- This communication summarizes the technical cooperation activities of the WHO in the area of public health, innovation and intellectual property that have taken place since the last report in October 2021 (document IP/C/R/TC/WHO/2). The overall objective of WHO's technical cooperation is to strengthen the capacity of developing countries in the areas of health innovation, access to medicines and management of intellectual property.
- WHO's technical cooperation is based on its mandate derived from the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI) as well as relevant resolutions and decisions of the World Health Assembly, including WHA72.8 on 'Improving the transparency of markets for medicines, vaccines, and other health products1', WHA73.1 on the 'COVID-19 response2', WHA74.6 on 'Strengthening local production of medicines and other health technologies to improve access3' and WHA75.14 on the extension of the time frame of the 'Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property' from 2022 to 2030.4
- In resolution WHA74.6, the Seventy-fourth World Health Assembly emphasized the need to improve access to quality, safe, effective and affordable medicines and other health technologies, inter alia, through cooperation with, support to and development of voluntary patent pools and other voluntary initiatives, such as the WHO COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool. WHA74.6, inter alia, requested the WHO Director-General to continue to provide technical support, as appropriate, upon request, in collaboration with other competent international organizations, in particular WIPO and WTO, including to policy processes and to countries that intend to make use of the provisions contained in the TRIPS Agreement, including the flexibilities affirmed by the Doha Declaration on the TRIPS Agreement and Public Health in order to promote access to pharmaceutical products.5
- WHO, through its headquarters, regional and country offices collaborates closely with relevant international organizations on topics related to the interface between public health, innovation, intellectual property and trade. WHO has requested full support and collaboration from World Intellectual Property Organization (WIPO), World Trade Organization (WTO) and other international organizations to ensure efficient and effective implementation of certain prioritized actions of the GSPA-PHI overall programme review panel. Activities focus on technical guidance, transfer of technology, local manufacturing, capacity-building and training, and direct technical assistance to countries. WHO, WIPO and WTO are also working in close collaboration to respond to the challenges posed by the COVID-19 pandemic in relation to the integrated health, trade and IP policy framework, including equitable access to COVID-19 health technologies, such as medicines, vaccines, medical devices, and diagnostics.
2 AN INTEGRATED HEALTH, TRADE AND INTELLECTUAL PROPERTY APPROACH TO RESPOND TO THE COVID-19 PANDEMIC
- On 30 August 2021, WHO, WIPO and WTO launched an update of the information note 'Integrated health, trade and IP approach to respond to the COVID-19 pandemic'.6 This information note maps the challenges posed by the COVID-19 pandemic in relation to the integrated health, trade and intellectual property framework set out in the second edition of the Trilateral Study on 'Promoting Access to Medical Technologies and Innovation'.7 The update contains developments up until 30 August 2021, including on the impact of COVID-19 on health systems and responses at the global level, policy challenges, meeting the demand for health technologies and medical services, international trade, intellectual property aspects, international initiatives to support research and development and equitable access, regulatory responses, transparency and mapping the way forward.
3 INTENSIFIED COOPERATION IN SUPPORT OF ACCESS TO MEDICAL TECHNOLOGIES WORLDWIDE TO TACKLE THE COVID-19 PANDEMIC
- Within the existing Trilateral collaboration framework between WHO, WIPO and WTO, the COVID- 19 Technical Assistance Platform was created as a one-stop shop for the three organizations to make available their expertise in public health, IP and trade matters in a coordinated and systematic manner to help Members address the COVID-19 pandemic.8 The Platform also facilitates the provision of tripartite technical assistance on the pathways for accessing vaccines, medicines and technologies, including through coordination between members facing similar challenges to facilitate collective responses.
- The Directors-General of the WHO, WIPO and WTO agreed to organize practical capacity-building workshops at the technical level to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies.9 The first in the series of workshops titled 'WHO, WIPO, WTO Workshop on Innovation in, and Access to, COVID-19 Technologies' was held on 27 September 2021 to discuss technology transfer and licensing as specific IP policy options. The workshop, held virtually, conveyed information to enhance knowledge and understanding of how IP, know-how and technology transfer work in practice, not only vis-à-vis medical technologies but also for related products and services. This was aimed at strengthening the capacity of policymakers and experts in member governments to address the pandemic accordingly.10
- On 1 February 2022, the Directors-General of WHO, WIPO and WTO met in Geneva to review progress made on the initiatives announced in their Joint Statement during their previous meeting in June 2021.11 They welcomed the launch of the trilateral technical assistance platform and reviewed the series of technical capacity building workshops planned, starting with the workshop on intellectual property licensing and technology transfer held in September 2021. The Directors- General also welcomed the ongoing efforts by their three organizations to make up-to-date information available, including the series of joint COVID-19 information notes to update the Trilateral Study 'Promoting Access to Medical Technologies and Innovation'. Finally, the three Directors-General confirmed that they would convene a high-level policy symposium in 2022 on the COVID-19 pandemic, taking stock of COVID-19 challenges and focusing on what is needed to recover from this health crisis and better prepare for future ones.
