Areas of work - Transplantation
Role and training of critical care professionals in deceased donation
While enormous efforts have been invested in the field of organ donation and transplantation and good progress has been made, the large deficit of organs for transplantation and the inability of countries to cope with their current and projected transplantation needs has resulted in deaths for those on waiting lists, deterioration in the quality of life of patients in need of an organ transplant and significant costs for healthcare systems.
With a view to improving this critical situation, the Committee of Ministers of the Council of Europe adopted Resolution CM/Res(2015)10 on the role and training of critical care professionals in deceased donation. This Resolution recommends that member states implement measures to ensure that healthcare professionals caring for potential organ donors have clear legal and ethical frameworks to guide their work, specifying which practices facilitating donation after death are permitted within a given jurisdiction. In addition, it encourages hospitals to incorporate organ donation as a routine activity in intensive care units (ICU) and emergency departments and recommends that professionals working in ICU and emergency departments, in co-operation with the relevant professional societies, receive continuous training in deceased donation from the outset of their clinical practice.
Kidney transplantation is the best therapeutic solution for patients with end-stage renal disease (ESRD), both in terms of treatment and cost effectiveness. Countries continue to work on optimising their deceased donation programmes and their deceased donation rates. However, no country manages to cover its needs only with organs from deceased donors.
Living kidney donation, based on recognised ethical and professional standards, is therefore assuming increasing importance as a complementary means of meeting the shortfall, although there are big differences among Council of Europe member states in the number of living donations performed. With a view to ensuring the health and safety of living donors, and taking into consideration all the legal, sociological and psychological aspects of living organ donation, the Council of Europe has produced a number of legal instruments and technical documents to harmonise practices in the member states, according to the most up-to-date scientific evidence.
Long-term outcome of living kidney donation
Even though the risk of developing end-stage renal disease (ESRD) after living donation is low, some recent studies have reported a slightly increased risk of developing ESRD among living kidney donors when compared to selected groups of healthy non-donors.
A position paper from the European Committee on Organ Transplantation (CD-P-TO) with the endorsement of the European Society for Organ Transplantation (ESOT), the International Society of Nephrology (ISN) and The Transplantation Society (TTS) strongly recommends the inclusion of this information in discussion with donors about risks and benefits of their donation and in the provision of informed consent.
Position Paper on the Long-term outcome of living kidney donation
Kidney exchange programmes in Europe
A position paper from the European Committee on Organ Transplantation (CD-P-TO) addresses kidney exchange programmes in Europe, including ethical and legal conditions, general organisational aspects, challenges and commonly agreed recommendations.
Position Paper on Kidney exchange programmes in Europe
Opposition to Global Kidney Exchange schemes
The concept of Global Kidney Exchange (GKE) has been recently proposed as a means to increase the number of pairs that can benefit from kidney exchange programmes in high-income countries. The CD-P-TO, with the support of the DH-BIO, has carefully studied these programmes and recommends member States of the Council of Europe, Health Authorities, hospitals and professionals not to engage in GKE as currently described, and hence not to consider the inclusion of “financially incompatible” donor-recipient pairs in any kidney exchange programme. To assist in addressing barriers to transplantation that arise from the difficulties in finding biologically compatible donors for certain recipients, member States should support the development of equitable kidney paired exchange programmes that do not exploit financial inequalities between pairs (or countries).
Ensuring the protection of non-resident living donors
In the present globalised times, where people travel more easily and live abroad, many countries are accepting non-resident living donors. However, variations are recognised across countries in their approach when accepting these donors, such as in the screening and consent process, the reimbursement of justifiable expenses related to the donation procedure, and in the access to post-operative and follow-up care.
In view of this situation, the Committee of Ministers of the Council of Europe has adopted Resolution CM/Res(2017)1 on principles for the selection, evaluation, donation and follow-up of non-resident living organ donors. This resolution is aimed at protecting non-resident living donors who, for a number of reasons – economic, emotional, cultural or physical – may be particularly vulnerable, and whose post-donation care and follow-up may be difficult to guarantee.
This resolution provides much-needed guidance for all countries accepting non-resident organ donors into their living donation programmes and details rigorous donor selection, evaluation and follow-up measures that these countries should set in place to ensure the protection and well-being of these donors.
Living Donor Registries
In 2015, the Committee of Ministers of the Council of Europe adopted Resolution CM/Res(2015)11 on Living Donation Registries. The aim is to provide recommendations to member states on the establishment of harmonised national living donor registries with the view to facilitating international data sharing.
