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

This bill was last introduced in the 40th Parliament, 3rd Session, which ended in March 2011.

This bill was previously introduced in the 40th Parliament, 2nd Session.

Sponsor

Judy Wasylycia-Leis  NDP

Introduced as a private member’s bill. (These don’t often become law.)

Status

In committee (House), as of Dec. 2, 2009
(This bill did not become law.)

Summary

This is from the published bill. The Library of Parliament often publishes better independent summaries.

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

Elsewhere

All sorts of information on this bill is available at LEGISinfo, an excellent resource from the Library of Parliament. You can also read the full text of the bill.

Votes

March 9, 2011 Passed That Motion No. 3 be amended by deleting all the words after the words “The provisions of this Act that amend the Patent Act” and substituting the following: “shall cease to apply on the day that is the tenth anniversary of the day on which this Act comes into force unless, before that day, the application of those provisions is subject to a comprehensive review by the standing committee designated by the House of Commons for that purpose, that committee recommends that they be maintained and the House of Commons approves that recommendation.”.
Dec. 2, 2009 Passed That the Bill be now read a second time and referred to the Standing Committee on Industry, Science and Technology.

Patent ActPrivate Members' Business

November 27th, 2009 / 1:30 p.m.


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NDP

Glenn Thibeault NDP Sudbury, ON

Mr. Speaker, I am extremely proud to stand today to support the legislation brought forward by my colleague from Winnipeg North.

Bill C-393 would, as the bill's summary states, amend the Patent Act and the Food and Drugs Act to make it easier to manufacture and export pharmaceutical products to address public health problems afflicting many developing and least developed countries, especially those resulting from HIV-AIDS, tuberculosis, malaria and other epidemics.

This is an extremely worthwhile bill and I would encourage all members of Parliament, regardless of their party, to come together to ensure that the bill passes into law.

Every day, 14,000 people around the world die from preventable diseases. Eight thousand people die each day from HIV-AIDS because they lack access to antiretroviral drugs. Half of the 2.3 million children with HIV in the developing world will not live to see their second birthdays. Morally, this is simply unacceptable.

These deaths destroy families and communities, undermine economic growth and leave thousands of children orphaned. According to the World Health Organization, two billion people cannot get or cannot afford drugs that could have a massive impact on their standards of living.

Research by Polaris shows that 93% of Canadians think it is important to help people in developing countries who need medicines to treat or prevent diseases such as HIV-AIDS, tuberculosis and malaria. The same study shows that a majority of Canadians do not believe the federal government is doing enough to help developing countries by making medication to treat these diseases more affordable. The intention of this bill is to correct this.

The current Canada's Access to Medicines Regime, introduced in 2004, which I remind the House was supported by all parties, was a good start. Competition from generic manufacturers has allowed the price of AIDS medications to fall by 95% in some developing nations, but this legislation only allows generic drugs to be sold to countries explicitly named in the legislation. Companies producing generic drugs must also apply for a special licence for each order of drugs for each country they will supply.

In fact, the total number of licences issued to Canadian companies that produce generic drugs is one. That is right. In five years, only one Canadian company has managed to jump all the hurdles to get Canadian access to the medicine regime's licence, and it has done so just once.

This shipment was sent out in two parts to Rwanda in September 2008 and then again September 2009. That company has come out and said that it will not go through the process again unless it is reformed significantly. There is simply too much red tape. Although the final stage of approval only takes two weeks, this ignores the months of negotiations required to get to the point of submitting an application. Now is the time to improve upon this regime.

The changes proposed in Bill C-393 would mean that companies producing generic drugs would need to obtain just one licence for each medicine they intended to produce. This licence would allow the company to produce multiple orders for as many eligible developing countries as needed, without the need to apply for a new licence for each drug order.

I understand some people are worried that changes to the current regime would undermine Canadian pharmaceutical companies and that this in turn would mean they would stop their research and developmental activities, but this is not the case. This bill would not alter the current provisions, which means brand name companies still receive royalties on the drugs they have patented and brand name companies are still able to compete against generic brands in developing nations.

