Bill C-398 (Historical)

An Act to amend the Patent Act (drugs for international humanitarian purposes)

This enactment amends the Patent 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The House resumed consideration of the motion that Bill C-398, An Act to amend the Patent Act (drugs for international humanitarian purposes), be read the second time and referred to a committee.

[Chris Warkentin, Conservative, Peace River, AB]

Mr. Speaker, I am pleased to have the opportunity to speak to Bill C-398, An Act to amend the Patent Act (drugs for international humanitarian purposes), which aims to modify certain fundamental aspects of Canada's access to medicines regime.

I join many members of the House in viewing the regime as a key component of Canada's long-term, multi-faceted approach to addressing the serious public health problems that affect many low and middle-income countries. However, this is only one weapon in the arsenal Canada has put together to fight disease, to provide access to medicines and to improve health conditions in the developing world.

In addition to our access to medicines regime, Canada makes significant contributions to global mechanisms for the procurement of low-cost drugs to respond to the needs of the developing world. Canada continues to provide leadership in the global fight against diseases such as AIDS, tuberculosis and malaria. Canadians are proud to have invested more per capita than any other country, according to the global fund.

Our comprehensive approach combines prevention of the spread of disease in co-operation with international partners to increase the impact of our funding and lower delivery costs; leadership, through initiatives such as the Muskoka initiative, to improve the health of children and mothers; and innovation to provide the right climate for the development of new medicines and treatments. Our strong track record of support also includes being a founding donor to the global drug facility, being the single largest donor of first-line tuberculosis drugs and working with the Gates Foundation to advance the HIV vaccine.

We embrace the bill's laudable objectives of improving public health in the developing world. However, it would not accomplish this goal.

Independent experts have testified that it would not benefit those in need. It cannot change the fact that there is a demand for lower-cost generic drugs from emerging markets. For instance, India produces 80% of the antivirals funded by countries such as Canada for the developing world. The bill would eliminate many of the checks and balances that were built into the current regime to prevent misuse, which could harm researchers who have invested their energy and know-how into developing new life-saving drugs. The approach suggested in the bill would hold back continued pharmaceutical investment here in Canada and reduce the type of new and innovative therapies being brought to the Canadian market.

Finally, many of the bill's proposed changes are not in keeping with the spirit of the World Trade Organization decision on which Canada's access to medicines regime is based. This decision was designed to provide access to countries facing health emergencies but lacking the means of acquiring needed medicines. The intention of the decision was to remove patents viewed as a barrier to the supply of drugs needed to address public health issues in developing nations. The decision brought together divergent stakeholder views to come up with the appropriate response to public health issues in the developing world, while at the same time respecting intellectual property protections. It was viewed as just one part of the broader international strategy to combat diseases that impact the developing world, a strategy to which Canada has been a key contributor.

In the end, the decision achieved the unanimous support of all members of the World Trade Organization. The World Trade Organization decision ensures that patent rules do not preclude the manufacturing and exporting of cheaper generic copies of patented medicines to the developing countries facing public health emergencies. The international consensus was that it was important to have safeguards to guarantee that the system would only be used for humanitarian purposes and would not be used and diverted for unintended purposes.

Canada's access to medicines regime incorporated all the key elements required by the World Trade Organization decision. It provides a framework for countries to access less expensive generic versions of patented drugs. It also respects Canada's domestic intellectual property framework.

Why is a stable and predictable international intellectual property regime important in Canada?

Intellectual property protection provides incentives for companies to invest in research and development into new and innovative drugs and medical devices. This research and development benefits all Canadians by improving our knowledge, generating research infrastructure, creating more highly paid, skilled jobs in Canada and leading to innovations that will help people live longer, healthier and more productive lives.

The protection and promotion of patents and innovation in the domestic pharmaceutical sector is also key in achieving this government's international humanitarian objectives. The generic industry relies on its brand name competitors to innovate in order to have the products to copy and to sell here in Canada and abroad.

Bill C-398 would interfere with the balanced approach of Canada's access to medical regime and make Canada a less stable, less reliable and less welcoming place for those people who want to invest and innovate.

There are clear reasons to believe that the proposed amendments would be inconsistent with Canada's trade obligations and harm our relationship of trust with our international trading and research partners.

The provisions of the Canadian access to medicines regime were carefully considered, designed and implemented to comply with the World Trade Organization rules. The intention of these rules was to address serious health issues in low and middle-income countries and not to create a system of exporting an unlimited amount of medicines for any reason without the proper checks. These rules require that countries have to notify the World Trade Organization of their intention to use the system. Bill C-398 would remove this requirement and, along with other proposed changes, would alter the intended purpose of the regime. It would also remove the mandatory safety reviews by Health Canada that are currently required.

