New US Policy on Exercise of March-In Rights to Curb High Drug Prices: Lessons for the Global South
By Nirmalya Syam
In response to soaring prescription drug costs, the United States government recently announced proposed changes to the exercise of march-in rights under the Bayh-Dole Act, allowing federal agencies to license taxpayer-funded inventions to other parties based on factors such as accessibility and affordability. This article explores the implications of the US policy shift on global pharmaceutical pricing and access, particularly for developing countries. Drawing parallels between the US approach and flexibilities under intellectual property laws such as compulsory licensing and government use authorizations that are allowed under the WTO TRIPS Agreement, the article suggests that similar strategies could be employed by developing nations to address public health needs and economic considerations.
Régimen de licencias obligatorias y uso público no comercial en Argentina
Por Juan Ignacio Correa
Con la adopción del Acuerdo sobre los Aspectos de Propiedad Intelectual relacionados con el Comercio (ADPIC), la Argentina debió adaptarse a las nuevas reglas internacionales en materia de derecho de patentes. Uno de los puntos centrales del Acuerdo es la posibilidad de establecer diferentes formas de licencias obligatorias y uso gubernamental no comercial. Este documento analiza las condiciones previstas en el artículo 31 del ADPIC con ese fin y examina en detalle las diferentes causales de licencias obligatorias contempladas en la legislación argentina y las condiciones aplicables a cada una de ellas, así como para el uso de patentes por parte del gobierno con fines no comerciales. Finalmente, con base en el margen normativo del ADPIC y la legislación vigente, el documento discute el posible contenido de una reglamentación de licencias obligatorias y uso público no comercial que permita a la Argentina utilizar de manera efectiva esas herramientas cuando se presente alguna de las circunstancias previstas en la actual regulación.
Self-withering: The Biodiversity Convention and its new Global Biodiversity Framework
By Dr S Faizi
The Convention on Biological Diversity’s (CBD) Global Biodiversity Framework (GBF), adopted at the end of 2022 marked another step in the process of weakening of the enforcement of the treaty that is finely balanced on the North-South axis. The CBD articles that protect the interests of the South continue to remain silenced, the West winning a virtual amendment of the treaty by default. The adoption of the GBF itself was procedurally flawed and while some of its 23 targets to be achieved by 2030 are meaningful, some are problematic. The target of increasing the global coverage of protected areas to 30 per cent each of the terrestrial and marine areas is likely to exclude the traditional caretakers of biodiversity and lead to further alienation of the historical custodians of biodiversity. The nature-based solutions (NbS) promoted by the GBF are likely to cause even more damage to the natural systems. The CBD provisions that are particularly favourable to the South are excluded from the GBF.
Support for awareness campaigns on Antimicrobial Resistance
By Mirza Alas
Civil society organisations (CSOs) are crucial in mobilising local action to address Antimicrobial Resistance (AMR) and provide health promotion strategies closer to the community. Recognising this, the South Centre continuously supports grass root and context-specific efforts in developing countries on raising awareness on the threat of rising resistance to medicines that is making it harder to treat infections.
The World AMR Awareness Week (WAAW) is held annually to increase global awareness and understanding of AMR. The theme for the 2023 WAAW campaign was “Preventing Antimicrobial Resistance Together,” which took place from November 18 to 24.
To support WAAW 2023, the South Centre offered small grants to eleven CSOs to design and launch awareness and education campaigns on AMR, with financial support from the Fleming Fund. The selected organisations represent youth, women, healthcare workers, veterinarians, and students. This report is a summary of all the different campaigns.
Leveraging ESG for promoting Responsible Investment and Human Rights
By Danish and Daniel Uribe
The growing integration of Environmental, Social, and Governance (ESG) principles into investment frameworks and corporate reporting reflects a heightened recognition of the interplay between business operations and human rights. This Policy Brief examines the evolution of ESG investing, particularly its role in promoting responsible investment and embedding human rights considerations throughout business practices and supply chains. While ESG frameworks hold promise for enhancing corporate accountability and sustainability, challenges persist in effectively linking ESG criteria with human rights standards. It also shows that disparities in ESG reporting criteria and methodologies, compounded by a lack of shared understanding, pose obstacles to meaningful engagement with human rights responsibilities. The Policy Brief also delineates between ESG investing and reporting, highlighting distinct objectives and practices. While ESG investing aims to mitigate financial risks associated with environmental, social, and governance factors, ESG reporting focuses on evaluating firms’ exposure to ESG risks. The Policy Brief underscores the limitations of ESG frameworks in identifying and preventing human rights impacts comprehensively, emphasising the need for complementary measures such as mandatory human rights due diligence. Finally, the paper considers the need for greater coherence and consistency in ESG frameworks to foster responsible investment, promote human rights, and advance sustainable development goals.
