1. This communication summarizes the technical cooperation activities of the World Health Organization (WHO) in the area of public health, innovation and intellectual property that have taken place since the last report in October 2020 (document IP/C/R/TC/WHO/1). 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.
2. 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 other relevant resolutions of the World Health Assembly, including WHA72.8 on 'Improving the transparency of markets for medicines, vaccines, and other health products', WHA73.1 on the 'COVID-19 response', and WHA74.6 on 'Strengthening local production of medicines and other health technologies to improve access'. Resolution WHA72.8, in particular, requests the Director-General to continue supporting existing efforts to determine the patent status of health products and promote publicly available user-friendly patent status information databases for public health actors and to work with other relevant international organizations and stakeholders to improve international cooperation, avoid duplication of work, and promote relevant initiatives.
3. In resolution WHA73.1, the Seventy-third World Health Assembly, inter alia, called on international organizations and other stakeholders to work collaboratively at all levels to develop, test, and scale-up production of safe, effective, quality, affordable diagnostics, therapeutics, medicines and vaccines for the COVID-19 response, including existing mechanisms for voluntary pooling and licensing of patents in order to facilitate timely, equitable and affordable access to them, consistent with the provisions of relevant international treaties, including the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the flexibilities within the Doha Declaration on the TRIPS Agreement and Public Health.
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 WIPO, 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, and diagnostics.
An integrated health, trade and IP approach to respond to the COVID-19 pandemic
6. WHO, WIPO, and WTO will soon launch an update of the information note in the Trilateral Study on 'An Integrated Health, Trade and Intellectual Property Approach to Respond to the COVID-19 Pandemic.' The text maps the challenges posed by the COVID-19 pandemic in relation to the integrated health, trade and intellectual property policy framework set out in the second edition of the Trilateral Study on Promoting Access to Medical Technologies and Innovation. 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.
COVID-19 Technology Access Pool (C-TAP)
7. In May 2020, the WHO COVID-19 Technology Access Pool (C-TAP) was launched by WHO, in partnership with the Government of Costa Rica, under a global Solidarity Call to Action endorsed by nearly 40 Member States. C-TAP provides a platform for developers of COVID-19 therapeutics, diagnostics, vaccines and other health products to voluntarily share their intellectual property, knowledge, and data, with multiple quality-assured manufacturers. This enables manufacturers that currently have untapped capacity to produce COVID-19 health products by giving them the legal rights to manufacture and sell the products; the technological know-how required to develop high‑quality products effectively and efficiently; and access to clinical data needed to obtain regulatory approval for their products.
8. C-TAP has been monitoring the patent and licensing status information and access challenges of vaccines, therapeutics, and in vitro diagnostics prioritized by WHO,, vaccines in the COVID-19 vaccine tracker and landscape., diagnostics in the FIND COVID‑19 Test Directory, and therapeutics in the Therapeutics and COVID-19: living guideline. C-TAP and its implementing partners have engaged COVID-19 vaccine, diagnostic, and therapeutic technology holders in bilateral discussions. On 28 May 2021 during a special press conference to mark the first anniversary of C-TAP, the Spanish National Research Council (CSIC) announced its intention to make its COVID-19 serological test technology available to C-TAP. C-TAP has held consultations and bilateral meetings with key stakeholders, including but not limited to, private sector, civil society organizations, international organizations, universities, national and regional research institutes, technology transfer offices, and technology seekers.
9. Among such meetings, the UK Government, working through the UK Intellectual Property Office, and WHO held a joint seminar on C-TAP to hear views and suggestions on how C-TAP can promote the detection, prevention and treatment of COVID-19. During the 14 January 2021 private sector consultation, WIPO Assistant Director General of Intellectual Property and Innovation Ecosystems participated as a speaker in the panel discussion on voluntary licensing and patent pooling. More information on consultations and events is available on the C-TAP events webpage. C-TAP also engages with WHO Member States to implement the Solidarity Call to Action and create an enabling environment to encourage sharing through C-TAP.
10. For example, an online Member States questionnaire is being conducted on national and regional incentives to facilitate scale up and access to COVID-19 health technologies, including vaccines, diagnostics, and therapeutics. WHO has been interacting with other key stakeholders, including COVID-19 research and development funders, international organizations, research institutes, academia and civil society, and technology seekers, to support C-TAP's goals and objectives. C-TAP has also been actively engaged in catalysing synergies with other global initiatives such as the COVID-19 Vaccines Global Access initiative (COVAX), the Access to COVID-19 Tools Accelerator (ACT-A), and the WHO COVID-19 mRNA vaccine manufacturing taskforce.
