WORLD TRADE  
ORGANIZATION  IP/C/W/478/Add.4 
23 October 2006 
 
 (06-5108) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:  English 
 
 
 
TECHNICAL COOPERATION ACTIVITIES:  INFORMATION FROM 
OTHER INTERGOVERNMEN TAL ORGANIZATIONS 
 
WORLD HEALTH ORGANIZATION  
(WHO)  
 
Addendum  
 
 
 At its meeting of 14-15 June 2006, the Council for TRIPS agreed to invite intergovernmental 
organization observers to the Council to update th e information on their technical and financial 
cooperation programmes relating to the impl ementation of the TRIPS Agreement.   
  The present document reproduces the inform ation which has been received from 
the World Health Organization (WHO) by means of a communication dated 19 October 2006.   
 
_______________ 
 
 I. INTRODUCTION 
1. In medicines, the goal of the World Health Organization is to help save lives and improve 
health by ensuring the quality, efficacy, safety and rational use of medicines, including traditional 
medicines, and by promoting equitable and sustai nable access to essential medicines, particularly for 
the poor and disadvantaged.  WHO, in its Medi cines Strategy (2004-2007), identified four key 
objectives;  namely:  the strengthening of national medicines policies;  improving access to essential medicines;  improving the quality and safety of medici nes;  and promoting their rational use.  In order 
to ensure that national medicines policies are e ffectively implemented to achieve the objective of 
improving access to priority medicines, WHO has iden tified the need to support countries in their 
efforts to use public health safeguards in intern ational, regional and bilateral trade agreements.
1  
WHO's programme on technical cooperation in this area is described below. 
II. TRADE, INTELLECTUAL PROPERTY RIGHTS AND ACCESS TO MEDICINES 
A. WHO  MANDATE  
2. WHO has a long-standing mandate in the area of trade, intellectual property rights and access 
to medicines.  Since 1997, resolutions of the Wo rld Health Assembly have provided WHO with a 
broad mandate to:  (1) monitor and analyse the pharm aceutical and health implications of multilateral, 
regional and bilateral trade agreements;  and (2) assist Member States to assess and develop 
pharmaceutical and health policies and regulatory measures to maximize the positive and mitigate the 
negative impact of these agreements.   
                                                      
1 WHO Medicines Strategy:  Countries at the Core (2004-2007) WHO, Geneva (WHO/EDM/2004.2). IP/C/W/478/Add.4 
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  3. Later resolutions of the World Health Assemb ly have directed these general objectives into 
more specific areas of technical cooperation.  In 2003, Resolution WHA56.27, in expressing "concerns about the current patent protection syst em, especially as regards access to medicines in 
developing countries", urged Member States to adapt "n ational legislation in order to use to the full 
the flexibilities contained in the Agreement on Trad e-Related Aspects of Intellectual Property Rights 
(TRIPS)".  Resolution WHA57.14 of 2004 urged Member  States, as a matter of priority "to encourage 
that bilateral trade agreements take into  account the flexibilities contained in the WTO 
TRIPS Agreement and recognized by the Doha Mini sterial Declaration on the TRIPS Agreement and 
Public Health".   
4. More recently, the 59
th World Health Assembly in May 2006 adopted two resolutions with 
direct relevance to trade and intellectual property rights issues.   
5. Resolution WHA59.26 of 2006 urges Member Stat es "to adopt, where necessary, policies, 
laws and regulations that deal with issues identif ied in that dialogue and take advantage of the 
potential opportunities, and address the potential challe nges that trade and trade agreements may have 
for health, considering, where appropriate, using th e flexibilities inherent in them".  Member States 
are urged to "continue to develop capacity at national level to track and analyse the potential 
opportunities and challenges of trade and trade agreem ents for health-sector performance and health 
outcomes".  The resolution requests WHO "to respond to Member States' requests for support of their 
efforts to build the capacity to understand the implic ations of international tr ade and trade agreements 
for health and to address relevant issues through polic ies and legislation that take advantage of the 
potential opportunities, and address the potential challe nges, that trade and trade agreements may have 
for health".  This strengthens WHO's existing mandate on issues related to trade agreements, 
intellectual property rights and public health, and fu rther endorses WHO's multi-agency approach in 
technical cooperation, which emphasizes working with and training trade, health and patent officials 
on trade and intellectual property issues.   
6. Resolution WHA59.24 of 2006 established an in tergovernmental working group (IGWG) as 
the follow-up to the report of the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH).  The IGWG is tasked with  the development of a global strategy and plan of 
action, based on the recommendations of the CIPIH report
2, which aims at, inter alia, " securing an 
enhanced and sustainable basis for needs-driven, essential health research and development relevant 
to diseases that disproportionately affect developi ng countries".  In conjunction, the resolution also 
mandated WHO to continue monitoring, "from a public health perspective, … the impact of 
intellectual property rights and other issues addressed  in the Commission's report, on the development 
of, and access to, health care products".  In this  connection, the CIPIH report had recommended, 
inter alia , that WHO establish a database of information on patents to remove potential barriers to 
availability of and access to products3 and to operationalize technology transfer provisions in the 
TRIPS Agreement for pharmaceutical production.4  The CIPIH report also questioned the public 
health justification for TRIPS-plus data protec tion rules and recommended that developing countries 
should not include data exclusivity provisions in th eir national law, and more generally, recommended 
that TRIPS-plus provisions that reduce access to medicines in developing countries should not be 
sought.5 
                                                      
