Generic justification of medical exposure to ionising radiations in two European countries

Abstract

Abstract The European Directive 2013/56/EURATOM aims to safeguard patients, members of the public and workers by setting out basic safety standards for protection against the dangers arising from exposure to ionising radiation. However, each European member state must consider how the Directive should be transposed at a national level and this has led to different organisational models being adopted. With regard to medical exposure to ionising radiation (MEIR), Ireland and Italy are interesting countries to compare because they have transposed the Directive in contrasting ways. Comparison of these models may highlight ways to harmonise approaches and improve efficiency. Case studies were prepared by reviewing national laws, analysing scientific documents and conducting interviews with managers of organisations assigned the responsibility for MEIR. The case studies focused on the generic justification (GJ) of MEIR, determining if the benefits of a radiological practice outweigh the risks, at a population level. Ireland implemented a centralised model by designating responsibility for the regulation of MEIR to an independent competent authority, the Health Information and Quality Authority (HIQA). The Health Technology Assessment Directorate in HIQA has built upon their experience in conducting evidence synthesis to inform health policy, but it may experience challenges as the single gateway for GJ decisions. In Italy, GJ is entrusted to national professional scientific radiological societies. The decentralised Italian model facilitates an immediate response to GJ applications from stakeholders, but the absence of strong national coordination may lead to duplication, loss of information and or partial knowledge of processes. Collaboration between European member states in the area of GJ of MEIR could support the standardisation of practices in Europe. This could be facilitated through the creation of a European working group. Key messages • The creation of a European working group focused on generic justification in radiation protection exposure is advocated. • A European working group would lead to less duplication of effort and a more streamlined process for generic justification.