Sustainability plan

Deliverable D7.6 Sustainability plan This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101008571 (PRISMAP). This document reflects only the view of the author(s). The Agency is not responsible for any use that may be made of the information it contains. Deliverable D7.6 ii Project Acronym PRISMAP Project Title The European medical isotope programme: Production of high purity isotopes by mass separation Grant Agreement No. 101008571 Topic INFRAIA-02-2020: Integrating Activities for Starting Communities Project start date 01 May 2021 Nature Report Dissemination level Public Due date M52 Date of delivery M56 Lead partner ILL Contributing partners CERN, SCK CEN Authors Thierry Stora (CERN), Ulli Köster (ILL) Reviewers Kirsten Leufgen (SCIPROM), Lucia Popescu (SCK CEN) Point of Contact Thierry Stora (CERN), Ulli Köster (ILL) E-mail [email protected] & [email protected] Phone +33476207154 © PRISMAP 2021. This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. Deliverable D7.6 iii Revision History Version Date Author Comment 0.1 10.11.2025 T. Stora First version 0.2 15.11.2025 U. Köster, T. Stora 2nd version 0.3 15.12.2025 U. Köster, T. Stora Integrated input from discussions at CM9 and statistics from D1.3 and D2.3 0.31 16.12.2025 U. Köster, T. Stora Ready for review 0.32 17.12.2025 L. Popescu Review 0.7 17.12.2025 K. Leufgen Review and formatting 0.8 17.12.2025 U. Köster, T. Stora Revisions to address the review comments, coordinator review 0.8.5 18.12.2025 K. Leufgen Review, formatting, version for review and approval by the general assembly 0.9 19.12.2025 P. Ulrich, K. Leufgen Inclusion of comments by the general assembly. Final review and formatting 1.0 22.12.2025 K. Leufgen Final version, approved by the general assembly Deliverable D7.6 iv Table of Contents Table of Contents iv! Abbreviations, Participant short names v! ... v! Abbreviations v! … v! Participant short names v! Summary 1! ... 1! // Keep this line in place. It is need to fix a Word-bug in the TOC. 1! 1.!Introduction 2! 2.!International and European context 3! 3.!Previous white paper 5! 4.!PRISMAP, a special INFRA project in H2020 6! 5.!Sustainability 8! 5.1!Sustainability of an emerging radionuclide 8! 5.2!Sustainability of producers of emerging radionuclides 9! 5.3!Sustainability of individual research projects 9! 5.4!Sustainability of the research community 10! 6.!Targeted INFRASERV call towards PRISMAP+ 11! 7.!ERVI process 13! 8.!Next steps: summary and outlook 14! … 15! References 15! ! !! Deliverable D7.6 v Abbreviations, Participant short names ... Abbreviations … CMIE Canadian Medical Isotope Ecosystem DoE Department of Energy, USA EESC European Economic and Social Committee ERVI European Radioisotope Valley Initiative ERVI-SCC ERVI Standing Coordination Committee IHI Innovative Health Initiative IPCEIs Important Projects of Common Interest JRIA Japan Radioisotopes Association MFF Multi Annual Financial Framework NFRF-T New Frontiers in Research Fund – Transformation PET Positron Emission Tomography RIPP Supply Platform of Short-Lived Radioisotopes SAMIRA Strategic Agenda for Medical Ionising Radiation Applications SME Small and medium size enterprises SPECT Single Photon Emission Computed Tomography TRL Technology readiness level USP User Selection Panel Participant short names CERN European organization for nuclear research NPL National Physical Laboratory PSI Paul Scherrer Institut CEA Commissariat à l’énergie atomique et aux énergies alternatives IST-ID Associação do Instituto Superior Técnico para a IST-ID Investigação e Desenvolvimento DTU Danmarks Tekniske Universitet CHUV Centre hospitalier universitaire vaudois GANIL Grand Accélérateur National d’Ions Lourds SCK CEN Studiecentrum voor Kernenergie / Centre d'étude de l'énergie nucléaire ARRONAX Groupement d’intérêt public ARRONAX ESS European spallation source ERIC TUM Klinikum rechts der Isar der technischen Universität München KULeuven Katholieke Universiteit Leuven Deliverable D7.6 vi MedAustron Entwicklungsund Betriebsgesellschaft MedAustron GmbH SCIPROM SCIPROM Sàrl MUI Medizinische Universität Innsbruck ILL Institut Max von Laue - Paul Langevin JRC JRC -Joint Research CentreEuropean Commission NCBJ Narodowe Centrum Badań Jądrowych GSI GSI Helmholtzzentrum für Schwerionenforschung GmbH LU Latvijas Universitāte INFN Istituto Nazionale di Fisica Nucleare UiO Universitetet i Oslo Summary ... // Keep this line in place. It is need to fix a Word-bug in the TOC. Sustainability aspects were taken into account from the outset of the PRISMAP project, with the overall objective being to establish the European medical radionuclides programme on a long-term. After approximately five years of implementing and developing PRISMAP, the European and international landscape, as well as that of nuclear medicine and radiopharmaceuticals, has evolved to a degree that far exceeds the most optimistic forecasts made when PRISMAP was first developed. In this document, we present the various aspects taken into account in the sustainability of PRISMAP, with an important milestone being the submission of a new PRISMAP+ project proposal aimed at providing a structure for