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.
Assessment of the Two-Pillar Approach to Address the Tax Challenges Arising from the Digitalization of the Economy
An Outline of Positions Favourable to Developing Countries
Report by the South Centre Tax Initiative’s Developing Country Expert Group
Irene Ovonji-Odida, Veronica Grondona, Samuel Victor Makwe
This report is written primarily for developing country negotiators in the Inclusive Framework and accordingly contains a technical assessment of Pillars One and Two. The aim is to discuss the positions and principles which can inform the negotiations in developing countries’ best interests. However, it is also written for a larger audience, particularly diplomats involved in financing for development discussions and international trade rule making, so as to sensitise them to the nuances of the ongoing discussion on the taxation of the digitized economy. In the midst of the COVID-19 pandemic and a devastating economic downturn, it is more important than ever to ensure that developing countries obtain their due taxing rights. This report is an initial contribution in that direction.
How Civil Society Action can Contribute to Combating Antimicrobial Resistance
By Mirza Alas Portillo
One of the key groups of actors that must be recognized for their influential role in shaping health policy outcomes are civil society organizations (CSOs). The antimicrobial resistance (AMR) space is no exception. AMR is one of the most significant health threats of our time, and many CSOs have had a critical role in shaping the national, regional and global responses to this health threat. However, CSOs working in the AMR space have received little financial support. In the final report submitted to the UN Secretary-General, the United Nations Inter-Agency Coordination Group (IACG) on AMR recommended increasing collaboration, as doing so is necessary for effective action and is an essential part of tackling AMR. IACG also provided specific recommendations for strengthening the engagement of CSOs. While the need for this engagement is broadly recognized, there is limited literature documenting how CSOs have been involved in shaping AMR policies. Increased evidence can strengthen the case for expanding financial support to CSOs work on AMR. A critical look into how CSOs are spearheading campaigns to tackle AMR and promoting accountability through monitoring governments’, international organizations’ and other actors’ AMR-related commitments, particularly in developing countries, would be especially useful.
This paper aims to contribute to the analysis of CSOs involvement in the global AMR response. It begins by defining what constitutes a CSO and offers examples of how CSOs have contributed to addressing other critical health issues to draw lessons for handling AMR. It then undertakes a case analysis of a prominent CSO coalition, the Antibiotic Resistance Coalition (ARC), and describes that organization’s essential contributions in the AMR space. Finally, the paper offers reflections on why CSO participation in the AMR space needs to be further enhanced and supported.
The South Centre Tax Initiative (SCTI) submitted its comments on the Interim Report of the High Level Panel on Financial Accountability Transparency and Integrity for Achieving the 2030 Agenda (FACTI Panel). The Report analyzed the “gaps, vulnerabilities and impediments present in the current international systems related to financial accountability, transparency and integrity issues” and found that “international systems can help countries prevent the drain of resources from development, contributing to achieving the 2030 Agenda, but that they lack co-ordination, leave gaps and may overlap and even conflict with each other. The shortcomings are systemic and require systemic responses.”
Guía para la concesión de licencias obligatorias y uso gubernamental de patentes farmacéuticas
Por Carlos M. Correa
Al igual que otros derechos, los derechos de patente no son absolutos. Hay situaciones en las que su ejercicio puede limitarse para proteger los intereses públicos. Esas situaciones pueden surgir, por ejemplo, cuando debe garantizarse el acceso a los productos farmacéuticos necesarios. Las licencias obligatorias y el uso gubernamental con fines no comerciales son instrumentos, previstos en la mayoría de las leyes de todo el mundo, que pueden utilizarse específicamente para atender las necesidades de salud pública. El presente documento tiene por objeto proporcionar orientación jurídica para el uso eficaz de esos instrumentos, de conformidad con el derecho internacional.
Designing Pro-Health Competition Policies in Developing Countries
By Vitor Henrique Pinto Ido
Competition law and policy has become an important tool for countries to promote access to pharmaceuticals. How can countries design and enforce competition policies that are suitable to the particularities of developing countries? What are the main anti-competitive tactics in the pharmaceutical sector, and how should they be dealt with? This paper deals with these issues, taking into account the socio-economic relevance of access to health products. It finds that developing countries should apply their competition laws in the pharmaceutical sector more actively, and that there is ample policy space under international law to do so. It provides an overview of the way in which competition policies have been applied in some industrialized and developing countries and explores how such policies can be designed and implemented in the context of developing countries.
Redistributing Taxing Rights to the Global South through the Digitalized Economy
By Carlos Protto
A historic discussion is underway within both the United Nations (UN) and the Organisation for Economic Co-operation and Development (OECD) on redistributing taxing rights to the Global South through proposals on taxing the digitalized economy. An overview of the issues at stake is provided in this SouthViews by Carlos Protto, Member of the UN Committee of Experts on International Cooperation in Tax Matters and Argentina’s representative in the Steering Group of the OECD/Group of Twenty (G20) Inclusive Framework on Base Erosion and Profit Shifting (BEPS). The text is based on his presentation at the international virtual seminar co-organized by the South Centre on “Equity in Global Tax Regimes and Implications for the SDGs” held on 7 October 2020. The recording is available here: https://www.youtube.com/watch?v=3wAESmfvRN4&ab_channel=uomlive.
