IP/C/W /704  
 
14 July 2023  
(23-4805) Page: 1/8 
Council for Trade -Related Aspects of  
Intellectual Property Rights  
 Original: English  
 
INTELLECTUAL PROPERTY, VOLUNTARY LICENSING AND TECHNOLOGY TRANSFER  
 COMMUNICATION FROM THE UNITED KINGDOM  
The following communication, dated 14 July 2023 , is being circulated at the request of the United 
Kingdom.  
 
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1  INTRODUCTION  
1.  The COVID -19 pandemic 's health, economic, and social impacts continue to be felt, particularly 
in developing and least developed countries, three years on from the W orld Health Organisation 's 
announcement of a public health emergency of international concern (PHEIC) .1 The pandemic has 
highlighted longstanding debates, particularly those concerning equitable access to health products 
and technologies, and the role of the multilateral trading system, including the TRIPS Agreement, 
to achieve equitable access.  
2.  The World Trade Organisation (WTO) has been a forum for extensive discussion on the pandemic 
response, particularly within the TRIPS Council. Here, Members contin ue to examine the role of 
intellectual property (IP) and access to COVID -19 health products and technologies. While positions 
diverge, Members share the objective of improving equitable access for all to products, both now 
and in the future.  
3.  In the contex t of the pandemic 's continued impacts, there is a need to reflect on both successes 
and shortcomings of the global pandemic response and make meaningful progress towards collective 
future pandemic preparedness. In particular, the pandemic illustrated a gro wing need to identify 
how trade can help facilitate voluntary licensing and/or technology transfer partnerships as part of 
collective efforts to address pandemic preparedness and equitable access concerns. The cross -
cutting nature of the topic requires inv olvement from various stakeholders and careful consideration 
of the needs of developing countries and least -developed countries.   
4.  A key outcome of the pandemic response has been the establishment of many new voluntary 
licensing and/or technology transfer partnerships between pharmaceutical companies and generic 
manufacturers for COVID -19 health products and technologies. The WIPO Patent Landscape reports 
on COVID -19 vaccines and therapeutics2,3 highlight the diversity and range of the successful  
collaborations seen globally during the pandemic. Examples include, but are not limited to, 
collaborations like AstraZeneca, Oxford University, and the Serum Institute of India; Pfizer -
BioNTech; as well as partnerships via the Medicines Patent Pool (MPP) for COVID -19 therapeutics.  
5.  The United Kingdom has long championed use of voluntary licensing and technology transfer, as 
have other Members. These partnerships not only contributed to the rapid scaling up of production 
for essential COVID -19 products, hel ping improve access, including pricing, and availability, but also 
represent the importance of international collaboration during times of a PHEIC.  
 
1 https://www.who.int/news/item/30 -01-2020-statement-on-the-second -meeting -of-the-international -
health -regulations -(2005) -emergency -committee -regarding -the-outbreak -of-novel -coronavirus -(2019 -ncov)  
2 https://www.wipo.int/publicatio ns/en/details.jsp?id=4589   
3 https://www.wipo.int/publications/en/details.jsp?id=4658  IP/C/W /704 
 
