Organ Donation – WMA – The World Medical Association

Adopted by the 173^rd WMA Council Session, Divonne-les-Bains, France, May 2006
and reaffirmed by the 203^rd WMA Council Session, Buenos Aires, Argentina, April 2016
and revised by the 226^th WMA Council Session, Seoul, Korea, April 2024
and adopted by the 75^th WMA General Assembly, Helsinki, Finland, October 2024

Whereas the WMA Statement on Human Organ and Tissue Donation and Transplantation stresses the importance of free and informed choice in organ donation and

Whereas the statement explicitly states that prisoners and other individuals in custody are not in a position to give consent freely, and therefore, their organs must not be used for transplantation and

Whereas, prior to 2014, there were reports of Chinese prisoners being executed and their organs procured for donation; and

Whereas the WMA reiterates its position that organ donation be achieved through the free and informed consent of the potential donor; and

Whereas the WMA General Assembly in Copenhagen in 2007 was informed that the Chinese Medical Association (ChMA) stated in a letter by Dr. Wu Mingjang, (then) Vice President and Secretary General of the ChMA that

the Chinese Medical Association agrees to the WMA Statement on Human Organ Donation and Transplantation, in which it states that organs of prisoners and other individuals in custody must not be used for transplantation, except for members of their immediate family. The Chinese Medical Association will, through its influence, further promote the strengthening of management of human organ transplantation and prevent possible violations made by the Chinese Government.”[1]

Whereas the Chinese Medical Association (ChMA) gave a statement regarding the proposed WMA Declaration on Organ Donation for Transplantation from Executed Prisoners at the 223^rd Council meeting in Nairobi 2023, stating:

“The Chinese Medical Association (ChMA) fully supports China’s complete prohibition on the use of organs from death penalty prisoners for transplantation, implemented on January 1st, 2015. This policy has significantly contributed to the successful development of voluntary deceased organ donation in China, propelling the nation to rank second globally in annual deceased organ donation and benefiting numerous Chinese patients.
ChMA firmly supports and adheres China’s comprehensive legal and regulatory system, as well as the technical capacity developed to facilitate the legal enforcement, ensuring the continued prohibition of using organs from executed prisoners and the ongoing success of the national organ donation program.
ChMA encourages all her members (to) actively participates (in) China’s efforts to establish a self-sufficient organ donation system in line with WHO guiding principle, condemns the practice of using organs from executed prisoners for transplantation. ChMA will continue, and also call upon all national medical associations, particularly those with legislation permitting the practice of the use of organs from executed prisoners, to educate physicians on ethical values and conduct in order to prevent such a practice.”

Whereas the WMA reiterates paragraphs 17,18 and 19 of the undisputed WMA Statement on Organ and Tissue Donation, last revised at the WMA 68^th. General Assembly in Chicago, United States, October 2017, which read:

17. Prisoners and other people who are effectively detained in institutions should be eligible to donate after death where checks have been made to ensure that donation is in line with the individual’s prior, un-coerced wishes and, where the individual is incapable of giving consent, authorisation has been provided by a family member or other authorized decision-maker. Such authorisation may not override advance withholding or refusal of consent.
18. Their death is from natural causes and this is verifiable.
19. In jurisdictions where the death penalty is practised, executed prisoners must not be considered as organ and/or tissue donors. While there may be individual cases where prisoners are acting voluntarily and free from pressure, it is impossible to put in place adequate safeguards to protect against coercion in all cases.

Whereas there have been reports of purported inappropriate organ procurement from prisoners within several nations and the WMA should remain firmly on record to condemn inappropriate organ procurement from prisoners and other people who are effectively detained in institutions in all nations.

The WMA will amend the title of the WMA Council Resolution on Organ Donation in China (2006) to the WMA Council Resolution on Organ Donation in Prisoners.

Therefore, the Workgroup on Organ Procurement (November 2023) proposes to amend the WMA Council Resolution on Organ Donation in China (2006), to read as follows:

The WMA reiterates its position that organ donation be achieved through the free and informed consent of the potential donor.

The WMA calls on its Constituent member associations to condemn any practice of using prisoners and other people who are effectively detained in institutions as organ donors in any manner that is not consistent with the WMA Statement on Organ and Tissue Donation and ensure that physicians are not involved in the removal or transplantation of organs from executed prisoners, and

the WMA demands all national governments to immediately cease the practice of using prisoners and other people who are effectively detained in institutions as organ donors in any manner that is not consistent with the WMA Statement on Organ and Tissue Donation.

[1] WMA News, Chinese Medical Association reaches agreement with WMA against transplantation of prisoner’s organs. Copenhagen, 2007 replace by original message.

