as the case may be—and it was that case in the Apotex example—as well as the Commissioner of Patents with a copy of the agreement. So once the agreement is signed with an importing country or user to supply a particular drug to a particular country, that's the obligation that appears. Currently in the Patent Act, under section 21.16, it's an obligation to provide a copy of the contract, basically.

Clause 13 of Bill C-393 would change the section. It would eliminate the requirement that the agreement to supply include the name and the particulars of the authorized product for export, the name of the country, and the name of the drug purchaser as applicable. It would remove a number of pieces of information that would have to be provided. It's of concern because, when read with other changes in Bill C-393, it would reduce the transparency in the system.

[Mona Frendo]

Yes, if you read clauses 9 and 10 of Bill C-393 together, they would allow a CAMR authorization holder to produce and export the drugs authorized in the application indefinitely. That is the consequence of clauses 9 and 10 read together, because there would be no limit to the duration of a CAMR authorization and no need for renewal because it would be indefinite.

[Mona Frendo]

Mr. Masse is correct. Currently, section 21.09 of the Patent Act states that a CAMR authorization is valid for two years from the date of the grant. That was reflective of several WTO requirements in the decision, including paragraph 2(c) of the waiver, which requires a country that authorizes the export--so a country like Canada--of a pharmaceutical product under its regime to notify the WTO of the quantities for which the authorization has been granted and the duration. Reflective of that and other WTO requirements, section 21.09 of the Patent Act presently describes the duration of an export, and it says that it would be valid for two years from the date of grant.

Clause 9 of Bill C-393 would delete this section altogether. It's a short section, but it is an important section in the regime.

[Mona Frendo]

I'm sorry. I meant section 21.05.

Clause 5 of Bill C-393 would change the current provisions in section 21.05 of the Patent Act by deleting all the references to quantity. It would also add a new proposed section, 21.051, that would put the onus on the authorization holder—the first or the manufacturer who is authorized under Canada's access to medicines regime to export. You would put the onus on that person to bear the responsibility of ensuring that the products that are sent are correctly labelled, as prescribed in the regulations.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

If I could, I'd like to go to the officials to have them explain what section 21.05 of the act does, first, and how it came about, and what the rationale is for 21.05 in the first place, and then what clause 5 of Bill C-393 would do--and what the effect would be.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Thank you, Mr. Chair.

Thank you to my honourable colleague. There was some stuff in there that I agree with. We had a conversation the other day. He is very passionate about the issue of helping people in Africa who need help. He mentioned that we have one solution before us and I've said repeatedly that I would disagree with that. I don't think we have any solution before us in this bill. I don't think this bill offers the solution we're looking for.

He mentioned the government and what the government is or isn't doing. I would argue that what this government is doing is working on solutions that are making a difference and increasing funding, our investment, in the global fund. Where other countries are not doing that, our country is increasing the investment and taking advantage of our role in leading the G-8 this past summer to put forward an initiative on maternal and infant health. That is tremendously important and it is something that is looking forward, looking toward the solution.

Unfortunately, I don't see a solution in this bill. Maybe when this is all done, we'll have the chance to talk. Those of us in committee who want to continue to look at ideas that might help can have conversations. I have committed to continuing the conversation with some of the folks who have been before the committee as witnesses as it relates to trying to have an impact on the devastation that is happening in parts of the world, where things are a little different from what they are here.

To go back to the bill here, if I could, we're on clause 4 right now. If I can bring the discussion back to clause 4 and taking a look at what clause 4 does, I'll give some explanation as to why I would vote against the Liberal amendment.

Clause 4 takes section 21.04 of the Patent Act and basically and systematically, in three subclauses of Bill C-393, wipes out three subsections of the Patent Act. Again, large portions of the Patent Act will be wiped out by this one clause, clause 4, in Bill C-393, and are replaced with a few paragraphs. For subsection 21.04(1), I think it adds one word, for subsection 21.04(2) it adds one word, and for subsection 21.04(3) I think it adds 16 words in replacing paragraph after paragraph of references to the WTO and TRIPS and those things.

So again, we see wording in a bill amending something as important as the Patent Act in a way that wipes out massive portions of it, and again, I think with substantial potential for very negative unintended consequences in the long run. The Liberal amendment addressed only one of the subsections that was being wiped out and left completely unaddressed the most substantial parts that were wiped out. That would be why I voted against the amendment and will be voting against clause 4 of Bill C-393.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you very much, Mr. Chair.

When we discussed clause 3, our Conservative colleagues voiced their concern that Bill C-393 would divert Canada's Access to Medicines Regime from its primary objective. They were concerned that the resulting bill, act or regime would serve commercial interests more than humanitarian ones. I am certain that is not the intention; nor is it the intention of all those witnesses who testified throughout the proceedings that we needed to provide appropriate aid to children with AIDS, to their families—those mothers, fathers and grandmothers who are worried about the future of their children and grandchildren. So that is not what the people who introduced Bill C-393 wanted; nevertheless, the concerns are there, and they are legitimate.

Throughout the debate on Bill C-393, I often encouraged the committee members to come up with other solutions. There are actually other solutions; there is a way to help facilitate the current regime, in order to build more examples, more experience, for analysis purposes.

If the committee does not adopt Bill C-393, there will be nothing to take its place—no report, no other solutions. There is only one solution before us, and that is Bill C-393, which seeks to amend the current regime.

I wonder how we can view this amended regime and ensure that it does not exceed the limits we want to see imposed. We do not want the regime to stop serving humanitarian interests, and humanitarian interests only. I was discussing it with my colleague, Robert Bouchard, and our only solution may be to adopt Bill C-393 and turn it into a pilot project.

I would encourage my colleague from the New Democratic Party to sit down, after the committee stage, and see what amendments could be made, at the report stage, to turn this into a pilot project. A sunset clause comes to mind first and foremost, in order to put a time limit on the bill.

The way I see it, we should have come up with a proposal when we originally began studying this bill. Unfortunately, this is the only proposal we have. The government members have not shown a willingness to find a way to improve the current regime and make it more usable. A system that has been used just one time has not really been used at all. We cannot even say whether it works or not. Well, I suppose it does work, since it has a 100% success rate based on the one time it was used.

As I already mentioned, Mr. Chair, we are going to support clause 4, we are going to support all the other clauses, and we are also going to support our colleague from the New Democratic Party, who wants to remove certain clauses to bring the regime in line with the Food and Drugs Act and to strengthen Parliament's role. Clearly, we will propose some amendments at the report stage to ensure that the regime serves solely humanitarian interests, as originally intended.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

I am still trying to wrap my head around this. Why do you not simply vote against clause 4, instead of trying to amend it by removing, as I was saying earlier, the heart of the changes that all the witnesses who spoke in favour of Bill C-393 want, as does the New Democratic Party, which introduced the bill?

Why not just vote against clause 4? Why did you decide to move an amendment that would remove lines 15 to 18?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

When I began studying Bill C-393, I wanted to understand why Canada's Access to Medicines Regime, CAMR, did not seem to be working—meaning that it worked once. I took it upon myself to do an in-depth analysis of why that was. I was also aware that similar regimes in other countries had not worked. I would say I approached the matter objectively. Of course, CAMR was almost never used, except in the case of Rwanda, with Apotex.

I wanted to know why a system that had been put in place with such good intentions and that, I would repeat, was designed to provide very important medicines to developing nations—especially to treat AIDS, malaria and tuberculosis—had not worked.

Let's consider the case of Rwanda with Apotex. I always come back to one thing. When Apotex applied for a licence to three pharmaceutical companies, the process took 68 days the first time. One year later, the first shipment of medicines arrived in Rwanda. Then, when they applied a second time, it took the pharmaceutical companies a week to authorize the application, if memory serves.

In my view, that does not explain why CAMR seems to be hampered or ineffective. The Liberal Party, which wants to provide medicines to the third world, where the need is greatest, has a proposal to guarantee that much-needed medicines will get to where they need to go. That is the approach the Liberal Party wants to adopt, one that does not include the proposed changes in Bill C-393.

Keep in mind, as well, that what this private member's bill, Bill C-393, inherently does is alter our obligations regarding intellectual property, our international obligations. Of course, there are arguments both in favour of and against that position. Some say that it could lead to problems with the international community, while others claim that would not be the case.

I think that Canada has to send a message about intellectual property, because it is crucial to research and development. After all, it is the pharmaceutical companies doing the research and development to come up with products that can then be passed on to generic drug manufacturers.

In short, we cannot lose sight of the real source of the problem. Everything I discovered regarding Rwanda has led me to believe that the problem does not lie with CAMR right now. It may be necessary to make some minor adjustments, but we need to find another way to accomplish what we all want to accomplish.

That is why I cannot support the proposed change in clause 4; I do not think that it focuses in on the real problem.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

My understanding, from your comments, was that a number of the clauses that could be dropped had little or no effect on the rest of the bill. In other cases, removing those clauses from Bill C-393 could have an impact on other clauses in the bill. That was my understanding, especially with regard to the first two clauses that could be removed, clauses 6 and 7.

The last clause you mentioned, however, clause 14, might be worth keeping, because it directly addresses the question I put to Mr. Masse on the addition or removal of listed products. That could give Parliament somewhat of an advisory role in the process. Of all the clauses you mentioned, I think that would be the one most worth keeping. So we are talking about clauses 21.17 to 21.2.

It is not with this addition or removal of clauses, as far as Bill C-393 goes, that we can really consider the second Liberal amendment. That amendment deals with another aspect of the bill and seeks to delete lines 15 to 18 of clause 4. My understanding, from what most of the witnesses said, was that that part was the real bone of contention.

I first want to ask Mr. Masse about that, since he is the one responsible for the bill right now. In your opinion, lines 15 to 18 of clause 4 speak to the heart of the bill. Without them, there is no bill.

[Rob Sutherland-Brown]

As I recall the proceedings from last Thursday, the proposal was that the sponsors of the bill would be prepared to drop clauses 6, 7, 8, 11, 12, 14, 16, and 17.

Clause 6 proposes to repeal section 21.06 of the Patent Act, the website disclosure, and in its place it proposes a more limited disclosure: the name of the product; the name of the importer; and distinctive features and labels in accord with the regulation requirement, which is not yet in place.

If you drop that proposal, you would revive subsection 21.06(1) of the Patent Act, so there would be a duty to disclose the authorized quantity. That would conflict with the repeal of section 21.04 in clause 4. It revives Health Canada's review and regulation--product features, labels, and packaging. Depending on the outcome of these other things, that would also conflict with the clause 4 authorization provisions. It revives the duty to disclose the name of every known party that would be handling the product while in transit from Canada to the importing jurisdiction. It also uses WTO language, but I understand that some of the amendments probably fix that.

Clause 7 of Bill C-393 purports to repeal section 21.07 of the Patent Act. This is the provision that requires the exporter to give an export notice. It is required to give that notice to the patentee, to the importing jurisdiction, and to whoever it is within that jurisdiction, or on behalf of that jurisdiction, who has purchased the product. This would create some problems for the anti-abuse provisions. By virtue of the repeal of section 21.04, application requirements, there is no way you can verify the disclosure to the patentee, as they are not identified in the new authorization process. It also uses WTO language, which would be fixed.

Clause 8 in Bill C-393 would amend the existing royalty provisions and it would remove the Federal Court review, at the instance of the patentee, of a royalty rate, which would be determined in accordance with the regulatory scheme but nevertheless in the judgment of the patentee was inadequate in the circumstances. The revival will bring this back into compliance with that review process. The review process is not required by the waiver decision itself but there is a requirement in article 31 of the TRIPS agreement that any decision as to the remuneration given to the patentee must be reviewable by a distinct higher authority. In the Canadian case, for a federal decision, that would be the Federal Court. This provision also uses the WTO language, which may well be fixed.

Clause 11 in Bill C-393 deals with section 21.13 in the Patent Act. That is a clause that deals with termination on the happening of a statutory event. These events are things such as the expiry of the two-year term certain for an initial authorization and the expiry of a two-year term certain renewal authorization, on the happening of the Minister of Health notifying the commissioner and others that the product at issue is no longer compliant with Health Canada efficacy regulations or the labelling and appearance regulations.

It also allows for automatic termination where a country has been removed from one of the country lists. So if you revive section 21.13, as the proposal to drop would do, you revive the concept of a two-year set term for initial authorization. You also revive a reference to re-authorization for another up to two years. So there's a conflict there between what's in Bill C-393 and what would stay in the Patent Act. Well, as the trade dress issues as defined by Health Canada regulations would be revived, and it revives the concept of a named product in an authorized quantity, all of that creates some tensions within what would remain if the bill proceeds.

Clause 12 is a termination clause on the instant or the suit of the patentee for a number of reasons. The termination for failure to label accurately and failure to give export notice--that could be okay if clause 7 is dropped, because that would revive the export notice. It would also replace Bill C-393's definition of a regional trade agreement with the original version in the Patent Act that was drafted to comply with the definition used in the WTO waiver decision.

Clause 14 would repeal sections 21.17 to 21.2. Section 21.17 is on termination in circumstances where bad faith is alleged because the contract is being used for commercial purposes. Section 21.18 is on the advisory committee designed to assist the Governor in Council and ministers in determining whether a drug should be added to schedule 1.

In section 21.19, a website is to be established by Canada to disclose applications that are made to it by a non-WTO member that would not have had an obligation to give notice to the TRIPS council under the WTO scheme. Canada went beyond its strict obligations in this regard, because they thought everybody should have access to the system on equal footing. We had to design something where a focal point for the notice from the demanding jurisdiction could be made public and transparent to the world.

Section 21.2 was a requirement for a ministerial review and reporting to Parliament, and that's essentially spent, so it would be removed in a housekeeping bill and not with whatever you do here.

That's it. There are several places where Health Canada is referenced. I'm not sure in which particular clauses. Perhaps we can deal with those when we come to them.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

I'm speaking against this amendment. This virtually guts the one licence solution. We heard testimony from witnesses who, first of all, explained that what we did created a regime that wasn't necessary. It wasn't required under the WTO to create some of the barriers that we have.

One of the problems that we faced in the access to this legislation is pure-out intimidation and threats. Some of them have been public, as in the Indonesian situation, for example. Others have been impossibly difficult to get over, requiring a series of attempts to move, to get CAMR to work, especially the one in the Rwanda situation. We heard that, yes, some elements from the technical aspect, once it got through, were okay, but because of the process involved in terms of identifying the country right away, identifying the drug right away, and identifying the quantity, it restricted the interests of those who wanted to use this legislation. Hence, the Canadian model, which is sometimes proposed as being very effective, really isn't being accessed.

It's also important to know that for some of the things that were contentious in this bill, we've decided to drop those clauses. Some of the things I don't think are necessary, but at the same time, there have been some good concerns raised on everything from the food and drug and safety act--that's the Health Canada provisions--to others as well, relating to diversions. But this particular element here would create the same system that exists today. We have our only customer--that being Apotex, which looked at this as a potential thing--saying they won't do it. They've also identified that they would actually, if we'd traded a different regime, look at getting pediatric drugs immediately overseas as well.

It's very important that this part of the bill be defeated in terms of this amendment. I believe we won't see the wanton abuse of patent elements in Bill C-393, which has the one licence solution in it. I don't think any evidence of that has been produced. I haven't seen any evidence from the generic companies or from the pharmaceutical companies that there would be problems.

It was interesting, though, because when we had GlaxoSmithKline testifying in front of us here about how they wanted to ensure safety and a series of products that weren't substandard, they were actually settling a $760-million lawsuit in the United States for having products that were deficient, including baby ointment.

We've set up a system here that clearly isn't working. It's one that we've designed. This is a critical part that I hope gets defeated. If not, we will see similar situations take place, in my opinion, where the licensing won't be granted.

Once again, I think the best evidence we have is from the one company that actually tried to use this bill. We had incredible testimony here from a number of different NGOs about the restrictions and the problems. We had some other good testimony from experts like Mr. Abbott who were there and who know we're not violating anything by going ahead.

I'm hoping this motion will be defeated. I would call for a recorded vote when it is appropriate.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Yes, certainly.

The proposal with respect to subclause 4(2) specifically was that under the current legislation, a pharmaceutical manufacturer applying for a compulsory licence under CAMR--under the current legislation, not under Bill C-393--is required to include information about the version of the product, the quantity of the product to be exported, the name of the patent holder, the name of the importing country, and the name of the importing entity. I would like to restore the legislation. I would like to make sure that Bill C-393 reflects that requirement.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Once again, it is to allow for the fact that in the new amended Bill C-393, there is a schedule 1 for medications and a schedule 2, which is the old unique schedule. Now we have to allow for the fact that this original unique schedule is now renumbered as schedule 2.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Does the amendment that we are talking about deal with the issues you've brought forward as problems with Bill C-393?

[Mona Frendo]

That subsection states that the Commissioner of Patents “shall...authorize the person to make, construct and use a patented invention solely for the purposes directly related to the manufacture of the pharmaceutical product named in the application”.

So it ties the authorization to a specific product named in the application. It also ties it to a particular country that would be listed in schedules 2 to 4 of the Patent Act—to the original three country lists also named in the application.

So there are two critical parts of subsection 21.04(1): that the product has to named in the application and that the country has to be named in the application. The authorization is tied to those two elements.

Clause 4 of Bill C-393 would significantly alter this authorization by the Commissioner of Patents. It would allow the Commissioner of Patents to authorize any person to manufacture more than one pharmaceutical product under the Patent Act and sell it for export to more than one country. It would also eliminate the requirements that the product be named in the application and that the country be named in the application. Again, it unties the process. It adopts what was referred to previously in this committee as a one licence solution.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Yes, Mr. Chair. In fact, Lib-1.5 and Lib-1.6 do the same as Lib-1.3 and Lib-1.4. They clarify that we're now dealing with schedule 2, that list of countries that used to be “the Schedule” in Bill C-393 but has now become schedule 2. It's really just a minor clarification.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Yes, Mr. Chair.

This amendment is an amendment to clause 13 of Bill C-393. It's to restore the existing paragraph 21.16(1)(a) because it's connected to the restoration of the existing application process in accordance with amendment Lib-2, which deleted, as you know, subclause 4(2). That's essentially what it is. It's related to clause 4, but it is in clause 13.

[Rob Sutherland-Brown]

There are a number of elements in Bill C-393. As I think I said last Thursday, this is very intricate: A goes to B to go to C, etc., so you have to follow the thread through the fabric, so to speak. But yes, I think that's a fair comment.

Some of the anti-abuse provisions that were in the Patent Act are removed by the proposals in Bill C-393. If you remove those anti-diversion or anti-abuse provisions, then you are in a very difficult situation if you try to enforce the limitations of the waiver agreement and the scheme for exporting drugs under compulsory licence.

Thank you, Mr. Chair.

[Rob Sutherland-Brown]

I think that's a fair comment. The non-commercial character of the scheme was something that was set out in what is referred to as the chairman's statement, and that, by definition of the General Council decision in the Patent Act, was incorporated into the Canadian legislation because we thought it was an important element of the whole scheme that was created at the WTO.

So it is an important element and it runs through our legislation as it exists prior to Bill C-393. It's reflected in the provisions whereby the Federal Court can review an authorization to see whether, at the price the drug is being exported, it is for a non-commercial purpose or at a commercial price as opposed to a “humanitarian price”. It was an important element in the scheme, yes.

[Mona Frendo]

I'll try to answer that.

Paragraph 21.03(1)(a) of the Patent Act, which has been struck out—but then effectively some sort of mechanism has been reinserted—is the process of amending schedule 1, the list of drugs for export. Paragraphs 21.03(1)(b) to (d) and subsection 21.03(2) of the Patent Act—that's basically the rest of section 21.03—have also been effectively removed. Those paragraphs and the subsection describe the processes and requirements for adding and removing a country from what were schedules 2 and 3 of the Patent Act, those lists of countries Mr. Sutherland-Brown was referring to that had various requirements for using the WTO waiver as per the international rules.

What clause 3 of Bill C-393 would do is, for these lists of countries, effectively modify that process so that only two factors—and there were many more in the Patent Act—could be taken into consideration for adding or removing an eligible country from the new schedule. This would significantly limit the ability to amend that list and take action.

I can give you a couple of examples of what clause 3 would eliminate, if that would help.

[Colette Downie]

As it stands without the amendments that are proposed--just as clause 3 stands--or as the amendments are proposed to clause 3 in Bill C-393: is that the question?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

As I understand it, Mr. Chair, this is really just to correct the fact that in Bill C-393 for the moment they refer to “the Schedule” because there is only one schedule. Now there are two schedules. This is to correct where it says “the Schedule” to say “Schedule 2”.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

On Thursday, we adopted the fourth Liberal amendment, which restores to the bill the process related to Schedule 1, where it lists the medications that can be sent. I thought there was no provision in the current bill, Bill C-393, stating who could add medications to the list or remove them from it. So it was important to clarify that; otherwise, there would have been a gap in the bill.

Do I understand correctly?

[Mona Frendo, Director, Patent and Trade-mark Policy Directorate, Department of Industry]

Clause 3 of Bill C-393 would remove the process that's currently in the Patent Act for adding or removing products from schedule 1, the list of eligible drugs for export under Canada's access to medicines regime. That process currently involves the Governor in Council making changes to the list based on the recommendations of the ministers: the Minister of Industry and the Minister of Health.

It would do a number of other things as well. It would collapse into one what are currently three schedules of countries in the Patent Act. This is all under Bill C-393. It would limit the process of amending to that list of countries, which was referred to as “the Schedule” in Bill C-393. That's basically what clause 3 of Bill C-393 would do.

As I understand Liberal amendment 1.2, it would reinsert the process for amending schedule 1, the list of eligible products for export under the Patent Act, because as a result of Liberal amendment 4 and Liberal amendment 2, which was withdrawn, schedule 1 has been reinserted into the Patent Act. That whole process of adding or removing to schedule 1 has been reinserted into the text of the Patent Act as a result of Liberal amendment 1.2.

I would say that there is no change to what is I guess now schedule 2, this list of countries, and the process of amending that schedule. That is not referred to in either Bill C-393 or in the Liberal amendments as far as I can see, but I'll have to check. It may be in further amendments.

[Mike MacPherson]

Liberal-5 from the past meeting had the effect of leaving in the original schedule 1 of the Patent Act, and the schedule in Bill C-393 would then become schedule 2. So most of the amendments--1.3 to 1.6--just correct references to schedule 2. I believe that Liberal-1.2 reinstates the minister's power to add drugs to the list, the schedule, but the officials at the back would be in a better position to speak to that.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

As you remember and as all of the members will recall, at the last meeting on Thursday, I had put forward what's called the old amendment Lib-1. It had created a certain amount of confusion, not only with some of the experts, but also with me.

Just to summarize, my intention had been to reinstate schedule 1 of medications that are in the Patent Act, to bring it into Bill C-393, and also to establish that any medications that would be used under CAMR had to have Health Canada approval.

Well, I didn't realize there were a number of other definitions that had been removed in Bill C-393 that were really required to be reinstated because they were called up, notably the definition of “patented product”, “WTO”, and things like that. It's also to make sure, as I said, that medications allowed under CAMR would meet Health Canada approval.

I got together with the legislative assistant on Thursday afternoon, which gave rise to a number of alternate amendments called Lib-1.1 through to Lib-1.6. That's really the new part of it, what is being introduced here this morning, which I believe will rectify the problems that were identified last Thursday afternoon.

Thank you, Mr. Chair.

Canada Consumer Product Safety Act

[Megan Leslie, NDP, Halifax, NS]

Mr. Speaker, I am pleased to rise today to speak to this bill, because it means that it is one step closer to becoming law.

The NDP has advocated for consumer protection for years. Judy Wasylycia-Leis, my former colleague, the former member for Winnipeg North, has been on this file for years, advocating for stronger consumer protection. I know that our leader has raised it with the Prime Minister, and in the 40th Parliament, this session, the member for Sudbury has been a strong advocate for changes to consumer protection laws that would actually result in protection for consumers.

As we have heard a few times in this House, the previous legislation is 40 years old. It is time for a change. It is time to catch up and modernize. All parties are in agreement that this legislation is desperately needed.

However, that does not necessarily ensure that product safety is going to be ensured in Canada. This legislation is going to need to be enforced in order for it be effective. As the member for Elmwood—Transcona has said, there are serious questions about whether or not enforcement is actually going to happen and whether or not sufficient resources are going to be put into this bill.

This is a good bill. I am proud to support it. Our party is proud to support it. I am proud that it is going to the other place and may soon get royal assent. We are hopeful that it will be soon. However, we need to stop and think critically about whether this bill is just a shell being carried into effect for show, or whether it will actually provide protection for consumers.

There are a number of reasons to think that the government might abdicate its responsibility on this bill, should it be passed through the other place. The reason is this: despite the fact that the legislation is their own, and despite their repeated statements that this legislation is important to them, the Conservatives have dragged their feet. There is no other way of putting this. They have dragged their feet in introducing this legislation to the session. Previously, they prorogued Parliament and killed similar legislation, not once but twice. There was significant delay in getting this to first and second reading.

Now we are rushing it through. I think that is fair. We know what is in this bill. It has been to committee before. We have debated it before. However, it has taken a long time for us to get to this point.

Even though we are at third reading now, we have to ask why has this process has taken so long. Why has the government not acted quickly on this legislation, when there have been many opportunities to do so? I think it demonstrates a level of unwillingness to emphasize the safety of Canadians. It is disconcerting that so much time and energy, resources and effort, were put into trying to eliminate the gun registry, while product safety was put on the back burner.

The member for Portage—Lisgar is driving around in a minivan saying “End the registry”. In fact, that minivan was idling outside of Confederation Building the other day, so clearly they do not care about the environment either. There is no minivan saying “protect consumers”. There are no flyers going into other ridings, no radio or TV ads saying that we should protect consumers. All we get is foot-dragging.

Over the last month, we have received alarming reports about Health Canada's failure to warn parents about the risks of cadmium in children's jewellery. Health Canada testing showed unacceptable cadmium levels much earlier than we had previously known. Some of the products that they tested had cadmium levels of 93%, and yet the government delayed letting Canadians know about this. This is children's jewellery, and we all know what children do with small objects. It goes right in the mouth.

Health Canada has actually stated that cadmium is more toxic than lead. Testing that revealed unacceptable cadmium levels occurred in the 2009-10 testing cycle. But that was not the first time it was discovered. The previous testing cycle also revealed unacceptable cadmium levels. Health Canada advisories until now have not mentioned any of these test results. It is hard to imagine. These tests were on children's jewellery.

Our children were at danger of ingesting cadmium from these products because of the government's lack of transparency on testing and a lack of public education on cadmium's dangers. This is just plain wrong. It is irresponsible. I cannot understand why the government would not have mentioned these test results, especially when there was a 93% level in some products containing cadmium. The risks were inherently clear.

How can we trust the government to be the guardians of public safety under this new regime that Bill C-36 offers, when it failed to warn the public that its own tests were revealing cadmium in children's products?

The bill is good, but it is going to require significant resources in order to be effective. It is going to require an adequate number of inspectors and a team that is able to respond effectively to product safety concerns. They will have to respond in such a way that every Canadian will be kept safe from dangerous products.

It goes without saying that the government has done poorly on similar files, like food inspection. We should be questioning the Conservatives' willingness to fund product safety protections adequately. So it is a step forward, but without teeth. Without the systems in place to carry out the intended functions, it is going to be a colossal failure.

We will see the government trumpet the bill's passage and send a message to Canadians that their products are safe, but this message needs to be backed up with funding. It needs to be backed up with resources. Otherwise, we will be giving Canadians a false sense of security.

