1 WTO and medicines: from Doha to Cancún Germán Velásquez Essential Drugs and Medicines Policy World Health Organization Geneva, October 2003

2 Failure of the WTO Ministerial Conference September “(…) instead of global rules negotiated by all, in the interest of all, and adhered to by all, there is too much closed-door decision-making, too much protection of special interests (…) and the victims can be counted in the billions.” (1) (1) Message of the UN Secretary-General, Kofi Annan to WTO Ministerial Conference in Cancún, 10 September 2003

3 The TRIPS Agreement and medicines Patent protection for pharmaceutical products Reinforcement of patent process 20 year minimum duration Transitional periods with exclusive marketing rights Enforcement

4 TRIPS/Public Health tensions HIV epidemic - pricing of ARVs Challenge to South Africa Law (compulsory licences and parallel imports) USA/Brazil on compulsory licences Bilateral trade/IPR agreements

5 Safeguards in TRIPS for public health Parallel imports Exceptions to exclusive rights (“Bolar”) Compulsory licences Government non-commercial use Extension of the transitional periods

6 WTO Doha/Health Negotiations On 14 November 2001, WTO Members issued the historic Doha Declaration on the TRIPS Agreement and Public Health

7 Calls for: Interpretation and implementation of the TRIPS Agreement to support WTO Members’ rights to protect public health, particularly access to medicines. The Doha Declaration...

8 Paragraph 6 of the Doha Declaration The Council for TRIPS must: Find a solution to the problem of WTO Members with insufficient or no pharmaceutical manufacturing capacity; Report to the General Council before the end of 2002.

9 Pending Problem of Paragraph 6 Permission for third parties to make, sell and export patented medicines and other health technologies to address public health needs

10 The Council for TRIPS: Held five formal meetings and several informal discussions (post-Doha to end 2002); Failed to reach a consensus.

11 30 August 2003 Decision on Paragraph 6 In good faith to protect public health and … not for industrial or commercial objectives Need to establish the lack of manufacturing capacity Notification to Council for TRIPS (name, quantity, period) and website 2 compulsory licences (importing and exporting country) Compulsory licence only to export specified amount Specific labelling or marking measures to prevent re-export Compensation

12 30 August 2003 Decision on Paragraph 6 Is the “decision” a “solution” ? Implementation will tell us...

13 International Community Responsibility Ensure that medicines and vaccines are affordable and accessible to the millions of people who need them

14 Next steps... We must monitor the implementation of the decision to ensure: Stability to guarantee its longevity; Transparency; Simple and speedy legal procedures; Equal opportunities for countries needing medicines; Facilitation of a multiplicity of potential suppliers; Broad coverage in terms of health problems and range of medicines.