EU regulators warn of ‘vulnerabilities’ in supply of radiopharmaceuticals

Europe faces limited supplies of medicines containing radioisotopes which are used to diagnose or treat cancer, according to EU-level and national drug regulators. Experts say European countries should step up manufacturing capacity which is currently ‘limited’ and has led to shortages.

The comments come from the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), which includes regulators from the European Medicines Agency (EMA) and the national Heads of Medicines Agencies (HMA). The group has set out a series of recommendations to address vulnerabilities in the European supply chain of radiopharmaceuticals.

The use of radiopharmaceuticals is steadily increasing, while manufacturing capacity in Europe is limited. Production of radiopharmaceuticals is reliant on stable isotopes and other materials that are sourced mainly from third countries. In addition, the supply chain of these medicines, including how to transport them safely, is complex.

The recommendations to the European Commission emphasise the need to increase the European Union’s domestic capabilities, warning of ‘ageing infrastructure’, such as nuclear reactors. The report also points to transport challenges which could be eased through harmonisation of certification procedures and standards across different countries.

‘Member States are advised to map their supply chains, coordinate transport solutions and consider the inclusion of new radiopharmaceuticals in horizon scanning activities,’ the experts advise.

The MSSG has been monitoring the security of supply of radiopharmaceuticals and managing availability issues by providing regulatory support to prevent or mitigate the impact of shortages on patients.

‘However, regulatory tools cannot address all the vulnerabilities identified in the supply chain, something which will also require long-term industrial policy measures, such as those in the Critical Medicines Act.’