Intellectual property
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.
Preface
At the heart of the World Trade Organization (WTO) is a set of rules that regulate trade between nations: a body of agreements which have been negotiated and signed by governments of most of the world’s trading nations with the aim of promoting transparency predictability and nondiscrimination in trading relations. These agreements covering trade in goods trade in services and trade-related aspects of intellectual property rights help to define and inform the multiple roles of the WTO as an international intergovernmental organization in administering the provisions of these agreements providing a forum for trade negotiations handling trade disputes monitoring national trade policies providing technical assistance and capacity building for developing countries and cooperating with other international organizations. Understanding these agreements and their practical policy and legal contexts therefore provides significant insights into the WTO as an institution its activities and international role its partnerships with other organizations and the way in which WTO member governments identify and pursue their national interests through this intergovernmental forum.
Trademarks
This chapter explains the provisions of Section 2 of Part II of the TRIPS Agreement entitled ‘Trademarks’. This Section contains seven articles from Article 15 to Article 21 and deals with the protection that members have to make available for trademarks.
TRIPS and public health
Public health has been one of the most extensively discussed aspects of the TRIPS Agreement both in terms of the treaty text itself and its implementation at the domestic level. Its significance is borne out by a proclamation at the ministerial level the 2001 Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) and by the ensuing amendment of the Agreement itself the first amendment of any WTO multilateral trade agreement undertaken specifically to provide the most vulnerable countries with an additional secure legal pathway to gain access to affordable generic medicines.
Guide to transparency under TRIPS
This Appendix provides a practical guide to the transparency mechanisms established under the TRIPS Agreement concerning how countries choose to implement provisions of the Agreement. These mechanisms help the TRIPS Council to monitor the operation of the Agreement and to promote understanding of members’ intellectual property (IP) policies and legal systems. This Appendix focuses only on the practical use of these mechanisms: the relevant chapters of this book should be consulted for their full background and context.
Dispute prevention and settlement
Chapters II to VIII have dealt with members’ commitments as regards the substantive standards for protection of IPRs under domestic laws as well as their enforcement through their domestic legal systems. An important feature of the TRIPS Agreement is that disputes between members about compliance by member governments with these TRIPS obligations are subject to the dispute settlement system of the WTO. The TRIPS provisions on dispute settlement are contained in Part V of the TRIPS Agreement entitled ‘Dispute Prevention and Settlement’.
Guide to TRIPS documents
The TRIPS Agreement includes a set of transparency mechanisms which require members to furnish extensive information about their IP laws and policies and details about how IPRs are administered and enforced in their territories; these laws are also reviewed in detail in the TRIPS Council. In addition the TRIPS Council has itself established a series of reporting processes concerning specific aspects of members’ IP systems. The operation of these transparency mechanisms in the years since 1995 has yielded a uniquely comprehensive and systematic body of information that now covers some 130 jurisdictions (essentially all WTO members other than LDC members for whom these provisions do not yet apply).
Acknowledgements
Preparation of the Handbook was a collective endeavour by the WTO Intellectual Property Government Procurement and Competition Division drawing on years of practical feedback from technical assistance and training programmes prepared and delivered by the Division in particular the material prepared for the first version of the TRIPS module of WTO eTraining. The former director of the Division Mr Adrian Otten substantively reviewed and enhanced earlier versions of this material.
Introduction to the TRIPS Agreement
This chapter provides an overview of the TRIPS Agreement. It first explains the historical and legal background of the Agreement and its place in the World Trade Organization (WTO). It then turns to the general provisions and basic principles as well as other provisions and institutional arrangements that apply to all the categories of intellectual property rights (IPRs) covered by TRIPS. Chapters II to VIII then discuss each of these categories their essential principles and their administration and enforcement in more detail.
Geographical indications
This chapter explains the provisions of Section 3 of Part II of the TRIPS Agreement entitled ‘Geographical Indications’. A geographical indication (GI) is defined in the TRIPS Agreement as an indication which identifies a good as originating in the territory of a member or a regional locality in that territory where a given quality reputation or other characteristic of the good is essentially attributable to its geographical origin. Typical examples would be ‘Cognac’ for a brandy coming from that region of France and ‘Darjeeling’ for tea coming from that region of India.
