IP/C/W/654/Add.1  
 
23 September  2019 
(19-6106) 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 6 June 2019, 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  2019. 
 
_______________  
 
 
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 201 8 (IP/C/W/ 644/Rev.1/Add.2 ). 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 (GSPoA) as well as other relevant resolutions of the 
World Health Assembly , including WHA72.8 on "Improving the transparency of markets for 
medicines, vaccines, and other health products. "1. Following discussions at its 142nd session (2018), 
the WHO Executive Board recommended to the Seventy -first Wor ld Health Assembly implementation 
of the recommendations from an overall programme review of the GSPoA. The Seventy -first World 
Health Assembly decided to urge Member States to implement GSPoA -consistent recommendations 
of the review panel addressed to Mem ber States while urging further discussion on recommendations 
not emanating from the GSPoA.2 An implementation plan is currently under development. As 
requested by  the Seventy -first World Health Assembly3, the Director -General presented a  road map 
report t o the Seventy -second World Health Assembly, outlining the programming of WHO 's work on 
access to medicines and vaccines, including activities, actions and deliverables for the period 
2019−2023 .4 
2  UPDATE OF THE WHO ES SENTIAL MEDICINES LI ST 
2.  WHO's Essential Medicines List (WHO EML) and List of Essential Diagnostics (WHO EDL) are core 
guidance documents that help countries prioritize critical health products that should be widely 
available and affordable throughout health systems.  
                                                
1 WHA72.8 https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8 -en.pdf   
2 WHA71(9) http://apps.who.int/gb/ebwha/pdf_files/WHA71/A71(9) -en.pdf  
3 WHA71(8) http://apps.who.int/gb/ebwha/pdf_files/WHA71/A71(8) -en.pdf  
4 A72/17. https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_17 -en.pdf  IP/C/W/654/Add.1  
 
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  3.  In April 2019, t he meeting of the 22nd WHO Expert Committee on the Selection and Use of 
Essential Medicines met to revise and update the WHO Model List of Essential Medicines (EML) and 
Model List of Essential Medicines for Children (EMLc). The Committee considered 65 appl ications, 
including proposals to add 53 new medicines and new formulations of 19 existing medicines, extend 
the indications for 34 listed medicines, and to remove ten medicines or formulations from the lists. 
The Expert Committee also considered reports an d recommendations from the EML Antibiotics and 
Cancer Medicines Working Groups. In accordance with applicable procedures, the Expert Committee 
evaluated the scientific evidence for the comparative effectiveness, safety and cost -effectiveness of 
the medicin es in question. In summary, the Expert Committee: r ecommended the addition of 28 
new medicines to the EML (12 to the core list and 16 to the complementary list); recommended the 
addition of 23 new medicines to the EMLc ( six to the core list and 17 to the c omplementary list); 
recommended the addition of new formulations of 16 currently listed medicines; recommended 
adding additional indications for 26 currently listed medicines; recommended the deletion of nine 
