IP/C/W/603/Add.1  
 
17 October 2014  
(14-5953)  Page: 1/6  
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 June 2014, 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 7 October 2014.  
_______________ 
 
 
1  INTRODUCTION 
1.1.  This communication summarizes the technical cooperation activities of the World Health 
Organization (WHO) in the area of public health, innovation and intellectual property that took 
place since the submission of the last report in September 2013.1 These are part of the 
implementation of the Global strategy and plan of action on public health, innovation and 
intellectual property  (Resolution WHA61.21). 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. Public health interests should be prioritized in 
the formulation of national policies and legislation on trade and intellectual property.  
1.2.  WHO's technical cooperation is based on its mandate derived from the Global strategy and 
plan of action  as well as from relevant resolutions of the World Health Assembly. For example, 
Resolution WHA67.6 on the prevention, diagnosis and treatment of viral hepatitis requested the 
Director-General "to work with national authorities, upon their request, to promote 
comprehensive, equitable access to prevention, diagnosis and treatment for viral hepatitis" and "to assist Member States to ensure equitable access to quality, effective, affordable and safe hepatitis 
B and HCV treatments and diagnostics, in particular  in developing countries". In 2014, contributing 
to the implementation of this resolution was one of the main activities in the area of public health 
and intellectual property. 
2  FOCUS ON HEPATITIS C 
2.1.  The WHO's 2014 Guidelines for the screening, care and treatment of persons with hepatitis C 
infection state that more than 185 million people  are infected with the hepatitis C virus (HCV) 
worldwide. Of these people, 350 000 to 500 000 di e each year. An estimated one third of those 
who become chronically infected develop liver cirr hosis or hepatocellular carcinoma. HCV infection 
can be cured, but most people infected with the virus are unaware of their infection and do not seek timely treatment. Several medicines are avai lable to treat HCV, but treatment duration is 
long, involves weekly injections, and side effects are considerable. With the development of new 
                                               
1 Communications of previous years can be found on the website of WHO: 
http://www.who.int/phi/wto_communications/en/index.html . IP/C/W/603/Add.1 
 
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  direct-acting antiviral medicines, the treatment la ndscape is rapidly changing. These new antivirals 
are expected to reach cure rates of more than 90% in persons with HCV infection across different 
genotypes, with fewer side effects and a shorte r duration of treatment. Two new compounds, 
simeprevir and sofosbuvir, have recently been a pproved in the United States and Europe and are 
recommended by the new WHO treatment guidelines. Many others are in various stages of 
development. However, the new treatments are currently out of reach for many of those in need. In the framework of developing national hepa titis programmes, WHO has thus advised a number 
of Member States through their national hepatitis task forces on their available options with 
respect to accessing the new treatments at affordable prices. WHO also presented on how to improve access to hepatitis C treatment in various fora, including the WHO Global Partners' Meeting on Hepatitis and the UNITAID/WHO 2014 HIV Market Forum in spring 2014. WHO 
Regional Office for South-East Asia (SEARO) made a presentation on "Access to Antivirals and 
Treatment" covering intellectual property aspects on the occasion of World Hepatitis Day, 28 July 2014, at the Institute of Liver and Biliary Sciences in New Dehli, India. A round table 
consultation on "Viral Hepatitis: Gaps, Challenges and Priorities" brought together stakeholders 
from the government, academia, clinics, public health, civil society, research institutions and partner agencies to deliberate on the issue.  
2.2.   In April 2014, the Pan American Health Or ganization/WHO Regional Office for the Americas 
(PAHO), the Ministry of Health of Brazil, Fundação Oswaldo Cruz (Fiocruz) and the Open Society Foundation co-organized a two day meeting to review options to facilitate access to high cost medicines, in particular for the new hepatitis C treatments. Participants, that included non-
governmental organizations and researchers, analyzed different paths to maintain balance 
between public health interests and intellectual pr operty protection and what could be the trade-
off between research and development, innovation  and access to essential medicines. In this 
context, participants assessed current progress to reform the Brazilian patent law and draw 
parallels to the dramatic price decrease for HIV treatment. Experts presented the main outcomes to the Brazilian Congress (Commission for Health and Social Affaires).
2 
2.3.  For countries to identify ways of increasing access to and affordability of new HCV medicines, 
they need clarity about patent status. To assess whether a medicine is patent protected in a certain country requires expert knowledge and acce ss to specialized databases that are not easily 
available. Therefore, WHO Secretar iat published an analysis of the patent situation of seven new 
hepatitis treatments. This also corresponds to the mandate provided by the WHO Global strategy 
and plan of action on public health , innovation and intellectual property  that requests WHO to 
support efforts to determine the patent status of health products (element 5.1c). The patent 
working papers identify the most relevant patents with respect to the seven medicines and list the 
countries in which these patents have been filed and granted.
3 
3  POLICY AND TECHNICAL GUIDANCE 
3.1.  Market failures in the discovery and deve lopment of new antibiotics are well-documented, 
underscoring the need for innovative approaches and models to sustainably encourage research and development in this area. Hence, WHO organized a technical consultation on innovative models for new antibiotics' development and preservation in Geneva, Switzerland, 13 May 2014.
4 
The meeting focused on innovative models fostering discovery and development of new antibiotics 
as part of the tool-kit to address challenges related to antimicrobial resistance.  
3.2.  The new WHO Technical Report on Access to antiretroviral drugs in low and middle-income 
countries  examines global trends in prices of an tiretroviral treatment and assesses how WHO 
treatment guidelines have influenced the uptake of  different formulations. It describes the current 
constraints limiting the use of second-line, third- line and pediatric treatment, and explores how 
the quality of antiretroviral treatment can be secu red and in-country distribution can be improved. 
                                               