Undisclosed information, unfair competition and anti-competitive practices
This chapter deals with the provisions of the TRIPS Agreement that set out standards for protection of undisclosed information including test data (Article 39 of Section 7 in Part II of the Agreement) and measures for the control of anti-competitive practices in licences (Article 40 of Part II of the TRIPS Agreement). It also deals with the suppression of unfair competition a matter which is specifically referred to in Articles 22 (relating to protection of geographical indications) and 39 (relating to protection of undisclosed information) and also arises through the reference in Article 2 of the TRIPS Agreement to the Paris Convention: Article 10bis of that convention sets out general standards for the suppression of unfair competition. As for all sections of Part II these sections have to be read together with the relevant provisions of pre-existing treaties in the area of international IP law which are incorporated by reference into the TRIPS Agreement. Reference will be made to these treaties in the sections below. This chapter will also have to be read in conjunction with other relevant provisions of the TRIPS Agreement explained in other chapters (such as concerning non-discrimination enforcement of IP rights and the administration of IP). Wherever appropriate cross-references are made to other chapters.
Industrial designs and layout-designs of integrated circuits
This chapter deals with the provisions of the TRIPS Agreement that set out standards for protection of industrial designs (Articles 25 and 26 in Section 4 of Part II of the Agreement) and protection of layout-designs or topographies of integrated circuits (Articles 35 to 38 in Section 6 of Part II). As for all sections of Part II these sections have to be read together with the relevant provisions of pre-existing treaties in the area of international IP law which are incorporated by reference into the TRIPS Agreement. Reference will be made to these treaties in the sections below. This chapter will also have to be read in conjunction with other relevant provisions of the TRIPS Agreement that are explained in other chapters (such as those concerning non-discrimination enforcement of IP rights and the administration of IP). Wherever appropriate cross-references are made to other chapters.
Enforcement
The purpose of this chapter is to introduce the key features of the provisions of Part III Sections 1 to 5 of the TRIPS Agreement entitled ‘Enforcement of Intellectual Property Rights’. This Part of the Agreement elaborates in 21 articles the enforcement procedures that members have to make available to permit prompt and effective action against infringements of IPRs covered by the TRIPS Agreement.
A Handbook on the WTO TRIPS Agreement
This Handbook describes the historical and legal background to the TRIPS Agreement its role in the WTO and its institutional framework. It reviews the following areas: general provisions and basic principles; copyright and related rights; trademarks; geographical indications; patents; industrial designs layout-designs undisclosed information and anti-competitive practices; enforcement of IPRs; dispute settlement in the context of the TRIPS Agreement; TRIPS and public health; and current TRIPS issues. It contains a guide to TRIPS notifications by WTO members and describes how to access the official documentation relating to the TRIPS Agreement and related issues. Furthermore it includes the legal texts of the TRIPS Agreement and the relevant provisions of the WIPO conventions referred to in it as well as subsequent relevant WTO instruments and related non-WTO treaties. The new edition covers the public health revision of the Agreement that entered into force in 2017 and provides updates on other recent developments.
Patent-Related Actions taken in WTO Members in Response to the COVID-19 Pandemic
COVID-19 caused by SARS-Cov-2 was declared to be a pandemic by the World Health Organization on 11 March 2020. Since then the issue of the relationship between patent protection and the development of and access to medical treatments and technologies – a longstanding and enduringly important public policy issue – has become central to the debate on the linkages between IP innovation access and public health between stakeholders with divergent interests.
The TRIPS Agreement and COVID-19
The WTO Secretariat has published a new information note about how the global intellectual property (IP) system relates to the COVID-19 pandemic and potential contributions it could make to efforts to address it. The note provides an overview of IP-related measures taken by WTO members and other stakeholders since the start of the crisis.
