IP/C/W/706  
 
23 October 2023  
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Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
COUNCIL FOR TRIPS  
 
PARAGRAPH 8 OF THE MINISTERIAL DECISION ON THE TRIPS AGREEMENT  
INFORMAL THEMATIC SESSION FOR EXTERNAL STAKEHOLDER INPUT  
Report by the Chair  
_______________  
 
 
1.  Under paragraph 8 of the Ministerial Decision on the TRIPS Agreement (document WT/L/1141 ), 
Members agreed to decide on an extension of the Decision to COVID -19 diagnostics and therapeutics 
within six months of adoption. Following the extension of this deadline by the General Council on 
19 December 20221, Members have continued their discussion on this question in the Council for 
TRIPS in formal and informal settings. In order to support a fact and evidence -based discussion, the 
Council agreed at its meeting in June 2023, to invite international organizations, civil society, 
business representatives and academics to share facts, evidence and experiences relevant to 
Members ' deliberations under paragraph 8 of the TRIPS Decision. This Informal Thematic Session 
for External Stakeholder Input was held on 28 September 2023 at the WTO premises in a hybrid 
format.  
2.  This was the first time that the Council organized a Thematic Session with outside speakers as 
part of its proceedings , and I would like to commend Members for having agreed to use this format 
for collecting views and information from outside the organization. With this approach we are 
following the example of Director -General Dr Ngozi Okonjo -Iwela, who is also championing a more 
direct engagement with stakehold ers from the "real world ", as w as evidenced at this year 's Public 
Forum. The programme for the Thematic Session was developed on the basis of suggestions received 
from Members . It aimed to provide a geographically and organizationally balanced cross -section of 
stakeholders  in the hope that the broad spectrum of expertise and views represented will be helpful 
for Members – and the Council as a whole – to find common ground and develop a c onstructive path 
forward.  
3.  The Council heard interventions f rom 22 speakers from a wide range of perspectives, who kindly 
agreed to share facts, evidence and experiences from their respective areas of expertise . The rich 
and detailed interventions helped il luminate certain points and arguments of this long -standing 
debate in much more detail. The data and analysis illustrated in the first session provided up -to date 
perspectives on the market situation of therapeutics and diagnostics, while recognizing certa in data 
gaps. The perspectives of our colleagues from international organizations in the second session 
highlighted their activities surrounding intellectual property in the context of pandemic response, 
and the Medicines Patent Pool provided first -hand ex perience of its licensing approach regarding 
COVID -19 treatments.  
4.  In the third session, civil society organizations explored the nature of the MC12 Decision in the 
context of TRIPS flexibilities and provided health -related experiences from the grass -roots in 
 
1 On 19 December 2022 the General Council agreed to the TRIPS Council 's 16 December 
recommendation ( document IP/C/95 ) to extend the six month deadline for deciding on an extension of the 
MC12 TRIPS Decision to diagnostics and therapeutics. The duration of such an e xtension remains before the 
General Council while substantive discussions continue in the Council  for TRIPS.  IP/C/W/706  
 
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  developing countries. Business representatives from the pharmac eutical industry – both originator 
and generic companies from a range of countries – shared their experiences and their views on what 
made collaboration and diversified production possible, and what was needed to ensure this in the 
future. Finally, academi cs gave a detailed legal view on the nature and legal operation of the 
MC12  Decision, and some proposed a more proactive and institutionalised licensing approach to 
tackle this and future pandemics.  
5.  Feedback across the membership suggests that the Thematic  Session was well received and 
considered useful, and I hope Member will consider using this or a similar format again in the future.  
6.  This report contains the programme of the event, the biographies of speakers, and summaries 
of the presentations that hav e been provided by the speakers themselves.2  
 
_______________  
 
 
  
 
2 Speakers ' presentations were made available  to Members via an internal WTO webpage . IP/C/W/706  
 
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COUNCIL FOR TRIPS  
 
PARAGRAPH 8 OF THE MINISTERIAL DECISION ON THE TRIPS AGREEMENT  
INFORMAL THEMATIC SESSION FOR EXTERNAL STAKEHOLDER INPUT  
 
Geneva, 28 September 2023 - Centre William Rappard, Room W  
8.45 a.m. – 5.30 p.m.  
 
Revised Programme  
8h45 – 9h00 Opening  
H.E. Ambassador Pimchanok Pitfield  – Chair of the Council for TRIPS  
 
9h00 – 10h00  Data collection and analysis on vaccines, therapeutics and diagnostics  
[Ms Paulina Rivas Calder ón, Market Research Officer, United Nations Children 's 
Fund (UNICEF) , Operator of the COVID -19 Market Dashboard]  
Mr Rasmus Bech Hansen , Co-founder & CEO at Airfinity Ltd.  
Dr Emma Hannay , Chief Access Officer, FIND, Global Alliance for Innovation in 
Diagnostics, co -convener of the ACT Accelerator Diagnostics Pillar  
 
Questions & Answers  (15 minutes)  
10h00 – 11h30  
 
 
 
 Intergovernmental organizations and international initiatives  
Prof. John Reeder , Director, Research for Health Department and Director TDR,  
World Health Organization (WHO)  
Ms Erika Dueñas Loayza , Technical Officer, Department of Essential Medicines and 
Health Products,  World Health Organization (WHO)  
Mr Edward Kwakwa , Assistant Director General, Global Challenges and Partnerships 
Sector, World Intellectual Property Organization (WIPO)  
Ms Amy Dietterich , Director, Global Challenges Division, World Intellectual Property 
Organization (WIPO)  
Mr Nirmalya Syam , Senior Program Officer , Health, Intellectual Prop erty and 
Biodiversity Programme, South Centre  
Mr Charles Gore , Executive Director , Medicines Patent Pool (MPP)  
 
Questions & Answers  (15 minutes)  
 
  
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Revised Programme  
11h30 – 13h00  
 
 Civil Society Organizations  
Mr Tahir Amin , CEO, Initiative for Medicines, Access & Knowledge (I -MAK), United 
States of America  
Dr Ellen 't Hoen , Director, Medicines Law and Policy , The Netherlands  
Ms Sangeeta Shashikant , Third World Network , Malaysia  
Mr James Packard Love , Director , Knowledge Ecology International , United States 
of America  
Ms Fatima Hassan , Director/Founder, Health Justice Initiative, South Africa  
Ms Jennifer Brant , Director, Innovation Council , Switzerland  
 
Questions & Answers  (15 minutes)  
13h00 – 14h30 Lunch  
14h30 – 16h30 
 
 
 
 
 
 
 
 Business   
Dr Julia Spencer , Associate Vice President , Global Multilateral Engagement  & 
Strategic Alliances, MSD 
Ms Els ie Soto , VP Supply Chain, Emerging Markets, Pfizer Global Supply  
Mr Cheik Tidiane Diagne , Head of Operations, DIA TROPIX , Institut  Pasteur de 
Dakar, Senegal  
Mr Osman Khalid Waheed , CEO, Ferozsons Laboratories Ltd., Pakistan  
Dr Morena Makhoana , CEO, Biovac, South Africa  
Mr Alejandro G ómez L ópez, Health Secretary of the District of Bogota, Speaker of 
BogotáBio, Colombian Public Enterp rise for the local production of vaccines  
 
Questions & Answers  (30 minutes)  
16h30 – 17h15 Academics   
Dr Daria Kim , Max Planck Institute for Innovation and Competition , Munich, 
Germany  
Prof. Dr Yangmu Huang , Deputy Director, Department of Global Health, Research 
Professor, Beijing  University, China  
Prof. William Fisher , Wilmer Hale Professor of Intellectual Property Law, Harvard 
University  
 
Questions & Answers  (15 minutes)  
17h15 – 17h30    Closing  
H.E. Ambassador Pimchanok Pitfield  – Chair of the Council for TRIPS  
 IP/C/W/706  
 
