Improving efficiency

Commission publishes results of second survey on EU medical device market availability

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has published results from its second survey on the availability of medical devices and in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Device Regulation (IVDR)). The survey covers both devices already placed on the market and those intended for future placement, considering legacy and newly developed products. It spans all risk classes, with particular focus on devices requiring the involvement of a notified body.

EU Council agrees position on Critical Medicines Act to tackle drug shortages

The Council of the European Union has agreed its position on the Critical Medicines Act (CMA), a proposed regulation aimed at addressing shortages of critical medicines including antibiotics, insulin and painkillers across the EU. The Council's position introduces requirements for Commission guidance on EU production determination, facilitates information exchange on contingency stocks, reduces the minimum number of member states needed for collaborative procurement from nine to six, and mandates resilience criteria in public procurement. The legislation will now proceed to negotiations with the European Parliament following the Commission's original proposal published on 11 March 2025.

DHSC highlights investment opportunities from UK–US pharmaceuticals deal

The Department of Health and Social Care (DHSC) has commented on the UK–US pharmaceuticals deal, highlighting its role in securing access to medicines for NHS patients and accelerating the arrival of innovative treatments. According to DHSC, the deal will help ensure that patients benefit from earlier access to groundbreaking therapies reaching the NHS frontline more quickly. DHSC notes that the agreement safeguards the UK’s medicines supply chain while supporting major investment in the UK life sciences sector. The deal makes the UK the only country to secure a 0% tariff on pharmaceutical exports to the US. Under the terms confirmed by the US, the UK will receive a preferential 0% tariff rate for at least three years—the lowest rate offered to any country. It has also helped attract investments from global firms such as Moderna, Bristol Myers Squibb and BioNTech, and includes preferential terms for medtech exports. The government also intends to raise investment in innovative treatments by around 25%, which aligns with NICE increasing its cost-effectiveness thresholds (from £20,000–£30,000 to £25,000–£35,000 per QALY).

EU Member State Coordination Group adopts 2026 Health Technology Assessment Work Programme

The EU Member State Coordination Group on Health Technology Assessment (HTACG) has adopted its annual Health Technology Assessment Work Programme, outlining its key activities and strategic priorities for 2026. The programme estimates the initiation of approximately 50 joint clinical assessments of medicines containing new active substances for cancer treatment and advanced therapy medicinal products. For the first time, the HTACG will also launch joint clinical assessments of selected high-risk medical devices, with approximately five assessments expected to begin in 2026. Health technology developers can submit requests for joint scientific consultations during four designated periods: 7 January to 4 February 2026, 1 to 29 April 2026, 3 June to 1 July 2026, and 23 September to 21 October 2026.