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.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Mr. Chairman, before we proceed with clause by clause consideration, if you don't mind, I would like to start by thanking Committee members.

As you know, I am not a regular member of this Committee. I want to extend my deepest thanks to all of you for the work we have been able to accomplish. I also want to thank the analysts and the clerk for their cooperation throughout this study.

I would just like to remind you, Mr. Chairman, that when we heard from officials at the Committee's first meeting, I pointed out that in examining Bill C-393, it would be important to look at the issue as a whole. I suggested considering an approach based on the model in Bill C-393, of course, in order to take advantage of APOTEX's experience with Rwanda. I suggested we take a look at our approach to be sure we could really help people, specifically in Africa, where they have a greater need for medications to treat HIV/AIDS.

At the time, I gave you a fairly extensive witness list. I want to thank you for trying to accommodate as many witnesses as possible so that, in a way, both perspectives could be heard.

However, now that we have heard from these witnesses, we are going to be moving to the next steps in this process, which means carefully considering the testimony we heard in order to find appropriate solutions. On the very first day of testimony, when we heard from officials, it was clear that, in their opinion, Bill C-393 was not the ideal solution, because a number of parameters had been defined in the bill with respect to our international commitments. That is something that should be preserved.

However, considering how the system has been used, we clearly have a 100% success rate. It was used there once and it worked well. It is clear that the goal of many of the witnesses we heard from, including those representing the National Action Committee of the Grandmothers-to-Grandmothers Campaign, who were here at our last meeting, was for more medications to be made available. So, I think there is good reason to review the system, all the commitments that have been made and the resources available to Canada to do more and do better.

Mr. Chairman, I know that the mandate of this Committee, both today and throughout this study, was to examine Bill C-393. I also know that the Committee has a full schedule, and that its work plan includes several bills and committee studies that have yet to be addressed. At the same time, however, I think we need to take the time to report the testimony we heard to the House and put down in writing some of the representations made as part of that testimony. That way, it would be possible to look for ways to improve the system while still keeping the current framework, and draft a list of irritants. We could also include in that report what is currently being done, as well as what we are suggesting in order for Canada to do better and do more.

I would like to repeat what representatives of the National Action Committee for the Grandmothers-to-Grandmothers Campaign said to us at the last meeting. They said that they had been to Africa, that they had seen a certain number of things, that they had made commitments to the grandmothers of Africa and would report back on what the House of Commons and the Committee decided to do for them. So, I think it would be sad if, upon completing our examination of Bill C-393, we simply closed our books and moved on to something else, without trying to go a little further.

Given the comments we've made and what we can do in relation to Canada's international obligations as a signatory, I think it would be rather sad if we didn't make the effort being asked of us, which is to refer this issue back to the House.

Thank you very much for your attention, Mr. Chairman.

[The Chair, Conservative, David Sweet]

Good morning, ladies and gentlemen.

Bonjour à tous. Welcome to meeting number 41 of the Standing Committee on Industry, Science and Technology.

We are going to be doing a clause-by-clause review of Bill C-393 today.

Before I begin, I'd like to introduce our experts from the public service who are with us today. We have with us Colette Downie, director general, marketplace framework policy branch, Department of Industry; Rob Sutherland-Brown, senior counsel, legal services, Justice Canada; and Mona Frendo, director, patent and trade-mark policy directorate, Department of Industry. From the Department of Foreign Affairs and International Trade, we have with us Edith St-Hilaire, director, intellectual property, information and technology trade policy division. Finally, from the Department of Health, we have Lisa Lange, associate director, bureau of policy, science and international programs, therapeutic products directorate.

Thank you very much for joining us today and giving us your expertise as we proceed to this bill.

Mr. Wallace.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Okay. All right.

Mr. Schwartz, there are different interpretations as to whether C-393 would result in a violation of our TRIPS agreements, and we've heard different people say it does and others say it doesn't. I believe you fall into the camp that says that we could be challenged on it. You spoke about article 31, and you spoke about the waivers associated with pharmaceuticals in certain cases.

