The Comprehensive and Progressive Agreement for the Trans-Pacific Partnership: Data Exclusivity and Access to Biologics
By Dr. Zeleke Temesgen Boru
The test data rule concerning biological medicines (hereafter biologics) has been suspended from the scope of application of the Comprehensive and Progressive Agreement for the Trans-Pacific Partnership (CPTPP). While the suspension is commendable from the general standpoint of access to medicines and biologics in particular, the suspended provision may not provide assurance for the Parties to the CPTPP that they can rely on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities to promote access to biologics. In part this is because the Parties may end the suspension if and when they choose to do so. Simply put, the agreement does not promise that the suspended provision will remain suspended; rather, the Parties may revive the provision as originally negotiated under the Trans-Pacific Partnership (TPP) Agreement. The provision, if revived, may inhibit the Parties from implementing an obligation to ensure access to biologics, medicines that target chronic and rare ailments like cancer, clotting factors and several others.
Against this backdrop, this research paper focuses on the test data rule relating to biologics as negotiated under the TPP. In particular, it explores whether the CPTPP Parties would be able to use TRIPS flexibilities effectively to promote access to biologics, as advanced by international human rights instruments, in particular the International Covenant on Economic, Social and Cultural Rights (ICESCR). The paper also provides potential responses to the question of whether the test data rule deters the realization of access to biologics. In response, the author has determined that the rule on test data can limit access to biologics, as it would delay the entry of affordable biologics (biosimilars) into markets.
Antimicrobial Resistance: Examining the Environment as Part of the One Health Approach
By Mirza Alas
Antimicrobial Resistance (AMR) is a serious issue that is threatening the medical and agricultural advances of today. The connections that exist among human health, food production and the environment necessitate a One Health approach to address the challenge of AMR. Recent research points to the environment as an essential factor in the spread of AMR, as well as a possible reservoir of antimicrobial resistant bacteria and genes. The process, however, of the environmental transmission of resistance genes, along with their effects and how to mitigate them, is still being examined. As new research emerges, so to have new challenges regarding the selective pressure of antibiotics on the environment. AMR in the environment is not new, with resistance genes found even in isolated places (e.g. in permafrost or volcanoes) but understanding this natural process and its implications for tackling AMR continue to pose many questions. This paper aims to examine some of the emerging research on AMR from a One Health perspective and in particular to highlight the role of the environment. It will explore the use of antibiotics and their effects in different ecosystems, as well as the challenges they pose for developing countries: in particular, in designing policies to address antimicrobial resistance that take into account the connections among humans, animals and the environment.
South Centre Quarterly Report, 1 October to 31 December 2019
This Quarterly Report summarizes the activities undertaken by the South Centre during the period 1st October to 31 December 2019. It is intended to provide information, organized by themes, about recent developments in the areas covered by the Centre’s Work Program, meetings organized or co-organized by the Centre to examine particular issues or provide analytical support for negotiations taking place in various international fora, and conferences and other meetings where the Centre has participated. It also informs about publications made and publication/websites/social media metrics.
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.
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.
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.
South Centre Quarterly Report, 1 April to 30 June 2019
This report summarizes the programmatic activities of the South Centre during the period 1st April to 30th June 2019. It is intended to provide information, organized by themes, about recent developments in the areas covered by the South Centre’s Work Program and publications made and meetings organized or co-organized by the Centre to examine particular issues or to provide analytical support for international negotiations taking place in various fora. It also informs about external conferences and other meetings where the Centre has participated.
South Centre Statement on Access to Biosimilars/Biogeneric Medicines at the WHA 72
The revision of the guidelines on similar therapeutic products mandated by Resolution WHA67.21 is crucial for promoting the availability of and access to biosimilars. The reduction in prices ensuing from the introduction of these products has become essential to address public health needs in developed and developing countries. The WHO Document A72/59 under consideration by the WHA 72 (agenda item 21.3) states in paragraph 80 that “WHO expert committees have approved guidance on (…) biotherapeutics, including an update of the 2009 similar biotherapeutic products guidelines”. This statement is not accurate, as the guidelines were not updated as mandated by Resolution WHA67.21. Below is the South Centre statement in relation to this issue.
Declaration of the XII Ministerial Meeting of the Ministers of Health of the Non-Aligned Movement (NAM), “Universal Health Coverage: Leave no one behind”
The Non-Aligned Movement (NAM) Health Ministers noted that making progress on Universal Health Coverage (UHC) is critical to address goal number 3 and other goals in the 2030 Agenda, and called for intensified cooperation and support to achieve such objectives. Below is the declaration adopted on occasion of the 72nd World Health Assembly on 21 May 2019.
South Centre Statement at the Meeting of the Non-Aligned Movement (NAM) Health Ministers
Dr. Carlos Correa, Executive Director of the South Centre, stressed the need to preserve the World Health Organization (WHO) as a public, independent agency that effectively addresses the health problems of developing countries, at the Non-Aligned Movement (NAM) Health Ministers Meeting held on the occasion of the 72nd World Health Assembly. Below is the statement of the South Centre delivered at the Palais des Nations, Geneva on 21 May 2019.