The scope covers all the EU countries hosting nuclear installations, including a specific focus on those used in radioisotope supply chains. Using a country-by-country approach, with detailed examples and case studies to illustrate the situation, the analysis (i) identify in detail the critical issues at stake; (ii) describe the main problems encountered, and the measures taken;(iii) assesses their effectiveness, highlight good practices and develop recommendations for future action:​

- Determine the key challenges influencing the availability of nuclear generation capacity under enduring or new pandemic conditions​,
- Identify the critical supply chains essential for safe operations and maintenance of the nuclear facilities​,
- Ascertain the near-term impacts on availability of fuel supplies,​
- Assess the economic impacts of the pandemic on the prospects of new and existing planned nuclear investment projects.

NucAdvisor contributed as a technical advisor for different due diligence projects over the past years, for major investments in either production installations or buyouts of radioisotopes and radiopharmaceutical players.​

Namely, NucAdvisor implemented the following tasks:​

- Evaluation of capital expenditures for future investment related to nuclear safety in medical radioisotopes and radiopharmaceuticals installations,​
- Evaluation of operational expenditures, including maintenance costs for radioisotopes production equipment,​
- Evaluation of industrial production efficiency,​
- Radioisotopes/Radiopharmaceuticals market analysis, including supply chain maps, strategic analysis of the main players, estimation of the market, demand and supply, analysis of the market risks from an investor point of view and development of market scenarios, etc.

An industrial player developing therapeutic radiopharmaceuticals with a Phase III trial expected to start within the next years, contacted NucAdvisor to get a review & assessment of the various options that exist in terms of the framework under which a Phase III, and therefore also commercial therapeutic RP product, can be manufactured. Focus is to be made on US and EU.​

Different options were assessed in detail, in terms of a pros and cons analysis, cost aspects, manufacturing locations, and other relevant parameters: ​

- Full outsourcing,​
- Build, own and run its facility,​
- Investment in an existing manufacturer for a dedicated suite & resources,​
- Revenue share approach,​
- Out-licence or in-license; etc.​

Additionally, the assessment considered the pros and cons of the therapeutic product being made from a kit-type format in decentralized radio-pharmacies, as opposed to the more commonly implemented centralised manufacturing model.

As part of the SAMIRA actions in the area of Quality and Safety of medical applications of ionising radiation, this study will contribute to supporting the implementation of high standards for quality and safety in Member States’ health systems. This study will specifically address the implementation of the Council Directive 2013/59/Euratom requirements for medical radiological equipment, concerning controlling, recording and reporting patients’ radiation exposures.​

​Main tasks implemented:​

- Collect and analyse up-to-date information on the implementation of the Council Directive 2013/59/Euratom requirements for medical radiological equipment, for controlling, recording and reporting of patients’ radiation exposures.​
- Develop best-practice guidance on the implementation of these requirements.​
- Discuss the results of the work with Member States, with the view of stimulating further national and EU-level efforts in this area.

The objective of this study was to provide the Commission with information on the diagnostic nuclear medicine market in the EU, focusing on 99Mo/99mTc generators. ​

In a fully complementary manner to the SAMIRA study, the SMER study focused upon :​

- Downstream part of the 99mTc supply chain: from the generators manufacturing up to the end-users, with a highlight on the Member States Health systems reimbursements and possible impacts on the sustainable supply of radioisotopes.​

- The efficiency of existing reserves in the use of 99mTc and focuses on how the different public health systems in the EU deal with diagnostic procedures based on the use of 99mTc, and how the organization of health care and the reimbursing scheme may affect the efficient and economically sustainable use of 99Mo/99mTc generators.

In early 2021, the Commission published a Staff Working Document on a Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA). The SAMIRA initiative is the energy sector's contribution to Europe's Beating Cancer Plan and a response to the Council’s conclusion on non-power nuclear and radiological technologies and applications. The SAMIRA Action Plan includes specific proposals in three priority areas: ​

- Supply of radioisotopes, ​
- Quality and safety of medical ionizing applications, ​
- Innovation in medical applications. ​

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The implementation of the SAMIRA Action Plan will require continuing support from EU budgets in the areas of Energy, Health and Research, with the objective of coordination and integration of activities across policy areas. The objective of this contract will be to ensure technical, scientific, administrative and logistical support to DG ENER for the implementation of the SAMIRA Action Plan.​

The objective of this study was to fill the gaps in the available information on the supply chains for the main established and novel radioisotopes that have, or are expected to have, significant uses in Europe. ​

