European Commission (DG 1) note on the WHO's Revised Drug Stategy



Directorate D -Sectoral trade questions, market access
New technologies, Intellectual property, public procurement

Brussels, 5 October 1998
1/D/3/BW D (98)

Note for the Attention of the 113 Committee (Deputies)

Subject: WTO TRIPS/World Health Organisation (WHO) -Revised Drug Strategy;
meeting of the "ad hoc working group" on 13 to 16 October 1998

I. Background

On 27 January 1998 the Executive Board of the WHO produced a recommendation, without preparatory examination in any WHO body, that the Fifty-first World Health Assembly adopt a resolution on a "Revised Drug Strategy" at its meeting in May 1998.

The following paragraphs, relevant to the TRIPS Agreement, were contained in the recommendation:

The Executive Board recommends [...] the adoption of the following resolution:

The Fifty-first World Health Assembly,

"concerned about the situation in which one third of the world's population has no guaranteed access to essential drugs, in which new world trade agreemeents may have a negative impact on local manufacturing capacity and access to and prices of pharmaceutical products in developing countries and in which poor quality pharmaceutical raw materials and finished products continue to move in international trade";

urges [WHO] Member States: "to ensure that public health rather than commercial interests have primacy in pharmaceutical and health policies and to review their options under the TRIPS Agreement to safeguard access to essential drugs" and

requests the Director -General: - "to assist Member States to analyse the pharmaceutical and public health implications of agreements overseen by the WTO and to develop appropriate policies and regulatory measures".

The draft resolution was the subject of considerable concern among the pharmaceutical industry (e.g. IFPMA - International Federation of Pharmaceutical Manufacturers Associations, EFPIA -European Federation of Pharmaceutical Industries and Associations), in EU Member States as well as like-minded WHO Members (e.g. U.S.A.).

On 3 April 1998 the issue was discussed in the 113 (Deputies) meeting in Brussels and it was concluded that no priority should be given to health over intellectual property considerations in particuar in light of the absence of any evidence of conflict between the two. On that basis, the Community and EU-Member States pursued a coordinated approach in the meetings at the WHO. Long lasting drafting sessions were held without WHO members reaching an agreement on the wording of a resolution on a "Revised Drug Strategy". The original Executive Board recommendation was strongly pushed by South Africa (supported by Zimbabwe, Malawi, Swaziland and Lesotho, but not strongly, or at all, by countries outside this region) and opposed by other WHO Member States. As a result, some critical and fundamental points could not be resolved e.g., the attribution of precedence to public health over commercial considerations in a confrontational style. Finally, a compromise was found through a procedural solution: action on this issue was postponed until 1999 and the Executive Board was mandated to produce a work programme. This work programme was designed to deliver a more acceptable proposal for adoption by the World Health Assembly in 1999. The Executive Board decided (for details see Annex) "to establish an open-ended ad hoc group to explore the many complex issues raised by EB 10 I.R 24 [="Revised Drug Strategy"] on the revised drug strategy". This ad hoc group meets on 13 to 16 October 1998 for the first time in Geneva.

II. Line to take Although this issue is not entirely trade-related it clearly has an impact on WTO TRIPS implementation. Therefore, it is important that EU Member States continue to pursue a coordinated approach (in correspondence with previous practice EU-coordination in Geneva, close cooperation Commission/Presidency).

With respect to the substance of a resolution on a "Revised Drug Strategy", any language should take into account the following considerations: A "high level of health protection" is a fundamental objective of the Community and its Member States 1 and reflected in the TRIPS Agreement 2. However, this should not be used to negate the protection of intellectual property. On the contrary, intellectual property is a means to "achieve health protection", e.g. via effective patent protection.

1. Article 3 (0) Maastricht Treaty : "The activities of the Community shall include [...] a contribulion to the attainment of a high level of health protection."

2. Articlc 8 states as a principle that "Members may. in formulating or amending their laws and rcgulations. adopt measures necessary to protect public health and nutrition [...]".