Bill C-393 (Historical)

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

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

Patent Act

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

moved that Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, be read the second time and referred to a committee.

Mr. Speaker, it is a real privilege for me today to begin to speak to a bill that has been the product of so many hours of work by community activists and NGOs right across this country and around world. I am pleased to speak today to Bill C-393, which is an act to amend the Patent Act and to ensure that we can flow drugs for international humanitarian purposes.

Our day to day work in this place clearly impacts upon every aspect of Canadian lives, but rarely are we, as members of Parliament, presented with so clear and direct an opportunity to save lives. We know that 14,000 people a day die from infectious disease, such as HIV-AIDS, tuberculosis and malaria, and that these deaths are preventable because they can be treated with medicines that are on the market today. The dimensions of this crisis are almost impossible to comprehend, with the personal cost to victims' health, the cost to their families, the plight of those left as orphans, and the strain on grandparents thrust into the role of providers.

There are 33.2 million people living with HIV worldwide, 22.5 million, or 68%, live in sub-Saharan Africa. In 2007, 2.1 million adults and children died of AIDS, and 76% of them, or 1.6 million, were in sub-Saharan Africa alone. An estimated 2.1 million children under 15 were living with HIV worldwide in that same year, and again, nearly 90% were in sub-Saharan Africa. Some 13 million children have been orphaned by HIV-AIDS in sub-Saharan Africa, and it is now estimated that by the year 2010, as many as 20 million children will have been orphaned by AIDS worldwide.

Finally, without treatment, an estimated one-third of infants infected with HIV will die before reaching the age of one. Half will die before the age of two.

Tuberculosis patients and malaria sufferers are also losing their lives for lack of available medicines, medicines that are on the market today. Five thousand people die from tuberculosis every day, while more than one million people die each year from severe malaria, a disease relatively easy to treat with proper drugs.

This is mind-boggling when we think about it. It is a crisis that no Canadian wants to turn his or her back on. Everyone in this country wants to see Canada do its job and carry out its responsibilities on such a serious life and death situation.

Canadians were very proud when Parliament took action quickly five years ago, following the landmark decision by the World Trade Organization in 2003. It allowed more prosperous nations, like Canada, to offer humanitarian medical support to developing nations.

Canadians were very proud when Parliament unanimously passed reforms to the Patent Act in 2004, called Canada's Access to Medicines Regime, otherwise known as CAMR. That regime was created to provide a framework to use a system of compulsory licensing to allow generic drug companies to produce cheaper versions of the latest most effective drugs to treat infectious diseases even though they were still under patent.

However, we all became disillusioned. Canadians right across this country were very disappointed when we actually came to realize that this medicines regime produced practically no results.

Since that time, four years ago, when we passed the legislation unanimously in the House, there has been only one compulsory licence completed under that legislation. Last September, the first and only shipment went out. It was a shipment of 7 million Apo-TriAvir tablets, shipped to Rwanda by Apotex, Canada's largest generic drug manufacturer. That was an important shipment. It will help 21,000 people. However, given the statistics I just mentioned, it is a drop in the bucket. That has been the only shipment.

There is obviously something wrong with the legislation. I am here today to try to fix it. The burden of drug costs for the world's lowest-income nations has intensified. Despite the efforts of those like my former colleague, the hon. Alexa McDonough, Canada and other prosperous nations are shamefully not on track to meet our commitments to the United Nations millennium development goals, such as reaching 0.7% of GNP in international assistance by the year 2015, increasing our efforts toward the global fund, reducing child and maternal death, and reducing HIV-AIDS.

Other G8 commitments to reduce poverty have not lived up to their hype. As a final blow, the world is now in the midst of an economic crisis of unprecedented proportions. Within their own borders, the devastating loss of large numbers of productive adults to infectious disease has further compounded the already difficult road to economic security and stability. Countries are obviously even less able to cope with high drug costs for their citizens. I am sure that members of Parliament realize that Canadians will not tolerate us carrying on with a dysfunctional drug system that keeps cheaper drugs from getting to where they are needed.

