Bridges Trade BioResVolume 2Number 16 • 24th October 2002

WTO Stalemate Persists over Developing Country Imports of Generics



WTO Stalemate Persists over Developing Country Imports of Generics

Meeting last week from 14-17 October, delegates from both Geneva-based trade missions and capitals were unable to reach a compromise around compulsory licensing options for developing countries under the WTO’s Doha mandate on Trade-Related Aspects of Intellectual Property Rights (TRIPs) and public health. Despite a Chair’s paper that aimed to reach convergence among Members’ disparate views on the subject, a notable split remained between developed and developing countries (see BRIDGES Weekly, 25 September 2002).

According to paragraph 6 of the Doha Declaration on the TRIPs Agreement and Public Health, the TRIPs Council must find a solution to the problems countries may face in making use of compulsory licensing (i.e. circumventing IP rights, for instance by producing generic versions of licensed pharmaceuticals) if they have too little or no pharmaceutical manufacturing capacity. The TRIPs Council is mandated to report to the WTO General Council on this by the end of 2002. Article 31(f) of the TRIPs Agreement says production under compulsory licensing should be predominantly for the domestic market. However, many developing countries facing public health problems are unable to produce pharmaceuticals with their existing domestic capacity.

Chair’s proposal

At the meeting, TRIPs Council Chair Amb. Eduardo Pérez Motta (Mexico) tabled a proposal (”Possible elements of a Paragraph 6 Mechanism”) that aimed to bridge the gap between Members’ positions. Developing countries are seeking greater leeway in their ability to import pharmaceuticals from the cheapest source, while developed countries, particularly the US and Switzerland, are loathe to grant patent-free pharmaceutical access to all developing countries.

The Chair’s proposal suggested, inter alia, that least-developed countries (LDCs) could have automatic access to the cheapest source of drugs, while other developing countries could use the system if they proved they did not have adequate pharmaceutical industries of their own. This was rejected by the Africa group of countries — who were supported by Brazil and India — who said all developing countries should have the right to use the cheapest source for drugs, regardless of patent rights.

According to sources, most developing countries objected to any Member being ruled ineligible in advance, and several objected to a decision that would create “new categories” of Members at the WTO. Countries such as Hong Kong and Singapore — while classified as developing countries at the WTO — said they would oppose criteria based on such things as income levels, while Hungary and Bulgaria expressed their concern that transition economies with lower incomes should not be excluded from access to cheap medicines.

For its part, Brazil was concerned that the talks were backsliding. “We’re going backwards,” said one Brazilian delegate. “They [the Quad group of Canada, the EC, Japan and the US] are trying to put in language that would be more restrictive than what now exists under TRIPs. It doesn’t look very good.” The delegate was referring, inter alia, to an attempt by the Quad to restrict foreign suppliers of generic medicines produced under compulsory licenses to those located only in developing countries. Developing country sources said the Quad proposal seemed aimed at restricting the ability of generic producers in industrialised countries to produce for developing countries, thereby reducing the possibility of medicines being illegally diverted to rich country markets.

While the chair said his paper was an effort to present a balanced basis for further work, Cuba, Ecuador and Venezuela said they felt the consultations had not been as transparent and inclusive as they would have liked. The Chair responded by saying that any delegation wanting to participate in the consultations was free to contact him, and that this practice would continue, with the aim of producing a proposal by the next formal TRIPs Council meeting on 25-27 November (the last meeting scheduled for this year). A group of developing countries including Cuba, India and South Africa said it would also prepare a document for the discussions.

Although the issue is intended to be resolved by the end of this year, developing countries say the delay could stall overall negotiations.

The General Council, to which the TRIPs Council must report its progress on compulsory licensing, is scheduled to convene on 9-11 and 13 December.

For further information on TRIPs and pharmaceuticals, visit: http://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm. For the Doha mandate on TRIPs and Public Health, visit: http://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm#trips.

ICTSD reporting; “Developing Countries Accuse Quad Group Of Seeking New Bars on Access to Medicines,” WTO REPORTER, 17 October 2002; “WTO members delay patent decision,” IAFRICA.COM, 17 October 2002.