WORLD TRADE  
ORGANIZATION   
IP/C/W/559/Add.1 
10 October 2011  
 
(11-4926) 
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 7 June 2011, 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 6 October 2011. 
 
_______________ 
 
 
I. INTRODUCTION   
1. Lack of access to existing medical products remains one of the most serious global health 
problems.  Despite the achievements of the past d ecades, nearly 30.000 children are dying every day 
from diseases that could easily be treated if they had access to a basic range of essential medicines.  In 
27 developing countries for which precise date were  obtained, the average availability of essential 
medicines in the public sector was only 34.9 per cent.
1  In the past years, governments, philanthropic 
foundations, pharmaceutical industry, and non-gove rnmental organizations and others have 
undertaken many initiatives and increased their efforts to address lack of access to medicines.  There 
are also an increasing number of research projects focusing on diseases disproportionately affecting 
developing countries initiated by public privat e partnerships, pharmaceutical companies and 
philanthropic organizations to address the research gap for neglected diseases.  Yet more needs to be 
done. 
II. IMPLEMENTATION OF THE GLOBAL STRATEGY AND PLAN OF ACTION ON 
PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY 
2. To foster innovation and improve access to medical products in developing countries, the 61st 
World Health Assembly in May 2008 adopted Resolution WHA61.21 on the Global strategy and plan 
of action on public health, innovation and intellectual property .  The Global strategy is a medium 
term plan (2008 - 2015) consisting of 8 elements grouping 108 specifi c actions that have to be 
implemented by WHO, its Member States and a wide range of other stakeholders.   
                                                      
1 WHO, Continuity and Change - Implementing the third WHO Medicines Strategy 2008–2013, 
http://www.who.int/medicines/publications/medstrategy08_13/en/index.html IP/C/W/559/Add.1 
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  3. To implement the Global strategy and plan of action, WHO has developed an assessment tool 
that will be pilot tested in a number of countries.  The tool will yield a gap analysis to identify specific 
needs for technical assistance and possible development of national implementation plans.  National case studies will be developed in collaboration with  some Member States who have already taken 
actions at national level. 
4. Following the adoption of Resolution 63.28 by the 63
rd World Health Assembly in May 2010, 
a Consultative Expert Working Group on the Financing and Coordination for Research and 
Development  has been set up to examine proposals for new and innovative sources of financing to 
stimulate research and development related to di seases that disproportionately affect developing 
countries.  The group, which is composed of 21 in ternational experts, will submit its report to the 
2012 World Health Assembly.2 
5. In order to develop regional strategic policy gu idelines under the Global strategy and plan of 
action, the Regional Office for South-East Asia in collaboration with WHO headquarters organized a 
"Regional Consultation on Developing a Regional Framework for the Global Strategy and Plan of 
Action on Public Health, Innovation and Intellectual Prope rty" on 6-7 April 2011 in New Delhi.  This 
Regional Consultation examined th e relationship between intellectua l property, innovation and public 
health focusing on priorities of the South-East Asian region. Besides raising awareness among WHO 
Member States in the region, the Consultation also  examined how to use intellectual property as a 
development tool for specific requirements of Sout h-East Asian regional and national contexts.  For 
this purpose, the Regional Consultation identified sp ecific action points on the 25 sub-elements of the 
plan of action relating to intellectual prope rty, innovation, trade and public health. 
6. To implement the Global strategy and plan of action and related regional resolutions, the Pan 
American Health Organization (PAHO) has star ted a conceptual mapping on public health and 
intellectual property in the region.  The purpose is to  establish a framework of analysis that offers an 
objective diagnosis to facilitate the action of stat e authorities and improve the efficiency and the 
effectiveness of its programmes in the promotion of access to drugs with regard to the management of 
intellectual property rights.  In the framework of  this project, eleven Member States have begun 
analyzing their domestic legal and institutional hea lth frameworks with regard  to the management of 
intellectual property rights.  The information gath ered is analyzed in each country by health 
authorities to improve coordination between hea lth and other sectors in the management of 
intellectual property rights with a view  to improving access and health outcomes.3   
7. WHO is developing a global monitoring and ev aluation web-based platform to monitor 
progress in implementation of the plan of action over the years, providing Member States with a user-
friendly reporting tool and ensuring harmonization of  all the relevant WHO reporting mechanisms on 
areas related to innovation for and access to health products and technologies.  
8. To steer the direction of R&D in areas where fu rther research is needed, WHO is currently in 
discussion with the European Union (EU) to pr ovide an update of the WHO report on "Priority 
Medicines for Europe and the World" that was produced under the Dutch EU presidency in 2004 and 
identified a series of priority disease areas where cu rrently no appropriate treatments are available.4 
The European Council decided in December 2010 that there is a need for update of the study.  
                                                      
