WTO, TRIPS and access to drugs

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WTO, TRIPS and access to drugs
Karin Timmermans
Canberra September 2002
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WTO Agreements

• GATT
• - Agriculture
• Textiles
• SPS
• .

TRIPS
GATS ( General Agreement on Trade in Services )
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• WTO Agreements
• binding on all WTO Member States
• subject to WTOs dispute settlement
• mechanism

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• Patents are a public policy tool
• to promote and reward
• innovation
• to disclose the invention and
• make it available to society

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TRIPS - patents

• all fields of technology
• product and process inventions
• minimum standards 20 years
• effective enforcement

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Introduction of TRIPS standards

• delays introduction of generics
• gt increased prices/reduced access

• potential negative impact on
• the pharmaceutical industry
• in developing countries

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• Proponents expect TRIPS will
• enhance local innovation
• increase foreign direct investment
• increase technology transfer

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Limited evidence that this will happen

• Study Thailand
• (introduced pharmaceutical patents in 1992)
• technology transfer minimal
• imports increased
• little foreign direct investment

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Broad agreement Prices of new drugs will be
higher

• TRIPS supporters
• impact will be limited
• real problem is lack of health infrastructure

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• Access to (essential) drugs depends on
• rational selection and use of drugs
• adequate and sustainable financing
• affordable prices
• reliable supply and care systems

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Public spending as of total spending on
pharmaceuticals
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• Moreover, non-IPR strategies exist to reduce
  prices, e.g.
• reduce/abolish taxes on drugs
• generic substitution
• price control

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TRIPS is a framework, to be operationalized via
national law
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TRIPS is a framework, to be operationalized via
national law there is (limited) flexibility and
there are some safeguards
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• The most important safeguards are
• compulsory licensing
• parallel importation
• Bolar provision

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• Bolar provision
• allows testing and regulatory
• approval of generic drugs before
• patent expires
• facilitates generic competition

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• Parallel importation
• (international) exhaustion of rights
• importation without the consent of the
• patent holder, of a patented product
• marketed in another country either by
• the patent holder or with the patent
• holders consent
• enables promotion of competition

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(No Transcript)
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• Article 6 of TRIPS states that parallel
• importation cannot be challenged
• under the WTO dispute settlement
• system

• The Doha Declaration has confirmed
• that countries are free to use parallel
• importation.

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Compulsory license (CL)

• license granted without permission of the
  patent holder
• many countries laws have CL provisions
• CL is allowed under TRIPS

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TRIPS allows Compulsory Licensing for reasons of
public health, national emergency or extreme
urgency, public non-commercial use, to remedy
anti-competitive practices etc.
TRIPS does NOT limit the grounds for issuing a
Compulsory Licensing.
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TRIPS does specify conditions to be applied to
Compulsory Licensing, including

• case-by-case decision
• first try voluntary license
• adequate remuneration patent holder
• non-exclusive, non-assignable
• predominantly for domestic market

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Flexibility in TRIPS

• adequate remuneration
• strict or flexible criteria for patentability
  strict criteria limit evergreening
• opposition procedures
  help prevent frivolous patents

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There is some flexibility within TRIPS, as well
as provisions for safeguards, which can
mitigate potential negative effects
on access to
drugs, but these can only
be used when
incorporated in
national laws.
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Countries should use this flexibility to design
legislation which allows them to protect the
public interest, including the public health
interest.
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Article 39.3 Members, when requiring, as a
condition of approving the marketing of
pharmaceutical or of agricultural chemical
products which utilize new chemical entities, the
submission of undisclosed test or other data, the
origination of which involves a considerable
effort, shall protect such data against unfair
commercial use. In addition, Members shall
protect such data against disclosure, except
where necessary to protect the public, or unless
steps are taken to ensure that the data are
protected against unfair commercial use.
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• Data protection
• only required for NCEs
• drug registration data are not invented
• requirement considerable effort
• gt protects investment, not invention

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• Protection required is
• against unfair commercial use
• against disclosure
• data exclusivity is not required

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• Options for obtaining ARVs
• originator product
• generic

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• Originator product
• full price
• reduced price
• donation

gt No IPR issues gt Registration
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• Generic product
• local production
• import
• donation (?)

gt IPR issues gt Registration
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• Local production of generics
• if no patent OK
• if patented Compulsory license

Question feasibility, technically economically
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• Importation of generics
• if no patent OK
• if patented Compulsory license
• parallel import

Question Source of supply
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• TRIPS will enter into force
• developing countries 2000
• few developing countries
• (which did not grant
• pharmaceutical patents) 2005
• least-developed countries 2006

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• TRIPS will enter into force
• developing countries 2000
• few developing countries
• (which did not grant
• pharmaceutical patents) 2005
• least-developed countries 2016

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Thank you