Editorial   2010: CRISIS AND DECISION FOR NUCLEAR MEDECINE   The meaning of the word "crisis" in Greek is "decision" and it is clear that after the 2010 research reactor crisis for the European nuclear medicine industry, we now have a unique window for decision making in 2011. This is a one time opportunity. After having featured on the front-page of news media worldwide, the EU authorities (the Commission, the Parliament and the Council of Ministers) many governments, their agencies, EANM and many stakeholders, together with AIPES are now ready to  solve the two main challenges:   · The short and long term supply solutions for 'moly' or 99Mo' and · A viable economic model for the supply of 99mTc and radionuclides in general.  In its two study reports issued in 2010, OECD has acknowledged the significant contribution of AIPES and its members. OECD represents an independent voice in this debate but has highlighted the impractical and illogical economic market situation that currently exists for the supply of 99mTc supply. Many of the regulators in Europe now appear ready to change this situation and to implement radical solutions to improve this unsatisfactory situation.   Two avenues of approach are possible for us: · According to the authorities, the coordination between the research reactor operators in Europe has worked pretty well and this is mainly due to the efforts of the AIPES Reactor and Isotopes Working Group. However until now regulators and governments have not realized the severity of the industry's problem, the high level of costs involved and the organizational effort needed to overcome the structural problems. Some AIPES members believe that in order to have sufficient funding for future reactor operation and new constructions, as well as raising full awareness from all stakeholders about this supply issue. Only a public-private partnership will solve the problem.   In order to create such a system, agreement must be reached with a sufficient number of sponsors such as the European Commission, individual governments, EANM, nuclear reactor operators and probably the 99Mo processing companies. It is the duty of AIPES and its members to formulate a proposal that will support a long term and reliable structure for the 99Mo supply industry. This will be one of the major challenges that the AIPES membership will have to address in 2011. · Another challenge which is allied to the previous one is - the perennial and ongoing economic problem in nuclear medicine that radionuclide production costs have to support additionally four major cost items: 1. The expense of nuclear safety regulations, 2. The nuclear proliferation and security requirements, 3. The provisions for nuclear decommissioning 4. The disposal of radioactive waste.   Those costs do not arise in the conventional pharmaceutical industry but they impact on all parties involved in the supply chain of radionuclides. These are serious societal issues where fiscal compromises cannot be considered. In the overall procedure for reimbursement by Social Security (or Health Insurance) systems, only separate reimbursement of the radionuclide component can solve this inadequacy. This is what is applied with all procedures in other medical disciplines.   This concept of separate reimbursement has already received a good response from the European Presidency in 2010 and some government agencies.  Some scientific societies see this approach as the only way to show value on the specificity and unique features of our discipline. AIPES has been asked to come up with a proposition following the last EU meeting in Luxemburg.  EANM in particular is now fully convinced that this is the only solution in order to have the both appropriate coverage of nuclear costs and to foster innovation with cost effective new tracers.  Nuclear medicine is probably at a turning point in its history, AIPES together with its member companies must take the current opportunity to secure the future for nuclear medicine which has such a large potential in the healthcare landscape of the future.   The AIPES Executive Committee: Marc Gheeraert, President  Guy Turquet de Beauregard, Vice President  Jean Bonnet, Vice President Dewi M. Lewis, Vice President and Jocelyne Baldasso, Administrator   Programme of the AIPES Executive Committee  The research reactor crisis was the focus for AIPES and dominated the activities in 2010.   As in 2009, the AIPES Executive was invited to join the High Level Task Group which had been set up by the OECD to secure 'moly' production during the 2010 shortage and two AIPES executive members attended the OECD/NEA meeting in Paris in June 2010 (Jean-Pierre Cabocel and Guy Turquet de Beauregard). Later in the summer, OECD officially informed all stakeholders that as part of an on-going coordination role, efforts will be made by AIPES and its members to determine how best to address coordination of surplus supply, to ensure the availability of reserve capacity, and how best to communicate levels of available reserve capacity as an indicator of supply reliability.   