A topic that has received increasing attention in recent years is the question of access to medicines under the TRIPS Agreement. The primary concern is the extent to which patent protection in the pharmaceutical sector has negative consequences for getting medicines for life-threatening diseases to developing countries. The WTO Doha Ministerial Conference in November of 2001 adopted a declaration addressing this problem (Declaration on the TRIPS agreement and public health of 14 November 2001 – Doha Declaration). The Declaration calls attention to the flexible solutions provided by the TRIPS Agreement to fight diseases such as HIV/AIDS, tuberculosis and malaria and to assure that the necessary medicines are supplied. In particular, Member States of the TRIPS Agreement can grant compulsory licenses for the production of patent protected medicines. However, the medicines may only be used for the domestic market and not for export. In 2003, the WTO General Council decided to make access to patent protected medicines easier for countries with insufficient domestic manufacturing capacities in the pharmaceutical sector (WTO General Council Decision of 30 August 2003).

In the run-up to the 6th WTO-Ministerial Conference (Hong Kong, December 13-18, 2005) the 149 Members of the WTO agreed on December 6, 2005 on an amendment of the WTO TRIPS Agreement in order to improve access to affordable medicines for developing countries facing a serious public health problem.
Through the amendment, WTO Members will be allowed to grant a compulsory license for the production and the export of patented pharmaceuticals to countries which have no or insufficient manufacturing capacity in the pharmaceutical sector and that are confronted with a public health problem (IP/C/41, pdf 99 KB). This amendment formally translates a Decision of the General Council (GC) of the WTO of August 30, 2003 into the TRIPS Agreement. The GC Decision of 2003 already provided for the possibility of granting such compulsory licences for export purposes by waiving the application of the relevant provisions of the TRIPS Agreement. In accordance with its humanitarian tradition, Switzerland is in the process of implementing the new flexibility within the framework of its current patent law revision in order to put the Swiss production capacities at the disposal of developing countries in need. The Protocol of the revised TRIPS Agreement is open for acceptance by WTO Members until 1 December 2007.

WTO facilitates access to drugs for developing countries - Switzerland ratifies amendment of the WTO/TRIPS Agreement. Media release in German (pdf 22 KB), French (pdf 22 KB) or Italian (pdf 21 KB).

Article published in the New Gazette of Zurich of 11 September 2003, p. 17: "Mehr Generika für die Dritte Welt: WTO-Vereinbarung als Tropfen auf den heissen Stein?" in German (pdf 183 KB).

WTO breakthrough on access to medicines for developing countries: What next ? (English adaptation of "Le Temps" article of 5 September 2003 "Les médicaments bon marché ne suffiront pas à améliorer la santé dans les pays pauvres", pdf 84 KB) .

Switzerland welcomes the WTO decision to improve access to medicines (Press release, September 1 2003, in French or German, pdf 64 KB).

Switzlerland and the WTO Negotiations on Easier Access to Medicines for Developing Countries (Press release in German or French, pdf 70 KB) of 22 December 2002).

Use of compulsory licenses by WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector: Switzerland favours an efficient, equitable and legally secure solution (Non-paper by Switzerland, dated 13 September 2002, pdf 154 KB).

On July 1, 2002, the TRIPS Council adopted a decision to conditionally extend the transition period for least-developed Members to fulfill certain obligations regarding pharmaceutical products. Under the decision, they will only be required to guarantee patent protection and test data protection in pharmaceuticals after January 1, 2016. IP/C/25.

Statement of Switzerland (pdf 8 KB) of March 2002, as transcripted in the Minutes of the TRIPS -Council Meeting prepared by the WTO Secretariat.

Swiss Contribution (pdf 13 KB) to the Meeting of the TRIPS Council, June 18 – 22, 2001.

Swiss Federal Institute of Intellectual Property
Mathias Schäli
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