European Union (EU)

SouthViews No. 266, 19 June 2024

Knocking Down Business-related Human Rights Abuses with a Feather: Is the European Corporate Sustainability Due Diligence Directive Sufficient to Tackle Corporate Impunity?

By Daniel Uribe

In April 2024, the European Parliament approved the Corporate Sustainability Due Diligence Directive (CSDDD), aiming to ensure that European firms and their partners uphold human rights and environmental standards in their supply chains. This Directive applies to large EU and non-EU companies, with a phased implementation starting in 2027. The CSDDD mandates the integration of due diligence in corporate policies and the development of transition plans aligned with the Paris Agreement. Despite these advancements, the Directive’s scope and civil liability provisions are limited to effectively hold corporations accountable for human rights abuses. The ongoing negotiations on an International Legally Binding Instrument on Business and Human Rights offer an opportunity to adopt common standards on due diligence and jurisdiction to improve access to justice and remedies for victims of corporate-related abuses.

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Research Paper 198, 31 May 2024

What Can Cambodia Learn from Thailand and India as It Prepares to Graduate from Least Developed Country Status?

By Brigitte Tenni, Deborah Gleeson, Joel Lexchin, Phin Sovath, and Chalermsak Kittitrakul

Cambodia is expected to graduate from Least Developed Country status soon, at which time it will be required to make patents available for pharmaceutical products and processes to meet its obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Given its impending transition from LDC status, there is a need to balance Cambodia’s intellectual property (IP) policies and regulations with public health priorities to ensure access to affordable life-saving medicines. This will be critical to achieving universal health coverage, one of the United Nations’ Sustainable Development Goals. This paper examines Cambodia’s IP laws and regulations to identify provisions that could reduce access to affordable generic medicines when it starts granting patents for pharmaceuticals. It systematically compares Cambodia’s IP laws and regulations with those of Thailand and India – two developing countries that have had some successes in preserving access to medicines despite the introduction of pharmaceutical patents. It identifies lessons for Cambodia from the experiences of Thailand and India in implementing TRIPS and using TRIPS flexibilities such as compulsory licensing to ensure access to a sustainable supply of affordable generic medicines. Key recommendations for reform for Cambodia include strengthening the use of preventive and remedial TRIPS flexibilities and removing criminal sanctions for patent infringements. Cambodia should reject any TRIPS-plus provisions in its patent legislation and avoid membership in bilateral or plurilateral trade agreements that include TRIPS-plus provisions as well as signing patent treaties and memorandums of understanding  that may facilitate the granting of unwarranted patents.

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Research Paper 197, 28 May 2024

Compulsory Licensing as a Remedy Against Excessive Pricing of Life-Saving Medicines  

By Behrang Kianzad

The COVID-19 crisis intensified decade-long debates on the interaction between intellectual property rights (IPRs), competition law and access to affordable life-saving treatments and vaccines. Compulsory licensing of patented medicines is a tried-and-tested method to expand access, particularly in a situation of “national emergency or other circumstances of extreme urgency” within the meaning of Article 31(b) of the TRIPS Agreement. Some legislations, such as European competition law, offer a toolbox for curbing the exercise of IPRs if they would be found in conflict with certain competition rules, such as rules prohibiting excessive pricing by dominant undertakings. The paper analyses the interface between intellectual property law and competition law in general, moving on to the settled case law of the Court of Justice of the European Union (CJEU) on this matter. It provides a general overview of legal and economics arguments related to excessive pricing prohibition and the main case law of European competition law on the matter and discusses whether compulsory licensing as a remedy against excessive pricing of patented life-saving pharmaceutical products can be a viable and appropriate remedy. Finally, the paper offers policy recommendations relating to compulsory licensing based on excessive pricing.

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Policy Brief 124, 5 February 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.

