Invitation

MINISTERIO Organización Nacional de Trasplantes, O.A. DE SANIDAD TOWARDS GLOBAL CONVERGENCE IN TRANSPLANTATION: SUFFICIENCY, TRANSPARENCY & OVERSIGHT A summit co-organized by the Organización Nacional de Trasplantes, the World Health Organization and the Council of Europe under the Spanish Presidency of the Council of the European Union Co-sponsored by the Transplantation Society and the European Society for Organ Transplantation With the support of the International Society of Nephrology Santander, Spain 9-10 November 2023 BACKGROUND: Transplantation is the best if not the only therapeutic option available for patients with end-stage organ failure, which mostly results from non-communicable diseases (NCDs). Patients who develop organ failure experience a reduced quality of life and premature death, and communities confront important costs for alternative treatment modalities (e.g. dialysis) and loss in productivity.1 The number of organ transplants worldwide has steadily increased over time until 2020, when it was reduced by 18%, as a consequence of the COVID-19 pandemic.2 However, despite the progressive increase in transplant activities, it is estimated that these barely cover 10% of the global needs, which are notably rising due to the growing burden of NCDs.3 Of note, chronic kidney disease is expected to become the 5th cause of death in the world by 2040.4 1 Domínguez-Gil B, Ascher NL, Fadhil RAS, et al. The Reality of Inadequate Patient Care and the Need for a Global Action Framework in Organ Donation and Transplantation. Transplantation 2022;106(11):2111-2117. doi: 10.1097/TP.0000000000004186. 2 Aubert O, Yoo D, Zielinski D, et al. COVID-19 pandemic and worldwide organ transplantation: a population-based study. Lancet Public Health 2021;6(10):e709-e719. doi: 10.1016/S2468-2667(21)00200-0. 3 International report on organ donation and transplantation activities. Available at: https://www.transplant- observatory.org/wp-content/uploads/2022/12/2021-data-global-report-1.pdf. Accessed: February 2023. 4 Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl 2022;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003. www.ont.es C/ Sinesio Delgado, 6-8 – Pabellón 3 [email protected] 28029 Madrid TEL: +34 91 727 8699 FAX: +34 91 314 2956  MINISTERIO Organización Nacional de Trasplantes, O.A. DE SANIDAD In the European region, an important progress has been made in the field of transplantation over the past years. The European Commission launched a specific Action Plan for the period 2009-2015 targeted to increase the availability of organs for transplantation, improve the accessibility of patients to transplant therapies and ensure the quality and safety of organs for clinical use.5 The European Union (EU) has promoted a number of initiatives reinforcing these same goals during and after the period of implementation of the above mentioned Action Plan. In an orchestrated way, the Directive 2010/53/EU also established minimum quality and safety standards for human organs to be used for transplantation in the EU.6 The transplantation of human tissues and cells has been regulated by Directive 2004/23/EC that sets minimum quality and safety standards.7 At present, the European Parliament and Council are debating a draft Regulation proposed by the European Commission on the quality and safety of Substances of Human Origin (SoHO), other than organs.8 The Regulation will repeal the previously mentioned Directive and bring all SoHO (except for organs) under a common regulatory framework, setting a new paradigm in the practice of transplantation of human tissues and cells in the near future. The draft Regulation also intends to support Member States in ensuring sufficiency of SoHO, improving the level of protection of both donors and recipients, reinforcing oversight and transparency of practices, and facilitating innovation in a rapidly evolving field. The European Commission has funded or co-funded several projects aimed at achieving sufficiency, quality and safety of SoHO in the EU setting. The Council of Europe has contributed to set technical standards to improve the practice of transplantation, has established a unique ethical framework, and adopted key measures to combat unethical practices in this field (e.g. thorough the Council of Europe Convention on the fight against trafficking in human organs).9,10 Both the EU 5 Study on the uptake and impact of the EU Action Plan on Organ Donation and Transplantation (2009-2015) in the EU Member States. The Factor Study. Available at: https://health.ec.europa.eu/system/files/2019- 03/2017_euactionplan_2009-2015_impact_exe_en_0.pdf. Accessed: February 2023. 