Former UN special envoy for HIV-AIDS in Africa and respected Canadian Stephen Lewis has been at this for years, tirelessly. He has never given up trying to reduce the incidents of HIV-AIDS in Africa and elsewhere, and has never stopped pushing and prodding us to find solutions. He, like all of us, is concerned about the inaction under the legislation we passed five years ago. He said:

Delaying action is inexcusable when the path forward is so clear: streamline CAMR, get affordable medicines to those who are dying for them, save thousands of lives, particularly those of children with HIV. Every day counts,

Stephen Lewis is right. Every day counts. Canadian generic drug maker Apotex has made a priority of clearing up the mess. It has committed to making a low-cost version of an important pediatric AIDS medication as soon as this access to medicines regime is made workable. I want to remind members that, in sub-Saharan Africa, half of all the children born with HIV died before reaching their second birthday.

This type of drug, which is so needed, is not currently being made. If we could only change the rules, it would happen and it would improve the treatment of these children tremendously. Peggy Edwards, co-chair of the national advocacy committee of the grandmothers to grandmothers campaign, echoes the call for CAMR reform. She says:

Right now, African grandmothers are carrying the burden of caring for children orphaned by AIDS and dying of AIDS without appropriate medicines. Streamlining CAMR and getting affordable medicines to children with HIV would ease that burden considerably.

That is very well said. Let me also quote Richard Elliott, who is the executive director of the Canadian HIV/AIDS Legal Network. I should mention that his organization has studied this process more than anyone and knows it inside and out. He says:

The current system just doesn’t work...The need is enormous, but CAMR just isn’t user-friendly in its current form.

That is why, in Bill C-393, I have drawn on the legal network's expertise and that of others knowledgeable of the strengths and weaknesses of the current CAMR system to come up with a workable proposal for change. It is a proposal that will get these drugs into production and to the children and adults who have been waiting for them for far too long.

Bill C-393 proposes critical changes to Canada's access to medicines regime. Let me mention a few of them.

It provides for a one licence system to replace the need for single applications for every drug, for every amount of drug produced, and for every country which is seeking medications. That is important.

It gets rid of the narrow list of eligible drugs in order that new medicines can be incorporated at the earliest possible time.

It gets rid of the two-year time limit on compulsory licences with only one reapplication allowed.

It lives up to our international trade agreements while dumping the CAMR's requirements that exceed WTO demands.

Finally, it discourages unnecessary legal action by allowing generic producers to correct minor errors within a limited time.

The reforms we are proposing today in the bill have been supported by many, including 37 humanitarian and health organizations in Canada. They have said so in their submissions to government. That we are here today aware of the problems with CAMR and with solutions to offer to resolve these problems is due to the ongoing effort of so many individuals and organizations.

I want to particularly thank the Canadian HIV/AIDS Legal Network, Results Canada, Stephen Lewis Foundation and Oxfam Canada. I would particularly like to mention the incredible work of the Grandmothers to Grandmothers Campaign that now has more than 200 groups spread across Canada working tirelessly to raise awareness and rally support for these grandparents struggling for their own and their families' survival in sub-Saharan Africa in the wake of their children's premature deaths from HIV-AIDS. In Winnipeg, the group is named Grands 'n' More Winnipeg and I have been helped by discussions and information from Linda Watson, Irene Rempel, Enid Butler, Nancy Cosway and Shelley Coombes.

This spring, the grandmothers, as they have become known around this place, and I am wearing the pin that they have given to us all, brought petitions with more than 32,000 signatures to Parliament. We all had the privilege of presenting some of those petitions.

I want to cite the work of a present colleague of mine who formerly worked on this issue. The member for Windsor West was active on this file when Parliament first passed this bill a number of years ago.

