Supply and shortages of radiopharmaceuticals

Supply and shortages of radiopharmaceuticals

The reliable supply of radiopharmaceuticals is critical for the continuous and effective functioning of nuclear medicine. These products, essential for both diagnostic and therapeutic purposes, often have short half-lives, making timely production and delivery imperative. Disruptions in supply can severely impact patient care and clinical outcomes. The EANM is committed to addressing the challenges associated with the supply chain and mitigating the risks of shortages to ensure that radiopharmaceuticals are consistently available across Europe. In this respect, the EU needs to develop a robust supply chain which goes from the research reactor to the patients and includes the supply of starting materials as well as processing materials.

Main Advocacy Priorities for the EANM

• Robust Supply Chain Infrastructure: Advocate for the development and maintenance of a resilient supply chain infrastructure capable of meeting the demands of the healthcare system.
• Supply Chain Transparency: Encourage transparency throughout the supply chain, from production to delivery, to identify potential bottlenecks and areas for improvement.
• Enhanced Communication: To minimise patient impact, all supply chain actors, including healthcare professionals, wholesalers, manufacturers and national competent authorities, should have the obligation and responsibility to collaborate more closely in terms of not only monitoring but addressing the shortage problem. Such communication should be carried out in a timely manner and contain insights on how imminent the issue is, the expected duration of the shortage and whether alternatives are available.
• Healthcare system readiness: Healthcare infrastructures should be built, renewed, or maintained, in order for all European patients to have equal access to dedicated centres with Nuclear Medicine facilities. The increase in hospital readiness for the delivery of Nuclear Medicine services is fundamental for scaling up their full treatment potential.  Investment in Nuclear Medicine state-of-the-art equipment should be reinforced when developing the EU Network of National Comprehensive Care Centre and through EU funding schemes (Cohesion Funds).
• Improved Data Collection: The inclusion of Nuclear Medicine into the Cancer Inequalities Registry should be supported to have a clear picture of EU discrepancies in terms of Nuclear Medicine facilities.

The EANM’s Role

Committed to ensuring improved supply of radiopharmaceuticals, the EANM is collaborating in various stakeholders’ groups:

• The EU Observatory for the Supply of Medicinal Radioisotopes: Established in 2012 by the European Commission, it aims at bringing together all relevant information to the decision makers in the EU institutions and national governments in order to assist them in defining strategies and policies for their implementation. The European Observatory has four general strategic objectives:
  • to support a secure Mo-99/Tc-99m supply across the EU
  • to ensure that the Mo-99/Tc-99m supply issue is given high political visibility
  • to encourage the creation of a sustainable economic structure of the supply chain
  • to establish periodic reviews of the supply chain and capacities.
• The Radioisotopes Valley Initiative Stakeholder Group and Steering Group: As a flagship initiative of the SAMIRA Action Plan, the European Commission has established a European Radioisotope Valley Initiative (ERVI) to maintain Europe’s global leadership in the supply of medical radioisotopes and help accelerate the development and introduction of new radioisotopes and production methods. Over the next few years, the EU Commission will engage with stakeholders and launch feasibility studies before considering a legal framework for this initiative.
• The Critical Medicines Alliance: The Critical Medicines Alliance (CMA), set up in January 2024, is a consultative mechanism bringing together relevant stakeholders from EU Member States, key industries, the civil society, and the scientific community. The Alliance aims to identify key areas and priorities for action, proposing solutions to strengthen the supply of critical medicines in the EU, ultimately enhancing efforts to prevent and address shortages effectively.  Being involved in the CMA, the EANM is committed to assisting the European Commission in identifying effective measures to address and prevent shortages of critical medicines. As part of EANM contribution, we focus on:
  • ensuring the security of the supply of radiopharmaceuticals
  • enhancing their availability
  • mitigating dependencies within the EU supply chain.