Bill C-9 (Historical)
An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa)
This bill was last introduced in the 37th Parliament, 3rd Session, which ended in May 2004.
Lucienne Robillard Liberal
This bill has received Royal Assent and is now law.
Private Members' Business
November 21st, 2012 / 6:50 p.m.
Brian Masse Windsor West, ON
Mr. Speaker, I rise today to speak to the bill that my colleague has brought forth. I rise with a sense of regret and shame for a country that has failed to deliver on a promise that it made nearly 10 years ago. As a result of that failure and that promise that was never kept, we have witnessed children, men and women suffer and die because we did not get a chance to provide medications.
We built the system. This is important to recognize when we go back and look at the past. Bill C-56 was the original bill. It was nicknamed Jean Chrétien's aid to Africa act. We said at that time that we would put a system in place that would be the envy of the world. It would allow generic drugs to get to those who were suffering, whether it be from HIV-AIDS, tuberculosis or malaria. We promised.
When Parliament recessed Bill C-56 came back to the House as Bill C-9 in 2004. We made another promise. Experts appeared at committee a couple of times. We brought in witnesses. We had expert testimony from many people from around the world. People testified to make sure that we were WTO and TRIPS compliant, that we were within the mandate with regard to allowing the patented drugs to be generically created and distributed, and that we would follow certain rules. Basically, we wanted to create an open and accountable process. Instead we built a monster that really has only been exercised once in all of these years. It really is a monster, because it is preventing us from stopping death and suffering.
Why is it important? Lots of numbers get thrown out and there have been some improvements over the years. The reality is that many people are still suffering. I cannot understand it when I look at the problems being faced in sub-Saharan Africa. What are we doing when children are becoming the heads of households because their parents are dying? We are taking out the capacity for the family unit to be effective. These children are losing the knowledge of how to raise themselves, how to become successful, how to get an education and work co-operatively with others. We are undermining people because we are not providing the resources that are there.
There is a will out there. I want to read some comments from organizations that are in favour of the legislation, because it needs to be noted that they did their part. They did their part for many years on the Hill as we have moved this issue forward.
When we moved Bill C-393, the previous legislation, it ended up dying in the Senate. Unfortunately, we are back here today. It is important to move this legislation again to committee because it does have a few changes, some improvements and some compromise. It is not like we did not compromise along the way. At one point I submitted over 100 amendments to the original bill at industry committee because we knew the legislation was so badly constructed. The Canadian access to medicines regime was built to defeat itself.
The organizations that did their part include the Canadian HIV/AIDS Legal Network, Grandmothers Advocacy Network, Results Canada, the Federation of Medical Women of Canada, the Canadian Federation of University Women, the Ontario Nurses' Association, UNICEF, Bracelet of Hope, World Vision, the United Church of Canada. A whole coalition, a rainbow of organizations have come together and worked together.
There have been some important changes and there is some hope. We were fighting with the brand name drug companies along the way. We have gone through a whole range of issues about certain countries being listed and certain drugs being listed, and fought back and forth on all of those things.
However, now there has been a shift in their position. In a letter dated November 19 from research-based pharmaceutical companies to my leader, the hon. member for Outremont, it says they are open to looking at a more constructive approach. They list a series of concerns. Some I do not think are as valid as others, but there are important ones to note. They talk about transparency, amount and term, anti-diversion, eligible countries, eligible medicines and safety appeal mechanisms.
The good news is that there is no reason for any member now to vote against the bill. If a member is voting against the bill, he or she is voting directly against the pharmaceutical companies, the generics, and all the organizations I mentioned, that want to see this move forward. I thank them for coming to the table this time. In the past, we have witnessed a relationship that has been rocky at best. However, at this moment in time there has been a change in position. We are going to hopefully see this legislation move to committee so we can start to deal with some of the issues they raised to improve the legislation.
It is important. We have set an example internationally with this legislation. If we can get the changes here, other countries can also get some changes. We have a situation where some of the global funds are diminishing, so we have an issue with supply and management right now, and the costs.
I will conclude that I have come here today speaking out of frustration and disappointment, but there is a glimmer of hope this time. I am hoping all the members understand that there is nobody else out there against moving forward, so let us do it together with all members' support.
Private Members’ Business
October 16th, 2012 / 6:45 p.m.
Ted Hsu Kingston and the Islands, ON
Mr. Speaker, I would like to begin by thanking the hon. member for Laurier—Sainte-Marie for bringing this matter before us again by introducing this bill.
I thank the hon. member for Laurier—Sainte-Marie for bringing forward Bill C-398, which would amend the Canadian access to medicines regime. It is my pleasure to speak today in support of the bill and to move it to committee stage by voting for it at second reading. It is time to move the bill to committee and move on the legislative process, which was interrupted in the last election after it passed this House with support from all parties.
We are very fortunate in Canada that we live in a country where we are able to benefit from medication and as a country we have the infrastructure and the know-how to produce medicines. As Canadians, we also feel that we have an obligation to help those around the planet who are less fortunate, who are sick or dying and could be helped if they had access to medicines that exist today.
That was the motivation for Bill C-9, the original Canada access to medicines regime, also known as the Jean Chrétien Pledge to Africa Act.