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  6.  While these partnerships have clearly made a successful contribution to expanding access to 
COVID -19 products, there has been criticism of their not being a silver bullet, primarily due to not 
all manufacturers being able to secure voluntary licensing and/or technology transfer partnerships. 
We must also acknowledge the growing discourse and idea s on the role of trade and technology 
transfer taking place within the WTO from other Members and the need for a pragmatic way forward.   
2  OBJECTIVE  
7.  The United Kingdom considers there to be strong merit in examining the factors influencing and 
underpinning t he formation of these partnerships and for Members to share experiences on how 
more partnerships may be formed as a further step to achieving equitable access to health products 
and technologies. Together, Members should look systematically at collective e xperience to inform 
our future approach.4  
3  IP SYSTEMS, THE TRIPS AGREEMENT, AND VOLUNTARY LICENSING  
8.  The multilateral intellectual property (IP) framework was instrumental in the COVID -19 response. 
Prior to COVID -19 being declared a PHEIC, the framework h elped incentivise and resulted in the 
development of innovative, safe, high quality and effective health products and technologies for the 
treatment, prevention, and containment of COVID -19 by providing rightsholders and other 
stakeholders with confidence to invest in R&D activity, e.g., mRNA platform technology.  
9.  Once the pandemic was declared, previously developed technologies and products were 
repurposed to urgently respond to the spread of COVID -19. The production of COVID -19 products 
was scaled up thro ugh the various voluntary licensing and/or technology transfer partnerships 
mentioned earlier, and data provided by the WIPO Patent Landscape reports on COVID -19 vaccines 
and therapeutics. It is the TRIPS Agreement, as the international minimum standards a greement for 
IP, which plays an integral part in providing a constructive means to structure and enable the 
formation of these partnerships.   
10.  A voluntary arrangement, whereby IP and know -how is transferred from the right holder to a 
manufacturer on mutuall y agreed terms, has numerous advantages as a model for upscaling 
production of health products and technologies. It creates a sound basis for long -lasting, beneficial 
relationships and incentives to produce and disseminate new inventions, such as life -changing 
vaccines. Where possible, a range of options, such as voluntary licensing including non -exclusive 
forms, should be promoted to maximise the scope of a licence scope and therefore to increase 
opportunity for equitable access.  
11.  An inherent benefit of a balanced IP system and successful voluntary licensing partnerships are 
their contribution to the innovation ecosystem through making public information on innovations, 
allowing innovation to be disseminated for further development, and the confidence it pr ovides to 
IP rightsholders to collaborate between institutions and internationally , and dedicate resource s to 
innovative activity which benefits the public.  
12.  There are multiple factors to consider when considering eligibility for a voluntary licensing 
agreement. Existing technical capacity and experience is important, alongside a relationship of trust 
and transparency. Another equally key element is the protection and enforcement of IP rights, which 
provides confidence to the entity entering a business rela tionship that their IP will not be infringed 
and, if it is, that legal recourse for infringement is available. Voluntary arrangements provide a 
means of consolidating the confidence which the IP framework provides.   
13.  Demand generation for the product itself  is a fundamental success criterion. Several factors 
contribute to this including, but not limited to, ensuring a country can diagnose the disease in 
question and has the willingness and infrastructure to treat it; and ensuring willingness from the 
governm ent or purchaser to procure the product.  
 
4 Paragraph 23 and 24, Ministerial Declaration on the WTO Response to the COVID -19 Pandemic and 
Preparedness for Future Pandemics, 
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/WT/MIN22/31.pdf&Open=True  IP/C/W /704 
 
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  14.  While the TRIPS Agreement 's substantive obligations provide confidence for entities to form 
voluntary partnerships, it contains a specific provision focused on increasing technology flows, which 
may be beneficial i n supporting equitable access if the enterprise holds technology related to health 
products and technologies.  
15.  As mandated by Article 66.2, “Developed country Members shall provide incentives to 
enterprises and institutions in their territories for the pur pose of promoting and encouraging 
technology transfer to least -developed country Members in order to enable them to create a sound 
and viable technological base” .5  
16.  Recognising the critical lessons that all Members must learn from the COVID -19 pandemic, W TO 
Members should clarify and build upon the effective role which the multilateral IP framework has 
played in the global pandemic response by further examining the framework 's relationship with 
voluntary licensing and technology transfer partnership format ion.  
4  IP, VOLUNTARY LICENSING, AND TECHNOLOGY TRANSFER  
17.  Contained within some, but not all, voluntary licensing arrangements is the transfer of 
technology and know -how, often protected via IP, which is a necessary component required to scale 
up production.  For example, technology transfer can feature as part of contract manufacturing 
partnerships.  
18.  There are multiple factors to consider when assessing if a manufacturer is eligible for technology 
transfer. Protection and enforcement of IP is only one factor in the formation of partnerships. This 
paper focuses on IP and, therefore, is within the TRIPS Council 's competency to examine further. 
Other WTO fora of relevant competency would likely benefit from exploring other factors and their 
connection to t he formation of partnerships in closer detail.  
19.  Such factors may include, but are not limited to, the availability of sustainable manufacturing 
capacity; sustainable market demand underpinned by policy and demand forecasting which create 
incentives for lic ensees and/or generic companies; experience of manufacturing the relevant 
product; the availability of skilled personnel; adherence to harmonised regulatory standards 
including those recognised internationally; rule of law being established and enforced su pportive of 
an innovation -friendly environment; being a trusted partner demonstrating behaviour conducive to 
trust-based relationships; and clear economic development priorities which promote technology 
transfer and inward investment for continual developm ent. While overlap with IP may exist in these 
factors, they are not the core focus of the TRIPS Council 's remit or competency.  
5  BARRIERS TO EFFECTIVE PARTNERSHIPS  
20.  The effectiveness of voluntary partnerships may also be affected by trade barriers, including 
tariff and non -tariff barriers. For example, high applied tariffs and other taxes on pharmaceuticals 
around the world mean it is often costly to import essential therapeutics to treat patients. Moreover, 
high applied tariffs on certain inputs to vaccines r emain high, which can have a cumulative impact 
on manufacturing costs.6  
21.  The use of export restrictions can cause significant disruption to global trade, leading to an  
inequitable and regressive distribution of goods.  Applying export restrictions too readily, without 
clarity or over a prolonged period may have an acute  impact on developing countries who rely on 
imports and have limited capability to scale up domestic production during times of shortage. For 
example, export restrictions  impeded access to COVID -19 vaccine inputs, leading to uncertainty on 
delivery timeframes by suppliers. They also hindered clinical trials by impeding the movement of 
critical biological samples from global clinical trials to centralised testing sites.7  
 