11. ACT-A is a collaboration to accelerate the development, production and equitable global access to new COVID-19 essential health technologies. ACT-A is organized around four main pillars of work: diagnostics, treatment, vaccines and a cross-cutting pillar on health systems strengthening. As of 19 July 2021, COVAX, the vaccines pillar of ACT-A, has shipped more than 129 million vaccines to more than 136 economies. Major achievements of the diagnostics pillar include procurement of over 27 million molecular tests and 12 million rapid antigen tests for low- and middle-income countries. WHO and partners established the COVAX Manufacturing Task Force as a proposed pathway to increasing supply and ensuring regional health security.
12. The Task Force aims to increase immediate supply (three to six months) for existing vaccines, ensure vaccines coming onto market can be produced at maximum scale and not constrained by existing contracts, enable low- and middle-income countries to acquire COVID-19 vaccine production technology and establish sustainable outbreak response capacity for regional health security. As part of the task force, WHO established in April 2021 a COVID-19 mRNA vaccine technology transfer hub to scale up global manufacturing. WHO and its COVAX partners are working with a South African consortium to establish first COVID mRNA vaccine technology transfer hub. Future hubs for other technologies, such as viral vectors and proteins, are foreseen. The WTO Secretariat is actively contributing to the workstreams of the COVAX Manufacturing Task Force.
WTO-WHO High Level Dialogue: Expanding COVID-19 Vaccine Manufacture to Promote Equitable Access
13. On 21 July 2021, WTO and WHO co-hosted a high-level dialogue on expanding COVID-19 vaccine manufacture to promote equitable access. The dialogue brought together representatives from vaccine manufacturers, governments, public health advocacy groups, and development finance institutions. The Directors-Generals of the WHO, WIPO, and WTO offered opening remarks. The remainder of the dialogue took place under Chatham House Rules. WHO Director-General, Dr Tedros Adhanom Ghebreyesus, called on funders and industry to facilitate voluntary, transparent and non-exclusive licensing of patents, transfer of know‑how and data through the COVID-19 Technology Access Pool (C-TAP).
Fair Pricing Forum 2021
14. From 13-22 April 2021, WHO hosted the third Fair Pricing Forum with support from the Ministry of Health of Argentina. The virtual forum focused on improving access to medicines and health products through fair pricing and follows previous events held in the Netherlands in 2017 (10‑11 May) and in South Africa in 2019 (11-13 April). The Forum brought together representatives from Member States and relevant stakeholders from civil society, academia, private health sector and UN agencies with the aim of 1) sharing countries' experiences, including from the COVID-19 pandemic, in ensuring affordability and transparency of prices and costs of health products; 2) advancing discussion and knowledge on approaches and system factors pertaining to the pricing and R&D of pharmaceutical products for enhancing affordability, transparency, and innovation, and achieving health sustainable development goals; and 3) activating additional support for countries to achieve more affordable and fairer access to pharmaceutical products during the COVID-19 pandemic and beyond.
15. On 21 April 2021, a plenary session titled 'Moving towards fair prices by public health-driven application and management of Intellectual Property' was held to encourage the application and management of intellectual property in a manner that maximizes health-related innovation and promotes access to health products and that it is consistent with the provisions in the TRIPS Agreement and other WTO instruments. The objectives of the session were to 1) facilitate an open exchange on the recent initiatives related to the application and management of IP to promote equitable access to health technologies, particularly during extreme situations, 2) promote a better understanding of how different initiatives could support the achievement of the same goal, and, 3) understand how intellectual property laws and policies could be implemented in a manner that maximizes public health-driven research and development and equitable access for all. The session featured, among others, speakers from the Intellectual Property, Government Procurement and Competition Division of WTO, the Medicines Patent Pool, the International Federation of Pharmaceutical Manufacturers & Associations, and the South African Permanent Mission to the World Trade Organization.
COVID-19 and Vaccine Equity: What can the WTO Contribute?
16. On 14 April 2021, WTO organized a meeting among governments, vaccine manufacturers, civil society and international organizations which aimed to serve as the basis for dialogue aimed at delivering results in terms of increased vaccine production volumes in the short-term as well as longer-term investments in vaccine production and enhancing the trading system's contribution to pandemic preparedness. Among the speakers, WHO Director-General delivered remarks and outlined three ways in which WHO believes vaccine equity obstacles can be overcome, production can be increased and lives can be saved. He called on companies to share know-how, intellectual property and data with other qualified vaccine manufacturers, including in low-and middle-income countries, and invited COVID-19 health technology holders to share with the COVID-19 Technology Access Pool. He also urged countries to strengthen their regulatory capacity and invest in local vaccine manufacturing.
Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries
17. On 30 June 2021, WHO and WTO along with the World Bank Group and the International Monetary Fund issued a joint statement following the first meeting of the Multilateral Leaders Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics. The first meeting of the task force addressed the urgency of increasing supplies of vaccines, therapeutics, and diagnostics for developing countries, including practical and effective ways to track, coordinate and advance delivery of COVID-19 vaccines to developing countries. The joint statement called on G20 countries to take action to 1) embrace the target of at least 40% in every country by end-2021, and at least 60% by the first half of 2022, (2) share more vaccine doses now, including by ensuring at least 1 billion doses are shared with developing countries in 2021 starting immediately, (3) provide financing, including grants and concessional financing, to close the residual gaps, including for the ACT-Accelerator, and (4) remove all barriers to export of inputs and finished vaccines, and other barriers to supply chain operations.
Intensified cooperation in support of access to medical technologies worldwide to tackle the COVID-19 pandemic
18. On June 15, 2021, the Directors General of WHO, WIPO and the WTO met in a spirit of cooperation and solidarity to map out further collaboration to tackle the COVID-19 pandemic and the pressing global challenges at the intersection of public health, intellectual property and trade. The three Directors-General agreed to further build on the long-standing WHO-WIPO-WTO Trilateral Cooperation which aims to support and assist all countries as they seek to assess and implement sustainable and integrated solutions to public health challenges. The organizations agreed to enhance and focus their joint support in the context of the COVID-19 pandemic through two specific initiatives. The trilateral organizations will collaborate on the organization of practical, capacity‑building workshops to enhance the flow of updated information on current developments in the pandemic and responses to achieve equitable access to COVID-19 health technologies. Furthermore, the three organizations will implement a joint platform for tripartite technical assistance to countries relating to their needs for COVID-19 medical technologies, providing a one‑stop shop that will make available the full range of expertise on access, intellectual property and trade matters in a coordinated and systematic manner.
World Local Production Forum: Enhancing access to medicines and other health technologies
19. From 21-25 June 2021, WHO, with the support of Member States and partners, organized the first virtual World Local Production Forum (WLPF). The WLPF is a regular forum for the global community comprising foremost government leaders, technology experts, representatives of industry associations, the international community and other stakeholders under the auspices of WHO, and the co-host of Ethiopia, for public health impact. The first WLPF provided a global arena to stimulate dialogue and collaboration on opportunities and mechanisms for the promotion of local production and technology transfer as part of health technology programmes in line with national, regional and global health needs. The first WLPF aimed to call Member States' attention in aligning the production of health products as essential long-term infrastructure to protect national, regional and global security. It also aimed to transform the spirit of the first interagency statement on promoting local production into practice. The objectives of the Forum included: 1) to provide a global platform to discuss challenges in promoting local production and technology transfer to improve access to quality, safe and effective health products and technologies, and to safeguard global, regional and national health security, 2) to identify priority health technologies with greatest need for transfer to LMICs to address challenges like shortages, high prices and monopolies, 3) to explore mechanisms and opportunities to promote/facilitate the transfer and local production of high priority technologies in LMICs, 4) to identify key areas of training that support capacity-building for local production and technology transfer, 5) to promote partnerships and business linkages in the areas of technology transfer and local production, 6) to provide recommendations and actions for implementation by stakeholders.
COVID-19 Vaccine Supply Chain and Regulatory Transparency Symposium
20. On 29 June 2021, WTO hosted the COVID-19 Vaccine Supply Chain and Regulatory Transparency Symposium. The technical symposium was opened with remarks from the Deputy Director-General, WTO, the Assistant Director-General, WHO, and the Deputy Secretary-General, World Customs Organization. The event featured the following sessions: Mapping vaccine manufacturing and trade; Mapping cross-border movement of vaccine inputs; Promoting transparency and convergence in the regulatory landscape, and; Beyond vaccines: mapping other COVID-19 essential health technologies and trade. The symposium closed with remarks from the Deputy Director-General, WTO.
