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Rwanda to Import Generic HIV Drugs Under WTO Agreement

August 1, 2007

Rwanda has become the first country to invoke a provision of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement that would enable it to import generic HIV drugs from Canada, the World Trade Organization (WTO) announced.

The provision, which falls under paragraph six of the Doha Declaration on the TRIPS Agreement, is based on a 2003 WTO decision to allow countries with public health problems to import generic drugs if they are unable to manufacture the medicines themselves, the WTO said.

In its July 19 notification announcement, Rwanda said it expects to import 260,000 packs of a fixed-dose combination product, which contains generic zidovudine, lamivudine and nevirapine, and is manufactured by Canadian drugmaker Apotex, over the next two years.

Richard Elliott, deputy director at the Canadian HIV/AIDS Legal Network, explained that Rwanda’s move is different from what Brazil and Thailand have done because Rwanda is planning to import generic versions of patented drugs, while the other countries are looking to manufacture such medicines intranationally.

Under the 2003 decision, countries must notify the WTO of their intention to import, and exporter countries must have laws in place to allow compulsory licensing, which Canada has in the form of the Access to Medicines Regime, Elliott said.

The law was enacted in 2004, Elliott said, noting that his group has been pressuring the Parliament of Canada to simplify and remove barriers from within the legislation ever since. Rwanda is the first developing country to attempt to import drugs under the legislation.

“This is the closest we’ve come so far to seeing the regime achieve what it’s meant to do,” he said. “But even if Rwanda and Apotex are successful in getting this order through, parliament still needs to streamline the regime to ensure that this isn’t the only time we’ll see the regime used.”

Besides Canada, a few other countries, including India, China and the European Union, have adopted laws in accordance with the 2003 WTO decision, Elliott said. He added that the U.S., however, has not.

Apotex could not be reached for comment by press time. — Breda Lund