  WORLD TRADE  
ORGANIZATION  IP/C/W/424/Add.2 
26 October 2004  
 
(04-4530) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
TECHNICAL COOPERATION ACTIVITIES:  INFORMATION FROM 
OTHER INTERGOVERNMEN TAL ORGANIZATIONS 
  
WORLD HEALTH ORGANIZATION 
 
 
Addendum
 
  
 The present document reproduces the informa tion on technical and financial cooperation 
activities relevant to the implementation of the TR IPS Agreement, which has been received from the 
World Health Organization (WHO) by means of a communication dated 20 Sept ember 2004.  It was 
circulated as an advance copy for the Council's meeting on 21 September 2004.   
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I. INTRODUCTION 
Since 1999, resolutions of the World Health Assembly have requested WHO to undertake 
work that ensures that its medicines strategy addr esses the important issue of impact of international 
trade agreements on public health and access to me dicines.  Taken together, these resolutions have 
provided WHO a mandate that may be broadly summar ized to include the following:  (1) monitoring 
and analysis of the pharmaceutical and health implica tions of international trade agreements;  and (2) 
assisting member States to assess and develop phar maceutical and health policies and regulatory 
measures that maximize the positive and mitigat e the negative impact of those agreements. 
More recent resolutions have elaborated on the key focus of these broad objectives.  
Resolution WHA56.27, in May 2003, expressed "concer ns about the current patent protection system, 
especially as regards access to me dicines in developing countries," a nd urged member States to adapt 
"national legislation in order to use to the fu ll the flexibilities contained in the Agreement on 
Trade-Related Aspects of Intellectual Property Right s (TRIPS)."  It further established a time-limited 
body to collect data and proposals from the different actors involved, and produce an analysis of intellectual property rights, innovation and public  health, including the question of appropriate 
funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing co untries.  In addition, Resolution WHA57.14 of 
22 May 2004 urged member States to "encourage that bilateral trade agreements  take into account the 
flexibilities contained in the WTO TRIPS Agreem ent and recognized by the Doha Ministerial 
Declaration on the TRIPS Agreement and Public Health." IP/C/W/424/Add.2 
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II. WHO POLICY PERSPECTIVES AND APPROACHES 
1. Doha Declaration on the TRIPS Agreement and Public Health 
Consistent with the above mandate, WHO seek s to provide appropriate technical assistance 
and country support to member States to promote implementation of the TRIPS Agreement that is 
consistent with the protection of public health and promotion of access to medicines.  This work is 
guided by WHO's policy perspectives, which place pub lic health and access to medicines as priorities, 
consistent with the basic tenets of the Doha Ministerial Declaration on the TRIPS Agreement and 
Public Health  (hereinafter "the Doha Declaration"). 
The Doha Declaration affirmed that the TRIPS Agreement "can and should be interpreted and 
implemented in a manner supportive of WTO Member s' right to protect public health and, in 
particular, to promote access to medicines for all."  In this regard, the Doha Declaration enshrines the 
principles WHO has publicly advocated and advanced  over the years, namely, the re-affirmation of 
the right of WTO Members to make full use of the safeguard provisions of the TRIPS Agreement in order to protect public health and promote access to medicines. 
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. 
2. Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS 
Agreement and Public Health 
Paragraph 6 of the Doha Declaration instructed the WTO Council for TRIPS to find an 
expeditious solution to the problem faced by WTO Members with insufficient or no manufacturing 
capacity in the pharmaceutical sector, of making effec tive use of the compulsory licensing provisions 
of the TRIPS Agreement.  On 30 August 2003, the Decision on the Implementation of Paragraph 6 
of the Doha Declaration on the TRIPS Agreement and Public Health  (hereinafter "the August 
Decision") was finally adopted after lengthy negotiations.  The full impact of the August Decision will depend on how effectively it can be implemented in countries. 
 During the negotiations for an "expeditious so lution" to the Paragraph 6 problem, WHO's 
view was, and continues to be, that the guiding principle must be that patients in a country without or lacking domestic pharmaceutical production capacity  should be no less protected by compulsory 
licensing provisions (or indeed other TRIPS safegua rds) than those in countries capable of producing 
the product, nor should they face any greater procedural hurdles.
1 
 
 In line with this principle, WHO has enuncia ted the key features of effective implementation 
of the August Decision, as follows:  a rapid and effec tive response to public hea lth needs;  equality of 
opportunities for countries in need, irrespective of the patent status of a drug in the importing country, 
and without regard to its membership in the WTO;  the sustainability of quality supply at affordable 
prices;  the facilitation of a multiplicity of poten tial suppliers, both from de veloped and developing 
countries, which can compete to drive prices down;  and provision of a wide range of pharmaceutical 
products to meet an array of health problems.  All these elements should ideally be incorporated 
within a stable international legal framework, wh ich would ensure legal certainty and security.  
Within this framework, WHO is fully committed to assisting its member States to make the most 
effective use of the August Decision.  
                                                     
