European Association of Nuclear Medicine
EANM
The EANM is the largest organisation dedicated to nuclear medicine and multi-modality imaging and related subjects in Europe.
ID: 348978437245-85
Lobbying Activity
Response to EU cardiovascular health plan
15 Sept 2025
The European Association of Nuclear Medicine (EANM) welcomes the European Commissions initiative to develop a comprehensive EU Cardiovascular Health Plan. Cardiovascular diseases remain the leading cause of mortality in Europe, and a coordinated EU-level strategy is both timely and essential. As the leading scientific society for nuclear medicine in Europe, EANM represents clinicians, researchers, and technologists dedicated to advance non-invasive diagnostics and personalised care. Please see the EANM reply to the consultation attached.
Read full responseResponse to EU Life sciences strategy
17 Apr 2025
The European Association of Nuclear Medicine (EANM) welcomes the opportunity to provide feedback on the European Life Sciences Strategy. Please find the EANM feedback attached.
Read full responseResponse to EU rules on medical devices and in vitro diagnostics - targeted evaluation
14 Mar 2025
The European Association of Nuclear Medicine (EANM) appreciates the opportunity to comment on the call for evidence for an evaluation of the EU rules on medical devices and in vitro diagnostics. Please find attached the feedback of the EANM.
Read full responseResponse to Critical Medicines Act
27 Feb 2025
The European Association of Nuclear Medicine (EANM) welcomes the opportunity to provide input on this Call for Evidence on the EU Critical Medicines Act. Please find the EANM feedback attached.
Read full responseMeeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)
11 Jun 2024 · Exchange of views with the European Association of Nuclear Medicine on the EU rules on radiopharmaceuticals.
Response to Interim evaluation of the Euratom Research and Training Programme 2021-2025
23 May 2024
Please find the EANM reply in the attached document.
Read full responseResponse to Evaluation and revision of the general pharmaceutical legislation
8 Nov 2023
The European Association for Nuclear Medicine (EANM) welcomes the European Commission´s initiative for a revision of the pharmaceutical legislation package for the European Union. Nuclear Medicine is a powerful tool for diagnosis and treatment of a variety of diseases and has seen a tremendous development, especially in the last two decades. Radiopharmaceuticals are a special class of medicinal products that, due to their unique characteristics, deserve special attention. EANM, and the related Nuclear Medicine National Societies, are pleased to see that a number of suggestions for a better framework for regulating this type of medicinal products have already been included in the rapporteurs list of amendments as detailed in the rapporteurs 1st report, ENVI-PR-753470_EN.pdf. However, in order to establish a future-proof legislative framework that supports innovation and secures the availability and safety of radiopharmaceuticals for patients in need, further amendments are needed. Especially radiopharmaceuticals that have to be prepared in-house for immediate use in healthcare establishments, need a regulatory framework that adequately supports the preparation process by providing a clear distinction from (otherwise applicable) industrial standards. We, therefore, have prepared the following documents that we would like to share with the Commission: 1) a detailed description of the issues that in-house production of radiopharmaceuticals currently faces and 2) a document that tabulates detailed proposals for further amendments based on the Commissions draft of a new directive, taking already into account the suggested amendments by European Parliaments rapporteur for the directive. In addition, we would like to share 3) a recently published Editorial on this topic that summarizes the current situation and offers solutions to the identified issues (https://link.springer.com/article/10.1007/s00259-023-06472-1) EANM encourages the Commission to take these suggestions into account in order to meet the ultimate goal of making the European pharmaceutical system more patient-centred, future-proof and crisis-resistant by creating a suitable legal environment for innovation, secure supply, address shortages and contribute to the overall aims of Europes Beating Cancer Plan while maintaining high quality and safety standards!
Read full responseResponse to Evaluation and revision of the general pharmaceutical legislation
27 Apr 2021
EANM highly appreciates the initiative to revise the legislative framework for medicinal products in Europe and takes the chance to highlight aspects of significant importance for the application of Nuclear Medicine technology. We propose modifications well suited to contribute to the overall aims of the revision (access to affordable medicines, foster innovation, security of supply, new scientific and technological developments, reduce red tape) and suggest revising the directive 2001/83 EC regarding definitions, scope and the requirements for market placement for the following items:
Radionuclide generators: a marketing authorization (MA) for all radionuclide generators to be placed on the market is mandatory. However, there are new generators available that give an eluate that can neither be applied in a kit like preparation nor be used as a pharmaceutical itself like it is the case for the well-established 99mTc/99Mo generator. The requirement for a MA for a generator that produces an eluate that meets the definition of a starting material only is not acceptable. A clear distinction of these types of generators is needed by revising the current definition (Article 1 §7).