2 http://www.paho.org/bra../index.php?option=com _content&view=article&id=4618:fundacao-oswaldo-
cruz-fiocruz-open-society-foundati on-osf-organizam-oficina-sobre-direitos-humanos-saude-ao-acesso-
medicamentos-no-rio-janeiro&catid=844:bra-02-c-noticias&Itemid=455  
3 The working papers can be found on: 
http://www.who.int/phi/implementation/ip_trade/ip_patent_landscapes/en/  
4 http://www.who.int/phi/impleme ntation/consultation_imnadp/en  IP/C/W/603/Add.1 
 
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  The report includes chapters on the role of intell ectual property in access to treatment, on prices, 
quality assurance, increasing global demand as well as on supply chain management.5 
3.3.  Developed from the consultation on access to HIV medicines in middle-income countries held 
from 10 to 12 June 2013 in Brasilia, Brazil, WHO published the report Increasing access to HIV 
treatment in middle-income countries: Key data on prices, regulatory status, tariffs and the 
intellectual property situation6 in June 2014. The paper provides information on the prices paid by 
20 middle-income countries for adult and pediatric formulations of antiretroviral treatments 
recommended by WHO. It links pricing information with an analysis of the intellectual property 
situation of the selected medicines taking into account existing license agreements as well as compulsory licenses. It also includes data and general information on a number of other determinants of prices and availability of ARVs, including tariffs, markups and taxes as well as the 
regulatory status.
7 The data shows that middle-income countries are a heterogeneous group and 
that procurement prices vary widely. Middle-income countries supported by the Global Fund to Fight AIDS, Tuberculosis and Malaria pay low prices for first-line and many second-line treatment 
regimens, comparable to those paid by low-income countries. Other middle-income countries pay 
higher prices, especially for newer second line and third line treatments sourced from originator producers. 
3.4.  WHO launched the Global Platform for Innovation and Access (GPIA)
8 in May 2014. The 
Platform hosts initial data from two key sources, the PAHO Regional Platform on Access and Innovation for Health Technologies and the WHO Pharmaceutical Country Profiles. It provides information on national research and development infrastructure, policies, human resources, local 
production of medical technologies, intellectual property, regulation of and access to health 
technologies. The finalization of the development of the GPIA is expected in early 2015.  
4  TRANSFER OF TECHNOLOGY  AND LOCAL PRODUCTION 
4.1.  Within the context of the implementation of the Global strategy and plan of action , WHO is 
leading a European Union supported project on local production to increase access to medical products in developing countries.
9 The first phase aimed at identifying the main challenges of local 
production and technology transfer in developing  countries regarding medicines, vaccines, blood 
and blood products, and medical devices. The second phase is a country-based policy analysis. It assesses policy coherence across industrial and he alth policies, the degree of promotion of local 
production, and compares prices of locally produced medicines with those of imported medicines. 
It also includes training and capacity-building for manufacturers and national regulatory authorities 
to support quality production across a range of medical products. In the framework of the project, WHO identifies essential medicines that are most suitable for local production, determines the 
feasibility of local production of blood products, assesses selected medical devices on their 
potential for local production and analyses the patent situation for a number of medicines.  
4.2.  In the framework of the Global Pandemic Influenza Action Plan (GAP), WHO facilitated the 
transfer of influenza vaccine production technology to fourteen vaccine manufacturers in 
developing countries. So far five countries have es tablished local production of approved influenza 
vaccines, amounting to a combined capacity of 330 million pandemic doses. WHO continues to help manufacturers through technical support and clinical trial implementation. With three clinical 
trials ongoing in 2014 and others planned for 2015, the goal is to exceed 500 million dose capacity 
by 2016. 
5  TRAINING AND ENHANCING CAPACITY 
5.1.  Training and capacity building, carried out in collaboration with other competent 
organizations, are among the core activities of WH O, with regard to public health and intellectual 
property.  
                                               