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  BIOGRAPHIES OF SPEAKERS  AND SUMMARIES OF THEIR INTERVENTIONS  
1  DATA COLLECTION AND ANALYSIS ON VACCINES, THERAPEUTICS AND DIAGNOSTICS  
1.1  Mr Rasmus Bech Hansen, CEO, Airfinity, Predictive Health Intelligence and Data 
Analytics  
1.  Rasmus is a globally recognised global health security 
expert and data entrepreneur. The first part of his career he 
worked as strategist and partner in various boutique advisory 
firms working for governments, UN entities, and corporates, in 
particular pharmaceuticals. He also had a regular column in a 
national newspaper and wrote a book on innovation.  
He founded Airfinity as a result of having personally 
experienced how better health data can or could have saved 
lives. For the last 8 years, he has, as CEO, spearheaded the 
company 's development and driven its hig h impact predictive 
analysis.  
2.  He is often quoted in leading media outlets such as Financial Times, Bloomberg and CNN and is 
a regular key -note speaker at events such as the Rhodes Summit and the FT Pharma and Biotech 
Summit. He holds a B.Sc. in Political S cience, a MPA from Harvard University and is a recipient of 
the Crown Prince Frederic award for excellent scholarship. He lives in London with his wife and two 
sons.  
1.1.1   Summary of Intervention  
3.  Airfinity 's proprietary data set on COVID -19 provides a unique ins ight into the landscape for 
treatments and the issues surrounding supply, access and demand. Airfinity 's presentation to the 
TRIPs council aimed to explore whether intellectual property is a barrier to equitable supply and 
access.  
4.  The success rate of COVID -19 treatment development is low with less than 5% of candidates 
entering clinical trials reaching market to date. 900 candidates have begun preclinical development, 
44 of which have been approved with only seven receiving WHO endorsements. WHO recommended  
treatments have widespread regulatory authorisations worldwide but there is low coverage for 
approvals across Africa.  
5.  Publicly available data on global supply agreements suggests nearly 80% of total oral antiviral 
supply has gone to high income countries  (HICs), with 2.8% going up upper middle income countries 
(UMICs), 6% to lower middle income countries (LMICs) and 5% to low income countries (LICs).  
6.  Analysis on when licensing agreements were signed to improve access for poorer nations reveals 
many were signed shortly after regulatory approval and sometimes before so. The first voluntary 
license agreements (VLAs) for Remdesivir were announced 12 days after FDA approval. The first 
VLAs for Merck 's Molnupiravir were signed 217 days before EUA approval. The first MPP agreements 
for Pfizer 's Paxlovid were signed 50 days after FDA approval. There is a total of 107 MPP agreements 
and VLAs publicly announced. Nearly 47% of the global population is covered by all three of the 
Medicines Patent Pool (MPP) licencing agreements, with the majority residing in the global south.  
7.  There have been 185 industry collaborations on the production of COVID -19 treatments, of which 
105 were specifically designed to increase access to LMICs.  
8.  Analysis comparing the industry 's respo nse to COVID -19 with that of HIV shows a roughly equal 
number of MPP licencing agreements. For COVID -19 treatments there has been 80 licencing 
agreements facilitated by the MPP in less than two years, this compares to 76 for HIV across four 
years.  
9.  The production and supply of COVID -19 treatments is of a drastically smaller scale than 
COVID -19 vaccines. To date over 16 billion COVID -19 vaccines have been produced while only 
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  103 million treatments of antivirals and monoclonal antibodies (mAbs) have been p roduced. The 
trend is repeated in supply agreements with over 20 billion vaccine doses ordered in public supply 
agreements with only 75 million courses known to have been under contract for antivirals and mAbs.  
10.  There are still data holes in the global pub lic health infrastructure which would help answer the 
question of equitable access. Improved data availability and sharing on disease prevalence, testing, 
rollout capacity and uptake would provide the industry and policy makers with a more holistic view 
on the dynamics involved.  
1.2  Dr Emma Hannay, Chief Access Officer, FIND, Global Alliance for Innovation in 
Diagnostics  
11.  Emma is FIND 's Chief Access Officer and recently led the ACT -
Accelerator Diagnostics Partnership on behalf of FIND and The Global Fund. 
She is a public health doctor with a focus on global health strategy and 
delivery. Her work has been centred at a global level on organizational 
strategy in global health, and at a country level in implementing health 
systems reforms in complex operating e nvironments.  
12.  In her previous role as Head of Health at Acasus, she was part of the 
team leading the Pakistan Health Reforms Roadmaps, which improved 
primary care for more than 150 million people, and the DRC 's Mashako Plan 
to increase immunization coverage  for children. Prior to joining Acasus she 
was the manager of the Market Dynamics Team at Unitaid in Geneva, and 
an Engagement Manager for McKinsey & Company based out of Dubai and 
Washington, DC. She holds a medical degree from the University of Auckland,  New Zealand and a 
Master of Public Health from Harvard University.  
1.2.1   Summary of Intervention  
13.  Following the waiver  of certa in patent -related Articles of the World Trade Organization (WTO) 
Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) for COVID -19 vaccines, 
there have been ongoing discussions around a potential extension of this waiver to cover the 
production and supply of COVID -19 therapeutics and diagnostics. This statement summarizes FIND 's 
position on these discussions.  
14.  First, most COVID -19 diagnostics are composed of biomarkers (which are not patentable), 
capture agents (which can be proprietary  or non -proprietary), detection reagents (which are mostly 
generic commodities), and sensing technologies (the basis for most diagnostics patents). Many 
COVID -19 diagnostic tests were based on PCR and lateral flow, for which key patents are expired. 
As a r esult, access to COVID -19 diagnostics has not been limited by enforceable patents. Neither 
compulsory nor voluntary licenses on diagnostic technologies would have been likely to stimulate 
innovation or sufficient to enable local manufacturing of COVID -19 tests in middle -income countries. 
Nonetheless, patent -related waivers under the TRIPS Articles may one day be applicable to essential 
diagnostics or diagnostics for future pandemics, such as emerging sensing technologies.  
15.  Second , unlike therapeutics, compet itive advantages in the diagnostics industry are often 
linked to engineering know -how, manufacturing technologies, and production costs. For low - and 
middle -income countries (LMICs), the lack of manufacturing 'know how ' and the dearth of technology 
transfe r programmes to support local manufacturing are one of the largest trade -related barriers to 
global access to diagnostics.  
16.  Consequently, TRIPS Articles concerning trade secrets and technology transfer are more 
relevant to equitable global diagnostics acces s than those relating to patents and waivers. Trade 
secrets are addressed in Article 39, Section 7 of the TRIPS Articles; technology transfer is addressed 
in Article 66, Section 66.2, which states : "Developed country Members shall provide incentives to 
enterprises and institutions in their territories for the purpose of promoting and encouraging 
technology transfer to least developed country Member s in order to enable them to create a sound 
and viable technological base ". This statement has been reaffirmed  in paragraph 7 of the Doha 
Declaration.  
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  17.  Third , given the importance of manufacturing technology and manufacturing know -how to 
equitable global diagnostics access, we believe that full application of the principles in Section 66.2 
could have an important impact. We are there fore calling for Article 66 to be brought to the forefront 
of ongoing WTO discussions around equitable global access to healthcare products, to remind 
Members of their commitments to technology transfer, and to advocate for the establishment and 
use of mea ningful incentive programmes to transfer diagnostic manufacturing know -how and 
technology to LMICs.  
18.  Fourth , we are calling for further WTO engagement beyond the scope of the TRIPS Agreement 
to address other trade -related barriers that adversely affect the availability of diagnostics in LMICs. 
These include barriers relating to import duties, product registration, and regulatory harmonization.  
19.  In summary , leveraging Article 66 of the TRIPS Agreement has the potential to yield a 
significant impact on access t o diagnostics, even more so than an extended waiver of patent -related 
TRIPS Articles. We believe that this, along with initiatives to address other trade -related barriers, 
could represent an effective strategy to improve equitable global access to diagnost ics. 
2  INTERGOVERNMENTAL ORGANIZATIONS AND INTERNATIONAL INITIATIVES  
2.1  Prof. John Reeder, Director Research for Health Department and Director of the 
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in 
Tropical Diseases (TDR), World Health Organization, (WHO)  
20.  Professor John Reeder is Director of TDR, the Special Programme for 
Research and Training in Tropical Diseases (since 2012) and Director of 
the WHO Research for Health Department (since 2019). In these positions 
he has responsibility for co -ordinating an effective, strategic and well -
harmonized research effort across the WHO.   
21.  Before joining WHO, he was most recently Co -Director of the Centre 
for Population He alth at the Burnet Institute, Melbourne, Australia. Before 
this, he was Director of the Papua New Guinea Institute of Medical 
Research, where he worked on translating scientific findings from the field 
into policy for improved health.  
22.  John began his caree r in medical microbiology laboratories in the United Kingdom and then 
moved to health training as a development volunteer in the Highlands of Papua New Guinea, before 
joining the world -renowned malaria research team at the Walter and Eliza Hall Institute.  
23.  A naturalized Australian, born and educated in England, he received his PhD in medical 
microbiology at the University of Manchester. He has published around 200 scientific papers, that 
span basic laboratory research to large community -based field studies . Among a number of honours, 
Professor Reeder received the 2020 Mitchell Humanitarian Award for his contribution to end the 
debilitating disease onchocerciasis.  
2.1.1   Summary of Intervention  
24.  As the COVID -19 pandemic is coming to an end, we are observing that new variants of the virus 
are still causing waves of infection, however, at much lower levels and with smaller health impact. 
This contrasts to the first months of the pandemic when countries struggling to respond to the 
largest public health emergency in rece nt history. The pandemic brought to the fore a substantive 
global inequity in terms of access to health technologies to fight the pandemic. For the case of 
vaccination rates, high -income countries achieved rates that were twice as high as in the rest of th e 
world and, combined with better health systems, led to significantly lower excess mortality.  
25.  The reasons for the global vaccine inequity were multiple. One being that countries with the 
ability to manufacture vaccines, often stockpiled them, while countr ies with no vaccine 
manufacturing capacity were struggling to secure a sufficient supply of vaccines. This experience 
has changed the thinking of many governments about health security. WHO has received strong 
feedback from its Member States that they want  to increase their domestic manufacturing and R&D 
capacity.  
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  26.  Increasing the effectiveness of R&D and innovation systems and developing technologies 
adapted to local context is an important part of work program of WHO 's Science Division. For R&D 
systems to d eliver new health technologies, several elements need to be in place: (i) an intellectual 
property regime (as discussed in -depth by other presenters during the meeting); (ii) sufficient 
human resource capacity for R&D; (iii) global supply chains that conti nue working during pandemic 
times; (iv) ethics committee and mature regulatory agencies; (v) national, regional and global R&D 
plans and networks; and finally (v) funding and financing opportunities for R&D.  
27.  WHO has been working on those elements for many years, starting even before the pandemic. 
Examples of some of those efforts by WHO include (i) technology transfer and local production 
programs (e.g., mRNA technology transfer program); (ii) regulatory system strengthening; (iii) 
workforce training (e.g.,  biomanufacturing workforce training hub); and (iv) the WHO Framework 
for Strengthening R&D and Innovation Systems.  
28.  The main lessons learned from the pandemic are the following: First, to ensure access to new 
health technologies, an entire eco -system needs to be in place, spanning from basic research, 
applied R&D to manufacturing. Second, there is a need for better coor dination of R&D policies across 
different sectors, across countries and across regions. And finally, one needs to build R&D systems, 
infrastructure, and institutions in peacetime in order to be working and be ready for scale up during 
crises.  
2.2  Ms Erika Dueñ as Loayza, Technical Officer, Department of Essential Medicines and 
Health Products, World Health Organization (WHO)  
29.  Erika Dueñas  leads the Intellectual Property Unit at WHO HQ/Access 
to Medicines and Health Products Division providing technical advice on 
issues related to innovation, access to health technologies, and 
Intellectual Property (IP). She also supports activities to buil d and 
strengthen national and regional capacities in the intersections between 
public health, trade and IP. Erika worked at the Medicines Patent Pool 
and has more than 20 years of experience in the field of access to 
medicines, innovation and IP. As a care er diplomat, she worked many 
years for the Bolivian government. After her diplomatic mission at the 
Embassy in Washington as Chargée d 'Affaires, she was Vice -Minister at 
the Ministry of Foreign Affairs in Bolivia. Erika holds a Master 's degree 
in Internati onal Law and Economics (LLM) from the World Trade 
Institute/Universities of Bern, Fribourg & Neuchâtel – Bern, Switzerland.  
2.2.1   Summary of Intervention  
30.  Erika Duenas reiterated the importance of the implementation of Paragraph "8. No later than 
six months from the date of this Decision, Members will decide on its extension to cover the 
production and supply of COVID -19 diagnostics and therapeutics. " Bringing to the attention that 
WHO supports member States to use all the tools in their hands to promote timely gl obal equitable 
access for all, as indicated by Dr. Tedros Adhanom Ghebreyesus, WHO Director General to The 
Guardian since the beginning of the Pandemic, " boosting manufacturing won 't happen by itself. We 
are living through an exceptional moment in history and must rise to the challenge. Whether it 's 
dose sharing, tech transfer or voluntary licensing, as the WHO 's own C OVID -19 Technology Access 
Pool initiative encourages, or waiving intellectual property rights, as South Africa and India have 
suggested, we n eed to pull out all the stops. " 
31.  The message from WHO is "Pandemic is not over ". On 5 May 2023, more than three years into 
the pandemic, the WHO Emergency Committee on COVID -19 recommended to the Director -General, 
who accepted the recommendation, that given  the disease was by now well -established and ongoing, 
it no longer fit the definition of a PHEIC. This does not mean the pandemic itself is over, but the 
global emergency it has caused is, for now. A Review Committee is developing long -term, standing 
recom mendations for countries on how to manage COVID -19 on an ongoing basis.  
32.  She highlighted that WHO promotes and integrated approach for health: Prevention, detection 
and treatment are essential pillars and she provided examples with reasons why none of these  pillars 
should be left behind to get find real solutions. Access to diagnostics and therapeutics remain a 
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  challenge and she mentioned the WHO Living Guideline from 13 January 2023 that responds to 
emerging evidence on existing and new COVID -19 treatments,  where in many cases the challenges 
related to availability and affordability remain.  
33.  Countries with manufacturing capacities are excluded from the geographical scope of existing 
licenses and affordable prices. She also presented a joint briefing recently  published with UNITAID  
on improving access to novel COVID -19 treatments and how member States can navigate on 
interfaces between public health and intellectual property. 
https://www.who.int/publications/m/item/improving -accessto -novel -covid-19treatments . 
34.  In relation to the implementation of the WHO Global Strategy and Plan of Action on Public 
Health, Innovation and Intellectu al Property (GSPA -PHI), she informed that the World Health 
Assembly decided 75(14) to extend the time frame for the implementation from 2022 to 2030. 
https://apps.who.int/gb/ebwha/pdf_files/WHA75 -REC1/A75_REC1_Interactive_en.pdf#page=1 . 
WHO member States agreed on the continuing relevance of the GSPA -PHI recommendations, 
reenforced by country experiences during the COVID -19 pandemic. The eight elements of the 
GSPA -PHI remain valid and well connected with the current discussions on a pandemic accord in 
WHO.  https://apps.who.int/gb/ebwha/pdf_files /A61/A61_R21 -en.pdf . 
35.  Finally, she indicated that WHO -WIPO -WTO DGs agreed recently that Members should fully 
implement at domestic level the wide range of available options to secure timely and equitable 
access to health technologies. Trilateral cooperation should address these challenges by intensifying 
activities to provide support to Members, including through joint technical seminars for delegates 
handling health, trade and IP issues in Geneva.  
2.3  Mr Edward Kwakwa, Assis tant Director General, Global Challenges and Partnerships 
Sector, World Intellectual Property Organization (W IPO) 
36.  Edward Kwakwa is Assistant Director General, Global Challenges and 
Partnerships Sector, World Intellectual Property Organization (WIPO) in 
Geneva. He served as General Counsel at WIPO from 2004 until September 
2016. Kwakwa holds an LL.B. degree from the University of Ghana, an LL.M. 
from Queen 's University in Canada, and an LL.M. and a J.S.D. from Yale Law 
School in the U.S.A.  
37.  Before joining WI PO, Kwakwa practiced with the law firm of O 'Melveny 
and Myers in Washington, D.C., worked as International Legal Adviser at 
the Commission on Global Governance in Geneva, as Senior Legal Adviser 
at the Office of the United Nations High Commissioner for Refugees 
(UNHCR), and as Legal Affairs Officer at the World Trade Organization 
(WTO).  
2.4  Ms Amy Dietterich, Director, Global Challenges Division, World Intellectual Property 
Organization (WIPO)  
38.  Marion "Amy" Dietterich is the Director of the Global Challenges 
Division at the World Intellectual Property Organization (WIPO). In this 
role, she covers Intellectual Property (IP) -related global policy issues in 
the areas of Global Health, Climate Change, and Food Security.  
39.  Amy has twenty years of ex perience in the fields of public health, 
water & sanitation, and governance, spanning community -based 
organizations, international NGOs, global health partnerships, and United 
Nations institutions. Prior to joining WIPO in 2018, she worked with the 
Interna tional Federation of Red Cross and Red Crescent Societies (IFRC) 
to ensure stronger community engagement in health systems governance 
and service delivery, and with the Parliamentary Network on the World 
Bank and IMF to support parliamentary oversight of d evelopment 
cooperation and financing.   
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  40.  Ms. Dietterich earned her academic qualifications in Public Health, Biology, and French from the 
London School of Hygiene and Tropical Medicine (LSHTM) and Bucknell University in 2005 and 2000 
respectively.  
2.4.1   Summary of  WIPO Intervention  
41.  WIPO continues to operationalize its commitment to universal, equitable access to COVID -19 
vaccines, therapeutics, and diagnostics. WIPO sees intellectual property (IP) broadly as a powerful 
tool to achieve this objective. WIPO acknowled ges the challenges in ensuring timely and equitable 
access to COVID -19 vaccines, therapeutics and diagnostics, however access and innovation 
determinants are multi -faceted reflecting the complex health, IP and trade ecosystem.1 Factors 
impacting on innova tion and access include regulatory hurdles, market demand, trade restrictions, 
supply chain disruptions, manufacturing capacity, health system resilience, and vaccine 
misinformation. It is crucial to use empirical evidence to understand the role of IP, and  its 
relationship with other factors, in achieving public health objectives. Through the WIPO COVID -19 
package and the WHO -WIPO -WTO Trilateral Cooperation, WIPO gathered evidence relevant to 
consideration of access and innovation determinants in relation t o COVID -19 vaccines, therapeutics 
and diagnostics.  
42.  Drawing on this evidence and its experiences with member States and stakeholders such as the 
Medicines Patent Pool, WIPO presented three general findings to the Thematic Session on Paragraph 
8 of the Mini sterial Decision on the TRIPS Agreement: (1) IP tools may have different applications 
depending on the medical technology2, (2) IP supported innovation and production of C OVID -19 
vaccines3 and therapeutics by enabling funding, R&D collaboration agreement s, purchasing and 
licensing4, and, (3) IP is an enabler for access by supporting tailored licensing practices including 
public -health focused voluntary licensing, which may include clauses for alternate dispute 
resolution.5 WIPO outlined its experience of the important role of technical assistance in developing 
domestic IP frameworks that are equipped to deliver public health -related policy objectives.6 In this 
regard, WIPO has provided support to its member States for the development of innovation 
ecosystems and skills and capacity related to IP management and technology transfer for life 
sciences, for example. WIPO has also provided legislative assista nce and advice including on the use 
of TRIPS flexibilities for public health. Future work by WIPO may support ongoing discussions on the 
role of the IP framework in supporting equitable access, including studies on voluntary licensing, the 
management of IP  in publicly -funded R&D and the interplay between patents and trade secrets 
throughout the innovation process and product value chain in the field of medical technologies .7 
43.  WIPO stands ready to provide further facts, evidence and experience as requested b y TRIPS 
Council Members in their deliberation on relevant matters.  
 
