Access to Medicines

Book by the South Centre, 2019

Seeking Remedies for Access to Medicines and Intellectual Property: Recent Developments 

 

About the Book: This book is a collection of research papers by Germán Velásquez published by the South Centre, between 2015 and 2019 on the recent international deliberations and negotiations in the United Nations on access to medicines and their relationship with international trade and intellectual property regimes.

Author: Germán Velásquez is the Special Adviser, Policy and Health of the South Centre.

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Call for Papers, September 2019

Call for Papers – TRIPS Flexibilities and Public Health (Deadline: 20 October)

The South Centre and the Max Planck Institute for Innovation and Competition are organizing a Global Forum on Intellectual Property, Access to Medicines and Innovation, in Munich, on 9-10 December 2019. The Forum is designed to bring together policymakers from developing countries with established scholars, early career academics and PhD students across multiple disciplines, allowing cross-fertilization of ideas that advance both scholarship and practice in the field.

This call for papers will receive innovative ongoing and/or unpublished research from early career scholars and PhD students on substantive flexibilities in the IP system afforded by the TRIPS Agreement that are relevant to pursue public health goals. Case studies, comparative analyses, empirical and statistical studies, as well as legal reflections with a policy perspective will be considered.

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Statement, September 2019

South Centre Statement at the United Nations High Level Meeting on Universal Health Coverage

Access to health is a human right and Universal Health Coverage (UHC) is essential to achieve health for all. States should ensure through public funding, based on solidarity and the fair redistribution of wealth, that nobody is deprived from health care. Policies that promote competitive markets for pharmaceuticals, particularly in the area of procurement, regulatory approvals (including biologicals) and intellectual property, should be implemented. Governments should make use of the available space in the TRIPS Agreement to apply rigorous definitions of invention and patentability standards and use other flexibilities allowed.Below is the South Centre’s Statement to the UN High-Level Meeting on UHC held on 23 September 2019 at the UN headquarters in New York. The Centre noted the recognition, in the draft political declaration, of the responsibilities of governments as well as of their right to choose their own path towards achieving UHC.

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The South Centre Monthly, August 2019

The worldwide problem of the rise in antimicrobial resistance (AMR) is a serious threat to global public health.  The loss of efficacy of antibiotics and other antimicrobials affects everyone. Yet the threat is greater in developing countries, due to the higher incidence of infectious diseases. Developing countries will be unequivocally affected by AMR, deteriorating the health of the population, reducing economic growth and exacerbating poverty and inequalities. The blueprint for addressing AMR as a global problem is advanced. Countries are progressing in developing and implementing national action plans and overall the public awareness of AMR is increasing.

However, we are at the tip of the iceberg of response. AMR is not yet a key priority of most governments, and global coordination and resource mobilization to enable all countries to do their part are lagging. The Secretary-General of the United Nations (UN) in the upcoming 74th UN General Assembly (UNGA) will be reporting on the implementation of the UN resolution on AMR of 2016, including the recommendations of the Interagency Coordination Group (IACG) on Antimicrobial Resistance.  The UNGA will also host a High-Level Meeting to build support for advancing Universal Health Coverage (UHC), that is essential for AMR response. Expanding primary health care services, strengthening the health work force, improving infection prevention and control and measures to secure access to essential medicines and others to reduce health inequities can help contain AMR in developing countries. Developing countries need to be actively involved in shaping the global agenda on antimicrobial resistance, including the new global governance mechanisms that are being set up for AMR.

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Informe Sobre Políticas 64, Agosto 2019

USMCA debe ser enmendado para asegurar el acceso a medicamentos en México

El capítulo del U.S.-Mexico-Canada Agreement (USMCA)/Tratado entre México, los Estados Unidos y el Canadá (T-MEC) dedicado a los derechos de propiedad intelectual (DPI) otorga monopolios más prolongados y amplios a las empresas de medicamentos originales que los que están actualmente en vigor en México, a costa de los pacientes y los contribuyentes. Entre otras cosas, México tendría que conceder a las ampliaciones de la vigencia de las patentes períodos de exclusividad más amplios y prolongados, también para los medicamentos biológicos costosos, tanto por las demoras en la concesión de patentes como para aquellas que se encuentren en el proceso reglamentario de aprobación, y ampliar las normas de patentabilidad, por ejemplo, exigiendo la concesión de patentes para nuevos usos. México es, sin lugar a dudas, el país del T-MEC que se verá más perjudicado, pero si los miembros del Partido Demócrata de la Cámara de Representantes de los Estados Unidos pueden renegociar algunas de estas disposiciones para restablecer cierto equilibrio entre la necesidad de fomentar la innovación y la competencia, el Gobierno del presidente López Obrador y el Congreso de México todavía pueden cambiar la situación.

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Documento de Investigación 96, Agosto 2019

Antivirales de acción directa para la Hepatitis C: evolución de los criterios de patentabilidad y su impacto en la salud pública en Colombia

La hepatitis C en el siglo XXI y el VIH en el final del siglo XX han representado los más relevantes retos de salud pública para la comunidad internacional. No solamente por ser enfermedades infecciosas y transmisibles (razón de ser de la salud pública) sino por su carácter mortal si no se recibe tratamiento de manera oportuna. En Octubre de 2015, la fundación IFARMA solicitó que todos los medicamentos antivirales para la hepatitis C, utilizables para curar una infección crónica transmisible potencialmente mortal, fueran declarados de interés público, dado que su precio amenazaba la sostenibilidad financiera del sistema de salud. Una declaración de interés público para estos medicamentos sería el primer paso para la emisión de licencias obligatorias. Este trabajo se ha llevado a cabo para identificar las patentes existentes en Colombia para estos productos, su alcance y sus consecuencias, en el marco de una discusión sobre la transparencia del sistema de patentes y la evolución del rigor con que se evalúan las solicitudes y se conceden las patentes.

