On 3 September 2026, Advocate General Kokott delivered a significant Opinion in Case C‑193/25, Poland v Parliament and Council, recommending the annulment of the provisions of the revised Urban Waste Water Treatment Directive 2024/3019 (UWWTD) that require pharmaceutical and cosmetics producers to finance 80% of the costs of quaternary wastewater treatment. While the AG accepts the legitimacy of applying the polluter-pays principle to micropollutants in wastewater, she concludes that the EU legislature failed adequately to substantiate the scientific basis for selecting those industries to pay 80% of the costs.
Continue Reading AG Kokott recommends annulment of Urban Wastewater Directive’s pharmaceutical and cosmetics levyCJEU ruling clarifies scope of medical device definition
By Adela Williams, Christopher Bates & Heba Jalil on
The CJEU has delivered a preliminary ruling in Case C-427/24 Diagramm Halbach, which provides guidance on determining whether a product is a medical device within the meaning of Regulation (EU) 2017/745 (“MDR”). The judgment confirms that the manufacturer’s advertising of a product is not necessarily decisive in determining whether it has a “medical purpose” within the definition of “medical device” under the MDR, and that the product must also objectively perform one (or more) of those medical purposes to fall within that definition. The judgment also provides guidance on what constitutes a solely administrative function that does not fall within those medical purposes. The decision has the potential to guide other classification decisions of borderline products used in the healthcare sector.
Continue Reading CJEU ruling clarifies scope of medical device definitionCJEU rules on GDPR access rights and abuse of rights: what the Brillen Rottler judgment means for life sciences companies
By Sabrina Seveno, Alexander Roussanov & Camille Vermosen on
On 19 March 2026, the Court of Justice of the European Union (CJEU or Court) issued its judgment in Case C-526/24, Brillen Rottler GmbH & Co. KG v TC. The case concerned a data subject who subscribed to a German optician’s newsletter and, thirteen days later, submitted an access request under Article 15 GDPR. The company refused the request, arguing it was abusive. The data subject maintained it was legitimate and claimed at least €1.000 in non-material damages.
The CJEU’s judgment addresses three questions of broad significance: (1) when a first access request can be refused as “excessive”; (2) whether a violation of the right of access alone can give rise to a compensation claim under Article 82 GDPR; and (3) how non-material damage should be assessed in that context. While the judgment is relevant to all companies subject tot GDPR, we examine below the considerations it raises for life sciences companies specifically.
Continue Reading CJEU rules on GDPR access rights and abuse of rights: what the Brillen Rottler judgment means for life sciences companiesEU Digital Omnibus: What the Proposed Reforms Mean for Pharma and MedTech
On 19 November 2025, the European Commission published two legislative proposals – the Digital Omnibus on AI Regulation Proposal and the broader Digital Omnibus Regulation Proposal (“Proposals”) – as part of a wider initiative to simplify and streamline the EU’s digital regulatory framework. Together, the Proposals introduce targeted but significant amendments across a broad range of instruments, including the EU AI Act (Regulation (EU) 2024/1689), the GDPR (Regulation (EU) 2016/679), the ePrivacy Directive (2002/58/EC), the NIS2 Directive ((EU) 2022/2555), and the EU Data Act (Regulation (EU) 2023/2854).
Continue Reading EU Digital Omnibus: What the Proposed Reforms Mean for Pharma and MedTechVirtual and Digital Health Digest – October 2025
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 September and early October 2025 from the the United Kingdom, and European Union.
This month, the EU and UK have been actively processing the future of AI development and regulation in life sciences and health care through a combination of legislative initiatives, opportunities for stakeholder engagement, and investment in infrastructure. In the EU, the European Commission has published draft guidance on reporting serious AI incidents under the AI Act, and the European Medicines Agency has initiated a stakeholder survey to define AI priorities in medicines regulation. In the UK, the UK government has announced a National Commission on the Regulation of AI in Healthcare and a new AIR-SP cloud platform. These developments signal a shift from theoretical regulation to practical implementation. There have also been two important decisions from the Court of Justice of the European Union refining the legal boundaries of digital health services and data protection.
Continue Reading Virtual and Digital Health Digest – October 2025CJEU to Clarify Rules on Packaging Requirements in Parallel Trade of Medicines
By Dr Beatriz San Martin & Shama Aktar on
On 8 September 2025, the Court of Justice of the European Union (CJEU) received a preliminary request from the Bundesverwaltungsgericht, the German Federal Administrative Court BVerwG, referring a series of questions seeking interpretation on the applicability of certain rules to parallel trade of medicines, including whether German language and packaging requirements are proportionate or compatible with EU law. The request follows an order for a preliminary reference made by the BVerwG in March 2025. Notably, the request does not disclose the identity of the parallel importer, the manufacturer of the medicinal product, or the name of the product itself.
Continue Reading CJEU to Clarify Rules on Packaging Requirements in Parallel Trade of MedicinesCJEU 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 dataThe 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 restrictiveAn update from the European Court of Justice on discount campaigns run by mail order pharmacies
By Libby Amos-Stone, Katya Farkas & Heba Jalil on
Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products? The European Court of Justice (CJEU) in the case of Apothekerkammer Nordrhein (C-517/23) has held that they do not.
Following on from the AG Opinion of Advocate General Szpunar, which we provided an update on earlier in the year, this case is the latest in a stream of cases on advertising practices involving DocMorris, a Dutch mail-order pharmacy that supplies medicines to end customers in Germany. The CJEU concluded that the discount campaigns regarding unspecified POMs do not fall within the definition of “advertising of medicinal products” (Article 86(1) Directive 2001/83) as the discount is implemented at the point of purchase of the POM. The decision of which product to prescribe has already been taken by a doctor and all the patient is left to do is choose the dispensing pharmacy. As such, the Court held that the purpose of the discount campaign is not to encourage patients to purchase medicinal products. Rather, it is simply to attract them to a specific pharmacy.
The facts of the case are set out in our previous blog available here.
Continue Reading An update from the European Court of Justice on discount campaigns run by mail order pharmaciesNotable developments in the interpretation of key GDPR concepts – why should Life Sciences companies care?
By Alexander Roussanov on
In the last month, both the European Data Protection Board (“EDPB”) and the Court of Justice of the European Union (“CJEU”) provided their interpretation of key data protection concepts that are crucial for ensuring compliance with Regulation (EU) 2016/679 (“GDPR”).
In Opinion 22/2024, the EDPB provided guidance to data controllers on how to effectively oversee the activities of their (sub-)processors in a GDPR-compliant manner. The opinion was requested by the Danish data protection authority and likely related to the enforcement actions against Danish hospitals which allegedly failed to oversee processors (see our blog – https://www.biosliceblog.com/2024/02/proposed-fine-against-danish-hospital-for-failure-to-supervise-data-processors/).
In early October, the CJEU provided an answer to a key question raised by the courts in the Netherlands – can the legitimate interests legal basis be used for processing of personal data for commercial purposes (e.g., sharing with third parties for advertising and promotion) (Case C‑621/22).
Continue Reading Notable developments in the interpretation of key GDPR concepts – why should Life Sciences companies care?