WORLD TRADE  
ORGANIZATION   
IP/C/W/581/Add.2 
19 October 2012 
 (12-5700) 
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 5 June 2012, 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 information which has been received from the World 
Health Organization (WHO) by means of a communication dated 12 October 2012. 
 
_______________ 
 
I. INTRODUCTION  
1. This communication summarizes the technical cooperation activities of WHO in the broader 
area of public health, intellectual property and trade that took place since the submission of the last 
report in October 2011.  Communications of prev ious years can be found on the website of WHO.
1  
This report presents WHO's activities aimed at the implementation of the Global strategy and plan of 
action on public health, innovation and intellectual property that was adopted by the 61st World 
Health Assembly in May 2008 (Resolution WHA61.21), including in the area of providing policy and technical guidance, transfer of technology and lo cal production, training and enhancing capacity and 
direct country support.  
II. IMPLEMENTATION OF THE GLOBAL STRATEGY AND PLAN OF ACTION ON 
PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY  
2. Based on previous assessments, the Global strategy and plan of action observed that 
"Proposals should be developed for health-needs dr iven R&D that include exploring a range of 
incentive mechanisms, including where appropriate, a ddressing the de-linkage of the costs of research 
and development and the price of health products  …".  More specifically WHA 61.21 required WHO 
to establish an expert working group "to examine cu rrent financing and coor dination of research and 
development, as well as proposals for new and innova tive sources of financing to stimulate research 
and development related to Type  II and Type III diseases and the specific research and development 
needs of developing countries in relation to Type I diseases". 
 
                                                      
1 http://www.who.int/phi/wto_c ommunications/en/index.html . IP/C/W/581/Add.2 
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A. CONSULTATIVE
 EXPERT  WORKING  GROUP 
3. Based on this mandate, a first Expert Work ing Group on R&D Financing (EWG) collected 
more than 100 proposals from various sources on ho w to increase such R&D.  The EWG developed a 
specific methodology to assess the feasibility of these proposals.  While the report2 was presented to 
the WHA in 2010, WHO Member States decided to establish a subsequent Consultative Expert 
Working Group (CEWG).  The mandate of the CE WG focused on deepening the analysis of the 
EWG, considering additional submissions and prop osals from relevant stakeholders and examining 
the appropriateness of different R&D financing a pproaches, including the feasibility of implementing 
these approaches in each of the six WHO regions (WHO Resolution WHA63.28).  Based on a set of 
established criteria, the CEWG made a number of  recommendations for further action:  a global 
framework on research and development; open a pproaches to research and development and 
innovation;  pooled funds;  direct grants to compani es;  milestone prizes and end prizes;  and patent 
pools.3  
4. The CEWG report was presented to the 65th World Health Assembly in May 2012, resulting 
in the decision to hold an open-ended meeting of Me mber States to further analyse the report and the 
feasibility of the recommendations proposed by the CEWG.  
B. GLOBAL  AND  REGIONAL  INFORMATION  PLATFORMS 
5. WHO presented a prototype of a Global Plat form for Innovation and Access during the 65th 
World Health Assembly.  The purposes of the pl atform would be to provide a comprehensive 
mechanism to share and access in formation related to innovation for and access to medical products 
and technologies in developing countries, as well as to facilitate the engagement of interested 
stakeholders on topics linked to the Global strategy and plan of action.  This platform is being 
developed based on the Pan American Health Or ganization (PAHO) Regional Platform on Access and 
Innovation for Health Technologies.4   
6. Since the Conceptual Mapping on Public Hea lth and Intellectual Property was initiated in 
previous years, PAHO has continued to systema tize key information on national intellectual property 
frameworks in the Americas.  Based on the concep tual mapping and the WHO Pharmaceutical Sector 
Country Profile5, indicators are defined and classified as basic or advanced according to the depth of 
information that they provide related to intellect ual property rights management.  The standardization 
of information across Member States constitutes an important step towards a better understanding of 
intellectual property frameworks from a public health perspective and can facilitate the 
implementation of related monitori ng and evaluation mechanism.  The information gathered is easily 
accessible to all stakeholders through the PAHO  Regional Platform on Access and Innovation for 
Health Technologies.  The Regional Platform is a dynamic instrument centered on member countries´ 
public health needs.  It facilitates networking,  collaborative projects and the development of 
competencies in the health technology and innovation sector.  The platform promotes and supports innovation, access to medicines, rational use, qua lity and governance of the health technologies 
sector.  Users will find not only intellectual propert y management profiles but also other relevant 
information.  Currently PAHO has released data from five countries and plans to include four 
additional countries by the end of this year.   
                                                      
