Bill C-9 (Historical)

An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa)

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.

[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.

[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.

[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.

[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.

Message from the Senate

[The Speaker]

I have the honour to inform the House that a communication has been received as follows:

Rideau Hall

Ottawa

May 13, 2004

Mr. Speaker:

I have the honour to inform you that the Honourable Adrienne Clarkson, Governor General of Canada, signified royal assent by written declaration to the bills listed in the Schedule to this letter on the 13th day of May, 2004 at 6:56 p.m.

Yours sincerely,

Barbara Uteck,

Secretary to the Governor General

The schedule indicates that royal assent was given to Bill C-24, an act to amend the Parliament of Canada Act--Chapter No. 18; Bill C-20, an act to change the names of certain electoral districts--Chapter 19; Bill C-28, an act to amend the Canada National Parks Act--Chapter 20; Bill C-15, an act to implement treaties and administrative arrangements on the international transfer of persons found guilty of criminal offences--Chapter 21; Bill C-30, an act to implement certain provisions of the budget tabled in Parliament on March 23, 2004--Chapter 22; and Bill C-9, an act to amend the Patent Act and the Food and Drugs (The Jean Chrétien Pledge to Africa)--Chapter 23.

I also have the honour to inform the House that a communication has been received as follows:

Rideau Hall

Ottawa

May 13, 2004

Mr. Speaker,

I have the honour to inform you that the Right Honourable Adrienne Clarkson, Governor General of Canada, signified royal assent by written declaration to the bill listed in the Schedule to this letter on the 13th day of May, 2004 at 9:10 p.m.

Yours sincerely,

Barbara Uteck

The schedule indicates the bill assented to was Bill C-3, an act to amend the Canada Elections Act and the Income Tax Act--Chapter 24.

Budget Implementation Act, 2004

[Deepak Obhrai, Canadian Alliance, Calgary East, AB]

Mr. Speaker, it is a pleasure to speak for the second time to Bill C-30. I am speaking to the bill because it deals with a very important issue, the budget.

Mr. Speaker, I will be sharing my time with my colleague from Dauphin—Swan River.

When the Prime Minister took office after being elected as leader of the Liberal Party, he promised Canadians a new vision that would be different from the previous government. He promised in the throne speech that he would connect with Canadians and offer them an alternative.

We then moved from the throne speech into the budget speech, where, in all honesty, after taking everything into consideration, we saw it as band-aid solution budget. We all knew the Prime Minister wanted to call an election because he was riding high in the polls and he thought the steam engine of the Liberal Party could sweep the country.

Lo and behold, the record of the Liberal government smacked it right in the face, as the member of the NDP just pointed out. The scandal of the management of Canadian taxpayer dollars hit it right smack in the face. What happened? We are now in a holding pattern.

The Prime Minister wants to call an election but he does not know when to call it. The vision he talked about has disappeared. Where will this bill on the budget go? As we all know, we are waiting for the Prime Minister to call an election but he cannot even decide when to call it. Whether it will be on June 14, June 28 or July 5, nobody knows.

The country is now being run in a holding pattern while Canadians wait for important issues to be solved. The last thing on the minds of Canadians is an election. They expect the government to come up with a plan, the budget being one of those plans.

As the critic for international development, I see in the budget that $248 million will go into the international assistance development envelope, which would bring the CIDA budget to over $2.5 billion. People may not know this but CIDA has a budget of $2.5 billion, which is a lot of money, and yet CIDA operates without a legislative mandate. It is left to the mercy of the government or the Prime Minister and politics are being played.

As an international development critic for the last three years, I have seen four ministers at the head of that department and each minister has tried to pass on her or his own ideas and agenda. Why? The reason is that we now have legislation that directs where the money will go. It is left to the whim of the minister and the senior bureaucrats in CIDA. That is why questions keep being raised about where this money is being spent.

Canadians do not know what CIDA is doing. CIDA may have a good international name in countries where it does little patches of work but Canadians do not know where the tax dollars are going in international development. I keep asking that question in the House. Canadians are wondering why emerging economies in countries like China are receiving over $50 million.

Canadians shake their heads about why we are giving a country like China that aid. Every time I raise this question the answer is that there is poverty in China. Yes, we know there is poverty in China. We are very happy to see China as an emerging nation, but China is now in a situation where it has the resources to take care of its people.

Its leaders can take care of its people, but what do they do? They send people into space. They spend all that money for sending people into space. As well, there is an increase in their military expenditures of over 12%. They can do that, yet we stand here and use Canadian taxpayers' dollars and say there is poverty there that we need to address so we have to give them $50 million.

Would that money not be better spent in Africa or in Latin America, in the slums there? I do not understand why and how we can stand up and let the Chinese leaders off the hook. They should be responsible for their own people.

However, this highlights the problem, which I am trying to say is the way CIDA is structured, the way CIDA is operated and the way CIDA is giving out money. The question that comes up time after time is this one: What is happening and where is this money?

Sure, Canadians are very generous. They would like to assist the unfortunate around the world. I am very glad and very proud, and so are members of my party today, to stand up and vote for Bill C-9. I have to give credit to the government for introducing that legislation, but we were the party that was there right away supporting that bill, because we knew Canadians wanted that bill to be supported. That bill is going to give generic drugs to Africa to help in the fight against HIV, malaria and TB. Yes, based on that, we supported it.

