Access to Medicines and Vaccines: Implementing Flexibilities Under Intellectual Property Law
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.
Developing Countries Require Appropriate Means of Implementation to Deal with the Climate Crisis
South Centre Statement
26th United Nations Climate Change Conference of the Parties (COP 26)
Glasgow, 31 October – 12 November 2021
Climate finance is crucial to support developing countries’ efforts to implement their NDCs. Climate finance must not increase developing countries’ debt distress. Art.6 negotiations should increase the level of ambition.
The International Treaty on Plant Genetic Resources for Food and Agriculture: Saving, Sharing and Taking Care of the Plants and Seeds that Feed the World
By Dr. Kent Nnadozie
This Policy Brief provides an introduction to the International Treaty on Plant Genetic Resources for Food and Agriculture and its contribution to conserve, sustainably use and fairly and equitably share the benefits of plant genetic resources for food and agriculture, for sustainable agriculture and food security. The brief also provides an update on the involvement of the ITPGRFA in the prevailing issues under discussion in various biodiversity-related fora, including ongoing negotiations for a Post-2020 Global Biodiversity Framework, and response to the COVID-19 global pandemic.
Governing Seed for Food Production: The International Treaty on Plant Genetic Resources for Food and Agriculture
By Nina Isabella Moeller
Plant genetic resources for food and agriculture (PGRFA) are part of the foundation of agriculture and of central importance to food sovereignty. These gain an increasingly pivotal role in the context of climate crises, which are threatening predictable crop production, and the erosion of agricultural biodiversity. The main instrument for the governance of PGRFA is the International Treaty on Plant Genetic Resources for Food and Agriculture. Strengthening the Treaty is crucial. The Treaty establishes a binding international framework for the conservation and sustainable use of plant genetic resources for food and agriculture, and the fair and equitable sharing of the benefits arising from their use. Since 2013, negotiations have been underway to enhance the functioning of the Multilateral System of Access and Benefit-sharing. Current informal consultations may pave the way for constructive negotiations at the next Governing Body meeting in May 2022.
Some Key Elements for Developing Countries in Climate Change Negotiations of COP 26: Climate Finance, Article 6 Negotiations and Implications
By M. Natalia Pacheco Rodríguez and Luis Fernando Rosales
Human influence is deepening the climate crisis at an unprecedented pace. Developing countries’ economies have been hit hard by the crisis caused by COVID-19. Means of implementation are crucial for them to contribute to the achievement of the Paris Agreement goal. Developed countries must fulfill their commitments to provide US$ 100 billion per year by 2025 to climate finance. The latest years’ negotiations have shown the importance of improving the reporting methodology and the need for an agreed operational climate finance definition. In turn, Article 6 negotiations offer an opportunity to ensure higher ambition of both mitigation and adaptation through cooperative approaches while respecting the agreed balance between market and non-market approaches. What should developing countries expect on these issues at COP 26?
The Post COVID-19 Recovery: A Stringent Test for the Business and Human Rights Discourse
By H.E. Ambassador Luis Benigno Gallegos Chiriboga
Although the global economic outlook seems to be improving for the rest of 2021 and 2022, such benefits seem to only affect developed economies, while furthering the gap with emerging markets and developing economies. This shows that ‘recovery for all’ will remain gloomy for several years, as access to the COVID-19 vaccine continues to showcase the global inequalities between the rich and the poor. In this scenario, States require to make full use of their regulatory and policy space to protect and promote the human rights of all people and persons in their jurisdictions, including the right to health, while safeguarding the necessary fiscal space towards guaranteeing development expenditures to build back fairer and better. It is time for reducing inequalities rather than increasing the gap between developed and developing nations.
South Centre Statement to the 7th Session of the Open Ended Intergovernmental Working Group on transnational corporations and other business enterprises with respect to human rights
The South Centre, as the intergovernmental organization of developing countries, has keenly followed the evolution of the process towards the adoption of a Legally Binding Instrument on transnational corporations and other business enterprises since its inception and over the various sessions of this Working Group.
