Data protection and life sciences

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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

European Commission adopts delegated act on Master UDI-DI for spectacle products

The European Commission adopted on 12 June 2025 a delegated act amending Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), to introduce the Master UDI-DI solution for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. This solution, which already covers contact lenses, uses a single identifier, the Master UDI-DI, to represent certain devices with high individualisation, instead of assigning standard unique device identification (UDIs) to each device individually. The delegated act is currently under a scrutiny period and will be published afterwards. Additionally, a Medical Device Coordination Group guidance document is being developed to outline the implementation timelines for the Master UDI-DI concerning spectacle frames, spectacle lenses, and ready-to-wear reading spectacles and provide practical details for manufacturer.s

EFPIA issues recommendations to stop chemical safety assessments animal testing

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued recommendations on 12 June 2025 on phasing out animal testing for chemical safety assessments. Its latest proposals, based on the '3Rs' principles of Replacement, Reduction, and Refinement, introduce a three-tiered approach that categorises tests according to their current applicability and future potential, thereby outlining a clear pathway for implementation. This roadmap illustrates a broader evolution in scientific strategy, embracing advances in organ-on-chip technology and AI-driven toxicology, as well as encouraging global collaborative efforts to align with emerging regulatory and ethical standards. While recognising challenges such as regulatory fragmentation, data silos, and intellectual property concerns, the strategy relies on transparent engagement and a commitment to harmonising international efforts, striving for a future of safety science that is both innovative and ethical.

EU publishes implementation timeline for EU AI Act

The European Parliamentary Research Service releases an ‘at a glance’ document outlining the implementation timeline of the EU AI Act. The EU AI Act published in July 2024, will take at least three years to fully implement. The EU AI Act establishes a regulatory framework that categorises AI systems according to their risk levels and general-purpose AI models based on their capabilities. Additional regulatory instruments, including guidelines, standards and codes, are expected to complement the EU AI Act's implementation. The full regulatory framework is anticipated to be operational by mid-2027.

European Commission pushes on with AI models Code of Practice despite possible law delay

MLex: The European Commission is pressing ahead with finalising a Code of Practice for general-purpose AI (GPAI) model developers, intended as a key compliance tool for the likes of OpenAI, Anthropic and Microsoft, for application in August 2025, even though discussions on pausing the EU AI Act that underpins it are now formally on the table. The Code, GPAI guidelines, the template to disclose training datasets and related guidelines are expected by the first week of July 2025. Leading AI companies are being engaged to secure their support for the Code, though they are still in the dark on the critical copyright-related parts.

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