I'd like to get a little bit more of a feeling. Let's say we have a situation where Canada is challenged. Let's say C-393 is accepted and we are challenged. What are the practical implications for a country like Canada? Intellectual property is pretty dry stuff. But for Canadians, I think it's important for us to understand the implications if somebody successfully challenges Canada on a violation of the TRIPS agreement.

[David Schwartz, Chair, Biotechnology Patents Committee, Intellectual Property Institute of Canada]

Thank you, sir. Bonjour, and good morning.

My name is David Schwartz. I'm a lawyer and a patent agent. I'm a partner in the firm Smart & Biggar, and I appear here today on behalf of my professional association, the Intellectual Property Institute of Canada, or IPIC.

I'm pleased to appear before you today on behalf of IPIC.

IPIC is the professional association in Canada of patent agents, trademark agents, and lawyers practising in all areas of intellectual property law. I'm the chair of IPIC's biotechnology patents committee and appear here today in that capacity. I have practised exclusively in the patent field for 17 years. My technical background is in genetics and my work principally involves assisting inventors in obtaining patent protection for their innovations at the Canadian patent office and those of other countries.

I hope I can provide some contributions to the very thoughtful and informed discussion we've heard this morning.

It's accepted that innovation is important to the economic and social well-being of our country. Patent legislation is a key element of any country's innovation system, and this legislation must achieve a fine balance between competing policy goals and must conform with a number of international treaties.

IPIC's expertise is in intellectual property law and not the manufacturing of medicines or the policy concerning assistance to developing countries. Our submission, therefore, is limited to studying the compliance of Bill C-393, in the form that we've seen it so far, I would emphasize, with the TRIPS agreement, and its possible effect on the patent system in Canada and elsewhere.

The TRIPS agreement of the WTO sets out agreed minimum standards for the protection of intellectual property rights. Member states may therefore provide more extensive protection than required by TRIPS, but they're not permitted to establish laws that provide less protection than required under the TRIPS agreement.

To use a very simplistic analogy, consider speed limits in school zones. If a provincial law, a law of Ontario, requires that the speed limit in a school zone be no more than 40 kilometres an hour for safety, the City of Ottawa would be permitted to lower the speed limit to 30 or 35 kilometres an hour, but we couldn't raise it to 50. I am going to come back to that point toward the end of my comments.

Article 31 of TRIPS provides for use of a patent invention by someone other than the patentee without the authorization of the patentee, in certain circumstances. Now importantly, paragraph (f) provides that the use of the invention shall be authorized predominantly “for the supply of the domestic market”. That would mean Canada. There are also requirements about remuneration of the patentee in the domestic market. These requirements are problematic for those countries that don't have the manufacturing capacity or technical expertise in their own markets, that is, in their own countries, to make and use a patented invention, even if they had the authorization to do so.

So the general council decision of the WTO in 2003 implementing paragraph 6 of the Doha declaration provides a solution to this problem—and I know we've already heard about it this morning. It waives paragraphs (f) and (h) of article 31 for pharmaceutical products in certain circumstances and sets out the requirements of a country, typically a least-developed or developing country, to import patented medicines under the waiver. The general council decision is, of course, implemented in Canada in the Patent Act as CAMR.

I emphasize these two points because the Canadian legislation must therefore comply with two significant aspects of TRIPS. First, there must be requirements for the rest of article 31 that wasn't waived. Second, the waiver of paragraphs (f) and (h), if it's to be used, must be done in accordance with the requirements of the general council decision, which is that it be used in good faith to protect public health, and not as an instrument to pursue industrial or commercial policy objectives. This purpose would be defeated if products supplied under the decision were diverted from the markets for which they were intended. Accordingly, all reasonable measures are to be taken to prevent such diversion in accordance with the relevant paragraphs of the general council decision. These overarching principles are explained in the chairperson's statement that was associated with the general council's decision, which I'm effectively quoting from.

If the Canadian legislation is not in compliance with TRIPS, the legislation is at risk of being challenged under the WTO dispute settlement procedure. Twice already, both times in 2001, it has been necessary to amend Canada's Patent Act as a result of challenges by other countries, where the WTO found that our law was not in compliance with TRIPS. In one instance, the challenge involved a complaint by the European Union about our stockpiling provisions, which Mr. Dearden mentioned. There was another instance, also in 2001, where we amended the act to change the term of patent protection after a complaint by the United States. So twice already we've amended our act in recent years because of complaints.