I stand here representing the voices of consumers from coast to coast to coast. I thank the government for finally bringing in this legislation, and I ask that they commit the resources to enforce it. Otherwise, the bill will be meaningless. I desperately hope that two, five, or ten years from now we are not lamenting a failure to act and saying “I told you so”.

I was reading the newspaper today and there was a quote by James Orbinski. It was not about this bill. It was about the access to medicines regime, Bill C-393. It was brought forward by my former colleague, Judy Wasylycia-Leis, but is now being handled by my colleague from Windsor West. Bill C-393, if passed, would facilitate selling developing countries generic drugs still under patent. It would fix the 2005 regime that was created by the Martin government. The bill should be supported by all members who believe in justice and fairness.

James Orbinski is the co-founder of Dignitas and a world-renowned health activist. In referring to Bill C393, he inadvertently said something related to Bill C-36: “Right now CAMR is a rhetorical success and a practical failure. Bill C-393 is an effort to make CAMR a practical success”. I read that and thought of Bill C-36. We must not let it become a rhetorical success but a practical failure. We need to ensure that there are resources in place.

I talked about justice and fairness. The bill should also raise levels of justice and fairness for low-income Canadians. It goes without saying that dangerous products touch the lives of socio-economically disadvantaged Canadians proportionately more than the rest of society. Cheap products rely on cheaper manufacturing processes, and these products are wreaking havoc on the lives of people who cannot afford better choices. These people are poorly positioned to deal with health consequences or with wages lost due to taking time off from work to care for themselves or their loved ones.

I believe strongly that product safety should not just be the prerogative of the rich. This issue goes to the heart of the equality principles held by Canadians, and product safety legislation should play a central role in moving toward economic justice in our country.

I would like to touch on an issue that I do not think has been raised in the House very often. Sometimes when I am out in the community I am approached by people who say that they have problems with Bill C-36. They see some constitutional issues they would like to see addressed; they are worried about the constitutionality of this legislation.

Recently, the member for Sudbury raised this constitutionality issue with lawyers who appeared at committee, asking whether we had to worry about this. According to the lawyers, there were no constitutional problems with this bill, nothing really to worry about.

The last time around, when this bill was called Bill C-6, it made it through the House and was then sent to the other place. When senators considered the bill at committee, the Public Interest Advocacy Centre made a presentation on this specific issue. It is not only important for members of the House to understand some of the constitutional issues that were raised, but also some thorough analysis would show, that we really do not need to worry about.

For background, the Public Interest Advocacy Centre is a non-profit organization that was established in 1976. Its mandate is to enable the representation of ordinary and vulnerable consumers when decisions are made concerning the important products and services they obtain. Of course, they are a natural organization to turn to when we consider product safety, whether it is legislation, regulation or action.

PIAC made a formal written presentation to the senate committee and I will read from the memorandum it submitted. I reads:

It is particularly disheartening to find the oppositional posture to this Bill presented as a matter of protection of the civil rights of business and property owners engaged in the sale and distribution of the consumer products that are the subject matter of this bill. Such individuals are amply protected by the provisions in the Canadian Charter of Human Rights and possible civil remedies for government behaviour that exceeds the ambit of its protective statutory mandate. Monetary loss, embarrassment and hurt feelings are regrettable, but nonetheless compensable in the event of improper government conduct.

On the other hand, harm caused to public health and citizen livelihood may only be imperfectly remedied. What will be the explanation given to a parent grieving the loss or permanent injury of a child caused by the use of a product irresponsibly brought to market, when the reason is the lack of, or delay in application, of proper enforcement tools by the responsible authority caused by these amendments? There is no guarantee that even an inadequate remedy of compensation may be available in the event of a breach of health and safety requirements that is of such widespread effect that it is ultimately financially ruinous of the supplier.

The rights of defendants in circumstances where criminal and/or quasi-criminal related behaviour may be involved are important, particularly in relation to the consequences that may be visited upon a defendant. But it is decidedly inappropriate to expose innocent Canadian consumers to potentially negligent market behaviour because of the fear that government inspectors may lack either the appropriate motive or skills of enforcement. It is a grievous misallocation of the Senate's legislative superintendence to cater to the misplaced fears of a few over the real health and safety concerns of the many potentially at risk. PIAC urges the Senate to reject the amendments of the committee and adopt Bill C-6 without change.

Michael Janigan, the executive director of PIAC, has his name at the bottom of the memo. That is a good positioning of the two sides that we have to balance here. We need to look out for the consumer protection of Canadians. We need to ensure that people can rely on the fact that their products are safe. It is absolutely imperative. I think he did a great job of showing the balance that has to be struck between the two and where, ultimately, how justice would bring us to the one side.

It is a great summary of the constitutional arguments and I really do support the perspective of PIAC. Thanks should be extended to PIAC for getting involved in this issue and contributing to the discussion in the other place.

I am strongly supportive of Bill C-36. It is an excellent framework. We need to move forward after 40 years of old legislation that is not modern. Ultimately, we cannot make this a rhetorical success but a practical failure. We need to ensure that the government puts adequate resources behind this bill to ensure it is a success for all Canadians.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you very much.

Earlier, I asked a question about Mr. Masse's proposal. Could you please comment on it and give us your view of the potential consequences of striking these clauses from Bill C-393, as proposed by Mr. Masse? I obviously realize that time is short and that we are dealing with a very complex issue.

[Rob Sutherland-Brown]

I can't speak to the WTO negotiations because that was a very long multi-year process, but certainly when the WTO member states were trying to find a way to make compulsory licensing work in jurisdictions that had no pharmaceutical manufacturing capacity, there were a number of things that concerned them, and that was if you allowed jurisdictions with the capacity to manufacture without any constraint, this would eviscerate the patent system around the world. They said, okay, people who have a need to issue a compulsory licence but don't have local manufacturers can request products from the WTO and jurisdictions with capacity can then issue a compulsory licence domestically. The request from the putative importer to the WTO had to name the product involved and the quantum that they needed to treat their local health problems.

That was a critical element of the WTO agreement and it's a critical element of the Canadian implementing legislation that tried to put the system in place. The same is true, I guess, with the names of the importers, because what happens in the international drug markets is that a lot of product gets diverted. It seems critical that this kind of information be available about compulsorily licensed products, so that the patentees and the granting nations can control how the product is used, that in fact it gets to the destination that's intended.

It took a lot of negotiation here domestically when we were doing the legislation, because as Bill C-393 shows, there are a lot of interest groups that have ideas about what the perfect system would be. I think that in the course of developing the initial CAMR legislation, Canada was concerned that it remain compliant with its WTO obligations or that it didn't create a scheme that would go beyond the scope of the TRIPS waivers decisions. It's a long process, both domestically and internationally.

[Mona Frendo]

Clause 4 of Bill C-393 would change the system of authorization that is currently in CAMR to a particular country and to a production of a particular drug. It would change this completely. It would allow the Commissioner of Patents to authorize any person to manufacture more than one pharmaceutical product and sell it for export to more than country. That would be a significant change. It would also eliminate the requirements that the manufacturer of the pharmaceutical product and the importing country be named in the application.

That's what Bill C-393 proposes to do in clause 4. It would also delete a number of the specifics that would have to be named by the generic manufacturer and the potential applicant under CAMR when applying to the Commissioner of Patents for an authorization.

Again, it's what I was mentioning earlier: the name of the product, the prescribed information about the product, the maximum quantity to be exported and sold, the name of the patentees, and the name of the importing country. It would delete that at the legislative level in the Patent Act.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you, Mr. Chairman.

I'm sure you would acknowledge that Mr. Garneau followed the proper process before presenting his amendments. They were submitted in advance so that members could review them. Now you have just talked about the clauses you would like to have removed from Bill C-393. Considering how little time we have left, it would be rather difficult to examine that suggestion properly. In terms of what you just said, I would like to hear from officials as to how they interpret this.

Considering how little time we have left, I am really just wondering if it will be possible to arrive at an informed opinion regarding Mr. Masse's suggestion.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

I would just like to ask Mr. Masse for clarification. He seemed to be saying he is prepared to amend that clause of Bill C-393.

Could you explain once again which clauses that are affected by subclause 4(2) that you would be willing to retain under the current Act?

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Could I ask the officials to comment on the amendment? What impact would the amendment have on Bill C-393? What might it fix and what might it not fix?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Mr. Chairman, we can certainly dispose of the amendment and clause 2, or pass them, but either way, we are creating a problem. We have to resolve that problem before we can decide whether we want to accept or reject both the amendment and the clause.

We previously passed a schedule identifying which drugs could be sold in accordance with the Patent Act. However, Bill C-393 does not tell us either who or how that schedule could be amended.

My proposing a new definition of “pharmaceutical products”, Mr. Garneau was trying to identify the ideal mechanism whereby drugs could be added or removed from Schedule 1.

Department officials are saying that in terms of how as pharmaceutical products are currently defined, the mechanism is not sufficiently clear, refined and detailed. Before going any further, I think we have to find a way to fix this. If we just create problems by trying to dispose of the amendment and the clause too quickly, as framers of the legislation, we will not have done our job properly. I think that is what we should do, because that is what we're here for, Mr. Chairman.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

It certainly is very complicated. If we need this mechanism, if we want the medications to be Health Canada approved, what do we have to change in Bill C-393 to achieve that objective?

[Rob Sutherland-Brown]

Thank you, Chairman.

It's hard to know where to begin. As you have noted, this is very complex and very interrelated, and that's the way legislation is usually crafted, so that when it's presented in the House the interconnections between (a) and (b) and (c), etc., are clear.

But the question is, if you stay with the definition of “pharmaceutical product” that is in Bill C-393 now, that is defined by reference to the Food and Drugs Act, and the Food and Drugs Act definition of “drug” is everything in the world: any substance that can be used as a medicine, not only for humans but also for animals. It also includes disinfectants for cleaning kitchen surfaces and stuff like that.

So there is no need to amend if you stay with that. If you introduce the prospect of a Minister of Health or a Minister of Industry joint recommendation, they have to recommend to somebody. In the existing legislation--Bill C-9 or the Patent Act--it is the Governor in Council who makes amendments to the schedules that are in that act and does so on the recommendation of the appropriate ministers. In the case of a drug, that recommendation is given by both the Minister of Health and the Minister of Industry. Amendments to the other country schedules are done on the recommendation of the ministers for industry, international affairs, and CIDA, and I think for international trade as well.

The original legislation, the Patent Act, that purports to be amended by Bill C-393 has a mechanism that's built in for amendments to all those things and the circumstances that have to be met. If you use the definition that's proposed in amendment Lib-1, there is no mechanism left in the act, because Bill C-393 gets rid of all those mechanisms for amending. So it may say “on the recommendation of a minister”, but there is no mechanism in the legislation to permit it.

It's very intricate and very interrelated.

[Mona Frendo]

The simple answer is no. If you revert to the pharmaceutical product definition that is in the Patent Act currently, there is no reference to any ability to add to that list on the recommendation of the Minister of Industry and the Minister of Health. That ability is found in section 21.03 of the Patent Act currently.

Clause 3 of Bill C-393 proposes to eliminate that section of the Patent Act. Therefore, if you revert to the definition of pharmaceutical product that is in the Patent Act without also considering the changes to clause 3 of Bill C-393, you will not have an amending ability for schedule 1.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

That is not what I understood to be the correct interpretation. Departmental officials said that, based on the current wording of Bill C-393, if we do not add that drugs listed in Schedule 1 must be recommended by the Minister or another entity, in fact, we don't really know how drugs could be added or what process would have to be followed to add them to the schedule.

Now Mr. Masse is saying that he is going to remove a certain number of clauses from Bill C-393, so that there will not longer be an issue as to who would be authorized to add products to Schedule 1, and so as to ensure that this will in fact be done based on the recommendation from the Minister of Health.

I simply want to be sure that if we revert to the definitions as they currently appear in section 21.02 of the Act—and if Bill C-393 is subsequently passed—there will be some mechanism whereby we could actually identify the individual or entity authorized to add products to Schedule 1.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

In looking at Mr. Garneau's amendment and then at the existing Patent Act, what this appears to be doing is simply reinstating the wording from the existing Patent Act. It talks about reinserting the words “patented product listed in Schedule 1...if applicable, the dosage form, the strength and the route of administration specified in that Schedule in relation to the product”.

But for some reason—and I guess this is what we're trying to figure out, Mr. Garneau--you're reinstating the old definition for pharmaceutical product, except for one little exception. You're adding the words “on the recommendation of the Minister and the Minister of Health”. Those words are found in the existing Patent Act in paragraph 21.03(1)(a).

I'm just wondering why you've mixed two clauses that have both been removed under Bill C-393 and have reinserted them under the definition of pharmaceutical product. I'm wanting an idea of what the rationale is there.

[Mona Frendo]

If I understand what Liberal amendment 5 does, it restores Bill C-393's schedule of countries; it restores schedule 1 of the Patent Act, which currently lists the drugs that are eligible for export under CAMR, and it references Bill C-393's list of countries as schedule 2. That would not affect other clauses of Bill C-393 that eliminate the possibility of adding to schedule 1, for example.

So schedule 1 is currently— There are x number of products on that schedule and currently there is a process under the Patent Act on the recommendation of the Ministers of Industry and Health to add to that list to respond to countries' needs. That would no longer exist as a result of one of Bill C-393's proposed changes to CAMR.

[Mona Frendo]

Yes, in the sense that.... Section 21.03 of the Patent Act currently refers to schedule 1, the list of drugs, and the process for adding to those drugs on the recommendation of the Minister of Industry and the Minister of Health. Bill C-393 would delete not only schedule 1, but the process for amending that schedule.

So the reference that is in your definition, Mr. Garneau, to “on the recommendation of the Minister of Industry and the Minister of Health”, would not exist under Bill C-393.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

That's a good question. I'm told that under the current legislation, in order for a product to be licensed, it has to be approved by Health Canada.

Under Bill C-393, without Schedule 1, products requiring approval could apparently be approved by someone other than Health Canada, in particular by the countries importing those drugs. My intention was to ensure that only drugs approved by Health Canada would be eligible. What we want to do is ensure that these products are all reviewed by Health Canada before being shipped to other countries.

If section 21.02 is reinstated, as opposed to clause 2 here, there is no mention of Health Canada in the definition of “pharmaceutical product”. But is it covered in other parts of the act--that it limits products to being Health Canada products approved by the Minister of Health?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

We are currently discussing potentially deleting clause 2 of Bill C-393 and restoring section 21.02, as drafted in the current Act, and thereby bringing all the definitions back in. However, Mr. Garneau's intention, in amending the definition of “pharmaceutical product” through amendment LIB-1, was to ensure that it would be appropriate, given the amendments we have just passed, and thereby to amend the schedules.

I'm just wondering whether, by retaining the definitions as they appear in the current Act, the definition of “pharmaceutical product” will still be comprehensible and correct.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thanks again, Mr. Chairman, for giving me the floor. I would like to ask our legislative clerk for clarification.

Mr. Garneau's goal was to only amend the definition of the term “pharmaceutical product” in order to make it consistent with those clauses that are amended by amendments LIB-4, LIB-5 and LIB-6, and specifically amendment LIB-5.

Once clause 2 has been completely deleted from Bill C-393, will the definition of “pharmaceutical product” still be adequate considering the amendments we have just passed?

[Mona Frendo]

Not alone, no. Clause 9, on section 21.09, of Bill C-393 and clause 10, on section 21.12, of Bill C-393 would also delete the renewal and that duration of the export, so--

[Mike Wallace, Conservative, Burlington, ON]

I will speak to that point.

My question is for the bureaucratic expert we have here in front of us today. If clause 2 is completely defeated, what was just mentioned by Mr. Lake as one of the issues that we're having problems with.... Would that then bring back the CAMR definitions that are already in there, in legislation that is already passed and is law and has been used? That would then eliminate that opportunity that Bill C-393 is trying to do in terms of the renewal aspects. So if clause 2 is completely defeated, the issue about renewal will not be an issue any more because we're using the CAMR definitions, which require a renewal.... That's where I'm getting....

I understand what Mr. Garneau was trying to do. I understand that he didn't try to put the definitions back in. The suggestion is to get rid of the whole clause altogether. I want to know what the ramifications are. One of the issues we've heard about at committee from all stakeholders was whether we want that renewal piece back in or not. It is an issue. Is it added back in if clause 2 is deleted?

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

In fairness, I sometimes find this process confusing, too, and it is tough sometimes when we're looking at Bill C-393. You see what is replacing what was taken out, but you don't see what was actually taken out. That's sometimes the problem that causes confusion.

In this case, Bill C-393 takes out all the references I was talking about, but we don't see that in Bill C-393 itself. I think that's what you're speaking about in terms of the confusion, Mr. Garneau.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

If it's important for the interpretation for the rest of Bill C-393, as the experts seem to suggest, then it's an oversight on my part. My intent was to go to the “pharmaceutical product” definition. I have to admit that I did not realize that we'd left hanging some definitions here that might be important.

If they're really required for the rest of the act, which they appear to be, it would be good to bring them back in, although they weren't there with the current proposal.

[Brian Masse, NDP, Windsor West, ON]

Why don't we just delete clause 2 of Bill C-393 and restore the current system?

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Mr. Garneau referred to the other definitions that are in section 21.02 of the act that is being amended here. To be clear, the other definitions in the Patent Act that are struck out by clause 2 of Bill C-393 are references to “General Council”, “General Council Decision”, “TRIPS Agreement”, “TRIPS Council”, and “WTO”.

Now Mr. Garneau, I'm not sure if it's the Liberal position to wipe out all references in the Patent Act to “General Council”, “General Council Decision” “TRIPS Council”, and “WTO”, but that's the effect of clause 2 of Bill C-393.

Mr. Garneau's amendment changes the definition of “pharmaceutical product”, but it doesn't address the wiping out of all of the references to WTO, TRIPS Council, TRIPS agreement, and all of those things. Is that correct?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

This is one of the disadvantages of being an engineer instead of a lawyer. My intent was not to get rid of other definitions. I only see two definitions in Bill C-393. I wasn't aware of the existence.... I have to admit that I didn't pick up on all these other definitions. I have no problems with those other definitions being brought into here, if it will help the situation. My intent was to define “pharmaceutical product”.

[Mona Frendo]

I'll answer that question by listing the definitions that are currently in CAMR. There are definitions for: “authorization”, “General Council”, “General Council Decision”, “patented product”, “pharmaceutical product”, “TRIPS Agreement”, “TRIPS Council”, and “WTO”. Bill C-393 would delete all of those definitions except for the definition of “authorization” and “pharmaceutical product”. And, as I heard Mr. Garneau say, he would choose to revise the definition for “pharmaceutical product” put forward in Bill C-393.

On the issue of the other definitions, “patented product”, for example, is referred to in the definition of “pharmaceutical product”. If you delete the definition of “patented product”, you are creating potential uncertainty in the definition of “pharmaceutical product” that Mr. Garneau has proposed.

In terms of deleting the definition of “WTO”, I just did a quick search of the provisions, and that term is referred to in subparagraph 21.13(d)(ii) and paragraphs 21.14(g) and 21.14(f), so there would be implications in other sections of the act. That word is referenced in other parts.

“General Council Decision” is referred to in at least one other place that I could find quickly, and that is subsection 21.17(2).

There would be implications if you delete a number of these definitions and only leave “authorization” and “pharmaceutical product”. You're going to have carry-through implications for other provisions in the bill.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Mr. Chairman, if we reconsider our decision to pass clause 12 as amended by LIB-4 and we pass this amendment to the definitions in clause 2 of the bill, it will no longer be possible to add any definitions if there is a need to do so.

Earlier, I asked the officials who are here with us what definitions are needed in order to understand the Patent Act. Bill C-393 is obviously going to amend that Act, and we will be removing all the definitions that currently appear there if we pass clause 2 as amended, or even if we pass it as it appears in the bill.

So, I'd like to reformulate my question and ask it again. We are currently debating clause 2. What definitions are needed in order to understand the Act, whether or not it is amended by Bill C-393?

[Mike MacPherson]

Bill C-393 appears to be including a definition for the term “pharmaceutical product”. It states that it is the same definition as “section 2 of the Food and Drugs Act. If we go to section 2 of the Food and Drugs Act, we have “drug”, which is what this would be referring to, and there is a complete definition there of what a “drug” is. Mr. Garneau's amendment would replace that with a straight reference to section 1 of the Patent Act, which would now be the first section of Bill C-393.

[Mike MacPherson]

It appears that Bill C-393 is defining “pharmaceutical product” according to section 2 of the Food and Drugs Act, and the amendment is replacing that definition with a reference to schedule 1 of Bill C-393, which is actually the old schedule 1 of the Patent Act.

[Mona Frendo]

I was only going to add that I think it is because clause 2 of Bill C-393 states, “Section 21.02 of the Act is replaced by the following”, and there are two definitions after that. One is for “authorization” and one is for “pharmaceutical product”. So the understanding was that when the Liberal amendment was put forward it was to deal with those two definitions and not--

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

I don't know whether there is simply an error in the amendment, because the intent was simply to… In the previous amendment, we established a new list of products that is now part and parcel of Bill C-393. The intent was simply to include a definition that would be consistent with the criteria used to draft such a list, which is now the new list # 1 in the document. It was simply to have a definition of “pharmaceutical product” that would be consistent with the criteria used for the new list that is now in the bill.

[Rob Sutherland-Brown, Senior Counsel, Legal Services, Justice Canada, Department of Industry]

It's all very complex and interrelated, but essentially, the original CAMR legislation, Bill C-9, made reference to things like the WTO waiver decision. To do that, a number of the definitions were technical; WTO is used, so there's a definition of WTO to tell you what the World Trade Organization is.

For “General Council” and which General Council, it tells you that. But it also, importantly, tells you about the “Decision”, which is referred to throughout the legislation as somebody importing or exporting in conformity with the authorization.

For “patented product”, again, it's a technical definition to tell you what it means. It's defined in terms of infringement. That's what this is about. It's about authorizing otherwise unauthorized users to infringe.

So these play both a definitional and a drafting role throughout the original legislation. Those references have been removed in Bill C-393, so they may or may not have much impact on Bill C-393 itself, but they do have an impact on the overall schema, in the sense that it loses the tie to the WTO agreements, both the main agreement and the TRIPS, the trade-related aspects of intellectual property agreement.

[Mona Frendo]

Clause 2 as it was put forward in Bill C-393 would have deleted the reference to schedule 1 and would have expanded the scope of eligible products for export under Canada's access to medicines regime to any drug as defined under section 2 of the Food and Drugs Act. That would have been the impact of clause 2 of Bill C-393. It would also have changed the definition of authorization under Canada's access to medicines regime to delete a reference that's currently in the act and that talks about a renewal system.

So together with other clauses in Bill C-393, it would have had the impact of removing any limits on the duration of an export authorization in CAMR. That would have been the impact of Bill C-393's clause 2.

In terms of the Liberal amendments, it does not affect Bill C-393's proposed changes to the definition of authorization, hence the issues with regard to no limits on duration continue. It also does not reinsert other definitions that were deleted by Bill C-393.

Currently the act defines things like “General Council Decision”, which is the WTO decision on which CAMR was based, and the meaning of “patented product”. There are a number of other technical definitions that, together with other elements of the regime, add clarity and help define what in fact the purpose of this regime is.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Yes. Essentially what happens here is that we are... As you know, in Bill C-393 there's a description of a pharmaceutical product, and we are now referring to pharmaceutical products that come under the new schedule 1 that we just finished talking about, that came from the Patent Act. There's the additional point that these are at the recommendation of the Minister of Health. So there's that fact that this is a list of medications approved by Health Canada.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

If this is done, what problems remain in this regard in Bill C-393?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

If you look at the current schedule in Bill C-393, we can argue about whether countries such as Poland, Singapore, and Hong Kong should be on the list. I didn't tackle that issue in what we're talking about today.

The reason I wanted to put this schedule 1 list of medications back in is that at the moment, the way the legislation is written, there is no defined list of medications.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Mr. Chair, it's really understood in the context of what we're talking about now plus the first two amendments I've put in. If you look at these three together, it makes sense--I think it makes sense. The intent was to get the list of medications back into Bill C-393. It had been removed.

The other schedule, the existing schedule in there, is the schedule of countries. Whilst I may have some problems recognizing that Singapore should be eligible for CAMR medication, I'm not going to go after that in today's discussion.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

That's right. So the effect of this amendment refers to schedules 2 to 4, but there's only one left right now. I'm not understanding where schedules 2 to 4 come in. I understand that by adding one more schedule—the schedule of drugs—you get one more schedule, but you're referring to schedules 2 to 4.

Bill C-393 leaves us with only one schedule. You're adding one. We don't have a schedule 3 or a schedule 4. So what do schedules 2 to 4 of the act refer to?

[Mona Frendo]

Bill C-393 proposed, as Mr. Marc Garneau said, to remove schedule 1, which is a list of drugs that was contained in CAMR, the drugs that were eligible for manufacture and export under the regime. It also contained three lists of countries--so schedules 2 to 4.

The countries that were included were least developed countries, countries that were WTO members, and others. Each of those lists had varying responsibilities as per the WTO requirements and they were classified according to their pharmaceutical manufacturing capacity and their level of development.

My understanding of Bill C-393 would be that it would remove all four schedules, as per clause 15.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

That's what I'm trying to clarify. I guess my question to the officials is what the impact of Bill C-393 is, so just for clarity, let's go back to the beginning.

What impact does Bill C-393, as it stands, have on the schedules?

[Brian Masse, NDP, Windsor West, ON]

Essentially what it does is ensure that CAMR is consistent with Bill C-393 in terms of the drugs and the countries. That's what will happen by these consequential acts.

Although TRIPS and WTO didn't require that list, it was built in during the original CAMR, for a number of different reasons. I'm agreeing to them even though I don't believe it's necessary, but at the same time, it is what was done before and there has been some concern expressed about that, so that will allow the current Bill C-393 to be consistent with the drugs and the countries and the language from the previous bill.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

I'm not talking about changing schedules 2 to 4 in the Patent Act. I'm not touching them; they're not affected by this. It's only bringing schedule 1 from the Patent Act into Bill C-393 and moving the existing schedule of countries to become schedule 2.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Except for the one that's in there, which is a kind of a composite of what were schedules 2 to 4. What I'm proposing is that the aim is to get a new schedule into Bill C-393, which is a list of drugs approved under CAMR, and that becomes the new schedule 1, and therefore the existing schedule in Bill C-393 becomes schedule 2.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

But Bill C-393 takes all of them out except one--

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Mr. Chair, what I'm suggesting, essentially, is that we take schedule 1 that exists in the Patent Act and make it schedule 1 in Bill C-393. The existing schedule that's in there right now would become schedule 2, so we'd have schedules 1 and 2.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

As you know, Bill C-393 deals with a part of the Patent Act that deals with the use of patents for international humanitarian purposes to address public health problems. In it there are four schedules. One of them is a list of drugs that are approved under CAMR. The other three are lists of countries that have a slightly different status.

As you know, Bill C-393 in clause 15 sort of eliminated those, so we're left with one schedule at the back, which is a schedule of countries only. My aim, with a couple of these amendments, is to reintroduce the schedule 1 that is in the Patent Act and that lists eligible drugs under CAMR as approved by the Minister of Health.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

I'm glad Mr. Malo led off with a discussion about compromise and willingness to work and make this bill better, because we still have an opportunity to do so.

So towards that common good, I have several suggestions today in support of this Liberal amendment. Although I don't believe it is necessary under WTO and TRIPS in the agreement, it has caused some concern for some members, and I certainly value their input and suggestion on that. This also, then, provides for CAMR to reach its current footprint, although restricted to some degree. At the same time, it would still be of benefit if we passed further amendments to the bill.

