IP/C/W/633/Add.2  
 
2 October  2017 
(17-5260) Page: 1/8 
Council for Trade -Related Aspects of Intellectual 
Property Rights  Original: English  
 
 
TECHNICAL COOPERATIO N ACTIVITIES: INFORM ATION FROM  
OTHER INTERGOVERNMEN TAL ORGANIZATIONS  
WORLD HEALTH ORGANIZ ATION (WHO)  
Addendum  
At its meeting of 13 June 2017, 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 20 September 2017 . 
 
_______________  
 
 
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 prop erty that have 
taken place since the last report in October 2016 (IP/C/W/614/Add.4.).  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 mana gement 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 as well as other relevant resolutions of the World 
Health Assemb ly. 
2  THE GLOBAL ANTIBIOTI C RESEARCH AND DEVEL OPMENT PARTNERSHIP ( GARDP)  
2.  The Global Antibiotic Research And Development Partnership (GARDP) was established in 
May 2016 as a joint initiative by the World Health Organization (WHO) and the Drugs for Neglected 
Diseases initiative  (DND i). As an important element of the WHO Global Action Plan on 
Antimicrobial Resistance, this not -for-profit research and development (R&D) organization 
addresses global public health needs by developing and delivering new or improved antibiotic 
treatments while endeavoring to ensure sustainable access.  
3.  On 4 September 2017, a number of countries and foundations pledged EUR 56.5 million to help 
develop new treatments to fight against antibiotic resistance at a fundraising event for GARDP . 
The meeting was hosted in Berlin by the German Federal Ministry of Health and the  German 
Federal Ministry of Education and Research. Funding will support GARDP 's portfolio of R&D 
programmes as articulated in its business plan1 published in May 2017.  Initially GARDP will launch 
four programme areas:  
 Sexually -transmitted Infections: GARDP has developed a roadmap to treat STIs, starting 
with a focus on gonorrhoea. In July 2017, in its first partnership with a company, GARDP 
announced its plans to co -develop zoliflodacin, one of the few drugs in the pipeline to 
                                                
1 "Business Plan 2017 -2023 Developing new antibiotic treatments and ensuring  sustainable access for 
all" https://www.gardp.org/wp -content/uploads/2017/05/GARDP_Business_Plan_2017 -2023.pdf   IP/C/W/633/Add.2  
 
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  treat drug resistant gonorrhoea, in a global Phase III clinical trial. Latest WHO data 
shows that more than 60% of countries surveyed across the world have reported 
resistance to the last -line antibioti c. 
 Antimicrobial Memory Recovery and Exploratory programme: The Memory Recovery 
programme will engage more than 100 world -class experts in its bid to recoup essential 
knowledge and lost memory of abandoned antibiotic development projects to help 
identify n ew drug opportunities. A digital hub, "REVIVE ", will provide a space for experts 
and new researchers to network and learn.  
 Neonatal Sepsis: An estimated 214,000 neonatal sepsis deaths each year are believed to 
result from drug -resistant infections. GARDP w ill initiate work to develop new treatment 
regimens for babies with neonatal sepsis.  
 Paediatric Antibiotic Platform: Currently in development, this programme aims to 
optimize current treatments and accelerate the development of new antibiotics 
specifically  adapted for children, through an R&D programme which expects to include 
a network of clinical trials.  
4.  GARDP is an essential element of the Global Framework For Development & Stewardship to 
Combat Antimicrobial Resistance that was discussed at the Seventie th World Health Assembly 
in May 2017.2  
3  FAIR PRICING FORUM  
5.  Access to medicines is a major challenge for all, including for patients, governments and 
industry. The current situation with respect to medicines prices highlights two problems: high 
prices causi ng access issues on the one hand, and low prices leading to shortages on the other. 
Fair pricing of essential medicines would mitigate these challenges while at the same time 
providing space for innovation for health technologies to address existing unmet needs. To discuss 
the challenges and the way ahead, a Fair Pricing Forum was held from 10 -11 May 2017 in 
Amsterdam, The Netherlands. The main objective of the Forum was to discuss options for a fairer 
pricing system that is sustainable for both health syst ems and innovation. The Forum was 
an initiative of the World Health Organization and was organized in collaboration with the Dutch 
Ministry of Health. The report on the Fair Pricing Forum 2017 is available on the WHO website.3  
4  GLOBAL REPORT ON ACC ESS TO HEPATITIS C TREATMEN T: FOCUS ON OVERCOMI NG 
BARRIERS  
6.  Worldwide, approximately 71 million people are living with chronic hepatitis C virus (HCV) and 
millions more are newly infected each year. Annually, 399,000 people die from HCV -related 
complications, incl uding cirrhosis and hepatocellular carcinoma (HCC). Despite the scope and 
severity of the epidemic caused by HCV, until recently, the global response to reduce the burden 
of this disease has been very limited and the available treatment was expensive, poor ly tolerated 
and had low cure rates. Once infected with hepatitis C , there was little chance of being cured, 
particularly for people living in low - or middle -income countries.4 
7.  In 2016, WHO published the first global report on treatment access to hepatitis  C medicines. 
The report provides the information that countries and health authorities need to identify 
the appropriate HCV treatment and procure it at affordable prices. The report uses the experience 
of several pioneering countries to demonstrate how ba rriers to treatment access can be overcome. 
It also provides information on the production of new hepatitis C drugs and generic versions 
worldwide, including where the drugs are registered, where the drugs are patented and where not, 
and what opportunities  countries have under the license agreements that were signed by some 
companies as well as current pricing of all recommended direct -acting antivirals (DAAs), including 
by generic companies all over the world.  
                                                