In presenting the bill, I feel a great sense of responsibility. Normally, I have had the responsibility in this place to speak for my constituents in Winnipeg North. That responsibility is daunting in itself.

Today, I am speaking to this bill for millions of women, men and children who have a right to health, a right to life, just as we do, but who through circumstances of birth find themselves faced with serious conditions and diseases in countries unable to afford them the help they and their families need because of economic limitations.

As I have said, the challenges are unimaginable, but the spirit of the struggle is strong. We have a choice today, whether to break down a barrier that is denying them a future or to stay with the status quo and extinguish that spirit. I urge members to choose the former.

[Bob Dechert, Conservative, Mississauga—Erindale, ON]

Mr. Speaker, I would respectfully request the hon. member to explain why she would be in favour of making a review by Health Canada optional? I understand that Bill C-393 does this. Perhaps she could explain why she thinks that it is not unethical to export products to other countries which have not met the same safety standards that we have for consumption by Canadians?

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Speaker, I should put the question back to the member because in fact it was the government that committed to a review to ensure that all drugs were safe, that all drugs met the requirements as he is expressing today. The government has failed to carry out its commitments, so we are back today with legislation that is trying to redress this situation, address those problems, and to move forward the agenda.

It is clear when we have had only one shipment for one drug to one country in all of these years that something is wrong. I have identified those barriers to the problem. I have presented some very modest proposals to improve the situation so we can actually start to flow drugs as quickly as possible.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Mr. Speaker, I want to congratulate the member for Winnipeg North for this initiative and especially the response and support that she is giving to the Grandmothers to Grandmothers Campaign. I am a very strong supporter of that campaign.

I had the chance to meet with some of the grandmothers from South Africa in my riding of Vancouver Quadra. Being from Africa myself, I have a great deal of empathy for the struggles they are facing, especially at a time when the government has reduced by half the number of the poorest African countries that are being supported by CIDA on its priority list, so it is very badly needed that the help comes some other way.

What would be the estimated timeframe that the member's bill would enable these drugs to get to the people who need them so badly?

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Speaker, I appreciate the question from the member for Vancouver Quadra. I especially want to acknowledge her expertise in this area.

I do not have personal experience in terms of Africa. I was fortunate to be part of a Results Canada voyage to Bangladesh, where I learned so much about the importance of taking one forward step at a time, that some of the smallest efforts can produce the biggest rewards, and that for a few pennies a day we can get drugs to stop tuberculosis, something we thought we had rid ourselves and society long ago.

It is important that we take this step forward and start to flow the drugs. As for the timeframe, I believe that once the bill is through the House, including a thorough review at the committee stage, we should be ready to ensure its full implementation before the end of this year. I am hopeful that 2009 will be the year that we actually conclude this process and begin the application so that drugs actually start to flow.

I believe that the generic drug companies are ready, willing and able to embark upon immediate production, and shipments to other countries would begin as soon as possible. I know that with this initiative we will have made a huge difference.

[Paul Dewar, NDP, Ottawa Centre, ON]

Mr. Speaker, I want to thank the member for this initiative. If Canada is able to do this and the bill goes through, what effect might that have on other countries, like Norway, that are looking at this? In other words, will the bill be a good example and an opportunity for other countries to join in to help in this initiative?

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Speaker, that is an important question from my colleague, who is very familiar with this whole area and has much more expertise than I do. I believe that Canada had been a leader in the world on this issue. Since the failure of the application of the legislation, our light has grown dim in the eyes of the world. By correcting the flaws of the legislation and moving quickly, we cannot only show that we are leaders around the world but we can encourage other countries to follow suit.

[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.

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

Mr. Speaker, I am pleased to have the opportunity to address Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, which aims to modify certain fundamental aspects of Canada's Access to Medicines Regime.