 2 Public health, innovation and intellectual property rights .  Report of the Commission on Intellectual 
Property Rights, Innovation and Public Health, WHO, April 2006 available at 
 http://www.who.int/intellectualproperty  
3 See CIPIH Report recommendations 4.16 and 4.17. 
4 See CIPIH Report recommendation 4.18. 
5 See for e.g., CIPIH Report recommendation 4.20, 4.21 and 4.26.  IP/C/W/478/Add.4 
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  B. WHO  POLICY PERSPECTIVES  
7. Consistent with the above mandate, WHO works to support its Member States in the use of 
measures to protect public health and promote access to  medicines, consistent with the provisions of 
the TRIPS Agreement and the Doha Ministerial Declaration on the TRIPS Agreement and Public 
Health (hereinafter, the Doha Declaration).  WHO is guided by clear policy perspectives, which place 
public health and access to medicines as priorities, in consonance with the basic tenets of the 
Doha Declaration.   
8. WHO is further committed to assisting Member St ates to make effective use of the system to 
permit the export of pharmaceutical products ma nufactured under compulsory licence, as agreed 
under the proposed amendment to the TRIPS Ag reement adopted by the General Council 
on 6 December 2005.  WTO Members agreed to convert the interim system adopted by the WTO in 
August 20036 into a new article of the TRIPS Agreement, Article 31 bis.  Article 31 bis will come into 
force in December 2007, if two-thirds of the WTO membership ratifies the amendment.  In the WHO 
guide to implementing the system, WHO suggests th at a public health-oriented interpretation and 
implementation of the provisions would be required to achieve th e objective of access to medicines.7  
In some cases, it would also require changes to the national laws.8  In exporting countries, this would 
include provisions that permit the export of pharmaceutical products produced under compulsory 
licence, by explicitly stating that the supply of an  export market is a possible ground for a compulsory 
licence.  In the case of countries wishing to import generic medicines, national laws should permit compulsory licences for import and also include specific provisions for government use or public, 
non-commercial use of patents, and the waiver of pa yment of remuneration or royalties to the patent 
holder.  National laws should also not limit the impl ementation of the system to a restricted list of 
products or diseases, by incorporating a broad defi nition of "pharmaceutical products" for which the 
system can be used, and include diagnostics, vacci nes and medical devices used for treatment, within 
the definition.  Least developed countries may wish to make the necessary changes to their legislation 
in order to make use of Paragraph 7 of the Doha  Declaration, which allows them to defer the 
implementation and enforcement of pharmaceutical patents until at least 2016. 
III. WHO TECHNICAL COOPERATION 
9. In many developing countries, there is still a ne ed to facilitate informed  approaches to address 
health implications of trade and intellectual prope rty-related issues at the national, subregional and 
regional levels.  Given that there is still insufficient awareness and assessment of the provisions in 
international, regional and bilateral trade agreem ents that can be used to safeguard access to 
medicines, WHO's strategic priorities in technical cooperation have been to support Member States in 
their efforts to improve access to medicines through direct country support and technical assistance on 
the use of flexibilities and safeguards in thei r national legislation in accordance with the 
Doha Declaration on the TRIPS Agreement and Public Health.   
10. WHO seeks to provide the appropriate technical assistance and country support, within a 
comprehensive and coherent strategy, to Memb er States to promote implementation of the 
TRIPS Agreement that is consistent with the prot ection of public health and promotion of access to 
medicines.  To this end, WHO has prepared a Strategy for Technical Cooperation (2006-2007) on 
                                                     