medicines and of specific formulations of a fur ther four medicines; and; rejected 21 applications for 
inclusion, change or deletion of 31 medicines.5 Based on current data from MedsPal 11% of 
medicines in the new EML are under patent protection, either primary and/or secondary patents.6  
3  FAIR PRICING F ORUM  
4.  In August 2019, the second Fair Pricing Forum was convened in Johannesburg, South Africa. The 
Forum was hosted by the South African National Department of Health together with WHO, and 
attended by representatives from Member States, non -governmental and patient organizations, and 
the innovator and generic pharmaceutical industry. The event addressed the following objectives: 
1) to share experiences in employing regulatory and non -regulatory measures for achieving 'fair' 
prices for pharmaceutical produ cts that are affordable to patients and healthcare systems while 
incentivizing enterprise, efficiency and innovation; 2) to explore tools, approaches and system 
factors that could facilitate affordable and sustainable pricing of pharmaceutical products; 3)  to 
identify areas of actions that would support countries in achieving fairer pricing of pharmaceutical. 
The Forum consisted of a series of participatory workshops, followed by plenary and parallel panel 
discussions on key issues of current interest, and concluded by a plenary discussion on key learnings 
and commitments for further action.  Participants acknowledged difficulties in defining a price that is 
truly fair, but also that it is most important to think practically about what fairness means in pract ice 
and how all stakeholders can work together to achieve it. To that end, a set of technical working 
groups will focus on specific areas of pricing to determine what is achievable in the short - and 
medium -term, reporting to the next Fair Pricing Forum in 2021, in line with WHA72.8, which requests 
the Director -General "to continue WHO 's efforts to biennially convene the Fair Pricing Forum with 
Member  States and all relevant stakeholders to discuss the affordability and transparency of prices 
and costs relating to health products ." 7  
4  TECHNICAL REPORT: PR ICING OF CANCER MEDI CINES AND ITS IMPACT S 
5.  In December 2018, WHO published a "Technical Report on Pricing of Cancer Medicines and its 
Impacts. "8 The comprehensive report examines pricing approaches adopte d by the pharmaceutical 
industry and authorities responsible for the pricing of medicines, with a specific focus on medicines 
for the prevention and treatment of cancer. It reviews pricing approaches applied throughout the 
"value chain " (i.e., activities r equired to bring medicines to patients, from R&D to service delivery), 
and at different time points of product life cycle from market launch to the entry of clin ically 
substitutable medicines . The report presents evidence relating to the impacts of pricing  approaches 
(or lack thereof) on the price, availability and affordability of cancer medicines. It examines the 
possible relationship between pricing approaches and (a) R&D of cancer medicines, including 
incentives for investment in R&D on cancer and in in novation of these measures, as well as possible 
gaps in undertaking research and development (that is, a possible shortfall in funding or activities 
                                                
