Intersección entre Competencia y Patentes: Hacia un Ejercicio Pro- Competitivo de los Derechos de Patente en el Sector Farmacéutico
Por María Juliana Rodríguez Gómez
La interacción entre propiedad industrial, particularmente patentes farmacéuticas, y el derecho de la competencia, tiene un impacto en asuntos de interés general como los derechos a la salud, al acceso a los beneficios de la tecnología y a la libre competencia. La cuestión es cómo hacer compatible un mercado farmacéutico competitivo y dinámico, con el sistema de patentes, que otorga monopolios legales significativamente amplios sobre productos considerados innovaciones. A partir de un análisis legislativo y casuístico, se concluye que son necesarias mejores políticas pro competitivas -en especial en países en desarrollo- para enfrentar prácticas como el reverdecimiento (‘evergreening’) de patentes, los acuerdos para demorar la entrada de competidores y la negativa a licenciar, entre otras usadas en el sector farmacéutico para bloquear la entrada de la competencia. Los competidores, los consumidores y los sistemas de salud son vulnerables al creciente número de patentes y a esas prácticas. Diversas medidas pueden adoptarse, sin embargo, para lograr un balance entre la protección de la innovación y la competencia.
Contribution of the South Centre to the Report of the Secretary-General on the Implementation of UN General Assembly Resolution A/RES/74/7 dated 12 November 2019 on the “Necessity of ending the economic, commercial and financial embargo imposed by the United States of America against Cuba”
The imposition of unilateral economic, financial and trade measures against Cuba, in violation of basic principles of the United Nations (UN) Charter, has severe socio-economic impacts on the Cuban population. The UN General Assembly adopted by an overwhelming majority the resolution “Necessity of ending the economic, commercial and financial embargo imposed by the United States of America against Cuba” (document A/74/L.6). In response to the request in paragraph 4 of this resolution, the South Centre prepared a contribution to the report of the Secretary-General. This highlights, in particular, the obstacles that the US embargo poses for the attainment of the right to health in Cuba.
Antimicrobial Resistance: Examining the Environment as Part of the One Health Approach
By Mirza Alas
Antimicrobial Resistance (AMR) is a serious issue that is threatening the medical and agricultural advances of today. The connections that exist among human health, food production and the environment necessitate a One Health approach to address the challenge of AMR. Recent research points to the environment as an essential factor in the spread of AMR, as well as a possible reservoir of antimicrobial resistant bacteria and genes. The process, however, of the environmental transmission of resistance genes, along with their effects and how to mitigate them, is still being examined. As new research emerges, so to have new challenges regarding the selective pressure of antibiotics on the environment. AMR in the environment is not new, with resistance genes found even in isolated places (e.g. in permafrost or volcanoes) but understanding this natural process and its implications for tackling AMR continue to pose many questions. This paper aims to examine some of the emerging research on AMR from a One Health perspective and in particular to highlight the role of the environment. It will explore the use of antibiotics and their effects in different ecosystems, as well as the challenges they pose for developing countries: in particular, in designing policies to address antimicrobial resistance that take into account the connections among humans, animals and the environment.
Political Declaration on the occasion of the twenty-fifth anniversary of the Fourth World Conference on Women
Ministers and representatives of governments of the Member States of the United Nations met at a special one-day session of the 64th meeting of the Commission on the Status of Women (CSW64) and adopted a Political Declaration commemorating the 25th anniversary of the Fourth World Conference on Women, held in Beijing in 1995, and its major seminal output, the Beijing Declaration and Platform for Action (BD & BPfA).
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.
This policy brief provides an overview of the outcomes of selected agenda items that were discussed at the 72nd session of the World Health Assembly (WHA) of the World Health Organization (WHO), held from 21 to 26 May 2019 in Geneva. These items reflect some of the health priorities of developing countries.
Enabling and Benefitting from Tax Avoidance: The Case of Canada in Africa’s Extractive Sector
By Alexander Ezenagu, PhD
The treatment of multinational entities as separate entities for tax purposes is incompatible with economic reality. As such, multinational entities are able to erode tax bases and shift profits to low tax jurisdictions. Due to the base erosion and profit shifting activities of multinational entities, African countries struggle to achieve the Sustainable Development Goals (SDGs) – to eradicate poverty, invest adequately in infrastructure and its industries, significantly reduce illicit financial flows and strengthen domestic resource mobilization – as they rely heavily on corporate taxation for a large part of their public revenue.
If African countries are to achieve their SDGs, there is an urgent need for a new international tax system that aligns where economic activities occur with where profits are taxed. A practical alternative is the unitary taxation of multinational entities. Unitary taxation treats multinational companies as a single entity, allocating the global profit to the jurisdictions where economic activities occur and value is created.
This article calls for the purposeful study of the unitary taxation approach to income allocation and serious consideration of its merits by the relevant supranational bodies. (more…)
Second Medical Use Patents – Legal Treatment and Public Health Issues
By Clara Ducimetière
This paper attempts to give an overview of the debate surrounding the patentability of new therapeutic uses for known active ingredients, both in developed and developing countries. After close scrutiny of international patentability standards, this paper concludes that second medical uses do not qualify per se for patent protection and have only been protected in several jurisdictions by means of a legal fiction. The increasing acceptance of second medical use patents seems to result from strategic patent filing from pharmaceutical companies to extend the life of existing patents, justified mainly for financial reasons. However, these practices have a detrimental impact on generic competition and, hence, on the access to medicines and the public health, in particular in developing countries. Therefore, this paper argues that a sound patent policy in line with public health objectives, in particular, an enhanced access to medicines, should not allow for the grant of second medical use patents.
Medicines and Intellectual Property: 10 Years of the WHO Global Strategy
By Dr. Germán Velásquez
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.
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.
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.
The Core Elements of a Legally Binding Instrument: Highlights of the Revised Draft of the Legally Binding Instrument on Business and Human Rights
By Daniel Uribe Terán
Discussions towards the adoption of a legally binding instrument on business and human rights have reached its fifth year. The Chairperson-rapporteur submitted the Revised Draft of the legally binding instrument on 16 July 2019, having in view the comments and proposals received until the end of February 2019. The present policy brief reviews the core elements of the legally binding instrument as they are proposed in the revised draft, with the aim to provide analytical support to States’ delegations and other stakeholders during the negotiations on the binding instrument. This brief examines a number of issues, concerns and legal aspects that have been addressed during the previous sessions of the Open-ended Intergovernmental Working Group (OEIGWG) on transnational corporations and other business enterprises with respect to human rights and how they have evolved going towards the 5th Session of the OEIGWG.
