Wolfson College, Oxford

1
Wolfson College, Oxford

• The TRIPS Agreement and
• Access to Essential Medicines
• Duncan Matthews
• Intellectual Property Research Institute
• Queen Mary, University of London
• 7 October 2004

2
International law and access to medicines

• WTO Agreement on Trade-Related Aspects of
  Intellectual Property Rights (TRIPS) 1994
• Establishing minimum standards of patent
  protection in all WTO Member countries
• Access to essential medicines in developing
  countries antiretroviral drugs

3
Patents for medicines

• patents shall be available for any inventions,
  whether products or processes, in all fields of
  technology
• Article 27(1) TRIPS

4
Compulsory licensing

• reasonable period of time to negotiate a
  licence with the right holder on the basis of
  reasonable commercial terms, but these conditions
  can be waived in the event of a national
  emergency or other circumstances of extreme
  urgency
• Article 31(b) TRIPS
• But

5
The TRIPS Agreement problem

• Generic drugs produced under compulsory
  licensing shall be authorized predominantly for
  the supply of the domestic market of the Member
  authorizing such use
• Article 31(f) TRIPS

6
The TRIPS time bomb

• After 1 January 2005 developing countries will
  be required to extend patent protection to areas
  of technology not protected on the date of
  general application of the TRIPS Agreement
• Article 65(4) TRIPS

7
Increasing awareness of the problem 2001

• South Africa public interest versus the
  pharmaceutical industry
• United States threatens Bayer with compulsory
  licence over price of Cipro

8
Doha Declaration on the TRIPS Agreement Public
Health 14 November 2001

• We recognize that WTO members with insufficient
  or no manufacturing capacities in the
  pharmaceutical sector could face difficulties in
  making effective use of compulsory licensing
  under the TRIPS Agreement.
• Paragraph 6 Doha Declaration

9
WTO Decision on the TRIPS Agreement Public
Health 30 August 2003

• Temporary waiver of predominantly for the supply
  of the domestic market requirement for
  compulsory licences
• Limits on importing countries

10
30 August safeguards

• Anti-diversion measures
• Shared understanding on good faith

11
The future potential problems

• Hindering new research into developing country
  diseases?
• Part of a wider structural problem in development
  policy?
• United States FTAs TRIPS-plus?

12
A stimulus for pragmatic initiatives

• Corporate donations of medicines
• Public private partnerships
• Global Fund to Fight HIV/AIDS, Tuberculosis and
  Malaria