WORLD TRADE  
ORGANIZATION  IP/C/W/456/Add.1 
19 October 2005 
 (05-4807) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
TECHNICAL COOPERATION ACTIVITIES:  INFORMATION FROM 
OTHER INTERGOVERNMEN TAL ORGANIZATIONS 
 
WORLD HEALTH ORGANIZATION 
 
Addendum  
  
 The present document reproduces the informa tion on technical and financial cooperation 
activities relevant to the implementation of the TR IPS Agreement, which has been received from the 
World Health Organization by means of a communication dated 30 September 2005. 
  
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INFORMATION ON TECHNICAL AND FINANCIAL COOPERATION PROGRAMMES 
CARRIED OUT BY THE WORLD HEALTH ORGANIZATION AND THAT ARE 
RELEVANT TO TRIPS IMPLEMENTA TION AND ACCESS TO DRUGS 
 
 
I. INTRODUCTION 
WHO's goal in medicines is to help save lives and improve health by ensuring the quality, 
efficacy, safety and rational use of medicines, including traditional medicines, and by promoting 
equitable and sustainable access to essential medicin es, particularly for the poor and disadvantaged. 
Striving towards this goal, WHO continues to res pond to challenges in the medicines arena through 
strategic interventions.  The WHO Medicines Strate gy (2004-2007) is based on four key objectives: 
strengthening national medicines policy;  improving access to essential medicines;  improving the 
quality and safety of medicines;  and promoting th eir rational use.  In ensuring the implementation 
and monitoring of national medicines policies, WHO has identified the need to support countries in 
their efforts to use public health saf eguards in international, regional and bilateral trade agreements to 
improve access to priority medicines.
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II. TRADE, TRIPS AND ACCESS TO MEDICINES 
1. WHO mandate 
WHO's mandate in the area of trade, intellectual property rights and access to medicines, 
derived from successive resolutions of the World H ealth Assembly, can be briefly described as 
follows:  (1) monitor and analyse the pharmaceutical and health implications of international trade 
agreements;  and (2) assist Member States to assess and develop pharmaceutical and health policies 
                                                      
