IP/C/W/591/Add.2  
 
19 September 2013  
(13-4958)  Page: 1/5  
Council for Trade-Related Aspects of 
Intellectual Property Rights  Original: English  
 
 TECHNICAL COOPERATION ACTIVITIES: INFORMATION FROM  
OTHER INTERGOVERNMENTAL ORGANIZATIONS 
WORLD HEALTH ORGANIZATION (WHO) 
Addendum 
At its meeting of 11-12 June 2013, the Council for TRIPS agreed to invite intergovernmental 
organization observers to the Council to update the information on their technical and financial cooperation programmes relating to the implementation 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 16 September 2013.  
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1  INTRODUCTION  
1.  This communication summarizes the technical cooperation activities of WHO in the area of 
public health, intellectual property and trade that took place since the submission of the last report 
in October 2012.
1  It 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).  
2.  The overall objective of WHO's technical cooperat ion in this area is to strengthen the capacity 
of developing countries in the areas of health innovation and management of intellectual property. 
Public health interests should be adequately taken into account in the formulation of national 
policies and legislation on trade and intellectual property. This includes the implementation and use of the flexibilities provided by the WTO Ag reement on Trade-Related Aspects of Intellectual 
Property Rights (TRIPS Agreement) and the Doha  Declaration on the TRIPS Agreement and Public 
Health.  
3.  WHO's technical cooperation is driven by demand and based on its mandate as derived from 
the Global strategy and plan of action, as well as from other relevant resolutions. In fulfilling this 
mandate, WHO, through its Headquarter, Regional  and County Offices collaborates closely with 
relevant international organizations. Activities focus on policy and technical guidance, transfer of technology, capacity building and training, and direct technical assistance.  
2  POLICY AND TECHNICAL GUIDANCE 
4.  In the past years, WHO, the World Intellect ual Property Organization (WIPO) and WTO have 
closely collaborated to foster a better understan ding of the linkage between public health and 
intellectual property policies and to enhance a mutually supportive implementation of those 
policies. The joint study by the WHO, WIPO and the WTO, "Promoting Access to Medical 
Technologies and Innovation - Intersections Between Public Health, Intellectual Property and Trade"
2 is the fruit of this new trilateral collaboration. The study was launched on 5 February 2013, 
                                               
1 Communications of previous years can be found on the website of WHO: 
http://www.who.int/phi/wto_communications/en/index.html . 
2 http://www.who.int/phi/promoting_acc ess_medical_innovation/en/index.html. IP/C/W/591/Add.2 
 
