The Artificial Intelligence Act (AI Act) of the European Union (EU) claims to be based on a risk-based approach to avoid over-regulation and to respect the principle of legislative proportionality. This paper argues that risk-based regulation is indeed the right approach to AI regulation. At the same time, however, the paper shows that important provisions of the AI Act do not follow a truly risk-based approach. Yet, this is nothing that cannot be fixed. The AI Act provides for sufficient tools to support future-proof legislation and to implement it in line with a genuine risk-based approach. Against this background, the paper analyses how the AI Act should be applied and implemented according to its original intention of a risk-based approach, and what lessons legislators around the world can learn from the AI Act in regulating AI.

Cell and gene therapies derive from a substantial manipulation of cells or the application of gene editing techniques. They are promising products because they enable therapy personalisation, are potentially helpful for treating rare or resistant diseases, and may become useful in future epidemics. Because of this strategic worth, the infrastructure needed for manufacturing these therapies is turning into a subdomain within the domain of critical infrastructures (CIs), understood as the structures whose operation is key for the integrity and security of a nation. This paper analyses why cell and gene therapy infrastructure can be considered as an emergent CI domain, stressing three aspects: automated manufacturing equipment; software solutions (including the growing adoption of artificial intelligence and cloud technology); and human expertise. These complex manufacturing systems, which are becoming increasingly automated and digitalised, may be surrounded by new risks and vulnerability points, which requires adequate regulatory solutions and governance initiatives. A comprehensive approach is therefore advanced here, where therapy manufacture has medical and technological relevance, but is equally crucial from the viewpoint of nations’ public health and internal stability.

On 5 March 2024 the European Court of Justice (CJEU) issued a landmark decision on access to harmonised standards that grant presumption of conformity with legal requirements. The CJEU ruled that such standards should be made available free of charge because, once incorporated in EU legislation, they form part of EU law. While the decision was positively received in the scholarly community, it is expected to carry profound consequences for European standards organisations, who hold copyrights over harmonised standards and rely on their sales to finance their standardisation activities. The judgment may also affect the European Commission, whom the Advocate General and the CJEU placed at the centre of European standardisation due to its role in transforming harmonised standards into EU law. This case note engages with the ruling and aims to shed light onto its possible implications for the European standardisation system.

In comparison to other high-risk industrial sectors, human rights due diligence (HRDD) in the arms sector remains unclear and underdeveloped. This article elucidates how supply chain regulations can provide pertinent guidance for clarifying and elaborating the standards and requirements of the HRDD obligations of arms companies. Part I reaffirms the importance of independent HRDD obligations for arms companies due to the significant human rights risks posed by arms exports. Part II contextualises the limitations in the development of HRDD in the arms industry by examining the corporate policies of major arms companies. Part III explicates why supply chain regulations for conflict minerals are suitable guidance for clarifying and elaborating the HRDD obligations of arms companies. Part IV details five elements of an HRDD framework for arms companies that are essential for comprehensively identifying, evaluating and addressing the human rights risks of arms exports. Part V offers concluding remarks.

The European legislator has included the fulfilment service provider (FSP) in European product safety legislation as a new responsible economic operator (EO) in e-commerce for instances where no other EO is based in the European Union. As a matter of coherency, this adjusted personal scope of product safety law will likely be mirrored in a revised product liability directive. This article explores to what extent the aims and expectations of European legislator with respect to these legal changes (law in the books) align with the perceptions of FSPs and legal advisors in the field (law in action). This is done by means of a legal analysis of the goals and envisioned effects of these changes as well as a semi-structured interview study on how FSPs and legal advisors in the field perceive this new role, responsibility, and liability. The findings provide indications that product safety law currently in force might not (yet) lead to the desired effects. The findings also make us question the extent to which victim compensation is actually improved by the proposed adjustment of the personal scope of the product liability directive.

Small claim. Regulation 861/2007 (European Small Claims Procedure Regulation). Unfair term in terms of service agreement. Breach of contract through shadowbanning. Infringement on Articles 12 and 17 of Regulation 2022/2065 (Digital Services Act).

The COVID-19 pandemic has clearly demonstrated that international cooperation to combat pandemics is insufficient. The World Health Organization has, therefore, recently reformed the International Health Regulations based on the experience of the COVID 19-pandemic. The World Health Assembly also plans to adopt a new Pandemic Agreement to further strengthen international cooperation. However, negotiations have not yet been successful, and this year’s World Health Assembly agreed to extend the negotiations for the Pandemic Agreement by one year. Reason enough to analyse and critically evaluate the reform efforts in detail, and to give an outlook on the future of international pandemic law.

