WORLD TRADE  
ORGANIZATION  IP/C/W/516/Add.1 
15 October 2008 
 
 (08-4889) 
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 17 June 2008, the Council fo r 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 im plementation of the TRIPS Agreement. 
 The present document reproduces the inform ation which has been received from 
the World Health Organization (WHO) by mean s of a communication dated  2 October 2008. 
  
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INFORMATION ON TECHNICAL AND FINANCIAL COOPERATION PROGRAMMES 
CARRIED OUT BY THE WORLD HEALTH ORGANIZATION RELEVANT TO 
THE IMPLEMENTATION OF THE TRIPS AGREEMENT 
AND PUBLIC HEALTH 
 
 
I. INTRODUCTION 
 One of the goals of the World Health Organi zation (WHO) is to help save lives and improve 
health particularly for the poor and disadvantaged  by promoting equitable and sustainable access to 
essential medicines, that meet standards of quality,  efficacy, safety and rational use of medicines.  
 In furthering this goal, since 1997, resolutions  of the World Health Assembly have provided 
WHO a mandate particularly in the area of trade, intellectual property rights and access to medicines. 
To this end, WHO works to support member States in  the use of measures to protect public health and 
promote access to medicines, consistent with th e 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 pe rspectives, which place public health and access to 
medicines as priorities, in consonance with th e basic tenets of the Doha Declaration.  IP/C/W/516/Add.1 
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  II. PUBLIC HEALTH, INTELLECTUAL PROP ERTY RIGHTS AND ACCESS TO 
MEDICINES 
A. T
HE INTERGOVERNMENTAL WORKING GROUP ON PUBLIC HEALTH , INNOVATION AND 
INTELLECTUAL PROPERTY  
1. The WHO Secretariat on Public Health, Inn ovation and Intellectual Property (PHI), was 
established in September 2006 to facilitate the work of the Intergovernmental Working Group 
(IGWG) on Public Health, Innovation and Intellectual Property.  Over a period of 18 months, WHO 
member States and other stakeholders met in several  meetings of the IGWG to discuss ways to foster 
innovation, build capacity and improve access to health  products to achieve be tter health outcomes in 
developing countries.  In May 2008, the 61st World Health Assembly adopted Resolution WHA61.21 
on the Global strategy and plan of action on public health, innovation and intellectual property  
(GSPOA). 
2. The strategy aims to promote new thinking in innovation and access to medicines, which 
would encourage needs-driven resear ch rather than purely market-driven research to target diseases 
which disproportionately affect people in developing  countries.  To achieve this, the strategy proposes 
that WHO should play a strategic and central role  in the relationship between public health and 
innovation and intellectual property within its mand ate.  Moreover, Element five of the GSPOA on 
"Application and management of intellectual propert y to contribute to innovation and promote public 
health", states that the strategy will encourag e and support the applica tion and management of 
intellectual property in a manner that maximizes h ealth-related innovation, especially to meet the 
R&D needs of developing countries;  protect public health and promote access to medicines for all;  
as well as explore and implement, where appropriate, possible incentive schemes for R&D. 
B. WHO  POLICY PERSPECTIVES  
3. The work of the PHI Secretariat on technical cooperation on public health and intellectual 
property (IP) is guided by the GSPOA and the releva nt resolutions of the World Health Assembly. 
4. WHO is further committed to assisting memb er States in making effective use of the 
"Paragraph 6" system to permit the export of pharmaceutical products manufactured under 
compulsory licence, as agreed under the proposed amendment to the TRIPS Agreement adopted by 
the General Council on 6 December 2005.  WTO Members agreed to convert the interim system 
adopted by the WTO in August 20031, into a new article of the TRIPS Agreement, Article 31 bis. 
Article 31 bis will come into force in December 2009, if two-thirds of the WTO membership ratifies 
the amendment.  To date, 18 WTO Members have formally accepted the amendment:  United States;  Switzerland;  El Salvador;  Republic of Korea;  Norway;  India;  Philippines;  Israel; Japan;  
Australia;  Singapore; Hong Kong, China; Europ ean Communities; Mauritius; Egypt; Mexico and 
Jordan. 
5. The WHO guide on implementing the "Paragraph 6" system suggests that a public health-
oriented interpretation and implementation is essential to achieving the objective of access to 
medicines
2.  In some cases, this objective al so requires changes to national laws3.  In exporting 
countries, this could include provisions that permit the production exclusively for export of 
                                                      
1 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. 