The bill would also not alter the anti-diversion measures that ensure that generic drugs are distinguished from branded drugs so they cannot be sold elsewhere. In fact, Bill C-393 is completely in line with intellectual property rights, both here in Canada and at the World Trade Organization.

In 2003, the World Trade Organization explicitly stated that developed countries should have more flexible policies to promote access to drugs for people in developing states. These changes will cost the taxpayer nothing and will actually stimulate the Canadian pharmaceutical industry. As companies in Canada ship more orders to developing nations, they will be able to sustain jobs and increase exports from Canada.

Even though this bill is first and foremost a humanitarian issue, there are clearly good economic reasons to reform Canada's access to medicines regime. Implementing this bill is a win-win situation. Developing nations will gain access to much needed drugs and Canadian companies can continue to grow.

I would also like to point out that these changes will not eliminate the review of the safety and quality of the drugs that will be available to developing nations. Drugs will still need to be reviewed by Health Canada, the importing country's government, or by the World Health Organization. The bill will only avoid the duplication of the review processes, meaning that drugs can get to the people who need them and get there faster.

In the one case where drugs were shipped under Canada's access to medicines regime, the company manufacturing the drug spent seven months undergoing a Health Canada review, only for that review to be repeated and duplicated at the World Health Organization. That adds a significant delay to getting the drugs approved. By streamlining the process, we can eliminate any duplication and make sure that these drugs get to the people who need them as quickly as possible.

Some people have suggested that voluntary programs, that is, programs where brand name pharmaceutical companies voluntarily ship drugs to developing countries, mean that no new legislation is required. These voluntary programs are laudable and we should congratulate the companies that have undertaken these efforts, but I do not believe they offer a credible alternative to this legislation.

Put simply, far too few drugs are produced and shipped through these programs to help everyone in the developing world who needs access to them. This legislation would increase the amount of drugs available to people living in developing states and it would also mean that generic brand drugs can reach the countries where they are most needed.

I would like to remind the House that next year, when Canada hosts both the G8 and G20 meetings, we have a real opportunity to shape the global agenda in many areas, including how to deal with the aftermath of the global economic slowdown and how to cope with climate change. These are the things that we can talk about. The best way to shape this agenda is to enact domestic legislation such as this bill, which shows that Canada is ready to lead by example. However, we have to act now.

We have a moral duty to do the right thing and I urge all parliamentarians to support Bill C-393.

Patent ActPrivate Members' Business

November 27th, 2009 / 1:40 p.m.


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Edmonton—Mill Woods—Beaumont Alberta

Conservative

Mike Lake ConservativeParliamentary Secretary to the Minister of Industry

Mr. Speaker, I am pleased to have the opportunity to address Bill C-393, which aims to modify certain fundamental aspects of Canada's access to medicines regime.

In 2004 members of Parliament and senators from all parties unanimously supported legislation introduced by the Liberal government of the day to establish this regime by amending the Patent Act and the Food and Drugs Act.

Canada's access to medicines regime's stated purpose is to improve access to lower cost Canadian-made generic versions of patented drugs and medical devices to address public health problems in developing countries. It was designed to achieve this humanitarian objective while respecting Canada's international trade obligations and maintaining the integrity of Canada's patent system.

The public health problems that gave rise to Canada's access to medicines regime in 2004 continue to exist today. This government remains committed to supporting this initiative.

I, and I am sure other members of the House, view it as a key component of Canada's long-term comprehensive approach to addressing serious public health problems that affect many developing and least developed countries, such as HIV/AIDS, tuberculosis, malaria and other epidemics.

In addition to Canada's access to medicines regime, this approach includes significant contributions from the Government of Canada to other global mechanisms and alliances, which have come into existence in recent years and have become leading instruments for procuring lower cost drugs to respond to the needs of developing and least developed countries.

For example, the government has contributed more than $500 million to the global fund to fight AIDS, tuberculosis and malaria. It has also pledged another $450 million to the fund over the next three years. In addition, the government is working with the Bill and Melinda Gates Foundation to fund the development of HIV/AIDS vaccination.