the period 2026-2029, as a new phase of the European medical radionuclides programme, in order to connect with the evolving landscape of cutting-edge European research in nuclear medicine. Deliverable D7.6 2 1. Introduction The sustainability plan for PRISMAP and beyond is one of the important activities developed as part of our project over the last five years. It is part of the context of significant developments observed in the field of nuclear medicine itself and in the European landscape associated with research on unconventional medical radionuclides. While research on medical radionuclides has been supported for many years in the United States of America by the national isotope programme, centrally funded by the Department of Energy (DoE), efforts in this area have been lacking in Europe. The situation changed significantly when Europe launched the SAMIRA-ERVI initiative, with the aim of establishing a long-term framework for the supply chain of radionuclides and their safe use. While SAMIRA-ERVI was under development, PRISMAP had already taken sustainability-related elements into account, as outlined in a previous white paper [1]. PRISMAP will come to an end in 2025, and important conclusions can already be drawn to inform sustainability plans. Following a dedicated call for projects published earlier in 2025, the results of the PRISMAP+ proposal submission are pending, and their evaluation and implementation, planned to serve a growing user community in Europe, will form the basis for a longterm sustainable European medical radionuclides programme dedicated to research, development and innovation. In this regard, PRISMAP, PRISMAP+ and their successor programmes could be considered as successive phases of the European medical radionuclides programme, which we wish to continue in the long term. Deliverable D7.6 3 2. International and European context Nuclear medicine has witnessed important changes in recent years, notably with the advent of new radiotherapeutics used in combination with diagnostic companions, able to address a growing need in Europe and further, such as the radiopharmaceuticals Pluvicto® and Lutathera® marketed by Novartis, which have reached or are nearing the rank of pharma blockbuster with over 109 US$ annual sales. The number of clinical trials involving radiopharmaceuticals is rapidly growing. Some are based on new radionuclides introduced in the field, such as Pb-212, Ac-225 or Tb-161. Their mode of production involves a large spectrum of infrastructures and partners across the full supply chain. In this context, the resilient supply of medical radionuclides is strategic to enable research in the field and make Europe an attractive research area. The landscape in the USA is significantly different and more integrated, with an active and successful Isotope Programme which has been strongly supported by the DoE for the past decades and a significant acceleration in the last years. As already communicated, this programme will continue to receive increasing long-term support with strong financial commitment [3]. Other geographical regions, such as Canada or Japan, have different levels of integration. We could mention in this context the multi-institute consortium NFRF-T: New Frontiers in Research Fund – Transformation in Canada. The consortium comprises 15 institutes and the programme is funded for the period 2023-2029. In parallel, the Canadian Medical Isotope Ecosystem (CMIE) is backed by the Government of Canada’s Strategic Innovation Fund. It accepts project calls for innovation in the field of radiopharmaceutical and medical isotope technologies. Japan has benefited from different programmes, the best known being the Japan Radioisotopes Association (JRIA) and the Supply Platform of Short-Lived Radioisotopes (RIIP) for the provision of short-lived radionuclides [4,5]. In Europe, the Council and, more recently, the European Economic and Social Committee (EESC) have put forward recommendations and calls for action. The Council urged the Commission to act on five key pillars: ¡ Europe’s global leadership role in the supply of medical radioisotopes by making tangible and swift progress on the relevant identified actions; ¡ Monitoring and forecasting demand and supply for all relevant medical radioisotopes; ¡ Research and innovation on topics related to medical radioisotopes and other medical radiological technologies; ¡ Assessment and development of critical skills; ¡ Assessment of the framework for transporting radioisotopes for medical use in order to contribute to ensuring access for patients in all Member States. However, the most recent geopolitical developments and the initiatives following the new Commission's Political Guidelines, such as the proposal for amendments to the Cohesion policy instruments, the Competitiveness Compass, the REPowerEU Roadmap, the proposed reform of the Important Projects of Common Interest (IPCEIs) or the new Critical Medicines Act, could impact the conclusions of the ERVI report [6,7]. The Commission President issued Political Guidelines for the next European Commission (2024-2029). The Commission has issued its 2025 work programme, with a