Training and Enhancing Capacity WTO Technical Workshop Organized by the WTO Secretariat with the cooperation of the WHO and WIPO Secretariats
21. On 21 October 2020, the WTO Secretariat, with the cooperation of the Secretariats of WHO and WIPO, organized a technical workshop titled 'An Integrated Health, Trade and Intellectual Property Approach to Address the COVID-19 Pandemic.' The workshop was intended for policymakers and aimed at building capacity to assess domestic health systems, intellectual property regimes and trade policy settings to use these tools effectively in an integrated and coherent way to respond to the pandemic. WHO presented an overview of health challenges posed by the pandemic, discussed the importance of ensuring transparency in accordance with IHR 2005, outlined regulatory challenges, approval of vaccines and repurposed medicines, the solidarity clinical trials, the WHO procedure for emergency use listing, presented on procurement of medicines/vaccines, and delineated an overview of key initiatives to promote public health, development of new products, as well as an effective response to the pandemic, including the WHO Access to COVID-19 Tools Accelerator (ACT-A), WHO Resolution WHA73.1 on the COVID-19 response, the Solidarity Call to Action and the COVID-19 Technology Access Pool (C-TAP), and COVID-19 Vaccines Global Access (COVAX).
Virtual Sub-regional Meeting on Public Health for Selected Arab Countries
22. On 30 November 2020 and 1 December 2020, WIPO hosted a Virtual Sub-regional meeting on Intellectual Property, Innovation and Public Health for selected Arab Countries. The event was organized by WIPO in cooperation with the Egyptian Patent Office (EgPO), WTO and WHO. WHO participated in a roundtable discussion on Mapping the interface between health, trade and intellectual property – key issues, and provided comments on The WTO TRIPS Agreement and public health. A representative from the WHO Regional Office for the Eastern Mediterranean Region (EMRO) presented on The regional public health context: overview and determinants for access. WHO also provided comments to The patent system International framework, implementation, flexibility; patentability criteria; patent examination; exceptions and limitations (scientific research exception; regulatory review exception, exhaustion, compulsory and government use licenses); pre- and post-grant opposition; patent information. A WHO Headquarters representative presented on Health regulation and substandard and falsified health technologies and WHO also provided comments Health-related provisions in bilateral and regional trade agreements.
WTO Virtual Workshop on the Implementation of Article 66.2 of the TRIPS Agreement: Incentives for Technology Transfer to least developed countries (LDCs)
23. From 2-4 and 10 March 2021, WTO hosted a virtual workshop on incentives for technology transfer to least developed countries (LDCs) under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The aim of the workshop was 1) to facilitate communication between LDC members and developed country members 2) to promote the effective implementation of Article 66.2 of the TRIPS Agreement on technology transfer to LDCs and 3) to enable LDCs to create a sound and viable technological base essential for addressing current and future challenges. WHO participated in Theme I of the workshop on technology transfer in the area of health technologies. The WHO representative highlighted relevant recommendations prioritized by the WHO overall programme review panel of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI), including recommendation 14 which recommend that the WHO Secretariat work with the Secretariat of WTO to identify how Article 66(2) of the TRIPS Agreement could be implemented more effectively in relation to health technology transfer in countries. Recommendation 15 of the review panel calls on the WHO Secretariat to identify new opportunities for collaboration with other United Nations organizations (e.g. UNIDO, UNCTAD) to promote technology transfer as part of local health technology production programmes in developing countries in line with country needs.
Health, IP and Trade Workshop for ECOWAS Member States
24. On 22-23 March and 29 March 2021, WTO and the Economic Community of West African States (ECOWAS) Commission, in collaboration with WHO and WIPO, organized a three-day virtual workshop on health, intellectual property and trade policy-making for ECOWAS member states and the ECOWAS Commission. WHO participated in a roundtable discussion on Mapping the Interface between Health, Trade and Intellectual Property as well as on An Integrated Health, Trade and IP Approach to respond to the COVID-19 pandemic. WHO representatives presented the public health context-overview of the regional public health context and provided comments to the sessions on The Role of IPRs in Innovation and Access to Health Technologies, The TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health, and The International Patent System and Domestic Implementation Issues. WHO also presented on Government Procurement, Regulation of Health Technologies, Substandard/Falsified Medical Products, and Health-Related Provisions in Regional Trade Agreements.
Trade and Public Health Virtual Course with a Special Focus on the COVID-19 Pandemic
25. From 3 May to 11 June 2021, WTO, in collaboration with WHO and WIPO, hosted its first Virtual Course on Trade and Public Health, which focused on the COVID-19 pandemic. The five-week virtual course brought together government officials and technical experts from across the world working on health, intellectual property and trade policy issues. WHO provided participants with a technical refresher on health, including data, factual information and terminology and also participated in a moderated forum on the technical dimensions of health, trade and intellectual property. WHO also participated in a moderated forum on the innovation dimension and presented on health-system related determinants related to access. WHO briefed participants on procurement rules and practices, including a review of responses during the pandemic, and presented during a public webinar on regulatory cooperation during the COVID-19 pandemic. WHO experts also updated on approval, quality control and effectiveness of medicines, including falsified and substandard as well as counterfeit medicines.