Some medicines are expensive and the point of CAMR is to make available to developing countries safe, generic versions of medicines manufactured in Canada and to do it within international rules on trade and on intellectual property rights. It is intended to provide the competitive pressure to reduce the cost barrier to those countries that would never be able to afford the medicine but would greatly benefit from it and where people are in dire need of the medicine. We know that other countries can produce generic drugs but the Canadian product is produced with higher standards in quality control and it will provide competition on that basis.
CAMR came into force in 2005 but, as people have noticed, since that time this regime has only been used to provide one shipment of medicine to one country so far, which is why we believe there are barriers. One of the barriers that has been identified is the cumbersome licensing process.
The core of Bill C-398 is to provide the so-called one licence solution, which would remove the need for each individual country to make a request for a compulsory licence to produce generic drugs that are needed for serious health problems in these countries. It would remove the need for individual countries to apply and, instead, a Canadian generic pharmaceutical manufacturer would apply for the licence for all countries.
This reform has been sought for several years now, and in the previous Parliament, Bill C-393, upon which Bill C-398 is based, passed this House with support from all parties and probably would have come into force had the May 2011 election not been called.
I want to expand a little bit on the remarks that my colleague from Laurier—Sainte-Marie made and I want to talk a little bit about intellectual property issues, which were the subject of the speech by my hon. colleague from the Conservative benches.
Advocates for reforming CAMR do not wish to jeopardize pharmaceutical R and D in Canada. They have said that an I think they do believe in the importance of the knowledge economy , and one of its pillars, the value of intellectual property.
I think we all agree that Canada's future will depend very much on its participation in the knowledge economy and nobody wants our kids to be competing in the world on the basis of providing the lowest cost labour. I believe that the drafters of Bill C-398 recognize some of these concerns.
For example, Bill C-398 improves upon Bill C-393 in that respect by specifying that Canadian generic manufacturers must post online the quantities of medicine being exported to each country. They must also put online the notification that each WTO country gave to the WTO trade related aspects of intellectual property rights council, or, for a non-WTO country, the notice that country gave to the Government of Canada.
The old bill, Bill C-393 from the last Parliament, at first removed a two-year time limit on licences before a renewal was required. In the last Parliament this was amended in committee to restore that time limit. Bill C-398 keeps that two-year time limit in the current draft. Drafters of the bill have responded to concerns about an open-ended licence in time.
In the spirit of the changes that the drafters of Bill C-398 have made, compared to Bill C-393 that already passed the House in the last Parliament, we could make some amendments to emphasize that it is not the intent of the bill to negatively impact any R and D investment in Canada. It is not the intent of the bill to devalue intellectual property that is a pillar of a knowledge economy.
People have asked me, for example, why Qatar is on the list of countries in the bill. It is a country with a per capita income of $90,000 per annum. I believe that no one wants that distraction. It really is distracting from the fact that people are sick and dying and need medicines that they cannot afford. Therefore, this is something we could look at in committee, the list of countries in schedule 2 of the bill, to remove these distractions that may lead people to question some aspects of the bill.
My colleague from the Conservative Party is worrying about safety issues. Some critics have worried that the generic drugs would not be subjected to safety reviews. However, section 21.04(3)(b) in the current legislation remains unchanged under Bill C-398 and affirms that any generic product must meet the requirements of the Food and Drugs Act and its regulations. Therefore, my hon. colleague is incorrect when he makes that point. It is an old point that was made in the past but this bill is slightly different and that point is covered. In fact, the advantage of importing drugs from Canada is that products are manufactured with higher standards and with better quality control.
I will be voting in favour of the bill. It is time to move toward reforming Canada's access to medicines regime, a process that was accidentally interrupted at the last election, but which had already passed the House. We must not delay in sending the bill to the next stage of the legislative process, to committee where we can examine it and related issues in detail, as we should examine every bill. We must move this bill to committee and I urge my colleagues to vote for the bill at second reading.
Private Members' Business
March 3rd, 2011 / 5:15 p.m.
Frank Valeriote Guelph, ON
Mr. Speaker, I rise in the House this evening to speak in support of Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act.
I strongly urge all members to support the bill and the amendments put forward by my hon. colleagues from Halifax and from Windsor West, calling for a one license solution to cut the red tape currently preventing the sale of generic drugs overseas and to also restore the definition of pharmaceutical products to protect the knowledge developed by name brand drug manufacturers. Accepting these amendments will simultaneously help those in the developing world and will also protect the investment and the knowledge developed by pharmaceutical companies.
On May 14, 2004, the Martin Liberal government passed Bill C-9, An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa). This act established the legal framework for Canada's Access to Medicine Regime, or CAMR, which sought to balance Canada's trade and intellectual property obligations with the humanitarian objectives set out in Bill C-9 and help us honour our commitment to realize the sixth millennium development goal to combat HIV and AIDS.
Despite this act's best intentions, CAMR was unsuccessful in its objective to facilitate timely access to generic versions of patented drugs for people in the least developed or developing countries to fight HIV-AIDS, malaria, tuberculosis and other diseases. This act's complexities are blamed for the daunting inability and serious obstacles to the supply of generic drugs to fight HIV-AIDS in the developing world. As a result, drugs have only been delivered to one country on one single occasion, Rwanda.