 
6 WTO General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration on 
the TRIPS Agreement and Public Health, WT/L/540 of 2 September 2003. 
7 Implementation of the WTO General Council Decision on Paragraph 6 of the Doha Declaration on 
the TRIPS Agreement and Public Health , WHO Health Economics and Drugs, EDM Series N° 16, 2004, 
available at: 
http://www.who.int/medicines/areas/po licy/WTO_DOHA_DecisionPara6final.pdf  
8 See also Production and Export of Generic Medicines under the TRIPS Agreement , WHO Drug 
Information, Vol. 20, No. 1, 2006. IP/C/W/478/Add.4 
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  Access to Medicines in the context of Intellect ual Property Rights and Trade Agreements.  The 
Strategy is an attempt to clearly set out the obj ectives of WHO's technical cooperation programme in 
the area of intellectual property rights and trade agre ements, so as to realize the objectives and vision 
of the WHO Medicines Strategy (2004-2007).  The Strategy, currently pending approval for 
publication, focuses on four key interventions:  (1) policy and technical guidance;  (2) training and 
enhancing capacity;  (3) direct country s upport;  and (4) monitoring and analysis. 
A. P
OLICY AND TECHNICAL GUIDANCE  
11. Within this intervention, WHO continu es to identify key issues related to the 
TRIPS Agreement and Doha Declaration implemen tation, and to develop technical and policy 
guidance in the form of technical publications a nd briefing documents, in consultation with various 
experts and relevant international organizations.  WHO will also build upon its network of experts on 
international trade, intellectual property and pub lic health issues, which provides sound technical 
advice for the development and review of techni cal and policy documents.  Recent publications of 
note include the following: 
12. WHO and the United Nations Developmen t Programme (UNDP) jointly published 
Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies , in 
December 2005.  The study documents various stat e practices on the determ ination of adequate 
remuneration, and proposes possible approaches for adoption by developing countries.  Whilst the 
Doha Declaration has confirmed the right of countri es to grant compulsory licences for public health 
purposes, the absence of an appropriate administrative/legal infrastructure and procedures to 
implement the compulsory licensing system may hi nder its effective use.  Since most developing 
countries do not have sufficient expertise or experi ence in this area, it is hoped that the publication 
will provide a useful guide to developing countri es on a crucial requirement in the compulsory 
licensing regime.   
13. A third revised French edition of Globalization and Access to Drugs ( Mondialisation et Accès 
aux Médicaments:  Perspectives sur l'Accord sur les ADPIC de l'OMC ) was also published in 
late 2005.  The third edition updates the first edition published in 1998, with a comprehensive analysis 
of the implications of the Doha Declar ation and the Paragraph 6 Decision.   
14. WHO is also in the process of publishing the Guide for the Application and Granting of 
Compulsory Licences and Authorization of Go vernment Use of Pharmaceutical Patents .  The concept 
of the Guide had been agreed upon at an inter-a gency technical workshop organized by WHO and 
UNICEF, with the support of UNAIDS in August 2005.  Participants included representatives from 
UN agencies and international organizations such  as the Global Fund for the Fight against AIDS, 
Tuberculosis and Malaria (GFATM), UNAIDS, UNDP, UNICEF and WHO.  This Guide focuses on 
the grant of compulsory licences and government use authorization, in the context of the purchase and 
import of patent-protected pharmaceutical produc ts.  It provides general recommendations to 
governments, procurement agencies and nongovern mental organizations on the modalities for the 
application of compulsory licences and government u se authorization.  It also addresses the special 
situation of least developed countries, as provided fo r in Paragraph 7 of the Doha Declaration on the 
TRIPS Agreement and Public Health, which allows  least developed countries a transition period 
