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Ref. Ares(2022)1438870 - 25/02/2022 Luxembourg, 30 March 2021 Mission statement Purpose The Observatory provides a platform for the stakeholders to discuss, monitor and support the EU supply of widely used medical radioisotopes with the focus on Mo-99/Tc-99m. The Observatory compiles the information provided and brings it further for decision makers in the EU, national governments, national and international official bodies, the medical community and the European industry in order to assist them to define strategies and policies of their implementation. The role of the European Observatory is not to take decisions. Background Following the Council Conclusions "Towards the Secure Supply of Radioisotopes for Medical Use in the European Union" adopted on 6 December 2010, the “European Observatory on the supply of medical radioisotopes” (“Observatory”) was jointly proposed in November 2011 and set-up in June 2012 by the European Commission and the industry organisation for Europe, AIPES (now renamed NMEu). The Observatory supports the security and sustainability of the supply in the EU. It follows the OECD/NEA principles established by the High-Level Group on Medical Radioisotopes (HLG-MR), focusing on their European specificities. Objectives The Observatory has the following objectives: (1) to support secure and sustainable medical radioisotope supply across the EU taking into account the worldwide need and supply; (2) to ensure that the medical radioisotope supply issue is given high political visibility in international and national institutions, organisations and bodies; (3) to identify any event or trend likely to impact the medical radioisotope supply, including logistics, and call relevant parties to take appropriate countermeasures; (4) to promptly disseminate through agreed communication channels the enquired information regarding any possible supply disruptions or other supply related issues; 1  (5) to establish periodic reviews of the medical radioisotope supply chain and capacities with all stakeholders across the EU, taking into account the worldwide need and supply, and to forecast future needs; (6) to build a foresight overview of the supply and demand of medical radioisotopes at EU level; (7) to acquire the latest information on the development and implementation of new and alternative methods and technologies of medical radioisotope production. Membership and working methods The Observatory brings together supply chain stakeholders (industry, research organisations and EU Member States), nuclear medicine organisations, members of NMEu, international organisations concerned as well as relevant Commission services and EU Agencies. Upon request, the Observatory may accept the membership of other EU-based stakeholders and organisations if approved by the chairs. Upon request, the Observatory could grant an observer status to other non-EU-based stakeholders and organisations relevant for the mission of the Observatory. The Observatory, if approved by the chairs, may invite other stakeholders, external organisations, policy-makers and academics to participate in the meetings as and when needed. A plenary meeting takes place at least once a year, unless otherwise decided. Ad-hoc meetings or working groups can be organised to deal with specific questions, should this be necessary. Scope For the purpose of the Observatory, the following core themes will be addressed: (1) Reactor scheduling and Mo-99 supply chain monitoring on a short, medium and long term basis; (2) Status of research reactors and processors conversion from highly enriched uranium (HEU) to low-enriched uranium (LEU) for medical isotope production; (3) Mo-99/Tc-99m capacity and infrastructure development, including transport and regulatory issues to find conditions conducive to the smooth supply of medical radioisotopes; (4) Development of alternative Mo-99/Tc-99m production methods; (5) The Observatory will review the scope forward looking as needed, taking into consideration recently widely used diagnostic as well as therapeutic medical radioisotopes (e.g. I-131 and Lu-177). Values and principles Work for public benefit - The European Observatory is committed to carrying out work, which could lead to evidence-based decision-making. Delivering results will be of the utmost importance. The European Observatory will seek and share information about those results. 