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

Members of the House view Canada's Access to Medicines Regime as a key component of Canada's long-term approach to addressing serious public health problems that affect many developing and least developed countries, such as HIV-AIDS, tuberculosis, malaria and other epidemics. In addition to Canada's Access to Medicines Regime, this approach includes significant contributions from the Government of Canada to other global mechanisms and alliances which have come into existence in recent years and have become leading instruments for procuring lower cost drugs to respond to the needs of developing and least developed countries.

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

The government has serious concerns with Bill C-393's proposed modification to the regime's legislative framework. If passed by Parliament, the bill will result in the elimination of many of the key operational elements in Canada's Access to Medicines Regime in order to adopt a very broad, one-licence approach. This could have serious negative implications for continued pharmaceutical investment and growth in Canada. In addition, many of the bill's proposed legislative changes may not be in keeping with the spirit of the World Trade Organization decision on which Canada's Access to Medicines Regime is based.

This decision was the result of years of intensive international negotiations by members of the World Trade Organization. Those negotiations sought a solution to international patent obligations that impeded the export of critical medicines from countries with pharmaceutical manufacturing capabilities to countries without.

In August 2003, WTO members reached a landmark decision. They agreed to waive two of the patent obligations in the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS, in order to improve access to patented drugs and medical devices needed to address public health problems in developing and least developed countries.

Canada's regime is one of the nine regimes in existence to have implemented the World Trade Organization decision, but it is the only one to have successfully authorized the export of drugs to a developing country. This important event occurred on September 24, 2008, when a Canadian drug manufacturer, Apotex Inc., sent approximately seven million tablets of HIV-AIDS therapy to Rwanda.

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

In December 2007 the Minister of Industry tabled a report on the results of the statutory review in Parliament. The report concluded that insufficient evidence was accumulated to warrant making changes to the regime at that juncture.

This conclusion remains valid today, since the case for making legislative or regulatory changes to Canada's Access to Medicines Regime has still not been made. The fact that Canada is the only country today to see drugs shipped to a country in need under its access to medicines regime demonstrates that our system does work.

However, for Canada's Access to Medicines Regime to be used again, another country in need must inform the World Trade Organization of its intent to import lower-cost versions of patented pharmaceutical products under the terms of the August 2003 WTO decision.

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

It is for these reasons that I urge all hon. members of this House not to support Bill C-393.

[Nicolas Dufour, Bloc, Repentigny, QC]

Mr. Speaker, the Bloc Québécois acknowledges the need for immediate action to ensure that low-cost medications are sent to low-income countries.

As the Canadian HIV/AIDS Legal Network has said, the numbers speak for themselves. In 2007, the United Nations estimated that 33 million people were living with HIV/AIDS, including 2.5 million children. More than 8,000 people die every day from HIV/AIDS in the world.

The Bloc Québécois is aware of the different challenges surrounding research and development, of the problem with intellectual property on patents, of the need to pursue scientific research, and of the difficulty in balancing this with accessibility of low-cost medications in low-income countries. The Bloc also recognizes Canada's international obligations regarding the protection of intellectual property and the balance between accessibility and scientific research on this subject. As the Bloc Québécois has said many times, we must have another look at the Patent Act and Canada's access to medicines regime, now that law has been applied and the first medications sent to an African country.

It is more clear than ever that we need to act quickly. We must call together the various stakeholders to determine the advantages and disadvantages of Canada's access to medicines regime, and to come up with ideas to improve the current regime. We have a number of questions about the current effectiveness of this regime and its first application. Did it achieve the goal of bringing medications to the people? What were the relationships between the suppliers of the low-cost medications and the receiving country? Did the country have the necessary infrastructure to help sick people obtain the medication? Did the medication have the desired effect? How did negotiations work between the companies producing name-brand and generic medications?

The Bloc Québécois believes it is important to review Canada's access to medicines regime and the Patent Act, and to conduct in-depth follow-ups on the first application. Only after evaluating each step of the regime will we be able to determine how to improve it.