This work paved the way for long-term European cooperation in this area. The study focused on:​

- The identification of currently used radioisotopes and those which are expected to be in use in the near future for medical and industrial applications,​
- The identification of existing and emerging methods and technologies for radioisotopes production, and an evaluation of corresponding supply chains for identified radioisotopes,​
- The analysis of current European supply chain players and their associated installations, and the identification of upcoming threats and limitations,​
- The development of scenarios and concrete options for a sustainable and secure supply of radioisotopes in the EU.​ Link to publication - https://op.europa.eu/s/xH3Q

NucAdvisor performed compliance audits in different radiopharmaceutical manufacturing sites (for PET, SPECT and therapeutic applications) to review its current regulatory status (national and international) and evaluate the capacity to maintain long-term compliance with nuclear regulatory requirements. The analysis included:​

- Evaluation of licensing situation (existing licenses, authorisations) to highlight the current limitations (e.g., expiry, renewal process, current licensing constraints, etc.)​
- Evaluation of radioactive waste management onsite and offsite​
- Evaluation of transport and logistics risks (e.g. record of radioactive materials, national nuclear transport regulation compliance)​
- Review of radiological protection processes for employees, members of the public and the environment (e.g., review of dose registries, staff incidents, ALARA strategy, etc.)​
- Review of past events (incidents and accidents), mitigation measures taken (if any), and emergency planning and preparedness considerations.​
- Evaluation of site considerations (e.g., site boundaries, physical security, etc.)​
- Review of internal safety organisation and safety documentation,​
- Review of internal inspection programmes results, corrective actions taken (if any) and their implementation.​

NucAdvisor supported a large industrial player in the enrichment sector to underpin their strategic vision by performing a strategic analysis of this business and propose recommendations leveraging existing government support (Europe and US) for building new capabilities, partnering (JV/ collaboration) or just be a supplier/customer.​

NucAdvisor analysis included:​

- For each potential partner and country, client wanted to understand what irradiation and or processing capability next to a reactor already exists. ​

- For each reactor (research or power ), client wanted to get general specifications and basic details plus openness to collaboration and partnerships, existing collaboration and partnerships, medical isotopes experience, irradiation capability, production and products, challenges and opportunities, and point of contact.​

- An evaluation of the global irradiated 176Yb processing capability: in which countries, which alignment, partnerships and customers? Which operating models? Which deployability, complexity, and chances of success. What about the same processing capability used to process other isotopes? Are modifications required?

The SAMIRA Action Plan foresees the establishment of a European Radioisotope Valley Initiative (ERVI) aiming, in the long-term, to maintain Europe's global leadership in the supply of medical radioisotopes, reduce dependencies on foreign suppliers and help accelerate the development and introduction of new radioisotopes and production methods.​

This study aims to define and evaluate the possible options for establishing the European Radioisotope Valley Initiative (ERVI), in line with the objectives proposed in the SAMIRA action plan. ​

In order to achieve this general objective, the study hereby procured will:​

- Develop six “ERVI projects” for further analysis.​

- Conduct feasibility studies of the ERVI projects.​

- Analyse the available options for establishing ERVI.​

- Develop an ERVI basic design.

NucAdvisor supported a large industrial player in PET radiotracer market to underpin their strategic vision by performing a strategic analysis of the European PET market business and its expected evolution over the next decade.​

NucAdvisor analysis included:​

- Pricing considerations in Europe for FDG, FCH and novel radiodiagnostic tracers like PSMA, FAPi and GRPR​

- Reimbursement considerations in Europe for PET tracers, including analysis of the public and private insurance schemes for different countries​

- Analysis of manufacturing and competitive considerations ​

- Analysis of PET radiodiagnostic products under development (i.e. exhaustive analysis of products under development), including Neurology​

- Evaluation of PET scanner installed base in Europe

The client is a private investment fund considering a large investment in an irradiation and processing plant.​

NucAdvisor analysis included:​

- Evaluation of current and future global demand per radiochemical and radiopharmaceuticals, including market prices and trends. This was performed through a mapping of diagnostic and therapeutic radiopharmaceuticals under development (market entry, mapping of clinical needs, cancer incidences, …)​
- Evaluation of irradiation and processing international landscape and competitive framework, including an evaluation of each player competitive position and likelihood of success for new projects​
- Evaluation of healthcare systems capabilities to sustain a global increase of radiopharmaceutical use over the next decades,​
- Analysis of business case, including preparation of new scenarios for market evolution, review of input parameters and long-term evolution.