In the additional Explanatory Memorandum which accompanies this resolution, there is a detailed list of parameters intended for inclusion in any national Living Donor Registry, defining a mandatory data set and an expanded set of variables, as well as those to be included in a ‘Registry of Registries’ aimed at international data sharing. It also contains a glossary of terms, intended to provide clarity on the way each parameter should be measured or collected and to facilitate harmonised international data sharing.
Technical guidance for professionals
The EDQM/Council of Europe has regularly published the Guide to the quality and safety of organs for transplantation and the Guide to the quality and safety of tissues and cells for human application. Both guides are the result of the efforts of experts from all over the world who have contributed different aspects and have done a tremendous job in reviewing the literature and extracting knowledge from numerous international guidelines, collaborative projects and diverse publications and websites, with the aim of providing recommendations based on available evidence and expert opinion.
Evaluation of the impact of policy changes on donation and transplantation rates
Organ donation rates vary greatly among the Council of Europe member states. Recent data show that some countries have been able to increase their donation rates substantially during the last decade. Internationally, there have been numerous initiatives undertaken to promote learning from best practice and to identify the key factors that may influence donation rates. Yet only limited information is available about the specific measures that have been implemented in member states which have succeeded in increasing donation rates.
A project has been initiated by the EDQM/Council of Europe with the aim of gaining insight into the impact of policy changes on donation and transplantation programmes in the member states. Subsequently, once the different strategies leading to increases in deceased donation rates have been identified, it is planned to develop guidance to support member states in choosing the strategies best suited to their particular situation.
Scientific article (published on behalf of the CD-P-TO) Evolution of Deceased Organ Donation Activity Versus Efficiency Over a 15-year Period: An International Comparison
Critical Factors for Success in Deceased Donation: An International Study - Survey results and final report
Fight against organ trafficking
Trafficking in human beings for the purpose of organ removal (HTOR) and trafficking in human organs (THO) are real and growing problems all over the world. According to the WHO, 5–10% of all transplants performed worldwide are conducted illegally. The most frequently encountered form of trafficking related to organ transplantation involves living unrelated donors. However, deceased donors can also be a source of trafficked organs.
In order to prevent these unethical practices, the EDQM/Council of Europe has carried out a number of projects and adopted several legal instruments to help harmonise legal frameworks and encourage concerted action at global level.
Management of patients having received an organ transplant abroad
Organ shortages, or lack of access to a deceased donor programme, have encouraged trafficking in human beings for the purpose of organ removal (HTOR) and trafficking in human organs (THO), often involving patients seeking to receive an organ transplant abroad. Patients who have received an organ transplant abroad either through proper travel for transplantation or through unethical transplant tourism, typically return to their country of origin shortly after the procedure to receive post-transplantation care.
At the same time, not all those that travel abroad for transplantation may be involved in illicit activities. Ethical travel for transplantation – as opposed to transplant tourism – can take place in exceptional circumstances and be linked to personal or family reasons or to the availability of translation services in the context of agreements between the governments of the countries involved. Such ethical travel for transplantation should never entail transplant-related crimes or reduce the ability of countries of destination to cover the transplantation needs of their own patients.
Whatever the scenario, it is clearly established that the systematic and appropriate registration in national transplant registries of all patients who undergo organ transplantation allows transparency, connection between traceability and biovigilance systems and enables the evaluation of the long-term outcomes of transplantation. These benefits are desirable not only for patients having received an organ transplant domestically but also for those who have received a transplant abroad. In the latter case, registration in national transplant registries would also allow gathering of up-to-date epidemiological information and provision of personalised care depending on the country where the patient has received the organ transplant. This is especially important for those having received an organ transplant abroad in illicit circumstances since they are much more likely to suffer serious complications or life-threatening conditions, particularly infections caused by opportunistic pathogens, microorganisms not previously seen in their home country or multidrug resistant organisms – which entail a risk not only to the patient but also to public health.
In response, the Committee of Ministers of the Council of Europe has recently adopted Resolution CM/Res(2017)2 which aims at protecting all patients who have received an organ transplant, regardless of the circumstances in which it was obtained, and to safeguard public health by recommending that all patients undergoing organ transplantation are systematically registered in national transplant records.