The Bloc Québécois is in favour of sending Bill C-393 to committee. We recognize that there are some provisions in the current regime that are keeping it from working properly. The committee will be able to carry out an in-depth analysis of how this legislation was applied on the ground for the first time.

However, the Bloc Québécois already has several concerns about the details of relaxing the requirements in relation to the current system, namely, expanding the list of countries, eliminating the wait time, Canada's commitments regarding intellectual property and how this bill will affect those commitments, the fact that brand name pharmaceutical companies are losing their oversight on agreements, the balance between intellectual property, the humanitarian aspect of the system, and the commercial aspect, which is more significant in Bill C-393 than in the current system.

Obviously, this bill raises many questions. The Bloc Québécois believes, however, that urgent action is required on this issue and that a study of Bill C-393 would be an excellent forum to begin discussions on potential ways to make the current system more flexible. Bearing in mind that a certain balance must achieved between the commercial and humanitarian aspects, the Bloc Québécois will definitely propose several amendments to this bill.

The World Health Organization, the Joint United Nations Programme on HIV/AIDS and UNICEF produced a report in 2008 entitled Towards universal access: Scaling up priority HIV/AIDS interventions in the health sector. That report reveals that access to anti-retroviral treatment for advanced HIV/AIDS improved between 2006 and 2007 in low-income and moderate-income countries. At the end of 2007, nearly 3 million people were being treated, that is, nearly 950,000 more people than in 2006, which is 31% of the 9.7 million people requiring anti-retroviral therapy.

Since 2001, the number of people receiving anti-retroviral therapy has increased 15-fold, from under 200,000 to 3 million, including 2 million people in Africa.

The greatest increase in treatment rates was in sub-Saharan Africa. That seems encouraging, but the fact remains that less than a third of the people who need treatment are receiving it. Some 2.5 million people were infected that same year, while fewer than 1 million new patients began receiving treatment.

There have been other improvements as well. Some 33% of HIV-positive pregnant women in those same countries received antiretroviral medications to prevent transmission of the disease to their child. Only 10% of pregnant women had access to that treatment in 2004. Once again, there has been a substantial improvement, but two-thirds of HIV-positive pregnant women still do not have access to these drugs.

With respect to children, nearly 200,000 of them had access to treatment in 2007, compared to 127,000 in 2006 and 75,000 in 2005. However, less than 5% of children have access to pediatric AIDS treatment, the kind of treatment specially developed for them. Treatment for children can cost up to eight times more than treatment for adults.

Every day, there are nearly 1,800 new cases of HIV infection in children under the age of 15, mainly as a result of mother to child transmission. In addition, every day, 1,400 children under 15 die from AIDS-related illnesses. More than 6,000 young people between the ages of 15 and 24 are infected with HIV. After more than 20 years of effort, less than 10% of pregnant women have access to services to prevent them from transmitting HIV to their newborn. Less than 10% of the children who are orphaned or made vulnerable by AIDS receive public assistance or have access to support services. Less than one-third of young women between 15 and 24 in sub-Saharan Africa really understand how to avoid the disease.

In the fall of 2008, Apotex, a generic drug company, began delivering triple combination anti-AIDS pills to Rwanda, and the contract calls for 21,000 people to be treated over two years. This is the first initiative of its kind in the world. Other countries have laws that allow low-cost drugs to be sent to developing countries, but none has shipped any yet.

According to patent drug companies, authorization to use their products was given very quickly, within two months, which proves the efficiency of the program. In terms of generic drugs, and more specifically Apotex, there are too many restrictions and the effort is not worth it. Apotex has stated that it would not want to repeat the experience in the current conditions.

Let us take a look at the background. At the end of the 1990s, charitable organizations initiated an awareness campaign. Pharmaceutical patents were deemed to be one of the main obstacles to drug access. Developing countries called on the World Trade Organization to relax intellectual property rules. Others considered corruption and insufficient infrastructure, in African countries in particular, to be the main obstacle.

