Understanding patents

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
Arent generics illegitimate?
Who paid for the RD 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 RD
6
Wrong assumption 3 The pharmaceutical industry
will suffer from generic competition

• Africa represents only 1.3 of the pharmaceutical
  market, and according to pharmas 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 dont (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
Bushs 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_at_yale.edu
• www.geocities.com/medicinepolicy
• Ustr_action-subscribe_at_yahoogroups.com