WORLD TRADE
ORGANIZATIONIP/C/W/376/Add.3
1 November 2002
(02-6037)
Council for Trade-related Aspects
of Intellectual Property RightsOriginal:  English
TECHNICAL COOPERATION ACTIVITIES:  INFORMATION FROM
OTHER INTERGOVERNMENTAL ORGANIZATIONS
WORLD HEALTH ORGANIZATION
Addendum
The present document reproduces the information which has been received from the World
Health Organization (WHO) by means of a communication dated 2 September 2002.  It was
circulated as an advance copy at the TRIPS Council meeting held on 17 September 2002.
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INFORMATION ON TECHNICAL AND FINANCIAL COOPERATION PROGRAMMES
CARRIED OUT BY THE WORLD HEALTH ORGANIZATION AND THAT ARE
RELEVANT TO TRIPS IMPLEMENTATION AND ACCESS TO DRUGS
Under the mandate of the WHO medicines strategy (resolution WHA54.11) and the Revised
Drug Strategy (resolution WHA52.19), the World Health Organization (WHO) cooperates with its
member States, at their request, and with relevant  organizations to:  (1) assist member States to
develop pharmaceutical and health policies related to international agreements;  and (2) monitor,
analyze, study and report on existing and future health implications of international trade agreements.Furthermore, WHO will assess the public health implications of the Doha Declaration and will advise
member States, upon their request, on the implementation of the Declaration into national legislation.
I. WHO POLICY PERSPECTIVES ON ACCESS TO DRUGS
1. Basic principles and values  - The enjoyment of the highest attainable standard of health is
one of the fundamental rights of every human being, as defined in the Constitution of the World
Health Organization.  Progressive realization of that right involves access to health facilities,
prevention, care, treatment and support, including access to medicines.  Access to essential drugs
depends on:  (1) rational selection and use of medicines;  (2) sustainable adequate financing;
(3) affordable prices;  and (4) reliable health and supply systems.
2. The Doha Declaration on TRIPS and Public Health , adopted by the WTO Ministerial
Conference, in November 2001, which affirms that the TRIPS Agreement should be interpreted and
implemented so as to protect public health and promote access to medicines for all marks a watershed
in international trade, demonstrating that a rules-ba sed trading system is compatible with public health
interests.  The Declaration re-affirms the right of WTO Members to make full use of the safeguardprovisions of the TRIPS Agreement in order to protect public health and promote access to medicines.
WHO expects that, as instructed by the Doha Ministerial Declaration, the WTO Council for TRIPS
will find an expeditious solution for the use of compulsory licensing by WTO Members with
insufficient or no manufacturing capacities in the pharmaceutical sector.  WHO re-affirms itsIP/C/W/376/Add.3
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commitment to support WTO Members and the TRIPS Council in whatever way they wish to find an
expeditious solution to this problem.  A WHO publication, Implications of the Doha  Declaration on
the TRIPS Agreement and Public Health (WHO/EDM/PAR/2002.3) maps out some of the options and
their implications for public health.
3. Patent protection has been an effective in centive for research and development for new
drugs - Protection of intellectual property rights, including patent rights, has supported research and
development for new pharmaceuticals.  But questions remain as to whether the patent system is
sufficient to ensure investment in medicines need ed largely by the poor.  Strong public involvement
and investment is needed to ensure development of needed new drugs for priority health problems of
the poor.
4. Affordability of essential drugs is a public health priority  - Low-income populations in
developing countries cannot afford to pay the same price for newer essential drugs as do the wealthy.Differential pricing is now recognised as a means through which prices can be adapted to the
purchasing power of governments and households.  An April 2001 WHO-WTO workshop observed
that differential pricing could be achieved th rough a combination of factors, which may include
market mechanisms, negotiation, bulk purchasing, voluntary licensing, compulsory licensing, and
establishment of a flexible global differential pr icing system.  In addition, WHO supports other
measures to improve access to essential drugs, including mechanisms to promote competition, such
as:  price information;  generic policies;  reduced duties, taxes, and mark ups;  and the application of
safeguards contained within the WTO/TRIPS Agreement.
5. Essential drugs are not simply another commodity - TRIPS safeguards are crucial as
affirmed by the Doha Declaration - Patents for pharmaceuticals should be managed in an impartial
way, protecting the interest of the patent holder and safeguarding the basic public health principles.
Hence, WHO supports WTO/TRIPS-related safeguards, to be applied where justified in accordance
with the provisions of TRIPS, to enhance affordability and availability of existing medicines, while
not discouraging the development of needed new medicines.  These safeguards include setting
standards of patentability which reflect public health concerns, legislative provision for compulsorylicensing, parallel importation, exceptions to exclusive rights and other measures which promote
generic competition, as well as extension of the transitional period.  WHO recommends that countries
assess the public health impacts of the TRIPS Agreement before introducing TRIPS-plus
requirements or extending TRIPS requirements to non-WTO Members.
