Organ Transplantation Laws in Asian Countries: A Comparative Study

Organ Transplantation Laws in Asian Countries: A Comparative Study

Organ Transplantation Laws in Asian Countries: A Comparative Study A. Bagheri ABSTRACT Legal tools are a necessity in organ procurement to allow trans...

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Organ Transplantation Laws in Asian Countries: A Comparative Study A. Bagheri ABSTRACT Legal tools are a necessity in organ procurement to allow transplant surgeons to remove organs from potential sources. In some countries the organ transplantation law may not only increase the organ retrieval rate, but may also decrease the number of transplantations. Reassessing the impact of organ transplantation laws on the application of transplant technology is therefore an emerging issue. This article discusses organ transplantation laws in eight Asian countries: Japan, Korea, India, Iran, Philippines, Saudi Arabia, Singapore, and Turkey. The organ transplantation laws of each of these countries were compared in terms of how they address the issues of definition of death; donor consent; the role of family and surrogate decision making; age limitation for organ donation; organ trade and donor compensation; and the organ procurement model.

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N MANY ASIAN COUNTRIES, tackling infectious diseases still remains a health priority. Uses of new lifesaving technology vary across cultural and socioeconomic backgrounds. Therefore, a variety of capacities exist in terms of expertise, legislation, access to sophisticated transplant facilities, and the economic affordability of organ replacement therapy. A number of publications have shown that patients move between Asian countries to receive transplants.1,2 Asia has also become a focus of attention, because it is a source of organs for many needy patients from other regions. This migration has caused critics of the organ market to highlight Asian cases. The goal in this work was not to present a critique but to review and compare these laws as well as to share information and gain experience on organ transplantation laws in eight Asian countries.

OUTLINES OF THE ORGAN TRANSPLANTATION LAWS Japan

The 1997 “Law Concerning Human Organ Transplants” was the fruit of a long debate on brain death and organ transplantation, which involved the general public and experts in the relevant fields in Japan. According to the law,3 organs can be removed only if: (1) the donor has expressed his intention with respect to the definition of death and organ donation in a written document beforehand; (2) if the family had already signed the donor card and also agreed with the organ removal. The concept of brain death, which is defined as “an irreversible cessation of all function of the entire brain including the brain stem,” is normally used only when an organ is intended to be used for

organ transplantation. Selling and buying organs as well as organ removal from persons less than 15 years of age were prohibited. The law allowed individuals to choose a definition of death, either brain-based or traditional cardiacbased, using their personal views (pluralism of human death).4 The family was given the authority to veto an individual’s organ donation by refusing to sign the donor card. There cannot be a surrogate decision maker for organ donation even for their children.5 Therefore the law adopted a double standard approach to the role of family.6 The legislation resulted in only 33 “brain-dead” cases being used for organ transplantation since the law came into force in 1997.7 Korea

An Organ Transplantation Law was passed in Korea in 2000. Brain death was defined as the irreversible cessation of the whole brain function,8 which must be diagnosed by two specialist doctors and the patient’s physician and must be approved by a “brain-death determination committee.” Donor consent was required for organ removal, but the family has a strong voice to not allow organ donation if it disagrees. The Korean Network for Organ Sharing is a centralized authority for organ procurement. After the From the Department of Neurology, Institute of Clinical Medicine, University of Tsukuba, Tsukuba Science City, Japan. Address reprint requests to Alireza Bagheri, MD, PhD, Department of Neurology, Institute of Clinical Medicine, University of Tsukuba, Tsukuba Science City, 305-8575, Japan. E-mail: [email protected]

© 2005 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710

0041-1345/05/$–see front matter doi:10.1016/j.transproceed.2005.11.016

Transplantation Proceedings, 37, 4159 – 4162 (2005)

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law’s enactment, the number of brain-death diagnosis and donations has decreased. For example, before the law enforcement, 162 cases were diagnosed as brain dead, but only 43 cases in 2003. Selling and buying of organs are prohibited. There is a priority setting for recipient selection; for instance, if there are two patients on the waiting list for the same organ, priority is given to: (1) a patient who has already donated an organ; (2) the younger age patient; and (3) first come, first served. In Korea setting a difficult procedure for the diagnosis of brain death has been cited as the main reason for the decreasing number of diagnosed cases of brain death and subsequent organ transplantations.9 India

The Transplantation of Human Organ Act recognizes “brain stem” death as human death.10 Organ removal is legal only from a person of not less than 18 years of age with individual consent before death in writing and in the presence of two witnesses, of whom at least one must be a close relative of the person. Surrogate decision making by the family has been recognized when an individual has not left an indication of either willingness for organ donation after death or any objection. In the case of brain stem death of a minor, less than 18 years of age, organ removal may be authorized by the parents. As for an unclaimed body, organ removal may be authorized by the persons in charge of the hospital or the prison after 48 hours. Organ removal from a living donor may be performed only if the recipient is a close relative. If not a close relative, a human organ cannot be removed and transplanted without the prior approval of an authorization committee. Iran