Kits: The definition (Article 1 §8) is reflective of the past but is far too general to be of use today. Due to technical advances, there is a great number of products available that by nature are starting materials for the more complex preparation process of radiopharmaceuticals. Nevertheless, they fall under the current kit-definition, hence require a marketing authorization. We need a clear distinction between true kits that are used in compounding processes (eg 99mTc-preparations) and starting materials that are used in more complex multistep preparation processes.
Radionuclide precursors: a marketing authorization (MA) is required to distribute a radionuclide from a production site to another institution that requires it as starting material for the production of a final radiopharmaceutical because it is defined as radionuclide precursor (Article 1 §9). This requirement is only reasonable for radionuclide precursors that are used in kit-like preparations where the final radiopharmaceutical is prepared in a simple compounding process. The requirement for a MA is not acceptable if a radionuclide is used as a starting material in a more complex preparation process. We need a clear distinction between radionuclide precursors for kit preparations and those for more complex processes [see enclosed; doi:10.1186/s41181-019-0074-3].
In-house, small scale preparation of radiopharmaceuticals (RPH): Many RPH must be prepared on-site at hospitals or research centers on a small scale due to short half-lives of radionuclides. This practice and their rather infrequent use makes industrial manufacturing and marketing authorization impractical. Directive 2001/83 exempts pharmacy practices from the scope of the directive (Article 3 §§1,2). However, due to the technical requirements and/or radioactive nature of such RPH, a pharmacy status is not always possible and not legally foreseen in some member states. We propose to widen the exemption of directive 2001/83 for RPH that are prepared on a non-routine basis to specific quality standards for individual patients. Such exemptions specifically for diagnostic RPH as Investigational Medicinal Products already exist in the Clinical Trials Regulation 536/2014.
The current legislation restricts the availability of products needed for the preparation of innovative highly efficient personalized medicine with high impact in cancer treatment. Hence it is a major hurdle preventing efficient implementation of EU initiatives like Europe’s Beating Cancer Plan, while the application of radiopharmaceuticals is not limited to that field of care. The Commission has well perceived the enormous potential of the medical application of ionizing radiation as shown in projects like “Rocc-n-Roll” developing a research roadmap (H-2020/NFRP-13)
Read full responseResponse to Europe’s Beating Cancer Plan
3 Mar 2020
The nuclear medicine community, represented through the European Association of Nuclear Medicine (EANM) highly appreciates the Beating Cancer Plan initiative. Many key aspects outlined in the road map are embraced by EANM, this especially includes access, equality and quality of life of our patients.
Regarding access and therewith connected inequality, EANM is deeply concerned by the fact that pharmaceutical companies do not convert all EMA-approved drugs into national dossiers throughout the European countries. This affects smaller European countries in particular, for which revenues are considered negative or too low either due to the size of the population and/or achievable prices for drugs. This is a strongly limiting factor that in addition puts patients from these countries at a major disadvantage. It furthermore increases the inequality between patients that are (economically) better off and those who are not in the position (financially or due to health restrictions) to travel abroad for their treatments. The second factor is the availability of hardware (e.g. scanners used for nuclear medicine procedures) which is still far from optimal in many parts of Europe, leaving cancer patients in certain European countries or regions without access to technology that is considered standard and state-of-the-art in current guidelines. This directly affects the quality of cancer care that can (or cannot) be granted to patients.
The nuclear medicine community is furthermore facing significant difficulties in daily patient care due to over-regulation and contradictory regulation. Nuclear medicine is an ever-evolving specialty with research in academic institutions being one of the key drivers that ensures even better and more personalized diagnosis and treatment of various disease including cancer. Until recently, these innovations could be used without major delay for the benefit of the patient without industry support for licensing. However, this development was curtailed by a recent EMA legislation (mandating that radiopharmaceuticals are seen as regular pharmaceuticals, which is clearly not a given as their characteristics and circumstances of use are very different).
Unfortunately, since nuclear medicine is considered a small “market” there is reluctance from industry to commercialize academic innovations towards approved products (for both therapeutic but even more for diagnostic use). In cases when the final phase of drug development is not led by a (big) pharma company, the process of making the drug available for use in patients is either extremely slowed down or stopped entirely. This increasing gap between academic development and development of approved products is limiting patients’ chances for potentially life-saving treatments.
On top of this, nuclear medicine is facing different and contradictory requirements issued through pharmaceutical directives and those mandated by the EU Basic Safety Standards for radiation protection.
The EANM and the wider nuclear medicine community would be grateful if access, equality and quality of life of patients would be addressed considering the above-outlined context.
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