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Future Supply of Medical Radioisotopes for the UK Report 2014

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Future Supply of Medical Radioisotopes for the UK Report 2014 Report prepared by: British Nuclear Medicine Society and Science & Technology Facilities Council. December 2014 1 Preface Technetium-99m (99mTc) is the principal radioisotope used in medical diagnostics worldwide. Current estimates are that 99mTc is used in 30 million procedures per year globally and accounts for 80 to 85% of all diagnostic investigations using Nuclear Medicine techniques. Its 6-hour physical half-life and the 140 keV photopeak makes it ideally suited to medical imaging using conventional gamma cameras. 99mTc is derived from its parent element molybdenum-99 (99Mo) that has a physical half-life of 66 hours. At present 99Mo is derived almost exclusively from the fission of uranium-235 targets (using primarily highly-enriched uranium) irradiated in a small number of research nuclear reactors. A global shortage of 99Mo in 2008/09 exposed vulnerabilities in the supply chain of medical radioisotopes. In response, and at the request of member states, the Organization of Economic Co-operation and Development (OECD) Nuclear Energy Agency (NEA) assembled a response team and in April 2009 formed a High-Level Group on the security of supply of Medical Radioisotopes (HLG-MR). The HLG-MR terms of reference are: to review the total 99Mo supply chain from uranium procurement for targets to patient delivery; to identify weak points and issues in the supply chain in the short, medium and long-term; to recommend options to address vulnerabilities to help ensure stable and secure supply of radioisotopes. The UK has no research nuclear reactors and relies on the importation of 99Mo and other medical radioisotopes (e.g. Iodine-131) from overseas (excluding PET radioisotopes). The UK is therefore vulnerable not only to global shortages, but to problems with shipping and importation of the products. In this context Professor Erika Denton UK national Clinical Director for Diagnostics requested that the British Nuclear Medicine Society lead a working group with stakeholders including representatives from the Science & Technology Facilities Council (STFC) to prepare a report. The group had a first meeting on 10 April 2013 followed by a working group meeting with presentations on 9th September 2013 where the scope of the work required to produce a report was agreed. The objectives of the report are: to describe the status of the use of medical radioisotopes in the UK; to anticipate the potential impact of shortages for the UK; to assess potential alternative avenues of medical radioisotope production for the UK market; and to explore ways of mitigating the impact of medical radioisotopes on patient care pathways. The report incorporates details of a visit to the Cyclotron Facilities at Edmonton, Alberta and at TRIUMF, Vancouver BC in Canada by members of the report team. Brian Neilly, December 2014. 2 Authors Brian Neilly, (Report Lead). Consultant Physician, Nuclear & Respiratory Medicine, Glasgow Royal Infirmary, Glasgow G4 0SF, Past-President BNMS, Chair Intercollegiate Committee Nuclear Medicine. Sarah Allen, Lead Clinical Scientist, Nuclear Medicine, Guys and St Thomas' NHS Foundation Trust, London SE1 9RT. Jim Ballinger, Chief Radiopharmaceutical Scientist, Nuclear Medicine, Guys and St Thomas' NHS Foundation Trust, London SE1 9RT. John Buscombe, Consultant Physician, Addenbrookes Hospital, Cambridge CB2 0QQ. Rob Clarke, Acting Head of Experimental Science Group, Central Laser Facility, STFC Rutherford Appleton Laboratory, Harwell Science and Innovation Campus, Didcot OX11 0QX. Beverley Ellis, Head of Radiopharmacy Services at Central Manchester and Manchester Children's University Hospitals NHS Trust, M13 9WL. Glenn Flux, Head of Radioisotope Physics at the Royal Marsden NHS Trust and Institute of Cancer Research, Sutton SM2 5PT. Louise Fraser: Specialist Scientist - Nuclear Medicine, Centre for Radiation, Chemical and Environmental Hazards, Public Health England, Chilton OX11 0RQ. Adrian Hall, Head of Radiopharmacy at the Royal Marsden NHS Trust, Sutton SM2 5PT. Hywel Owen, Lecturer in Accelerator Physics, School of Physics and Astronomy, University of Manchester, Manchester M13 9PL. Audrey Paterson, Professor and Past-Director of Professional Policy, The Society and College of Radiographers, London SE1 2EW. Alan Perkins, Professor of Radiological and Imaging Sciences, Medical Physics and Clinical Engineering, School of Medicine, Queen’s Medical Centre, Nottingham NG7 2UH. Andrew Scarsbrook, Consultant Radiologist & Nuclear Medicine Physician, Leeds Teaching Hospitals NHS Trust, Honorary Clinical Associate Professor, University of Leeds, Department of Nuclear Medicine, St James's University