Four years after it was passed unanimously by Parliament, a bill drafted to allow low-cost Canadian-made AIDS drugs to be exported to developing countries may finally be on the verge of producing results.

Generic drug maker Apotex Inc. announced Wednesday that it has been awarded a contract by the government of Rwanda to sell its three-in-one AIDS pill Apo Triavir to the African country. Securing that contract was the final legal hurdle that Apotex had to manoeuvre in the onerous process of making Canada's Access to Medicines Regime work.

"We're almost there," Elie Betito, the company's director of public and government affairs, said in an interview.

"By October sometime we're hoping that the product will be on a plane on delivery to Rwanda."

He noted, though, that nothing will be final until that actually happens. The companies that hold the patents on the drugs in the Apotex combined medication can still withdraw permission for the sale to take place "even on the day we are shipping."

Manufacturers criticized for delays

Apotex is the first generic drug manufacturer to make it through the obstacle-laden process, a process that has been heavily criticized by AIDS activists and generic drug makers.

And while groups that have been working to try to make the system work hailed Wednesday's news, they reiterated that this isn't the humanitarian tool envisaged when the then-named Jean Chrétien Pledge to Africa Act sailed through Parliament in May 2004. The Conservative government renamed the legislation after coming to power.

"It's a terrifically important development. Should have happened three years ago. I hope it teaches the government a lesson that their wasting of time puts lives at stake," Stephen Lewis, the former UN special envoy for AIDS in Africa, said of the news.

"The first reaction that I have is that it took long enough," added Kevin Coppock, humanitarian affairs liaison with Medecins Sans Frontiers (Doctors Without Borders), which had hoped to use the legislation to secure affordable antiretroviral drugs for AIDS-afflicted African countries.

"Is it really a success? That is the question. Certainly from … an MSF perspective it's not a practical way for us as an agency to get these types of drugs from Canada."

Most parties familiar with the Herculean effort required to even get one company to this point fear this Apotex sale may be the only time low cost AIDS drugs get shipped to a developing country under the existing Access to Medicines Regime.

Richard Elliott, executive director of the Canadian HIV-AIDS Legal Network, admitted reaching this milestone is bittersweet.

"What's terribly bitter about it is that this could be a one-off unless this system actually gets fixed, because it's unlikely that we're going to see the use of it again in its current form," he said in Toronto.

"And that is pretty depressing. In fact, it's pretty tragic if we actually have this potential to help keep people alive with medicines that are cheap to produce but we're just not willing to take the steps to fix the process so that can happen."

Canada was applauded internationally when the legislation passed in 2004. But the applause later turned to ridicule when it became apparent the multi-stage process was so complex as to be almost unworkable. Despite the criticism, a federal government review of the legislation, tabled in Parliament last December, recommended against changes at this stage.

Apotex will sell Apo Triavir — a combined form of the drugs Zidovudine, Lamivudine and Nevirapine — for 19.5 cents US a dose. If bought separately and from their patent holders, the drugs would cost $6 US a dose.

Betito said the company essentially developed the drug as a goodwill gesture, and will not recoup its development costs at that price.

Nor is it likely to brave the process again, unless the regime is changed. "The way the legislation is done right now I doubt if we would do this process again," he admitted.

As Apotex is the largest of Canada's generic drug makers, if it is unwilling to press on, others are unlikely to try, Elliott said.

"I don't think the experience of Apotex is going to inspire them to say 'OK, yeah, now we'll step up to the plate and do it' unless of course we fix the system and make it much smoother and easier."