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Policy Brief 122, 30 November 2023

Data Access and the EU Data Strategy: Implications for the Global South

By Marc Stuhldreier

This study explores the value of data in the digital economy and the challenges surrounding data ownership, access rights, and equitable distribution of the value. It examines the European Data Strategy and highlights its shortcomings as well as its implications for the Global South. This contribution emphasises the need for unlocking the potential of collected data by enhancing accessibility and challenging protectionist measures and discusses the importance of fair competition and innovation. It also discusses the importance of balancing access rights with legitimate privacy concerns, trade secrets, and intellectual property rights. The paper concludes by highlighting the importance for developing countries to introduce tailored regulations that suit their specific needs, empowering them to seize opportunities and navigate the digital economy effectively.

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Policy Brief 116, 7 March 2023

Understanding the Functioning of EU Geographical Indications

By Andrea Zappalaglio

This contribution investigates the functioning of the EU sui generis Geographical Indication (GI) system, with a specific focus on the regime for the protection of agricultural products and foodstuffs within the scope of EU Regulation 1151/2012. In particular, based on the results of the recent “Study on the Functioning of the EU Geographical Indications System” of the Max Planck Institute for Innovation and Competition (February 2022), this paper: (1) clarifies the nature of EU GIs as it emerges from an empirical assessment of the specifications of all the products that appear on the EU register; (2) comparatively analyses the national practices of the EU Member States and explores the discrepancies that exist among them to date; (3) provides an in-depth assessment of the structures of the specifications of EU GIs, highlighting the domestic specificities; (4) investigates the contents and functions of the amendments to the specifications of the registered products. It concludes by emphasizing the importance of the present research in light of the current EU international agenda, with a specific focus on the bilateral agreements recently or currently negotiated.

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Policy Brief 114, 19 October 2022

Reducing the Unnecessary Use of Antimicrobials in Animal Farming

By Dr. Viviana Muñoz Tellez

Antimicrobial resistance is aggravated due to excessive and inappropriate use of antimicrobials in human and animal health and in plant and animal agriculture. While international standards are being developed, governments are rolling out regulations with the aim to curb the overuse and misuse of antimicrobials, to preserve their efficacy for as long as possible. This Policy Brief discusses two new regulations introduced by the European Union (EU) on medicated animal feed (Regulation (EU) 2019/4 and veterinary medicinal products (Regulation (EU) 2019/6) that entered into effect on 28 January 2022. As part of the implementation of the regulations, the EU should devise a comprehensive plan to help implementation by countries and producers of animal food products of the Global South, linked to supporting the transition to sustainable agricultural systems and development.

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Book by the South Centre, 2022

Harnessing the Multilateral Patent and Plant Variety Protection Regimes to Advance Food Security:

Implications of the EU-ECOWAS Economic Partnership Agreement

Description:

This thesis analyzes the provisions of contemporary intellectual property (IP) and trade agreements to explore whether these provisions advance, or compromise, food security in West Africa. The agreements have been examined for how their provisions integrate IP and food security norms and policies, and the extent to which the IP frameworks are adaptable to the regional conditions that determine food security in the West African context. Critical analysis is made of a regional agreement signed between the Economic Community of West African States (ECOWAS) and the European Union (EU), the 2014 EU-ECOWAS Economic Partnership Agreement (EPA), to assess what implications the agreement may have for food security in West Africa. Interdisciplinary research is carried out to identify the characteristics needed to advance food security in the region of West Africa. Also, philosophical and doctrinal analysis of IP laws and legal theories is conducted to identify which legal principles are best suited for advancing food security in the region. Based on the findings, the thesis draws up a model framework for IP protection that is more suitable for enhancing food security in West Africa.

Author: Uchenna Felicia Ugwu is a lawyer and academic researcher with over ten years’ experience extensively investigating the relationship between Intellectual Property (IP) norms and socio-economic development in developing countries. She recently received a PhD in International IP Law and Development from the University of Ottawa.

