Making Intellectual Property Rules Fair Session on Critical Issues Facing the Poor: What Progress has the world made in fulfilling the basic needs of the poor? - PowerPoint PPT Presentation

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Making Intellectual Property Rules Fair Session on Critical Issues Facing the Poor: What Progress has the world made in fulfilling the basic needs of the poor?

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Title: Making Intellectual Property Rules Fair Session on Critical Issues Facing the Poor: What Progress has the world made in fulfilling the basic needs of the poor?


1
Making Intellectual Property Rules FairSession
on Critical Issues Facing the PoorWhat Progress
has the world made in fulfilling the basic needs
of the poor?
  • James Love
  • Consumer Project on Technology
  • CUTS Partnership Conclave Governance and its
    Relationship with Poverty Reduction
  • 13 March 2003
  • New Dehli, India

2
Who obtains patent protection?PCT Patent
Filings, 2002
 
3
Tim Hubbards demand curve problem
Cost
People treated
4
Changes in Prices for Fluconazole in Thailand,
following the introduction of competition in 1998
5
Global brainstorming on intellectual property
  • Open Source/GPL models for software development
  • Peer to peer technologies and social organization
    models
  • UK Commission on Intellectual Property Rights
  • TACD IP agenda
  • Royal Society brainstorming on IPR
  • OECD IPR studies
  • US National Academies of Science
  • US Federal Trade Commission / Department of
    Justice hearings on competition and intellectual
    property.
  • MSF Working groups on IPR/DND
  • IETF working group on IPR
  • UNDP Human Development Report 2001
  • Blur/Banff discussions on music
  • Rockefeller Bellagio meetings / collective
    management of intellectual property rights
  • World Business Council for Sustainable
    Development Project on Intellectual Property
    Rights
  • Aventis Radical IPR scenarios
  • Ransom / Matching Funds model
  • WIPO access to genetic resources / traditional
    knowledge and folklore
  • WHO/Harare proposal

6
For TRIPS to be fair to the poor, rights to
patent owners must be subject to limitations and
exceptions
7
Under the Present TRIPS Accord there is limited
but important flexibility
  • WTO member countries may
  • Set their own standards for novelty and utility
  • exclude some inventions under Article 27
  • offer limited royalty free exceptions to patent
    rights under Article 30
  • Issue compulsory licenses to patents under
    Article 31
  • Allow for domestic or international exhaustion of
    rights after sale of product (1st sale doctrine),
    under Article 6, thereby permitting parallel
    trade

8
In 2001 in Doha, the WTO promised its patent
rules could and should protect public health
9
Paragraph 4 of the Doha Declaration on TRIPS 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.
  • In this connection, we reaffirm the right of
    WTO Members to use, to the full, the provisions
    in the TRIPS Agreement, which provide flexibility
    for this purpose.

10
Paragraph 5 of the Doha Declaration on TRIPS
  • (b) Each Member has the right to grant
    compulsory licences and the freedom to determine
    the grounds upon which such licences are granted.
  • (c) Each Member has the right to determine what
    constitutes a national emergency or other
    circumstances of extreme urgency, it being
    understood that public health crises, including
    those relating to HIV/AIDS, tuberculosis, malaria
    and other epidemics, can represent a national
    emergency or other circumstances of extreme
    urgency.

11
Doha Declaration, Paragraph 6
  • 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.

12
US, Japan, EU used paragraph 6 negotiations to
renegotiate and undermine Doha Declaration on
TRIPS
  • In order to get consensus on paragraph 6
  • US Government seeks to limit scope of diseases
  • EU proposed list of diseases including AIDS and
    diseases with little commercial market, such as
    yellow fever
  • Japan asks for exclusion of vaccines and other
    technologies
  • Japan others seek to limit to emergencies only
  • EU/US/Japan/Canada demand tight restrictions on
    eligible countries, excluding nearly every
    country with any level of economic development
  • EU insists on extraordinary complex and costly
    procedures

13
NGOs say bad deal on paragraph 6 is worst than no
deal
  • LDCs have ignore patents on medicines until
    2016, and be source of exports of cheap generic
    drugs
  • Every country can permit exports under Article
    31.k of the TRIPS
  • Possibly under refusal to deal grounds
  • Exports can be permitted under Article 30, if
    allowed by panel
  • Canadian early working case
  • European Parliament Amendment 196

14
The US and EU are hostile to efforts to expand
access to medicines
  • AIDS Generic manufacturers cannot achieve
    economies of sale without access to middle income
    country markets
  • Diabetes More than 100 persons in developing
    countries now have diabetes
  • Asthma Common among children in developing
    countries. Lack of access to best drugs (such as
    singulair) lead to unnecessary suffering and
    death
  • Cancer 80 million persons in developing
    countries lack access to treatment for cancer.

15
Glivec Story
  • Very effective drug
  • Treats rare forms of leukemia
  • Developed with significant US government RD
    support
  • Norvartis charges in as much as 50,000 annual
    for treatment of chronic condition
  • National health care systems are bankrupted by
    cost of such drugs

16
Demonstrations in Korea over pricing of Glivec
lead to arrests
17
Korea government is pressured to reject
compulsory license
  • The Korean Government reached agreement with the
    United States in 1999 to price new, innovative
    drugs at the average ex-factory price of A-7
    countries
  • United States, United Kingdom, Germany, France,
    Italy, Switzerland, and Japan.
  • Europe has also been involved in pressure in
    Korea over drug prices

18
US now seeking higher prices on medicines in many
trade negotiations
19
Developing countries need good rules for
compulsory licenses
  • Administrative proceedings should be cheap and
    fast
  • Compensation should be predictable and affordable
  • UNDP royalty guidelines
  • Grounds should be straightforward

20
Access Gap Theory
  • If one can establish that there exists a
    significant gap between those who need medicine
    and those who actually have the medicine, and
  • Price is a barrier to access
  • It is illegal to refuse to license the patent on
    a non-exclusive basis at a reasonable royalty

21
Advantages of Access Gap Theory
  • Empirical burden is straightforward
  • Based upon public health data
  • Policy is straightforward,
  • Mechanism to give effect to access to medicine
    for all provisions of Doha Declaration
  • Exports permitted under Article 31.k of TRIPS

22
For more information
  • Consumer Project on Technology
  • http//www.cptech.org
  • Subscribe to ip-health
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