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.
Enhancing Access to Remedy through International Cooperation: Considerations from the Legally Binding Instrument on Transnational Corporations and Other Business Enterprises
By Danish
The shortcomings in international cooperation between regulatory authorities in different countries can open up a gap in their legal regimes which could be exploited by transnational corporations and allow them to elude responsibilities for the violation or abuse of human rights. The Revised Draft of the Legally Binding Instrument on Transnational Corporations and Other Business Enterprises seeks to bridge this gap and works towards increasing collaboration among countries for ensuring access to effective remedies for victims of human rights violations or abuses due to business activities. This brief looks at some of its salient features and how they can be utilized by countries for the protection and promotion of human rights in their territories.
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.
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.
The Olympic ideal and inclusive sports and their contribution to the promotion of human rights, peace and development were extensively deliberated on at the United Nations Human Rights Council Social Forum 2018. The outcome of the forum could contribute to strengthening inclusion and solidarity through a human rights- and Sustainable Development Goals-based approach to major sporting events, in particular the 2024 Paris Olympics. (more…)