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Research Paper 150, 21 March 2022

The Liability of Internet Service Providers for Copyright Infringement in Sri Lanka: A Comparative Analysis

By Ruwan Fernando

The exclusive rights enjoyed by a copyright owner to reproduce his protected work in any material form, including any permanent or temporary storage in electronic form will have a direct impact on the lawful activities of an internet service provider (ISP). Any transmission of temporary copies of material protected by copyright law by their subscribers or third parties using the networks provided by an ISP may amount to unauthorised reproduction of such protected material. The exclusive rights granted to a copyright owner may, thus, place an ISP in a difficult position that may seriously affect the legitimate services and facilities provided by an ISP such as transmitting, routing and storing of information on their networks. It would be impracticable however, to equate the position of a person who engages in traditional copyright infringement with that of an ISP who may merely provide access to the internet and various services to its subscribers facilitated by its networks.

The making of temporary copies exception was developed in the copyright law to safeguard the legitimate interests of an ISP, which may under certain conditions, exempt an ISP from liability for copyright infringement on the internet initiated by its subscribers or third parties by using the system provided by an ISP. There are laws in force in many countries to limit the liability of an ISP for the infringement of copyright that takes place on its networks. An ISP in Sri Lanka may not enjoy the same privilege for the infringement of unauthorised material initiated by its users or third parties on their networks. The current law is unlikely to provide adequate protection for the legitimate activities of ISPs in an attempt to minimize the vulnerability against copyright infringement claims.

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Policy Brief 104, October 2021

Compulsory licensing vs. the IP waiver: what is the best way to end the COVID-19 pandemic?

By Olga Gurgula

This policy brief examines the currently discussed proposals at the World Trade Organization (WTO) that aim to resolve the problem of the production shortages of COVID-19 vaccines. This includes the two key submissions, i.e. the proposal by South Africa and India on the Intellectual Property (IP) waiver, partially supported by the United States (US), and the European Union (EU) proposal to clarify the use of compulsory licensing. While each of these mechanisms may help to improve the production of COVID-19 vaccines to various degrees, there is intense debate about which of these proposals is the most effective. This policy brief outlines the strengths and weaknesses of each of them with a view to informing the policy decisions by WTO Members on the best way to promptly accelerate the vaccine production that is urgently needed today. It concludes that the proposed IP waiver is a more effective solution for addressing the current emergency.

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SC Webinar, 7 October 2021

Emerging Trends in FTAs and Public Health: Are the EU, USA, and China shifting positions?

Thursday, 7 October 2021

16:00 – 17:30 CET

The South Centre is holding a series of webinars on emerging trends related to free trade agreements (FTAs) and investment agreements that impact public health. The goal is to generate awareness, share experiences and expand knowledge for academics, policymakers and negotiators in ongoing and/or future negotiations. After our first webinar focused on investment treaties and IP, we this webinar examines the EU, USA, and China’s recent experiences.

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Policy Brief 102, September 2021

Accelerating COVID-19 Vaccine Production via Involuntary Technology Transfer

By Dr. Olga Gurgula

This policy brief explains that the currently discussed proposals at the WTO related to increasing the production of COVID-19 vaccines, including the EU proposal to clarify the use of compulsory licensing and the submission by South Africa and India on the intellectual property (IP) waiver, require complementary mechanisms to rapidly improve the production of COVID-19 vaccines that are urgently needed today. The key problem is that to accelerate the manufac- ture of COVID-19 vaccines, access to knowledge and know-how, that are protected by trade secrets owned by several pharmaceutical companies, is required. It is therefore important that governments implement an additional mechanism of compulsory licensing of trade secrets that would allow an involuntary transfer of COVID-19 vaccine technologies. Such a mechanism would be compliant with the TRIPS Agreement and relevant whether the TRIPS waiver is adopted or not agreed upon. While this mechanism must provide full access to the information necessary to manufacture the vaccines in question, it must also ensure the protection of the transferred trade secrets.

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