Debate On Malaria And Trade Flexibilities At WHO

Tove Iren S. Gerhardsen | 06 Feb 2007
Intellectual Property Watch
A recent top-level meeting of the World Health Organization discussed member states' rights to address malaria using flexibilities in international trade and intellectual property law. But there was strong disagreement as to how far this language should go, according to sources.

At the 22-30 January WHO Executive Board meeting, some developing countries wanted a draft agreement to include language urging WHO member states to include in their national laws flexibilities found in international law - which allow, under certain conditions, the bypassing of patents - in order to access anti-malarial medicines, sources said.

The United States referred to language in an earlier, already agreed resolution (WHA57.14), which says member states should consider, when necessary, adapting national legislation to allow them to use trade law IP flexibilities. But it did not want to link this directly to proposed language on access to medicines and technologies, sources said.

Several versions of the language appeared during the meeting. The language on access appeared directly linked with flexibilities in a 25 January draft, but these points were broken into two paragraphs in a draft version from 1 February 2007 (EB120.R16).

The World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which contains flexibilities, was mentioned in the earlier conference paper entitled, "Malaria, including a proposal for establishment of World Malaria Day" (EB120/Conf.Paper No. 8).

A 25 January version of the draft resolution (containing amendments proposed by delegations to draft resolution contained in EB120/5) urged member states, "to provide in their legislation for use to the full of the flexibilities contained in the agreement on TRIPS in order to increase access to anti-malarial medicines, diagnostics and preventive technologies" (Article 1.3).

The TRIPS agreement allows for a government to issue a compulsory license and thereby use a patented subject matter without the consent of the patent holder in times of a national emergency, extreme urgency or for public non-commercial use, according to TRIPS Article 31.b.

"It was agreed that the resolution goes to the 69th World Health Assembly with the two wordings for discussion at the assembly," Dr James Nyikal, director of medical services at the Kenyan Ministry of Health, told Intellectual Property Watch. "We were not satisfied with this," he said. "We would have preferred a clear decision at the board level, how we shall pursue the matter further at the assembly in May 2007."

WHO declined to comment on the EB discussions or the process of the draft resolution, and it is unclear what exact status document EB120.R16 has. But WHO said that the debates would be taken onboard and a new draft on malaria, with the changes incorporated, would be ready by the assembly in May.

A government source told Intellectual Property Watch that the United States proposed agreed language on TRIPS from an earlier agreed-to resolution, WHA57.14, in order to find consensus. This paragraph urges member states to: "consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights" (Article 2.4).

The United States agreed to refer to "anti-malarial medicines, diagnostics and prevention technologies" - but not linked to the TRIPS language found in WHA57.14, the government source said.

The 1 February draft version (EB120.R16) of the malaria resolution now contains the TRIPS language from the earlier resolution in one paragraph, which, "Urges member states ... to consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the Agreement on TRIPS," (Article 1.5).

The 1 February draft then contains a separate paragraph mentioning medicines:

" ... to aim at reducing transmission risk-factors through integrated vector management, promoting improvement of local and environmental conditions and healthy settings, and increasing access to health services, anti-malarial medicines, diagnostics and preventative technologies in order to reduce the disease burden," according to EB120.R16.

Earlier versions, including one from 29 January, still showed the two issues together in the same paragraph. Some countries argue the linking of the two issues is one of the options before the assembly.

Kenya and the United States

Kenya and the United States were particularly involved in the discussions, sources said. "Kenya wanted a language that 'urges' member states to 'include' in their legislation TRIPS agreements in order to improve access to anti-malarial drugs, diagnostics and technology," Nyikal said.

Dr Ahmed Ogwell, head of international health relations at the Ministry of Health in Kenya, said that Kenya "vigorously" supported including language referring to compulsory license in the malaria resolution. "Too many people, especially women and children, are dying of malaria while solutions exist and are only inaccessible due to cost," he said.

According to WHO, "Malaria is an infection caused by a parasite and carried from person to person by mosquitoes. It is preventable and curable but kills more than one million people - most of them young children living in Africa - each year."

The resolution also proposes that 25 April be commemorated annually as Malaria Day, and mentions the "substantial resources" available from a variety of organisations.

Tove Iren S. Gerhardsen may be reached at