While the government's commitment to addressing public health problems in the developing world and to Canada's access to medicines regime is unwavering, there are concerns with Bill C-393's proposed modifications to the regime's legislative framework.

This is because the bill, if passed by Parliament, would result in the elimination of many of the key operational elements of Canada's access to medicines regime in order to adopt a very broad, one-licence approach that could have serious negative implications for continued pharmaceutical investment and growth in Canada.

In addition, many of the bill's proposed legislative changes may not be in keeping with the spirit of the World Trade Organization decision on which Canada's access to medicines regime is based. Canada's access to medicines regime was the result of years of intensive international negotiations by Canada and other developed and developing country members of the World Trade Organization to find a means to export needed medicines from countries with pharmaceutical manufacturing capacity to countries with little or no such capacity.

In August 2003 this process concluded when all of the World Trade Organization members reached a landmark decision. They agreed to waive two of the patent obligations in the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights in order to improve access to the patented drugs and medical devices needed to address public health problems in developing and least developed countries, such as HIV/AIDS, tuberculosis, malaria and other epidemics.

Canada's access to medicines regime was developed to implement this decision domestically. Canada's regime is one of nine regimes in existence that have implemented the World Trade Organization decision, but it is the only one to have successfully authorized an export of needed drugs to a developing countries. This important event occurred on September 24, 2008, when the Canadian drug manufacturer Apotex Inc. sent approximately seven million tablets of an HIV/AIDS therapy to Rwanda.

In 2007 the government completed a statutory review of the regime. As part of that process, it reviewed all public input on Canada's access to medicines regime. That input included extensive written submissions received in response to a 2006 consultation paper on the regime. It included expert testimony heard at hearings by the House of Commons Standing Committee on Industry, Science and Technology in April 2007, as well as input from developing countries in a workshop organized by non-governmental organizations.

In December 2007 the Minister of Industry tabled in Parliament a report on the results of the statutory review. The report concluded that insufficient evidence had accumulated to warrant making changes to the regime at that juncture. This conclusion remains valid today, since the case for making legislative or regulatory changes to Canada's access to medicines regime has still not been made.

The fact that Canada is the only country to date to see drugs shipped to a country in need under its access to medicines regime demonstrates that our system does work. However, for Canada's access to medicines regime to be used again, another country in need must inform the World Trade Organization of its intent to import lower cost versions of patented pharmaceutical products under the terms of the August 2003 decision.

The government continues to encourage developing and least developed countries to use the system and it hopes that such a notification happens. In the meantime, however, the government will continue to support Canada's access to medicines while fighting diseases and helping improve public health conditions in the developing world through other initiatives in its long-term comprehensive strategy on access to medicines.

Before I conclude, I would like to thank those who have advocated so tirelessly on this issue. In particular, I would like to acknowledge the hard work of the grandmothers to grandmothers campaign, which has continued to raise awareness and mobilize support for this bill.

Although we may disagree on the effects of the proposed modifications in Bill C-393 on the legislative framework of Canada's access to medicines regime, we can certainly agree on the need to address public health in the developing world. The grandmothers have shown true commitment to this cause and I believe their efforts deserve recognition.

With that said, the reasons I have outlined here today prevent me from voting in favour of this bill.

Patent ActPrivate Members' Business

November 27th, 2009 / 1:45 p.m.


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Liberal

Joyce Murray Liberal Vancouver Quadra, BC

Mr. Speaker, I am pleased to speak in support of Bill C-393 today. The bill would amend a bill passed in 2004, which was known at the time as the “Jean Chrétien pledge to Africa act”. I would like the listeners to keep in mind that objective.

The original bill created what is now known as Canada's Access to Medicines Regime. The stated purpose of this law was to help get more affordable generic medicines to patients in developing countries for public health needs, including HIV-AIDS, tuberculosis and other epidemic diseases, a very worthy objective, indeed.

This legislation was brought in by a Liberal government and, as the member opposite has just noted, was passed with unanimous support from all political parties in May, 2004, reflecting Canadians' beliefs and the empathy that Canadians feel for those who are in need.