until 2016 during which they need not  provide for, nor enforce, patent rights and exclusive marketing 
rights in relation to pharmaceutical products.   
B. TRAINING AND ENHANCING CAPACITY  
15. Recognizing that effective collaboration between he alth, trade and patent agencies is essential 
for informed and coherent decision-making on publ ic health and intellectual property issues, WHO 
continues to adopt a multi-agency approach in conducting briefings and training sessions for health,  IP/C/W/478/Add.4 
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  trade and patent officials.  The focus is to enha nce developing country capacity to ensure effective 
participation in trade negotiations, a nd to ensure that public health interests are adequately taken into 
account in national policy and legislation.   
16. In 2005-2006, WHO organized and facilitated a series of regional and national training 
workshops for developing country policy makers, w ith a focus on enhancing the capacity of trade 
negotiators, policy makers and ins titutions to understand and monitor th e impact of trade agreements, 
and to build negotiating skills.  No table amongst these were the following: 
1. Intellectual Property Rights and Public Health:  Towards an Intellectual Property 
Regime that Protects Public Health and Patients' Rights, Buenos Aires (March 2006)  
17. This two-week course was co-sponsored by th e Ministry of Health of Argentina, the 
Pan American Health Organization (PAHO), the University of Buenos Aires and the UNDP.  The 
objectives of the course, included increasing awareness of the importance of applying intellectual 
property laws and policies in a manner consistent with  public health requirements and patients' rights;  
improving knowledge of internationa l and national laws and policies related to intellectual property 
(including patents, trademarks a nd data protection);  and strengthe ning national capacity to design and 
implement intellectual property policies consistent with public health needs and patients' rights.  
Participants from 11 Latin American countries (Argentina, Bolivia, Brazil, Chile, Colombia, 
Costa Rica, Dominican Republic, Guatemala, Peru, Paraguay and Venezuela) participated in the 
course.  Feedback from participants and donors has been positive, and plans are being formulated to 
design similar courses for the Asian and African Regions.   
2. WHO Intercountry Seminar on Intellectual Pr operty Rights and Access to Medicines, 
Dhaka  (March 2006)  
18. The intercountry seminar was organized in conjunction with the WHO Regional Office for 
South-East Asia (SEARO).  The objectives of the seminar included:  (a) providing updates of 
relevant, recent developments in the area of in tellectual property rights and trade agreements;  
(b) discussing how such developments will imp act on access to medicines, (including HIV/AIDS 
medicines and oseltamivir) at the national leve l;  and (c) recommending specific actions at the 
regional and national levels in or der to benefit from public health provisions in trade agreements.  
Participants included health, trade and patent offi cials from the Member States of the Region, in line 
with the WHO's intersectoral approach to facilitate coherent policy-making. 
3. WHO Regional Workshop on Local Production of Essential Medicines, including ARVs, 
Brazzaville (February 2006)  
19. The regional workshop was organized in collaboration with the WHO Regional Office for 
Africa (AFRO).  The key objectives of the workshop were to:  (a) review current capacities for the 
production of essential medicines in the African Regi on;  (b) discuss feasible strategies and policy 
options to strengthen production of essential medici nes, including ARVs;  (c) prepare a strategic 
framework of activities, with a view to st rengthening local production capacities for essential 
medicines, including ARVs, for the period 2006-2010;  and (d) formulate a work plan for WHO in the 
implementation of the strategic framework.  The strategic framework that was developed by the 
Workshop covered key aspects, including the policy aspect - including national medicines policies, 
intellectual property and trade-related issues.   
4. World Trade Organization training workshops 
20. WHO continues to participate actively in th e WTO series of regional workshops on TRIPS 
