IP/C/W/609/Add.5  
 
12 October 2015  
(15-5313)  Page: 1/8  
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 9-10 June 2015, 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 9 October 2015.  
_______________ 
  
1   INTRODUCTION 
1.  This communication summarizes the technical cooperation activities of the World Health 
Organization (WHO) in the area of public health, innovation and intellectual property that have taken place since the submission of the last report in October 2014.
1 The overall objective of 
WHO's technical cooperation is to strengthen the capacity of developing countries in the areas of 
health innovation, access to medicines and management of intellectual property. WHO's technical cooperation is based on its mandate derived from the Global strategy and plan of action on public 
health, innovation and  intellectual property (Resolution WHA61.21) and from relevant resolutions 
of the World Health Assembly.  
2  RECENT UPDATE OF THE WHO ESSENTIAL MEDICINES LISTS 
2.  The WHO Essential Medicines Lists (WHO EML) are an important tool to guide reimbursement 
decisions, procurement of medicines and the rati onal use of medicines in general. Essential 
medicines are defined as "those that satisfy the prio rity health care needs of the population". They 
are thus designed to allow countries to focus on medicines that are most needed and most 
important from a public health perspective. The selection of medicines is based on the public 
health relevance of the disease and a comprehensiv e review of available evidence for benefits and 
harms. 
3.  There are two equally important lists: the most  efficacious, safe and cost-effective medicines 
for priority conditions are included in the main EML. The complementary EML includes additional medicines for priority diseases, for which specialized diagnostic or monitoring facilities, and/or 
specialist medical care, and/or specialist training are needed, for example cancer medicines that 
demand specialised health care facilities or for example amiodarone, an antiarrhythmic agent for the treatment of heart problems that requires specific diagnostic monitoring. The WHO EML are used by governments and institutions worldwide to guide the development of their essential 
medicines lists and to make appropriate procurement decisions.   
                                               
1 Document IP/C/W/603/Add.1. 
 IP/C/W/609/Add.5 
 
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  4.  In April 2015, the WHO Expert Committee on the Selection and Use of Essential Medicines 
considered 77 applications for the inclusion of new medicines in the WHO EML that included among others 29 treatment regimens for cancer, new treatments for hepatitis C and tuberculosis. The Committee decided to include in the 19
th Essential Medicines List, 16 new medicines for cancer, all 
six newly available innovative oral treatments for hepatitis C and five tuberculosis treatments. The 
inclusion reflects growing public health needs for example in the area of cancer as well as the 
emergence of more effective new innovative treatm ents for example in the area of hepatitis C. 
Despite the fact, that the price of a treatment or the patent situation are not criteria that are 
considered by the Committee in its decision-making, traditionally the WHO EML included very few patented medicines due to its focus on priority he alth care needs. The emergence of HIV/AIDS led 
to the inclusion of a number of patented antiretr oviral treatments in the 2002 revision. The current 
revision of the list is adding several medicines that are still patented in major markets (all new oral 
treatments for hepatitis C, several cancer drugs and two new treatments for multi-drug resistant tuberculosis). By integrating these new medicines, WHO is underscoring the need for uniform 
strategies to make these treatments affordable worldwide to ensure equitable access.
2  
3  POLICY AND TECHNICAL GUIDANCE 5.  In an increasingly globalized world, health -related products, services, and consumers cannot be 
restricted by national borders. To allow health  policy-makers to better understand the mechanisms 
linking trade and health, WHO published Trade and Health: Towards building a national strategy  in 
September 2015. The book provides a comprehens ive overview of issues relevant to the 
development of a national strategy on trade an d health. Core evidence is presented to help 
decision-makers address the key challenges to public health, while taking advantage of new 
opportunities for achieving a higher standard of health, wealth and development.
3 
6.  The WHO Regional Office for Europe launched the report "Access to new medicines in Europe: 
technical review of policy initiatives and opportunities for collaboration and research". The report 
reviews policies that affect medicines throughout their lifecycle from research and development to disinvestment. While many European countries have not traditionally required active priority-
setting for access to medicines, appraising new medicines using pharmacoeconomics is 
increasingly seen as critical in order to impr ove efficiency in spending while maintaining an 
appropriate balance between access and cost–effectiveness. The study features findings from 27 countries and explores how European countries are dealing with high spending on new 
medicines, including methods such as restrictive treatment guidelines, target levels for use of 
generics, and limitations on the use of particul arly expensive drugs. The study also outlines 
possible policy directions and choices that may help governments to reduce high prices when 
introducing new drugs.
4 
7.  To assess whether a medicine is patent protected in a certain country requires expert 
knowledge and access to specialized databases that  are not easily available. Therefore, the WHO 
Secretariat published an analysis of the patent situation of seven new hepatitis treatments in 
August 2014 and updated the patent information on  daclatasvir, ledipasvir and sofosbuvir in 
2015.5 The patent  working papers identify the most relevant patents and list the  countries in which 
these patents have been filed and granted.  
8.  On request of WIPO, WHO provided technical input to a Feasibility Study on the Disclosure of 
International Nonproprietary Names (INN) in Patent Applications and/or Patents  which was 
presented to the WIPO Standing Committee on the Law of Patents. The study explores the 
possibilities and pros and cons for including INNs in patent applications to facilitate patent 
searches by different users of the patent system . Discussions on the subject item and the study 
continue in the WIPO Standing Committee on the Law of Patents.6 
                                               