I want to get on record as saying that this is a humanitarian, non-partisan issue that relates to the health and safety of those less fortunate in developing countries.

A country as lucky as Canada has the responsibility to do everything in its power to facilitate the access and distribution of medicines to those countries that are suffering from the devastating effects of diseases such as HIV.

On a personal level, I immigrated to Canada from South Africa at a young age. I went back in the 2000s and met people who were struggling with this terrible affliction. I am very concerned about compassionate assistance to help the AIDS epidemic.

The amendments in Bill C-393 are supported by a wide variety of organizations, including the Canadian Grandmothers to Grandmothers Campaign, which is an organization of women working to support the courageous South African grannies who are looking after those children who have been orphaned by the AIDS scourge.

Another point of context is that these amendments to the Canada's Access to Medicines Regime come at a time when the Conservative Government of the day has reduced by half the number of the poorest African countries that are being supported by CIDA on its priority list. With these cuts, alternative means of support for these countries is badly needed.

There are problems with the current Canada's Access to Medicines Regime. Despite the fact that the member opposite just celebrated CAMR, and I appreciate his positive statements about this Liberal initiative, it is not a successful regime. It is not working. In fact, in more than four years, only one country, Rwanda, and one Canadian generic manufacturer has used the regime for a single shipment of a single AIDS drug. That is not my definition of success.

Issuing one licence to export only one drug to only one country in almost five years since the law has passed tells us that there is something missing and something else is needed. It is not the expeditious solution for which parliamentarians and WTO members were looking.

The fact is no developing countries, other than Rwanda, have come forward or shown any interest to utilize CAMR in order to get much needed medicines for their citizens. Nor has any country sought to use laws comparable to this that have been passed in other countries. Therefore, this tells us that this law needs to be fixed.

A comprehensive access to medicines regime is needed more than ever. According to a joint UN program on HIV, more than 2.3 million children under the age of 15 are infected with AIDS, most of whom are living in developing countries. Without treatment, an estimated one-third of infants infected with HIV will die before reaching the age of one and half will die before reaching the age of two.

If the need for medicines is so critical, which clearly it is, what is preventing these developing countries from coming forward to utilize the Canada's Access to Medicines Regime? Simply put, the regime puts up unnecessary barriers and red tape.

The major concern I have heard in regard to the existing legislation is that the processes and requirements in place may be unnecessarily complex. As a result, they are dissuading the developing countries and generic pharmaceutical companies from stepping forward, utilizing the legislation and bringing forward the solutions for which everyone is looking.

There are many other difficulties to overcome following the delivery of medication to a developing country. We know that at times there are inadequately developed infrastructure, untrained medical staff, unregulated distribution of the drug and disorganized administration. These are all legitimate challenges on the ground.

However, in terms of this legislation, the question in Canada is actually simply. How can we make Canada's Access to Medicine Regime as simple, straightforward and risk-free as possible for the developing countries, for the generic pharmaceutical companies to use, while maintaining fairness for brand name drug providers? This amendment does that.

I will just speak a bit more about the barriers the existing legislation presents.

Under the current regime, the process for a generic drug manufacturer in Canada to get a compulsory licence to supply developing countries does not reflect the very procedures the developing countries typically go through when procuring medicines.

As the regime stands now, the law contains over 100 clauses that are required to be met. Clearly, that is shown to be a barrier. There are simply too many hurdles that developing countries have to jump over before they can place and receive an order. In thinking about the bill, it is important that we remember that in these developing countries the doctors, nurses and volunteers, and not the lawyers, are ordering these drugs.

Criticism levied against these proposed reforms mainly focus on how they will negatively impact the patented pharmaceutical industry, but the fact is their drugs are simply too expensive to be purchased at their current price and they have not taken the action necessary to get affordable medicines to developing countries.

Nothing in these amendments nor in CAMR itself prevents brand name pharmaceutical companies from competing to supply their patented products to developing countries and under these amendments, royalties would still be based on the sales of the generic product and would flow to the pharmaceutical company.

