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An Integrated Health, Trade and IP Approach to Respond to the COVID-19 Pandemic
The coronavirus disease 2019 (COVID-19) pandemic constitutes an extraordinary global public health crisis. It has created a pressing need for intensified global cooperation. The pandemic has from its outset raised issues at the crossroads of public health policy trade policy and the framework for and management of innovation including those relating to intellectual property rights. The second edition of the joint WHO WIPO and WTO publication “Promoting Access to Medical Technologies and Innovation: Intersections between public health intellectual property and trade” published in 2020 included a special insert mapping the challenges posed by the COVID-19 pandemic in relation to the integrated health trade and IP policy framework set out in the study. This update revises the information contained in the last version launched in October 2021 in the light of more recent developments as of 17 May 2023.
Trade in Knowledge
Technological change has transformed the ways knowledge is developed and shared internationally. Accordingly in the quarter-century since the WTO was established and since its Agreement on Trade-Related Aspects of Intellectual Property Rights came into force both the knowledge dimension of trade and the functioning of the IP system have been radically transformed. The need to understand and respond to this change has placed knowledge at the centre of policy debates about economic and social development. Recognizing the need for modern analytical tools to support policymakers and analysts this publication draws together contributions from a diverse range of scholars and analysts. Together they offer a fresh understanding of what it means to trade in knowledge in today’s technological and commercial environment. The publication offers insights into the prospects for knowledge-based development and ideas for updated systems of governance that promote the creation and sharing of the benefits of knowledge.
Competition policy and intellectual property in today's global economy
The fast-evolving relationship between the promotion of welfare-enhancing competition and the balanced protection of intellectual property (IP) rights has attracted the attention of policymakers analysts and scholars. This interest is inevitable in an environment that lays ever greater emphasis on the management of knowledge and innovation and on mechanisms to ensure that the public derives the expected social and economic benefits from this innovation and the spread of knowledge. This book looks at the positive linkage between IP and competition in jurisdictions around the world surveying developments and policy issues from an international and comparative perspective. It includes analysis of key doctrinal and policy issues by leading academics and practitioners from around the globe and a cutting-edge survey of related developments across both developed and developing economies. It also situates current policy developments at the national level in the context of multilateral developments at WIPO WTO and elsewhere.
A dramatic impact on health systems and responses at the global level
The coronavirus disease 2019 (COVID-19) pandemic constitutes an extraordinary global public health crisis. It has created a pressing need for intensified global cooperation. The pandemic has from its outset raised issues at the crossroads of public health trade intellectual property (IP) policy and the framework for and management of innovation and access including issues related to technology transfer.
Intellectual property aspects
The global IP system provides an incentive framework in which urgently needed innovation in relation to COVID-19 can be encouraged. It covers the stages from invention to supply of a product or service. The impact of patents on access is complex and an area of particular focus. Other IP rights including trade secrets are also being discussed. IP policy and the administration and enforcement of IP laws aim to balance and accommodate a range of interests in a way that promotes overall public welfare. A wide range of policy options and flexibilities are built into the international IP regime and can be used to promote access to health products and other public health objectives.
The way forward
The COVID-19 pandemic has placed immense pressure on health systems and trade systems around the world. The urgent search for technologies that may help to control the pandemic has mobilized unprecedented research efforts and investments. It has given rise to new models of working. Rapid and efficient innovation is needed more than ever and global equitable access to new technologies is of paramount importance. Adequate management of IP is central to achieving these goals.
Introduction
The second edition of the joint WHO WIPO and WTO publication “Promoting Access to Medical Technologies and Innovation: Intersections between public health intellectual property and trade” (the Trilateral Study) published in 2020 included a special insert mapping the challenges posed by the COVID-19 pandemic in relation to the integrated health trade and IP policy framework set out in the study. The Trilateral Study and the special insert were designed to serve as background reference for policy-makers in the widest sense – lawmakers government officials delegates to international organizations non-governmental organizations (NGOs) and researchers who seek a comprehensive presentation of the full range of issues including institutions and legal concepts with which they may be unfamiliar. It is also designed to serve as a factual resource for the three organizations’ technical cooperation activities.
Preserving effective international trade
While low- and middle-income countries face particular challenges caused by the global scarcity of key health technologies the vast majority of countries are net importers of all categories of health technologies including those needed to address COVID-19.
Regulatory responses
Regulatory assessment and approval of health technologies are essential in every health system to ensure product quality safety and efficacy. An effective COVID-19 treatment has not yet been found. Clinical trials are ongoing for new treatments as well as for repurposed medicines. “Compassionate use” of medicines (i.e. their clinical use before approval) is taking place in specific cases.
