Bolar

Research Paper 141, November 2021

Utilising Public Health Flexibilities in the Era of COVID-19: An Analysis of Intellectual Property Regulation in the OAPI and MENA Regions

By Yousuf A Vawda and Bonginkosi Shozi

The paper explores the unique approaches to IP protection in the countries belonging to the Organisation Africaine de la Propriété Intellectuelle/African Intellectual Property Organization (OAPI) and the Middle East and North Africa (MENA) regions; the limited extent to which legal and policy frameworks with regard to TRIPS flexibilities have been adopted and implemented in pursuit of access to medicines in those countries; and makes recommendations in order to optimise the use of the flexibilities in advancing public health objectives. In the context of the COVID-19 pandemic, the impact of IP rights on access, and some approaches to countering the challenges to access are also discussed.

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STATEMENT ON THE DOHA DECLARATION ON TRIPS AND PUBLIC HEALTH ON ITS 20TH ANNIVERSARY, 14 November 2021

STATEMENT BY THE SOUTH CENTRE ON THE WTO DOHA MINISTERIAL DECLARATION ON TRIPS AND PUBLIC HEALTH ON ITS TWENTIETH ANNIVERSARY

Twenty years since its adoption on this day, the WTO Doha Declaration on TRIPS & Public Health has helped to advance TRIPS flexibilities in national laws, judgements, panel reports and FTAs. However, the COVID-19 pandemic has exposed significant challenges to the full use of TRIPS flexibilities that should be addressed by WTO Members.

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Book by the South Centre, 2021

Access to Medicines and Vaccines: Implementing Flexibilities Under Intellectual Property Law

Description:

This book is an outcome of a partnership between the Max Planck Institute (MPI) for Innovation and Competition and the South Centre, which jointly organized a Global Forum on Intellectual Property, Access to Medicine and Innovation in Munich on 9– 10 December 2019.

This book examines topics of particular relevance for shaping intellectual property regimes that take into account public health concerns. It provides not only deep analyses but options for the interpretation of existing regulations or the adoption of new legislation that, being consistent with the TRIPS Agreement, can allow the judiciary and policy makers to take such concerns into account. In different chapters, the book addresses various dimensions of the flexibilities allowed under the TRIPS Agreement. Although there is a significant literature and statements on the subject, such as the ‘Declaration on Patent Protection. Regulatory Sovereignty under TRIPS’ elaborated under the auspices of the MPI, the book contains new reflections and examines recent developments in case law and legislation.

The covered issues include how the TRIPS Agreement can be interpreted to implement its flexibilities, the use of competition law to promote access to medicines, the role of cooperation in the examination of patent applications, patentability requirements, the impact of TRIPS plus provisions (such as the linkage between patents and drug regulatory approvals), the patentability in the area of CRISPR genome editing technologies, as well as an analysis of the scope of exceptions and limitations to exclusive rights provided for by the Agreement, such as the exhaustion of rights and parallel imports, compulsory licenses, the ‘Bolar exemption’, and procedural mechanisms like pre-grant oppositions. The implications of the protection of test data are also examined.

While celebrating the opportunity of working together in organizing the Global Forum, we hope that this book will assist policy makers and judges and provide new inputs for academic research. While, as mentioned, there is a differentiated impact of intellectual property rights depending on the level of development of the country where it applies, the reconciliation of such rights with public health interests, particularly in relation to access to medicines, is a matter of concern for all countries.

Editors: Carlos M. Correa and Reto M. Hilty

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Research Paper 132, June 2021

Interpreting the Flexibilities Under the TRIPS Agreement

By Carlos M. Correa

While the TRIPS Agreement provides for minimum standards of protection of intellectual property, it leaves a certain degree of policy space for WTO members, whether developed or developing countries, to implement the Agreement’s provisions in different manners, to legislate in areas not subject to the minimum standards under the Agreement, and to develop legal interpretations of such provisions to determine the scope and content of the applicable obligations. This paper focuses on some aspects of how panels and the Appellate Body of the WTO have interpreted said provisions. The paper also draws general conclusions for the implementation of TRIPS flexibilities, which are of crucial importance for the design of a pro-competitive intellectual property system and, in particular, for achieving public health objectives, as specifically recognized by the Doha Declaration on TRIPS and Public Health.

