WT/GC/W/899  
 
19 July 2023  
(23-4911) Page: 1/8 
General Council  Original: English  
 
  
INTELLECTUAL PROPERTY, VOLUNTARY LICENSING AND TECHNOLOGY TRANSFER  
COMMUNICATION FROM THE UNITED KINGDOM* 
The following communication, dated 18 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 World 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 conti nue 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 conte xt 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 gr owing 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 in volvement 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 u p of production 
for essential COVID -19 products, helping improve access, including pricing, and availability, but also 
represent the importance of international collaboration during times of a PHEIC.  
 
* This communication was also circulated as IP/C/W/704 on 14 July 2023.  
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/publications/en/details.jsp?id=4589   
3 https://www.wipo.int/publications/en/details.jsp?id=4658  WT/GC/W/899  
 
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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 ackno wledge the growing discourse and ideas 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 fa ctors influencing and 
underpinning the 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 experience 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 bei ng declared a PHEIC, the framework helped 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 through 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 t he international minimum standards agreement 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 mutually 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 dissemina te 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 equitabl e 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 d evelopment, and the confidence it provides 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 eligib ility 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 relationship 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.  Dema nd 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 e nsuring willingness from the 
government 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  WT/GC/W/899  
 
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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 technol ogy flows, which 
may be beneficial in 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 instituti ons in their territories for the purpose 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, WTO 
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 formation.  
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 the formation of partnerships in closer detail.  
19.  Such factors may include, but are not limited to, the availability of sustainable manufacturing 
capacity; sustain able market demand underpinned by policy and demand forecasting which create 
incentives for licensees and/or generic companies; experience of manufacturing the relevant 
product; the availability of skilled personnel; adherence to harmonised regulatory stan dards 
including those recognised internationally; rule of law being established and enforced supportive of 
an innovation -friendly environment; being a trusted partner demonstrating behaviour conducive to 
trust-based relationships; and clear economic develo pment priorities which promote technology 
transfer and inward investment for continual development. 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 remain high, which can have a cumulative impact 
on manufacturing costs.6  
21.  The use of export restrictions can cause significant disruption to global trade, leadin g 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 dome stic 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 biolog ical 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   WT/GC/W/899  
 
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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 situations, 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 ne cessary 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 navigat e potential challenges.   
24.  It is also important to recall least developed countries ' (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 STAKEHOLDE RS 
25.  Recognising the growing importance of trade and technology transfer, Members 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 ambit ions through a holistic trade 
approach. It has experience of progressing this 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 reco gnises 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 whic h will require constructive engagement across the WTO Membership. There should 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 te chnology 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 the ir 
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 Organisation (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 th ematic 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 p olicy questions, share 
experience, explore challenges, and consider possible 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 countries.  
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 broade r discussions 
at the WTO.   
 
8 https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/WT/MIN22/31.pdf&Open=True  WT/GC/W/899  
 
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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 item 
"IP and COVID -19" to include "Pandemi c 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 voluntary 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 helpe d 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 succes s?  
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 partnerships, and how were they overco me?  
e. What challenges are Members currently experiencing in helping facilitate partnerships?   
  WT/GC/W/899  
 
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  ANNEX A:  
EXAMPLES OF SUCCESSFUL VOLUNTARY LICENSING AND/OR TECHNOLOGY TRANSFER 
PARTNERSHIPS AND THEIR IMPACT  
Information contained within 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 (MPP).  
 
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 agreements 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 betwee n 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 knowing 
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 ma nufacturing 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 b y 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 accelerated timeline.  
 
MSD 
 
9. In April 2021, p rior 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.  
 WT/GC/W/899  
 
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  10. MSD currently has eight bilateral voluntary licensees producing generic molnupiravir. The 
selection crit eria 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 medi cal 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, Pakistan, South Africa, South Korea, 
and V ietnam). 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 percent 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 voluntary 
licence agreement for Shiono gi'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 manufacture and supply 
ensitrelvir to 117 countries, pending regulatory authorisation or approval in those countries. 
In June 2023, sublicence agreements were signed with three generic manufacturing 
companies from China; two from India; and one from Vietnam.  
 
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 pandemic 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 know -how with more than 20 experienced va ccine 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 th e 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 world. Approximately two thirds of the d oses 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 WT/GC/W/899  
 
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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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