Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2025 from the the United Kingdom, and European Union.
Continue Reading Virtual and Digital Health Digest – November 2025EU Legislation
Can a chemically synthesised medicine be authorised as a generic of a biological medicine? And who can challenge this?
On 23 October 2025, Advocate General (“AG”) Emiliou delivered his opinion in Case C-118/24: Laboratoires Eurogenerics and Theramex France.[1]
The AG opines on three key questions regarding the use of the decentralised procedure for generic medicinal products:
(i) The national courts of the EU Member States are allowed by EU law to judicially review the legality of a marketing authorisation (“MA”) granted via the decentralised abridged procedure where it is alleged that the medicinal product in question does not meet the criteria of a generic medicinal product. This is applies even if the judicial review is conducted by a national court in an EU Member State other that the reference Member State for the decentralised marketing authorisation procedure.
(ii) The applicant seeking such judicial review does not need to be the marketing authorisation holder for the reference medicinal product or the applicant for the generic marketing authorisation. The applicant could also be a third party with a vested interest, such as the marketing authorisation holder for a biosimilar medicinal product which will be competing with the newly authorised generic medicinal product. This conclusion by the AG remains unaffected by the fact that such applicant may not be admissible if the action was brought at EU level to the Court of Justice of the European Union (“CJEU”) if the direct and individual concern of the applicant is not demonstrated. According to the AG, it is for the EU Member States in the framework of their procedural autonomy to decide whether a right to challenge an MA exists in these circumstances.
(iii) Chemically synthesised products are not precluded from meeting the criteria to be a generic of a reference biological medicinal product.
This third finding will, if followed by the CJEU, also apply to the centralised marketing authorisation procedure and arguably facilitate market access for synthetic copies of biological medicinal products. It would mean that, in practice, applicants for generics of biological medicinal products would not be required to submit additional pre-clinical and/or clinical data (as opposed to biosimilar applicants) and may potentially benefit, once authorised, from more advantageous pricing and reimbursement conditions (e.g., substitutability at pharmacy level which may not be available for biosimilar medicinal products).
Continue Reading Can a chemically synthesised medicine be authorised as a generic of a biological medicine? And who can challenge this?Development of a new EMA guideline on the clinical evaluation of ready to use radiopharmaceuticals[1]
By Carla Schoonderbeek, Bart Jong & Anna Pothof on
[1] This post and the paper it links to were prepared at the instruction of Novartis; it reflects the views of the authors.
Radiopharmaceuticals are a special type of medicinal products. Where they are prepared industrially or by a method involving an industrial process and are intended to be placed on the market in the European Union (‘EU’), they are subject to the rules of Directive 2001/83/EC on medicinal products for human use (the ‘Medicines Directive’). In addition, if patients are treated with radiopharmaceuticals, account should be taken of Directive 2013/59/EURATOM (the ‘Euratom Directive’) which lays down basic standards for the protection of individuals against radiation exposure.
Continue Reading Development of a new EMA guideline on the clinical evaluation of ready to use radiopharmaceuticals[1]European Commission’s call for evidence on the revision of the MDR/IVDR
By Arnold & Porter & Eleri Abreo on
On 8 September 2025, the European Commission published a call for evidence on “the targeted revision of the EU rules for medical devices and in vitro diagnostics”. This is part of the Commission’s on-going “targeted evaluation” of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), with the aim of identifying methods to tackle critical issues experienced throughout the industry caused by the regulations.
Continue Reading European Commission’s call for evidence on the revision of the MDR/IVDRCJEU clarifies the concept of pseudonymised data
By Alexander Roussanov on
On 4 September 2025, the Court of Justice of the European Union (“CJEU”) delivered a notable judgment on what is considered pseudonymised personal data under EU data protection law. While, technically speaking, the judgment concerns the interpretation of Regulation (EU) 2018/1725 (which governs the processing of personal data by the EU institutions and bodies), it fully applies to the interpretation of the concepts of personal data and pseudonymised data under Regulation (EU) 2016/679 (“GDPR”).
This question is essential for many companies operating in the EU, and in particular Life Sciences companies handling key-coded or otherwise pseudonymised patients’ personal data in the context of research and development, supply of healthcare products and related safety monitoring.
Continue Reading CJEU clarifies the concept of pseudonymised dataIs change on the horizon for the UK product liability regime? [Updated]
By Libby Amos-Stone on
The Law Commission, an independent organisation established to keep the law of England & Wales under review and recommend reform, has announced a review of the law in relation to liability for defective products.
Continue Reading Is change on the horizon for the UK product liability regime? [Updated]The European Court of Justice rules that Poland’s laws prohibiting pharmacies from advertising are overly restrictive
By Libby Amos-Stone & Katya Farkas on
The European Court of Justice (the “Court”) has ruled that Poland’s law prohibiting advertising by pharmacies and pharmaceutical outlets is overly restrictive and contrary to EU law.
The Polish legislation (Article 94a(1) of the Law on Medicines, as amended) which had been in force since 2012, prohibits pharmacies and pharmaceutical outlets from engaging in any form of advertising or promotional activity other than providing limited information on their location and opening hours. Any person who is found to be in breach of the provisions is liable to a fine of up to 50,000 Polish zloty (PLN) (approximately EUR 12,000).
Continue Reading The European Court of Justice rules that Poland’s laws prohibiting pharmacies from advertising are overly restrictiveCouncil of the European Union backs reforms to the EU Regulatory Framework for Medicinal Products
Introduction
On 4 June, EU Member States, meeting in the Council of the European Union (‘Council’), have agreed on a position on the pharmaceutical reform package.
This agreement was reached despite significant divergences between EU Member States in the preceding weeks. It marks a key milestone in the process for adoption of the EU revision of EU’s general pharmaceutical legislation, as it sets out the Council’s position for the trilogue negotiations to find a text agreeable to the Parliament and the Council, which can now begin.
The innovative pharmaceutical industry will welcome aspects of the Council’s adopted negotiating mandate as it provides greater certainty with regards to regulatory data protection and it lightens some of the obligations introduced in the European Commission proposal for reform of the EU pharmaceutical legislation adopted in April 2023 and the European Parliament’s position adopted on 10 April 2024 (see our detailed advisory). At the same time, the Council has adopted positions on some aspects of the proposals that could be seen as less favourable to industry.
We discuss some of the key provisions and changes in the Council’s adopted position below. This is, however, not covering all elements of the reform of the EU pharmaceutical legislation and the final outcome of the legislative process remains uncertain.
Continue Reading Council of the European Union backs reforms to the EU Regulatory Framework for Medicinal ProductsProposed GDPR Simplifications for SMEs and SMCs
On 21 May 2025, the European Commission published its Proposal for a Regulation (“Proposal”), amending several existing regulations, including the General Data Protection Regulation (EU) 2016/67 (“GDPR”), to simplify obligations for small and medium-sized enterprises (“SMEs”) and extend certain mitigating measures to small mid-cap enterprises (“SMCs”).
Continue Reading Proposed GDPR Simplifications for SMEs and SMCsThe EU AI Act: Impact on the Life Sciences Industry
Much has been written about the EU AI Act, which has now been published in the Official Journal as Regulation (EU) 2024/1689 and entered into force on 1 August 2024.
The AI Act is so-called “horizontal legislation”, meaning it applies across industries, and its impact will be felt from agriculture to aerospace and beyond. …