Nuclear Medicine Europe
NMEu
Nuclear medicine Europe is a European Industrial Association working on promotion, awareness and defence of Nuclear Medicine and Nuclear Healthcare in Europe.
ID: 382490247809-11
Lobbying Activity
Meeting with Olivier Chastel (Member of the European Parliament)
30 Sept 2025 · Politique de santé de l'UE - Médecine nucléaire
Response to EU Life sciences strategy
15 Apr 2025
Each day, over 100,000 patients worldwide benefit from nuclear medicinea vital area of healthcare that uses medical isotopes for early diagnosis and targeted treatment, particularly in oncology. As this field evolves rapidly, it promises more personalized, precise, and effective care. With demand now exceeding 49 million procedures annually, the need for innovation, infrastructure, and skilled professionals is more urgent than ever. Europe has been at the forefront of many recent breakthroughs in nuclear medicine, contributing to improved patient outcomes and aligning with the objectives of the EU Beating Cancer Plan. However, the sector faces mounting pressure to meet growing healthcare needs while remaining globally competitive. The EU must invest in research, workforce development, and industrial capacity to maintain its leadership and strategic autonomy. Supporting nuclear medicine not only strengthens Europes innovation and competitiveness but also enhances health outcomes and economic resilience.
Read full responseResponse to Critical Medicines Act
26 Feb 2025
Nuclear Medicine, Europe (NMEU) represents the majority of the pharmaceutical & imaging equipment companies in the field of Nuclear Medicine and follows European initiatives pertaining to medical applications of ionising radiation. Every year, more than 10 million patients in Europe benefit from the use of radiopharmaceuticals in nuclear medicine for unique diagnostic procedures and specific treatment target options, with many different radiopharmaceuticals in clinical use in Europe, predominantly in oncology. The radiopharmaceutical landscape has dramatically advanced in the last 20 years with a much greater focus on therapeutic radiopharmaceuticals and a wave of new therapeutic and diagnostic radiopharmaceuticals are coming to the market in Europe, holding the promise to represent a new pillar of cancer care and offering new opportunities in terms of personalised medicine. With regards to the proposed legislative initiative to help mitigate shortages of critical medicines in the future, NMEU would like to draw attention to the unique characteristics of radiopharmaceuticals and the challenges that would need to be addressed through such an initiative. Unique Challenges of Radiopharmaceuticals: Radiopharmaceuticals are a diverse class of medicinal products with radioactivity as the common denominator. The radioactive decay is responsible for unique logistical challenges for radiopharmaceuticals due to short (days) to very short (minutes) half-lives of the radionuclides. This natural decay necessitates timely delivery to ensure therapeutic potency, rendering stockpiling unviable. Transporting radiopharmaceuticals is inherently complex due to their radioactive nature. The supply chain for radiopharmaceuticals is further complicated by the external dependency on raw materials, particularly those sourced from Russia, underscoring the importance of securing these critical inputs to maintain a resilient supply chain. A considerable number of radiopharmaceuticals administered to patients must be produced close to or prepared on-site in a hospital, highlighting the need for special considerations for radiopharmaceuticals. There are currently regulatory hurdles that can impact radiopharmaceuticals in Europe which cannot be addressed by the supplier, such as the ability to swiftly create new manufacturing capabilities. Due to national laws (e.g. environmental, radioprotection considerations etc), navigating the local regulatory frameworks can be very time consuming, and as such, when ensuring the supply of radiopharmaceuticals to the EU, the full regulatory framework should be considered. Simply including radioisotopes or the finished products on a critical medicines list would not solve these fundamental challenges. NMEU recognizes the challenges of supply security for radiopharmaceuticals. As such, it has created the Security of Supply Workgroup. This Workgroup brings together NMEU members who operate Research Reactors or use their output for medical isotope production purposes. The main goal of this Workgroup is to achieve the best possible coordination of the periods during which the different Reactors are operating, to provide adequate global coverage during planned reactor shutdown periods for refuelling and maintenance. This coordination is necessary to ensure the production continuity of the mother isotopes and ensure the supply of final Radiopharmaceutical products and Therapy sources to hospitals all year round. Therefore, the Security of Supply Working Group at NMEU plays a crucial role in the security of radiopharmaceutical supply where a significant focus is on the shortage of radioisotopes. As such, it is recommended that a structured dialogue with NMEU is undertaken when considering radiopharmaceuticals as critical medicines, as mitigation strategies that would be appropriate for other drugs would not be viable for radiopharmaceuticals.