An Organ Transplantation Act was passed in 2000 after the same attempt failed in 1996. According to the law,11 organ removal is legalized for the purpose of transplantation with either: (1) Donor prior declaration as well as family agreement. Donor prior declaration can be in a written statement or oral consent. Later it must be confirmed in writing by one of the family members. (2) In the case of lack of donor declaration, the family has a right to make a decision on behalf of their loved ones in his or her best interest. Brain death must be diagnosed in a public university hospital by an expert committee. The members of the diagnosis committee should not be associated with the transplant team. Selling and buying of organs are absolutely prohibited. Living donation to relatives as well as nonrelatives is accepted. In order to prevent the organ trade, donor and recipient should be compatriots.12 Philippines

The Organ Donation Act of 1991 in the Philippines defines death as the irreversible cessation of circulatory and respiratory functions or the irreversible cessation of all functions

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of the entire brain including the brain stem.13 In defining a deceased individual, the act includes a stillborn infant or a fetus. Consent to donation must be signed by the testator in the presence of two witnesses who must sign the document in his presence. If the body of the deceased is classified as an accident, trauma, or other medicolegal case after 48 hours, failing to locate the nearest relative or guardian, the surrogate decision making is extended to the physician in charge of the patient or the head of the hospital. As for cornea it can be authorized within 12 hours after death, (added to section 9 in 1995). There is an international sharing of human organs or tissues. Sharing of human organs or tissues shall be made only through exchange programs duly approved by the Department of Health, provided that the foreign organ or tissue bank storage facilities and similar establishments grant reciprocal rights to their Philippine counterparts to draw organs or tissues at any time. Saudi Arabia

According to the law,14 a person is pronounced legally dead if one of two conditions has been established: (1) total cessation of cardiac and respiratory functions, and (2) total cessation of all cerebral functions. No member of the medical team involved in the transplantation of organs should participate in the diagnosis of brain death. Consent for organ donation is valid, if the deceased has expressed his desire to donate organs, when alive, or consent was obtained from the heirs of a brain-death case. In the case of an unclaimed body, if the brain-death case is unidentified after 48 hours, the consent of the official authorization must be obtained for organ removal. Several scientific committees have been established including a “convincing committee” that obtains family agreement. In the case of organ donation from a living donor, written consent is necessary before performing living related transplantations with a blood relationship attested by an official organization (except for bone marrow). Singapore

The Human Organ Transplant Act was passed in 1987 and amended in 2004. According to the law,15 the designated medical doctor can authorize in writing the removal of any organ from the body of a person who has died in the hospital for the purpose of the transplantation, except from a person: (1) who has during his lifetime registered his objection to the removal of the organ from his body after his death (presumed consent); (2) who is neither a citizen nor a permanent resident of Singapore; (3) who is below 21 years of age unless the parent or guardian has consented to such removal and who is above 60 years of age; and (4) who is a Muslim. A committee consisting of not fewer than five members appointed by the director of the hospital is in charge of matters relating to the selection of proposed recipients. There is a priority setting for selection of the proposed

TRANSPLANTATION LAWS IN ASIAN COUNTRIES

recipients, who must be persons who have not registered any objection with respect to that organ shall have priority over a person who has registered an objection. As for living organ donation, written authorization of the transplant ethics committee of the hospital and donor consent in writing for the removal of the specified organ from his body are necessary. Turkey

The Turkish Organ and Tissue Transplantation law allows organ removal from individuals above 18 years old with their verbal or written consent.16 If a testament is not present, the relatives of the decedent can give permission. Living donation can be performed with the donor’s consent in the presence of two witnesses. An interesting point in Turkish organ and tissue transplantation act is that the doctor is obliged to inform the donor’s spouse as well. THE COMPARISONS OF SURVEYED LAWS

Surveyed laws stances on the following issues were compared. Definition of Death

All surveyed countries define cessation of the entire brain function, including brain stem, as human death except India, where the definition of death is based on the cessation of brain stem function. Japanese law introduces two alternative definitions for human death, giving the individuals the opportunity to choose a definition of death, either the traditional or the brain-based one based on their own views. Donor Consent and Surrogate Decision Making