2 Report of the EWG:  http://www.who.int/phi/publich earing_researchdev/en/index.html  
3 A detailed presentation of all these proposals and their analysis is provided in Annex 3 of the CEWG 
report:  http://www.who.int/phi/cewg_report/en/index.html  
4 http://prais.paho.org/  
5 http://www.who.int/med icines/areas/coordination/coor dination_assessment/en/index.html   IP/C/W/581/Add.2 
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  III. WHO TECHNICAL COOPERATION  
7. The overall objective of WHO's technical coope ration is to strengthen the capacity of 
developing countries in the areas of health innova tion and management of intellectual property.  
Public health interests should be adequately taken into account in the formul ation of national policies 
and legislation on trade and intellectual property, including through the implementation and the use of 
the flexibilities provided by the WTO TRIPS Agreement and the Doha Declaration on the TRIPS 
Agreement and Public Health.  
8. WHO's technical cooperation is driven by dema nd and based on its mandate as derived from 
the Global strategy and plan of action, as well as fr om other relevant resolutions.  In fulfilling this 
mandate, WHO is collaborating closely with WHO C ountry and Regional Offices, along with relevant 
international organizations.  Activ ities focus on transfer of technology, capacity building and training, 
and direct technical assistance.  
A. POLICY AND TECHNICAL GUIDANCE  
9. The WHO, WIPO and WTO are currently colla borating on a joint study on "Promoting access 
and medical innovation: intersections between public health, intellectual property and trade".  The 
new publication aims to inform policy debates from an  empirical perspective on the relationships and 
interactions between intellectual property, trad e and the dynamics of access to and innovation in 
medical technologies.6  
10. WHO contributed to the annual report of th e Millennium Development Goals (MDGs) Gap 
Task Force that was published in September 2012 regarding the state of play regarding the implementation of MDG 8- Develop a global partnership for development.
7  WHO  presented current 
data on access to medicines and prices, as well as on the management of inte llectual property rights. 
11. To steer the direction of R&D in areas wher e further research is needed, the European 
Commission and WHO have agreed to update the W HO report on "Priority Medicines for Europe and 
the World" in the course of the year 2012/13.  Th e first edition of the Priority Medicines Report was 
produced under the Dutch EU presidency in 2004 and identified a series of priority disease areas 
where no appropriate treatments were available at the time.  
12. To guide Member States in the design of their medicines policies, WHO is preparing the third 
edition of the World Medicines Situation Report, bri nging together data on more than 20 key topics 
relating to pharmaceutical production and consumption,  innovation, regulation and safety.  To date, 
several chapters have been published, includi ng on the topics of medicine expenditures, 
pharmacovigilance and safety of medicines, selection of essential medicines, procurement and access 
to essential medicines as an integral part of th e right to health.  Additional topics will address 
financing, intellectual property, regulation, s upply chain management, human resources, and quality 
of medicines, among others.8  
13. Upon the invitation of the Developing Countri es Vaccine Manufacturers Network (DCVMN), 
WHO participated in the annual meeting of the DCVMN in November 2011, where it presented its 
perspective on the role of intellectual property in the development of and access to vaccines.  
                                                      
