WTO and medicines from Doha to Cancn Germn

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

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 decisionmaking, too much protection of special interests (…) and the victims can be counted in the billions. ” (1) Message of the UN Secretary-General, Kofi Annan to WTO Ministerial Conference in Cancún, 10 September 2003

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

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

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

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

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.

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.

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

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

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.

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

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

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

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. . .

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. . .