How Should the WHO Pandemic Treaty Negotiations Tackle Intellectual Property?
By Viviana Muñoz Tellez
The WHO pandemic instrument should commit the Parties to limit the exclusionary effects that government-granted patents and other IPRs may have during pandemics in support of rapid diffusion of new vaccines, diagnostics, medicines and other tools and facilitate collaboration and freedom to operate. The current draft text of Article 11 would not make any change to the status quo.
The pandemic instrument must increase equity, multilateral cooperation and accountability. See the South Centre’s statement to the 8th meeting of the World Health Organization’s Intergovernmental Negotiating Body:
Implementation of TRIPS Flexibilities and Injunctions: A Case Study of India
by Shirin Syed
The proponents of intellectual property (IP) have increasingly utilized injunctions with indiscriminate propensity as a strategic tool for IP enforcement, resulting in adverse socio-economic implications, including the enjoyment of human rights. This trend has eclipsed the flexibilities provided in the Doha Declaration on the TRIPS Agreement and Public Health. Although a substantial volume of the literature focuses on the flexibilities of compulsory license or scope of patentability, little attention has been given to the flexibilities related to IP enforcement. Discussing the implications of IP enforcement on public interest, the paper examines the gaps in the articulation of flexibilities of intellectual property rights (IPRs) enforcement, with special reference to injunctions in India. It examines how far the courts consider the implications on the enjoyment of fundamental rights while granting injunctions on patents. This paper argues that the Indian courts have deviated from the cautious approach provisioned under the TRIPS flexibilities that allows the courts to consider the public interest aspect and human rights implications while granting injunctions in patent litigation. Moreover, it asserts that the courts should exercise prudence in granting injunctive relief in cases involving patent infringement, and take into account the potential impact of such relief on the exercise of human rights. This suggests a need for a careful examination of the potential implications of injunctive remedies in such cases.
This Policy Brief discusses issues concerning trade, intellectual property, and technology transfer that are most relevant for consideration at the 13th World Trade Organization (WTO) Ministerial Conference (MC13) in February 2024 and inclusion in its outcomes.
The following recommendations are proposed:
TRIPS non-violation and situation complaints: MC13 Decision on the scope and modalities of non-violation and situation complaints under the Agreement on Trade related Aspects of Intellectual Property Rights (TRIPS). A second option is to extend the moratorium.
TRIPS, diagnostics and therapeutics for COVID-19: MC13 Decision that extends the MC12 TRIPS waiver Decision (only applicable to vaccines) to diagnostics and therapeutics
Relationship between TRIPS and the Convention on Biological Diversity: to be addressed in the MC13 Outcome Document
Follow up to the MC12 Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics: to be addressed in the MC13 Outcome Document
Relationship of trade and technology transfer: include in the MC13 Outcome Document to reinvigorate and give direction to the Working Group on Trade and Technology Transfer (WGTTT) and increase attention in all relevant bodies on how the WTO can promote technology transfer
Inputs for the analytical study on the impact of loss and damage from the adverse effects of climate change on the full enjoyment of human rights, pursuant to Human Rights Council Resolution 53/6 on human rights and climate change
31 January 2024
The adverse impacts of climate related loss & damage on human rights in the Global South require concrete actions. Our submission shows that a just and fair green transition requires protecting human rights while prioritizing the needs of developing countries, especially by providing climate finance, access to green tech and integrating human rights in climate actions.
See the inputs provided by South Centre to an upcoming study by the UN Secretary-General. The study will be presented to the Human Rights Council in September 2024.
How the EU’s Carbon Border Adjustment Mechanism discriminates against foreign producers
By Peter Lunenborg and Vahini Naidu
In April 2023, the European Parliament adopted the final text of the Carbon Border Adjustment Mechanism (CBAM) and revisions to the European Union (EU) Emissions Trading System (ETS). One of the stated objectives of CBAM is to create a level playing field for selected sectors in the EU market and to protect against the risk of ‘carbon leakage’. Based on an analysis and comparison between the legal texts of CBAM and ETS, this paper finds that CBAM discriminates against foreign producers in favour of EU domestic producers in many areas including with regard to the scope and type of emissions covered, free allocation of allowances, exemptions under EU ETS not mirrored in CBAM, buying and selling of ETS allowances in comparison with CBAM certificates, verification, penalties, authorization, use of credits from the Carbon Development Mechanism (CDM) and guarantees.
The paper also provides a brief overview of how the CBAM and ETS align with WTO rules, highlighting the potential discrepancies in the implementation as they apply to foreign and EU producers respectively. The paper provides several suggestions on how to make EU’s CBAM more WTO-compatible and a recommendation for further legal research.
