Tc99m SHORTAGE WARNING

Association of Imaging Producers & Equipment Suppliers (1)

(European Industrial Association for Nuclear Medicine and Molecular healthcare)

AIPES in its role of global coordinator of the reactor schedules and crisis communication has the duty to inform that despite the tremendous effort of the Canadian engineers and staff, the NRU(2) reactor will not be operational before August 2010.

This situation, added to the current HFR(3) stop for repairs, will create two major shortage periods. The first one between May 15 ‐20, with nearly zero output of Mo99 from the current reactors, and the second one, with a very limited output from July 1st until July 20th.

This level of shortage has never been occurred before.

The Tc99m shortage will affect global patient scanning at the end of May and in the first three weeks of July. AIPES therefore recommends EANM, SNM and the national societies of Nuclear Medicine, after having requested more precise information from their local generator providers, to prioritize the necessary examinations.

AIPES and its members continue to work on the short, mid and long term solutions. As a result, three more research reactors are now producing Mo99 in 2010, while the BR2 (Belgium)(8), Osiris (France) and SAFARI (Republic of South Africa)(9) reactors deliver at maximum capacity.

AIPES and all medical, institutional and governmental stakeholders continue to work together to implement sustainable solutions that preserve the delivery of Tc99m in the near and long term future.

Technetium generator availability for Europe:

a representation of the future lack of supplies is indicated below

In the meantime, the OPAL (Australia)(4), Maria (Poland)(5) and REZ (Czech Republic)(6) reactors are producing Mo99, but their combined output is limited to 15 – 20 % of the world requirements.

The Executive Committee

(1): About AIPES: AIPES (Association of Imaging Producers & Equipment Suppliers) brings the major

pharmaceutical laboratories in nuclear medicine together with the major producers of medical equipments for this area of medicine, both multinationals and local medium size companies. In addition to its role as lobbyist to the European institutions for positive treatment of diagnostic imaging procedures at the European Commission, both in respect to reimbursement and regulatory constraints; its role as provider of a forum for addressing specific radiopharmaceutical issues similar to CORAR in the US and its role as an industrial partner to the European Association of Nuclear Medicine and any other European medical society that could help in the promotion of diagnostic imaging, AIPES has as its goal, to communicate to the public the medical potential and the latest technical developments in the field of nuclear medicine.

(2): About NRU: Since it began operation in 1957, the NRU reactor has made substantial contributions to the science, technology, energy, health and economy of Canada. Medical isotopes produced in NRU are used in the treatment and diagnosis of more than 20,000,000 patients around the world each year: a huge contribution to world health, and a significant Canadian export business.

(3) About HFR : The High Flux Reactor is the most prominent nuclear research facility in The Netherlands. It is an indispensable facility for the production of isotopes for the medical sectors, and during normal operation is able to cover more than 100% of European demand. In addition it plays a key role in international nuclear research projects, among which are projects on new fuels and materials for fission and fusion reactors. The HFR is presently closed for repairs, with scheduled restart in mid August 2010.

(4)About OPAL: OPAL is one of a small number of reactors with the capacity for the commercial production of radioisotopes. This capacity combined with the open pool design and operating utility, places OPAL among the best research reactors in the world. While OPAL is the centrepiece of ANSTO's research facilities, the suite of neutron beam instruments housed next to the reactor building represent a significant addition to ANSTO's research capabilities.

(5)About MARIA: Maria reactor is Poland's second research nuclear reactor and currently the only one still in use. It is also the only reactor of Polish design. It is located at Świerk-Otwock, near Warsaw. Maria is a multifunctional research tool, with a notable application in production of radioisotopes, research with utilization of neutron beams, neutron therapy, and neutron activation analysis. It operates about 4000 h annually, usually in blocks of 100 h.

(6)About REZ: The reactor LVR-15 is a light water tank type reactor with the thermal power 10 MW. The reactor uses IRT-2M fuel enriched to 36% of 235U and combined water-beryllium reflector. This core composition provides in the core maximum thermal neutron flux of 1.5x1018 n.m-2s-1 and maximum fast neutron flux of 3x1018 n.m-2s-1. LVR-15 operates in three-week cycles, usually 9-10 cycles per year. The main research projects are aimed to material testing. 5 water loops and several irradiation rigs are used for this purpose. Another significant use of the reactor is irradiation of samples for medical purposes and radio-pharmaceutical production. Some experiments, including clinical tests, were also done at the thermal column in the field of neutron capture therapy.

(7) About OSIRIS: OSIRIS is an experimental reactor located within the French Atomic Energy Commission (CEA) centre at Saclay, with a thermal power of 70 megawatts. It is a light-water reactor, open-core pool type, the principal aim of which is to carry out tests and irradiate the fuel elements and structural materials of nuclear power plants under a high flux of neutrons, to produce radioisotopes and semiconductors for the industry.

(8): About BR2: The BR2 Belgian reactor was first operated in January 1963. This Materials Testing Reactor is SCK•CEN's most important nuclear facility. It was operated during the past forty years within the framework of many international programmes concerning the development of structural materials and nuclear fuels for various types of nuclear fission reactors as well as for fusion reactor research.

(9): About SAFARI: SAFARI-1 is a tank in pool type reactor of Oak Ridge design which has a design power of 20 MW. The reactor's 9 x 8 core matrix contain 28 MTR type fuel elements and six control rods. The remaining lattice positions are either aluminum or beryllium reflector elements. The locally produced fuel elements consist of 19 flat plates constructed from uranium-aluminum alloy clad with aluminum A five-week operational cycle, which includes one shutdown week, is followed. In-core irradiation positions have neutron fluxes of ~2 x 1014 n.cm-2.s-1 at 20 MW and are primarily used for isotope production.