However, we need to keep asking this question: Where does the money go?

It is very interesting that the Prime Minister just went down to Washington and made a speech there. He talked about international development assistance, but then what do we say? It is a simple answer: We are giving more money. We are giving more money so we are meeting our commitment to international assistance.

Really, giving more money and using money wisely and effectively is a challenge. It is a challenge unless and until there are structural reform changes that take place in CIDA. Most important, unless CIDA is legislated and is told that these are the areas in which we expect results--i.e., we expect to see money going to poverty reduction or education--only then can we say it is an effective use of dollars. Right now money is spread out as thinly as possible across 105 countries, with every kind of end use, some very good and some excellent, but the result is that nobody is happy.

Then we have CIDA-INC giving money for business ventures. It was proven by my colleague from Cypress Hill, at the time from the Reform Party, that the money was going to the companies with ties to the Liberal Party. The companies took advantage of that.

The bottom line is that while we speak about the budget, while we speak of giving money, it is critically important that the money be effectively spent. That is what Canadians are demanding from the budget.

Let me say very briefly that the budget does not address many of the issues that are most important to people in my riding. What are their issues? Of course one is health care and we are seeing the flip-flops coming out from the government on health care.

Also, I want to say to that New Democratic Party, once and for all, tell us, quote for us, give us the name of who has said for profit health care or private health care. Where did we say that? Tell the hon. member to tell us, Mr. Speaker. The hon. member stands up and blames the Conservative Party, but let her quote from where we have said that.

I also want to say that she knows what our most important issues are, and most important is tax reform, because unless and until Canadians have money in their pockets, only then will that be an effective use of money.

In conclusion, I say we are drifting. We are drifting because of this election and because this Prime Minister and this government have not been able to put forth the vision they promised to Canadians.

Patent Act

[The Speaker]

Order, please. It being 1:04 p.m., the House will now proceed to the deferred recorded division on the motion at third reading stage of Bill C-9.

Call in the members.

(The House divided on the motion, which was agreed to on the following division:)

Criminal Code

[Jacques Saada, Liberal, Brossard—La Prairie, QC]

Mr. Speaker, in view of the extreme popularity of Bill C-9, an act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), I have a request to make.

I would like to ask for the consent of the House to deem the motion for third reading of Bill C-9 carried.

Patent Act

[Charles Caccia, Liberal, Davenport, ON]

Mr. Speaker, in putting forward some thoughts on the discussion of Bill C-9, I would also like to put on the record an observation made yesterday in this chamber by the Minister for International Cooperation, because it seems to me that she made a very important point which ought to be repeated.

She said that the legislation before us in this chamber, namely Bill C-9, otherwise known as the Jean Chrétien pledge to Africa, is one that recognizes, on Canada's part, a “moral imperative”, that is, the imperative that we have to make available those medical treatments that are required, and in African countries in particular, to the millions of people who are suffering from these pandemics, in particular, of course, the pandemic of HIV-AIDS.

That point was elaborated on further by the Minister for International Cooperation with regard to voluntary licensing, when she said that “the amendments eliminate the requirement that patent holders be given the right of first refusal”. That was of course an amendment of considerable significance and importance during the deliberation at second reading.

In the discussion before question period, the member for Palliser made reference to Stephen Lewis, and quite rightly so, because this Canadian at the United Nations has been actively engaged in advancing the cause of helping African countries and the population there with respect to HIV-AIDS on that continent.

Mr. Stephen Lewis made a statement a few days ago which I would like to put on the record because it gives further background as to why we are engaged with this legislation and why we have developed such a unique parliamentary cohesion and unanimity behind it.

On April 6 of this year, in New York, Stephen Lewis, the United Nations special envoy on this matter, made the following statement:

I wish to join today with the legions of activists and advocates in Africa and worldwide who salute the quite remarkable collaboration on the provision of anti-retroviral drugs, jointly announced by The Clinton Foundation, The World Bank, UNICEF and the Global Fund. This initiative...could well spell the turnaround of the...pandemic in Africa.

Simply put, the Clinton Foundation will negotiate the drug prices, UNICEF will employ its procurement capacity, and the Global Fund and World Bank will provide the funding. There will be protocols and administrative requirements, of course, but nothing should now stand in the way of rolling out treatment to hundreds of thousands--soon to be millions--in the immediate future.

The best dimension of all of this is the price tag to be paid. We're talking of fixed-dose combinations of generic drugs, pre-qualified by the World Health Organization, to be purchased overwhelmingly from generic companies...at prices as low as $140 per person per year. It falls entirely within the World Trade Organization consensus agreement negotiated on August 30th, 2003. And it puts to rest the self-defeating jousting between generics and brand name pharmaceuticals. Clearly, when you have the power, the imprimatur and the dollars of the Clinton Foundation, World Bank, UNICEF and Global Fund weighing in behind generics, the debate is over. These four bodies make it clear in their statement that brand name companies are free--indeed, invited--to tender, and to meet the low prices. But it's equally clear that huge numbers of African lives will be prolonged and saved by generics...generic drugs at one-third to one-half the cost of the patent drugs. Just think of how much further the money will go.

Mr. Lewis concluded by saying:

This is all tremendously exciting, and it will be made even more so if WHO finally receives the seed money it needs--$200 million over two years--to help to coordinate the interventions at country level, to train the tens of thousands of additional people, to provide the emergency technical assistance, to keep the drug supplies flowing and to address the ongoing problems of infrastructure. In a phrase: to achieve 3 by 5.

