As the Director General of the Spanish National Transplant Organization (ONT), you oversee the world’s most recognized organ Donation and Transplantation structure, the Spanish Model. What is the secret of your and the organization’s success?
BD-G: It is common to believe that convincing the population to donate is the fundamental aspect for increasing deceased donation rates. However, when donation is low in a given jurisdiction, this is not because of the people; it is because the healthcare system is doing something wrong. These are not my words, but those of my predecessor as Director of ONT, Dr Rafael Matesanz.1 This was very early understood in Spain: the key for success to increase organ donation—and transplant opportunities—is an exquisite management of the process of deceased donation, a process of high complexity.
There are very few persons who die under conditions consistent with organ donation. If we just consider potential donors after brain death, they only represent 1%–2% of those dying in a hospital (Spanish data). If the system is not designed to systematically identify those exceptional circumstances of death and convert them into actual donations, nothing will happen, even if people are willing to donate organs. Our system is addressing those challenges, based on a network of in-hospital donor coordination units, led by intensive care physicians, who are provided with continuous training and ad hoc procedures and are subject to continuous evaluation of results to identify areas for improvement. The system is properly resourced, funded, and supported by the national and the regional authorities.2,3
A major element of the Spanish system has been the engagement of the critical care community. Intensive and emergency care professionals should consider donation opportunities when a patient dies or is about to die under conditions that allow for organ donation; if donation is consistent with the wishes and values of the individual, our in-hospital professional staff will work on facilitating donation. In Spain, the engagement of the intensive care community is outstanding—intensivists acknowledge organ donation as their responsibility in their ethical code of practice,4 include donation in their indicators of quality in intensive care,5 and promote the principle that donation should be an integral component of end-of-life care.6 The fact that most of our donor coordinators are intensive care physicians likely explains this high level of engagement in Spain. Based on the Spanish model, other countries have implemented so-called clinical leads in organ donation or donation physicians and are witnessing an impressive improvement in organ donation.
The other key factor that explains the success of the Spanish system is innovation. We have observed a progressive decline in the pool of potential donors in the country, while the transplant needs of the population are increasing and expected to keep increasing in the future. This has prompted the adoption of different strategies over time.7 We are now implementing the 50 × 22 Plan, aiming at 50 donors per million population and >5500 transplants in 2022.8 The main pillars of this Plan are the harmonization of practices in what we call intensive care to facilitate organ donation, an optimized use of organs from expanded and nonstandard risk donors, the promotion of donation after circulatory death (DCD) and of pediatric donation, as well as the incorporation of the private sector that is emerging in Spain in the donation activity supported by the public healthcare system.
From an outside view, the Spanish Model succeeded in a unique way getting an entire nation to support organ donation and transplantation and reaching into Spain’s social, cultural, and political life. What have been steps on the way?
BD-G: If professionals are convinced of what they are doing, communicating this in a transparent and effective way, this enthusiasm will spread to the society in general. We have made great efforts in engaging professionals in organ donation, and in making them understand that donation is a necessary activity because of the transplant needs of patients, but also to fulfill the wish of individuals to become donors after their death. This has implied abandoning a classical paternalist attitude by which physicians thought that donation imposed a burden to a grieving family; it is the individual and their family who must decide about donation, not the professional. The engagement of professionals has been achieved through the establishment of key strategic alliances with the relevant societies (ONT has specific agreements with the Spanish intensive care and emergency care societies, among others) and through continuous professional training.
Importantly, the training in organ donation in Spain is covered by health authorities. We devote 25% of the ONT annual budget to train all professionals who directly or indirectly participate in the deceased donation process: donor coordinators, intensive care physicians (they mandatorily take a course during their residency period) and nurses, emergency care personnel, coroners, judges, and others. I would say that in our country, even if you are not actively seeking to be trained in organ donation, you will be so at a given moment.
In parallel, we have worked very closely with the mass media, in a way that they have become true allies in promoting donation and transplantation; we have managed to be contacted by the media immediately to explain negative news, should they occur, aiming to offer a balanced information; we also have an opportunity in publishing good news on a periodical basis. Our communication policy implies a full-time availability to the media; I dedicate up to 30% of my time to them. We also hold annual meetings with the participation of donor coordinators and the media, so both professional groups can learn about their mutual needs.
With time, the entire country (professionals and the society as a whole) feel to be part of the system and proud of our mission as a collective success. In the midst of the last economic crisis in Spain, people used to say “At least we are good in soccer and tennis… and in organ donation.”
Opt-in versus Opt-out legislation continues to be a controversial debate. Do you see clear advantages of one approach over the other?
