Q&As

Q&As

These Q&As seek to briefly address common questions faced when dealing with Life Sciences matters.

The Q&As supplement and link to other more detailed content within Lexis®+ UK, but are intentionally short. It is anticipated that a brief Q&A will be most helpful when you need a quick overview of an issue and its likely impact. This might arise, for example, for lawyers needing to provide advice, provide business development or training at short notice. The Q&A content on Lexis®+ UK Practical Guidance is date stamped. This date is the publish date and

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Latest Life Sciences News

DHSC consults on expanding medicines data reporting regime

The Department of Health and Social Care (DHSC) has published its 2025 annual review of the Health Service Products (Provision and Disclosure of Information) Regulations 2018 and the Health Service Medicines (Price Control Penalties and Price Control Appeals Amendment) Regulations 2018, and is consulting on proposed amendments to strengthen medicines reimbursement, supply oversight and compliance across the UK. Published on 10 February 2026 and covering the period July 2022 to June 2025, the review concludes that the objectives of the regulations remain appropriate but that changes are needed to improve the effectiveness of NHS reimbursement arrangements, enhance management of medicines shortages and ensure better value for money for taxpayers.

Life Sciences weekly highlights—12 February 2026

This week's edition of Life Sciences weekly highlights includes analysis of the Supreme Court’s decision in Emotional Perception AI Ltd v Comptroller-General of Patents, Designs and Trade Marks, in which the court held that an artificial neural network system is not excluded from patentability as a ‘program for a computer…as such’, aligning UK law more closely with European Patent Office jurisprudence. Also included, is news that the DHSC has opened a consultation on changes to the statutory scheme for branded medicines pricing to align with the voluntary scheme, DHSC also released its finding and recommendations on the operation of the Medicines and Medical Devices Act 2021 in its five-year report and it has also opened a consultation on proposed amendments to strengthen medicines reimbursement, supply oversight and compliance further to its 2025 annual review of the Health Service Products 2018 regulations. Further developments include NICE launching the National HealthTech Access Programme, MHRA updating its pharmacovigilance requirements for UK authorised products further to Commission Implementing Regulation (EU) 520/2012 (CIR 520/2012), the Notified Bodies industry publishing a letter addressing proposed cybersecurity amendments to the medical devices regulations, the adoption of the international standards ICH M15 guideline for model-informed drug development, the EMA launching a consultation on making Annex 15 GMP qualification and validation guidelines mandatory, and the EFPIA published proposals to strengthen EU pharmaceutical competitiveness, among other stories.

EFPIA updates European hospitality thresholds scorecard for pharmaceutical industry

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its updated thresholds for meals and drinks, setting out maximum hospitality limits permitted across member countries. In some jurisdictions, higher limits are conditional on a minimum scientific programme duration. The scorecard shows varying limits ranging from €32 per meal in Ukraine to €135 in Iceland, with some countries requiring minimum scientific activity durations and different VAT treatment approaches. For example, Belgium permits hospitality of €45 for lunch and €90 for dinner (incl. VAT), subject to a minimum of six hours of scientific activities. France, Germany, Spain and Italy set per-meal limits of approximately €70–75 (incl. VAT), while Ireland sets a limit of €90 per meal (incl. VAT). In the UK, a maximum of £75 plus VAT and gratuities is permitted only in exceptional circumstances.

DHSC publishes statutory 5-year review of Medicines and Medical Devices Act 2021

The Department of Health and Social Care (DHSC) has published its statutory five-year report on the operation of the Medicines and Medical Devices Act 2021 (MMDA 2021), concluding that while the UK’s legislative frameworks for human medicines, veterinary medicines and medical devices remain effective and protective of public and animal health, aspects of the legislation would benefit from consolidation, restructuring and reform of the delegated powers and procedural requirements governing how regulations are made and amended.