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 2019 (document IP/C/W/654/Add.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 (GSPoA) 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'1 and WHA73.1 on the “COVID-19 response.”2 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 TRIPS Agreement and the flexibilities within the Doha Declaration on the TRIPS Agreement and Public Health.
3. 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 GSPoA overall programme review panel. Activities focus on technical guidance, transfer of technology, local manufacturing, capacity building and training, and direct technical assistance to countries.
Trilateral Study on Promoting Access to Medical Technologies and Innovation, 2nd Edition
4. In July 2020, the Directors-General of the WHO, WIPO, and WTO launched a second edition3 of the Trilateral Study on Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade. Building on the first edition launched in 2013, the publication seeks to strengthen the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and how they affect innovation and access to medical technologies, such as medicines, vaccines and medical devices. The second edition provides an improved, evidence-based foundation for policy debate and informed decision-making at a critical time for global health and comprehensively reviews the existing material and captures new developments in key areas since the initial launch of the study in 2013. New topics include antimicrobial resistance and cutting-edge health technologies and includes updated data on health, innovation trends in the pharmaceutical sector, and trade and tariffs. The second edition includes an updated overview of access to medical technologies globally and key provisions in free trade agreements and takes account of developments in intellectual property legislation and jurisprudence. A COVID-19 section at the start of the publication provides a factual overview of the developments and measures taken to address this extraordinary public health crisis, which began after the work on the second edition of the study had been completed. The pandemic has created a pressing need for intensified global cooperation and has raised issues at the crossroads of public health policy, trade policy and the framework for and the management of innovation, including those relating to intellectual property rights. The COVID-19 section of the study maps myriad challenges posed by the outbreak in relation to the integrated health, trade and intellectual property policy frameworks set out in the study. It guides the reader to parts of the study that are of direct relevance to the issues that have been raised during the pandemic such as: key policy challenges; preservation of effective international trade; intellectual property; international initiatives to support research and development of, and equitable access to, COVID-19 technologies; regulatory responses; and ensuring transparency.
COVID-19 Technology Access Pool (C-TAP)
5. In May 2020, WHO, in collaboration with the Government of Costa Rica and international stakeholders, launched the COVID-19 Technology Access Pool (C-TAP)4 alongside the COVID-19 Solidarity Call of Action.5 The Solidarity Call to Action, as a complement to the WHO COVID-19 Strategic Preparedness and Response Plan6 and the Access to COVID-19 Tools (ACT-A) Accelerator,7 urges key stakeholders and the global community to commit to undertaking urgently needed actions to advance the pooling of knowledge, intellectual property and data. Forty WHO Member States and other supporting organizations engaged in COVID-19 health technology related access work, including notable personalities, have endorsed the Solidarity Call to Action. Specific actions are outlined for governments and other research and development funders, holders of knowledge, intellectual property or data to existing or new therapeutics, diagnostics and vaccines, researchers, patients and communities, inter-governmental, non-governmental and civil society organizations, and other stakeholders. One action, for example, urges all stakeholders to “place, in the WHO COVID-19 Technology Access Pool (C-TAP) or its implementing partner platforms, references to shared information and/or commitments to all relevant technologies, knowledge, intellectual property, and data on terms that facilitate their use in research, development and innovation and manufacturing and that would permit effective technology transfer and early access to key technologies for the detection, prevention, treatment and response of COVID-19.” C-TAP aims to compile, in one place, pledges of commitment made under the Solidarity Call to Action to voluntarily share COVID-19 health technology related knowledge, intellectual property and data. The WHO Secretariat is currently outlining a plan to operationalize the Pool, which will draw on relevant data from existing mechanisms, such as the Medicines Patent Pool, the UN Technology Bank-hosted Technology Access Partnership and Open COVID Pledge.
6. ACT-A is a partnership between WHO and a number of global health actors including the Bill and Melinda Gates Foundation, CEPI, Gavi, the Global Fund, UNITAID and Wellcome Trust. ACT-A’s mission is the accelerated development, equitable allocation and scaled-up delivery of vaccines, therapeutics and diagnostics. An Access and Allocation Programme, which is developing the principles, frameworks and mechanisms needed to ensure the fair and equitable allocation of these tools, cuts across the three main ACT-A pillars (vaccines, therapeutics, diagnostics) as well as a Health Systems Connector to strengthen local capacities to deliver new tools. ACT-A is principally about mobilizing funds to develop new tools for COVID-19, prioritizing technologies needed, coordinating international action, and ensuring that new products that are safe and effective become available at country level through scaling up production. C-TAP provides additional and complementary advantages including concrete interventions for accelerating product development and manufacturing by promoting through voluntary means open innovation models, knowledge sharing and technology transfer as well as promoting equitable global access through non-exclusive and access-oriented licensing or other voluntary strategies that facilitate technology transfer and access. These include, for example, free licenses and pledges offered by the Open COVID Pledge and other initiatives and the waiving of patent rights by some companies on products that may prove effective against COVID-19.