2 For further information on the EML see: 
http://www.who.int/medicines/publications/essentialmedicines/en/  
3 http://www.who.int/phi/implementation/trade/en/  
4 http://www.euro.who.int/__data/assets/pdf_file/0003/273819/WHO-Medicines-Report-
FINAL2015.pdf?ua=1  
5 http://www.who.int/phi/implementatio n/ip_trade/ip_pate nt_landscapes/en/  
6 http://www.wipo.int/meetings/en/doc_details.jsp?doc_id=287105  IP/C/W/609/Add.5 
 
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  9.  In July 2015, WHO published a discussion paper to spur the debate on the question of how to 
improve access and affordability of medicines and other health technologies for noncommunicable diseases (NCDs). The paper describes the key bottlenecks that Member States face regarding the achievement of voluntary target 9 of the WHO Global action plan for the prevention and control of 
noncommunicable diseases . By suggesting different ways on how WHO and other relevant 
stakeholders can support Member States, the paper aims to stimulate feedback on WHO’s work to improve access to essential medicines and basic health technologies for NCDs in the developing 
world. With respect to affordable prices, the pape r highlights high taxes and unregulated mark ups 
while it considers unaffordability due to intellectual property rights as less of an impediment for NCDs as with the exception of cancer, the essential medicines to treat the major NCDs are available from generic sources.
7  
10.  Another WHO study that was published in 2015 explores the Cuban experience with local 
production of medicines, technology transfer and improving access to health. It includes a chapter 
on the Cuban intellectual property framework and presents the interaction between different 
Cuban stakeholders to provide a better understanding of potential pathways towards policy-
coherence.8 
4  TRANSFER OF TECHNOLOGY  AND LOCAL PRODUCTION 
11.  In July 2015, WHO collaborated with the Ethiopian government in developing and launching a 
National strategy and plan of action for pharma ceutical manufacturing development in Ethiopia 
(2015 - 2025). The report was launched jointly by the Deputy-Prime Minister of Ethiopia and the Director-General of WHO in July 2015. Under strategi c objective 5, the strategy and plan of action 
emphasizes the support for the development of a local cluster for the production of new active 
pharmaceutical ingredients.
9 WHO is now working with the Ethiopian government to establish a 
mechanism for implementation of the strategy and monitoring of its impact. Similar technical 
support work is continuing in Tanzania, Ghana and Nigeria.  
5  TRAINING AND ENHANCING CAPACITY 12.  Training and capacity building, carried out in collaboration with other competent 
organizations, are among the core activities of WHO with regard to public health and intellectual 
property. The table at the end of this report prov ides an overview of related WHO activities that 
included the following: 
13.  Every year, the WHO Department of Essentia l Medicines and Health Technologies organizes 
two Technical Briefing Seminars (one in English and one in French) aimed at people working in 
pharmaceutical related areas in developing countries and countries in transition. The seminars provide an update on topics related to medicine quality, access, use, regulation, and innovation. In 
November 2014, 29 participants from 19 countries attended the English speaking Seminar, which 
included sessions on "Global initiatives and alternative mechanisms for pharmaceutical R&D". A panel of experts from UNITAID, Médecins Sans Fr ontières and WHO debated on access to hepatitis 
treatments, focusing on public health and intellectual property issues.  
14.  As every year, WHO worked closely with WTO in the organization of the Workshop on Trade 
and Public Health that took place in Geneva, 14  - 18 November 2014. The workshop provided a 
comprehensive overview of key issues such as promotion of innovation, access to medicines and 
protection of intellectual property. 
15.  WHO contributed lectures on trade, intellec tual property and public health to the annual 
Executive Course on Intellectual Property, Diplomac y and Global Public Health as well as to the 
Executive Course on Global Health Diplomacy organized by the Global Health Programme of the 
Graduate Institute in Geneva in February and June 2015. 
16.  At the invitation of the Committee of Social  Affairs, Health and Sustainable Development of 
the Parliamentary Assembly of the European Council, WHO presented in the hearing on the report 
Protecting patients against undue influence of the pharmaceutical industry  at the European Council 
                                               
