Manufacturing for Export: A TRIPS-Consistent Pro-Competitive Exception
by Carlos M. Correa and Juan I. Correa
The paper discusses the flexibilization of the sui generis system of supplementary protection certificates (SPCs) under European law recently introduced to allow for the manufacturing, stockpiling and export of covered products. Against this background, it examines the viability under the Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement) of an exception allowing for the manufacture and export of patent-protected products. It concludes that such an exception would promote competition and enhance access to medicines (including biologicals) for the general public while being consistent with Article 30 of the TRIPS Agreement if read in accordance with the principles of interpretation of customary international law.
COVID-19 Vaccines as Global Public Goods: between life and profit
By Katiuska King Mantilla and César Carranza Barona
In the context of a health emergency like the COVID-19 pandemic, the global availability of and access to vaccines are imperative. This research paper provides an analysis from the perspective of international political economy, of the financing of COVID-19 vaccines and of the market strategies adopted by some of the companies that developed them. It notes that the development of vaccines was supported by substantial public funding from countries that later received preferential access to those vaccines through advance purchases. Despite such public support, the vaccines were not deemed as public goods but remained under the control of their developers.
Patent Analysis for Medicines and Biotherapeutics in Trials to Treat COVID-19
by Srividya Ravi
This report provides an analysis of patents covering medicines in trials to treat COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the examination of the claims contained in relevant patents or patent applications.
The medicines considered for the patent analysis in this report are remdesivir, ruxolitinib, favipiravir, molnupiravir and nirmatrelvir, and the biotherapeutics tocilizumab, siltuximab and sarilumab.
An Examination of Selected Public Health Exceptions in Asian Patent Laws
By Kiyoshi Adachi
This study examines the variations within Asia of two exceptions to patent rights that are commonly justified under Article 30 of the World Trade Organization (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement), namely the research and experimentation exception and the regulatory review (or “Bolar”) exception. Both these exceptions are important in the context of the 2001 Doha Declaration on the TRIPS Agreement and Public Health insofar as they are designed to provide flexibility to protect public health and support countries’ overall scientific and technological aspirations. The study examines, from a comparative perspective, examples of these respective exceptions in patent legislation in South, Southeast and East Asia, and identifies peculiarities in the variations among countries in these sub-regions.
Escaping the Fragility/Conflict Poverty Trap: How the interaction between service delivery, capacity development and institutional transformation drives the process of transition out of fragility
By Mamadou Dia
The main background and rationale of this research paper is that while donors’ scaled-up engagements in Fragility and Conflict-affected States (FCS) during the last decades were a resounding success in terms of official development resources devoted to FCS, the value for money compared to the ultimate goal of helping these countries move out of fragility was well below expectations. The World Bank ex post evaluation of the results of its engagement in FCS found that 80 percent of FCS that were on the harmonized list of fragile situations in 2012 remain on it today and the author’s observational study of a sample of 16 African FCS over a 5-year period found that only 1 made progress while 12 stayed in the status quo and 3 regressed. The main reason for the poor value for money is that while International Financial Institutions (IFIs) have spent tremendous amount of resources and brain power to build an excellent knowledge base about fragility and resilience, no such efforts were made to help understand the process and stages for a successful transition from fragility to resilience. The purpose of this paper is to help fill the knowledge gap in order to encourage development partners engaging in FCS to shift from a Fragility-focused to a Transition-based Engagement Business Model and thus minimize the risks of the poor value for money results. The paper will do so by outlining a methodology and framework for a better understanding of the process and a road map for a successful transition from fragility to resilience with measurable stage/sign posts and benchmarks to evaluate progress and necessary adaptation to donors’ strategic and operational support instruments.
¿Podrán las negociaciones en la organización mundial de la salud resultar en un marco justo para la prevención, la preparación y la respuesta ante pandemias como bienes públicos globales?
Por Viviana Muñoz Tellez
Los Estados miembros de la OMS, tras haber acordado los objetivos de avanzar equidad y solidaridad para la futura prevención, preparación y respuesta a la pandemia, ahora deben ponerlos en práctica. Este documento avanza sugerencias para las discusiones en los procesos en curso de la OMS de 1) el examen de las recomendaciones que está revisando el Grupo de Trabajo sobre el Fortalecimiento de la Preparación y la Respuesta de la OMS a las Emergencias Sanitarias, 2) la consideración de posibles enmiendas al Reglamento Sanitario Internacional (RSI) de 2005, y 3) la elaboración de un proyecto de texto para un instrumento internacional sobre la preparación y la respuesta ante una pandemia.
Les négociations au sein de l’Organisation mondiale de la santé peuvent-elles aboutir à un cadre juste pour la prévention, la préparation et la riposte aux pandémies en tant que bien public mondial?
Par Viviana Muñoz Tellez
Ce document avance que les États membres de l’OMS, ayant accepté de promouvoir des objectifs d’équité et de solidarité pour la prévention, la préparation et la riposte futures aux pandémies, doivent maintenant les mettre en œuvre. Le document propose des suggestions pour les processus en cours à l’OMS concernant : 1) l’examen des recommandations en cours de révision par le Groupe de travail sur le renforcement de la préparation et de la riposte de l’OMS aux urgences sanitaires, 2) l’examen des amendements potentiels au Règlement sanitaire international (RSI) 2005, et 3) l’élaboration d’un projet de texte pour un instrument international sur la préparation et la riposte aux pandémies.
