Equity and Pandemic Preparedness: Navigating the 2024 Amendments to the International Health Regulations
By Nirmalya Syam
The amendments to the International Health Regulations (2005) (IHR) agreed upon in May 2024 are important for strengthening global health emergency preparedness and response. The negotiations resulted in the IHR amendment now recognizing the importance of equity, including equitable access to health products, enhancing IHR core capacities, and mobilizing financing. The amendments note the role of the World Health Organization (WHO) in facilitating timely access to necessary health products by removing barriers and supporting local production and distribution. However, the WHO authority to effectively act in those areas is limited. The IHR as amended will establish a Coordinating Financial Mechanism to provide predictable and sustainable financing for its implementation, particularly in developing countries.
Despite some advancements, the amendments fall short of imposing concrete obligations on developed countries to facilitate timely access to health products and financial support and transfer of technology to developing countries. Overall, the amended IHR represent a significant step toward a more equitable global health framework, setting a precedent for future international health instruments, including the proposed pandemic treaty.
Foreign Direct Investment Screening for ‘National Security’ or Sustainable Development: a blessing in disguise?
By Daniel Uribe Teran
Over the past decade, the global adoption of Foreign Direct Investment (FDI) screening mechanisms (ISMs) has surged, reflecting developed countries’ policies aiming at restricting FDI on the grounds of broadly defined ‘security’ or ‘national’ interests. Recent geopolitical and economic crises have further fuelled this trend, leading to increasingly stringent ISMs. This paper explores the definition, evolution, and current practices of ISMs, highlighting their resurgence and differing motivations globally. It examines how, if properly used, ISMs could also be used to promote sustainable development and resilience, and advance climate action agendas. The paper also provides policymakers with insights into maximizing the impact of ISMs to achieve sustainable development and economic resilience in an interconnected world.
Negotiating Health and Autonomy: Data Exclusivity, Healthcare Policies and Access to Pharmaceutical Innovations
By Henrique Zeferino De Menezes, Julia Paranhos, Ricardo Lobato Torres, Luciana Correia Borges, Daniela De Santana Falcão and Gustavo Soares Felix Lima
This paper analyzes the debate over the international dissemination of data exclusivity as a form of protection for clinical trial data. This is a critical demand for pharmaceutical companies seeking larger market shares and longer periods of monopoly in order to recover investments in research and development and greater profitability. However, this is a sensitive issue with economic and social repercussions for developing countries that adopt this protection regime. This paper highlights critical issues for the political economy of innovation and presents a review of empirical studies that show that data exclusivity delays the entry of generic drugs into the market, increasing prices and reducing access. At the same time, its adoption has no benefits because there are no positive effects on internal technological innovation, nor reduction of the “International drug lag”, nor the development of drugs for specific epidemiological demands.
The Vaccine Industry After the COVID-19 Pandemic: An International Perspective
By Felix Lobo
The purpose of this report is to analyze the impact that the COVID-19 pandemic has had on the vaccine industry from an international perspective. The objective is to learn from the experience and contribute to the design of better tools for future vaccine development and manufacturing, as we must be prepared for future emerging infectious diseases with the potential for global expansion. This industry makes fundamental contributions to global social welfare, but from a business point of view it is complex and difficult to manage, and from an economic point of view it is an industry that does not fit the paradigm of competitive market efficiency with notorious market failures.
We examine the impact of the pandemic on innovation and the scientific, technological and industrial development of vaccines and find that certain elements of the industry’s structure have changed, while others have remained. We also summarize the lessons learned from the deployment of some public policies to boost supply and drive demand, paying particular attention to the inequity in the global distribution of vaccines and to the COVAX program. We conclude that some of the policies have been very effective, while others have not fully achieved their objectives. From the achievements and limitations, lessons can be drawn for the reformulation and expansion of global public policies that would stimulate R&D, manufacturing, distribution and access.
