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.
The ISDS Reform Process: The missing development agenda
By Nicolás M. Perrone
The foreign direct investment (FDI) governance agenda is centred on the reform of international investment agreements (IIAs) and investor-state dispute settlement (ISDS). The proliferation of IIAs and ISDS has contributed to narrowing the FDI agenda. A key policy question is whether this fragmented approach remains consistent with the 2030 Sustainable Development Goals (SDGs). Current FDI discussions point at the need for a holistic approach in this policy area, quite the opposite of a regime primarily aimed to protect foreign investors through treaty standards and international arbitration. The realisation of the SDGs depends on multi-stakeholder partnerships to combat poverty and provide clean water and energy to the world population. Crucially, these partnerships will require more cooperation and coordination than IIAs and ISDS can promote and nurture.
The Core Elements of a Legally Binding Instrument: Highlights of the Revised Draft of the Legally Binding Instrument on Business and Human Rights
By Daniel Uribe Terán
Discussions towards the adoption of a legally binding instrument on business and human rights have reached its fifth year. The Chairperson-rapporteur submitted the Revised Draft of the legally binding instrument on 16 July 2019, having in view the comments and proposals received until the end of February 2019. The present policy brief reviews the core elements of the legally binding instrument as they are proposed in the revised draft, with the aim to provide analytical support to States’ delegations and other stakeholders during the negotiations on the binding instrument. This brief examines a number of issues, concerns and legal aspects that have been addressed during the previous sessions of the Open-ended Intergovernmental Working Group (OEIGWG) on transnational corporations and other business enterprises with respect to human rights and how they have evolved going towards the 5th Session of the OEIGWG.
Enhancing Access to Remedy through International Cooperation: Considerations from the Legally Binding Instrument on Transnational Corporations and Other Business Enterprises
The shortcomings in international cooperation between regulatory authorities in different countries can open up a gap in their legal regimes which could be exploited by transnational corporations and allow them to elude responsibilities for the violation or abuse of human rights. The Revised Draft of the Legally Binding Instrument on Transnational Corporations and Other Business Enterprises seeks to bridge this gap and works towards increasing collaboration among countries for ensuring access to effective remedies for victims of human rights violations or abuses due to business activities. This brief looks at some of its salient features and how they can be utilized by countries for the protection and promotion of human rights in their territories.
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.
Developing Country Coalitions in Multilateral Negotiations: Addressing Key Issues and Priorities of the Global South Agenda
By Adriano José Timossi
The recent increasing and unprecedented attacks on multilateralism and its institutions as well as the growing dangers of weakening international cooperation are regrettably leading to an enormous setback in the history of the international system. These developments could reverse decades of collective efforts to establish a more stable, equitable and inclusive path of development and social justice for all. An immediate impact is that international negotiations, which have increasingly become important for developing countries over the past decades, are now becoming even more complex. If the resurging path of unilateralism and protectionism adopted by some powerful countries is maintained, the risks of further deterioration grow even larger. The instabilities of the contemporary world pose serious risks to the achievement of the longstanding development goals of the Global South such as poverty eradication, the South’s ability to successfully address emerging challenges such as climate change, and to overall global stability, a pattern not seen since the Second World War. In this context, developing countries’ negotiating coalitions such as the Group of 77 (G77) + China and the Non-Aligned Movement (NAM), while respecting and adapting to the differences that might emerge within these large groups, need to remain together and ensure that their coalitions are preserved and strengthened. Working collectively will improve negotiating capacity and leverage and increase bargaining power of developing countries in the multilateral negotiations in order to get more balanced outcomes.
The worldwide problem of the rise in antimicrobial resistance (AMR) is a serious threat to global public health. The loss of efficacy of antibiotics and other antimicrobials affects everyone. Yet the threat is greater in developing countries, due to the higher incidence of infectious diseases. Developing countries will be unequivocally affected by AMR, deteriorating the health of the population, reducing economic growth and exacerbating poverty and inequalities. The blueprint for addressing AMR as a global problem is advanced. Countries are progressing in developing and implementing national action plans and overall the public awareness of AMR is increasing.
However, we are at the tip of the iceberg of response. AMR is not yet a key priority of most governments, and global coordination and resource mobilization to enable all countries to do their part are lagging. The Secretary-General of the United Nations (UN) in the upcoming 74th UN General Assembly (UNGA) will be reporting on the implementation of the UN resolution on AMR of 2016, including the recommendations of the Interagency Coordination Group (IACG) on Antimicrobial Resistance. The UNGA will also host a High-Level Meeting to build support for advancing Universal Health Coverage (UHC), that is essential for AMR response. Expanding primary health care services, strengthening the health work force, improving infection prevention and control and measures to secure access to essential medicines and others to reduce health inequities can help contain AMR in developing countries. Developing countries need to be actively involved in shaping the global agenda on antimicrobial resistance, including the new global governance mechanisms that are being set up for AMR.
Impacts of Unilateral Coercive Measures in Developing Countries: the need to end the US embargo on Cuba
By Vicente Paolo Yu and Adriano José Timossi
On 1 November 2018, the 193 Member States of the United Nations (UN) held the twenty-seventh consecutive annual vote of the General Assembly on a resolution entitled “Necessity of ending the economic, commercial and financial embargo imposed against Cuba.” The resolution was adopted with a near unanimous vote of 189 in favor, 2 abstentions (Ukraine and Moldova) and 2 against (United States of America and Israel). Before the vote and for the first time since the resolution was submitted in 1992, the US presented a set of eight proposed amendments to be considered by the 193 Member States, which were all rejected.
The present policy brief is a summary of the input prepared by the South Centre as a contribution to the 2019 report of the Secretary-General with respect to the imposition of unilateral economic, finance and trade measures by one State against another that is prepared pursuant to UN General Assembly Resolution 73/8.
Inequality is one of the greatest challenges that the world needs to face. Inequality is intimately linked with poverty. Although there has been progress in reducing poverty, a large part of the global population (overwhelmingly living in developing countries) is still denied access to a dignified life. While no poverty and reduced inequality are two of the outstanding Sustainable Development Goals, these and other goals are unlikely to be achieved by 2030. In fact, inequality is on the rise. Changing this situation will certainly require significant efforts at the national and regional level. But it also requires an international architecture that supports those efforts by respecting the policy space that countries need and coordinating constructive actions within the multilateral system. The current initiatives to ‘reform’ this system will only be legitimate if they recognize the gaps in the levels of development and contribute to effectively address them under a fair, pro-development system of rules. Please see last month’s SouthViews on “Understanding global inequality in the 21st century” by Jayati Ghosh, development economist and Professor of Economics at Jawaharlal Nehru University.
South Centre Quarterly Report, 1 January to 31 March 2019
This report summarizes the programmatic activities of the South Centre during the period 1st January to 31st March 2019. It is intended to provide information, organized by Program and 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 Quarterly Report, 1 October to 31 December 2018
This report summarizes the programmatic activities of the South Centre during the period 1st October to 31 December 2018. It is intended to provide information, organized by Program and 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.