2 More information can be found at: http://w ww.who.int/phi/news/cewg_2011/en/index.html 
3 Information on the project and its scope can be found at:  
"http://new.paho.org/hq/index.php?option=com_c ontent&task=view&id=2781&Itemid=1178&limit
=1&limitstart=2&lang=en "   
4 http://whqlibdoc.who.int/hq/2004/WHO_EDM_PAR_2004.7.pdf  IP/C/W/559/Add.1 
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  III. WHO TECHNICAL COOPERATION 
9. WHO's technical cooperation is driven by dema nd and based on its mandate derived from the 
Global strategy and plan of action as well as other re levant resolutions adopted by the World Health 
Assembly.  In fulfilling this mandate WHO has been  working continuously a nd in collaboration with 
relevant international organiza tions and together with WHO Country and Regional Offices.  
Implementation activities focus on technical cooperati on, including transfer of technology, capacity 
building and training as well as direct technical assistance.  
10. The overall objective of WHO's technical coopera tion is to strengthen developing country 
capacity in health innovation and access, transfer of  technology and application and management of 
intellectual property in a manner that maximizes health-related innovation and promotes access to 
medical products, to implement and to use the fl exibilities provided by the TRIPS Agreement and the 
Doha Declaration on the TRIPS Agreement and Pub lic Health and to ensure that public health 
interests are adequately taken into account in the formulation of national policies and legislation on 
trade and intellectual property. 
A. POLICY AND TECHNICAL GUIDANCE  
11. Further to the adoption of the Global strategy  and plan of action, WHO, WIPO and WTO 
have strengthened their efforts to effectively coor dinate work in the field of public health and 
intellectual property to foster the understanding of public health policy and intellectual property and 
to increase efficiency in capacity building and technical cooperation.  
12. Within the scope of this trilateral collaborati on, the three organizations have started to 
organize a series of joint technical symposia on i ssues covered by the Global strategy and plan of 
action.  The symposia will enhance the dialogue between the relevant orga nizations and provide a 
platform for exchanging information and experiences.  The second symposium on "Access to medicines, Patent Information and Freedom to Op erate" was held on 18 February 2011 at WHO in 
Geneva.
5 
13. Currently, WHO, WIPO and WTO are preparing a joint study on "Promoting access and 
medical innovation: intersections be tween public health, intellectual pr operty and trade". This study is 
meant to be a sequel to the joint study by the WHO and the WTO Secretariats on WTO agreements 
and public health published in 2002.  The new publica tion aims to harvest the fruits of strengthened 
trilateral cooperation, capturing a broad range of experience in dealing with the interplay between 
intellectual property, trade rules and the dynamics of access to and innovation of medical technologies.
6 
14. To guide Member States in the design of their medicines policies, WHO is currently 
publishing the third edition of the World Medicines Situation Report bringing  together new data on 
24 key topics relating to pharmaceutical production and consumption, inn ovation, regulation and 
safety.  Topics include selection, procurement, supply management, rational use, financing and 
pricing.  Cross-cutting chapters cover househol d medicines use, access and human rights, public 
health and intellectual property, good governance,  human resources and national medicines policies.7  
                                                      
