Esindaja nimetamine

Ref. Ares(2024)8927047 - 13/12/2024 SoHO COORDINATION BOARD (SCB): DECLARATION OF INTERESTS OF A MEMBER/ALTERNATE FROM EU MEMBER STATES’ AUTHORITIES Legal basis: Article 68(3) of Regulation (EU) 2024/19381 Definitions: "Conflict of interest" means any situation where an individual has an interest that may compromise or be reasonably perceived to compromise the individual’s capacity to act independently and in the public interest in relation to the subject of the work of the SoHO Coordination Board (SCB). "Immediate family member" means the individual’s spouse, children and parents. "Spouse" includes a partner with whom the individual has a registered non marital regime. "Children" means the child(ren) the individual and the spouse have in common, the own child(ren) of the individual and the own child(ren) of the spouse. "Legal entity" means any commercial business, industry association, consultancy, research institution or other enterprise whose funding is significantly derived from commercial sources. It also includes independent own commercial businesses, law offices, consultancies or similar. "Body" means a governmental, international or non-profit organisation. "Meeting" includes a series or cycle of meetings. *** In accordance with Art 68 (3) of the SoHO Regulation, Member States shall submit the names and affiliation of their nominated members and alternates, together with the corresponding declaration of interests for any member and alternate, to the SCB Secratiat. The nominated members shall represent the views and positions ensdoressed by the SoHO competent authority. To the end of determining existence of the conflic of interest, you are invited to answer each of the questions below. If the answer to any of the questions is "yes", please briefly describe relevant interests and circumstances, as appropriate. If you do not describe relevant interests, your DOI form will be considered incomplete and, therefore, you may not participate in the work of the SCB. Please note that having a declared interest does not necessarily mean having a conflict of interest. 1 Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC On the basis of this DOI template, Member States shall ensure toassess wether the conflic of instrest of the candidate exist and ensure that members and alternates that have no conflict of interest are nominated Please note that the DOI will be published by the Euopean Commission in accordance with Article 68(3) of SoHO Regulation. [Placeholder for a privacy statement] First name: Family name: Name of the Member States’s authority: Country Member/alternate of the SCB: [please specify] Date of first nomination: 1 EMPLOYMENT CONSULTANCY AND LEGAL REPRESENTATION Within the past 5 years, were you employed or have you had any yes no other professional relationship with a natural or legal entity, or held any non-remunerated post in a legal entity or other body with an interest in the field of SoHO or related fields of biotechnology, including a role within a tissue or blood establishment? 1a Employment   1b Consultancy, including services as an advisor   1c Non-remunerated post   1d Legal representation   Activity Time period Name of entity or Description (from… until body month/year) 2 2 MEMBERSHIP OF MANAGING BODY, SCIENTIFIC ADVISORY BODY OR EQUIVALENT STRUCTURE Within the past 5 years, have you participated in the internal yes no decision-making of a legal entity or other body with an interest in the field of SoHO or related fields of biotechnology, including a role within a tissue or blood establishment, or have you participated in the works of a Scientific Advisory Body with voting rights on the outputs of that entity? 2a Participation in a decision-making process   2b Participation in the work of a Scientific Advisory Body   Activity Time period Name of legal entity Description (from… until or body month/year) 3 RESEARCH SUPPORT Within the past 5 years, have you, or the research entity to which yes no you belong, received any support from a legal entity or other body with an interest in the field of SoHO or related fields of biotechnology? 3a Research support, including grants, rents, sponsorships,   fellowships, non-monetary support Activity Time period Name of legal entity Description (from… until or body month/year) 3 4 FINANCIAL INTERESTS Do you have current investments in a legal entity with an interest in yes no the field of SoHO or related fields of biotechnology, including holding of stocks and shares, and which amounts to more than 10,000 EUR per legal entity or entitling you to a voting right of 5% or more in such legal entity? 4a Shares   4b Other stock   Investment Name of legal entity Description 5 INTELLECTUAL PROPERTY Do you have any intellectual property rights that might be affected yes no by the outcome of the work carried out by the SCB? 5a Patent, trademarks, or copyrights   5b Others   Intellectual property Description 6 PUBLIC STATEMENTS AND POSITIONS 4  Within the past 5 years, have you provided any expert opinion or Yes no testimony in the field of SoHO or related fields of biotechnology, for a legal entity or other body as part of a regulatory, legislative or judicial process? Have you held an office or other position, paid or unpaid, where you represented interests or defended an opinion in the field of SoHO or related fields of biotechnology? 