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Fernand Robichaud

The Hon. Fernand Robichaud, P.C. Appointed to the Senate by the Rt. Honourable Jean Chrétien, Senator Fernand Robichaud represents the province of New Brunswick and the Senatorial Division of Saint-Louis-de-Kent. He has served in the Senate of Canada since September 23, 1997.

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Patent Act

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Statement made on 21 March 2011 by Senator Sharon Carstairs (retired)

Hon. Sharon Carstairs:

Honourable senators, I rise today to speak to a bill that I think is the very best of private members' bills. I mean that Bill C-393 is the kind of bill that received support from all parties in the other place. Yes, some did not support the bill; some of those were in the Conservative Party and some were in my party. The vast majority of members of the other place — 172 in total — supported this important piece of legislation. Honourable senators, I rise with a great deal of pleasure to speak to Bill C-393, whose purpose is to reform Canada's Access to Medicines Regime, better known as CAMR.

What is CAMR and why does it need to be amended?

I would ask honourable senators to cast their minds back to 2004 when the CAMR legislation was passed unanimously, in not only the House of Commons but also here in the Senate. Its purpose was to provide inexpensive drugs to a limited number of Third World countries to ensure that human beings in those countries did not die needlessly from treatable diseases like malaria, tuberculosis and HIV/AIDS.

The original bill envisaged a mechanism for issuing what are known as compulsory licenses on patented medicines. These licences authorized exports of lower-cost, generic versions of the expensive, brand name medicines to eligible developing countries.

The tragedy is that, seven years later, only one licence has been issued for one AIDS drug to one country, Rwanda. The good thing is that 21,000 Rwandans will live longer and better lives as a result of this drug. Why have we been unable to manufacture and to sell to these developing countries more of these appropriate drugs?

The tragedy is that the legislation, not by itself but by way of regulation, became so cumbersome that Apotex Inc., who made the only AIDS drug, will not make any others under the current process. All other generic drug makers have also failed to respond. Yet, 23 million sub-Saharan Africans are living with HIV or AIDS, and even more suffer and die from malaria.

This bill, which fixes the problem, must be passed if we are to meet our humanitarian obligations to Africa.

This is not the first time this bill has been before this chamber in principle. Former Senator Yoine Goldstein brought this bill before us, and I took it over upon his retirement, only to have it die on the order paper because of prorogation. However, the bill did go to committee. A similar bill was also introduced in the House of Commons at the same time. As the House of Commons has a procedure to restart private members' bills after prorogation, which this institution does not, I deferred to the bill in the other place.

Now, after their passage of this bill, we have this legislation once again before us. I can only hope that on this basis it will go to committee quickly, since it has already been in our Standing Senate Committee on Banking, Trade and Commerce.

This bill has enormous support from artists, musicians, the Grandmothers to Grandmothers Campaign, church leaders and Canadians from coast to coast. Indeed, in one poll, 80 per cent of Canadians indicated they supported this initiative.

We have all received emails. Certainly, my office has received e-mails by the hundreds urging us to support this bill as quickly as we possibly can.

Honourable senators, I could spend my time this afternoon talking about those poignant, heart-wrenching cases of people who are dying needlessly in foreign destinations. However, I believe that every single member of this chamber supports the bill ensuring that drugs reach those who need them. I do not think anyone in this place does not agree with that goal.

Some Hon. Senators: Hear, hear.

Senator Carstairs: Where there may be disagreement is within the actual provisions of the bill itself. I will deal with the arguments that some have posed as to why we should not pass this bill.

One argument is that Bill C-393 would weaken current safeguards aimed at ensuring that medicines are not diverted or illegally sold. Critics of Bill C-393 have claimed this bill will weaken existing measures of Canada's Access to Medicines Regime to prevent diversion and illegal resale of medicines, or that the bill would allow substandard medicines to be exported to developing countries. These claims, in my view, were never accurate. However, in any event, such objections are no longer valid as those clauses that were giving rise to some of that negativity were removed in the House of Commons. The bill before honourable senators does not include those phrases.

All the requirements to disclose quantities of medicine being shipped, and to which countries, are also preserved. These safeguards were already deemed satisfactory by Parliament in 2004. I think they will continue to be satisfactory in 2011.

Another argument is that Bill C-393 would remove measures to ensure the quality of medicines being supplied to developing countries. Clearly, anything leaving this country must be of the highest quality. The claim made here is simply not true. Under Bill C-393, a Health Canada review must continue to be required for all exports under CAMR.

