Rwanda News Agency/Agence Rwandaise d'Information (Kigali)
21 July 2007
Kigali — Rwanda plans to import a generic HIV/AIDS medicine made in Canada, making it the first country to test a World Trade Organization waiver on drug patents, the World Trade Organisation (WTO) has reported.
In a submission to the WTO by Rwanda, according to its website, the country said it expects over the next two years to buy 260,000 packs of TriAvir, a fixed-dose combination of widely used anti-AIDS drugs lamivudine, zidovudine and nevirapine. The generic product is manufactured in Canada by Apotex Inc.
This essentially means Rwanda has 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.
When contacted about the development, National Aids Commission Executive Secretary Dr. Agnes Binagwaho declined to talk to RNA on phone preferring an arranged interview in her office next month. She said she was at the airport "filling in documents" for her flight.
However after persuasion, she referred RNA to the Ministers of Health. By Press time, RNA could neither establish contact with the Minister Dr. Ntawukuriryayo Jean Damascene nor his deputy - Dr. Nyaruhirira Innocent.
The trade body writes that Rwanda on July 19 2007 became the first country to inform the WTO that it is using the 2003 decision designed to ease the way for countries with public health problems to import cheaper generics. These drugs are made under compulsory licensing elsewhere when they are unable to manufacture the medicines themselves.
The waiver - often referred to as the "paragraph 6 system" covering implementing paragraph 6 of the Doha trade Declaration on the TRIPS Agreement and Public Health.
The Rwanda notification comes under paragraph 2 which requires eligible importing countries to report the details of the medicines they intend to import.
However, the WTO also said as a least-developed country, Rwanda does not have to notify that it wants to be an "eligible importing member" of the 2003 decision (and 2005 amendment decision).
According to Reuters, development campaigners such as Oxfam have criticized "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, Reuters wrote.
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.
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.
Celine Charveriat, head of Oxfam's Make Trade Fair campaign, told Reuters 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.
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