issues.  In September 2005, WHO staff presented a session on TRIPS implementation and access to IP/C/W/478/Add.4 
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  medicines, including on medicines regulatory issues at the WTO Seminar on Implementation of 
Paragraph 6 of the Doha Declarati on, in Geneva.  In 2006, WHO sta ff participated as resource persons 
in all of the four regional workshops on TRIPS implementation organized by the WTO Secretariat, 
held in Macao, Ankara, Kuwait and Costa Rica.  At these workshops, WHO staff provided briefings 
and training for health, trade and patent official s from the Asian Economies, the Central-Eastern 
European and Central Asian Economies, the Arab  and Latin American countries on a public-health-
oriented approach to the implementation of th e TRIPS Agreement and the Doha Declaration. 
21. In addition, WHO collaborated with WTO in a training module on the TRIPS Agreement and 
access to medicines, in the June 2006 training course on Health Policy in a Globalizing World , held in 
Geneva.  The course was aimed at introducing cu rrent and emerging health policy issues in the 
context of today's globalized world to WHO staff and graduate students. 
C. D
IRECT COUNTRY SUPPORT  
22. WHO has provided, and will continue to provi de, direct country support to countries to 
facilitate the review of national policy and legal frameworks.  Such country support is focused on 
developing public health sensitiv e patent legislation and incorporating the TRIPS flexibilities within 
the domestic legislation.   
23. The approach has been to iden tify the key issues and problems, in close consultation with the 
WHO Country and Regional Offices.  WHO's ne twork of National Professional Officers who are 
based in-country to assist in the planning, impl ementation and monitoring of medicines and other 
related policies has also contributed to provision of  technical cooperation that is specific and tailored 
to the needs of the particular Memb er State.  The focus is to facilitate the review of national policy 
and legal frameworks, with a view to incorporating pro-public health perspectives, in particular, the 
implementation of the TRIPS flexibiliti es or public health safeguards.   
D. MONITORING AND ANALYSIS  
24. The public health impacts of intellectual prope rty protection have yet to be fully assessed.  
There needs to be continued monitoring and analys is of the impact of trade agreements on public 
health and access to essential medicin es, including the impact of new trends and developments.  There 
is a further need to systematically collect and analyse data relevant to assessing the implication of 
economic globalization and the TRIPS Agreemen t for the challenge of improving access to 
medicines.  The focus will be on monitoring and anal ysis of the impact of trade agreements on public 
health and access to essential medicines, includi ng new, emerging trends and developments.  The 
priorities and related activities of WHO's monitori ng and analysis work can be described as follows: 
1. Determining the patent status of essential medicines 
25. Despite the long-standing debate on the imp lications of patent protection on access to 
medicines, there is still considerable uncertainty regarding the existence of patents on particular 
medicines.  WHO has embarked on a pilot project with several partners, including the European 
Patent Office (EPO), the World Intellectual Prope rty Organization (WIPO) and a selected number of 
national patent offices.  The project seeks to inv estigate and analyse the extent to which specified 
essential medicines are protected by patents in de veloping countries, for the purpose of determining 
the patent "landscape" for the essen tial medicines.  It is intended to respond to requests to WHO for 
patent data on medicines from Member States a nd UN agencies in order to facilitate efficient 
medicines procurement practices, a nd to provide relevant information to Member States to facilitate 
informed policy decisions regarding medicines pr ocurement and the use of TRIPS flexibilities, by 
increasing the transparency of and access to patent  information related to essential medicines.    IP/C/W/478/Add.4 