6a For a legal entity or other body as part of a regulatory,   legislative or judicial process 6b Represented interests or defended an opinion   Activity Time period Name of legal entity Description (from… until or body month/year) 7 INTERESTS OF IMMEDIATE FAMILY MEMBERS yes no 7a To your knowledge, are there any interests of your immediate   family members which could be seen as undermining your independence when participating in the works of the SCB? Interests Time period Name of legal entity Description (from… until or body month/year) 7b If interests of your immediate family members are declared, it is your responsibility to inform them about the collection and publication of information on their interests included in the DOI and to provide them with the privacy statement attached to the guidance for filling in this DOI, and this at the latest when you file the DOI form with the Commission. 5 8 OTHER RELEVANT INFORMATION yes no 8a Are there any other elements that could be seen as undermining   your independence when participating in the works of the SCB? Description: I declare on my honour that the information disclosed in this form is true and complete to the best of my knowledge. Should there be any change to the above information, including as regards upcoming activities, I will update this DOI and describe the changes in question. I am informed that my personal data are stored, processed and published by the Commission in accordance with Regulation (EU) 2018/17252 and Regulation (EU) 2024/1938. I have been provided with the corresponding privacy statement which provides further information on how the Commission processes my personal data. Date: ________________ Signature: ________________________________ ***** In accordance with Article 68(3) of Regulation (EU) 2024/1938, your DOI form shall be made publicly available on the EU SoHO Platform, as long as you are appointed to the SCB. Technical measures will be taken to indicate to search engines that your DOI form should not appear in search results. 2 Regulation (EU) 2018/1725 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data. 6 SoHO COORDINATION BOARD (SCB): DECLARATION OF INTERESTS OF A MEMBER/ALTERNATE FROM EU MEMBER STATES’ AUTHORITIES Legal basis: Article 68(3) of Regulation (EU) 2024/1938 Definitions: " Conflict of interest " means any situation where an individual has an interest that may compromise or be reasonably perceived to compromise the individual’s capacity to act independently and in the public interest in relation to the subject of the work of the SoHO Coordination Board (SCB). " Immediate family member " means the individual’s spouse, children and parents. "Spouse" includes a partner with whom the individual has a registered non marital regime. "Children" means the child(ren) the individual and the spouse have in common, the own child(ren) of the individual and the own child(ren) of the spouse. " Legal entity " means any commercial business, industry association, consultancy, research institution or other enterprise whose funding is significantly derived from commercial sources. It also includes independent own commercial businesses, law offices, consultancies or similar . " Body " means a governmental, international or non-profit organisation. " Meeting " includes a series or cycle of meetings. *** In accordance with Art 68 (3) of the SoHO Regulation, Member States shall submit the names and affiliation of their nominated members and alternates, together with the corresponding declaration of interests for any member and alternate, to the SCB Secratiat. The nominated members shall represent the views and positions ensdoressed by the SoHO competent authority. To the end of determining existence of the conflic of interest, you are invited to answer each of the questions below. If the answer to any of the questions is "yes", please briefly describe relevant interests and circumstances, as appropriate. If you do not describe relevant interests, your DOI form will be considered incomplete and, therefore, you may not participate in the work of the SCB. Please note that having a declared interest does not necessarily mean having a conflict of interest. On the basis of this DOI template, Member States shall ensure to assess wether the conflic of instrest of the candidate exist and ensure that members and alternates that have no conflict of interest are nominated Please note that the DOI will be published by the Euopean Commission in accordance with Article 68(3) of SoHO Regulation. [Placeholder for a privacy statement] First name: Family name: Name of the Member States’s authority: Country Member/alternate of the SCB: [please specify] Date of first nomination: 1 EMPLOYMENT CONSULTANCY AND LEGAL REPRESENTATION Within the past 5 years, were you employed or have you had any other professional relationship with a natural or legal entity, or held any non-remunerated post in a legal entity or other body with an interest in the field of SoHO or related fields of biotechnology, including a role within a tissue or blood establishment ? yes no 1a Employment o o 1b Consultancy, including services as an advisor o o 1c Non-remunerated post o o 1d Legal representation o o Activity Time period (from… until month/year) Name of entity or body Description 2 MEMBERSHIP OF MANAGING BODY, SCIENTIFIC ADVISORY BODY OR EQUIVALENT STRUCTURE Within the past 5 years, have you participated in the internal decision-making of a legal entity or other body with an interest in the field of SoHO or related fields of biotechnology , including a role within a tissue or blood establishment, or have you participated in the works of a Scientific