Guidelines for the examination of patent applications relating to pharmaceuticals
By Carlos M. Correa
This document represents a follow-up to an earlier document, Guidelines for the Examination of Pharmaceutical Patents: Developing a Public Health Perspective, which was published in 2007 as a working paper by the International Centre for Trade and Sustainable Development (ICTSD), the United Nations Conference on Trade and Development (UNCTAD) and the World Health Organization (WHO).
The present document takes into account developments since the publication of the ICTSD-UNCTAD-WHO working paper in 2007. It includes new examples of patent applications and/or grants, and analysis of and references to the initiatives of a number of countries that have adopted laws and/or policies that seek to factor in public health considerations in the examination of patent applications.
With this document, the aim is to provide guidance for the development or revision of guidelines on patent examination processes in developing countries in response to concerns about the rise of patent numbers in the pharmaceutical sector. For this purpose, a number of recommendations are made with regard to the examination of the patentability of applications relating to pharmaceutical products and processes.
Issues in Financing Education as a Human Right: Central principles for public policy responses
by Kishore Singh
The realization of the right to education requires adequate financing of education. Public policy responses to the need and importance of financing education remain inadequate. And now there is a trend towards decreasing public investment in education. Not only should States shoulder the primary responsibility for education under human rights law, but non-State actors should also invest in education because of corporate social responsibility. Besides, the need and importance of preserving education as a public good and public interest in education should be kept in the forefront as regards multi-stakeholders and provision of education through public-private partnerships. The role devolves upon the parliamentarians in shaping regional and global architecture. In the conclusion, the author proposes ten central principles for a Global Alliance to do the task of world-wide advocacy in support of the architecture for financing education.
The Investment Facilitation Framework & Most Favoured Nation (MFN) Treatment
By Peter Lunenborg
The issue of Investment Facilitation (IF) is one of the ‘Joint Statement Initiatives’ which has been under negotiation for a number of years between certain World Trade Organization (WTO) Members. It has not been without controversy as there is no multilateral mandate at the WTO for these negotiations. Questions have been raised about how the outcomes of these IF negotiations can be brought into the WTO framework. Despite these uncertainties, there is a draft Investment Facilitation Framework (IFF) text. This Policy Brief discusses the Most Favoured Nation (MFN) treatment as contained in Article 2 of the Investment Facilitation Framework (IFF), also referred to as the Investment Facilitation for Development Agreement (IFDA). This brief highlights the potential implications of the proposed text and proposes some options.
Comments on the Statement on a Two-Pillar Solution to Address the Tax Challenges Arising from the Digitalisation of the Economy
The BEPS Monitoring Group, 31 July 2021
On 1 July 2021 a statement was issued by the OECD outlining the agreement reached through the Inclusive Framework of the OECD/G20 base erosion and profit shifting (BEPS) project. These comments by the BEPS Monitoring Group (BMG) aim to contribute to a wider public understanding of the issues involved. The BMG is a network of experts on various aspects of international tax, set up by a number of civil society organizations which research and campaign for tax justice including the Global Alliance for Tax Justice, Red de Justicia Fiscal de America Latina y el Caribe, Tax Justice Network, Christian Aid, Action Aid, Oxfam, and Tax Research UK. This report has not been approved in advance by these organizations, which do not necessarily accept every detail or specific point made here, but they support the work of the BMG and endorse its general perspectives. It is based on previous reports, and has been drafted by Sol Picciotto with comments and contributions by Abdul Muheet Chowdhary (Senior Programme Officer, South Centre Tax Initiative), Jeffery Kadet, Annet Oguttu, Sudarshan Rangan, Attiya Waris, and Francis Weyzig.
South Centre Submission to the 18th Session of the CGRFA
The South Centre presents its compliments to the Commission on Genetic Resources for Food and Agriculture (CGRFA) and is pleased to send to the Commission the following information on its programmes and activities relevant to the prioritized themes for the 18th session of the CGRFA.
EU Proposals regarding Article 31bis of the TRIPS Agreement in the Context of the COVID-19 Pandemic
By Nirmalya Syam
This Policy Brief presents an analysis of the proposal by the European Union (EU) with regards to Article 31bis of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as part of a Declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic. It discusses the EU’s proposed clarifications, why Article31bis does not provide an effective solution to promote access to pharmaceutical products and possible options.
Virtual Consultation in support of the UN Working Group’s 2021 Report to the UN General Assembly on Human Rights-Compatible International Investment Agreements
South Centre, 23 June 2021
Foreign direct investment (FDI) should support States’ efforts to “bring the SDGs and goals of the Paris Agreement to life for all people, everywhere.” However, achievement of these objectives is slowed down in the current situation where investor-State dispute settlement (ISDS) mechanisms are included in international investment agreements (IIAs). These mechanisms have increased the exposure of States to claims from foreign investors against regulatory measures taken to protect and guarantee a clean and safe environment, public health, human rights, social inclusion, and poverty reduction.
In the current scenario marked by the impact of the COVID-19 pandemic, FDI can be a valuable source of financing a better and fairer recovery, including investment needed to achieve the full realisation of all human rights. But to achieve this potential, there is a need to reshape the international investment regime, including through the reform of its substantive rules and standards, as well as of the ISDS mechanisms embedded in existing IIAs.