6 www.who.int/phi/news/ promoting_access_medical_i nnovation/en/index.html 
7 Millennium Development Goal 8,  The Global Partnership for De velopment: Making Rhetoric a 
Reality , MDG Gap Task Force Report 2012, United Nations, New York, 2012, http://iif.un.org/  
8 The different chapters  can be found at:  
http://www.who.int/medicines/ar eas/policy/world_medicines_situ ation/wmsr_table /en/index.html   IP/C/W/581/Add.2 
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  14. In cooperation with WIPO, WHO continues to pr ovide patent information upon the requests 
of UN agencies and other international organiza tions working in the area of public health.  
15. The WHO Regional Office for South-East Asia  (SEA) provided technical input for an 
informal consultation on implementation of the Pa ndemic Influenza Preparedness (PIP) Framework 
for the sharing of influenza viruses and other be nefits in New Delhi, on 5-6 March 2012.  Two 
technical presentations on the topics of "Backgr ound to the development of Pandemic Influenza 
Preparedness Framework" and "Proposed arrangements for sharing of benefits" were made.  Detailed 
discussions on the importance of standard material tran sfer agreements for the region were part of the 
deliberations.    
16. The SEA Regional Office provided technical input  for regional consultations on the changing 
role of medical education and emerging health ch allenges.  The development of new curricula and 
teaching materials in medical education reflected  current concerns, based on greater awareness and 
practical implementation of international public he alth law, such as the WH O International Health 
Regulations and the WHO Framework Convention on Tobacco Control.  They were also influenced 
by the impact of international trade on public health, as well as experiences related to medical 
tourism, food safety, ethical issues in advertising of medical products, and da ta protection provisions 
and research on patients by the pharmaceutical industry.  
B. T
RANSFER OF TECHNOLOGY AND LOCAL PRODUCTION  
17. To implement the 2006 Global Pandemic Influenza Action Plan (GAP)9, WHO has now 
facilitated the transfer of influenza vaccine produc tion technology to fourteen vaccine manufacturers 
in developing countries, through a central technology transfer hub.10  WHO's grants to local 
manufacturers led to a significant increase in local i nvestments in the manufacturing facilities.  As a 
result of the technical and financial assistance, five developing countries have already established 
local production of approved pandemic influenza vacc ines, while nine more are in the pipeline. 
18. To facilitate access to live attenuated influen za vaccine technology which can produce a high-
yield and low-cost vaccine that is easy to admini ster, WHO, on behalf of vaccine manufacturers in 
developing countries, negotiated and acquired a transferable non-exclusive license to this 
technology.11  Sublicenses to this technology have been granted to three vaccine manufacturers in 
developing countries.  Two of these have obtained the authorization to market their vaccines. In addition to influenza vaccine technology, WHO h as facilitated access for manufacturers in developing 
countries to technology for human papillomavirus , other vaccines and delivery devices.  
19. Within the context of the implementation of the Global strategy and plan of action, WHO is 
leading a European Commission-supported project on lo cal production, to increase access to medical 
products in developing countries.  The project has involved a number of partners, including the United 
Nations Conference on Trade and Development (UNC TAD) and the International Centre for Trade 
and Sustainable Development (ICTSD).  Phase I of the project concentrated on identifying the main 
challenges and obstacles to local production and related technology tran sfer for medical products in 
developing and least-developed countries (LDCs) .  Phase I included pharmaceuticals, diagnostics, 
vaccines, medical devices and bl ood and blood pr oducts. The concluding output of phase I is a 
                                                      
9 The Global Pandemic Influenza Action Plan to increase vaccine supply WHO 2006, 
http://whqlibdoc.who.int/hq/2006/WHO_IVB_06.13_eng.pdf   
10 Hendriks J, et al, An International technology platform for influenza vaccines, Vaccine , 1 July 2011, 
29(Suppl.1):A8-A11  
11 Rudenko L, et al, Live attenuated pandemic influenza vaccine: Clinical studies on 
A/17/California/2009/38 (H1N1) and licensing of the Russian-developed technology to WHO for pandemic 
influenza preparedness in developing countries, Vaccine , 1 July 2011, 29(Suppl.1):A40-A4   IP/C/W/581/Add.2 
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  framework paper - Local Production for Access to Medical Products – developing a framework to 
improve public health12, launched at a seminar hosted in the Eu ropean Parliament in October 2011.  
Phase II activities will focus on in-country work and will test the conclusions of Phase I.  A range of 
activities will be undertaken, including country-based  policy analysis to identify policy coherence 
across industrial and health policies, promoti on of local production, development of a price 
comparison methodology to compare local production with imported medicines, and training and 
capacity building work to support quality produc tion across a range of medical products, both for 
manufacturers and staff within national regulatory authorities.  A targeted action will consist of 
analyzing the patent situation for a number of medicines, in order to assess the possibilities for 
local/regional production in developing countries. 
20. The SEA Regional Office provided technical i nput on intellectual property and trade and 
health related to the management of platform technologies in pharmaceuticals, at the "Regional 
Meeting of Centres of Expertise in Tropical Diseas es in Faridabad, Haryana, India 28-30 November 
2011" for Tropical Disease Institutes.  
C. TRAINING AND ENHANCING CAPACITY  
21. Training and capacity building are among the core  activities of WHO, with regard to public 
health and intellectual property.  WHO orga nizes training and capacity building events in 
collaboration with relevant intern ational organizations.  Within the framework of the trilateral 
cooperation, WHO participates in WIPO and WTO training events.  
22. In close collaboration with WHO and WIPO, the annual WTO Workshop on Intellectual 
Property and Public Health took place in Geneva on 9 - 12 October 2012.  This workshop provided a 
comprehensive overview of the key issues related to the promotion of innovation and protection of 
intellectual property rights from the perspective of pu blic health impacts.  It included presentations on 
noncommunicable diseases, regulatory questions, data  on access to medicines and prices, the role of 
license agreements and local production and transfer of technology. 
23. WHO and WTO organized a joint training progr amme on intellectual property and public 
health for Central and Eastern Europe, Central As ia and the Caucasus Countries in Zagreb, Croatia 
(26 - 28 September 2012), based on the programme of  the Geneva Workshop on Intellectual Property 
and Public Health.  WHO also presented on publ ic health and intellectual property at the WTO 
Regional Workshop on Intellectual Property and Public  Policy for Arab and Middle-East Countries, in 
Kuwait City, (28 - 31 May 2012).  
24. WHO also contributed to the programme on pub lic health and intellectual property of the 
fourth joint WIPO-WTO Advanced Course on In tellectual Property for Government Officials 
(Geneva, 12 - 23 March 2012), as well as to the ei ghth WIPO-WTO Colloquium for teachers of 
intellectual property (Geneva, 11 - 22 June 2012).  The Colloquium brings together university 
teachers from various disciplines working in the fiel d of intellectual property with the objectives of 
strengthening the research and teaching capacity of  developing countries on intellectual property law 
and policy, and of provid ing a forum for exchange of informa tion and ideas between the teachers and 
the relevant international organizations.  
25. In recent years, WHO Member States have been confronted with an increasing number of 
threats of trade or investment challenges regardi ng intended tobacco control measures, especially the 
introduction of plain packaging requirements.  Responding to the need for training and capacity building on questions related to international trad e rules and tobacco control measures, WHO and the 
Secretariat of the WHO Framework Convention on Tobacco Control (FCTC) have organized a 
                                                      