Parliamentarians have made a number of attempts to fix the obstacles preventing the shipment of generic drugs to those who need it. Now we have another opportunity to meaningfully help those in need. The opportunity is right now. We have the chance to pass Bill C-393, which will help to clear these obstacles and reduce the complexity of the current CAMR regime, so we can begin to deliver on our pledge to improve the health of the world's poorest people. It is absolutely imperative that we do so, to stop people from dying when they could be living and to alleviate suffering when they could be blessed with an extension of their lives for their own well-being and the well-being of their entire family.
The statistics are alarming. There are more than 33 million people living with HIV-AIDS globally, 22.5 million of whom live in sub-Saharan Africa. Three-quarters of all AIDS related deaths since 2008 occurred in Africa. There are 2.3 million children infected with HIV. One in two children with HIV in the developing world dies before their second birthday. Less than 15% of the children who need treatment are getting it. More than half a million children die of AIDS every year. Every day 7,100 people become infected with AIDS.
Yet statistics themselves can be desensitizing, thrown around at random to make a point. I have a hard time conceptualizing what 2.3 million children infected with HIV really means, so I thought I would put this into perspective.
I recall a documentary called Paper Clips, where children in a middle school in Tennessee, attempting to grasp the enormity of just how big the number six million really was, gathered six million paper clips, one for each life. If we did the same and placed the clips in boxes of 100, just like the ones we have in our offices, the number of children with HIV in developing countries would equal the number of paper clips contained in 23,000 of these boxes.
Let me give the House another comparison. Thirty-three million people in the world are living with HIV-AIDS globally. That is the entire population of Canada. Imagine attempting to treat this many people in a meaningful way, with our hands tied because of ineffective and cumbersome legislation that we can now change.
Developing countries in Africa are already suffering from the government's withdrawal of foreign aid dollars, which in part resulted in our loss of a seat at the United Nations Security Council. We must not allow this ambivalence to prevail.
If we do not vote for this bill, we will wake tomorrow and we as a country will be no better able to help the 7,100 newly-infected people with HIV tomorrow. Nor will we be in a position to prevent another 7,100 people from becoming infected two days from now. Today we have to make a choice and there is only one right decision. I am voting for Bill C-393. I am voting for helping people in need and for doing what is right. I implore everyone in the House to do the same.
I am acutely aware of the way HIV-AIDS destroys the lives of people, having personally witnessed this epidemic while doing international aid work in San Pedro Sula, Honduras, the city with the highest incidents of AIDS in Central America at the time I was there. As part of my continuing international aid work in central and South America, I have helped build schools in the hope that knowledge and health education can keep children safe and help prevent the infection of HIV.
A 2008 UN report estimated that seven million cases of AIDS could be prevented in the next decade if every child received a primary education.
I am also aware of the impact that AIDS can have through my work with Anne-Marie Zajdlik and the Masai Centre for the treatment of AIDS in Guelph while on the Bracelets of Hope Campaign, where we raised over $1 million selling red and white beaded bracelets made by the women of Lesotho in southern Africa to fund AIDS treatment centres in that country.
In discussing this bill, Dr. Zajdlik said:
In the last 5 years I have treated hundreds of HIV positive children...Despite our best attempts, many, many of these children died.
In our world of unprecedented wealth, information and technology, no child should die of a preventable disease. The life saving miracle of medicine and medical technology is part of the intellectual property of the world and should be made available to all.
Prevention has to be taken seriously. This can be achieved in several ways. Building schools, improving educational programming, increasing HIV testing and treatment sites are but some. We must also facilitate the provision of antiretroviral drugs, or ARVs, that actually prevent the transmission of AIDS from a pregnant woman to her newborn. Providing these drugs will prevent infant deaths and will save hundreds of thousands of children from suffering from HIV-AIDS.
In 2009, 370,000 children were infected with HIV during the perinatal and breast-feeding period of growth. That is 370,000 children who could have been saved through the use of ARVs and other HIV-AIDS drugs that would have prevented the transmission of this virus. That is another 370,000 children who would not have grown into adulthood with the risk of passing HIV onto others.
While resources need to be devoted to preventing HIV-AIDS, we must also acknowledge that we need to do our part to help treat HIV-AIDS in the developing world until it is eradicated. That means developing the best legislation and regulatory system possible to ensure that generic and affordable medication is available for those who need it.
According to a 2010 UN report, access to antiretroviral drugs has resulted in a gain of 14.2 million life years worldwide. In Botswana, AIDS-related deaths fell from 18,000 deaths in 2002 to 9,100 deaths in 2009 as a result of antiretroviral drug use. Accordingly the rate of children orphaned by AIDS fell by 40%. This is not only a matter of life and death; it is also an enormous moral and social issue.
The House should be grateful for the efforts of the Guelph GoGo Grandmothers who have nobly and passionately worked towards the passage of this legislation. I can feel the impact that its members have had on the House. I sincerely hope its efforts have not been in vain.
If we pass this bill and embrace this noble strategy, we can prolong lives and prevent the transmission of this insidious disease. Imagine a world without AIDS, where people could live and thrive knowing that they would live to be able to provide for their loved ones and raise their children with the knowledge that they could have a child without transmitting HIV to them, a world where their energy could be spent productively contributing to their families, communities and economies.
Wishing this to be true will not make this happen. We must be intentional in our efforts to pass legislation so it will happen. I implore the members to vote with me in favour of Bill C-393 and make it happen.
October 28th, 2010 / 12:20 p.m.
