Canada to ‘fast track’ generic drugs for Africa

The Canadian government will fast track legislation to allow drug companies in Canada to manufacture generic antiretroviral drugs for export to developing countries.

The announcement comes after a deal was finally struck within the World Trade Organisation to allow poor countries to import generic versions of patented HIV/AIDS drugs.

Despite the plan receiving in-principle support in Doha, Qatar, in 2001, negotiations had been stalled since the end of last year due to US insistence that any agreement be limited to a short list of infectious diseases. US negotiators dropped this demand in June, allowing the deal to go through.

The new rules will allow a country to issue a “compulsory license” to import generic drugs if it needs them to protect public health but does not have the capacity to manufacture them itself. Previously, only those developing countries with substantial domestic manufacturing capability, such as Brazil and India, had access to generic antiretrovirals [1]A medication or other substance which is active against retroviruses such as HIV..

Manufacturers and governments will be required to put in place extensive measures to prevent smuggling of the low-cost versions into developed countries, such as special packaging or different coloured tablets. Smuggling is a problem which has plagued the roll-out of treatment in Africa.

AIDS activists cautiously welcomed the deal, but many expressed concern that the “Chairman’s Statement” attached to the agreement placed too many restrictions which could lead to it becoming unworkable. “Today’s deal was designed to offer comfort to the US and the Western pharmaceutical industry,” said Ellen ’t Hoen of aid group Médecins Sans Frontiéres. “Unfortunately it offers little comfort for poor patients.”

The UN Special Envoy on AIDS in Africa, Stephen Lewis, called on G7 countries to take the initiative and allow drug manufacturers to make generics for export to Africa. He challenged his own country, Canada, to “set an example” for other developed nations by acting quickly. The Canadian Prime Minister, Jean Chrétien, said his government would fast track the necessary legislation.

Despite initial concern, brand-name pharmaceutical companies in Canada have said they will not object to the plan, opening the way for Canada’s large generic drug sector to begin exporting HIV drugs. “Canada has an opportunity to show international leadership through a sound implementation of the WTO decision,” the manufacturers said in a statement.

In South Africa, the Treatment Action Coalition (TAC) welcomed Canada’s “brave step,” which it said would make a significant contribution to improving treatment access in developing countries.

Canadian legislators are said to be “working around the clock” to draft the necessary legislation, which has multi-party support, before the Canadian parliament rises in preparation for Chrétien’s retirement. But Toronto’s Globe and Mail reports that “insiders say the drafting is proving harder than … initially thought and it may be ‘next to impossible’ to push through” during the current parliamentary session.

Even if the government manages to pass the legislation quickly, it could be 18 months or more before the first shipment of drugs, due to the time needed to apply for government manufacturing approvals, obtain raw materials and start production, according to one of Canada’s largest generic manufacturers, Apotex.

One drug which Apotex could produce quickly is AZT. The company had been making generic AZT until last year, when a court ordered it and another Canadian manufacturer to stop, after finding that it had infringed patents.

—Washington Post, Globe and Mail, Kaiser Network