A Canadian plan to get low-cost medicine to the world's poor will help save countless lives - hopefully.

Fourteen million men, women and children die each year of treatable infectious diseases. The drugs that can save these lives exist, yet the world's poor can't afford the medicine.

But two-and-a-half years ago, public health appeared to trump the intellectual property rights of the companies behind those treatments. At World Trade Organization (WTO) meetings, sequestered far away from protestors in Doha, Qatar, trade ministers agreed that countries could issue compulsory licenses to generic drug manufacturers to produce low-cost drugs for fighting diseases like AIDS, malaria and tuberculosis.

While the Doha declaration was seen as a milestone, it was little help to the poorest countries, which do not have generic drug industries. It took until August 2003 - about 25 million lives later - for the WTO to reach a second agreement that allowed countries without manufacturing capacity to import generic versions of patented medicines.

Now, eight months and another nine million lives later, Canada is the first country to enact legislation allowing its generic manufacturers to produced patented drugs for export. Time will tell if Bill C-9 will help slow the counter of lives lost in the developing world.

"This bill has the potential to be a profoundly important humanitarian gesture, one that rises above partisan politics or commercial interests," Kevin Perkins of the Canada-Africa Partnership on AIDS told the Standing Committee on Industry, Science and Technology in March.

The proposed piece of legislation had galvanized an impressively broad coalition of Canadian organizations. The Canadian Labour Congress, the United Church of Canada, World Vision and the Canadian Medical Association are just some of the organizations that fought for Canada to introduce, then amend, and finally pass Bill C-9 on May 4th - with rare unanimous support in the House of Commons.

Canadians, and the world, can thank them that the bill, though flawed, is as good as it is. In a conciliatory gesture to his predecessor, Prime Minister Paul Martin renamed the bill the "Jean Chrétien Pledge to Africa Act."

Richard Elliott of the HIV/AIDS Legal Network, along with colleagues at Médecins Sans Frontières (also known as Doctors Without Borders), spent years guiding the effort to make Canadian generic drugs available to less developed countries. His work has been as tireless as the big pharmaceutical lobby - one factor he credits for the long delay in acting on the Doha Declaration of 2001.

"Big Pharma" fought "tooth and nail," Elliott says, along with its ally the United States, against any loosening of patent rights. "The US was the lead bully fighting developing countries and proposals from civil society to loosen up the rules under the TRIPS agreement." The Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) is a key component of the WTO that enhances the rights of patent-holders in the global economy.

Elliott argues that individual countries could have acted years ago, unilaterally, to get anti-retroviral and other drugs flowing to the developing world. "We had been saying all along, 'Look, even within TRIPS, flawed though it may be, there are provisions... that allow you to define in your own law limited exceptions to patent rights... '"

Elliott points out that both Canada and the US threatened to use these provisions in their own interest against Bayer during the anthrax scare after September 2001. "Why can't we show the same sort of backbone when it comes to getting medicines to people in Zambia?"

Canada waited for all the countries in the WTO to agree on to how to extend to the poorest countries the right to access affordable, generic drugs. "That's the downside of multilateralism," says Elliott.

Elliot credits a "perfect storm" of forces that came together to spur the government to implement the August 2003 WTO decision

The tireless UN special envoy for HIV/AIDS in Africa, Stephen Lewis, was a gale force wind in that storm. Lewis has spoken in front of thousands of Canadians, and has been heard by millions more through the media, in his effort to convince us that the tragedy of AIDS in Africa is of urgent importance.

Lewis was the guest speaker at the annual meeting of the HIV/AIDS Legal Network last September. Elliott asked him to comment on the issue of intellectual property rights and how they have hampered the global fight against AIDS. Lewis obliged, and then repeated his remarks at a major conference on AIDS in Nairobi. The speech generated a considerable amount of media interest. Days later, the Canadian government said it would act.

"The fact that the UN Special Envoy [on AIDS in Africa] is a very well-known, articulate, respected

Canadian figure, combined with a coalition of Canadian civil society groups that had been working on this issue for some time, combined with the fact that this decision had been made at the WTOall of those things made the iron hot," says Elliott.

And as the first country to implement the WTO decision, there was enormous pressure on Canada to get it right. Bill C-9 will serve as a precedent, as other countries look at amending their patent acts. Canada's proposed legislation attracted interest from UNICEF, UN Secretary-General Kofi Annan and Irish rock star and activist Bono.

But Canada is not immune to pressure from the pharmaceutical lobby. Bill C-56, introduced late in the Chrétien government, and then reintroduced as Bill C-9 by the Martin government, nodded to that pressure by giving the patent-holders the right of first refusal on contracts between developing countries and Canadian generic manufacturers.

About 20 separate witnesses including medical doctors, Non-Governmental Organizations staff, representatives of the generic drug industry and a trade expert delivered one message to the Industry committee studying the proposed legislation: this won't work. Official testimony was backed up by direct lobbying of MPs, and a flood of letters from concerned citizens.

Brian Masse heard that message as the NDP committee member. "Their message consistently gave us courage, and gave us the ability to press for the changes that were so desperately needed," he says. "It made the government realize that they had to amend their own legislation." Bill C-9, as passed by the House of Commons on May 4, does not include that right of first refusal, and nor does it include a restrictive list of countries eligible to import generic drugs from Canada.

"Those two things are out [of the bill] entirely because of NGO advocacy," says Gerry Barr, president of the Canadian Council for International Co-operation, an umbrella group for non-profit Canadian development agencies. "Sadly, we weren't able... to remove the list of [exempt] medicines." That list of medicines is, according to Rachel Kiddell-Monroe of Médecins Sans Frontières, a major flaw in Canada's response to the WTO decision.

"Already, most of the front-line drugs that we use in treating malaria, tuberculosis and AIDS, and other more neglected diseasesthey're simply not there," she says. The list creates an opportunity for pharmaceutical companies to lobby on a drug-by-drug basis. Brian Masse learned that first hand when he got a call from Bayer, asking for one of its drugs - the pneumonia medicine moxiflaxacin, under the brand name Avelox - to be taken off the approved drugs list in the legislation.

The Canadian government knows the bill is not perfect, and counters that governing is about compromise. Masse likens Bill C-9 itself to a bitter pill that he had to swallow. He's waiting to see the effect it will have. "It's only a victory if people who are suffering from malaria, HIV/AIDS and tuberculosis... receive affordable drugs through generic production," says Masse.

Others liken the bill to a glass of water - half-full or half-empty, but better than nothing. And Canada has been praised as a pioneer. The next three years, before the legislation comes up for review, will show if Canada has helped to slow that global tally of deaths from treatable disease. If not, Canadian civil society will respond again, and do its best to top up the glass.

Written May 2004.