Senior Counsel, Legal Services, Justice Canada, Department of Industry
Thank you, Chairman.
It's hard to know where to begin. As you have noted, this is very complex and very interrelated, and that's the way legislation is usually crafted, so that when it's presented in the House the interconnections between (a) and (b) and (c), etc., are clear.
But the question is, if you stay with the definition of “pharmaceutical product” that is in Bill C-393 now, that is defined by reference to the Food and Drugs Act, and the Food and Drugs Act definition of “drug” is everything in the world: any substance that can be used as a medicine, not only for humans but also for animals. It also includes disinfectants for cleaning kitchen surfaces and stuff like that.
So there is no need to amend if you stay with that. If you introduce the prospect of a Minister of Health or a Minister of Industry joint recommendation, they have to recommend to somebody. In the existing legislation--Bill C-9 or the Patent Act--it is the Governor in Council who makes amendments to the schedules that are in that act and does so on the recommendation of the appropriate ministers. In the case of a drug, that recommendation is given by both the Minister of Health and the Minister of Industry. Amendments to the other country schedules are done on the recommendation of the ministers for industry, international affairs, and CIDA, and I think for international trade as well.
The original legislation, the Patent Act, that purports to be amended by Bill C-393 has a mechanism that's built in for amendments to all those things and the circumstances that have to be met. If you use the definition that's proposed in amendment Lib-1, there is no mechanism left in the act, because Bill C-393 gets rid of all those mechanisms for amending. So it may say “on the recommendation of a minister”, but there is no mechanism in the legislation to permit it.
It's very intricate and very interrelated.
October 28th, 2010 / 11:35 a.m.
Senior Counsel, Legal Services, Justice Canada, Department of Industry
As I said, some of them are definitional and they make sense within Bill C-9 because the terms were used throughout the legislation. Those are just sort of drafting techniques, but there are others. “General Council Decision” is used throughout the legislation to describe specific criteria that are going to have to be met in an application for an authorization.
October 28th, 2010 / 11:35 a.m.
Senior Counsel, Legal Services, Justice Canada, Department of Industry
Some of them are just there for drafting convenience, but others do have an impact. For instance, where in Bill C-9 you see references to “in accordance with the General Council Decision”, that has substance to it. The circumstance of a manufacture and exportation and importation meets the restraints or the limitations that were imposed by the TRIPS agreement when it was initially negotiated.
October 28th, 2010 / 11:35 a.m.
Rob Sutherland-Brown Senior Counsel, Legal Services, Justice Canada, Department of Industry
It's all very complex and interrelated, but essentially, the original CAMR legislation, Bill C-9, made reference to things like the WTO waiver decision. To do that, a number of the definitions were technical; WTO is used, so there's a definition of WTO to tell you what the World Trade Organization is.
For “General Council” and which General Council, it tells you that. But it also, importantly, tells you about the “Decision”, which is referred to throughout the legislation as somebody importing or exporting in conformity with the authorization.
For “patented product”, again, it's a technical definition to tell you what it means. It's defined in terms of infringement. That's what this is about. It's about authorizing otherwise unauthorized users to infringe.
So these play both a definitional and a drafting role throughout the original legislation. Those references have been removed in Bill C-393, so they may or may not have much impact on Bill C-393 itself, but they do have an impact on the overall schema, in the sense that it loses the tie to the WTO agreements, both the main agreement and the TRIPS, the trade-related aspects of intellectual property agreement.
October 26th, 2010 / 10:30 a.m.
Grant Perry Vice-President, Public Affairs/Reimbursement, GlaxoSmithKline Canada
Honourable members, thank you for the opportunity to appear today to discuss GSK's experience with Canada's access to medicines regime and our company's extensive efforts, both globally and locally, to improve access to health care in the developing world.
There are three points I'd like to make. First, CAMR is efficient and effective at achieving its objectives. Second, the provision of medicines is only one essential element in addressing health care issues in the developing world. Third, GSK is committed through action to addressing access to medicines through frameworks like CAMR and other means. GSK's experience with CAMR has shown that it is an effective framework for Canada to meet its international obligations and for increasing developing world access to much needed medicines.
While 32 other countries in the EU and elsewhere have passed legislation similar to CAMR, to the best of our knowledge Canada is the only country from which a shipment has actually taken place. This first shipment of a triple combination HIV/AIDS drug to Rwanda from Apotex in Toronto took place in September of 2008.
First allow me to congratulate Apotex for stepping up to address the issue in Rwanda. The following chronology of events leading up to that shipment is important, because it demonstrates that only 68 days elapsed from the time Apotex made the request of GSK until they were granted authorization to begin exporting Zidovudine and Lamivudine to Rwanda. Please allow me to review this timeline with you.
You will recall that Bill C-9 came into effect in May of 2005, creating the Jean Chrétien Pledge to Africa Act, now called CAMR. Almost a full year passed before GSK and two other patent donors were approached by Apotex requesting voluntary licences. GSK responded promptly, indicating a willingness to discuss the granting of a licence and seeking clarification on key questions relating to anti-diversion and patient safety, both very real issues to GSK. Apotex did not respond at that time to our request for further information. Fourteen months later, GSK received another request from Apotex for a voluntary licence, and within 26 days we provided our consent to the commissioner of patents to issue an authorization pursuant to CAMR. Ultimately, one more year passed before the first shipment of a triple combination product was shipped from Apotex, not because of red tape, not because of a complex and lengthy process, but for reasons outside the administrative and legal process and not within the control of GSK. Apotex took more than one year to start shipping their generic drug to Rwanda.