1 WHO, WIPO, WTO, Promoting Access to Medical Technologies and Innovation, Intersections between 
public health, intellectual property and trade , 2nd Edition (2020)  
2 WHO, WIPO, WTO, An Integrated Health, Trade and IP  Approach to Respond to the COVID -19 
Pandemic , 2nd Edition (2023)  
3 R.M. Conti, The Determinants of COVID -19 Vaccine Development Success  (2021) and CEPR,  EPO, 
KULeuven USPTO and WIPO, Global Innovation Responses to COVID -19 (2022)  
4 WIPO, COVID -19-related vaccines and therapeutics: Preliminary insights on related patenting activity 
during the pandemic  (2022) and WIPO, COVID -19 vaccines and therapeutics: Insights into related patenting 
activity throughout the pandemic  (2023)  
5 WIPO, WIPO Alternative Dispute Options for Life Science Disputes and Resolution , (2022)  
6 IP/C/R/TC/WIPO/4  Technical Cooperation Activities: Information from other Intergovernmental 
Organizations World Intellectual Property Organization (WIPO) (2023)  
7 WIPO discussion paper on the interplay between patents and trade secrets and how they interact with 
each othe r throughout the innovation process and product value chain in the field of medical technologies a t 
the policy, law and practical levels  to be launched on October 18, 2023.  IP/C/W/706  
 
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  2.5  Mr Nirmalya Syam, Senior Program Officer, The South Centre  
44.  Mr Syam has more than 10 years ' experience on issues related to 
IPRs and access to medicines. He holds a bachelor 's degree in law  
(LL.B) from the University of Calcutta and a master 's degree (M.Phil.) 
in international law from Jawaharlal Nehru University, New Delhi.  
2.5.1   Summary of Intervention  
45.  The discussion on extension of the MC12 decision should be seen 
in the context of the scope of  the decision as applicable currently to 
vaccines, in terms of objective and duration. Paragraph 1 of the 
Decision makes it clear that the objective of the decision is to allow 
eligible Members to limit the rights provided for under article 28.1 of the TRI PS Agreement to the 
extent necessary to address the pandemic. In terms of duration, the Decision clearly states that it 
is for a duration of 5 years.  
46.  This implies that at the time of adopting this Decision, the negotiators had clearly envisaged 
that it may  be necessary to allow eligible Members to limit the patent rights provided under article 
28.1 for a duration of 5 years. Moreover, the Decision would also be applicable as long as it is force, 
to not only an existing COVID -19 pandemic but also to the pote ntial re -emergence of the pandemic 
because of new variants. This approach is logical given the ebb and flow of the COVID -19 pandemic 
with emergence of new variants that spread rapidly from time to time.  
47.  The WHO also clearly recognizes that the virus which causes COVID -19, SaRS CoV 2, is a 
pathogen of pandemic potential, and new variants continue to emerge. In a span of 1 month from 
July-August 2023 over 1.4 million new COVID -19 cases and over 1800 deaths were reported to the 
WHO. According to the WHO, due t o reduction in testing and reporting globally, the reported cases 
do not accurately reflect currently prevalent infection rates.  
48.  In August 2023 the WHO classified a new variant of COVID -19 - EG.5 - as a variant of interest, 
implying that countries should monitor this strain more closely because of mutations that could make 
it more contagious or severe. Recently the US CDC has authorized broad use of updated vaccines to 
target new variants.  
49.  What are the facts relating to patenting of COVID -19 therapeutics?  According to the WIPO 
patent landscape report on COVID -19 related vaccines and therapeutics, patent applications on 
COVID -19 therapeutics are 4 times higher than vaccine patent applications. While voluntary licenses 
may enable access where the patentee co nsents to grant such license, often voluntary licenses have 
restrictive conditions and are limited in geographical scope, making them a sub -optimal solution for 
rapid access in fast spreading global pandemic.  
50.  This is exemplified by the limitation on acces s to nirmatrelvir -ritonavir (Paxlovid) - a drug that 
is recommended by WHO for patients with non -severe illness with highest risk of hospitalization. 
WHO has admitted that obstacles to access to this drug due to cost and availability could be 
formidable in  low and middle income countries. Nevertheless, patent applications on the drug have 
been filed in more than 160 countries, with a broad range of claims on compounds, specific 
compositions (including with ritonavir) and use of the drug for treatment of COV ID-19. At the same 
time, many developing countries (e.g., most Latin American countries) have been excluded from the 
voluntary license on the drug.  
51.  In view of the above circumstantial evidence, it is imperative that the TRIPS Decision is 
extended to thera peutics and diagnostics.  
2.6  Mr Charles Gore, Executive Director, Medicines Patent Pool (MPP)  
52.  Charles Gore is the Executive Director of the Medicines Patent Pool (MPP). Following a career in 
patient representation and public health advocacy, he took up the pos t in July 2018 to guide MPP in 
its expansion into new areas covered by the WHO Essential Medicines List.   
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  53.  He was diagnosed with hepatitis C in 1995 and cirrhosis in 1998. In 
2000 he set up The Hepatitis C Trust in the UK which he ran for 18 years. 
In 2002 he was treated and cured of the virus. He helped create the 
European Liver Patients Association and was its first President in 2004. In 
2007 he established the World Hepatitis Alliance and was President until 
December 2017. As a result of advocacy by the Alliance, WHO adopted 
successive viral hepatitis resolutions in 2010, 2014 and 2016, culminating 
in endorsement of the goal of eliminating hepatitis B and C by 2030.  
54.  Charles has sat on a number of national and international advisory 
bodies including th e WHO Director -General 's HIV and Hepatitis STAC, 
various WHO regional STACs and up till 2019 was a member of all the WHO guideline development 
groups on testing and treating viral hepatitis.  
2.6.1   Summary of Intervention  
55.  The Medicines Patent Pool (MPP) is a publ ic health organization established by Unitaid in 2010 
to accelerate access to innovative medicines and new health technologies in Low - and Middle -Income 
Countries (LMICs). MPP 's mandate was initially focused on HIV, but its work has progressively 
expanded to include hepatitis C, tuberculosis, non -communicable diseases, COVID -19, and 
countermeasures to pandemics and other international health emergencies. See MPP's website  for 
details about MPP 's work and impact.  
56.  MPP operates through the voluntary licensing of intellectual property rights and technology 
transfer, based on the principles of public health, transparency, and market non -exclusivity. The 
process include s negotia ting of licences on innovative medicines and health technologies with patent 
holders; sub -licensing the products to multiple manufacturers to ensure availability and affordability 
in LMICs through competition; facilitating technology transfer and providing  support to sub -licensees 
on product development and regulatory filings; managing the implementation of sub -license 
agreements to ensure adherence to license terms; and supporting market entry and uptake. See 
this publication  for additional information on MPP 's approach.   
57.  During the COVID -19 pandemic, MPP secured licenses for three patent -protected COVID -19 
therapeutics – molnupiravir, nirmatrelvir/ritonavir, and ensitrelvir from Merck, Sharp & Dohme 
(MSD), Pfizer, and Shionogi & Co., Ltd respectively. It signed sublicence agreements with generic 
manufacturers based in 16 countries across all continents: 27 companies to manufacture and supply 
molnupiravir in 106 LMICs; 36 companies for nirmatrelvir in 95 LMICs; and seven companies for 
ensitrelvir in 117 LMICs. The countries covered account for 56% of the world population. Prior WHO 
prequalification (PQ) was required for the sale of licensed products. All three products were royalty 
free during the period that COVID -19 was classified as a Public Health Emergency of Internation al 
Concern (PHEIC). See here for a chronology of key activities and access the license agreements 
through this link.  
58.  Lessons learnt:  
a. MPP-licensed COVID -19 therapeutics reached regulatory approval in record time. It took 
1 year as against 3 -4 years in pre -pandemic times. Yet, opportunities exist to further 
shorten timelines in future pandemics:  
i. Relevant access provisions in funding agreements on research and development (R&D) 
could push licensing and technology transfer to happen sooner.  
ii. Pre-selection of manufacturers, building on the existing network of ma nufacturers 
established in the context of COVID -19 as recently proposed by the G20 health 
ministers, removes the need for the process during a crisis.  
iii. The use of pre -agreed licence templates could reduce negotiating time.  
iv. Possible collaborative mechanism that could enable the sharing of starting materials 
and RLDs with generics even before innovator products are proven to be effective could 
be explored.   
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  b. MPP-facilitated provision of innovator 's technology transfer package permitted accelerated 
product development for manufacturers that needed it.  
c. Although MPP 's criteria enabled the selection of manufacturers from a broad geography, 
very few applications for licenses were received from certain regions of the world.  
i. To ensure more diversified manufacturing, stakeholders would need to provide 
necessary support to local/regional manufacturers from regions with less developed 
capacities.  
d. Demand projections for  therapeutics did not materialize and several sublicensees 
terminated their agreement with MPP or put development on hold.  
i. It would be critical to de -risk early development and manufacturing of generics in 
future health emergencies to stimulate manufacture r interest and investment.  
e. Conditional waivers on regulatory requirements for molnupiravir enabled earlier access in 
India, before WHO -PQ  
i. Relevant global public health community could explore complementary regulatory 
pathways allowing for speed in a pand emic context while not compromising quality.  
3  CIVIL SOCIETY ORGANIZATIONS  
3.1  Mr Tahir Amin, Initiative for Medicines, Access & Knowledge ( "I-MAK") 
59.  Tahir Amin, LL.B., Dip. LP., is a founder and executive director of 
the Initiative for Medicines, Access & Knowledge (I -MAK), a non -profit 
organisation working to address structural inequities in how medicines 
are developed and distributed. He has over 25 years of experience in 
intellectual property (IP) law, during which he has practised with two of 
the leadin g IP law firms in the United Kingdom and served as IP Counsel 
for multinational corporations. His work focuses on re -shaping IP laws 
and the related global political economy to better serve the public 
interest, by changing the structural power dynamics tha t allow health 
and economic inequities to persist.   
60.  He is a former Harvard Medical School Fellow in the Department of Global Health & Social 
Medicine. Amin has served as legal advisor/consultant to many international groups, including the 
European Patent O ffice, UNITAID and World Health Organization, and has testified before the U.S. 
Congress  on intellectual property and unsustainable drug prices.  
3.1.1   Summary of Intervention  
61.  The facts, evidence and experiences relevant to the production of, and access to vaccines, 
therapeutics and diagnostics and the case for extending the decision to such products need to be 
considered in the context of the history of how the WTO TRIPS Agreement was imposed on many of 
today 's Member states that previously did not have IP regimes, and the impact it has had over the 
last 28 years when it comes to the lack of access to medicines and technology transfer. Without 
such contex t, the framing of the current debate is misleading and allows the Global North and its 
pharmaceutical manufacturers that hold the IP rights on many COVID -19 technologies to control the 
narrative and set the terms of the debate.  
62.  Even though the TRIPS Agreem ent provides Members with flexibilities to manage IP issues in 
public health emergencies, opposing political pressure from the United States, Europe and other 
Global North nations, as well as lobbying from their pharmaceutical manufacturers, has created a 
chilling effect. As a result, many countries that would benefit from utilising such flexibilities have 
refrained from doing so. Alongside the imposition of TRIPS, these constant trade threats have 
squeezed the sovereignty and policy space within which Glob al South members can serve their 
national needs – something wealthy Global North countries never had to face as they developed 
technologically.  
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  63.  This squeezing of the policy space through TRIPS and other free trade agreements has, by 
design, led to an incre asing reliance on the voluntary measures of IP holders. These voluntary 
measures, such as licenses, not only undermine the flexibilities a country may want to use or have 
tried to use, they also manage the competition by heavily restricting the territories  where Global 
South manufacturers can sell their products. For example, the voluntary licenses for Paxlovid that 
Pfizer entered into have excluded many middle and upper - middle income countries. This will be 
repeated for other products going forward. As su ch, voluntary measures around IP offered by 
pharmaceutical companies are not a solution that meets the global needs of COVID -19 or pandemic 
preparedness.  
64.  Finally, the argument that the proposal to suspend IP for therapeutics and diagnostics is 
outdated due  to there no longer being any demand, misrepresents the current situation in Global 
South countries. With only approximately 20% of people in these nations fully vaccinated, 
treatments are the only way to limit hospitalisations, death and economic losses. Demand is very 
much linked to availability and affordability of treatments and diagnostics. The assessment of unmet 
need should reflect people 's actual needs – based on infection rates and the target populations that 
would be treated – were testing and aff ordable treatments readily available.  
65.  In light of the COVID -19 treatments in the pipeline and the experiences of the past three years, 
it should be an open and shut case to extend the Ministerial Decision in order to get ahead of the 
limited supplies that will be swallowed up by the wealthier nations should there be an increase in 
demand due to another outbreak. In fact, given the manufacturing capability that exists in many 
Global South countries to produce therapeutics and diagnostics, the Ministerial Dec ision should have 
already been extended at the outset. Despite this undue delay, a decision now would not only meet 
the current moment, it would help prepare for future equitable pandemic preparedness.  
3.2  Dr Ellen 't Hoen, Director, Medicines Law and Policy  
66.  Ellen 't Hoen (1960) is the director of  Medicines 
Law & Policy  (ML&P) , a group of legal and policy experts 
offering advice to i nternational organizations, NGOs 
and governments. ML&P regularly publishes briefing 
documents and commentaries on legal and policy 
developments in the field of medicines. ML&P also 
maintains a public database of the use of TRIPS 
flexibilities for public health purposes . She is the 
founder and former executive director of the Medicines 
Patent Pool. She is also a Global Health Law Fellow at 
the law faculty of  the University of Groningen.   
67.  She has published widely and is the author of several books. In 2017 she received the Prix 
Prescrire  for her book "Private Patents and Public Health: Changing intellectual property rules for 
public health. " In 2020, she was appointed Officer of the Order of Oranje -Nassau, a Dutch royal 
award given in recognition of her work on access to medicines. She has a master 's degree in law 
from the University of Amsterdam and a PhD from the University o f Groningen.  
3.2.1   Summary of Intervention  
68.  Discussions at the World Trade Organization (WTO) on the TRIPS Agreement and C OVID -19-19 
have been taking place since India and South Africa tabled a proposal for a pandemic waiver  in 
October 2020. On 17 June 2022, the Ministerial Decision on the TRIPS Agreemen t was adopted. The 
Decision is modest, limited to vaccines for one disease,  limited in time, and mostly reiterates existing 
Members ' rights to use TRIPS flexibilities. Paragraph 3(b) of the Decision is the one bright light, 
waiving the requirement that production under a compulsory licence (CL) must be predominantly 
for the domes tic market without having to resort to TRIPS Article 31 bis. See comments here.  
69.  Medicines Law & Policy (ML&P) has tracked the use of TRIPS flexibilities for health purposes 
since the adoption of the Doha Declaration on TRIPS and Public Health in 2001. Lessons from ML&P 's 
TRIPS Flexibilities Database may be useful in the TRIPS Council deliberations. They include that 
TRIPS Flexibilities have been more widely used than generally assumed . The database  
currently documents 172 instances, of which 122 concern CLs. CLs have proven to be useful in a 
IP/C/W/706  
 
