Organ transplantation
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 saglı.tr or .tr. 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: zeynepcoskun2008@.
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.
The President’s Council on Bioethics is currently conducting a far-reaching inquiry into organ transplantation with the aim of issuing a report in early spring of 2007; representatives of key groups within the transplant community and the medical profession have testified before the Council and its staff as part of a broad-based effort to canvass the opinions and recommendations of various constituencies. It is important to note that these developments have occurred against the backdrop of increased reports of unethical as well as illegal trafficking in organs and the exploitation and coercion of potential donors worldwide.
More information on this topic is available at:
CYPRUS (2006)
Please note the following Laws and Regulations related to Bioethical issues that are currently in force in the Republic of Cyprus:
The Republic of Cyprus has ratified the Oviedo Convention through the adoption of the Law “The Convention for the protection of Human Rights and Dignity of human being with regard to the application of biology and medicine (Ratification Law) and other provisions related to the application of the convention Law 31(ΙΙΙ)/2001”
Transplantation of Organs and Tissues of Human Origin Law of 1987-1999 [L.97/87-5(I)/99]
(a) The Law on the essential requirements to be fulfilled by specific product categories
(b) The Law on the essential requirements for the use and applications of medical devices (Κ.Δ.Π 598/2003 and Κ.Δ.Π 599/2003)
The above mentioned laws and regulations provide that the Cyprus National Bioethics Committee is the authorized body for the bioethical review of biomedical research on human beings for the clinical trials on medicinal products for human use for clinical trials and medical research using medical devises.
In accordance with the above laws and regulations the Cyprus National Bioethics Committee has the authority to delegate the above authority to other suitable bodies.
The National Bioethics Committee has delegated this authority to subcommittees and monitors the bioethical review they perform.
On the 30th of July 2006, the Council of Ministers has appointed the members of the new Cyprus National Bioethics Committee, who will serve for four years until the 30th of July 2010.
WHO (2006)
Biotechnology Ethics
Transplantation: In response to World Health Assembly Resolution 57.18, ETH is continuing to work with the Department of Essential Health Technologies (EHT/HTP) on updating and expanding the "Guiding Principles on Organ Transplantation" (1991). Two regional consultations were held in November 2005 in Manila (for the Asia and Western Pacific regions) and in Karachi (for the Eastern Mediterranean region). For more information, please see .
UNITED KINGDOM (2006)
Human Tissue Act
The Human Tissue Act - -
received Royal Assent on 15 November 2004. The Act covers the removal, retention and use of human organs and tissue from the deceased, and retention and use of such material from living patients, for health-related purposes such as transplantation and medical research. It includes provisions for consent as the underlying principle, for a regulatory framework and for penalties where consent is not obtained. It applies in England, Wales and Northern Ireland, with the exception of a new offence of having human material with the intention of analysing its DNA without consent, which also applies in Scotland.
Scotland has its own human tissue legislation, the Human Tissue(Scotland) Act 2006, which received Royal Assent on 16 March 2006 and will come into operation on 1 September this year. It deals specifically with organ donation and transplantation from both the living and the dead, with hospital post-mortem examinations and anatomical examinations. Its fundamental principle of authorisation, which equates to consent under the 2004 Act, emphasises the importance of respecting after death the wishes people express during life on this range of issues.
The remit of the Human Tissue Authority does not generally extend to Scotland, but by agreement with the Scottish Ministers it will act as the competent authority for Scotland under the EU Directive on the Safety of Tissue and Cells, as well as dealing with all cases of living donation involving Scotland.
BOSNIA AND HERZEGOVINA (2006)
It is a fact that medical science as well as practice, like other biological science are becoming more riscant and dehumanized and more impersonal, and from that reasons legislation in Bosnia and Herzegovina are putting bigger pressure on recognition of individual rights on self-determination and reformulation of guarantee of patients other law.
Taking Universal declaration about human rights, European Convention about human rights and equality, as well as declaration about patient rights as starting point, Law of Health care regulates inalienable rights of patients-citizens. By this Law it is predicted that citizens have rights on standard quality and the same content of health care, as well as rights on compensation in case that inadequate health care and professional mistake are proved. The Law regulates the procedure for realization of above mention rights.
It is regulated by the Law of transplantation of parts of human body in purpose of healing, that taking and replanting parts of human body could be performed only in case of medical justification or in case when that is the best way of healing.
Law is also regulating transplantation from leaving donor and dead person-cadaver.
