No room for petty politics in goodwill program

Canada is the first country to ship cheap AIDS drugs to Africa, but a morass of red tape continues to threaten humanitarian efforts

Andre Picard

From Thursday's Globe and Mail

Yesterday, a box of generic AIDS medication left Toronto for Kigali. The box contained seven million doses of Apo-TriAvir, a once-a-day antiretroviral pill; there are enough drugs in the shipment to treat 21,000 Rwandans for a full year, probably saving many of them from certain death.

Yet it was a bittersweet moment.

Canada's shipment of desperately needed, low-cost AIDS drugs to Africa was the result of innovative legislation that should be a source of great pride. But a humanitarian law that was supposed to encourage the distribution of life-saving drugs to the world's poorest and sickest has, in its implementation, become bogged down in a morass of red tape and petty politics.

Yesterday's shipment of HIV-AIDS drugs may well be the last, and this tragic reality should fill us with shame.

In 2004, Canada adopted the Access to Medicines Regime, a law that allowed "compulsory licensing" of patented medicines so generic companies could legally produce and export low-cost versions of brand-name medicines to the developing world.

Four years and eight million AIDS deaths later, Canada remains the only country in the world to allow compulsory licensing.

The medication that left Canada yesterday should be a beacon of hope but, rather, it is symbolic of the world's failure to act.

There are approximately 33 million people worldwide infected with HIV-AIDS, according to UNAIDS.

Only about three million people in the developing world are being treated with antiretroviral drugs, an estimated 31 per cent of those who could benefit.

Those who are being treated get their drugs thanks to clinical trials, donations of brand-name drugs and charities such as the Clinton Foundation, which purchases low-cost generic drugs from India.

Compulsory licensing was supposed to be a way for wealthy countries such as Canada to do more, to tap into the knowledge of its brand-name drug companies and the manufacturing capacity of its generic companies.

Practically, what the policy means is that antiretroviral drugs to treat HIV-AIDS, which can cost up to $20,000 a year in countries such as Canada, could be produced for as little as $200 by generic companies.

The Apo-TriAvir shipped to Rwanda, for example, costs only 39 cents a day for each person.

The Access to Medicines Regime made it clear that the low-cost versions of drugs could only be exported to low-income countries that could never afford brand-name versions. The law is no threat to lucrative markets in the developed world.

The law also made it obligatory for generic companies to negotiate with brand-name pharmaceutical companies for access to their recipes and procedures, obviously with severe restrictions.

Generic giant Apotex Inc. had to first get permission, or a voluntary licence, from brand-name pharmaceutical companies Boehringer Ingelheim (Canada) Ltd. and GlaxoSmithKline Inc., which together hold patents for the three components in Apo-TriAvir.

Apotex also needed a compulsory licence from the federal Commissioner of Patents before it could formally submit a bid to the open tender process by the Rwandan government.

The generic drug company would have to repeat all these steps to make another drug or to sell Apo-TriAvir to another country.

Apotex says it spent $3-million in the process, not including legal fees. The bid became a massive money-losing proposition. The Canadian Generic Pharmaceutical Association has made it clear that no other company is interested in producing low-cost AIDS drugs under the current red-tape-laden rules.

Obviously, the law needs to be streamlined if it is going to be meaningful.

The Canadian HIV/AIDS Legal Network, which has championed compulsory licensing, has provided the government with a series of sensible proposals to make the law work.

Chief among the proposed amendments was a simple "one-licence solution" that would eliminate the need for separate negotiations and separate licences for each country and each order of medicines.

Yet the federal government has not acted on those recommendations.

Why?

First and foremost, there are petty partisan politics at play. The Liberals introduced the Access to Medicines Regime, and the Conservatives are not overly keen to make it work.

Second, brand-name pharmaceutical companies are not very enthusiastic about the legislation, and the government has given more weight to their concerns than to those of generic drug companies.

Sadly, the big losers in the process are the children, women and men of Africa who are infected with HIV-AIDS.

Millions upon millions of them are in desperate need of care, including treatment with antiretroviral drugs.

The technical challenges of making these drugs available to those in need are formidable. There is no excuse for compounding them with bureaucratic and political pettiness.

Canada made a promise to the world to make more low-cost AIDS drugs available.

Leaving this promise unfulfilled diminishes us as a nation.

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