Advisory Body with voting rights on the outputs of that entity? yes no 2a Participation in a decision-making process o o 2b Participation in the work of a Scientific Advisory Body o o Activity Time period (from… until month/year) Name of legal entity or body Description 3 RESEARCH SUPPORT Within the past 5 years, have you, or the research entity to which you belong, received any support from a legal entity or other body with an interest in the field of SoHO or related fields of biotechnology ? yes no 3a Research support, including grants, rents, sponsorships, fellowships, non-monetary support o o Activity Time period (from… until month/year) Name of legal entity or body Description 4 FINANCIAL INTERESTS Do you have current investments in a legal entity with an interest in the field of SoHO or related fields of biotechnology , including holding of stocks and shares, and which amounts to more than 10,000 EUR per legal entity or entitling you to a voting right of 5% or more in such legal entity? yes no 4a Shares o o 4b Other stock o o Investment Name of legal entity Description 5 INTELLECTUAL PROPERTY Do you have any intellectual property rights that might be affected by the outcome of the work carried out by the SCB? yes no 5a Patent, trademarks, or copyrights o o 5b Others o o Intellectual property Description 6 Public statements and positions Within the past 5 years, have you provided any expert opinion or testimony in the field of SoHO or related fields of biotechnology , for a legal entity or other body as part of a regulatory, legislative or judicial process? Have you held an office or other position, paid or unpaid, where you represented interests or defended an opinion in the field of SoHO or related fields of biotechnology ? Yes no 6a For a legal entity or other body as part of a regulatory, legislative or judicial process o o 6b Represented interests or defended an opinion o o Activity Time period (from… until month/year) Name of legal entity or body Description 7 Interests of immediate family members yes no 7a To your knowledge, are there any interests of your immediate family members which could be seen as undermining your independence when participating in the works of the SCB? o o Interests Time period (from… until month/year) Name of legal entity or body Description 7b If interests of your immediate family members are declared, i t is your responsibility to inform them about the collection and publication of information on their interests included in the DOI and to provide them with the privacy statement attached to the guidance for filling in this DOI, and this at the latest when you file the DOI form with the Commission. 8 Other relevant information yes no 8a Are there any other elements that could be seen as undermining your independence when participating in the works of the SCB? o o Description: I declare on my honour that the information disclosed in this form is true and complete to the best of my knowledge. Should there be any change to the above information, including as regards upcoming activities, I will update this DOI and describ e the changes in question. I am informed that my personal data are stored, processed and published by the Commission in accordance with Regulation (EU) 2018/1725 and Regulation (EU) 2024/1938. I have been provided with the corresponding privacy statement which provides further information on how the Commission processes my personal data. Date: ________________ Signature: ________________________________ ***** In accordance with Article 68(3) of Regulation (EU) 2024/1938, your DOI form shall be made publicly available on the EU SoHO Platform, as long as you are appointed to the SCB. Technical measures will be taken to indicate to search engines that your DOI form should not appear in search results. Saatja: [email protected] <[email protected]> Saaja: Marten Kokk, [email protected], Agne Nettan-Sepp, Kadi Avingo, BAERT Katleen, VAN DER SPIEGEL Stefaan, Esindus EL juures üldaadress Teema: Nomination of members for the SOHO Coordination Board (SCB) _ to Estonia Our Ares Ref: (2024) 8927047 Dear Ambassador Kokk, Please find enclosed a letter regarding the nomination of members for the SOHO Coordination Board (SCB) as stipulated in the recently adopted Regulation (EU) 2024/1938 on safety and quality of substances of human origin. Thank you for your attention. Sincerely Secretariat D2 [cid:[email protected]] European Commission Directorate-General for Health and Food Safety – DG SANTE Unit D2 – Medical products: quality, safety, innovation 101 rue Froissart / B-1049 Brussels/Belgium EUROPEAN COMMISSION DIRECTORATE GENERAL FOR HEALTH AND FOOD SAFETY The Director-General Brussels, SANTE D2/KB/eb/(2024)9962963 Your Excellency, Subject: Request for the nomination of members of the SoHO Coordination Board (SCB) I am writing to you regarding the nomination of members and alternates to the newly established SoHO Coordination Board (SCB) following the adoption of Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin (SoHO) intended for human application. The role of the SCB is to promote and support coordination between Member States concerning the implementation of the SoHO Regulation, as well as to facilitate cooperation with stakeholders in that regard. The tasks of the SCB include documenting best practices on the implementation of SoHO supervisory activities and conditions for compensation, providing advice on whether the SoHO Regulation applies and providing opinions on the regulatory status for