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Material de capacitación 1 sobre Propiedad intelectual y acceso a medicamentos, Junio 2021

Propiedad intelectual y acceso a medicamentos: una introducción a cuestiones clave – algunos términos y conceptos básicos 

Por Germán Velásquez

La propiedad intelectual y las patentes en particular se han convertido en uno de los temas más debatidos sobre el acceso a los medicamentos, desde la creación de la Organización Mundial del Comercio (OMC) y la entrada en vigor del Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC). Las patentes no son de ninguna manera las únicas barreras para el acceso a medicamentos que salvan vidas, pero pueden desempeñar un papel significativo, o incluso determinante. Durante el período de protección de la patente, la capacidad del titular de la patente para determinar los precios, en ausencia de competencia, puede hacer que el medicamento resulte inalcanzable para la mayoría de las personas que viven en los países en desarrollo. Este primer número de los “Materiales de capacitación del South Centre” pretende, en su primera parte, ofrecer una introducción a cuestiones clave en el ámbito del acceso a los medicamentos y la propiedad intelectual. La segunda parte describe y define algunos términos y conceptos básicos de esta área relativamente nueva de las políticas farmacéuticas, que son los aspectos comerciales de los derechos de propiedad intelectual que regulan la investigación, el desarrollo y el suministro de medicamentos y las tecnologías sanitarias en general.

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Research Paper 127, December 2020

Revisiting the Question of Extending the Limits of Protection of Pharmaceutical Patents and Data Outside the EU – The Need to Rebalance

By Daniel Opoku Acquah

The European Union (EU) has instituted internal and external measures aimed at protecting and enforcing intellectual property rights. In the area of pharmaceutical patents, the Union has also sought to protect its industries through patent term extension and data exclusivity. Recent EU free trade agreements (FTAs) with developing countries contain chapters on intellectual property that extend patent terms and data exclusivity for pharmaceutical products. Such acts further prolong the lifespan of protection given to existing products and limit generic market entry. I identify the issue as one of “cross-pollination” of laws and argue that since similar laws exist in the internal regime of the EU, incorporating them into the EU would not be too technically difficult. However, to the extent that this regime is simulated in developing countries, implementation would damage the health sectors and economies of these countries. I therefore propose that developing countries should not be forced to adopt such laws through FTAs. If they are forced to adopt the laws after all, there should be a compulsory inclusion of (1) a clause on transitional arrangements for developing countries specific to intellectual property; (2) a clause that clearly links the objectives for intellectual property protection and enforcement (in this context, patent term extension and data exclusivity) to balance the promotion of technological innovation with access to medicines; and (3) a clause on Bolar exemption and a manufacturing waiver.

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Policy Brief 84, September 2020

A New Trend in Trade Agreements: Ensuring Access to Cancer Drugs

By Maria Fabiana Jorge

A World Health Organization (WHO) report on cancer indicates that the cancer burden will increase at least by 60% over the next two decades, straining health systems and communities.  Companies develop cancer drugs in part because payers are less resistant to paying high drug prices for these drugs.  As Barbara Rimer, Dean of the University of North Carolina and Chair of the U.S. President’s Cancer Panel stated, “[m]ost cancer drugs launched in the United States between 2009 and 2014 were priced at more than $100,000 per patient for one year of treatment.”  Many of the new cancer drugs are biologics. Such prices are clearly out of reach for most patients who will need them increasingly more to stay alive.  While competition is critical to ensure lower drug prices, we have seen a number of strategies, including through trade agreements, to prevent competition and extend monopolies over these drugs and their very high drug prices.  It is no accident that the exclusivity granted to biologic drugs has been one of the most conflictive provisions in recent trade agreements such as the United States-Mexico-Canada Agreement (USMCA) and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).  Nevertheless a new trend in trade agreements started in 2007 when U.S. Members of Congress pushed back against the interests of powerful economic groups seeking longer monopolies for drugs.  These Members of the U.S. Congress prevailed then in restoring some balance in the trade agreements with Peru, Colombia and Panama and further consolidated this new trend in 2019 in the USMCA.  Moreover, following the U.S. withdrawal from the original Trans-Pacific Partnership (TPP), the negotiators of the remaining 11 countries also pushed back to ensure a better balance between innovation and access in the CPTPP.  People around the world need to be aware of these precedents and ensure that they also work for access to medicines for their own citizens.