6. Informed country approaches to health and trade  - Countries with the least capacity for
implementing international trade agreements are most at risk in terms of access to medicines.  WHO
will continue to provide independent data and technical assistance to countries to help them developinformed approaches to addressing the health implications of trade issues at national, subregional and
regional levels.  WHO advises countries to monitor - carefully - the implementation of the TRIPS
Agreement.  A network of legal experts who have  specialized knowledge and understanding of the
public health and pharmaceutical impact of international trade agreements is being developed as a
resource for developing countries.
II. WHO PROGRAMME OF WORK ON PHARMACEUTICALS AND TRADE
1. Policy guidance and information support
Critical among WHO policy guidance is the WHO medicines strategy (World Health
Assembly resolutions WHA54.11 and WHA52.19).  The Director-General's speeches, WHO
publications and related documents provide other WHO policy guidance and information support forMember States.  The following examples, availa ble upon request through the WHO Department of
Essential Drugs and Medicines Policy  documentation centre, include:IP/C/W/376/Add.3
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- WTO Agreements & Public Health, A joint study by the WHO and the WTO
Secretariat, 2002
- Protection of Data Submitted for the Regi stration of Pharmaceuticals: Implementing
the Standards of the TRIPS Agreement, (Published in collaboration with the South
Centre), 2002
- Implications of the Doha Declaration on the TRIPS Agreement and Public Health,
WHO/EDM/PAR/2002.3
- Trends in Drug Patenting: Case Studies , a study conducted by the University of
Buenos Aires for the WHO Department of Essential Drugs and Medicines Policy.
- Network for Monitoring the Impact of Globalization and TRIPS on Access to
Medicines, Report of a meeting, February 2001, Bangkok, Thailand,
WHO/EDM/PAR/2002.1
- Globalization, TRIPS and Access to Pharmaceuticals.  WHO Policy Perspectives on
Medicines . No. 3, March 2001.
- TRIPS, CBD and Traditional Medicines:  Concepts and Questions.  Report of an
ASEAN Workshop in the TRIPS Agreement and Traditional Medicine. Jakarta,13-15 February 2001.
- Globalization, Patents and Drugs.  An Annotated Bibliography, Second Edition.
EDM/PAR/2001.1.
- Integrating Public Health Concerns into Patent Legislation in Developing Countries ,
South Centre, 2000 (cosponsored by The Rockefeller Foundation, the South Centre
and WHO/EDM).
- The TRIPS Agreement and Pharmaceuticals.   Report of an ASEAN Workshop on the
TRIPS Agreement and its impact on Pharmaceuticals.  Jakarta, 2-4 May 2000.
- Mission conjointe MSF/OMS/ONUSIDA.  R evue de la Politique pharmaceutique au
Cameroun.  Les Brevets de Médicaments dans les Pays d'Afrique francophone.
February 2000, World Health Organization.
- Essential drugs in the new international economic environment , Bulletin of the World
Health Organization, Volume 77, Number 3, 1999.
- Globalization and Access to Drugs - Perspectives on the WTO/TRIPS Agreem ent ,
WHO/DAP/98.9, Revised, January 1999.
2. Direct country support and regional awareness meetings
WHO provides direct country support on request, such as briefings on the TRIPS safeguards
and advice on the revision of national pharmaceutical legislation.  Recent examples include support to
Brazil, Brunei Darussalam, the People's Republic of China, Colombia, the Islamic Republic of Iran,
South Africa and Thailand.  WHO also sponsors or participates in interregional, regional and nationalawareness meetings (e.g. Association of South-East Asian Nations (ASEAN),  Southern African
Development Community (SADC) countries, the WHO South-East Asia Region  countries and the
WHO Region for Africa).  Each country's strategy with regard to the production, distribution and useIP/C/W/376/Add.3
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of drugs will need to be incorporated into its National Pharmaceutical Policy, a component of the
National Health Policy.
Examples of planned and completed country and regional support include:
- Meeting for OAPI countries on the TRIPS Agreement in the context of the Doha
Declaration and the Revised Bangui Agreement, (Yaoundé, May 2002)
- Intercountry meeting on the TRIPS Agreement and its impact on access and prices of
pharmaceuticals in Eastern Europe (Warsaw, September 2001).
- Workshop on TRIPS and the implementation of its safeguards in relation to
pharmaceuticals in the WHO African Region (Harare, August 2001).
- Briefing on WHO policy perspectives on globalization and access to medicines for
the drug regulatory authorities of Ibero-America (Costa Rica, September 2000).
- Briefing on TRIPS to Ministers of Health of the Member States of the Southern
African Development Community (South Africa, June 2000).
