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.
Spotlight: Africa and the Implementation of the Beijing Platform for Action
Regional Round-up on progress in implementing the Beijing Platform of Action in light of the upcoming 25th Anniversary of the platform. Spotlight: Africa.
Contribution of the South Centre to the Report of the Secretary-General on the Implementation of UN General Assembly Resolution A/RES/74/7 dated 12 November 2019 on the “Necessity of ending the economic, commercial and financial embargo imposed by the United States of America against Cuba”
The imposition of unilateral economic, financial and trade measures against Cuba, in violation of basic principles of the United Nations (UN) Charter, has severe socio-economic impacts on the Cuban population. The UN General Assembly adopted by an overwhelming majority the resolution “Necessity of ending the economic, commercial and financial embargo imposed by the United States of America against Cuba” (document A/74/L.6). In response to the request in paragraph 4 of this resolution, the South Centre prepared a contribution to the report of the Secretary-General. This highlights, in particular, the obstacles that the US embargo poses for the attainment of the right to health in Cuba.
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.
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.
Title: Antimicrobial Resistance (AMR) – Agriculture and Sustainable Development Goals (SDGs)
Date: 20 June, 2019
Venue: International Conference Centre Geneva (CICG)
Organizers: Organized by the South Centre and the Food and Agriculture Organization of the United Nations (FAO), in collaboration with the Permanent Missions of Ghana and Norway
Title: Financing the SDGs: Revealing the Links between Illicit Financial Flows and Domestic Resource Mobilization
Date:15 February 2018, 6:15-7:15 PM
Venue: Conference Room 11, United Nations, New York
Organizers: The South Centre, Friedrich-Ebert-Stiftung, the Global Alliance for Tax Justice (GATJ) and the Civil Society Financing for Development (FfD) Group
Overview of outcomes of the November 2017 UNFCCC climate talks
The annual climate change talks under the United Nations Framework Convention on Climate Change (UNFCCC), the Kyoto Protocol (KP) and the Paris Agreement (PA) took place in Bonn, Germany, on 6-18 November 2017, ending a day later than scheduled due to last-minute wrangling among Parties, mainly over issues related to finance.
Playing with Financial Fire: A South Perspective on the International Financial System
By Andrew Cornford
Playing with Fire (PWF) is a continuation of the analysis of the integration of Emerging and Developing Economies (EDEs) into the international financial system which Yılmaz Akyüz has carried out in his roles as senior economist for many years responsible for UNCTAD’s Trade and Development Report and Chief Economist at the South Centre. The treatment covers cross-border financial flows, increased commercial presence of foreign financial institutions in EDEs and their increased participation in their local financial markets as well as policy and regulatory issues. PWF deploys data on major cross-border financial flows on a gross as well as a net basis. This innovative approach facilitates identification of financial stability issues posed by the increased participation of EDEs in international financial markets.
