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Life Sciences weekly highlights—18 December 2025

This week's edition of Life Sciences weekly highlights includes news that the Council of the EU and the European Parliament have reached a provisional agreement on the proposed pharmaceutical legislation reform package, the European Commission has published proposed amendments to the medical device regulations, and it also has published the long-awaited draft Biotech Act along with a draft directive for genetically modified micro-organisms, together with announcing €10bn investment into the sector, which aim to boost EU biotech competitiveness, accelerate EU clinical trials and strengthen biosecurity. Further news included is that the European Parliament adopted an amended draft Critical Medicines Act, the MHRA has established a Regulatory Innovation Corridor with Singapore that allows companies to engage with both nation’s regulators simultaneously to obtain early joint advice and streamline clinical trial design for breakthrough health technologies, the Commission has published a draft implementing regulation establishing the operational framework for the European Health Data Space (EHDS) Board, the Commission has released the three-year working plan agendas for five working groups (Biosimilars, Biologics, joint CHMP/CVMP Quality, Non-clinical domain and Synthetic Peptides) and the ASA continues to sanction companies for advertisements of weight-loss medicines that are prescription-only medicines (POMs) and for claims that go beyond the medicine’s authorised indication, among other stories.

Execution of multi-party deeds

Banking & Finance analysis: The case of Macdonald Hotels alarmed lenders and their lawyers earlier in the year, with obiter comments suggesting that, for the ‘face value’ requirement to be met for a deed, all parties have to make it clear in the document that they intend it to be a deed, not just those executing as a deed. The City of London Law Society subsequently issued a note giving their opinion on the comments and how to meet the face value requirement. This News Analysis looks at where we have got to on this issue as 2025 draws to a close.

Commission publishes draft Biotech Act and related GMO directive

The European Commission has published the draft European Biotech Act and a related draft directive on genetically modified micro-organisms, setting out new measures to boost EU biotech competitiveness, accelerate clinical trials and strengthen biosecurity, alongside announcing with the EIB Group a new initiative to mobilise €10bn investment for the sector.

Commission proposes regulation to simplify medical device rules

The European Commission has published a proposal to amend the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) aimed at simplifying regulatory requirements and reducing administrative burdens on manufacturers. The proposal introduces streamlined conformity assessment procedures, dedicated pathways for breakthrough and orphan devices, regulatory sandboxes for innovative technologies, and enhanced coordination between national authorities. It expands the European Medicines Agency's role in supporting expert panels and coordinating national competent authorities, while introducing new digitalisation measures and international cooperation mechanisms. The changes respond to implementation challenges since the MDR took effect in May 2021 and IVDR in May 2022, including capacity constraints at notified bodies and disproportionate compliance costs that have threatened device availability.

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