Now that Apotex has won a bid to produce and ship copycat AIDS meds to Rwanda, the generic drugmaker says it will never participate in the goodwill program again unless the federal government simplifies the process,The Toronto Globe & Mail reports.
Apotex became the first generic drugmaker in the world yesterday to be awarded a tender under a 2003 World Trade Organization deal to manufacture and supply copycats to AIDS-stricken nations. But Canadian legislation based on the agreement makes for such a cumbersome process that it took four years for Apotex to get this far, the paper writes.
"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 tells the paper. "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 generic drugmakers to make copies of patent-protected medicines, including a three-in-one AIDS cocktail, so they can be sent to developing nations 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 WTO 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, Rwanda's interest wasn't 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 Boehringer Ingelheim and Glaxo, which together hold patents for the three components in Apo-TriAvir in Canada.
Apotex then 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 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 October 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," he tells the paper.
An Industry Canada report tabled in December said the government had no plans to change the process.
Source: The Globe & Mail