Constraints to and Prospects for Sustainable Livestock Sector Practices in Argentina with Emphasis on Antimicrobial Usage
By David Oseguera Montiel
Antimicrobial resistance (AMR) is a top threat for global health and development as it has the potential to become the next pandemic. Agriculture roughly accounts for three-quarters of all the antimicrobial usage. Modern animal husbandry systems use antimicrobials for disease prevention and growth promotion. Regulations and restrictions regarding antimicrobial use in agriculture vary across the regions of the world. This paper explores the situation of the Argentina livestock sector with regard to antimicrobial use. Argentina is renowned as a global food producer, notably for its grain and livestock production potential. This paper analyzes the constraints to and prospects for transitioning towards a more sustainable livestock farming production in Argentina by relying less on antimicrobials and without compromising productivity. The livestock sector in Argentina has embarked on the intensification of farming, especially beef farming, in the last thirty years. Farming intensification generally requires the use of greater quantities of antibiotics. Alternative sustainable intensification is necessary to overcome antimicrobial overuse. Various factors, including economic, social, and cultural, shape consumption patterns. The Argentine farming sector needs to focus on these context-specific situations, which will drive animal food production.
Antimicrobial Resistance: Optimizing Antimicrobial Use in Food-Producing Animals
By Viviana Munoz Tellez
The increasing resistance of microorganisms to antimicrobials that help to treat and control spread of infections is a major public health problem around the world. Antimicrobial resistance is aggravated by inappropriate use of antimicrobials in human and animal health and in plant and animal agriculture. This paper tackles the question of how to shift animal food production to implement adequate antimicrobial stewardship practices.
The complex web of challenges confronting humanity – climate change, pandemics, economic inequality, and violent conflict – demands a robust global governance system. However, the current architecture, centred on the United Nations, is widely considered inadequate. This document delves into this debate, analysing proposed reforms for the UN system in the Summit of the Future context. At the centre of the discussion is the need for an update to the UN System, particularly strengthening its effectiveness, efficiency, and democratic representation. The document recognises the need for prioritisation, focusing on reforms that tackle the “triple crisis” – climate change, inequality, and conflict – while remaining politically achievable. The document also highlights the disconnect between economic and political institutions, arguing for a more unified approach. Reform proposals encompass a wide spectrum, including institutional changes, consultative practices, decision-making rules and financing. The reforms proposed aim to empower the UN to take decisive action on pressing global issues, looking at past reform efforts, assessing the feasibility of current proposals, and prioritising those most likely to yield tangible results. This publication aims to serve as a roadmap for navigating the complexities of UN reform and providing a comprehensive overview of proposed changes towards shaping a more effective and democratic global governance system for the future.
A Toss Up? Comparing Tax Revenues from the Amount A and Digital Service Tax Regimes for Developing Countries
By Vladimir Starkov and Alexis Jin
In this paper, we attempt to estimate the tax revenues to be gained by the Member States of ATAF, WATAF, AU and the South Centre under the Amount A and an alternative stylized DST taxation regime. Our research demonstrates that the comparative revenue effects of the Amount A and DST taxation regimes largely depend on (a) the mix of relevant domestic economic activities at market jurisdictions (i.e., revenues sourced to the country as a market jurisdiction under Amount A and the level of revenues from automated digital services generated in the country), (b) design details of the DST regime such as the DST tax rate and the nature of activities to be taxed and (c) the relief from double taxation, if any, countries will grant to domestic and foreign taxpayers under DST. This paper contains analysis relying on sources of information available to private sector researchers and it does not involve review of any information that individual taxpayers provided to tax authorities.
What Can Cambodia Learn from Thailand and India as It Prepares to Graduate from Least Developed Country Status?