Namely, that would be putting three million people into treatment by the end of 2005.

It seemed to me quite appropriate to put this statement by Stephen Lewis at the United Nations within the larger context of the Jean Chrétien pledge to Africa, namely Bill C-9, because it fits perfectly in it and it also gives us a broader picture as to why we are all engaged in this global effort, which is really bringing out the best in humanity and definitely appeals to the basic and most positive constructive sentiments that inspire the global community in every country.

I would like to congratulate the government for having persisted in bringing the bill to a happy conclusion despite all the technical difficulties. We look forward to third reading approval and to the speedy processing of it by the Senate so that it can be promulgated at a very early date.

Business of the House

[Jacques Saada, Liberal, Leader of the Government in the House of Commons and Minister responsible for Democratic Reform]

Mr. Speaker, it is a great pleasure for me to reassure my colleague and Canadians that we are working on a number of bills.

We will proceed this afternoon with third reading of Bill C-9, an act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa). This bill, which we introduced and which is now at third reading, makes it possible for us to send pharmaceutical products to help countries in Africa.

This will be followed by third reading stage of Bill C-12, an act to amend the Criminal Code (protection of children and other vulnerable persons) and the Canada Evidence Act.

Then we will move on to report stage of Bill C-23, an act to provide for real property taxation powers of first nations, to create a First Nations Tax Commission, First Nations Financial Management Board, First Nations Finance Authority and First Nations Statistical Institute and to make consequential amendments to other Acts.

This will be followed by the debates on the motions for referral to committee before second reading of Bill C-29 and Bill C-32. I would like to point out that it is as part of our democratic reform that we are now regularly referring bills to committees before second reading, to allow them to review the legislation.

Therefore, before second reading, we will refer Bill C-29, an act to amend the Criminal Code (mental disorder) and to make consequential amendments to other Acts, and Bill C-32, an act to amend the Criminal Code (drugs and impaired driving) and to make related and consequential amendments to other Acts. We know that Canadians really want us to deal with the issue of impaired driving.

Of course, we will deal with third reading of Bill C-10, an act to amend the Contraventions Act and the Controlled Drugs and Substances Act.

This is for today. We may not have time to finish everything, because there is a lot to do. In any case, tomorrow we will deal with report stage and, if possible, with third reading of Bill C-30, an act to implement certain provisions of the budget tabled in Parliament on March 23, 2004.

Then, we will undertake our review of Bill C-28, an act to amend the Canada National Parks Act.

Of course, next week we will continue with any unfinished business.

Incidentally, Thursday of next week, May 6, will be an allotted day. I would suggest that hon. members get a good rest, because there is still a lot of work to do.

Patent Act

[Charles Caccia, Liberal, Davenport, ON]

Mr. Speaker, first of all, I would like to thank the House for giving me this opportunity today to speak to Bill C-9.

The purpose of this bill is quite clear and simple; the bill amends the Patent Act to facilitate access to 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.

I would like also to indicate that it would be quite appropriate in this discussion to congratulate the member for Algoma—Manitoulin, the chair of the industry committee, for the outstanding work that he has performed in getting this bill through. There were, I am told, over 200 amendments and they were dealt with very thoroughly through hard work and extended hearings. Finally, the bill was reported back to the House for third reading yesterday. It recognizes the dedication of the chair and the members of the committee to this cause. It is only appropriate that we should recognize this because the working committee is seldom publicized and brought to the attention of constituents.

Next, it is desirable to indicate that while the title of the bill reads in a rather cut and dry manner, an amendment to the Patent Act and Food and Drugs Act, which would be very obscure unless it was explained at large, it also carries a subtitle to which other speakers in this debate have already made reference. The subtitle, which is in brackets, and I am very glad to see it, reads “The Jean Chrétien Pledge to Africa”.

I find this most appropriate and desirable considering the tremendous effort that the former prime minister made in advancing the cause at international fora, particularly at the G-8 meetings, to the dramatic and tragic situation of the African continent. He did that on a number of occasions, particularly in Kananaskis in 2002, when the NEPAD policy was launched with the support of the G-7. Africa was put on the political map of those gathered at Kananaskis with complete support, by way of funding, by all the leaders who met on that occasion.

It seems to me, and I take into full account the comments just made by my colleague from the NDP, that perhaps there are many who have advanced the cause of dealing with pandemics in Africa. It is most appropriate that the leadership of the former prime minister be recognized and given appropriate exposure in this legislation and hopefully also beyond Canada's boundaries.

The purpose of the legislation is of course much larger than just the scope of the bill. The legislation intends to be part of a larger government effort intended to provide aid and medicinal assistance to countries in need. It is my understanding that Canada has already committed $100 million to the global fund to fight HIV and AIDS, and in addition to that some $62 million to the Canadian fund for Africa.

Therefore, we can see that the legislation is coming in as a reinforcing element within the framework of a broader policy effort, and it is most appropriate and timely. It is also a demonstration that the global community is taking on a responsibility for a problem that is hundreds of miles away, but nevertheless touches us all because we are all members of a human community that ties us together.

