WORLD TRADE  
ORGANIZATION  IP/C/W/407/Add.4 
26 March 2004  
 
(04-1379) 
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 following communication, dated 9 March 2004,  has been received from the office of the 
Director for Government, Civil Society and Private Sector Relations of the WHO. 
 
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TECHNICAL AND FINANCIAL COOPERATION PROGRAMMES CARRIED OUT BY 
THE WORLD HEALTH ORGANIZATION (WHO) AND THAT ARE RELEVANT 
TO TRIPS IMPLEMENTATION  AND ACCESS TO DRUGS 
  
I. INTRODUCTION 
 Under the mandate of the WHO medicines st rategy (resolution WHA54.11), the Revised 
Drug Strategy (resolution WHA52.19) and resoluti on WHA56.27 on Intellectual property rights, 
innovation and public health, the World Health Orga nization 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 agreem ents;  (2) monitor, analyse, study and report on 
existing and future health implications of interna tional trade agreements;  and (3) collect data and 
proposals from the different actors involved and produce an analysis of intellectual property rights, 
innovation, and public health, including the qu estion of appropriate funding and incentive 
mechanisms for the creation of  new medicines and other products against diseases that 
disproportionately affect developing countries.   II. 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 a ttainable standard of health is 
one of the fundamental rights of every human bei ng, 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 medi cines;  (2) sustainable adequate financing; 
(3) affordable prices;  and (4) reliable health and supply systems.  
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2. The Doha  Declaration on the TRIPS Agreement and Public Health  (Doha Declaration), 
adopted by the WTO Ministerial Conference, in November 2001, which affirms that the TRIPS Agreement should be interpreted a nd implemented so as to protect public health and promote access 
to medicines for all, marks a watershed in internatio nal trade, demonstrating that a rules-based trading 
system is compatible with public health inter ests.  The Declaration re-affirms the right of WTO 
Members to make full use of the safeguard provisi ons 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.  
2.1. Paragraph 6 of the Doha Declaration in structed the WTO Council for TRIPS to find an 
expeditious solution to the problem, faced by Memb ers with insufficient or no manufacturing capacity 
in the pharmaceutical sector, of making effective u se of the compulsory licensing provisions of the 
TRIPS Agreement.  The Council for TRIPS failed to  reach solution within the required time.  A 
Decision was finally agreed by consensus on 30 Au gust 2003, based on the 16 December 2002 draft, 
with an explanatory introduction by the Chair of the Council for TRIPS.  This Decision covers all 
medicines and the WHO will work with the countries  which could make use of the new arrangements 
to assist them to achieve the full public health bene fit from the lower prices.  The full impact of the 
Decision will depend on how effectivel y it can be implemented in countries. 
 3. Patent protection has been an effective in centive for research and development for new 
drugs - protection of intellectual property rights, incl uding 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 needed largely by the poor.  Strong public involvement 
and investment is needed to reinvigorate efforts to develop innovations that add real therapeutic 
advantage in treating the world's major killer disea ses, especially in developing countries.  Resolution 
WHA56.27 expresses "concerns about the current pa tent protection system, especially as regards 
access to medicines in developing countries".  4. Affordability of essential drugs is a public health priority  - WHO considers it a priority to 
assess the impact of trade agreements, the Doha D eclaration and the recent Decision on paragraph 6 
on the affordability of essential drugs, particularly  those still on patent.  Low-income populations, 
especially in developing countries, cannot afford to  pay the same price for newer essential drugs as do 
the wealthy.  Equity pricing is now recognized as a means through which prices can be adapted to the 
purchasing power of governments and households.  Equity pricing can be achieved through a combination of factors, which may include market mechanisms, negotiation, bulk purchasing, voluntary licensing, compulsory licensing, and implementation of the paragraph 6 Decision.  In 
addition, WHO supports other measures to improve access to essential drugs , including mechanisms 
to promote competition, such as: price informati on; 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 
re-affirmed by the Doha Declaration.  Patents for pharmaceuticals should be managed in an impartial 
way, protecting the interests of the patent holder an d 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 affordab ility and availability of existing medicines.  These 
safeguards include setting standards of patentability which reflect public health  concerns, legislative 
provision for compulsory licensing, parallel importation, exceptions to exclusive rights, implementation of the Decision on paragraph 6 and other measures which promote generic 
competition, as well as the full use of the possibility to extend the transitional periods in accordance 
with Article 66.1 of the TRIPS Agreement and Artic le 7 of the Doha Declaration.  WHO recommends 
that countries assess the public health impacts of the TRIPS Agreement before introducing TRIPS-
plus requirements in national legislation or as a part  of subregional or bilateral trade agreements or 
extending TRIPS requirements to non-WTO Members.  They should also ensure that the data  IP/C/W/407/Add.4 
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protection requirements of Article 39.3 of the TRIPS Agreement do not become a barrier to the registration and introduction of generic dr ugs and the use of compulsory licensing.  
 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 in dependent data and technical assistance to countries to help them develop 
informed approaches to addressing the health implications of trade issu es at national, sub-regional and 
regional levels.  WHO advises countries to monitor - carefully - the implementation of the TRIPS 
Agreement, the Doha Declaration a nd the paragraph 6 Decision.  A ne twork of legal experts who have 
specialized knowledge and understa nding of the public health and pharmaceutical impact of 
international trade agreements is being deve loped as a resource for developing countries. 
 