7 http://www.who.int/nmh/ncd-tools/targets/Final_medicines_and_technologies_02_07_2015.pdf  
8 http://apps.who.int/medicinedocs/documents/s21938en/s21938en.pdf  
9 http://www.who.int/phi/publications/Ethi opia_strategy_local_poduction.pdf?ua=1  IP/C/W/609/Add.5 
 
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  in Strasbourg, 24 June 2015. WHO provided its expe rtise on protection of intellectual property and 
its implications for public health regarding innovation and access to medicines in Europe. 
6  DIRECT COUNTRY SUPPORT 17.  In collaboration with relevant international organizations, through its Headquarter, Regional 
and Country Offices, WHO provides technical and po licy support in framing national policies, laws 
and regulation to favour application and management of intellectual property in a manner that maximizes health-related innovation and promotes access to health products and services. Such 
support is provided upon request to assist Member States in devising ways to safeguard public 
health interests, while adhering to their oblig ations under international trade agreements.  
18.  UNDP and WHO, upon request of the Ministry of Health of the Repub lic of Moldova, held a 
National Consultation on access to HIV and other essential medicines and intellectual property in 
the context of a recently concluded Association Agreement with the EU, Chisinau, 18-19 November 
2014. The Consultation focused on the required amendments in Moldova’s national intellectual 
property legislation and related laws. The goal was to examine the likely impact of these 
developments on access to treatment for people li ving with HIV and co-infections and to explore 
measures that could be employed by Moldova to meet its obligation to ensure access to affordable medicines.  
19.  In cooperation with WHO SEARO, Sri Lanka conducted a workshop on "Promoting innovation 
and access to health products in Sri Lanka" in Colombo, 28 - 29 April 2014, utilizing the assessment tool developed for the WHO Global Strate gy and Plan of Action. The analysis based on 
the assessment tool allowed the identification of  clear and implementable policy recommendations 
for the government to increase its effectiveness in promoting health products innovation through 
institutional development, investment and better coordination of different policies.
10  
20.  In light of challenges to tobacco control me asures, such as tobacco plain packaging and large 
graphic health warnings, under international trade and investment agreements, WHO has 
responded to requests for training and technical assistance in a number of Member States. Since October 2014, this work has included training or technical assistance in Thailand 
(November 2014), Chile (December 2014), Honduras (May 2015), Nicaragua (May 2015), 
Costa Rica (June 2015), Chad (June 2015) and Ecuador (June 2015). 
21.  In this context, the WHO South-East Asia Regional Office (SEARO) has provided technical 
input for capacity building and facilitated th e National Workshop on Tobacco and Trade, 
24-26 November 2014, Bangkok, Thailand that provided a platform of exchange for governmental 
representatives from Ministries of Health, Trade and other relevant sectors as well as advocates from civil society. The achievement of public  health goals and the intersection between 
international trade agreements and the tobacco control policies, articulated in the WHO Framework 
Convention on Tobacco Control (WHO FCTC), were discussed. 
                                               
10 http://www.who.int/phi/implementation/ monitoring/Sri_Lanka-report.pdf?ua=1  
  IP/C/W/609/Add.5  
 