The situation in Africa is desperate. It is important to put on the record some data. It is a fact that there are some 36 million people apparently who are affected by AIDS at the present time. Two-thirds of these 36 million souls live in five countries: Ethiopia, India, Kenya, Nigeria and South Africa. In five other African countries, namely, Botswana, Lesotho, Swaziland, Zambia and Zimbabwe, one adult out of five who registers positively on tests for AIDS or has already incurred into the AIDS pandemic. This data is from the World Health Organization.

As a result, the average life expectancy in many African countries has been reduced by 23 years. When we are witnessing a trend in the opposite direction, namely longer and longer life expectancies, we have a continent where the life expectancy is going down and being reduced as a result of this pandemic. There are other countries which seem not to be completely exempt from this terrible disease. Reference has been made to the Bahamas, Cambodia, the Dominican Republic, Guyana and to Haiti where it is expected that the average life expectancy is to be reduced by at least three years.

These statistics necessarily are cut and dry, but they hide another very important social reality. That is that as a result of the deaths within a population, there is a dramatic decrease in the number of teachers in the schools, workers in agriculture and in industry, clerical workers, people in the health care sectors, in hospitals, et cetera. Therefore, the fragile and limited structures in these countries are affected by this disease. In other words, there is an impact on numbers and social structures in the countries I mentioned earlier. These are poor countries which lack the resources to remedy the situation, in particular to provide, acquire and purchase the medicines and drugs necessary to stop the spread of this pandemic.

Therefore, we have these initiatives by Canada and other like-minded countries in trying to come to grips with getting to the root of the problem and to prevent the spread of this disease. In this respect we are all very proud of the fact that Canada is in the forefront of this initiative. This is why this bill is so important, why it has received the support of every party and why there is an element of urgency attached to the bill itself.

I would like to continue in my presentation by adding some words on the intervention yesterday by the Minister for International Cooperation. However, since you wish me to recognize the clock, Mr. Speaker, I will yield the floor and perhaps resume my comments after three o'clock.

[Dick Proctor, NDP, Palliser, SK]

Mr. Speaker, I am pleased to speak to Bill C-9, the humanitarian bill. It is certainly important for all caucuses to support the legislation because the need for access to medicines has been recognized internationally. It is important that Canada participates and sets an example for the world, although it does remain to be seen whether we will have set a good example. I will have more on that later.

Every day a countless number of people die in the developing world of diseases for which there are cures, diseases such as tuberculosis, malaria and pneumonia, simply because of a lack of access to medicines most often due to the high cost of pharmaceutical products.

Although there is yet no cure for the HIV-AIDS pandemic, there are drugs to ameliorate it. In Africa alone, every day 6,000 people die of AIDS, while 11,000 more contract the disease.

I think we would all agree that Stephen Lewis, the Canadian special envoy on this at the United Nations, has done more not only in Canada but around the world to raise this issue and to force us to realize it than any other human being alive.

On health, education and security, any initiative to improve in these areas will have many different components, and this bill seeks to address one of those core components, namely the access to medicines.

Improved health is linked to increased school attendance for children and their ability to do well while at school. As we all know, education is a lifelong process and has a lifelong impact on an individual's well-being and economic productivity.

We have heard lots of talk about security in recent days. In fact, the Prime Minister is talking about that very subject this afternoon in Washington. I firmly believe one of the most important ways that we can make our world more secure is through improving the health of the people in that world because it leads them to participate more fully in the social, economic and cultural events and aspects of their countries and their home communities.

Many studies show the devastating economic impact of infectious diseases such as malaria and the AIDS pandemic. The World Health Organization's recent commission on macroeconomics and health stated:

The evidence confirms that countries with the weakest conditions of health and education have a much harder time achieving sustained growth than do countries with better conditions of health and education.

There is no surprise there.

On the international process over the past several years, the background to this legislation is that when it is passed, Bill C-9 will be among the first pieces of legislation of its kind in the world, the end product of several years of negotiations on the international stage. It goes back to November 2001 at the WTO Doha round on intellectual property rights. The declaration affirmed that countries have the right to protect public health and improve access to affordable medicines, including through compulsory licensing of pharmaceutical products.

This international acknowledgement was incredibly important because, although many countries officially recognized the need for a better balance between intellectual property rights and human rights, the need for a north-south sharing of technologies and knowledge, the reality of intellectual property rights made the practicalities of that sharing difficult, which meant that little of substance was actually being done.

The WTO agreement last August is the practical solution to the principles agreed to at Doha and was historic in that it gave World Trade Organization members the right to export to developing countries those generic medicines still under patent without fear of trade retaliation and it acknowledged the importance and urgency of so doing.

On the competition aspects of the bill, because of intellectual property rights, patent holder or innovator companies have monopolies on their drug products in this country for a period of 20 years, which the health critic for the Bloc Québécois was explaining very well a few moments ago. That 20 year patent protection rule varies from country to country around the world.

In developing new drug products there is often many years of research and development and patent holders obviously must recoup their costs and these costs, particularly for new experimental drugs such as those used in HIV-AIDS, are often far too high for developing countries and NGOs delivering health services in those developing countries to meet the need and demand for the products.

As a result, many patent holders have entered into agreements with countries and specific programs to provide their drugs at lower prices or at no cost at all but those efforts have been insufficient to meet the demand.

Increasing competition, by allowing generic producers to enter the market earlier, is seen as crucial to ensuring that those needing treatment have access to those medicines as required. Increasing competition increases supply and decreases prices, and both of these are needed for developing countries in order for them to be able to meet the urgent health care needs of their people.

