Supply of Medical Radioisotopes. IPET Vienna October 10, Kevin Charlton Nuclear Development Division OECD/NEA

Transcription

1 Supply of Medical Radioisotopes IPET Vienna October 10, 2015 Kevin Charlton Nuclear Development Division OECD/NEA

2 Kevin Charlton Senior Analyst - Nuclear Energy Agency (NEA) of the OECD Secretariat - High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) Previous Experience in Medical Radioisotopes (since 1977) The Radiochemical Centre (TRC), England: became Amersham International plc: Radiopharmaceutical, Radioisotope, Radiochemical and Irradiation Source producer (now GEHC) Amercare Ltd, England: Glove Box systems for Nuclear Pharmacies Mallinckrodt Medical UK, England: Distributor of Medical Radioisotopes Mallinckrodt Medical BV, The Netherlands: Mo-99 Generator Producer NRG, The Netherlands: Operator of HFR Reactor Irradiator Vice Chairman of the AIPES Reactor and Isotope Workgroup 2

3 The NEA is a specialist agency of the Organisation for Economic Cooperation Development (OECD), an intergovernmental organisation of industrialised countries based in Paris The NEA MISSION - To assist its member countries in maintaining and further developing, through international co-operation, the scientific, technological and legal basis required for a safe, environmentally friendly and economical use of nuclear energy for peaceful purpose 3

4 The High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) was established at the request of NEA member countries, following the Mo/ 99m Tc supply shortage which highlighted fragility of global supply HLG-MR Terms of Reference Review the total 99 Mo/ 99m Tc supply chain from U procurement for targets to patient delivery identifying weak points and issues Recommend options to address the vulnerabilities to help ensure stable and secure supply of radioisotopes Work with supply chain participants to implement policy recommendations Now completing its third mandate ( ) and preparing for a fourth mandate ( ) 4

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6 and Argentina, Brazil and South Africa (NEA non-members) plus the EU and ESA and IAEA as participants Plus EANM, SNMMI, CARS, AIPES, CORAR, NANP and supply chain companies from reactors to nuclear pharmacy 6

7 1 st Mandate HLG-MR: June Assessed the factors making supply chain vulnerable Identified a classical market failure Economic structure unsustainable: does not support investment Potential shortages when current infrastructure reached end of life Developed 6-Policy Principles to help ensure future reliability of supply 7

8 6-Policy Principles agreed to by all major 99 Mo-producing countries All 99 Mo/ 99m Tc supply chain participants implement full-cost recovery (FCR) Reserve production capacity should be sourced and paid for by the supply chain (ORC) Governments should establish a proper environment for efficient and safe market operations, without intervening directly Government should help facilitate the conversion to low-enriched uranium by reactors and processors International collaboration should continue through a policy and information-sharing forum Periodically review the supply chain s progress towards economic sustainability and security of supply 8

9 Following self-assessments by market participants and stakeholders, an additional Joint Declaration on the Security of Supply of Medical Radioisotopes was agreed Provides a formal and co-ordinated political commitment of the 14 governments that have formally adopted the Joint Declaration to ensure implementation of the 6-policy principles Provides a common basis for producing and user countries, whether on a bilateral or multilateral basis, on their involvement in the supply chain New market entrant countries need to adopt and adhere to the Joint Declaration to ensure long term supply reliability 9

10 The existing supply chain participants have successfully met some difficult challenges in the last few years Despite some operational problems, supply has been maintained with only minor disruptions and in some countries Successfully meeting demand has been achieved by Better co-ordination and planning (AIPES R&I Workgroup) Supply chain diversification Active risk management activities More paid ORC held in the supply chain 10

11 Short to mid-term changes in production capacity Planned outage BR2 (BE) early-2015 to mid-2016 Exit of OSIRIS (F) at end-2015 Exit of NRU/Nordion (C) in late-2016 Now possible extension of NRU operation until early-2018 Commitment by European processors to convert to LEU (by ) Some possible associated capacity reduction Additional near-term capacity planned by existing supply chain ANSTO (AUS), triple LEU processing capacity by 2017 Addition of FRM II Reactor (DE), from 2018 Linked with European LEU target conversion Alternative and new technologies will contribute in the near term New OECD/NEA Demand and Capacity projection recently published 11

12 Capacity projections (period ) prepared for a number of scenarios for both irradiation and processing capacity Scenario A: Existing supply chain only (existing facilities) Scenario B: Technological challenges (Scenario A + qualified new projects) Scenario C: Project delays (Scenario B + 1 year delay) To assume additional delays is well justified, there was clear project timeline delay seen between this and the previous analysis (2014) Important Changes Substantial additional capacity added by some existing supply chain participants Anticipated LEU conversion effects reduced (down to -10%) Canadian announcement (February 2015) about potential change to NRU operational period and contingency capacity 12