5 Paragraph 66.2 of the TRIPS Agreement,  
https://www.wto.org/english/docs_e/legal_e/trips_e.htm#part6  
6 https://www.wto.org/english/tratop_e/covid19_e/bottlenecks_update_oct21_e.pdf   
7 https://www.wto.org/english/tratop_e/covid19_e/bottlenecks _update_oct21_e.pdf   IP/C/W /704 
 
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  22.  Wider elements, such as those recognised in the Ministerial Declaration on the WTO Response 
to the COVID -19 Pandemic and Preparedness for Future Pandemics of 17 June 20228, may also 
impact the effectiveness of a partnership.  
23.  It is important to recognise that not all manufacturing entities in Member jurisdictions have 
been recipients of voluntary licensing and/or technology transfer partnerships. The TRIPS Agreement 
has flexibilities built into its architecture, including compulsory licensing in certain si tuations, to 
reflect the importance of achieving public health policy objectives. It is critical to recall that existing 
flexibilities may be utilised by Members, where considered necessary and appropriate, to achieve 
their public health policy objectives.  Where Members feel that they are unable to use the TRIPS 
Agreement 's existing flexibilities, we encourage the sharing of evidence to understand this and 
discussion on how to navigate potential challenges.   
24.  It is also important to recall least developed co untries ' (LDCs) exemption from implementing 
the TRIPS Agreement 's substantive obligations until July 2034 or upon graduation, whichever comes 
first.  
6  ROLE OF WTO AND OTHER STAKEHOLDERS  
25.  Recognising the growing importance of trade and technology transfer, Me mbers should consider 
how the WTO can drive forward shared interests on voluntary licensing and technology transfer.   
26.  The WTO has a role to play in progressing equitable access ambitions through a holistic trade 
approach. It has experience of progressing t his ambition as exemplified by the Ministerial Declaration 
on the WTO Response to the COVID -19 Pandemic and Preparedness for Future Pandemics of 17 June 
2022. The United Kingdom recognises the ongoing work to address trade barriers within the 
Committee on Market Access (CMA), and the need for coordination across WTO committees.   
27.  It is evident that voluntary licensing and/or technology transfer is a complex and cross -cutting 
topic which will require constructive engagement across the WTO Membership. There sh ould be a 
particular focus on the experiences of and challenges faced by developing and least developed 
countries to better identify pragmatic next steps.   
28.  Voluntary licensing and technology transfer is a complex but essential tool for achieving 
equitable access. WTO bodies of relevant competence, recognising the increasing importance of 
technology transfer in trade policy limited not only to health, may benefit from examining how their 
competency may help or hinder the formation of voluntary licensing and technology transfer 
partnerships.  
29.  To ensure any discussion is underpinned by evidence, the involvement of external stakeholders 
with expertise should also be considered, such as the World Intellectual Property Organisation 
(WIPO) and World Health Organisa tion (WHO), as part of their ongoing trilateral cooperation. The 
role of business, civil society, and academia should also be considered. Such discussions could be 
held as part of thematic sessions organised by TRIPS Council as they relate to IP aspects of  a 
partnership.   
30.  There is also scope for discussion at the Working Group on Trade and Technology Transfer 
(WGTTT). It may be used as a forum to address the cross -cutting aspects of policy questions, share 
experience, explore challenges, and consider possib le recommendations on steps that might be 
taken within the mandate of the WTO, including within TRIPS Council and other forums of relevant 
competency, to increase technology transfer flows between countries, particularly to developing and 
least developed c ountries.  
31.  We welcomed the recent WGTTT Chair consultations on how members might better use this 
forum and seek to engage constructively in conversations that might enrich the broader discussions 
at the WTO.   
 