Objections in an international forum that our Patent Act doesn't comply with TRIPS create uncertainty and may diminish Canada's reputation as a country that respects IP rights, negatively affecting domestic and foreign investment in research and development. Thus, in our view, it is important that CAMR be compliant with TRIPS, so that it does not invite objections as described above.

This involves not only ensuring that the black-letter provisions of article 31 and the general council decisions are met, but also ensuring that the procedural aspects of the legislation provide the appropriate, practical safeguards to ensure that the purpose and intent of the waiver set forth in the general council decision is met.

To return very briefly to my speed limit analogy, sure, we can set a speed limit of 35, but if we don't inform the public of the speed limit, if we don't post signs, and if we don't have police to monitor the speed, then the limit is really, for practical purposes, not effective. So we have similar concerns with respect to some aspects of C-393.

To conclude,C-393 has clearly created debate. We've learned that this week and last week, and it has raised awareness about very important issues. However, as you'll see from our very detailed written submissions, we have concerns with respect to the bill's compliance with TRIPS and the general council decision, and we've identified some patent-specific issues as well.

Thank you for inviting us to appear.

Thank you for inviting our association to appear here, and I'd be very pleased to address any questions you have today.

Thank you.

[Jim Keon, President, Canadian Generic Pharmaceutical Association]

Thank you, Mr. Chair.

Thank you, ladies and gentlemen.

We're pleased to have the opportunity to speak to Bill C-393.

I represent the generic pharmaceutical industry, which has been an important part of the Canadian economy and health care system for more than 50 years. We are fortunate to have a large and sophisticated generic drug industry in Canada. Today it directly employs approximately 12,000 Canadians in high-skilled manufacturing and R and D positions.

Most of the generic drugs sold in Canada are manufactured in world-class facilities right here in Canada. The largest drug company in Canada, brand or generic, is Ontario drug maker, Apotex. The largest drug company in Quebec, brand or generic, is Pharmascience, also a generic.

Our industry fills six out of ten prescriptions in Canada today, and that number is growing quickly. There has been talk recently about the price of generic medicines in Canada and the ability to supply good-quality medicines at good prices abroad. Generic prices in Canada have traditionally supported pharmacy strongly. That system is changing. Provincial governments are changing that system. Generic drug prices in Canada have come down dramatically over the past year, as pharmacy funding is now being looked at in a different manner. Generic drugs have provided value for the Canadian health care system and are providing better value than ever.

In addition, Canadian generic drug makers actively support international humanitarian aid efforts. CGPA member companies are among the leading donors to Health Partners International of Canada, a non-profit relief and development organization that works through other partnerships to increase access to medicine and improve health in the developing world.

Our members are also active more recently in relief efforts in Haiti, donating millions of dollars worth of medicine through organizations like World Vision, Feed The Children, and Health Partners International.

This committee is studying a particular mechanism aimed at delivering drugs for humanitarian purposes to the developing world, Canada's access to medicines regime. The World Trade Organization decision, which is a decision of 120 countries, that led to the creation of CAMR, is a result of international recognition that the needs of the developing countries were not being met solely by the brand-name industry. Brand companies were generally unwilling, without competition, to lower their prices for drugs under patents to levels that these developing and least-developed countries could afford. That's why the international community came together and developed the so-called Doha agreement.

CAMR provides a legal and regulatory mechanism under which generic manufacturers in Canada are permitted to develop, produce, and export medicines covered by domestic patents to developing and least-developed countries for humanitarian purposes.

We've heard about some of the complexities of the regime, and we know that despite those, Apotex has developed and produced two shipments of its triple combination AIDS drug, Apo-TriAvir, to Rwanda. Unfortunately, the company has publicly stated that it will be difficult to use the regime again without changes being made.

There has been a lot of discussion this morning about whether CAMR works in its current form. The Canadian Generic Pharmaceutical Association's answer is no. Apotex's answer is no.

