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

Council and Parliament agree on new rules to enhance efficiency in pharmaceutical sector

The Council of the EU and the European Parliament have reached a provisional agreement on reforming the EU’s pharmaceutical framework, focusing on patient access, regulatory efficiency, industry competitiveness, and medicinal supply security, with incentives to address antimicrobial resistance. Under the agreement, new medicines will receive eight years of data exclusivity and one year of market protection post-authorisation and Article 56a will allow Member States to require sufficient medicine supplies to meet national demands. The EU pharma package will also expand activities for generic/biosimilar manufacturers for market entry post-IP rights expiry, including procurement tenders and introduce a transferrable exclusivity voucher, granting one extra year of protection for developing priority antimicrobials, among other things. The provisional agreement will need to be endorsed by the Council and Parliament, before it is formally adopted and published in the Official Journal of the EU.

Life Sciences weekly highlights—11 December 2025

This week's edition of Life Sciences weekly highlights includes analyses of the European Commission’s published Digital Omnibus on AI Regulation Proposal and an MLex analysis of Member States criticisms of planned delays for key EU AI Act duties. Also included, is news that the UK government has reduced the 2026 Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) rebate rate for newer medicines to 14.5% (from 22.9% in 2025) with a total 2026 rebate for newer medicines at 15.5%, the UK and EU welcome the establishment of the world’s first global carbon footprint standards framework for assessing the environmental impact of pharmaceutical products, an EFPIA report highlights governance challenges and the policy actions needed to implement AI regulation across medicines’ lifecycles and the DHSC launched a consultation on proposed changes to give ministers limited powers to set NICE cost-effectiveness thresholds for health technology assessments. Further news included is that Medicines for Europe has called for urgent drug pricing reform to address antibiotic shortages caused by low national price caps of off-patent antibiotics despite increasing production costs, the BIA has called for a new pathway to improve UK patient access to rare disease medicines, the EMA updated its guidance on stepwise paediatric investigation plans (sPIPs), MedTech Europe supports the Commission’s proposal for a European Competitiveness Fund to support scaling up innovative digital health tech and the ASA has upheld a series of complaints in its crackdown on online advertising for food supplements claiming to alleviate medical conditions or diseases, among other stories.

Commission launches consultation on European Health Data Space Board operations

The European Commission has published a draft implementing regulation establishing the operational framework for the European Health Data Space (EHDS) Board under Regulation (EU) 2025/327. The draft sets out the Board’s governance arrangements, its cooperation with the eHealth Network during the transition period, and the actions it may take to ensure consistent application of the EHDS rules. These include issuing technical implementation guides, non-binding guidelines, and other written contributions to support the exchange and use of electronic health data, as well as facilitating cooperation, peer learning, and the sharing of best practices among Member States, the Commission, and invited bodies.

EFPIA endorses PAS 2090:2025 pharmaceutical carbon footprint assessment standard

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has endorsed PAS 2090:2025, published on 30 November 2025, as the most robust approach for harmonised Product Carbon Footprint (PCF) frameworks for pharmaceuticals. The specification, sponsored by NHS England, the Office for Life Sciences (OLS) and the Pharmaceutical LCA Consortium, represents the first publicly available standard establishing harmonised, internationally applicable Product Category Rules for Life Cycle Assessments (LCAs) and PCFs of pharmaceutical products. PAS 2090 sets requirements for data quality, methodological consistency and transparent reporting to address the previous absence of pharmaceutical-specific standards that had led to divergent methodologies and inconsistent results across the sector. EFPIA member companies have committed to collaborate with stakeholders and global authorities to implement the framework, with the organisation acknowledging stakeholder interest in product environmental data to support climate goals.