I'll suggest as well that I'll be dropping issues, such as the changes to the food and drugs safety act, as a compromise to make sure that we can actually get a bill passed in this chamber to report back to the House of Commons that will improve CAMR.

I'm hoping that the Bloc and the Liberals will be open to those amendments that are certainly going to strengthen the bill but also will serve the purpose at the end of the day. There are certain ones that will create some difficulty ,but there are other ones like this one, where I'm certainly willing to live with the consequences. Unfortunately, the drugs won't reach as many people in different nations, but at the same time, with all due respect, it still creates the environment we currently have.... There are other things we can do in Bill C-393 that will actually improve the bill. So in that spirit I will support this amendment and its consequential amendments.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Malo.

Certainly the committee might want to comment on what would be an additional report on the evidence we heard, on top of the issue we're seized with right now, which is the clause-by-clause consideration of Bill C-393.

But I have acknowledged that Mr. Masse wanted the floor, so go ahead, please, Mr. Masse.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Mr. Chairman, before we proceed with clause by clause consideration, if you don't mind, I would like to start by thanking Committee members.

As you know, I am not a regular member of this Committee. I want to extend my deepest thanks to all of you for the work we have been able to accomplish. I also want to thank the analysts and the clerk for their cooperation throughout this study.

I would just like to remind you, Mr. Chairman, that when we heard from officials at the Committee's first meeting, I pointed out that in examining Bill C-393, it would be important to look at the issue as a whole. I suggested considering an approach based on the model in Bill C-393, of course, in order to take advantage of APOTEX's experience with Rwanda. I suggested we take a look at our approach to be sure we could really help people, specifically in Africa, where they have a greater need for medications to treat HIV/AIDS.

At the time, I gave you a fairly extensive witness list. I want to thank you for trying to accommodate as many witnesses as possible so that, in a way, both perspectives could be heard.

However, now that we have heard from these witnesses, we are going to be moving to the next steps in this process, which means carefully considering the testimony we heard in order to find appropriate solutions. On the very first day of testimony, when we heard from officials, it was clear that, in their opinion, Bill C-393 was not the ideal solution, because a number of parameters had been defined in the bill with respect to our international commitments. That is something that should be preserved.

However, considering how the system has been used, we clearly have a 100% success rate. It was used there once and it worked well. It is clear that the goal of many of the witnesses we heard from, including those representing the National Action Committee of the Grandmothers-to-Grandmothers Campaign, who were here at our last meeting, was for more medications to be made available. So, I think there is good reason to review the system, all the commitments that have been made and the resources available to Canada to do more and do better.

Mr. Chairman, I know that the mandate of this Committee, both today and throughout this study, was to examine Bill C-393. I also know that the Committee has a full schedule, and that its work plan includes several bills and committee studies that have yet to be addressed. At the same time, however, I think we need to take the time to report the testimony we heard to the House and put down in writing some of the representations made as part of that testimony. That way, it would be possible to look for ways to improve the system while still keeping the current framework, and draft a list of irritants. We could also include in that report what is currently being done, as well as what we are suggesting in order for Canada to do better and do more.

I would like to repeat what representatives of the National Action Committee for the Grandmothers-to-Grandmothers Campaign said to us at the last meeting. They said that they had been to Africa, that they had seen a certain number of things, that they had made commitments to the grandmothers of Africa and would report back on what the House of Commons and the Committee decided to do for them. So, I think it would be sad if, upon completing our examination of Bill C-393, we simply closed our books and moved on to something else, without trying to go a little further.

Given the comments we've made and what we can do in relation to Canada's international obligations as a signatory, I think it would be rather sad if we didn't make the effort being asked of us, which is to refer this issue back to the House.

Thank you very much for your attention, Mr. Chairman.

[The Chair, Conservative, David Sweet]

Good morning, ladies and gentlemen.

Bonjour à tous. Welcome to meeting number 41 of the Standing Committee on Industry, Science and Technology.

We are going to be doing a clause-by-clause review of Bill C-393 today.

Before I begin, I'd like to introduce our experts from the public service who are with us today. We have with us Colette Downie, director general, marketplace framework policy branch, Department of Industry; Rob Sutherland-Brown, senior counsel, legal services, Justice Canada; and Mona Frendo, director, patent and trade-mark policy directorate, Department of Industry. From the Department of Foreign Affairs and International Trade, we have with us Edith St-Hilaire, director, intellectual property, information and technology trade policy division. Finally, from the Department of Health, we have Lisa Lange, associate director, bureau of policy, science and international programs, therapeutic products directorate.

Thank you very much for joining us today and giving us your expertise as we proceed to this bill.

Mr. Wallace.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Okay. All right.

Mr. Schwartz, there are different interpretations as to whether C-393 would result in a violation of our TRIPS agreements, and we've heard different people say it does and others say it doesn't. I believe you fall into the camp that says that we could be challenged on it. You spoke about article 31, and you spoke about the waivers associated with pharmaceuticals in certain cases.

I'd like to get a little bit more of a feeling. Let's say we have a situation where Canada is challenged. Let's say C-393 is accepted and we are challenged. What are the practical implications for a country like Canada? Intellectual property is pretty dry stuff. But for Canadians, I think it's important for us to understand the implications if somebody successfully challenges Canada on a violation of the TRIPS agreement.

[David Schwartz, Chair, Biotechnology Patents Committee, Intellectual Property Institute of Canada]

Thank you, sir. Bonjour, and good morning.

My name is David Schwartz. I'm a lawyer and a patent agent. I'm a partner in the firm Smart & Biggar, and I appear here today on behalf of my professional association, the Intellectual Property Institute of Canada, or IPIC.

I'm pleased to appear before you today on behalf of IPIC.

IPIC is the professional association in Canada of patent agents, trademark agents, and lawyers practising in all areas of intellectual property law. I'm the chair of IPIC's biotechnology patents committee and appear here today in that capacity. I have practised exclusively in the patent field for 17 years. My technical background is in genetics and my work principally involves assisting inventors in obtaining patent protection for their innovations at the Canadian patent office and those of other countries.

I hope I can provide some contributions to the very thoughtful and informed discussion we've heard this morning.

It's accepted that innovation is important to the economic and social well-being of our country. Patent legislation is a key element of any country's innovation system, and this legislation must achieve a fine balance between competing policy goals and must conform with a number of international treaties.

IPIC's expertise is in intellectual property law and not the manufacturing of medicines or the policy concerning assistance to developing countries. Our submission, therefore, is limited to studying the compliance of Bill C-393, in the form that we've seen it so far, I would emphasize, with the TRIPS agreement, and its possible effect on the patent system in Canada and elsewhere.

The TRIPS agreement of the WTO sets out agreed minimum standards for the protection of intellectual property rights. Member states may therefore provide more extensive protection than required by TRIPS, but they're not permitted to establish laws that provide less protection than required under the TRIPS agreement.

To use a very simplistic analogy, consider speed limits in school zones. If a provincial law, a law of Ontario, requires that the speed limit in a school zone be no more than 40 kilometres an hour for safety, the City of Ottawa would be permitted to lower the speed limit to 30 or 35 kilometres an hour, but we couldn't raise it to 50. I am going to come back to that point toward the end of my comments.

Article 31 of TRIPS provides for use of a patent invention by someone other than the patentee without the authorization of the patentee, in certain circumstances. Now importantly, paragraph (f) provides that the use of the invention shall be authorized predominantly “for the supply of the domestic market”. That would mean Canada. There are also requirements about remuneration of the patentee in the domestic market. These requirements are problematic for those countries that don't have the manufacturing capacity or technical expertise in their own markets, that is, in their own countries, to make and use a patented invention, even if they had the authorization to do so.

So the general council decision of the WTO in 2003 implementing paragraph 6 of the Doha declaration provides a solution to this problem—and I know we've already heard about it this morning. It waives paragraphs (f) and (h) of article 31 for pharmaceutical products in certain circumstances and sets out the requirements of a country, typically a least-developed or developing country, to import patented medicines under the waiver. The general council decision is, of course, implemented in Canada in the Patent Act as CAMR.

I emphasize these two points because the Canadian legislation must therefore comply with two significant aspects of TRIPS. First, there must be requirements for the rest of article 31 that wasn't waived. Second, the waiver of paragraphs (f) and (h), if it's to be used, must be done in accordance with the requirements of the general council decision, which is that it be used in good faith to protect public health, and not as an instrument to pursue industrial or commercial policy objectives. This purpose would be defeated if products supplied under the decision were diverted from the markets for which they were intended. Accordingly, all reasonable measures are to be taken to prevent such diversion in accordance with the relevant paragraphs of the general council decision. These overarching principles are explained in the chairperson's statement that was associated with the general council's decision, which I'm effectively quoting from.

If the Canadian legislation is not in compliance with TRIPS, the legislation is at risk of being challenged under the WTO dispute settlement procedure. Twice already, both times in 2001, it has been necessary to amend Canada's Patent Act as a result of challenges by other countries, where the WTO found that our law was not in compliance with TRIPS. In one instance, the challenge involved a complaint by the European Union about our stockpiling provisions, which Mr. Dearden mentioned. There was another instance, also in 2001, where we amended the act to change the term of patent protection after a complaint by the United States. So twice already we've amended our act in recent years because of complaints.

Objections in an international forum that our Patent Act doesn't comply with TRIPS create uncertainty and may diminish Canada's reputation as a country that respects IP rights, negatively affecting domestic and foreign investment in research and development. Thus, in our view, it is important that CAMR be compliant with TRIPS, so that it does not invite objections as described above.

This involves not only ensuring that the black-letter provisions of article 31 and the general council decisions are met, but also ensuring that the procedural aspects of the legislation provide the appropriate, practical safeguards to ensure that the purpose and intent of the waiver set forth in the general council decision is met.

To return very briefly to my speed limit analogy, sure, we can set a speed limit of 35, but if we don't inform the public of the speed limit, if we don't post signs, and if we don't have police to monitor the speed, then the limit is really, for practical purposes, not effective. So we have similar concerns with respect to some aspects of C-393.

To conclude,C-393 has clearly created debate. We've learned that this week and last week, and it has raised awareness about very important issues. However, as you'll see from our very detailed written submissions, we have concerns with respect to the bill's compliance with TRIPS and the general council decision, and we've identified some patent-specific issues as well.

Thank you for inviting us to appear.

Thank you for inviting our association to appear here, and I'd be very pleased to address any questions you have today.

Thank you.

[Jim Keon, President, Canadian Generic Pharmaceutical Association]

Thank you, Mr. Chair.

Thank you, ladies and gentlemen.

We're pleased to have the opportunity to speak to Bill C-393.

I represent the generic pharmaceutical industry, which has been an important part of the Canadian economy and health care system for more than 50 years. We are fortunate to have a large and sophisticated generic drug industry in Canada. Today it directly employs approximately 12,000 Canadians in high-skilled manufacturing and R and D positions.

Most of the generic drugs sold in Canada are manufactured in world-class facilities right here in Canada. The largest drug company in Canada, brand or generic, is Ontario drug maker, Apotex. The largest drug company in Quebec, brand or generic, is Pharmascience, also a generic.

Our industry fills six out of ten prescriptions in Canada today, and that number is growing quickly. There has been talk recently about the price of generic medicines in Canada and the ability to supply good-quality medicines at good prices abroad. Generic prices in Canada have traditionally supported pharmacy strongly. That system is changing. Provincial governments are changing that system. Generic drug prices in Canada have come down dramatically over the past year, as pharmacy funding is now being looked at in a different manner. Generic drugs have provided value for the Canadian health care system and are providing better value than ever.

In addition, Canadian generic drug makers actively support international humanitarian aid efforts. CGPA member companies are among the leading donors to Health Partners International of Canada, a non-profit relief and development organization that works through other partnerships to increase access to medicine and improve health in the developing world.

Our members are also active more recently in relief efforts in Haiti, donating millions of dollars worth of medicine through organizations like World Vision, Feed The Children, and Health Partners International.

This committee is studying a particular mechanism aimed at delivering drugs for humanitarian purposes to the developing world, Canada's access to medicines regime. The World Trade Organization decision, which is a decision of 120 countries, that led to the creation of CAMR, is a result of international recognition that the needs of the developing countries were not being met solely by the brand-name industry. Brand companies were generally unwilling, without competition, to lower their prices for drugs under patents to levels that these developing and least-developed countries could afford. That's why the international community came together and developed the so-called Doha agreement.

CAMR provides a legal and regulatory mechanism under which generic manufacturers in Canada are permitted to develop, produce, and export medicines covered by domestic patents to developing and least-developed countries for humanitarian purposes.

We've heard about some of the complexities of the regime, and we know that despite those, Apotex has developed and produced two shipments of its triple combination AIDS drug, Apo-TriAvir, to Rwanda. Unfortunately, the company has publicly stated that it will be difficult to use the regime again without changes being made.

There has been a lot of discussion this morning about whether CAMR works in its current form. The Canadian Generic Pharmaceutical Association's answer is no. Apotex's answer is no.

The problem with CAMR, which makes it ultimately unworkable, is the licensing scheme. The WTO decision that led to the creation of CAMR outlines four basic requirements that need to be met for an exporting country to grant a compulsory licence to a generic manufacturer, and these could have more easily been implemented by Canada. Instead, the CAMR licensing process is backwards; it is largely a process controlled by the interests of intellectual property rights holders and not the interests of those who desperately need access to life-saving medicines in times of health crises.

As outlined in our brief, CGPA supports the changes to the Patent Act that are outlined in Bill C-393. In our view, the streamlined application and licensing process in the bill embodies the spirit of the Doha declaration and the WTO decision, while at the same time ensuring Canada's compliance with its TRIPS obligations.

We have one issue with the bill, and that relates to the proposed amendment to the Food and Drugs Act that would allow for foreign drug approvals under CAMR. In our view, this is not necessary, and it's not supported by our association. The generic pharmaceutical industry continues to support a Health Canada approval.

With that, I will conclude my remarks, as I'm sure you will have several questions for the panel. I would be pleased, along with my colleague, to answer any questions you may have regarding Canada's access to medicines regime.

Thank you.

[Dr. Frank Plummer]

Good morning again.

My name is Frank Plummer. I'm the scientific director of the National Microbiology Laboratory in Winnipeg and the chief scientific officer with the Public Health Agency of Canada. I'm also a distinguished professor at the University of Manitoba and a physician scientist who has spent his career working on HIV and AIDS in Africa. It is in those latter capacities that I'm appearing before the committee today.

I would like to thank the committee for soliciting my input and giving me the opportunity to talk about some of my work and, moreover, allowing me to appear from Seattle. I'm attending an important meeting of the Gates grand challenges in global health program, which I couldn't afford to miss.

I'd also be remiss if I didn't thank the Gates Foundation for the gracious loan of their video conferencing facilities.

I know the committee is reviewing legislation to make Canadian-made generic drugs still under patent by non-generic pharmaceutical companies more accessible and affordable for developing countries, and that the original legislation was targeted largely to antiretroviral therapy for HIV.

First I'd like to tell the committee about some of the amazing work Canada has done related to the HIV epidemic in Africa. I lived in Nairobi for 17 years, directing a highly acclaimed collaboration between the universities of Nairobi and Manitoba. The research done through this collaboration was among the first to recognize that HIV was widespread in East Africa and did pioneering work to understand the epidemic and how to prevent the transmission of HIV.

As committee members will know, HIV is transmitted primarily through heterosexual relationships in Africa, and it also spreads from mother to newborn child. Through research funded largely by the Government of Canada, we learned that commercial sex is a key driver of the HIV epidemic. Ordinary sexually transmitted diseases such as gonorrhea and chlamydia promote HIV transmission. Circumcision of men reduces their susceptibility to HIV, and breast feeding is an important risk factor for transmission of HIV from mother to child.

Each of these understandings was translated into effective interventions by our group and ultimately changed global health policy. They make up the core of effective HIV prevention in Africa and elsewhere. Many tens of thousands of people don't get HIV infected each year because of this foundation work done by the universities of Manitoba and Nairobi and funded by the Government of Canada.

This long-standing collaboration and my involvement in it continue. This year we celebrated our 30th anniversary. In recent years the research work of the collaboration has focused on understanding natural immunity to HIV. This work, which may discover how to make an HIV vaccine, is funded by the Government of Canada and the Bill and Melinda Gates Foundation, which is why I'm here in Seattle today.

The work is carried out in a state-of-the-art laboratory complex built and equipped with a grant from the Government of Canada through the Canada Foundation for Innovation. So Canada has done and continues to do a lot in the fight against HIV and AIDS in Africa.

Now to Bill C-393. It is beyond my competence to comment on whether the current legislation and proposed amendments to it are problematic or not. I know there's been criticism of the effectiveness of the current program and only one country has yet accessed it. However, I doubt that the structure of the Canadian program has anything to do with why it's not being used. I think most likely the original, well-intentioned program was overtaken by events. The global fund to fight HIV, tuberculosis, and malaria, the U.S. PEPFAR program, the President's emergency plan for AIDS relief, the availability of high-quality antiretrovirals from generic manufacturers elsewhere, and drops in the price of non-generic drugs all contribute to a lack of interest in the Canadian program, and that's seen with other programs of a similar nature around the world.

Unfortunately, you were unable to hear from my colleague, Dr. Kimani from Nairobi, but it's his experience that availability of antiretroviral drugs is not the real problem. The ability to deliver high-quality treatment programs with qualified personnel is more of a problem.

While I'm certainly supportive of making antiretroviral drugs available to those who need them, I would also remind the committee that the current antiretroviral drugs are not cures. Importantly, they prolong life; however, it's my belief we will not solve the HIV pandemic by treating AIDS. People are becoming newly infected with HIV at a far greater rate than they are being put on treatment. Furthermore, treating AIDS is many times more expensive than preventing an HIV infection. We know how to prevent new infections effectively and inexpensively, and in my view, far too little emphasis and investment has been put into simple preventive strategies that we know work. We also need to focus research on technologies to prevent HIV transmission such as a vaccine or a microbicide.

I'll close there with a thank you for asking me to speak to you today, and for your attention. I look forward to your questions.

[Robert Bouchard, Bloc, Chicoutimi—Le Fjord, QC]

You're talking about voluntary measures. You also said, Mr. Williams, that there's room for improvement. Aside from the amendments set out in Bill C-393, what changes could remedy CAMR's shortcomings?

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

I would ask that maybe the research providing the testimony from Apotex, which was provided in the Senate with regard to Bill S-232--because they did answer on that--be distributed. That may be the next best thing we can get, because it is official, on-the-record testimony under the same rules as that of the House Commons.

Ms. MacLean, you made me smile when you talked about the watch, because that was one of the things we were told. I've heard these condescending arguments about “oh your intent is good”, and “if you just understood things a little bit better....” It diverts people from the real issue, which is that Parliament decided there was a role for the private sector to play with regard to this human catastrophe we have across the globe. We, as the public sector, could continue to do, and should do, some other things, such as what Mr. Williams was suggesting, and as common global citizens we could use public sector money to build that infrastructure. But the legislation is set up with the intent, and to recognize, that the members of the private sector, especially given the fact that they get generous research and development and a series of other tax breaks, could actually expand the usage of those terrific breakthroughs. We thank them for the work they're doing, and as long as that information was protected and respected, we would develop a system to expand the use of patents across the globe.

Mr. Perry, we've had only one case so far with Apotex. Say, for example, Bill C-393 went through and we had five per year that were granted from there on. I'm speaking hypothetically. Would that drive away investment from your company, from Canada, because the usage of that went further?

[Linda Watson]

I'd like to answer them all, but I will start by saying that I don't believe, with all due respect, that voluntary donations are an answer. Mr. Williams has quoted that something like $235 million worth of product has been donated by brand-name pharmaceuticals since 1990. When you divide that by the number of years and the number of companies, that's $265,000 a year. That does not substantially address any issue in the southern world.

Second, preferential pricing would still only bring prices down to one-quarter of the price in the developed world, whereas generic competition has dropped the prices 17 times over against brand-name prices. The generics have to be part of the picture. It's not an option. That's where the action is. That's what's saving lives right now.

Also I just have to take issue with some of the comments. I believe it was Mr. Williams who said that he regretted that time was being wasted on Bill C-393 when we could be spending our time more fruitfully coming up with answers to some of the other kinds of issues of infrastructure and sanitation and all those sorts of things. I believe the House of Commons is the body that decided Bill C-393 was deserving of the attention of this committee, and we are doing House of Commons business, the business of Canadians, and it's right that we do it well.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

I want to begin by saying to Mrs. Rennie that her testimonial was very moving, and the part I remember the most was her comment that this can only be solved if we increase the supply of medicines to those who need them.

I've had the pleasure of having the Grandmothers for Africa twice in my office during the past year. I had two grandmothers, so I know how powerful grandmothers can be. I want to say again, with respect to the intent, I share that intent 100% to get those medicines to those who need them.

I'm an engineer. I think in very Cartesian terms, and I'm saying to myself, some people are saying that CAMR doesn't work as written and we need Bill C-393. Other people say it does work and we don't really need to focus on that, but rather we should be focusing on all of the other challenges with respect to infrastructure and other matters, which I think you probably agree with, that all those other things also need to be addressed.

But as part of my trying to understand this argument, it's very difficult for me to understand who is right, because the positions are diametrically opposite in many ways. I dearly wish that Apotex had been here this morning. It's very unfortunate they're not here, because I had some definite questions to ask them.

Given that they're not here, I'm going to ask my questions to Mr. Perry and Mr. Williams, and I'm coming back to this issue. Under current CAMR rules there's been one case, the Rwanda case, and Apotex was involved. I want to hear again, because this timeline is really confusing me. It was 68 days that was supposedly required for the three providers of patent medicine to grant a voluntary licence to Apotex. Then it took a year for the medicines—supposedly 15 million pills were authorized—for the first batch to get there, and then another year for the second batch.

I'm trying to understand why, when it appears that the process worked well in terms of granting of the voluntary licence, it took a year to get the medicines over there. I'd like to understand that a little bit better, so I'd like to hear your interpretation. I wanted to ask this question of Apotex, but they're not here. I'd like to ask Mr. Perry and Mr. Williams what their view is of that.

Mrs. Rennie and Mrs. MacLean, I'd be glad to hear your views too.

[Laurence Dotto, Director, Government and External Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)]

Thank you.

I'm very happy to be here today. I have been volunteering in Africa for eight years through our family-focused charity that provides assistance to women and children in Malawi. So far, we have successfully completed more than 15 local sustainable development projects, which were mostly health-oriented.

When I first visited Malawi, in 2003, access to HIV testing was extremely limited. Companies like Abbott provided free screening tests, but administering those tests was always an issue.

Today, fortunately, testing is much more widespread. There are HIV treatment programs in rural areas, and most small hospitals have now set up HIV programs with trained volunteer counsellors, paid counsellors, and are receiving antiretroviral drugs through several NGOs.

Today, the drug supply issue has essentially been solved in many of these countries. Generic HIV drugs are starting to stream in from India and South Africa. Hospitals today are receiving free HIV drugs and free antimalarial drugs through these NGO government partnerships.

In my view, the biggest challenge facing countries like Malawi today is a continuing absence of health care infrastructure. There's only one doctor for 50,000 Malawians and one nurse for 20,000 people. As well intentioned as Bill C-393 may be, it does not address the real challenges, the core issues of poverty, education, nutrition, and access to basic health care faced by less developed countries.

In my view, if Canada were to make a serious contribution to the fight against HIV/AIDS in Africa, here are a few priorities to consider: greater support for prevention of mother-to-child transmission counsellors who go from village to village and counsel and test pregnant mothers; more mobile health clinics to travel to the villages; and how about transportation funds to allow an HIV-positive mother to take that minibus to an ARV clinic that's two days' walk away from where she lives?

Programs to identify HIV-positive children are urgently needed so they can find their way to a treatment program. With 80,000 HIV-positive children in Malawi and only a few hundred in Canada, what could be more important than trying to support the Malawi of tomorrow?

In my view, these are the real needs and these are the practical ways to build a more effective health care infrastructure in countries like Malawi.

[Angus Livingstone]

That's as close as it comes.

At the outset, I'd like to acknowledge that I'm not speaking to you on behalf of the University of British Columbia but rather as a member of the university community, and the views expressed are my own.

I'm very proud to say that in 2007, UBC was the first Canadian university to publicly adopt the global access principles, which, stated briefly, make a commitment to making UBC technologies available to developing countries for health, environmental, and security purposes. This position was strengthened in 2009 as we worked with Yale and Harvard to develop the statement of principles and strategies for equitable dissemination of medical technologies.

To date, UBC has included a number of global access provisions in its licence agreements, including requirements for compulsory licensing, at-cost provision of medicines, and return of country of source. UBC and its affiliated hospitals conduct over half a billion dollars of research annually, and about 60% of that is in the life sciences.

My world has changed dramatically in the past five years, and technology licensing is increasingly difficult with the global distress of both the biotech and venture capital industries. Meanwhile, government is asking us to demonstrate a return on investment on the considerable funds that they have given us to conduct research.

It's in this difficult environment that I am seeking global access terms in my licence agreements, and it can be a very difficult sell. Drug development is an expensive and risky business without adding global access provisions that would only be implemented after drug approval some 10 or 15 years hence, when the world that we all know will look considerably different than it does today.

In reviewing Bill C-393 and the previous hearings, some things are clear to me. Everyone salutes the goal of making medicines available globally to those in need. There are many stars that must align, from the access to affordable drugs, to local infrastructure, medical personnel, water, sanitation, and other social determinants. While Bill C-393 may help alleviate the access to affordable drugs issue, in and of itself it is insufficient to ensure access to those in need. However, it does seem reasonable to remove the cost barrier in areas where they may exist, and such is the intent of Bill C-393.

Given the need for pediatric formulations, access to second-line drug regimes, and changing patent laws in India and China, the need to access patent medicines may arise more frequently.

My caution lies in the implementation and the potential unintended consequences as the pendulum swings from regulations that, by virtue of Apotex's Rwanda experience, have been seen to be cumbersome and unwieldy to the one-licence, all-country unlimited solution proposed by Bill C-393, which, in my opinion, lacks sufficient checks and balances.

In particular, I am troubled by the lack of country-by-country approval process and a licence bound by time. Couple this with the opportunity for countries to accept drugs not approved by Health Canada or the pre-qualified program of the WHO and there is potential for drugs without adequate safety or efficacy profiles to be in circulation. Removing requirements for specific marking, colouring, or labelling invites diversion opportunities both to other countries and also to other economic classes within the country of destination.

While diversion has not been a substantive issue to date, I know that 95% of the WHO's essential medicines are off patent and the incentive for diversion will increase with the costing control in the differential associated with patented drugs, which is the subject of Bill C-393.

Another legitimate concern expressed to me by companies in the first world market is the potential for first world market consequences of third world market adverse medical events. This could result in the regulatory halt of the drugs used in Canada and/or a substantive drop in market opportunities.

Finally, I think we need to consider the possible consequences of one major event related to either diversion or adverse medical events. This, in my belief, would reduce the R and D investment potentially funded by pharmaceuticals in Canada. That being the case, it could diminish our ability to develop drugs within the country and certainly my abilities to license them in the university environment. If that's the case, it could result in reduced access to medicines by Canadians.

Pharmaceutical development is a global business, and it's possible for industry to avoid jurisdictions that present unacceptable risks.

In summary, I support the revisions to the Canadian access to medicines regime to improve the efficiencies and effectiveness, but this must be balanced with adequate checks and balances to ensure that access is delivered in a controlled and accountable manner.

Thank you.

[Linda Watson]

I'll just say that we have brought in this morning 3,000 additional pieces of correspondence, and more has been added just now, to the already 9,000 pieces of correspondence that have come from Canadians across this country to this committee in support of Bill C-393.