BD-G: There are advantages in theory, but not in practice. In my personal opinion, having a legislation that promotes donation by presuming that everyone is a donor, can be considered good because of the type of message that is communicated to the society. At the same time, presumed consent may not be as impactful as some believe and may, in some situations, distract from tackling more meaningful shortcomings.9
Spain has an opt-out policy since 1979, which is frequently perceived as the reason for its high deceased donation rates. However, it was not until 1989 when deceased donation started to increase in our country following the implementation of the organizational approach to donation briefly summarized above. Besides, in our daily practice, we do not strictly apply the presumed consent policy. Donor coordinators must always explore the wishes of the individual regarding posthumous donation, that can be recorded in the national advanced directives registry, or may have been expressed by any other means—including a conversation with family members. Donor coordinators always hold an interview with the relatives of the potential donor to confirm or explore whether organ donation was consistent with the patient’s wishes and values. Although the system is meant to respect the willingness of the individual, if the family oppose donation, the procedure will not follow. This is a very similar approach to the one in countries with an opt-in policy. Finally, there is really no example of a country in the world that has observed important and sustained increases in organ donation following the adoption of an opt-out policy.
Organs from donors after circulatory death contribute significantly to the overall transplant volume in Spain and other countries including the United States. What are obstacles for a broader acceptance of DCD donors?
BD-G: Focusing on controlled donation after circulatory death (cDCD), we in Spain had a moratorium on this practice from 1996 to 2009. Professionals and the donor coordination network were reluctant to promote it, afraid of creating the social perception that the withdrawal of life-sustaining therapies was not a previous and independent decision from any consideration of organ donation. This position completely changed in 2009, when it became evident that many patients were dying in our intensive care units following the decision to withdraw care without being offered the opportunity to donate organs. In such scenario, the decision was made to pilot a cDCD program. Based on the acquired experience, a new regulatory framework was developed that embraced and established the requirements for the practice of cDCD. This was followed by great efforts in professional training and guidance, public education, and ongoing institutional support. Today, DCD accounts for 32% of the overall deceased donation activity in Spain and the practice has allowed our country to register 49 donors pmp in 2019.10 Thus, DCD is a necessary practice to advance towards self-sufficiency in transplantation and to offer more patients the opportunity to donate their organs after death.
At this time, there is really a very limited number of countries that have incorporated the practice of DCD and that of cDCD in particular. Based on a recent study that we undertook at the Council of Europe, we know that cDCD is only implemented in 12 European countries.11 The remaining European countries acknowledge ethical and legal issues as the most important barriers to the development of cDCD. As it happened in Spain, this is what most countries need to overcome. It is important to make evident that many patients are dying following the decision to withdraw (or withhold) care because it is considered that intensive care measures are no longer beneficial to the patient. If that reality is made evident (and I invite readers to visit the results of the recently published Ethicus 2 study),12 countries may be motivated to explore how to make donation possible and ethically appropriate in this situation. The need for separate decisions (withdrawal of care and organ donation) and of procedures for the determination of death—where the permanent cessation of circulation is a surrogate of the irreversible cessation of circulation—are fundamental elements of these future legal-ethical frameworks. I am also convinced that international cooperation is necessary to make cDCD possible throughout the world. The Transplantation Society should play a key role in promoting DCD.
You have been instrumental in formulating The Council of Europe Convention against Trafficking in Human Organs. Can you share some key components?
BD-G: The great value of this Convention13 is that it provides, for the very first time, an internationally agreed upon definition of the practices that constitute organ trafficking. This is essential for the prosecution of a crime that usually has a transnational scope. At present, organ trafficking is prohibited and criminalized in most countries, but the crime is not defined in a uniform manner, which makes prosecution a real challenge.
The other important aspect of the Convention is that it addresses important loopholes in international legal frameworks that had been traditionally used to combat transplant-related crimes, for example, trafficking in human beings. Thus far, frameworks have been insufficient to combat all sort of activities implied in organ trafficking and to prosecute the many actors involved in these heinous crimes as healthcare professionals. The new Convention fills these gaps, facilitates international cooperation, and requires the implementation of preventive measures and measures to protect victims. Thus, I would ask readers of Transplantation to help move their countries towards adopting this Convention. If we can harmonize the legal frameworks in accordance with the elements of this treaty, we will be in a much better position to combat organ trafficking globally.
You have advised policymakers and politicians around the world. What is your advice on achieving self-sufficiency for organ transplantation?
BD-G: Our advice is not to exclusively focus on what the population thinks about donation, not to waist energy in changing the legislation to put in place a presumed consent policy, but to focus on professionals. To set up and invest in a system where possible donors are systemically identified and referred, professionals are trained, and practices are evaluated continuously (we cannot improve if we do not measure).