5 http://www.who.int/hiv/pub/amds/access-arv-2014/en/  
6 http://www.who.int/phi/publications/hiv_increase_access/en/  
7 http://www.who.int/phi/publications/WH O_Increasing_access_to_HIV_treatment.pdf  
8 http://69.90.223.32:9090/oms  
9 http://www.who.int/phi/publications/local_production/en/  IP/C/W/603/Add.1 
 
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  5.2.  In this context, the WHO made a substant ial contribution to the Workshop on Intellectual 
Property and Public Health that was organised by  the WTO in close collaboration with the WHO and 
WIPO in Geneva, from 10 to 13 December 2013. This workshop provided a comprehensive overview of the key issues related to the promotion of innovation, access to medicines and the 
protection of intellectual property. It included pr esentations on the impact of intellectual property 
on prices and access to medicines, regulatory questions, license agreements and other related 
issues. 
5.3.  WHO also presented at the Conference on Intellectual Property and Health Innovation - 
Challenges for the Future organized by WIPO an d the Hellenic Industrial Property Organization, 
28 April 2014 in Athens, Greece, focusing on the trilateral cooperation and the challenges of facilitating access to the new hepatitis C treatments.  
5.4.  WHO participated in a two-days' workshop on the WTO TRIPS Agreement and public health 
organized jointly by the European Commission and the Ministry of Health of Belarus, on 11-12 August 2014. Presentations and discussions aimed at fa miliarizing participants with selected issues 
at the crossroad between intellectual property and public health, focusing on Belarus' continuing 
negotiations on accession to the World Trade Organization.  
5.5.  WHO contributed to a WTO national workshop on intellectual property and public health in 
Bandung, Indonesia, 11 to 12 November 2013. This workshop provided a comprehensive overview 
of the key issues related to the promotion of innovation, access to medicines and the protection of intellectual property rights. It included presentations on the implementation of TRIPS flexibilities and on special compulsory licenses for the export of medicines.  
5.6.  For the 23
rd Meeting of the WHO South East Asia Region National AIDS Programme 
Managers, held in New Delhi from 1 to 4 July 2014, SEARO prepared a technical paper and made a presentation on "Access to medicines for HIV/AIDS and hepatitis: the intellectual property rights 
context". The meeting brought together partners UNAIDS and UNICEF as well as the US Center for 
Disease Control and The Global Fund to Fight AIDS, Tuberculosis and Malaria. 
5.7.  The World Health Organization Regional Office for the Western Pacific co-sponsored a 
consultation on overweight, obesity, diabetes and law held in Manila, Philippines, from 9 to 11 April 
2014 and provided among other contributions a presen tation on intellectual property rights and 
trade issues titled "Access to Medicines for Non-Communicable Diseases". The consultation introduced some central concepts of public health law, besides outlining the role that law can play 
in creating healthy environments and supporting he althy behaviours. It highlighted the role that 
legislation and regulation have played in all major public health successes.   
5.8.  WHO contributed lectures on trade, intelle ctual 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 2014. WHO also presented the findings of its 
trilateral study with WIPO and WTO, Promoting access to medical inno vation: Intersection between 
public health, intellectual property and trade , at the Meeting of Experts of Biological Weapons 
Convention from 12 to 16 August 2013 in Geneva.
10  Furthermore, WHO contributed to the 
seminar on the right to enjoy the benefits of scientific progress and its applications hosted by the 
United Nations Human Right Council, from 3 to 4 October 2013.11 The meeting aimed at providing 
further clarification on the normative content of the right to enjoy the benefits of scientific progress and its applications as well as to clarify its relationship with other human rights.  
5.9.  As every year, WHO also contributed to the 11
th WTO-WIPO Colloquium for teachers of 
intellectual property from developing countries and countries with economies in transition, which 
took place in Geneva from 16 to 27 June 2014, as well as to the sixth WIPO-WTO Advanced course 
on intellectual property for government officials in Geneva, from 10 to 21 March 2014.  
                                               
