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Transplantation : axes de travail

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Organs

Tissues and Cells

 

Organs

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.

Download  Resolution CM/Res(2015)10 on the role and training of critical care professionals in deceased donation

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Living donation 

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.

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.

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.

Download Resolution CM/Res(2017)1 on principles for the selection, evaluation, donation and follow-up of the non-resident living organ donors

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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.

For more information, please visit our dedicated website.

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International monitoring

Monitoring of practices in the member states is evidently needed to allow transparency and international benchmarking. To this end, since 1996 the EDQM/Council of Europe has published the Newsletter Transplant, which is coordinated by the Spanish National Transplant Organization. This publication summarises comprehensive data provided by national focal points (NFP) designated by governments, on donation and transplantation activities, management of waiting lists, organ donation refusals and authorised centres for transplantation activities. As of today, the Newsletter Transplant provides information from over 70 countries worldwide, including Council of Europe member states, observer countries and observer networks (e.g. Iberoamerican Donation and Network Council on Organ Donation and Transplantation, Mediterranean Network). To avoid duplication of efforts, the Newsletter Transplant database is connected with other international data collection projects, e.g. the WHO Global Observatory on Organ Donation and Transplantation and the Eurocet database. The Newsletter Transplant has evolved into a unique official source of information that continues to inspire policies and strategic plans globally.

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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.

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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 a global level.

International Network of National Focal Points on transplant-related crimes

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).  This Resolution recommends that member states designate 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. The nomination of reference NFPs will be essential to gain a better knowledge of transplant-related crimes and gives a valuable opportunity to provide comprehensive and integrated information and recommendations on these matters at national level. In addition, this international network of NFP will also play a crucial role at national and international level in ensuring that a comprehensive and integrated approach to the fight against transplant-related crimes is put in place and that victims, as well as patients can receive due attention and support.

Commercialisation of human organs

The Committee on Bioethics (DH-BIO) and the European Committee on Organ Transplantation (CD-P-TO) of the Council of Europe are concerned by suggestions made, sometimes in international forums, that some forms of commercialisation of human organs could be accepted in response to the shortage of organs for transplantation.

In this context, the DH-BIO and the CD-P-TO strongly emphasise the need to respect the fundamental legal principle that the human body and its parts shall not, as such, give rise to financial gain. Human organs must not therefore be bought or sold or give rise to financial gain or comparable advantages for the person from whom they have been removed or for a third party.

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Management of patients having received an organ transplant abroad

Organ shortages, or lack of access to a deceased donor programme, have encouraged organ trafficking and human trafficking for the purpose of organ removal, 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 transplant tourism, typically return to their country of origin shortly after the procedure to receive post-transplantation care.

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.

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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.

Black Sea Area (BSA Project)

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, Turkey 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.

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Donation after circulatory 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

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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.

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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.

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European Day for Organ Donation and Transplantation

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.

For more information, please visit our dedicated website.

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Tissues and Cells

Preparatory study on trafficking of human tissues and cells

The European Committee on Organ Transplantation (CD-P-TO) is collecting evidence on the different unethical and deceitful 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 will be drafted to raise awareness among Council of Europe decision-making bodies and to establish the need for an international legal instrument aimed at combatting these practices.

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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.

Download the brochure “Umbilical cord blood banking – A guide for parents

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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 brochures aimed at promoting women’s health literacy with regard to their reproductive capacities. By increasing access to scientifically accurate and balanced information, these brochures will support women in their discussions with health providers and physicians so they can make the decisions to best suit their needs.

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