What is being proposed in Bill C-393? I will take a moment to read into the record parts of a letter I received from a group in my riding of Vancouver Quadra. It is from the UBC Medical Undergraduate Society, signed by Mattias Berg, the president. He speaks about Bill C-393, proposing a simplified one-licence solution. He says:

This approach, widely recommended by multiple humanitarian organizations including Médecins Sans Frontières...would cut through most of the red tape that prevents CAMR from being used to its full potential.

He goes on to add:

As concerned Canadians and future physicians, we are asking you to please support this bill and help save the lives of millions of children and patients in the developing world.

A compulsory licence will require that the generic manufacturer pay a royalty to the company that holds that patent and royalties would still be based on the sales of the generic product to the developing country, as in the existing CAMR formula. If the legislation is reformed, Canada's largest generic pharmaceutical company has committed publicly that it will make a desperately needed three-in-one AIDS drug that is suited for children in developing countries. This is all about that.

As we know, very few children in these countries have access to medicines to combat HIV, and they suffer unnecessarily. This is a human tragedy which we are trying to address. By streamlining the access to medicines regime, we would not create any additional costs to Canadian taxpayers. In fact, it requires the government to spend no additional funds.

Nobody claims that Canada's access to medicine regime, either in its existing form or in an amended version, would provide a complete solution. Barriers to accessing medicines in the developing world will continue. However, Canadians right across the country want to say that they are doing our part to help fight sickness and poverty around the world. It is part of our humanness to want to help.

This amended legislation is a policy tool that has the potential to put into action the desire of Canadians to help those less fortunate and help facilitate developing countries to gain access to affordable and timely treatment. For both compassionate and pragmatic reasons, the bill deserves Parliament's support and I hope the members will provide it.

Patent ActPrivate Members' Business

November 27th, 2009 / 1:55 p.m.


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NDP

Jim Maloway NDP Elmwood—Transcona, MB

Mr. Speaker, I commend the previous speaker for an absolutely excellent speech on the bill at hand. I thought I heard another speech from one of her colleagues that was quite a bit different. Her colleague indicated that he would not support the bill. That is the way I heard it anyway. However, I am very pleased that not only did the member make an excellent speech, but she dealt square on with the whole issue at hand.

She outlined how the legislation originally was to be a legacy to Jean Chrétien. The legislation passed unanimously in May 2004. Its goal was humanitarian. It was non-partisan. It was supported by all members of the House, yet in five years all we have to show for this is one shipment of an AIDS drug by one company to one country. After half a decade, that is unbelievable.

It reminds me of the great intentions of the United States government to deal with Hurricane Katrina. It supposedly had a whole plan in place. At the end of the day, we saw a disaster that was compounded by the efforts of the government to help solve the disaster. Among many other things, people were living in trailers that turned out to be toxic. It was a total disaster. That was a case with a country that had huge resources and supposedly a plan.

Here we have a lack of resources, but at least we had the intention to do something good for people who were suffering. Members have brought out statistics on how quickly people are dying in Africa as a result of disease. The question is this. How could this have gone so wrong in such a short period of time and what will we do as a group, as a collective, to try to solve this issue?

We will not solve it and we will not make progress when we have speakers defending big pharma, the drug companies and the patent system. They say that they cannot get involved in this because it would offend drug companies in their ridings and that the drugs they produce are not available yet for generic companies to produce. Therefore, they are going to vote against this because they are concerned about jobs in their ridings.

Sadly, that is what this may turn out to be at the end of the day and that is really a sad commentary on the whole country in some ways.

I understand the intellectual property argument. Manitoba had huge fights in the seventies over the whole issue of whether generic drug companies should even be allowed to survive. The big guys wanted to get them out of business and argued that it was totally unfair. Then a government somewhere along the line, whether Liberal or Conservative, gave the drug companies a 20 year patent protection. I am uncertain, but I believe it was the Mulroney government.

Nevertheless, I do remember that argument at the time. There was a lot of reaction to it in Manitoba because Manitoba does not have a lot of big pharmaceutical companies but it does have generic companies that are trying to produce drugs at a reasonable cost. They are the ones who would be stepping up to the plate to help in a situation like this.

