Intellectual property
The TRIPS negotiations: An overview
As a former official within the Secretariat of the GATT/WTO with responsibility for TRIPS matters my aim in this chapter is to set the scene for the contributions to this book of the negotiators themselves by outlining the origins and various stages of the negotiations that led to the TRIPS Agreement. I will also make some general observations on the negotiations in particular on how it proved possible to negotiate an agreement as substantial as the TRIPS Agreement and on why the WTO has been finding it difficult to achieve results comparable to those of the Uruguay Round of multilateral trade negotiations. I will of course do this from the perspective of a former Secretariat official; other chapters will add additional perspectives. I should add that I left the WTO Secretariat in 2008.
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.
Foreword by the Directors-General
Public health has been a priority for global action for many years. The right of everyone to the enjoyment of the highest attainable standard of physical and mental health is a universal human right just as the burden of disease is shared by all humanity.
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.
Access to medical technologies: The context
This chapter offers an overview of the main determinants of access related to health systems intellectual property (IP) and trade policy. Many other very important socio-economic factors determine access to medical technologies – factors such as health financing the importance of a qualified health care workforce poverty and cultural issues – and lack of access is rarely due entirely to a single determinant but these are not addressed in this study as they are not part of the interface between health IP and trade.
The current R&D landscape
This section reviews the challenges faced by today’s pharmaceutical industry against the background of its evolution outlined in the previous section.
¿Pueden las cadenas de bloques revolucionar el comercio internacional?
Son muchos los titulares en los que se sostiene que la cadena de bloques puede revolucionar diversas esferas del comercio internacional desde la financiación del comercio hasta los procedimientos aduaneros y la propiedad intelectual. El carácter transparente descentralizado e inalterable de la cadena de bloques ha despertado el interés de los agentes privados -y de los Gobiernos- en explorar las posibilidades que ofrece esta tecnología para mejorar la eficiencia de los procesos comerciales por lo que ya se han realizado multitud de estudios de viabilidad y proyectos piloto utilizando la cadena de bloques en prácticamente todos los ámbitos del comercio internacional.
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.
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.
A Handbook on the WTO TRIPS Agreement
This handbook describes the historical and legal background to the TRIPS Agreement its role in the World Trade Organization (WTO) and its institutional framework and 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 intellectual property rights; 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 and make use of the official documentation relating to the TRIPS Agreement and connected 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.
Sharing of influenza viruses and access to vaccines and other benefits
A highly significant development in itself given its central role in preparing for a potential pandemic the PIP Framework also serves to illustrate many of the points made in earlier sections of this chapter relating to the role of public-sector institutions and networks capacity-building in medical innovation sharing of benefits of the fruits of innovation and dealing with IP in a public health context.
Foreword
As we mark the 20th anniversary of the WTO it seems appropriate that we should put a spotlight on the TRIPS Agreement which also turns 20 this year. When the TRIPS Agreement came into being in 1995 it introduced substantive and comprehensive disciplines on intellectual property rights (IPRs) into the multilateral trading system.
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.
Dispute prevention and settlement
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 VII then discuss each of these categories in more detail.
Negotiating for Argentina
To prepare a chapter that presents the experiences of a negotiator of the TRIPS Agreement as close as possible to reality is not an easy task. This is because the Agreement is complex as it covers many subjects related to IP and is made up of a set of rules with varied degrees of specificity and detail. Approaching this task 25 years after the negotiations has introduced complications and involuntary distortions that have made this task even more difficult.
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’.
Health systems-related determinants of access
There are different determinants of access and any lack of access to medicines or other medical technologies is rarely due entirely to a single determinant. The following sections discuss the main determinants of access that are linked to health IP and trade.
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).
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.
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.
Public health policy
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 described comprises 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 rules on trade in services government procurement and regional and bilateral free trade agreements (FTAs). In addition it outlines the human rights dimension of access to medicines.
Conclusion
Le monde tel que nous le connaissons aujourd’hui a été façonné par les innovations technologiques. Une nouvelle technologie la chaîne de blocs – technologie de registres distribués – a été accueillie par beaucoup avec enthousiasme et optimisme comme le prochain grand facteur de changement. La chaîne de blocs qui permet de diffuser des données et des informations numériques de manière sûre transparente et immuable sans avoir à recourir à un tiers de confiance unique est une technologie particulièrement prometteuse. Elle pourrait permettre aux individus et aux entreprises du monde entier d’effectuer des transactions de manière plus efficace plus économique et plus rapide tout en conservant un haut niveau de sécurité. Elle pourrait avoir un impact considérable sur la façon de réaliser les opérations commerciales qu’il s’agisse des transactions financières ou des transactions commerciales transfrontières physiques en réduisant les coûts de traitement de vérification de suivi de coordination et de transport grâce à la simplification et à la numérisation des processus qui impliquent de multiples parties prenantes et qui étaient jusqu’à présent fortement tributaires du papier. Elle pourrait réduire la fraude permettre une meilleure administration des droits de propriété intellectuelle renforcer la traçabilité et la confiance dans les chaînes de valeur et offrir de nouvelles possibilités aux petites entreprises.
Copyright: A Nordic perspective
During the Uruguay Round of multilateral trade negotiations I worked at the Finnish Ministry of Education and Culture where my main responsibilities included copyright law and policy. I participated in coordination of the Nordic countries (Finland Iceland Norway and Sweden) in the capitals and represented the Nordic countries in the later stages of the TRIPS negotiations in Geneva. During the same period I was also actively involved in WIPO’s work on copyright and the protection of layout-designs of integrated circuits and also contributed to the intergovernmental work under various other international and European fora such as the International Convention for the Protection of Performers Producers of Phonograms and Broadcasting Organizations (Rome Convention). Since January 1995 I have served at the WTO Secretariat IP Division.
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.
Copyright: An Indian perspective
My unexpected participation in the TRIPS negotiations as my country’s sole negotiator on copyright remains one of the unforgettable experiences of a 38-year civil service career.
Traditional knowledge and traditional medicine
Traditional medicine has long been used as a mainstay of health care for many populations. This section reviews a number of issues concerning traditional medical systems with respect to IP regulatory systems and trade.
Overcoming market failure: The challenge of neglected diseases
There is a particular problem in incentivizing medical R&D for diseases that disproportionately affect poor people in developing countries as the market mechanisms such as intellectual property rights (IPRs) do not work in this case. A key factor is the limited purchasing power of both governments and patients in the countries where such diseases predominate; unlike for other diseases there is no positive spillover from drug development targeted at more affluent markets. These diseases are called neglected diseases and this section deals with the challenges of medical innovation in this area.