2 Ref. Ares(2022)1438870 - 25/02/2022 Luxembourg, 30 March 2021 Terms of Reference European Observatory on the Supply of Medical Radioisotopes (Observatory) The legal basis of the Observatory is the Council Conclusions on “Towards the Secure Supply of Radioisotopes for Medical Use in the European Union”, adopted on 6 December 2010, to establish a mechanism at EU level in order to contribute to the coordination of reactor operating and maintenance programmes as well as processors’ and Tc-99m generators’ production schemes and adjustment and to regularly assess and forecast at EU level of the demand of Tc-99m, on the basis of information from national health authorities. Its mission is defined in the Mission Statement approved on 29/6/2021 during its plenary session. The Observatory works according to the following terms of reference: 1. Commitments: All the members and observers commit to: 1.1. taking any initiatives within its mandate to secure supply of radioisotopes for patient care in nuclear medicine; 1.2. complying with competition rules. All necessary precautions against potential competition infringements should be taken prior to adoption of relevant measures; 1.3. enabling each designated member or observer of the Observatory to contribute with relevant data and information dealing with its own domain of expertise or responsibility; 1.4. working in partnership with all stakeholders, governments and international organisations to describe comprehensively and to analyse radioisotope supply for health needs; 1.5. looking at EU and non-EU experience to support taking evidence-based decisions; 1.6. communicating effectively with policy-makers through a range of comprehensive, relevant data and reports; 1.7. taking into account all legal frameworks - especially for nuclear safety, waste management, nuclear non-proliferation, decommissioning and security. Commission européenne, 2920 Luxembourg, LUXEMBOURG - Tel. +352 43011 Office: EUFO 02/393 - Tel. direct line +352 4301-34294 2. Membership 2.1. The leading organisations are Euratom Supply Agency (ESA) and Nuclear Medicine Europe (NMEu), which provide the joined chairmanship and the secretariat for the Observatory. 2.2. The member organisations should be based in EU. 2.3. Applications from non-EU based organisations or state representatives having an observer status may be considered when duly justified by its relevance to the mission of the Observatory, subject to the consent of ESA and NMEu. 2.4. Each member organisation and observer can propose up to two individuals for potential participation in the meetings and work of the Observatory. ESA and NMEu will endorse these proposals and maintain the list of these individuals (Annex 1). 2.5. The participation of ESA and NMEu will reflect their roles in the work of the Observatory and will not be subject to the above limitation. 2.6. Any requests of the memberships or changes to the representatives of the member organisations to the Observatory are to be communicated in writing to ESA and NMEu in a timely manner. 3. Meetings and working methods 3.1. The Observatory holds up to two plenary meetings per year (unless otherwise decided) – alternatively organised in Luxembourg/Brussels hosted by ESA/NMEu and another location, hosted by one of the member organisations. 3.2. Due to specific circumstances, meetings can be organised virtually through digital means. 3.3. Ad-hoc meetings can be organised – by proposal of a member and upon agreement of ESA and NMEu - to deal with specific issues, should this be necessary. 3.4. The Observatory may create ad-hoc or permanent working groups to discuss specific topics. These working groups shall report to the Observatory. 3.5. ESA and NMEu decide, after consultation with other Observatory members, the dates and locations of plenary and other meetings, and provide the draft agenda. 3.6. The plenary meetings are chaired jointly by ESA and NMEu, who agree together on the Agenda. 3.7. Practical arrangements (meeting venue including equipment and catering) of plenary meetings, including their cost are taken care of by the organisation hosting the meeting. 3.8. Observers may participate to the information points on the agenda. ESA and NMEu may invite them to a discussion point if considered useful. Observers are not members and will not have the right to vote. 3.9 The Observatory provides two observer seats in the plenary meetings to the European Council working parties relevant for atomic questions and public health matters, to be represented by the Presidency of the Council of the EU. 2  3.9. ESA and NMEu may invite also other participants to the meetings, or individual item on the agenda, than nominated members, when considered needful. 