27 countries where more than 500 million people live with an average life expectancy of 78 years and speak over 200 languages: that is how impressive the European Union is. In order to regulate very technical subjects, European Union Authorities need and seek professional expertise and advice. Nowadays, lobbyists are well respected stakeholders involved in EU-decision making processes. The European Union has chosen to institutionalize lobbying. This benefits everyone. The involvement of private stakeholders in the EU decision-making processes provide legislative and regulatory authorities with information over some highly technical issues. This guarantees that the wording included in final legislation reflects the balanced interests of all public and private stakeholders.
In addition to traditional players in the field of molecular medicine, Nuclear Medicine Europe stays in close contact with political and regulatory European Authorities (members of the European Parliament, of European Commission Directorates and Medical Agencies) as well as with the media and patient associations.
Nuclear Medicine Europe is recognized as the privileged interlocutor between the European Union and industry representatives in the field of radiopharmaceuticals, molecular imaging systems and related medical equipment. The growing interest of EU representatives and of Member States Authorities for Health and Energy strengthens the role of Nuclear Medicine Europe in this field.
The clinical potential of molecular healthcare involves many aspects regulated by the EU. Nuclear Medicine Europe daily monitors numerous European decision-making processes that impact member’s activity and patient wellbeing.
Being part of the current imaging diagnostics revolution; through Nuclear Medicine Europe, the nuclear medicine and molecular imaging industry wants to provide the public with relevant and compliant information.
On 29 June 2012, the European Commission and the European industrial association of Nuclear Medicine (NMEu) 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 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:
• to support secure Mo-99/Tc-99m supply for the medium and long term, across the EU taking into account the worldwide need and supply;
• to ensure that the Mo-99/Tc-99m supply issue is given high political visibility in international and national institutions, organisations and bodies,
• to encourage the creation of a sustainable economic structure of the Mo-99/Tc-99m supply chain through supporting the implementation of the full-cost recovery methodology developed by OECD/NEA High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR);
• to establish periodic reviews of the Mo-99/Tc-99m supply chain and capacities, with all stakeholders across the EU, taking into account the worldwide needs and supply capacities, and to forecast future needs.
The Observatory will function through Working Groups on four issues:
• global reactor scheduling and Mo-99 supply monitoring,
• full-cost recovery mechanisms for the Mo-99 supply in compliance with OECD/NEA HLG-MR policy principles,
• management of conversion from highly enriched uranium (HEU) to low-enriched uranium (LEU) for medical isotope production,
• Mo-99/Tc-99m capacity and infrastructure development.
The Observatory is composed of 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), the Euratom Supply Agency, working as one team with the relevant industry experts” explained Augustin Janssens, Chairman of the Observatory’s Steering Committee.
“The Observatory is a primeur,” highlighted Marc Gheeraert, former president of Nuclear Medicine Europe (ex-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) 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.
In order to be able to assess all potential shortage situations, to mitigate them and to inform the healthcare supply chain in a coordinated and responsible way, NMEu and the Security of Supply Working Group decided, in 2012, to create a special Unit inside the WG “Security of Supply” named “Emergency Response Team” (ERT).
The ERT is composed of 4 representatives which are technically knowledgeable decision makers each respectively emerging from reactors, processors, generators and manufacturers. They are elected by the representatives of NMEu Members that take part in the WG “Security of Supply”, one of them is elected as “head of the ERT”.
The head of the ERT reports to the Security of Supply Working Group and to the Executive Committee. The minutes of the ERT are shared by the members of the Security of Supply WG and transmitted to the Steering Committee of the “European Observatory Steering Committee for the Supply of medical radioisotopes” (“European Observatory”).
The role of the ERT is to share information about the emergency and identify plans to minimize the impact. In addition, the ERT participates in planning exercises.
These exercises are intended to identify potential obstacles that would prevent or delay the efforts of the ERT team in the process of minimizing the impact of the emergency on Mo-99 availability.