5 More information, including a summary report can be found at: 
http://www.who.in t/phi/access_medicines_fe b2011/en/index.html 
6 http://www.who.int/p hi/news/promoting_access_medical _innovation/en/index.html 
7 The different chapters  can be found at:  
http://www.who.int/medicines /areas/policy/world_medicines_situation/en/index.html IP/C/W/559/Add.1 
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  15. In cooperation with Health Acti on International, WHO is producin g a series of papers related 
to medicine pricing issues.  The topics covered so  far are External Reference Pricing, the Role of 
Health Insurance in the Cost Effective Use of  Medicines, Regulation of Mark ups in the 
Pharmaceutical Supply Chain, Competition Policy and Sales Taxes on Medicines. A further four 
reviews are in development.
8 
16. Together with the United Nations Development Programme (UNDP) and UNAIDS, WHO 
published a policy brief on the flexibilities in the TRIPS Agreement to improve access to HIV/AIDS 
treatment.  The paper reviews how countries can use and have used the flexibilities of the TRIPS 
Agreement to increase access to HIV treatment.9 
17. To provide ministries of health in the Eastern Mediterranean Region with a clear analysis of 
the public health implications of provisions include d in bilateral free trade agreements that go beyond 
the level of protection required by the TRIPS Agre ement, the WHO Regional Office for the Eastern 
Mediterranean has published a policy guide addressed to negotiators and implementers in the Region 
on "Public health related TRIPS-plus pr ovisions in bilateral trade agreements".10  The Regional Office 
is also finalizing selected country case studies assessing national intellectual property policies and 
infrastructure in relation to access to HIV/AIDS medicines. 
18. Together with WIPO, WHO is de veloping a global patent landscape  on patenting trends in the 
field of vaccines.  To date, no comprehensive overv iew on the patent trends in the field of vaccines 
exists.  The patent landscape repor t is intended to provide an overvie w on what is being patented in 
terms of disease targets and approach, who is doing th e patenting, where patents are filed and on how 
patent policies change over time. 
19. WHO and WIPO continue to explore the possibilit y of creating a web based tool or database 
providing information on the legal pa tent status of medicines on the 17th WHO Model List of 
Essential Medicines. 
B. TRANSFER OF TECHNOLOGY AND LOCAL PRODUCTION  
20. To implement the 2006 Global Pandemic Influenza Action Plan (GAP)11, WHO facilitated 
transfer of influenza vaccine production tec hnology to eleven developing country vaccine 
manufacturers through a central technology transfer  hub from which technology transfer to multiple 
recipients could be conducted efficiently.12  While the WHO grants to  local manufacturers were 
modest, these served as catalysts for significant lo cal investment, on average up to 16-fold the WHO 
grant, in the manufacturing facilities.  As a result  of the technical and financial assistance three 
developing countries have already established lo cal production of approve d pandemic influenza 
vaccines, and eight more are in the process.  W HO is currently reviewing grant-applications from 
several new candidates, including several from Sub-Saharan Africa  and Central Asia. 
21. To facilitate access to live attenuated influenza vaccine technology for producing a high-yield 
low-cost vaccine that is easy to administer, WHO, on behalf of developing country vaccine 
                                                      
