Minutes of the extraordinary meeting of the Management Board for the appointment of the Executive Director

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5 October 2015 Adopted Extraordinary Management Board Meeting 1 October 2015 Minutes of the extraordinary meeting of the Management Board for the appointment of the Executive Director Held in London on 1 October 2015 The extraordinary meeting of the Management Board was held to consider the shortlist submitted by the European Commission of candidates for the position of Executive Director. The meeting took place in a restricted format, observing the Board s Rules of Procedure, with only members or their alternates, observers from EEA countries, the Deputy Executive Director, the Head of the Legal Department and the EMA Management Board Secretariat present. The chair opened the meeting and welcomed Mr. Xavier Prats Monné, new Director General of DG SANTE, attending the European Medicines Agency s Management Board meeting for the first time. 1. Draft Agenda [EMA/MB/392855/2015] The agenda was adopted without amendments. No interests were declared in relation to items on the agenda. 2. Outline of the procedure for the appointment of the Executive Director [EMA/MB/451685/2015] The Chair reminded the board of the procedural steps that lead from the publication of a vacancy notice to the nomination and then appointment of a successful candidate by the Management Board. The whole process is made up of two distinct phases, the first run by the European Commission, which provides the board with a shortlist of candidates, the second under the responsibility of the Management Board, which nominates a candidate who is appointed after having made a statement to the European Parliament and answered questions put by its members. Separation of the two phases is essential, as shown by the Judgment of the Civil Service Tribunal which annulled the appointment in 2011 of the European Medicine Agency s Executive Director on procedural grounds based on the failure to disconnect fully these two parts. The Management Board is represented by an observer to the pre-selection panel within the phase run by the European Commission. 3. Proceedings for the nomination of the Executive Director [EMA/MB/452503/2015] The Management Board adopted the proceedings for the nomination of the Executive Director, setting out the way the meeting was to be conducted, the programme of the day and the instructions on the voting. 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

4. Outline of the day The Chair informed the board on organisational matters and on the interview process. The candidates would be interviewed separately and in alphabetical order. After having delivered a statement with their reasons for applying for the post of Executive Director and personal vision for this role over the next five years if appointed, candidates would address questions prepared by five volunteers of the Management Board (John Joseph Borg, Klaus Cichutek, Kristin Raudsepp, W.H.J.M. Wim Wientjens and Christa Wirthumer-Hoche) whom the chair thanked for their collaboration over two teleconferences and a meeting. The board would further be provided with the opportunity for open questions before a closing statement by the candidates. Discussion and voting would follow. 5. Delegation of powers to the Chair of the Management Board for the appointment of the Executive Director [EMA/MB/517262/2015] The Management Board adopted delegation of powers to the chair for the appointment of the nominated Executive Director. This will allow the chair to appoint the Executive Director on behalf of the board and to sign the offer of employment and the contract once the Agency is notified by the European Parliament that the requirement for the statement to the ENVI committee has been met. 6. Announcement of proxies The chair announced the following proxy votes: Nikos Dedes (Representative of patients' organisations) gave his proxy to Wolf-Dieter Ludwig (Representative of doctors' organisations) Marius Savu (Romania) gave his proxy to Assena Stoimenova (Bulgaria) 7. Appointment of tellers The Board appointed the observers Brigitte Batliner (Liechtenstein), Audun Hågå (Norway) and Runa Hauksdottir Hvannberg (Iceland) to act as tellers. 8. Announcement of candidates The chair announced the following candidates on the shortlist presented by the European Commission on 8 September 2015: 9. Report from the MB observer to the Commission pre-selection panel Hugo Hurts, observer to the European Commission pre-selection panel, had previously reported to the Management Board on the observed procedure at the March and the June meetings. He informed the board that according to his observations the proceedings in the pre-selection process were solid and well run. For future reference he suggested extending the observership by the Management Board also to the phase that follows the pre-selection procedure at the European Commission, in order to provide complete oversight of the process. He further observed that the time period for the whole process appears to be unduly long, and should be looked into in the interest of the candidates and of the organisations. 2/5

After expressing his wish for future good cooperation with the European Medicines Agency, the Director General of DG SANTE assured the board of the robustness of the second step of the shortlisting process, which is common to all appointments in senior positions at the European Commission. After the pre-selection panel, the second step of the procedure is handled by the Commission s Consultative Committee on Appointments (CCA) which avails itself also of the opinion of an independent Assessment Centre. The composition and functioning of the CCA are standard: as for all Director-level appointments, the CCA meeting for the selection of the EMA Director was chaired by the Commission's Director General for Human Resources, not by DG SANTE or DG GROW, and, in line with the Commission s standard practice regularly followed for all selection processes in EU Agencies, the observer from the relevant Management Board did not attend the meetings of the CCA. The CCA examined the candidates proposed by the pre-selection panel, and in turn proposed a shortlist of two names to the European Commission; on this basis, the Commission presented the candidates to the EMA Management Board for nomination. 10. Interviews The Management Board heard each candidate in alphabetical order, in accordance with the agreed proceedings. 11. Deliberations The board decided to proceed to the vote. 12. Vote The Management Board vote took place by secret ballot. The results of the vote were as follows: 13. Announcement of the final result The chair announced the Management Board nomination of Mr. Guido Rasi as the EMA Executive Director. The chair informed the candidates individually and in private of the outcome of the selection. On behalf of the board the chair thanked Andreas Pott, Deputy Executive Director, for his year-long willingness and commitment to running and legally representing the European Medicines Agency. These efforts will continue until the day on which the new Executive Director takes up his responsibilities. 3/5

List of participants at the Extraordinary meeting of the Management Board, held in London, 1st October 2015 Chair: Sir Kent Woods Belgium Bulgaria Czech Republic Croatia Denmark Germany Estonia Ireland Greece Spain France Italy Cyprus Latvia Lithuania Luxembourg Hungary Malta Netherlands Austria Poland Portugal Romania Slovakia Slovenia Finland Sweden United Kingdom European Parliament European Commission Representatives of patients' organisations Representative of doctors' organisations Members Xavier De Cuyper Assena Stoimenova Zdenek Blahuta Mette Aaboe Hansen Klaus Cichutek Kristin Raudsepp Rita Purcell Despoina Makridaki Belén Crespo Sánchez- Eznarriaga Dominique Martin Luca Pani Loizos Panayi Gintautas Barcys Laurent Mertz Beatrix Horváth John J Borg Hugo Hurts Christa Wirthumer-Hoche Grzegorz Cessak Hélder Mota-Filipe Apology received for Marius Savu Jan Mazág Katarina Štraus Giuseppe Nisticò Björn Lemmer Xavier Prats Monné (DG SANTE) Carlo Pettinelli (DG GROW) W.H.J.M. Wim Wientjens Apology received for Nikos Dedes Wolf-Dieter Ludwig Alternates (and other participants) Viola Macolić Šarinić Pekka Kurki Johan Lindberg Ian Hudson 4/5

Representative of veterinarians' organisations Observers Members Alternates (and other participants) Christophe Hugnet Runa Hauksdottir Hvannberg (Iceland) Brigitte Batliner (Liechtenstein) Audun Hågå (Norway) European Medicines Agency Andreas Pott Stefano Marino Silvia Fabiani Sophia Albuquerque 5/5