European nuclear trade association Foratom on 14 June released a position paper on, “Medical Uses of Nuclear Technology Role, Challenges & Perspectives”, urging the European Union (EU) to promote new research reactor capacity along with innovation in the sector and the design modification of the current fleet. The 24-page paper, issued jointly with Nuclear Medicine Europe, made a number of recommendations aimed at maintaining the current level of medical radioisotopes supply.

“Nuclear technology offers many different important applications apart from providing low-carbon electricity at an affordable cost. Nuclear medicine is one of them as it enables access to diagnostic and lifesaving treatments technologies”, said Foratom Director General Yves Desbazeille. “Although the EU is involved in the nuclear medicine sector and its developments, more has to be done to address the current challenges in order to maintain the edge that the EU enjoys today in this field globally.”

The position paper explains the technicalities of nuclear medicine, presents the scope of the current nuclear medicine sector in the European Union and highlights the challenges that have to be overcome both at regulatory and supply chain levels.

“The European nuclear medicine sector – like the wider nuclear industry – faces several challenges, from negative attitudes towards nuclear energy/radiation, uncertainty over funding in new nuclear energy capacity and management of nuclear waste. It has, however, also its own challenges, such as a regulatory system that needs improvement, sustainable reimbursement models and equal access to modern equipment and applications across all member states”, said Antonis Kalemis, President of Nuclear Medicine Europe. “We recommend that nuclear technology and its non-power applications should be better recognised and supported at EU level. We also call for an EU roadmap dedicated to nuclear medicine research and development.”

Foratom points out that 9 million patients in Europe benefit from nuclear medicine every year, while 1.5 million radiotherapy procedures for cancer therapy ae carried out annually. There are 100 such procedures that have been approved by health regulators and four of the six research reactors providing 95% of the world’s molybdenum-99 (Mo-99) or lutetium-177 production, are based in the EU.

The global nuclear medicine business in 2019 was estimated at €4 billion and is expected to grow to €7-10 billion by 2024. The therapy part of the overall business is poised to grow from a 12% to a 31% share of the total value. Market growth over the next decade will predominantly come from Positron Emission Tomography (PET) and Therapy with a sustained growth in Single-Photon Emission Computerized Tomography (SPECT) resulting in the need to ensure resilience in the Mo-99 (SPECT) infrastructure but also PET/Therapy which has vast R&D and advanced stage clinical trial pipeline.

The European nuclear medicine sector is currently facing a number of challenges, which may have a significant impact on its future role if no changes are implemented, Foratom noted. These challenges fall into two categories: supply chain investment needs and regulatory framework.

Supply chain investment challenges include:

  • Insufficient funds for investment in new capacity which may increase EU’s dependence on reactors in other parts of the world;
  • Market failures – including disincentives to private investment, lack of harmonisation and the ability to monitor and anticipate the need for public investment to assure security of supply in the absence of commercial production;
  • Supply chain challenges – including ageing of research reactors (need for new investment and long-term operation);
  • Need for investment in – and implementation of – additional innovative solutions for the management of used nuclear fuel and radioactive waste produced by research reactors; and
  • Production of some radioisotopes requiringes High-Assay Low Enriched Uranium (HALEU), delivered from limited stocks in either the US or from Russia.

Regulatory framework challenges include:

  • No clear level-playing field conditions for investment in nuclear technology at EU level;
  • Differences in approach towards internationally agreed policies by EU member states;
  • A complicated regulatory environment across the 27 member states which impacts innovation;
  • Inequalities in market access and reimbursement of nuclear medicine applications across different countries exacerbated by differing medicine regulations for each country;
  • The need for closer coordination among the national licensing authorities;
  • Negative attitudes towards the nuclear sector and misinformation that impact the future of nuclear medicine in the EU.

Foratom makes the following recommendations with respect to the supply chain:

  • The EU should promote new research reactor capacity along with innovation in the sector and the design modification of the current fleet to enable the production of some radioisotopes such as cobalt-60 or Lu-177.
  • The EU should reconsider reimbursement systems and levels for radiopharmaceutical products to ensure that irradiation sites are fully remunerated for the costs incurred.
  • The EU needs to develop a robust supply chain which goes beyond irradiation and includes the supply of target material and processing capabilities.
  • EU should reconsider and adapt clinical R&D of new radiopharmaceutical compounds as well as for application marketing authorisations or variations to authorised medical products.

With respect to the regulatory framework, Foratom recommends:

  • Better recognition and support for the role of nuclear technology and its non-power applications at EU level with relevant policies and legislation.
  • A quick implementation of the action identified in the SAMIRA Action plan ‘Research roadmap for medical applications of ionising radiation technologies;
  • EU support for the implementation and use of low enriched uranium for radioisotopes production;
  • Standardisation of market access, regulatory framework for the development of new medicines and reimbursement models for nuclear medicine applications across all member states;
  • Renovation of nuclear medicine equipment especially in EU periphery countries in order to allow similar levels of diagnoses across the entire EU;
  • Securing a level-playing field the development of all low-carbon technologies; and
  • Inclusion of nuclear in the EU Next Generation Recovery Plan & Industrial Strategy.