inclusion in the SoHO Compendium, setting indicative criteria for ‘critical SoHO’ and for ‘critical SoHO entities’, providing support for joint oversight activities related to inspections and to the assessment of SoHO preparation processes, supporting the Commission on the specifications for the SoHO platform and supporting the coordination during emergencies. Art 68(2) of the SoHO Regulation specifies that each Member State shall appoint two permanent members and two alternates representing the SoHO national authority and, where the Member State chooses so, the Ministry of Health or other relevant authorities. The SoHO national authority may nominate members from other SoHO competent authorities. Appointed members shall nevertheless ensure that the views and suggestions they express are endorsed by the SoHO national authority. I herewith invite your Member State to submit, in accordance with Art 68(3) of the SoHO Regulation, the names and affiliation of your nominated members and alternates, together with their corresponding declaration of interests. To this end, a form for the declaration of interests is Annexed to this letter. Member States shall nominate only members and alternates who do not have such conflicts. Please note that the Commission will make publicly available, on the EU SoHO Platform, the membership list, including the name, the institution of origin and the declaration of interests. To all Deputy Permanent Representatives of the EU Member States Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË The SCB will start its activities in early 2025 and will gradually take over the activities related to blood, cells and tissues currently performed by the Competent Authorities on Substances of Human Origin Expert Group (BTCO), including the activities performed by its sub-groups on vigilance (VES), inspections in blood, cells and tissues (IES), and coding of tissues and cells (CES). Therefore, the SCB could be composed, for example, of members with a profile similar to the members of the Expert Group BTCO. The members of the SCB will actively contribute to the above-mentioned tasks and should therefore be selected for their competence and experience in the field of SoHO. The composition of the SCB should be balanced to allow discussions of technical, policy and legal nature, in order to contribute to the work of the SCB and its sub-groups. It should be noted that members of the SCB will have the responsibility to disseminate information and documentation shared with the SCB members to other relevant competent authorities within their Member State. The Commission will also set-up sub-groups of the SCB on inspections (replacing IES), vigilance and traceability (replacing VES and CES), authorisation and assessment of SoHO preparations, regulatory questions, supply of critical SoHO; and registration of entities and authorisation of establishments. Member States will be invited to nominate members for these sub-groups once these have been established (expected later in the course of 2025). Nominees for the sub-groups can be the same or different from the SCB nominees. Please note that the existing Expert Group BTCO will be maintained but will be convened for meetings on organs only. Regarding the adoption of implementing acts under the SoHO Regulation, a dedicated (regulatory) Committee will need to be set up, in accordance with Art 79 of the SoHO Regulation. The first meeting of the SCB will take place virtually via Webex on Friday 24 January 2025. During this meeting, the rules of procedure, as specified in Art 68 (8) of the SoHO Regulation, will be presented for approval. Candidates for co-chairing the SCB are invited to express their interest by Friday 31 January 2025. The second meeting of the SCB will take place physically at the Commission premises in Brussels in the week of 10 February 2025. At this meeting, the co-chair of the SCB will be elected. In order to keep the above-mentioned timeframe, the European Commission would be very grateful if you could provide the requested information, i.e. the names and affiliation of your nominated members and alternates together with the corresponding declaration of interests for any member and alternate, by 8 January 2025 at the latest. Should you need any additional information, you may contact Stefaan Van Der Spiegel, Team Leader SoHO/ SANTE D2 (email: [email protected], office number: +32 229 55406) and Katleen Baert, Policy Officer SoHO/ SANTE D2, (email: [email protected], office number +32 229 55981). Yours sincerely, Sandra GALLINA 2 Annex: Form to declare interests Privacy statement Copy: Health attachés, L. BOIX ALONSO, R. BECKER, R. MCGEEHAN, L. BATTISTINI, M. MOYA DIAZ, B. GAUTRAIS, M. CICCARELLO, S. VAN DER SPIEGEL, M. AMBROSIO, K. BAERT, E. MARCHAND, R. PITEIRA (SANTE) 3 Saatja: Webdesktop <[email protected]> Saadetud: 13.12.2024 15:15 Adressaat: <[email protected]>; <"Maret Voore"> Koopia: <"[email protected]">; <"Tiina Rootamm"> Teema: Webdesktop: Esindaja nimetamine SoHO koordinatsiooni komiteesse Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.Tundmatu saatja korral palume linke ja faile mitte avada.Tere!Edatsan Komisjoni kirja.EV AEEL juures reg. number: 10.2-11/1288Reg. kuupäev: 13.12.2024Sisu: Esindaja nimetamine SoHO koordinatsiooni komiteesse. Coordination Board (SCB) as stipulated in the recently adopted Regulation (EU) 2024/1938 on safety and quality of substances of human origin.-- Heade soovidegaTiiu Noobelsekretär, EV alaline esindus EL juures&#43;32 2227 4337