Practical Implications of ‘Vaccine Nationalism’: A Short-Sighted and Risky Approach in Response to COVID-19
By Muhammad Zaheer Abbas, PhD
To end the COVID-19 pandemic and ensure a return of normalcy, an effective and safe vaccine is the best hope. The vaccine nationalism approach, adopted by some countries to gain preferential access to emerging COVID-19 vaccines, poses a threat to the fair and equitable distribution of the potential vaccines across the globe. This research paper critically evaluates the approach of vaccine nationalism and argues that this self-centred political behaviour of leaving others behind is short-sighted, potentially risky, morally indefensible, and practically inefficient in containing the pandemic. This paper highlights why it is important for national governments to support the collaborative and coordinated effort of the COVID-19 Vaccines Global Access (COVAX) facility for the timely development and efficient delivery of potential COVID-19 vaccines. It concludes that an effective response to the current health and economic crisis should be guided by values of international solidarity, multilateralism, equality, and global collaboration. It proposes the adoption of an enforceable global framework to address the concerns arising from the combination of vaccine nationalism and intellectual property exclusivities.
The Nagoya Protocol International Access and Benefit Sharing Regime
By Viviana Munoz Tellez
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity entered into force in October 2014. Ten years have now passed since the adoption of the Protocol by the Parties to the Convention on Biological Diversity, now with 129 Parties. The Protocol requires countries to set up access and benefit sharing rules and procedures for the Protocol’s implementation at the national level. This policy brief describes the main characteristics of the Protocol and makes recommendations for countries to advance in its implementation. Importantly, the Protocol’s language empowers countries with considerable policy space for the design of domestic access and benefit-sharing rules.
The United Nations Declaration on the Rights of Peasants and Other People Working in Rural Areas: One Step Forward in the Promotion of Human Rights for the Most Vulnerable
By Maria Natalia Pacheco Rodriguez and Luis Fernando Rosales Lozada
Peasants and other people living rural areas are among the most vulnerable in the world. In 2015, an estimated of 736 million people in the world lived in extreme poverty, of which 589 million – 80 per cent – live in rural areas. Despite increasing urbanization in the last decades, almost 45 per cent of the global population still lives in areas defined as rural, and most of them are among the poorest of the world. The situation is most likely worsening because of the COVID-19 pandemic. In 2018, the United Nations (UN) General Assembly, adopted the United Nations Declaration on the Rights of Peasants and Other People Working in Rural Areas by the supporting vote of a vast majority of countries. There are many reasons to consider the Declaration as one of the most relevant actions in the realm of human rights law taken by the United Nations in recent years. Some of them are the recognition of peasants as specific subjects of rights; the reaffirmation of existing standards tailored for the reality of people living in rural areas; and the development of international law to address existing gaps in the protection of their rights in complex subject matters such as the right to land, the right to seeds, and the right to means of production. In underscoring the importance of the Declaration for the world, this research paper narrates the process of construction of the Declaration, its contributions to international human rights law and stresses on its potential for poverty reduction and food security, in line with the sustainable development goals (SDGs) and the strategies of the UN Decade on Family Farming.
Las reformas de la Organización Mundial de la Salud en la época de COVID-19
Por Germán Velásquez
A lo largo de sus 70 años de historia la OMS ha pasado por varias reformas lideradas por varios directores generales, como Halfdan Mahler en la Conferencia de Alma ata sobre la atención primaria de salud, 1978, Gro Harlem Brundtland con su « reach out to the private sector » 1998, Margaret Chan con su inconcluso debate sobre el rol de « los autores no estatales » 2012 . Una vez mas, y de forma contundente la crisis sanitaria del 2020 pone en evidencia la fragilidad de la Organización y nos revela que la OMS no tiene los instrumentos y mecanismos legales necesarios para aplicar sus normas y orientaciones y que su manera de financiamiento no es sostenible y adecuada para responder al desafío de la COVID-19. Este documento trata de identificar cuales son los problemas principales de que sufre la OMS y cuales serian las medidas necesarias que una reforma de la Organización tendría que abordar.
Analysis of the Overcapacity and Overfishing Pillar of the WTO Fisheries Subsidies Negotiations
By Peter Lunenborg
Sustainable Development Goal (SDG) 14.6 asks World Trade Organization (WTO) Members to “prohibit certain forms of fisheries subsidies which contribute to overcapacity and overfishing”. Hence, the pillar on overcapacity and overfishing (O&O) is the most important pillar of the fisheries subsidies negotiations. However, WTO Members have not yet agreed on the approach to prohibition. This research paper distinguishes three types of approaches: the fisheries management linked approach (sometimes referred to as effects-based approach), capping and list-based approach.
This paper argues that the core of the prohibition in the Overfishing and Overcapacity pillar should be list-based and be applicable to large scale fisheries who receive the bulk of global fisheries subsidies especially those that are capacity-enhancing. For subsidies which are not prohibited an effects-based test might be considered. A supplementary subsidy prohibition covering areas beyond national jurisdiction (ABNJ) could be considered, or the vessels or operations targeted by proponents of the ABNJ proposals could be deemed ‘large scale’. If capping remains on the table, capping subsidies per fisher could be explored. Special and Differential Treatment should be an integral element of the outcome as developing countries whose fisheries sector are less developed should not take on the same commitments.