- On 28 February 2022, WHO, WIPO and WTO jointly organized a workshop focused on access and use of information resources for COVID-19 response.12 The purpose of the workshop was to enhance understanding of the characteristics, potential uses and limitations of particular information sources related to the pandemic. Points raised for future consideration included the connection of various data resources, the importance of coherent information across resources, the utility of expanding resources to include data related to other diseases and how to leverage or improve resources to prepare for future pandemics.
4 COVID-19 TECHNOLOGY ACCESS POOL (C-TAP)
- Since its creation in May 2020, the WHO COVID-19 Technology Access Pool (C-TAP) has prioritized engagement with technology holders to encourage sharing of intellectual property, know- how or data to promote global equitable access of COVID-19 vaccines, therapeutics, diagnostics or other medical devices. In November 2021, under the auspices of C-TAP, the Medicines Patent Pool (MPP) signed a worldwide license with the Spanish National Research Council (CSIC) for a COVID- 19 serological antibody diagnostic test.13 The diagnostic test effectively checks for the presence of anti SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine. This license was the first transparent, global, non-exclusive license for a COVID-19 health tool, and the first test license signed by MPP and included in C-TAP. The license will facilitate the rapid manufacture and commercialization of CSIC's COVID-19 serological test worldwide. The agreement covers all related patents and the biological material necessary for manufacture of the test. CSIC will provide all know-how to prospective licensees as well as training. The license will be royalty-free for low- and middle-income countries and will remain valid until the date the last patent expires.14 The MPP subsequently sublicensed this technology to Biotech Africa to promote access in low and middle-income countries.15 Under the sublicense, CSIC will share all proprietary know-how and other technical knowledge relating to its patent rights which may be necessary for Biotech Africa to make full use of the patents and biological material.16
- In May 2022, under the auspices of C-TAP, the MPP signed two licensing agreements with the United States National Institutes of Health (NIH) for the development of 11 innovative therapeutics, early-stage vaccines and diagnostic tools for COVID-19.17 This was the second worldwide, non-exclusive and transparent license for technologies included in C-TAP. The license was granted after an assessment of the technologies by C-TAP's Technical Advisory Group (TAG).18
- On its second-year anniversary, C-TAP organized a Panel Discussion Webinar to stimulate the debate on advancing C-TAP's ability to promote equitable access to COVID-19 health technologies, informed by two papers prepared by the C-TAP Secretariat. The first paper reviewed existing literature on technology transfer and affordable access in funding agreements in the context of medical products to address pandemic diseases. The review focused on specific contractual terms and conditions and associated policies related to the funding of research and development (R&D), clinical trials, and the manufacturing of medical products, particularly those needed to respond to international public health crises. The second paper provided in its first section a summary of responses by Member States to a WHO C-TAP incentive questionnaire.
- The questionnaire listed a set of measures that could be implemented by Member States to encourage technology holders to pool technologies through C-TAP. The second part of the paper included a review based on academic papers, conferences, and any other publicly available resource that was undertaken by C-TAP Secretariat to complement and facilitate the discussion. Panelists and participants were invited to share their views on how to make C-TAP more attractive to technology holders based on the findings from the two papers.19
5 THE mRNA VACCINE TECHNOLOGY TRANSFER HUB
- In June 2021, WHO in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance, collaborated with a South African consortium (comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the African Centers for Disease Control and Prevention) to establish the first COVID-19 mRNA vaccine technology transfer hub located in Cape Town, South Africa.20 The creation of the technology transfer hub is a strategy to build capacity in low- and middle- income countries to produce mRNA vaccines, thus promoting equitable access in under- served regions.21 The technology transfer hub will perform clinical development of licensed technology and serve as a training facility for interested manufacturers from low-and middle-income countries. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.