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Documents de Formation 1 sobre Propriété Intellectuelle et Accès aux Médicaments, Août 2020

Propriété Intellectuelle et Accès aux Médicaments : Une Introduction aux Grandes Problématiques – Quelques Termes et Concepts de Base

Par Germán Velásquez

La propriété intellectuelle et les brevets en particulier sont devenus l’une des questions les plus débattues sur l’accès aux médicaments, depuis la création de l’Organisation mondiale du commerce (OMC) et l’entrée en vigueur de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (ADPIC). Les brevets ne sont nullement les seuls obstacles à l’accès aux médicaments qui sauvent des vies, mais ils peuvent jouer un rôle important, voire déterminant. Pendant la durée de protection d’un brevet, la capacité du titulaire du brevet à déterminer les prix, en l’absence de concurrence, peut faire en sorte que le médicament soit inabordable pour la majorité des personnes vivant dans les pays en développement. Ce premier numéro du “South Centre Training Papers” vise, dans sa première partie, à fournir une introduction aux questions clés dans le domaine de l’accès aux médicaments et de la propriété intellectuelle. La deuxième partie décrit et définit certains termes et concepts de base de ce domaine relativement nouveau des politiques pharmaceutiques, qui sont les aspects liés au commerce des droits de propriété intellectuelle qui régissent la recherche, le développement et la fourniture de médicaments et les technologies de la santé en général.

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Book by the South Centre, 2020

Modulos de Introduccion a la Propiedad Intelectual y Salud Pública

Descripción:

Este libro contiene cuatro módulos para la capacitación en materia de propiedad intelectual y salud pública. Su objetivo es presentar una introducción a las diversas categorías de derechos de propiedad intelectual y, en particular, ilustrar sobre los derechos aplicables a la producción y comercialización de medicamentos en el marco de las llamadas ‘flexibilidades’ contenidas en el Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio de la Organización Mundial del Comercio. Los módulos proporcionan elementos para comprender el alcance y las implicaciones de los derechos de propiedad intelectual, especialmente las patentes de invención, en el acceso a los medicamentos. Ellos brindan asimismo pautas para el diseño y la aplicación de esos derechos en una manera consistente con dicho Acuerdo y con políticas de protección de la salud pública. Los módulos contienen información general y enfoques prácticos para orientar a los encargados de formular y aplicar políticas públicas en el tratamiento del tema, tanto en el campo administrativo como judicial.

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Research Paper 103, February 2020

Eighteen Years After Doha: An Analysis of the Use of Public Health TRIPS Flexibilities in Africa

By Yousuf A Vawda and Bonginkosi Shozi

As we observe the 18th anniversary of the Doha Declaration on the TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) and Public Health, it is appropriate to take stock of intellectual property developments and endeavour to present a comprehensive account of the situation in the African continent in respect of the implementation of TRIPS flexibilities, specifically those regarding access to medicines. This research paper provides an overview of the extent to which selected African countries have adopted legal and policy frameworks with regard to TRIPS flexibilities, examines the actual use of these flexibilities in enabling access to medicines in those countries, and suggests some recommendations for optimising the use of the flexibilities in pursuing public health imperatives.

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Training Paper 1, December 2019

Intellectual Property and Access to Medicines: An Introduction to Key Issues – Some Basic Terms and Concepts

Intellectual property and patents in particular, have become one of the most debated issues on access to medicines, since the creation of the World Trade Organization (WTO) and the coming into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Patents are by no means the only barriers to access to life-saving medicines, but they can play a significant, or even determinant, role. During the term of patent protection, the patent holder’s ability to determine prices, in the absence of competition, can result in the medicine being unaffordable to the majority of people living in developing countries. This first issue of the “South Centre Training Materials” aims, in its first part, to provide an introduction to key issues in the field of access to medicines and intellectual property. The second part describes and defines some basic terms and concepts of this relatively new area of pharmaceuticals policies which are the trade related aspects of intellectual property rights that regulate the research, development and supply of medicines and health technologies in general.

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Informe Sobre Políticas 64, Agosto 2019

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

Por Maria Fabiana Jorge

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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