Adopted by the 71^st WMA General Assembly (online), Cordoba, Spain, October 2020

PREAMBLE

In 2017, almost 140,000 solid organ transplants were performed worldwide. Although impressive, this activity provided for only 10% of the global need for transplanted organs. The disparity between supply and demand of organs has led to the emergence of transplant-related crimes, including trafficking in persons for the purpose of the removal of organs and trafficking in human organs.

These crimes violate fundamental human rights and pose serious risks to both individual and public health. The true extent of transplant-related crimes remains unknown, but it is estimated that 5% to 10% of transplants globally take place in the context of the international organ trade, often involving transplant tourism to destinations where laws against the sale and purchase of human organs are nonexistent or poorly enforced. Trafficking in persons for the purpose of the removal of organs and trafficking in human organs can also take place within the boundaries of a given jurisdiction, not involving travel for transplantation. In all cases, the most vulnerable parts of the population often become victims of exploitation and coercion.

Concerned by the increasing demand for organs and by emerging unethical practices in the field, the World Health Organization has called on governments and health professionals to pursue self-sufficiency in transplantation, through strategies targeted at decreasing the burden of diseases treatable with transplantation and increasing the availability of organs, maximising donation from the deceased and ensuring the overall protection of the living donor. Progress towards self-sufficiency in transplantation is consistent with the establishment of official cooperation agreements between countries to share organs or to facilitate patients’ access to transplant programs that have not been developed in their countries of origin. Agreements between countries should be based on the principles of justice, solidarity and reciprocity.

Progress towards self-sufficiency in transplantation is the best long-term strategy to prevent transplant-related crimes.

The distinctive feature of transplant-related crimes is the necessary involvement of health professionals. It is precisely this feature that provides a unique opportunity to prevent and combat these crimes. Health professionals are key in evaluating prospective living donor and recipient pairs. They also care for desperate patients who are vulnerable and at risk of engaging in illicit transplant activities. In addition, since patients who receive a transplant require long-term specialised care, physicians must deal with the many challenges of providing care to patients who have received an organ through illicit means, while unveiling trafficking rings.

International organisations, including the Council of Europe, the European Union and the United Nations, as well as international professional platforms, have developed treaties, resolutions and recommendations for a concerted fight against transplant-related crimes.

The WMA emphasises the responsibility of physicians in preventing and combatting trafficking in persons for the purpose of the removal of organs and trafficking in human organs, as well as the important role of physicians and other health-care professionals in assisting international organisations, medical associations and policy makers in the fight against these criminal activities.

In the fight against transplant-related crimes it is of utmost importance that the principles of transparency of practice, traceability of organs and continuity of care are guaranteed for every transplant procedure performed nationally or abroad.

The WMA reaffirms its Statement on organ and tissue donation and its Declaration of Sydney on the determination of death and the recovery of organs. Condemning all forms of trafficking in persons for the purpose of the removal of organs and trafficking in human organs, the WMA calls for the implementation of the following recommendations.

RECOMMENDATIONS

Policy makers and health actors:

Governments should develop, implement and vigorously enforce legislative frameworks that prohibit and criminalise trafficking in persons for the purpose of the removal of organs and trafficking in human organs, these should include provisions to prevent these crimes and protect their victims.
Governments should consider ratifying or acceding to the United Nations Convention against Transnational Organised Crime and the Protocol to Prevent, Suppress and Punish Trafficking in Persons, Especially Women and Children, supplementing the United Nations Convention against Transnational Organised Crime, as well as the Council of Europe Convention against Trafficking in Human Organs. They should also consider cooperating with existing international organisations for a more effective fight against transplant-related crimes. The WMA should play a leading role in influencing ethical practices in donation and transplantation.
Health authorities should develop and maintain registries to record information regarding each organ recovery and transplantation procedure, as well as information on the outcomes of living donors and organ recipients, to ensure the traceability of organs, with due regard to professional confidentiality and personal data protection. Registries should be designed to record information on procedures that take place within a country and on transplant and living donation procedures on residents of that country carried out in other destinations.
Countries are encouraged to periodically contribute this information to the Global Observatory on Donation and Transplantation developed in collaboration with the World Health Organization.
Health authorities and medical associations should ensure that all health professionals are trained in the nature, extent and consequences of transplant-related crimes, as well as in their responsibilities and duties in preventing and fighting these criminal activities and in the means to do so.
As self-sufficiency is the best long-term strategy to prevent transplant-related crimes, health authorities and policy makers should develop preventive strategies to decrease the burden of diseases treatable with transplantation and increase the availability of organs.
Increasing organ availability should be based on the development and optimisation of ethically sound deceased donation programs following the determination of death by neurological and by circulatory criteria. Of note is that donation after the determination of death by circulatory criteria is accepted in a limited number of countries. Governments should explore whether donation after the circulatory determination of death is a practice acceptable within their community and, should this be the case, consider introducing it within their jurisdiction.
In addition, governments should develop and optimise living donation programs based on recognised ethical and professional standards and ensure due protection and follow-up of living donors.
Health authorities and/or insurance providers should not reimburse the costs of transplant procedures that have occurred in the context of transplant-related crimes. However, the costs of medications and post-transplant care should be covered, as for any other transplant patient.
Authorities should also ensure that medical and psychosocial care is provided to victims of trafficking in persons for the purpose of organ removal and of trafficking in human organs. Consideration should be given to effective compensation of these persons for the damage suffered.
National Medical Associations should advocate for and cooperate with authorities in developing frameworks for health professionals to report any confirmed or suspected case of trafficking of persons for the purpose of the removal of organs and of trafficking in human organs to the relevant authorities. National Medical Associations should advocate for the ability of health professionals to report suspected trafficking of individual persons, on an anonymous basis if necessary, to protect the safety of the reporter. Where applicable, the reporting of trafficking cases should be a permitted exception to the physician’s obligation to maintain patient confidentiality