We have other really good examples, such as Bill Gates and Warren Buffett. I do not know how many people know Warren Buffett. He owns half of the companies in the United States, everything from 10% of Gillette and 10% of Coca-Cola, and Dairy Queen and Fruit of the Loom and so on. Warren Buffett is the second-richest man in the world and he is worth around $50 billion or close to it, slightly less than Bill Gates.

Rather than doing what some single billionaires do, this multi-billionaire decided that his kids did not need this kind of money so he gave it to Bill and Melinda Gates' trust in which they put an equal amount. They would give out the money on his behalf. The desire of both Gates and Buffett is to send the money to Africa to be used for the AIDS cause.

Warren Buffett lives in Omaha. I had the good fortune to drive through Omaha on the way to a legislators' conference in August. We decided to find Warren Buffett's house. People in Omaha know where he is. They see him around. He even hands out candies to kids at Halloween. His house has no number on it, but it was not hard to find. I did knock on his door, but he did not happen to be at home.

My point is that Warren Buffett is a fairly selfless individual. Certainly in business he has taken his knocks over the years. I could spend hours talking about the things that Warren Buffett has done in business. This man recognizes that he is not going to live forever, and he has given money to the Bill and Melinda Gates Foundation to be used in Africa. I am not saying we have to go to the Bill and Melinda Gates Foundation for a donation, but it is something that might have to be considered.

Another idea has come up, and I do not know how practical it is but articles have been written on it. The British are in charge of trying to eradicate the poppy in Afghanistan. Besides trying to spray it and kill it, they are trying to put in other crops. Some people have suggested that the opium crop from the poppies should be used in areas of the world that need the drug as a painkiller.

The majority of people in Africa are not used to the same sort of medical treatment that we are here in Canada. When we have a procedure done in the hospital, we are given good pain medication. People in Africa do not even have the basics. In a way we would be killing two birds with one stone if we could somehow take that crop that is going to be poisoned and sprayed and torn out of the ground and actually harvest it and use it for good in Africa. There may be some problems associated with that idea. We have to find ways to solve these problems. It is a wonderful idea.

The member of our caucus is tireless in her efforts not only in this area, but in everything she does. I actually sat with her in the Manitoba legislature some 20 years back.

We need to get something done about this. We need to straighten out this problem--

Patent ActPrivate Members' Business

November 27th, 2009 / 2:05 p.m.


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Conservative

The Deputy Speaker Conservative Andrew Scheer

Order. I will stop the member there. We will go to the member for Burlington. I will just remind him that he will only have about eight or nine minutes in his slot before we will have to put the question.

Patent ActPrivate Members' Business

November 27th, 2009 / 2:05 p.m.


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Conservative

Mike Wallace Conservative Burlington, ON

Mr. Speaker, if you give me a notice that I have a minute left, I will wrap it up.

It is my honour to stand here with this opportunity to address Bill C-393, which seeks to make substantial operational changes to the legislative framework for Canada's access to medicines regime under the Patent Act and under the Food and Drugs Act.

While I and I am sure other hon. members in the House are committed to improving access to medicines in the developing world via Canada's access to medicines regime and other initiatives, I have some strong reservations about Bill C-393 and its proposed revisions.

However, let me begin today with some background on Canada's access to medicines regime. The stated purpose of the regime is to increase access to lower-cost, Canadian-made generic versions of patented pharmaceutical products needed to address public health problems in developing and least-developed countries. The development of Canada's access to medicines regime was a landmark event as there was no other international precedent at the time.

Thus, in crafting the regime, the government focused on three important objectives: first, to increase access to patented drugs and medical devices in the developing world; second, to continue to respect Canada's international trade obligations; and third, to maintain the integrity of our domestic patent system for pharmaceuticals.

In 2004, the then-Liberal government introduced legislation to establish the regime by amending the Patent Act and the Food and Drugs Act. Shortly thereafter, Bill C-9 received royal assent with the unanimous support of all parties on both sides of the House and the Senate.

I will now turn to discuss some of the problematic elements of Bill C-393 that propose to alter the scope of eligible drugs for export under the regime, and the health and safety review that these pharmaceutical products go under.