2 http://www.who.int/phi/implementation/research/WHA_BackgroundPaper -
AGlobalFrameworkDevelopmentStewardship.pdf?ua=1  
3 http://who.int/medicines/access/fair_pricing/FairPricingForum2017MeetingReport.pdf?ua=1  
4 http://www.who.int/mediacentre/factsheets/fs164/en/  IP/C/W/633/Add.2  
 
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  5  UPDATE OF THE WHO ES SENTIAL MEDICINES LI STS 
8.  The WHO Essential Medicines Lists (WHO EML) are used by governments and institutions 
worldwide to guide the development of their essential medicines lists and to make appropriate 
reimbursement and procurement and decisions and guide the ration al use of medic ines in general.  
9.  In March 2017, the WHO Expert Committee on the Selection and Use of Essential Medicines 
considered 92 applications for about 100 medicines and added 55 to the EML.  The updated list 
adds 30 medicines for adults and 25 for children, and spec ifies new uses for 9 already -listed 
products, bringing the total to 433 drugs deemed essential for addressing the most important 
public health needs.  New advice on which antibiotics to use for common infections and which to 
preserve for the most serious ci rcumstances is among the additions to the WHO Model List of 
Essential Medicines for 2017.  WHO experts added 10 antibiotics to the list for adults, and 12 for 
children. The updated EML also includes several new drugs, such as two oral cancer treatments, 
and a new pill for hepatitis C that combines two medicines.  
6  TRAINING AND ENHANCI NG CAPACITY  
10.  The new WHO -WIPO -WTO joint online course on Promoting Access to medical Technologies 
and Innovation  gives an overview of the factors that shape access to, and influenc e innovation of, 
medical technologies. The course describes how these two issues are connected by many 
overlapping factors that span the policy fields of public health, intellectual property and 
international trade. The target audience for this course prim arily includes technical professionals 
such as patent examiners, health policymakers and their assistants, drug procurement specialists, 
IP specialists and senior students. This course requires approximately 10 hours of study time over 
a period of 4 -5 week s. Registration for the first offering of the course was available on 
25 October  2016 on the occasion of the WIPO, WHO, WTO Joint Technical Symposium on 
Antimicrobial Resistance.5 
11.  The sixth WHO -WIPO -WTO Joint Technical Symposium on Antimicrobial Resistance : How to 
Foster Innovation, Access and Appropriate Use of Antibiotics was held in Geneva on 25 October 
2016 and reviewed issues related to antimicrobial resistance (AMR). AMR occurs when bacteria, 
parasites, viruses and fungi become resistant to the drugs which are used to treat infections 
caused by these organisms. AMR affects all areas of health, involves many sectors and has 
an impact on the whole of society.  
7  POLICY AND TECHNICAL  GUIDANCE  
12.  The WHO Regional Office for South East Asia (SEARO) collaborates w ith Ministries of Health in 
the countries to provide information on the interface of intellectual property rights, trade and 
public health. The objective is to raise awareness regarding trade negotiation processes and their 
policy implications for access t o all medi cal products for public health.  
13.  Policy coherence for trade and health in the context of the S ustainable Development Goals 
also finds mention in the  WHO-India Country Cooperation Strategy 2018 -2022. The focus is on 
strengthening the Central Drugs Standard Control Organization (CDSCO) and state drug regulatory 
authorities as well as drug testing laboratories to augment the capacity of generic Indian 
pharmaceutical enterprises to meet quality, safety and efficacy standards at national and global 
levels, promote the use of generic medicines, develop programmatic, evidence -based guidance 
and country support on antimicrobial resistance, promote health research and development (R&D) 
and develop rese arch collaboration initiatives.  
14.  The development of the WH O Country Cooperation Strategy 2017 –20216 in Thailand includes 
international trade and health as a separate priority area. With the increase of regional and 
bilateral trade, the direction of trade agreements and policies has changed and concern on 
the impact on health is increasing. More recent trade agreements are increasingly covering areas 
that impact access to medical products and medicine pricing systems. Balancing international 
trade and health is now receiving higher attention at the global and natio nal policy national levels. 
                                                
