Evolution of Data Exclusivity for Pharmaceuticals in Free Trade Agreements
By Wael Armouti
Free trade agreements (FTAs) introduce higher intellectual property (IP) protection than those established in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS-plus provisions) that deprive the parties from benefits of the use of flexibilities found in the TRIPS Agreement to protect public health. One such TRIPS-plus requirement is that of data exclusivity. It establishes that the government should provide an exclusivity period for the test data developed by the originator company, on the grounds of an incentive rationale and considerations of fairness. The negative impact of the data exclusivity approach in developing countries means that the entry of cheap generic products is delayed, even under a compulsory license, which will affect access to affordable medicines. Countries that have already signed the FTAs can mitigate its effects on public health by limiting the scope of and providing exceptions to data exclusivity in national legislation.
Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock
By Dr. Germán Velásquez
The unprecedented global health crisis caused by the coronavirus –COVID-19– pandemic, during the first quarter of 2020, brings back with particular urgency the discussion about the research and development (R&D) model for pharmaceuticals and other health technologies. The COVID-19 crisis shows that there is an urgent need to re-design the global public health governance for health R&D. The adoption of a binding instrument –as allowed by Article 19 of the WHO Constitution– on this matter was proposed many years ago. This brief argues that it is time to revive and materialize this initiative.
Challenges and Opportunities for Implementing the Declaration of the Right to Development
By Yuefen Li, Daniel Uribe and Danish
The 1986 Declaration on the Right to Development was a milestone for both human rights and development. The Declaration recognizes that the right to development (RTD) is an inalienable human right and introduced an alternative and holistic approach to development that goes beyond the economic field to include social, cultural and political development. Although there are current concerns about the pace of progress in fulfilling the RTD, this Policy Brief examines the linkages of the right to development and different global initiatives tackling current challenges for different aspects of the RTD. This brief shows that there has been broader support by countries and people since 1986 to fulfill the RTD although much still needs to be done for addressing income and other inequalities while empowering people in the processes of formulating and implementing people-centered development policies. Despite challenges, the brief also examines some promising opportunities for the RTD.
The COVID-19 Pandemic: R&D and Intellectual Property Management for Access to Diagnostics, Medicines and Vaccines
By Viviana Muñoz Tellez
The ongoing rapid spread of COVID-19 is challenging the capacity of governments and of the World Health Organization (WHO) to timely put in place a global coordinated response to the pandemic. Developing countries and Least Developed Countries (LDCs) in particular in Africa are especially vulnerable to the unfolding effects of the public health crisis. A priority area for global collaboration is to advance research and development (R&D) for vaccines and medicines that are made available, affordable and accessible worldwide.
There is currently no vaccine and no proven safe and effective direct therapy for COVID-19. There is also the need to accelerate testing capacity and tools in developing countries and LDCs with increased access to low-cost diagnostics. The approach to the management of intellectual property rights by research institutions, pharmaceutical and biotech companies and R&D funders will decisively affect availability and access, as well as the transfer of technology and know-how. Governments must ensure that they have legislative and procedural frameworks in place to enable them to over-come any patent, data exclusivity and trade secret barriers to procure and produce COVID-19 diagnostics, vaccines, medicines and other therapeutics.
Flirting with the Private Sector: The GCF Private Sector Facility — achievements, challenges and constraints in engaging the private sector
By Rajesh Eralil, Mariama Williams and Dianyi Li
The Green Climate Fund (GCF) is committed to include the private sector as both driver and beneficiary of climate action. It envisions in particular the inclusion of not only large enterprises, but puts much emphasis on the cooperation with micro, small and medium-sized enterprises (MSMEs) in developing countries. This paper evaluates the state of play of the GCF work with the private sector and its MSMEs. It finds that the fund’s success in stimulating private sector engagement has been underwhelming and imbalanced. To begin with, only a minority of GCF projects are in fact private and a considerable amount of these projects operate through multilateral and other public institutions. GCF’s private sector projects show on top of that a strong bias towards energy access and generation, while only little funding goes to adaptation. Attempts to include MSMEs in developing countries have moreover been largely unsuccessful, although MSMEs constitute an important pillar of developing countries’ economies. It is suggested that there is a need for a bottom-up approach when dealing with the private sector in developing countries, including a more sustained and sustainable focus on MSMEs, including capacity building of MSME networks.
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.
In a more and more climate change threatened world, Africa’s energy vision should be premised on moving from an energy landscape based on underdeveloped and carbon intense pathways to a modern, clean and decentralized energy system. This transition is a critical enabler of meaningful and endogenous socio-economic development. While the continent may face a broad set of challenges in achieving this vision, it has at the same time the opportunity to avoid the fossil fuel lock-in that many industrialized countries face and to take advantage of vast supplies of untapped energy resources and/or any stranded asset problem. The Africa Energy Transition Program in the making under the auspices of the African Energy Commission forms a continent-wide and coordinated approach in facilitating the required transformation for the realization of Africa’s development aspiration.
The Role of South-South Cooperation in Combatting Illicit Financial Flows
By Manuel F Montes
Developing countries bear the brunt of costs from illicit financial flows (IFFs). These losses are the result of the facilities that the global system provides transnational companies, operating in multiple tax jurisdictions, to move their profits to favorable locations. International cooperation has been seen to be a key ingredient in restricting IFFs. However, a difference in interests in the treatment of many types of transactions between developed and developing countries is an obstacle to a fast solution of the problem. Developing countries must seek to seize the initiative to restrict their losses from IFFs. They can deploy various joint and concerted actions, within the umbrella of the principles of South-South cooperation for this purpose.
US-China trade deal: preliminary analysis of the text from WTO perspective
By Peter Lunenborg
The long-awaited ‘Phase 1’ trade deal between the United States and China, officially termed the ‘Economic and Trade Agreement between the Government of the United States of America and the Government of the People’s Republic of China’, was signed on 15 January 2020. It will enter into force on Valentine’s Day, on Friday, 14 February 2020. This deal is a result of US exercise of political power and unilateral World Trade Organization (WTO)-inconsistent tariffs in order to extract trade concessions, an expression of the most pure protectionism that the WTO is supposed to prevent. Nevertheless, the WTO was unhelpful in addressing the US economic aggression against China. This failure to protect a Member from illegitimate unilateral measures is, perhaps, one of the most significant manifestations of the often-mentioned ‘crisis’ of the WTO, and actually is one of the subjects on which the proposed ‘reform’ of the organization should focus.
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.
Lights Go Out at the WTO’s Appellate Body Despite Concessions Offered to US
By Danish and Aileen Kwa
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’.
The State of Play of Climate Finance – UNFCCC Funds and the $100 Billion Question
By Mariama Williams; editing support and data by Rajesh Eralil
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.