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 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

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 Patent protection for pharmaceutical products Reinforcement of patent process 20 year minimum duration Transitional periods with exclusive marketing rights 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 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

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

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...