Dear readers, greetings from the Far East, where I will be for the next month or so. While waiting in Schipol Airport (Amsterdam) for my KLM connecting flight, I came across this very important article in the print edition of the International Herald Tribune on how Rwanda is likely to become the first country to test the WTO's drug patent waiver to import generics. You may have heard of countries such as Thailand and Brazil producing patented AIDS drugs under "compulsory licensing" schemes. The case of Rwanda is slightly different for the country does not have local production capabilities. So, while it too is seeking to override the patents for AIDS drugs for putative health emergency reasons, Rwanda will attempt to import generics for this purpose:Rwanda...will become the first government to use global trade rules to override pharmaceutical patents and import generic drugs.Reuters has a similar story on the matter. It notes that the EU is still undecided on whether to make this scheme a permanent feature of the WTO's TRIPS (trade-related aspects of intellectual property rights) Agreement and that Rwanda will serve as its first test case:The African country said that it expected to buy 260,000 packs during the next two years of TriAvir, a fixed-dose combination of the widely used anti-AIDS drugs lamivudine, zidovudine and nevirapine. The generic product is manufactured in Canada by Apotex.
Under Word Trade Organization rules, countries can issue compulsory licenses to disregard patent rights, but only after negotiating with the patent owners and paying them adequate compensation. An agreement in 2003 allowed poorer countries to import the drugs from abroad if they cannot produce the medicines themselves.
"Because it is not possible to predict with certainty the extent of the country's public health needs, we reserve the right to modify the foregoing estimate as necessary or appropriate," Rwanda said in a letter released Friday by the WTO.
Combivir, made by GlaxoSmithKline of Britain, contains lamivudine and zidovudine. Nevirapine is a generic version of Viramune, made by Boehringer Ingelheim of Germany.
Brazil and Thailand have recently issued compulsory licenses to develop cheap generic versions of U.S. AIDS drugs, among other medicines. Health campaigners praised them, but industry groups criticized the countries, and the United States later placed Thailand on its copyright watch list.
Many AIDS patients have developed resistance to older anti-retrovirals and now need more expensive, second-line drugs. The international aid group Oxfam says that the patent-busting procedure is almost never used because developing countries face pressure from wealthy governments acting on behalf of their drug companies. In a report last year Oxfam said that 74 percent of AIDS medicines were under monopoly, and that 77 percent of Africans lacked any access to AIDS treatment.
"Rwanda is making a bold move," Céline Charveriat of Oxfam, said. "This provision was set up to ensure poor countries get access to affordable medicines."
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.
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."