Physicians and other health professionals:

Physicians should never perform a transplant using an organ that has been illicitly obtained. If there are reasonable concerns about the origin of an organ, the organ must not be used. If a physician or a surgeon is asked to perform a transplant with an organ that has been obtained through a financial transaction, without the valid consent of the donor or without the authorisation required in a given jurisdiction, they must refrain from performing the transplant and should explain the reasons to the potential recipient.
Physicians who participate in the preoperative evaluation of potential living donors should not only assess the medical suitability of the individual, but also attempt to ensure that the person has not been subject to coercion of any kind or is participating in the procedure for financial gain or any other comparable advantage. The legitimacy of the donor-recipient relationship and the altruistic motivations for donation should be scrutinised. Physicians should be particularly vigilant of “red flags” suggestive of a transplant-related crime. Non-resident living donors may be particularly vulnerable and should be given special consideration. For linguistic, cultural and other reasons, assessing the validity of their consent to donation can be especially challenging, as can ensuring that appropriate follow-up is offered to them. A referring physician should be identified in the country of origin of the living donor – and in that of their intended recipient, where appropriate.
Physicians should never promote or facilitate the engagement of patients in transplant-related crimes. Moreover, they should inform patients of the risks these activities pose for their own health, that of their loved ones and, more generally, for public health. Patients should also understand that these activities entail an exploitation of vulnerable individuals who may themselves suffer from severe medical and psychosocial complications. By counselling patients, professionals may dissuade them from engaging in illicit transplant activities.
Physicians have a duty to care for transplant patients, even if their organ was illicitly Should a physician have ethical or moral objections about caring for a patient who has received an illicit organ, they should make the necessary arrangements to transfer the care of the patient to another physician.
Physicians should contribute to guaranteeing transparency of practices and traceability of organs. When patients who have undergone a donation or a transplantation procedure abroad seek follow-up care in their country of residence, all relevant information should be recorded in national transplant-registries and reported to health authorities, as should happen for all donation and transplantation procedures performed within the national transplant system.
. Physicians have a responsibility to increase the deceased donor pool in order to satisfy the transplantation needs of patients. Physicians also have a duty towards possible organ donors in considering and facilitating organ donation if this is consistent with patients’ values and principles. Donation should be routinely offered as an option at the end of life, always in a respectful manner, taking into account the culture and religion of the potential donor and their surrogates. Conversations about donation opportunities should be led by experienced and trained professionals.
Physicians should promote research in the field of donation and transplantation, in particular research targeted at increasing the availability of organs for transplantation, improving the outcomes of transplanted organs, and identifying alternative organ replacement strategies, as in the case of bioartificial organs.

Adopted by the 63^rd WMA General Assembly, Bangkok, Thailand, October 2012
and revised by the 68^th WMA General Assembly, Chicago, United States, October 2017

PREAMBLE

1. Advances in medical sciences, especially surgical techniques, tissue typing and immuno-suppressive drugs, have made possible a significant increase in the rates of successful transplantation of human organs and tissue. Yet, in all countries, a shortage of organ donors results in potentially avoidable loss of life. National medical associations should support attempts to maximise the number of donor organs available in their countries and to ensure that the highest ethical standards are maintained. The World Medical Association has developed this policy to assist medical associations, physicians, other health care providers and policy makers to achieve this.

This policy is based on a number of core ethical principles: altruism, autonomy, beneficence, equity and justice. These principles should guide those developing national policies and those operating within it, both in relation to organ procurement and to the distribution and transplantation of donor organs. All systems and processes should be transparent and open to scrutiny.