3.10. If no nominated individual member is able to participate in a meeting, a substitute may be provided by the member organisation. This substitute should be communicated to ESA and NMEu in a timely manner prior to the meeting. 3.11. The decisions will in principle be taken by reaching consensus. If necessary, a simple vote will be taken and the result will require unanimous agreement by both chairs. 3.12. The draft minutes of meetings are provided by the secretariat for all the participants for comments. The final minutes are approved at the following meeting. 3.13. Document distribution is taken care by the Observatory secretariat with the means of European Commission’s CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens) platform1. 4. Special considerations 4.1. Any oral or written information exchanged between the members and/or the observers in the context of the Observatory activities are to be treated as confidential, unless otherwise stated. Each member or observer should maintain confidentiality of all such information, and without obtaining a consent of the member/observer concerned, it will not disclose it to any third parties, except for the information that is or will be in the public domain. 4.2. In order to avoid any issues under the anti-trust laws, members and observers will avoid discussing selling prices or other terms of sales (e.g. discounts, credit terms, delivery charges, etc.). Also, during the discussions and communications, members and observers will avoid mentioning elements like the allocation of customers, specific product strategies, sales territories, boycotts, refusal to deal. Members and observers will also avoid discussing costs or actions that they may want to take in the market (e.g. entering or exiting specific product/geographic markets, pricing actions, etc.). 5. Approval, validity, update 5.1. These Terms of Reference are approved at the plenary meeting of the Observatory. 5.2. These Terms of Reference are effective from 29 June 2021, and continue until terminated by agreement between the parties. 5.3. The Terms of Reference are to be updated when a need occurs, with the agreement of the member organisations. The update is drafted by the chairs and the secretariat and subsequently approved by the member organisations in the plenary meeting of the Observatory. 1 https://circabc.europa.eu 3  ANNEX I List of nominated individuals (example): Member of Member Organisation/Service Category Country Individual NMEu since (Y/N) Bernard Ponsard, Co-chairman Nuclear Medicine Europe Industry n/a BE (NMEu) Jocelyne Baldasso, Rapporteur NMEu – WG Awareness Industry n/a BE Philippe Van Put NMEu – WG Innovation Industry n/a BE Maria Martinez NMEu – WG Regulatory Industry n/a UK Helen Barker Affairs NMEu – WG Security of Industry n/a IR Ira Goldman Supply NMEu – WG Transport Industry n/a BE Gilles Degauque Experts Konrade von NMEu – EU Affairs Industry n/a BE Bremen International OECD/NEA - organisation Alberto Fernandez Fernandez SPF Economie Government BE Ira Goldman Lantheus Medical Industry IR Imaging (LMI) Arlena Kubiak Ministry of Climate Government PL Brendan Cuddy European Medicine EU Organisation NL Agency (EMA) 4 ANNEX II Nomination form Member organisation: Category: ☐ International organisation ☐ Government ☐ Industry ☐ EU Organisation ☐ Other (specify): Member of NM-EU: ☐ Yes ☐ No Address: Telephone: e-mail: Webpage: 5 Individual representatives: 1. Name Position Address Telephone e-mail 2. Name Position Address Telephone e-mail 6 Saatja: Webdesktop <[email protected]> Saadetud: 01.03.2022 18:00 Adressaat: SM Info <[email protected]>; Elen Ohov <[email protected]> Koopia: <[email protected]>; Ursula Tubli Brüsselis <[email protected]>; <[email protected]> Teema: Webdesktop: Kiri nr 14-4/217 / Esindajate nimetamine - European Observatory on the Supply of Medical Radioisotopes Tere!Edastan Euroopa Komisjoni kirja. Ühe varasema kirja järgi eeldan, et see on SoM teema, aga palun vaadake üle ja saatke veel edasi, kui vaja.Reg. number: 14-4/217Reg. kuupäev: 01.03.2022Sisu: Member nominations to the European Observatory on the Supply of Medical RadioisotopesHeade soovidegaTiiu [email protected]är, EV alaline esindus EL juures Saatja: Esindus EL juures üldaadress </O=ESTONIAN MINISTRY OF FOREIGN AFFAIRS/OU=EVM/CN=RECIPIENTS/CN=ESINDUSELJUURESYLDAADR> Saaja: Tiiu Noobel Teema: FW: Member nominations to the European Observatory on the Supply of Medical Radioisotopes From: BILAN Agnieszka <[email protected]> Sent: Friday, February 25, 2022 3:20 PM To: Esindus EL juures üldaadress <[email protected]> Cc: JACKSON Niina <[email protected]>; BARANCZYK Remigiusz <[email protected]> Subject: Member nominations to the European Observatory on the Supply of Medical Radioisotopes Dear Sir/Madam, Please find attached a letter concerning nomination requests for a Member/Observer to the European Observatory on the Supply of Medical Radioisotopes. Kind regards, European Commission EURATOM Supply Agency Euroforum Building 02/393A 1 rue Henri Schnadt L-2920 Luxembourg Tel: +352 4301 35190 E-mail: [email protected] <mailto:[email protected]> Ref. Ares(2022)1438870 - 25/02/2022 Euratom Supply Agency Director-General Luxembourg NOTE FOR THE ATTENTION OF MR AIVO ORAV HEAD OF THE PERMANENT REPRESENTATION OF ESTONIA TO THE EU Subject: Member nominations to the European Observatory on the Supply of Medical Radioisotopes I am writing to inform you about the European Observatory on the Supply of Medical Radioisotopes (the Observatory) and invite to nominate representatives of your Member State to participate in its work. The Observatory was established in 2012 by the European Commission and relevant stakeholders to support secure and sustainable supply of medical radioisotopes across the EU, initially of the most used diagnostic isotope Molibdenum-99/Technetium-99m, more recently also of other isotopes (e.g. Iodine-131, Luthetium-177). The Observatory has the following objectives:  to support a secure and sustainable medical radioisotope supply across the EU;  to ensure that the medical radioisotope supply issue is given high political visibility;  to identify any event or trend likely to impact the medical radioisotope supply;  to promptly disseminate the enquired information regarding any possible supply disruptions or other supply related issues;  to establish periodic reviews of the medical radioisotope supply chain and capacities across the EU;  to build a foresight overview of the supply and demand of medical radioisotopes at EU level;  to acquire the latest information on the development and implementation of new and alternative methods and technologies of medical radioisotope production. The Observatory is co-chaired by the Euratom Supply Agency (ESA) and the industry association Nuclear Medicine Europe (NMEu), and is composed of members from ESA, the relevant European Commission services and Agencies (e.g. European Medicines Agency, EMA), the European Association of Nuclear Medicine (EANM), international Office: 1, rue Henri Schnadt, L-2530, Luxembourg, EUFO 2393 – Correspondence: ENER.EEA, L-2920 Luxembourg e-mail: [email protected]  organisations (e.g. IAEA, OECD/NEA) and various industry stakeholders most of which grouped within NMEu. A plenary meeting takes place at least once a year, and ad-hoc meetings or working groups can be organised to deal with specific questions, should this be necessary. As of 30 March 2021, the Observatory has an updated Mission Statement and new Terms of Reference (ToR) to better define its way of operating. In the new context, the member organisations have been requested to formally send the nominations of the representatives. The EU Member States are also kindly invited to nominate their national representatives, which would greatly contribute to the work of the Observatory by bringing more national competencies, experiences and insights within the remit of the Observatory’s work. Therefore, we would be glad to receive a filled in Member Nomination Request Form in order to welcome the representative(s) of your country’s authorities (max. 2). The filled form is to be sent to [email protected]. Should you have any questions concerning the matter, please contact Remigiusz Barańczyk (Head of Sector) or Niina Jackson (Policy Officer). Agnieszka KAŹMIERCZAK Contacts: BARANCZYK Remigiusz, [email protected], tel. +352 4301 32998 JACKSON Niina, [email protected], tel. +352 4301 37204 Enclosures: Mission Statement Terms of Reference Observatory Member Nomination Request -form Electronically signed on 24/02/2022 16:19 (UTC+01) in accordance with article 11 of Commission Decision C(2020) 4482 Ref. Ares(2022)1438870 - 25/02/2022 Nomination request form (please fill in both pages) To be sent to [email protected] Member organisation: Category: ☐ International organisation ☐ Government ☐ Industry ☐ EU Organisation ☐ Other (specify): Member of NM-EU: ☐ Yes ☐ No Address: Telephone: e-mail: Webpage: Individual representatives: 1. Name Position Address Telephone e-mail 2. Name Position Address Telephone e-mail 2