[Richard Dearden]

The requirement in CAMR now for Health Canada approval actually isn't mandated by the general council decision, but I don't think anybody, the generics or the innovative drug industry, object to the requirement being in there that safe drugs actually do get exported under the compulsory licence system.

My problem, Mr. Wallace, with any drug is that the “pharmaceutical product” definition in the general council decision was looking at epidemics and serious problems, not lifestyle drugs. Bill C-393 is offside, in my opinion, because it applies to all drugs, not the ones that we see in schedule 1, which is a limited list. That puts it offside there.

My colleague also wanted to add something, so I'll give him my time.

[Rachel Kiddell-Monroe]

I have a very quick comment to make, Mr. Bouchard. I don't think that there's only one possible solution. There are many initiatives Canada could undertake. Bill C-393 is one of them; it can help. There are certainly other initiatives that could be undertaken. The Global Fund to Fight AIDS, Tuberculosis and Malaria is very important. The funding Mr. Lake talked about earlier is a very important Canadian contribution.

Canada can also help without Canadians incurring costs. It can do that by simply letting our pharmaceutical companies, our generic medicine manufacturers, do their work properly. Those companies have developed very specific products that could really have a major impact on the global health scene.

[Robert Bouchard, Bloc, Chicoutimi—Le Fjord, QC]

Correct me if I'm wrong, but you said earlier that we should forget about Bill C-393, CAMR, because it doesn't work. We should, instead, direct our energies toward other kinds of reforms.

What do you suggest Canada do to help the cause?

[Dr. Frederick Abbott]

Thank you very much, Mr. Masse.

It is pretty clear, as a matter of the TRIPS agreement and the August 30 decision, that it is perfectly permissible for Canada to adopt a single-licence solution in which a substantial quantity of drugs is provided over a period of time. There is no requirement in the August 30 decision that the sequencing involved in the Canadian legislation be followed. Provided that notifications are provided at the time the drugs are shipped, Canada will have met all of its international obligations.

Let me add another point. There is no country in the world that is going to initiate a dispute settlement action at the WTO against Canada for providing low-cost drugs to poor people in developing countries. I repeat, no country in the world is going to bring a dispute settlement action against Canada for providing low-cost HIV antiretroviral medicines to people in developing countries at low prices.

Even assuming there were a morally and ethically challenged country that would do that, the worst-case scenario for Canada would be that after a period of three to five years it would have to fix what might be considered wrong with its legislation, and Bill C-393 is not inaccurate.

I want to make one other point. This argument by Mr. Attaran I find absolutely astonishing—and that Canadian parliamentarians are actually caring to echo it. His argument basically is that Canadian pharmaceutical producers are incompetent and cannot compete on global markets. And because they are incompetent and cannot compete on global markets, we should not let them compete on global markets. It's as if to say that because Canadians are not very good at playing basketball we should prevent Canadians from playing basketball and from joining any league that plays basketball.

Apotex supplies a large quantity of drugs to the highly competitive U.S. market. Teva Novopharm is one of the most competitive and largest suppliers of generic drugs in the world. The idea that Canadian industry is unable to compete with Indian industry—and I represent the Indian industry—I find absolutely an astonishing argument for preventing them from attempting to compete.

What are we talking about? We're talking about changing a few words on a piece of paper in Canada: we let you compete. The argument from Mr. Attaran is that we shouldn't change the piece of paper; because they are providing higher-priced medicines, we should foreclose them from competing. I really just find this argument so nonsensical it's hard for me to believe that a group of parliamentarians is sitting in a room accepting it.

I apologize for going on like that, but it's just such a nonsensical argument.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr.Chair.

Mr. Attaran, you've actually convinced me, as someone who has sat through this entirely over the last number of years, even when this was Bill C-56, to continue my efforts even more than ever before. Even looking at the face of your argument, you're actually advocating for generic rip-off drugs to get to people, as opposed to Canadian drugs. That's what would happen and would continue to happen under your scenario.

You used the word “unethical” in terms of the medical aspects of this. I find it unethical.... If you don't believe in Bill C-393, then come here with a solution that's actually going to help. I stood in the halls of Parliament when we all stood together to say that we wanted to make a difference, wanted this law to actually work.

I want to use my time with Mr. Abbott, who has actually been there. Mr. Abbott has spent his time at the WTO, has spent his time on the TRIPS, has advocated for a number of different groups and organizations.

Mr. Abbott, we've heard from the department and the lawyers here that we're going to violate pretty well every international treaty under the sun—now including NAFTA—by working on this bill, but at the same time that this bill won't even work. It's an interesting scenario, but I would like from you your testimony about why Canada won't be violating any international agreement by changing this bill, or how we can do it.

[Rachel Kiddell-Monroe]

Yes, I absolutely do, and I think that is because of the entrance of generic competition into the market and bringing down the prices. That's exactly why that has been accomplished. We also have to remember there are still nine million people who have HIV/AIDS who do not have access to treatment. Those people are desperately in need. There is still a huge need, and the second-line, third-line drug issue is a big issue.

India is not going to be the solution to that. One of the big reasons is that many of those drugs are under patent in India. Due to its compliance with the WTO from the first of January 2005, it can no longer just produce many of those drugs under generic versions, so its prices will be higher.

Canada has a role to play in order to bring another player into the market, have their generic companies.... When Apotex came into the market, it forced Indian companies to go and make sure that their drugs were of adequate quality and get them pre-qualified with the WHO program. This was a hugely important aspect of what Apotex managed to do.

If the limitations are taken off, as would be the case under Bill C-393, we would be able to provide another player in the market, which would encourage competition.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Thank you, Mr. Chair.

Thank you to the witnesses for coming today.

Ms. Kiddell-Monroe, while you and I may disagree on some aspects of this, I definitely appreciate the passion that you have for the issue. It's clear that you have a tremendous passion. And around this table--and from what Mr. Garneau said as well--if the question is do we want to help the people of Africa who are suffering, absolutely, I think that you'd find agreement all around the table and in this room. The question we're trying to answer today is does Bill C-393 actually accomplish this, or are there other things that are working or that we should be focusing on to accomplish this?

I go back to Mr. Kilby's testimony before the committee here the other day, when he was talking about the numbers of people who are receiving antiretroviral drugs. He talked about the numbers in 2003 and he said that 400,000 were receiving those drugs; by 2005 we got up to 1.5 million; and by the end of 2010 we expect to get to 5.2 million people being treated. That seems like a significant number. In fact Mr. Kilby, to quote him from the meeting, said:

Essentially a comprehensive model for care many believed could never be built emerged in a few short years. What has been accomplished is nothing short of a miracle, 5.2 million people on treatment by 2010.

Do you agree with what Mr. Kilby had to say regarding the progress?

[Rachel Kiddell-Monroe]

Bill C-393 actually specifically addresses some of the barriers that we saw in trying to use the legislation.

First of all, in terms of the countries and the notification, the system under the current regime makes a country declare its intention to the WTO to ensure compulsory licence. This is a huge barrier for developing countries when they face repercussions that they have from the U.S. government, from the European Union, and from pharmaceutical companies themselves. Bill C-393 will remove that barrier; that's the first thing.

The second thing is it's a one-licence solution. It simplifies it massively from the situation that we have now. It removes the need for the long period of voluntary licence negotiations. When there is a need there can be simply one licence issued by the Canadian government.

The other issue is that the proposed bill will remove the two-year limit on the compulsory licence and remove the quantity requirements. This is extremely critical, because what happened was that Rwanda made an order for a specific number of people, for a specific number of drugs. After they'd put in that order they realized that they actually needed more. In order for them to increase their order they had to go all the way back through the process from the beginning.

This new piece of legislation would remove that need. It will no longer require countries to be specifically identified; it will enable a licence to be given for an order for drugs for those countries that are listed. So that's how it still makes sure that it only goes to those countries that are listed, that are needed for this.

That will definitely go to the whole issue of creating a market. For a company like Apotex, while they said they would not use the CAMR as it stands again, they would, however, use the reformed CAMR as proposed under Bill C-393 and they deliberately said that they would produce a pediatric version of the Apo-TriAvir for export.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

First of all, thank you to the witnesses for your presence here this morning. This is a passionately debated issue, and I want to say for the record that I subscribe 100%. I would be out at the front of the parade with respect to any mechanism that will assure that we can get HIV/AIDS, malaria and tuberculosis, and other medicines to those who need them in Africa. I want to make that very, very clear from the beginning.

Ms. Kiddell-Monroe, thank you for your testimony. I'd like to hear from you succinctly in your opinion why Bill C-393will, if not open the flood gates to this medicine that is so needed in countries...why it will solve the problem.

[Dr. Frederick Abbott]

Good morning.

I appreciate the opportunity to appear before the committee regarding the bill to enact proposed changes to the CAMR.

I appeared before this committee on March 10, 2004, during what was then consideration of Bill C-9, which, as amended, was ultimately enacted as the CAMR. In the course of dialogue with committee members in 2004 I raised several concerns regarding the terms of the then draft legislation. I was of the view that a number of the restrictions and limitations under consideration would hamper effective use of the legislation as then proposed.

Though some improvements were made in the legislation prior to its adoption, it was clear that Canada had decided not to take full or effective advantage of the flexibilities in the TRIPS agreement, the Doha declaration, and the August 30 waiver. It was foreseeable that limitations would significantly restrict the ability of the CAMR to address very serious public health problems confronting developing countries, with limited or no capacity to give effect to compulsory licensing. It's therefore not surprising that this committee is revisiting CAMR with the objective of making it a more effective and useful mechanism.

Let me spend a few moments explaining why I might reasonably be considered to have expertise on the subject of legislation to implement the August 30 decision. I've written and published extensively on the subjects of the TRIPS agreement, trade and IPRs, and on the relationship between that subject matter and public health, including access to medicines. I regularly have served as an expert consultant to the World Health Organization, the World Bank, the WTO, UNCTAD, and other multilateral organizations regarding trade, IP, and public health matters.

I served as legal consultant to the group of developing countries that formulated the proposal for the 2001 Doha declaration, worked with those countries throughout the process in which it was negotiated and adopted, and subsequently advised a core group of developing countries that was primarily responsible for negotiating the August 30 waiver at the WTO from the inception to the completion of that process. I have written and published about those negotiating processes in the American Journal of International Law and The Journal of International Economic Law.

I prepared for the World Bank a set of model-implementing legislation and documents for developing countries to implement the August 30 decision. I would note that one of my draft notification forms was used by Rwanda in its notification to the WTO. I've been to Canada again in the review of the CAMR. I've participated as an expert consultant at UNDP to reconsider this bill.

Finally, I would note, as a matter of disclosure, that I'm presently advising the Government of India in dispute settlement consultations at the WTO, where India and Brazil have initiated consultations with the European Union concerning the seizure of generic drugs in transit through airports in the European Union, and that Canada is a third-party participant in that set of consultations.

The August 30 decision has been criticized by NGOs promoting access to medicines, by some academics, by some generic producers, and by some developing countries for establishing an overly cumbersome set of rules that make it difficult to give effect to the basic objective of permitting export of low-priced generic pharmaceutical products to developing countries. I've consistently observed that the decision was a process of a long and intensive negotiation involving stakeholders with decidedly different perspectives, and that the August 30 decision represented a compromise between those perspectives.

Neither the NGOs seeking to provide the easiest mechanism for facilitating access to medicines nor the originator pharmaceutical industry found or find the August 30 decision to reflect an ideal world of either access to medicines or industrial protection. But my own view is that it can be made workable with appropriate implementing legislation and with conscientious work by lawyers, pharmaceutical procurement specialists, and others, in giving effect to the provisions of the August 30 decision. Nonetheless, for whatever reason, the CAMR was designed to add obstacles to the provisions of the August 30 decision, which make it more difficult to implement in practice.

Why the approach of Bill C-393?

Bill C-393 seeks to streamline CAMR to take advantage of flexibilities inherent in the August 30 decision by providing a pharmaceutical producer with the opportunity to obtain a single licence from the commissioner of patents that will authorize it to make and use a patented pharmaceutical invention for purposes of export to developing countries that identify public health needs.

A principal reason for proposal of the single licence is to solve a significant problem affecting the way international pharmaceutical procurement works in practice.

Many or most pharmaceutical procurement authorities acquire medicines by publishing a request for bids or proposals for supply of medicines, soliciting a response from industry. Competitive bidding isn't always practised. Nonetheless, it's extremely difficult for a producer, for example a prospective Canadian supplier, to respond to a bid request conditionally, indicating that supply is predicated upon obtaining a compulsory licence and that obtaining that compulsory licence may be a lengthy process that involves modifying a government list to add the subject-matter medicine to a list of products, opening negotiations with a patent holder or patent holders for a voluntary licence, and awaiting an ultimate determination by the commissioner of patents regarding whether a licence should be issued.

A public health procurement authority in a developing country would and should be understandably reluctant to award a contract based upon the fulfilment of an uncertain set of contingencies on the part of the producer-supplier.

Requiring a Canadian producer to request a compulsory licence on a case-by-case, country-to-country basis presents obvious difficulties. It presumes that a producer can and should develop a pharmaceutical production line to fulfill a single contract to be negotiated and put into effect over a protected period of time. But the licence is set to terminate after two years.

Simply put, you have heard and undoubtedly will hear from Canadian generic producers that this is a non-economic proposition. It's almost certain to drain business and personnel resources--

[Dr. Amir Attaran, Canada Research Chair, Law, Population Health, and Global Development Policy, University of Ottawa, As an Individual]

Thank you, Mr. Chairman, and good morning.

I'm an anglophone, so I'll speak in English, but I would be more than happy to answer your questions in French.

I'm a professor in the faculties of medicine and law and the Canada research chair for population health and global development policy at the University of Ottawa.

I began my research on access to medicines over a decade ago while employed at Harvard, Yale, and Chatham House in London. I've published on the subject in The Lancet and in the Canadian Medical Association Journal. In full disclosure, I am or have been on the editorial teams of both those medical journals. I've also been unusually privileged to serve on all sides of this debate as a consultant. I have served Médecins Sans Frontières as a consultant at one time and I've served developing country governments such as Brazil and Malawi. I've served drug companies such as Novartis and international organizations like the World Health Organization and the World Bank.

I thank you for calling on me to discuss Bill C-393, and as I sit here I know all of you, all members, all political parties approach this bill with good intentions. This is clear. And you have hopes and prayers that will help the world's poor. This is clear. It is therefore my unhappy job to tell you why I think the bill will probably have zero results for public health and would likely even do harm. Please let me explain.

When CAMR was enacted in 2005, its raison d'être was to make it possible for poor countries to buy cheaper generic medicines manufactured in Canada. To make this possible, CAMR authorized patent overrides of a kind called compulsory licences, and Parliament believed that by overriding patents in cases of acute humanitarian urgency like malaria, like AIDS, poor countries would beat a path to Canada's door for those medicines.

However, as you know, it hasn't worked out that way. Everyone agrees that CAMR has been a one-shot wonder, and only a single country, as Rachel correctly said, Rwanda, bought medicines under CAMR from a Canadian company, Apotex. As Apotex's own spokesperson, Elie Betito, said to the Ottawa Citizen, “We will not be doing this again.” Everyone agrees, this law is a failure.

Well, how come? In a correct diagnosis, CAMR has failed for economic and not legal reasons. The causes of failure are not in the statute of CAMR, which Bill C-393 could amend, but in reality the causes of failure are in global medicine markets, which no conceivable bill can affect. Rachel's correct about this. I'm sorry to say so, but Parliament simply is powerless to make this law work.

Here's the basic problem: for CAMR to succeed and achieve regular exports of Canadian generic medicines to poor countries, it's necessary for those Canadian generic medicines to be priced competitively compared to other generics on the global market. If Canadian generics cost more than foreign generics, poor countries will buy foreign generics, as well they should: that's how free trade works.

Canadian generics, though, and this is unfortunate, are among the most expensive in the world. And let me share with you some data from the federal government's Patented Medicine Prices Review Board. In 2006 this federal agency compared generic medicine prices in Canada and abroad and it found that compared to Canada generics cost 35% less in America, 51% less in Finland, and a whopping 77% less in New Zealand. Now, I emphasize that these are not industry-sponsored data. They are not activist-sponsored data. They are federal government data of a federal government agency and are trustworthy. What they show is that Canadian generics are among the most expensive in the world, and certainly the most expensive in that study. And as you might guess, overpriced medicines don't sell.

So put yourself in the shoes of an African health minister. Why use CAMR to buy generics from Canada when you can buy generics from America, Europe, India, China, New Zealand, and what have you, for less? This economic reality makes it puzzling why certain AIDS activists insist on supplying the world's poor with Canadian medicines manufactured under CAMR. It's patriotic of them. It's definitely well-meaning of them, I don't wish to take that away; it is well-meaning, but it's also naive.

By selling poor countries more expensive Canadian medicines, the corollary is that fewer patients could be treated on a given budget. It could do harm.

Knowing this, the activists support Bill C-393's amendments to amend the Food and Drugs Act and remove generics produced under CAMR from Health Canada's regulations. That aspect of Bill C-393 is, frankly, terrifying. For activists to champion the deregulation of life and death medicines to save a buck, it is not simply vertiginously irresponsible, it's also medically unethical.

If I may have one minute, I'll wrap up.

In closing, my advice is to forget about Bill C-393 and accept the present reality that including Canada, as elsewhere, there are about 30 countries with such laws. Laws such as CAMR don't work.

This is not to say the House should cease caring about public health in poor countries--far from it. Please maintain your interest, but take the energies, the very good, well-intentioned energies you and others have, that are now absorbed in the sinkhole of CAMR and direct them to reforms of other kinds.

Fix the fact that CIDA is a sclerotic agency. Fix the fact that one-third to one-half of malaria medicines, like I'm holding here, are fakes, are counterfeits in developing countries. They kill children. Stop exporting asbestos. These are things Canadians can do that will save lives. Bill C-393 I don't believe will.

[Rachel Kiddell-Monroe, Chair, Universities Allied for Essential Medicines]

Good morning. Thank you for inviting me to your meeting. I am very happy to be here.

I also want to thank my students from McGill University, who gave me permission to be here today. Another professor is replacing me, and I'd like to thank him as well.

I have worked with human aid organizations, mostly in Asia and through the Doctors Without Borders organization. Memories of Africa still haunt me.

My team took over a project from the French military in 1994 in the dying gasps of the genocide in northwestern Rwanda. We walked into a very fine hospital with fine surgical units, with wards where the patients could be. There was one room where the doors were locked. I asked, “What is behind this door?” I was told those were people I could do nothing for and just to focus on the people I could help. I asked to look behind those doors, and what I saw basically were breathing skeletons. They were people who were dying from HIV/AIDS. At that time, while patients in Canada, Britain, the U.S., and many other developed countries in the world were able to receive life-saving HIV/AIDS treatment, those people did not have access.

I called my headquarters and asked if we could get some medicines for those people: “What we can do? We have to help them.” They said they were sorry, but it would cost $12,000 per patient, per year. They said: “These people have a chronic disease. We cannot help them.” So we had to sit every night and hold these people's hands. We had to comb their hair and talk to them because we were the last people who were to have any contact with them. We watched those patients die.

I believe it's important to bring that to you people here and to those who say we shouldn't make this an emotional issue. But this is about human lives. This is about people who are dying while people in our countries do not have to die. This is about a situation where people do not have access to essential medicines.

It's not the first time I have appeared before this parliamentary committee in the last seven years, which is how long I have been working on this issue. I first appeared in 2004 before this same committee, urging it to reform Canada's access to medicines regime as was then proposed, because there were fundamental flaws in it. The legislation was passed as it was, and we decided as Médecins Sans Frontières to try to test the legislation, because there was so much goodwill, both in the government, the Prime Minister's Office, and from all parties who voted in favour of the legislation and making this work.

So we decided to try to test it. After four years—four years—we managed to get one drug for a limited number of patients to one country. In those four years, about 40 million people died because they did not have access to essential medicines.

We're not saying that Canada is the solution to the whole crisis, but that Canada has a role to play. Canada is not a panacea, but it has an international commitment that it took in 2003 to try to make the August 30 decision work in Canada. We still have that commitment today. We can do it better, and we should do it better.

I worked with my colleagues inside of MSF, and Cailin Morrison in particular, as well as Richard Elliott from the Canadian HIV/AIDS Legal Network, to try to make this order happen, with all the best intentions and goodwill. We went to many countries through our MSF teams, asking governments to please apply and to use that piece of legislation. When we approached the health ministries, they were all thrilled. They would say: “Wonderful, it's another way maybe we can get drugs for our people at last. We need every single mechanism we can find to treat our patients.” We were hopeful. Then when they went to their foreign affairs ministries or to their trade ministries, a block was put on it.

Why was that block put on it? The block was put on it because of the experiences of countries like Thailand, who tried to use flexibilities in their regimes to use compulsory licensing, as Richard Dearden was saying earlier, in domestic situations. When Thailand used a compulsory licence, sanctions immediately came down on them. Abbott, a pharmaceutical company, withdrew drugs and threatened to withdraw other drugs from the Thai market if they didn't change the way they were acting. The U.S. government put Thailand onto the 301 watchlist, as a partner who should not be trusted in matters of intellectual property.

The European Union trade commissioner, Peter Mandelson, sent a letter to the Thai government, threatening them over their use of compulsory licenses and saying they should spend more time negotiating with pharmaceutical companies. They had in fact held over 20 meetings with pharmaceutical companies on this issue to try to get AIDS drugs for the dying Thai population.

Why is the law failing? Some people will refer to market failures, as my colleague on my right will say. Well, I would respectfully submit, the market failures are not an issue for parliamentarians around this table. What you have to do is to make a law that has all the best chances to win, which Bill C-393 has. The market issues are things that should be left to the pharmaceutical companies and the generic companies in trying to make it work.

I would say that references to other forms of fixed-dose combination, which are not same as the fixed-dose combination Apotex produces, will not give fair price comparisons.

Finally, I would like to raise something that has been of great concern to me and many of my colleagues. We've been hearing that there is a move afoot to kill Bill C-393. In the next session, when a vote has to be held on the new sponsor of this private member's bill, there will be people who will prevent it from passing. I would like to submit that this is not a way to democratically deal with the bill, and it would definitely undermine the extremely important work this honourable committee is doing. So I wanted to raise that to your attention, and I do sincerely hope, as a new Canadian citizen, who got her citizenship in March this year, that this is not what Canada would do to this bill.

As a final thing, when I came here to Canada with my family, I had promised the patients I had worked with for over 15 years in Africa and Asia that I would be able to do something here. I believe that Canada is a great country and we have a power to make change.

Thank you.

[Richard Dearden, Partner, Gowlings, As an Individual]

Thank you, Mr. Chair and members of the committee, for permitting me to testify about why, in my opinion, Bill C-393 fails to comply with Canada's international treaty obligations.

I am a partner at Gowling Lafleur Henderson. I have practised international trade law for over three decades. You'll find a short biography in tab 1 of my written submissions. Those written submissions, members, explain why Bill C-393 violates the TRIPS agreement and also the carefully negotiated international solution to the access to medicines problem embodied in the WTO's General Council decision of August 2003.

Today I wish to address two points for your consideration, if I could. Firstly, Bill C-393's one-licence regime is not authorized by flexibilities found in the TRIPS agreement. And secondly, TRIPS article 30's limited exceptions provision does not authorize Canada to abrogate its compulsory licence obligations that Canada has agreed to, both in the TRIPS agreement and in the General Council decision.

Now, point one, you'll hear some people argue that you can replace CAMR, Canada’s access to medicines regime, through flexibilities available under the TRIPS agreement. The 2001 Doha declaration required members to maintain their commitments in the TRIPS agreement but recognized that there were flexibilities in the TRIPS agreement. And it gave several examples, one of which was compulsory licensing. But the compulsory licensing obligation that existed at the time was only predominantly for the supply of the domestic market, so it didn't solve the problem.

That's why, Mr. Chair and members of the committee, the WTO ministers gave the following instructions to the TRIPS council. And they're found in paragraph 6. That's why you hear of it as the “paragraph 6 system”. It reads:

We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem....

And that expeditious solution, Mr. Chair and members, is what you find in the 2003 General Council decision.

So Canada can only rely on this decision to issue compulsory licences for export if it complies with the conditions in that decision. And in my respectful opinion, CAMR does that and Bill C-393 does not.

I'd also, as a sidebar here, point out to you that my submissions only deal with TRIPS, but NAFTA has an almost identical compulsory licence obligation in article 1709(10). And you should know that Canada and the U.S. entered a memorandum of understanding that suspended the compulsory licence obligations you find in NAFTA article 1709(10)(f), which was identical to the TRIPS compulsory licensing obligation. That suspension is only valid with respect to the compulsory licence issued in accordance with the WTO General Council decision.

So if the Bill C-393 system were allowed, in my respectful submission, it would be violating NAFTA article 1709(10) because it allows for any drug, in unlimited quantities, for an unlimited term, for export to 140 countries. And that is not in accordance with the General Council decision. It would be offside the NAFTA obligations. And Canada, in my opinion, would end up in a dispute settlement panel under NAFTA.

My second point, Mr. Chair, is with respect to an argument that the single-licence regime proposed by Bill C-393 would be authorized by a limited exceptions provision we find in article 30 of TRIPS. Now, let's not forget, Mr. Chair and members of the committee, that the WTO membership rejected TRIPS article 30 as an expeditious solution to the access to medicines problem. But even if article 30 was available to Canada, the burden would be on Canada to demonstrate before a WTO panel that this one-licence regime is a limited exception; does not “unreasonably conflict with normal exploitation of the patent”; and does not “unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties”.

Canada lost a WTO case involving a Patent Act provision that allowed generic manufacturers to stockpile pharmaceutical drugs for the last six months of a 20-year patent term. We lost that. Canada defended it by arguing that it was okay using the limited exceptions under article 30. The panel rejected that, saying six months was a commercially significant period of time, especially since there were no limits at all on the volume of production allowed or the market destination of such production. So rather than being a limited exception, Mr. Chair, Bill C-393is an unlimited exception because it authorizes a compulsory licence for any drug, in unlimited quantities, for an unlimited duration of time. It does not take into account the legitimate interest of patients who benefit from the incentives that patent protection provides for research and development of life-saving drugs or drugs that improve Canadians' quality of life.

In conclusion, Mr. Chair, what are the proponents of Bill C-393 asking you to do? They're asking you to bypass the WTO and unilaterally renegotiate Canada's compulsory licence obligations through this one licensing system. But what has changed in terms of compliance with our international treaty obligations since the Minister of Industry's 2007 report on the statutory review of CAMR? The only change has been that Canada has accepted the protocol amending the TRIPS agreement that would make the general council decision a permanent amendment. So rather than Canada retreating from CAMR, Canada has in fact further entrenched its commitment to CAMR.

Thank you, Mr. Chair and members.

[Richard Elliott]

Thank you.

Let me just address two points quickly, to get back to the question that a few people posed.

The first point is the issue of diversion of medicines, which of course we don't want to see happen. Dr. Kilby put it very well. We have to take some risks here. The legislation preserves the measures that were already negotiated and in place to mitigate the risk, to minimize the risk of diversion happening, and, let's not forget, that we cannot let the perfect be the enemy of the good here.

We have not had a significant problem with diversion, for example, of the donated discounted brand-name drugs that have been provided in these countries because they are using the same sorts of mechanisms that are provided for here for generic drugs. That has not been a significant problem.

That is not to say never say never. Should there be at some point a shipment of medicines that gets diverted, let's say if 99% of the shipment got through and we saved hundreds of thousands of lives because of it, if one shipment went missing, that is a price worth paying. But we have mechanisms in place that are there to prevent that from happening. Let's not overstate the risk there and use it as an excuse for not fixing this and making it workable.