This statement applies to organ and tissue donation from both deceased and living donors. It does not apply to blood donation.

RAISING PUBLIC AWARENESS

2. It is important that individuals are aware of the option of donation and have the opportunity to choose whether or not to donate organs and/or tissue before and after their death. Awareness and choice should be facilitated in a coordinated multi-faceted approach by a variety of stakeholders and means, including media awareness and public campaigns. In designing such campaigns account needs to be taken of any religious or cultural sensitivities of the target audience.

3. Through awareness raising campaigns, individuals should be informed of the benefits of transplantation, the impact on the lives of those who are waiting for a transplant and the shortage of donors available. They should be encouraged to think about their own wishes about donation, to discuss their wishes with their family and friends and to use established mechanisms to formally record them by opting into, or out of, donation.

4. The WMA advocates informed donor choice. National medical associations in countries that have adopted or are considering a policy of “presumed consent” (or opt-out), in which there is an assumption that the individual wishes to donate unless there is evidence to the contrary, or “mandated choice”, in which all persons would be required to declare whether they wish to donate, should make every effort to ensure that these policies have been adequately publicised and do not diminish informed donor choice, including the patient’s right not to donate.

5. Consideration should be given to the establishment of national donor registries to collect and maintain a list of citizens who have chosen either to donate or not to donate their organs and/or tissue. Any such registry must protect individual privacy and the individual’s ability to control the collection, use, disclosure of, and access to, his or her health information for other purposes. Provisions must be in place to ensure that the decision to sign up to a register is adequately informed and that registrants can withdraw from the registry easily and quickly and without prejudice.

6. Living organ donation is becoming an increasingly important component of transplantation programmes in many countries. Most living donation is between related or emotionally close individuals and small but increasing numbers are donating to people they do not know. Given that there are health risks associated with living organ donation, proper controls and safeguards are essential. Information aimed at informing people about the possibility of donating organs as a living donor should be carefully designed so as not to put pressure on them to donate and to minimise the risk of financial or other coercion. Potential donors should know where to obtain detailed information about what is involved, should be informed of the inherent risks and should know that there are safeguards in place to protect those offering to donate.

PROTOCOLS FOR ORGAN AND TISSUE DONATION FROM DECEASED DONORS

7. The WMA encourages its members to support the development of comprehensive, coordinated national protocols for deceased (also referred to as cadaveric) organ and tissue procurement in consultation and cooperation with all relevant stakeholders. Ethical, cultural and societal issues arising in connection with donation and transplantation should be resolved, wherever possible, in an open process involving public debate informed by sound evidence.

8. National and local protocols should provide detailed information about the identification, referral and management of potential donors as well as communication with those close to people who have died. They should encourage the procurement of organs and tissues consistent with this statement. Protocols should uphold the following key principles:

Decisions to withhold or withdraw life-prolonging treatment should be based on an assessment of whether the treatment is able to benefit the patient. Such decisions must be, and must be seen to be, completely separate from any decisions about donation.
The diagnosis of death should be made according to national guidelines and as outlined in the WMA’s Declaration of Sydney on the Determination of Death and Recovery of Organs.
There should be a clear separation between the treating team and the transplant team. In particular, the physician who declares or certifies the death of a potential donor should not be involved in the transplantation procedure. Nor should he/she be responsible for the care of the organ recipient.
Countries that carry out donation following circulatory/cardiac death should have specific and detailed protocols for this practice.
Where an individual has expressed a clear and voluntary wish to donate organs and/or tissue after death, steps should be taken to facilitate that wish wherever possible. This is part of the treating team’s responsibility to the dying patient.
The WMA considers that the potential donor’s wishes are paramount. Relatives and those close to the patient should be strongly encouraged to support a deceased person’s previously expressed wish to donate organs and/or tissues. Whenever possible, these conversations should occur prior to the death of the patient.
Those charged with approaching the patient, family members or other designated decision maker about organ and tissue donation should possess the appropriate combination of knowledge, skill and sensitivity for engaging in such discussions. Medical students and practising physicians should seek the necessary training for this task, and the appropriate authorities should provide the resources necessary to secure that training.
Donation must be unconditional. In exceptional cases, requests by potential donors, or their substitute decision makers, for the organ or tissue to be given to a particular recipient may be considered if permitted by national law. Donors seeking to apply conditions that could be seen as discriminatory against certain groups, however, should be declined.

9. Hospitals and other institutions where donation occurs should ensure that donation protocols are publicised amongst those likely to use them and that adequate resources are available for their implementation. They should also foster a pro-donation culture within the institution in which consideration of donation is the norm, rather than the exception, when a patient dies.

10. The role of transplant coordination is critical to organ donation. Those performing coordination act as the key point of contact between the bereaved family and the donation team and usually also undertake the complex logistical arrangements to make donation happen. Their role must be recognised and supported.