 
1 Statement by the representative of the World Health Organization at the WTO TRIPS Council, 
17 September 2002, Geneva.  IP/C/W/424/Add.2 
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3. Informed country approaches to health and trade   
 WHO will continue to provide independent data  and technical assistance to countries to help 
them develop informed approaches to addressing th e health implications of trade issues at the 
national, subregional and regional levels. Count ries with the least capacity for implementing 
international trade agreements are most at risk in te rms of access to medicines.  It is therefore crucial 
that countries are informed of all available options  in the implementation of the TRIPS Agreement, 
the Doha Declaration and the August Decision.  In this regard, WHO's focus in technical cooperation 
will be:  
(1) awareness raising and capacity building of po licy makers and negotiations of the health  
impacts of international trade agreements, so  as to ensure effective participation in 
international and regional nego tiations, and that developing country needs and interests 
are adequately taken into account;  
 (2)  review of national health, pharmaceutical and intellectual property policies, legislation 
and practices, with a view to promoting th e development and incorporation of TRIPS 
safeguards within the national policy and legal framework; and 
 (3)  continued monitoring and analysis of the impact of trade agreements on public health 
and access to essential medicines, including the impact of new trends and developments at the regional and bilateral levels. 
 
III. WHO TECHNICAL ASSISTANCE AND COOPERATION 
 WHO's programme on technical assistance and cooperation can be described as follows: 
 
1. Policy and technical guidance 
 Critical to WHO's technical cooperation progra mme is policy and technical guidance.  WHO 
provides policy guidance and technical advice thr ough its publications and re lated documents, which 
are made available to member States.  Such polic y and technical documents undergo a review process, 
including consultations with other international or ganizations and independent experts.  The most 
recent publications in the Health Economics and Dr ugs Series of the Department of Essential Drugs 
and Medicines Policy - a WHO series of  analysis papers looking at the implications of the new trade 
and economic context on health and drug policies - include the following: 
 - IPR, Innovation, Human Rights and Access to Drugs - An Annotated Bibliography , Health 
Economics and Drugs, EDM Series No.14 
- IPR in China: The Doha Declaration and the Pr otection of Public Health - A Review of 
Chinese Legislation , Health Economics and Drugs, EDM Series No.15 
- Implementation of the WTO General Counc il Decision on Paragraph 6 of the Doha 
Declaration on the TRIPS Agreement and Public Health , Health Economics and Drugs, EDM 
Series No.16 (forthcoming). IP/C/W/424/Add.2 
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2. Country support and capacity building  
 Direct country support and regional meetings  over the past years have contributed to 
heightened awareness of the relevant issues and more importantly, increased capacity for effective 
participation in international a nd regional negotiations.  WHO has adopted a multi-agency approach 
in conducting briefings and training sessions for health , trade and patent officials from more than 80 
countries, and will continue to do so.  In respons e to individual country requests, WHO has also 
provided policy guidance and technical advice.    Through the review of national policies and legi slation, WHO experts have assisted individual 
developing countries in their efforts to review and amend their national laws so as to incorporate 
public health safeguards within their national pol icy and legal frameworks.   A network of legal 
experts who have specialized knowledge and unders tanding of the public health and pharmaceutical 
impact of international trade agreements is  being developed as a resource for these purposes. 
  Recent meetings and briefi ngs include the following: 
 
- Informal technical briefing and discussion on the TRIPS Agreement and the Doha 
Declaration implementation (Kua la Lumpur, February 2004) 
- Technical briefing on TRIPS, intellectual property rights issues and cost containment 
measures, Joint Ministry of Health/WHO/UNAIDS Mission (China, February-March 2004) 
- Technical briefing to ANDEAN Ministers of Health on bilateral and regional trade 
agreements, intellectual property rights and im plications for public health (Venezuela, 
March 2004).  This briefing resulted in the request for individual briefings to the 
Ministries of Health of Colombia and Peru on the impact of intellectual property rights and patents on the health of their popula tion, which took place in May and July 2004 
respectively. 
- Informal technical discussion on the Impl ementation of the WTO General Council 
Decision on Paragraph 6 of the Doha Declar ation on the TRIPS Agreement and Public 
Health (Jakarta, May-June 2004) 
- Technical briefing on globalization, trade, in tellectual property rights and health to the 
9
th Meeting of Health Secretaries of the Countries of South-East Asia (New Delhi, July 
2004) 
 Other planned country and regional support activities include: 
 