Hospital, Leeds LS9 7TF. 3 Stakeholders British Nuclear Medicine Society Public Health England (Formerly Health Protection Agency) Royal College of Physicians Royal College of Radiologists Royal College of Radiologists Patient Representative Science & Technology Facilities Council Society and College of Radiographers The initial meeting of the Medical Radioisotope Development Group took place in London on April 9th 2013 and was attended by the following: Stakeholder Representative(s) Department of Health Erika Denton, NCD Diagnostics Phillip Webster British Nuclear Medicine Society Brian Neilly, President BNMS Clinical Science Alan Perkins Public Health England Louise Fraser Molecular Radiotherapy Glenn Flux Patient representative Chris Wiltsher Royal College of Physicians John Buscombe Royal College of Radiologists Andrew Scarsbrook Pete Cavanagh Radiopharmacy Beverley Ellis, Jim Ballinger Science & Technology Facilities Council Barbara Camanzi Society and College of Radiographers Audrey Paterson Specialty Advisor Accelerator Science Hywel Owen Specialty Advisor Accelerator Research Susan Smith Specialty Advisor Nuclear Physics Ian Lazarus/John Simpson Specialty Advisor Laser Science Rob Clarke 4 Acknowledgements BNMS would like to thank Barbara Camanzi of the Science & Technology Facilities Council (STFC) for her help and encouragement with the project. Funding for the two meetings of the medical radioisotopes group was provided by the BNMS and by the STFC. Funding for the delegation to Canada (Chapter 8) was provided by the Global Partnership Fund of the Foreign and Commonwealth Office and by the STFC. BNMS wish to thank Aatif Baskanderi, Science, Innovation and Energy Officer of the British Consulate-General, Calgary, Alberta, Canada for his help securing the arrangements for the visit of the UK delegation to Edmonton and Vancouver. The BNMS also would like to thank the staff at the Medical Isotope and Cyclotron Facility, Edmonton and at TRIUMF, Vancouver for their time, consideration and openness during the delegation visit. Thanks also to Charlotte Weston for arranging the travel itinerary and the accommodation in Canada. Thanks to Bernard Ponsard for his input to Chapter 1 and his permission to reproduce Figure 1.4. 5 Table of Contents Future Supply of Medical Radioisotopes for the UK Report 2014 ..................... 1 Preface ....................................................................................................................................... 2 Authors ...................................................................................................................................... 3 Stakeholders .............................................................................................................................. 4 Acknowledgements ................................................................................................................... 5 Glossary of Terms ...................................................................................................................... 9 Executive Summary ................................................................................................................. 12 Recommendations................................................................................................................... 17 Chapter 1: The Molybdenum Supply Chain ............................................................ 19 1.1 Background ........................................................................................................................ 19 1.2 Global Demand for 99Mo/99mTc.......................................................................................... 20 1.3 The Molybdenum 99 Supply Chain .................................................................................... 22 1.3.1 Uranium Targets ........................................................................................................ 22 1.3.2 Nuclear Reactor Supply: ............................................................................................. 23 1.3.3 Processors .................................................................................................................. 25 1.4 Full-Cost Recovery and Outage Reserve Capacity ............................................................. 26 1.4.1 Full-Cost Recovery (FCR) ............................................................................................. 27 1.4.2 Outage Reserve Capacity (ORC) ................................................................................. 27 1.5 Future Demand and Supply ............................................................................................... 28 1.5.1 Present Global Irradiator Capacity ............................................................................. 28 1.5.2 Present Global
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