- On 18 February 2022, WHO announced the first recipients of technology from the mRNA vaccine technology transfer hub to produce mRNA vaccines.22 The first selected countries are Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia. WHO and partners will work with the beneficiary countries to develop a roadmap for necessary training and support so that they can start producing vaccines on the African continent. As of August 2022, the list of recipients has been expanded to include Argentina, Brazil, Bangladesh, India, Indonesia, Pakistan, Serbia, Ukraine and Viet Nam.23 The WHO mRNA technology transfer hub is part of a larger effort aimed at empowering low- and middle- income countries to produce their own vaccines, medicines and diagnostics to address health emergencies and reach universal health coverage.
- On 23 February 2022, WHO led the establishment of a global bio-manufacturing training hub in the Republic of Korea to serve all low- and middle-income countries wishing to produce biologicals, such as vaccines, insulin, monoclonal antibodies and cancer treatments.24 The facility located outside Seoul, will provide technical and hands-on training on operational and good manufacturing practice requirements and is set to complement the trainings delivered by the mRNA vaccine technology transfer hub in South Africa.
- As part of the 'Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and other Health Technologies in the Americas' initiative led by the Pan American Health Organization in collaboration with WHO and the Medicines Patent Pool, a group of vaccine manufacturers from Brazil and Argentina were the first to receive technology transfer training in mRNA vaccines.25 The training was carried out at Afrigen in South Africa. It is aimed at scaling up local manufacturing capacity to improve equitable access to essential medicines and health technologies in the Latin American region.
6 ACCESS TO COVID-19 TOOLS ACCELERATOR (ACT-A)
- ACT-A was launched in April 2020 as a collaborative effort to accelerate the development, production and equitable access to COVID-19 tests, treatments, and vaccines. ACT-A is organized around three main pillars of work: diagnostics, therapeutics and vaccines (COVAX), with a cross- cutting Health Systems and Response Connector (HSRC) and Access and Allocation workstream. As of 30 June 2022, COVAX, the vaccines pillar of ACT-A, has delivered more than 1.6 billion COVID- 19 vaccine doses.26 The Diagnostics pillar has procured more than 175.7 million tests and more than USD 767 million worth of personal protective equipment (PPE). The therapeutics pillar has procured over USD 578 million worth of medical oxygen supplies and repaired 180 Pressure Swing Adsorption (PSA) plants. Other major achievements of ACT-A include funding research and development of new therapeutics, diagnostics and vaccines, as well as supporting the market entry of new, affordable rapid tests.27
- In January 2022, WHO partnered with UNICEF and Gavi, the Vaccines Alliance, to create the COVID-19 Vaccine Delivery Partnership to expedite vaccine delivery in 34 countries that were at or below 10% full vaccination coverage to progress towards national and global targets.28 This initiative prioritizes full vaccination and boosters for high-priority populations such as older adults, health care workers and persons with co-morbidities.
7 MULTILATERAL LEADERS TASK FORCE ON COVID-19 VACCINES, THERAPEUTICS AND DIAGNOSTICS
- The Multilateral Leaders Task Force, co-led by WHO, WTO, the World Bank Group and the International Monetary Fund, held a series of meetings between October 2021 and December 2021.29 On 9 November 2021, the Task Force held the 2nd High Level Consultations with the CEOs of leading COVID-19 vaccine manufacturing companies.30 The objective of the meeting was to identify how to ensure more equitable distribution of vaccines and all those participating pledged to continue working together to gain greater clarity on donations, vaccine swaps and delivery schedules so that distribution of the life-saving vaccines can be more effectively targeted towards those countries most in need. At the meeting, all participants agreed on the urgency of delivering more vaccine doses to low-income countries, where less than 2.5% of the population has been fully vaccinated.
- At its eighth meeting in March 2022, the Task Force focused on rapid vaccine delivery to where they are needed the most and putting those vaccines into arms.31 In its joint statement, the Task Force called for sustained investment in geographically diversified manufacturing capacity and new technologies for vaccines, therapeutics, and diagnostics as key for ensuring more equitable, affordable, and timely access to tools for developing countries. It also emphasized close coordination among all stakeholders as crucial to aligning supply with demand, reducing supply fragmentation, and deploying vaccines in the most effective way.
- The Task Force, along with ACT-A, rolled out the 'COVID-19 Global Tracker' – a new tool designed to track progress towards ending the COVID-19 pandemic along key dimensions, including access and deployment of vaccines, treatments, tests, PPE, other tools, and the financing needed to end the pandemic.32