8 http://www.haiweb.org/medicineprices/ 
9 http://www.who.int/phi/phi_trips_policybrief_en.pdf 
10 http://www.emro.who.int/publications/Book_Details.asp?ID=1081 
11 The Global Pandemic Influenza Action Plan to increase vaccine supply WHO 2006, 
http://whqlibdoc.who.int/hq/2006/WHO_IVB_06.13_eng.pdf   
12 Hendriks J, et al, An International technology pl atform for influenza vaccines, Vaccine , 1 July 2011,  
29(Suppl.1):A8-A11  IP/C/W/559/Add.1 
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  manufacturers, negotiated and acquired a transfer able non-exclusive license to this technology.13 
Sublicenses to this technology have been granted to three developing country vaccine manufacturers 
and one of these is already marketing the resulting vaccine.  
22. In vaccine production, adjuvants are used to e nhance the immune response to an antigen, and 
enable the use of less antigen per dose of vaccine and hence, an increase in the number of doses that 
can be produced.  To overcome current know-how ba rriers, WHO facilitated the establishment of an 
adjuvant technology transfer hub that is using the information described in patents on adjuvants to 
establish production processes in developing countri es where the patents were not filed or granted.14  
Adjuvant for pandemic influenza production has been transferred to Indonesia and technology transfer 
to Vietnam is in process. 
23. Within the context of element 4 of the Global strategy and plan of action, WHO inter alia 
initiated a European Commission supported project  in partnership with the United Nations 
Conference on Trade and Development (UNCTAD) 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 rela ted technology transfer in developing and least 
developed countries (LDCs) for medical tec hnologies including pharmaceuticals, diagnostics and 
vaccines.  The project involved: commissioned litera ture reviews to describe the current landscape, 
historical and current trends; regional workshops wi th a broad range of stakeholders; and in-country 
work to investigate and describe a series of co mpany focussed case studies from low- and middle- 
income countries.  The concluding output of phase I is a framework paper -  Local production and 
access to medical products: A framew ork for improving public health.  Reports of these activities and 
the framework paper will be launched at a seminar hosted in the European Parliament in October 
2011.  In phase II the framework will be utilized to guide actions in support of  local production within 
developing and least developed countries.
15 
C. TRAINING AND ENHANCING CAPACITY  
24. Training and capacity building has been among the core activities of WHO with regard to 
public health and intellectual property for a number of  years.  In this context, WHO works closely 
with other relevant organizations.  As part of the ongoing trilateral collaboration, WHO participates 
actively in training and capacity building workshops organized by and in collaboration with WTO and 
WIPO. 
25. The forthcoming WTO "Workshop on Intellectua l Property and Public Health" (Geneva, 
10-13 October 2011) has been organized in close collaboration with WHO and WIPO.  This training 
module aims at familiarizing partic ipants with the interface betwee n intellectual property and public 
health. The workshop addresses the respective intellectual property pr ovisions and flexibilities in the 
TRIPS Agreement and other instruments of relevance to public health as well as issues ranging from 
procurement to regulatory questions.  WHO also provided input and speakers to last year's WTO 
"Workshop on the TRIPS Agreement and Pub lic Health" (Geneva, 21-24 September 2010). 
26. WHO Headquarters and the WHO European Regi onal Office collaborated with WTO in the 
organization of a Regional Workshop for Central an d Eastern European and Central Asian Countries 
                                                      
13 Rudenko L, et al, Live a ttenuated 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-A44. 
14 Collin N, Dubois P.M, The Vacci ne Formulation Laboratory: A pl atform for access to adjuvants, 
Vaccine , 1 July 2011,  29(Suppl.1):A37-A39. 
15 All reports associated with this project will be available for free download from 30 October 2011 at:  
http://www.who.int/phi/en/ IP/C/W/559/Add.1 
Page 6  
 
