Canada: Senator Proposes Bill to Rush Canadian Drugs Overseas

A senator recently proposed amending the Patent Act to make it easier to provide low-cost drugs to poorer developing nations under Canada's Access to Medicines Regime (CAMR). In 2004, the act was amended to encourage the export of generic drugs against HIV, TB and malaria. Since then, only the generic-drugs firm Apotex has used the provision, producing the AIDS drug Triavir for Rwanda last fall. At the time, Apotex said it would not use the measure again, calling it burdensome and costly.

The "one-license solution" proposed in bill S 232 would enable generic-drug firms to send multiple shipments of the same medicine to a variety of countries without requalifying each shipment. CAMR currently requires that each shipment be requalified. "The red tape that is built into the legislation inhibits people from doing it, they just don't want to be bothered," said Sen. Yoine Goldstein, sponsor of the measure.

Canada's brand-name drugs lobby disagrees. "Parliament has reviewed it and come to the conclusion that it doesn't need changing," said Russell Williams, president of RX&D. "The bill is fair, functional and efficient. It is an emotional debate but I believe that targeting CAMR is a problem. I don't see it as a barrier."

"I don't know whether we did the developing world a favor or a disservice by getting that first shipment of Triavir out," said Bruce Clark, vice president of regulatory affairs for Apotex. "It seems to have appeased the conscience of the legislators and of the brand industry, and let them think we don't need to do anything else."

"It was sheer effort on our part to get that first shipment out," Clark said. "The brands say it's fair, fast, and functional, but by whose definition? Would the patients in Africa say it's functional?"

The bill could get a second reading in the Senate in early May.

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