ONT, as collaborating center of the World Health Organization (WHO) in donation and transplantation, has a robust program in international cooperation. We have transferred our knowledge and expertise through international organizations (European Union, Council of Europe, WHO, and Red/Consejo Iberoamericano de Donación y Trasplantes [RCIDT]) and bilateral cooperation programs with many different countries. We are proud to see that the WHO has recognized the Spanish system as a model of reference and that the European Union promoted an Action Plan14 and a Directive15 inspired by elements of our system. Countries in different regions of the world have totally or partially reproduced the Spanish Model in a manner adapted to their reality, with successful results. The incorporation of intensive care physicians to this field, first promoted in Spain, is now a reality in countries such as Australia, Canada, the United Kingdom, the United States, to give you some examples.
You chaired and represented transplantation and donation in many International Organizations. What have been key achievements chairing the Transplantation Committee of the Council of Europe (CD-P-TO)?
BD-G: Some of the most relevant achievements have been linked to the fight against organ trafficking. Not only because of the development and the promotion of the corresponding Council of Europe Convention.13 We have also developed groundbreaking Resolutions that, although not legally binding, can be of invaluable support to policymakers, authorities, and professionals to prevent and combat such crimes; the resolutions of the Committee of Ministers of the Council of Europe are considered as a reference documents.16 For example, we have provided guidance to Member States about the management of nonresident living donors and of patients who return home after transplantation abroad for follow-up care.
Another major achievement has been the creation of an International Registry on Travel for Transplantation in which key individuals designated by the Ministries of Health of participating countries (so far 26 countries) compile information about patients returning home after transplantation abroad. The exercise has allowed to identify a number of patients traveling across jurisdictions every year—either in the context of: (1) what we define as proper travel for transplantation (in the framework of a cooperation agreement between countries or with a related living donor); (2) organ trafficking; or (3) undermining the ability of the country of destination to cover the transplantation needs of their own patients. This information is extremely helpful to quantify and describe the phenomenon of travel for transplantation, and to present it to the responsible authorities for them to take action.
In addition to all this work, the CD-P-TO elaborates technical guidance documents for healthcare professionals and authorities that are highly valued and appreciated in the field. In particular, we periodically publish a Guide on the Quality and Safety of Human Organs intended for Transplantation—we are now working on its eighth edition—and on the Quality and Safety of Human Tissues and Cells for clinical use—the fifth edition is now under preparation.17 These 2 documents provide robust recommendations for an exquisite development of the process of donation and clinical use of human organs, tissues, and cells. The documents are also great tools that can help to increase the availability of substances of human origin for clinical use while ensuring high quality, safety, and ethical standards.
The Ibero-American Network/Council on Organ donation and Transplantation aims to exchange best practices, facilitates training, and provides guidance to governments. What have been success stories and challenges in this cooperation?
BD-G: The RCIDT, established in 2005 by the heads of the Iberoamerican Countries is a story of great success. The RCIDT is composed of the representatives in the field of donation and transplantation of 19 Latin American countries, Portugal and Spain, designated by their corresponding Ministries of Health. The WHO and the Council of Europe are observer organizations, along with a set of professional societies, including The Transplantation Society and the Declaration of Istanbul Custodian Group.18
Thanks to this cooperation, legislations have been enacted, national transplant agencies and donation networks have been set up and professional guidance issued. We are particularly proud of the so called Máster Alianza, running since 2005. This is a training initiative in which professionals selected by the authorities of Latin American countries are trained as donor coordinators in Spain as part of a 2 months stay in Spanish hospitals. This initiative has allowed to train almost 500 professionals who are now undertaking relevant activities at a hospital, regional, and national level. Since the RCIDT was created, donation has almost doubled in the region. This impressive increase in donation activity has not been observed in any of the WHO Regions.
As a proposal of the RCIDT and thanks to the work of this network, the Pan American Health Organization promoted the development of a Strategy and Plan of Action on Donation and Equitable Access to Organ, Tissue, and Cell Transplants 2019–2030—that was formally adopted by the Ministers of Health of the American countries in 2019.19 This plan defines specific objectives and lines of work for the years 2020–2030. We believe this is a unique opportunity for the Region to increase the availability of organs, ensure high quality and safety standards, and combat unethical practices in the field.
Most recently, you became a member of the WHO task force promoting ethical practices in the donation of organs, tissues, and cells. What have been key achievements?
BD-G: The WHO Task Force was created in response to the request of Member States (China, Qatar, Spain, among others) and the international community (with the involvement of the Pontifical Academy of Sciences) to support the WHO to implement its Guiding Principles on the Transplantation of Human Tissues, Cells, and Organs.20 The Task Force is a group of individual experts in the field from different WHO regions. The group is led by Dr Francis Delmonico (United States) and Dr Faissal Shaheen (Saudi Arabia), and I am proud of being one of its members. The group is working on providing guidance to member states to help them progress towards self-sufficiency in transplantation and towards transparency of practices. This includes the reporting of data to the Global Observatory on Organ Donation and Transplantation, managed by the ONT in cooperation with the WHO, intending also to provide international benchmarking.21 Our objective is that all countries with transplant programs periodically report to the Global Observatory on Organ Donation and Transplantation. Allow me to use these lines to highlight the relevance of this reporting.
