Application de l’Exception Bolar: Différentes approches dans le droit de l’UE
Par Dmytro Doubinsky
Ce Document de recherche aborde le problème toujours plus aigu de l’accès aux médicaments essentiels, en se concentrant sur le rôle des droits de propriété intellectuelle, en particulier les droits de brevet, qui restreignent l’accès en permettant des monopoles sur le marché pharmaceutique qui maintiennent les prix des médicaments à un niveau élevé. Le document explore l’exception Bolar, un mécanisme juridique conçu pour permettre aux fabricants de médicaments génériques de demander l’approbation réglementaire avant l’expiration d’un brevet, empêchant ainsi l’extension de facto des monopoles de brevets. L’étude examine la transformation de l’exception Bolar d’un cas juridique spécifique en un instrument important en matière de droit de la propriété intellectuelle, de droit commercial et de droit pharmaceutique. Elle analyse les principaux cadres juridiques internationaux et les directives européennes relatifs à l’exception Bolar et met en évidence les interprétations divergentes de l’exception dans les jurisprudences allemande et polonaise. Grâce à cette analyse comparative, le document encourage une mise en œuvre plus large des exceptions Bolar afin d’améliorer l’accès à des médicaments abordables et de réduire les coûts des soins de santé.
Will the Pact for the Future Advance a Common Global Agenda on the Challenges Facing Humanity?
By Viviana Munoz Tellez, Danish, Abdul Muheet Chowdhary, Nirmalya Syam, Daniel Uribe
At a time when multilateralism is needed more than ever to address the global challenges and rising geopolitical tensions, paradoxically, the capacity and delegated power of the United Nations (UN) to uphold a rule-based order to keep peace and security is being weakened. Even in an increasingly multipolar world, a retreat towards unilateralism by world powers masked as national sovereignty is dangerous and highly unfavourable for developing countries. In this light, the United Nations Pact for the Future, a new forward-looking agenda of commitments adopted by consensus by UN Member States in September 2024, is a welcome initiative. The Pact for the Future, nonetheless, is short in delivering commitments on transformative changes in global governance and solutions to the most pressing global challenges. This document briefly examines some of the actions and high-level commitments in the Pact of the Future to strengthen multilateral cooperation and provides recommendations for their implementation.
Assessing Five Years of the African Continental Free Trade Area (AfCFTA): Proposals on Potential Amendments
By Kiiza Africa
On 30th May 2024, the African Continental Free Trade Area (AfCFTA) celebrated its fifth anniversary, which legally implied that the agreement is up for review for possible amendments. To kickstart this review, the Thirty-Seventh Ordinary Session of the African Union Summit (held in February 2024) directed the AfCFTA Secretariat to take necessary measures for the start of the review of the Agreement. This review comes at a moment when the AfCFTA implementation and its vehicle, the Guided Trade Initiative (GTI), have been fraught with challenges. Broadly, these challenges include the slow submission of tariff liberalization schedules by State Parties, infrastructure deficits, persistent non-tariff barriers and trade wars in regional economic communities, and overlapping regional trade commitments. Thus, the upcoming AfCFTA review provides an opportunity to assess progress, identify implementation bottlenecks, and propose actionable amendments. This paper examines these challenges through a comprehensive analysis of the AfCFTA’s state of play, illuminating the progress while highlighting the slow momentum registered for the past five years of its operation. Proposals for the agreement’s amendment revolve on accelerating infrastructure development, harmonizing rules of origin, integrating labor rights, and fostering industrial diversification. By moving beyond liberalization as its raison d’être and prioritizing the scaling up of State Parties’ productive capacities, the AfCFTA can evolve from a mere trade liberalization agreement into a transformative driver of Africa’s economic renaissance. It is hoped that this timely assessment underscores the urgency of reorienting the AfCFTA to unlock its full potential for propelling intra-Africa trade.
Application of the Bolar Exception: Different Approaches in the EU
By Dmytro Doubinsky
This Research Paper addresses the growing problem of access to essential medicines, focusing on the role of intellectual property rights, particularly patent rights, in restricting access by enabling pharmaceutical market monopolies that keep drug prices high. The paper explores the Bolar exception, a legal mechanism designed to allow generic drug manufacturers to seek regulatory approval before a patent expires, thus preventing the de facto extension of patent monopolies. The study examines the transformation of the Bolar exception from a specific legal case into a significant tool of intellectual property, commercial, and pharmaceutical law. The paper analyzes key international legal frameworks and European directives related to the Bolar exception and highlights divergent interpretations of the Exception in German and Polish case law. Through this comparative analysis, the paper argues for the broader implementation of Bolar exceptions to improve access to affordable medicines and reduce healthcare costs.
