Rwanda launches key test of WTO drug patent waiver

Fri Jul 20, 2007 10:24am EDT

(Adds background paragraphs 5-6, Oxfam paragraphs 9-10)

By Laura MacInnis

GENEVA, July 20 (Reuters) - Rwanda plans to import a generic HIV/AIDS medicine made in Canada, making it the first country to test a World Trade Organisation waiver on drug patents, the WTO said on Friday.

In a filing to the global trade arbiter, Rwanda said it intended to import 260,000 packs of TriAvir, a fixed-dose antiretroviral drug made by Apotex Inc., a Toronto-based generic drugmaker, over the next two years.

The central African nation invoked a never-before-used August 2003 waiver to WTO's intellectual property rules, meant to allow poor countries with public health problems to import generics when they cannot manufacture the drugs themselves.

Development campaigners such as Oxfam have criticised "the paragraph 6 solution," as the waiver is often called, as being too burdensome because of its onerous reporting rules and because it requires would-be exporters to negotiate with drug patent holders for the right to sell generics abroad.

Under WTO rules, countries can issue a "compulsory license" to manufacture generic versions of patented drugs deemed critical to public health so long as the medicines are meant to be distributed domestically.

Thailand has over the past year issued compulsory licenses for generics for its own market, meaning it did not need to notify the WTO as Rwanda has. Drugmakers often reduce prices to keep countries as clients and avoid compulsory licensing.



DIFFICULT PROCEDURES

The WTO's 150 member states have until December to ratify a decision to make the waiver a permanent amendment of the TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement, but until the Rwandan move, no country had used it.

European Union lawmakers this week delayed endorsing the mechanism, saying it was too cumbersome and restrictive to deal with poor nations' problems accessing drugs to combat HIV/AIDS, malaria and other diseases that kill millions every year.

Celine Charveriat, head of Oxfam's Make Trade Fair campaign, said that Rwanda's experience may determine the future for the WTO waiver designed to improve access to medicines for the poor.

"We hope that Rwanda's action will lead to an increase in the number of poor people who can get antiretrovirals. If found unworkable, the provision must be changed," she said.

Pascale Boulet, a legal advisor for Medecins Sans Frontieres (Doctors Without Borders) and its Access to Essential Medicines campaign, said developing countries have been reticent to use the "paragraph 6" system because of its difficult procedures.

Boulet said the aid group would follow the Rwandan case with great interest to see if the medicine it wants from Apotex does reach the country, where about 3 percent of the population is infected with HIV/AIDS.

"It is important to keep in mind that this is just one shipment of one product for Rwanda," she said, stressing the WTO mechanism had a very limited scope.

"It is a system that works on a country-by-country and case-by-case basis. It may indeed respond to the needs of Rwanda for this specific medicine but this is not a solution to the broader problem."




Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.