WTO Reexamines Compulsory Pharmaceutical Licensing

According to William New writing for Intellectual Property Watch on October 25, 2005, one of the key issues being addressed at a meeting of the World Trade Organization committee responsible for intellectual property rights matters are various proposals for a permanent amendment to the TRIPS agreement that would allow WTO members to import and export patent-protected pharmaceuticals made under compulsory license.

According to the WTO's frequently Asked Questions on TRIPS and Health, Article 31 of the TRIPS Agreement allows domestic compulsory licences to be granted mainly to supply the domestic market. However, the subsequent 2001 Doha Declaration on TRIPS and Public Health stated that countries unable to manufacture the pharmaceuticals could obtain cheaper copies elsewhere (from exporters) if necessary. The legal means of making that change ocurred on August 30, 2003 when the General Council decided to waive the TRIPS provision, allowing generic copies made under compulsory licences to be exported to countries that lack production capacity, provided certain conditions and procedures are followed.

According to the WTO, "the waiver on its own is not enough." To use the system, potential exporting countries probably have to change their laws too. This is where their laws complied with the original TRIPS provision by requiring production under compulsory licensing to be predominantly for the domestic market. So far Norway, Canada and India have informed WTO members (through the TRIPS Council) that their new laws and regulations are in place. The EU, Switzerland and Republic of Korea have said they are close to completing the legislation.

However, as part of the 2003 waiver, a group of 23 developed nations plus 10 new members of the European Union, agreed not to use the waiver for import with an eye toward keeping out cheaper generic versions of the patented drugs. Some non-governmental groups have raised fears that the opt-out of the 2003 waiver means that these developed countries cannot import drugs necessary to address an emergency such as an avian flu pandemic.

In light of Avian flu outbreaks, India has begun exploring the compulsory licensing of Roche's Tamiflu (oseltamivir) for the domestic market as well as for export. According to the Wall Street Journal's Avian Flu News Tracker, Roche has reportedly warned countries not to make their own generic versions of Tamiflu without permission from the Swiss drug maker. "It needs special knowledge, special know-how to produce this drug," Roche spokeswoman Martina Rupp said. "Since we have been making this drug for the last 10 years, it would be best for countries to enter into a discussion with us." However, Taiwanese health officials reported that they've created a homegrown version of Tamiflu in just 18 days. Sweden's Medical Products Agency said that it will limit pharmacy sales of Tamiflu to ensure there won't be a shortage of the flu drug.