5 Executive Summary: The Selection and Use of Essential M edicines 2019:   
https://apps.who.int/iris/bitstream/handle/10665/325773/WHO -MVP-EMP-IAU-2019.05 -
eng.pdf?sequence=1&isAllowed=y  
6 MedsPal: The Medicines Patents and Licences Data base, www.medspal.org  
7 Fair Pricing Forum Johannesburg: https://apps.who.int/iris/bitstream/handle/10665/326407/WHO -
MVP-EMP-IAU-2019.09 -eng.pdf?ua=1  
8 Technical Report: Pricing of cancer medicines and its impacts 
https://apps.who.int/iris/bitstream/handle/10665/277190/978924151 5115-eng.pdf?ua=1  IP/C/W/654/Add.1  
 
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  in certain areas of cancer research); (b) transparency in price and governance; and (c) benefits and 
uninte nded negative consequences that would deviate from the original policy intent.  
5  TRAINING AND ENHANCI NG CAPACITY  
6.  The WHO, WIPO and WTO are currently collaborating on an update to the joint study on 
"Promoting access to medical technologies and innovation: In tersections between public health, 
intellectual property and trade. " The publication updates the first edition, published in 2013. Several 
trilateral workshops were conducted with the aim of discussing the latest information and evidence 
on the relationshi ps between intellectual property, trade and the dynamics of access to and 
innovation in medical technologies. The study update will inform ongoing technical cooperation 
activities undertaken by the three organizations and support policy discussions.  
7.  In Jul y 2019, the WTO Secretariat, in close collaboration with the Secretariats of WIPO and WHO 
and the UEMOA Commission, organized a regional workshop in Dakar, Senegal. The workshop 
discussed the WTO TRIPS Agreement, including the use of public health flexibilities and how 
countries in the UEMOA region can implement certain provisions. Another main topic was pricing 
issues and best practices for government procurement of pharmaceutical products. In addition to 
two case studies and a roundtable discussion, WHO presentations addressed the following  topics : 
"Introductory session on public health, the trade, intellectual property and markets public, " "Public 
health in UEMOA: state of the art situation and challen ges," and "The regulatory dimension: Quality, 
safety and effectiveness of drugs, including substandard, falsified and counterfeit. " 
8.  In June 2019, the 16th WIPO -WTO Colloquium for Teachers of Intellectual Property was held in 
Geneva, Switzerland. During The me 5 on "Intellectual Property and Public Health " WHO participated 
in a "Panel Discussion on the Intersections of Public Health, Intellectual Property and Trade, " and 
presented "WHO Perspective: Public Health and the Intellectual Property System. " 
9.  In June 2019, d uring the Thirtieth Session of WIPO 's Standing Committee on the Law of Patents  
in Geneva,  WHO was invited to present its "Current Work on IP and Access to Achieve UHC Licensing 
and Access Provisions for Medicines and Health Technologies " during  the "Sharing Session on Patents 
and Health. "  
10.  In April 2019, during the WIPO Global Challenges Seminar on Urgent Innovation: Policies and 
Practices for Effective Response to Global Health Crises  WHO Chief Scientist, Soumya Swaminathan, 
provided the keynote address and the WHO Health Emergencies Programme participated in the 
event, including moderating Panel 1 on "Science & Innovation – IP and R&D models to accelerate 
innovation in response to publ ic health crises. " The seminar brought together experts in R&D, policy 
and delivery from a range of public and private sector organizations involved in facilitating innovation 
in response to health crises. It provided the opportunity to explore critical qu estions such as: How 
are urgency and innovation defined in these contexts? What are the priorities and targets, and how 
can they be achieved? What lessons can be drawn from past experiences?  
11.  In November 2018, WHO-WIPO -WTO in collaboration with the IMF -Middle East Center for 
Economics and Finance, hosted the  "Regional Workshop on Public Health, Intellectual Property, and 
Trade " to provide technical support and guidance to Arab and Middle Eastern countries on issues at 
the intersection of public health, intel lectual property and trade. WHO participated in several 
sessions, including: "Roundtable Discussion: Mapping the Interface between Health, Trade and 
Intellectual Property, " "The Intellectual Property System as Determinant for Innovation in the 
Medical Tech nologies Sector, " "The Public Health Context: Overview and Determinants for Access, " 
"Using the IP System and its Policy Options to Support Access to Medical Technologies, " 
"Health -Related Provisions in Bilateral and Regional Trade Agreements, " "Competitio n Policy and 
Rules, " "Pooled Procurement, " "Approval, Quality Control and Effectiveness of Medicines, including 
Falsified and Substandard, as well as Counterfeit Medicines, " and "Protection of Clinical Trial Data – 
Policy, Legal and Economic Aspects. " 
12.  In October 2018, WTO, in close collaboration with WHO and WIPO, hosted the 14th Annual WTO 
Workshop on Trade and Public Health. Key features of the programme included: public health 
determinants; the intellectual property system; pricing and procurement policies; competition policy 
and rules; tariffs, quotas and licensing; health ser vices; and regulatory issues. Under regulatory 
issues, participants looked at approval, quality control and effectiveness of medicines, the protection IP/C/W/654/Add.1  
 
