Chapter 1: COVID-19 Vaccines: Between Ethics, Health and Economics -- Chapter 2: Medicines and Intellectual Property: 10 Years of the WHO Global Strategy -- Chapter 3: Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 -- Chapter 4: Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock -- Chapter 5: Intellectual Property and Access to Medicines and Vaccines -- Chapter 6: The World Health Organization Reforms in the Time of COVID-19 -- Epilogue.
The unprecedented global health crisis caused by the coronavirus (COVID-19) pandemic since the first quarter of 2020 has reopened the now-urgent discussion about the role of local pharmaceutical production in addressing the health needs in developing countries. The COVID-19 crisis has highlighted the interdependencies in the global production of pharmaceuticals—no country is self-sufficient. Many industrialized countries are making the decision to repatriate or initiate the production of active pharmaceutical ingredients (APIs) and medicines. Governments are beginning to talk about 'pharmaceutical sovereignty' or 'health security'. If this becomes a reality and the production of pharmaceuticals is led by nationalistic policies, developing countries that still lack manufacturing capacity will have to start or expand the local production of pharmaceuticals, whether at the national or regional level. The war to get access to the future vaccine for COVID-19 does not look easy with these new developments.
The negotiations of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) (2006-2008), undertaken by the Member States of the World Health Organization (WHO), were the result of a deadlock in the 2006 World Health Assembly where the Member States were unable to reach an agreement on what to do with the 60 recommendations in the report on Public Health, Innovation and Intellectual Property submitted to the Assembly in the same year by a group of experts designated by the Director-General of the WHO. The result of these negotiations was the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) that was approved by the World Health Assembly in 2008. One of the objectives of the IGWG's Global Strategy and Plan of Action was to substantially reform the pharmaceutical innovation system in view of its failure to produce affordable medicines for diseases that affect the greater part of the world's population living in developing countries. The intellectual property (IP) rights imposed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the trade agreements could become some of the main obstacles to accessing medicines. The GSPOA made a critical analysis of this reality and opened the door to the search for new solutions to this problem. Ten years after the approval of the GSPOA, the results are uncertain and poor.
Until recently, the link between the examination of patents carried out by national patent offices and the right of citizens to access to medicines was not at all clear. They were two functions or responsibilities of the State that apparently had nothing to do with each other. Examining the growing literature on intellectual property and access to medicines, it seems that the analysis of one actor has been left out: the patent offices. And the reason is clear: patent offices are administrative institutions. Patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators. There is now greater understanding that the examination of patents and the role played by patent examiners are key elements that could contribute to or obstruct access to medicines. Given the impact of pharmaceutical patents on access to medicines, patent offices should draw up public policies and strategies that respond to national health and medicine policies.
ilustraciones, graficas, mapas ; Existe una creciente tendencia de implementar césped sintético en diferentes espacios deportivos, soluciones constructivas y áreas públicas en todo el mundo. En Colombia se promociona como una solución constructiva ágil y eficiente para el aprovechamiento del espacio público con fines deportivos; existe literatura que expone los beneficios y posibles perjuicios de estos campos sintéticos, en Colombia no se han adelantado estudios específicos, por tanto, se desconoce si la construcción y uso de estos campos representa efectos ambientales significativos. Sin embargo, este trabajo evalúa los efectos ambientales de la construcción y uso de campos sintéticos deportivos y formula lineamientos ambientales. En Bogotá entre los años 2016 y 2020 se construyeron 157 nuevos campos sintéticos deportivos públicos, lo que representa un aumento superior al 900% en solo 5 años, estos campos sintéticos se construyen en los parques del sistema distrital, que hacen parte de la Estructura Ecológica Principal (EEP) de la ciudad. Se identificaron las principales actividades asociadas a las fases de construcción y uso de los campos sintéticos deportivos, los factores ambientales más relevantes con los que esas actividades se relacionan y los efectos ambientales de mayor significancia. Se proponen lineamientos para 19 elementos entre actividades de