Organ transplantation

Keywords: Human tissue, Xenotransplantation, Biomedical Research

ISRAEL (2008)

For CDBI

Developments in the field of Bioethics: ISRAEL - November 2007-May 2008

1. New Israeli Legislation in Biomedicine

Two important laws were recently adopted by the Israeli parliament (Knesset) on Brain death and on Organ transplantation. They are available (in Hebrew) at the Bioethics Israeli website

Following is a non-official summary of the two Laws.

Law regarding Brain-respiratory death

The law establishes that death can be declared in case of brain death causing cessation of autonomous respiration, as distinguished from Heart-respiratory death (i.e. cessation of heart pulsation). Brain-respiratory death can be declared only by two physicians who have been specifically certified as competent for this purpose. Certification, after appropriate training, will be bestowed on medical specialists by a committee comprised of a) four expert physicians, b) three rabbis experts in Jewish law one of which being himself a physician, and c) one ethicist, one philosopher and one lawyer, these 3 being appointed on the recommendation of the President of the Supreme Court, when one these three is also a physician, and one is also a representative of a non-Jewish sector of the Israeli public. The physicians who will declare a Brain-respiratory death must not be treating physicians of the dying patient, and not be involved in organ transplantation. The conditions to declare Brain-respiratory death include a) that the cause of the brain damage be clearly known, b) a clinically proven absolute cessation of autonomous respiration, c) a clinically proven complete and irreversible absence of brain function, including of the brain stem, d) the demonstration of the absence of brain and brain stem activity by instrumentation including Brainstem Auditory Evoked Response (B.A.E.R.), Transcranial Doppler (TCD), Sensory Evoked Potential (SEP), Computerized Tomography (CT) - Angiography (CT - A), Magnetic Resonance Imaging (MRI) and Angiography (MRA), as well as e) elimination of any medical situation that could cause an error on the instrumental results. After Brain-respiratory death is declared, the treating physician will inform the family inquiring whether the patient had expressed a specific will on the matter, so that if determination of Brain-respiratory death is against the religion or the specific will of the patient, he will not be disconnected from articial respiratory machines and will continue to receive sustaining treatment until Heart death.

(Law adopted March 31, 2008, going into effect in May 2009)

Law for Organ transplantation

The law prohibits anyone from receiving remuneration for an organ taken from his own body or from another person, whether it is taken during life or after death. Likewise, it is prohibited to give remuneration for an organ to be transplanted in one's own body or to another person. However, the law does not prohibit certain types of transaction or rewards: 1) that a living person consents to donate an organ to a patient in exchange for the consent of a parent or friend of the second to donate an organ to a parent or friend of the first; 2) reimbursement of expenses incurred by a live donor (according to section 22 of the law, see below); 3) forms of reward given by an organism especially accredited by the Ministry (according to section 29, see below); 4) payment of funeral and transport of the body of a deceased from which organs were donated after his death. But the law particularly prohibits any financial transactions through intermediaries or agents making deals between donors and recipients. The law does not prohibit transactions for transplantation in another country provided the laws of the other country are respected and all measures prohibiting organ trafficking are respected.

In Israel, the law establishes a National center for organ transplantation (NCOT) at the Ministry of Health, that will act to maximize the potential for organ donation and manage a data base and waiting list for transplantation. The NCOT is the body responsible for supervising and monitoring all activities related to organ donation and transplantation, and will be directed by an interdisciplinary steering committee comprising at least three physicians, a nursing specialist, a lawyer, a psychologist, a social worker, a medical ethicist, and representatives of patient's organizations and of religious bodies. Among the duties of the steering committee is to make rules about how to allocate the legally donated organs, rules which in addition to medical considerations will also take into account 1) the prior consent to donate organs after death given by a person who is now himself in need of receiving a transplant, or has a first-degree relative in need of a transplant; 2) the prior donation of an organ from a deceased, if a first-degree relative is in need of a transplant; 3) the prior donation during life of an organ for the benefit of anyone, if the donor or a first-degree relative is in need of a transplant. The steering committee will make its rules by majority of votes. A physician will be appointed as comptroller of the procedures.