Meeting the demand for health technologies and medical services
The pandemic continues to trigger a massive global demand for vaccines as well as for existing health technologies to respond to COVID-19 including diagnostics medicines ventilators and other medical devices and consumables used in hospitals such as personal protective equipment (PPE). This has put pressure on public procurement systems and led to shortages and other supply and access challenges for certain products in developed and developing countries. WHO provides information about the global response such as R&D landscapes regulatory approval status and the manufacturing and distribution of vaccines.
Promoting Access to Medical Technologies and Innovation, 2nd edition
Updated extract: integrated health trade and IP approach to respond to the COVID-19 pandemic 30 August 2021. The coronavirus disease 2019 (COVID-19) pandemic constitutes an extraordinary global public health crisis. It has created a pressing need for intensified global cooperation. The pandemic has from its outset raised issues at the crossroads of public health policy trade policy and the framework for and management of innovation including those relating to intellectual property rights. The second edition of the joint WHO WIPO and WTO publication “Promoting Access to Medical Technologies and Innovation: Intersections between public health intellectual property and trade” published in 2020 included a special insert mapping the challenges posed by the COVID-19 pandemic in relation to the integrated health trade and IP policy framework set out in the study. This update revises the information contained in that insert in the light of more recent developments as of 30 August 2021.
COVID-19 technologies: international initiatives to support R&D and equitable access
Since the start of the COVID-19 pandemic myriad public and private actors have launched collaborative global efforts to develop treatments vaccines and diagnostics with the aim of guaranteeing equitable access to those technologies. Many such efforts strive to address R&D and access needs simultaneously. Collaborative efforts include substantial investments in product development partnerships (PDPs) to support the non-commercial development of vaccines and large multi-stakeholder R&D initiatives.
Ensuring transparency
Transparency and the availability of up-to-date information on measures taken by governments are of critical importance and cut across both legal and policy areas addressed in the Trilateral Study.
Policy challenges posed by the pandemic
The COVID-19 pandemic has generated sudden farreaching impacts on health systems with significant social and economic repercussions around the world. The International Monetary Fund (IMF) Chief warned that while there has been strong economic growth in wealthy countries developing countries are being held back by slow vaccination rates and that this is a: “[...] danger for the coherence of growth and it is also a danger for global stability and security.” World Bank data indicate that the pandemic has resulted in a steep increase in debt especially in emerging markets and developing economies. Statistical briefs published by the UN Committee for the Coordination of Statistical Activities analysing the social and economic impact of the pandemic suggest that 71 to 100 million people are being pushed into extreme poverty by the pandemic.
Intellectual Property and Digital Trade Mapping International Regulatory Responses to Emerging Issues
This paper explores how regulatory responses to emerging IP issues in digital trade may develop at the international level and in particular how existing mechanisms might influence the chances of developing internationally agreed rules in this regard. The primacy of state sovereignty in intellectual property up to the late 19th century gave way to the important WIPO treaties which still retained some independence of member states and based international regulatory responses directly on national experience. While more regulatory sovereignty was ceded in TRIPS the WIPO Copyright Treaty and the WIPO Performances and Phonograms Treaty the adoption of non-binding instruments (such as the WIPO Joint Recommendations in the area of trademarks) show the limits of decision making by consensus.
The Shifting Contours of Trade in Knowledge
This paper charts the evolution and diversification of trade in knowledge that has taken place in the quarter-century since the WTO TRIPS Agreement came into force. Entirely new markets have come into being potentially redefining the very character of 'trade'.
Copyright and related rights
Part II of the TRIPS Agreement sets out the substantive standards for the protection of IP that WTO members should follow. This chapter outlines the provisions of Section 1 of Part II (running from Article 9 to Article 14) which sets out the protection that members must make available in the area of copyright and related rights – specifically for literary and artistic works performances phonograms (or sound recordings) and broadcasts.
Current TRIPS issues
This chapter provides a general overview of the ongoing work in the TRIPS Council and other WTO bodies on other aspects of TRIPS and public policy as of the time of writing focusing on the issues which have been the most prominent
Patents
This chapter explains the provisions of Section 5 of Part II of the TRIPS Agreement entitled ‘Patents’. Section 5 which contains eight articles from Article 27 to Article 34 sets out the obligations of members with respect to standards concerning the availability scope and use of patents. Starting with a general explanation of terms this chapter goes on to explain each specific provision in this Section of the TRIPS Agreement.