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  pandemic . Since 2020, 10 instances of CLs concerned products needed to prevent or treat 
COVID -19. High -income countries also use TRIPS flexibilities . It would t herefore be sensible 
for them to opt back into the Article 31(bis) mechanism . Further, CLs can be useful for countries 
excluded from the Medicines Patent Pool licences . For details see: Presentation slides  and 
submission to the USITC.  
70.  The Decision focuses on CLs. CLs can be effective to secure access to certain technologies for 
which access to patents alone is sufficient, such as small molecule medicines and certain diagnostic 
tools. But a CL may not be su fficient for more complex technologies such as mRNA vaccines, 
monoclonal antibodies and other biologics or complex diagnostics which require access to trade 
secrets/knowhow that remain outside the reach of a CL.  
71.  Ironically, the Decision covers only vaccin es, for which it is least useful, and excludes 
technologies such as therapeutics and diagnostics that would likely benefit from its provisions. The 
answer to the question whether the Decision should be extended to therapeutics and diagnostics is 
therefore an easy one: it would be the most logical step to take.  
72.  Access to trade secrets/knowhow may be essential for certain technologies. The issue of trade 
secrets is not addressed in the Decision. It is also not addressed in any of the drafts of the WHO 
Pandemic Accord that are publicly available. It would be import ant to provide for measures to ensure 
the possibility to compel the sharing of trade secrets. This can be done in a manner compliant with 
the TRIPS Agreement and operationalised in WHO Pandemic Accord. Here is a proposal for a trade 
secrets provision.  
73.  Regardless of decisions taken at the WTO or WHO, the efficacy of TRIPS flexibilities g enerally 
depends on implementation in national and regional law. These include, easy to use compulsory 
licensing/ government use provisions as well as waivers of data exclusivity to enable registration of 
products produced under a CL. The European Commission has embarked on such implementation 
for the EU.  
74.  Finally, compulsory measures may not be necessary where voluntary measures are effective. 
However, considering the reluctance by certain rights holders to enter into voluntary agreements 
during the C OVID -19 pandemic it seems prudent to ensure effective non -voluntary mechanisms are 
in place.  
3.3  Ms Sangeeta Shashika nt, Third World Network, Malaysia  
75.  Sangeeta Shashikant is the coordinator of Third World Network 's 
Development and IP programme. She has Bachelor of Laws (University of 
Malaya); Masters Degree in Public International Law (University College 
London), and ha s practiced as an advocate and solicitor with the Malaysian 
Bar. She has 19 years of research and advocacy experience in intellectual 
property and public policy matters in particular access to medicines. She 
has collaborated with regional and international  organizations and advised 
governments on intellectual property and access to medicines. She has 
authored and contributed towards numerous publications including 
"Negotiating a 'Development Agenda ' for the World Intellectual Property 
Organisation "; "Intellectual Property and Technology Transfer Issues in 
the Context of Climate Change "; "The African Regional Intellectual Property Organization (ARIPO) 
Protocol on Patents: Implications for Access to Medicines " and the "Pandemic Preparedness: Creating 
a Fair an d Equitable Influenza Virus and Benefit Sharing System ". 
3.3.1   Summary of Intervention  
76.  Experts warn "there remains uncertainty about how the virus will behave, the path of its 
mutations and C OVID -19's long -term effects " adding that "the unknowns could have public -health 
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  consequences in the years ahead ".8 Recognizing this, the WTO must proactively take measures 
to safeguard public health interests in the face of such a formidable adversary .9 
77.  Throughout the pandemic, developing countr ies struggled to obtain timely affordable access to 
needed medical tools. Shortages and prohibitively high prices w ere seen across all medical products 
including diagnostics and therapeutics recommended by WHO10, a primary factor driving 
transmission of CO VID-19. 
78.  A key conclusion reached by expert reviews of COVID -19 response is that manufacturing is 
too concentrated, the need for diversified production, expanding supply options  to meet 
the needs of developing countries.11 
79.  Voluntary licenses (VL) are inadeq uate and are not a substitute for compulsory license 
(CL). By its very nature, VLs are not guaranteed. VL terms are determined by the patent holder, 
often delay access, are anti -competitive, as well as exclude many developing countries from being 
supplied by the licensees.12 For e.g. the MPP - Pfizer Paxlovid VL prohibits the licensee from supplying 
many developing countries including most Latin American countries even as patents in all of these 
countries will last until at least 2041.13 This same VL contain s troubling conditions preventing R&D 
on combination regimens, co - formulation, and even co -packaging that may be helpful to treat 
COVID -19.14 
80.  VLs also do not provide the prompt affordable access that is needed in times of health 
emergency . It generally ta kes more than a year before affordable generics enters the market. 
Meanwhile, there is no access to affordable treatment. Generic supply only became available in 
December 2022, one year after the MPP - Pfizer VL was signed, and that as well only from one ge neric 
company to supply a limited number of countries.  
81.  In contrast, CLs allow governments to take immediate action to facilitate access, and has 
demonstrated to improve timely access.15 Extension of the TRIPS Decision will make available to 
developing coun tries an important flexibility to facilitate timely affordable access to therapeutics and 
diagnostics. In particular, waiving the limitation on exports contained in Article 31(f) of 
TRIPS will allow manufacturers to achieve economies of scale, and to suppl y developing 
countries with insufficient manufacturing capacity  with much needed affordable therapeutics 
and diagnostics.  
82.  Claims that CLs discourage R&D and profits are baseless . In fact, CLs played a significant 
role in COVID -19 response as several countr ies enacted progressive CL provisions to make it easier 
to use CL, while others have actually issued CL to address shortages of COVID -19 therapeutics. 
These instances have not adversely impacted pharmaceutical profits or R&D as evidenced by the 
thriving R& D pipeline for COVID -19 therapeutics and record -breaking profits of the pharmaceutical 
companies.  
83.  The Decision should apply to existing and future COVID -19 diagnostics and 
therapeutics . WHO itself maintains a "Therapeutics and COVID -19 living guideline " with 
recommendations that changes multiple times every year as new variants circulate and evidence 
emerges. National treatment guidelines may follow WHO or may vary.  
84.  Concerns about extending the TRIPS Decision are unjustified . The Decision is limited, 
narrow in scope as in COVID -19, time -bound as well as only applicable to 'developing countries ". It 
 
8 https://www.wsj.com/articles/what -do-we-actually -know-about -covid-19-not-enough -ec1dcafe  
9 See Articles  7 and 8 of TRIPS  Agreement  
10 See for e.g. https://www.who.int/publications/i/item/WHO -2019-nCoV-therapeutics -2023.1  
11 https://www.who.int/publications/m/item/act -accelerator -facilitation -council -working -group -report -
on-diagnostics -and-therapeutics?utm _source=substack&utm_medium=email  
12 See https://msfaccess.org/voluntary -licenses -access -medicines  
13 https://msfaccess.org/latin -america -how-patents -and-licensing -hinder -access -covid-19-treatments  
14 See https://healthgap.org/pfizerletter/  and https://infojustice.org/archives/44914  
15 See Country  experiences  in using  TRIPS  safeguards:  Part 1, WHO at Country -experiences -TRIPS -
Part1.pdf (who.int)  IP/C/W/706  
 