construcción, actividades de uso y efectos ambientales, que orientan el diseño e implementación de campos sintéticos deportivos; la aplicación de estos lineamientos puede prevenir efectos ambientales negativos y potenciar los efectos positivos que genera este tipo de infraestructura, también pueden funcionar como estrategia de mejoramiento de la inversión pública y recuperación del espacio público. (Texto tomado de la fuente) ; There is an upward trend to implement synthetic turf in different sports areas, building solutions and public areas around the world. In Colombia it is promoted as quick and efficient constructive solution of the public use area for sports purposes; there is literature that exposes synthetic fields benefits and possible damages, but not specific studies have been carried out in Colombia, therefore, it is not known if the construction and use of these fields represent significant environmental effects. Nevertheless, this study analyzes the construction and use of synthetic sport fields environmental effects, and develops environmental guidelines. From 2016 to 2020, in Bogota 157 new public synthetic sports fields were built, which represents an increase of more than 900% in just 5 years, these synthetic fields are built on governmental district system parks, which belong to the city EEP part. The main activities associated with the construction steps and synthetic sports fields use, the most relevant environmental factors with which these activities are related and the most significant environmental effects were identified. Guidelines are proposed for 19 elements among them; construction activities, use activities, and environmental effects, which guide the synthetic sports fields design and implementation; the application of these guidelines can prevent negative environmental effects and enhance the positive effects generated by this kind of infrastructure; they can also function as a strategy in order to improve public investment and public space recovery. ; Maestría ; Magíster en Medio Ambiente y Desarrollo ; Economía, ambiente y desarrollo
This South Centre research paper discusses first, the limitations of the current research and development (R&D) model and its implications for access to medicines. Second, it considers the tension between intellectual property rights applied to medicines and States' observance of the fundamental right to health. Third, it examines the case of access to medicines for the treatment of Hepatitis C, illustrating the barriers to access created by intellectual property and the high prices normally associated with its exercise. Fourth, it presents the background, main aspects and obstacles to the achievement of the objectives of the Doha Declaration on the TRIPS Agreement and Public Health (2001). To conclude, this paper examines the experiences of compulsory licensing and government use of patents in Latin America (particularly in Ecuador, Peru and Colombia).
Este documento de investigación del South Centre analiza primero las limitaciones del modelo actual de investigación y desarrollo (I&D) y sus implicaciones para el acceso a los medicamentos. En segundo lugar, considera la tensión entre los derechos de propiedad intelectual aplicados a los medicamentos y la observancia de los Estados del derecho fundamental a la salud. En tercer lugar, examina el caso del acceso a medicamentos para el tratamiento de la hepatitis C, ilustrando las barreras de acceso creadas por la propiedad intelectual y los altos precios normalmente asociados con su ejercicio. En cuarto lugar, presenta los antecedentes, los principales aspectos y los obstáculos para el logro de los objetivos de la Declaración de Doha sobre el Acuerdo sobre los ADPIC y la Salud Pública (2001). Para concluir, este documento examina la concesión de licencias obligatorias y el uso por el gobierno de patentes, en experiencias en América Latina (en particular, Ecuador, Perú y Colombia). ; This South Centre research paper discusses first, the limitations of the current research and development (R&D) model and its implications for access to medicines. Second, it considers the tension between intellectual property rights applied to medicines and States' observance of the fundamental right to health. Third, it examines the case of access to medicines for the treatment of Hepatitis C, illustrating the barriers to access created by intellectual property and the high prices normally associated with its exercise. Fourth, it presents the background, main aspects and obstacles to the achievement of the objectives of the Doha Declaration on the TRIPS Agreement and Public Health (2001). To conclude, this paper examines the experiences of compulsory licensing and government use of patents in Latin America (particularly in Ecuador, Peru and Colombia).
OBJECTIVE: The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. METHODS: Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires). FINDINGS: By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic. CONCLUSION: The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization ...
