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

99Mo – 99mTc :

• LMI

OSIRIS BR2 HFR NRU SAFARI Nordion Covidien IRE NTP GE IBA/CIS bio Covidien

Uranium targets

Air : 99Mo extracted

Road :

99Mo producers  Distributors

Reactors 

Covidien MARIA OPAL ANSTO

99Mo extracted

LVR15 CNEA RA-3

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

• perational 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

99Mo - 99mTc : une production mondiale à flux tendu

• 99mTc : 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 235U en réacteur
• Séparation du 99Mo
• Fabrication/distribution de générateurs 99Mo - 99mTc
• Production : 7 jours minimum
• Utilisation : 10 jours maximum

Irradiation des cibles U Séparation du 99Mo Utilisation dans les hôpitaux Distribution des générateurs Mo-Tc 5-7 jours 1-2 jours 1-10 jours

SAFARI BR2 ! ! HFR

!

OSIRIS

! NRU

: reactors used for fission 99Mo market

OPAL

50 research reactors produce various RI world wide

Australia

           

Japan

    

Korea

           

MARIA LVR15 RA-3

Scénarios de production européenne du 99Mo 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

• f 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 99Mo 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 99Mo, 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 99Mo en réacteur demeure une solution robuste et

irremplaçable au moins jusqu’en 2020, le cyclotron intervenant après