The policy context for action on innovation and access
This chapter outlines the policy framework for public health intellectual property (IP) international trade and competition focusing on how they intersect with particular emphasis on medical technologies. The framework comprises the human rights dimension of access to medicines; the policy economic and legal features of IP and innovation systems; regulation of medical products; competition policy; and relevant trade policy measures including import tariffs non-tariff measures rules on trade in services government procurement and regional and bilateral free trade agreements (FTAs). In addition it discusses the economics of innovation and access to medical technologies and outlines the interface between genetic resources traditional knowledge and traditional medicine IP and trade.
Medical technologies: the fundamentals
Against the background of the global burden of disease (GBD) and global health risks this chapter outlines the fundamental imperative for collaboration. It demonstrates the need for a coordinated approach taking into account health intellectual property (IP) and trade variables to ensure coherent decision-making in the area of public health at the international regional and domestic levels.
Executive summary
Public health is inherently a global challenge and thus assumes high priority for international cooperation. The World Health Organization (WHO) is the directing and coordinating authority for health but the interaction between health issues and other policy domains human rights development policy intellectual property (IP) and international trade creates a strong rationale for cooperation and coordination between the WHO and other international organizations in particular the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO). This study and its updated and reviewed second edition have emerged from an ongoing programme of trilateral cooperation among these agencies. It responds to an increasing demand particularly in developing countries for strengthened capacity for informed policy-making in areas of intersection between health trade and IP focusing on access to and innovation of medicines and other medical technologies. The need for cooperation and coherence at the international level has intensified over the past decades as successive multilateral decisions have confirmed.
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 the management of innovation including those relating to intellectual property (IP) rights.
Medical technologies: the innovation dimension
Chapter II has described the main elements of the policy framework for innovation and access. This chapter considers how this policy framework applies to innovation in medical technologies. It reviews the factors that have spurred innovation in medical technologies in the past identifies how current models of R&D are evolving and charts the role of established and new participants in the innovation process including in the context of neglected diseases emerging pathogens with pandemic potential and antibacterial treatments. It also covers the role of IP particularly patents in the R&D system.
Medical technologies: the access dimension
Chapter III explained the role of intellectual property (IP) and other policy measures in health innovation; this chapter provides a detailed description of the access dimension and the concepts laws and policies underlying it as well as data on availability and access to health technologies and methodological approaches to their measurement. It also offers an overview of the main determinants of access related to health systems IP and trade policy.
Foreword
International cooperation on public health is inherently multi-dimensional with a focus on building effective health systems. It is dynamic and responsive to the demands of countries around the globe. Towards this goal the World Health Organization (WHO) the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO) have been working closely together for almost two decades to support global endeavours to improve health outcomes.
Promoting Access to Medical Technologies and Innovation, 2nd Edition
Medical technologies – medicines vaccines and medical devices – are essential for public health. Access to essential medicines and the lack of research to address neglected diseases have been a major concern for many years. To promote innovation and to ensure equitable access to all vital medical technologies policy-makers need a clear understanding of the innovation processes that lead to new technologies and of the ways in which these technologies are disseminated in health systems. This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health trade and intellectual property and of how they affect medical innovation and access to medical technologies. This collaborative effort by the World Health Organization the World Intellectual Property Organization and the World Trade Organization draws together the three Secretariats’ respective areas of expertise. The study is intended to inform ongoing technical cooperation activities undertaken by the three organizations and to support policy discussions. It has been prepared to serve the needs of policy-makers as well as lawmakers government officials delegates to international organizations non-governmental organizations and researchers. The second edition comprehensively reviews the existing material and captures new developments in key areas since the initial launch of the study in 2013. Among the new topics covered by the study are antimicrobial resistance and cuttingedge health technologies. The second edition provides updated data on health innovation trends in the pharmaceutical sector and trade and tariffs. It includes an updated overview of access to medical technologies globally and key provisions in free trade agreements and takes account of developments in IP legislation and jurisprudence.
Acknowledgements
This publication is the product of extensive collaboration between the WHO WIPO and WTO Secretariats led by the Department of Public Health Innovation and Intellectual Property in the WHO the Global Challenges Division in WIPO and the Intellectual Property Government Procurement and Competition Division in the WTO.