The South Centre and the United Nations Working Group on human rights and transnational corporations and other business enterprises convened a virtual consultation to identify and assess the different challenges developing countries face while negotiating or reforming IIAs in line with their international human rights obligations. The virtual consultation aimed at highlighting and discussing some of the most common concerns and challenges those developing countries face in the promotion of responsible investment practices, including an exploratory discussion about balancing the rights and obligations of investors in IIAs and safeguarding the sovereign right of States to regulate in the public interest for building back better and fairer in face of the COVID-19 pandemic. It also discussed possible reforms of the ISDS mechanism.
COVID-19 y la necesidad de una organización internacional
Velásquez, Germán: Vacunas, medicamentos y patentes. COVID-19 y la necesidad de una organización internacional. Vacunas covid-19: entre la ética, la salud y la economía. Desarrollo de la vacuna COVID-19; la inmunidad y el contagio; el nacionalismo de las vacunas; el mecanismo COVAX; licencias obligatorias; Acceso a medicamentos y vacunas: un nuevo actor. Medicamentos y propiedad intelectual: diez años de la estrategia mundial de la oms. Repensando la fabricación mundial y local de productos médicos tras el covid-19. Repensando la i+d para productos farmacéuticos después del covid-19. Propiedad intelectual y acceso a medicamentos y vacunas. Las reformas de la organización mundial de la salud en la época de covid-19. 2021. 244 pp. ISBN 978-9915-650-31-9.
Autor: Germán Velásquez, Asesor especial sobre políticas y salud, South Centre de Ginebra
The TRIPS COVID-19 Waiver, Challenges for Africa and Decolonizing Intellectual Property
By Yousuf Vawda
The intellectual property (IP) regimes of African countries are a function of their colonial past, which imposed strong protections, and which have been entrenched through the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). This has had a devastating effect on their ability to access necessary health products both before and during the current COVID-19 pandemic. It is important to reflect on the challenges that African countries face, before considering the implications of the WTO TRIPS waiver on COVID-19 (henceforth, waiver). In assessing the challenges faced by these countries, as well as the possibilities of improving access, this paper argues that while the waiver offers the best available solution to overcome the current supply shortages of a range of COVID-19 health products, in the longer term a break from this past—the decolonization of IP regimes—is necessary.
Malaria and Dengue: Understanding two infectious diseases affecting developing countries and their link to climate change
By Mirza Alas
Developing countries will face more complex challenges as infectious disease patterns transform due to climate change and climate variability. These challenges include how to reduce the incidence of malaria (including the significant challenge of resistant malaria), dengue, and other vector-borne and water-borne diseases that are likely to experience alterations in geographical range and lengthening of the transmission seasons due to changing temperatures and rain patterns. Climate extremes, e.g., heat and floods, are implicating the spread of climate-sensitive infectious diseases such as dengue and malaria transmitted by vectors like mosquitoes. In the context of growing financial pressure on governments due to COVID-19, the ensuing fiscal challenges may severely limit the capacity to effectively respond to health challenges in countries already affected by malaria and dengue. Other countries that have made gains in controlling vector-borne infections could also be vulnerable to rising disease burden. This research paper aims to analyze how changes in malaria and dengue pose a challenge for developing countries as they prepare mitigation and adaptation strategies for climate health. The paper will also provide some general recommendations on the importance of integration of health in national climate change strategies.
The Implementation of the UN Declaration on the Rights of Peasants and Other People Working in Rural Areas: what is next?
By Luis Fernando Rosales Lozada
The UN Declaration on the Rights of Peasants and Other People Working in Rural Areas (UNDROP) was adopted in December 2018. However, its application seems challenging. The South Centre organized a virtual meeting to discuss the implementation of the UNDROP on 4th June 2021, aiming to promote a debate about future actions to move forward the implementation of the UNDROP. The meeting provided an opportunity to listen to the views of government representatives, peasants’ associations, civil society organizations and academia. During the meeting, different questions were discussed such as how the current health and social crisis, caused by the COVID-19 pandemic, has impacted the situation of peasants, the role of the UNDROP in promoting and protecting peasants’ rights, the latest developments in the realization of the rights of peasants under the UNDROP and what steps are needed to promote its implementation.
The WTO TRIPS Waiver Should Help Build Vaccine Manufacturing Capacity in Africa
By Faizel Ismail
The current global health crisis created by the COVID-19 pandemic has re-focused our attention on the inadequacy of the TRIPS agreement and the patent system to address global public health crises. This time, developing countries must ensure that the TRIPS waiver succeeds in creating the impetus for the building of manufacturing capacity in the poorest countries, especially in Africa, for vaccines, pharmaceuticals and other health technologies. This is the only effective way in which African countries can reduce their dependence on imports of essential medicines and build their health security, contributing to the achievement of the sustainable development goals, for the poorest countries.
Velásquez, Germán: Vacunas, medicamentos y patentes. COVID-19 y la necesidad de una organización internacional. Vacunas covid-19: entre la ética, la salud y la economía. Desarrollo de la vacuna COVID-19; la inmunidad y el contagio; el nacionalismo de las vacunas; el mecanismo COVAX; licencias obligatorias; Acceso a medicamentos y vacunas: un nuevo actor. Medicamentos y propiedad intelectual: diez años de la estrategia mundial de la oms. Repensando la fabricación mundial y local de productos médicos tras el covid-19. Repensando la i+d para productos farmacéuticos después del covid-19. Propiedad intelectual y acceso a medicamentos y vacunas. Las reformas de la organización mundial de la salud en la época de covid-19. 2021. 244 pp. ISBN 978-9915-650-31-9.