The European Union organised several meetings and workshops during 2010, which were attended by the AIPES representatives. EMA workshop on clinical needs of raionuclides in February, DG-Energy workshop on proposed solutions in May and November.  AIPES submitted its position and recommendations to the Belgian Presidency concerning the future of the Mo99 production. The EU Commission submitted its conclusions to the European Council on "Securing supply of radioisotopes for medical use in the European Union."  These conclusions have been adopted by the EU Council at its meeting on Employment, Social Policy, Health and Consumer Affairs, early December 2010.    In May the annual meeting of the General Assembly of AIPES member companies was convened in Brussels; the AIPES programme was reviewed, the activities of the working groups were summarized, the accounts were approved and a new four-man Executive Committee was appointed. Jean Bonnet (Covidien) and Dewi M. Lewis (AAA and CERN) were nominated as new members of the Executive Committee.   The Executive Committee has agreed to develop closer contact with the individual nuclear medicine national societies in Europe. In June, AIPES gave presentations at the BELNUC Meeting in the Cliniques Universitaires Saint Luc in Brussels - one by Dewi Lewis on 99Mo supply and one on regulatory aspects of radiopharmaceuticals production and distribution by Jean Bonnet supported by consultant An Temmerman.   During the year, two new member companies joined AIPES - Guerbet S.A. who is an international contrast agent company based in Paris, France and Swan Isotopen A.G.  who is a radioisotope company based in Switzerland. Unfortunately during the year SkyScan of Belgium decided to leave the association.    AIPES represented the interests of it members in April and investigated the non-compliant sale of 18F Choline in Italy.   At the SNM Congress in Salt Lake City, AIPES Executives attended the annual international CORAR Meeting, a combined meeting between AIPES and EANM and a face to face AIPES Executive Committee was held.   In July, AIPES signed a cooperation agreement with JRIA (the overall Japanese radio isotope association: http://www.jrias.or.jp/index.cfm/11,3965,141,html) enabling JRIA to become an Associate Partner of AIPES.   EIBIR (European Institute for Biomedical Imaging Research) invited AIPES to join the PEDDOSE.NET scientific Advisory Board (a European FP7 programme dedicated to evaluating the potential health impacts of diagnostic imaging agent doses). Richard Zimmermann from IBA is the AIPES representative and participated at the first Advisory Board Meeting on October 2010 in Vienna.  This group is collecting all the information in this area with the idea to make these available to the whole nuclear medicine community by end of 2011 (www.peddose.net).   In addition AIPES has accepted the IMI proposal (Innovative Medicine Initiatives) to join the consortium and Marc Gheeraert will be the representative (www.imi.europa.eu)   The WFNMB (World Federation of Nuclear Medicine and Biology) has reorganised itself recently with a permanent office and to have all the standard activities controlled and run by a specialized company (Vereint) in Vienna.   AIPESmet with the  Vereint GmbH during the EANM Congress, to discuss the WFNMB activities and indicated that it was opposed to the further organisation of a world NM congress and exhibition, but on the contrary was supportive of organising trainings and promotional activities to increase awareness and development of nuclear medicine globally.   AT the European Congress in Vienna, a joint meeting was held between EANM and AIPES with EANM appearing enthusiastic on suggestions to collaborate on the AIPES new website dedicated to patients (www.whatisnuclearmedicine.com) with materials and translations into different EU languages through their national societies of nuclear medicine.   Activities of the AIPES Working Groups   Reactor and Isotope Working Group:   In February, AIPES issued a communication paper addressed to the EU authorities and all stakeholders involved in the Moly crisis, requesting that all relevant institutional and medical stakeholders be ready to work together to minimize the impact of the 99mTc shortage for the patients and recommending that each hospital and nuclear medicine department contact its local supplier company for detailed information on weekly/daily 99mTc availability and plan their patient scheduling accordingly.    In April, AIPES issued a press release stating that, due to the efforts made to cover the needs of 99Mo, member companies had secured reactor cycles at additional reactors for isotope production and that the reactor organisations at Maria (Poland) and Rez (Czech Republic) would be joining the AIPES working group.   In an AIPES communication to stakeholders in September, AIPES highlighted the fact that during the difficult year 2010, very significant support has been provided by new production from the MARIA reactor (Poland) and the LVR-15 reactor (Czech Republic). Also the SAFARI (South Africa) and the BR2 (Belgium) reactors have worked very hard to minimize the shortages that have occurred during this very critical period.  