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.
Implementation of TRIPS Flexibilities and Injunctions: A Case Study of India
by Shirin Syed
The proponents of intellectual property (IP) have increasingly utilized injunctions with indiscriminate propensity as a strategic tool for IP enforcement, resulting in adverse socio-economic implications, including the enjoyment of human rights. This trend has eclipsed the flexibilities provided in the Doha Declaration on the TRIPS Agreement and Public Health. Although a substantial volume of the literature focuses on the flexibilities of compulsory license or scope of patentability, little attention has been given to the flexibilities related to IP enforcement. Discussing the implications of IP enforcement on public interest, the paper examines the gaps in the articulation of flexibilities of intellectual property rights (IPRs) enforcement, with special reference to injunctions in India. It examines how far the courts consider the implications on the enjoyment of fundamental rights while granting injunctions on patents. This paper argues that the Indian courts have deviated from the cautious approach provisioned under the TRIPS flexibilities that allows the courts to consider the public interest aspect and human rights implications while granting injunctions in patent litigation. Moreover, it asserts that the courts should exercise prudence in granting injunctive relief in cases involving patent infringement, and take into account the potential impact of such relief on the exercise of human rights. This suggests a need for a careful examination of the potential implications of injunctive remedies in such cases.
Desafíos actuales y posibles escenarios futuros de la salud mundial
By Germán Velásquez
Hace cuatro décadas los principales actores en la salud global eran la Organización Mundial de la salud (OMS), el Fondo de las Naciones Unidas para la Infancia (UNICEF) y los Estados Unidos de América y los países de Europa del Norte (mediante cooperación bilateral). Hoy asistimos a la proliferación de actores en este campo si bien con diferentes roles , ámbito de acción y niveles de influencia: La OMS, UNICEF, el Programa Conjunto de las Naciones Unidas sobre el VIH/SIDA (ONUSIDA), UNITAID, la Organización Mundial del Comercio (OMC), la Organización Mundial de la Propiedad Intelectual (OMPI), el Programa de las Naciones Unidas para el Desarrollo (PNUD), la Organización de las Naciones Unidas para la Agricultura y la Alimentación (FAO), el Fondo Monetario Internacional (FMI), el Banco Mundial, el G7 y el G20, el G77+China, el Movimiento de No Alineados, los BRICS (Brasil, Rusia, India, China y Sudáfrica), el Fondo Global, GAVI, COVAX, la industria farmacéutica, Bill & Melinda Gates y otras fundaciones y organizaciones no gubernamentales (ONGs) sin o con ánimo de lucro.
Este documento de investigación analiza el papel de los múltiples actores (públicos, privados y filantrópicos) en la salud global y, con base a ello, procura esbozar posibles escenarios futuros. En particular, examina el papel de la OMS bajo cuyos auspicios los países miembros están, desde hace dos años, negociando una reforma del Reglamento Sanitario Internacional (RSI) del 2005 y la posible adopción de un nuevo instrumento internacional para prevenir y dar una respuesta a futuras pandemias como la del COVID-19. La aplicación de estos instrumentos, si se adoptaran, estaría en manos de la OMS, uno de los principales actores de la salud mundial.
Pautas para el examen de patentes sobre anticuerpos monoclonales
Por Juan Correa, Catalina de la Puente, Ramiro Picasso y Constanza Silvestrini
La investigación tiene como objetivo conocer el estado de las solicitudes de patente en materia de anticuerpos monoclonales (mAbs). El documento analiza las distintas estrategias en materia de reivindicaciones que utilizan los solicitantes con el fin de obtener protección por derecho de patentes. Se utilizó como fuente de información la base de datos construida y descrita en el Documento de Investigación No. 186 de South Centre. Se indaga sobre las principales reivindicaciones utilizadas en el campo de los mAbs, el tipo de clasificación CIP y el tipo de invención (producto o proceso) más frecuente en las patentes concedidas vigentes o caducas en Argentina. Finalmente, se analiza la utilización de las directrices de patentamiento argentinas en el caso de mAbs y se hacen recomendaciones respecto de posibles reformas a dichas directrices.
TRIPS Waiver Decision for Equitable Access to Medical Countermeasures in the Pandemic: COVID-19 Diagnostics and Therapeutics
By Nirmalya Syam and Muhammad Zaheer Abbas, PhD
The Marrakesh Agreement Establishing the World Trade Organization (WTO) allows WTO Members to agree to temporarily waive obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). However, the TRIPS Decision adopted by the 12th WTO Ministerial Conference in June 2022, after lengthy and protracted negotiations lasting for 20 months in the middle of a pandemic, allowed only a fragment of the waiver proposal submitted by India and South Africa. Moreover, since the adoption of the Decision there has been an impasse in the WTO about extending the Decision to COVID-19 diagnostics and therapeutics even though the WTO Members were mandated by the Decision to decide on this matter within six months of the Decision. This research paper analyses the current state of play and concludes that there is a need to immediately and unconditionally extend the Decision to COVID-19 diagnostics and therapeutics. Moreover, the paper suggests options for how the TRIPS flexibilities can be optimally utilized in a pandemic situation without developing countries being resigned to the vagaries of negotiations on a waiver which is supposed to be an urgent emergency solution. In this regard, the paper also suggests options that could be considered for reforming the process of decision-making on a waiver proposal to ensure that decisions on waivers are taken in a timely and expedited manner without being negotiated for an extensive period of time in the midst of an emergency.