11. Deceased organ donation must be based on the notion of a gift, freely and voluntarily given. It should involve the voluntary and unpressured consent of the individual provided before death (by opting in or opting out of donation depending upon the jurisdiction) or the voluntary authorisation of those close to the deceased patient if that person’s wishes are unknown. The WMA is strongly opposed to the commercialisation of donation and transplantation.

12. Prospective donors or their substitute health care decision makers should have access to accurate and relevant information, including through their general practitioners. Normally, this will include information about:

The procedures and definitions involved in the determination of death,
The testing that is undertaken to determine the suitability of the organs and/or tissue for transplantation and that this may reveal previously unsuspected health risks in prospective donors and their families,
Measures that may be required to preserve organ function until death is determined and transplantation can occur,
What will happen to the body once death has been declared,
What organs and tissues can be donated,
The protocol that will be followed in the event that the family objects to donation, and
The possibility and the process of withdrawing consent.

13. Prospective donors or their substitute health care decision makers should be given the opportunity to ask questions about donation and should have their questions answered sensitively and intelligibly.

14. Where both organs and tissues are to be donated, information should be provided, and consent obtained, for both together in order to minimise distress and disruption to those close to the deceased.

15. In some parts of the world a contribution towards funeral costs is given to the family of those who donate. This can be viewed either as appropriate recognition of their altruistic act or as a payment that compromises the voluntariness of the choice and the altruistic basis for donation. The interpretation may depend, in part, on the way it is set up and managed. When considering the introduction of such a system, care needs to be taken to ensure that the core principles of altruism, autonomy, beneficence, equity and justice are met.

16. Free and informed decision making requires not only the provision of information but also the absence of coercion. Any concerns about pressure or coercion must be resolved before the decision to donate organs or tissue is made.

17. Prisoners and other people who are effectively detained in institutions should be eligible to donate after death where checks have been made to ensure that donation is in line with the individual’s prior, un-coerced wishes and, where the individual is incapable of giving consent, authorisation has been provided by a family member or other authorized decision-maker. Such authorisation may not override advance withholding or refusal of consent.

18. Their death is from natural causes and this is verifiable.

19. In jurisdictions where the death penalty is practised, executed prisoners must not be considered as organ and/or tissue donors. While there may be individual cases where prisoners are acting voluntarily and free from pressure, it is impossible to put in place adequate safeguards to protect against coercion in all cases.

ALLOCATION OF ORGANS FROM DECEASED DONORS

20. The WMA considers there should be explicit policies, open to public scrutiny, governing all aspects of organ and tissue donation and transplantation, including the management of waiting lists for organs to ensure fair and appropriate access.

21. Policies governing the management of waiting lists should ensure efficiency and fairness. Criteria that should be considered in allocating organs or tissue include:

Severity and urgency of medical need,
Length of time on the waiting list,
Medical probability of success measured by such factors as age, type of disease, likely improvements in quality of life, other complications, and histocompatibility.

22. There must be no discrimination based on social status, lifestyle or behaviour. Non-medical criteria must not be considered.

PROTOCOLS FOR ORGAN AND TISSUE DONATION FROM LIVING DONORS

23. Living donation is becoming increasingly common as a way to overcome the shortage of organs from deceased donors. In most cases donors provide organs to relatives or people to whom they are emotionally close. A small number of individuals choose to donate an organ altruistically to a stranger. Another scenario is where one or more donor and recipient pairs are incompatible with each other but donate in the form of a cross-over or pooled donation system (for example, donor A donates to recipient B, donor B donates to recipient C and donor C donates to recipient A).

24. All potential donors should be given accurate and up to date information about the procedure and the risks of donation and have the opportunity to discuss the issue privately with a member of the healthcare team or a counsellor. Normally this information will include:

The risks of becoming a living donor,
The tests that are undertaken to assess suitability for donation and that this may reveal previously unsuspected health problems,
What will happen before, during and after donation takes place, and
In the case of solid organs, the long-term implications of living without the donated organ.

25. Prospective donors should be given the opportunity to ask questions about donation and should have their questions answered sensitively and intelligibly.

26. Procedures should be in place to ensure that living donors are acting voluntarily and free from pressure or coercion. In order to avoid donors being paid and then posing as a known donor, independent checks should also be undertaken to verify the claimed relationship and, where this cannot be proven, the donation should not proceed. Such checks should be independent of the transplant team and those who are caring for the potential recipient.

27. Additional safeguards should be in place for vulnerable donors, including but not limited to, people who are dependent in some way (such as competent minors donating to a parent or sibling).