Access of non-resident patients to national deceased waiting lists
The CD-P-TO has started working on a new project aimed at elaborating a draft Resolution to support member States in making decisions related to access of non-residents to national/regional deceased donor waiting lists. This is a matter of great importance as member States need to provide adequate and humanitarian solutions for non-resident patients while meeting the transplantation needs of their own resident patients, whose chances of receiving the needed organ would be impacted by the influx of non-resident patients onto national/regional waiting lists.
A survey to evaluate the current situation in member States is on-going to analyse current practices and guide the elaboration of future recommendations.
International network of National Focal Points on Travel for Transplantation and International Database on Travel for Transplantation
Council of Europe Resolution CM/Res(2013)55 calls member states to adopt procedures and methods for the regular collection of data on illicit transplantation procedures performed outside the framework of a domestic transplantation system and to communicate the results to the European Committee on Organ Transplantation (CD-P-TO). In the context of this Resolution, member states have designated a reference person or National Focal Point (NFP), based at the existing national transplantation organisation and/or Ministry of Health, to be in charge of this data collection.
Later work evidenced that reporting transplant centres should not be put in the position to decide if their patients had been involved in illicit transplant-related activities. Thus, it was decided that the data collection exercise would involve all patients having received a kidney transplant abroad, regardless of the nature of the transplant (i.e. should it have been obtained through proper travel for transplantation or through transplant tourism). This decision is also in line with Council of Europe Resolution CM/Res(2017)2, which establishes that the same principles of transparency, traceability and continuity of care desirable for patients having received an organ transplant domestically also apply for those having received a transplant abroad.
In June 2017 a dedicated International Database on Travel for Transplantation was launched. In this database, NFP provide information about all patients who travelled abroad to receive an organ transplant. The international exchange of information about these patients would help to better understand and analyse the phenomenon of travel for transplantation, to assess its dimension, and to identify possible hot spots of transplant tourism that deserve careful investigation by the concerned countries. In addition, it would help gain better knowledge of the profile of donors and recipients, the quality in the transfer of recipient care and its impact on post-transplant outcomes.
International co-operation projects
Over the last few years, the EDQM/Council of Europe has implemented several projects mainly directed towards the development of effective legislative frameworks and the establishment of national transplant authorities and programmes.
From these efforts, it has become evident that experiences from countries with well-developed and established transplantation programmes should be shared and that national initiatives could provide models for increasing transplantation activity as well as for the implementation of safety and quality programmes throughout Europe.
In 2011, the EDQM/Council of Europe launched a three-year collaborative project that aimed to combat organ shortages and to improve access to transplant health services in the Council of Europe BSA member states (Armenia, Azerbaijan, Bulgaria, Georgia, Moldova, Romania, Russian Federation, Türkiye and Ukraine).
The BSA project contributed to the development of transplantation activities in the participant countries by providing expertise and guidance. Thanks to the project, it was possible to analyse, assess and compare the different legal and organisational systems in these countries. The BSA project also evaluated the organ donation and transplantation programmes in each participant country and provided recommendations, guidelines and educational tools to enhance and consolidate them.
Donation after circulatory determination of death
This project aims at providing an updated review of the developments in donation after circulatory death (DCD) in the Council of Europe member states, with a focus on the quantity and type of donation and transplantation activities, the procedures used in clinical practice and the results of transplants performed with DCD donor organs.
Related article Current situation of donation after circulatory death in European countries, 2011
Vascular composite allotransplantation
The transplantation of vascularised composite allografts (VCA) is a treatment for complex tissue injuries and defects. To date, primary applications of this type of transplantation have been of the extremities and face (partial and full), although there are also reported cases of several other VCA, including those of the larynx, uterus or abdominal wall.
Unlike most solid-organ transplantations, the transplantation of VCA is not usually life-saving, and its primary aim is to increase a patient’s quality of life. Since these transplants will expose patients to a lifelong regimen of immune-suppressive drugs and rejection episodes and will often result in catastrophic events, risks and benefits have to be carefully evaluated on a case-by-case basis and the procedures carried out under a very specific and strict regulation.
The European Committee on Organ Transplantation (CD-P-TO) is currently working on a document to provide guidelines to professionals on aspects such as recipient selection, immunosuppressive strategies, post-transplant complications information, and legal basis and authorisation procedures in order to ensure a common safety framework among member states.
