Barriers to generic drug entry in developing countries Asia Russell Health GAP Coalition www'healthg

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Barriers to generic drug entry in developing
countriesAsia Russell Health GAP Coalition
www.healthgap.org
TACD Committee on Intellectual Property
Meeting on the Impact of Intellectual Property
Rules on Consumers of Health Care
Services October 31-November 1, 2002
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NGO founded by U.S. HIV/AIDS, human rights and
fair trade activists Campaigns for changes to
United States Administration and to US
corporations policies obstructing access in poor
countries to affordable medicines to treat HIV
Campaigns for resources (money, technology
transfer, other investments from governments and
private sector) from donor countries to sustain
medicines and treatment access in poor countries
and Educates and mobilizes the grassroots
thousands of people living with HIV and other
health care consumers in the United States
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Pressuring decision makers 1999
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Essential medicines are not luxury goods,
reserved for the wealthiest of the world
but are too often priced like them, causing
preventable suffering and death.
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Defining the problemThe people with HIV are
where the drugs are not.
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Realities AIDS death rates drop in the U.S. and
other rich countries
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But life expectancy plummets in Africa.
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Barriers to generic drug entry

• Pressure from the U.S.
• Current (FTAA, new bilateral agreements, etc.)
• Stain of recent past
• TRIPS export restrictions
• Patent protection in key countries where
  production is necessary for manufacturers to
  achieve economies of scale (eg South Africa,
  Botswana)
• Patent protection of key second-line therapies
• Industry-driven technical assistance
• Accelerating Access Initiative distraction from
  sustainable, coherent, patient-driven solutions

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New trade agreements
USTR position will undermine achievements of
Doha IP rules are TRIPS plus--industry effort
to expand on already strict WTO rules Proposed
FTAA comprises developing countries capable of
production for export spillover affect outside
South America
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Technical assistance whose agenda?

• US AID and other donor development assistance
  agencies contract with consulting firms that
  prioritize patent rights over patient rights
• Procurement policies require purchase from
  originator companies
• More intellectual property protection is not
  always better--can WIPO abide by this pro-public
  health standard?
• Anything less is malpractice
• WIPO is inexpert in technical assistance when it
  impacts health and medicines access

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WHOs Accelerating Access Initiative

• Any new access to medicines is good, but
• Power in the hands of Pharma negotiators
• Slow, non-transparent, redundant, cumbersome (11
  countries, 2 years, only 22,000 people)
• Conditional, exclusionary price reduction
  programs
• WHO as broker for initiative that contravenes
  rational and just public health guidelines
• Advocates press for multiple suppliers and
  generic competition to achieve prices as close as
  possible to the marginal cost of drug
  production--quickly!

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Pressuring decision makers 2002
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Overcoming barriers

• Practical tools
• Implementation of the Doha Declaration on TRIPS
  and Public Health at national level
• WHO Pre-qualification Project
• Non-exclusive voluntary and non-voluntary
  licenses for public and private sector
• Pro-public health policies
• Advocacy for rational procurement policy of the
  Global Fund to fight AIDS, TB, and Malaria, and
  for efficient procurement of generic medicines
• Monitoring donor pressure on GF recipient
  countries

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Overcoming barriers contd

• Pro-public health policies
• Doha standard must not be exceeded in new trade
  agreements use Kennedy Amendment to Fast Track
• Demanding procurement of generics by corporations
  beginning to treat their workers
• Support grassroots advocacy for compulsory
  licenses with special attention to fixed dose
  combination medicines that simplify treatment
• Advocate for pro-public health solution to
  production for export problem

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Declaration on the TRIPS Agreement and Public
Health

• We agree that the TRIPS Agreement does not and
  should not prevent Members from taking measures
  to protect public health. Accordingly, while
  reiterating our commitment to the TRIPS
  Agreement, we affirm that the Agreement can and
  should be interpreted and implemented in a manner
  supportive of WTO Members' right to protect
  public health and, in particular, to promote
  access to medicines for all.

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A word on money

• 40 million currently infected UNAIDS predicts
  the pandemic is in its infancy almost 30
  million living with HIV in sub Saharan Africa
• Scarce, finite resources mean waste is criminal
• Cheaper generics stretch limited resources
  further prioritizing human rights over patent
  rights is a matter of life and death
• The Bush Administrations contributions to the
  Global Fund rank the US last among rich countries
  when assistance is measured as percent of GNP
• U.S. stinginess requires high level attention to
  overcoming barriers preventing generic drug access

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Compare and contrast

• Rwanda gives 1 million to Global Fund
• US gives 200 million to Global Fund
• Making Rwanda more ten times more generous,
  proportionately

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Unfinished Business at the WTO

• 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.

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TRIPS Agreement looking past Doha

• U.S. and EU currently blocking a good-faith,
  workable solution
• An unworkable solution will call into question to
  ability to strike a balance between IPRs and
  public health if the present form of TRIPS is
  upheld
• Lack of resolution on para 6. issues will beg the
  question of the need to reform the Agreement in
  favor of those who bear the greatest burden from
  lack of access to medicines