Understanding patents & medicine access

1. Understanding patents & medicine access the WTO, free trade agreements & patent law

2. Key terms • The World Trade Organization (WTO) • Trade-Related Aspects of Intellectual Property Rights (TRIPS) • Compulsory licensing: government gives compan(ies) permission to produce generics • Parallel importing: countries resell patented drugs to other countries

3. Aren’t generics illegitimate? Who paid for the R&D on AIDS drugs? Taxpayers did. Source: Harvard Med, 2000

4. Wrong assumption #1: High price = High production cost Source: Doctors Without Borders, 2001

5. Wrong assumption #2: Profits are going into R&D

6. Wrong assumption #3: The pharmaceutical industry will suffer from generic competition • Africa represents only 1.3% of the pharmaceutical market, and according to pharma’s own employee, providing drugs for free in Africa would amount to little more than “three days fluctuation in exchange rates” (Washington Post, 2001) • Generic drugs have been produced cheaply in India for two decades, without infiltrating or undermining Western markets (Oxfam, 2003)

7. Pharma Profit Levels:

8. Pharma profit levels:

9. Problems with getting generics to the poor • The US Trade Representative (USTR) has threatened countries with trade sanctions if they try to import generics (Oxfam, 2002) • Even when not threatened, importing only patented drugs (without generic competition) reduces prices marginally, without helping most people (MSF, 2001) • Compulsory licensing helps more, but current rules make it almost impossible unless a country has pharmaceutical production facilities …most poor countries don’t (WTO, 2001)

10. A solution: the Doha Declaration • Trade ministers signed this agreement to fix the problems: • Preventing the USTR from threatening countries: “the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health” • Helping poor countries: “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. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.”

11. Did it work? • Before the deadline to potentially allow poor countries without manufacturing facilities to import generics: • The USTR called a private meeting in Sydney and threatened other countries that it would withdraw from its agreements on other issues (CPTech, 2002) • At the WTO Council Meeting weeks later, the USTR, under direct instructions from the White House, argued that the Doha Declaration was incorrectly written, and could not be enacted as planned (Financial Times, 2002) • Instead of finding a “solution”, the meetings broke down because the USTR refused to compromise

12. Why fight so hard for big pharmaceutical companies?

13. The scale of political contributions:

14. What happens now? • Many poor countries, which harbor 95% of those infected with HIV, along with thousands of sufferers from other treatable diseases, will not be able to import generic drugs unless this policy changes at the next WTO meeting (MSF, 2003) • On February 10th, the WTO council meeting will begin to decide if this will be allowed • Meanwhile, the USTR is trying to slip in stronger anti-generic rules into a Western hemisphere trade act called the Free Trade Area of the Americas (FTAA)

15. Bush’s “Emergency Plan for AIDS Relief” – the plan: • $15 Billion over 5 years for prevention, care, and treatment • Goal: Avoid 7 million new infections, treat 2 million people with ARVs, care for 10 million more. • 14 target countries in Africa and the Caribbean: Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zambia • Based on Uganda model

16. Emergency Plan for AIDS Relief: Critical questions: • What funding will Congress actually approve? And where will it come from? • Pace and coverage? • Bilateral or multilateral? • What kind of prevention programs? • Will treatment programs use generics?

17. TRADE: Our agenda for action • Targeting key White House officials involved in blocking the deal • Targeting Senator Kerry of Massachusetts, favored for the Democratic nomination for President – accepted drug company donations, siding with big pharma on legislation while claiming to support the fight against AIDS • Protest in DC: February 8th

18. FUNDING: Agenda for Action • Focus efforts on the U.S. Senate, especially majority leader Bill Frist (R-TN) and Sen. John Kerry (D-MA) • Call for maximum funding this year • Support directing the funds to Global Fund for AIDS, TB, and Malaria • Leverage contributions from other countries

19. More information Come to Yale AIDS Network meetings: Mondays, 9pm in Dwight Hall Email: amy.kapczynski@yale.edu www.geocities.com/medicinepolicy Ustr_action-subscribe@yahoogroups.com