 
8 https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/WT/MIN22/31.pdf&Open=True  IP/C/W /704 
 
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  7  CONCLUSION  
32.  As a first step, Members should consider what experiences of IP 's connection with voluntary 
licensing and/or technology transfer can be brought to the TRIPS Council which could progress 
discussion. To achieve this, the UK supports suggestions to expand the TRIPS Council agenda ite m 
“IP and COVID -19” to include “Pandemic Preparedness”. This communication should be used to kick -
start a longer dialogue on pertinent policy questions focused on progressing collective efforts for 
pandemic preparedness which can be incorporated with other  WTO forums of relevant competency 
such as the WGTTT and CMA.   
Questions to initially consider include but are not limited to:   
 
a. Noting the importance and prevalence of voluntary licensing and/or technology transfer, 
how could Members facilitate further vo luntary licensing and/or technology transfer?   
b. What other factors may affect the successful formation of partnerships?  
c. What national and/or international, public and/or private stakeholder experiences could 
be brought for discussion? For example:   
i. How have domestic policies helped Member 's pandemic response efforts?   
ii. Where has a Member successfully incentivised technology transfer?  
iii. Where has an entity in a Member successfully been the recipient of technology transfer 
and/or voluntary licensing and what  were the factors for success?  
iv. Where has an entity in a Member been unsuccessful in forming a partnership – if so, 
why?  
d. What challenges have entities in a Member experienced previously in securing voluntary 
licensing and/or technology transfer partnershi ps, and how were they overcome?  
e. What challenges are Members currently experiencing in helping facilitate partnerships?   
  IP/C/W /704 
 
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  ANNEX A:  
 EXAMPLES OF SUCCESSFUL VOLUNTARY LICENSING AND/OR TECHNOLOGY TRANSFER 
PARTNERSHIPS AND THEIR IMPACT  
Information contained w ithin this Annex was provided by the Association of the British 
Pharmaceutical Industry (ABPI) and International Federation for Pharmaceutical Manufacturers and 
Associations (IFPMA), with other material publicly available from the Medicines Patent Pool (MP P). 
 
Pfizer  
 
1. Reflecting the urgency of the situation, Pfizer 's agreement with the MPP was signed in 
November 2021, before its antiviral had received approval or emergency use authorisation 
anywhere. The agreement covers 95 countries, and sublicensing agree ments for the generic 
version of Pfizer 's oral COVID -19 treatment are in place with a large number of generic 
partner companies.  
 
2. As of June 2023, Pfizer and BioNTech have shipped 4.6 billion vaccine doses to 181 countries 
and territories around the world . The partnership between the two companies is an example 
of the collaboration involved in not only development of COVID -19 vaccines, but also in their 
manufacturing and distribution.    
 
3. Pfizer and BioNTech had been working together since 2018 on a potential mRNA vaccine for 
influenza, so there was an existing relationship and trust between the partners. Reflecting 
the urgency of the situation in March 2020, the two companies signed a Mate rial Transfer 
and Collaboration Agreement for co -development and distribution of a potential COVID -19 
vaccine. This allowed them to immediately start to work together on a range of areas 
including development and manufacturing, and finalize the details of their partnership at a 
later date.    
 
4. Under the agreement between the companies, BioNTech retained the IP rights to the vaccine 
and its related technology. Meanwhile, Pfizer contributed its expertise and capabilities in 
R&D, regulatory work, production and  distribution. This included working with BioNTech to 
expand manufacturing capacity substantially to enable production at sufficient scale to 
respond to the pandemic.    
 
5. The work involved investing at risk, including scaling up manufacturing, before knowin g 
whether a vaccine would be successfully approved. With deployment of a new technology, 
mRNA, at scale for the first time, this also required building supply chains, including supplier 
networks and cold chain technologies, mid -crisis, from scratch.    
 
6. The manufacturing and supply network for the vaccine comprises over 20 sites in Europe, 
the US, Brazil and South Africa. It includes both sites operated by the two companies 
themselves and, critically, sites operated by their contract manufacturing partners.    
 
7. Technology transfer was a key enabler of this scale up. Core elements of this work included 
training, sharing of know -how, equipment installation, engineering and process qualification 
tests, and regulatory approvals.    
 