28. Prisoners should be eligible to be living donors only in exceptional circumstances, to first or second degree family members; evidence should be provided of any claimed relationship before the donation may proceed. Where prisoners are to be considered as living donors, extra safeguards are required to ensure they are acting voluntarily and are not subject to coercion.

29. Those who lack the capacity to consent should not be considered as living organ donors because of their inability to understand and decide voluntarily. Exceptions may be made in very limited circumstances, following legal and ethical review.

30. Donors should not lose out financially as a result of their donation and so should be reimbursed for general and medical expenses and any loss of earnings incurred.

31. In some parts of the world individuals are paid for donating a kidney, although in virtually all countries the sale of organs is unlawful. The WMA is strongly opposed to a market in organs.

PROTOCOLS FOR RECIPIENTS

32. Protocols for free and informed decision making should be followed in the case of recipients of organs or tissue. Normally, this will include providing information about:

The risks of the procedure,
The likely short, medium and long-term survival, morbidity, and quality-of-life prospects,
Alternatives to transplantation, and
How organs and tissues are obtained.

33. In the case of a delayed diagnosis for infection, disease or malignancy in the donor, there should be a strong presumption that the recipient will be informed of any risk to which they may have been exposed. Individual decisions about disclosure need to take account of the particular circumstances, including the level and severity of risk. In most cases disclosure will be appropriate and should be managed carefully and sensitively.

COSTS AND ORIGIN OF ORGANS AND TISSUES

34. Organs or tissue suspected to have been obtained through unlawful means must not be accepted for transplantation.

35. Organs and tissues must not be sold for profit. In calculating the cost of transplantation, charges related to the organ or tissue itself should be restricted to those costs directly associated with its retrieval, storage, allocation and transplantation.

36. Transplant surgeons should seek to ensure that the organs and tissues they transplant have been obtained in accordance with the provisions of this policy and should refrain from transplanting organs and tissues that they know, or suspect, have not been procured in a legal and ethical manner.

TRANSPARENCY AND ACCOUNTABILITY

37. National Medical Associations should work with governments and relevant institutions to ensure that appropriate, effective structures and processes are in place to:

support relevant traceability and follow-up of all transplant recipients and living donors including those who require ongoing medical management receive care and support;
record information on donation and transplantation rates and outcomes;
assess the short and long-term outcomes, quality, safety and efficacy of organ donation and transplantation activities;
assess the adherence to ethical and clinical protocols of organ donation and transplantation activities;

38. The data arising from these activities should be publicly accessible and open to scrutiny (notwithstanding appropriate protection of donor and recipient confidentiality).

FUTURE OPTIONS

39. Public health measures to reduce the demand for donated organs should be seen as a priority, alongside initiatives to increase the effectiveness and success of organ donation systems.

40. New developments and possibilities, such as xenotransplantation and the use of stem cell technology to repair damaged organs, should be monitored. Before their introduction into clinical practice such technologies should be subject to scientific review and robust safety checks as well as ethical review. Where, as with xenotransplantation, there are potential risks that go beyond individual recipients, this process must also involve public debate.

Adopted by the 52^nd WMA General Assembly, Edinburgh, Scotland, October 2000,
revised by the 57^th WMA General Assembly, Pilanesberg, South Africa, October 2006,
and rescinded at the 65^th WMA General Assembly, Durban, South Africa, October 2014

A. INTRODUCTION

Advances in medical sciences, especially surgical techniques, tissue typing and immuno-suppressive drugs, have made possible a significant increase in the rates of successful transplantation of organs. In the light of these developments, there is a need for renewed reflection on ethical issues concerning organ donation and transplantation and on principles relevant to the resolution of these issues. Therefore, the World Medical Association has undertaken a review of issues and principles concerning transplantation and has developed this policy to provide guidance to medical associations, physicians and other health care providers as well as to those who develop policy and protocols bearing on these issues.
This policy is based on principles of general and medical ethics. In matters of ethics, conflicts of values and principles are unavoidable; for example, there is a tension between a desire to procure organs for the purpose of providing important medical treatments on the one hand and the preservation of choice and personal liberty on the other. Applicable principles are referenced throughout this policy where they may help to clarify and make explicit the reasoning behind a given statement.

B. PROFESSIONAL OBLIGATIONS OF PHYSICIANS

The primary obligation of physicians is to their individual patients, whether they are potential donors or recipients of transplanted organs. In conjunction with this obligation physicians may also have responsibilities to the family members and close friends of their patients, for example, to seek and consider their views on organ retrieval from their deceased relative or friend. The obligation to the patient has primacy over any obligations that may exist in relationship to family members. Nevertheless, this obligation is not absolute; for example, the physician’s responsibility for the well-being of a patient who needs a transplant does not justify unethical or illegal procurement of organs.
Physicians have responsibilities to society, which include promoting the fair use of resources, preventing harm and promoting health benefit for all; this may include promoting donation of organs.
Transplant surgeons should attempt to ensure that the organs they transplant have been obtained in accordance with the provisions of this policy and shall refrain from transplanting organs that they know or suspect have not been procured in a legal and ethical manner.

