Developments in the field of Bioethics - for CDBI
Organ and Tissue Transplantation
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 optingout system.
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Period November 2007 to May 2008
Important law was recently adopted by the Israeli parliament (Knesset). It is available (in
Hebrew) at the Bioethics Israeli website http://www.academy.ac.il/bioethics/index.html
Following is a non-official summary of this Law.
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 firstdegree 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,
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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 DirectorGeneral 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).
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