At its September working group meeting Working Group reviewed the reactor schedule until the end of 2010 and noted that there should not be any further severe shortages during this period.    The Reactor & Isotope and Associate Members Working Group nominated Bernard Ponsard of CSK/CEN (Mol, Belgium) as the new chairperson for a period of three years following the retirement of Bernard David (IRE, Belgium). In December.   Regulatory Affairs Working Group:   AIPES participated in the Workshop on "Current Use and Future Needs of Radiopharmaceuticals labelled with Radionuclides Produced in Reactors and Possible Alternatives" - organized by the EMA in London in February. The intention of this meeting was to assess which 99mTc procedures were essential and which could be replaced by other imaging methods.   AIPES  met with the French agency (AFFSAPS) in Paris on data matrix issue and the meeting resulted in an agreement to remove the data matrix exclusively for radioactive radiopharmaceuticals saving unnecessary costs on all packaging.   New Technologies Working Group:   A conference was organized in Brussels in February entitled "From Pharmaco-Economics to Health Technology Assessment (HTA): Can Radio Pharmaceuticals be HTA Compatible for Re imbursement?" with Konrade von Bremen as speaker.    A draft version of the White Paper on PET/SPECT CT was produced by the Working Group and was welcomed by the Directorate General for Research of the EU. A decision was taken for the paper to be finalised including market statistics for 1st March 2011 before being sent to the EU Commission for publication.   The group issued a "Pictorial View of Nuclear Medicine SPECT and planar scintigraphy":  (http://www.aipes-eeig.org/fileadmin/Sc_SPECT_V3.pdf).  Another Pictorial View on Therapy is under preparation and will be issued early Q2 2011.   Transport Experts Working Group:    The Working Group continued with its programme of lobbying for Transport considerations within one of the EU directives and worked also on limiting the denial of shipments by airline pilots.  Meetings were held with IAEA and the DG transport to improve transport regulations. Those issues were addressed also at the OECD meetings.   Nuclear Medicine Awareness Working Group:    In January the Nuclear Medicine Awareness Working Group met for the first time during a conference call and approved a draft mission statement and elected Hester Larkin (Lantheus Medical Imaging) as the chair of the Working Group.  This new Working Group recently set up by the AIPES assembly and has the task to provide all relevant information regarding the Nuclear Medicine and Molecular Imaging industry to all communities: European Union Commission, EU governments, drug agencies, physicians, patient groups and public in general. AIPES, through this Working Group, must also be able to provide the accurate scientific information to journalists that will relayed to the Press.    At the General Assembly in May, an initiative was approved to develop a website dedicated to inform the general public about nuclear medicine and including a 2 minute cartoon, explaining in simple terms what is nuclear medicine.   Other Activities in 2010   Marc Gheeraert gave a lecture at the First World Nuclear University School on Radioisotopes (16 May - 4 June 2010) to radioisotope professionals from 30 countries in Seoul, South Korea, during an extensive training programme.  Other faculty members were Werner Burkart, DG of the IAEA, Bernard Ponsard and Henri Bonnet.   AIPES was invited by the European Science Foundation in Strasbourg, France, in a Look Consensus Conference on 'Implementation of Medical Research into Clinical Practice' held at the Council of Europe.     An EU Workshop Report was published on the "Development of New Diagnostics" "Molecular Testing and Biomedical Imaging", as a result of a three-year project research; this was published by the Directorate for Health (RTD) and the AIPES contribution was given by Richard Zimmermann.   A paper by Dewi M. Lewis on "Alternative Methods for producing 99Mo" was published in the December issue of the Dutch Nuclear Medicine Journal.  In the same Journal, Richard Zimmermann (IBA Molecular) published an article on "Molybdenum-99 supply shortage: is cyclotron-produced Technetium-99m a realistic alternative?"   2011  Jean Pierre Cabocel has decided to terminate his duties of Director General of AIPES, effective 1st January 2011. For many years, Jean Pierre has been a pioneer in the Nuclear Medicine industry as well as  for our organization, before assuming the responsibilities of President during 6 years and becoming thereafter our Director General. We are all aware of all the numerous successes achieved by Jean Pierre since 1989, thanks not only to his scientific knowledge, but also to his determination and his ability to deal with technical issues, business entities and international authorities.  He will stay in contact with all of us and we will take any opportunity to involve him in any future projects for our organization.