The second point I wanted to speak to was your question about the amendment to the Food and Drugs Act. It is fair to say that the core of the problem with the current access to medicines regime has been the licensing process. The process about how you review the drugs for quality and safety and so on is secondary.

We should, if there are difficulties with something like the proposed subsection 38(1) that's in Bill C-393, look at that. If you feel it doesn't provide adequate protection for making sure that things are properly reviewed before they get to the countries, let's tweak it and let's make it work there, but let's not lose sight of the core objective here and use that as an excuse to not pass this.

The reality is if you talk to the generics—I think they'll tell you this next week—they're going to go through the Health Canada review process anyway, because that is the thing they are familiar with. So as you see in this proposed provision in paragraph 38(3)(a), all of the existing regulations that are made under part II of the Food and Drugs Act, section 30, which is the one that has all of the regulations about quality, safety, and efficacy, will be entirely applicable. Bill C-393 will not change that.

[Richard Elliott]

That's right. I will continue in English, if I may.

The majority of the 5.2 million people who are receiving HIV treatment now in the developing world are on generic medications because that's what has made it affordable. That's how we've made the progress Mr. Lake was referring to.

There is nothing now that prevents the patent-holding brand-name companies from selling in those markets, and there is nothing in CAMR and nothing in Bill C-393 that prevents them from doing that. The point of having a patent is you actually have the right to sell the product. In fact, you have the exclusive right to sell the product unless someone else gets a licence, which is what CAMR is supposed to do.

This is simply about opening up the field, allowing greater competition in those markets. When the brand-name companies have had to face competition in the developing world selling their products, we've seen that that is what has brought the prices of medicines down. We need to keep that dynamic going. That's the purpose of something like le Régime canadien d'accès aux médicaments.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

The thing that concerns me is that while we want the same thing, we recognize there are issues. I think the issues you're talking about, the things we need to address, we can probably have a common conversation around, with agreement on many things. What we've heard from the experts—and keep in mind that the government experts who were before us at the previous meeting aren't partisan experts, they were people who were the experts under the Liberal government and they're the same people who are the experts under the Conservative government—from four different departments was that they were adamantly opposed to this bill, saying the bill would accomplish virtually nothing and yet would have untold unintended consequences. And that's very concerning to me as a member of Parliament.

Again I come back and I'd just like you to comment if you could on the health question I asked. Does it not concern you that under C-393 we would have a regime whereby drugs are being approved by a country in Africa and having no approval process subject to the same considerations that a Canadian using those same drugs would be subject to?

[Richard Elliott]

Yes, I can.

I wanted to, before I forget, draw your attention to a document that you have in the materials we gave you. This is a briefing paper prepared by Doctors Without Borders--Médecins Sans Frontières--describing their experience of attempting to use the legislation, working with Apotex to get this drug because MSF had identified that they needed it.

This part of the story that MSF lays out in this brief walks you through the chronology. However, it stops in the middle of 2006 because MSF ultimately abandoned the effort to use it, after trying for about 18 months to get a country to come forward.

When we hear repeatedly that it only took 68 days from start to finish for this piece of legislation to work, to get this licence out the door, that leaves out of the story the entire months and months and months leading up to the point where finally a country did come forward. That's because the law, the way it's drafted now, requires that the country be known ahead of time in order to then move through the process of trying to get a licence. But that's not the full story if you just look at, “Oh, now we finally have a country, so we can start the process of trying to get a voluntary licence from the brand-name company, and if that doesn't work after 30 days, then we can try to get a compulsory licence to supply a fixed quantity of a drug for only two years”, and so on.

All of the back story is left out of that narrative, about why this bill took so long to even have one successful use. It's because it created this kind of impediment where you made the use of it contingent upon knowing one specific country ahead of time.

That's why the one-licence solution that is in Bill C-393 would get around that problem, because it would say it's not contingent upon having one country identified ahead of time to get a licence. You get the licence and then you go out and actually bid to supply countries. If you're offering a good product at a competitive price--which you would be in a better position to do if this is simpler to use--then you can actually supply because you have the licence already to supply that eligible country.

So I would encourage people to learn what the experience was and where the stumbling blocks were encountered with the existing legislation, which is precisely what we thought they were going to be. I think we can then learn from that to make it work better.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

One of the interesting things about the bill....The department is very critical of it. Setting up the standards, it could be a runaway success. I guess a runaway success would be that we'd have a lot of different drugs that then would be exported, treating people and actually saving lives. It's kind of an interesting analysis of it. But they also painted the picture that Apotex in Rwanda was a success story.

You know, getting the drugs to those individuals, yes, that is a success. But the process wasn't. And they painted the picture that CAMR worked very efficiently in that, but CAMR requires you to do some work before you actually do your paperwork with it. Can you maybe go through that experience?

What I find kind of incredible about the department's attitude in this is that.... I asked them during a briefing that if they don't think Bill C-393 is a good bill, could they offer suggestions on how to improve it, and not one of the departments could offer one suggestion on that. I find that incredible, because if we don't change it, it's just not going to get used at all.

The hoops that were jumped through to get the Apotex Rwanda thing done.... Back in 2003, when we started this, there were warnings that it wouldn't work. But at the same time, when we had the final piece, we all said we'll put down our swords, stop fighting over it and try to make it work. Now that one success story is being used against fixing the system.

Can you provide some insight into the timelines of what happened in Rwanda?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

As Mr. Braid said earlier—and Mr. Masse mentioned it in his question—there is the whole issue of traceability. And this does not necessarily have to do with whether the medication will be returned, but whether it will be distributed elsewhere for commercial purposes. So a drug diversion problem would arise. When the officials appeared before us last week, that is one of the aspects they drew our attention to, saying that Bill C-393 reduces traceability, or does not allow for the traceability of drugs in order to ensure that they are really going where they are supposed to.

Mr. Elliott, in your presentation, you were challenging some of the negative arguments against Bill C-393 made by the officials last week. In your opinion, their warnings to us were not justified. Could you perhaps provide more details on the topic? Could you explain why, in your opinion, officials responsible for the smooth operation of Canada's Access to Medicines Regime, that is the officials responsible for making sure that vulnerable populations have access to drugs, would want to put up roadblocks, so to speak? Why would they be against improving the program, which is designed to ensure that vulnerable populations get the help they need?

[Richard Elliott]

I would differ slightly with Dr. Kilby about the perhaps overly rosy picture regarding access here to medicines being perfect. In the U.S. there are barriers to access, but not necessarily the patent barriers.

I did want to specifically speak to the legal aspect of preventing this kind of diversion from happening. And while most of our brief is focused on this question of compliance with WTO rules, there's actually a section toward the end that talks about this misconception, that somehow Bill C-393 is going to remove all the safeguards against this sort of diversion of medicines. It actually preserves safeguards that would require different labelling, different packaging, colour, shape, and so on of medicines that are being exported. And if that's not clear to you in the bill now, then let's work on making that clear, because we want those safeguards to be in place.

The other thing I want to say is that under Bill C-393, provisions that are in the current law are preserved that require generic manufacturers to disclose the quantities of medicines that they're shipping and to which countries. That information has to be disclosed to the patent holders; it has to be posted on a publicly available website. You have to disclose that not only to prevent the diversion of medicines but also so you can calculate the royalties that you have to pay to the brand-name companies.

So those things are all in there as important parts of the mechanism. They're preserved.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair, and thank you to our guests here today.

We had rather interesting testimony from the departments the other day. In their deck and presentation and in another document that was provided as a briefing, they were saying that on one hand, the proposals in C-393 would enter us into a trade challenge and maybe threaten investment in Canada. There would be a series of other problems. At the same time, it wouldn't work.

It didn't make any sense. They were making both claims.

One of the points I wanted you to maybe comment on is that they say here:

There is no evidence that changing CAMR will result in more developing countries using the regime to import drugs from Canada rather than continuing to purchase low-cost drugs from other sources.

We were just talking a little bit about that with Mr. Braid. I'd like you to talk a little bit about the Apotex situation. The reality is that we have generic companies in this country that are world-class successful and would increase jobs if production actually increased. Can you comment on that, please?

[Richard Elliott]

On the first question, about compliance with WTO obligations, the proposals that are in Bill C-393 have been drafted with the expertise of people who know what the WTO law says, and very much taking that into consideration.

There is extensive discussion in our brief of this very point. It walks you through why it is that the provisions that are core to Bill C-393 are in fact compliant with the decision of the WTO General Council from August 30, 2003--which is the key instrument here--and with the underlying treaty, the agreement on trade-related aspects of intellectual property rights, TRIPS.

There are international legal experts who have been tapped to provide input in the drafting of this bill. I mentioned earlier that we convened a consultation of a number of legal experts earlier this year with the UN Development Program. We spent a day going through the provisions of Bill C-393, looking at whether these were compliant with the requirements of the WTO. The answer was pretty much yes.

There were one or two places--as you'll see in the report of that meeting, which is coming to you as soon as it's back from translation--where the experts said, “This is compliant with WTO. However, you could see that there might be some ambiguity here. So here is a recommendation about how you make a slight tweak to remove any question that this is compliant with WTO obligations.” That was the purpose of the consultation. We wanted to know if it was compliant with WTO, and if it's not, what we should do to address that. The answer was that it's compliant as is, but here are some things you can actually do to make it even better.

I think that will be useful for the committee's deliberations once you have it, and we'd certainly be happy to discuss the details there.

[Dr. Don Kilby, President and Founder, Canada Africa Community Health Alliance]

Thank you very much for having me here. I will keep my remarks a little briefer than my colleague and make sure I stay close to time.

I'm a family physician, an HIV primary care physician, and as you've heard, I'm a founder of the Canada Africa Community Health Alliance, a small local volunteer-based charity based out of Ottawa working with partners in Africa to improve the health of rural African villages. There are about 150 to 200 Canadians a year who choose CACHA in order to volunteer on medical missions. They volunteer their time and underwrite the full cost of each mission, including the medications that we dispense free of charge and the medical supplies, as well as surgical supplies needed to enhance the level of care of our partners.

We work on a determinants of health model, and we believe that health is proportional to access to housing, secure food supplies, education, water, sanitation, transportation, employment, and personal security and freedom. We do not restrict our efforts to medical care only. We also support orphans and vulnerable children programs; build infrastructure, including a made-in-Canada floating dispensary; provide solar lighting in villages for students to study; drill wells; support microfinance; and support people living with HIV and AIDS. Given the recent reports on Canadian charities, we do this using at least 90% of all taxable revenues directly in the countries. This is a young organization, an organization that's only been around since 2002.

Today what I want to talk about is the whole issue of access to medications in resource-limited countries and the role Canada had hoped to play and could still play in order to contribute in a significant manner to the world's continued and growing needs for affordably priced essential drugs.

In 2003 I was here supporting legislation for Canada's access to medicine regime, and we believed at the time that it was the right thing to do and it was a good move. I will admit that also at that time, given the complexity of the regulations around securing a compulsory licence to produce, we seriously doubted that any drug under this regime would ever make its way from Canada to another country. We didn't criticize Parliament's efforts at the time but rather took pride in the fact that Canada was the first G-8 country to amend its national laws in order to implement the World Trade Organization's decision to allow generic versions of still patented drugs to be manufactured and exported under compulsory licensing.

Canada's leadership would bolster efforts in other countries to do the same, so that developing countries could have access to a steady supply of cheaper drugs available in a more competitive market. In the area of HIV, access to generic, co-formulated, triple-drug therapy available from India became the hope of nations in the scale up of treatments of AIDS in Africa. So in 2003 we had 400,000 people in low- to middle-income countries who received antiretroviral drugs. By 2005 we had 1.3 million, and by the end of this year, there will be 5.2 million people on antiretroviral therapy in resource-limited settings. In 2009 alone, there were 1.2 million new patients initiating antiretroviral therapy.

In 2002 at the International Aids Conference in Barcelona, we were all told it couldn't be done. I remember attending a presentation that was done by Médecins Sans Frontières, who were working on a project outside of Cape Town in South Africa, and a Harvard group in a project in Haiti. They had presented successful demonstration projects that we then used in order to replicate these thousands of times across Africa and the Caribbean.

At that time I remember a very heated discussion and a lot of criticism coming from the International Monetary Fund and the World Bank. It was said at the time that people in resource-limited settings would not be compliant with therapy, not as compliant at least as people in North America or Europe, that local governments could not put in place the infrastructures as well as the procurement and distribution systems necessary to get drugs to patients, that there were not the trained personnel needed to treat so many people, that the world could just not afford it, and that the business model was flawed.

To the credit of the G-8 leaders, at the insistence of groups like Médecins Sans Frontières and others, and the World Health Organization's global fund, and the bilateral U.S. President's emergency plan for AIDS relief, they committed to the goal of three million people in treatment by 2005.

So procurement processes were put in place, thousands of allied health-care providers were trained, clinics were built, testing programs and mother-to-child transmission strategies were expanded, as well as programs dealing with the social and economic fallout, including millions of orphans and vulnerable children. There are now home-based programs and local AIDS service organizations in place throughout all of the world today.

Essentially what we have been able to do is develop a comprehensive model of care many believed could never be built, and this in only a few short years. What was accomplished is nothing short of a miracle: 5.2 million people on treatment by 2010.

CAMR and other compulsory licensing programs should also have evolved during this time to ensure that we have a continuous flow of medicines at affordable prices. In all other areas, other than procurement of drugs, the concerted international efforts ensure today that all that needs to be in place to get medicine to people is in place.

CACHA is working with partners in Benin, Gabon, Tanzania, and Uganda, now since 2002. We concentrate our efforts in the hardest-to-reach populations in remote rural communities where there were no services for people living with HIV and AIDS. We help our local partners articulate needs, identify those infected through testing, and secure infrastructure necessary to treat people with HIV. And we secure this through strategic partnerships that are south-south, north-north, and north-south.

In Tanzania in three remote village areas we have seen our partners go from no HIV patients in care to more than 10,000 people in care in less than three years. Up until recently drug procurement and access has not been an issue. But this success is now being threatened in other countries, not only in Tanzania, by the limited supplies of affordable therapies.

The supply issues have nothing to do with getting drugs to local markets. The problem is procurement of cheaper, first-line therapies in sufficient quantities to treat all those who should be on treatment. Today, 5.2 million need to remain on treatment, and close to another 5 million need to be on treatment.

Canada's access to medicines regime should become a viable source of affordable medication available in a manner consistent with traditional procurement practices of purchasing countries that would allow these countries to ask for competitive tenders in order to ensure best pricing and timely delivery of product to market.

What we have in place is not meeting the desired goal. We have worked with government officials in two of the countries and we have examined with them the procurement mechanisms in both cases. And both countries have found that they are too cumbersome when other markets were available to them, despite their strong desire to purchase drugs from a North American generic company.

The other issue we have is that today, as people fail on therapy because of drug intolerance or toxicity, or compliance issues, countries now need to invest in newer drugs, second-line therapies, but these are at ten to fifty times the costs of first-line therapies. Health-care budgets in these countries cannot sustain such costs without significantly limiting the number of new patients who would access cheaper first-line treatments. Compulsory licensing, therefore, is needed even more today. It is needed to ensure an adequate supply of both affordable first and second-line treatments.

We can't rely on a system that's so encumbered by regulations. We need a system of compulsory licensing that is not time-limited, with no set limit on quantities to be purchased, and that can turn on a dime.

So CACHA supports a one-licence solution: one compulsory licence on patented medicine, regardless of quantity of medicine ordered or the number of eligible countries requesting the drug. Doing this will cost Canadian taxpayers nothing, beyond the international aid dollars we have already committed. And doing this will do nothing to reduce the profits of multinational pharmaceutical companies. There really is virtually no market for their patented drugs in developing countries, and without a market there is no real threat to their future or to the future of research and development in resource-rich settings like our own. In fact, CAMR royalties from otherwise non-existent markets would be paid to these patent holders.

This doesn't mean that these drugs that are produced in Canada that are destined for other markets would make their way back to Canada to be sold on the black market in resource-rich settings. We have enough processes in place in terms of the labelling and sanctions, and in fact if we look at our market and at that of our neighbours to the south, virtually all people with HIV and AIDS have access to drugs that are paid for through either private or public funding mechanisms. So enacting Bill C-393 will make the much-needed medicine more accessible and, through competition, also more affordable.

Thank you.

[Richard Elliott]

Thank you.

Perhaps I could save the fourth part of my remarks--the question of what Bill C-393does not do--for the question-and-answer session, because I expect that I will get a number of questions about what it is claimed that Bill C-393 will do, and I would be happy to correct the record.

Thanks very much.

[Richard Elliott, Executive Director, Canadian HIV/AIDS Legal Network]

Thank you, Mr. Chair, and thank you to the members of the committee for the opportunity to appear before you today. Thank you as well to the committee for actually studying this bill, because I know that was something that has been in some question.

I want to draw your attention to the material that we have provided. You will find a copy of our brief. I think it's been provided to you already. I will come back to it in the course of my remarks, and I hope it will address many of the questions that you have. I hope to answer those questions over the course of the next two hours.

By way of introduction, I'm a lawyer who has been working on HIV-related legal issues for 18 years. For the last nine years I've been working intensively on questions of international law, including WTO law, and access to medicines, including doing graduate work on the subject.

This is also a personal issue for me, not just an intellectual one. I was born in Africa and raised there for a significant portion of my life. I have worked for many years in Africa with various partner organizations responding to the global AIDS crisis.

The organization for which I work, the Canadian HIV/AIDS Legal Network, has been working on this particular issue for nine years now, from back when the World Trade Organization members were adopting a declaration recognizing that they needed to do something about the barriers that patents pose for developing countries in getting access to affordable medicines, to the discussions that led to the drafting of Canada's access to medicines regime--enacted unanimously by Parliament in 2004--to organizing international consultations with experts from around the world on pharmaceutical procurement and intellectual property law, to a consultation that we held earlier this year with the UN Development Programme. This consultation generated some analysis that will be coming to you as an additional submission on the question of whether the proposed reforms in Bill C-393 are compliant with Canada's obligations as a member of the World Trade Organization.

This is an issue on which we have a fair depth of knowledge. It is perhaps not a surprise, therefore, that the brief we've submitted to you is some 50 pages in length. However, I hope it will be of use to you, and I want to draw to your attention the appendix in particular, because I think it will be a particularly useful reference for you.

As you know from reading Bill C-393, the bill makes a number of amendments to two pieces of existing legislation, the Patent Act and the Food and Drugs Act. Of course, it's hard to get the real sense of what the bill does unless you track all of the changes that the bill would make to the existing statutory provisions. To make it simpler, we've done that for you; in the appendix to our brief you'll find the relevant sections from the Patent Act that constitute Canada's access to medicines regime and the relevant provisions in the Food and Drugs Act. We have tracked onto the existing text of the law the additions and deletions that Bill C-393 proposes to make so that you can actually read it through in its entirety and see what the final text of the law would look like with these proposed amendments. I find it's much easier to have the discussion when you can see what we're actually talking about, and not in isolation.

I'd like to cover four areas in my remarks today, if I could: I'd like to tell you what CAMR is supposed to do, but I won't belabour that too much, because you know that; I'd like to say what CAMR has actually done, but that won't take very long, because the answer is “not much”; I'd like to tell you what Bill C-393 would do; and I'd like to tell you what Bill C-393 would not do, because there is a fair bit of misinformation circulating, including some of what you heard from government representatives last Thursday at your meeting, claiming all sorts of things about what Bill C-393 supposedly would do, and that information is not in fact correct. Let me speak to each of those four, if I could.

Briefly, what is CAMR, the access to medicines regime, supposed to do? The fundamental purpose of CAMR, as reflected in the discussions that preceded it at the World Trade Organization, is to help developing countries make effective use of compulsory licensing. That is the terminology negotiated by World Trade Organization members, including Canada. They are to make effective use of compulsory licensing in order to address public health problems by getting more affordable medicines.

The goal, stated by WTO members themselves, is to promote access to medicines for all. This arises out of discussions at the WTO in 2001, nine years ago, in which WTO members, including Canada, explicitly recognized that patent restrictions on medicines are a barrier--not the only barrier, but a barrier, and an important barrier--to affordable medicines getting to patients in developing countries.

Very specifically, one of the things WTO members recognized was that when you have patent restrictions in a place like Canada, where there is the capacity to make generic medicines and to supply them to developing countries that don't, you need to have some mechanism to get around that; otherwise it's patent infringement for a generic manufacturer here to be producing and exporting these generics. So WTO members set themselves the task of coming up with a mechanism that would get around that barrier, and that was a decision adopted in 2003, about which you've heard a great deal and which is really the central piece of WTO law relevant to any discussion of the existing CAMR and the reforms proposed in Bill C-393.

The purpose of CAMR—to implement a mechanism so that developing countries can make effective use of compulsory licensing to get generic drugs from Canada—is aimed at harnessing the power of competition. We're operating within a market paradigm here and we're harnessing the power of competition in the market to drive the prices of medicines down for developing countries. That is the purpose, and that in fact is what we've seen globally, that when countries have had the ability to get generic AIDS drugs, the prices of those drugs have dropped from over $10,000 U.S. per patient per year to $100 per patient per year now for some regimens. That's an order of magnitude of difference, and of course it makes feasible the task of putting people on life-saving treatment.

Because of this we have now seen four million people with AIDS in the developing world getting life-saving medicines in just a matter of a few years. This has only been made possible because there was competition in the pharmaceutical marketplace for those countries, and generic medicines were available at much lower prices. None of that would have been possible if the limited moneys made available for donor aid to buy medicines had to be spent to buy $10,000 courses of a treatment per patient per year, as opposed to $100 per patient per year.

That's what CAMR is supposed to do. Second, what has CAMR actually done?

As you know, it's been more than six years since CAMR was enacted by Parliament, and in that time, after a lot of work by a number of NGOs, after the commitment from one generic manufacturer, we have seen one drug leave this country to go to one country. That's tremendously significant for us, because it shows that we can do things, that we can make a difference. But I think it would be wrong to conclude that it somehow proves that the current access to medicines regime works. That result came about, as I said, because of years of hard work by various NGOs. It came about partly by chance. It came about because of conditions that are not easily replicable in future, and the one generic manufacturer that had made a commitment to NGOs, that is, to Doctors Without Borders, to try to make this regime work has said it will not attempt to do it again because its experience so far has not been encouraging.

However, that same company has also publicly committed that if the legislation is streamlined the way Bill C-393 proposes to do, the first next step for them would be to make a pediatric version of this drug. Access to AIDS treatment for children living with HIV falls way behind access to treatment for adults with HIV—who already are less than half of the people who need treatment now, and who will die without it. That's why it's so important that we have pediatric formulations of antiretroviral drugs, because 80% of children who are born with HIV will die by the age of two if they do not get medicines.

There are some medicines out there now that are being used to treat children. In many cases, they are not particularly user-friendly. If you can imagine that you're a grandmother caring for several orphans, some of whom are HIV-positive, it's not a particularly helpful way to make AIDS treatment available to children if you have to periodically get to a clinic—if they have the medicine at an affordable price—to get a syrup that you have to carry back to your home, where you may or may not have refrigeration.

If you could instead get something in simple tablet form, that is, something much more portable and not requiring refrigeration for storage, or in the form perhaps of something dispersible so it could be administered more easily to infants, then you would really be trying to get into the real world of getting medicines to people in a form that is easily usable. That's something that we can do if we fix this legislation. It would be a first next step, and then we would move beyond that with more medicines from generics at lower prices.

So what CAMR has actually done so far is relatively little. I don't think we can say that one drug to one country in six years is a success, given the need out there and given what was promised.

What would Bill C-393 do then?

You will have heard and seen in our material that we have described the core of Bill C-393 as putting in place what we call a one-licence solution.

Under the current legislation, every single drug order for each individual country requires a separate process of trying to get a licence to supply that country with a fixed quantity of medicines. It also requires that you know ahead of time the country and the specific quantity of medicines that you want to supply. In CAMR's experience to date, that has proven to be one of the most significant stumbling blocks, and it explains in part why it took two and half years to get to the point of having the first licence issued. I can explain to you why that is.

Our proposal in Bill C-393, which we fully support, is to change that process of licensing so that a generic manufacturer will get one licence, once, that will authorize that generic manufacturer to supply any of the eligible developing countries that are already recognized in the WTO law and in the Canadian legislation with the quantities of those medicines that developing countries will notify from time to time.

That will reduce the transaction costs of using the system. It would put generic manufacturers in a better position, because they can bid to supply multiple countries simultaneously, knowing that they already have the legal authorization in hand to do that. In the current process, they have to go into a bidding process individually with the different countries, without even knowing whether they'll be able to get the licence in the end to supply the drug, should their bid be chosen, because they will need to go through the current cumbersome CAMR process. Bill C-393 would simplify that and cut through that.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

I'll provide this to the clerk to follow up. This is the Journal of the International AIDS Society. They studied the Indian experience with the supply of drugs into Africa. The conclusion is that it's now at risk in the pricing because of the WTO, TRIPS, and other movements they have made. I will table this for the committee, because the current status quo from India is not going to maintain itself and there are going to be rises in costs and prices.

One of the statements you make in your deck here is that Bill C-393 is unlikely to increase demand to use CAMR. Ironically, it is also a threat for Canada with the WTO and everything else. What evidence do you have of that? How do you square that with Apotex, which has said they would use the CAMR more if it were changed?

[Peter Braid, Conservative, Kitchener—Waterloo, ON]

Okay. There's a $60,000 question for me, then. If we understand that Bill C-393 has flaws and CAMR has limitations, then the question is, how can Canada provide an increased quantity of HIV/AIDS medications to the developing world?

[Peter Braid, Conservative, Kitchener—Waterloo, ON]

Okay. Thank you.

Mr. Ready, turning to you, sir, with respect to the trade obligations, you mentioned that Bill C-393 could violate the terms of TRIPS and WTO. I just want to push back a little bit on that. When I read the word “could”, I read “may or may not”, so I just wanted to ask what the probability is of Bill C-393 violating trade obligations. What does that look like? Can you give an example? What would the consequences be?

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

This is a critical issue. I find it interesting that in the conclusions it says that Bill C-393 would not overcome the systemic issues of health care delivery and disease prevention in the developing world.

That's almost an absurd statement. I don't know of any organization, group, or interested party that has ever made that claim. Nobody here is saying that this will be the one single solution to human suffering. At the same time, we have a bill that Parliament passed that has only been triggered once. I suppose we have a Parliament that likes to set up legislation that doesn't work or isn't used. We spent a lot of time and money on this, so there's a problem here.

Ms. Downie, you almost indicated that if this is changed, we're going to have all kinds of generic drugs flying out across the world and not be able to track them. But the reality is that the generic drugs must have different markings and different packaging. It has to be stated what country they're going to and the quantity.

What other mechanisms are necessary to protect? You would have a company publicly doing something fraudulent out there. What is the real risk? I don't understand, especially given the Rwanda situation, where we had one out there. What is the threat here? They're still going to be identified, the company still has to identify where they're going, and they're going to be tracked.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Are there other options that we could be exploring? In your concluding remarks, you stated that CAMR is only one of the tools that Canada uses. Are there other lesser known tools? NGOs maintain that the regime isn't working. This morning, I'd like us to try and answer the question as to why the regime is failing. You made it clear in your closing remarks that Bill C-393 will not result in more applications being filed under CAMR. Could we be exploring other options?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you very much, Mr. Chair.

