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Fixing Access To Medicines Regime Essential

By Richard Elliott

26 October, 2010

At the United Nations last week, Canada reiterated its commitment to the Millennium Development Goals. But one critical initiative to advance global health is languishing unnecessarily: Parliament could easily fix Canada's Access to Medicines Regime with Bill C-393, which passed Second Reading last December and is currently in limbo before a committee.

Back in 2004, every single parliamentarian voted unanimously in favour of legislation creating CAMR, a mechanism for issuing what are known as "compulsory licences" on patented medicines. These licences authorize exports of lower-cost, generic versions of the expensive brand-name medicines to eligible developing countries.

Six years later, only one licence has been issued, to export one AIDS medicine to one country, Rwanda. Why? Because CAMR's cumbersome licensing processes and requirements are at odds with the practical realities facing developing countries and generic pharmaceutical manufacturers.

Bill C-393's reforms would make CAMR user-friendly by creating a "one-licence solution." A generics manufacturer could get a single compulsory licence to export lower-cost medicines to the developing countries already covered by the law, rather than requiring a separate negotiation and licensing process for every single drug order from every single country as in the current law, with all the associated transaction costs.

The "one-licence solution" would clear the way for generic suppliers and developing countries to navigate the bidding and procuring process without multiple hurdles and uncertainty along the way, making it the rapid solution that Canada promised to deliver years ago.

Yet the reforms proposed in Bill C-393 are facing misguided and misinformed objections-none of which stand up under the barest scrutiny.

First, there is the nonsensical claim that the barrier is not medicine prices but the poverty of developing countries and their lack of health systems and other infrastructure.

There is overwhelming evidence that prices are a barrier to access and that generic competition in the global marketplace has propelled the dramatic and sustained decrease in the prices of some first-line AIDS medicines-from over US$10,000 per year a decade ago to now under US$100.

Furthermore, what medicines are doctors and clinics supposed to give to patients if the medicines aren't affordable?

Second, Big Pharma regularly raises the spectre of exports being diverted from intended recipients and resold illegally. This is another diversion from the real issue.

Brand-name pharmaceutical companies are short on concrete examples showing that this has been a major problem, including in developing countries where generic medicines have been made available. In any event, Bill C-393 maintains safeguards aimed at preventing diversion.

Third, Big Pharma claims that simplifying CAMR will reduce incentives for brand-name pharmaceutical companies to invest in developing new medicines. But the current law already enacted by Parliament already limits exporting lower-cost generic medicines to just eligible developing countries. These are listed in CAMR and were already agreed by all countries at the WTO.

Exports to high-income countries, in which brand-name pharmaceutical companies make almost all their profits, are not authorized by CAMR. Enabling competition from lower-cost generic medicines in these markets in no way affects Big Pharma's decisions about research and development.

In addition, under a formula already in CAMR, generic manufacturers must pay brand-name companies royalties on any sales in these countries. Bill C-393 changes none of this.

Finally, it has been claimed by Big Pharma's lawyers that the reforms proposed in Bill C-393 would violate Canada's obligations under WTO treaties to protect intellectual property. This is simply inaccurate.

As the director of the WTO's intellectual property division testified before Parliament, as a WTO member, Canada has considerable leeway in interpreting and implementing those obligations.

Furthermore, a group of leading international experts on WTO law convened earlier this year to review the reforms to CAMR proposed by Bill C-393 and agreed they comply with Canada's obligations as a WTO member.

Streamlining CAMR through Bill C-393 will enable greater access to lower-priced medicines for developing countries by harnessing the power of market competition. This will save lives and bring hope to people who are literally dying for drugs.

Lower medicine prices means limited resources for health-from developing countries' own national budgets and from donors such as Canada, including via mechanisms such as the Global Fund to Fight AIDS, TB and Malaria-can have even greater impact.

A more workable CAMR would create more opportunity for Canadian generic pharmaceutical companies in the global marketplace, while compensating fairly through royalties the research investment of brand-name pharmaceutical companies.

With all the talk about "aid effectiveness" and "value for money," this is a winner all around.

In contrast, failing to fix CAMR would be yet another betrayal of promises to the developing world. Each day, more than 8,000 people worldwide are dying of AIDS. Half of the hundreds of thousands of children in the developing world born with HIV will not live to see their second birthday because they lack medicines.

A national poll found that 80 per cent of Canadians support fixing CAMR. Dozens of prominent Canadians in various sectors have called on Parliament to reform CAMR. Bill C-393 provides parliamentarians, of whatever political stripe, the opportunity to do the right thing. It should be a no-brainer.

Richard Elliott is executive director of the Canadian HIV/AIDS Legal Network.