C. ORGAN PROCUREMENT: SOCIAL ASPECTS

The WMA encourages its members to support the development of comprehensive, coordinated national strategies concerning organ procurement in consultation and cooperation with all relevant stakeholders. In developing strategy, due consideration should be given to human rights, ethical principles and medical ethics. Ethical, cultural and societal issues arising in connection with such a strategy, and with the subject of donation and transplantation in general, should be resolved, wherever possible, in an open process involving public dialogue and debate informed by sound evidence.
Some types of organ transplantation have become established and important health care services. To the extent that the lack of organs is a barrier to the provision of needed treatment, the medical profession has an obligation to promote policies and protocols to procure organs for needed treatment consistent with societal values.
It is important that individuals become aware of the option of donation and have the opportunity to choose whether or not to donate (e.g. facilitated choice). Awareness and choice should be facilitated in a coordinated multi-faceted approach by a variety of stakeholders and means, including media awareness and public campaigns. Physicians should provide their patients with the opportunity to make a choice with respect to organ donation, ideally in the context of an ongoing relationship with the patient and in advance of any crisis giving urgency to the choice.
The WMA supports informed donor choice. National Medical Associations in countries that have adopted or are considering a policy of “presumed consent”, whereby there is a presumption that consent has been given unless there is evidence to the contrary, or “mandated choice”, whereby all persons would be required to declare whether they wish to donate, should make every effort to ensure that these policies do not diminish informed donor choice, including the patient’s right to refuse to donate.
Consideration should be given to the establishment of national donor registries to collect and maintain a list of country citizens who have chosen either to donate or not to donate their organs. Any such registry must protect individual privacy and the individual’s ability to control the collection, use, disclosure of and access to his or her health information for purposes other than registration. Provisions must be in place to ensure that the decision is adequately informed and that registrants can withdraw from the registry without penalty.

D. ORGAN PROCUREMENT AT THE INSTITUTIONAL AND INDIVIDUAL LEVELS

Organ donation can be enhanced by local policies and protocols. The WMA recommends that organ procurement programmes, hospitals and other institutions in which procurement occurs should:
1. Develop policies and protocols encouraging the procurement of organs consistent with the statements in this policy. Such policies should be consistent with physicians’ professional obligations and societal values, including free and informed decision making, privacy, and equitable access to needed medical care.
2. Make these policies and protocols known to transplant coordinators, physicians and other health care providers in the institution.
3. Ensure that adequate resources are available to support proper implementation of the policies and protocols.

E. DONATION AFTER DEATH

Physicians have an obligation to ensure that interactions at the bedside, including those discussions related to organ donation, are sensitive and consistent with ethical principles and with their fiduciary obligations to their patients. This is particularly so given that conditions at the bedside of dying patients are not ideal for the process of free and informed decision making. Protocols should specify that whoever approaches the patient, family members or other designated decision maker about the donation of organs should possess the appropriate combination of knowledge, skill and sensitivity for engaging in such discussions. Medical students and practising physicians should seek the necessary training for this task, and the appropriate authorities should provide the resources necessary to secure that training. It is mandatory that the person who approaches the patient or family about the donation decision not be a member of the transplant team.