Like Ms. Wasylycia-Leis, I am also my party's health critic. Basically, she expressed what we are all feeling. Since the regime was first implemented, only one drug has been shipped overseas for humanitarian purposes. In an effort to resolve this issue, she tabled Bill C-393. However, you have looked at the proposed legislation and you indicated to us during your opening remarks that this option presents a number of risks, as we feel it does. In fact, you do not believe that the solution she is advocating is the right one.

As we consider Bill C-393, Mr. Chair, we also need to ask ourselves why a number of NGOs believe the regime is not working. We need to look at whether the regime can be made more flexible. That's why we came up with a list of about twenty potential witnesses, to help us conduct a more in-depth study and look beyond Bill C-393. I hope committee members will agree to this proposal, Mr. Chair. I really think that we need to take a closer look at this regime and ask the questions that need to be asked. It has been in place for some time now and the only example that applies is the case of Rwanda and Apotex.

Ms. Downie, you stated in your closing remarks that the regime is working. Several NGOs would disagree with your assessment and would argue that only one drug has been exported as a result of the CAMR mechanism. So then, how can you claim the regime is working?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Yes. Indeed, it is a complex problem, there's no question about it.

Reference was made to the fact that some of the countries in Africa are getting their medicines from other, cheaper sources, and it's in many ways a challenge for Canada, because of labour costs and other things, to actually undercut those prices.

Another issue related to it is the consequence of our reputation with respect to our IP regime. I think that is something we can't overlook. I've read some of the testimony from S-232, the Senate bill, that's very similar to C-393.

One of the witnesses was Richard Dearden. He was representing Gowling Lafleur Henderson. He went so far as to say:

First, Bill S-232's one-licence regime is not authorized by flexibilities that are found in the TRIPS Agreement. Second, TRIPS Article 30's limited exceptions provision does not authorize Canada to abrogate its compulsory licence obligations.

I won't go on. I know that's not agreed to by those who feel that TRIPS is not violated, but I would like to hear from you, sir, from Foreign Affairs, on your interpretation of whether or not that is the case, that we are in danger of violating our TRIPS agreement with respect to C-393.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

If I had one word to describe my personal experience with Bill C-393, it would be the word “agonizing”. Let me define what I mean here, because it's not often a politician will talk about an experience as being agonizing. It's agonizing in the sense that I believe so much in the high-level objective of CAMR, which is to provide much needed medicine to people who are in need of it, and I've been solicited by a huge number of people who feel passionately about it. At the same time, I have not been convinced that this particular bill will solve that problem. Your testimony today generally supports my thinking, in the sense that you have pointed out what it can do and what it can't do and what it risks causing in terms of problems and other realities.

I want to start with something you said, Ms. Downie, at the very beginning. It is that the biggest problem is the result of poverty; it's not the result of a problem with our patent law. I'd like to ask you, perhaps, to expand a little bit more on that statement.

[Brigitte Zirger, Director, Policy Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health]

I'll try to do this on the fly, then.

As Ms. Downie has already mentioned, Health Canada's regulatory role within Canada's Access to Medicines Regime is three-fold.

Firstly, the department is responsible for undertaking a regulatory review of a drug submission to verify that the product meets the same requirements for safety, efficacy and quality as drugs available to Canadians.

Secondly, Health Canada is responsible for ensuring that the pharmaceutical product is distinguishable from the patented version available in Canada. This is aimed at preventing diversion or re-importation of the product.

Third, Health Canada is responsible for performing pre-export inspections to verify, among other things, the distinguishing features and the quantities to be exported. These details would be stated on the manufacturer's application for compulsory licence that is sent to the Commissioner of Patents.

Now, the products of most interest under CAMR are antiretrovirals used for the treatment of HIV/AIDS. In Canada, the vast majority of these drugs are still under patent protection, which means that Canadian generic versions have not yet been developed. This was the case with Apo-TriAvir.

I would add that submissions that are received and have been received under CAMR are taken into review immediately upon arrival and are completed well within the performance target. These reviews are undertaken with the same diligence as any domestic submission review we undertake, and that is mainly because at the end of that review, and when the patents expire, those drugs can come to Canada.

Companies, whether they are brands or generics, don't develop risk-free products. If they did, Health Canada would never have to issue a negative decision. And it is Health Canada's view that there should be no question of a double standard, nor should there be any concern that a drug leaving Canada destined for humanitarian purposes might be unsafe. Bill C-393 could put this in jeopardy. By removing the mandatory review, it is unclear what safety, efficacy, and quality standards would be applied to drugs exported from Canada under a government-issued compulsory licence.

Maintenance of quality once drugs are in that country and the trade of substandard, falsely labelled, counterfeit, and falsified medicines are serious public health problems. These pose significant challenges to developing countries, which receive drugs from many different sources, including Canada, and where the capacity of national drug regulatory agencies varies significantly. Removing Health Canada's review of drugs exported under CAMR simply moves the drug assessment to lesser-resourced agencies in developing countries or to WHO, which itself depends on regulatory agencies such as Health Canada to do the reviews.

Health Canada, its regulatory counterparts, and organizations like WHO work collaboratively to build regulatory capacity in developing countries. For example, there are quite a number of international harmonization projects, which I've named here but will skip, which focus on the development of lesser-resourced regulatory agencies.

In 2009, Health Canada replaced numerous annual ad hoc visits from these agencies with an international regulatory forum aimed at providing training. The forum is being repeated in two sessions this year and it involves some 27 participating countries. One of them is taking place next week.

We have an HIV vaccine initiative, which is a collaboration between the Government of Canada and the Bill and Melinda Gates Foundation, that is aimed at advancing the science of HIV vaccines and the prevention of mother-to-child transmission of HIV. An element of this collaboration, again, is aimed at capacity-building in the area of vaccines.

Most importantly, Health Canada works with WHO's pre-qualified program, which is actually mentioned in the bill. It aims to ensure that medicines and vaccines for high-burden diseases meet the global standards for safety, efficacy, and quality. The pre-qualified list is used by UN procurement agencies as well as by developing countries when making procurement purchases. Health Canada and many other countries undertake product reviews for this program, and it's because of this work that Apo-TriAvir was added to the pre-qualified list on the basis of Health Canada's product review.

In summary, Canada is committed to increasing access to high-quality medicines and health care in developing countries. Health Canada's role in CAMR is one aspect of this commitment, and so is Health Canada's contribution to building capacity in lesser-resourced regulatory authorities.

[Brian Masse, NDP, Windsor West, ON]

That's fine as long as the witnesses are going to stick to Bill C-393. I don't think we need to hear about other issues.

[Colette Downie]

Thank you, Rob.

I'm on to slide 5 now. I'll just back up for a second to say that Canada's patent system rewards the extensive investment that's needed to develop new, innovative products, including medicines, by giving patent holders exclusive rights to sell the results of their research for a number of years. In Canada, it's 20 years. When the patent expires, of course, others are free to sell the product, as when we see generic drug manufacturers selling copies of formerly patented medicines.

The access to medicines regime is an exception to our patent system. It allows the Canadian government to authorize someone other than the patent holder, whose property the patent is, to manufacture a patented drug or a medical service for export to a list of particularly needy countries. In recognition of the tremendous investment that's needed to develop these products, and because we want to continue to encourage companies to develop innovative new products, and medicines in particular, Canada's access to medicines regime, CAMR, was designed in a specific way to clearly define its limits, essentially.

While the process for applying for a special authorization under CAMR is actually pretty straightforward—and if the committee is interested, I could share the forms that are required, because when you see them they're actually quite straightforward—CAMR does contain some important disclosure provisions, which were designed first of all to promote transparency and prevent abuse, including the diversion of products back to Canada or to other markets where they might not actually be needed for humanitarian reasons, and, as I said, to ensure that the drugs manufactured are actually used for humanitarian and public health reasons and not for commercial purposes. Also, it's to allow the government or the Federal Court to cancel a licence if, for example, it's abused, is not used in good faith, or is used for commercial reasons. It's important to know that the regime relies on patent holders and not the government to police the use of products licensed under CAMR.

What Bill C-393 proposes to do is remove some of the important anti-diversion and transparency measures that make the regime enforceable. For example, it reduces the information that an applicant must disclose before it gets government approval—basic things such as the requirement to identify the patents involved, the name of the patent holder, the quantity shipped, where it's being shipped to; it would make the authorizations unlimited in duration and quantity; it would remove requirements to notify the patent holder when the medicine is being shipped, how much is being shipped, where it's being shipped to, and who will be handling it in transit as well; it proposes to remove requirements that licensed products have special markings, colouring, and labelling, to make them distinguishable from the patented versions available in Canada. It would significantly also narrow the ability of the government to terminate an authorization, and it eliminates the ability of a patent holder to challenge the shipment of goods, if they're for commercial purposes, in court.

What this means is that anyone could apply to the government for a licence to sell unlimited quantities of products outside Canada, and the government would be required to issue a licence on the basis of not a lot of information and without a mechanism at the back end to make sure that products are actually being shipped for commercial reasons, or to the country they're intended for.

Research and development-focused pharmaceutical companies have global reach, they have global perspective, they have flexibility about where they invest their R and D dollars, and they naturally favour jurisdictions that provide strong and predictable IP regimes. We're concerned that reducing the safeguards provided in CAMR will result in pharmaceutical companies' hesitating to invest in Canada for lack of certainty about the protection of their investments. If they believe the patented products they sell in Canada could also be sold in an unlimited way to other countries, including perhaps being diverted to relatively well-off countries like the ones I mentioned earlier, such as Mexico or Poland or Hungary, they might hesitate to invest the time, money, and resources to bring new and innovative products to Canada.

Another key concern with Bill C-393 is that it introduces a double standard: it would no longer require—it makes optional—that drugs manufactured and exported under the regime pass the Canadian health and safety review at Health Canada.

Many of these developing countries do not have the infrastructure in place to make sure that drugs they are purchasing are safe and effective. The Health Canada review process under CAMR makes sure that they receive the same level of protection as is provided to Canadians.

I'll just turn for a moment to Brigitte, who can expand a little on that point.

We're really now just getting to the end of slide 5, and on to slide 6 in a second.

[Colette Downie]

I think everyone has a copy of our deck before them...? Fantastic. That's what we'll be going through.

I'll start by thanking you for the invitation today to speak about Canada's access to medicines regime, or CAMR, as it's often called, and to speak about the possible implications of private member's Bill C-393, which proposes to significantly change this regime.

Together, my colleagues and I will be speaking about CAMR and Bill C-393. Our presentation will be divided up according to our various responsibilities, but it will, I hope, highlight the following.

First, there is the complex problem of delivering medicines to the developing world and what the Canadian government is doing about that. An access to medicines regime like CAMR, like Canada's, can't by itself solve the main problems of access to medicines, which are really the result of poverty, not patent laws.

A number of risks are associated with removing the conditions that exist in CAMR to give what would be essentially a blanket licence well beyond what would be needed to deal with some of the humanitarian problems that motivate this private member's bill. In particular, it would allow for export of almost any patented drug made in Canada for an unlimited time and to many countries that are relatively well off, like Poland, Mexico, and Brazil. There would be no policing mechanism to ensure good faith in the shipments, all of which potentially would have--at least we're concerned about it--concerns for Canadians' access to innovative new medicines and research and development jobs.

So while the proposed bill raises these risks, at the same time the government's view is that it's very unlikely to achieve its very laudable goals, which are to increase the exports of much-needed medicines to developing countries.

Following our joint presentation, all of the officials here would be happy to answer your questions.

I'll turn over the beginning of the deck to Louise Clément.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

I'll be brief. I think it's important for us to talk to the witnesses who are here today.

I want to start by thanking my colleagues for continuing with the study of Bill C-393, as Judy Wasylycia-Leis, the original sponsor of the bill, has moved on. I want to thank my colleagues for living up to the commitment they made to have hearings in this committee. I do appreciate that.

I want to provide a little bit of context. I won't get into many of the details of the bill, but I will maybe talk a little bit about why the bill is important and provide a little bit of the history for members who weren't around at that time.

I was elected back in 2002. When I came to Parliament Hill, there was already a movement to have a bill or a law to deal with some of the world's poorest and developing nations to help them get access to pharmaceuticals and medicines, since the simple status quo was not acceptable.

A year later, the WTO and a series of other global endeavours led to an opportunity for Canada to be one of those countries to actually put a system in place for generic drugs to be produced in advance of patents to help those suffering from tuberculosis, malaria, HIV/AIDS, and other types of catastrophic diseases and health problems. Bill C-56 was tabled in the House of Commons, and a subsequent government tabled Bill C-9, known as Jean Chrétien's Pledge to Africa bill.

At that time, the committee had lots of hearings. We had several different panels come forward. There were really comprehensive examinations. And just so my colleagues know, I actually proposed 100 amendments to that bill at that committee, believing at the time that it was flawed. Now, that's not to say I was right, but, at the end of the day, in the House of Commons all political parties ended up agreeing unanimously to a bill.

The explicit goal of everybody in that room and in the House of Commons was to have Canada put in place a system to be able to get these drugs to children and people across the globe who are suffering. As things stand, each day around 14,000 people die of HIV or AIDS, and when children actually have HIV/AIDS, one-third die by the age of one, and one-half by the age of two. We simply have the tools necessary to correct this situation.

Only one patent has gone through this regime to date. That was to Rwanda. It's been very limited in scope. That's from Apotex. There have been generic drug companies that say they will send more drugs overseas if we fix the legislation, and that's what we're proposing to do.

Once again, I'm proud to sponsor this bill, but, at the same time, I'm ashamed of my record on this, because I voted for a bill, and we promised the world we would do something that hasn't taken place. It certainly hasn't met what people said in the House of Commons and what they said here at committee, so I want to seek solutions to fix that.

I voted for the bill even though I thought it was flawed, because we stand unanimously together, as parliamentarians, to try to make a difference. We put those things aside to see whether or not the bill would actually work and if the problems we thought would happen weren't going to take place. But the reality is that they have.

So I stand here today to once again try to correct this situation, and to work cooperatively with everyone, because I think there was honest and sincere debate from all members and all parties to actually have a country that actually has a solution for this and that contributes and shows leadership. But we have failed people on this. There's no doubt about it. People are suffering. People are dying. People are not getting treatment. We put a lot of weight behind this and we need to solve it. I think it's a moral and ethical obligation for us, and I think Canada has the tools to be, once again, a leader in this field.

I thank you again for continuing with your commitment to have this heard in the halls of this committee, and hopefully in Parliament as well.

Thank you, Mr. Chair.

[The Chair, Conservative, David Sweet]

Order, please.

Good morning, ladies and gentlemen. Bonjour à tous.

Welcome to the 37th meeting of the Standing Committee on Industry, Science and Technology, the third meeting of this session.

We have a small piece of business that I'd like to deal with.

Members have in front of them the budget for our study regarding Bill C-393. Could I have someone—

Access to Medicines Regime

[Brian Masse, NDP, Windsor West, ON]

Mr. Speaker, it is an honour for me to table a petition on Bill C-393 regarding the reform of Canada's access to medicines regime.

Fourteen thousand women, men and children die every day from infectious diseases such as tuberculosis, malaria, HIV and AIDS. This country has yet to fix Canada's access to medicines regime which was created a number of years ago, back in 2003, which still has not helped provide access to low cost medicines for those abroad. We are literally letting children, women and men suffer unnecessarily.

The petitioners call upon Canada to reverse its policy and to become a contributor to the health and well-being of those individuals as opposed to ignoring them.

Industry, Science and Technology

[Michael Chong, Conservative, Wellington—Halton Hills, ON]

Mr. Speaker, I have the honour to present, in both official languages, the second report of the Standing Committee on Industry, Science and Technology, concerning its study of Bill C-309, An Act establishing the Economic Development Agency of Canada for the Region of Northern Ontario. The committee requests an extension of 30 days to be able to properly study the bill.

I also have the honour to present, in both official languages, the third report of the Standing Committee on Industry, Science and Technology, in relation to its study of Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act.

The committee requests a 30-day extension in order to give the bill proper consideration and to hear all witnesses who wish to appear.

Access to Medicines Regime

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Speaker, I am very pleased to be able to table my very last petition in the House before I leave this place after 13 years. Actually, this will be the very last time that I will say anything on the official record of the House of Commons. I cannot think of a better issue around which to do this than on the matter raised by petitioners from my constituency and across Canada, particularly from the Canadian Grandmothers for Africa organization.

The petitioners call upon this House to follow through with the support that it gave Bill C-393, my private member's bill on the access to medicines regime, to ensure that more drugs flow at costing rates to Africa and other developing nations.

Members will know that this bill was supported by the House of Commons at second reading. It has gone to committee and the petitioners implore members of the House from all parties to see the process through, to discuss this matter at committee, to call witnesses, and to ensure that we change Canada's access to medicines regime to ensure that drugs flow to countries in need and to ensure that Canada lives up to its reputation as a leader in terms of humanitarian and compassionate issues around the world.

I thank all of those who have worked so hard on this issue, especially the grandmothers across Canada. I urge the House to help me leave this as a lasting legacy for all Canadians and the world.

Business of the House

[The Speaker, Liberal, Peter Milliken]

I would like to make a statement concerning private members' business. Standing Order 86.1 states that all items of private members' business originating in the House of Commons that have been listed on the order paper during the previous session shall be deemed to have been considered and approved at all stages completed at the time of prorogation.

In practical terms, this means that notwithstanding prorogation, the list for the consideration of private members' business established at the beginning of the 40th Parliament shall continue for the duration of this Parliament.

All items will keep the same number as in the first and second sessions of the 40th Parliament. More specifically, all bills and motions standing on the list of items outside the order of precedence shall continue to stand. Bills that had met the notice requirement and were printed in the order paper, but had not yet been introduced, will be republished on the order paper under the heading “Introduction of Private Members' Bills”. Bills that had not yet been published on the order paper need to be re-certified by the office of the Law Clerk and Parliamentary Counsel and be resubmitted for publication on the notice paper.

All items in the order of precedence are deemed to have been considered and approved at all stages completed at the time of prorogation. Thus, they shall stand, if necessary, on the order paper in the same place or, as the case may be, referred to the appropriate committee or sent to the Senate.

At prorogation, there were 11 private members' bills originating in the House of Commons adopted at second reading and referred to the appropriate committee. Therefore, pursuant to Standing Order 86.1: Bill C-290, An Act to amend the Income Tax Act (tax credit for loss of retirement income), is deemed referred to the Standing Committee on Finance.

Bill C-300, An Act respecting Corporate Accountability for the Activities of Mining, Oil or Gas in Developing Countries, is deemed referred to the Standing Committee on Foreign Affairs and International Development.

Bill C-304, An Act to ensure secure, adequate, accessible and affordable housing for Canadians, is deemed referred to the Standing Committee on Human Resources, Skills and Social Development and the Status of Persons with Disabilities.

Bill C-308, An Act to amend the Employment Insurance Act (improvement of the employment insurance system), is deemed referred to the Standing Committee on Human Resources, Skills and Social Development and the Status of Persons with Disabilities.

Bill C-309, An Act establishing the Economic Development Agency of Canada for the Region of Northern Ontario, is deemed referred to the Standing Committee on Industry, Science and Technology.

Bill C-310, An Act to Provide Certain Rights to Air Passengers, is deemed referred to the Standing Committee on Transport, Infrastructure and Communities.

Bill C-391, An Act to amend the Criminal Code and the Firearms Act (repeal of long-gun registry), is deemed referred to the Standing Committee on Public Safety and National Security.

Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, is deemed referred to the Standing Committee on Industry, Science and Technology.

Bill C-395, An Act to amend the Employment Insurance Act (labour dispute), is deemed referred to the Standing Committee on Human Resources, Skills and Social Development and the Status of Persons with Disabilities.

Bill C-442, An Act to establish a National Holocaust Monument, is deemed referred to the Standing Committee on Transport, Infrastructure and Communities.

Bill C-464, An Act to amend the Criminal Code (justification for detention in custody), is deemed referred to the Standing Committee on Justice and Human Rights.

Pursuant to Standing Order 97, committees will be required to report on these reinstated private members’ bills within 60 sitting days of this statement.

In addition, one private members’ bill originating in the House of Commons had been read the third time and passed. Therefore, pursuant to Standing Order 86.1, the following bill is deemed adopted at all stages and passed by the House.

Bill C-268, An Act to amend the Criminal Code (minimum sentence for offences involving trafficking of persons under the age of eighteen years). Accordingly, a message will be sent to the Senate to inform it that this House has adopted this bill.

As they are no longer members of this House, all the items standing in the name of Ms. Dawn Black, Mr. Bill Casey and Mr. Paul Crête will be dropped from the order paper.

Consideration of Private Members’ Business will start on Friday, March 5, 2010.

To conclude, hon. members will find at their desks an explanatory note recapitulating these remarks. I trust that these measures will assist the House in understanding how private members' business will be conducted in the third session. In addition, the table can answer any questions members may have.

International Aid

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Mr. Speaker, I am pleased to rise in the House today to present a petition that calls on Parliament to set a timetable to meet Canada's development assistance commitments, to increase Canada's foreign aid commitments to combat HIV-AIDS, tuberculosis and malaria, and to make the legislative changes necessary for Canada's access to medicines regime to facilitate immediate and sustainable lower cost generic medicines flowing to developing countries. They call on the government to support Bill C-393.

The petition is signed by residents of Vancouver Quadra. It stems from the heroic efforts of the African grandmothers who raise children orphaned by AIDS. They are supported by the efforts of over 200 grandmother groups across Canada.

Drugs and Pharmaceuticals

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Speaker, I have three petitions. The first petition has to do with concerns from constituents and others about the 14,000 men, women and children who die every day from tuberculosis, malaria and HIV-AIDS.

The petitioners call upon this House to support Bill C-393, my private member's bill. They are pleased that it received support at second reading, and call upon this House to complete the process and ensure that it becomes law.

International Aid

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Speaker, I am very pleased to present yet another petition that was organized by the Grandmothers to Grandmothers Campaign in support of my Bill C-393, reforms to the Canada access to medicines regime, and also generally to ensure we meet our millennium development goals.

The petitioners call upon all of us to do our part to ensure that 0.7% of our gross national product goes to development assistance internationally and that we contribute our share to the global fund to fight AIDS, TB and malaria.

I want to thank the grandmothers again for their incredible pioneering work in gathering thousands of petitions in support of Bill C-393, and in their show of courage and conviction to ensure that people around the world benefit from the resources of this rich nation.

Patent Act

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Madam Speaker, I am pleased to table a petition that was organized by the Grandmothers for Grandmothers campaign who wanted to see Bill C-393 pass through the House to committee.

They are delighted with the results of the vote in the House last night. They urge all parliamentarians to continue working on the bill to ensure that necessary medications get to those countries that cannot otherwise afford them to deal with such horrible and deathly diseases as HIV and AIDS, tuberculosis and malaria.

On behalf of everyone in the House, I would like to thank the grandmothers again for their great work on this issue.

[The Deputy Speaker, Conservative, Andrew Scheer]

The House will now proceed to the taking of the deferred recorded division of the motion at second reading stage of Bill C-393 under private members' business.

The House resumed from November 27 consideration of the motion that Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, be read the second time and referred to a committee.

World AIDS Day

[Chris Charlton, NDP, Hamilton Mountain, ON]

Mr. Speaker, in this place which so often generates more heat than light, I want to pay tribute to the thousands of Canadians who act where government fails. One area where this is painfully obvious is in our response to HIV-AIDS.

Organizations such as the Hamilton AIDS Network are doing incredible work in preventing HIV transmission, and recognizing and responding to the stigma and challenges posed by HIV-AIDS. But, instead of partnering with NGOs on their essential programs, the government is forcing them to do more with less.

The same is true for the Grandmothers to Grandmothers Campaign that was launched by the Stephen Lewis Foundation. Volunteers are dedicating themselves to ensuring that whether one lives or dies with HIV is not determined by one's race, gender or citizenship.

The government could so easily support these efforts by passing the NDP's Bill C-393, but instead, it puts the needs of big pharma ahead of the need to win the battle against AIDS in the global human family.

On this World AIDS Day, I want to salute the Hamilton AIDS Network and the Grandmothers of Steel for their compassion and commitment. I want to challenge the government to support their efforts with resources instead of just rhetoric.

Access to Medicines Regime

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Speaker, I am pleased to table another petition. The signatures were gathered by grandmothers speaking out for grandmothers in Africa across this nation.

They are very concerned about the status of legislation before the House, which will come to a vote on Wednesday. They urge all members to support private member's Bill C-393. They urge all of us to make the necessary changes to Canada's access to medicines regime, and ensure that the commitments we made to the poorest nations of the world are kept.

Patent Act

[Mike Wallace, Conservative, Burlington, ON]

Mr. Speaker, if you give me a notice that I have a minute left, I will wrap it up.

It is my honour to stand here with this opportunity to address Bill C-393, which seeks to make substantial operational changes to the legislative framework for Canada's access to medicines regime under the Patent Act and under the Food and Drugs Act.

While I and I am sure other hon. members in the House are committed to improving access to medicines in the developing world via Canada's access to medicines regime and other initiatives, I have some strong reservations about Bill C-393 and its proposed revisions.

However, let me begin today with some background on Canada's access to medicines regime. The stated purpose of the regime is to increase access to lower-cost, Canadian-made generic versions of patented pharmaceutical products needed to address public health problems in developing and least-developed countries. The development of Canada's access to medicines regime was a landmark event as there was no other international precedent at the time.

Thus, in crafting the regime, the government focused on three important objectives: first, to increase access to patented drugs and medical devices in the developing world; second, to continue to respect Canada's international trade obligations; and third, to maintain the integrity of our domestic patent system for pharmaceuticals.

In 2004, the then-Liberal government introduced legislation to establish the regime by amending the Patent Act and the Food and Drugs Act. Shortly thereafter, Bill C-9 received royal assent with the unanimous support of all parties on both sides of the House and the Senate.

I will now turn to discuss some of the problematic elements of Bill C-393 that propose to alter the scope of eligible drugs for export under the regime, and the health and safety review that these pharmaceutical products go under.

First, I am concerned that Bill C-393 seeks to eliminate the list of pre-approved products for export in Canada's access to medicines regime. While some critics of the regime allege that the list makes CAMR too rigid and inflexible, it does serve an important and practical purpose. Specifically, the list of pre-approved products for export minimizes the discretionary elements of the regime and, as a result, expedites the decision making process. It also provides prospective users with the assurance that, assuming all other statutory requirements are met, an application for authorization under the regime will be used by the commissioner of patents.

Second, I am concerned about the proposed changes in the drug review process in Bill C-393. If passed, these changes would significantly alter the level of domestic oversight regarding the safety and quality of the products exported under CAMR. This is because Bill C-393 suggests, among other things, to make the existing mandatory Health Canada review optional.

Further, it suggests allowing the export of eligible products under Canada's access to medicines regime to be made on the basis of a review by a foreign regulatory authority. Such an abeyance of Health Canada's review would not be permitted for drugs and medical devices destined for the Canadian market.

In addition, during the statutory review of the regime in 2007, developing countries and generic drug manufacturers expressed strong approval of the very drug review that Bill C-393 seeks to remove. These potential users of CAMR went on record as saying that Health Canada's review was a useful mechanism for ensuring that products sent to the developing world under this system were safe and of high quality.

Some critics of Canada's access to medicines regime state that the Health Canada drug review is unnecessary and allege that it duplicates the World Health Organization's pre-qualification process for listing pharmaceutical products that are eventually purchased by international aid agencies and developing and least-developed countries without appropriate regulatory capacities. However, I do not agree with them.

Health Canada has a long-lasting and excellent relationship with the World Health Organization in this regard, both in undertaking reviews for the international organization's pre-qualification program, and in working with the World Health Organization and other initiatives to build regulatory health and safety capacity in developing and least developed countries.