Scientific article (published on behalf of the CD-P-TO) Vascularized composite allotransplantation - a Council of Europe position paper
Transplantation and physical activity
Regular physical activity and supervised physical exercise in transplanted patients is not only safe but also provides beneficial effects on their quality of life. Therefore, the European Committee on Organ Transplantation (CD-P-TO) recommends member states to promote specific physical activity programmes as a complementary tool in the care of transplanted patients.
Download the Position Paper on Transplantation and Physical Activity
Download the booklet
European Donation Day
With the aim of drawing public attention to organ donation and transplantation, the Council of Europe celebrates the European Day for Organ Donation and Transplantation (EODD) in a different member state every year usually on the second Saturday of October.
The main objectives of the EODD are to raise public awareness and establish trust within the general public towards responsible, ethical, non-commercial and professional organ donation and transplantation, to engage policy-makers and the medical community, and to encourage public debate and provide information so that each person can decide about donation and make their wishes known to their family. EODD is also an opportunity to honour all organ donors and their families and to thank transplantation professionals throughout Europe, whose hard work helps to save lives and improve the quality of life of many people.
Understanding post-mortem blood testing practices for tissue donation
Screening donors for infectious diseases is a critical step in tissue donation. Ideally, this should be done using a blood sample obtained prior to the death of the donor, as certain characteristics of samples collected post-mortem may give rise to non-specific reactivity or false negative results; however, this is not always possible.
With a view to understanding post-mortem blood screening practices in Europe, the EDQM/Council of Europe convened a working group of experts in the field nominated by member States. The result of their efforts is a report which describes the state of the art and provides recommendations to improve post-mortem testing practices. The ultimate goal of this work was to support future policy decisions that will make it possible to increase the number of tissue donors while maintaining the required levels of specificity and sensitivity for the detection of infectious diseases.
This project was co-ordinated by the EDQM within the framework of Grant Agreement 2018 53 01 with the European Commission.
Harmonising activity data collection exercises in the field of tissues and cells in Europe
Achieving self-sufficiency based on voluntary unremunerated donation and security of supply, as well as timely and equitable access to safe transplantation, are important national and European goals. A realistic assessment of supply and needs are fundamental for the rational, fair and effective distribution of tissues and cells and, most importantly, to avoid overreliance on 3rd countries outside the EU or on a few EU countries. Furthermore, having accurate activity data would also be essential in order to put into context the figures related to serious adverse events and reactions related to the use of tissues and cells of human origin.
However, at present we only have a fragmented and incomplete picture of tissue and cell activity. This applies not only to the tissues and cells procured and distributed in individual countries but also to those being exchanged between EU member states and at international level. Paradoxically, many stakeholders, including some member states and professional societies, are trying to collect activity data in this field, posing a significant burden on reporting bodies such as tissue establishments and clinical users. Nonetheless, their efforts have been undermined by the lack of consensus and clarity on the data needed for different purposes, the heterogeneous terminology and units used to describe and quantify tissues and cells and the absence of a legal mandate at EU level to collect this type of data.
In an attempt to streamline and harmonise data collection exercises in the EU, and in the framework of a co-operation Grant Agreement between the European Commission and the EDQM/Council of Europe, the EDQM has co-ordinated a project entitled “Harmonising Activity Data Collection Exercises in the Field of Tissues and Cells in Europe”. This project started in 2019 and has built on the experience from member States and relevant professional societies in the field of tissues and cells. It has aimed at agreeing on a minimum dataset that would serve the purposes of transparency for citizens and as denominators for the EU biovigilance exercises. It has entailed reaching an agreement on the parameters, units and expected quality of the data to be collected, as well as making recommendations on who should be accountable for the collection and validation of this data and ensure dissemination among all relevant stakeholders. This exercise is of particular importance in the context of the upcoming revision of the EU legislation in the field of tissues and cells.
Recommendation CM/Rec(2022)19 of the Committee of Ministers to member States on establishing measures for the harmonised collection of activity data related to the availability and use of tissues and cells of human origin with a view to supporting self-sufficiency and facilitating international data sharing
Preparatory study on trafficking of human tissue and cells
The European Committee on Organ Transplantation (CD-P-TO) has collected evidence on the different illicit and unethical activities identified in the field of tissues and cells, involving lack of consent, falsification of documents, commercialisation of tissues, processing, transport and storage of tissues in illegal facilities, etc.
A document has been elaborated to raise awareness among Council of Europe decision-making bodies of the necessity to explore the need for an additional protocol to define, prevent and combat illicit activities in the chain of donation to clinical application of human tissue and cells, and to protect donors and recipients.