First, I am concerned that Bill C-393 seeks to eliminate the list of pre-approved products for export in Canada's access to medicines regime. While some critics of the regime allege that the list makes CAMR too rigid and inflexible, it does serve an important and practical purpose. Specifically, the list of pre-approved products for export minimizes the discretionary elements of the regime and, as a result, expedites the decision making process. It also provides prospective users with the assurance that, assuming all other statutory requirements are met, an application for authorization under the regime will be used by the commissioner of patents.

Second, I am concerned about the proposed changes in the drug review process in Bill C-393. If passed, these changes would significantly alter the level of domestic oversight regarding the safety and quality of the products exported under CAMR. This is because Bill C-393 suggests, among other things, to make the existing mandatory Health Canada review optional.

Further, it suggests allowing the export of eligible products under Canada's access to medicines regime to be made on the basis of a review by a foreign regulatory authority. Such an abeyance of Health Canada's review would not be permitted for drugs and medical devices destined for the Canadian market.

In addition, during the statutory review of the regime in 2007, developing countries and generic drug manufacturers expressed strong approval of the very drug review that Bill C-393 seeks to remove. These potential users of CAMR went on record as saying that Health Canada's review was a useful mechanism for ensuring that products sent to the developing world under this system were safe and of high quality.

Some critics of Canada's access to medicines regime state that the Health Canada drug review is unnecessary and allege that it duplicates the World Health Organization's pre-qualification process for listing pharmaceutical products that are eventually purchased by international aid agencies and developing and least-developed countries without appropriate regulatory capacities. However, I do not agree with them.

Health Canada has a long-lasting and excellent relationship with the World Health Organization in this regard, both in undertaking reviews for the international organization's pre-qualification program, and in working with the World Health Organization and other initiatives to build regulatory health and safety capacity in developing and least developed countries.

Furthermore, since Health Canada's reviews are accepted by the World Health Organization for an alternate listing process, Canada's domestic drug reviews are not duplicated. The alternate listing process, which is an abbreviated process for listing drugs to the pre-qualified program, is available for drugs reviewed by Health Canada, the United States Food and Drug Administration and the European Medicines Agency.

I would like to conclude by reiterating that while the government remains committed to Canada's access to medicines regime and a broader, long-term approach to fighting public health diseases in the developing world, it opposes Bill C-393 and its proposed changes to the regime.

In my opinion, several of the changes to the Patent Act and the Food and Drugs Act raise concerns about the potential impact on the effective operation of CAMR. Many of these changes also do not support the humanitarian objective of improving access to safe medicines for the developing world.

Finally, there is little evidence that Bill C-393's proposed amendments will make a meaningful difference in the volume and frequency of exports under Canada's access to medicines regime.

To date, Canada's compulsory licensing and export regime is the only one of its kind worldwide to have successfully authorized and exported drugs to a country in need.

For all of these reasons, I urge hon. members in the House not to support Bill C-393. I do want to say in closing, however, that I do appreciate the efforts of the member for Winnipeg North in this matter. I have had a number of meetings in my riding with citizens who are deeply concerned that this regime is not working, but this bill does not meet their needs, based on our review of how it has been laid out. However, I do appreciate the member bringing this to the attention of the House of Commons.

Patent ActPrivate Members' Business

November 27th, 2009 / 2:15 p.m.


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NDP

Judy Wasylycia-Leis NDP Winnipeg North, MB

Mr. Speaker, my colleague from the Conservative Party is right. This is the only one of its kind in the world. Canada's access to medicine regime, CAMR, was an innovative, pioneering move five years ago. It still is today, but it is not working and it needs to be overhauled. It needs to be fixed. We need to keep our commitment to the world to ensure drugs get to people who need them in developing nations.

For all of the arguments we have heard in opposition today and in the past, there are strong rebuttals. There are all kinds of arguments that have been made in this House and the other place. I am here to urge members to let this bill go to committee so that we can spend the time rebutting those arguments or hearing concerns and making any necessary amendments.