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  2. Developing a public health perspective for the examination of pharmaceutical patents 
26. While only a small number of new chemical entities are approved annually, the number of 
patents applied for protection of pharmaceutical products are increasing.  There is a need to monitor and analyse trends in pharmaceutical patenting, to respond to growing concerns
9 about the increase in 
patents that protect variants of existing drugs or processes while the number of patents on new 
molecular entities is small and declining.  In the circumstances, the criteria applied to examine and 
grant pharmaceutical patents are extremely relevant fo r public health policies, and not only a matter of 
concern for patent and industrial polic y.  Policy makers in the health area, as well as patent examiners, 
should be aware that decisions relating to the gran t of a patent (which is generally presumed valid 
until proven to the contrary) can directly affect the health and lives of the people of the country where 
the patent is granted and enforced.  WHO has co mmissioned a study on various categories of patent 
claims for pharmaceutical products, with a view to assessing the practice of some patent offices.  The 
study suggests some of the mechanisms that may be adopted to incorporate public health perspectives 
in procedures for the granting of pharmaceutical patents.  The study proposes a set of general guidelines for the assessment of so me of the common modalities of pharmaceutical patent claims, and 
suggests elements for development of public health  sensitive guidelines for the evaluation and review 
of pharmaceuticals patents at the national level in developing countries.  The study has undergone 
several expert and technical consultations:  a t echnical consultation was organized by the Food and 
Drug Authority of Thailand in October 2005 (c omprising representatives of drug regulatory 
authorities and patent offices of China, Indonesia, Malaysia and Thailand);  and more recently, in 
September 2006 a technical consultation, jointly hosted by the United Nations Conference on Trade 
and Development (UNCTAD), the International Ce ntre for Trade and Sustainable Development 
(ICTSD) and WHO, took place in Geneva, wherein representatives from the South Centre, the Swiss 
Patent Office, WIPO and WTO were consulted for their technical inputs.  The document emanating 
from this study is currently being finalized for pu blication as a working paper in order to facilitate 
broader consultation and inputs.   
3. Impact assessment of trade agreements 
27. There is an increasing demand for clear analysis of bilateral and regional trade agreements 
from a public health perspective, including the impli cations of provisions such as data exclusivity, 
patent term extensions, restric tions on compulsory licensing and the patent-drug regulatory authority 
linkage on public health and access to medicin es.  WHO, in partnership with The World Bank 
Institute (WBI) and the ICTSD, held  an expert consultation on " Developing a Methodology to Assess 
the Impact of TRIPS-plus Provisions affecting Drug Prices ", Geneva, 31 July to 1 August 2006.  The 
objective of the joint ICTSD-WBI-WHO impact ass essment project is the development of a common 
methodological framework to improve the capacity in developing countries for evaluating the public 
health impact of TRIPS-plus standards.  This framework is targeted at governments, research 
institutes, and civil society organizations.  The avai lability of credible empirical evidence can serve a 
variety of ultimate purposes, including:  (i) st rengthening the overall negotiating capacity of 
governments;  (ii) identifying areas where flexibilities in the negotiation of new IPR standards may be 
warranted;  and (iii) identifying areas where complementary policies may help alleviate possible 
adverse public health implications of TRIPS-plus  standards.  The framework will hopefully be a 
useful contribution to debate on the implications of TRIPS-plus provisions, by providing tools for 
empirical analysis and data to enable informed decision-making. 
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 9 See, e.g., Federal Trade Commission (FTC) (2003);  Jaffe and Lerner (2004).