In November 2001, in Doha, WTO members unanimously accepted that pharmaceutical patents were one of the main obstacles to access to drugs. In August 2003, WTO members agreed to allow developed countries to export low-cost drugs to developing countries. On August 30, 2003, WTO members agreed to make legal changes to certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights that seemed to prevent poor countries from importing pharmaceuticals.

I am told that I have only one minute remaining and so I will say that the Bloc Québécois supports some of the principles contained in Bill C-393. As I mentioned at the very beginning, we have a number of questions. Therefore, we would like this bill to be sent to a committee for more in-depth study. And, as I mentioned, the Bloc will propose a number of amendments to ensure that the bill will respect not only the industry but above all the charitable organizations that work primarily in Africa in order to ensure that we do all we can to fight AIDS.

[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.

[Paul Dewar, NDP, Ottawa Centre, ON]

Mr. Speaker, I want to thank my colleague from Winnipeg North for bringing this important piece of legislation to the House of Commons. This bill will improve another piece of legislation.

The bill will tweak and improve what was an honourable piece of legislation which, when it was put into practice, certain aspects were clearly deficient and needed to be improved. That is what this legislation is about.

My father was a negotiator for GATT. He spent a lot of time in Brussels negotiating the General Agreement on Tariffs and Trade. My father was very proud of the work Canada did at the negotiating table. I will focus a lot of my comments on TRIPS. It is important to understand that with respect to GATT, the WTO and going back in time to negotiations that happened before Doha and others, Canada was a leader in providing innovative ways to come to an agreement.

We have always been a country that has put forward innovations to benefit people beyond our borders. That is really important to understand, because what we are hearing from some members in the House is that according to TRIPS, ne touche pas, we cannot go there. The reverse is the case, because time and time again in the history of this country, we have gone to the international table and provided ways that countries can open up and not close off opportunities to help. That is exactly what needs to happen when it comes to TRIPS.

Let us look at what happened with TRIPS in 2001. I will not provide the arguments on why the drugs are needed. We will assume everyone in this place wants to send more drugs to Africa to help. Let us assume that, but let us take a look at how that can be done.

The bill would open the range and would streamline the process so that licences would be more than just one-off every time. Those involved in the Rwanda experience tell us that they will never do it again. That is an indication of the need to improve the legislation. Some say we cannot do that because it would jeopardize investments in our drug industry because of the patent protection that was provided in legislation passed by a previous Conservative government.

I think that is wrong. Clear rules need to be set. We need to streamline how legislation is put forward and then go to the international table and ask what the problem is. Is the list too wide? Does it overlap on any agreements for patent protection?

The government and some of my friends in the Liberal Party seem to be saying that we cannot go there, let us not even try. I do not think that is the Canadian way. The Canadian way is to put ideas on the table and make sure everyone understands the intention, and look for a pathway forward. That is what needs to happen.

In 2001, Doha was about asking for opportunities for African countries to receive the help they need.

I want to give an example of how this is not working. We know the Canadian experience needs to be changed. When Bill Gates and Mr. Clinton formulated an opportunity to help those in Africa who needed the ARVs and other drugs to fight malaria, they went forward with an initiative. They bought the drugs, not from the United States, not from Canada, but from India. It is important to underline this.

Unlike Canada at the time, India resisted the patent protections the industries were trying to foist upon them. India told them, “We will set terms with you, but we will not have it done to us”. The drug companies said that if India did not abide by their terms, they would leave. The Indian government of the day left the table. What followed is very interesting. India actually made drugs on its own. It provided innovation on its own. It created one of the most successful examples of drug production. To this date, India is in the WTO.

What is the result? Bill Clinton and Bill Gates went to India to do their bulk buy. Why? Because it was affordable. Why? Because the Indians looked at innovation and tried a different model. They have provided cheaper drugs to this day. That is important to understand. If we do not try to innovate, then we leave people behind. That is not sufficient.