The problem with CAMR, which makes it ultimately unworkable, is the licensing scheme. The WTO decision that led to the creation of CAMR outlines four basic requirements that need to be met for an exporting country to grant a compulsory licence to a generic manufacturer, and these could have more easily been implemented by Canada. Instead, the CAMR licensing process is backwards; it is largely a process controlled by the interests of intellectual property rights holders and not the interests of those who desperately need access to life-saving medicines in times of health crises.

As outlined in our brief, CGPA supports the changes to the Patent Act that are outlined in Bill C-393. In our view, the streamlined application and licensing process in the bill embodies the spirit of the Doha declaration and the WTO decision, while at the same time ensuring Canada's compliance with its TRIPS obligations.

We have one issue with the bill, and that relates to the proposed amendment to the Food and Drugs Act that would allow for foreign drug approvals under CAMR. In our view, this is not necessary, and it's not supported by our association. The generic pharmaceutical industry continues to support a Health Canada approval.

With that, I will conclude my remarks, as I'm sure you will have several questions for the panel. I would be pleased, along with my colleague, to answer any questions you may have regarding Canada's access to medicines regime.

Thank you.

[Dr. Frank Plummer]

Good morning again.

My name is Frank Plummer. I'm the scientific director of the National Microbiology Laboratory in Winnipeg and the chief scientific officer with the Public Health Agency of Canada. I'm also a distinguished professor at the University of Manitoba and a physician scientist who has spent his career working on HIV and AIDS in Africa. It is in those latter capacities that I'm appearing before the committee today.

I would like to thank the committee for soliciting my input and giving me the opportunity to talk about some of my work and, moreover, allowing me to appear from Seattle. I'm attending an important meeting of the Gates grand challenges in global health program, which I couldn't afford to miss.

I'd also be remiss if I didn't thank the Gates Foundation for the gracious loan of their video conferencing facilities.

I know the committee is reviewing legislation to make Canadian-made generic drugs still under patent by non-generic pharmaceutical companies more accessible and affordable for developing countries, and that the original legislation was targeted largely to antiretroviral therapy for HIV.

First I'd like to tell the committee about some of the amazing work Canada has done related to the HIV epidemic in Africa. I lived in Nairobi for 17 years, directing a highly acclaimed collaboration between the universities of Nairobi and Manitoba. The research done through this collaboration was among the first to recognize that HIV was widespread in East Africa and did pioneering work to understand the epidemic and how to prevent the transmission of HIV.

As committee members will know, HIV is transmitted primarily through heterosexual relationships in Africa, and it also spreads from mother to newborn child. Through research funded largely by the Government of Canada, we learned that commercial sex is a key driver of the HIV epidemic. Ordinary sexually transmitted diseases such as gonorrhea and chlamydia promote HIV transmission. Circumcision of men reduces their susceptibility to HIV, and breast feeding is an important risk factor for transmission of HIV from mother to child.

Each of these understandings was translated into effective interventions by our group and ultimately changed global health policy. They make up the core of effective HIV prevention in Africa and elsewhere. Many tens of thousands of people don't get HIV infected each year because of this foundation work done by the universities of Manitoba and Nairobi and funded by the Government of Canada.

This long-standing collaboration and my involvement in it continue. This year we celebrated our 30th anniversary. In recent years the research work of the collaboration has focused on understanding natural immunity to HIV. This work, which may discover how to make an HIV vaccine, is funded by the Government of Canada and the Bill and Melinda Gates Foundation, which is why I'm here in Seattle today.

The work is carried out in a state-of-the-art laboratory complex built and equipped with a grant from the Government of Canada through the Canada Foundation for Innovation. So Canada has done and continues to do a lot in the fight against HIV and AIDS in Africa.

Now to Bill C-393. It is beyond my competence to comment on whether the current legislation and proposed amendments to it are problematic or not. I know there's been criticism of the effectiveness of the current program and only one country has yet accessed it. However, I doubt that the structure of the Canadian program has anything to do with why it's not being used. I think most likely the original, well-intentioned program was overtaken by events. The global fund to fight HIV, tuberculosis, and malaria, the U.S. PEPFAR program, the President's emergency plan for AIDS relief, the availability of high-quality antiretrovirals from generic manufacturers elsewhere, and drops in the price of non-generic drugs all contribute to a lack of interest in the Canadian program, and that's seen with other programs of a similar nature around the world.

