Canada Will Be
First to Export Generic AIDS Drugs

Canada has the become the first country to announce it has authorized a company to make for export a cheap, generic version of a patented AIDS drug, the WTO said Friday.

The Canadian decision is aimed at treating people with HIV in Rwanda, where some 190,000, or 2.1% of the population, are living with the condition, according to the United Nations.

''The triple combination AIDS therapy drug, TriAvir, can now be made and exported to Rwanda, which is unable to manufacture the medicine itself,'' a World Trade Organization statement said.

Canada's notification that it would make use of the so-called ''compulsory license'' procedure completes action that began July 17 when Rwanda informed the WTO that it would invoke the provision in ordering the drugs from Canada.

That was ''the first notification from any government that it has authorized a company to make a generic version of a patented medicine for export under special WTO provisions agreed in 2003,'' WTO said. Under WTO rules, countries can issue compulsory licenses to disregard patent rights only after negotiating terms with the patent owners.

Rwanda said originally that it intended to import 260,000 packs of TriAvir fixed-dose combination product of zidovudine, lamivudine, and Nevirapine over two years. The drug is being made in Canada by Apotex Inc., which is calling it Apo-Triavir.

''Both notifications were required for the medicine to be exported to Rwanda,'' WTO said. The accord eases the way for countries with public health problems to import cheaper generics made under compulsory licensing elsewhere when they are unable to manufacture the medicines themselves.

Combivir, made by Britain's GlaxoSmithKline PLC, contains lamivudine and zidovudine. Nevirapine is a generic version of Viramune, made by Boehringer Ingelheim GmbH of Germany.

Boehringer Ingelheim issued a statement saying it ''not only does not object to the grant of this authorization under Canada's Access to Medicines Regime but does support the CIPO (Canada's patent office) decision in this respect.''

Jack Kay, president and chief operating officer of Apotex, said, ''We are doing this on a not-for-profit basis and hope that this lifesaving drug gets to the thousands of patients in Africa dying every month. The Canadian Federal Government must change the process to get quality affordable medicines to those who have no access,'' he said.

Many AIDS patients have developed resistance to older antiretrovirals and now need more expensive second-line drugs. The international aid group Oxfam says the patent-busting procedure is almost never used because developing countries face pressure from rich governments acting on behalf of their drug companies.

Brazil and Thailand have recently issued compulsory licenses to develop cheap generic versions of American AIDS drugs for use domestically, but they have yet to use the notification procedure for exporting the drugs. Industry groups criticized the countries, and the United States later placed Thailand on its copyright watch list. (AP)