I my colleagues to talk to people who have looked at Doha. I ask them to look at TRIPS and the challenges there. When my father went to the table on behalf of Canada for the GATT agreements, he did not do so to pitch for industry, to pitch for one side or the other, he went to pitch for Canada.

That is what we want to do. We want our government to pitch for Canadians to help out people abroad, not pitch for an industry that says that it has such constraints and that it will never be able to invest in innovation if these kinds of opportunities are opened up.

I do not think that is what Canadians want. I know what the African population needs. It needs to have this legislation changed, so we can open up and flow drugs, not at the expense of our industry but to help others.

For those who have questions about this, they should look at Doha and look at the opportunities for us to open up the TRIPS to ensure it will be fair-minded and help people abroad. No one is asking for a free lunch. We ask that those people, who are suffering greatly in Africa right now, to have the same access to medicines and health care that we have here.

Does anyone really believe the existing legislation is working? If they do, then I ask them to talk to grandmothers who have been overseas helping out. I ask them to talk to Stephen Lewis who has dedicated his life to this. I ask them to talk to any of the ambassadors in this city from Africa. They will tell us that there needs to be a response from Canada, that there needs to be a change to this legislation.

At the AIDS conference In 2006, the government pledged that it would do a comprehensive review on the legislation. One was done, but it was not sufficient. This bill will provide what is needed, and that is a change to this regime so people in Africa can benefit, not at the cost of industry here but at the benefit of Africans abroad.

I urge all my colleagues to support the bill.

[The Deputy Speaker, Conservative, Andrew Scheer]

The time provided for the consideration of private members' business has now expired and the order is dropped to the bottom of the order of precedence on the order paper.

It being 2:30 p.m., the House stands adjourned until next Monday at 11 a.m. pursuant to Standing Order 24(1).

(The House adjourned at 2:30 p.m.)

The House resumed from June 12 consideration of the motion that Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, be read the second time and referred to a committee.

[Bernard Patry, Liberal, Pierrefonds—Dollard, QC]

Mr. Speaker, I am pleased to rise in this House today to add my remarks with respect to Bill C-393.

I will try to make myself as clear as possible. I firmly believe that a nation as well off as Canada has to do everything in its power to facilitate access to and distribution of medicines in countries that are suffering terribly from the crippling impact of diseases like HIV/AIDS, malaria and tuberculosis.

That is why a Liberal government—needless to say—introduced legislation to establish Canada's access to medicines regime, otherwise known as CAMR.

That piece of legislation was passed unanimously by Parliament because it reflected our Canadian values, and the compassion Canadians have for those less fortunate in particular.

As we know, Rwanda was the first and only country to test CAMR by importing HIV/AIDS drugs from the Canadian generic drug manufacturer APOTEX.

We also know that three separate pharmaceutical companies holding the appropriate Canadian patents answered the call and authorized APOTEX to manufacture and deliver the requested product without having to pay any royalties. Incidentally, I should point out that these three companies recently reiterated their offer, again, royalty free.

After receiving the authorization, it took Apotex about one year to manufacture and ship the product and an additional year to ship the remaining amount permitted under the licence.

The fact that it was the only application of CAMR in Canada, and that no other country with a similar system has ever provided generic drugs to developing countries, leads us to the following question: why is CAMR not used more?

Unfortunately, rather than carrying out an in-depth analysis of the problem, some have concluded that the problem was that the legislation, although well intentioned, had shortcomings and that amending it would make it easier to apply. This resulted in Bill C-393, which puts forward the solution of a single licence system.

If we look at the facts surrounding the shipment of generic drugs to Rwanda, we see that the patent-holding pharmaceutical companies reacted very quickly when they were contacted. From beginning to end, the mandatory licensing process took 68 days.

I am pointing this out because it is extremely important to establish whether the licensing process caused the undue delay in shipping the drugs to their destination.