12 http://www.who.int/phi/publicati ons/local_production/en/index.html  IP/C/W/581/Add.2 
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  number of training events.  The FCTC Secretaria t hosted a workshop on international trade and 
tobacco control issues at the WHO headquarters on 15 - 16 March 2012.  The workshop, which was 
funded by Health Canada, was he ld to promote cooperation, knowl edge and information sharing on 
trade-related tobacco-control issues.
13  In 2012, WHO also organized two regional consultations to 
build inter-governmental collaboration in the W estern Pacific Region and in the SEA Region of 
WHO, on issues relating to trade and tobacco.  A representative of the WTO participated in those 
meetings.  WHO published a technical paper on the impact of trade policies on tobacco control, 
"Confronting the tobacco epidemic in a new era of trade and investment liberalization," that provides 
further guidance for WHO Member States.14 
26. WHO hosted a panel discussion on the "Trends in  the pharmaceutical industry and potential 
impacts on future innovation and access to medici nes" with speakers from WHO, the Medicines 
Patent Pool and industry representatives on 25 Apr il 2012 in Geneva.  Key issues discussed included 
future projections for the pharmaceutical industry, intellectual property protection, and public health 
and access to medicines.15 
27. WHO also provided technical input to the 5th High-Level Symposium on Global Health 
Diplomacy on 23 November 2011 organized by the Graduate Institute of International and 
Development Studies at the WTO.  The three WHO,  WTO and WIPO Directors-General opened the 
event with a joint dialogue on "Ten  Years after the Doha Declaration:  The future agenda at the 
interface of public health, innovation and trad e - an outlook on the next ten years".16 
28. The Regional WHO offices are also carrying out training and capacity building activities.  
The Regional Office for Africa hosted a regional workshop on traditional medicine research and 
development in Harare, Zimbabwe, 21-23 May 2012, with one of the key objectives being the sharing 
of country experiences on protection of intellectual property.17 
29. The SEA Regional Office participated in th e training programme "Intellectual Property 
Rights and Innovation Management in Medical Resear ch," in New Delhi, India on 11-12 November 
2011.  This training was organized by the Indian Council of Medical Research and National Research 
Development Corporation.  It was geared towards medical scientists, to sensitize them to intellectual 
property and trade issues in public health.  Presentati ons were also made by the Regional Office at the 
Global Intellectual Property Conference on 5-8 January  2012 in New Delhi, providing a public health 
perspective on intellectual property and access to medicines.  
30. The SEA Regional Office supported a workshop on "Globalizing Asia:  Health Law and 
Policy, Approaches, and Gaps" on 16-18 April 2012 or ganized by Thammasat University in Bangkok.  
Besides presenting a technical paper on "Patent Ha rmonization: Public Health Perspective for South 
East Asia", WHO contributed to the identificati on of possible domestic and regional legal and policy 
approaches that could serve as a basis for meeting in ternational obligations, in the area of trade and 
intellectual property, including the use of TRIPS flexibilities that may help protect public health.18  
31. The SEA Regional Office also participated in  a workshop on the "Use of TRIPS Flexibilities 
to Access to Affordable Antiretrovirals in Asia ," in Bangkok from 29–31 May 2012.  This was  
                                                      