Procedure for organ donation from the living. A person wishing to donate an organ to a patient in need of a transplant, must seek authorization either 1) from a Local Evaluation committee appointed by the hospital director, if the patient in need is a relative of the donor (including brother/sister in law), or 2) from a Central Evaluation committee appointed by the Ministry of Health, if the patient in need is not a relative of the donor (including an unidentified recipient). These Evaluation committees will be headed by a senior hospital physician not involved in organ transplantation, and include a psychiatrist or specialist in clinical psychology, a social worker, a representative of the public sector to whom the donor applicant belongs (if he so wishes), a judiciary-qualified lawyer. The authorization will be delivered only if the committee is convinced that 1) the donor has no medical or mental conditions which could cause him to incur a special risk; 2) the donor has given his free voluntary consent, in clear mind and without any pressure being it familial, social or economic pressure; 3) the donor and the recipient have given their informed consent to the surgical procedures involved; 4) the donor did not give his consent in return for an actual or promised compensation that is prohibited by the law and also not for the purpose of receiving the reimbursement of expenses authorized by the law; 5) the donor understands that he can withdraw his consent at anytime without prejudice. In addition to thorough medical and psychological examination, and social evaluation, the donor and the recipient will be directly interviewed by the evaluation committee, and the decision will be by majority of votes and given within 60 days. If a member of a local evaluation committee opposes the authorization, he can ask to refer the case for a new evaluation by the central committee. A positive decision to authorize the live donation will be transmitted in all its details to the Director-General of the Ministry of Health, who must approve it, or else reject it, within 7 days. Once approved, the procedure should be carried out within 24 hours. The law further addresses the right of the donor and recipient to be informed of the results of the evaluation. The law also addresses the case of donors who are minors, where a judgment by appropriate courts of law is required on top of the evaluation.

Expense reimbursements (Section 22): The Minister of Health, with the authorization of the appropriate parliament committee, will decide on a fixed sum that the State will pay to the donor as compensation for loss of income that reasonably results from the organ donation procedure, as well as decide on conditions for the reimbursement of expenses such as 1) purchase of a private medical insurance, insurance for loss of capacity to work or to earn a living, life insurance; 2) psychological treatment; 3) convalescence leave of absence, all for a determined time and amount (the sum for kidney transplant is about 3,350 Euros). Payment will be carried out after the transplantation and is not transferable to another person. The Minister will bestow a certificate of gratitude to the donor, who will also receive free entrance to national parks.

Procedure for postmortem organ donations. Patients in need of an organ transplant will be registered in the NCOT data bank for the purpose of finding a suitable organ donated from the dead. The application form will indicate whether the patient has himself given consent for organ donation after death, whether a first-degree relative was a post-mortem donor, or whether he or a first-degree relative donated an organ from the living to an unidentified recipient.

The director of a hospital in which occurred a death compatible with organ donation [see Law on Brain-respiratory death], and after the legal requirements for organ harvest are fulfilled [consent given before death by signing an organ donor card, authorization from close relatives], will inform the NCOT director who in turn will identify a suitable recipient from the data bank, according to the rules set out by the NCOT steering committee (see above).

Organ donor card: By law, the NCOT has the authority to receive (by itself or through a recognized organism) the consent of a living person to donate organs after death for the purpose of transplantation and likewise the consent of that person that a compensation be given to a relative of his, in return for the donation.

Incentive for postmortem donation (section 29). An organization especially accredited by the Minister of Health for this purpose, is authorized to give to a living person or to a relative, a reward for the person's consent to donate organs after death, or for the relative's consent that organs be taken from the body of the deceased. The form of reward will be specified in the Minister's accreditation of the organization and published in the Official State Record [the intention of the law is for example advantageous conditions given by an HMO, or other health or social security service]. The Minister can decide that rewarding of a relative will not be done unless the donor had agreed during his life that such a reward be given. (Law adopted March 24, 2008, going into effect May 1, 2008).

TURKEY(2008)

The recent developments in the field of Health Law in Turkey include the creation of:

(a) the Outlines of a new “Draft Law on Organ, Tissue and Cell Transplants” and

(b) the current “Bylaws on Banking for Umbilical Cord Blood” (under revision).

(c) Moreover, the Ministry of Health has informed me that a Working Group composed of experts has been working to revise some current laws (Kanun), regulations (Tüzük), bylaws (Yönetmelik) and communiques (Teblig) on health field. The documents are only available in Turkish.

For the Turkish texts of the Health Legislation in Turkey pls see or Moreover to obtain detailed information on the abovementioned legislation you can contact Dr. Zeynep Coskun, Head of the Division for Tissue and Cell Transplant at the Directorate General for Treatment Service, Ministry of Health (Saglık Bakanlıgı, Tedavi Hizmetleri Genel Müdürlüğü Doku ve Hücre Naklı Subesi), Sıhhıye, Ankara, TR (Phone: 90 (312) 585 1509; 0505 914 6065; Email: .