The Liability of Internet Service Providers for Copyright Infringement in Sri Lanka: A Comparative Analysis
By Ruwan Fernando
The exclusive rights enjoyed by a copyright owner to reproduce his protected work in any material form, including any permanent or temporary storage in electronic form will have a direct impact on the lawful activities of an internet service provider (ISP). Any transmission of temporary copies of material protected by copyright law by their subscribers or third parties using the networks provided by an ISP may amount to unauthorised reproduction of such protected material. The exclusive rights granted to a copyright owner may, thus, place an ISP in a difficult position that may seriously affect the legitimate services and facilities provided by an ISP such as transmitting, routing and storing of information on their networks. It would be impracticable however, to equate the position of a person who engages in traditional copyright infringement with that of an ISP who may merely provide access to the internet and various services to its subscribers facilitated by its networks.
The making of temporary copies exception was developed in the copyright law to safeguard the legitimate interests of an ISP, which may under certain conditions, exempt an ISP from liability for copyright infringement on the internet initiated by its subscribers or third parties by using the system provided by an ISP. There are laws in force in many countries to limit the liability of an ISP for the infringement of copyright that takes place on its networks. An ISP in Sri Lanka may not enjoy the same privilege for the infringement of unauthorised material initiated by its users or third parties on their networks. The current law is unlikely to provide adequate protection for the legitimate activities of ISPs in an attempt to minimize the vulnerability against copyright infringement claims.
The International Discourse on the Right to Development and the Need to Reinvigorate its Implementation
By Yuefen Li, Daniel Uribe and Danish
The world is currently at an ebb for realizing the Right to Development (RtD). Weakening of multilateralism, de-globalization, the scars left by the COVID-19 pandemic, misinterpretation and dilution of the RtD, and inertia to reform international governance are among the multitude of reasons for this phenomenon. However, the need for a better, more inclusive and greener recovery, and the efforts necessary to attain the 2030 Agenda, have provided the international community an opportunity to reinvigorate the realization of the RtD. These efforts have shown the great relevance of RtD to promote a people-centred and fairer development process and the need for an international enabling environment in order to promote the kind of development we want.
This paper reviews the history of international discourse on RtD including major milestones, main divisive issues between the global South and the North, the evolution of voting patterns on intergovernmental outcomes, existing legal and political issues currently being discussed, the various mechanisms on the RtD, and recommendations on the way forward to revitalize the implementation of RtD at the 35th anniversary of the Declaration on Right to Development.
Marine Genetic Resources Beyond National Jurisdictions: Negotiating Options on Intellectual Property
By Siva Thambisetty
Negotiations on marine biological diversity of areas beyond national jurisdiction (BBNJ) convene after a significant hiatus during which intellectual property monopolies have come under intense normative and pragmatic scrutiny. This paper historicises developments in legal arrangements over intellectual property and biodiversity to propose several negotiating options on the control, use and circulation of marine genetic resources of areas beyond national jurisdiction. The text-based options presented here operationalise an equitable approach taking into account the interests of low power groups, cross-cutting issues and the often ignored question of the ownership and use of marine genetic resources through intellectual property rights.
Can Negotiations at the World Health Organization Lead to a Just Framework for the Prevention, Preparedness and Response to Pandemics as Global Public Goods?
By Viviana Muñoz Tellez
This paper advances that WHO Member States, having agreed to the objectives of advancing equity and solidarity for future pandemic prevention, preparedness and response, now must operationalize these. The paper offers suggestions for the ongoing WHO processes of: 1) review of recommendations under examination by the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, 2) consideration of potential amendments to the International Health Regulations (IHR) 2005, and 3) elaboration of a draft text for an international instrument on pandemic preparedness and response.
A Review of WTO Disputes on TRIPS: Implications for Use of Flexibilities for Public Health
By Nirmalya Syam
The use of TRIPS flexibilities by WTO members involves interpretation of the obligations under TRIPS which can be challenged under the WTO dispute settlement system. Mutually agreed solutions, panel or Appellate Body decisions adopted in such disputes can thus impact the scope of TRIPS flexibilities to address, among others, public health objectives. This paper explores how the WTO dispute settlement system applies to disputes under TRIPS, and reviews the outcomes of the disputes relating to the implementation of TRIPS obligations in the context of pharmaceutical products. The paper points to both systemic and substantive concerns arising from the application of the dispute settlement system to disputes under TRIPS. It finds that the dispute settlement system is not aligned to the unique nature of the TRIPS Agreement in the WTO as an agreement that creates positive obligations, and consequently how jurisprudence arising under disputes concerning other covered agreements having negative obligations, have led panels and Appellate Bodies to adopt narrow interpretations of the scope of TRIPS flexibilities in some of the few disputes arising under the TRIPS Agreement. Moreover, mutually agreed settlements adopted in the context of some of the disputes arising under TRIPS have also led to the adoption of TRIPS plus standards, limiting the scope of TRIPS flexibilities. However, in a recent decision, the WTO panel has also relied on the Doha Declaration on TRIPS and Public Health as a subsequent agreement to guide the interpretation of its provisions. In this context, the paper advances some suggestions to address the systemic and substantive issues arising from the application of the dispute settlement system to the TRIPS Agreement.