WTO and medicines: from Doha to Cancún

1. WTO and medicines: from Doha to Cancún Germán Velásquez Essential Drugs and Medicines Policy World Health Organization Geneva, March 2004

2. Failure of the WTO Ministerial Conference, Cancún, Sept. 2003… • “(…) 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. TRIPS/Public Health tensions • HIV epidemic – pricing of ARVs • Challege to South Africa Law (compulsory licences and parallel imports) • USA/Brazil on compulsory licences • Bilateral trade/IPR agreements

4. 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

5. Safeguards in TRIPS for public health • Parallel imports • Exceptions to exclusive rights ("Bolar") • Compulsory lincenses • Government non-commercial use • Extension of the transitional periods

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

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

8. Paragraph 6 of the Doha Declaration The Council for TRIPS should have: • Found a solution to the problem of WTO Members with insufficient or no pharmaceutical manufacturing capacity; • Reported 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 othe 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. The Paragraph 6 Decision • WHO is content with the consensus reached • Is the Decision a solution? Its implementation will tell us … • WHO will follow and support countries during its implementation.

12. 30 August 2003 Decision on Paragraph 6 • A good decision? • A solution?

13. 30 August 2003 Decision on Paragraph 6 • In good faith to protect public health and … not for industrial or commerical objectives • Need to establish the lack of manufacturing capacity • Notification to Council for TRIPS (name, quantity, period) and website • 2 CL (importing and exporting country) • Compulsory lincense only to export specified amount • Specific labelling or marking measures to prevent re-export • Compensation

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 multiplicity of potential suppliers; • Broad coverage in terms of health problems and range of medicines

15. 2 years of negotiations... • Many new actors: NGOs, media and communications, other agencies and UN agencies; • The legal trade debate has become an ethical and human rights issue; • The response is still insufficient and extremely slow ...

16. The future of the debate must pass through ... • The ethical aspects of the problem • The ED as a public good • Access to ED as a human right • Alternatives to R & D based on the real health problems...