Workshop on Intellectual Property Rights: Are Essential Medicines Like Any Other Product

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Workshop on Intellectual Property Rights Are
Essential Medicines Like Any Other Product?

• Rachel M. Cohen
• Access to Essential Medicines Campaign
• Doctors Without Borders/Médecins Sans Frontières
  (MSF)
• 5th Meeting of the Transatlantic Consumer
  Dialogue October 30, 2002

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The Access to Medicines Crisis

• Communicable diseases leading causes of death
  in developing countries, accounting for over 25
  of all deaths globally
• 14 million die each year, 97 in developing
  countries
• - HIV/AIDS 3 million per year
• - Tuberculosis 2 million per year
• - Malaria 1-2 million per year
• 1/3 of world lacks access to essential quality
  drugs, diagnostics, vaccines

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The Example of HIV/AIDS
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HIV/AIDS The Price Barrier

• HIV/AIDS
• - 40 million people infected with HIV worldwide
• - Antiretroviral (ARV) therapy proven to
  dramatically extend and improve lives of people
  living with HIV/AIDS in wealthy countries,
  reducing AIDS-related deaths by over 70.
• - Average cost of antiretroviral cocktail in
  the US 10,000-15,000 per patient per year
• - Over 95 of PWAs in developing countries lack
  access to ARVs, largely because of the price of
  drugs
• 8,000 people with HIV/AIDS will die today

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High Prices Linked to Patent Protection

• Effects of Generic Competition
• Sample AIDS Triple Combination Lowest World
  Prices(stavudine (d4T) lamivudine (3TC)
  nevirapine)

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Best offers for first-line regimens proposed in
the WHO guidelinesOctober 2002
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Patent Rights vs. Patient Rights
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What Was Accomplished in Doha?

• The fundamental argument was settled
• 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.
• Ministerial Declaration on the TRIPS Agreement
  and Public Health
• November 2001

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The CIPR Report IPRs Health September 2002

• Patents are tools of public policy and must
  operate to serve the greater public good.
• Developing countries should narrow to an absolute
  minimum the type and scope of pharmaceutical
  patents, and LDCs should consider delaying the
  granting of pharmaceutical patents for as long as
  possible.
• Need quick, easy-to-use measures to ensure
  generic competition to bring drug prices down in
  developing countries (e.g. compulsory licensing
  as rule rather than exception to ensure that
  patent system does not hamper the development of
  a competitive pharmaceutical market).
• Solution to production for export problem must be
  quick and easy to implement, give long term
  security and be economically viable (Article 30
  approach).
• Patent system is failing to stimulate innovation
  to meet many medical needs, particularly the
  needs in developing countries.
• Further recognition of the need for greater
  action and support to help developing countries
  put health first.

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What More Is Needed?

• Equity pricing for
• equitable access

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What is Equity Pricing?

• Equity pricing is the policy of assuring
  dramatically reduced prices of medicines that are
  truly affordable to individuals in need
• Ensures sustainability (not based on charity,
  e.g. donations or voluntary goodwill, e.g. ad hoc
  price reductions)
• Strengthens developing countries autonomy

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Conditions for a Systematic Approach to Tiered
Pricing

• Global approach, not arbitrarily limited in scope
  of diseases, time, and place
• The lowest possible prices based on marginal cost
  of production (competition is the only way to
  know price is as low as possible)
• Transparency of price offers (independent
  auditing for eligible offers)
• Effective measures to prevent diversion to high
  income markets

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Prevent Diversion of Medicines to High Income
Markets

• Differential labeling, coloring, and packaging
• Licensing agreements with local producers
• Encourage technology transfer and generic
  production in developing countries
• Proposals about reference pricing/parallel trade
  issue
• Do not confuse with production of generic
  medicines for export/paragraph 6 of the Doha
  Declaration under discussion at the WTO

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Thank You

• rachel.cohen_at_newyork.msf.org
• www.doctorswithoutborders.org
• www.accessmed-msf.org