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

EMA launches three new priority medicines tools to support medicine development

The European Medicines Agency (EMA) has launched three new features under its priority medicines (PRIME) scheme, following a two-year pilot, to enhance support for medicines targeting unmet medical needs. The features—a regulatory roadmap and product development tracker, expedited scientific advice, and a submission readiness meeting—aim to streamline scientific dialogue, provide faster responses, and help developers prepare for marketing authorisation applications. The EMA has indicated that these tools will become permanent PRIME features as it prepares for the revised EU pharmaceutical legislation.

Life Sciences weekly highlights—19 March 2026

This week's edition of Life Sciences weekly highlights includes an MLex analysis of the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) issuing a joint opinion on the proposed EU Biotech Act, supporting harmonisation of clinical trials rules under the proposal, but calling for specific safeguards for sensitive health data. Also included, is news that the Council of the EU has agreed its position on the Digital Omnibus on AI proposal, and that the European Parliament’s Internal Market and Consumer Protection and Civil Liberties committees have adopted their joint position, supporting proposals to simplify AI rules, including amendments to revise timelines for high-risk systems, MedTech Europe has published a joint industry statement on packaging and sustainability requirements affecting medical devices, as well as news that the House of Lords has opened an inquiry into innovation in the NHS, focusing on personalised medicine and AI, EFPIA has published research on EU competitiveness for pharmaceutical investment and updates on Innovative Health Initiative (IHI) projects tackling health challenges ranging from antimicrobial resistance and AI to big data and regulatory innovation. Further news included is that the EMA has published an implementation strategy for the revised International Council for Harmonisation (ICH) E2D(R1) pharmacovigilance guideline, and has also opened a consultation on paediatric oncology development, the EMA and the Heads of Medicines Agency (HMA) have approved a 2026–28 workplan on using AI and big data in medicines regulation, the MHRA has highlighted the potential of medicines reclassification, involving switches from prescription-only (POM) to pharmacy, general sales list and over-the-counter (OTC) status, and a key Patents Court decision in Nador Cott Protection SAS v Asda Stores Ltd confirming that a mandarin variety was not essentially derived for Plant Breeders’ Rights purposes, among other stories.

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European Parliament committees back Digital Omnibus on AI Act amendments

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