particular focus on the Competitiveness Compass, which is aligned with these Guidelines. With regard to reducing the EU's dependencies on imports for critical supplies, the EC President stresses, for instance: ¡ The importance of the future Critical Medicines Act to reduce dependencies relating to critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries and the importance of diversifying medicines supply chains. ¡ A new European Biotech Act would make it easier to bring biotech from the laboratory to the factory and then onto the market, as part of a broader Strategy for European Life Sciences, including providing the infrastructure and innovative laboratories the researchers need to test and develop ideas through new public-private partnerships, such as joint undertakings and strengthening University Alliances. ¡ The new Commission will revise the Public Procurement Directive, allowing for preferences to be given to European products in public procurement for specific strategic sectors. It will help ensure EU added value for our citizens, along with security of supply for vital technologies, products and services. Deliverable D7.6 10 ends, and a new phase needs to be proposed and started. This creates gaps during which users cannot be served, and they might get discouraged when the gaps are too frequent and too long. Such a less efficient stop-and-go situation should be avoided. Certain user groups do not have sufficient base financing of their research activities (i.e. to pay temporary personnel or consumables) to adopt new opportunities (here the use of emerging radionuclides) as soon as these become available. Instead, they have to integrate such options into their midterm research plans or submit dedicated research projects to their national funding agencies. The imposed timescales and deadlines of national base funding could often be incompatible with the frequency of calls for proposals from the shortterm phases of 3-4 years of the European medical radionuclide programme. This means that once national core funding has been approved and a doctoral or postdoctoral researcher has been hired, a PRISMAP followup funding phase that is too short-lived may already have come to an end. Therefore, a stop-and-go situation of the emerging radionuclide suppliers has to be avoided as this could harm the fundraising efforts of the user groups. Since the mechanisms of financing research are different in different EU countries, it would also contribute to equal opportunities for researchers from all countries if they could rely on having the European medical radionuclides programme still operating once their national research grant has been approved. The time horizon of the different phases should be extended sufficiently to provide a long-term stability of the services offered. There are examples of such long-lasting supports in Europe, where a proper framework should be defined. This helps improve efficiency of supporting the user projects and improve visibility in some countries that have not yet benefited from PRISMAP services. 5.4 Sustainability of the research community Long-term continuity and reliability are key requirements not only for individual research groups, but even more so for the entire research community using emerging radionuclides. This long-term commitment of regular supply is also a form of “supply security”, not yet for daily clinical use but to enable research towards new and improved radiopharmaceuticals that will provide patient benefit in the long run. Assuring this form of supply security cannot be left on the shoulders of individual producers, but is a broader public mission. The challenge for producers of emerging radionuclides can be compared to that of public transport: Established routes with high user demand are easily served by commercial operators. Even multiple operators (e.g. train, bus, plane) may coexist and all operate economically. However, for emerging routes with low or irregular user demand, an upfront planning of optimised transport capacities is more challenging or impossible, and economic self-financed operation of a new service cannot be guaranteed from its start. Imagine one intends to reduce individual car traffic by providing a new bus service. It will not be sufficient to schedule a few buses at the time of peak demand, but there must be sufficient options to return also late (when the bus is not full and might not operate economically) to build sufficient confidence in users that they can really live without their individual transport option. This process requires reliability of the proposed transport option and is a long-term commitment where the time scale may be many years until users change their lifestyle (and decide not to buy a new car). Such a long-term process can only be guaranteed via an initially public-subsidised operation of private bus lines. Long-term success should not be assessed by the direct economic return of this given bus line, but by the considerable indirect returns, in this example via a significant reduction of external costs (pollution, traffic jams, accidents, etc.), a more equal access to transport, etc. Similarly, the introduction