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  by the heads of the three organizations.3 The study is intended to inform ongoing technical 
cooperation activities undertaken by the three organizations and to support policy discussions. 
5.  The study provides a holistic picture of trade, IP and health-related determinants of innovation 
in and access to medical products. Among the health-related determinants of access covered are 
regulatory questions, including the need for fu rther convergence of regulatory standards, the 
importance of more transparency in clinical trials and the challenge of creating safe regulatory pathways for biosimilars. It also addresses rational selection of essential medicines, pricing 
policies, adequate financing and procurement, as well as supply chain management, including the 
control of taxes and mark ups. The study also covers the main trade determinants for access, including procurement and competition policy and how it can support access to medical products. It goes on to discuss tariffs on pharmaceutical products and their impact on prices. With respect to 
intellectual property, the study covers inter alia the flexibilities contained in the WTO TRIPS 
Agreement that WTO members can use to facilitate access to medicines, including compulsory licenses. It explains the development of socially responsible licensing policies as well as the 
interface between substandard, spurious, false, falsified, counterfeit medicines and the 
counterfeiting of trademarks. It discusses the different options to protect clinical test data, contains a comprehensive chapter on bilateral an d regional trade agreements and describes the 
relevant IP elements of these agreements and their likely impact on public health. In the area of 
patent policies, the study explains the problem of "evergreening" of patents as part of the life cycle management of pharmaceutical products and related legislative developments in different developing countries. In this respect the study also highlights the need for incremental innovation 
and the fact that small changes such as new routes of delivery or new dosage forms can have a 
huge impact on the life of patients and, for example, may increase patient compliance.  
6.  The chapter on innovation discusses the cost of R&D of new medical products as well as recent 
changes in the R&D landscape, particularly in the area of biotechnology. In relation to neglected 
diseases the study describes models on how to en courage R&D. This is where innovative financing 
and new ways of working for ensuring needed R&D are discussed, including models that separate 
the costs of the R&D from the price of the en d product in order to make medicines more 
affordable, a concept referred to as de-linkage. This section also highlights related efforts of the industry, including the renewed commitment in the "London Declaration on Neglected Tropical Diseases"
4 and other positive examples such as the dedicated research institutes for neglected 
diseases that have been created by a number of pharmaceutical companies. 
7.  On 5 July, as part of their trilateral coop eration, WHO, WIPO and WTO organized their third 
joint Technical Symposium on "Medical Innovation — Changing Business Models". The purpose of 
this Symposium was to discuss current changes in the innovation landscape and explore new and 
potential business models in medical innovation. Speakers from the GAVI Alliance, Drugs for Neglected Diseases initiative (DNDi), the Bill & Melinda Gates Foundation, Novartis, academia and 
other organizations discussed the current changes in pharmaceutical research and the challenges 
to address new diseases and increasing resistance to existing treatments emphasizing the need for 
further innovation and new models for innovation ensuring broad access to any new treatments.
5 
8.  Together with UNAIDS, UNITAID, the Brazilian Government and in collaboration with the 
Medicines Patent Pool, WIPO and WTO, WHO organized a consultation on access to HIV medicines 
in middle-income countries (MICs) in Brasilia, Brazil, 10-12 June 2013. The meeting focused on how to increase access to antiretroviral treatment in these countries. In recent years, the global 
community has seen great progress in access to HIV treatment. Nevertheless, MICs in all regions 
face significant challenges in sustaining their treatment programmes. In order to frame the debate, WHO in collaboration with the Medicines Patent Pool, drafted a background paper that 
provides data on the prices paid by MICs for the WHO recommended first, second and third line 
treatments.
6 The paper links these prices with data on the patent status of the respective 
products, voluntary and compulsory licenses as well as tariff and regulatory data. The paper identifies the products for which certain countries still pay high prices and aims to identify the 
                                               
3 http://www.who.int/mediacentre/news/re leases/2013/book_launch_20130205/en/index.html . 
4 Uniting to Combat NTDS, “London Declaration on Neglected Tropical Diseases”, 30 January 2012 
5 http://www.who.int/phi/changing_models_July2013/en/index.html . 
6 The final version of the background paper will become available by end 2013:  
http://www.who.int/phi/en/  and  
http://www.who.int/hiv/amds/en/ . IP/C/W/591/Add.2 
 
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  underlying reasons and thus provide the facts that will allow local policy makers to take 
appropriate actions. The meeting highlighted the need for pursuing collaboration among 
organizations on providing information and strengthening information exchange between the countries on regulatory approvals, IP status and prices of HIV medicines.   
9.  The challenges in accessing affordable medicines in MICs were also highlighted by several WHO 
presentations at the International AIDS Society Co nference in Malaysia, Kuala Lumpur that took 
place on 30 June to 3 July 2013.  
10.  WHO provided input with respect to data on access to medicines and management of 
intellectual property to the annual report of the Millennium Development Goals (MDGs) Gap Task Force regarding the state of play of the implementation of MDG 8 - Develop a global partnership 
for development.
7  
11.  To steer the direction of R&D in areas where further research is needed, WHO, the University 
of Utrecht and the Boston University have publishe d an updated version of the report on "Priority 
Medicines for Europe and the World". This repo rt was first published in 2004.  The European 
Commission who financed the update will use the Report as a resource in planning its 
Horizon 2020 combined research programme. The primary audience for the 2013 update are the decision-makers working in the European Commission, Parliament, and Council who will be 
responsible for defining the Horizon 2020 Programme.
8 
12.  WHO, renewing its engagement in collection and dissemination of critical information on 
innovation and access to medical products and technologies, revised the scope of the Global Platform for Innovation and Access based on feedba cks received during informal consultations with 
stakeholders and is finalizing its development pl an. The platform is scheduled to go live in 
May 2014, hosting initial data from readily available key sources, i.e. the Pan American Health Organization (PAHO) Regional Platform on Access and Innovation for Health Technologies
9 and the 
WHO Pharmaceutical Country Profiles among others.   
3  TRANSFER OF TECHNOLOGY  AND LOCAL PRODUCTION  
13.  To implement the 2006 Global Pandemic Influenza Action Plan (GAP)10, WHO has facilitated 
the transfer of influenza vaccine production technology to fourteen vaccine manufacturers in 
developing countries, through a central technology transfer hub.11 WHO's grants to local 
manufacturers led to a significant increase in local investments in the manufacturing facilities. As a result of the technical and financial assistance, so  far five developing countries have established 
local production of approved influenza vaccines. To date this has resulted in a combined capacity 
of 330 million pandemic vaccine doses, with the goal to exceed the 500 million dose capacity from these manufacturers by 2016. 
14.  To facilitate access to live attenuated influenza vaccine technology which can produce a high-
yield and low-cost vaccine that is easy to administer, WHO, on behalf of vaccine manufacturers in developing countries, negotiated and acquired a transferable non-exclusive license to this 
technology.
12  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, and one has achieved WHO prequalification. In addition to influenza vaccine technology, WHO has facilitated access for manufacturers in developing countries to technology for human 
papillomavirus , other vaccines and delivery devices, and to rabies monoclonal antibody technology 
for post-exposure prophylaxis to three developing country manufacturers.   
                                               
