Jurisdiction(s):
United Kingdom

EU and UK life sciences legal update: Critical Medicines Act, UK vaccine changes, EHDS/IP, MDR/IVDR impacts, EMA-FDA AI principles, and £500m UCB R&D investment

Published on: 22 January 2026

Published by a LexisNexis Life Sciences expert

Legal News

Article summary

Pharmaceuticals—regulatory framework

European Parliament adopts Critical Medicines Act proposal to address supply shortages

The European Parliament has endorsed plans to bolster the availability and supply of essential medicines across the EU, approving the proposals by 503 votes in favour, 57 against and 108 abstentions. The package seeks to lessen the EU’s reliance on non‑EU countries and strengthen pharmaceutical competitiveness by backing strategic industrial projects to expand and modernise manufacturing capacity within the Union. Under the proposals, contracting authorities would be required to apply procurement criteria that favour manufacturers producing a significant share of critical medicines in the EU, with price no longer the sole determinant for contract awards. The measures also lower the bar for joint cross‑border procurement from nine to five countries and create an EU co‑ordination mechanism for national stockpiles of critical medicines, empowering the Commission, as a last resort during shortages, to reallocate medicines between Member States. Industry has reacted critically to the current text, warning that certain provisions could dilute the original intent of the Critical Medicines Act (CMA)...

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