2 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/policy/WTO_DOHA_DecisionPara6final.pdf  
3 See also Production and export of generic medicines under the TRIPS Agreement , WHO Drug 
Information, Vol. 20, No. 1, 2006.  IP/C/W/516/Add.1 
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  pharmaceutical products produced under a compulsory li cence, by explicitly stating that the supply of 
an export market is a possible ground for granting a compulsory licence.  Countries wishing to import 
generic medicines may consider revising their comp ulsory licence laws to provide for importation and 
also include specific provisions for government use or public, non-commercial use of patents, and the 
waiver of payment of remuneration or royalties to the patent holder.  National laws should also not 
limit the implementation of the system to a restricted list of products or diseases, by incorporating a 
broad definition of "pharmaceutical products" for which the system can be used, and including 
diagnostics, vaccines and medical devices used for tr eatment, within the definition.  Least-developed 
countries may wish to make 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 
6. In many developing countries, there remain s a need for more informed approaches to 
addressing the health implications of trade and in tellectual property-related issues at the national, 
subregional and regional levels.  For example, ther e is insufficient awareness and assessment of the 
provisions in international, regiona l and bilateral trade agreements that can be used to safeguard 
access to medicines. 
7. In response, WHO's strategic priorities in tec hnical 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 their national legislation in accordance with the 
Doha Declaration on the TRIPS Agreement and Pub lic Health.  WHO seeks to provide appropriate 
technical assistance and country support, within a comprehensive and coherent  strategy, and promote 
implementation of the TRIPS Agreement in a way th at is consistent with the protection of public 
health and promotion of access to medicines.  To this end, technical assistance has focused on four 
key interventions:  1) policy and technical guidance;   2) training and enhancing capacity;  3) direct 
country support;  and 4) monitoring and analysis. 
A. P
OLICY AND TECHNICAL GUIDANCE  
8. Within this intervention, WHO continues to id entify key issues related to the implementation 
of the TRIPS Agreement and the Doha Declaration,  and to develop technical and policy guidance in 
the form of technical publications and briefing doc uments, in consultation with various experts and 
relevant international organizations.  WHO builds up on its network of experts on international trade, 
intellectual property and public health issues, which provides sound technical advice for the 
development and review of technical and policy documents.  
9. In this regard, WHO is in the process of fina lizing a series of technical briefing papers on 
current issues in the area of intellectual property a nd access to medicines.  These short analysis papers 
are intended to provide policy makers and regulat ors with a non-specialist and succinct examination 
of topical issues in the area of intellectual propert y rights, public health and access to medicines. 
These include: 
• Patents and access to medicines - an introduction to key issues; 
• Access to medicines - intellectual property protection:  impact on public health; 
• Production and export of generic medicines under the TRIPS Agreement; 
• Implementation of the TRIPS Agreement post-2005:  implications for access to 
medicines; 
• Use of compulsory licences for public health purposes:  lessons from the experiences of 
developing countries. 
 IP/C/W/516/Add.1 
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  10. Moreover, WHO has developed a guide for the application and granting of compulsory 
licences and authorization of government use of pharmac eutical patents.  This project is being carried 
out in collaboration with the Global Fund for the Fight against AIDS, Tuberculosis and Malaria 
(GFATM), UNAIDS, UNDP and UNICEF.  The guide focuses on the grant of compulsory licences 
and government use authorization, in the context of the purchase and import of patent-protected pharmaceutical products and pr ovides general recommendations to governments, procurement 
agencies and nongovernmental organizations on the modalities for the application of compulsory 
licences and government use authorization. 
B. T
RAINING AND ENHANCING CAPACITY  
11. 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 conduct briefings and training sessions for health, trade and patent officials.  These aim 
to enhance developing country capacity to ensure e ffective participation in trade negotiations, and to 
ensure that public health interest s are adequately taken into account in national policy and legislation. 
With respect to these activities, WHO adopts an mu lti-agency approach, drawing on the expertise of 
other relevant international in tergovernmental organizations.  
