Twenty-seven countries where more than 500 million people live, with an average life expectancy of 78 years and speaking over 200 languages: that is the scale of the European Union. To regulate highly technical subjects, European Union authorities need and seek professional expertise and advice. Today, stakeholder engagement is a well-respected and integral part of EU decision-making processes. The European Union has chosen to institutionalize stakeholder participation, benefiting all parties. The involvement of private stakeholders in EU decision-making processes provides legislative and regulatory authorities with information on highly technical issues, ensuring that 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 maintains close contact with political and regulatory European authorities, including members of the European Parliament, European Commission directorates, and medical agencies, as well as with the media and patient associations.
Nuclear Medicine Europe is recognized as the primary 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 member state authorities in health and energy strengthens Nuclear Medicine Europe’s role in this field.
The clinical potential of molecular healthcare involves many aspects regulated by the EU. Nuclear Medicine Europe monitors daily the numerous European decision-making processes that impact member activity and patient wellbeing.
As part of the current imaging diagnostics revolution, Nuclear Medicine Europe enables the nuclear medicine and molecular imaging industry to provide the public with relevant and compliant information.
EU Observatory
On 29 June 2012, the European Commission and the European industrial association of nuclear medicine jointly established the European Observatory on the Supply of Medical Radioisotopes. Medical radioisotopes are routinely used to diagnose, enable, and monitor treatments for a wide variety of diseases, including cancer, heart disease, and degenerative diseases.
Over 10,000 hospitals worldwide use radioisotopes for in vivo diagnosis or treatment of approximately 35 million patients every year, of which 9 million are 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 that includes irradiation of uranium targets in nuclear research reactors to produce molybdenum-99 (Mo-99), extraction of Mo-99 from targets in specialized 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 Council Conclusions on 6 December 2010 titled “Towards the Secure Supply of Radioisotopes for Medical Use in the European Union,” asking the European Commission to define a European solution for ensuring medium and long-term security of supply of radioisotopes within the EU.
The first response to this request was the creation of the European Observatory on the Supply of Medical Radioisotopes, whose role is to recommend strategies and policies for a sustainable and secure supply of medical radioisotopes to decision-makers in the EU, national governments, national and international official bodies, the medical community, and European industry by gathering relevant and comprehensive information.
The European Observatory has the following general strategic objectives:
- Support secure Mo-99/Tc-99m supply for the medium and long term across the EU, taking into account worldwide need and supply
- Ensure that the Mo-99/Tc-99m supply issue is given high political visibility in international and national institutions, organizations, and bodies
- Encourage the creation of a sustainable economic structure of the Mo-99/Tc-99m supply chain by 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)
- Establish periodic reviews of the Mo-99/Tc-99m supply chain and capacities with all stakeholders across the EU, taking into account worldwide needs and supply capacities, and forecast future needs
The Observatory functions through working groups on four issues:
- Global reactor scheduling and Mo-99 supply monitoring
- Full-cost recovery mechanisms for 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 from the European Commission and various industry stakeholders who are key players in 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 first,” highlighted Marc Gheeraert, former president of Nuclear Medicine Europe (formerly 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 patient health in Europe and across the world.”
This European project is unique and has global reach and responsibility, enabling faster, more accurate, and safer ways to detect diseases, enable treatment, and monitor their evolution.
Communication Protocol
Process
- Mo-99 suppliers inform Nuclear Medicine Europe in case of any event affecting Mo-99/Tc-99m supply
- Nuclear Medicine Europe organizes an Emergency Response Team (ERT) meeting
- ERT sends its conclusions to the Joint Communication Team (JCT) and informs about possible impact (no impact, short-term, or long-term)
- JCT prepares a communication release to be agreed with the ERT
- JCT distributes the communication release via agreed channels
Emergency Response Team
To assess all potential shortage situations, mitigate them, and inform the healthcare supply chain in a coordinated and responsible manner, Nuclear Medicine Europe and the Security of Supply Working Group created a special unit in 2012 within the Security of Supply Working Group called the Emergency Response Team (ERT).
The ERT is composed of four representatives who are technically knowledgeable decision-makers, each representing reactors, processors, generators, and manufacturers respectively. They are elected by the representatives of Nuclear Medicine Europe members participating in the Security of Supply Working Group, and one 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 with members of the Security of Supply Working Group and transmitted to the Steering Committee of the European Observatory on the Supply of Medical Radioisotopes.
The role of the ERT is to share information about emergencies and identify plans to minimize impact. In addition, the ERT participates in planning exercises intended to identify potential obstacles that would prevent or delay the ERT’s efforts to minimize the impact of emergencies on Mo-99 availability.