supply of medical radioisotopes ipet 2015 - vienna october ... · 2015 medical isotope supply...

Supply of Medical Radioisotopes

IPET 2015 - Vienna October 10, 2015

Kevin Charlton

Nuclear Development Division OECD/NEA

[email protected] IPET 2015 : October 6, 2015

• 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

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• The NEA is a specialist agency of the Organisation for Economic Co-operation 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

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• 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 2009-2010 99Mo/99mTc supply shortage – which highlighted fragility of global supply

• HLG-MR Terms of Reference • Review the total 99Mo/99mTc 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 (2013-2015) and preparing for a fourth mandate (2015-2017)

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[email protected] IPET 2015 : October 6, 2015 5


• 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


• 1st Mandate HLG-MR: June 2009-2011 • 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


• 6-Policy Principles agreed to by all major 99Mo-producing countries

• All 99Mo/99mTc 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

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• 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

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• 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

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• 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 2016-17) • 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

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• Capacity projections (period 2015-2020) 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”

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• 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 99Mo 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

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Demand and Processing Capacity 2015-2020 Current demand (9 000 6-day Ci 99Mo/week EOP) and demand +35% ORC v processing

capacity – total and processing capacity – conventional only, 2015-2020: Scenario B

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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

2014 2015 2016 2017 2018 2019 2020

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NEA Demand growth (with no ORC) NEA Demand growth (+ 35% ORC)

Total processing capacity Total processing capacity conventional technology


• 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

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• On 6 February 2015, Natural Resources Canada announced adjusted plans for the NRU reactor that affected the potential supply of 99Mo supported by the CNL and Nordion • Subject to licencing approvals, NRU reactor to operate from 31 October 2016

to 31 March 2018 for non-99Mo purposes, so the NRU reactor would remain in “hot operation”

• Associated facilities required for 99Mo 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

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Potential NRU Contingency Capacity 2015-2020 Current demand (9 000 6-day Ci 99Mo/week EOP) and demand +35% ORC v

processing capacity – current and total, with and without NRU CC

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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

2014 2015 2016 2017 2018 2019 2020

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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


• 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

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• Future sustainability of 99mTc 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

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• 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

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The Supply of Medical Radioisotopes Series (11 reports) 2015 Medical Isotope Supply Review: 99Mo/99mTc Market Demand and Production Capacity Projection, 2015-2020 (August 2015)

Results from the Second Self-assessment by the Global 99Mo/99mTc 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 (2011-2013) (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)

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Thank You!

www.oecd-nea.org

All documents and reports are available at:-

www.oecd-nea.org/med-radio/docs

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http://www.oecd-nea.org/med-radio/docs





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