Read full responseMeeting with Peter Liese (Member of the European Parliament)
19 Feb 2024 · Austausch
Response to Evaluation and revision of the general pharmaceutical legislation
8 Nov 2023
The New EU Pharmaceuticals law is a very important legislation for the future of healthcare in the European Union and Nuclear Medicine Europe (NMEU) would like to draw your attention to some specific aspects that touch on the field of Nuclear Medicine. NMEU represents the majority of the pharmaceutical & imaging equipment companies in the field of Nuclear Medicine. NMEU has therefore been following closely the Revision of the EU general pharmaceuticals legislation, as well as all connected European initiatives pertaining to medical applications of ionising radiation. As a medical application of nuclear technology, Nuclear Medicine uses radioactive drugs (radiopharmaceuticals), which are employed to diagnose patients through imaging or to treat patients (with a specific focus on cancer - more than 80% of all nuclear-medicine therapies are related to cancer treatment). Every year, more than 10 million patients in Europe benefit from the use of radiopharmaceuticals in nuclear medicine for unique diagnostic procedures and specific treatment target options, with a large number of different radiopharmaceuticals in clinical use in Europe, but only very few centrally approved by the European Commission under the existing EU legislation. This underlines the current importance of national registration procedures and other national routes of patient access, especially for diagnostic radiopharmaceuticals, and the need for a regulatory framework adapted to the unique class of radiopharmaceuticals could significantly speed up innovation in this field in the European Union. For Radiopharmaceuticals, the regulatory hurdles are specifically high in Europe because of highly varied local regulations for this type of product based on different interpretations of the current directive. Radiopharmaceuticals are a very diverse class of medicinal products with radioactivity as the common denominator. The radioactive decay is responsible for unique logistical challenges for radiopharmaceuticals due to short (days) to very short (minutes) half-lives of the radionuclides, therefore keeping ready-available stocks impossible. Therefore, a considerable number of all radiopharmaceuticals that are applied to patients must be produced close to or prepared on-site in the hospital, justifying the need for special consideration for radiopharmaceuticals. In the opinion of NMEU, one of the guiding principles for the revision of the general pharmaceutical legislation is to meet the needs of patients across Europe while fostering innovation. The radiopharmaceutical landscape has dramatically advanced in the last 20 years with a much greater focus on therapeutic radiopharmaceuticals and a wave of new therapeutic and diagnostic radiopharmaceuticals are coming to the market in Europe, holding the promise to represent a new pillar of cancer care and offering new opportunities in terms of personalised medicine. These advances now need to be adequately supported by a tailored regulatory framework in order to maintain Europes leadership position in this field. Furthermore, NMEU would like to draw the attention of the Commission and the European Parliament to the fact that radiopharmaceuticals are governed by DG SANTE and DG ENER (regarding radiation safety) and have to adhere to both sets of legislative requirements (dual governance). The challenges posed by the current directive manifest in different ways: o Uncertainties among Member States´ authorities as well as producers and users in how to interpret the Directive; o Resulting in an increased level of heterogeneity in the interpretation of the Directive among Member States; o Ultimately impacting on the availability of radiopharmaceuticals for patients. NMEU believes EC consideration of our proposed amendments will help address the specialties of radiopharmaceuticals and we would be pleased to continue a dialogue on these matters.
Read full responseMeeting with Susanna Ceccardi (Member of the European Parliament)
28 Sept 2023 · Meeting with Nuclear Medicine EU
Meeting with Salvatore De Meo (Member of the European Parliament)
27 Sept 2023 · Nuclear Medicine