1 WHO Medicines Strategy: Countries at the core (2004-2007) WHO, Geneva IP/C/W/456/Add.1 
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 and regulatory measures that maximize the positiv e and mitigate the negative impact of those 
agreements.  Recent resolutions have further elabor ated on the priorities within these broad objectives. 
Resolution WHA56.27 of 28 May 2003, expressed "c oncerns about the current patent protection 
system, especially as regards access to  medicines in developing countries", and urged Member States 
to adapt "national legislation in order to use to th e full the flexibilities contained in the Agreement on 
Trade-Related Aspects of Intellectual Property Rights (TRIPS)".  Resolution WHA57.14 of 22 May 
2004 urged Member States to "encourage that bila teral trade agreements take into account the 
flexibilities contained in the WTO TRIPS Agreem ent and recognized by the Doha Ministerial 
Declaration on the TRIPS Agreement and Public Health".  
2. WHO Policy Perspectives 
Consistent with the above mandate, WHO is committed to supporting Member States in the 
use of measures to protect public health and prom ote access to medicines, consistent with the 
provisions of the TRIPS Agreement and the Doha D eclaration.  In this, WHO is guided by clear 
policy perspectives, which place public health and acces s to medicines as priorities, consistent with 
the basic tenets of the Doha Declaration.  
WHO has also enunciated the key features of effective implementation of the WTO General 
Council Decision on the Implementation of Paragr aph 6 of the Doha Declaration on the TRIPS 
Agreement and Public Health (hereinafter, the A ugust Decision) as follows:  a rapid and effective 
response to public health needs;  equality of opp ortunities for countries in need, irrespective of the 
patent status of a drug in the importing country, and without regard to its membership in the WTO;  
the sustainability of quality supply  at affordable prices;  the fac ilitation of a multiplicity of potential 
suppliers, both from developed and developing countries, which can compete to drive prices down; 
and provision of a wide range of pharmaceutical pr oducts to meet an array of health problems.  
Within this framework, WHO is fully committed to assisting its Member States to make effective use 
of the August Decision.  In the context of the permanent amendment to the TRIPS Agreement, all 
these elements should be incorporated within a st able international lega l framework, which would 
ensure legal certainty and security, and most im portantly, promote access to medicines for all.  
III. WHO TECHNICAL COOPERATION 
In many countries, especially low-income countries, there is  still insufficient awareness, 
implementation and assessment of the provisions in  international, regional and bilateral trade 
agreements that can be used to safeguard access to medicines;  t hus there is a need to develop 
informed approaches to addressing h ealth implications of trade and intellectual property-related issues 
at the national, subregional and re gional levels.  With respect to its mandate on intellectual property 
rights and public health, WHO seeks to provide th e appropriate technical assistance and country 
support, within a comprehensive and coherent stra tegy, to Member States to promote implementation 
of the TRIPS Agreement that is consistent with the protection of public health and promotion of 
access to medicines.  
WHO's strategic priorities in technical coopera tion have been to support Member States in 
their efforts to improve access to medicines through direct country support and technical assistance on the use of flexibilities and safeguards in their na tional legislation in accordance with the Doha 
Declaration on the TRIPS Agreement and Public He alth, including effective implementation of the 
30 August Decision of the WTO General Council, and to  promote a permanent solution that is simple 
and workable.  In order to provide adequate and appropriate support to Member States on the use of 
TRIPS flexibilities and safeguards, WHO focuses on three key interventions:  1) policy and technical 
guidance;  2) briefings and training work shops;  and 3) direct country support.  IP/C/W/456/Add.1 
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 1. Policy and technical guidance 
WHO continues to identify key issues related to  the TRIPS Agreement and Doha Declaration 
implementation and provides practical and assessable policy guidance and technical advice  through 
its publications and related docum ents.  A recent publication of the Health Economics and Drugs 
Series of the Department of Essential Drugs and Medicines Policy - the series of analysis papers 
looking at the implications of the new trade and economic context on health and drug policies - is 
"Determining the Patent Status of Essential Medi cines in Developing Countries", EDM Series No. 17, 
published jointly with the UNAIDS Secretariat and Mé decins Sans Frontières.  There are a range of 
policy options for countries in the use of public  health safeguards in TRIPS to access affordable 
medicines, depending on the particular circumstanc es and needs in the country.  However, a crucial 
factor to ensure effective decision-making on such  issues must be the availability of accurate and 
up-to-date information about the patent status of esse ntial medicines.  Unfortunately, such information 
is not always easily accessible or available in developing countries.  The report publishes a patent 
table which sets out the patent situation of key HIV/AIDS medicines in 29 developing countries, for 
which such data was available. 
A forthcoming publication, which will be  jointly published by UNDP and WHO, on the 
development of guidelines or best practices for compensation or royalty-setting in the context of 
compulsory licensing and government use of patent s.  Although the Doha Declaration on the TRIPS 
Agreement and Public Health has confirmed the ri ght of countries to grant compulsory licences for 
public health purposes, the absence of an appr opriate administrative/legal infrastructure and 
procedures to implement the compulsory licensing sy stem may hinder the effective use.  One of the 
key requirements for compulsory licensing is the pa yment of adequate remuneration to the patent 
holder, and most developing countries do not have suffi cient expertise or experi ence in this area.  It 
has been recommended by the UNDP and the United Kingdom Commission on Intellectual Property 
Rights that clear and easy-to-apply guidelines for setting royalty rates should be adopted.  The study 
assesses various state practices regarding the determ ination of adequate re muneration, and makes 
recommendations on suitable approaches for developing countries. 
2. Briefings and training workshops 
WHO briefings and training workshops over the past years have contributed to heightened 
awareness of the relevant issues and, more importa ntly, increased capacity for effective participation 
in international and regional negotiations.  WHO adopts a multi-agency approach in conducting 
briefings and training sessions for health, trade and pa tent officials, to ensure coherent decision- and 
policy-making, and will continue to do so, recogni zing that the collaboration between health, trade 
and patent agencies is essential for informed d ecision-making on public health and intellectual 
property issues. 
WHO collaborated with UNDP and partners from non-governmental organizations in the 
organization of a series of regional training workshops  for health, trade and patent officials in the 
Asia-Pacific and African Regions in 2004-2005.  These workshops were intended to fulfil three main 
objectives:  1) to provide training and strengthe n capacity of government agencies to address the 
related issues of intellectual property, TRIPS implem entation and access to medicines;  2) to provide 
training for WHO staff, in particular the National Professional Officers (NPOs) who are based in-
country, to provide technical assistance to the MOH;   and 3) to bring together resource persons from 
the regions in order to set up networks of experts that can help advise and provide technical assistance 
and training to Member States. 
WHO also actively participated in the WTO ser ies of regional workshops on TRIPS issues.  
In 2004-2005, WHO staff and consultants participat ed as resource persons in 5 of the 7 regional 
workshops on TRIPS implementation organized by the WTO Secretariat, and provided briefings and IP/C/W/456/Add.1 
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 training for health and trade officials from countri es from the African, Asia-Pacific and Arab regions 
(which encompasses the majority of the ACP countri es) on a public health oriented approach to the 
implementation of the TRIPS Agreement and the Doha Declaration. 
3. Direct country support 
The provision of appropriate policy and t echnical guidance on public-health sensitive 
implementation of the TRIPS Agreement to polic y makers, in consultation with the relevant 
stakeholders in each country, is an essential com ponent of WHO's technical cooperation programme. 
The approach here has been to identify, in cons ultation with the WHO Country and Regional Offices, 
suitable partners in this process, including worki ng with the WHO NPOs, who are locally recruited by 
WHO Country Offices, to assist in the planning, implementation and monitoring of medicines and other related policies.  Examples of such direct c ountry support include the following:  1) a national 
workshop in Nigeria on "TRIPS and Public Health: Strengthening Domestic Legislation" organized 
by the Federal Ministries of Health, Commerce and Ju stice, in collaboration with WHO (Abuja, April 
2005);  and 2) WHO, MOH and HAI-Africa/HEPS in Ug anda jointly-organized a national workshop 
on Patents and Access to Medicines: Incorporation of WTO/TRIPS Safeguards into the National Laws 
and Policies (Kampala, July 2005). 
4. Technical cooperation with international organizations 
Another essential component of WHO's technical  cooperation programme is cooperation with 
international organizations, with a view to maximizing outreach and promoting coherence and 
cooperation between those organizati ons working in the same fields. 
In this context, WHO organized an inter-agen cy workshop, in cooperation of UNICEF Supply 
Division, to bring together representatives of UN agencies working on medicines procurement and 
intellectual property issues, with the aim of impr oving coordination and collaboration, so as to be 
more effective in contributing to achievement of  the fundamental objective of ensuring access to 
medicines.  The key objectives of the workshop were to:  1) facilitate and promote coherence in the 
perspectives on intellectual property rights in the cont ext of medicine procurement;  2) develop, where 
appropriate, common approaches and strategies on these issues;  and 3) develop legal tools and 
instruments for use in the procurement process.  It was agreed that a common approach in terms of the 
use of TRIPS flexibilities would be a good start towa rds building coherence.  The workshop agreed 
that there should be development of a common set of templates on TRIPS flexibilities that would translate the common policy of the UN agencies on the use of TRIPS flexibilities into concrete tools 
for use by countries. 
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