Unfortunately, you were unable to hear from my colleague, Dr. Kimani from Nairobi, but it's his experience that availability of antiretroviral drugs is not the real problem. The ability to deliver high-quality treatment programs with qualified personnel is more of a problem.

While I'm certainly supportive of making antiretroviral drugs available to those who need them, I would also remind the committee that the current antiretroviral drugs are not cures. Importantly, they prolong life; however, it's my belief we will not solve the HIV pandemic by treating AIDS. People are becoming newly infected with HIV at a far greater rate than they are being put on treatment. Furthermore, treating AIDS is many times more expensive than preventing an HIV infection. We know how to prevent new infections effectively and inexpensively, and in my view, far too little emphasis and investment has been put into simple preventive strategies that we know work. We also need to focus research on technologies to prevent HIV transmission such as a vaccine or a microbicide.

I'll close there with a thank you for asking me to speak to you today, and for your attention. I look forward to your questions.

[Robert Bouchard, Bloc, Chicoutimi—Le Fjord, QC]

You're talking about voluntary measures. You also said, Mr. Williams, that there's room for improvement. Aside from the amendments set out in Bill C-393, what changes could remedy CAMR's shortcomings?

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

I would ask that maybe the research providing the testimony from Apotex, which was provided in the Senate with regard to Bill S-232--because they did answer on that--be distributed. That may be the next best thing we can get, because it is official, on-the-record testimony under the same rules as that of the House Commons.

Ms. MacLean, you made me smile when you talked about the watch, because that was one of the things we were told. I've heard these condescending arguments about “oh your intent is good”, and “if you just understood things a little bit better....” It diverts people from the real issue, which is that Parliament decided there was a role for the private sector to play with regard to this human catastrophe we have across the globe. We, as the public sector, could continue to do, and should do, some other things, such as what Mr. Williams was suggesting, and as common global citizens we could use public sector money to build that infrastructure. But the legislation is set up with the intent, and to recognize, that the members of the private sector, especially given the fact that they get generous research and development and a series of other tax breaks, could actually expand the usage of those terrific breakthroughs. We thank them for the work they're doing, and as long as that information was protected and respected, we would develop a system to expand the use of patents across the globe.

Mr. Perry, we've had only one case so far with Apotex. Say, for example, Bill C-393 went through and we had five per year that were granted from there on. I'm speaking hypothetically. Would that drive away investment from your company, from Canada, because the usage of that went further?

[Linda Watson]

I'd like to answer them all, but I will start by saying that I don't believe, with all due respect, that voluntary donations are an answer. Mr. Williams has quoted that something like $235 million worth of product has been donated by brand-name pharmaceuticals since 1990. When you divide that by the number of years and the number of companies, that's $265,000 a year. That does not substantially address any issue in the southern world.

Second, preferential pricing would still only bring prices down to one-quarter of the price in the developed world, whereas generic competition has dropped the prices 17 times over against brand-name prices. The generics have to be part of the picture. It's not an option. That's where the action is. That's what's saving lives right now.

Also I just have to take issue with some of the comments. I believe it was Mr. Williams who said that he regretted that time was being wasted on Bill C-393 when we could be spending our time more fruitfully coming up with answers to some of the other kinds of issues of infrastructure and sanitation and all those sorts of things. I believe the House of Commons is the body that decided Bill C-393 was deserving of the attention of this committee, and we are doing House of Commons business, the business of Canadians, and it's right that we do it well.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

I want to begin by saying to Mrs. Rennie that her testimonial was very moving, and the part I remember the most was her comment that this can only be solved if we increase the supply of medicines to those who need them.

I've had the pleasure of having the Grandmothers for Africa twice in my office during the past year. I had two grandmothers, so I know how powerful grandmothers can be. I want to say again, with respect to the intent, I share that intent 100% to get those medicines to those who need them.