On the international obligation front, Canada has many international obligations in this area, including having recognized since 1945 the right to health as a fundamental right, the UN's special session on HIV-AIDS to make, in an urgent manner, every effort to increase the standard of treatment for people suffering from HIV-AIDS, including the prevention and treatment of opportunistic infections.

It is important to ensure that as parliamentarians we fully respect and reflect Canada's obligations to taking this important step toward the full realization of the human right to health, including the promotion of access to affordable medicines for all.

My colleague, the member for Windsor West, who has worked very hard and tirelessly on this legislation, presented both at committee and here at report stage several other pharmaceutical products that can be of use to developing countries. An amendment was made to include an important fixed dose drug for the treatment of tuberculosis and that was passed at report stage and, I am happy to say, is included in the bill.

Unfortunately, two other drug products that he had proposed were rejected at report stage. One of them is on the World Health Organization's pre-qualified list of drugs for HIV-AIDS and the other is currently indicated for pneumonia, which is the leading killer of children in the developing world under the age of five. This drug is also being studied for possible anti-tuberculosis use.

I sincerely hope that the Minister of Health and the Minister of Industry will together move quickly to receive advice on those two products and include them on a future schedule of drugs.

We first saw Bill C-9 as Bill C-56, which was introduced last November but died on the Order Paper when the House of Commons prorogued on December 12. It was reintroduced in its initial form on February 12 but the government proposed many changes following that.

Testimony was given at committee from a variety of groups, and while all witnesses appearing made it clear that they were supportive of the initiative, many problems with the bill that were identified by those expert witnesses. They included the first right of refusal, which would have allowed the patent holder, the pharmaceutical companies, to scoop a contract negotiated by a potential generic producer. This would drive up the cost of the eventual drug.

With regard to the schedule, testimony on this aspect was clear. It was felt that there should be no schedule of drugs. It was felt by the overwhelming majority of witnesses that this would be flawed at the outset and that having a schedule, regardless of how flexible it may be intended to be, would add another unnecessary step in the process of getting drugs to the developing world. The reason for that is that if the drug is not listed on the schedule there would have to be a process to first, get it on the schedule, and then get it to where it was needed.

Respected organizations, such as Doctors Without Borders, testified that the language did not allow for the participation of non-governmental organizations. It was felt that the wording would not allow them to participate because NGOs do not consider themselves as agents of any government and they play a crucial role in many developing countries in providing health care services, including access to medicines.

Many witnesses also presented testimony about the need to expand the schedules of eligible countries. In its original form only WTO member developing countries and least developed countries were eligible, while many witnesses testified that there was no requirement by international trade rules to exclude those several dozen other developing countries, such as Vietnam, Iran and Iraq, countries which also face substantial health issues that we see regularly on our television sets and that could be better addressed if they had access to medicines at affordable cost.

I want to turn now to the major problems that we see in the bill. Over 100 amendments that were submitted by my colleague, the member for Windsor West would have done several things, including eliminating the first right of refusal, extending the list of eligible countries and drug products and, lastly, clarifying the language around the participation of non-government organizations.

After the committee hearings, the government took more than a month to present its amendments to the bill. It made substantial amendments, including eliminating the first right of refusal, allowing for other developing countries to apply through diplomatic channels to be eligible to participate and to allow NGOs to participate. Although some of these changes presented further additional problems that may affect the workability of the bill, myself, the member for Windsor West and my colleagues in the New Democratic Party caucus are supportive of the majority of those proposed amendments.

We did raise at committee the new concerns around the increased opportunities for legal battles between patent and generic drug companies that could seriously impact how this bill will actually work in reality, the unnecessary requirement that developing countries wishing to be added to the list of eligible countries are required to be added specifically with reference to a particular drug product and it is unclear what process has to be followed after that.

My colleague from Windsor West was pleased to have the support of the committee and wanted it recognized on several amendments, including those to ensure that humanitarian concerns be considered the first determination if the Federal Court is required under the appropriate section as to whether a royalty rate has been established according to the formula that will be prescribed in the regulations.

The section on page 12 of the bill now reads:

The Federal Court may make an order...taking into account

(a) the humanitarian and non-commercial reasons underlying the issuance of the authorization;

(b) the economic value of the use of the invention or inventions to the country or WTO Member

We can see the importance of reversing those two clauses.

Another amendment ensures that there is a minimum of a 30 day waiting period that a potential generic producer must observe to apply for a voluntary licence from the patent holder before applying to the Commissioner of Patents for a compulsory licence.

The third amendment was a language change to ensure that the minister be required to establish an advisory committee to advise on the inclusion of further drug products in schedule 1.

There are some continuing problems that have been identified and the first that remains is on the scheduling. As the House has heard before, there is a consensus that the presence of a schedule at all provides further inflexibility in ensuring that countries have access to the drugs that they require.

A list by its nature is exclusionary because it does not include all possibilities and the negotiations that led to the historic WTO waiver last August examined and rejected the idea of creating a list.

Under Bill C-9, if a country wants a drug that is already approved for use and sale here in Canada, it will have to start a process to get that drug included before a generic producer could apply for a voluntary or compulsory licence to supply the country with that medication.

We presented at committee and in the House amendments to improve the schedule, and we will continue to monitor the impact of the existence of the schedule on the workability of the bill.