5 WIPO Academy. http://www.wipo.int/academy/en/  
6 http://apps.who.i nt/iris/bitstream/10665/255510/1/9789290225829 -eng.pdf  IP/C/W/633/Add.2  
 
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  For example, SDG target 3.b focuses on TRIPS flexibilities to ensure access to affordable essential 
medicines and vaccines.  
15.  SEARO supported Member countries in the region in conducting self -assessments of the Global 
Strategy and  Plan of Action on Public Health, Innovation and Intellectual Property (GSPA). 
The results were useful for guiding implementation and fostered country ownership of WHA61.21.7 
16.  South -East Asia Regulatory Network (SEARN)8 was established and progress was made  on 
the development of an information sharing platform. The WHO South -East Asia Region Member 
States launched South -East Asia Regulatory Network (SEARN) to enhance information sharing, 
collaboration and convergence of medical product regulatory practices a cross the region for access 
to high -quality medical products, including through trade among the countries. The guiding 
principle for SEARN is to elect state -of-the-art models of regulation to address current challenges 
of medical products regulation.  
17.  SEARO  provided technical comments through peer review for "Population Mobility and Malaria: 
Review of International, Regional and National Policies and Legal Frameworks that Promote 
Migrants and Mobile Populations Access to Health and Malaria Services in the Gr eater Mekong Sub -
Region (Cambodia, Lao People 's Democratic Republic, Myanmar, Thailand and Viet Nam) " for 
Malaria and Border Health, Emergency Response to Artemisinin Resistance (ERAR -GMS). SEARO 
provided training for Ministry of Commerce and Industry offi cials on "Basics of WTO and 
International Trade " and "Challenges of TRIPS regime for India."  
8  DIRECT COUNTRY SUPPO RT  
18.  In collaboration with relevant international organizations, through its headquarters, regional 
and country Offices, WHO provides technical and policy 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 and services. Such 
support is pr ovided upon request to assist Member States in devising ways to safeguard public 
health interests, while adhering to their obligations under international trade agreements.  
19.  The WHO Pan American Health Organization (PAHO) provided technical assistance to 
the Government of Chile on the use of flexibilities of the TRIPS Agreement  (May 2017) . PAHO 
attended a two -day seminar organized b y the WTO, followed by meetings with local authorities 
and provided information and inputs on many related subjects as well as other countries ' 
experience on the use of flexibilities. A similar event was held on request by the Government of El 
Salvador (August 2017). PAHO participated with an expert in the seminars and follow -up meetings 
in order to provide technical assistance an d to foster co -operation within the Americas Region in 
support of WHO work.  
20.  PAHO finalized the conceptual framework of the situation of Central America and Dominican 
Republic on intellectual property and public health. The main objective was to have a clea r vision 
of the existing legal framework of intellectual property in this subregion, including trade 
agreements and other binding instruments that may have consequences on access to medical 
products. This will help PAHO guide its technical cooperation on t his subject to the subregion.  
 
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7 http://apps.who.int/medicinedocs/documents/s21429en/s21429en.pdf  
8 http://www.searo.who.int/entity/medicines/regulation/en/   
  IP/C/W/633/Add.2  
 