III. 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, WHA52.19 and WHA 56.27).  The Direct or General's speeches, WHO publications and 
related documents provide other WHO policy guidance and information support for Member States. 
The following examples, available through the WHO Department of Essential Drugs and Medicines 
Policy (EDM) documentation centre, include:  
-  Cost-containment Mechanisms for Essentia l Medicines, including antiretrovirals, in 
China, WHO/EDM/PAR/2003.6. 
 
- WTO Agreements & Public Health, A joint study by the WHO and the WTO Secretariat, 
2002. 
 
- Protection of Data Submitted for the Regist ration of Pharmaceuticals: Implementing the 
Standards of the TRIPS Agreement, (Published in collaboration with the South Centre), 
2002.   
 
- Implications of the Doha Declarati on on the TRIPS Agreement and Public Health, 
WHO/EDM/PAR/2002.3. 
  
- Network for Monitoring the Impact of Globa lization and TRIPS on Access to Medicines,  
Report of a meeting, February 2001, Bangkok, Thailand, WHO/EDM/PAR/2002.1.    
 
-  Trends in Drug Patenting: Case Studies , a study conducted by the University of Buenos 
Aires for the WHO Department of Essen tial Drugs and Medicines Policy, 2001.  
 
- Globalization, TRIPS and Access to Phar maceuticals.  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 Traditiona l 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 Rock efeller Foundation, the South Centre and 
WHO/EDM). IP/C/W/407/Add.4 
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 - 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.  Revue 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 - P erspectives on the WTO/TRIPS Agreement.  
WHO/DAP/98.9, Revised, January 1999. 
  
- Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Implementation of 
TRIPS Safeguards in Relation to Phar maceuticals in the WHO African Region . Report of 
Workshop, Harare, 21-23 August 2001.  AFR/EDP/02.1.  
 - 3 Statements by the Representative of WHO at the WTO Council for TRIPS 
(September 2001, March 2002 and Sept ember 2002).  Available from URL: 
http://www.who.int/medicines/organization/ood/trips_med.shtml 
 
2. Direct country support and regional awareness meetings 
 WHO provides direct country support on request, such as training or briefings on the TRIPS 
safeguards and advice on the revision of nationa l pharmaceutical legislation.  Recent examples 
include support to Brazil, Cambodia, China, Colo mbia, Indonesia and Thailand.  WHO also sponsors 
or participates in interregional, regional and nati onal awareness meetings (e.g., Association of South-
East Asian Nations (ASEAN),  Southern African Development Community (SADC) countries, the 
WHO South-East Asia Region (SEARO) countries, the WHO African Region and Eastern European countries).  Each country's strategy in regard to globalization in the field of the production, 
distribution and use of drugs will need to be incorp orated into its National Pharmaceutical Policy, a 
component of the National Health Policy.  
 
 Examples of planned and completed country and regional support include: 
 
- International Seminar on the impact of  globalization on public health (Madrid, 
planned for 2004). 
 