6 Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation. Available at: https://eur-lex.europa.eu/legal- content/EN/ALL/?uri=cel ex%3A32010L0053. Accessed: February 2023. 7 Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004L0023. Accessed: February 2023. 8 Proposal for a Regulation on Substances of Human Origin. Available at: https://health.ec.europa.eu/blood-tissues- cells-and-organs/overview/proposal-regulation-substances-human-origin_en. Accessed: February 2023. 9 Activities of the European Directorate for the Quality of Medicines and Health Care on Substances of Human Origin. Available at: https://www.edqm.eu/en/substances-of-human-origin. Accessed: February 2023. 10 Council of Europe Convention on action against trafficking in human organs. Available at: https://rm.coe.int/16806dca3a. Accessed: February 2023. www.ont.es C/ Sinesio Delgado, 6-8 – Pabellón 3 [email protected] 28029 Madrid TEL: +34 91 727 8699 FAX: +34 91 314 2956  MINISTERIO Organización Nacional de Trasplantes, O.A. DE SANIDAD and the Council of Europe have adopted legal instruments to effectively fight against the trafficking in human beings for the purpose of the removal of organs. 11,12 Since 1998 the Council of Europe has additionally organized the European Day for Organ Donation and Transplantation (EODD)13 in a different country every year. The EODD is an opportunity to raise awareness on donation and transplantation among governments, professionals and society at large. The World Health Organization (WHO) issued the Guiding Principles on Human Tissue and Organ transplantation in 2010,14 adopted by the World Health Assembly, through Resolution 63.22.15 This Resolution calls upon action on Member States and gave a mandate to the WHO to support the development of transplantation and the worldwide implementation of the WHO Guiding Principles. Non-governmental organizations (NGOs) have been pivotal in further developing transplantation within and outside the European region. Bringing all these outstanding stakeholders together can provide the unique opportunity of identifying priority actions in this field for countries, international organizations and NGOs. Thus, an international summit entitled “Towards Global Convergence in Transplantation: Sufficiency, Transparency and Oversight” will be convened by the Organización Nacional de Trasplantes (ONT) under the Spanish Presidency of the Council of the EU in November, 2023. AIM: The Spanish Presidency aims at building an EU for health, through new priorities targeted at improving the protection of the vulnerable, promoting initiatives of preparedness and response to health-care threats (as witnessed in the COVID-19 pandemic) and aligning the health-care agenda with the United Nations Sustainable Development Goals and One-Health. In this context, the goal of this international summit is to critically review the current situation of donation and transplantation, identify key challenges and devise the future 11 Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims, and replacing Council Framework Decision 2002/629/JHA. Available at. https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32011L0036. Accessed: February 2023. 12 Council of Europe Convention on action against trafficking in human beings. Available at: https://rm.coe.int/168008371d. Accessed: February 2023. 13 European Day for Organ Donation & Transplantation. Available from: https://www.edqm.eu/en/eodd . 14 WHO Guiding Principles on human cell, tissue and organ transplantation. Available at: https://apps.who.int/iris/bitstream/handle/10665/341814/WHO-HTP-EHT-CPR-2010.01-eng.pdf?sequence=1. Accessed: February 2023. 15 World Health Assembly Resolution on Human Organ and Tissue Transplantation. Available at: https://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R22-en.pdf. Accessed: February 2023. www.ont.es C/ Sinesio Delgado, 6-8 – Pabellón 3 [email protected] 28029 Madrid TEL: +34 91 727 8699 FAX: +34 91 314 2956  MINISTERIO Organización Nacional de Trasplantes, O.A. DE SANIDAD of transplantation in the global arena. The summit also aims at celebrating the 2023 EODD. ORGANIZATION: The summit will be organized by the Organización Nacional de Trasplantes (ONT), the World Health Organization (WHO) and the Council of Europe as an initiative of the Spanish Presidency of the EU. The summit is co-sponsored by The Transplantation Society (TTS) and the European Society for Organ Transplantation (ESOT). It is supported by the International Society of Nephrology (ISN), and counts with the participation of the Pontifical Academy of Sciences. PARTICIPANTS: Maximum 120 persons  Spanish authorities (national/regional)  National Health Authorities from EU and non-EU countries of the European Region  Selected representatives from non-European countries (approx. 