A waiver to World Trade Organization rules intended to aid people in poor countries in gaining access to medicines has remained essentially unused in the over six-and-a-half years since it was put in place. On Friday, member states of the WTO will in an informal meeting discuss this situation and see what, if anything, needs be done.

The 2003 waiver was made an amendment in 2005 within the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to allow for increased export of medicines made under compulsory licences. This was intended to give a helping hand to nations without a domestic pharmaceutical industry, who might have public health needs for a patented and unaffordable medicine they are unable to produce themselves.

Under TRIPS, compulsory licences are meant to primarily serve a national market, but the TRIPS public health amendment (often referred to as the “paragraph 6” solution referring to the Doha Declaration on TRIPS and Public Health) allows countries with pharmaceutical industries to manufacture and export more medicines under a compulsory licence to countries without them, provided certain conditions are met.

The system has been used exactly once since implementation, to make two shipments of AIDS medicines to Rwanda in 2008 and 2009. The Canadian generic drug company involved has said it will not use it again (IPW, IP Burble, 17 September 2009). The majority of WTO member states have yet to accept the protocol.

This was “supposed to be an expeditious solution for public health needs,” one developing country representative told Intellectual Property Watch. But the “general feeling is that this is neither expeditious nor is it a solution.”

At a TRIPS Council meeting on 27-28 October, members of the African Group, the Least-Developed Country Group and several other developing nations including Brazil, Ecuador, India, and Pakistan, said that the lack of use and the lack of acceptance of the decision was an indication that there are problems, and asked for a review to figure out ways to solve those problems (IPW, WTO/TRIPS, 30 October 2009).

But the United States argued that the limited use of the system indicated countries with no domestic manufacturing capacity were getting access to medicines via aid, according to the TRIPS Council report to the WTO General Council in December.

The US objected to a review on grounds that the example of the Canada/Rwanda shipment indicated the system is usable, but in the end allowed consensus to go through on the condition that there be only a single meeting on the issue and that it would have no outcome document except “possibly” reporting to the TRIPS Council what had been said, according to the General Council report.

The 12 February gathering is that one informal meeting.

Developing countries are hoping to see a solution as some think public health is heading in a “very scary” direction in which it is more exposed to the “whims and fancies of the pharmaceutical industry.” There are strong generic versions of many drugs on the market now, but the worry is that future drugs – such as much-needed paediatric formulations or second-line medicines to treat HIV/AIDS – come along there may be no one with the freedom to manufacture them, said a developing country delegate.

In a past interview with Intellectual Property Watch, IP and health expert Ellen ‘t Hoen called the paragraph 6 solution an agreement “gone wrong,” as it is “based on a case-by-case, drug-by-drug, country-by-country process,” conditions under a sustainable generics drug industry cannot be supported.

Meanwhile, there was another informal meeting of the TRIPS Special Sessions, dedicated to the creation of a mandated international register for geographical indications (product names associated with specific places) on wines and spirits on 5 February. This meeting was a chance for new chair of the Special Sessions, Amb Karen Tan of Singapore, to meet member states in her new role. She is temporarily taking over for the previous chair Trevor Clarke of Barbados, who has joined the World Intellectual Property Organization as an assistant director general. The General Council of the WTO will elect a new chair in February.