- Support to Asian, Caribbean and Pacific countries in the implementation of the TRIPS 
safeguards, including the recent Decision on paragraph 6 of the Doha Declaration 
(ongoing). 
 - Regional meeting on the follow-up to the WTO Declaration on the TRIPS Agreement 
and Public Health (Jakarta, May 2003). 
 - Briefing to Chinese Ministries of Health and Trade on mechanisms and safeguards for 
negotiations with the pharmaceutical industr y for the reduction of prices of medicines 
(December 2002) and relevant national au thorities related to the revision of 
pharmaceutical legislation in the light of the TRIPS Agreement (October 2002). 
    
- Meeting for OAPI countries on the TRIPS Agreement in the context of the Doha 
Declaration and the Revised Bangui  Agreement, (Yaoundé, May 2002). 
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- Intercountry meeting on the TRIPS Agreemen t and its impact on access and prices of 
pharmaceuticals in Eastern Europe (Warsaw, September 2001). 
 - Workshop on TRIPS and the implementa tion 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, Indonesia, South Africa). 
 
3. Monitoring and analysing the effect s of globalization on access to drugs 
 The public health impact of TRIPS requirements  has yet to be fully assessed.  Therefore, the 
previously mentioned World Health Assembly resolu tions provide WHO with a mandate to study and 
report on existing and future health implica tions of international trade agreements.  
   
3.1  Network for monitoring the impact 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. The annual meetings of the Network are attended by experts from four WHO 
Collaborating Centres (Brazil, Spain, Thailand and the United Kingdom of Great Britain and Northern 
Ireland) and other advisers. 
 
 Meeting in Beijing (February 2003) 
 
 The meeting reviewed data collected fro m 12 selected countries on the use of TRIPS 
safeguards in national legislati on to protect public health and ensure access to drugs.  The 
report of the meeting is in preparation. 
 
Meeting in Brazil  (February 2002) 
 
The meeting reviewed and revised selected mode l indicators to offer important information 
regarding the following four questions: IP/C/W/407/Add.4 
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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 sp eed 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) 
  
The meeting harmonized selected model indicators, to be adapted according to the particular 
characteristics of each region, in order to monito r and analyse the impact of trade agreements 
on access to drugs.  Dr Supachai Panitchpakdi, then  Director-General Designate of the World 
Trade Organization, made the opening remarks at the meeting. 
 3.2  Monitoring and analysing through four WHO Collaborating Centres (WHO CC) and 
other partners:  
- WHO CC for Health Economics, Thailand :  Transfer of technology and increase of 
research and development.  Study of the Implications of the WTO TRIPS Agreement 
for the Pharmaceutical Industry in Thailand  was published in October 1999. 
 - WHO CC for Drug Policies, Brazil :  Evolution of drug prices, including AIDS-
related drugs. The WTO TRIPS Agreement and Patent Protection in Brazil: recent 
changes and implications for local production and access to medicines  was published 
in April 2000. 
 - WHO CC for Health Economics and Drug Policies, 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. 
 - WHO/Public Interest NGO Roundtable process :  Developing a methodology for 
comparative monitoring of essential drug prices. 
 
3.3  Additional studies to support the activities of the four WHO CCs :  
 
 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)  
 
 Review of Public Health aspects of Intellect ual Property Legislation of the People's Republic 
of China in the Light of the Doha Declara tion on the TRIPS Agreement and Public Health.  
(Forthcoming). 
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4. Cooperation with international 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 occasions 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. 
 - As a UNAIDS Cosponsor, WHO serves as the le ad agency within UNAIDS with 
responsibility for HIV/AIDS care and treat ment, including the area of international 
trade rules and access to HIV medicines.  The UNAIDS Secretariat has observer 
status at the WTO ministerial conferences and has been granted ad hoc observer status 
by the WTO Council for TRIPS.  WHO and the UNAIDS Secretariat collaborate closely on all trade issues relating to  response to the AIDS epidemic.   
 - Close collaboration with the South Centre, particularly in the review, publication, 
translation and dissemination of specific doc uments in the area of globalization and 
access to drugs, in coordination with the Rockefeller Foundation. 
 - International organizations, including UNICEF, UNCTAD, UNDP, WIPO and WTO, 
are systematically invited to WHO meetings  on issues 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 NGOs.  
 - Participation in WTO Ministerial Confer ences in Doha, Novemb er 2001, and Cancún, 
September 2003. 
 
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