Transcript Globalization, TRIPS and access to medicines: from the Revised Drug Strategy 1997 to Doha 2001 Dr Germán Velásquez Essential Drugs and Medicines Policy World Health.

Globalization, TRIPS and access
to medicines:
from the Revised Drug Strategy 1997 to Doha 2001
Dr Germán Velásquez
Essential Drugs and Medicines Policy
World Health Organization
October 2002
Globalization, TRIPS and access to
medicines
Background 1997-2002
World Trade Organization
WTO/TRIPS/DOHA
WHO policy perspectives
and activities
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Background 1997-2002
The Revised Drug Strategy: 1997-1999
Resolution WHA52.19 requested the DirectorGeneral:
“… to cooperate with Member States, at their
request … in monitoring and analysing the
pharmaceutical and public health implications
of relevant international agreements, including
trade agreements, so that Member States …
are able to maximize the positive and mitigate
the negative impact of those agreements …”
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Background 1997-2002
Basic reference document
More than 16 000 copies distributed in 4 years
Available in English, Chinese, French and Spanish
Summaries available in Arabic and Russian
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Background 1997-2002
Important new actors:
 Solidarity
and unity of developing countries
 MSF (Nobel Prize) Campaign on Access to Medicines
 South Centre: technical assistance & publications
 Consumer Project on Technology (CPT), Washington DC
 Independent international experts (Abbott, Correa,
Reichman, Remiche)
 AIDS activists (Act Up, etc.)
 International media
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Background 1997-2002
International debate on drug
prices for AIDS-related drugs
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Transnational pharmaceutical companies announce in
international newspapers drug price reductions from
US$ 15 000 to US$ 700 (May 2000)
Generic manufacturer CIPLA offers the same BUT
for US$ 300
South Africa wins the court case against 39
pharmaceutical companies (April 2001)
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Background 1997-2002
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UN Secretary-General announces the creation of
the Global Fund, April 2001
USA vs. Brazil, June 2001
WTO African Group requests a special session on
access to medicines at the WTO TRIPS Council
20 June 2001: First time in
the 50-year history of the
multilateral trade system
that issues related access to
health/medicines are discussed
in this forum
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Globalization, TRIPS and access to
medicines
Background 1997-2002
World Trade Organization
WTO/TRIPS/DOHA
WHO policy perspectives
and activities
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World Trade Organization (WTO)
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Created during the Uruguay Round (1986-1994)
Entered into force in 1995 to replace GATT
144 Members (2002)
All WTO Members are bound by
WTO multilateral agreements
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TRIPS: Agreement on Trade-Related
Aspects of Intellectual
Property Rights
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Establishes minimum standards in the field of
intellectual property and enforcement
obligations
All WTO Members must incorporate these
standards into their national intellectual
property legislation
Disputes between Members are subject to the
WTO dispute settlement mechanism
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Articles of the TRIPS Agreement of
greatest relevance to pharmaceuticals

Parallel importation («international exhaustion
of patent rights»)
(Article 6)
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Objectives of TRIPS (social and economic welfare)
(Article 7)
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Protection of public health
(Article 8)
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Process and product patents
(Article 27)
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Exceptions which facilitate prompt marketing
of generic drugs («Bolar» provision)
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(Article 30)
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Articles of the TRIPS Agreement of
greatest relevance to pharmaceuticals

Compulsory licensing
(Article 31)
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20-year minimum term of protection
(Article 33)
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Data protection
(Article 39)
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Transitional arrangements for developing
country WTO Members
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Transfer of technology and technical
cooperation
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(Articles 65 & 66)
Review
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(Articles 66 & 67)
(Article 71.1)
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Doha Declaration on the TRIPS
Agreement and Public Health,
November 2001
 The Declaration confirmed the principles that
WHO has been publicly defending over the past
4 years.
 The Declaration reaffirmed the “right of WTO
Members to use, to the full, the provisions in
the TRIPS Agreement” which provide flexibility
for the purpose of protecting public health and
“in particular”, promoting “access to medicines
for all”.
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Globalization, TRIPS and access to
medicines
Background 1997-2002
World Trade Organization
WTO/TRIPS/DOHA
WHO policy perspectives
and activities
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Concerns expressed by developing
countries on the impact of TRIPS
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The TRIPS Agreement treats drugs as any
other commodity, but drugs are not ordinary
consumer products
High prices for new drugs in countries with no
previous patent protection
Generic competition delayed in countries with
previous patent term less than 20 years
Weakening of local pharmaceutical industry concentration of drug production increasing
dependence of developing countries
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Access to essential drugs depends
on:
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rational selection and use of medicines;
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adequate and sustainable financing;
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affordable prices; and
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reliable health and supply systems.
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Prices of drugs can be affected by
several factors
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price information;
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price competition and price negotiation;
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price controls;
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reduced duties and taxes on essential drugs;
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improved distribution efficiency;
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reduced marketing, distribution and dispensing
expenses.
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WHO perspectives on access
to drugs:
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Access to essential drugs is part of the
fundamental right to health.
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Essential drugs are not simply another commodity.
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Patent protection has been an effective incentive
for research and development for new drugs, BUT
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Patents should be managed in an impartial way,
protecting the interests of the patent-holder, as
well as safeguarding public health principles.
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WHO Policy perspectives points for policy makers
 Introduction of a public health perspective into the
intellectual property protection regime
 Use of the flexibility permitted by the Agreement
in the revision of national laws and regulations
(e.g. Bolar provision, compulsory licensing,
exceptions to exclusive rights, extension of the
transitional period)
 Implementation of the Doha Declaration
 Caution with "TRIPS-plus" provisions
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Monitoring of the health impact of new trade
agreements
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Non-WTO Members
As at July 2002, over 45 WHO Member States
were not WTO Members.
From a public health perspective, countries which
are not bound by TRIPS should evaluate TRIPS
requirements and incorporate into national
legislation and trade-related practices those
elements which clearly benefit public health.
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Key questions for monitoring the
public health impact of TRIPS
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Drug prices?
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Evolution of the generic market?
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Transfer of technology, increasing or
decreasing?
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R&D for neglected/tropical diseases,
increasing or decreasing?
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Helping countries to develop informed
approaches to health and trade
Countries briefed on the TRIPS Agreement (57)
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