- 5 - ANNEX1 
 
Activity  Date  Location  Brief Description  Link to further details 
(if available)  
Technical brief on TRIPS, 
intellectual property rights  
and access to medicines  July 2017  New Delhi, India  SEARO issued revised  technical briefs on 
TRIPS and related issues in order to inform 
Member States of the latest legal and policy 
developments.  http://apps.who.int/iris/bitstream/106
65/258915/1/TRIPS.pdf  
Fair Pricing Forum  10-11 
May 2017  Amsterdam,  
Netherlands  The main objective of this Forum was to 
discuss options for a fairer pricing system, 
that is sustainable for both health systems 
and innovation. The Forum was an initiative 
of the World Health Organization and is 
organized in collaboration with the Dutch 
Ministry of Health.  http://www.fairpricingforum2017.nl/h
ome 
http://who.int/medicines/access/fair_
pricing/FairPricingFo rum2017MeetingR
eport.pdf?ua=1  
Global Framework for 
Development & 
Stewardship to Combat 
Antimicrobial Resistance: 
Draft Roadmap  May 2017  Geneva, 
Switzerland  The draft roadmap describes the current 
state of play and the way forward with 
respect to the estab lishment of a global 
framework. It was developed in close 
collaboration with OIE and FAO.  http://www.who.int/phi/implementati
on/research/WHA_BackgroundPaper -
AGlobalFrameworkDevelopmentStewa
rdship.pdf?ua=1  
Greater Mekong Sub -
Regional Workshop on 
Regulatory Actions to 
Counter Substandard and 
Falsified Medicines  25-27 
April 2017  Bangkok, Thailand  SEARO supported the 3 -day workshop  that 
took up the issue of substandard and 
falsified antimalarial medicines that are a 
particular concern in the region due to the 
spread of drug -resistant malaria. The 
workshop was  jointly organized with SEARO 
and WPRO and supported by Asian 
Development B ank (ADB). Participants 
included regulatory agencies from Cambodia, 
Lao People's Democratic Republic, Myanmar, 
Thailand, and Viet Nam.  https://www.duke -
nus.edu.sg/cor e/page/greater -
mekong -subregional -workshop  
                                                
1 In English only.   
  IP/C/W/633/Add.2  
 
- 6 - Activity  Date  Location  Brief Description  Link to further details 
(if available)  
First Annual Meeting of  
South -East Asia 
Regulatory Network  
(SEARN)  11-12 
April 2017  New Delhi, India  During the First Annual Meeting of SEARN,  
discussions for developing an information 
sharing platform among regu lators took 
place which will be given final shape by the 
steering group (of Member country 
regulators) established for SEARN.  http://www.searo.who.int/regional_dir
ector/speeches/2017/first -annual -
meeting -of-south -east-asia-
regulatory -network/en/  
Regional workshop on 
scaling up health sector 
response to viral Hepatitis 
in SEAR  10–12 
April 2017  New Delhi, India  SEARO provided technical support and made 
a presentation at the "Regional workshop on 
scaling up health sector response to viral 
Hepatitis in  SEAR. " http://www.searo.who.int/regional_dir
ector/speeches/2017/regional -
workshop -scaling -up-health -sector -
response -viral-hep/en/  
International Forum on: 
Patient Safety and Access 
to Safe Online Pharmacies  1-2 March 
2017 New Delhi, India  SEARO provided technical support for 
"Patient Safety and access to Safe Online 
Pharmacies, " in particular, on "Global Best 
Practices on Safe Online Pharmacies. " http://safemedicinesindia.in/PSMNewz
/17Feb17/images/India%20Forum%2
0Agenda%202 -16-17.pdf  
National Symposium on 
Global Health, Innovation 
and Trade Issues  14-15 
December 
2016 Riyadh, Saudi 
Arabia  The Symposium provided an opportunity to 
consolidate cooperation between the King 
Abdul Aziz City for Science and Technology 
and the World Intellectual Property 
Organization, whic h could provide 
opportunities within the Kingdom and the 
countries in the region to benefit from the 
bilateral cooperation.  http://www.wipo.int/tad/en/activityde
tails.jsp?id=11655  
Training at the National 
Institute of Biologicals  12-24 
December 
2016 Noida, India  SEARO provided training for 35 Drug 
Inspectors of States/UTs and 25 Drugs 
Inspectors of Central Drugs Standard Control 
Organization on WHO Role in Combat of 
Spurious, Counte rfeit and Fake Drugs -
"Investigation Technique and Launching of 
Prosecutions. "  
Medicines Regulatory 
Agencies of BRICS  17-18 
November 
2016  SEARO provided legal and technical support 
for the "Workshop of Medicines Regulatory 
Agencies of BRICS on Regulatory  
Collaboration, Goa, '' including legal drafting 
for text for health ministers meeting. The 
parties decided to promote and develop 
cooperation in the field of medical products 
regulation within the respective jurisdictions 
on the basis of equality and mutua l benefit.    
  IP/C/W/633/Add.2  
 
