Generic AIDS drugs: What happened to Canada's pledge to Africa?

CBC News Online | Aug. 4, 2006

A week from now, nearly 20,000 delegates from about 120 countries will be arriving in Toronto for the XVI International AIDS Conference. With the conference theme Time to Deliver, it will be the perfect opportunity to pillory Canada for failing to come through on its promise to flood the developing world with cheap, generic AIDS drugs.

Indeed, the finger-pointing has already begun, witness the recent front-page story in The Toronto Star, "Canada Breaks AIDS pledge: Africa still waiting for life-saving drugs two years after Ottawa passed 'breakthrough' law."

It was based on comments from a spokesperson for Canada's generic drug industry as well as another from Doctors Without Borders, the group that is on the front lines in the war against AIDS. Though with any issue as complex as this, there is more than enough blame to go around.

Three years ago, Canada was the darling of the international set. Even U2 front man Bono loved us then.

We were the first country to introduce legislation to allow for the export of generic AIDS drugs to impoverished nations — over the objections of the patent-holding big brands if necessary.

Finally, everyone said, after years of yakkity-yak at world trade conferences and the like a developed nation — one with a thriving generic drug industry to boot — was stepping to the plate.

And none too soon. As many as 8,000 people die each day from AIDS, most of them in Africa. Modern antiretroviral drugs (we're on our fifth and sixth generations here in North America) have worked wonders at extending the lives of those with HIV. But even the early versions of these meds are barely available in places like sub-Saharan Africa.

By the World Health Organization estimate for 2005, about 1.3 million AIDS sufferers there had access to antiretrovirals. A further 6.5 million did without.

Canada's plan

Canada wanted to help change this equation. But three years later, not one generic AIDS drug has left our shores.

Yes, we have a new act. The improbably titled Jean Chrétien Pledge to Africa Act was passed in the spring of 2004 and came into force a year later. (The Conservatives recently changed its name to the Access to Medicines Regime, which is their right: Not only are they in power now but, it has to be noted, they voted for it at the time.)

Also, a few months ago, Health Canada approved its first generic AIDS drug for export, a combo three-in-one cocktail developed by Toronto-based Apotex, which is now trying to negotiate the rights to the main ingredients from three brand-name competitors.

This looks to be a long and convoluted process and the whole thing is one, an Apotex spokesman says, the company is "unlikely to repeat."

Both Apotex and Doctors Without Borders, who are partners in this endeavour, say the Canadian law is more cumbersome than it needs to be. But the real problem here does not seem to be the legislation so much as that Apotex is not able to offer up the name of an African country willing to buy its product, despite the obvious need.

The simple fact is no African nation has formally requested that Canada, or any of the other jurisdictions that have subsequently passed similar legislation, including the European Union, supply it with generic AIDS medications. And that request is needed to trigger the compulsory licensing process.

Why hasn't one? That's a good question. The problem does not seem to be the cost of the drugs so much as deep-rooted African anxieties about trade rules and development grants, as well as perhaps a longer-term fight by aid groups to get the broad rules on pharmaceutical patents changed on humanitarian grounds.

Political football

Canada's law followed closely on the heels of a World Trade Organization ruling in August 2003, which opened the door to generic drug makers to export to developing countries, almost regardless of patents. In fact, the Canadian law was announced only a month after the WTO ruling, at the specific urging of Canadian Stephen Lewis, the UN's special representative on HIV/AIDS.

Like the WTO, the Canadian legislation attempted to walk the line between the generic manufacturers, the big brands who held the patents (after expensive R&D in most cases) and the large non-governmental organizations, NGOs like Doctors Without Borders and UNICEF, who were in the business of buying up cheap medications and distributing them.

Doctors Without Borders, for example, currently provides antiretroviral therapy to about 57,000 patients in over 30 countries. And its interest in being a broader supplier, especially on behalf of African nations that might be afraid of trade retaliation if they angered big drug makers directly, is at least partly responsibly for the current dilemma.

The initial WTO ground rules, which Canada followed, included: Brand-name patent holders must first be invited to negotiate voluntary licensing agreements with generic manufacturers before they could be compelled to hand over their patents for humanitarian use. If there was to be compulsory licensing, this had to be on a one-shot contract with an identifiable country as purchaser (royalties were to be based on a specific country's ability to pay, among other criteria). As a result, the deal couldn't be made through an NGO.

These requirements are part of the catch-22 holding up the current Apotex deal.

Apotex claims it doesn't even know at this point who the end buyer will be. Doctors Without Borders has been doing all the negotiating for this project and its chief co-ordinator, Montreal-based Rachel Kiddell-Monroe, says there are two or three countries that are interested but none want to be identified, for a variety of reasons.

The doctors group wants Apotex to try to negotiate a voluntary deal with the brand-name companies basically to end-run the legislation and deliver these much-needed drugs to well-intentioned NGOs, like Doctors Without Borders.

This is allowed, Kiddell-Monroe says: "If the will is there, a brand-name company can give a voluntary licence on any terms."

The catch, though, is that this type of negotiation can go on forever. If Apotex and Doctors Without Borders want to trigger the Canadian law and seek compulsory licensing, then there is a mere 30-day limit to negotiations before Ottawa is asked to intervene and make a decision.

But to trigger the access law, there has to be a specific buyer, and it has to be an under-developed country. Those are the rules and that's the embarrassing part for a country like Canada that led with its chin and is now about to host an AIDS conference called Time to Deliver.

The backstop

Why would a responsible group like Doctors Without Borders play chicken with generic AIDS drugs, allowing negotiations to drag on, when the need is so great? Well, for the moment at least there is a moral and manufacturing backstop — India.

India has a huge generic drug industry and it currently accounts for the lion's share of the antiretroviral drugs in Africa and much of the Third World. In fact one of its companies, Aurobindo Pharma, just received U.S. regulatory approval for its three-in-one pill, which uses the same three first-line drugs (zidovudine, lamivudine and nevirapine) as Apotox.

Competition among India's generic industry is the reason, Kiddell-Monroe points out, why prices for antiretroviral drugs in Africa have dropped from something like $10,000 US a year per patient in the late 1990s to something like $150 per patient today. NGOs can just fax in their orders and have them delivered.

India's low-cost generic drug industry is also why Canada's noble gesture can be seen as largely academic — at least for the time being. (It's hard to imagine Toronto-based manufacturing companies being able to compete with India on price. Maybe that's why Apotex is the only one that's come forward publicly.)

India's advantage in this field is that it didn't come under the WTO purview until 2005, and even then much of its pharmaceutical patents have been grandfathered. But India's AIDS-drug industry is largely confined to first-generation medications.

When these meds start to become ineffective in Africa and the Third World, which is likely given the history of this virus, that is when the more sophisticated, next-generation drugs will be needed. And that's when countries like Canada, with their well-intentioned laws and their mix of generic manufacturing and front-line research companies, will come under greater pressure to do more.

The current impasse here is "absolutely not Canada's fault," says Kiddell-Monroe. "My only criticism is that they've added some extras to the law that we don't think they should have. But I don't doubt for an instant the goodwill of the Canadian government and its senior officials." Nor Apotex, she adds.

The bottom line for her is that the WTO, and Canada, should simply have allowed compulsory licensing of AIDS and other essential public health drugs whenever there was a clear and present humanitarian need in the developing world.

That was the fight that animated the introduction and passage of Canada's "breakthrough" legislation, and it's the fight that's still to come when the next generation of AIDS drugs becomes more critically needed in the developing world.

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