The second major problem that remains, in our opinion, is that NGOs in countries where they are legally entitled to purchase and distribute pharmaceutical products to contract directly with generic suppliers in Canada. Again, NGOs play a crucial role in many developing countries in their broader health care programs, including purchasing and distributing of essential medicines, and this barrier is a major cause of concern around the workability of this bill.

The third major problem stems from those amendments the government proposed at committee stage to replace the first right of refusal. The new legislation, as amended, now includes opportunities for patent holders to take generic products to the federal court about the royalty rate and the price of the product. Over the past decade there have been at least 300 cases brought against generic producers in federal court and court battles can be lengthy and costly, as we all know. Given that the price generic producers can charge is now to be regulated by a fixed and flexible cap, there is concern that they may not be able to participate to increase supply on the variety of products that might have been possible without these new sections and without the first right of refusal clauses. Generic producers will have significant outlay of cost to increase their own research and development and operational costs to get into this business of increasing supply, and with the price cap there may be a serious disincentive for generic producers to participate.

Problems, as I have tried to indicate, do remain with the bill, but it is in the best interests of the people who the bill is intended to assist for us to give the regime a try and to pass the legislation quickly.

Canada has made numerous international commitments, which I and my colleagues in the New Democratic Party caucus support, to help address the pandemic of HIV-AIDS and other diseases like tuberculosis and malaria. While we continue to be critical of some government action, or better said, inaction, in some of these areas, if Bill C-9 actually works to increase pharmaceutical products through competition, then it will be an important tool and broader strategies to improve health in countries across the world.

We have gone through the process of hearing expert witnesses, amending legislation and exchanging ideas on how we think the bill should work. However there was a definite mindset and will be in all parties, including my own, to ensure that we deal with the bill as quickly as possible to ensure that we at least try to get cheaper pharmaceutical drugs on the market.

We in the NDP will continue to watch and monitor how the bill works and whether it provides enough incentive for generic producers to actually get into the business of producing cheaper versions of drugs for export to developing countries, the role and efficacy of the advisory committee and the schedule of drugs.

Just before I take my seat, I was interested to hear that this bill has been named the Jean Chrétien bill. While I do not wish to take anything away from the former prime minister and I know his interest in Africa, there will be very few Canadians who will think that this should be related to Jean Chrétien. It should be known as the Stephen Lewis bill. It was Stephen Lewis who brought this to the attention of Canadians and, indeed, people around the world and it is important that it be recognized at this time.

[Réal Ménard, Bloc, Hochelaga—Maisonneuve, QC]

Mr. Speaker, it is a great pleasure for me to take part in this debate on Bill C-9. As I was saying yesterday, I do so with the belief that, to some extent, we are contributing not only to the north-south dialogue, but we are clearly making history, since this bill was passed unanimously and therefore received extremely strong and continuous support from all parties.

As members know, all the parties committed to working together to ensure speedy passage of the bill, in hopes that the other place will do likewise. However, we know this is another matter entirely.

Bill C-9 addresses the important issue of the contribution of companies manufacturing pharmaceutical products. My caucus colleagues know that, for about ten years now, I have taken an interest in the actions of drug companies, both the generic products industry and the innovative drug industry. I am extremely proud to say that I do not think I have ever been too critical, as the member for Verchères—Les-Patriotes knows.

Today, I would be remiss if I did not pay tribute to the innovative drug industry, which has assumed its responsibilities. Let us take a closer look at this issue.

In 1989, the Conservatives, under Brian Mulroney, ended the compulsory licensing program. In other words, it was possible, before Bill C-22, which became Bill C-91 under the Conservatives, to obtain a licence from a company with a monopoly. This licence was granted to a generic drug company, which had to pay royalties to be able to produce and reproduce the drug.

We must not forget that, back then, the term of a patent was ten years. What is a patent? I think that the President of the Privy Council has doubtless thought about this. A patent is important because it is a social contract. The President of the Privy Council will agree with me that it is a social contract by which society gives exclusive right to the protection and production of an invention or pharmaceutical product.

Furthermore, 18 months after the patent is filed, a full description of the invention is made public. There are, however, three criteria that must also be met. There are three criteria for patentability, at least in Canada.

First, the invention must be new. A search is conducted worldwide, not just in North America. The Commissioner of Patents conducts an international search to ensure that it is a new invention.

Second, the invention must show ingenuity.

Third, the invention should be useful.

If these three conditions are met, a patent is granted, and it provides trade exclusivity and complete protection. Copying the invention or chemical process is against the law, and there can be counterfeit charges. This is an extremely strict system.

In matters of copyright, we have case law and judicial mechanisms, since extremely important trade issues underlie the whole concept of copyright.

In 1989, the Conservatives did away with compulsory licensing. From then on, Canada was in line with what was being done in other countries. That was very important for Montreal, since the biotechnology industry is concentrated there. The Conservatives set the patent protection at 20 years, once the patent has been granted by the commissioner and the three conditions—new, useful and not obvious—have been met. Patent protection is then provided.

However, when Bills C-22 and C-91 were enacted, they also had provisions forbidding the export of drugs. It was illegal to export drugs, and sanctions could be imposed.

Since 1989, another factor has been added, and this is intellectual property rights. Governments signed what has been called the TRIPS agreement.

Moreover, two years ago a bill was passed to harmonize all Canadian patents. Some were still in the 10-year system, others 20. There was a challenge by the U.S. under the TRIPS agreement, and the mandatory arbitration went against Canada.