Canada's approach has a proven track record of improving access to treatment and health care delivery. Together, the global efforts that Canada supports are producing significant results. The supply of lower cost medicines has increased as has their ability to those in need. I will give one example. According to the World Health Organization, nearly eight million people living with HIV in low and middle-income countries are now receiving HIV antiviral treatment.

Our government continues to support an access to medicine regime with the proper checks and balances, that respects our international obligations and serves as one essential part of a comprehensive approach to improving health and fighting diseases in developing countries.

For those reasons, I urge all members of the House not to support Bill C-398.

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

moved that Bill C-398, An Act to amend the Patent Act (drugs for international humanitarian purposes), be read the second time and referred to a committee.

Mr. Speaker, it is a somewhat emotional moment for me to see debate begin this evening on Bill C-398, the purpose of which is to reform Canada’s access to medicines regime. Essentially, this bill could save hundreds of thousands of lives. I am therefore really very honoured.

This is not the first time that the House has had the opportunity to discuss a bill of this type, that is, a bill relating to Canada’s access to medicines regime. It may therefore be worthwhile to review the history of that regime. In 2004, the House of Commons unanimously adopted Canada’s access to medicines regime, in response to World Trade Organization decisions designed to ensure that patent legislation did not prevent the developed countries from doing their basic humanitarian duty and providing medicines to people in the most disadvantaged countries, who are in desperate need of them.

Unfortunately, in the years that followed, we realized that the system approved in 2004 was not working, because there were all sorts of obstacles and problems with its basic model.

In fact, during the first attempt at using CAMR, Canada's access to medicines regime, people rapidly realized that there were too many roadblocks that were not foreseen when the original law was drafted. There was basically too much red tape preventing it from functioning.

And so it was decided that something had to be done to make sure that Canada’s access to medicines regime did what it was meant to do. Accordingly, in 2009, the first bill to reform Canada’s access to medicines regime was introduced. It is important to note that the bill had widespread support at the time.

Tens of thousands of citizens signed a petition supporting the bill. A poll revealed that 80% of Canadians approved of the bill. Civil society rose to the challenge and numerous organizations, some of which are here this evening, started speaking out and working very hard in support of the bill. Finally, MPs from all parties united in the House of Commons to approve the bill. Unfortunately, it died on the order paper.

As my mother would have said: “Measure twice, cut once.” That is why we have to get back to work on this today and put this bill back on the agenda. We have to do it because this is a necessary bill, one that so many people are hoping for.

In the last few months I have met numerous actors. I have talked to loads of people concerned with this issue. I have met with brand name and generic pharmaceutical companies. I have met with citizens; with civil society organizations; with people active in the field, working in Africa, for example; and with MPs and senators. I can say that I am really confident that together we can achieve this. We can reform CAMR and make it work.

The essential point is that reforming Canada’s access to medicines regime is a win-win situation. The pharmaceutical companies win, of course. They gain access to new markets—markets, it is important to note, that are of little or negligible importance to the biggest pharmaceutical companies. Africa, for example, represents only 2% of the big pharmaceutical companies’ sales. This is a win for generic drug companies.

The big pharmaceutical companies also win because they are making a social contribution. That is important. I know it is important to them and they are committed to this. They lose very little, because we are talking about markets that hold little value for them, as I said, and they receive royalties.

Canadian taxpayers also win. They win, first, because the bill will not cost them a single penny. As someone said, the only cost associated with the bill is the electricity for evenings when we sit like this and discuss the bill. However, they win at an even more basic level, because this bill will mean that more can be done with our very limited development assistance resources.

As has been said, it is very simple: the generic drug companies will allow medicines to be supplied that will be cheaper, much cheaper, because the competition the generic companies engage in, in the markets, is the biggest factor in reducing the cost of medicines; in fact, this factor can reduce costs by up to 95%. That amounts to an enormous figure. So we can do a lot more with the same amount of money, and this in turn will make our co-operation much more effective.

I have lived in Africa. I have seen the effect these diseases have on people. We are talking about AIDS, but also about tuberculosis and malaria. Those diseases do not just destroy lives; they destroy families and communities. They are often the main factor holding back development in these countries. If we want the money we invest in international aid to be effective, it is absolutely essential that we use this tool to help combat these public health crises.