Our experience is that CAMR can and does work when put to the test. In October 2009, GSK announced that it remains ready and willing to do our part within the framework of CAMR to ensure that the objectives are being met. We must not lose sight of the needs of patients in the developing world. While CAMR includes important safeguards and transparency requirements that help encourage R and D investment and support new drug discoveries, we must refrain from using CAMR as a means to re-open the intellectual property debate in Canada. While Canada lags behind other countries in IP protection, the protection afforded by Canada's rules holds the key to developing new medications that can fight and eventually eradicate many diseases that ravage the developing world. We must not become embroiled in an IP debate that would create further instability and drive away crucial investments in our country.
This brings me to our second point. The provision of medicines is only one essential element of many needed to address health care. As you've already learned from Ms. Downie and others, simply delivering medicines, whether brand or generic, doesn't nearly address the challenges developing countries face, such as poor sanitation and education, as well as social barriers. There are significant infrastructure issues related to the availability of health care workers, distribution networks, and health care facilities.
Finally, corruption and criminal activity can lead to diversion of medicines from the intended patients, either within the country itself or even before the medicines reach the national authority. We need a broader approach, one that goes beyond CAMR, and this is our third point.
GSK has long taken an innovative, responsible, and sustainable approach to improving the health of patients in the developing world. Working in partnership with governments, NGOs, and the private sector, GSK has among other things deliberately focused our R and D efforts on diseases of the developing world, such as HIV, TB, and malaria. We have sought to eliminate many diseases, including lymphatic filariasis, one of the world's most debilitating diseases, and we have consistently offered preferential pricing on antiretrovirals and vaccines.
This legacy of commitment is not enough. We have stopped saying it is not our fault there is no infrastructure to deliver health care and have started asking ourselves what else we can do to ensure that infrastructure does exist. Consequently, we have established several new initiatives that continue to address these broader issues and specifically advance GSK's leadership role. Specifically, we have recently begun sharing our intellectual property on neglected tropical diseases by setting up a patent pool and inviting others to join us.
We have opened the doors of our research centre, dedicated to diseases of the developing world, to all other researchers. We have reduced the price of our patented medicines in the least developed countries to no higher than 25% of what it is in the developed world, and we have committed to reinvest 20% of the profits made on medicines in these countries in local health care infrastructure projects. Finally, we have expanded the donation of albendazole to treat children at risk of intestinal worms, a condition that the World Health Organization's first report on neglected tropical diseases confirms causes more ill health in school-aged children than any other infection.
I am very proud to be part of the renewed partnership agreement between Canada's Research-Based Pharmaceutical Companies and Health Partners International of Canada to help speed the delivery of medicines and other supplies to people in need across the developing world.
In closing, we have illustrated that CAMR is only a piece of the larger puzzle, and that piece has proven to work effectively and efficiently when used. GSK's belief is that our collective efforts and intentions are best focused by serving the broader issue of improving health care in the developing world through leadership and action.
I thank you for your time, and I welcome any questions.
Private Members' Business
June 12th, 2009 / 2:15 p.m.
Blaine Calkins 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.
Private Members' Business
June 12th, 2009 / 1:50 p.m.
Marc Garneau Westmount—Ville-Marie, QC
Mr. Speaker, I would like to begin by saying that I truly believe that as a country, we must do everything we can to help people in developing countries get access to much-needed medicines. Such a humanitarian initiative must be supported, because we all know that many people are suffering in poorer parts of the world.
Having said that, I personally do not believe that we can achieve that goal by changing the law associated with Canada's Access to Medicines Regime. Allow me to explain.
Canada's Access to Medicines Regime, or CAMR, came into force in May 2005, following the adoption by Parliament of Bill C-9. CAMR's purpose was to put in place a low-cost generic drug-based mechanism to deliver lifesaving medications to countries which could not otherwise afford them. The purpose was laudable and remains laudable, and the bill passed with the consent of all parties.
As an amendment to the Patent Act, CAMR allows generic drug companies to obtain the compulsory licence to manufacture patented pharmaceutical products and to export those products to developing countries that do not have internal capacity to manufacture products required to address public health problems.
If one looks at the flow of generic medicines to developing countries since the implementation of CAMR, one can only cite one example of such a transfer from Canada, and that was to Rwanda.
Similar legislation to CAMR implemented in other countries has also not resulted in the flow of generic medicines to developing countries.
The reasons for this situation are complicated, but they have nothing to do with the difficulty of complying with the current legislation, as the bill before us today suggests. The amendments proposed in Bill C-393 will not make things better, because the main challenges involved in getting medicines to the people who need them have nothing to do with the flaws in the current legislation.
The balance that was established in the legislative process through amendments to the Patent Act and the Food and Drugs Act was deemed appropriate by the review conducted in 2007 by Industry Canada in collaboration with Health Canada, CIDA and DFAIT.
Although critics of CAMR have said that the law is too complicated, it is worth noting that Douglas Clark, the former director of Patent Policy at Industry Canada, has stated that this criticism is not credible.