13 Data collection process Analysis was at the Irradiator and Processor level, current irradiator and processor capacity tables were reviewed and corrected Retrospective % capacity-use data on a Quarterly basis was provided by most market participants for 2012, 2013 and 2014 Prospective new Irradiator and Processor project timeline plans were reviewed and collected in a single structured format and new tables developed Demand Total market demand for the last 3 years has been structurally lower (about 10%) than previously estimated:- 9,000 6-day Ci 99 Mo per week EOP Demand growth rate assumption unchanged from previous report This recent level of demand is supported by the near full market supply achieved in 2013 and 2014 during periods of substantial challenge 13

14 Demand and Processing Capacity Current demand ( day Ci 99 Mo/week EOP) and demand +35% ORC v processing capacity total and processing capacity conventional only, : Scenario B day curies 99 Mo EOP/6 month period Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec NEA Demand growth (with no ORC) NEA Demand growth (+ 35% ORC) Total processing capacity Total processing capacity conventional technology 14

15 Scenario B processing capacity technology challenges Even without all planned new processing projects being included, technology challenges processing capacity looks to be sufficient to meet the projected demand +35% ORC requirement, throughout the six-year forecast period The end of production in Canada in 2016 is partially offset by increased capacity in the existing fleet and additional capacity in Australia (2017) From 2017, the additive capacity from alternative technology projects primarily in the United States is progressive and quite substantial Scenario C projects delayed (1-year) Compared to scenario B, scenario C almost identical in 2015 and 2016 Capacity decreases in the Jan-June 2017 period because the scenario models a one-year delay of the additional Australian capacity After 2017 capacity recovers progressively, primarily due to the introduction of alternative technologies that have been delayed 15

16 On 6 February 2015, Natural Resources Canada announced adjusted plans for the NRU reactor that affected the potential supply of 99 Mo supported by the CNL and Nordion Subject to licencing approvals, NRU reactor to operate from 31 October 2016 to 31 March 2018 for non- 99 Mo purposes, so the NRU reactor would remain in hot operation Associated facilities required for 99 Mo processing would be kept in a hot standby mode for the same period Allowing NRU Contingency Capacity (NRU CC) to be made available under special conditions of market supply shortage The protocol for activating NRU CC if required are being discussed and established by a joint working group including AIPES, Canadian government, ESA and NEA 16

17 Potential NRU Contingency Capacity Current demand ( day Ci 99 Mo/week EOP) and demand +35% ORC v processing capacity current and total, with and without NRU CC day curies 99 Mo EOP/6month period Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec NEA Demand growth (with no ORC) NEA Demand growth (+ 35% ORC) Total processing capacity Current processing capacity Total processing capacity + NRU CC Current processing capacity + NRU CC 17

18 Overall, while the supply situation looks to be under control; it will continue to require careful and well considered planning to minimise security of supply risks A high degree of cooperation between the supply chain participants will continue to be essential for the foreseeable future The possible extension of the NRU operating period could be a useful stop-gap in the 2017 and early 2018 period, with the potential provision of substantial contingency capacity The market situation will require regular monitoring A regular review of progress in bringing the proposed new production capacity to market is essential 18

19 Future sustainability of 99m Tc SPECT imaging has not yet been achieved While Full Cost Recovery is increasingly being achieved in the early steps of the supply chain And Outage Reserve Capacity is being held and paid for at higher levels at many steps in the supply chain Some things still need to be done to ensure sustainability Full Cost Recovery has to be achieved throughout the supply chain A higher level of paid Outage Reserve Capacity must he held at all levels The true medical value of the product has to be fully recognised Sufficient reimbursement has to be made available Sufficient value must be successfully transfer back up the whole supply chain The supply chain must be able to invest 19

20 The sustainability of SPECT is important to PET, because SPECT and PET are complimentary and SPECT remains the backbone of Nuclear Medicine services The development of SPECT/CT, PET/CT and PET/MRI will continue to push forward the diagnostic value of Nuclear Medicine Nuclear Medicine is the original nanotechnology Equipment and targeting technology improvements will continue and will further the development of personalised medicine Both SPECT and PET remain undervalued and reimbursement is often set too low Important to understand the needs of a sustainable supply chain Necessary to improve the efficiency of use of medical isotopes Essential to promote the unique medical value of functional imaging Don t forget targeted isotope therapy 20

21 The Supply of Medical Radioisotopes Series (11 reports) 2015 Medical Isotope Supply Review: 99 Mo/ 99m Tc Market Demand and Production Capacity Projection, (August 2015) Results from the Second Self-assessment by the Global 99 Mo/ 99m Tc Supply Chain (July 2014) Progress and Future Challenges in Implementing the HLG-MR Policy Principles: Final Report of the Second Mandate of the HLG-MR ( ) (September 2013) Guidance documents (3 documents) Provision of Outage Reserve Capacity for Molybdenum-99 Irradiation Services (January 2013) Full-cost Recovery for Molybdenum-99 Irradiation Services (Feb 2012) 21

22 Thank You! All documents and reports are available at:- 22