The pharmaceutical companies and Canadian taxpayers win, but ultimately, and most importantly, let us not forget that people in the developing countries win, human beings who are in desperate need of these medicines.

We must remember that sub-Saharan Africa is the region most affected by the AIDS pandemic and more often than not does not have the resources to deal with it. Sub-Saharan Africa is where 90% of the children in the world who have AIDS live, and one child in two born with HIV will die before their second birthday.

We are talking about tens, hundreds of thousands of people who are waiting for this aid, people for whom it will make things enormously better.

This also highlights the fact that the functioning CAMR would contribute significantly to the government's child and maternal health initiative and would stretch our aid money by providing low-cost medicine to the people who need it most. I think it is really a win-win situation for everyone.

We can reform CAMR and make it work. If we can do it, then we should do it because it will save lives.

We can do it by working together and listening to all the Canadians who have already stood up, who have been standing up for years, to say this is the right thing to do, it is what they want their representatives to do.

In fact, on the question of the contributions by Canadians and Canadian organizations all across the country, I cannot fail to mention the extraordinary role played by so many individuals and organizations that have put all their energy into supporting this private member’s bill.

I am thinking in particular of Richard Elliott of the Canadian HIV/AIDS Legal Network, and Pat Evans, Bonnie Johnson, Andrea Beal, Bev McGibbon and Norah Menzies of the Grandmothers Advocacy Network, also known as GRAN.

I am talking about Meg French and Carleen McGuinty of UNICEF.

I am talking about of Tara Fischer and Robin Jackson of the Canadian Federation of University Women.

I am talking about Anne Gardiner of Bracelet of Hope, and Pastor James Qhobela of the Apostolic Faith Mission Social Development Division of Lesotho and his wife, who I had the pleasure of meeting.

I am talking about Ariane Cartwright of Results Canada.

I also want to express special thanks to the Association québécoise des organismes de coopération internationale, or AQOCI, and its executive director, Gervais L'Heureux, for their support. Thanks to support like that from partners and from tens of thousands of Canadians who have stood up and called on their representatives to approve this bill, we can do it. We can reform Canada’s access to medicines regime and we can save lives, in the interests of us all.

Access to Medicines

[Dominic LeBlanc, Liberal, Beauséjour, NB]

Mr. Speaker, I am happy to rise today and present a petition given to me by a group of grandmothers and others from New Brunswick, the Sackville and Tantramar area of my constituency. These people have done a lot of work in bringing the issue of access to medicines, particularly in Africa, to the attention of parliamentarians. They are calling upon Parliament to support Bill C-398, which would improve access to many of these medications. It is legislation I have always supported.

I am happy to present this petition on behalf of a group of great people from my constituency who have collected signatures from all over the Maritimes in support of this important bill.

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

Mr. Speaker, I rise today to present a petition on behalf of Canadians, most of whom are from the beautiful city of Saskatoon, calling upon the government to support Bill C-398.

Health

[Kevin Lamoureux, Liberal, Winnipeg North, MB]

Mr. Speaker, it is with pleasure that I table a petition in support of Bill C-398. The advocacy group network, known as the Grandmothers, has been circulating the petition and asking members of Parliament to table it.

The petition highlights the fact that millions of people die needlessly each year from treatable diseases, such as HIV-AIDS, TB and malaria. Half of the people who require treatment for these diseases are not able to receive it because of the cost of medication.

HIV-AIDS

[Pat Martin, NDP, Winnipeg Centre, MB]

Mr. Speaker, I have a petition signed by hundreds of constituents of my riding put together by the Grandmothers Advocacy Network.

The petitioners point out that millions of people in sub-Saharan Africa are dying of HIV-AIDS and that Canada's Access to Medicines Regime has been stalled and is not operative.

Therefore, they call upon Parliament to pass Bill C-398, which is currently before the House, to make necessary amendments to the Canada's Access to Medicines Regime to get drugs flowing to HIV-AIDS victims of sub-Saharan Africa.

Access to Medicines Regime

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

Mr. Speaker, I am presenting a petition from 65 of my constituents from Saskatoon. The petitioners want to draw the government's awareness to the many men and women in sub-Saharan Africa who have died from HIV-AIDS, leaving millions of children orphaned.

The petitioners call upon members of Parliament to support Bill C-398, a bill which would reform Canada's access to medicines regime to make life-saving generic medicines more available to those countries in sub-Saharan Africa.

Patent Act

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

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

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

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

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

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

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

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

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

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