- Technical assistance and country support to Asian, Caribbean and Pacific (ACP) 
countries in the implementation of the TRIPS safeguards, including the August 
Decision 
- Technical briefing on TRIPS implementati on and review of national legislation 
(Nigeria, October 2004) 
- Regional workshop on TRIPS implementati on - post-Doha and August Decision 
(Ghana, November 2004)  IP/C/W/424/Add.2 
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3. Monitoring and analysing the effects of  globalization on access to medicines  
 The public health impact of the TRIPS requi rements for intellectual property protection has 
yet to be fully assessed.  The WHO Network for Monitoring the Impact of Globalization and 
TRIPS on Access to Medicines (TRIPS Network)  was initiated with a view to systematically 
collecting and analysing data relevant to asse ssing how the processes of economic globalization and 
the TRIPS Agreement are related to the challenge  of improving access to medicines.  The TRIPS 
Network has been refining standard monitoring tool s, methods and selected indicators to be used for 
monitoring and analysis of the impact of the TRIPS Agreement on access to medicines.  In this regard, the TRIPS Network has been coordinating its work with that of the WHO/Health Action 
International Project on Medicine Prices, in order to  ensure coherent and syst ematic data collection. 
 
 The meetings of the TRIPS Network are a ttended by experts from four WHO Collaborating 
Centres (Brazil, Spain, Thailand and the United Ki ngdom of Great Britain and Northern Ireland), as 
well as other invited experts, advisers and research ers.  Recent meetings and developments include 
the following: 
 
- Regional Meeting of the TRIPS Network in April 2004, organized by the Centre for 
Health Economics, Chulalongkorn Univers ity (Bangkok Collaborating Centre). The 
meeting brought together researchers from c ountries in the Asian Region to exchange 
information on drug and other related polici es.  Researchers from China, Indonesia and 
Thailand, who were involved in the field testing of the Template of indicators 
developed by the TRIPS Network, reviewed the Template and provided suggestions for 
improvements and revision.  The meeting also resulted in the proposed TRIPS surveys in China and Pakistan, due to be undertaken by the end of 2004. 
- The annual meeting of TRIPS Network (Ba ngkok, July 2004) was convened to address 
the following issues: revision of the Templa te of indicators so as to incorporate the 
WHO/HAI pricing surveys and the future use of Template as a monitoring tool; and to 
coordinate the future work programme of the TRIPS Network and its proposed outputs. 
The final revised Template is expected in September 2004. 
4. Technical cooperation with international organizations 
Cooperation with internationa l organizations remains an essential component of WHO's 
programme on technical cooperation and assistance.  
 
WTO: As an observer on an ad hoc  basis at the WTO Council for TRIPS, WHO is now able 
to monitor all relevant issues under discussion at WT O that may have implications for the health 
sector and to provide informal support to member St ates at their request.  In addition, WHO has now 
been invited to participate in the WTO Secretar iat's programme of technical assistance on TRIPS 
implementation.  WHO has participated in three of  the seven regional workshops in the WTO plan for 
2004;  namely in Malaysia, South Africa and Camer oon.  WHO will continue to participate in these 
activities, as an active participant to promote an adequate public health focus in trade technical 
assistance programmes.  
 UNAIDS: As a UNAIDS co-sponsor, WHO serves as th e lead agency within UNAIDS with 
responsibility for HIV/AIDS care and treatment, incl uding the area of international trade rules and 
access to HIV medicines. WHO and the UNAIDS Secret ariat will continue their collaboration on all 
trade issues, in particular intellectual property ri ghts issues, relating to the response to the AIDS 
epidemic. 
 IP/C/W/424/Add.2 
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 Other international organizations, including UNCTAD, UNDP,  UNICEF, WIPO  and WTO , 
are systematically invited to WHO meetings on issues relating to trade, globalization and access to medicines.  These include expert consultations and reviews of WHO policy and technical guidance 
documents relating to TRIPS implementation.  On e such example was the WHO Expert Consultation 
(New York, March 2004) convened to  review the draft paper, " Implementation of the WTO General 
Council Decision on Paragraph 6 of the Doha Decl aration on the TRIPS Agreement and Public 
Health",  hosted by the Ford Foundation.  The one- day consultation included participants from 
international organizations (UNAIDS, UNDP, WIPO  and WTO), government and nongovernmental 
organizations, as well as academic trade, intell ectual property and public health experts.  
 
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