Your responsibilities and time commitment are demanding. How do you manage to fit it all in? What do you enjoy outside of work?
BD-G: Outside work, I enjoy my family: my husband and my 3 kids. I am mother of 3 marvelous girls who are growing and getting to know life. When I am not working, my time is fully devoted to them.
1. Time to introduce organ donation to the concept of precision? Lancet. 2015; 386:404
2. Matesanz R, Dominguez-Gil B. Strategies to optimize deceased organ donation. Transplant Rev. 2007; 21:177–188
3. Matesanz R, Domínguez-Gil B, Coll E, et al. Spanish experience as a leading country: what kind of measures were taken? Transpl Int. 2011; 24:333–343
4. Cabré Pericas LL, Abizanda Camposb R, Baigorri González F, et al.; Grupo de Bioética de la SEMICYUC[Code of ethics of the Spanish Society of Intensive Care, Critical and Coronary Units (SEMICYUC)]. Med Intensiva. 2006; 30:68–73
5. Spanish Society of Intensive Care, Critical and Coronary Units (SEMICYUC)Quality indicators in critically ill patients: 2017 update
[SEMICYUC Website].2017Available at https://semicyuc.org/wp-content/uploads/2018/10/2017_qualityindicators_eng.pdf
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6. Hernández-Tejedor A, Peñuelas O, Sirgo Rodríguez G, et al. Recommendations of the Working Groups from the Spanish Society of Intensive and Critical Care Medicine and Coronary Units (SEMICYUC) for the management of adult critically ill patients. Med Intensiva. 2017; 41:285–305
7. Matesanz R, Domínguez-Gil B, Coll E, et al. How Spain reached 40 deceased organ donors per million population. Am J Transplant. 2017; 17:1447–1454
8. National Organization of TransplantStrategic plan in organ donation and transplantation 2018-2022
[Article in Spanish] [National Organization of Transplant Website].2018Available at http://www.ont.es/infesp/Documents/PLAN%20ESTRATÉGICO%20DONACIÓN%20Y%20TRASPLANTE%20DE%20ÓRGANOS%202018-2022.pdf
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9. Matesanz R, Domínguez-Gil B. Opt-out legislations: the mysterious viability of the false. Kidney Int. 2019; 95:1301–1303
10. Miñambres E, Rubio JJ, Coll E, et al. Donation after circulatory death and its expansion in Spain. Curr Opin Organ Transplant. 2018; 23:120–129
11. Lomero M, Gardiner D, Coll E, et al.; European Committee on Organ Transplantation of the Council of Europe (CD-P-TO)Donation after circulatory death today: an updated overview of the European landscape. Transpl Int. 2020; 33:76–88
12. Sprung CL, Ricou B, Hartog CS, et al. Changes in end-of-life practices in European intensive care units from 1999 to 2016. JAMA[Epub ahead of print. October 2, 2019]. doi: 10.1001/jama.2019.14608
13. Council of Europe: Treaty OfficeCouncil of Europe convention against trafficking in human organs
[Council of Europe Portal Website].Available at https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/216
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14. Commission of the European CommunitiesAction plan on organ donation and transplantation (2009-2015): strengthened cooperation between member states
[Commission of the European Communities Website].Available at https://ec.europa.eu/health/ph_threats/human_substance/oc_organs/docs/organs_action_en.pdf
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15. European UnionDirective 2010/53/EU on standards of quality and safety of human organs intended for transplantation
[EUR-Lex Website].Available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=LEGISSUM%3Asp0008
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16. European Directorate for the Quality of Medicines & HealthCareCouncil of Europe legal framework in donation and transplantation
[Council of Europe Portal Website].Available at https://www.edqm.eu/en/legal-framework
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17. European Directorate for the Quality of Medicines & HealthCareOrgans, tissues and cells - technical guides
[Council of Europe Portal Website].Available at https://www.edqm.eu/en/organs-tissues-and-cells-technical-guides
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18. Matesanz R, Soratti C, Pérez-Rosales MD; Red/Consejo Iberoamericano de Donación y Trasplante (RCIDT)Regional perspective: the Iberoamerican network/council on donation and transplantation. Transplantation. 2015; 99:1739–1742
19. Pan American Health OrganizationStrategy and plan of action on donation and equitable access to organ, tissue, and cell transplants 2019-2030
[Pan American Health Organization Website].Available at http://iris.paho.org/xmlui/handle/123456789/51392
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20. World Health OrganizationWHO guiding principles on human cell, tissue and organ transplantation
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21. Global Observatory on Donation and TransplantationAvailable at http://www.transplant-observatory.org/
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