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  does not waive all IP, as often erroneously claimed by pharmaceutical companies. Nor does it not 
affect the sales of pharmaceutical companies which tends to be  in developed country markets.  
85.  Further resources:  
a. See TWN 's Detailed Submissions to the USITC Investigation rebutting concerns and 
arguments raised by those opposing extension of the TRIPS Decision to diagnostics and 
therapeutics . 
https://www.twn.my/title2/intellectual_property/TWNSubmissionstoUSITC.htm  
b. See Voluntary Licenses and Access to Medicines, MSF Technica l Briefing Document 
available at https://msfaccess.org/sites/default/files/2020 -10/IP_VoluntaryLicenses_full -
brief_Oct2020_ENG.pdf  
3.4  Mr James Love, Director, Knowledge Ecology International (KEI), United States of 
America  
86.  James Love is Director of Knowledge Ecology International. His 
training is in economics and finance, and work focuses on the 
production, managem ent and access to knowledge resources, as well 
as aspects of competition policy.   
87.  The current focus is on the financing of research and development, 
intellectual property rights, prices for and access to new drugs, 
vaccines and other medical technologies, as well as related topics for 
other knowledge goods, including data, software, oth er information 
protected by copyright or related rights, and proposals to expand the production of knowledge as a 
public good. James Love holds a Master of Public Administration from Harvard University 's Kennedy 
School of Government and a Master in Public Affairs from Princeton 's Woodrow Wilson School of 
Public and International Affairs.  
3.4.1   Summary of Intervention  
88.  The June 17, 2022 decision  on the TRIPS Agreement and COVID -19 vaccines was very narrow. 
It was a temporary, conditional waiver of Article 31.f of the TRIPS Agreement, which provided 
additional but limited flexibility on exports under a non -voluntary authorizat ion to use patented 
inventions. The decision only applied to one virus, only to vaccines, is temporary, and attached 
conditions.  
89.  In the decision, the WTO limited eligibility to developing countries, for both importing and 
exporting, subject to further opt -outs. This condition limits the ability of vaccine manufacturers to 
benefit from economies of scale and importers ' ability to engage with many potential suppliers. There 
were some clarifications issued regarding the decision, but in the nature of restating  existing 
flexibilities in the TRIPS Agreement. The decision did not address IP or investment provisions in 
bilateral or plurilateral agreements, nor did it deal with access to know -how protected in Article 39.2 
of TRIPS. The decision has not been used by WTO Members.  
90.  Despite its limitations, the decision does have some potential value, particularly for 
therapeutics, where the regulatory pathway is less challenging than is the case for vaccines, and 
where there is a robust and promising pipeline, including both new and repurposed drugs. 
Negotiators should also consider that for example, in HIV, HCV, and other diseases often combination 
treatments are more effective. There can be patent challenges even for testing combination products 
given the terms of some voluntary licensing agreements, such as the Pfizer license for Paxlovid.  
91.  Negotiators should also reflect on the contrasts between the narrow and limited 17 June 2022 
decision and what measures high -income countries enacted in their domestic legislation in  2020 and 
2021, and are continuing to do today. In the Spring of 2020, Canada and Germany created very 
broad exceptions to patent rights for emergencies, exceptions that were not limited to vaccines. The 
United States of America issued dozens of contracts with FAR 52.227 -1 authorization and consent 
clauses, giving Merck, Sanofi, Lilly, Moderna, Novavax, Siemens, Philips, Quidel, and others the 
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  freedom to use any US government -issued patents, to make and sell a very diverse set of 
countermeasures.  
92.  Today the  European Commission has proposed legislation for exceptions to intellectual property 
rights that include multi -country compulsory licenses, exceptions to rights in test data, a cap on 
royalties of four percent of the generic price and the ability to compe l the sharing of manufacturing 
know -how or other complementary measures. The EU 's proposed exceptions will be permanent, not 
limited to particular diseases or viruses, and will apply to all countermeasures.  
93.  As an alternative to extending the extremely limi ted 17 June 2022 decision, WTO Members 
should consider new exceptions and other measures more in line with the ambitions of the current 
European Commission 's proposal on compulsory licensing.  
94.  Links and references:  
a. COM(2023)224 - Proposal for a regulation o f the European Parliament and of the Council 
on compulsory licensing for crisis management and amending Regulation (EC) 816/2006.  
b. FAR 52.227 -1 Authorization and Consent. https://www.acquisition.gov/far/52.227 -1 
c. German Government Plans Possibilities to Limit Patents In View of Corona Pandemic 
Thomas Musmann (Rospatt Osten Pross)/March 2 4, 2020. 
https://patentblog.kluweriplaw.com/2020/03/24/german -government -plans -
possibilities -to-limit-patents -in-view-of-corona -pandemic/  
d. Governmental Use of Patented Inventions during a Pandemic: A Global Survey, April 16, 
2020. Norton Rose Fullbright. https://www.nortonrosefulbright.com/ -
/media/files/nrf/nrfweb/knowledge -pdfs/governmental -use-of-patented -inventions -
during -a-pandemic.pdf  
e. KEI Briefi ng Note 2022:3: Selected differences between Article 30, 31 and 44 of the WTO 
TRIPS Agreement as regards non -voluntary use of patented inventions.  
f. KEI Research Note 2023:2. Examples of US agency uses of FAR 52.227 -1.  
g. BIO COVID -19 Therapeutic Development T racker, https://www.bio.org/policy/human -
health/vaccines -biodefense/coronavirus/pipeline -tracker  
3.5  Ms Fatima Hassan, H ealth Justice Initiative, South Africa  
95.  Fatima Hassan is a human rights lawyer and social justice activist and 
the founder of the HJI. She is the recipient of the 2022 Calgary Peace Prize 
and is a 2023 Echoing Green Fellow. She has dedicated her professiona l life 
to defending and promoting human rights in South Africa, especially in the 
field of HIV/AIDS. She has worked as a Ministerial Advisor, and in 
philanthropy as well as the not -for-profit sector.   
96.  She has served on several NFP boards and is the recipie nt of several 
awards, and often writes for local and international media publications. She 
is currently a Board member of Global Witness and serves on the Advisory 
Group for Resolve to Save Lives.  
3.5.1   Summary of Intervention  
97.  The world has lived through  vaccine nationalism  since 2020. Hoarding of life saving vaccine 
supplies was accompanied by knowledge hoarding and racism.  The WHO estimates at least 
14.9 million  direct and indirect deaths from COVID -19 in 2020 -2021. But right now, the tests and 
treatments to track and manage COVID -19 infections are out of reach for many of us in the Global 
South. At the beginning of COVID -19, we were promised solidarity . But, when it mattered the most, 
we were not beneficiaries  of that solidarity. What we experienced  was pernicious bullying  by 
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  manufacturers  and delayed negotiations  at the WTO.  Even t he SA President likened our terrible 
experience to being a 'beggar '. 
98.  And the reason we were 'beggars ' is simple: The market failed us. It was unregulated and used 
its power to distort equity norms while benefiting from public funding and trial participation of our 
people. That, coupled with no restrictions on excessive IP protectio n during a global health crisis and 
the absence of a timely and time bound IP waiver meant that we were left with concentrated 
manufacturing; high prices , refusal of broad knowledge sharing; limited generic entrants; bullying , 
one-sided demands  including contractual secrecy  and minimal transparency  in respect of material 
elements of pandemic contracting.  
99.  This cannot be repeated: There is a pipeline of treatments for COVID -19, dozens of whic h are 
in late -stage clinical trials and many could even be more effective than Paxlovid. But we are unlikely 
to benefit in a timely and affordable manner. We cannot access affordable and widespread testing 
kits including test consumables  either, because decisions regarding access, timing and price are not 
prioritised and manufacturi ng (test consumables especially) remain highly concentrated  with very 
few countries  being able to alter that on their own. That is the crux of the issue here: the drugs and 
treatments in the pipeline. Without easing limits to enable wider production and export of generic 
versions and easier access we cannot manage to contain COVID -19, treat it, or even diagnose it in 
an optimal manner.  
100.  I live in one of the most unequal countries in the world, with an apartheid based, two -tier, 
unequal health system. Yet, SA is often regarded as 'middle income ', a classification that often 
excludes SA from  licensing deals for our entire health sector. For about 2 years, we challenged  the 
secrecy that companies demanded of SA and others  elsewhere  in the procurement of COVID -19 
vaccines (paid for by public funds ). On 17 August  2023 the HJI won an important, precedent setting 
case when the High Court ordered  the public and unredacted disclosure of all vaccine  procurement 
contracts.  When we initiated the case, we were told that even the contracting parties ' details were 
a ''secret ''. Our analysis  of the four unredacted contracts show one -sided,  onerous terms and 
conditions  as well as worrying, 'bullying ' behaviour from certain pharmaceu tical companies. Since 
the disclosure, government officials have publicly admitted  that they were 'bullied ' in 'take it or leave 
it' negotiations. The now opened contracts  indeed tell a disturbing story.  
101.  The market has let us do wn before: Alone, it cannot secure  equity; timely access; affordability . 
We nee d proper countermeasures . We therefore urge Member s to make a final decision on extending 
Para 8 for therapeutics and diagnostics. Further delays will risk making the WTO increasingly 
unhelpful  and irrelevant for people in the Global South.  
3.6  Ms Jennifer Brant, Director, Innovation Council, Switzerland  
102.  Jennifer Brant runs a consulting business called Innovation  Insights, 
based in Geneva, Switzerland. She works with companies, NGOs, 
governments, and international organizations on policy issues related to 
intellectual property (IP) and innovation, technology transfer, international 
trade, and public health. She is  committed to gender parity, leading global 
advocacy campaigns to tackle IP diversity gaps and serving as member of 
the International Gender Champion network.   
103.  As part of her consulting work, Jen leads a cross -sectoral innovators ' 
group called Innovation C ouncil. This global organization connects 
policymakers to organizations that are bringing technology solutions to 
society. Jennifer is trained in international law, development, and 
economics. She has authored and co -authored many reports and articles, 
including Unprecedented (2022), which analyses the role of intellectual property in the COVID -19 
innovation response, and Biomanufacturing Resilience (2023), which endorses action by 
governments and companies to reinforce biologics supply chains.  
3.6.1   Summary of I ntervention  
104.  Jennifer Brant  presented recent interview -based research projects, the findings of which 
were published in reports entitled Unprecedented  (2021, co -authored with Prof. Mark Schultz), 
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  Making Biologics  (2022), and Biomanufacturing Resilience  (2023). She noted that the topic of the 
Special Session – extension of the 2022 TRIPS decision – is really about ensuring adequate health 
products supply and extending biomanufacturing capacity, for health security. The three reports 
touch on th ese issues.  
105.  As documented in Unprecedented , IP played an enabling role at all stages of the COVID -19 
innovation response:  
106.  Development of relevant background IP . Existing technologies and know -how were quickly 
leveraged for the pandemic response. These wer e the result of past R&D, enabled by IP within the 
biopharma innovation ecosystem. In some cases, public research outcomes were moving to market 
via hand -off to companies. COVID technologies were "overnight successes years in the making ". 
a. Development of CO VID technologies.  Collaboration was crucial to developing and 
repurposing COVID technologies in record time, and for developing and optimizing the 
manufacturing processes for them. Nobody could develop and deliver products at the scale 
needed on their own.  IP made it less risky to work with others.  
b. Scaling manufacturing for a pandemic response.  Collaboration was essential to establish 
the necessary global manufacturing networks; in -house capacity was inadequate for a 
pandemic response. Capable partners were  identified (not an easy task) then innovators 
shared technology and know -how with them, also helping them to set up supply chains 
and clear regulatory hurdles.  
c. Investments for the pandemic response . IP enabled investments in a highly uncertain 
environment . Companies produced at risk, redirected resources to COVID -19, made 
commitments to suppliers, set up voluntary licensing arrangements, and upgraded 
manufacturing capacity – even before receiving regulatory approval. Government action 
helped to de -risk suc h activities.  
107.  Industry leaders interviewed for Unprecedented  said that, had there not been IP protection, 
their companies would have supported the pandemic response but with less collaboration; sharing 
tech and know -how would have been unduly risky. This w ould have resulted in a slower, and perhaps 
very different, pandemic response. Without collaboration, manufacturing at the scale needed to fight 
COVID -19 would not have been possible.  
108.  By mid -2021 there were already 300 vaccine partnerships (more than 230 i nvolving tech 
transfer). Technology and know -how were shared during the pandemic response. IP was managed 
to maximize global supply.  
109.  Making Biologics  and Biomanufacturing Resilience , focus on promising practices for 
building resilient biomanufacturing capa city globally.  
110.  Making Biologics  identifies four key pathways for building capacity, based on historic evidence 
and insights from biologics industry leaders. All the pathways require collaboration and tech transfer, 
along with legally certain business envir onments that include IP protection. One approach for 
building vaccine production capacity is "backwards integration "; companies start with activities like 
fill and finish, then work side -by-side with tech transfer partners over many years to gain expertise  
and move up the value chain, ultimately performing R&D and activities like bulk antigen production. 
A backwards integration success story is Biovac (South Africa).  
111.  Biomanufacturing Resilience  suggests actions for governments and companies to reinforce 
biopharma supply chains and thus improve healthcare delivery and pandemic preparedness. The 
report highlights the significant, IP -driven innovation in the upstream part of these value chains, 
where companies deliver manufacturing equipment, consumables, and s ervices like facility design 
and workforce training. Such innovation is facilitating the establishment of efficient, flexible 
biopharma production in more regions. Upstream companies are often global tech transfer partners 
for regional manufacturers, with IP facilitating technology and knowledge exchange. The report 
suggests that governments contribute to resilience by tackling trade barriers, improving regulatory 
systems and regulatory coordination, and providing financial and other support for local produ cers. IP/C/W/706  
 