10 http://www.unog.ch/80256EE600585943/(htt pPages)/EED3E63397C2144B C1257BF80054FE12?Open 
Document  
11 http://www.ohchr.org/EN/Issues/CulturalRights/ Pages/Seminarbenefitsofscientificprogress.aspx  IP/C/W/603/Add.1 
 
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  6  DIRECT COUNTRY SUPPORT 
6.1.  In collaboration with relevant internationa l organizations, through its Headquarter, Regional 
and Country Offices, WHO provides technical and po licy support in framing 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. Provided upon 
request, such support is directed to assisting Member States in devising ways to safeguard public health interests, while adhering to their oblig ations under international trade agreements.  
6.2.  On request of the Egyptian Ministry of Health and Population, WHO in collaboration with WTO 
and WIPO organized a joint training workshop on in tellectual property and public health in Cairo, 
Egypt from 3 to 5 June 2014. The workshop focused on the granting process for patents in the pharmaceutical field and the involvement of health authorities in this process as well as on the 
relationship between the intellectual property sy stem and the regulatory system. Participants and 
speakers came from the Ministry of Health and Population, the Egyptian Patent Office and the 
Ministry of Foreign Affairs.
12  
6.3.  WHO Country Office for India and the Minist ry of Health & Family Welfare, Government of 
India jointly organized a number of events, includin g a colloquium on intellectual property rights 
for high-level policymakers from 17 to 20 September 2013 in New Delhi, India.13 The forum 
provided a platform for cross exchange between high-level policymakers from several key union 
ministries and the states on these issues. Repres entatives from WTO, WIPO and WHO and national 
experts contributed as resource persons. The colloquium aimed at enhancing knowledge of policymakers on the relationship between public health and intellectual property, including how to 
optimally apply the flexibilities contained in the WTO TRIPS Agreement. On 2 July 2014, a follow 
up symposium on public health and intellectual property rights in India was organized in New Delhi.
14 The objective was to further familiarize participants with current developments relating to 
intellectual property and access to medicines, and biologicals as well as bilateral investment 
treaties. The symposium was attended by senior government officials, policymakers, international organizations, academics, non-governmental organizations, and intellectual property experts. 
From 7 to 9 August 2014, WHO Country Office for In dia in collaboration with Ministry of Health & 
Family Welfare, Government of India and the Centre for Technology and Policy organized a national consultation in Chennai, India on improving access and promoting innovation in the context of universal health coverage. The workshop brought together government officials, 
representatives from WHO, WTO, civil society and industry as well as other key organizations with 
the mandate to ensure universal access to drugs.
15 The consultation focused on access to 
medicines and innovation in the context of universal health coverage, voluntary and compulsory 
licensing and finally the importance of global health diplomacy in relation to international trade 
agreements.  
6.4.  The WHO Framework Convention on Toba cco Control (FCTC) Secretariat convened a 
workshop at the WHO headquarters on 31 March 2014 for health and trade representatives of 
Permanent Missions in Geneva, focusing on international trade and investment issues relevant to implementation of the WHO FCTC, and to facilita te sharing of the national experiences that 
continue to accumulate in this area. Representatives of WHO, WTO, UNCTAD and WIPO 
participated in the workshop and provided pres entations. A background paper to the workshop 
summarizes the developments that have taken place in this area since the first similar workshop was convened in 2012. It provides an overview of relevant laws and legal concepts with reference 
to the law of the World Trade Organization, and International Investment Agreements 
respectively, as they are relevant to implementation of the WHO FCTC.
16 
6.5.  SEARO made a technical presentation on "T rade and Health, Intellectual Property Rights in 
Medicines and Medical products related R&D" fo r the Global Conference on Community Health, 
Sustaining Change in Community Health held from 19 to 21 March 2014 in Dhaka, Bangladesh. This conference focused on the need to address co mmunity health for realizing national and global 
                                               