I am not saying this bill is perfect. I am saying it is absolutely essential. We cannot miss this opportunity. We owe it to too many people here in this country and around the world to fail at this point.

Two years ago we had an opportunity to fix CAMR and we did not. We failed at that point. We dare not fail today. We dare not let the world be disappointed by our inaction because we did not have the courage at least to hear the arguments at committee, make the case and improve this legislation. We owe it to those who need our medicines. We owe it to those whose lives have to be saved.

I owe so much to the grandmothers across this nation for the work they have done on this issue. I want to acknowledge their work. I want to thank Sharon Swanson from the Lanark County Grannies who is with us today. I want to thank Peggy Edwards, Kathleen Wallace-Deering, Gillian Sandeman, Elizabeth Rennie, Andrea Beal and Marilyn Coolen from the Ottawa group. I want to thank from Winnipeg the group Grans 'N' More, especially Linda Watson, Enid Butler, Charlotte Caron, Barb Fletcher, Shelley Coombes, Nancy Cosway, Jean Sorko, Jean Altemeyer and many others.

Finally, I want to say that we are doing this for people who need our support. In the last minute of debate, I want to quote Stephen Lewis, who is a pioneer in this area and who helped form the Grandmothers to Grandmothers Campaign. I want to quote from an article in the Globe and Mail of Saturday, October 22, 2005:

The 40 million people infected worldwide--26 million in Africa. The millions, mainly young women, without access to treatment because the world won't pay for it....

His voice drops again to a whisper: “And they're all young women, they're all in the 20s and 30s. You go into a hospice, 25 beds, 23 of them filled by women in their 20s. You can't get the drugs to them in time. You know they're going to die in a matter of months”.

In talking about the children, he said:

You go into a little community centre for kids...and I remember this...you have a whole group of kids sitting in a little room. They look as though they're 4 or 5, they're all stunted, and they're really 8, 9, 10 years old, all HIV-positive, and there are no drugs. And you know these kids are measuring their lives in minutes. And you just wonder...why is this? How long can it happen? How long does it have to go on incrementally?

It's just so bad. It's so awful.

Let us not fail these children, these women, the people in other parts of the world who need our help. Let this bill go to committee.

The vote on the bill will be on Wednesday. We do not have enough support for it. All of the Bloc and all of the NDP members are committed to supporting it. We only have a third of the Liberals and a handful of Conservatives. That is not enough to move this bill forward. We need each and every member to think about this and at least allow for a positive vote on Wednesday so we can study this matter further. We must ensure that this country stands up to its promise in the world and is true to the commitment it has made to people everywhere.

Patent ActPrivate Members' Business

November 27th, 2009 / 2:20 p.m.


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Conservative

The Deputy Speaker Conservative Andrew Scheer

The question is on the motion. Is it the pleasure of the House to adopt the motion?

Patent ActPrivate Members' Business

November 27th, 2009 / 2:20 p.m.


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Some hon. members

Agreed.

No.

Patent ActPrivate Members' Business

November 27th, 2009 / 2:20 p.m.


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Conservative

The Deputy Speaker Conservative Andrew Scheer

All those in favour of the motion will please say yea.

Patent ActPrivate Members' Business

November 27th, 2009 / 2:20 p.m.


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Some hon. members

Yea.

Patent ActPrivate Members' Business

November 27th, 2009 / 2:20 p.m.


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Conservative

The Deputy Speaker Conservative Andrew Scheer

All those opposed will please say nay.

Patent ActPrivate Members' Business

November 27th, 2009 / 2:20 p.m.


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Some hon. members

Nay.

Patent ActPrivate Members' Business

November 27th, 2009 / 2:20 p.m.


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Conservative

The Deputy Speaker Conservative Andrew Scheer

In my opinion the yeas have it.

And five or more members having risen:

Pursuant to Standing Order 93, the division stands deferred until Wednesday, December 2, 2009, immediately before the time provided for private members' business.

It being 2:22 p.m., this House stands adjourned until next Monday at 11 a.m., pursuant to Standing Order 24(1).

(The House adjourned at 2:22 p.m.)