I'm an engineer. I think in very Cartesian terms, and I'm saying to myself, some people are saying that CAMR doesn't work as written and we need Bill C-393. Other people say it does work and we don't really need to focus on that, but rather we should be focusing on all of the other challenges with respect to infrastructure and other matters, which I think you probably agree with, that all those other things also need to be addressed.

But as part of my trying to understand this argument, it's very difficult for me to understand who is right, because the positions are diametrically opposite in many ways. I dearly wish that Apotex had been here this morning. It's very unfortunate they're not here, because I had some definite questions to ask them.

Given that they're not here, I'm going to ask my questions to Mr. Perry and Mr. Williams, and I'm coming back to this issue. Under current CAMR rules there's been one case, the Rwanda case, and Apotex was involved. I want to hear again, because this timeline is really confusing me. It was 68 days that was supposedly required for the three providers of patent medicine to grant a voluntary licence to Apotex. Then it took a year for the medicines—supposedly 15 million pills were authorized—for the first batch to get there, and then another year for the second batch.

I'm trying to understand why, when it appears that the process worked well in terms of granting of the voluntary licence, it took a year to get the medicines over there. I'd like to understand that a little bit better, so I'd like to hear your interpretation. I wanted to ask this question of Apotex, but they're not here. I'd like to ask Mr. Perry and Mr. Williams what their view is of that.

Mrs. Rennie and Mrs. MacLean, I'd be glad to hear your views too.

[Laurence Dotto, Director, Government and External Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)]

Thank you.

I'm very happy to be here today. I have been volunteering in Africa for eight years through our family-focused charity that provides assistance to women and children in Malawi. So far, we have successfully completed more than 15 local sustainable development projects, which were mostly health-oriented.

When I first visited Malawi, in 2003, access to HIV testing was extremely limited. Companies like Abbott provided free screening tests, but administering those tests was always an issue.

Today, fortunately, testing is much more widespread. There are HIV treatment programs in rural areas, and most small hospitals have now set up HIV programs with trained volunteer counsellors, paid counsellors, and are receiving antiretroviral drugs through several NGOs.

Today, the drug supply issue has essentially been solved in many of these countries. Generic HIV drugs are starting to stream in from India and South Africa. Hospitals today are receiving free HIV drugs and free antimalarial drugs through these NGO government partnerships.

In my view, the biggest challenge facing countries like Malawi today is a continuing absence of health care infrastructure. There's only one doctor for 50,000 Malawians and one nurse for 20,000 people. As well intentioned as Bill C-393 may be, it does not address the real challenges, the core issues of poverty, education, nutrition, and access to basic health care faced by less developed countries.

In my view, if Canada were to make a serious contribution to the fight against HIV/AIDS in Africa, here are a few priorities to consider: greater support for prevention of mother-to-child transmission counsellors who go from village to village and counsel and test pregnant mothers; more mobile health clinics to travel to the villages; and how about transportation funds to allow an HIV-positive mother to take that minibus to an ARV clinic that's two days' walk away from where she lives?

Programs to identify HIV-positive children are urgently needed so they can find their way to a treatment program. With 80,000 HIV-positive children in Malawi and only a few hundred in Canada, what could be more important than trying to support the Malawi of tomorrow?

In my view, these are the real needs and these are the practical ways to build a more effective health care infrastructure in countries like Malawi.

[Angus Livingstone]

That's as close as it comes.

At the outset, I'd like to acknowledge that I'm not speaking to you on behalf of the University of British Columbia but rather as a member of the university community, and the views expressed are my own.

I'm very proud to say that in 2007, UBC was the first Canadian university to publicly adopt the global access principles, which, stated briefly, make a commitment to making UBC technologies available to developing countries for health, environmental, and security purposes. This position was strengthened in 2009 as we worked with Yale and Harvard to develop the statement of principles and strategies for equitable dissemination of medical technologies.

To date, UBC has included a number of global access provisions in its licence agreements, including requirements for compulsory licensing, at-cost provision of medicines, and return of country of source. UBC and its affiliated hospitals conduct over half a billion dollars of research annually, and about 60% of that is in the life sciences.

My world has changed dramatically in the past five years, and technology licensing is increasingly difficult with the global distress of both the biotech and venture capital industries. Meanwhile, government is asking us to demonstrate a return on investment on the considerable funds that they have given us to conduct research.

