Transcript Presentation - Consumer Project on Technology

Barriers to generic drug entry
in developing countries
Asia 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
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
Pressuring decision makers: 1999
QuickTime™ and a
GIF decompressor
are needed to see this picture.
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.
Defining the problem:
“The people with HIV are where the drugs are not.”
Realities: AIDS death rates drop in the U.S. and
other rich countries
But life expectancy
plummets in Africa.
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
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
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
WHO’s 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!
Pressuring decision makers: 2002
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
Overcoming barriers: cont’d
• 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
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.”
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 Administration’s 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
Compare and contrast
0.018
0.016
0.014
0.012
0.01
0.008
0.006
0.004
0.002
0
1
2
• Rwanda gives $1
million to Global Fund
• US gives $200 million
to Global Fund
• Making Rwanda more
ten times more
generous,
proportionately
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.”
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