Canada has taken a major step toward becoming the first country to ship cheap, life-saving drugs to disease-stricken nations.
The World Trade Organization said it received notification from Canada on Wednesday that the Federal Commissioner of Patents had authorized generic drug manufacturer Apotex Inc. to make a three-in-one AIDS drug for export to Rwanda. The WTO has not received similar notifications from any other country.
The compulsory licence, issued to Apotex late last month, was required before the company could start producing the pills, whose molecules are patented by two brand-name companies.
“We're in the final processes of the development of the product now, so we should be in the production stages soon,” said Elie Betito, director of public and government affairs at Apotex. “If everything goes as planned, by mid-December we should have product flowing to Africa.”
But even with the shipment date finally in sight, critics of Canada's Access to Medicines Regime say the legislation needs to be changed sooner rather than later if it is going to help other nations in need.
It was more than three years ago that Canada brought in the regime, which allows manufacturers of generic drugs to make affordable copies of patent-protected medicines, including the AIDS drug, for export to developing countries.
After a slow start, Rwanda this summer became the first country to ask for Canada's help by notifying the World Trade Organization that it wanted to purchase 260,000 packages of the anti-retroviral therapy, enough to treat 21,000 people for one year.
But under Canadian legislation, the African country's interest doesn't necessarily mean Apotex can simply produce and ship the drugs. It had to first get voluntary licences from Boehringer Ingelheim (Canada) Ltd. and GlaxoSmithKline Inc., which hold the patents in Canada for the three drugs that make up Apo-TriAvir.
The next step was getting the compulsory licence from the Commissioner of Patents.
While Apotex, with the help of the Clinton Foundation, continues to source cheap materials required to make the drug, Mr. Betito said the company still has to wait for Rwanda to issue an official tender for the drugs to the WTO.
Once that tender is made, any country can bid on it. Several generic drug manufacturers in India have recently come forward expressing interest. Rwanda would then choose a country.
But Mr. Betito is confident that Apotex will have competitive prices. “I think we will have the best price in the world,” he said.
Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, welcomed the news of the compulsory licence, but at the same time said its timing should be a wakeup call to the Canadian government to make the legislation more user-friendly.
“Even though we have the first compulsory licence issued, that doesn't mean somehow that there's no problem with the legislation. It took nearly three years to get to this point,” he said yesterday, adding that it's unlikely that the Canadian legislation will be used again unless it's simplified and streamlined.
“It's unlikely that Apotex, or any generic manufacturer, will want to go through this process again.”
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