- 5 - ANNEX1 
Activity Date Location Brief Description Link to further details 
Post-2015 Sustainable Development 
Agenda Roundtable 29 September – 
3 October 2014 Washington DC, 
USA The 53rd Directing Council of the Pan American 
Health Organization (PAHO) discussed the 
proposed-health related development goals with a special focus on ensuring research and 
development of vaccines and medicines 
primarily affecting developing countries and access to medicines. http://www.paho.org/hq/index.php?opti
on=com_content&view=article&id=9774
:53rd-directing-
council&Itemid=41062&lang=en  
WHO Essential Medicines and Health 
Technologies Technical Briefing Seminar 
(TBS) in English 3 - 7 November 
2014 Geneva, 
Switzerland The Seminar provided an update on topics 
related to medicine quality, access, use, 
regulation, and innovation. http://who.int/medicines/technical_briefi
ng/tbs/tbs_en_programme_nov_2014/e
n/ 
WTO Workshop on Trade and Public 
Health organized in close collaboration with WHO and WIPO 14 - 18 November 
2014 Geneva, 
Switzerland The Workshop covered key issues related to the 
promotion of innovation , access to medicines 
and the protection of intellectual property, as 
well as wider trade and health policies. https://www.wto.org/en glish/tratop_e/tr
ips_e/events_e.htm#healthworkshops  
 
National Consultation on Access to HIV 
Treatment and other Essential Medicines 
and Intellectual Property 18 - 19 November 
2 
014 Chisinau, 
Republic of 
Moldova UNDP and WHO, organized a National 
Consultation on the impact of the Association 
Agreement with the Eu ropean Union and its 
impact on equitable and affordable access to 
HIV and essential medicines.  
National Conference on Free Medicines’ 
Schemes in the States of India 18 - 20 November 
2014 Chennai, India The Conference was organized by the WHO 
SEARO in collaboration wi th the Indian Ministry 
of Health & Family Welfare in the context of Universal Health Coverage under the National 
Health Mission   
                                               
1 In English only.  
  IP/C/W/609/Add.5  
 
- 6 - Activity Date Location Brief Description Link to further details 
WHO National Workshop on Tobacco and 
Trade 24 - 26 November 
2014 Bangkok, 
Thailand The workshop provided a forum for 
governmental representati ves from Ministries of 
Health, Trade and other relevant sectors, as 
well as advocates from civil society. The 
discussion centred around the intersection 
between international trade agreements and 
the tobacco control policies articulated in the 
WHO Framework Convention on Tobacco 
Control.  
WIPO Global Challenges seminar on 
Innovation and Access to Medicines: Case Study for HIV/AIDS and Hepatitis C 5 December 2014 Geneva, 
Switzerland The seminar series aims to address topics of 
innovation and intellectual property relating to global challenges. WHO provided a presentation 
on voluntary licensing in the area of HIV and 
hepatitis treatments. http://www.wipo.int/meetings/en/details
.jsp?meeting_id=35262  
 
Regional Meeting for the Assessment of 
Progress in Implementing the Global 
Strategy and Plan of Action on Public 
Health, Innovation and Intellectual 
Property for South-East Asia 16 - 18 December 
2014 Bangkok, 
Thailand This Regional Meetin g organized by WHO 
SEARO focused on the assessment of the global 
strategy and plan of action.   
International Conference on Intellectual 
Property and Competition in the Pharmaceutical Industry in Rome jointly organized by the Italian Competition 
Authority and WIPO 19 - 20 March 2015 Rome, Italy WHO presented it’s perspective on linkages 
between public health an d intellectual property 
and WHO activities to promote competition.  
 http://www.agcm.it/trasp-
statistiche/doc_download/4752-
finalprogramipconference.html  
 
India Pharma Summit 2014-15 
 23 March 2015 Mumbai, India WHO SEARO assisted in the conceptualization 
of and participated at the India Pharma Summit 
2014-15, in particular on the Session on 
"Promoting Production and Technology Adoption 
in Pharmaceutical Enterprises".   
  IP/C/W/609/Add.5  
 