7 http://iif.un.org/ . 
8 http://www.who.int/medicines/areas/priority_medicines/en/.  
9 http://prais.paho.org/ . 
10 The Global Pandemic Influenza Action Pl an to increase vaccine supply WHO 2006, 
http://whqlibdoc.who.int/hq/2006/WHO_IVB_06.13_eng.pdf .  
11 Hendriks J, et al, An International te chnology platform for influenza vaccines, Vaccine , 1 July 2011, 
29(Suppl.1):A8-A11.  
12 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/591/Add.2 
 
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  15.  Within the context of the implementation of the Global strategy and plan of action, WHO is 
leading a European Commission supported project on local production, to increase access to medical products in developing countries.
13 The first phase aimed to identify the main challenges 
of local production of medical products and related technology transfer to developing countries in a 
number of areas, including medicines, vaccines, blood and blood products, and medical devices. 
The second phase of this project will include a country-based policy analysis to identify the existence of policy coherence across industrial and he alth policies, the degree of promotion of local 
production, the development of a price comparison methodology to compare locally produced 
medicines with imported medicines, and training  and capacity-building work to support quality 
production across a range of medical products for manufacturers and national regulatory authorities. Targeted actions will include the iden tification of essential medicines that are most 
suitable for local production, determination of the feasibility of local production of blood products, 
as well as analyzing the patent landscape for a number of medicines in order to assess the possibilities for local/regional production in developing countries. 
4  TRAINING AND ENHANCING CAPACITY  
16.  Training and capacity building are among the co re activities of WHO, with regard to public 
health and intellectual property.  WHO organizes tr aining and capacity building events in the area 
of public health and intellectual property in collaboration with relevant international organizations.  
17.  In close collaboration with WHO and WIPO, the annual WTO Workshop on Intellectual Property 
and Public Health took place in Geneva from 9 to 12 October 2012. This workshop provided a 
comprehensive overview of the key issues related to the promotion of innovation, access to 
medicines and protection of intellectual property rights. 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.
14 
18.  WHO provided a number of presentations on public health and intellectual property related 
questions in the Regional Seminar for certain African Countries on the Implementation and Use of Several Patent-Related Flexibilities that was organized by WIPO in cooperation with the 
Department of Trade and Industry of South Af rica in Durban, South Africa in January 2013.
15 
19.  WTO in close collaboration with WHO, WIPO and the Secretariat of the East-African 
Community organized a joint training programme on intellectual property and public health for English speaking African countries in Arusha, Ta nzania, from 29 to 31 May 2013, based on the 
programme of the Geneva Workshop on Intell ectual Property and Public Health. WHO’s 
contributions included presentations on access to medicines, license agreements, traditional medicines, and regulatory issues.   
20.  WHO also contributed to the programme on pub lic health and intellectual property of the fifth 
joint WIPO-WTO Advanced Course on Intellectual Property for Government Officials (Geneva, 11 to 22 March 2013), as well as to the tenth WIPO-WTO Colloquium for Teachers of Intellectual 
Property from Developing Countries (Geneva, 17 to 28 June 2013). The Colloquium brings 
together university teachers from various disciplines working in the field of intellectual property with the objectives of strengthening the research and teaching capacity of developing countries on 
intellectual property law and policy, and of pr oviding a forum for exchange of information and 
ideas between the teachers and the relevant international organizations.  
21.  WHO contributed lectures to the annual Executive Course on Intellectual Property, Diplomacy 
and Global Public Health organized by the Global Health Programme of the Graduate Institute in 
Geneva, 13 to 15 February 2013. 
22.  In the recent past, a number of WHO Memb er States have been subject to lawsuits and 
arbitration procedures under bilateral investment agreements with respect to tobacco control 
measures, including the introduction of plain packaging requirements.  This resulted in the need 
for specific training and capacity building on questions related to international trade rules and 
                                               