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  of clinical trial data under the Agreement on Trade -Related Aspects of Intellectual Property Rights 
(TRIP S), and health -related measures in the Committee on Technical Barriers to Trade (TBT) and 
the Committee on Sanitary and Phytosanitary Measures (SPS). WHO led or participated in the 
following sessions: Roundtable Discussion: Mapping the Interface between He alth, Trade and 
Intellectual Property; The Intellectual Property System as Determinant for Innovation in the 
Pharmaceutical Sector: Implementing and Managing IPRs; Breakout Session on Anti -Microbial 
Resistance: How to Foster Innovation, Access and Appropri ate Use of Antibiotics;  The Public Health 
Context: Overview of Determinants Related to Access; Using the IP System and its Policy Options 
to Further Global Access to Health Technologies; Procurement Rules and Practices; Breakout Session 
on Non -Communicable  Diseases: Tobacco Plain Packaging; Approval, Quality Control and 
Effectiveness of Medicines, including Falsified and Substandard, as well as Counterfeit Medicines.   
6  COUNTRY SUPPORT  
13.  In collaboration with relevant international organizations, through its He adquarters, 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 pr omotes 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 obligations under international trade agreements.  
14.  In July 2019, WHO,  jointly with the World Intellectual Property Organization and the World 
Trade Organization, participated in a panel discussion on "Public health, trade, intellectual property 
and public procurement in Senegal. " The national workshop respond ed to a demand of Ministry of 
Trade of Senegal and the intellectual property office, focusing on access to medicines and other 
medical technologies.  WHO, jointly with the World Intellectual Property Organization and the World 
Trade Organization, participated in a panel d iscussion on "Public health, trade, intellectual property 
and public procurement in Senegal. " The national workshop responded to a  demand of Ministry of 
Trade of Senegal and the intellectual property office, focusing on access to medicines and other 
medica l technologies.  
15.  In November 2018, the National Intellectual Property Office of Kyrgyz Republic (KyrgyzPatent) 
and WIPO  organized a national seminar, in close collaboration with WHO and WIPO. The seminar 
provided trilateral technical support on issues at th e intersections of public health, intellectual 
property and trade with a focus on access to and innovation of medicines and other medical 
technologies and especially to the Kyrgyz Republic on the implementation of their amended patent 
law. Participants cam e from various government agencies, including the Ministry of Economy, the 
Ministry of Health, and KyrgyzPatent, as well as from agencies such as UNDP, local representatives 
supporting the country on public procurement of medicines and civil society repres entatives. WHO 
presented on "Promoting Access to Medical Technologies: Public Health Perspective. "  
 
_______________  
 
  
  IP/C/W/654/Add.1  
 
- 5 - ANNEX1 
 
Activity  Date  Location  Brief Description  Link to further details (if  available)  
Fair Pricing Forum  11-13 
August 
2019 Johannesburg, South 
Africa  The Forum was hosted by the South African 
National Department of Health together with WHO, 
and attended by representatives from Member 
States, non -governmental and patient 
organizations, and the innovator and generic 
pharmaceutical industry. The event addr essed the 
following objectives: 1) to share experiences in 
employing regulatory and non -regulatory measures 
for achieving 'fair' prices for pharmaceutical 
products that are affordable to patients and 
healthcare systems while incentivizing enterprise, 
efficiency and innovation; 2) to explore tools, 
approaches and system factors that could facilitate 
affordable and sustainable pricing of 
pharmaceutical products; 3) to identify areas of 
actions that would support countries in achieving 
fairer pricing of pharma ceutical.  https://apps.who.int/iris/bitstream/handle/
10665/326407/WHO -MVP-EMP-IAU-
2019.09 -eng.pdf?ua=1   
National Workshop on Public 
Health and Intellectual 
property  5 July 2019  Dakar, Senegal  WHO, jointly with the World Intellectual Property 
Organization and the World Trade Organization, 
participated in a panel discussion on "Public health, 
trade, intellectual property and public procurement 
in Senegal. " The national  workshop  responded  to a 
demand  of Ministry  of Trade  of Senegal  and the int
ellectual  property  office,  focusing  on access to 
medicines and other medical technologies.  http://tamis.wto.org/sites/default/files/SE
N19-
103.05.2019%20SENEGAL%20atelier%20n
ational%20version%20provisoire.docx   
 