A noteworthy point about the WTO is that the relative clout of the countries has no importance. There are dispute settlement mechanisms in place that allow a country like Costa Rica to win out over the United States. Canada lost and so it has to harmonize all of its patents to the 20-year period.

Today we have a bill before us that will make it possible to export drugs, but not to export them just anywhere, just to designated importing countries listed in the schedule to the bill. Basically, these are the developing countries.

The list was incomplete in the first version of the bill, and the Minister of Industry has revised it. To all intents and purposes, the countries able to import drugs fall into the category classified as developing countries.

How will this be possible? Countries wishing to obtain drugs issue a call for tenders on a web site, so the competition is international, of course. Canadian companies will be competing with others in the U.S. and Europe.

When a company wants to compete in order to supply drugs to a third world country, there are two things in the bill that govern this. First, generic companies will be able to obtain the contract. Initially the bill contained what was termed the right of first refusal. This meant that companies holding a patent could, even if the contract had been negotiated by the generic companies, be the first supplier because they were the patent holders.

All of the international cooperative bodies criticized this bill, from Development and Peace to Doctors without Borders. All those involved in delivering humanitarian aid said that this was impossible, that if this right of first refusal were maintained there would be a dissuasive effect on the generic companies which might want to negotiate contracts.

At least in this one instance, though far from a regular occurrence, the government did heed the stakeholders in committee, and the right of first refusal was done away with.

The supply of drugs is not a trivial issue. Just think that, every year, 10 million children die from diseases relating to malnutrition which could have been avoided. Every year, one million people, most of them children under the age of five, die of malaria. Every day, over 8,000 people in the world die of AIDS. We know that the HIV-AIDS epidemic is concentrated in certain parts of the world, particularly in African countries.

Why are these figures important? Because, for each of the diseases that I mentioned, there is a drug available. However, if this drug is not accessible at a lower cost to countries that are facing these epidemics, we will not be able to fight these epidemics.

Even if Canada, through cooperation agencies such as CIDA, allocated $100 million per year for the development of third world countries, if the nationals of these countries are not themselves active, productive and healthy citizens who can make a commitment to help build and improve their country and their economy, these developing countries have a major problem on their hands.

We need legislation that will allow third world countries to have access to drugs at a lower cost. The way drugs are being produced—and that includes the factory price and the distribution to retailers—it is clear that the system is not competitive.

Of course, in Canada, the Patented Medicine Prices Review Board was established when the Conservatives passed Bill C-91. The board is a quasi-judicial tribunal. Let me give an example. When Merck Frosst produces a drug, the Patented Medicine Prices Review Board monitors the situation to ensure that, once the drug leaves the factory and is distributed to wholesalers and retailers, the price charged is not prohibitive or exorbitant. We have a price index to determine if prices are excessive. If they are, the Patented Medicine Prices Review Board may ask the company to refund the overcharged amount. Such a measure has been taken in a number of cases.

When it comes to exporting drugs from Canada, the Patented Medicine Prices Review Board has no jurisdiction. It was up to the international community to amend agreements on intellectual property rights and trade in order to make these drugs accessible at a better price, a cheaper price. This raised a number of issues.

I think that everyone in this House understands how this works. A voluntary licence is issued by the patent holder. If the latter refuses to issue the licence, the patent commissioner may issue an order. The agreement amended in August 2003 does not require the patent holder to transfer their drug.

A royalty of roughly 2% of the commercial value of the product has to be paid out. This is not a donation. Companies that hold the patents will receive royalties for the person or company that obtained this voluntary licence. If there is disagreement on the royalty or the terms of the licence transfer—which initially has to be voluntary—the patent commissioner can be asked to rule and the licence, which was to be voluntary, will become mandatory.

Concerns were raised during the work at committee on how NGOs fit into this. For example, there is Doctors Without Borders, and Development and Peace, which are Canadian NGOs working in third world countries. Some NGOs, if not all, would have liked to be able to negotiate directly with the manufacturer. Obviously, thought needed to be given to this. There was a risk of interfering in national sovereignty.

Governments are subject to international law. In major international conventions, government means something. One of the first conventions provided a definition of sovereignty. That word simply rolls off my tongue. Sovereignty was defined in 1934 at Montevideo. It was said that a government has five characteristics: a functioning government; a permanent population, of course; control over a territory, which is increasingly being described as a defined territory; the capacity to recognize citizenship; and, of course, international relations.

Once a government or administration is in office, it is responsible for the delivery of health care. I understand the industry minister has amended the bill to ensure not that NGOs can directly negotiate with the manufacturers but that they can be involved in the negotiations since they have the ultimate responsibility for service delivery. That is one of the responsibilities governments have.

Parliamentarians also wanted to ensure that the additional pharmaceuticals needed to supply third world countries are manufactured in a manner that distinguishes them from the products sold on the domestic market. Under the bill, pharmaceuticals for export would be differentiated through different colours and different labels.

This is an extremely humane and responsible piece of legislation. I want to say a few words about the companies grouped under Rx&D. I remember having breakfast at the parliamentary restaurant with representatives of that organization, along with our industry critic, the hon. member for Kamouraska—Rivière-du-Loup—Témiscouata—Les Basques, and also, of course, our international trade critic, the hon. member for Verchères—Les-Patriotes. The hon. member for Trois-Rivières, who has a long-standing interest in the third world, also joined us. I even recall that he asked very relevant questions. He was most interested in Africa.

