Data protection and life sciences

Personal data is at the very core of every life science business. Life sciences companies handle significant amounts of personal data and are reliant upon the collection and use of personal data, which often includes sensitive health-related data, in order to carry out key business functions. For example, conducting clinical trials on patients, collecting data on drug safety and adverse reactions in order to comply with pharmacovigilance requirements, and collecting genetic information for the development of personalised medicines all rely on the collection and processing of data relating to individual data subjects. Consequently, it is vitally important that life sciences companies understand, and are in compliance with, the strict rules that apply to the processing of personal data.

This Overview provides an introduction to the application of the data protection regimes to key areas of the life sciences under the EU General Data Protection Regulation, Regulation (EU) 2016/679 (EU GDPR) and the United Kingdom General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR) (together the ‘GDPR regimes’).

Assimilated law is the name given to retained EU law (‘REUL’) which remains in force after

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Latest Life Sciences News

Life Sciences weekly highlights—4 September 2025

This week’s edition of Life Sciences weekly highlights includes a Law360 news analysis on the Patents Court striking out Sandoz’s claim for an account of profits made from selling blood-thinning treatment Xarelto during an interim sales ban against Bayer and news that the Patents Court addressed cost and interim payments following patent litigation in a complex dispute involving diabetes treatment dapagliflozin. Also included is news that the European Economic and Social Committee (EESC) published its opinion on the proposed EU Critical Medicines Act and Medicines for Europe responded to the European Parliament’s draft report on the Act, highlighting areas of concern, the Commission opened a consultation on revised Good Manufacturing Practice (GMP) quality system guidelines, the MHRA published an update to its March 2025 government response on statutory fees following post-market surveillance legislation for medical devices and published revised guidance on clinical investigations for medical devices, MedTech Europe published a position paper on aligning EU digital legislation with sector-specific frameworks and responded to the Commission’s consultation on extending the Carbon Border Adjustment Mechanism (CBAM). Further news included is that the ABPI announced that the Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) scheme review negotiations with the UK government have ended without agreement, the EESC issued its opinion on the EU’s cybersecurity action plan for healthcare, the HRA published a report on the legal and ethical use of patient information in research, the Prescription Medicines Code of Practice Authority (PMCPA) updated guidance on Clauses 3.1 and 11 of the ABPI Code of Practice, which prohibit the promotion of medicines prior to marketing authorisation, among other stories.

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