12. In 2007-2008, WHO continued to organize and facilitate regional and national training 
workshops for developing country policy makers.  They focussed on enhancing the capacity of trade 
negotiators, policy makers and ins titutions to understand and monitor the impact of trade agreements 
and to build negotiating skills.  No table amongst these were the following: 
1. Meeting of procurement experts of the Southern African Development Community 
(SADC) on TRIPS and Access to Medicines, Lilongwe (May 2007) 
13. This meeting was organized by SADC, in collaboration with UNDP and the WHO Regional 
Office for Africa (AFRO), in order to inform proc urement experts and regul ators in the 14 Member 
States of SADC on the issue of intellectual property,  trade agreements and access to medicines.  This 
topic is of particular importance to SADC member States in the light of the fact that they are now 
addressing issues of pooled procurement and are being en couraged to amend their patent laws in order 
to make use of the flexibilities of the TRI PS Agreement to improve access to medicines. 
2. Meeting of experts on enabling legislation to facilitate an increase in access to essential 
medicines in West Africa, Accra (July 2007) 
14. This workshop was organized by the Economic Community of West African States 
(ECOWAS), the West African Health Organization (WAHO), UNDP, and in collaboration with 
WHO.  The objectives of the workshop were to examine the various policy and legislative tools 
available for reducing essential drug prices and taki ng advantage of the flexibilities of the TRIPS 
Agreement, including through an evaluation of ex isting capacity in the region for generic production 
of medicines.  The meeting was attended by representatives of patent offices, drug regulatory authorities and generic manufacturers of ECOWAS member States. 
3. Designing intellectual property regimes that protect public health and patients' rights:  
integrating public health concerns into the evaluation of pharmaceutical patents 
15. WHO is also developing a new training c ourse to improve capacity to evaluate 
pharmaceutical innovations.  This project is intended to assist developing countries in the 
implementation of national patent re gimes, in a manner that is suppor tive of public health objectives, 
particularly the right to health.  The expected outco mes of the project include:  an increased awareness 
of the importance of applying patent laws and polic ies in a manner consistent with public health  IP/C/W/516/Add.1 
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  requirements and patients' rights;  a general set of guidelines for use by patent offices and other 
interested parties in the evaluation of pharmaceu tical patents (further explained under Monitoring and 
Analysis below);  and strengthening of national ca pacity to design and implement patent policies 
consistent with public health needs and patients' rights.  The first of such training courses was held in 
New Delhi, India, in December 2007. 
4. World Trade Organization training workshops 
16. WHO continues to actively participate in th e WTO series of regional workshops on TRIPS 
issues.  In 2007-2008, WHO staff participated as resource persons in regional workshops on TRIPS 
implementation organized by the WTO Secretariat,  held in Tunis, Cape Town, Macao and Quito 
providing briefings and training for health, trade and patent officials on a public-health-oriented 
approach to the implementation of the TRIPS Agreement and the Doha Declaration.   
17. WHO also collaborated with WIPO and WTO in a training module on TRIPS and public 
health, in the 2007 and 2008 colloquiums for teachers of  intellectual property.  The aim of the course 
was to update university teachers of intellectual pr operty in developing countries and countries with 
economies in transition on the activities and instruments of WIPO and WTO. 
18. In addition,  WHO collaborated with WTO in  a training module on the TRIPS Agreement and 
access to medicines, in the 4th annual training c ourse in June 2008 on Health Policy in a Globalizing 
World, held in Geneva.  The course was aimed at introducing current and emerging health policy 
issues in the context of today's globalized world to WHO staff and graduate students. 
5. Intellectual property rights and public health: towards an intellectual property regime 
that protects public health and patients' rights, Buenos Aires (March 2007 and  March 2008)  
19. This two-week course was co-sponsored by the Ministry of Health of Argentina, the Pan 
American Health Organization (PAHO), the University  of Buenos Aires and  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 h ealth requirements and patients' rights;  improving 
knowledge of international and nati onal laws and policies related to  intellectual property (including 
patents, trademarks and data protection);  a nd strengthening national capacity to design and 
implement intellectual property policies consistent with  public health needs and patients' rights.  Fifty-
one participants from 19 Latin American countri es (Argentina, Bolivia, Brazil, Chile, Colombia, 
Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, 
Nicaragua, Panama, Paraguay, Peru, Uruguay and Ve nezuela) participated in these two courses. 
Feedback from participants and donors has been pos itive, and PHI is intending to design similar 
courses for the Asian and African Regions.  