13 The website of the project is available from 
http://www.who.int/phi/publications/local_production/en /. 
14 http://www.wipo.int/meetings/en/details.jsp?meeting_id=27882 . 
15 http://www.wipo.int/meetings/en/details.jsp?meeting_id=24982 . IP/C/W/591/Add.2 
 
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  tobacco control measures. WHO has organized a number of such regional consultations involving 
Ministries of Trade and Ministries of Health of about 70 countries throughout 2012 and 2013. 
Consultations took place in the South-East Asia Region in October 2012 in New Delhi, India, in Windhoek, Namibia for Africa in February 2013, in Cairo, Egypt for the Eastern Mediterranean 
Region in March 2013, in Santa Cruz, Bolivia for the Region of the Americas in April 2013 and in 
Madrid for the European Region in June 2013. 
23.  The Regional Office for South-East Asia (SEARO) provided training on trade-related aspects of 
intellectual property rights for participants of the Executive Post Graduate Diploma in International 
Business Programme for the Indian Institute of Foreign Trade, New Delhi. SEARO staff also contributed to the Judicial Training Programme for Controllers of Patents at National Law University, Delhi for "Compulsory Licensing and TRIPS". 
24.  SEARO contributed to a workshop on R&D and access organized by Delhi Science Forum, Third 
World Network, Resource Group for Women and Health (SAMA) and Doctors without Borders which covered various issues such as clinical trials in India, challenges in identifying patents on new 
medicines, licensing, patent litigation, access to expensive biotech medicines as well as to the 
treatment for hepatitis C and cancer, and the concept of a possible global biomedical R&D treaty.  
25.  Staff from SEARO participated in the National Forum of Sharing Best Practices on Intellectual 
Property for Micro, Small and Medium-Sized Enterp rises, Policy Makers & Facilitating Agencies 
organized by the Confederation of Indian Industri es, Indian Ministry of Micro, Small and Medium 
Enterprises and WIPO in New Delhi, India on 17 and 18 September 2012.  
26.  Furthermore, in the framework of the trilateral cooperation with WIPO and WTO, a 
representative of the WHO country office in Colomb ia provided input to the WTO regional training 
workshop for Latin American countries on public policy and the WTO TRIPS Agreement taking place in Bogota, Colombia, 16 to 18 April 2013. 
5  DIRECT COUNTRY SUPPORT  
27.  In collaboration with relevant international organizations, through its Headquarter, Regional 
and Country Offices, WHO is providing technical and policy support in framing national policies, 
laws and regulations to favor application and management of intellectual property, in a manner 
that maximizes health-related innovation and promotes access to health products. Provided upon request by Member States, such support is directed to assisting Member States in devising ways to safeguard public health interests, while adhering to their obligations under international trade 
agreements. This involves guidance on developing public health-sensitive patent legislation and 
incorporating TRIPS flexibilities within domestic legislation.  
28.  WHO Regional Offices are also providing direct technical support to countries in their 
respective regions. The WHO Regional Office for Eu rope promotes the use of safeguards in national 
legislation, provides assistance in updating national medicines policies across the Region, including EU members and non-EU members and endeavours to work with governments to improve 
communication and coordination between intellectual property and health authorities. 
29.  SEARO developed technical information for a BRICS (Brazil, Russia, India, China and South 
Africa) Health Ministers meeting in January 2013 in New Delhi. This input related to the Report of the WHO Consultative Expert Working Group on  Research and Development: Financing and 
Coordination (CEWG) and the implem entation and follow-up to this report. The Office also provided 
technical assistance to other countries in the region in this area as well as on intellectual property issues relating to research on medicinal plants and traditional medicines.  
30.  SEARO continued to provide technical assistance relating to micro, small and medium 
pharmaceutical enterprises to the Government of In dia. This included evaluation of proposals from 
micro, small and medium enterprises to facilitate access to intellectual property management 
practices by these enterprises through the Ministry  of Micro, Small and Medium Enterprises Project 
Implementation Committee. 
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