From what I have just outlined, it does not seem that the CAMR legislation, in its current form, is the cause. It seems that the problem lies elsewhere.

Why did it take one year to send the first shipment if the CAMR legislation was not at issue? It is important that we be fully aware of this fact given that we are attempting to determine the true causes of the problem.

Much has been made of the issue of intellectual property rights. Some claim that the pharmaceutical companies are hiding behind our international obligations under the WTO agreement on trade-related intellectual property rights, known by the acronym TRIPS, in order to hold back the flow of generic drugs.

Recognizing intellectual property rights is crucial for the future discovery of drugs that will save lives. If we do not protect intellectual property rights, we will deprive ourselves of key research, not only in the pharmaceutical sector but in all sectors driven by research. This will have extremely negative consequences for Canada.

Dozens of new drugs to treat HIV, malaria and similar illnesses are currently being tested. Related research is absolutely critical and is being carried out by patent drug manufacturers.

In testimony he gave on October 20 before the Senate Committee on Banking, Trade and Commerce about a similar bill, Bill S-232, a lawyer for the pharmaceutical industry said that the amendments proposed in Bills S-232 and C-393 are not in keeping with Canada's international trade obligations regarding intellectual property.

Are we going to ignore that conclusion? That said, let us focus on some of the known causes of the current problem.

More than 90% of the 319 drugs on the list of essential drugs for developing countries are not patented. Less than 10% are patented. It is important to understand that.

A recent study of 65 countries by Dr. Amir Attaran, a biologist and lawyer with the University of Ottawa, found that the main barrier to access to drugs in developing countries is not the granting of a single patent licence, but poverty. Yes poverty, always poverty.

Let us look at some other realities.

If we look at the necessary drugs that reach developing countries, we see that most of them come from countries like India, China and South Africa. Why not Canada? Certainly not because of the CAMR. It is because these drugs are available for less than what Canadian generic drug manufacturers charge, which is higher because of our higher labour costs.

This is certainly one of the reasons why developing countries do not turn to Canada for drugs under the CAMR. They have cheaper options.

The challenge at present is not the supply of drugs. The supply is there. But how are we going to deal with the very real challenge posed by the fact that recipient countries lack the infrastructure to make a proper diagnosis and to deliver, distribute, administer and store drugs?

We need to turn to organizations such as Health Partners International Canada, which have extensive experience in the field in managing the distribution of drugs in developing countries that have very little infrastructure.

I firmly believe that we can work productively with these organizations to get drugs to where they are needed. I also believe that this is a much better way to achieve our objectives than what Bill C-393 offers.

According to Margaret Chan, WHO Director-General, “Health systems are the tap root for better health. All the donated drugs in the world will not do any good without an infrastructure for their delivery.”

This bill offers no solutions to the problem of drug distribution infrastructure. It should have proposed the following measures: the creation of partnerships between the private sector and NGOs, which have a lot of experience in this area, to ensure effective drug distribution; and accountability and transparency of the access to medicines regime and distribution. This bill leaves out some important requirements in this area, which could make it easier for drugs to be diverted to recipients other than the developing nations they are meant for.

Health Partners International Canada has also recommended that the government take all reasonable measures to ensure that drugs from Canadian suppliers are not diverted from their intended recipients.

The problem of counterfeit and poor quality drugs will only get worse if Canada's Access to Medicines Regime is amended as set out in Bill C-393.

Therefore I call upon my colleagues in the House to clearly focus on the problems before us and send developing countries the drugs they desperately need, but also help those countries improve their infrastructure.

This bill makes no mention of the many different aspects of poverty, but rather talks about one licence. Instead of being a disposable, limited-time measure, agreeing to one licence would eliminate the voluntary licence step in agreements on trade-related aspects of intellectual property rights, or TRIPS, within the WTO.

I believe that intellectual property rights are essential in our society, and this bill offers no guarantee that those rights will be protected. In conclusion, I cannot support Bill C-393.