Another argument is that Bill C-393's amendments would violate Canada's obligations under the World Trade Organization treaty on intellectual property rights. Detailed analyses, including those by some of the world's leading legal experts on the subject, have shown that this argument is not correct.

All countries at the WTO, including Canada, have repeatedly and explicitly agreed that issuing compulsory licences on patented medicines to facilitate exports of lower priced, generic medicines is entirely consistent with WTO rules. WTO members agreed in the 2001 Doha Declaration that the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights, TRIPS, can and should be implemented and interpreted in ways that support WTO members in protecting public health, including promoting access to medicines for all.

In the same Doha Declaration, WTO members also explicitly agreed that developing countries need to be able to make effective use of compulsory licensing to this end. This licensing is the very purpose of CAMR in the first place. Bill C-393's one-licence solution simply eliminates the unnecessary bureaucratic impediments of using the system so that the licensing system is simple and flexible to address the evolving needs of developing countries.

Independent international legal experts have confirmed that the one-licence solution complies with WTO law. These experts include one of the world's leading experts, Professor Frederick Abbott, who co-authored the leading international text on this subject and was actively engaged in negotiating the decision by the WTO general council in 2003. That decision is the basis for CAMR. Professor Abbott has twice testified before Parliament that the one-licence solution is WTO-compliant.

Earlier this year, the United Nations Development Programme convened an international consultation with legal experts who reviewed Bill C-393 and also concluded the one-licence mechanism was consistent with WTO rules. The director of the intellectual property division at the WTO secretariat has also twice testified before Parliament emphasizing that WTO members have insisted on maintaining their flexibility when it comes to legislating on intellectual property issues.

A further argument is that Bill C-393 and the one-licence solution is unfair to brand-name pharmaceutical companies. This claim makes no sense. The proposed one-licence solution does not, as some inaccurately claim, create unfair competition for brand-name pharmaceutical companies.

To be clear, nothing in Bill C-393 prevents brand-name pharmaceutical companies from competing to supply their patented products to developing countries. Indeed, we wish they would. Rather, Bill C-393 aims to enable competition by generics to supply those eligible countries, and preserves the requirement that general manufacturers pay royalties to patent holding pharmaceutical companies in the event of any compulsory license being issued according to the existing CAMR formula already enacted by Parliament. Bill C-393 is about making this requirement workable: something already endorsed by Parliament.

Competition in the global marketplace has been the single most important factor driving down the prices of medicines to bring them within reach of developing countries. These dramatically reduced prices have made it possible to scale up AIDS treatment, such that 5.2 million people in the developing world are now receiving these life-saving medicines, although this is still only 36 per cent of the 14.6 million who currently need it according to the World Health Organization. CAMR is supposed to enable such competition, which is increasingly important as it becomes more challenging for developing countries to obtain the Indian-made generic medicines that have been central to treatment successes so far.

Encouraging such competition is the very function of a mechanism such as CAMR. It permits compulsory licensing of patented medicines for the limited purpose of exporting lower-cost generic medicines to eligible countries. All WTO member countries have already repeatedly endorsed compulsory licensing for this purpose.

Some will argue that Canadian generic drug manufacturers will not be able to supply medicines at prices competitive with generic manufacturers elsewhere, primarily in India. This claim is simply unfounded. Indeed, the goal is not to get business for Canadian companies; the goal is to get quality medicines at the lowest possible price for as many patients in developing countries as possible. It makes no sense, I would suggest, honourable senators, to simply assume that Canadian companies cannot compete globally. They often do already.

Indeed, in the one case to date in which the CAMR legislation has been used, the Canadian generic drug company supplied the medicine to Rwanda at exactly the same price being offered by the Indian generic manufacturers: 19.5 U.S. cents a tablet, or 39 cents a day for the daily dose of two tablets. That is 39 cents a day, honourable senators, and we can save people's lives.

Furthermore, the simpler it is for developing countries and generic manufacturers to use CAMR to supply multiple developing countries, the greater the economies of scale and the lower the costs of production that can be achieved by generic manufacturers in Canada. As it stands, CAMR presently impedes effective competition by Canadian generic companies. Those who support greater competition in the market, including by Canadian companies, should support the one-licence solution proposed by Bill C-393, since it would make it easier for Canadian companies to compete globally to supply medicines at the lowest possible price. More competition ultimately benefits those developing countries that need to purchase the medicines and hence the patients in those countries.

Streamlining CAMR would undermine incentives for brand name pharmaceutical companies to research and develop new medicines, some critics say.

