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

Guaranteed failure (Peter Dunn v Kostas Kazolides)

Commercial analysis: Dov Ohrenstein of Radcliffe Chambers considers the case of Peter Dunn v Kostas Kazolides which addresses interesting questions about limitation periods, insolvency, the formal requirements for the execution of deeds, and how variation to the contract between the principal debtor and creditor may discharge a guarantor.

ABPI publishes blog post urging government to reform UK medicines investment environment

The Association of the British Pharmaceutical Industry (ABPI) has published a blog post calling on the government to strengthen the UK’s commercial environment for medicines investment. Building on The King’s Fund’s recent explainer on medicines pricing, the ABPI's Executive Director of Point Access, David Watson, sets out as case for reform to safeguard the UK’s global standing in life sciences and secure long-term patient access to innovative treatments. The ABPI warns that the current design of the Voluntary Scheme for branded Medicines Pricing, Access and Growth (VPAG) is failing to meet its objectives and raises concerns about the UK’s ability to meet the ambitions of the 10 Year Health Plan for England and the Life Sciences Sector Plan. From 1 January 2025, levies under VPAG rose by 50%, requiring companies to repay around £3.5bn—£1bn more than expected. The levy on innovative products is 22.9%, rising to 35% for older medicines. The ABPI says this is driving disinvestment, with companies withdrawing UK investments, cutting headcounts and retreating from NHS partnerships. The UK’s uptake of new medicines is 52% of the average in comparator countries in year one, and only 62% after five years. The ABPI warns that without reform, the UK risks missing its 2030 ambition to lead Europe in commercial R&D and patient access

Commission publishes FAQ on health technology assessment regulation implementation

The European Commission has published guidance clarifying the implementation of Regulation (EU) 2021/2282 on health technology assessment (HTA). The FAQ document outlines the conditions under which products are subject to JCA, including those with new active substances for cancer treatment and advanced therapy medicinal products, starting from 13 January 2025. The regulation follows a stepwise approach, expanding to orphan medicinal products in 2028 and all relevant products by 2030. Applications must comply with Article 8(3) of Directive 2001/83/EC, excluding generics, biosimilars and other simplified procedures.

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.