In fact, the reasons why CAMR does not work as we had hoped have to do with real problems in the field, in the countries that need these medicines. They have to do with access to properly trained medical staff, whether they be doctors or nurses. They have to do with clean water supply, refrigeration facilities, accurate diagnosis, secure infrastructure for distributing the medicines and so on. In short, they have to do with poverty and the need to make developing countries aware of CAMR. Those are the real challenges.
It is not the process itself of requesting the medicine. That process is uncomplicated, even with its checks and balances that ensure compliance with international obligations under the WTO TRIPS agreement, the agreement on trade-related intellectual property rights.
Canada does have obligations related to TRIPS and it is important to respect them. The World Trade Organization's agreement on trade-related intellectual property rights, to which Canada is a signatory, generally prohibits countries from engaging in compulsory licensing for purposes of export.
Canada and other WTO member countries are authorized to adopt regimes like CAMR only as a result of an agreement reached between WTO member countries in August 2003, which waives the restriction that compulsory licensing can only be used for their domestic markets. This waiver sets out strict and limited conditions under which Canada and other exporting WTO members may grant compulsory licences to manufacture and export pharmaceutical products for humanitarian purposes.
It is important to remember that Canada is only one of many nations that have implemented the waiver as part of their domestic legal regimes. CAMR appropriately uses this waiver as the basic framework for Canada's regime. The waiver is also used by other nations as the basis for their domestic law equivalence of CAMR.
The changes to CAMR proposed by Bill C-393 would eliminate all references to the TRIPS agreement and waiver and would eliminate most of the elements of CAMR that help Canada to comply with the applicable conditions governing the issuance of compulsory licences.
The amendments proposed to CAMR in the bill would render the regime non-complied with Canada's WTO obligations as established in the TRIPS agreement and waiver.
Key deficiencies in the proposed amendments, from the standpoint of WTO compliance, include the fact that TRIPS requires the applicant for licence to seek a voluntary licence from the patent owner.
Bill C-393 would repeal the provision of CAMR that requires the prospective licensee to seek from the patentee a voluntary licence to manufacture and sell pharmaceutical products for export. This is inconsistent with the spirit of the waiver, which is intended, where feasible, to encourage voluntary agreements rather than impose compulsory licences.
TRIPS requires that the scope and duration of the licence must be limited to the purpose for which it is authorized. The bill would repeal all limitations on the scope and duration of the compulsory licence, theoretically granting a perpetual and unlimited legal right.
TRIPS requires that a licence should be terminated if and when the circumstances that lead to its issuance cease to exist or are unlikely to recur. Under Bill C-393, absent an application by a patent owner, a licence would only terminate if relinquished by the licensee.
TRIPS requires that the patent owner be paid adequate compensation in the circumstances of each case. Bill C-393 would repeal the CAMR provision that allows the patent owner to seek a higher royalty than the formula established by CAMR, if warranted.
The waiver applies only to pharmaceutical products needed to address public health problems. Bill C-393 would repeal schedule 1 of CAMR, which is the list of eligible products, and would not put in place any limitation on the patented pharmaceutical products for which a compulsory licence may be granted.
The waiver requires all importing WTO members to make a notification to the WTO, specifying the name and quantity of needed pharmaceutical products. Importing members, which are not least-developed countries, must also establish that they do not have the manufacturing capability to produce the pharmaceutical product. Bill C-393 would not require any notification or copy of the notification submitted by an importing country regarding its need for a pharmaceutical product or setting out the quantity required or speaking to manufacturing capacity.
The waiver states that exporting members, like Canada, can only authorize manufacture and export of that amount of product necessary to meet the needs of the importing member and states that all of the product must be exported to that importing member, as opposed to other members or countries. Bill C-393 places no limits on the amounts of product that may be manufactured under the compulsory licence and would permit unlimited quantities of the product to be exported to any eligible importing country regardless of their need.
The issues noted above are only the most obvious problems of Bill C-393 to comply with Canada's international obligations. It is clear that if this bill were to become law, Canada would be in default of its international trade treaty obligations under the TRIPS agreement.
Canada is a well-intentioned country that wishes to provide much needed assistance to countries in need of medicines to prevent or combat diseases such as tuberculosis, malaria, HIV-AIDS and other epidemics. That is why Parliament voted for Bill C-9, the original CAMR legislation. In other words, our intentions were and remain honourable.
In the intervening years, however, we have come to the conclusion that what we had intended, a flow of generic drugs to countries in need, is not happening. We are all in agreement on this point, however, there is a different interpretation as to why CAMR is failing.
There are many things that Canada can and should do through CIDA, and that is where Canada should focus its efforts. That will enable Canada's Access to Medicines Regime, which is part of the solution, to do everything it is supposed to do.
Message from the Senate
The Royal Assent
May 14th, 2004 / 10:05 a.m.
I have the honour to inform the House that a communication has been received as follows:
May 13, 2004
I have the honour to inform you that the Honourable Adrienne Clarkson, Governor General of Canada, signified royal assent by written declaration to the bills listed in the Schedule to this letter on the 13th day of May, 2004 at 6:56 p.m.