WHO-WIPO-WTO Technical Symposium to Address Opportunities and Challenges of Cutting-Edge Health Technologies
7. In October 2019, WHO, WIPO, and WTO organized the 8th joint Technical Symposium8 to address the importance of innovation in, and access to, cutting-edge health technologies to ensure progress towards universal health coverage and the achievement of the health-related UN Sustainable Development Goals. The Symposium event marked the ten-year anniversary of more focused cooperation between the secretariats of WHO, WIPO and WTO regarding matters at the crossroads of health, trade and intellectual property. Hosted by WTO, the Directors-General of the three organizations opened the Symposium. The first panel reviewed the landscape of cutting-edge technologies. Panelists discussed perspectives on future health outcomes through biotechnology, information technology and big data as applied in the medical and medical devices sectors. The second panel discussed the opportunities and challenges of optimizing the benefits of these new technologies from a health, intellectual property and trade perspective, considering how these policy mechanisms can function together in the most effective way. Panelists also addressed increasing costs for healthcare systems, access and affordability challenges, and possible country options to facilitate wider use of these technologies as well as the use of confidential patient information data and resulting ethical considerations.
Training and Enhancing Capacity
8. In December 2019, WHO presented at the African regional training seminar on the Role of Patent Offices in Promoting Access to Medicines. The objective of the seminar, co-organized by the African Union and the South Centre and, was to increase the institutional capacity of patent offices and relevant authorities in African countries to effectively use the flexibilities of the TRIPS Agreement to protect public health. The goal was to ensure that the patent system is supportive of public health goals and innovation while avoiding creating unnecessary barriers to access to affordable quality medicines and generic competition.
9. In November 2019, WHO presented on understanding patents in the medical products industry in a training workshop on key enabling factors for successful local production and supply of quality-assured medical products in the SEARO Region. Held in Bangkok, Thailand, the specific objectives for the workshop were to: Provide training and guidance to manufacturers and other participants on key business, policy, regulatory and other factors critical to successful local production of medical products; Share experiences and lessons learned in achieving quality local production of medical products, and; Understand the gaps and needs in building the capacity of local manufacturers and regulators to promote quality local production. The workshop was expected to deliver the following outcomes and outputs: Capacity building for participants; Meeting report including any identified gaps in capacity building for manufacturers; Training package based on a compilation of the training materials presented during the workshop, and; Principles and/or key concepts for consideration towards development of a ‘points to consider’ for local pharmaceutical production.
10. In November 2019, WHO presented at the “2019 World Conference on Access to Medical Products Achieving the SDGs 2030,”9 in New Delhi, India. Organized by the Ministry of Health & Family Welfare with the support of World Health Organization, the objective of the conference was accelerating access to medical products for achieving universal health coverage in the context of the Sustainable Development Goals. The specific objectives were to: Explore new approaches in innovation landscape in medical products for achieving Universal Health Coverage and the 2030 goals; Identify regulatory mechanisms for improved access to quality and safe medical products, and; Discuss the role of intellectual property and current trade agreements to promote access to medical products. Conference outcomes included: Engaging with a wide set of stakeholders to explore new approaches in innovation landscape in medical products for achieving Universal Health Coverage and the 2030 goals; Tracking progress on recommendations of 2018 World Conference at national and international levels; Strengthen regulatory cooperation and collaboration to improve the quality, safety and availability of medical products, and; Promote engagement for public health in trade agreements for accelerated access of medical products.
11. In November 2019,10 WTO, in close collaboration with WHO and WIPO, hosted the 15th Annual WTO Workshop on Trade and Public Health. Key themes of the programme included: Technical Refreshers on Health and Intellectual Property/Trade; The Innovation Dimension; The Access Dimension; Making Effective Use of Special Compulsory Licences for Export; The Trade Dimension, and; The Regulatory Dimension. WHO led or participated in the following sessions: Mapping the Interface between Health, Trade and Intellectual Property; Technical Refresher on Health; The Public Health Context: Overview of Determinants Related to Access; Using the IP System and its Policy Options to Further Global Access to Health Technologies; Health-Related Provisions in Regional Trade Agreements; Procurement Rules and Practices; Anti-Microbial Resistance: How to Foster Innovation, Access and Appropriate Use of Antibiotics; and Approval, Quality Control and Effectiveness of Medicines, including Falsified and Substandard, as well as Counterfeit Medicines.
12. In September 2019, WHO participated in a capacity building workshop organized by the Burkina Faso Ministry of Health, the Burkina Faso Ministry of Industry, Trade and Crafts and the Yolsé Association on the flexibilities of the TRIPS Agreement, access to medicines and local production of generics. The specific objectives of the workshop included training participants on the legal aspects of the TRIPS Agreement and the Bangui Agreement, challenges and opportunities for access to medicines and for local production; demonstrated how, in terms of regulation, the protection of data on pharmaceutical products can influence access to medicines; and presenting the mechanisms and strategies necessary to promote access to medicines and local production in Burkina Faso and West Africa.
1 WHA72.8 https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8-en.pdf
2 WHA73.1 https://apps.who.int/gb/ebwha/pdf_files/WHA73/A73_R1-en.pdf