Regulatory norms, rules, and arrangements enshrined in and established by EU pharmaceutical law travel internationally and influence foreign legal systems, regulatory practices, pharmaceutical company conduct, health systems’ functioning, and ultimately patient access to medicines and human health worldwide. This paper applies the mechanisms of Europeanisation (conditionality, socialisation, externalisation, and mimicry) to explain how these EU norms, rules and arrangements are diffused globally, with a focus on developing economies. Using the ongoing revision of the EU’s pharmaceutical legislation as a case study, this paper selects three innovative legislative proposals therein (i.e. environmental risk assessments for antimicrobials; reporting of public funding for medicines R&D; revised clinical test data and market protection, including a transferrable exclusivity voucher). Through the lens of Europeanisation, this paper postulates how these three legislative proposals, if adopted, would travel globally to developing economies, under which conditions, and with which likely impacts. This paper addresses several gaps in the literature, namely by introducing a global lens to the existing analyses of the EU’s revision of pharmaceutical law, by revealing the theory behind the emerging evidence of the EU’s influence over global pharmaceutical markets, and by positioning the case of pharmaceutical regulation in low- and middle-income countries among the scholarship on the global regulatory influence of EU internal market law.

This paper traces the legislative process of the EU Artificial Intelligence Act (AI Act) to provide an empirical and critical account of the choices made in its formation. It specifically focuses on the dynamics that led to increasing or lowering fundamental rights protection in the final text and their implications for fundamental rights. Adopting process-tracing methods, the paper sheds light on the institutional differences and agreements behind this landmark legislation. It then analyses the implications of political compromise for fundamental rights protection. The core message it aims to convey is to read the AI Act with its institutional setting and political context in mind. As this paper shows, the different policy aims and mandates of the three EU institutions, compounded by the unprecedented level of redrafting and the short time needed to reach a political agreement, influenced the formulation of the AI Act. Looking forward, the paper points to the role of implementation, enforcement and judicial interpretation in enhancing the protection of fundamental rights in the age of AI.

The rapid advancement of quantum computing presents unparalleled opportunities and challenges for the legal field. This article investigates the key legal implications of quantum computing, focusing on intellectual property, data security, regulation, and ethical considerations. The unique characteristics of quantum algorithms and hardware pose significant challenges for the existing patent system, necessitating a clear and consistent framework for protecting quantum innovations while fostering collaboration. The threat of quantum computing to current encryption methods highlights the urgent need for forward-looking data protection policies and the adoption of post-quantum cryptography. As quantum technologies continue to evolve, policymakers must work closely with stakeholders to develop adaptive, principles-based regulations that strike a balance between promoting innovation and mitigating risks. Moreover, the societal and ethical impacts of quantum computing cannot be overlooked; prioritising applications that deliver significant social good and establishing robust ethical guidelines will be crucial. Preparing the legal workforce for the quantum era requires a concerted effort to develop quantum literacy and expertise. By adopting a proactive, interdisciplinary approach, the legal community can play a vital role in shaping the quantum future, ensuring that this transformative technology upholds the rule of law, protects individual rights, and promotes the greater good of society.

The ECtHR’s landmark judgment in the case Verein KlimaSeniorinnen Schweiz and Others v. Switzerland contains novel findings on procedural and substantive aspects of human rights protection in the climate change context. To reconcile effective protection of Convention rights with the exclusion of actiones populares, the Court set a high threshold for the individual applicants’ victim status while applying mostly formal criteria to the locus standi of the applicant association. On this count, only the association’s application was admissible. On the merits, the Court found violations of Articles 8 and 6(1) ECHR because Switzerland failed to comply with its positive obligation to protect individuals from the adverse effects of climate change and its courts did not engage seriously with the applicant association’s action. This case note takes a closer look at the ECtHR’s interpretation of standing for individuals and associations and discusses its (non-)alignment with previous case law. In particular, it reflects on the Court’s implicit understanding of the concept of victim in KlimaSeniorinnen and explores whether allowing representative standing is justified based on the Court’s existing case law. The case note concludes with an outlook on the enforcement of collective human rights issues through associations.