- 7 - Activity  Date  Location  Brief Description  Link to further details 
(if available)  
WHO-WIPO -WTO Joint 
Technical Symposium on 
Antimicrobial Resistance: 
How to Foster Innovation, 
Access and Appropriate 
Use of Antibiotics  25 
October 
2016 Geneva, 
Switzerland  The Symposium reviewed issues related to 
antimicrobial resistance (AMR) . AMR occurs 
when bacteria, parasites, viruses and fungi 
become resistant to the drugs which are 
used to treat infections caused by these 
organisms. AMR affects all areas of health, 
involves many sectors and has an impact on 
the whole of society.  https://www.wto.org/english/news_e/
news16_e/trip_02nov16_e.htm  
http://www.wipo.int/edocs/pubdocs/e
n/wipo_pub_gc_13.pdf  
WTO Workshop on Trade 
and Health for Capital -
based officials from 
Developing Countries, in 
collaboration with WHO 
and WIPO.  17-21 
October 
2016 Geneva, 
Switzerland  The workshop built on similar traini ng 
activities held at WTO as well as on earlier 
workshops on intellectual property and public 
health that had been organized by the WTO 
Secretariat since 2005. It broadly follows the 
approach developed in the WHO -WIPO -WTO 
trilateral study "Promoting Access  to Medical 
Technologies and Innovation: Intersections 
Between  Public Health, Intellectual Property 
and Trade. " https://www.wto.org/english/news_e/
news16_e/trip_17jun16_e.htm  
Workshop on "Access to 
medicines and intellectual 
property: a discussion on 
new approaches and 
remaining challenges " 
World Health Summit  9 October 
2016 Berlin, Germany  The workshop session covered the following 
topics: encouraging access -oriented 
intellectual property (IP) management in the 
industry;  
access to and prices of hepatitis C treatment 
in Asia; and the economics of innovation: 
trends in management of IP in 
pharmaceutical innovation.  https://d1wjxwc5zmlmv4.cloudfront.n
et/fileadmin/downloads/2016/WHS/Do
cs/WHS_Program_2016.PDF  
https://www.worldhealthsummit.org/a
bout-whs/history/2016.html  
WHO, WIPO, WTO joint 
online course on 
Promoting Access to 
medical Technologies and 
Innovation  October 
2016 Geneva, 
Switzerland  Technical courses targeted to professionals 
such as patent examiners, health 
policymakers and their assistants, drug 
procurement specialists, intellectual property 
specialists and senior students.  The course 
provides an overview of the factors that 
shape access to, and influence innovation of, 
medical technologies . http://www.wipo.int/export/sites/www
/academy/en/pdf/dl701_executive_co
urse_flyer.pdf   
  IP/C/W/633/Add.2  
 
- 8 - Activity  Date  Location  Brief Description  Link to further details 
(if available)  
Global Report on Access to 
Hepatitis C Treatment: 
Focus on Overcomi ng 
Barriers  October 
2016 Geneva, 
Switzerland  First-ever global report on treatment access 
to hepatitis C medicines. The report provides 
the information that countries and health 
authorities need to identify the appropriate 
HCV treatment, and procure it at affordable 
prices. The report uses the experience of 
several pioneering countries to demonstrate 
how barriers to treatment access can be 
overcome.  http://www.who.int/hepatiti s/publicati
ons/hep -c-access -report/en/  
Projected uptake of new 
antiretroviral (ARV) 
medicines in adults in low - 
and middle -income 
countries: a forecast 
analysis 2015 -2025 October 
2016 Geneva, 
Switzerland  Forecast analysis, using secondary WHO and 
UNAIDS data sources, to estimate the 
number of people living with HIV (PLHIV) 
and the market share and demand for a 
range of new and existing ARV drugs in 
LMICs up to 2025.  http://www.who.int/hiv/pub/journal_a
rticles/projected -uptake -new-arv-
2015-2025/en/  
Challenges and 
opportunities  in improving 
access to medicines  
through efficient public 
procurement in the WHO 
European Region  October 
2016 Copenhagen, 
Denmark  This report maps different methods used by 
countries to conduct more efficient 
procurement and to improve access to  
treatment with a focus on procurement of 
medicines.  http://www.euro.who.int/__data/asse
ts/pdf_file/0003/323598/Challenges -
opportunities -improving -access -
medicines -efficient -public -
procurement.pdf?ua=1  
 
 
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