Second Medical Use Patents – Legal Treatment and Public Health Issues
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.
Lights Go Out at the WTO’s Appellate Body Despite Concessions Offered to US
As of 11 December 2019, the Appellate Body (AB) of the World Trade Organization (WTO) has been rendered non-functional. This policy brief provides a summary of the issues discussed amongst WTO Members in the last two years, in their valiant efforts to address the US’ concerns regarding the AB. The issues include: the use of AB Members’ services to complete an appeal after their term has officially expired; timelines for issuance of AB reports; the meaning of municipal law; advisory opinions; precedence-setting; and overreach by the AB. After much effort by Members in the ‘Walker process’ of negotiations, concessions have been proposed to the US in the draft General Council Decision of 28 November 2019. Language was provided limiting the scope of appeals to questions of law, even though there are situations where the boundary between issues of law and fact are difficult to draw. The text also provides that ‘precedent’ is not created through WTO dispute settlement proceedings. In the area of anti-dumping, the language inserted by the US into the anti-dumping agreement to protect their zeroing practices is confirmed. Nevertheless, the US has rebuffed these offered concessions. It seems determined to amplify its leverage by taking the WTO’s Appellate Body hostage, to extract still more from other Members, including in terms of far-reaching ‘WTO Reforms’.
Medicines and Intellectual Property: 10 Years of the WHO Global Strategy
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.
Vacancy Announcement – National Technical Coordinator, Green Climate Fund Readiness Project in Lebanon
The South Centre was established in 1995 as a permanent inter-Governmental organization of developing countries. It has full intellectual independence in working towards the establishment of a fair, equitable, and rule-based global order. In responding to the needs of the South, it is open to new ideas and approaches (including multilateralism and regionalism) that can promote better South-South and North-South dialogue and cooperation.
In that context, the South Centre is seeking to recruit a National Technical Coordinator, in the implementation of the ‘GCF Readiness and Preparatory Support project’ with the Ministry of Environment, Lebanon. The National Technical Coordinator shall report to the Project Manager at the Ministry of Environment in Lebanon and the Program Coordinator, Sustainable Development and Climate Change program at the South Centre.
The National Technical Coordinator will be engaged on a full time basis by the South Centre until 29 January 2021, which may be renewed subject to satisfactory performance and the availability of funding.
The selected candidate will work under the direct supervision of the Project Manager at the Ministry of Environment in Lebanon and the Program Coordinator, Sustainable Development and Climate Change program.
The State of Play of Climate Finance – UNFCCC Funds and the $100 Billion Question
Climate finance is key to achieving the ambitions set out in the Paris Agreement as well as in fulfilling the climate actions that developing countries have proposed to implement in their Nationally Determined Contributions (NDCs), the key vehicles for implementing the agreement reached in Paris in 2015. However, there is much concern that the current flow of finance is inadequate to meet the expectations surrounding both the NDCs and the Paris Agreement. This brief presents quick snapshots of the state of play of climate finance of one dimension of the broad, complex and increasingly fragmented universe of climate finance. It focuses on the flow of climate finance that can be monitored and tracked under the United Nations Framework Convention on Climate Change (UNFCCC) in the context of the developed countries’ collective goal of mobilizing US $100 billion annually to support developing countries’ climate actions. The issues on both the demand and supply side of climate finance flows are explored, with specific attention to the ebb and flows and achievements of the multilateral public funds. After highlighting some of the more serious challenges with the flow of climate finance, the brief ends with an overview of the key negotiating issues around future climate finance flows.
International Tax Cooperation: Perspectives from the Global South
About the Book:
A substantive reform of the global tax system involving a variety of multilateral platforms is underway. The question is not whether the tax standards and practices will change, but in which direction.
Developing countries have long sought changes in rules, standards and procedures shaping the allocation of taxing rights among sovereign states. In the wake of the 2008-2010 Great Recession, developed country governments engaged in massive public sector layoffs and channeling enormous public resources to bail out large financial companies and their wealthy investors. The Panama Papers, the Paradise Papers, the Lux Leaks became household words in the United States and Europe because of the journalistic coverage. Other scandals, such as the “cum/ex” fraud in Germany involving a loophole in the taxing of dividend receipts were less known but just as materially significant. Tax reform, particularly as it applied to the treatment of corporations working in multiple tax jurisdictions, thus became not only a problem of developing countries but an issue of global concern.
Crisis at the WTO’s Appellate Body (AB): Why the AB is Important for Developing Members
The World Trade Organization (WTO)’s Appellate Body (AB) will be made dysfunctional by 11 December 2019. A disabled AB means that the WTO’s dispute settlement system loses its enforcement mechanism. Even though many smaller developing countries are not major users of the dispute settlement system, nevertheless, they are beneficiaries of the rule of law, and a more predictable trading environment. Several stop-gap measures have been suggested. None are satisfactory. The right to appeal is an important right for all Members which was part of the Uruguay Round package. If this right is removed, why should other parts of that package also not be changed? The future is uncertain – between a much weakened multilateral trading system similar to the days of the General Agreement on Tariffs and Trade (GATT); or deep reform of the WTO, in ways that primarily benefit the US and its partners, whilst foreclosing important policy choices for the developing world.
* PLEASE BE INFORMED THAT THIS VACANCY HAS BEEN CANCELLED.
Vacancy Announcement – Program Coordinator, Sustainable Development and Climate Change (SDCC)
The South Centre was established in 1995 as a permanent inter-governmental organization of developing countries. It has full intellectual independence in working towards the establishment of a fair, equitable, and rule-based global order. In responding to the needs of the South, it is open to new ideas and approaches (including multilateralism and regionalism) that can promote better South-South and North-South dialogue and cooperation.
The South Centre is a small institution in which all staff members work in a team and help in whatever tasks they are requested and may be required to undertake.
In that context, the South Centre is seeking to recruit a Program Coordinator, in its Sustainable Development and Climate Change Program. The Program Coordinator shall report to the Executive Director of the organization.
The South Centre seeks proposals from approved travel agencies in order to select a travel agency that can provide high quality travel services at competitive rates as well as to provide assistance in reducing travel expenses by proposing best possible airfare rates at all times.
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.
Global Forum on Intellectual Property, Access to Medicines and Innovation*
A Global Forum on Intellectual Property, Access to Medicines and Innovation will be held on 9-10 December 2019 in Munich, Germany. This Global Forum is a joint effort of the South Centre and the Max Planck Institute for Innovation and Competition. The Global Forum will bring together policy makers and leading academic figures to examine how intellectual property policy and law are evolving to incorporate public health considerations. Discussions will centre on recent national experiences and policy choices available to governments. The Forum will serve to support evidence-based policy making and building intellectual property regimes in developing countries that are supportive of the goals of public health, in particular to promote access to health for all.