ISRAEL (2007)

Period October 2006 to November 2007

Organ transplantations

a) Legislation :The Israeli parliament (Knesset) is preparing a Law on Organ transplantation to regulate the operation of the Center for Organ transplantation at the Ministry of Health. The Law addresses both donations from living donors and from the deceased (brain-death). The Law deals with regulations (e.g. to ascertain free informed consent from living donors and avoid any commercialization, to give first degree relatives the right to oppose taking organs from a deceased), and also addresses the question of how the number of organ donations can be increased. Whereas no financial transaction is allowed, some State-administered compensation for living donors is considered. The form of compensation is still being debated, as well as the possibility to extend incentives to families that agree to donate organs from deceased. Another Law proposal defines medical brain-death, and has recently received agreement from religious authorities.

b) Bioethics: The Israel National Bioethics Council was asked to consider a proposal to increase the number of citizens holding an organ donation card indicating their agreement that organs could be taken after death. This is called in Israel the "Edi" card, and is presently proposed to all citizens by being attached to the forms sent for periodical renewal of the driving permit. Nevertheless, the number of card holders in Israel is still low in comparison to European countries or USA. Increasing this number is important because when a deceased was a card holder, the family almost always agrees to organ donation. In contrast, when the deceased had not expressed during his lifetime his willingness for organ donation, more than half of the families oppose the taking of organs after death. Several proposals for increasing the number of Edi card holders were considered. One proposal is to give some form of priority to card holders in case they would themselves require an organ transplantation. This priority would be limited in time (to minimize as much as possible the delay for non-holders), and the priority would be given only to long-time card holders. Moreover, in case of medical emergency requiring quasi-immediate organ transplant, non-holders will have the same priority as holders. Hence, the priority to card holders would be only in relation to non-holders who are in the same medical condition, that being a condition which permits to delay the organ transplant. Finally, the priority would be given only to card holders, and not to families of donors (i.e. not to families that have agreed to donate organs of a deceased).

Nevertheless, this incentive by priority raises ethical question because many feel that decisions on whom receives an organ should be purely medical and not subject to whether or not the patient was ready himself to donate organs. As an alternative way to increase organ donation, it was decided to re-examine the "presumed consent" or "opting-out" option, in which it would be permitted to take organs from a deceased if he did not state his opposition during his lifetime, and if first-degree family members do not object. In the past, the assumption of presumed consent did not seem acceptable in Israel, but due to more information about organ shortage and about the moral duty of saving patient's lives through organ donation, it is felt that the public opinion may have changed in relation to the opting-out system.

UNITED KINGDOM (2007)

Human Tissue Authority: new Code of Practice

The Human Tissue Authority conducted a consultation between October 2006 and January 2007 on a code of practice on the import and export of human bodies, body parts

and tissue. A post-consultation version of the Code will be available shortly.

Full information about the Human Tissue Act, the Human Tissue Authority and its Codes of Practices and licensing procedures, are set out on its website at .

Organ Donation Taskforce

Last year, Ministers established an Organ Donation Taskforce to consider options for improvement of organ donation rates within existing legal frameworks. The initial report of the Taskforce has just been presented to Ministers who are considering their response.

Organ Donation Taskforce – presumed consent

In his 2006 Annual Report On the state of public health published on 17 July 2007, the Chief Medical Officer recommended that:

legislation be amended to create an opt-out system for organ donation

more opportunities be taken to increase donation in hospitals and to maximise organ transplantation

there are targeted campaigns aimed at increasing organ donation in ethnic minority populations

As this Report was published, Alan Johnson said that a subgroup of the Organ Donation Taskforce would be established to ‘examine the potential impact on organ donation of introducing an “opt out” or presumed consent system in the UK, having regard to the views of the public and stakeholders on the clinical, ethical, legal and societal issues’.

The reason for asking a new subgroup of the Taskforce to look at the question of presumed consent was to:

  • fully understand the role of presumed consent in driving up donation rates in those countries that enjoy high rates, and the potential impact on donation rates in the UK.
  • factor in religious and faith community views as to how such a system would be received. For example, some areas of the Bangladeshi community in East London have extremely high refusal rates – need to understand this, and the wider context. The Taskforce could address this.
  • to be sure that any plans would be on a firm footing to stand up to Parliamentary and public scrutiny as legislation would be required.

UNITED STATES (2006)

Organ transplantation: Along with other countries, the United States is struggling with a chronic shortage of organs. Although there has been some progress in increasing the supply, potential recipients continue to die while waiting for organs, prompting discussions about the ethics of using incentives. In the United States, the National Organ Transplantation Act of 1984 bans “valuable consideration” in organ procurement and allocation. In May 2006, the Institute of Medicine, a branch of the National Academies, issued a report calling for new strategies and initiatives to increase donation, but rejecting any change in the current law, including the use of incentives.