Donor consent has been recognized as a necessity for organ donation in all these laws. Only in Singapore has an opting out system been applied, which means an individual who won’t be a donor after his death should fill out an objection form. In Japan a donor card, signed by the individual willing to donate as well as family agreement, has validity for organ removal. Individuals can choose “not to donate” at the back of the donor card. In other countries, although the attempt should be made to obtain the family agreement, donor consent alone is legally binding. In Iran oral consent confirmed by one family member in writing is accepted; in Turkey, oral consent is accepted. Except Japan, all these surveyed countries allow family surrogate decision making on behalf of the individual who has not left an advance directive. In some countries like the Philippines, India, and Saudi Arabia in cases of an unclaimed body after 48 hours due to failure to locate a family member, surrogate decision making has been extended to the official authority. Age Limitation

The age limitation for organ removal from children varies. For instance, in Japan organ removal from children less

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than 15 years of age is prohibited. In India, Philippines, Turkey, and Saudi Arabia organ removal from an individual less than 18 years is prohibited. In Korea 16 years of age and in Singapore, 21 years of age are considered the limit for organ removal. In Iran the decision is made on a case by case basis using medical indications/contraindications. It should be noted that in some countries like Singapore, Iran, the Philippines, and India, the law gives authority to the parents to permit organ removal from their child. Donor Compensation

In Japan based on Japanese tradition of Koden, the expression used for monetary condolence gift from friends, there was an initiative by a leading transplant surgeon for a “thank-you fund” to provide payment to the families of organ donors. This initiative has been criticized by other doctors17 and is no longer practiced. According to the current law, any monetary compensation is prohibited. In Iran a nongovernmental organization is responsible to present a certain amount of money as a social gift to kidney donors.18 In Singapore an organ donor has priority to receive an organ if she or he became a case in need of an organ, which can be considered an indirect incentive for donation. The Model of Organ Procurement

Donation model, which is an autonomy-based model, has been applied in Iran, the Philippines, Saudi Arabia, Korea, and India. In Singapore the law adopted a presumed consent policy, which is a routine salvaging with an opting out system. This model permits those who actively oppose organ procurement to be excluded. In this model although the interest of the state has no priority over an individual’s expressed choice, in the absence of such an advanced objection organs will be removed based on state authorization. The Japanese system does not clearly fall into one of the popular organ procurement models. REFERENCES 1. Ota K: Transplant Proc 36: 1865, 2004 2. Awaya T: Testimony at the US congress on the transplantation of organs from executed prisoner in China. The Review of Tokuyama University 50:177, 1998 3. The Law Concerning Human Organ Transplants. Law no. 104 1997. Translation, Japan Ministry of Health Labour and Welfare, 1999 4. Morioka M: Reconsidering brain death: a lesson from Japan, fifteen years experience. Hastings Center Report 31:41, 2001 5. Akabayashi A: Transplantation from a brain dead donor in Japan. Hastings Center Report 29:48, 1999 6. Bagheri A: Criticism of brain death policy in Japan. Kennedy Institute of Ethics Journal 13:359, 2003 7. Japan Organ Transplantation Network. Available at http:// www.jotnw.or.jp/news/news.html 8. Korean Organ Transplantation Law 1999. no. 5858, 2.8, 1999 9. Heo YH, Lee HJ: Problems over organ transplantation in Korea. In Macer D (ed): Challenges for Bioethics from Asia. Eubaios Ethics Institute; 2004, p 263

4162 10. Indian Transplantation of Human Organs Act, 1994, Act no. 42 of 1994. States of Goa, Himachal Pradesh and Maharashtra, 1994 11. Organ Transplantation from Cadaver, Law and Regulations in Iran, 2nd Edition. Tehran, Iran: Management Centre for Transplantation and Special Diseases. 2003. Available at http:// www.Irantransplant.org 12. Larijani B: Organ Transplantation: Medical, Ethical, Legal and Religious Aspects, Tehran, Iran: Entesharat Baraye Farda; 2004 13. Philippines “Organ Donation Act of 1991.” Republic Act no. 7170. Available at: http://www.chanrobles.com/republicactno7170. htm. Accessed March 21, 2004

BAGHERI 14. Saudi Organ Transplantation. Available at Saudi Center for Organ Transplantation: http://www.scot.org.sa/eng-index.html. Accessed December 1, 2004 15. Singapore Human Organ Transplant Act (HOTA). Act 15 of 1987, Cap. 131A. Amendment in January 2004. Available at: http://www.moh.gov.sg/corp/systems/organ/hota.do. Accessed May 2004 16. Turkish Organ and Tissue Transplantation Code, no. 2238, 1979 17. Lock M: Twice Dead: Organ Transplant and the Reinvention of Death. University of California Press; 2002 18. Larijani B, Zahedi F, Ghafouri-Fard S: Rewarded gift for living renal donors. Transplant Proc 36:2540, 2004