It's in this difficult environment that I am seeking global access terms in my licence agreements, and it can be a very difficult sell. Drug development is an expensive and risky business without adding global access provisions that would only be implemented after drug approval some 10 or 15 years hence, when the world that we all know will look considerably different than it does today.

In reviewing Bill C-393 and the previous hearings, some things are clear to me. Everyone salutes the goal of making medicines available globally to those in need. There are many stars that must align, from the access to affordable drugs, to local infrastructure, medical personnel, water, sanitation, and other social determinants. While Bill C-393 may help alleviate the access to affordable drugs issue, in and of itself it is insufficient to ensure access to those in need. However, it does seem reasonable to remove the cost barrier in areas where they may exist, and such is the intent of Bill C-393.

Given the need for pediatric formulations, access to second-line drug regimes, and changing patent laws in India and China, the need to access patent medicines may arise more frequently.

My caution lies in the implementation and the potential unintended consequences as the pendulum swings from regulations that, by virtue of Apotex's Rwanda experience, have been seen to be cumbersome and unwieldy to the one-licence, all-country unlimited solution proposed by Bill C-393, which, in my opinion, lacks sufficient checks and balances.

In particular, I am troubled by the lack of country-by-country approval process and a licence bound by time. Couple this with the opportunity for countries to accept drugs not approved by Health Canada or the pre-qualified program of the WHO and there is potential for drugs without adequate safety or efficacy profiles to be in circulation. Removing requirements for specific marking, colouring, or labelling invites diversion opportunities both to other countries and also to other economic classes within the country of destination.

While diversion has not been a substantive issue to date, I know that 95% of the WHO's essential medicines are off patent and the incentive for diversion will increase with the costing control in the differential associated with patented drugs, which is the subject of Bill C-393.

Another legitimate concern expressed to me by companies in the first world market is the potential for first world market consequences of third world market adverse medical events. This could result in the regulatory halt of the drugs used in Canada and/or a substantive drop in market opportunities.

Finally, I think we need to consider the possible consequences of one major event related to either diversion or adverse medical events. This, in my belief, would reduce the R and D investment potentially funded by pharmaceuticals in Canada. That being the case, it could diminish our ability to develop drugs within the country and certainly my abilities to license them in the university environment. If that's the case, it could result in reduced access to medicines by Canadians.

Pharmaceutical development is a global business, and it's possible for industry to avoid jurisdictions that present unacceptable risks.

In summary, I support the revisions to the Canadian access to medicines regime to improve the efficiencies and effectiveness, but this must be balanced with adequate checks and balances to ensure that access is delivered in a controlled and accountable manner.

Thank you.

[Linda Watson]

I'll just say that we have brought in this morning 3,000 additional pieces of correspondence, and more has been added just now, to the already 9,000 pieces of correspondence that have come from Canadians across this country to this committee in support of Bill C-393.

[Richard Dearden]

The requirement in CAMR now for Health Canada approval actually isn't mandated by the general council decision, but I don't think anybody, the generics or the innovative drug industry, object to the requirement being in there that safe drugs actually do get exported under the compulsory licence system.

My problem, Mr. Wallace, with any drug is that the “pharmaceutical product” definition in the general council decision was looking at epidemics and serious problems, not lifestyle drugs. Bill C-393 is offside, in my opinion, because it applies to all drugs, not the ones that we see in schedule 1, which is a limited list. That puts it offside there.

My colleague also wanted to add something, so I'll give him my time.

[Rachel Kiddell-Monroe]

I have a very quick comment to make, Mr. Bouchard. I don't think that there's only one possible solution. There are many initiatives Canada could undertake. Bill C-393 is one of them; it can help. There are certainly other initiatives that could be undertaken. The Global Fund to Fight AIDS, Tuberculosis and Malaria is very important. The funding Mr. Lake talked about earlier is a very important Canadian contribution.

Canada can also help without Canadians incurring costs. It can do that by simply letting our pharmaceutical companies, our generic medicine manufacturers, do their work properly. Those companies have developed very specific products that could really have a major impact on the global health scene.