I do not believe that that claim is credible. Exports to high-income countries, in which brand-name pharmaceutical companies make the vast majority of their profits and on which they base their decisions about R&D, are not authorized by the CAMR legislation. CAMR only authorizes exports of generic versions of patented medicines to certain eligible countries. Those countries were already agreed upon by Canada and all WTO members in 2003 and they are already reflected in the current CAMR as created by Parliament in 2004. Those countries represent a minor portion of total global pharmaceutical sales and the profits of brand name pharmaceutical companies. For example, the entire continent of Africa, the hardest hit by the AIDS pandemic, represents less than 2 per cent of global pharmaceutical sales. As brand-name drug companies make little or no profit in developing countries, these markets have little or no impact, I would suggest, on their investments in research and development. Leading Canadian academic experts in the economics of the pharmaceutical industry have also testified to this effect before the industry committee of the House of Commons.

Furthermore, the brand-name drug companies are entitled to receive royalties on these sales of generic medicines. Bill C-393's one-licence solution does not change these limitations and requirements in any way. Rather, it simply streamlines the licensing process so that CAMR is easy to use to supply more affordable medicines to the countries already agreed to unanimously by our Parliament.

The argument that the barrier to greater access is not the price of medicines but rather widespread poverty and the inadequate health systems of these countries is an argument that, frankly, saddens me.

Of course, there are multiple barriers to access to medicines in the developing world which vary from country to country and even within a given country. Major progress has been made in increasing access to treatment, including by strengthening health systems. It is simply inaccurate to claim the quality of health or physical infrastructure in some developing countries presents an insurmountable challenge to delivering affordable medicines. For example, with determination and innovative approaches, AIDS treatment is being delivered effectively in some of the most resource-limited settings imaginable. In just a few years, millions of people have been put on life-saving AIDS drugs in developing countries, thanks to both effective global investments in health systems — for example, through the Global Fund to Fight AIDS, Tuberculosis and Malaria — and the use of generic medicines purchased at dramatically lower prices. However, we are simply not reaching the millions who deserve these treatments.

Every credible organization and expert recognizes the obvious fact that the price of medicines is a key factor affecting access to these very medicines and that the prices of medicines prevent many patients with HIV, AIDS, tuberculosis or malaria from accessing life-saving treatments. Prices are higher when medicines are available only from brand-name pharmaceutical companies that hold patents on those medicines.

Making medicines affordable, strengthening health systems and other initiatives to tackle poverty and improve health in developing countries are not mutually exclusive. Rather, they are complementary and all are necessary. All the clinics, doctors and nurses in the world will not be able to help patients if they cannot give them the medicines they require because they cannot afford to purchase them.

Streamlining CAMR could effectively assist developing countries in overcoming one of the major barriers to affordable treatment. The lower the prices of medicines, the more people can be treated with limited resources and the more resources are then freed up for investing in infrastructure and other aspects of health care that are also so needed in these settings.

Some have also suggested that fixing CAMR is not worthwhile because it does not solve all the health, poverty and infrastructure challenges of the developing world. Following this logic, progress on any one social or economic problem could be pursued only if the proposed solution resolved all problems. No one has suggested that fixing CAMR is a panacea. It is, however, a practical, tangible part of a solution that will realize positive results. Pointing to other challenges that must also be addressed is not a justification for failing to support CAMR reform.

Finally, some would argue that CAMR worked quickly once the first application for a compulsory licence was made; therefore, there are no delays or impediments to CAMR and that CAMR works well. It is true that once the first application for a licence was filed, it was issued reasonably quickly. However, it is not true to claim that it took only 68 days from start to finish of the process, which is a claim often heard from the brand-name pharmaceutical companies. This simply ignores more than a year of lost time attempting to negotiate for a voluntary licence when the brand-name companies would not agree to any licence without a specific developing country being identified. As long as no specific country could be named, the licensing process was stuck in limbo and the possibility of exporting medicines was stalled.

The one-licence solution proposed in Bill C-393 would avoid this hurdle by not limiting a compulsory licence to authorizing supply to just one specific country, but instead authorizing exports to any of the developing countries that are already recognized currently in CAMR as being eligible importing countries.

Honourable senators, Canadians support this bill because Canadians are a generous people. They believe we must respond to those in Third World nations who are dying needlessly from diseases that we know we can either cure and/or treat.

Let us respond in this chamber with the same generosity shown by Canadians. Let us quickly send this bill to committee and let us quickly support it at third reading because it is simply the right thing to do. Canadians not only can be a leader, we must choose to lead. Here is our opportunity, honourable senators.

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