Autologous cord blood banks
In recent years, there has been a proliferation of cord blood banks charging families yearly fees for storage of their baby’s cord blood for possible future private uses, despite the absence of scientific evidence to support cord blood banking for autologous or family use. Concerned by the quality standards set in place in some of these banks and by their advertisement practices, the Council of Europe adopted Recommendation Rec(2004)8 of the Committee of Ministers to member states on autologous cord blood banks and its Explanatory Memorandum. This legal text recommends member states to allow the establishment of cord blood banks only as a result of altruistic and voluntary cord blood donation and to store donated cord blood units in public cord blood banks that will make them available for the treatment of patients with specific diseases and medical conditions.
In addition, the European Committee on Organ Transplantation (CD-P-TO) has prepared a guide for parents, providing clear, accurate and balanced information about the use of cord blood in medical treatment and guiding them through their storage options.
Improving information to women on their choices regarding oocyte preservation, donation and treatment
In recent years, progress in reproductive medicine and embryology has led to the development of Assisted Reproductive Technologies (ART), which provide a number of ways for women to improve their reproductive choices. These include: the treatment of fertility problems; reproduction in couples with infectious or genetic diseases; childbearing of women with no male partner; the preservation of fertility for women who wish to postpone conceiving for medical or social reasons, and the donation of gametes and embryos for the treatment of other women who may not be able to have children otherwise.
In this context, the European Committee on Organ Transplantation (CD-P-TO) is preparing several booklets aimed at promoting women’s health literacy with regard to their reproductive capacities. By increasing access to scientifically accurate and balanced information, these booklets will support women in their discussions with health providers and physicians so they can make the decisions to best suit their needs.
The first of these booklets, entitled “Donation of oocytes: A guide for women to support informed decisions”, elaborated in collaboration with the European Society of Human Reproduction and Embryology (ESHRE), aims at providing clear, accurate and balanced information about the donation of oocytes, including a general overview of the process of oocyte donation, potential risks for donors, uses of the donated oocytes, rights and responsibilities of donors and other important information that will help women through this important decision-making process.
also available in French.
The CD-P-TO is committed to address the heterogeneous approach to the follow-up of living haematopoietic progenitor cell (HPC) and gamete donors in Europe . In order to do this, a new project has been launched. The project is divided in two separate parts focusing on HPC donors and gamete donors. Practices in Europe will be evaluated through dedicated questionnaires and, subsequently, tailored recommendations will be elaborated.
Risk of commodification of substances of human origin
It is widely perceived that commodification of the human body and its parts places an unacceptable financial value on human life, a belief enshrined in Article 21 of the 1997 Council of Europe Convention on Human Rights and Biomedicine, as well as in many other national and international documents and legislation. On the other hand, it is conceivable to charge “reasonable fees” for legitimate medical or related technical services rendered in connection with substances of human origin (SoHO). However, what constitutes a “reasonable fee” has not been defined and this creates a grey area that is potentially conducive to profit making.
In this scenario, the use of SoHO to treat patients – including through the production of innovative treatments – has created a situation where procurement organisations, commercial tissue and blood banks, pharmaceutical companies and numerous brokers and distributors can charge fees for their services. This may have far‐reaching consequences for the allocation of SoHO, the access to treatment by patients and the sustainability of the public healthcare systems funding them.
The European Committee on Organ Transplantation (CD-P-TO) has evaluated the risks of commodification of SoHO in the current European setting. The outcome is a position statement (link below) setting out a series of proposals aimed at ensuring that the ethical principles of voluntary and unpaid SoHO donation and the non-commercialisation of the human body are respected, that the sustainability of healthcare systems is protected and that SoHO continue to be available (and accessible to patients), even in the context of innovative therapies that may, on occasion, need to be regulated under different regulatory frameworks.
(adopted by the CD-P-TO on 18 November 2022)
Guide to the quality and safety of organs for transplantation
Transplant medicine and transplantation have progressed during the last decades in a way that nobody would have imagined before. The transplantation of organs offers major therapeutic benefits and improvements to quality of life and is, in many cases, the only life-saving treatment for end-stage organ failure.
Guide to the quality and safety of tissues and cells for human applications
Human tissues and cells are being used in an increasing variety of ways, and advances in transplantation therapy have unquestionable benefits. Human cells and tissues for human application can save lives or restore essential functions, but the use of human tissues and cells also raises questions of safety and quality.