Commissioner for Crisis Management Janez Lenarčič, responding on behalf of the European Commission to a written question by MEP Gerald Hauser, outlined ongoing and planned measures to prevent shortages of nitrile products and helium, while stating that no materialised shortages have been reported. The answer, published on 23 June 2026, signals the Commission's reliance on recently adopted legislation and upcoming procurement actions to bolster supply security.

The reply notes that the new Pharmaceutical Regulation, proposed in April 2023, mandates early notification of potential shortages and requires companies to draw up prevention plans. Further reinforcement is expected from the Critical Medicines Act, on which co-legislators reached a political agreement on 12 May 2026, aiming to address vulnerabilities in supply chains for critical medicines.

Regarding nitrile medical countermeasures, the Commission said it has engaged with industry and received no notifications of actual shortages, but monitoring continues. To strengthen crisis supply, the Commission plans to launch a tender to reserve manufacturing capacity for nitrile examination gloves, as announced in a prior information notice on 21 April 2026 by the European Health and Digital Executive Agency (HaDEA).

On helium, the Commission, alongside the European Medicines Agency (EMA), is monitoring supply risks. Helium is classified as a critical raw material under the Critical Raw Materials Act (CRMA) of 2024. The Commission's analysis indicates that the EU does not source the majority of its helium from Gulf States and that a supply disruption is not imminent.

The answer also references the Medical Countermeasures (MCM) Strategy, which includes the creation of RAMP UP (Rapid Agile Manufacturing Partnerships for Union Protection) to establish manufacturing capacity through industry partnerships.

The Commission is pursuing a dual track of legislative hardening (Pharmaceutical Regulation, Critical Medicines Act) and operational procurement (tender for nitrile gloves, RAMP UP) to prevent shortages, while downplaying immediate risks. The answer contains concrete commitments (tender, monitoring) but no numerical targets or deadlines beyond those already in legislation.

The Commission will continue monitoring through EMA and the Medicines Shortages Steering Group. The tender for nitrile glove manufacturing capacity is expected to be launched in the coming months. The Critical Medicines Act, once formally adopted, will add further obligations on supply chain resilience.

EU healthcare providers and patients benefit from reduced shortage risk. Nitrile glove manufacturers face new tender requirements but gain guaranteed demand. Helium-dependent industries (medical imaging, pharma) receive reassurance but no immediate supply guarantee. EU taxpayers fund the capacity reservation and monitoring systems.

Asked byGerald HAUSER · answered by Hadja Lahbib
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