WORLD TRADE
ORGANIZATIONIP/C/W/305/Add.3
25 September 2001
(01-4556)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
TECHNICAL COOPERATION ACTIVITIES:  INFORMATION FROM
OTHER INTERGOVERNMENTAL ORGANIZATIONS
Addendum
WORLD HEALTH ORGANIZATION
The present document reproduces the updated information on technical and financial
cooperation activities relevant to the implementation of the TRIPS Agreement, which was received
from the World Health Organization on 14 September 2001.
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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.
I. WHO POLICY PERSPECTIVES ON ACCESS TO DRUGS
(See above-noted resolutions and Globalization, TRIPS  and access to pharmaceuticals,
WHO Policy Perspectives on Medicines, No. 3, March 2001)
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. 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.IP/C/W/305/Add.3
Page 2
3. Affordability of essential drugs is a public health priority  - WHO considers it a priority to
assess the impact of trade agreements on the affordabil ity of essential drugs, particularly those still on
patent.  Poorer populations in developing countries cannot afford to pay the same price for newer
essential drugs as do the wealthy for newer essential drugs.  Differential pricing is now recognised as
a means through which prices can be adapted to the purchasing power of governments andhouseholds.  An April 2001 WHO-WTO workshop observed that differential pricing could be
achieved through a combination of factors, which may include market mechanisms, negotiation, bulk
purchasing, voluntary licensing, compulsory licensing, and establishment of a flexible global
differential pricing 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.
4. Essential drugs are not simply another commodity - TRIPS safeguards are crucial -
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 thedevelopment of needed new medicines.  These safeguards include setting standards of patentability
which reflect public health concerns, legislative provision for compulsory licensing, exceptions to
exclusive rights and other measures which promote generic competition, as well as extension of the
transitional period.  Parallel importation of a patented drug from countries where it is sold more
cheaply is widely understood as being a matter of national discretion.  WHO recommends thatcountries assess the public health impacts of the TRIPS Agreement before introducing TRIPS-plus
requirements or extending TRIPS requirements to non-WTO Members.
5. 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 develop
informed approaches to addressing the health implications of trade issues at national, sub-regional 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 (Resolutions
WHA54.11 and WHA52.19).  The Director General’s speeches, WHO publications and relateddocuments provide other WHO policy guidance and information support for Member States. The
following examples, available upon request throug h the WHO Department of Essential Drugs and
Medicines Policy (EDM) documentation centre, include:
- Globalization, TRIPS and Access to Pharmaceuticals.  WHO Policy Perspectives on
Medicines . No. 3, March 2001.
- Globalization, Patents and Drugs.  An Annotated Bibliography, Second Edition.
EDM/PAR/2001.1.IP/C/W/305/Add.3
Page 3
- 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 Agreement,
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
China, Iran, South Africa, and Thailand.  WHO also sponsors or participates in interregional, regional
and national awareness meetings (eg, Associ ation of South-East Asian Nations (ASEAN),  Southern
African Development Community (SADC) countries , the WHO South-East Asia Region (SEARO)
countries and the WHO African Region).  Each country's strategy in regard to globalization in the
field of the production, distribution and use 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:
- 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/EDM-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/EDM-UNAIDS-MSF assessment of  the patent situation of AIDS-related
drugs in francophone African countries (February 2000).IP/C/W/305/Add.3
Page 4
- At the request of the Chinese Government, EDM mission to provide briefing to
Ministry of Health and Ministry of Trade officials on TRIPS (January 2000).
- Continuation of ongoing EDM 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 Expert Group :  To define standard monitoring tools, methods, and selected indicators to be
used periodically over the next five years.
- Experts from four WHO collaborating centres (Brazil, Spain, Thailand and the United
Kingdom of Great Britain and Northern Ir eland) and other members of the Expert
Group met in Thailand in February, 2001.  Dr Supachai Panitchpakdi, Director-General Designate of the World Trade Organization, made the opening remarks.
- 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, to 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?
3.2 Monitoring and analysing through four W HO collaborating centres (WHO CC) and other
partners:
- WHO CC 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 October1999.
- WHO CC 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 and access to medicineswas published in April 2000.
- WHO CC for Health Economics and Drug Policies, LSE, UK :  Evolution of the
generic drug markets.
- WHO CC for Research and Training in Pharmacoepidemiology, Spain :
Developing a list of indicator drugs for monitoring the impact of TRIPS on access to
essential drugs.IP/C/W/305/Add.3
Page 5
- WHO/Public Interest NGO Roundtable process :  Developing a methodology for
comparative monitoring of essential drug prices.
3.3 Additional study to support the activities of the three WHO CCs : Trends in Drug
Patenting: Case Studies , a study conducted by the University of Buenos Aires (in press).
4. Cooperation with inte rnational 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 and a joint workshop on Differential Pricing and Financing of
Essential Drugs in April 2001 in Høsbjør, Norway.
- 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 a nd industry NGOs, particularly through the
Director-General’s roundtable process.
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