pour la Mdecine Nuclaire Etat des lieux 52 me Colloque SFMNIM- St - PowerPoint PPT Presentation

Radionucléides pour la Médecine Nucléaire Etat des lieux 52 ème Colloque SFMNIM- St Etienne 15 Mai 2014 Guy Turquet de Beauregard, AIPES President

PLAN • ROLE de l’AIPES • GOUVERNANCE • Mo 99 PRODUCTION ORGANISATION • SCENARIOS POUR LE FUTUR

AIPES • Association Européenne des industriels de la médecine nucléaire basé à Bruxelles - Réacteurs, processeurs, radiopharmaceutiques, équipements et caméras TEP ou TEMP • 6 groupes de travail - Coordination des Réacteurs et processeurs - Affaires réglementaires pharmaceutiques - Affaires réglementaires nucléaires - Communication vers le public et les décideurs - Coordination avec le monde académique - Evaluation économique et sociétale

European

AIPES: Two Main Challenges in Nuclear Medicine Industry • Short- and long-term supply solutions for Mo-99 - Create the perennial conditions of Mo-99 supply in Europe and abroad • A viable economical and social model for SPECT or for PET - Review, create and secure rightful, sustainable and fair conditions - Create sustainable regulatory conditions for innovation and competitive healthcare system

PLAN • ROLE de l’AIPES • GOUVERNANCE • Mo 99 PRODUCTION ORGANISATION • SCENARIOS POUR LE FUTUR

Reactors  99 Mo producers  Distributors 99 Mo – 99m Tc : NRU GE HFR Nordion Covidien Covidien BR2 IRE MARIA Covidien • LMI OSIRIS LVR15 IBA/CIS bio SAFARI OPAL Uranium targets Road : 99 Mo extracted ANSTO NTP RA-3 Air : 99 Mo extracted CNEA

Key Steps on “Path to Reliable Supply” • Council of the EU : conclusions “Towards the Secure Supply of Radioisotopes for Medical Use in the European Union” • European Observatory : EU + AIPES • OECD/NEA steering committee support to six principles of the policy approach to ensure supply of Mo-99

The OECD HLG/MR Six Principles 1. All participants should implement full cost recovery including costs related to capital replacement. 2. Reserve capacity should be sourced and paid for by the supply chain. A common approach should be used to determine the amount of reserve capacity required. 3. Recognising and encouraging the role of the market, governments should: – Establish the proper environment for infrastructure investment; – Set the rules and establish the regulatory environment for safe and efficient market operation; – Ensure that all market-ready technologies implement full-cost recovery methodology; and – Refrain from direct intervention in day-to-day market operations as such intervention may hinder long-term security of supply. – Governments should target a period of three years to fully implement this principle, allowing time for the market to adjust to the new pricing paradigm.

The OECD HLG/MR Six Principles 4. Given their political commitments to non-proliferation and nuclear security, governments should provide support, as appropriate, to reactors and processors to facilitate the conversion of their facilities to low-enriched uranium (LEU) or to transition away from the use of highly enriched uranium (HEU), wherever technically and economically feasible. 5. International collaboration should be continued through a policy and information-sharing forum, recognizing the importance of a globally consistent approach to addressing security of supply of Mo-99/Tc-99m and the value of international consensus in encouraging domestic action. 6. There is a need for periodic review of the supply chain to verify whether Mo- 99/Tc-99m producers are implementing full-cost recovery and whether essential players are implementing the other approaches agreed to by the HLG-MR, and that the co-ordination of operating schedules or other operational activities have no negative effects on market operations.

European Observatory on Medical Radioisotopes Supply How: • Steering Committee: EU Directorate/Euratom/AIPES: Bring relevant information to decision-makers in EU • Four Working Groups (WGs): Four to six members – Reactor and processor scheduling – Full cost recovery: cost methodology, reimbursement process – Management of conversion from HEU to LEU – Mo-99/Tc-99m production capacity and infrastructure development

European Observatory on Medical Radioisotopes Supply WG 2: Full cost recovery methodology • Validate and foster the implementation of a full cost recovery methodology for European reactors’ network. • Alert European (local) health funding systems to provide appropriate funding for the use of medical radioisotopes to allow for the move to full cost recovery.

PLAN • ROLE de l’AIPES • GOUVERNANCE • Mo 99 PRODUCTION ORGANISATION • SCENARIOS POUR LE FUTUR

99 Mo - 99m Tc : une production mondiale à flux tendu • 99m Tc : radio-isotope le plus utilisé en médecine nucléaire  Monde : 35 millions d’examens/an  Europe : 8 millions d’examens/an • 3 étapes de fabrication nécessaires :  Irradiation de cibles d’uranium enrichi 235 U en réacteur  Séparation du 99 Mo  Fabrication/distribution de générateurs 99 Mo - 99m Tc • Production : 7 jours minimum • Utilisation : 10 jours maximum Séparation du 99 Mo Irradiation des cibles U Utilisation dans les hôpitaux Distribution des générateurs Mo-Tc 5-7 jours 1-10 jours 1-2 jours

50 research reactors produce various RI world wide Irradiations technologiques RUSSIE     HFR  MARIA  BR2 ! ! ! NRU LVR15  OSIRIS    !             Korea   Japan    Australia   OPAL SAFARI RA-3 : reactors used for fission 99 Mo market

Scénarios de production européenne du 99 Mo à moyen et long terme : 2016-2020 2020-2030

European

PLAN • ROLE de l’AIPES • GOUVERNANCE • Mo 99 PRODUCTION ORGANISATION • SCENARIOS POUR LE FUTUR

• NRG (Netherlands) has the objective of constructing and operating from 2024 a new reactor, PALLAS • The license of the OSIRIS (France) reactor expires end of 2015. • The new JHR reactor is under construction in Cadarache (France) • The Republic of Korea is working actively on a project to construct a new reactor KJRR and a new processing facility for the production of Mo-99. Start of production is expected in 2017: 2000 Ci ‘ 6- d’ per week.

• The FRM-II (Germany) reactor has a project to install new equipments for the irradiation of LEU targets from 2015, depending on the availability of LEU targets. • Russia and China are also developing additional irradiation and processing capacities. • Australia is building a new processing facility. Full production is expected to start in 2016, i.e. 3500 ‘ 6- d’ Ci per week.

Conclusions • La sécurité d’approvisionnement du 99 Mo est une question mondiale, mais avec des solutions de production régionales • La transparence des coûts de production de l’isotope le long de la chaîne de production est une nécessité afin d’établir une économie viable d’où l’importance du remboursement individualisé du radiopharmaceutique • Le désengagement du Canada, principal fournisseur actuel de 99 Mo, annoncé pour 2016, impactera l’approvisionnement mondial d’où la nécessité de prolonger Osiris • Après 2020 : 3 réacteurs de recherche coordonnés constituent un minimum pour assurer la continuité de production en Europe d’où l’importance des projets en construction (France, Corée et Russie) • Il faut conserver la gouvernance en Europe qui dispose des infrastructures, de l’expertise et d’un fonctionnement en réseau qui lui a permis de surmonter les périodes de pénurie 2008-2010 • La production de 99 Mo en réacteur demeure une solution robuste et irremplaçable au moins jusqu’en 2020, le cyclotron intervenant après