By Brigitte Tenni, Deborah Gleeson, Joel Lexchin, Phin Sovath, and Chalermsak Kittitrakul
Cambodia is expected to graduate from Least Developed Country status soon, at which time it will be required to make patents available for pharmaceutical products and processes to meet its obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Given its impending transition from LDC status, there is a need to balance Cambodia’s intellectual property (IP) policies and regulations with public health priorities to ensure access to affordable life-saving medicines. This will be critical to achieving universal health coverage, one of the United Nations’ Sustainable Development Goals. This paper examines Cambodia’s IP laws and regulations to identify provisions that could reduce access to affordable generic medicines when it starts granting patents for pharmaceuticals. It systematically compares Cambodia’s IP laws and regulations with those of Thailand and India – two developing countries that have had some successes in preserving access to medicines despite the introduction of pharmaceutical patents. It identifies lessons for Cambodia from the experiences of Thailand and India in implementing TRIPS and using TRIPS flexibilities such as compulsory licensing to ensure access to a sustainable supply of affordable generic medicines. Key recommendations for reform for Cambodia include strengthening the use of preventive and remedial TRIPS flexibilities and removing criminal sanctions for patent infringements. Cambodia should reject any TRIPS-plus provisions in its patent legislation and avoid membership in bilateral or plurilateral trade agreements that include TRIPS-plus provisions as well as signing patent treaties and memorandums of understanding that may facilitate the granting of unwarranted patents.
Compulsory Licensing as a Remedy Against Excessive Pricing of Life-Saving Medicines
By Behrang Kianzad
The COVID-19 crisis intensified decade-long debates on the interaction between intellectual property rights (IPRs), competition law and access to affordable life-saving treatments and vaccines. Compulsory licensing of patented medicines is a tried-and-tested method to expand access, particularly in a situation of “national emergency or other circumstances of extreme urgency” within the meaning of Article 31(b) of the TRIPS Agreement. Some legislations, such as European competition law, offer a toolbox for curbing the exercise of IPRs if they would be found in conflict with certain competition rules, such as rules prohibiting excessive pricing by dominant undertakings. The paper analyses the interface between intellectual property law and competition law in general, moving on to the settled case law of the Court of Justice of the European Union (CJEU) on this matter. It provides a general overview of legal and economics arguments related to excessive pricing prohibition and the main case law of European competition law on the matter and discusses whether compulsory licensing as a remedy against excessive pricing of patented life-saving pharmaceutical products can be a viable and appropriate remedy. Finally, the paper offers policy recommendations relating to compulsory licensing based on excessive pricing.
Licencias obligatorias para exportación: operacionalización en el orden jurídico argentino
Por Valentina Delich
En el año 2017, entró en vigor la enmienda del Acuerdo sobre los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC), por la cual se incluyó el artículo 31 bis en su texto. Esta disposición permite las licencias obligatorias para exportación a terceros países sin o con insuficiente capacidad de producción local. El objetivo es paliar las dificultades de los países sin infraestructura de producción de medicamentos para que puedan hacer un uso efectivo de las licencias obligatorias y así fortalecer el acceso a los medicamentos a un menor precio. Argentina es un país que tiene infraestructura de producción de medicamentos y potencialmente podría devenir en un exportador eficiente. Este documento explora la posible instrumentación del art. 31 bis en la legislación de Argentina, proponiendo incorporar en la ley de patentes nacional el instituto de la licencia obligatoria humanitaria.
Régimen de licencias obligatorias y uso público no comercial en Argentina
Por Juan Ignacio Correa
Con la adopción del Acuerdo sobre los Aspectos de Propiedad Intelectual relacionados con el Comercio (ADPIC), la Argentina debió adaptarse a las nuevas reglas internacionales en materia de derecho de patentes. Uno de los puntos centrales del Acuerdo es la posibilidad de establecer diferentes formas de licencias obligatorias y uso gubernamental no comercial. Este documento analiza las condiciones previstas en el artículo 31 del ADPIC con ese fin y examina en detalle las diferentes causales de licencias obligatorias contempladas en la legislación argentina y las condiciones aplicables a cada una de ellas, así como para el uso de patentes por parte del gobierno con fines no comerciales. Finalmente, con base en el margen normativo del ADPIC y la legislación vigente, el documento discute el posible contenido de una reglamentación de licencias obligatorias y uso público no comercial que permita a la Argentina utilizar de manera efectiva esas herramientas cuando se presente alguna de las circunstancias previstas en la actual regulación.
