News

Now that a Canadian pharmaceutical company has won the bid to produce and ship cheap, generic AIDS drugs to Rwanda, it says it will never participate in the goodwill program again unless the federal government simplifies the process.

Toronto-based Apotex Inc. became the first company in the world yesterday to be awarded a tender under a 2003 World Trade Organization agreement to manufacture and supply life-saving drugs to AIDS-stricken nations.

But Canadian legislation based on that agreement makes for such a cumbersome process that it took four years for Apotex to get to this point.

"We've spent millions of dollars on the [research and development], we've spent lawyers' time at our cost, just because it's the right thing to do. It would be difficult to do again unless the legislation is made simpler," Elie Betito said.

"Imagine if ... another country, like Malawi, comes forward asking for the drugs, we'd have to start this whole process again."

Jeff Connell, a spokesman for the Canadian Generic Pharmaceutical Association, went further, saying none of the group's members are willing to go through the CAMR process in its current form.

Canada's Access to Medicines Regime allows manufacturers of generic drugs to make copies of patent-protected medicines, including the three-in-one AIDS drug, so they can be sent to interested developing countries for an affordable price.

After a slow start, Rwanda last summer became the first country to ask for Canada's help in procuring drugs by notifying the World Trade Organization that it wanted to purchase 260,000 packages of a triple-drug anti-retroviral therapy, enough to treat 21,000 people for one year.

But under Canada's legislation, the African country's interest was not enough for Apotex, the only company to express interest in selling the medication at cost, to produce and ship the drugs.

Apotex had to 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 in Canada.

It then needed to get 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 that is required by the WTO deal. After considering several international offers, Rwanda this month selected Apotex, which will sell each pill for 19.5 cents. The first shipment will leave Canada by Oct. 1.

Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, called yesterday's development bittersweet. "While we're happy at the news of this one deal looking like it's going ahead, this should not be seen as some sort of excuse to not streamline the legislation. "

An Industry Canada report tabled in December said the government had no plans to change the process.