of emerging radionuclides will mostly provide indirect returns, such as improved healthcare, the generation of a flourishing radiopharmaceutical industry, etc. but should not be judged by the short-term return for one given radionuclide producer. The example of Tb-161 has shown that, ultimately, user demand will reach sufficient scale to support economic production by commercial suppliers. However, without the upfront investment of academic actors (PSI, ILL, SCK CEN, etc.) into supplying research quantities, this radionuclide may never have reached this stage. Deliverable D7.6 11 6. Targeted INFRASERV call towards PRISMAP+ A call from the European Commission in Horizon Europe was published in May 2025. It has addressed the strategic needs of the Commission for research infrastructure services to enable Research & Innovation (R&I), addressing the main challenges and EU priorities, notably for services for access to novel radionuclides and facilities. As identified in the European Radioisotope Valley Initiative ERVI process, Horizon Europe is well-suited to fill the gap in the transition from Horizon Europe to the next funding framework programme which will be put in place by the European Commission in 2028-2034, within the so-called next Multi-Annual Financial Framework MFF. The INFRASERV call directed to a PRISMAP+ follow-up phase is meant to address the following needs from the ERVI programme, while a Strategic Research and Innovation Agenda would serve in setting the ERVI roadmap for research with medical radionuclides in the years to come, as shown in Table 1 below. Table 1. The HORIZON EUROPE INFRASERV call Objective Nature of funding Recipients ERVI eligibility, R&D&I strand 2 EU Framework Programme for Research and Innovation. Networking and coordination, research, innovation, pilot actions, market deployment actions, training and mobility actions, dissemination and exploitation of results, etc. The programme is implemented directly by the Commission or through funding bodies that the Commission designates as responsible. The programme may provide funding in the form of grants, prizes, procurements and financial instruments. Those eligible for European partnerships. Scientists and academics, research organisations, universities, industry, small and medium-sized enterprises, students, etc. PRISMAP+, CSA action to define an SRIA Future comprehensive Research &Development &Innovation program on medical radioisotopes The INFRASERV call HORIZON-INFRA-2025-01 was therefore addressing the following needs to sustain the European medical radionuclide programme in the coming years: ¡ Expand a network of world-leading European facilities, including nuclear reactors, accelerators and radiochemical laboratories, offering a broad catalogue of radionuclides for medical research, and offer researchers access to radionuclides and to the complementary biomedical facilities. ¡ This is supported along three pillars: ¡ the provision of high-purity radionuclides; ¡ associated research in biomedical facilities; ¡ supporting translational research and preclinical research techniques, either self-service or fully performed as a service. ¡ Investigating towards upscaling of the production of these novel radionuclides, in the form of novel production technology, new purification methods, and proof-of-concept investigations showing the development of new treatments from test bench to patient care. ¡ Monitoring and engagement with other initiatives supporting the EU SAMIRA. The Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA) contributes to Europe's Beating Cancer Plan, and responds to the EU Council's conclusion from 24 May 2019 on non-power nuclear and radiological technologies and applications action plan, in particular as regards the supply of novel (stable or radio-) isotopes and the development of innovative production methods, based on existing or new facilities. ¡ Proposals could consider the inclusion of the European Commission's Joint Research Centre (JRC) research infrastructure. Our PRISMAP+ proposal, furthering the European Medical Radionuclide Programme, federates a consortium of leading European institutes. Based on recommendations from the Council of Europe to consolidate the European Radioisotope Valley Initiative programme and associated R&D for medical radionuclides, and Deliverable D7.6 12 therefore to extend the successful PRISMAP programme, PRISMAP+ aims to coordinate access for biomedical researchers in Europe. It intends to extend the supply chain in geographical reach and scope from the maturing PRISMAP consortium, including intense neutron sources, charged particle accelerators (including new ones) and mass separation facilities (including new ones), and hosting researchers in our biomedical hubs extended to a larger geographical reach. Planned for 2026-2029, the access platform radionuclides.eu is intended to display relevant evolving information, manage the access in the project selection and publish relevant information as project outcomes and dissemination. Deliverable D7.6 13 7. ERVI process In 2021, the Strategic Agenda for Medical Ionizing Radiation Applications (SAMIRA) proposed the