12 http://www.emro.who.int/egy/egypt-infocus/ workshop-on-intellectual-property.html  
13 http://www.unog.ch/80256EE600585943/(htt pPages)/EED3E63397C2144B C1257BF80054FE12?Open 
Document  
14 http://www.searo.who.int/india/mediacentre/events/2014/ipr_symposium/en/  
15 http://www.searo.who.int/india/mediacentre/releases/2014/national_consultation/en/  
16 http://www.who.int/fctc/workshop_trade_2014/en/  IP/C/W/603/Add.1 
 
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  development goals, and was organized together by the Bangladeshi government and Eminence 
and Partners for World Health, and supported by WHO.  
6.6.  SEARO assisted the Ministry of Health in Th ailand in the design of the International Trade and 
Health Conference that took place in Bangkok, Thailand, from 10 to 11 March 2014. It delivered 
presentations on international case studies at the interface of public health, innovation, intellectual 
property and trade as well as on the Global strategy  and plan of action on public health, innovation 
and intellectual property (GSPA-PHI) and on intellectual property related aspects of the Pandemic 
Influenza Preparedness Framework.  
6.7.  SEARO also provided technical support for the Regional Workshop on Strengthening 
Quantification and Procurement of Essential Medicines in New Delhi, from 10 to 12 June 2013, where countries of the region met to increase the availability of essential medicines through 
efficient procurement of medicines. 
6.8.  SEARO organized workshops and provided tec hnical support for Sri Lanka in the framework of 
the implementation of the Global strategy and plan of action for public health, innovation and 
intellectual property , from 29 to 30 April 2014. Sri Lanka is the first country in the SEARO region 
to undertake this assessment, which will facilitate development of a national roadmap for innovation, R&D and access to health technologies.  
6.9.  SEARO also provided training support on the WTO TRIPS Agreement and public health for 
Indian Foreign Service Officers and Indian Trade Se rvice Officers at the Indian Institute of Foreign 
Trade for Capacity Building Programme on Contemporary Issues in International Trade. It also provided training for the Certificate Course on Arbitration and Intellectual Property Rights in the 
context of public health for participants of th e Institute of Chartered Accountants of India. 
6.10.  As in the past years, SEARO provided suppo rt for the Indian Ministry of Micro, Small and 
Medium Enterprises under the scheme "Building Awar eness of Intellectual Property Rights" relating 
to micro, small and medium pharmaceutical enterpri ses. This included evaluation of proposals from 
these enterprises to facilitate access to intellectual property management practices. 
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