"Nuclear Medicine: The Osiris Reactor Must Be Prolonged"
Article published on 27th November, 2013
By Guy Turquet de Beauregard, President of the AIPES
AIPES COMMUNIQUE on November 8, 2013
Incidents in the Tc-m99 supply chain
You are probably aware of the HFR reactor delayed restart which occurred six weeks ago as well as coincidentally of the temporary stops of molybdenum processing facilities in The Netherlands(NRG licensed and Mallinckrodt operated) and South Africa(NTP).
The AIPES understands that, as early as within the next hours following these incidents, the companies involved have contacted their colleagues active in the field and, together, have initiated all possible necessary coordinated actions in order to mitigate the risks for the security of supply of the medical radio-isotopes. They have immediately informed their respective customers in the supply chain. All possible “Outage Reserve Capacity” is being activated wherever possible.
The AIPES and particularly the Reactors and Isotopes working group have been involved in an early stage in the communication towards the EANM, the European Community and other relevant associations. In order to ensure the optimization of the reactor schedule in relation with the last shutdowns at the “processor” level in South Africa and The Netherlands, the Emergency Response Team (ERT) has been conveyed on November 6, 2013, and is taking all possible additional mitigation actions.
The Executive Committee brings to the attention of the members that the communication towards their customers regarding the investigation programs and the timing for resuming operations will remain the responsibility of our members who have unfortunately been affected by the incidents.
We will keep you informed of any near future developments.
AIPES updates on mitigation of supply of medical radio isotopes
Brussels, 26 March 2013
The radiopharmaceuticals with Tc99m (Technetium) are used in the diagnosis of cancer, infections, heart and degenerative diseases because of its unique quality of providing functional imaging and information on the metabolism of the human body. Tc99m is derived from the production of Molybdenum 99 (Mo-99) as a side product of the irradiation of enriched Uranium in a limited number for nuclear research reactors across the world.
In its role as the facilitator of global communication and coordination of the availability of Mo-99 and its radiopharmaceutical daughter product Tc-99m, as mandated by the OECD High Level Group and the European Isotopes Observatory, AIPES is pleased to provide a general update on the status of Mo-99 production.
The European Isotopes Observatory was created jointly by the European Commission and AIPES (Association of Imaging Producers & Equipment Suppliers).
Since the HFR reactor in Petten, The Netherlands, went into unplanned shutdown in mid-November 2012, the European Isotope Observatory has met regularly to adjust the operating schedules and the production output of different reactors that have been available to take on this additional irradiation workload. This has included the addition of a series of reactor cycles in December to March 2013 by the MARIA Reactor (Poland), the adjustment of cycles by the by LVR-15 Reactor (Czech Republic) and a schedule adjustment of the OSIRIS Reactor (France). The additional output that was made available from these adjustments has been successful, and since November all nuclear imaging and therapy procedures required for patient treatment have been performed with no interruptions nor shortages. Because of this global effort to minimize impact to patient treatment, the availability of alternative production and the ongoing support of all stakeholders in the supply process, AIPES confirms that no significant shortage is anticipated for the period till the end of May 2013 and beyond.
All national nuclear safety agencies, local drug and regulatory agencies and research reactor operators have been involved in planning optimized operating schedules for the reactors for the whole of 2013 with the objective of maximizing reactor and Mo-99 availability. This is always done in compliance with the regulations for nuclear safety and taking account of technical and financial limitations. The uncertainty of an exact restart date of the production at the HFR reactor still remains and the current Mo-99 supply planning assumes that the HFR reactor will not restart before end of May 2013.
The local company producers and suppliers of Tc-99m generators will inform their own customers and the healthcare community in good time in the event of any possible localized and limited shortages during the last two weeks of May.
The European Commission and the Nuclear Medicine Industry have jointly created a European Observatory on the Supply of Medical Radioisotopes.
Brussels, 29 June 2012
Today the European Commission (http://ec.europa.eu/energy) and the European industrial association of Nuclear Medicine (AIPES) (www.aipes-eeig.org) have jointly set-up a European Observatory on the Supply of Medical Radioisotopes. Medical radioisotopes are routinely used to diagnose, enable and monitor treatments of a large variety of diseases including cancer, heart and degenerative diseases. Over 10000 hospitals worldwide use radioisotopes for the in vivo diagnosis or treatment of about 35 million patients every year, of which 9 million in Europe. Imaging using radioisotopes is often indispensable due to its ability to identify various disease processes early, long before other diagnostic tests. Technetium-99m (Tc-99m) is the most widely used diagnostic isotope. The production of Tc-99m is a complex process which includes irradiation of uranium targets in nuclear research reactors to produce Molybdenum-99 (Mo-99), extraction of Mo-99 from targets in specialised processing facilities, production of Tc-99m generators and shipment to hospitals.
Following the shortages of medical radioisotopes across the globe between 2008 and 2010 due to unplanned reactor shutdowns, the Council of the European Union (www.consilium.europa.eu) issued on 6 December 2010 Council Conclusions “Towards the Secure Supply of Radioisotopes for Medical Use in the European Union”, asking the European Commission to define a European solution for ensuring mid and long term security of supply of radioisotopes within the EU.
The first response to this request is the creation of the European Observatory on the Supply of Medical Radioisotopes, which role is to recommend strategies and policies for a sustainable and secure supply of medical radioisotopes to the decision makers in the EU, national governments, national and international official bodies, the medical community and the European industry, by gathering relevant and comprehensive information.
The European Observatory has the following general strategic objectives:
The Observatory will function through Working Groups on four issues:
The Observatory is composed by members coming from the European Commission and various industry stakeholders, who are key players in the Mo-99 production for medical purposes.
“It is a unique mixed panel of experts from the various competent Directorates-General of the European Commission (led by the Directorate-General for Energy (www.ec.europa.eu/energy) , the Euratom Supply Agency (www.ec.europa.eu/euratom) , working as one team with the relevant industry experts” explains Augustin Janssens, Chairman of the Observatory's Steering Committee.
“The Observatory is a primeur,” highlights Marc Gheeraert, president of AIPES and Co-Chairman of the Steering Committee, ”where European industry works hand in hand with the European Commission, the OECD/NEA and the European Association of Nuclear Medicine (EANM) (www.eanm.org) for the benefit of the health of patients in Europe and across the world.”
This European project is unique and has a global reach and responsibility, which will allow faster, more accurate and safer ways to detect, enable treatment of diseases as well as monitor their evolution.
The mission statement of the Observatory is available on the website: http://ec.europa.eu/energy/nuclear/radiation_protection/medical/doc/observatory_mission.pdf