C. D
IRECT COUNTRY SUPPORT  
20. Upon request, WHO continues to provide direct country support in the review of national 
policy and legal frameworks.  Such country support is focused on developing  public health sensitive 
patent legislation and incorporating the TRIPS flexibilities within the domestic legislation.  
21. The approach has been to identify 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 particular needs of member States.  Such direct country support has resulted in the review of IP/C/W/516/Add.1 
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  national policy and legal frameworks, with a view to  incorporating pro-public health perspectives, in 
particular, the implementation of the TRI PS flexibilities or public health safeguards. 
22. In the context of resolution WHA60.30, WHO/PHI and the Regional Office for South-East 
Asia, in collaboration with WTO, UNCTAD a nd UNDP, provided technical and policy support to 
Thailand, (January/February 2008) on the general ru les and mechanisms available for the use of the 
flexibilities contained in the TRIPS and other intern ational agreements in order to promote access to 
pharmaceutical products.  
D. M
ONITORING AND ANALYSIS  
23. To better understand the impact of internationa l trade agreements on public health, there is a 
need for further monitoring and analysis with resp ect to intellectual property provisions, including 
new trends and developments, and their relationship to access to medicines.  To this end, the 
systematic collection and analysis of relevant data  is essential.  The priorities and related activities of 
WHO's monitoring and analysis work can be described as follows: 
1. Determining the patent status of essential medicines 
24. 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), WIPO and a selected number of national patent offices.  The project seeks to 
investigate and analyse the extent to which specifi ed essential medicines are protected by patents in 
developing countries, for the purpose of determ ining the patent "landscape" for the essential 
medicines.  It is intended to respond to requests to WHO for patent data on medicines from member 
States and UN agencies in order to facilitate effici ent medicines procurement practices, and to provide 
relevant information to member States to facilit ate informed policy decisions regarding medicines 
procurement and the use of TRIPS flexibilities, by in creasing the transparency of and access to patent 
information related to essential medicines. 
2. Developing a public health perspective for the examination of pharmaceutical patents 
25. To respond to growing concerns4 about the increase in patents that protect variants of existing 
drugs or processes while the number of patents on ne w molecular entities is small and declining, there 
is a need to monitor and analyse trends in pharmaceu tical patenting.  Policy makers in the health area, 
as well as patent examiners, should be aware that deci sions relating to the grant 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 commissioned a study on various categories of patent claims for pharmaceu tical products, with a view to assessing the practices 
of some patent offices.  The study suggested so me of the mechanisms that may be adopted to 
incorporate public health perspectives into procedur es for the granting of pharmaceutical patents.  It 
proposed a set of general guidelines for the assess ment of some of the common modalities of 
pharmaceutical patent claims, and suggested elements  for the development of public health sensitive 
guidelines for the evaluation and review of pharmaceu ticals patents at the national level in developing 
countries.  In carrying this activity forward, W HO has collaborated with UNC TAD, the International 
Centre for Trade and Sustainable Development (IC TSD), the South Centre, WIPO, WTO and various 
member States.  The document emanating from this study was issued as a working paper in December 
2006 in order to facilitate broader consultation and i nputs.  Since then, consultations to refine the 
guidelines have taken place in Beijing in December  2006, Buenos Aires in June 2007 and Bangkok in 
September 2007. 
                                                     
 
4 See, e.g., Federal Trade Commission (FTC) (2003);  Jaffe and Lerner (2004).  IP/C/W/516/Add.1 
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  3. Impact assessment of trade agreements 
26. 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), the ICTSD and UNDP, is de veloping a common methodological framework to 
improve the capacity in developing countries for eval uating the public health impact of TRIPS-plus 
standards.  This framework is targeted at gove rnments, research institutes, and civil society 
organizations.  The availability of credible empi rical evidence can serve a variety of purposes, 
including:  (i) strengthening the overall negotiating capacity of governments;  (ii) identifying areas where flexibilities in the negotiation of new IPR stan dards may be warranted;  and (iii) identifying 
areas where complementary policies may help alleviat e possible adverse public health implications of 
TRIPS-plus standards.  The framework will hopefu lly 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.  It has already been tested in Costa Rica, th e Dominican Republic and 
Uruguay and a further meeting is planned to finalize the framework. 
 
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