Furthermore, since Health Canada's reviews are accepted by the World Health Organization for an alternate listing process, Canada's domestic drug reviews are not duplicated. The alternate listing process, which is an abbreviated process for listing drugs to the pre-qualified program, is available for drugs reviewed by Health Canada, the United States Food and Drug Administration and the European Medicines Agency.

I would like to conclude by reiterating that while the government remains committed to Canada's access to medicines regime and a broader, long-term approach to fighting public health diseases in the developing world, it opposes Bill C-393 and its proposed changes to the regime.

In my opinion, several of the changes to the Patent Act and the Food and Drugs Act raise concerns about the potential impact on the effective operation of CAMR. Many of these changes also do not support the humanitarian objective of improving access to safe medicines for the developing world.

Finally, there is little evidence that Bill C-393's proposed amendments will make a meaningful difference in the volume and frequency of exports under Canada's access to medicines regime.

To date, Canada's compulsory licensing and export regime is the only one of its kind worldwide to have successfully authorized and exported drugs to a country in need.

For all of these reasons, I urge hon. members in the House not to support Bill C-393. I do want to say in closing, however, that I do appreciate the efforts of the member for Winnipeg North in this matter. I have had a number of meetings in my riding with citizens who are deeply concerned that this regime is not working, but this bill does not meet their needs, based on our review of how it has been laid out. However, I do appreciate the member bringing this to the attention of the House of Commons.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Mr. Speaker, I am pleased to speak in support of Bill C-393 today. The bill would amend a bill passed in 2004, which was known at the time as the “Jean Chrétien pledge to Africa act”. I would like the listeners to keep in mind that objective.

The original bill created what is now known as Canada's Access to Medicines Regime. The stated purpose of this law was to help get more affordable generic medicines to patients in developing countries for public health needs, including HIV-AIDS, tuberculosis and other epidemic diseases, a very worthy objective, indeed.

This legislation was brought in by a Liberal government and, as the member opposite has just noted, was passed with unanimous support from all political parties in May, 2004, reflecting Canadians' beliefs and the empathy that Canadians feel for those who are in need.

I want to get on record as saying that this is a humanitarian, non-partisan issue that relates to the health and safety of those less fortunate in developing countries.

A country as lucky as Canada has the responsibility to do everything in its power to facilitate the access and distribution of medicines to those countries that are suffering from the devastating effects of diseases such as HIV.

On a personal level, I immigrated to Canada from South Africa at a young age. I went back in the 2000s and met people who were struggling with this terrible affliction. I am very concerned about compassionate assistance to help the AIDS epidemic.

The amendments in Bill C-393 are supported by a wide variety of organizations, including the Canadian Grandmothers to Grandmothers Campaign, which is an organization of women working to support the courageous South African grannies who are looking after those children who have been orphaned by the AIDS scourge.

Another point of context is that these amendments to the Canada's Access to Medicines Regime come at a time when the Conservative Government of the day has reduced by half the number of the poorest African countries that are being supported by CIDA on its priority list. With these cuts, alternative means of support for these countries is badly needed.

There are problems with the current Canada's Access to Medicines Regime. Despite the fact that the member opposite just celebrated CAMR, and I appreciate his positive statements about this Liberal initiative, it is not a successful regime. It is not working. In fact, in more than four years, only one country, Rwanda, and one Canadian generic manufacturer has used the regime for a single shipment of a single AIDS drug. That is not my definition of success.

Issuing one licence to export only one drug to only one country in almost five years since the law has passed tells us that there is something missing and something else is needed. It is not the expeditious solution for which parliamentarians and WTO members were looking.

The fact is no developing countries, other than Rwanda, have come forward or shown any interest to utilize CAMR in order to get much needed medicines for their citizens. Nor has any country sought to use laws comparable to this that have been passed in other countries. Therefore, this tells us that this law needs to be fixed.

A comprehensive access to medicines regime is needed more than ever. According to a joint UN program on HIV, more than 2.3 million children under the age of 15 are infected with AIDS, most of whom are living in developing countries. Without treatment, an estimated one-third of infants infected with HIV will die before reaching the age of one and half will die before reaching the age of two.

If the need for medicines is so critical, which clearly it is, what is preventing these developing countries from coming forward to utilize the Canada's Access to Medicines Regime? Simply put, the regime puts up unnecessary barriers and red tape.

The major concern I have heard in regard to the existing legislation is that the processes and requirements in place may be unnecessarily complex. As a result, they are dissuading the developing countries and generic pharmaceutical companies from stepping forward, utilizing the legislation and bringing forward the solutions for which everyone is looking.

There are many other difficulties to overcome following the delivery of medication to a developing country. We know that at times there are inadequately developed infrastructure, untrained medical staff, unregulated distribution of the drug and disorganized administration. These are all legitimate challenges on the ground.

However, in terms of this legislation, the question in Canada is actually simply. How can we make Canada's Access to Medicine Regime as simple, straightforward and risk-free as possible for the developing countries, for the generic pharmaceutical companies to use, while maintaining fairness for brand name drug providers? This amendment does that.

I will just speak a bit more about the barriers the existing legislation presents.

Under the current regime, the process for a generic drug manufacturer in Canada to get a compulsory licence to supply developing countries does not reflect the very procedures the developing countries typically go through when procuring medicines.

As the regime stands now, the law contains over 100 clauses that are required to be met. Clearly, that is shown to be a barrier. There are simply too many hurdles that developing countries have to jump over before they can place and receive an order. In thinking about the bill, it is important that we remember that in these developing countries the doctors, nurses and volunteers, and not the lawyers, are ordering these drugs.

Criticism levied against these proposed reforms mainly focus on how they will negatively impact the patented pharmaceutical industry, but the fact is their drugs are simply too expensive to be purchased at their current price and they have not taken the action necessary to get affordable medicines to developing countries.

Nothing in these amendments nor in CAMR itself prevents brand name pharmaceutical companies from competing to supply their patented products to developing countries and under these amendments, royalties would still be based on the sales of the generic product and would flow to the pharmaceutical company.

What is being proposed in Bill C-393? I will take a moment to read into the record parts of a letter I received from a group in my riding of Vancouver Quadra. It is from the UBC Medical Undergraduate Society, signed by Mattias Berg, the president. He speaks about Bill C-393, proposing a simplified one-licence solution. He says:

This approach, widely recommended by multiple humanitarian organizations including Médecins Sans Frontières...would cut through most of the red tape that prevents CAMR from being used to its full potential.

He goes on to add:

As concerned Canadians and future physicians, we are asking you to please support this bill and help save the lives of millions of children and patients in the developing world.

A compulsory licence will require that the generic manufacturer pay a royalty to the company that holds that patent and royalties would still be based on the sales of the generic product to the developing country, as in the existing CAMR formula. If the legislation is reformed, Canada's largest generic pharmaceutical company has committed publicly that it will make a desperately needed three-in-one AIDS drug that is suited for children in developing countries. This is all about that.

As we know, very few children in these countries have access to medicines to combat HIV, and they suffer unnecessarily. This is a human tragedy which we are trying to address. By streamlining the access to medicines regime, we would not create any additional costs to Canadian taxpayers. In fact, it requires the government to spend no additional funds.

Nobody claims that Canada's access to medicine regime, either in its existing form or in an amended version, would provide a complete solution. Barriers to accessing medicines in the developing world will continue. However, Canadians right across the country want to say that they are doing our part to help fight sickness and poverty around the world. It is part of our humanness to want to help.

This amended legislation is a policy tool that has the potential to put into action the desire of Canadians to help those less fortunate and help facilitate developing countries to gain access to affordable and timely treatment. For both compassionate and pragmatic reasons, the bill deserves Parliament's support and I hope the members will provide it.

[Mike Lake, Conservative, Parliamentary Secretary to the Minister of Industry]

Mr. Speaker, I am pleased to have the opportunity to address Bill C-393, which aims to modify certain fundamental aspects of Canada's access to medicines regime.

In 2004 members of Parliament and senators from all parties unanimously supported legislation introduced by the Liberal government of the day to establish this regime by amending the Patent Act and the Food and Drugs Act.

Canada's access to medicines regime's stated purpose is to improve access to lower cost Canadian-made generic versions of patented drugs and medical devices to address public health problems in developing countries. It was designed to achieve this humanitarian objective while respecting Canada's international trade obligations and maintaining the integrity of Canada's patent system.

The public health problems that gave rise to Canada's access to medicines regime in 2004 continue to exist today. This government remains committed to supporting this initiative.

I, and I am sure other members of the House, view it as a key component of Canada's long-term comprehensive approach to addressing serious public health problems that affect many developing and least developed countries, such as HIV/AIDS, tuberculosis, malaria and other epidemics.

In addition to Canada's access to medicines regime, this approach includes significant contributions from the Government of Canada to other global mechanisms and alliances, which have come into existence in recent years and have become leading instruments for procuring lower cost drugs to respond to the needs of developing and least developed countries.

For example, the government has contributed more than $500 million to the global fund to fight AIDS, tuberculosis and malaria. It has also pledged another $450 million to the fund over the next three years. In addition, the government is working with the Bill and Melinda Gates Foundation to fund the development of HIV/AIDS vaccination.

While the government's commitment to addressing public health problems in the developing world and to Canada's access to medicines regime is unwavering, there are concerns with Bill C-393's proposed modifications to the regime's legislative framework.

This is because the bill, if passed by Parliament, would result in the elimination of many of the key operational elements of Canada's access to medicines regime in order to adopt a very broad, one-licence approach that could have serious negative implications for continued pharmaceutical investment and growth in Canada.

In addition, many of the bill's proposed legislative changes may not be in keeping with the spirit of the World Trade Organization decision on which Canada's access to medicines regime is based. Canada's access to medicines regime was the result of years of intensive international negotiations by Canada and other developed and developing country members of the World Trade Organization to find a means to export needed medicines from countries with pharmaceutical manufacturing capacity to countries with little or no such capacity.

In August 2003 this process concluded when all of the World Trade Organization members reached a landmark decision. They agreed to waive two of the patent obligations in the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights in order to improve access to the patented drugs and medical devices needed to address public health problems in developing and least developed countries, such as HIV/AIDS, tuberculosis, malaria and other epidemics.

Canada's access to medicines regime was developed to implement this decision domestically. Canada's regime is one of nine regimes in existence that have implemented the World Trade Organization decision, but it is the only one to have successfully authorized an export of needed drugs to a developing countries. This important event occurred on September 24, 2008, when the Canadian drug manufacturer Apotex Inc. sent approximately seven million tablets of an HIV/AIDS therapy to Rwanda.

In 2007 the government completed a statutory review of the regime. As part of that process, it reviewed all public input on Canada's access to medicines regime. That input included extensive written submissions received in response to a 2006 consultation paper on the regime. It included expert testimony heard at hearings by the House of Commons Standing Committee on Industry, Science and Technology in April 2007, as well as input from developing countries in a workshop organized by non-governmental organizations.

In December 2007 the Minister of Industry tabled in Parliament a report on the results of the statutory review. The report concluded that insufficient evidence had accumulated to warrant making changes to the regime at that juncture. This conclusion remains valid today, since the case for making legislative or regulatory changes to Canada's access to medicines regime has still not been made.

The fact that Canada is the only country to date to see drugs shipped to a country in need under its access to medicines regime demonstrates that our system does work. However, for Canada's access to medicines regime to be used again, another country in need must inform the World Trade Organization of its intent to import lower cost versions of patented pharmaceutical products under the terms of the August 2003 decision.

The government continues to encourage developing and least developed countries to use the system and it hopes that such a notification happens. In the meantime, however, the government will continue to support Canada's access to medicines while fighting diseases and helping improve public health conditions in the developing world through other initiatives in its long-term comprehensive strategy on access to medicines.

Before I conclude, I would like to thank those who have advocated so tirelessly on this issue. In particular, I would like to acknowledge the hard work of the grandmothers to grandmothers campaign, which has continued to raise awareness and mobilize support for this bill.

Although we may disagree on the effects of the proposed modifications in Bill C-393 on the legislative framework of Canada's access to medicines regime, we can certainly agree on the need to address public health in the developing world. The grandmothers have shown true commitment to this cause and I believe their efforts deserve recognition.

With that said, the reasons I have outlined here today prevent me from voting in favour of this bill.

[Glenn Thibeault, NDP, Sudbury, ON]

Mr. Speaker, I am extremely proud to stand today to support the legislation brought forward by my colleague from Winnipeg North.

Bill C-393 would, as the bill's summary states, amend the Patent Act and the Food and Drugs Act to make it easier to manufacture and export pharmaceutical products to address public health problems afflicting many developing and least developed countries, especially those resulting from HIV-AIDS, tuberculosis, malaria and other epidemics.

This is an extremely worthwhile bill and I would encourage all members of Parliament, regardless of their party, to come together to ensure that the bill passes into law.

Every day, 14,000 people around the world die from preventable diseases. Eight thousand people die each day from HIV-AIDS because they lack access to antiretroviral drugs. Half of the 2.3 million children with HIV in the developing world will not live to see their second birthdays. Morally, this is simply unacceptable.

These deaths destroy families and communities, undermine economic growth and leave thousands of children orphaned. According to the World Health Organization, two billion people cannot get or cannot afford drugs that could have a massive impact on their standards of living.

Research by Polaris shows that 93% of Canadians think it is important to help people in developing countries who need medicines to treat or prevent diseases such as HIV-AIDS, tuberculosis and malaria. The same study shows that a majority of Canadians do not believe the federal government is doing enough to help developing countries by making medication to treat these diseases more affordable. The intention of this bill is to correct this.

The current Canada's Access to Medicines Regime, introduced in 2004, which I remind the House was supported by all parties, was a good start. Competition from generic manufacturers has allowed the price of AIDS medications to fall by 95% in some developing nations, but this legislation only allows generic drugs to be sold to countries explicitly named in the legislation. Companies producing generic drugs must also apply for a special licence for each order of drugs for each country they will supply.

In fact, the total number of licences issued to Canadian companies that produce generic drugs is one. That is right. In five years, only one Canadian company has managed to jump all the hurdles to get Canadian access to the medicine regime's licence, and it has done so just once.

This shipment was sent out in two parts to Rwanda in September 2008 and then again September 2009. That company has come out and said that it will not go through the process again unless it is reformed significantly. There is simply too much red tape. Although the final stage of approval only takes two weeks, this ignores the months of negotiations required to get to the point of submitting an application. Now is the time to improve upon this regime.

The changes proposed in Bill C-393 would mean that companies producing generic drugs would need to obtain just one licence for each medicine they intended to produce. This licence would allow the company to produce multiple orders for as many eligible developing countries as needed, without the need to apply for a new licence for each drug order.

I understand some people are worried that changes to the current regime would undermine Canadian pharmaceutical companies and that this in turn would mean they would stop their research and developmental activities, but this is not the case. This bill would not alter the current provisions, which means brand name companies still receive royalties on the drugs they have patented and brand name companies are still able to compete against generic brands in developing nations.

The bill would also not alter the anti-diversion measures that ensure that generic drugs are distinguished from branded drugs so they cannot be sold elsewhere. In fact, Bill C-393 is completely in line with intellectual property rights, both here in Canada and at the World Trade Organization.

In 2003, the World Trade Organization explicitly stated that developed countries should have more flexible policies to promote access to drugs for people in developing states. These changes will cost the taxpayer nothing and will actually stimulate the Canadian pharmaceutical industry. As companies in Canada ship more orders to developing nations, they will be able to sustain jobs and increase exports from Canada.

Even though this bill is first and foremost a humanitarian issue, there are clearly good economic reasons to reform Canada's access to medicines regime. Implementing this bill is a win-win situation. Developing nations will gain access to much needed drugs and Canadian companies can continue to grow.

I would also like to point out that these changes will not eliminate the review of the safety and quality of the drugs that will be available to developing nations. Drugs will still need to be reviewed by Health Canada, the importing country's government, or by the World Health Organization. The bill will only avoid the duplication of the review processes, meaning that drugs can get to the people who need them and get there faster.

In the one case where drugs were shipped under Canada's access to medicines regime, the company manufacturing the drug spent seven months undergoing a Health Canada review, only for that review to be repeated and duplicated at the World Health Organization. That adds a significant delay to getting the drugs approved. By streamlining the process, we can eliminate any duplication and make sure that these drugs get to the people who need them as quickly as possible.

Some people have suggested that voluntary programs, that is, programs where brand name pharmaceutical companies voluntarily ship drugs to developing countries, mean that no new legislation is required. These voluntary programs are laudable and we should congratulate the companies that have undertaken these efforts, but I do not believe they offer a credible alternative to this legislation.

Put simply, far too few drugs are produced and shipped through these programs to help everyone in the developing world who needs access to them. This legislation would increase the amount of drugs available to people living in developing states and it would also mean that generic brand drugs can reach the countries where they are most needed.

I would like to remind the House that next year, when Canada hosts both the G8 and G20 meetings, we have a real opportunity to shape the global agenda in many areas, including how to deal with the aftermath of the global economic slowdown and how to cope with climate change. These are the things that we can talk about. The best way to shape this agenda is to enact domestic legislation such as this bill, which shows that Canada is ready to lead by example. However, we have to act now.

We have a moral duty to do the right thing and I urge all parliamentarians to support Bill C-393.

[Bernard Patry, Liberal, Pierrefonds—Dollard, QC]

Mr. Speaker, I am pleased to rise in this House today to add my remarks with respect to Bill C-393.

I will try to make myself as clear as possible. I firmly believe that a nation as well off as Canada has to do everything in its power to facilitate access to and distribution of medicines in countries that are suffering terribly from the crippling impact of diseases like HIV/AIDS, malaria and tuberculosis.

That is why a Liberal government—needless to say—introduced legislation to establish Canada's access to medicines regime, otherwise known as CAMR.

That piece of legislation was passed unanimously by Parliament because it reflected our Canadian values, and the compassion Canadians have for those less fortunate in particular.

As we know, Rwanda was the first and only country to test CAMR by importing HIV/AIDS drugs from the Canadian generic drug manufacturer APOTEX.

We also know that three separate pharmaceutical companies holding the appropriate Canadian patents answered the call and authorized APOTEX to manufacture and deliver the requested product without having to pay any royalties. Incidentally, I should point out that these three companies recently reiterated their offer, again, royalty free.

After receiving the authorization, it took Apotex about one year to manufacture and ship the product and an additional year to ship the remaining amount permitted under the licence.

The fact that it was the only application of CAMR in Canada, and that no other country with a similar system has ever provided generic drugs to developing countries, leads us to the following question: why is CAMR not used more?

Unfortunately, rather than carrying out an in-depth analysis of the problem, some have concluded that the problem was that the legislation, although well intentioned, had shortcomings and that amending it would make it easier to apply. This resulted in Bill C-393, which puts forward the solution of a single licence system.

If we look at the facts surrounding the shipment of generic drugs to Rwanda, we see that the patent-holding pharmaceutical companies reacted very quickly when they were contacted. From beginning to end, the mandatory licensing process took 68 days.

I am pointing this out because it is extremely important to establish whether the licensing process caused the undue delay in shipping the drugs to their destination.

From what I have just outlined, it does not seem that the CAMR legislation, in its current form, is the cause. It seems that the problem lies elsewhere.

Why did it take one year to send the first shipment if the CAMR legislation was not at issue? It is important that we be fully aware of this fact given that we are attempting to determine the true causes of the problem.

Much has been made of the issue of intellectual property rights. Some claim that the pharmaceutical companies are hiding behind our international obligations under the WTO agreement on trade-related intellectual property rights, known by the acronym TRIPS, in order to hold back the flow of generic drugs.

Recognizing intellectual property rights is crucial for the future discovery of drugs that will save lives. If we do not protect intellectual property rights, we will deprive ourselves of key research, not only in the pharmaceutical sector but in all sectors driven by research. This will have extremely negative consequences for Canada.

Dozens of new drugs to treat HIV, malaria and similar illnesses are currently being tested. Related research is absolutely critical and is being carried out by patent drug manufacturers.

In testimony he gave on October 20 before the Senate Committee on Banking, Trade and Commerce about a similar bill, Bill S-232, a lawyer for the pharmaceutical industry said that the amendments proposed in Bills S-232 and C-393 are not in keeping with Canada's international trade obligations regarding intellectual property.

Are we going to ignore that conclusion? That said, let us focus on some of the known causes of the current problem.

More than 90% of the 319 drugs on the list of essential drugs for developing countries are not patented. Less than 10% are patented. It is important to understand that.

A recent study of 65 countries by Dr. Amir Attaran, a biologist and lawyer with the University of Ottawa, found that the main barrier to access to drugs in developing countries is not the granting of a single patent licence, but poverty. Yes poverty, always poverty.

Let us look at some other realities.

If we look at the necessary drugs that reach developing countries, we see that most of them come from countries like India, China and South Africa. Why not Canada? Certainly not because of the CAMR. It is because these drugs are available for less than what Canadian generic drug manufacturers charge, which is higher because of our higher labour costs.

This is certainly one of the reasons why developing countries do not turn to Canada for drugs under the CAMR. They have cheaper options.

The challenge at present is not the supply of drugs. The supply is there. But how are we going to deal with the very real challenge posed by the fact that recipient countries lack the infrastructure to make a proper diagnosis and to deliver, distribute, administer and store drugs?

We need to turn to organizations such as Health Partners International Canada, which have extensive experience in the field in managing the distribution of drugs in developing countries that have very little infrastructure.

I firmly believe that we can work productively with these organizations to get drugs to where they are needed. I also believe that this is a much better way to achieve our objectives than what Bill C-393 offers.

According to Margaret Chan, WHO Director-General, “Health systems are the tap root for better health. All the donated drugs in the world will not do any good without an infrastructure for their delivery.”

This bill offers no solutions to the problem of drug distribution infrastructure. It should have proposed the following measures: the creation of partnerships between the private sector and NGOs, which have a lot of experience in this area, to ensure effective drug distribution; and accountability and transparency of the access to medicines regime and distribution. This bill leaves out some important requirements in this area, which could make it easier for drugs to be diverted to recipients other than the developing nations they are meant for.

Health Partners International Canada has also recommended that the government take all reasonable measures to ensure that drugs from Canadian suppliers are not diverted from their intended recipients.

The problem of counterfeit and poor quality drugs will only get worse if Canada's Access to Medicines Regime is amended as set out in Bill C-393.

Therefore I call upon my colleagues in the House to clearly focus on the problems before us and send developing countries the drugs they desperately need, but also help those countries improve their infrastructure.

This bill makes no mention of the many different aspects of poverty, but rather talks about one licence. Instead of being a disposable, limited-time measure, agreeing to one licence would eliminate the voluntary licence step in agreements on trade-related aspects of intellectual property rights, or TRIPS, within the WTO.

I believe that intellectual property rights are essential in our society, and this bill offers no guarantee that those rights will be protected. In conclusion, I cannot support Bill C-393.

The House resumed from June 12 consideration of the motion that Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, be read the second time and referred to a committee.

Access to Medicines Regime

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Speaker, night has already fallen in much of Africa. Another day has passed and another 14,000 people have died needlessly from infectious diseases for which medicine is readily available, just not for them.

It is mostly grandmothers who care for the dying and who are left to piece together the shattered lives that remain. They tell us through the Grandmothers to Grandmothers Campaign, Canadian women devoting incredible energy in solidarity with their African sisters, that Canada's access to medicines regime, which was supposed to make more drugs available, is not working.

UNICEF, Oxfam, Canadian Crossroads International, Results Canada and the Canadian HIV/AIDS Legal Network all agree and have called for the changes set out in my private member's Bill C-393. I urge all members to vote for this bill to ensure that we fix Canada's access to medicines regime and get Canadian drugs moving to save lives.

Drugs and Pharmaceuticals

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Madam Speaker, I am very pleased to present yet another petition from Canadians who want to see changes to the Canadian access to medicine regime, so we can return to that noble goal of sending drugs as quickly and as cheaply as possible to sub-Saharan Africa and other countries.

The petitioners call upon the House to support my private member's bill, Bill C-393, a bill which is also similar to the one in the Senate being debated today, Bill S-232, a bill which just heard representation from experts showing, in fact, how nothing in these two bills contravenes the World Trade Organization, and is totally in compliance with everything we stand for in this country.

They call upon Parliament to help ensure access to affordable medicines wherever they are needed throughout the world as quickly as possible.

International Aid

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Madam Speaker, I am honoured to table a petition regarding Canada's access to medicines regime.

The petitioners call upon Parliament to support my private member's bill, Bill C-393, that proposes changes to this regime to make it possible for generic drugs to flow more effectively, efficiently and quickly to countries in need, especially in sub-Saharan Africa.

They want this to happen because 14,000 people die every day from diseases, such as HIV-AIDS, tuberculosis and malaria, diseases that are preventable if these countries were to have access to medicines that we take for granted in this country.

Grandmothers for Africa

[Denise Savoie, NDP, Victoria, BC]

Mr. Speaker, this past weekend I greeted Grandmothers for Africa as they pedalled into Victoria ending a 280-kilometre fundraising ride.

These remarkable women are recipients of the Rosemary Brown Award for Women for their tireless work in solidarity with grandmothers in Africa.

So today I rise to support the grandmothers' campaign to unblock Canada's access to medicines regime and get affordable generic drugs moving to the world's most vulnerable people.

This week, the second half of the first and only shipment under this legislation is leaving Canada for Rwanda, and the generic provider has said that it will be the last shipment unless the regime is amended.

My colleague, the member for Winnipeg North, has introduced Bill C-393 to remedy the regime's flaws. I urge all members to think like a grandmother and support this bill.

Patent Act

[Blaine Calkins, Conservative, Wetaskiwin, AB]

Mr. Speaker, I am pleased to have the opportunity today to address Bill C-393, which seeks to make substantial operational changes to the legislative framework for Canada's access to medicines regime under the Patent Act and for the Food and Drugs Act.

While I and other hon. members of the House are committed to improving access to medicines in the developing world via Canada's access to medicines regime and other initiatives, I have some strong reservations about Bill C-393 and its proposed changes. However, let me begin with some background on Canada's access to medicines regime.

The stated purpose of the regime is to increase access to lower-cost, Canadian-made generic versions of patented pharmaceutical products needed to address public health problems in developing and least-developed countries.

The development of Canada's access to medicines regime was a landmark event, as there was no other international precedent at that particular time. Thus, in crafting the regime, the government focused on three important objectives: first, to increase access to patented drugs and medical devices in the developing world; second, to continue to respect Canada's international trade obligations; and third, to maintain the integrity of our domestic patent system for pharmaceuticals.

In 2004, the then Liberal government introduced legislation to establish this regime by amending the Patent Act and the Food and Drugs Act. Shortly thereafter, Bill C-9 received royal assent with the unanimous support of all parties in both the House and the Senate.

I will now turn to discussing some of the problematic elements of Bill C-393 that propose to alter the scope of eligible drugs for export under the regime and the health and safety review of these pharmaceutical products.

First, I am concerned that Bill C-393 seeks to eliminate the list of pre-approved products for export in Canada's access to medicines regime. While some critics of the regime allege that the list makes Canada's access to medicines regime too rigid and inflexible, it does serve an important and practical purpose. Specifically, the list of pre-approved products for export minimizes the discretionary elements of the regime, and as a result, expedites the decision-making process. It also provides prospective users with the assurance that, assuming all other statutory requirements are met, an application for authorization under the regime will be issued by the Commissioner of Patents.

Second, I am concerned about the proposed changes to the drug review process in Bill C-393. If passed, these changes would significantly alter the level of domestic oversight regarding the safety, efficacy and quality of products exported under Canada's access to medicines regime. This is because Bill C-393 suggests, among other things, making the existing mandatory Health Canada review an option. Further, it suggests allowing the export of eligible products under Canada's access to medicines regime to be made on the basis of a review by a foreign regulatory authority.