- Meeting on the impact of globalization and trade agreements on access to
pharmaceuticals, organized by the Directorate General of Drug and Food Control,Ministry of Health, Indonesia, with EDM support (Jakarta, May 2000).
- Joint WHO/UNAIDS mission to Thailand to provide technical backup to the
continuing debate in Thailand on HIV/AIDS-related drugs that are under patent
protection (February 2000).
- Joint WHO/UNAIDS-MSF assessment of the patent situation of AIDS-related drugs
in francophone African countries (February 2000).
- At the request of the Chinese Government, WHO mission to provide briefing to
Ministry of Health and Ministry of Trade officials on TRIPS (January 2000).
- Continuation of ongoing WHO support to national comprehensive drug programmes
(e.g. Bolivia, Brazil, South Africa).
3. Monitoring and analysing the effects of globalization on access to drugs
The public health impact of TRIPS requirements has yet to be fully assessed.  Therefore, the
WHO medicines strategy (resolution WHA54.11) prov ides WHO with a mandate to study and report
on existing and future health implications of international trade agreements.
3.1 Network for monitoring the implications of globalization and TRIPS on access to
medicines :  To define standard monitoring tools, methods and selected indicators to be used
periodically over the next five years.
Meeting in Brazil  (February 2002)
Experts from four WHO collaborating centres (Brazil, Spain, Thailand and the United
Kingdom of Great Britain and Nort hern Ireland) and other members of the Expert Group met in Brazil
in February, 2002.
- Review and revision of selected model indicators.IP/C/W/376/Add.3
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- The WHO collaborating centres' plans of action and the selected model indicators
used in monitoring the impact of the TRIPS Agreement on access to essential drugs
are guided by four questions:
1. What is the impact, if any, on the prices of essential drugs under the new IPR 
regime?
2. Has there been any impact on the speed with which generic drugs are being 
introduced?
3. Are more new drugs for neglected diseases being developed?4. Are transfer of technology and direct foreign investment in developing  
countries increasing or decreasing?
Meeting in Thailand  (February 2001)
- Dr Supachai Panitchpakdi, then Director -General Designate of the World Trade
Organization, made the opening remarks.
- Harmonization of selected model indicators to be adapted according to the particular
characteristics of each region.
3.2 Monitoring and analysing through four WHO collaborating centres  and other partners:
- WHO Collaborating Centre for Health Economics, Thailand :  Transfer of
technology and increase of research and development.  A Study of the Implications of
the WTO TRIPS Agreement for the Pharmaceutical Industry in Thailand was
published in October 1999.
- WHO Collaborating Centre for Drug Policies, Brazil :  Evolution of drug prices,
including AIDS-related drugs.  The publication The WTO TRIPS Agreement and
Patent Protection in Brazil:  recent changes and implications for local production andaccess to medicines was published in April 2000.
- WHO Collaborating Centre for Health Economics and Drug Policies, LSE, UK :
Evolution of the generic drug markets.
- WHO Collaborating Centre for Research and Training in
Pharmacoepidemiology, Spain :  Developing a list of indicator drugs for monitoring
the impact of TRIPS on access to essential drugs.
- WHO/Public Interest Nongovernmental Organizations Roundtable process :
Developing a methodology for comparative monitoring of essential drug prices.
3.3 Additional study to support the activities of the three WHO Collaborating Centres :
Globalization, Patents and Drugs.  An Annotated Bibliography, Third Edition.  (Forthcoming)
Study  on the implications of "TRIPS-plus" measures  on access to medicines.  (Forthcoming)
A framework for setting compensation guidelines for compulsory licensing.  (Forthcoming)IP/C/W/376/Add.3
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4. Cooperation with intern ational organizations
- In June 2000, WHO was awarded observer status on an ad hoc basis by the WTO
Council for TRIPS.  WHO is now able to monitor all relevant issues under discussion
at WTO that may have implications for th e health sector and to provide informal
support to member States at their request.
- WHO and WTO on occasion organize joint briefings and workshops.  Examples
include a joint briefing on trade and health during the Fifty-third World Health
Assembly in May 2000, a joint workshop on Differential Pricing and Financing of
Essential Drugs in April 2001 in Høsbjør, Norway and a joint study on the WTO
Agreements & Public Health.  WTO Director-General Dr Supachai Panitchpakdi is a
member of the WHO Commission on Macro economics and Health.  In addition, he
opened the first meeting of the WHO monitoring network on TRIPS and
globalization.
- International organizations, including UNAIDS, UNCTAD, WIPO and WTO, are
systematically invited to WHO meetings on is sues relating to trade, globalization and
access to medicines.
- Matters related to trade agreements and access to essential drugs are addressed in
WHO collaboration with public-interest and industry Nongovernmental
Organizations, particularly through the Director-General's roundtable process.
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