F. FREE AND INFORMED DECISION MAKING ABOUT ORGAN DONATION

The WMA considers that the potential donor’s wishes are paramount. In the event that the potential donor’s wishes about donation are unknown and the potential donor has died without expressing a clear wish about donation, the family or a specified other person may serve as a substitute decision-maker and may be entitled to give or refuse permission for donation unless there are previously expressed wishes to the contrary.
Evidence of the free and informed decision of the potential donor, or, where legally relevant, of the appropriate substitute decision-maker, must be ascertained before organ procurement can begin. In countries where presumed consent is the legal norm, the organ procurement process should include reasonable steps to discover whether the potential donor has opted out of donation.
Success in procuring organs for transplant should not be construed as a criterion for measuring the quality of the process of free and informed decision-making. The quality of this process depends on whether the choice was adequately informed and free of coercion and not on whether the outcome is a decision to donate.
Free and informed decision making is a process requiring the exchange and understanding of information and the absence of coercion. Because prisoners and other individuals in custody are not in a position to give consent freely and can be subject to coercion, their organs must not be used for transplantation except for members of their immediate family.
In order for the choice to donate organs to be duly informed, prospective donors or their substitute decision makers should, if they desire, be provided with meaningful and relevant information. Normally, this will include information about:
1. in the case of living donors, the benefits and risks of transplantation,
2. in the case of deceased donors, procedures and definitions involved in the determination of death,
3. testing of organs to determine their suitability for transplantation, which may reveal unsuspected health risks in the prospective donors and their families,
4. in the case of deceased donors measures that may be required to preserve organ function until death is determined and transplantation can occur,
5. in the case of deceased donors what will happen to the body once death has been declared,
6. what organs they are agreeing to donate,
7. the protocol that will be followed concerning the family in the event that the family objects to donation, and
8. in the case of living donors, the implications of living without the donated organ.
Prospective donors should be informed that families sometimes object to donation; donors should be encouraged to discuss their choice with their family to prevent conflict.
Prospective donors or their substitute decision makers should be given the opportunity to ask questions about donation and should have their questions answered sensitively and intelligibly.
Where the wishes of the patient are known and there is no reason to believe that the choice to donate has been coerced, has not been adequately informed, or has changed, these wishes should be carried out. This should be clarified in law, policy and protocols. Under these circumstances, families should be encouraged to respect the patient’s clearly expressed wishes.
Where the wishes of the patient are unknown or there is uncertainty about the patient’s wishes, national law should prevail.
Protocols for free and informed decision making should also be followed in the case of recipients of organs. Normally, this should include information about:
1. the risks of the procedure,
2. the likely short, medium and long-term survival, morbidity, and quality-of-life prospects,
3. alternatives to transplantation, and
4. how organs are obtained.
In the case of living donors, special efforts should be made to ensure that the choice about donation is free of coercion. Financial incentives for providing or obtaining organs for transplantation can be coercive and should be prohibited. Individuals who are incapable of making informed decisions, for example minors or mentally incompetent persons, should not be considered as potential living donors except in extraordinary circumstances and in accordance with ethics committee review or established protocols. In order to avoid a conflict of interest, the physician who obtains informed consent from the living donor should not be part of the transplant team for the recipient.

G. DETERMINATION OF DEATH

The WMA considers that the determination of death is a clinical matter that should be made according to widely accepted guidelines established by expert medical groups, and as outlined in The World Medical Association’s Declaration of Sydney on the Determination of Death and the Recovery of Organs.
Protocols and procedures should be developed to educate patients and families about procedures for diagnosing death and the opportunities for donation after death.
In order to avoid a conflict of interest, the physician who determines and/or certifies the death of a potential organ donor should not be involved in the organ removal or in subsequent transplantation procedures or responsible for the care of potential recipients of these organs.

H. JUSTICE IN ACCESS TO ORGANS

The WMA considers there should be explicit policies open to public scrutiny governing all aspects of organ donation and transplantation, including the management of waiting lists for organs to ensure fair and appropriate access.
Policies governing the management of waiting lists should ensure efficiency and fairness. Criteria that should be considered in allocating organs include severity of medical need, length of time on the waiting list, and medical probability of success measured by such factors as type of disease, other complications, and histocompatibility. There should be no discrimination based on social status, lifestyle or behaviour.
Special appeals for organs for a specific recipient require further study and ethical examination to evaluate the potential impact on the fairness of allocation.
Payment for organs for donation and transplantation must be prohibited. A financial incentive compromises the voluntariness of the choice and the altruistic basis for organ donation. Furthermore, access to needed medical treatment based on ability to pay is inconsistent with the principles of justice. Organs suspected to have been obtained through commercial transaction must not be accepted for transplantation. In addition, the advertisement of organs in exchange for money should be prohibited. However, reasonable reimbursement of expenses such as those incurred in procurement, transport, processing, preservation, and implantation is permissible.
Physicians who are asked to transplant an organ that has been obtained through a commercial transaction should refuse to do so and should explain to the patient why such a medical act would be unethical: because the person who provided the organ risked his or her future health for financial rather than altruistic motives, and because such transactions are contrary to the principle of justice in the allocation of organs for transplantation.

I. EXPERIMENTAL AND NEWLY DEVELOPING TRANSPLANTATION PROCEDURES

The WMA considers that, although many transplantation procedures have become standard medical care for a range of medical conditions, others are experimental and/or morally controversial and require further research, safeguards, guidelines, and public debate.
Experimental procedures require protocols, including ethics review, that are different and more rigorous than those for standard medical procedures.
Xenotransplantation raises special issues, particularly in light of the risk of unwitting cross-species transmission of viruses and other pathogens. There is an urgent need for extensive public debate about xenotransplantation to ensure that developments in this field are consistent with societal values. International guidelines to govern these practices should be developed.
Transplantation of organs developed using cell nuclear replacement technologies requires scientific review, public debate and appropriate guidelines before becoming accepted.