Such an abeyance of Health Canada's review would not be permitted for drugs and medical devices destined for the Canadian domestic market. In addition, during the statutory review of the regime in 2007, developing countries and generic drug manufacturers expressed strong approval for the very drug review that Bill C-393 seeks to remove. These potential users of Canada's access to medicines regime went on the record as stating that Health Canada's review was a useful mechanism for ensuring that products sent to the developing world under the system are safe, efficacious and of high quality.

Some critics of Canada's access to medicines regime state that the Health Canada drug review is unnecessary and allege that it duplicates the World Health Organization's pre-qualification process for listing pharmaceutical products that are eventually purchased by international aid agencies in developing and least-developed countries without appropriate regulatory capacities.

However, I do not agree with them. Health Canada has a long-standing and excellent relationship with the World Health Organization in this regard, both in undertaking reviews for the international organization's pre-qualification program and in working with the World Health Organization on other initiatives to build regulatory health and safety capacity in the developing and least-developed countries.

Furthermore, since Health Canada's reviews are accepted by the World Health Organization for its alternate listings process, Canada's domestic drug reviews are not duplicative. The alternate listings process, which is an abbreviated process for listing drugs to the pre-qualified program, is available for drugs reviewed by Health Canada, the United States Food and Drug Administration and the European Medicines Agency.

I would like to conclude by reiterating that while the government remains committed to Canada's access to medicines regime and a broader long-term approach to fighting public health issues in the developing world, we simply oppose Bill C-393 and its proposed changes to the regime.

In my opinion, several of these changes to the Patent Act and the Food and Drugs Act raise concerns about their potential impact on the effective operation of Canada's Access to Medicines Regime. Many of these changes also do not support the humanitarian objective of improving access to safe and efficacious medicines in the developing world.

Finally, there is little evidence that the proposed amendments in Bill C-393 will make a meaningful difference in the volume and frequency of export under Canada's access to medicines regime. To date, Canada's compulsory licensing for export regime is the only one of its kind worldwide to have successfully authorized an exported drug to a country in need. This demonstrates that Canada's Access to Medicines Regime can and does, currently work.

For those reasons, I urge all hon. members in the House not to support Bill C-393 not because the intention is not good, but the bill is simply flawed.

[Nicolas Dufour, Bloc, Repentigny, QC]

Mr. Speaker, the Bloc Québécois acknowledges the need for immediate action to ensure that low-cost medications are sent to low-income countries.

As the Canadian HIV/AIDS Legal Network has said, the numbers speak for themselves. In 2007, the United Nations estimated that 33 million people were living with HIV/AIDS, including 2.5 million children. More than 8,000 people die every day from HIV/AIDS in the world.

The Bloc Québécois is aware of the different challenges surrounding research and development, of the problem with intellectual property on patents, of the need to pursue scientific research, and of the difficulty in balancing this with accessibility of low-cost medications in low-income countries. The Bloc also recognizes Canada's international obligations regarding the protection of intellectual property and the balance between accessibility and scientific research on this subject. As the Bloc Québécois has said many times, we must have another look at the Patent Act and Canada's access to medicines regime, now that law has been applied and the first medications sent to an African country.

It is more clear than ever that we need to act quickly. We must call together the various stakeholders to determine the advantages and disadvantages of Canada's access to medicines regime, and to come up with ideas to improve the current regime. We have a number of questions about the current effectiveness of this regime and its first application. Did it achieve the goal of bringing medications to the people? What were the relationships between the suppliers of the low-cost medications and the receiving country? Did the country have the necessary infrastructure to help sick people obtain the medication? Did the medication have the desired effect? How did negotiations work between the companies producing name-brand and generic medications?

The Bloc Québécois believes it is important to review Canada's access to medicines regime and the Patent Act, and to conduct in-depth follow-ups on the first application. Only after evaluating each step of the regime will we be able to determine how to improve it.

The Bloc Québécois is in favour of sending Bill C-393 to committee. We recognize that there are some provisions in the current regime that are keeping it from working properly. The committee will be able to carry out an in-depth analysis of how this legislation was applied on the ground for the first time.

However, the Bloc Québécois already has several concerns about the details of relaxing the requirements in relation to the current system, namely, expanding the list of countries, eliminating the wait time, Canada's commitments regarding intellectual property and how this bill will affect those commitments, the fact that brand name pharmaceutical companies are losing their oversight on agreements, the balance between intellectual property, the humanitarian aspect of the system, and the commercial aspect, which is more significant in Bill C-393 than in the current system.

Obviously, this bill raises many questions. The Bloc Québécois believes, however, that urgent action is required on this issue and that a study of Bill C-393 would be an excellent forum to begin discussions on potential ways to make the current system more flexible. Bearing in mind that a certain balance must achieved between the commercial and humanitarian aspects, the Bloc Québécois will definitely propose several amendments to this bill.

The World Health Organization, the Joint United Nations Programme on HIV/AIDS and UNICEF produced a report in 2008 entitled Towards universal access: Scaling up priority HIV/AIDS interventions in the health sector. That report reveals that access to anti-retroviral treatment for advanced HIV/AIDS improved between 2006 and 2007 in low-income and moderate-income countries. At the end of 2007, nearly 3 million people were being treated, that is, nearly 950,000 more people than in 2006, which is 31% of the 9.7 million people requiring anti-retroviral therapy.

Since 2001, the number of people receiving anti-retroviral therapy has increased 15-fold, from under 200,000 to 3 million, including 2 million people in Africa.

The greatest increase in treatment rates was in sub-Saharan Africa. That seems encouraging, but the fact remains that less than a third of the people who need treatment are receiving it. Some 2.5 million people were infected that same year, while fewer than 1 million new patients began receiving treatment.

There have been other improvements as well. Some 33% of HIV-positive pregnant women in those same countries received antiretroviral medications to prevent transmission of the disease to their child. Only 10% of pregnant women had access to that treatment in 2004. Once again, there has been a substantial improvement, but two-thirds of HIV-positive pregnant women still do not have access to these drugs.

With respect to children, nearly 200,000 of them had access to treatment in 2007, compared to 127,000 in 2006 and 75,000 in 2005. However, less than 5% of children have access to pediatric AIDS treatment, the kind of treatment specially developed for them. Treatment for children can cost up to eight times more than treatment for adults.

Every day, there are nearly 1,800 new cases of HIV infection in children under the age of 15, mainly as a result of mother to child transmission. In addition, every day, 1,400 children under 15 die from AIDS-related illnesses. More than 6,000 young people between the ages of 15 and 24 are infected with HIV. After more than 20 years of effort, less than 10% of pregnant women have access to services to prevent them from transmitting HIV to their newborn. Less than 10% of the children who are orphaned or made vulnerable by AIDS receive public assistance or have access to support services. Less than one-third of young women between 15 and 24 in sub-Saharan Africa really understand how to avoid the disease.

In the fall of 2008, Apotex, a generic drug company, began delivering triple combination anti-AIDS pills to Rwanda, and the contract calls for 21,000 people to be treated over two years. This is the first initiative of its kind in the world. Other countries have laws that allow low-cost drugs to be sent to developing countries, but none has shipped any yet.

According to patent drug companies, authorization to use their products was given very quickly, within two months, which proves the efficiency of the program. In terms of generic drugs, and more specifically Apotex, there are too many restrictions and the effort is not worth it. Apotex has stated that it would not want to repeat the experience in the current conditions.

Let us take a look at the background. At the end of the 1990s, charitable organizations initiated an awareness campaign. Pharmaceutical patents were deemed to be one of the main obstacles to drug access. Developing countries called on the World Trade Organization to relax intellectual property rules. Others considered corruption and insufficient infrastructure, in African countries in particular, to be the main obstacle.

In November 2001, in Doha, WTO members unanimously accepted that pharmaceutical patents were one of the main obstacles to access to drugs. In August 2003, WTO members agreed to allow developed countries to export low-cost drugs to developing countries. On August 30, 2003, WTO members agreed to make legal changes to certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights that seemed to prevent poor countries from importing pharmaceuticals.

I am told that I have only one minute remaining and so I will say that the Bloc Québécois supports some of the principles contained in Bill C-393. As I mentioned at the very beginning, we have a number of questions. Therefore, we would like this bill to be sent to a committee for more in-depth study. And, as I mentioned, the Bloc will propose a number of amendments to ensure that the bill will respect not only the industry but above all the charitable organizations that work primarily in Africa in order to ensure that we do all we can to fight AIDS.

[Dave Van Kesteren, Conservative, Chatham-Kent—Essex, ON]

Mr. Speaker, I am pleased to have the opportunity to address Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, which aims to modify certain fundamental aspects of Canada's Access to Medicines Regime.

Canada's Access to Medicines Regime's stated purpose is to improve access to lower cost, Canadian-made generic versions of patented drugs and medical devices to address public health problems in developing countries. It was designed to achieve this humanitarian objective, while respecting Canada's international trade obligations and maintaining the integrity of Canada's patent system.

Members of the House view Canada's Access to Medicines Regime as a key component of Canada's long-term approach to addressing serious public health problems that affect many developing and least developed countries, such as HIV-AIDS, tuberculosis, malaria and other epidemics. In addition to Canada's Access to Medicines Regime, this approach includes significant contributions from the Government of Canada to other global mechanisms and alliances which have come into existence in recent years and have become leading instruments for procuring lower cost drugs to respond to the needs of developing and least developed countries.

For example, the government has contributed more than $500 million to the global fund to fight AIDS, tuberculosis and malaria. It has also pledged another $450 million to the fund over the next three years. In addition, the government is working with the Bill & Melinda Gates Foundation to fund the development on an HIV-AIDS vaccination.

The government has serious concerns with Bill C-393's proposed modification to the regime's legislative framework. If passed by Parliament, the bill will result in the elimination of many of the key operational elements in Canada's Access to Medicines Regime in order to adopt a very broad, one-licence approach. This could have serious negative implications for continued pharmaceutical investment and growth in Canada. In addition, many of the bill's proposed legislative changes may not be in keeping with the spirit of the World Trade Organization decision on which Canada's Access to Medicines Regime is based.

This decision was the result of years of intensive international negotiations by members of the World Trade Organization. Those negotiations sought a solution to international patent obligations that impeded the export of critical medicines from countries with pharmaceutical manufacturing capabilities to countries without.

In August 2003, WTO members reached a landmark decision. They agreed to waive two of the patent obligations in the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS, in order to improve access to patented drugs and medical devices needed to address public health problems in developing and least developed countries.

Canada's regime is one of the nine regimes in existence to have implemented the World Trade Organization decision, but it is the only one to have successfully authorized the export of drugs to a developing country. This important event occurred on September 24, 2008, when a Canadian drug manufacturer, Apotex Inc., sent approximately seven million tablets of HIV-AIDS therapy to Rwanda.

In 2007 the government completed a statutory review of the regime as part of this process. It reviewed all public input in Canada's Access to Medicines Regime. That input included the extensive written submissions received in response to a 2006 consultation paper on the regime, expert testimony heard at separate hearings by the House of Commons Standing Committee on Industry, Science and Technology in April 2007, and I was a part of that committee, as well as input from developing countries at a workshop organized by non-governmental organizations.

In December 2007 the Minister of Industry tabled a report on the results of the statutory review in Parliament. The report concluded that insufficient evidence was accumulated to warrant making changes to the regime at that juncture.

This conclusion remains valid today, since the case for making legislative or regulatory changes to Canada's Access to Medicines Regime has still not been made. The fact that Canada is the only country today to see drugs shipped to a country in need under its access to medicines regime demonstrates that our system does work.

However, for Canada's Access to Medicines Regime to be used again, another country in need must inform the World Trade Organization of its intent to import lower-cost versions of patented pharmaceutical products under the terms of the August 2003 WTO decision.

The government has and continues to encourage developing and least developed countries to use the system and hopes that such a notification happens. In the meantime, however, it will continue to support Canada's access to medicines, while fighting diseases and helping improve public health conditions in the developing world through other initiatives in the government's long-term comprehensive strategy on access to medicines.

It is for these reasons that I urge all hon. members of this House not to support Bill C-393.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Mr. Speaker, I would like to begin by saying that I truly believe that as a country, we must do everything we can to help people in developing countries get access to much-needed medicines. Such a humanitarian initiative must be supported, because we all know that many people are suffering in poorer parts of the world.

Having said that, I personally do not believe that we can achieve that goal by changing the law associated with Canada's Access to Medicines Regime. Allow me to explain.

Canada's Access to Medicines Regime, or CAMR, came into force in May 2005, following the adoption by Parliament of Bill C-9. CAMR's purpose was to put in place a low-cost generic drug-based mechanism to deliver lifesaving medications to countries which could not otherwise afford them. The purpose was laudable and remains laudable, and the bill passed with the consent of all parties.

As an amendment to the Patent Act, CAMR allows generic drug companies to obtain the compulsory licence to manufacture patented pharmaceutical products and to export those products to developing countries that do not have internal capacity to manufacture products required to address public health problems.

If one looks at the flow of generic medicines to developing countries since the implementation of CAMR, one can only cite one example of such a transfer from Canada, and that was to Rwanda.

Similar legislation to CAMR implemented in other countries has also not resulted in the flow of generic medicines to developing countries.

The reasons for this situation are complicated, but they have nothing to do with the difficulty of complying with the current legislation, as the bill before us today suggests. The amendments proposed in Bill C-393 will not make things better, because the main challenges involved in getting medicines to the people who need them have nothing to do with the flaws in the current legislation.

The balance that was established in the legislative process through amendments to the Patent Act and the Food and Drugs Act was deemed appropriate by the review conducted in 2007 by Industry Canada in collaboration with Health Canada, CIDA and DFAIT.

Although critics of CAMR have said that the law is too complicated, it is worth noting that Douglas Clark, the former director of Patent Policy at Industry Canada, has stated that this criticism is not credible.

In fact, the reasons why CAMR does not work as we had hoped have to do with real problems in the field, in the countries that need these medicines. They have to do with access to properly trained medical staff, whether they be doctors or nurses. They have to do with clean water supply, refrigeration facilities, accurate diagnosis, secure infrastructure for distributing the medicines and so on. In short, they have to do with poverty and the need to make developing countries aware of CAMR. Those are the real challenges.

It is not the process itself of requesting the medicine. That process is uncomplicated, even with its checks and balances that ensure compliance with international obligations under the WTO TRIPS agreement, the agreement on trade-related intellectual property rights.

Canada does have obligations related to TRIPS and it is important to respect them. The World Trade Organization's agreement on trade-related intellectual property rights, to which Canada is a signatory, generally prohibits countries from engaging in compulsory licensing for purposes of export.

Canada and other WTO member countries are authorized to adopt regimes like CAMR only as a result of an agreement reached between WTO member countries in August 2003, which waives the restriction that compulsory licensing can only be used for their domestic markets. This waiver sets out strict and limited conditions under which Canada and other exporting WTO members may grant compulsory licences to manufacture and export pharmaceutical products for humanitarian purposes.

It is important to remember that Canada is only one of many nations that have implemented the waiver as part of their domestic legal regimes. CAMR appropriately uses this waiver as the basic framework for Canada's regime. The waiver is also used by other nations as the basis for their domestic law equivalence of CAMR.

The changes to CAMR proposed by Bill C-393 would eliminate all references to the TRIPS agreement and waiver and would eliminate most of the elements of CAMR that help Canada to comply with the applicable conditions governing the issuance of compulsory licences.

The amendments proposed to CAMR in the bill would render the regime non-complied with Canada's WTO obligations as established in the TRIPS agreement and waiver.

Key deficiencies in the proposed amendments, from the standpoint of WTO compliance, include the fact that TRIPS requires the applicant for licence to seek a voluntary licence from the patent owner.

Bill C-393 would repeal the provision of CAMR that requires the prospective licensee to seek from the patentee a voluntary licence to manufacture and sell pharmaceutical products for export. This is inconsistent with the spirit of the waiver, which is intended, where feasible, to encourage voluntary agreements rather than impose compulsory licences.

TRIPS requires that the scope and duration of the licence must be limited to the purpose for which it is authorized. The bill would repeal all limitations on the scope and duration of the compulsory licence, theoretically granting a perpetual and unlimited legal right.

TRIPS requires that a licence should be terminated if and when the circumstances that lead to its issuance cease to exist or are unlikely to recur. Under Bill C-393, absent an application by a patent owner, a licence would only terminate if relinquished by the licensee.

TRIPS requires that the patent owner be paid adequate compensation in the circumstances of each case. Bill C-393 would repeal the CAMR provision that allows the patent owner to seek a higher royalty than the formula established by CAMR, if warranted.

The waiver applies only to pharmaceutical products needed to address public health problems. Bill C-393 would repeal schedule 1 of CAMR, which is the list of eligible products, and would not put in place any limitation on the patented pharmaceutical products for which a compulsory licence may be granted.

The waiver requires all importing WTO members to make a notification to the WTO, specifying the name and quantity of needed pharmaceutical products. Importing members, which are not least-developed countries, must also establish that they do not have the manufacturing capability to produce the pharmaceutical product. Bill C-393 would not require any notification or copy of the notification submitted by an importing country regarding its need for a pharmaceutical product or setting out the quantity required or speaking to manufacturing capacity.

The waiver states that exporting members, like Canada, can only authorize manufacture and export of that amount of product necessary to meet the needs of the importing member and states that all of the product must be exported to that importing member, as opposed to other members or countries. Bill C-393 places no limits on the amounts of product that may be manufactured under the compulsory licence and would permit unlimited quantities of the product to be exported to any eligible importing country regardless of their need.

The issues noted above are only the most obvious problems of Bill C-393 to comply with Canada's international obligations. It is clear that if this bill were to become law, Canada would be in default of its international trade treaty obligations under the TRIPS agreement.

Canada is a well-intentioned country that wishes to provide much needed assistance to countries in need of medicines to prevent or combat diseases such as tuberculosis, malaria, HIV-AIDS and other epidemics. That is why Parliament voted for Bill C-9, the original CAMR legislation. In other words, our intentions were and remain honourable.

In the intervening years, however, we have come to the conclusion that what we had intended, a flow of generic drugs to countries in need, is not happening. We are all in agreement on this point, however, there is a different interpretation as to why CAMR is failing.

There are many things that Canada can and should do through CIDA, and that is where Canada should focus its efforts. That will enable Canada's Access to Medicines Regime, which is part of the solution, to do everything it is supposed to do.

[Bob Dechert, Conservative, Mississauga—Erindale, ON]

Mr. Speaker, I would respectfully request the hon. member to explain why she would be in favour of making a review by Health Canada optional? I understand that Bill C-393 does this. Perhaps she could explain why she thinks that it is not unethical to export products to other countries which have not met the same safety standards that we have for consumption by Canadians?

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

moved that Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, be read the second time and referred to a committee.

Mr. Speaker, it is a real privilege for me today to begin to speak to a bill that has been the product of so many hours of work by community activists and NGOs right across this country and around world. I am pleased to speak today to Bill C-393, which is an act to amend the Patent Act and to ensure that we can flow drugs for international humanitarian purposes.

Our day to day work in this place clearly impacts upon every aspect of Canadian lives, but rarely are we, as members of Parliament, presented with so clear and direct an opportunity to save lives. We know that 14,000 people a day die from infectious disease, such as HIV-AIDS, tuberculosis and malaria, and that these deaths are preventable because they can be treated with medicines that are on the market today. The dimensions of this crisis are almost impossible to comprehend, with the personal cost to victims' health, the cost to their families, the plight of those left as orphans, and the strain on grandparents thrust into the role of providers.

There are 33.2 million people living with HIV worldwide, 22.5 million, or 68%, live in sub-Saharan Africa. In 2007, 2.1 million adults and children died of AIDS, and 76% of them, or 1.6 million, were in sub-Saharan Africa alone. An estimated 2.1 million children under 15 were living with HIV worldwide in that same year, and again, nearly 90% were in sub-Saharan Africa. Some 13 million children have been orphaned by HIV-AIDS in sub-Saharan Africa, and it is now estimated that by the year 2010, as many as 20 million children will have been orphaned by AIDS worldwide.

Finally, without treatment, an estimated one-third of infants infected with HIV will die before reaching the age of one. Half will die before the age of two.

Tuberculosis patients and malaria sufferers are also losing their lives for lack of available medicines, medicines that are on the market today. Five thousand people die from tuberculosis every day, while more than one million people die each year from severe malaria, a disease relatively easy to treat with proper drugs.

This is mind-boggling when we think about it. It is a crisis that no Canadian wants to turn his or her back on. Everyone in this country wants to see Canada do its job and carry out its responsibilities on such a serious life and death situation.

Canadians were very proud when Parliament took action quickly five years ago, following the landmark decision by the World Trade Organization in 2003. It allowed more prosperous nations, like Canada, to offer humanitarian medical support to developing nations.

Canadians were very proud when Parliament unanimously passed reforms to the Patent Act in 2004, called Canada's Access to Medicines Regime, otherwise known as CAMR. That regime was created to provide a framework to use a system of compulsory licensing to allow generic drug companies to produce cheaper versions of the latest most effective drugs to treat infectious diseases even though they were still under patent.

However, we all became disillusioned. Canadians right across this country were very disappointed when we actually came to realize that this medicines regime produced practically no results.

Since that time, four years ago, when we passed the legislation unanimously in the House, there has been only one compulsory licence completed under that legislation. Last September, the first and only shipment went out. It was a shipment of 7 million Apo-TriAvir tablets, shipped to Rwanda by Apotex, Canada's largest generic drug manufacturer. That was an important shipment. It will help 21,000 people. However, given the statistics I just mentioned, it is a drop in the bucket. That has been the only shipment.

There is obviously something wrong with the legislation. I am here today to try to fix it. The burden of drug costs for the world's lowest-income nations has intensified. Despite the efforts of those like my former colleague, the hon. Alexa McDonough, Canada and other prosperous nations are shamefully not on track to meet our commitments to the United Nations millennium development goals, such as reaching 0.7% of GNP in international assistance by the year 2015, increasing our efforts toward the global fund, reducing child and maternal death, and reducing HIV-AIDS.

Other G8 commitments to reduce poverty have not lived up to their hype. As a final blow, the world is now in the midst of an economic crisis of unprecedented proportions. Within their own borders, the devastating loss of large numbers of productive adults to infectious disease has further compounded the already difficult road to economic security and stability. Countries are obviously even less able to cope with high drug costs for their citizens. I am sure that members of Parliament realize that Canadians will not tolerate us carrying on with a dysfunctional drug system that keeps cheaper drugs from getting to where they are needed.

Former UN special envoy for HIV-AIDS in Africa and respected Canadian Stephen Lewis has been at this for years, tirelessly. He has never given up trying to reduce the incidents of HIV-AIDS in Africa and elsewhere, and has never stopped pushing and prodding us to find solutions. He, like all of us, is concerned about the inaction under the legislation we passed five years ago. He said:

Delaying action is inexcusable when the path forward is so clear: streamline CAMR, get affordable medicines to those who are dying for them, save thousands of lives, particularly those of children with HIV. Every day counts,

Stephen Lewis is right. Every day counts. Canadian generic drug maker Apotex has made a priority of clearing up the mess. It has committed to making a low-cost version of an important pediatric AIDS medication as soon as this access to medicines regime is made workable. I want to remind members that, in sub-Saharan Africa, half of all the children born with HIV died before reaching their second birthday.

This type of drug, which is so needed, is not currently being made. If we could only change the rules, it would happen and it would improve the treatment of these children tremendously. Peggy Edwards, co-chair of the national advocacy committee of the grandmothers to grandmothers campaign, echoes the call for CAMR reform. She says:

Right now, African grandmothers are carrying the burden of caring for children orphaned by AIDS and dying of AIDS without appropriate medicines. Streamlining CAMR and getting affordable medicines to children with HIV would ease that burden considerably.

That is very well said. Let me also quote Richard Elliott, who is the executive director of the Canadian HIV/AIDS Legal Network. I should mention that his organization has studied this process more than anyone and knows it inside and out. He says:

The current system just doesn’t work...The need is enormous, but CAMR just isn’t user-friendly in its current form.

That is why, in Bill C-393, I have drawn on the legal network's expertise and that of others knowledgeable of the strengths and weaknesses of the current CAMR system to come up with a workable proposal for change. It is a proposal that will get these drugs into production and to the children and adults who have been waiting for them for far too long.

Bill C-393 proposes critical changes to Canada's access to medicines regime. Let me mention a few of them.

It provides for a one licence system to replace the need for single applications for every drug, for every amount of drug produced, and for every country which is seeking medications. That is important.

It gets rid of the narrow list of eligible drugs in order that new medicines can be incorporated at the earliest possible time.

It gets rid of the two-year time limit on compulsory licences with only one reapplication allowed.

It lives up to our international trade agreements while dumping the CAMR's requirements that exceed WTO demands.

Finally, it discourages unnecessary legal action by allowing generic producers to correct minor errors within a limited time.

The reforms we are proposing today in the bill have been supported by many, including 37 humanitarian and health organizations in Canada. They have said so in their submissions to government. That we are here today aware of the problems with CAMR and with solutions to offer to resolve these problems is due to the ongoing effort of so many individuals and organizations.

I want to particularly thank the Canadian HIV/AIDS Legal Network, Results Canada, Stephen Lewis Foundation and Oxfam Canada. I would particularly like to mention the incredible work of the Grandmothers to Grandmothers Campaign that now has more than 200 groups spread across Canada working tirelessly to raise awareness and rally support for these grandparents struggling for their own and their families' survival in sub-Saharan Africa in the wake of their children's premature deaths from HIV-AIDS. In Winnipeg, the group is named Grands 'n' More Winnipeg and I have been helped by discussions and information from Linda Watson, Irene Rempel, Enid Butler, Nancy Cosway and Shelley Coombes.

This spring, the grandmothers, as they have become known around this place, and I am wearing the pin that they have given to us all, brought petitions with more than 32,000 signatures to Parliament. We all had the privilege of presenting some of those petitions.

I want to cite the work of a present colleague of mine who formerly worked on this issue. The member for Windsor West was active on this file when Parliament first passed this bill a number of years ago.

In presenting the bill, I feel a great sense of responsibility. Normally, I have had the responsibility in this place to speak for my constituents in Winnipeg North. That responsibility is daunting in itself.

Today, I am speaking to this bill for millions of women, men and children who have a right to health, a right to life, just as we do, but who through circumstances of birth find themselves faced with serious conditions and diseases in countries unable to afford them the help they and their families need because of economic limitations.

As I have said, the challenges are unimaginable, but the spirit of the struggle is strong. We have a choice today, whether to break down a barrier that is denying them a future or to stay with the status quo and extinguish that spirit. I urge members to choose the former.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

moved for leave to introduce Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act.

Mr. Speaker, I am very honoured to introduce this bill in the House today. It would amend the Patent Act as a remedy to the serious flaws within Canada's access to medicines regime that was passed in this place unanimously in May 2004.

That initiative was intended to be a meaningful humanitarian tool to flow lifesaving medicines to the world's poorest nations at affordable below patent prices. The built-in problems have resulted not in a flow but a trickle and there has been only one successful application. Meanwhile, many people, thousands of men, women and children, suffer needlessly without getting access to the treatments that are available.

This bill is here with the help of the Canadian HIV/AIDS Legal Network and with the support of Canadian Grandmothers for Africa, Grands 'n' More Winnipeg, the Stephen Lewis Foundation, Doctors Without Borders, Results Canada, and many other organizations.

I recommend this bill because it offers members amendments to the act that would streamline the process and get urgently needed drugs to HIV and AIDS patients as soon as possible.

(Motions deemed adopted, bill read the first time and printed)