International Regulation of Industrial Designs: The TRIPS Agreement in the Light of European Union Law
By Adèle Sicot
This paper analyzes the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) on industrial designs, and the manner in which the narrow aspects dealt with by the Agreement have been addressed by European Union (EU) legislation. The paper highlights the absence of a definition of protectable subject matter, and the considerable flexibility left to the member countries of the World Trade Organization to determine the framework of protection, notably on the basis of copyright. The paper also notes certain areas in which European legislation is more elaborate, and others which could be considered incompatible with the TRIPS Agreement.
Navigating the WTO’s Working Group on Trade and Transfer of Technology: A Critical Analysis from the Perspective of Developing Countries
By Nirmalya Syam
This paper critically analyzes the operations and effectiveness of the World Trade Organization’s (WTO) Working Group on Trade and Transfer of Technology (WGTTT). Despite the establishment of the WGTTT in 2001 with a mandate to enhance technology flows to developing countries, the Group has struggled to produce meaningful outcomes due to divergent priorities between developed and developing countries. This paper finds that the WGTTT remains an exploratory discussion forum rather than a negotiation platform with the capacity to generate new initiatives that address the technology transfer needs of developing countries. Key reforms are proposed, including transitioning to a negotiation-oriented approach, improving the balance of member priorities, and focusing on actionable themes to enhance the WGTTT effectiveness in fostering technology transfer to developing countries.
Régulation internationale des dessins et modèles industriels : l’Accord sur les ADPIC à l’aune du droit de l’Union européenne
Par Adèle Sicot
Ce document analyse les dispositions de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (l’Accord sur les ADPIC) sur les dessins et modèles et la manière dont les aspects limités traités par l’Accord ont été abordés par la législation de l’Union Européenne (l’UE). Il note l’absence d’une définition de la matière susceptible de protection et une considérable flexibilité laissée aux pays membres de l’Organisation Mondiale du Commerce pour déterminer le cadre de protection, notamment sur la base du droit d’auteur. Le document note aussi certains aspects dans lesquels la législation européenne est plus élaborée et d’autres dans lesquels on pourrait observer une incompatibilité avec l’Accord sur les ADPIC.
The Implications of Treaty Restrictions of Taxing Rights on Services, Especially for Developing Countries
By Faith Amaro, Veronica Grondona, Sol Picciotto
Taxation of cross-border services has been identified as a high priority issue in the United Nations (UN) negotiations to establish a new global framework for tax. This paper analyses the defects of international tax rules as applied to services, and their exploitation by multinational enterprises (MNEs), focusing on the impact on developing countries. Services have become increasingly important for economic development, but international tax rules favouring delivery by non-residents act as a disincentive to the growth of local services providers, particularly disadvantaging developing countries which are mainly hosts to MNEs. We analyse the restrictions on source taxation of services in tax treaties, particularly those based on the model of the Organisation of Economic Co-operation and Development (OECD), and show that their spread has been accompanied by a widening deficit in services trade of developing countries, while the weakening of their attempts to protect their tax base through withholding taxes has resulted in increasing losses of tax revenue. The paper combines detailed qualitative analyses of tax treaties with quantitative estimates of their effects on trade and tax revenues for services of five developing countries: Argentina, Brazil, Colombia, Kenya and Nigeria. Our analysis suggests that a new approach is needed for taxation of services, breaking with the residence-source dichotomy, and adopting formulary apportionment. This could be based on the standards agreed in the Two Pillar Solution of the OECD/Group of Twenty (G20) project on base erosion and profit shifting (BEPS) and developed now through the UN.
Decision 15/9 and the Nagoya Protocol: Who should get what in the Multilateral Benefit-Sharing Mechanism?
