INTRODUCTION
This note sets out the role and key contributions that the global IP system, including its policy options and flexibilities as implemented in domestic law, can make to address COVID-19. It also provides an overview of measures taken by WTO members within this framework since the start of the crisis.
The WTO’s TRIPS Agreement is the most comprehensive multilateral agreement on IP. It provides for certain basic principles (such as non-discrimination), situates the IP system in terms of promoting innovation and disseminating technology for the public’s welfare, sets forth minimum standards of protection in respect of each of the areas of IP covered by the TRIPS Agreement, contains provisions that deal with domestic procedures and remedies for IP enforcement, and makes disputes between members about respect for TRIPS obligations subject to the WTO’s dispute settlement procedures.
The global IP system provides a framework in which urgently needed innovation in relation to COVID-19 can be encouraged, shared and disseminated. Innovation in health can be seen as a cycle: it covers the stages from initial invention to the supply to the public of a product or service. Within a balanced IP system, the exclusive rights conferred by IPRs can serve as an incentive for investment at each stage of the innovation cycle, and as a mechanism for combining and trading in technology inputs from different sources. Policy choices with respect to the design and implementation of the IP system made at the regional and national levels, along with the management of IP, can also directly influence research and development (R&D) outcomes and access.
Article 7 of the TRIPS Agreement describes the objectives of the IP system in terms of a balance of rights and obligations. The objectives refer to the protection and enforcement of IPRs in a manner which contributes to “the promotion of technological innovation”, “the transfer and dissemination of technology” to the mutual advantage of both “producers and users of technological knowledge”, and also “social and economic welfare”. Article 8 states that members may adopt measures necessary to protect public health and nutrition and to promote the public interest in sectors of vital importance to their socio-economic and technological development that are consistent with the provisions of the TRIPS Agreement.
The Doha Declaration on the TRIPS Agreement and Public Health, a landmark declaration adopted at the WTO Ministerial Conference in 2001, reaffirmed the objectives and principles of the Agreement as guidance for the implementation of TRIPS provisions in a manner that is responsive to public health objectives. WTO members affirmed that the TRIPS Agreement “can and should be interpreted and implemented in a manner supportive of Members’ right to protect public health and, in particular, to promote access to medicines for all”. The Doha Declaration also clarified certain policy options, or “flexibilities”, within the framework of the TRIPS Agreement. It is thus a well-established principle that the TRIPS Agreement can be interpreted and implemented in line with public health policy objectives and that it provides wide latitude for members to take action to protect public health.
While much public health policy attention has focused on the patent system as a key element of the system for innovation and dissemination of medical technologies, other areas of IP covered by the TRIPS Agreement are also significant.4 Trade secrets and clinical trial data are subject to protection, and the way that this is applied by members can be critical in ensuring that new technologies are carried forward without overly burdening generic followers. A well-run trademark system has a valuable role in ensuring accurate information for medical practitioners and consumers while safeguarding against potential confusion with critical terms such as the international non-proprietary names that are used to identify pharmaceutical substances and ingredients. A balanced copyright system that takes due account of the interests of rights-holders and the public at large to access copyright-protected works can support R&D activities and enable the development of digital solutions to support diagnostics and treatment.
IP systems are only one element of the innovation cycle that includes the discovery, development and delivery of new health technologies. An integrated approach to respond to the COVID-19 pandemic implicates numerous policy areas, including tariffs and import licensing, government procurement, regulatory standards, health services and competition policy.5 A standalone section in the 2020 study jointly published by the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and the WTO, Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade (second edition),6 on COVID-19 was added at the start of the publication to map the multiple challenges posed by the pandemic in relation to the integrated health, trade and IP policy frameworks set out in the study.
trips_report_eTo read the full report, click here.