13 http://www.who.int/fctc/w orshop_trade/en/index.html  
14 http://www.who.int/tobacco/pub lications/industry/trade/confronting_tob_epidemic/en/index.html  
15 http://www.who.int/phi/tre nds_innovation/en/index.html  
16 
http://graduateinstitute.ch/Jahia/site/globalhealth/ cache/offonce/home/pid/11817;jsessionid=29CE144B63845A2D4211DE9
262E9C804   
17 http://www.afro.who.int/en/media- centre/events/details/ 259-regional-workshop-on-traditional-medicine-
research-and-development.html   
18 http://www.idlo.int/english/What WeDo/Programs/Health/Pages/D etailsEvent.aspx?IDEVENT=227   IP/C/W/581/Add.2 
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  jointly organized by the Asia Pacific Network of People Living with HIV, UNDP and UNAIDS, in 
partnership with the International Treatment Prep aredness Coalition, Médecins Sans Frontières, 
TREAT Asia, UNICEF and WHO, to improve knowledge  of TRIPS flexibilities and legal options to 
facilitate access to antiretrovirals in Asia.  Th is workshop discussed several topics: the possible 
impact of introducing rules that go beyond the leve l of protection required by the TRIPS Agreement 
(so-called TRIPS plus provisions) in bilateral and regional free trad e agreements; initiatives relating to 
the enforcement of intellectual property rights; acc ess to affordable ARVs; and the Report of the 
CEWG.19  
32. Through its Regional Office in the Western Pacific Region, WHO also contributed a number 
of presentations to the Regional Workshop on Intell ectual Property, Public Health and Environment 
Policy for Asian and Pacific Region hosted by the WTO, the United Nations Economic, Social 
Commission for Asia and the Pacific and the Interna tional Islamic University of Malaysia, in Kuala 
Lumpur, 10-12 July 2012.20 
33. A representative of the WHO country office in  Colombia provided input to the Regional 
Seminar for Certain Latin American and Caribb ean Countries on the Implementation and Use of 
Several Patent-Related Flexibilities, organized by WIPO in cooperation with the Superintendence of 
Industry and Commerce (SIC) of Colombia, in Bogotá, D.C., Colombia, 6-8 February 2012.21 
D. DIRECT COUNTRY SUPPORT  
34. Upon request and in collaboration with WHO Country and Regional Offices and relevant 
international organizations, WHO is providing technical and policy support in framing national 
policies, laws and regulations to favour applicatio n and management of intellectual property, in a 
manner that maximizes health-rela ted innovation and promotes access to  health products.  Support is 
directed to assisting Member States in devising wa ys to safeguard public health interests, while 
adhering to their obligations under international trade agreements.  This involves guidance on 
developing public health-sensitive patent legisl ation and incorporating TRIPS flexibilities within 
domestic legislation, as well as implementing tobacco control policies.  
35. Regional Offices are also providing direct technical support to countries in their respective 
regions.  The Regional Office for Europe regularly provides technical assistance to countries in its region, on the implications of provisions on intellectual property on medicines prices, notably regarding demands in bilateral tr ade negotiations that go beyond the level of protection that is 
required by the TRIPS Agreement, such as in the ar ea of the protection of patents and clinical test 
data.    
36. The SEA Regional Office provided technical a dvice relating to micro-, small and medium 
pharmaceutical enterprises to the Government of India on the topic of access to medicines.  This input 
was reflected in the next five-year plan of th e government.  Additionally, WHO provided technical 
input for the evaluation by the Ministry, of proposals from micro-, small and medium enterprises, to facilitate access to intellectual property ma nagement practices by these enterprises. 
37. PAHO/WHO organized a conference on Trade and Public Health in January 2012 that 
examined the relationship between the WHO Fram ework Convention on Tobacco Control (FCTC) 
and WTO trade agreements with a specific focus on plain packaging for tobacco products.  A summary of these discussions was prepared and circ ulated to inform officials from Ministries of 
Health of Member States of the SEA Region an d to increase awareness of the importance of the 
                                                      
19 The workshop materials may be accessed at http://asia-pacific.undp.org/prac tices/hivaids/trip s-flexibilities-
workshop-photos/index.html  
20 http://www.unescap.org/tid /projects/trips2012.asp  
21 http://www.wipo.int/meetings /en/details.jsp?meeting_id=24982  IP/C/W/581/Add.2 
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  relationship between WTO agreemen ts and public health in gene ral and noncommunicable diseases in 
particular. 
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