- 7 - Activity Date Location Brief Description Link to further details 
Seventh WIPO-WTO Advanced course on 
intellectual property for government officials March 2015 Geneva, 
Switzerland WHO presented on the relationship between 
public health and intellectual property in this course. https://www.wto.org/en glish/tratop_e/tr
ips_e/events_e.htm#ipforpolicymakers  
 
Strategic Technical Advisory Committee 
for Viral Hepatitis /  Member State 
Consultation on the draft Regional Action 
Plan for Viral Hepatitis in the Western 
Pacific Region 27 - 29 April 2015 Manila, 
Philippines WHO provided presentations on challenges and 
mechanisms to achieve lower prices for 
hepatitis C and B medicines in the region at 
both meetings that were run by the WHO 
Regional Office for the Western Pacific (WPRO). http://www.wpro.who.int/hepatitis/resou
rce/features/regional_action_plan/en/  
 
Regional workshop on Implementation of 
Pandemic Influenza Preparedness Framework (PIP) 27 - 29 April 2015 Jakarta, 
Indonesia WHO informed about the standard material 
transfer agreements and communicated information on the Tech nical Expert Working 
Group on genetic sequence data.  
European Association for the Study of the 
Liver (EASL) monothematic conference: 
"Liver Diseases in Resource-limited 
Settings" 28 - 30 May 2015 Bucharest, 
Romania The Conference focused on challenges related 
to hepatitis C in Eastern Europe and Africa, with 
WHO staff providing a number of contributions 
on how to increase access to treatment. https://events.easl.eu/EventPortal/Infor
mation/EventInformat ion.aspx?EventInf
ormationPageCode=TIMETABLE&EventC
ode=MB  
WHO Workshop on legal issues relating to 
the implementation of plain tobacco 
packaging in Europe June 2015 Oslo, Norway The event organized by the Norwegian Ministry 
of Health and Care Serv ices, the McCabe Centre 
on Law and Cancer and the Norwegian Cancer Society brought together leading experts to 
discuss the legal issues of plain packaging in 
Europe. http://www.who.int/fctc/mediacentre/ne
ws/2015/osloworkshop/en/  
 
Committee of Social Affairs, Health and 
Sustainable Development of the 
Parliamentary Assembly of the European 
Council, Hearing on the report Protecting 
patients against undue influence of the 
pharmaceutical industry  24 June 2015 Strasbourg, 
France At the invitation of the Committee of Social 
Affairs, Health and Sustainable Development of 
the Parliamentary Assembly of the European 
Council, WHO presented on the protection of 
intellectual property and its implications for 
public health regardin g innovation and access 
to medicines in Europe.   
  IP/C/W/609/Add.5  
 
- 8 - Activity Date Location Brief Description Link to further details 
First Meeting of the National Focal Points 
for Viral Hepatitis organized by WHO Regional Office for the Eastern 
Mediterranean (EMRO) 8 - 10 June 2015 Cairo, Egypt This meeting included a session on access to 
hepatitis C and B treatment, focusing on challenges linked to the intellectual property 
situation.  
12th WIPO-WTO Colloquium for teachers 
of intellectual property from Developing 
Countries 
 
 15 - 26 June 2015 Geneva, 
Switzerland The Colloquium assembles teachers of 
intellectual property from developing countries 
to provide insights into the Geneva institutions, 
negotiations and other activities in the issue 
area of intellectual property. WHO contributed 
to the Workshop by prov iding a public health 
perspective on the topic of intellectual property, 
access to medicines and innovation. https://www.wto.org/en glish/tratop_e/tr
ips_e/events_e.htm#teachers  
 
Informal Consultation on the 
Development of an Approach for Using Health Technology Assessments in 
Reimbursement Systems 20 - 21 June 2015 Geneva, 
Switzerland A two day meeting was held to discuss the use 
of health technology assessment in low and middle income countries, including aspects of 
its use in relation to medicine and health 
technologies, pric ing policies and 
reimbursement decisions.  
2nd National Conference of the 
International Trade and Health 
Programme  7 - 8 July 2015  Bangkok, 
Thailand  WHO SEARO assisted in the design of the 
programme and provided technical input. The 
objectives of the conference were to provide a 
technical forum for participants to exchange 
knowledge and understanding on international 
trade and its impacts on health as well as to 
identify knowledge gaps that need to be 
addressed.   
 
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