Workshop on Public Health, 
Intellectual Property and 
Public Procurement for 
UEMOA Members  2-4 July 
2019 Dakar, Senegal  Organized by the WTO Secretariat in close 
collaboration with the Secretariats of WIPO and 
WHO and the UEMOA Commission, the regional 
workshop discussed  the WTO TRIPS  
Agreement,  including  the use of public  health  flexi
bilities  and how countri es in the UEMOA  region can 
implement certain provisions. Another main topic 
was pricing issues and best practices for 
government procurement of pharmaceutical 
products.  https://w ww.wto.org/french/news_f/news1
9_f/tra_04jul19_f.pdf  
                                                
1 In English only.   
  IP/C/W/654/Add.1  
 
- 6 - Activity  Date  Location  Brief Description  Link to further details (if  available)  
Delivering on the sustainable 
access of antibiotics: moving 
from principles to practice  1-2 July 
2019 Geneva, Switzerland  Organized by GARDP in partnership with the 
Medicines Patent Pool and WHO, a two -day 
interactive workshop convened a multi -disciplinary 
group of technical experts and stakeholders (public 
health organizations/non -governmental 
organizations/industry/government 
representatives from low - and middle -income 
countries and high -incomes countries) to consider 
and shape future access and stewardship 
interventions and understand how to make them 
successful. The outcome resulted in defining a 
roadmap of activities pre - and post - registration of 
a new antibiotic that promotes both access and 
stewardship and identified practical ways to 
implement the roadmap, including the key steps, 
potential funding mechanisms and critical success 
factors.   
Standing Committee on the 
Law of Patents -Agenda Item 
8: Patents and Health  24-27 June 
2019 Geneva, Switzerland  During the Thirtieth Session of the Standing 
Committee on the Law of Patents, WHO was invited 
to present its "Current Work on IP and Access to 
Achieve UHC Licensing and Access Provisions for 
Medicines and Health Technologies " during the  
"Sharing Session on Patents and Health. "  https://www.wipo.int/meetings/en/doc_det
ails.jsp?doc_id=440257  
16th WIPO -WTO Colloquium 
for Teachers of Intellectual 
Property  19 June 
2019 
 Geneva, Switzerland  Since 2004, the World Intellectual Property 
Organization (WIPO) and the World Trade 
Organization (WTO) have jointly organized annual 
two-week colloquiums for teachers of intellectual 
property from developing countries and cou ntries 
with economies in transition. During Theme 5 on 
"Intellectual Property and Public Health " WHO 
participated in a "Panel Discussion on the 
Intersections of Public Health, Intellectual Property 
and Trade, " and presented "WHO Perspective: 
Public Health and the Intellectual Property System. "  https://www.wto.org/english/tratop_e/trips
_e/collquium_prog19_e.pdf   
Congress  on Intellectual  Prop
erty and Access  to Medicines  3-5 June 
2019  Kyiv, Ukraine  The Ministry of Health of Ukraine requested WHO 's 
participation in a "Congress on Intellectual  
Property and Access to Medicines. " The national -
level technical meeting united government and civil 
society representatives with professionals in public  
health, intellectual property, trade and competition 
and served as a capacity building intervention which 
consisted of two parts: 1) oper ationalization of 
National Medicines Strategy (Day 1); 2) regional 
consultation (Ukraine, Moldova, Georgia) on   
  IP/C/W/654/Add.1  
 