30 participants)  Official representatives of the EU  Official representatives of the WHO  Official representatives of the Council of Europe  TTS  ESOT  ISN DELIVERABLE: Statement on the current challenges and international key priority actions in donation and transplantation, to be presented at the meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in December 2023. The Statement will be presented to the governing bodies of the Council of Europe. Report of the summit for publication at a scientific journal (four independent papers and the statement). www.ont.es C/ Sinesio Delgado, 6-8 – Pabellón 3 [email protected] 28029 Madrid TEL: +34 91 727 8699 FAX: +34 91 314 2956  MINISTERIO Organización Nacional de Trasplantes, O.A. DE SANIDAD METHODOLOGY: All participants will be assigned to four different working groups: 1. TRANSPLANTATION AS A HEALTH-CARE PRIORITY 2. DONATION AND TRANSPLANTATION 3. INNOVATION IN DONATION AND CLINICAL APPLICATION OF SUBSTANCE OF HUMAN ORIGIN 4. ETHICAL CHALLENGES Each working group will be composed of up to 15 experts from the transplantation field. Groups will have the possibility of engaging experts from other fields (e.g. regulatory agencies) to contribute to the work and participate on-line (with authorship acknowledged in the resulting paper). Each group will be led by two co-chairs. During the conference, four panelists selected by the working group (one per topic) will present the result of their deliberations. Each working group is expected to:  describe and document current challenges (confirming or expanding the pre- identified challenges specified in the agenda)  analyze models or initiatives of success in addressing those challenges  identify key priority actions on the side of Member States, international organizations and NGOs relevant to the field. Work will be performed on line from 1 May 2023 to 30 September 2023, and a draft paper should be delivered by each working group (no more than 6 000 words, excluding tables and figures). The work from each working group will be presented by the panelists for debate at a dedicated round table during the conference. The work of each group is intended for publication at a scientific journal. It will also serve as a basis for the elaboration of the final Statement of the conference. Two rapporteurs will be designated to prepare the draft Statement. www.ont.es C/ Sinesio Delgado, 6-8 – Pabellón 3 [email protected] 28029 Madrid TEL: +34 91 727 8699 FAX: +34 91 314 2956  MINISTERIO Organización Nacional de Trasplantes, O.A. DE SANIDAD PROGRAM: DAY 1 (November 9th 2022 – 9:00 – 18:30 CET) 8:30-9:00 h Registration 9:00-9:15 h Welcome address 9:15- 9:35 h Overview of donation and transplantation in the world 9:35 – 9:55 h Aims of the conference, methodology and expected outcomes Presentation of working group chairs and rapporteurs 10:00-12:15 h ROUND TABLE 1: Why transplantation should be a priority in the health-care agenda and how can transplantation contribute to attaining the UN Sustainable Development Goals Chairs: Elmi Muller, Luciano Potena Panelists: Case study 1: Making transplantation a health-care priority (15 min) The impact of transplantation upon health (NCDs & universal access to health) (20 min) The impact of transplantation upon other UN SDG (environment and social justice) (20 min) www.ont.es C/ Sinesio Delgado, 6-8 – Pabellón 3 [email protected] 28029 Madrid TEL: +34 91 727 8699 FAX: +34 91 314 2956  MINISTERIO Organización Nacional de Trasplantes, O.A. DE SANIDAD Transplantation as part of more resilient health-care systems (20 min) When and how to start a transplantation program in a low resource environment (20 min) DISCUSSION 12:15-13:15 h Lunch break 13:15-15:30 h ROUND TABLE 2: Donation and transplantation: challenges and way forward Chairs: Francis L. Delmonico, Dale Gardiner Panelists: Case study 2: Transforming deceased donation through DCD (15 min) Promoting the unifying concept of death (20 min) Reducing disparities in deceased donation and increasing organ utilization (20 min) Reducing disparities in living donation (include ref. to Kidney Paired Exchange programs) (20 min) Reinforcing oversight: activity monitoring and registries of post-donation and post- transplant outcomes (20 min) DISCUSSION www.ont.es C/ Sinesio Delgado, 6-8 – Pabellón 3 [email protected] 28029 Madrid TEL: +34 91 727 8699 FAX: +34 91 314 2956  MINISTERIO Organización Nacional de Trasplantes, O.A. DE SANIDAD 15:30-16:00 h Coffee break 16:00-18:15 h ROUND TABLE 3: Innovation in the donation and clinical application of substances of human origin Chairs: Nancy Ascher, Natividad