Secretary to the Governor General
The schedule indicates that royal assent was given to Bill C-24, an act to amend the Parliament of Canada Act--Chapter No. 18; Bill C-20, an act to change the names of certain electoral districts--Chapter 19; Bill C-28, an act to amend the Canada National Parks Act--Chapter 20; Bill C-15, an act to implement treaties and administrative arrangements on the international transfer of persons found guilty of criminal offences--Chapter 21; Bill C-30, an act to implement certain provisions of the budget tabled in Parliament on March 23, 2004--Chapter 22; and Bill C-9, an act to amend the Patent Act and the Food and Drugs (The Jean Chrétien Pledge to Africa)--Chapter 23.
I also have the honour to inform the House that a communication has been received as follows:
May 13, 2004
I have the honour to inform you that the Right Honourable Adrienne Clarkson, Governor General of Canada, signified royal assent by written declaration to the bill listed in the Schedule to this letter on the 13th day of May, 2004 at 9:10 p.m.
The schedule indicates the bill assented to was Bill C-3, an act to amend the Canada Elections Act and the Income Tax Act--Chapter 24.
Budget Implementation Act, 2004
May 4th, 2004 / 4:45 p.m.
Deepak Obhrai Calgary East, AB
Mr. Speaker, it is a pleasure to speak for the second time to Bill C-30. I am speaking to the bill because it deals with a very important issue, the budget.
Mr. Speaker, I will be sharing my time with my colleague from Dauphin—Swan River.
When the Prime Minister took office after being elected as leader of the Liberal Party, he promised Canadians a new vision that would be different from the previous government. He promised in the throne speech that he would connect with Canadians and offer them an alternative.
We then moved from the throne speech into the budget speech, where, in all honesty, after taking everything into consideration, we saw it as band-aid solution budget. We all knew the Prime Minister wanted to call an election because he was riding high in the polls and he thought the steam engine of the Liberal Party could sweep the country.
Lo and behold, the record of the Liberal government smacked it right in the face, as the member of the NDP just pointed out. The scandal of the management of Canadian taxpayer dollars hit it right smack in the face. What happened? We are now in a holding pattern.
The Prime Minister wants to call an election but he does not know when to call it. The vision he talked about has disappeared. Where will this bill on the budget go? As we all know, we are waiting for the Prime Minister to call an election but he cannot even decide when to call it. Whether it will be on June 14, June 28 or July 5, nobody knows.
The country is now being run in a holding pattern while Canadians wait for important issues to be solved. The last thing on the minds of Canadians is an election. They expect the government to come up with a plan, the budget being one of those plans.
As the critic for international development, I see in the budget that $248 million will go into the international assistance development envelope, which would bring the CIDA budget to over $2.5 billion. People may not know this but CIDA has a budget of $2.5 billion, which is a lot of money, and yet CIDA operates without a legislative mandate. It is left to the mercy of the government or the Prime Minister and politics are being played.
As an international development critic for the last three years, I have seen four ministers at the head of that department and each minister has tried to pass on her or his own ideas and agenda. Why? The reason is that we now have legislation that directs where the money will go. It is left to the whim of the minister and the senior bureaucrats in CIDA. That is why questions keep being raised about where this money is being spent.
Canadians do not know what CIDA is doing. CIDA may have a good international name in countries where it does little patches of work but Canadians do not know where the tax dollars are going in international development. I keep asking that question in the House. Canadians are wondering why emerging economies in countries like China are receiving over $50 million.
Canadians shake their heads about why we are giving a country like China that aid. Every time I raise this question the answer is that there is poverty in China. Yes, we know there is poverty in China. We are very happy to see China as an emerging nation, but China is now in a situation where it has the resources to take care of its people.
Its leaders can take care of its people, but what do they do? They send people into space. They spend all that money for sending people into space. As well, there is an increase in their military expenditures of over 12%. They can do that, yet we stand here and use Canadian taxpayers' dollars and say there is poverty there that we need to address so we have to give them $50 million.
Would that money not be better spent in Africa or in Latin America, in the slums there? I do not understand why and how we can stand up and let the Chinese leaders off the hook. They should be responsible for their own people.
However, this highlights the problem, which I am trying to say is the way CIDA is structured, the way CIDA is operated and the way CIDA is giving out money. The question that comes up time after time is this one: What is happening and where is this money?
Sure, Canadians are very generous. They would like to assist the unfortunate around the world. I am very glad and very proud, and so are members of my party today, to stand up and vote for Bill C-9. I have to give credit to the government for introducing that legislation, but we were the party that was there right away supporting that bill, because we knew Canadians wanted that bill to be supported. That bill is going to give generic drugs to Africa to help in the fight against HIV, malaria and TB. Yes, based on that, we supported it.
However, we need to keep asking this question: Where does the money go?
It is very interesting that the Prime Minister just went down to Washington and made a speech there. He talked about international development assistance, but then what do we say? It is a simple answer: We are giving more money. We are giving more money so we are meeting our commitment to international assistance.
Really, giving more money and using money wisely and effectively is a challenge. It is a challenge unless and until there are structural reform changes that take place in CIDA. Most important, unless CIDA is legislated and is told that these are the areas in which we expect results--i.e., we expect to see money going to poverty reduction or education--only then can we say it is an effective use of dollars. Right now money is spread out as thinly as possible across 105 countries, with every kind of end use, some very good and some excellent, but the result is that nobody is happy.
Then we have CIDA-INC giving money for business ventures. It was proven by my colleague from Cypress Hill, at the time from the Reform Party, that the money was going to the companies with ties to the Liberal Party. The companies took advantage of that.