European Radioisotope Valley Initiative (ERVI) to strengthen Europe’s radioisotope supply chain. Its objectives include ensuring access to source materials for medical radioisotope production (through fission and alternative methods) while enabling domestic production to reduce reliance on foreign suppliers. ERVI also aims to improve efficiency and optimise industrial-scale production for greater security, flexibility, resilience, and sustainability. Finally, it promotes innovation by developing new production methods through networking and advanced research on innovative techniques and technologies of production. The ERVI Feasibility study was launched in 2023 and developed in continuous collaboration with stakeholders through regular discussion with the ERVI Steering Group [6]. The Feasibility Study encompassed 4 Tasks: In Task 1, six projects were identified as most relevant from a broad range of topics. These include establishing European facilities for enrichment and metallisation of uranium to secure HALEU (High-Assay Low Enriched Uranium) supply, producing stable isotopes, and creating irradiation capabilities for radioisotope production. Other priorities focus on developing a medium-sized accelerator network, improving access to radioisotopes for (pre-)clinical trials, and supporting research into new isotopes and production methods. Additional efforts will address supply monitoring and enhance European coordination to ensure a secure and sustainable medical radioisotope supply chain. In Task 2, the projects and actions underwent a multicriteria feasibility analysis, encompassing their technological, financial, market, organisational, and legal aspects. It was also shown that some ERVI actions could be practically integrated into existing initiatives, tools, or organisations, provided the links between ERVI and the respective organisations were strengthened. It was also demonstrated that an overarching ERVI structure is essential to maintain and monitor a coherent roadmap, coordinate and support the activities and ensure political alignment with ERVI stakeholders. This structure should facilitate access to existing European and Member State programmes, initiatives, and instruments for ERVI actions and projects and promote ERVI’s position within EU policy frameworks. Furthermore, it must anticipate potential changes to EC instruments and leverage opportunities offered by recent initiatives, such as the STEP Seal and new MFF tools. The proposal put forward in the study was to establish an “ERVI Standing Coordination Committee” (tentatively ERVI-SCC) to coordinate ERVI actions under the three ERVI Strands as they develop, and notably on strand 2 relevant for PRISMAP matters. Deliverable D7.6 14 8. Next steps: summary and outlook The proposal put forward in the ERVI study was to create a ‘permanent ERVI coordination committee’ (provisionally referred to here as ERVI-SCC) to coordinate ERVI actions as they develop, in the form of phased stages of a comprehensive European programme on medical radionuclides. The development and regular supply of radionuclides for biomedical research will benefit from an integrated R&D programme on radionuclides, such as that proposed by the PRISMAP+ phase. The organisation of geographical centres of excellence and thematic nodes will enable better access to research radionuclides throughout Europe. In addition, it will be easier to rationalise and meet changing needs and demands. The strengths of the European nuclear medicine and radiopharmaceutical landscape, which has enabled the introduction of new radiotherapy products into clinical practice, will be reinforced. The structured PRISMAP+ phase, followed by a long lasting European medical radionuclides programme, could also help to develop lasting links with other existing or developing global programmes in North America and Japan. In this way, the young, specialised and skilled workforce needed to form the basis of a sustainable user community will be able to promote rapid innovation and take this field into a new phase in Europe, building on our integrated and sustainable ten-year European medical radionuclides programme, which is better suited to the effective integration of Europe's cutting-edge research infrastructures. Deliverable D7.6 15 … References [1] PRISMAP sustainability white paper: towards PRISMAP+, T. Stora ed., https://zenodo.org/records/11448842 [2] White Paper on Emerging Facilities for Production of Novel Radionuclides for Use in Nuclear Medicine, L. Zanini Ed, https://zenodo.org/records/17553316 [3] https://science.osti.gov/-/media/budget/pdf/sc-budget-request-to-congress/2026/FY-2026-Isotope-RDand-Production-Budget-Request.pdf [4] Japan Radioisotopes Association (JRIA): https://www.jrias.or.jp/e/ [5] Supply Platform of Short-Lived Radioisotopes (RIIP): https://www.rcnp.osaka-u.ac.jp/~riip/index.html [6] ERVI: https://circabc.europa.eu/ui/group/8f5f9424-a7ef-4dbf-b914-1af1d12ff5d2/library/311d098ad6b4-4631-a040-d47a2bdf5f07 [7] “Feasibility study and further analyses of the legal, economic and organisational options for establishing European Radioisotope Valley Initiative (ERVI)” N° ENER/D3/2022-80