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  It cites the range of factors – including workforce, procurement and demand, and access to raw 
materials – that influence success when extending biomanufacturing capacity.  
112.  Conclusions:  
a. IP played an important enabling role in the COVID -19 response an d would undoubtedly 
support rapid pandemic innovation in the future as well.  
b. IP continues to facilitate tech transfer and other collaborations that build global 
biomanufacturing capacity across regions, contributing to health security.   
c. Work at the WTO is  needed to ensure trade policies align with public health goals; for  
example, export restraints were problematic during the pandemic and their use should be 
disciplined.  
113.  Jennifer spoke in her personal capacity.  
4  BUSINESS  
4.1  Dr Julia Spencer, AVP, Global Multilateral Engagement, Strategic Alliances, and 
International Relations, MerkSD  
114.  Julia Spencer serves as the lead for MSD 's engagement with key 
global multilateral organizations, embassies, consulates, and missions in 
Washin gton, DC, New York, and Geneva, and is based in Geneva, 
Switzerland. She is also the focal point for and coordinates the company 's 
participation in international industry trade associations and business 
groups and directs the multilateral and strategic all iance policy agenda 
focused on UN and international health, trade, and innovation 
organizations; G7/G20 and other global government alliances; health 
security organizations, and economic and financing institutions.   
115.  Prior to taking on this role, Julia serv ed for 5 years as the Associate 
Vice President, Global Vaccines Public Policy, Partnerships, and 
Government Affairs, during which time she led global policy and advocacy 
efforts to expand and sustain access to MSD 's vaccines and to strengthen 
the immunizat ion systems delivering our products. Julia also served as the Chair of the International 
Federation of Pharmaceutical Manufacturers and Associations ' (IFPMA) Vaccine Committee from 
2021-2022.  
116.  Prior to joining Merck, Julia served for 15 years as a senior he alth official in the US Department 
of Health and Human Services (HHS). Her tenure at HHS included service as the Science Policy 
Director within the HHS Secretary 's policy, planning, and evaluation office (ASPE) where she was 
responsible for policy analysis , coordination, planning, and legislative development focused on the 
HHS science agencies – Centers for Disease Control and Prevention, Food & Drug Administration, 
National Institutes of Health, and Office of the Assistant Secretary for Preparedness and Re sponse.  
117.  During the decade she worked in ASPE, she led the creation of two 5 -year HHS Strategic Plans, 
the first HHS Global Health Strategy and the Health System Measurement Project; developed a new 
HHS-wide evaluation capacity development initiative; and served on assignment in the US CDC 
Rwanda Office.  
118.  Prior to joining ASPE, Julia spent six years working on tobacco policy and substance abuse 
prevention efforts with HHS 's Substance Abuse and Mental Health Services Administration. Julia 
holds a Doctor of Ph ilosophy degree in public health, Master of Science in public health, and 
Bachelor 's degrees in psychology and health education  
4.1.1   Summary of Intervention  
119.  MSD is co -developer and manufacturer of molnupiravir, an investigational oral COVID -19 
antiviral approve d or authorized in more than 25 countries.  In response to the COVID -19 pandemic, 
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  MSD pursued R&D partnerships for 4 vaccine and treatment candidates, with substantial investments 
in manufacturing scale up in parallel to clinical development. Due to the hi gh-risk nature of R&D, 
only one candidate, molnupiravir, advanced through early clinical development and MSD prioritized 
its rapid and equitable global access through a proactive, three -pronged strategy:  
a. Manufacturing at scale during clinical development to ensure ample supply at authorization 
and entering into advance supply agreements with approximately 40 governments for 
rapid availability.  
b. Engaging early with generic manufacturers to facilitate affordable access in low - and 
middle -income countries ( "LMICs"), through bilateral voluntary licenses and with the 
Medicines Patent Pool, which issued sublicenses to 27 generic manufacturers from 10 
countries. MSD 's voluntary licensed territory and local manufacturing partnerships cover 
approximately 90% of the population in LMICs.  
c. Reserving supply of MSD -manufactured product for global health programs. MSD made up 
to 5 million courses (more than 30% of our global supply) available to UNICEF and USAID 
at our best access price for distribution in 107 LMICs eligible for donor -supported funding; 
MSD donated 100,000 courses to Direct Relief for refugee programs.  
120.  Through MSD and our generic partners, more molnupiravir courses were available to LMICs 
(5.5M) during Q1 2022 than were supplied to high -income countri es (5M). Despite MSD 's efforts to 
ensure equitable molnupiravir access, procurement and distribution by governments and global 
health organizations have been slow or nonexistent for reasons unrelated to availability or price.   
a. Global health organizations have distributed few courses. UNICEF had access to 3 million 
molnupiravir courses in January 2022, but shipped only 60,478 courses to just 
10 countries through September 2023.  
b. Outside of Asia -Pacific, demand from many governments and public health programs  has 
been limited. Despite proactive MSD engagement, many governments, including 
Colombia, Mexico, South Africa, India, and Brazil, have not prioritized the purchase or 
recommended the use of COVID ‑19 antivirals as part of their pandemic response.  
c. Governme nts have been slow to implement and scale -up test -and-treat programs to 
identify individuals eligible for oral antiviral treatment within 5 days of symptom onset and 
help raise awareness of antiviral availability among health care providers.  
121.  There have bee n no supply barriers for molnupiravir and no shortages of funding for 
therapeutic procurement through ACT -A partners. Extending the TRIPS waiver to COVID -19 
therapeutics would not improve global access to this treatment. Rather, an extension may have an 
adverse impact on global health and access to medicines by weakening incentives for research -
based companies to continue investing in future innovations. Therapeutics regularly have multiple 
uses, so it would be impossible to constrain the impact of a TRIPS waiver to a product 's COVID -19 
use only, putting at risk investments underway to evaluate the potential of current COVID -19 
therapeutics as medicines against other viral threats.  
122.  Without IP protections, MSD likely could not have justified investment in th e development of 
molnupiravir as a COVID -19 treatment, which we did without external funding, and would be 
disincentivized to continue evaluating it against other diseases. MSD urges the Council to not support 
an extension of the TRIPS waiver to COVID -19 therapeutics and diagnostics, and instead to work to 
address the real barriers to access.  
123.  Additional References : 
a. MSD, U.S. International Trade Commission Written Comments to the Docket (May 2023) 
https://www.usitc.gov/press_room/news_release/2023/er0201_63483.htm . Note, In 
February 2023, The U.S. International Trade Commission (USITC) launched a factfinding 
investigation into extending the TRI PS Waiver to COVID -19 diagnostics and therapeutics. 
MSD submitted detailed comments to the docket, which can be found through the USITC IP/C/W/706  
 
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  Electronic Document Information System link above (please note free registration is 
required)  
b. International Federation o f Pharmaceutical Manufacturers and Associations, How Different 
Partnership Models Supported the Response against COVID -19 (June 2023), 
https://www.ifpma.org/news/first -of-its-kind-event -brings -together -10-companies -that-
partnered -to-deliver -vaccines -and-treatments -in-response -to-covid-19/  
c. Center for Global  Development, Lessons from Expanding Access to COVID -19 Treatments 
in LMICs through Voluntary Licsensing ( Dec 2022), 
https://www.cgdev.org/publication/lessons -expanding -access -covid-19-treatments -
lmics-through -voluntary -licensing   
d. International Federation of Pharmaceutical Manufacturers and Associations, Impact of a 
Waiver of Intellectu al Property Rights for COVID -19 Therapeutics (Dec 2022), 
https://www.ifpma.org/resources/impact -of-a-waiver -of-intellectual -property -rights -for-
covid-19-therapeutics/   
e. Brant, J. & Schultz, M.P., Unprecedented: How Intellectual Property Rights Helped the 
Pandemic Response  (Nov 2021), https://www.unpackingip.or g/ 
4.2  Ms Elsie Soto, VP Supply Chain, Emerging Markets & China, Pfizer Global Supply  
124.  Elsie initiated her career in Pfizer Puerto Rico in 1993. Elsie assumed 
positions of increased responsibility at the Vega Baja and Fajardo sites, and 
then internationally in Spain, Korea, the US and Hong Kong. Elsie was 
honoured in 2011 with the National H ispanics Corporate Achievers Award 
for her career accomplishments as a corporate leader at Pfizer. In 2013, 
Elsie was appointed Vice President Product Portfolio Management (PPM) for 
Pfizer 's Established Business.   
125.  In 2016 she assumed the role of VP PPM for  the Innovative Business. 
In 2019 she was appointed to her current role as VP Supply Chain Emerging 
Markets and China overseeing the supply strategic aspects and commercial 
interface of those areas. During the Pandemic, Elsie co -led Pfizer 's 
COVID -19 Manufacturing taskforce. Elsie is also currently leading the Manufacturing & Supply Chain 
activities related to the Accord for Healthier World. Elsie holds a bachelor 's degree in Industrial 
Engineering from the University of Puerto Rico at Mayaguez. She br ings 30 years of site, market, 
and centre experience in the areas of Procurement, Product Transfers, New Product Launches, Site 
Production Planning, Logistics, PGS Market Leadership, Business Development, Portfolio Strategy 
and Supply Chain Management in b oth Established and Innovative Businesses to her role.  
4.2.1   Summary of Intervention  
126.  Collaboration has been hardwired into Pfizer 's work in supporting the pandemic response, be 
it our partnership with BioNTech for our COVID -19 vaccine, or with manufacturers glob ally to scale 
up at risk and at pace for both our vaccine (with more than 20 partners) and our therapeutic (with 
more than 30 partners).  
127.  Producing vaccines and therapeutics at pace requires trust and partnership. The intellectual 
property (IP) system prov ided the framework that enabled the long -term risk -taking, collaboration 
and investments necessary to develop these products. It facilitated the transfer of information by 
providing the legal certainty needed to allow for tech transfer and information exch anges between 
companies.  
128.  As of September 2023, Pfizer and BioNTech have distributed more than 4.6 billion COVID -19 
vaccine doses to patients in 181 countries and territories worldwide; this includes over 1.8 billion 
doses to low -and middle -income countrie s. For our COVID -19 therapeutic, as of 30 June 2023, we 
have shipped approximately 53 million courses to 79 countries globally.  
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  129.  Equitable distribution is Pfizer 's North Star. Since day one we helped enable broad and 
equitable access to our COVID -19 therap eutic through, for example, tiered pricing, a voluntary 
license agreement with the Medicines Patent Pool (MPP)our therapeutic or a generic version through 
one or more of these pathways16, supply agreements with UNICEF and Global Fund, and other 
initiatives . Altogether, with the MPP, UNICEF, and Global Fund agreements, every low and middle -
income country in the world, except China, now has the potential to access.17  
130.  Despite these efforts, the principal access challenges for COVID -19 therapeutics are well 
documented.18 They include, for example, pandemic fatigue, healthcare professional education, 
testing capacity, and sustained overall pandemic response financing. In some countries our 
COVID -19 antiviral has still not been approved. Demand has been another s ignificant challenge. 
Pfizer initially allocated a significantly higher percentage of our total supply via the Global Fund and 
UNICEF, however, as of May 2023, of the 2.1 million units offered, just over 140,000 units - or 6% 
- were requested by the 59 low -and-lower -middle -income countries that opted in. And so far, we 
are aware of three sub -licensees for the MPP deciding to terminate their agreements, with two 
publicly citing commercial viability or considerably decreased usage as reasons for terminating.19  
131.  Weakening IP rules will not solve any of these challenges. In addition to not addressing the 
root causes of access challenges, any expansion of the June 2022 TRIPS Decision would introduce 
additional risks. It lacks clear guardrails for safety, post -market surveillance and equitable 
distribution found in voluntary licenses.  
132.  There is no factual basis for expanding the TRIPS Decision. Further weakening IP protections 
will undermine the ability of companies to invest in the type of innovation and partnershi ps that 
helped us confront the COVID -19 pandemic, and it will potentially stifle the ability to respond to 
future pandemics.  
133.  WTO Members should instead focus on strengthening and maintaining health infrastructure to 
deliver therapeutics; increasing access  to testing; implementing public information campaigns to 
increase awareness and acceptance of therapeutics; and, importantly, removing trade barriers.  
134.  More information on Pfizer 's efforts towards equitable access, including our forward -looking 
work throu gh 'An Accord for a Healthier World ', can also be found here:  
a. https://www.pfizer.com/TradeEquitableAccess    
b. https://www.pfizer.com/Therapeutics -Equitable -Access    
c. https://www.pfizer.co m/about/responsibility/global -impact/accord    
4.3  Dr Cheikh Tidiane Diagne, Head of Operations , DIATROPIX, Institute Pasteur, Dakar, 
Senegal  
135.  Dr Cheikh Tidiane Diagne trained at the Centre National de la 
Recherche Scientifiq ue and at the University of Toulouse (France) where 
he graduated in 2013 with a PhD in Structural and Functional Biology. His 
PhD research was focused on the dynamic analysis and assembly of site -
specific DNA recombination machineries using single molecule  techniques. 
From 2014 to  2016, he worked at the Electronics Department (LETI) of the 
French Commission for Atomic Energy and Alternative Energies (CEA) in 
Grenoble (France) as a postdoctoral researcher. There, his research efforts 
were focused on bio -inspired technologies for molecular electronics.   
136.  Dr Diagne joined the virology department and the WHO collaborating for arboviruses and 
haemorrhagic fever viruses of the Pasteur Institute of Dakar in Senegal in 2016. His primary interests 
 
16 Pfizer 's MPP agreement covers 95 low - and middle -income countries, covering 53% of the world 's 
population.  
17 Pfizer has other agreements in place to help facilitate access in China.  
18 https://www.ifpma.org/insights/is -an-extension -of-the-trips-waiver -needed -for-covid-19-tools/  
19 https://medicinespatentpool.org/licence -post/pf -07321332  (See section "Additional information ") 
IP/C/W/706  
 