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The South Centre Monthly, July 2019

Inequality is one of the greatest challenges that the world needs to face. Inequality is intimately linked with poverty. Although there has been progress in reducing poverty, a large part of the global population (overwhelmingly living in developing countries) is still denied access to a dignified life. While no poverty and reduced inequality are two of the outstanding Sustainable Development Goals, these and other goals are unlikely to be achieved by 2030. In fact, inequality is on the rise. Changing this situation will certainly require significant efforts at the national and regional level. But it also requires an international architecture that supports those efforts by respecting the policy space that countries need and coordinating constructive actions within the multilateral system. The current initiatives to ‘reform’ this system will only be legitimate if they recognize the gaps in the levels of development and contribute to effectively address them under a fair, pro-development system of rules. Please see last month’s SouthViews on “Understanding global inequality in the 21st century” by Jayati Ghosh, development economist and Professor of Economics at Jawaharlal Nehru University.

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Access to medicines: US democrat lawmakers oppose intellectual property rules in the USMCA restraining access to affordable biosimilars

Access to medicines: US democrat lawmakers oppose intellectual property rules in the USMCA restraining access to affordable biosimilars

On July 11, 2019, US democrat lawmakers signed a letter addressed to US Trade Representative Robert E. Lighthizer, expressing strong opposition to provisions that limit access to medicines in the United States-Mexico-Canada Agreement (USMCA). They are requesting to amend the USMCA to increase competition and enhance patient access to more affordable prescription drugs, particularly biosimilars. The current USMCA text would limit Congress’ ability to adjust the biologics exclusivity period, locking the US into policies that keep drug prices high while exporting this model to Mexico and Canada. Below is a link to the letter.

Le 11 juillet 2019, représentants démocrates du Congrès américain ont signé une lettre adressée à Robert E. Lighthizer, le représentant américain au commerce, exprimant leur forte opposition aux dispositions de l’Accord conclu entre les États-Unis, le Mexique et le Canada, qui limitent l’accès aux médicaments. Ils demandent que les dispositions de l’Accord soient modifiées afin de favoriser davantage la concurrence et de faire en sorte que les patients puissent accéder à des médicaments sur ordonnance à un coût abordable, en particulier les médicaments biosimilaires. Le texte actuel de l’Accord a pour conséquence de limiter la capacité du Congrès à ajuster la durée de la période d’exclusivité pour les médicaments biologiques, enfermant les États-Unis dans une politique tendant à maintenir le prix des médicaments à un niveau élevé tout en exportant le modèle au Mexique et au Canada. Vous trouverez ci-dessous le lien sous lequel la lettre peut être consultée.

El 11 de julio de 2019, legisladores demócratas de los Estados Unidos firmaron una carta dirigida al representante de Comercio de los Estados Unidos, Robert E. Lighthizer, expresando su firme oposición a las disposiciones que limitan el acceso a medicamentos en el Tratado entre México, los Estados Unidos y el Canadá (T-MEC). Solicitan modificar el T-MEC para aumentar la competencia y mejorar el acceso de los pacientes a medicamentos con receta más asequibles, especialmente a los biosimilares. El texto actual del T-MEC limitaría la capacidad del Congreso para adaptar el período de exclusividad de los medicamentos biológicos, lo que obligaría a los Estados Unidos a establecer políticas que mantengan altos los precios de los medicamentos mientras se exporta este modelo a México y al Canadá. A continuación, se encuentra un enlace a la carta.

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Policy Brief 65, July 2019

Time for a Collective Response to the United States Special 301 Report on Intellectual Property

This policy brief discusses the annual Special 301 report issued by the Office of the United States Trade Representative (USTR). The report is a unilateral tool of the US to pursue its foreign intellectual property (IP) policy by exerting pressure on countries to reform their IP laws and practices. Developing countries are particularly susceptible to this threat. The report identifies countries that are considered by the US as not providing adequate and effective protection of IP of rights holders from the US. The selection of countries is biased to the concerns raised by segments of the US industry. The report targets balanced provisions in countries’ legislations to ensure that IP rights do not hinder the ability of the government to adopt measures for promoting development priorities, particularly in the area of public health. A uniform and collective international response by the affected countries is long overdue. The way forward is to continue dialogue in appropriate multilateral fora, recognizing the need for all countries to maintain policy space to use IP as a domestic policy tool.

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Policy Brief 64, July 2019

The USMCA must be amended to ensure access to affordable drugs in Mexico

The intellectual property rights (IPRs) chapter of the U.S.-Mexico-Canada-Agreement (USMCA) grants longer and broader monopolies to originator pharmaceutical companies than those currently in force in Mexico, at the expense of patients and taxpayers. Among other things, Mexico would be required to provide patent term extensions both for delays in the granting of patents and for those incurred in the regulatory approval process, broader and longer exclusivity periods, including for expensive biologic drugs, as well as to adopt broader patentability standards, for example by requiring the granting of patents for new uses. Mexico is, without doubt, the country in the USMCA that will be most negatively impacted, but  if the  Democratic Members of the US House of Representatives are able to renegotiate some of these provisions to restore some balance between the need to foster innovation and competition, the Administration of President López Obrador and the Mexican Congress can still make a difference.

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