1

WTO and medicines: from Doha to Cancún

Germán VelásquezEssential Drugs and Medicines Policy

World Health OrganizationGeneva, October 2003

2

Failure of the WTO Ministerial Conference September 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

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.