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  were centred on inno vation for Global Health, particularly on the development and evaluation of 
point-of-care diagnostic tools, digital health for biosample transportation and banking and rapid 
extraction method for nucleic acid amplification. Since March 2020, he has been le ading the 
DIATROPIX laboratory, a social venture founded by the Institut Pasteur de Dakar (Senegal), the 
Merieux Foundation (France), the Foundation for Innovative New Diagnostic (Geneva) and the 
Institut de Recherche et de Développement (France). DIATROPI X focuses on local manufacturing of 
rapid diagnostic tests for neglected and epidemic diseases in Africa.  
4.3.1   Summary of Intervention  
137.  Institut Pasteur de Dakar is a public health institution in Senegal that collaborates with the 
Ministry of Health to monitor a nd combat outbreak -prone diseases in every region of the country. 
They also provide diagnostic support for infectious diseases in various African nations.  
138.  In 2019, the World Bank reported that countries with the lowest GDP per capita, mostly in 
Africa, had  the highest burden of communicable diseases, revealing the fragmentation and lack of 
accurate diagnostics in Africa 's healthcare system. Despite attempts to allocate 15% of government 
GDP to health, Africa spends significantly less per capita on healthcare than high -income countries, 
leading to a reliance on imported medical tools and a shortage of diagnostics during crises like the 
COVID -19 pandemic.  
139.  DIATROPIX aims to address these challenges by focusing on local manufacturing and a new 
business model. However, limited investment in research and development (R&D) in Africa has 
hindered the development of healthcare manufacturing capabilities on the continent.  
140.  During the COVID -19 pandemic, DIATROPIX collaborated with FIND and UNITAID to pr oduce 
COVID -19 products, expanding its manufacturing capacity. The transition from Bionote to 
DIATROPIX manufacturing presented challenges related to equipment, assembly line capacity, and 
personnel training. Due to the urgency of the pandemic, they initia lly focused on the packaging step. 
Product launch involved collaboration with local regulators and the West African Health Organization 
for safety and conformity assessments, and regulatory harmonization in the ECOWAS region.  
141.  As COVID -19 demand for diagnos tics decreased, DIATROPIX is updating its business model to 
focus on Neglected Tropical Diseases while working also on high volume products such as HIV and 
malaria. It plans to expand its product portfolio with support from FIND and UNITAID and increase 
manufacturing capacity to reduce product costs, although this requires premium payment support 
to expedite the process.  
4.4  Mr Osman Khalid Waheed, CEO, Ferozsons Laboratories Ltd., Pakistan  
142.  Osman Khalid Waheed joined Ferozsons Laboratories Limited, a 
publicly listed pharmaceutical company in 1993 after obtaining his 
undergraduate degree from Harvard. During his tenure as CEO since 1998, 
the company has forged alliances with international partners including the 
Boston Scientific Corporation and Gilead Sciences I nc. to expand access in 
disease areas including heart disease, viral hepatitis, HIV and C OVID -19. In 
2019, Ferozsons became one of 9 international producers selected to 
manufacture and supply its therapeutic remdesivir to 127 low and middle -
income countrie s under a voluntary license from Gilead. Mr. Waheed serves 
as a trustee of LUMS, Pakistan 's premier multi -disciplinary university, and 
was the founding chairman of the Lahore Biennale Foundation, a non -profit 
dedicated to public art.  
4.4.1   Summary of Interventio n 
143.  Ferozsons has worked with Gilead as a Voluntary Licensee since 2016, enabling access to viral 
hepatitis treatments to patients in Pakistan. Our VL collaboration, which includes local 
manufacturing, has helped us reach over 250,000 HCV patients at a treat ment cost that is among 
the world 's lowest.  
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  144.  At the start of the C OVID -19 pandemic, in line with its VL -driven access model, Gilead swiftly 
authorized 9 manufacturers from its VL network across India, Pakistan and Egypt to produce 
remdesivir for 127 LLMIC 's, within weeks of FDA 's EUA for the drug.  
145.  Gilead granted its licensee producers access to a complete technology transfer package to 
manufacture remdesivir in line with Gilead 's specifications. A dedicated team, headed by Elizabeth 
Murray, was available ro und-the-clock to help licensees meet technology, regulatory and supply 
chain challenges, particularly important for an injectable like Remdesivir. Ferozsons began 
production within 12 weeks of its agreement. The direct nature of the VL, coupled with Gilead 's pre-
existing relationships with its licensees, allowed for an exceptionally agile and proactive 
manufacturing response.  
146.  On day one of Covid operations, the Ferozsons team pledged that we would respond to every 
request for remdesivir, no matter how small  or distant. This pledge was tested early on, when we 
received an emergency mail from an ER Doctor in Costa Rica requesting treatment for one patient 
(11 vials). We were able to get the treatment across to the patient in one week, and to this day, we 
receive letters from the patient 's family expressing their appreciation for being there in their time of 
need.  
147.  Through the course of the pandemic, we were privileged to supply remdesivir to patients in 
24 countries, and collectively among the licensees, I belie ve that all requests for remdesivir were 
met. I am proud to report that despite the incredibly difficult relationship between India and Pakistan 
at the state level, we were able to work with Indian licensees to supply product to countries they 
were unable to reach during India 's delta surge and the resulting export ban imposed by their 
government.  
148.  Owing to its competitive nature (licensees were free to compete across all access countries), 
the VL model also helped drive down product costs dramatically. As manufacturing scaled up, robust 
competition among licensees ensured that the resulting economies were passed on to governments 
and patients in LLMIC 's.  
149.  Gilead 's VL model has also helped expand local capacity in LLMIC countries through 
knowledge -sharing and technology transfer. As an example, on the back of our track record of 
producing remdesivir, we were able to raise financing in Pakistan during C OVID -19 to undertake a 
USD 25 million expansion in our manufacturing lines, increasing ou r capacity to formulate specialty 
lyophilized and liquid therapeutics, and potentially vaccines, by 11 times.  
150.  Gilead 's experience across  two global emergencies (HIV and HCV) and the C OVID -19 
pandemic, clearly demonstrates that compared to IP waivers, Volu ntary Licensing through multiple 
licensees provides a significantly more robust model for ensuring equitable access to life -saving 
medicines and vaccines across all parts of the globe. I would also suggest, based on experience, 
that for quality assurance  and standardization , it is important to ring -fence voluntary licensing with 
IP-enforcement. During C OVID -19, unlicensed versions of product created, in some instances, 
serious quality concerns, particularly in countries that lacked capacities to ascertain p roduct safety 
and quality in the midst of a pandemic.  
4.5  Dr Morena Makhoana, CEO, Biovac, South Africa  
151.  Dr Morena Makhoana joined Biovac in 2004 and holds the role of Chief 
Executive Officer. He is a member of the Board and the Biovac Executive 
team. Prior to  his CEO role at Biovac he held the role of Deputy CEO and 
prior to that of Medical Affairs Director for Biovac.  
152.  His mandate is to realise the objective of building vaccine 
manufacturing capacity in Southern Africa. During his tenure Biovac has 
attracted t hree successful technology transfers with global pharmaceutical 
companies such as Sanofi and Pfizer that has allowed the company to grow 
its staff complement from 24 to over 400. Biovac 's next phase is to enter 
strengthen its product development as well as  its drug substance capability 
in order for Biovac and Africa to have end to end manufacture.   
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  153.  Morena is a medical graduate from the University of Cape Town (UCT) in South Africa. He has 
participated in numerous executive and business courses at both Harva rd and Stanford Universities . 
4.5.1   Summary of Intervention  
154.  Biovac was established in 2003, making us exactly 20 years old as a company. As an African 
manufacturer, with very limited means, we have been building our capacity slowly and gradually. 
We began operations with sales and marketing, moved on to packaging and lab elling and then to 
very specialized  area of fill -finish. However, as we did not have our own products, we recognized 
the need to learn, hence, partnered with companies that had the products and technical know -how. 
We partnered with a French -based company, Sanofi in localizing  a modern  6-in-1 combination 
vaccine for children  through fill and finish . 
155.  We then entered into another partnership with Pfizer on the pneumococcal conjugate vaccine 
(a 13-valent vaccine ). This one included formulation of the vaccine th at was a further step towards 
end-to-end manufacturing. As a result , when COVID -19 hit, we had those two experiences  to build 
on and enough experience to act quickly . 
156.  Biovac always had the ambition to be an to end vaccine manufacturer therefore it invested  
from the beginning in a small product development team of about 30 to 40 scientists . This enabled 
us to develop our skills in other  areas, starting with bacterial fermentation and conjugation 
platforms, albeit slowly . 
157.  Paragraph 8 : Our ability to intervene  in Africa during the COVID -19 pandemic was a result 
of our past relationships  with our multinational partners . With our  existing partnerships we could 
engage these companies for further collaboration.  
158.  Biovac, thus  entered into a second technology transfer  agreement with Pfizer to produce  the 
COVID -19 vaccine which had been developed together with BioNTech. Our past experiences 
empowered us to negotiate and conclude a technology transfer agreement quicker , in the wake of 
the pandemic. For context, our first  tech transfer with Sanofi took 7 years to execute ; the one with 
Pfizer on the pneumococcal conjugate vaccine also took about 5 years. However, with the COVID -19 
vaccine agreement, as we had gotten better at this, it took 15 months to execute .  
159.  Consequentl y, Biovac was able to establish  between 75 and 100 million doses of vaccines 
capability through the COVID -19 programme which  were to be made available not only to South 
Africa but to the rest of the African continent as well . However, Africa as we know, does not have 
the most needed drug substance capability. W e hope that w ith time and experience, developing 
countries would be able to respond better to pandemics  through building drug substance capability 
for routine vaccines.  A few initiatives have been established since the pandemic.  
a. The WHO 's mRNA Vaccine Technology Transfer Hub:  
i. This programme, hosted in South Africa by Afrigen, is responsible for developing the 
technology from scratch. The programme is aimed at sharing mRNA technology with 
others. This will hopefully get other African companies to engage in end -to-end 
manufacturing on platforms like the mRNA technology.  Biovac will be the first recipient 
of this technology. There were indeed some challenges in the mRNA technology . 
Initially , it was not clear whether Moderna would waive their patent rights as Afrigen, 
being  part of  the hub, was using technology similar to Moderna 's. Eventually, we learnt 
that Moderna waived those rights during the pandemic.  
ii. We are unable to predict what would  happen going forward in the post-pandemic 
period, and whether the patent rights would then be enforced , since  there is indeed 
some risk that the technology that was previously developed would then have limited 
use. Our interest in patents is in their impa ct and whether those patent rights are 
enforceable even after the pandemic.  
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  i. We need to acknowledge that progress has been made in Africa. This is because in 
2009 when the pandemic potential of the H1N1 flu was contained, many African 
countries did not have any capacity to produce vaccines. As a result of routine vaccines 
and partnerships that we have had, companies like Bio vac were now able to contribute 
during the COVID -19 pandemic our fill-and-finish o perations, albeit with limited 
resources . Our aim, not only as a company but as the African continent , led by the 
African Union and Africa CDC, is to ensure that many African manufacturers have the 
capacity for pandemic response to be able to do end -to-end manufacturing.  
160.  Biovac 's position on Paragraph 8 : The question to ask ourselves is whether some of these 
waivers should be extended to therapeutics and diagnostics. Our position is that the waivers have 
been granted to vaccines as one therapeutic category , but there ought to be standardization. It is 
important to remember that while vaccines were the most impactful medical intervention during the 
recent pandemic, vaccines may not be as effective another time. It is possible that therapeutics 
would rather b e needed in addition to diagnostics which are always required because of the need to 
test. This is why we need to develop a more holistic approach regardless of what term it gives them. 
For us, it is about accessibility. If we make all options (therapeutic s, diagnostics and vaccines) 
accessible through these licences or patent waivers we will be able to save the world . 
4.6  Mr Alejandro Gómez López, Health Secretary of the District of Bogota, Speaker of 
BogotáBio, Colombian Public Enterprise for the local production of vaccines  
161.  Medical Doctor. Specialist in Health Auditing and Finance. Master in Political 
and International S tudies. He has more than 20 years of experience in the health 
sector, holding positions in all areas: delivery, insurance and government. He 
was National Director of Nutrition for the Colombian Institute of Family Welfare 
(ICBF) and Director of Public Heal th for the Mayor 's Office of Medellín.   
4.6.1   Summary of Intervention  
162.  BogotáBio  is a brand -new public initiative for the production of vaccines 
and other biologicals, guided by public health needs. It contemplates a novel, 
complete technology transfer scheme to build a plant that allows for the local production, from start 
to finish, including the antigen, of the following vaccines: COVID -19, hepatitis A, chickenpox and 
polio. It is a medium -term project that will be completed in the next 8 years, whose construct ion 
and equipment are fully financed with the public budget of the city of Bogotá.  
163.  With BogotáBio , Colombia will resume its public vaccine production capacities, abandoned in 
the early 2000s. Indeed, many Latin American countries, and also some developed c ountries, 
stopped producing vaccines as public goods, to make way for a market logic in which vaccines were 
produced by private companies and free trade between countries was promised. The pandemic 
showed that this promise was failed. The need is now recog nized for the production of certain 
valuable goods, such as health technologies, to be deconcentrated and plans are designed for the 
repatriation of production.  
164.  Regarding the technology transfer model, Bogotá chose the figure of a mixed company as a 
model of collaboration with the private sector. The city deliberately avoided a 'customary ' voluntary 
license agreement. These schemes have a very limited scope (generally only for certain segments 
of the manufacturing process, such as fill and finish), a limite d duration, very narrow obligations for 
the private party and very strict conditions for the party receiving the technology. As the company 
that transfers the technology develops certain specific activities and complies with the schedule, the 
contracts wil l be deemed to have been executed, regardless of the result or its impacts. Under these 
figures, the private company may not guarantee that the technology transfer effectively results in a 
viable product. This has led to many voluntary licensing initiative s not being successful in the 
medium term or taking much longer than initially planned to deliver pharmaceutical products suitable 
for human consumption. Finally, the customary voluntary licenses are subject to very strong 
confidentiality issues, which do not adequately account for the needs of public production schemes 
such as this one.  
