Drug Access Waiver Debate Looms For June TRIPS Council Meeting

Following weeks of consultations, World Trade Organization members are set next week to discuss a proposal to review a little-used amendment of WTO intellectual property rules aimed at boosting availability of affordable medicines in developing countries.

Increasing access to pharmaceuticals is a crucial issue in many developing countries and is being discussed at several international fora. A waiver to the WTO intellectual property rights agreement is at the heart of one such discussion as a large number of member states are asking for an assessment of the use of this underutilised waiver, while a few others deem an evaluation superfluous.

Since the last meeting of the WTO Council on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in March, the Council Chairman Martin Glass of Hong Kong, has been holding informal consultations on a proposal to hold a workshop evaluating the so-called “paragraph 6” amendment. Consultations were to continue up to the next TRIPS Council meeting on 8-9 June, and may come to a head at the meeting.

Paragraph 6 refers to the 2001 WTO Doha Declaration on TRIPS and Public Health. It provides a mechanism to facilitate access to cheaper generic medicines for countries with no pharmaceutical manufacturing sector. It waives the obligation stated in TRIPS Article 31(f) reserving production of drugs under compulsory licensing to be predominantly for the domestic market, allowing more pharmaceutical products under compulsory licences to be exported to countries lacking production capacity.

WTO members had been unable to agree on a workshop to evaluate paragraph 6 during the March TRIPS Council and Glass said he would hold informal consultations on the issue (IPW, Public Health, 2 March 2010). On 6 May, several countries met with Glass in an informal consultation to discuss the workshop. Angola, Bolivia, Brazil, China, Colombia, Cuba, Ecuador, Egypt, India, Indonesia, Peru and Venezuela took part in that consultation, according to participants.

The paragraph 6 mechanism was agreed in August 2003 and made a permanent amendment to TRIPS in December 2005. But to date it has been used only once. Canada amended its national legislation in 2004 and established the Canada’s Access to Medicines Regime (CAMR) in order to use the mechanism. Apotex, a Canadian generic manufacturer, asked for a compulsory licence to make two shipments of AIDS medicines to Rwanda (IPW, Public Health, 1 March 2010). The company said it would not use it again because of the time and difficulty involved.

Civil society groups in Canada said that CAMR was unlikely to be used again because its mechanism is hard to use and have been actively advocating a change in the current legislation. “CAMR is an unnecessarily cumbersome and restrictive means of implementing the WTO decision,” Richard Elliott, executive director of the Canadian HIV/AIDS Legal Network, told Intellectual Property Watch.

According to officials from Brazil, Ecuador and India, during the 6 May informal consultation, there was consensus among participants on the necessity to have a workshop to hold a very technical and documented discussion on the paragraph 6 mechanism, based on previous experience of its use and on the mandate agreed by the WTO General Council on 30 August 2003, when the TRIPS waiver was agreed.

In the consultations, “a number of interested delegations took the opportunity … to express their views, inter alia, on how to take forward consideration of the operation of the paragraph 6 system, including the question of a workshop or similar gathering,” Glass told Intellectual Property Watch. “It is my current intention to continue such informal contacts in the run-up to the Council meeting on 8 and 9 June and report the views thus gathered for the Council’s further deliberation.”

The countries wish to hold a “very objective” workshop on the subject and draw some conclusions, said an official from a proponent country. A technical discussion would be desirable, with the inclusion of stakeholders such as Apotex and Médecins Sans Frontières, which were involved in the previous single use of paragraph 6, said the official.

But the participation of other stakeholders has brought reservations from some countries, the source said.

It is necessary to examine why this mechanism has only been used once, said a Brazilian official who posed the question whether it is because the mechanism is too difficult, or because there is no interest.

According to an Indian official, although during some February consultations there was consensus for a workshop, at the March TRIPS Council, the United States, Japan and Switzerland suggested there really was no need to hold a workshop and it was proposed to wait until the October TRIPS Council in which paragraph 6 is a regular agenda item to discuss the matter. However, some developing countries are very keen to discuss paragraph 6 now, such as the Africa Group, the least developed country group, Brazil, China, Ecuador, India, Indonesia, Peru and Venezuela. They are asking for an agenda item for the June TRIPS Council meeting, and they expect the request will be met with a discussion on the topic, he told Intellectual Property Watch.

“Most countries of the world do not have manufacturing capacities,” but all of them need drugs, he said. Paragraph 6 could be providing a solution to that problem.

India is a world leader in the fabrication of standard generic drugs.

Civil society is in favour of an assessment and revision of the paragraph 6 mechanism so that it is easier to use. Paragraph 6 is “unnecessarily cumbersome; this is something that we and many other NGOs and health advocates have said all along, from the time it was adopted,” said Elliott, “It should be revisited and streamlined.”

There is no doubt that paragraph 6 “is constraining, but how constraining depends on how narrowly or how flexibly WTO members choose to interpret it,” Elliot said.