  on Intellectual Property and Public Policy, Vienna, 26-28 January 2011.  A wide range of trade and 
intellectual property issues were discussed with a specific focus on trade and public health issues. 
27. WHO also presented on public health and intellectual property at the eighth "WIPO-WTO 
Colloquium for teachers of intellectual propert y" organized by WIPO and WTO (Geneva, 
20 June - 1 July 2011).  The Colloqui um brings together university t eachers of intellectual property in 
developing countries with the objective to strengthen the research and teaching capacity of developing 
countries on intellectual property law and policy, and to provide a forum for exchange of information 
and ideas between the teachers and the re levant internationa l organizations.  
28. WHO also participated and provided presentati ons in the "WIPO-University of Geneva 
Summer School on Intellectual Property" (4 - 15 July 2011) and the third joint "WIPO-WTO 
Advanced Course on Intellectual Property for Govern ment Officials" organized by WIPO and WTO, 
(Geneva, 16-27 May 2010), WHO provided presentations  on the issue of public health and intellectual 
property.  This course follows the concept of the Colloquium for Teachers of Intellectual Property from Developing Countries, but is tailored for gove rnment officials and public sector policymakers. 
29. The Regional WHO offices are also engaged in training and capacity building activities. 
Regional Office for South-East Asia provided training  on intellectual property, trade and public health 
for national health personnel.  Public health and intellectual property issues were also taken up for 
organizations and institutions that may influe nce public health outcomes and access to medical 
products, for example chartered accountants, co mpetition commission.  A capacity building 
programme on the TRIPS Agreement and public h ealth issues with special emphasis on LDCs for 
middle and senior level officials of the ministri es of trade and commerce was also undertaken.  
30. PAHO has supported training workshops in Cent ral America and the Caribbean attended by 
representatives of the ministries of health and ot her national actors.  It has provided support to 
Argentina's Ministry of Health in offering a course  on public health and intellectual property to train 
public officials from the ministries, regulatory agencies, and other entities. 
D. D
IRECT COUNTRY SUPPORT  
31. Upon request and in collaboration with relevant  international organizations, including WTO, 
WHO is providing technical and policy support in fram ing national policies, laws and regulations to 
favour application and management of intellectual property in a manner that maximizes health-related 
innovation and promotes access to health products.  S upport is directed to assisting Member States in 
how to safeguard public health interests while adhe ring to their obligations under international trade 
agreements, namely developing pub lic health sensitive patent legisl ation and incorporating the TRIPS 
flexibilities within domestic legislation.  Technical support is carried out in close collaboration with 
WHO Country and Regional Offices as well as relevant international organizations.  
32. Regional offices are also providing direct technical support to countries in the respective 
regions.  In response to the official request fro m the countries of the region, PAHO has offered 
assistance through a range of activities in the ar eas of trade and access to essential medicines, 
including for a study on pharmaceutical policies, the regulation of intellectual property, and access to 
drugs, in collaboration with CARICOM and other Caribbean countries.    
33. The Regional Office for South-East Asia is  providing technical and policy support for 
framing national policies, laws and regulations on request from Member States in the application and 
management of intellectual property and trade for access to public health pr oducts.  Member States 
have been assisted to address public health issues in  free trade agreements influencing availability of 
medical products and examine intellectual property rights provisions in legal documents aimed to 
broaden cooperation for disease control on emer ging global diseases among Member States.  The  IP/C/W/559/Add.1 
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  Regional Office provided assistance in the legislative review of patent legislation in line with the 
TRIPS Agreement and the Doha Declaration.  T echnical input was provided for Member States to 
include intellectual property rights and trade issues in  their international trade and health programmes.  
Intellectual property policy and technical support w as also provided for emerging new developments, 
such as implications of the Convention on Biological  Diversity and the Nagoya Protocol on Access to 
Genetic Resources and the Fair and Equitable Shar ing of Benefits Arisi ng from their Utilization on 
access and benefit sharing for medical products, e.g.  regarding pandemic influenza preparedness and 
standard material transfer agreements.  
34. The Regional Office for Europe supports countri es in eastern Europe in strengthening their 
national systems and policies to increase access to medicines in general.  With several countries 
discussions are ongoing on the issues regarding TRIPS and access to medicines, and several countries 
are exploring the use of flexibilities in orde r to increase access to HIV/AIDS medicines. 
35. Taking into account the TRIPS Council's Deci sion of 29 November 2005 which extended the 
transition period to implement the TRIPS Agreem ent for least developed country Members until 
2013, WHO is actively engaged in the LDC needs a ssessment process and participated also in the 
regional workshop organized by the WTO for LDCs  Members and Observers from French-speaking 
Africa (Dakar, Senegal, 9-11 November 2010).  The purpose of the workshop was to discuss the 
process of undertaking an assessment of priority n eeds to implement the TRIPS Agreement.  It 
provided an opportunity for WHO to set out the scope of technical assistance that it could provide to LDCs. 
__________