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.

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).