- 7 - Activity  Date  Location  Brief Description  Link to further details (if  available)  
opportunities to increase access to essential 
medicines (Days 2 and Day 3).  
WIPO Global Challenges 
Seminar on Urgent 
Innovation: Policies and 
Practices for Effective 
Response to Global Health 
Crises  16 April 
2019 Geneva, Switzerland  The seminar brought together experts in R&D, 
policy and delivery from a range of public and 
private sector organizations involved in facilitating 
innova tion in response to health crises. WHO Chief 
Scientist, Soumya Swaminathan, provided the 
keynote address and the WHO Health Emergencies 
Programme participated in the event, including 
moderating Panel 1 on "Science & Innovation – IP 
and R&D models to accele rate innovation in 
response to public health crises. " https://www.wipo.int/meetings/en/details.j
sp?meeting_id=51766  
UN Inter -Agency Meeting on 
Intellectual Property & Health  29 
November 
2018 Geneva, Switzerland  Hosted by WHO with participants from OHCHR, 
UNAIDS, UNCTAD, UNDP, Unitaid, WIPO, and WTO, 
the inter -agency meeting facilitated information 
sharing about major ongoing and planned activities 
and publications. The meeting also served as a 
venue to explore future areas of work and 
collaboration towards improved transparency and 
data/evidence gathering.   
WHO-WIPO -WTO Regional 
Workshop on Public Health, 
Intellectual Property, and 
Trade  18-21 
November 
2018 Kuwait City, Kuwait  The trilateral regional workshop, in collaboration 
with the IMF -Middle East Center for Economics and 
Finance, provided technical support and guidance to  
Arab and Middle Eastern countries on issues at the 
intersection of public health, intellec tual property 
and trade.   
National Seminar on 
Exceptions and Limitations to 
Patent Rights Relating to 
Inventions in the 
Pharmaceutical Field  15-16 
November 
2018 Bishkek, Kyrgyzstan  The seminar was organized by the National 
Intellectual Property Office of Kyrgyz Republic 
(KyrgyzPatent) and WIPO, in close collaboration 
with WHO and WIPO. The seminar provided 
trilateral technical support on issues at the 
intersections of public health, intellectual property 
and trade with a focus on access to and in novation 
of medicines and other medical technologies and 
especially to the Kyrgyz Republic on the 
implementation of their amended patent law. 
Participants came from various government 
agencies, including the Ministry of Economy, the 
Ministry of Health, and  KyrgyzPatent, as well as 
from agencies such as UNDP, local representatives 
supporting the country on public procurement of 
medicines and civil society representatives.    
  IP/C/W/654/Add.1  
 
- 8 - Activity  Date  Location  Brief Description  Link to further details (if  available)  
Working Group on Intellectual 
Property at the Expert 
Meeting on Access to 
Hepatitis B&C Treatment  22-24 
October 
2018 
 Casablanca, Morocco  The overall objective of the meeting was to improve 
access to quality and affordable hepatitis B and C 
medicines and diagnostics. The specific objectives 
were to: 1) review the situation in the region w ith 
respect to the availability of hepatitis antiviral 
medicines and their prices; 2) identify bottlenecks 
to price reduction and to share experiences on price 
reduction strategies; and to 3) address intellectual 
property rights issues related to those pro ducts; 
and develop strategies for price reduction for 
countries in different economic and epidemic 
situations. The meeting was attended by 
participants representing hepatitis programme focal 
points and experts in registration, pricing and 
procurement of he patitis B and C from 6 Member 
States of the region, namely Egypt, Iran, Morocco, 
Pakistan, Sudan, and Saudi Arabia. Additional 
participants from civil society organizations 
representing the most affected groups in the region 
and organizations with expertis e in advocacy and 
actions for improving access to treatment.   
14th Annual WTO Workshop 
on Trade and Public Health, 
Geneva, Switzerland  8-12 
October 
2018 
 Geneva, Switzerland  The 2018 workshop built on similar training  
activities held since 2014 as well as on earlier  
workshops on intellectual property and public  
health that had been convened by the WTO  
Secretariat since 2005. The workshop followed the  
approach of the WHO -WIPO -WTO Trilateral Study  
on "Promoting Access to Medical Technologies and  
Innov ation: Intersections Between Public health,  
Intellectual Property and Trade. "2 The programme 
of the workshop has evolved to cover the link 
between trade and public health in a comprehensive 
and multidisciplinary manner in order to build the 
capacity of gov ernments in developing countries 
and LDCs to take effective and coherent policy 
decisions.  https://www.wto.org/english/news_e/news
18_e/tra_15oct18_e.htm   
 
 
__________  
                                                
2 https://www.who.int/phi/promoting_access_medical_innovation/en/