We understand, of course, that pharmaceuticals would not only be exported to Africa. They could also be exported to Central and South America. However, I remember how much emphasis the member for Trois-Rivières put on Africa.

We wanted to ensure that the member companies of Rx&D would co-operate. It is clear that if the companies had not been interested in issuing voluntary licences, we would have found ourselves in a very embarrassing situation. Various arbitration mechanisms would have led to compulsory licensing. The commissioner of patents would have had to intervene and it is clear that it would have caused undue delay.

I must say that the innovative companies have behaved very responsibly in this matter. I hope that this sense of responsibility is reflected in the various domestic debates we shall have.

Perhaps I could take a few moments to talk about what is going on in Canada with respect to the price of pharmaceuticals, even though I know this is about the international level. Members are aware that it is the largest expense in all health care systems. In fact, each year in Canada, a total of $120 billion is spent on health. The fastest growing budgetary item in that area is the cost of drugs; the hon. member Abitibi—Baie-James—Nunavik knows this because he has sat on various regional health boards.

I had proposed a number of solutions to my caucus, in order to fight the rising cost of pharmaceuticals. In fact, the cost of medicine is rising at a faster rate than costs in the health care system in general. On average, health care costs in Canada, in each province, are rising by 5% per year, but the cost of medicine is rising more than that.

I shall conclude by saying that we are going to support the speedy passage of Bill C-9, because it is a good bill for third world countries, for our international obligations, and for the north-south dialogue.

I salute the innovative companies that have shouldered their responsibilities. I congratulate all members of this House—in particular, the hon. member for Kamouraska—Rivière-du-Loup—Témiscouata—Les Basques—who have worked very hard in committee. I hope the other place will enjoy the same kind of energy that has characterized this House's work on Bill C-9.

[Aileen Carroll, Liberal, Barrie—Simcoe—Bradford, ON]

More? In that case, I will add just a few more remarks as I know there are other colleagues who wish to speak. I do not want to in any way preclude that, but I do think it is important, speaking for a moment as one the five ministers on Bill C-9, to reflect a bit of our perspective in the Canadian International Development Agency. We see, as do our other department colleagues, that this is just one part of Canada's contribution to the global effort to combat disease in developing countries.

Canada's efforts also focus on preventing the spread of disease and helping people with disease live fulfilling and productive lives. As I mentioned yesterday in a response to a question here in the House, it is part of the very holistic approach CIDA takes to development because it works.

I used the example of what we are attempting to do in building the capacity of countries in the developing world to provide the kinds of health services so desperately needed, and of course to have the structures and systems in place to dovetail with the present and future availability of less expensive drug products. Indeed, improving access to those medications is essential, but as I say, in order to maximize their benefits, the health systems must be improved and we are actively involved in doing so.

This means, then, ensuring that there are enough doctors, nurses, hospitals and clinics to administer the medicine and to ensure the follow-up, so different from here in Canada. The care prior to the ravages of disease and the post-hospital or post-clinic care are imperative to treating the diseases that we are aiming to treat.

It also means ensuring that there is adequate access to clean water and sanitation, which curtails the spread of the disease. Some 60% of the diseases so rampant in developing countries are caused by a lack of clean water, so CIDA has many programs dedicated to the provision of clean water and to dealing with all the causes of contamination. In that regard, we partner with many very effective NGOs to accomplish that objective.

In addition to all of what we do to build up the health care systems, we of course have committed very serious and large amounts of our budget to address the HIV-AIDS pandemic generally. In the years from 2000 to 2005, our investment is in the area of $270 million. When we add to that an additional $1.2 billion allocated for health and nutrition initiatives, all a part of what we are attempting to achieve, it shows the very serious priority that we assign to health care and to the prevention and treatment of diseases in developing countries.

I have made reference to my efforts as minister for international development in international venues where I find myself. It is a great opportunity, as a member of group of six like-minded donors called the Utstein group, including Sweden, Norway, the Netherlands, England and Canada, that I am able to convey to them what we have done, being the first out of the gate with Bill C-9, and the first one to come into compliance with the TRIPS agreement, which we all signed as members of the WTO. Let me say that quite frankly I put an onus on them. They are very ready to bear that onus and very keen to receive all the details of this legislation, which has been the result of an excellent partnership of five departments of government, stakeholders in the community and in Canada, and a great willingness to come together to make sure that not only will we pass that legislation but that it will be an excellent piece of legislation.

I am delighted that we will have accomplished this today. It is a very exciting day. I think it is a wonderful news story. I hope that the media, who are very quick to note areas that they determine to be newsworthy, will make a major news story out of the passage of Bill C-9 in this House on this date, because it is a day that we all should mark.

Finally, let me say that yesterday I spoke briefly to the bill, along with other colleagues, and I made sure I stayed in the House to listen to the remarks of the hon. member for Calgary East, who spoke of his support for the bill and the work that he too brought to the process. He originally came from Tanzania and I had the opportunity to be in that country with him, long before I was given this position, to meet members of his family and to observe first-hand the experiences he has shared with the House. He has told us of the situation in that country as it faces the ravages of diseases and of the commitment it instilled in him to be a very supportive part of the team that brought this bill forward. I thank him for his remarks. I think Canadians should know that it is the Liberal government bringing in this bill but with tremendous support from all around this House.