165.  Bogotá then looked for a private strategic partner that was willing i) to form a partnership with 
the government, ii) to be a minority partner in that partnership, and iii)  to make a complete 
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  technological transfer that, beyond the filling and finishing of the vaccines, would allow the antigen 
to be learned and manufactured locally. Bogotá made a very broad call and a diplomatic effort for 
potential partners. No Western comp any was willing to follow a business model like the one proposed 
-with real technology transfer and learning, and not simple manufacturing processes -. 
166.  SINOVAC will be the partner of BogotáBio . The Chinese company will share with the public 
sector the benef its (represented in company dividends), but also the risks. Furthermore, since it is 
a partnership, there is a vocation for permanence with no specific term. This implies that SINOVAC 
will have incentives so that technology transfer is successful and trans lates into products that benefit 
Colombians.  
167.  This shows that there are viable models for real and impactful technology transfers, far 
superior to the simple voluntary licenses usually known and used.  
5  ACADEMICS  
5.1  Dr Daria Kim, Max Planck Institute for Innovat ion and Competition  
168.  Daria Kim is a Senior Research Fellow at the Max Planck Institute for 
Competition and Innovation (Munich). She holds MA (Indiana University of 
Pennsylvania), LLM (Munich Intellectual Property Law Center), and Dr iur . 
(University of Aug sburg) degrees.  
169.  Her research focuses on topics at the intersection of law, technology, and 
society, which include intellectual property law, governance frameworks for 
medical and genomic research, marketing authorisation regulations, and access 
to data wi thin the context of the data economy. 
https://www.ip.mpg.de/en/persons/kim -daria.html  
5.2  Summary of Intervention  
170.  The question of whether the Ministerial Decision on the TRIPS Agreement, adopted on 
17 June 2022 [Decision], should be extended to include therapeutics and diagnostics, is a matter of 
assessing its potential consequences. Ultimately, at issue is whether the Decision can improve the 
availability and accessibility of medicinal products, especially for new COVID -19 variants.  
171.  From a legal perspective, the Decision primarily clarifies the application of the existing 
flexibilities under the TRIPS Agreement, with only one requirement under Article 31(f) TRIPS being 
waived for the eligible Members. Hence, the extension of the Decision will not substantially change 
the legal status quo. This is not to diminish the importance of such clarifications, as they enhance 
legal certainty and can provi de interpretative guidance, especially concerning the instruments for 
issuing a compulsory licence or the interaction between test data protection and limitations on 
patents. This can be helpful, particularly for countries that might be hesitant to apply l imitations on 
patent rights or other TRIPS flexibilities where they are needed.  
172.  While the Decision refers to the exceptional circumstances of COVID -19, it is worth 
emphasising that clarifications of the TRIPS provisions cannot and should not be tied to the  unique 
circumstances of this pandemic. The application of the clarifications made by the Decision does not 
need to be justified by the exceptional circumstances of COVID -19, and the same applies to their 
duration.  
173.  The practical impact of the extension on access to affordable therapeutic and diagnostic 
products for COVID -19 would depend on the actual use of provisions under the Decision. Since the 
Decision was adopted, we have not witnessed a significant increase in the utilisation of TRIPS 
flexibilities, i ncluding for vaccine exports. However, the case of therapeutics and diagnostics might 
be different due to the distinct nature of these products.  
174.  Concerns regarding the offsetting effect on innovation incentives, often raised in opposition to 
extending the Decision, might be misplaced. In general, the impact of the Decision on innovation 
incentives should not be greater than the impact of the existing TRIPS flexibilities. The potential 
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  effect of waiving the 31(f) TRIPS requirement on innovation incentives is  speculative, especially 
given the low likelihood of it being routinely invoked in practice.  
175.  Overall, the extension of the Decision can be viewed as part of an effort to enhance and 
streamline the national implementation and application of TRIPS flexibilities. The motivation behind 
limiting the Decision to the production and supply of COVID -19 vaccines, while postponing its 
extension to therapeutics and diagnostics, was not clear from the outset. Ensuring access to 
therapeutics and diagnostics has  been no less critical than ensuring access to vaccines. There is 
hardly any justification for not applying the same measures and flexibilities to all medicinal products 
in the context of the COVID -19 pandemic and public health protection more broadly.  
5.3  Prof. Dr Yangmu Huang, Deputy Director, Department of Global Health, Research 
Professor, Beijing University, China  
176.  Yangmu Huang is deputy director, research professor and doctoral 
supervisor in the Department of Global Health, School of Public Health, 
Peking  University. Her research focuses on global health governance, R&D 
and public health, and health emergency, which mainly aims at the 
vulnerable population. She has hosted and participated in tens of national 
and international research projects supported by  National Natural Science 
Foundation of China, World Health Organization (WHO), etc. She has 
published over 60 articles in peer reviewed journals, such as the Lancet. As 
the senior consultant of the China 's Delegation, she has been invited to 
attend the Wo rld Health Assemble, WHO Executive Board annually. She has 
also provided consultation for China 's national ministries and commissions, 
such as the National Health Commission, UN agencies, etc. Due to her 
contribution and achievements, she was awarded as He alth Young Physician 
Leaders (ranked 1st in 2019) by the InterAcademy Partnership.   
5.3.1   Summary of Intervention  
177.  Beginning in the late 1970s, China 's in vitro diagnostics (IVD) and modern therapeutic 
industries has seen significant growth, thriving into the com plete supply chain ecosystem with 
improving R&D capacity and fast -growing markets, and moving from foreign company dominance 
to a scenario where domestic products command significant market share, especially in the mid and 
low-end market segments.  
178.  During t he past decade, China has issued a number of policies on regulatory and approval, 
R&D incentives, manufacturing and distribution, and technical standards to accelerate the high -
quality development of diagnostics and therapeutics. With all these supporting environments, very 
diverse disease types and technologies were developed for IVDs, with immunological, molecular and 
biochemical diagnostic share nearly 75% of market. However, there are still many challenges for 
IVD industry in China. For example, in the upstream, imported raw material products dominate the 
IVD market, with an average of 87%; in the midstream, domestic products dominate enzyme 
immunoassay, molecular diagnostics and biochemical diagnostics market, but in the more advanced 
high-end NGs, POCT , etc. are still dominated by imported products.  
179.  For therapeutics, the number of biologics and chemical drugs approved in China is increasing. 
By 2021, China becomes the world 's second largest pharmaceutical market. However, the proportion 
of biologics man ufacturers that rely on innovation is relatively small. As for traditional Chinese 
medicines, China has actively promoted scientific research on traditional Chinese medicines, with an 
upward trend of clinical trials, and has built a strong cooperative netw ork with more than 
20 countries.  
180.  In response to the COVID -19 pandemic, almost all the relevant departments in China ha ve 
quickly issued a number of policies on regulatory and approval, R&D incentives, and technical 
standards, with the foundation of previou s regulations and capacity strengthening of the system. 
China 's series of actions to promote COVID -19 vaccine innovation, accessibility and knowledge 
protection are consistent with the relevant regulations and purposes of international organizations. 
With all these supports, the number of patent applications for COVID -19 diagnostics reached the 
peak after four months since the outbreak. The State Intellectual Property Office (SIPO) has specially 
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  opened a green channel (or fast -track examination) for relevan t patent applications. More than half 
of the patents have an examination length of 1 to 6 months, which is significantly shorter than the 
average review time (18.5 months). Between 2020 and 2021, production capacity for diagnostics 
grows 21 -fold, largely r epresented by nucleic acid and antibody tests. The IVD exports reach 
RMB 34.9 billion in 2020 and RMB 84.6 billion in 2021. Lianhua Qingwen, the representative of 
proprietary Chinese medicine, has obtained regulatory approvals and/or import licenses in 
approximately 30  countries and regions.  
181.  With all these facts from China, we can see that strong and timely policy and regulatory 
supports are essential for promoting innovation and access, only if the upfront domestic capacity 
building has been long -term con structed. Stimulating innovation and accelerating patent approvals 
can better promote access to pharmaceutical products, in the basis of R&D. Considering advanced 
technology R&D takes a long time, one -time policy support is insufficient to promote rapid 
technological development. Cooperative R&D and technology transfer can better leverage the 
advantages of different countries to achieve health and equity. As for China, we have very strong 
policy support, complete supply chain, extensive product technology p ipeline, and adequate 
production capacity. However, China 's advantage of production capacity cannot be fully used to 
better serve global health unless with the support of new technology and innovation.  
182.  Together, let 's be a strong supporter and guarantor t o meet the challenges of emerging 
infectious diseases.  
5.4  Prof. William Fisher, William Fisher, Wilmer Hale Professor of Intellectual Property 
Law, Harvard University  
183.  William Fisher received his undergraduate degree (in American Studies) 
from Amherst College  and his graduate degrees (J.D. and Ph.D. in the History 
of American Civilization) from Harvard University. Between 1982 and 1984, 
he served as a law clerk, first to Judge Harry T. Edwards of the US Court of 
Appeals for the D.C. Circuit and then to Justice  Thurgood Marshall of the US 
Supreme Court. Since 1984, he has taught at Harvard Law School, where he 
is now the Wilmer Hale Professor of Intellectual Property Law. In 2013, he 
created the CopyrightX online course, which is now offered annually to 
approxim ately 1000 students worldwide. In 2011 he and Professor Ruth 
Okediji created a similar course on Patent Law and Global Public Health, which 
is now offered semi -annually in collaboration with the World Intellectual 
Property Organization. He is currently a d irector of Global Access in Action, a 
non-profit organization, based at Harvard Law School, whose primary mission is improving public 
health in low and middle -income countries.  
5.4.1   Summary of Intervention  
184.  The following seven points combine my own views on the issue confronting the TRIPS Council 
with a distillation of the most salient arguments made by other speakers during the thematic session.  
a. The decision that the Council is considering is narrow. The existing waiver represents a 
modest extension, limited to COVID -19 vaccines, of the general compulsory -licensing 
flexibilities that already exist under TRIPS. At issue is a possible extension of those 
flexibilities to COVID -19 diagnostics and therapeutics.   This should not be characterized 
as a general "weakening " of IP protection . 
b. Despite the narrowness of the issue, the decision taken by the Council will have a 
precedential effect. Determination of the scope of the COVID -19 waiver will affect not only 
the patterns of innovation and distribution of COVID -19 products, but also those patterns 
with respect to  products aimed at future pandemics . This is not necessarily an argument 
against proposed extension, but a recognition of its impact on our responses to future 
crises . 
c. Many contributors to the thematic sess ion have argued that more extensive use of 
voluntary licensing would be superior to extension of the existing waiver to therapeutics 
and diagnostics. The plausibility of that claim is enhanced if the characteristics of the 
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  voluntary licenses are specified.  What might be described as "access -oriented voluntary 
licenses " ("AVLs") have the following characteristics:  
i. Nominal royalties  (typically 5 -10% of generics ' revenues from finished products ); 
ii. Broad geographic field-of-use provisions ; 
iii. Mechanisms to ensure that the prices of the licensed generic products remain low  (such 
as competition among generics  and the m aintenance in LMIC markets of low -priced 
branded versions  of the drugs at issue);  
iv. Provisions mandating the transfer of technology from licensors to lice nsees;  
v. Quality -control mechanisms  (including licensees ' obligation to seek WHO 
prequalification, EMA  approval, or t entative FDA approval – and i ntegrated 
mechanisms for post -market surveillance ); 
vi. Transparency  
(Additional detail concerning the merits of licenses of this sort are available at 
https://ipxcourses.org/GAiA/VLAM_Report_v1.1.pdf .)  
d.  AVLs do indeed have  significant advantages over compulsory licenses within the zones to 
which they apply . Those advantages include: (a) Technology transfer makes possible more 
efficient and rapid manufacturing and distribution of the generic products  than is possible 
through co mpulsory licensing. (b) AVLs make it easier for the licensor  to ensure adequate 
markets for generic manufacturers in LMICs – and thus to accelerate capacity building . (c) 
Judicious s election of licensees and the establishment of long -term partnerships enha nces 
quality control  and thus both r educes the incidence of substandard or falsified medicines 
in LMICs  and p rotects the reputation of licensors . (d) Finally, to  maintain a valuable 
relationship  with the licensor , the licensees have an incentive to respect anti -diversion 
restrictions . Major examples of these benefits include the radical reduction in HIV deaths 
in sub -Saharan Africa and the near elimination of Hepatitis C in Egypt – both of which 
were made possible by the pioneering use of AVLs by Gil ead Sciences.  
e. However, AVLs have thus far failed to address fully the health needs of LMICs .  Examples 
of failures properly emphasized by other contributors to the thematic session include: 
Moderna 's long -standing resistance to use of AVLs  for its COVID -19 vaccine; the high 
prices and sharp field-of-use limitations that have thus far limited the benefit of AVLs with 
respect to COVID -19 therapeutics; and the limited use of AVLs with respect to m onoclonal 
antibodies aimed at diseases  other than COVID -19 (the subject of a recent conference 
organized by the MPP). AVLs thus should not be considered a panacea.  
f. The e xtension of the existing w aiver to COVID -19 Diagnostics and Therapeutics could help 
alleviate COVID -19 and future pandemics in two ways : (a) It would e nable LMIC 
governments to use compulsory licenses  to fill the gaps when IP holders refuse to use 
AVLs; (b) Equally important, the power of LMIC governments to use compulsory licenses 
as a last resort would increase incentives for innovators to use AVLs . 
g. If possible, the Council should also consider other ways of encouraging innovators to make 
greater use of AVLs. Such alternative strategies include:  
i. Educational programs to augment awareness of all of the so -called "TRIPS flexibilities " 
already available to LMICs – thereby increasing the leverage of LMIC governments 
when negotiating or catalyzing AVLs;  
ii. forbidding retaliation (either by the governments of upper -income countries or by 
innovator pharmaceutical firms) against LMIC governments that employ those  
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  iii. Providing institutional s upport for apprenticeship programs , which have proven to be 
the most efficient mechanism for technology transfer – and thus reduce the 
administrative burdens that AVLs impose on licensors.  
 
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