8. Technology transfer was facilitated by working with partners with strong track records on 
quality compliance and safety, technical capability, capacity availability; in many cases a 
prior working relationship was a vital enabler of this work on an accelera ted timeline.  
 
MSD 
 
9. In April 2021, prior to the completion of Phase 3 trials for molnupiravir and more than six 
months before its initial authorisation, MSD  entered into non -exclusive voluntary licensing 
agreements (VLAs) with multiple established Indian generics manufacturers, to facilitate 
availability of generic molnupiravir in more than 100 low - and middle -income countries 
(LMICs) following local approvals or emergency authorisation.  
 IP/C/W /704 
 
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  10. MSD currently has eight bilateral voluntary licensees producing gen eric molnupiravir. The 
selection criteria for these was important, and MSD selected manufacturers that were well 
known, and used to supplying with high manufacturing quality. Additionally, MSD 's 
agreement with the Medicines Patent Pool (MPP) – MPP's first voluntary license for a COVID -
19 medical technology – allows for sublicensing deals for supplies to 106 LMICs.  
 
11. Agreements are operational with more than 20 generic manufacturers from 10 countries 
(Bangladesh, China, India, Indonesia, Jordan, Kenya, Pakis tan, South Africa, South Korea, 
and Vietnam). Through these non -exclusive VLAs, the MPP sublicenses, and local 
manufacturing and supply partnerships established with companies in Brazil and China, 
MSD's voluntary collaborations cover approximately 90 perce nt of the population in LMICs.  
 
Gilead  
 
12. In May 2020, Gilead signed non -exclusive VLAs for remdesivir with generic pharmaceutical 
manufacturers based in India, Pakistan, and Egypt to enable them to supply remdesivir to 
127 developing countries.  
 
13. Since the  beginning of the pandemic, VEKLURY® and generic remdesivir have been made 
available to over 13 million patients around the world, including 8 million in low - and lower -
middle income countries (LLMICs) through Gilead 's voluntary licensing programme. Gilead 's 
voluntary licenses for remdesivir remain royalty free.  
 
Eli Lilly  
 
14. Lilly has signed voluntary royalty free license agreements with 8 generic manufacturers for 
baricitinib. The licensees set the price. Additionally, Lilly  announced a donations program 
making available courses of baricitinib free of charge to least, low, and middle -income 
countries and made donations to multiple countries, including India.  
 
Shionogi  
 
15. In October 2022, Japanese pharmaceutical company Shionogi, and MPP, signed a vo luntary 
licence agreement for Shionogi 's antiviral candidate ensitrelvir fumaric acid (S -217622).  
 
16. Under the terms of the licence agreement between Shionogi and MPP, qualified generic 
manufacturers that are granted sublicences by MPP will be able to manufa cture and supply 
ensitrelvir to 117 countries, pending regulatory authorisation or approval in those countries. 
In June 2023, s ublicence agreements were signed with three generic manufacturing 
companies from China ; two from India ; and one from Vietna m. 
 
17. Shionogi will waive royalties on sales in all countries covered by the agreement while COVID -
19 remains classified as a Public Health Emergency of International Concern by the World 
Health Organization (PHEIC).  
 
AstraZeneca  
 
18. In the early stages of the pand emic AstraZeneca partnered with Oxford University to enable 
global development, manufacturing and distribution of the vaccine. The result was a COVID -
19 vaccine that was developed in under a year. AstraZeneca 's approach has been to share 
technology and kno w-how with more than 20 experienced vaccine manufacturing 
organisations in countries where production can be ramped up at scale. For example, their 
voluntary licensing agreements with the Serum Institute of India (SII) and Fiocruz in Brazil 
facilitated the  scaling -up of manufacturing across the world.  
 
19. AstraZeneca believe this offers a more effective way of scaling up production and supporting 
innovation, and AstraZeneca 's model has enabled them to supply over 3 billion doses to 180 
countries around the wo rld. Approximately two thirds of the doses have gone to low and 
lower middle -income countries. Together with their partners they made a significant impact 
in terms of global public health. Based on data published in The Lancet and an analysis by 
Airfinity,  AstraZeneca 's vaccine is estimated to have saved over 6 million lives in the first IP/C/W /704 
 
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  year of vaccination. AstraZeneca was the first and largest contributor in 2020 and 2021 to 
COVAX, the global initiative for equitable access.  
 
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