By Joseph Henry Vogel, Natasha C. Jiménez-Revelles, Xavier A. Maldonado-Ramírez de Arellano
Article 10 of the Nagoya Protocol (NP), “Global Multilateral Benefit-Sharing Mechanism” (GMBSM), asks Parties to consider the distribution of benefits derived from the utilization of genetic resources in transboundary situations. A literature exists which applies the economics of information to genetic resources, when interpreted as “natural information”. The policy implication would incentivize reduction in the drivers of mass extinction, through economic rents in royalty obligations. Fifteen cases become thought experiments on how to share royalty income. A sixteenth case addresses the TP53 gene in elephants, which may revolutionize oncology. In parallel to Article 10 of the NP is Decision 15/9 of the fifteenth Conference of the Parties to the Convention on Biological Diversity. That Decision establishes a “multilateral benefit-sharing mechanism from the use of digital sequence information on genetic resources”. Redundancy with the GMBSM is only apparent. The Decision omits rents and thus renders its mechanism inefficient, unfair and inequitable.
AMR in Aquaculture: Enhancing Indian Shrimp Exports through Sustainable Practices and Reduced Antimicrobial Usage
By Robin Paul
This study on Antimicrobial Resistance (AMR) in Indian shrimp farming underscores its critical impact on public health, environmental sustainability, and economic viability. The global scenario with many export rejections on account of persistent residues of antibiotics, reiterate that antimicrobial use in aquaculture, demands urgent global attention.
In the Indian context, the shrimp industry grapples with a delicate balance between production demands and long-term shrimp health. Sustainable practices, including responsible antimicrobial use, are crucial for economic viability, given the industry’s reliance on specific markets like the United States, EU and China.
Sustainable aquaculture emerges as a pivotal solution, supported by government policies and a gradual industry shift towards best practices. However, challenges persist, requiring a comprehensive approach to balance economic interests with environmental conservation. The key challenges remain the large number of small stakeholders and huge geographical spread of farms which make implementation of regulations and sharing of best practices difficult. Traceability and certification programs can play a key role in promoting responsible aquaculture, ensuring transparency and accountability in the supply chain. Technological innovations, including block chain can offer efficient solutions for traceability.
The collaborative action suggested emphasizes the role of government bodies, regulatory agencies, industry players, researchers, and consumers in addressing AMR. Clearer implementable regulatory frameworks aligned with economic and environmental priorities are essential. Looking ahead, the study envisions a future where the blue economy is sustainable not just for the industry’s success but also to protect the wider environment. By enhancing domestic market presence and fostering collaboration with importing countries, the Indian industry can overcome the multiple challenges raised by AMR in shrimp aquaculture.
Catalyzing Policy Action to Address Antimicrobial Resistance: Next Steps for Global Governance
By Anthony D. So
The United Nations General Assembly has taken up Antimicrobial Resistance (AMR) twice in the past decade, but the follow-through on commitments and financing of both Global and National Action Plans on AMR have lagged considerably behind the policymaker pronouncements. The need to update the intersectoral approach to the Global Action Plan on Antimicrobial Resistance requires urgent attention if measurable progress is to be made in tackling this One Health challenge. This paper identifies where progress must pick up and outlines how intersectoral action might catalyze needed next steps.
Discussions on Draft Provisions on Damages in the Investor-State Dispute Settlement System in UNCITRAL Working Group III
By José Manuel Alvarez Zárate
This paper summarizes the discussions within the United Nations Commission on International Trade Law (UNCITRAL) Working Group III (WG III) on the reform of investor-state dispute settlement (ISDS) regarding the two draft provisions on damages prepared by the UNCITRAL Secretariat as part of the two drafts on procedural and cross-cutting issues. It covers the period from September 2022 to July 8, 2024. It describes the draft provisions on damages and related provisions on procedural and cross-cutting issues of document A/CN.9/WG.III/WP.231, dated 26 July 2023, as well as the comments made on it by some members of WG III and observers. It also describes the changes to the above document contained in the second draft on the procedural and cross-cutting issues, dated July 8, 2024, contained in document A/CN.9/WG.III/WP.244.
The purpose of this paper is to provide an overview of the comments made by some States on the draft provisions on damages, the substantive changes made by the Secretariat to the first draft, mostly based on the comments made by some States, and the exclusion of important aspects highlighted by some Global South States in their interventions. In the light of this review, countries of the Global South may consider commenting on document A/CN.9/WG.III/WP.244 to ensure that their concerns are effectively taken into account.