We welcome the strengthening of the text of the draft LBI with contributions of State delegations and civil society organisations, particularly from the Global South. The third revised draft of the LBI being discussed this week reflects many of the comments and textual suggestions made in the previous sessions of the Working Group and streamlines the provisions for their effective implementation. The process now moves into a very important phase with State-led direct substantive intergovernmental negotiations and raises hopes for the adoption of the LBI in the near future.
Carving Out a Role for Human Rights in International Investment Law
by Barnali Choudhury
The public health burdens that have been imposed on governments by Covid-19 serve as an important reminder of the importance for states to be able to regulate public health as well as other human rights issues. Commentators are already describing the myriad of investment arbitration claims that states may expect to face for their acts in handling the Covid-19 crisis. By carving out a role for human rights in international investment law, states can ensure that protection of human dignity, not property interests, will continue to be their ultimate objective.
Statement by the South Centre on the Two Pillar Solution to Address the Tax Challenges Arising from the Digitalisation of the Economy
The South Centre takes note of the Statement by 136 member jurisdictions of the OECD/G20 Inclusive Framework (IF) made on 8 October 2021, on a two-pillar solution to address the tax challenges arising from the digitalisation of the economy. The broad architecture of the agreement is now in place and it is clear to developing countries what they can expect from it.
Uso Público No Comercial y Licencias Obligatorias en América Latina: Estado de Situación
Este libro examina cómo han sido regulados en el derecho latinoamericano el uso público no comercial y las licencias obligatorias de patentes de invención, una de las importantes flexibilidades en el marco del acuerdo sobre propiedad intelectual de la Organización Mundial de Comercio. Igualmente, indaga y compendia las experiencias registradas en cuanto al uso efectivo de esos instrumentos, el que no se agota en el ámbito de la salud pública, si bien han sido especialmente utilizados tanto por países desarrollados como en desarrollo para facilitar el acceso a medicamentos, incluso en el contexto de la pandemia del COVID-19.
Autor: Guillermo Vidaurreta es Abogado de la Universidad de Buenos Aires, Magister en Propiedad Intelectual por FLACSO – Argentina. Profesor de la Universidad de Buenos Aires y FLACSO – Argentina. Investigador principal y subdirector del Centro de Estudios Interdisciplinarios de Derecho Industrial y Económico de la Facultad de Derecho de la UBA (CEIDIE).
STATEMENT BY DR. CARLOS CORREA, EXECUTIVE DIRECTOR OF THE SOUTH CENTRE, TO THE MINISTERS AND GOVERNORS MEETING OF THE INTERGOVERNMENTAL GROUP OF TWENTY-FOUR (G24)
The world economy is showing signs of recovery, yet very uneven, and is facing a multitude of challenges including rising inequality within and among countries, vaccine nationalism in the face of raging COVID-19 variants, escalated debt burden for many developing countries, ravages of climate change and weakening multilateralism.
Now, we are at a pivotal moment to mend and fix the global systemic problems so that we can recover better, greener, more inclusively, and more resiliently. It is time to address root causes of the fragility, instability, divergence and asymmetries of the global economy.
Call for Abstracts – 20 years of the Doha Declaration on TRIPS and Public Health
Deadline: 20 October 2021
The WTO Doha Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’) represented a groundbreaking moment in the history of intellectual property (IP) international policy, recognizing that Member States should not be prevented from taking measures to protect public health, reaffirming the right to use the so-called TRIPS flexibilities to that aim, such as compulsory licensing and parallel imports. The impact of IP protection on public health has continued to be at the forefront of debate to ensure equitable and affordable access to medicines and other medical products globally, and especially in the global South. The Covid-19 pandemic brought new challenges. Solutions are being discussed beyond use of TRIPS flexibilities, such as a temporary waiver to TRIPS during the pandemic.
At the 20th anniversary of the WTO Doha Declaration on TRIPS and Public Health, the South Centre opens a call for abstracts for new research in the field of IP and public health. The selected abstracts will be invited to write full papers, which will be presented at an international event in 2022 organized by the South Centre to commemorate such date and subsequent publication by the South Centre as open access. A small honorarium will also be offered for completed full papers that meet the South Centre standards of publication.