The bottom line is that while we speak about the budget, while we speak of giving money, it is critically important that the money be effectively spent. That is what Canadians are demanding from the budget.
Let me say very briefly that the budget does not address many of the issues that are most important to people in my riding. What are their issues? Of course one is health care and we are seeing the flip-flops coming out from the government on health care.
Also, I want to say to that New Democratic Party, once and for all, tell us, quote for us, give us the name of who has said for profit health care or private health care. Where did we say that? Tell the hon. member to tell us, Mr. Speaker. The hon. member stands up and blames the Conservative Party, but let her quote from where we have said that.
I also want to say that she knows what our most important issues are, and most important is tax reform, because unless and until Canadians have money in their pockets, only then will that be an effective use of money.
In conclusion, I say we are drifting. We are drifting because of this election and because this Prime Minister and this government have not been able to put forth the vision they promised to Canadians.
May 4th, 2004 / 3:05 p.m.
Order, please. It being 1:04 p.m., the House will now proceed to the deferred recorded division on the motion at third reading stage of Bill C-9.
Call in the members.
(The House divided on the motion, which was agreed to on the following division:)
April 29th, 2004 / 4 p.m.
Jacques Saada Brossard—La Prairie, QC
Mr. Speaker, in view of the extreme popularity of Bill C-9, an act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), I have a request to make.
I would like to ask for the consent of the House to deem the motion for third reading of Bill C-9 carried.
April 29th, 2004 / 3:05 p.m.
Charles Caccia Davenport, ON
Mr. Speaker, in putting forward some thoughts on the discussion of Bill C-9, I would also like to put on the record an observation made yesterday in this chamber by the Minister for International Cooperation, because it seems to me that she made a very important point which ought to be repeated.
She said that the legislation before us in this chamber, namely Bill C-9, otherwise known as the Jean Chrétien pledge to Africa, is one that recognizes, on Canada's part, a “moral imperative”, that is, the imperative that we have to make available those medical treatments that are required, and in African countries in particular, to the millions of people who are suffering from these pandemics, in particular, of course, the pandemic of HIV-AIDS.
That point was elaborated on further by the Minister for International Cooperation with regard to voluntary licensing, when she said that “the amendments eliminate the requirement that patent holders be given the right of first refusal”. That was of course an amendment of considerable significance and importance during the deliberation at second reading.
In the discussion before question period, the member for Palliser made reference to Stephen Lewis, and quite rightly so, because this Canadian at the United Nations has been actively engaged in advancing the cause of helping African countries and the population there with respect to HIV-AIDS on that continent.
Mr. Stephen Lewis made a statement a few days ago which I would like to put on the record because it gives further background as to why we are engaged with this legislation and why we have developed such a unique parliamentary cohesion and unanimity behind it.
On April 6 of this year, in New York, Stephen Lewis, the United Nations special envoy on this matter, made the following statement:
I wish to join today with the legions of activists and advocates in Africa and worldwide who salute the quite remarkable collaboration on the provision of anti-retroviral drugs, jointly announced by The Clinton Foundation, The World Bank, UNICEF and the Global Fund. This initiative...could well spell the turnaround of the...pandemic in Africa.
Simply put, the Clinton Foundation will negotiate the drug prices, UNICEF will employ its procurement capacity, and the Global Fund and World Bank will provide the funding. There will be protocols and administrative requirements, of course, but nothing should now stand in the way of rolling out treatment to hundreds of thousands--soon to be millions--in the immediate future.
The best dimension of all of this is the price tag to be paid. We're talking of fixed-dose combinations of generic drugs, pre-qualified by the World Health Organization, to be purchased overwhelmingly from generic companies...at prices as low as $140 per person per year. It falls entirely within the World Trade Organization consensus agreement negotiated on August 30th, 2003. And it puts to rest the self-defeating jousting between generics and brand name pharmaceuticals. Clearly, when you have the power, the imprimatur and the dollars of the Clinton Foundation, World Bank, UNICEF and Global Fund weighing in behind generics, the debate is over. These four bodies make it clear in their statement that brand name companies are free--indeed, invited--to tender, and to meet the low prices. But it's equally clear that huge numbers of African lives will be prolonged and saved by generics...generic drugs at one-third to one-half the cost of the patent drugs. Just think of how much further the money will go.
Mr. Lewis concluded by saying:
This is all tremendously exciting, and it will be made even more so if WHO finally receives the seed money it needs--$200 million over two years--to help to coordinate the interventions at country level, to train the tens of thousands of additional people, to provide the emergency technical assistance, to keep the drug supplies flowing and to address the ongoing problems of infrastructure. In a phrase: to achieve 3 by 5.
Namely, that would be putting three million people into treatment by the end of 2005.
It seemed to me quite appropriate to put this statement by Stephen Lewis at the United Nations within the larger context of the Jean Chrétien pledge to Africa, namely Bill C-9, because it fits perfectly in it and it also gives us a broader picture as to why we are all engaged in this global effort, which is really bringing out the best in humanity and definitely appeals to the basic and most positive constructive sentiments that inspire the global community in every country.
I would like to congratulate the government for having persisted in bringing the bill to a happy conclusion despite all the technical difficulties. We look forward to third reading approval and to the speedy processing of it by the Senate so that it can be promulgated at a very early date.