Cuende Panelists: Case Study 3: Cell therapy to induce tolerance (15 min) When SoHO become medicines and medical devices: regulatory borderlines and implications (20 min) Addressing clinical efficacy and safety before innovation reaches the bedside (20 min) Making innovation sustainable for health-care systems (20 min) Public-private partnerships to make innovation accessible to patients (20 min) DISCUSSION 19:30 – 20:30 h Social Event 20:30 – 22:30 h Dinner www.ont.es C/ Sinesio Delgado, 6-8 – Pabellón 3 [email protected] 28029 Madrid TEL: +34 91 727 8699 FAX: +34 91 314 2956  MINISTERIO Organización Nacional de Trasplantes, O.A. DE SANIDAD DAY 2 (November 10th 2022 – 9:00 – 13:30 CET) 9:00 – 11:15 h ROUND TABLE 4: Ethical challenges and the way forward to implement the WHO Guiding Principles Chairs: Marta López-Fraga, Dominique Martin Panelists: Case Study 4: Crisis and TBD transplantation (15 min) Revalidating and reinforcing the principle of unpaid donation (20 min) Ensuring equity and fairness in access to SoHO-based therapies (20 min) Facing the access of non- residents and migrants to transplantation therapies (20 min) Addressing trafficking in human organs and trafficking in human beings for the purpose of organ removal (20 min) DISCUSSION 11:15 – 11:45 h Coffee break 11:45 – 13:30 h FINAL SESSION: LOOKING TO THE FUTURE Chairs: www.ont.es C/ Sinesio Delgado, 6-8 – Pabellón 3 [email protected] 28029 Madrid TEL: +34 91 727 8699 FAX: +34 91 314 2956  MINISTERIO Organización Nacional de Trasplantes, O.A. DE SANIDAD The Santander Statement: Rapporteurs will present the draft statement with key components derived from the Conference (45 min) Round table: A vision of transplantation 10 years ahead (60 min) WHO Tbd - Council of Europe Tbc, European Parliament Tbd – European Commission Tbd- Minister of Health, Argentina Minister of Health, Spain 13:30 h Lunch DAY 3 HONORING DONORS: POPULAR RUN www.ont.es C/ Sinesio Delgado, 6-8 – Pabellón 3 [email protected] 28029 Madrid TEL: +34 91 727 8699 FAX: +34 91 314 2956 Saatja: <[email protected]> Saadetud: 23.08.2023 11:03 Adressaat: <[email protected]> Koopia: <[email protected]> Teema: Invitation to the Global Summit in Transplantation, entitled “Towards global convergence in transplantation: sufficiency, transparency & oversight” Manused: image001.jpg; image002.png; TOWARDS GLOBAL CONVERGENCE IN TRANSPLANTATION_ SUMMIT_SPANISH EU PRESIDE....pdf Dear Competent Authorities for Tissues & Cells and Organs, Please find below an invitation from the Organización Nacional de Trasplantes (ONT) to join the Global Summit in Transplantation entitled “Towards global convergence in transplantation: sufficiency, transparency & oversight”. For further information and registration, please contact directly ONT at [email protected] no later than 11 September 2023. Kindly note that onsite attendance to the Summit is restricted to one person per country. Best regards, The SoHO team. European Commission DG SANTE (Health and Food Safety) Unit D2 – Medical Products: quality, safety, innovation Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm Dear representatives of the EU competent authorities on Organ, Tissues and Cells Donation and Transplantation We are pleased to inform you on the Global Summit in Transplantation, entitled “Towards global convergence in transplantation: sufficiency, transparency & oversight”, organized by the Organización Nacional de Trasplantes (ONT) under the Spanish Presidency of the European Union, that will take place in Santander (Spain) next 9 and 10 November 2023. Please find enclosed the draft agenda of the Summit. Competent authorities are welcome to join this event that intends to critically review the current situation of donation and transplantation, identify key challenges and devise the future of transplantation in the EU and in the global arena. Due to logistic and financial reasons, onsite attendance to the Summit is initially restricted to one person per country. Please take into account that the meeting of the Committee of Transplantation of the Council of Europe (CD-P-TO) will be taking place at the same location the day before the Summit, should this be relevant to decide the representative of your country at the Summit. Travel and accommodation expenses are not covered by the organizers. Importantly, remote participation will also be possible for all those of you that are not able to attend the meeting in person, with no restriction on the number of participants. Please contact [email protected] to indicate your attendance (in person or on-line), no longer than 11 September 2023. Looking forward to welcome you in Santander, receive our very best regards Dr. Domínguez-Gil