In accordance with above mention law, nonliving donor could be adult, working and healthy person. Rarely, that donor could be underage person in case of donation of bone marrow.
Taking a part of body could be performed only in case if that procedure not putting human life in danger, and if it is not risk of permanent defect of human health. Medical doctor who is performing transplantation need to inform in written the donor and receiver of organ about possible risks on their health, and about possibility of success of such kind of treatment. Also, the doctor needs to have their written consent.
The written consent should be cancel/recall until the surgical treatment has started.
In cadaver transplantation all are potential donors except in a case when person rejected it during life and gave written rejection
In a case that dead person was underage or mentally disabled, the written rejection could be given by the parents, marital partner or adult kid or tutor. However, besides written consent the explanation cannot start without written consent given by the family, and before the cerebral death has been confirmed in accordance with medical criteria and formal procedure.
An unallowable transplantation part of human body is criminal activity and defined by Criminal Law.
Law about conditions and procedure for pregnancy interruption are regulated and guaranteed rights within this area. Freedom of decision-making is guaranteed by this law, and mans and women have right on any kind of professional advice regarding reproductive health.
UNITED KINGDOM (2005)
Human Tissue Act
The Human Tissue Act - -
received Royal Assent on 15 November 2004. The Act covers the removal, retention and use of human organs and tissue from the deceased, and retention and use of such material from living patients, for health-related purposes such as transplantation and medical research. It includes provisions for consent as the underlying principle, for a regulatory framework and for penalties where consent is not obtained. It applies in England, Wales and Northern Ireland, with the exception of a new offence of having human material with the intention of analysing its DNA without consent, which also applies in Scotland.
The Act:
• provides a consistent legislative framework for issues relating to whole body donation, and the taking, storage and use of human organs and tissue
• makes consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts, organs and tissue and the removal of material from the bodies of deceased persons
• sets up an over-arching authority (the Human Tissue Authority) to rationalise existing regulation of activities like transplantation and anatomical examination, and to introduce regulation of other activities like post mortem examinations, and the storage of human material for education, training and research
• achieves a balance between the rights and expectations of individuals and families, and broader considerations, such as the importance of research, education, training, pathology and public health surveillance to the population as a whole
Other Topics Concerned: Biomedical Research
SWEDEN (2005)
The Government has presented a proposal to the Riksdag on an amendment to the Transplants Act to the effect that hospitals where potential donors are treated have access to a doctor in charge of donations and a nurse responsible for contacts with relatives. These will have the task of preparing organ and tissue donations and providing support and information to the bereaved families. A National Council for Organ and Tissue Donation will be established at the National Board of Health and Welfare. The Council will function as a knowledge bank and will form opinion and disseminate information on donation and transplantation issues to the general public. In the contract between the state and the National Corporation of Swedish Pharmacies, the Government wishes to include national responsibility for supplying information on transplantation and organ and tissue donation. These proposals are to be found in the Government Bill Transplants save lives (2003/04:179). The Riksdag has approved the proposal on the amendment to the Transplants Act.
Fact sheet on Government Bill 2003/04:179, Transplants save lives:
WHO (2005)
Human organ and tissue transplantation
• In response to World Health Assembly Resolution, the Department of Ethics, Trade, Human Rights, and Health Law (ETH) is working with the Department of Essential Technologies to update the 1991 "Guiding Principles on Organ Transplantation". Regional consultations will be held in November 2005 in the Western Pacific and Eastern Mediterranean regions.
• WHO participates in the newly formed Global Alliance for Transplantation which seeks to improve knowledge and good practices. Particular emphasis is now being placed on development of a registry for transplant outcomes (with regular follow up), encompassing both organ recipients and living donors.
GEORGIA (2004)
Georgian Legislation Related to Bioethics
Legislation of Georgia related to bioethics comprise texts which regulate various aspects of medicine/health care: rights of patients and research subjects (including vulnerable groups; such as minors, persons with mental disorders, patients with HIV/AIDS etc.), duties and responsibilities of health care professionals, human organ transplantation, assisted reproductive technologies etc.
Below in the table the list of laws (which are on different stages of preparation/adoption) related to bioethical issues are given. From these laws the Law of Georgia on Health Care is considered to be the framework law, which determines the priorities and sets out fundamental principles of the health care legislation of Georgia.
Table 1. Laws on the different stages of preparation/adoption (1995-2004)
| |BEFORE GOVERNMENT |BEFORE PARLIAMENT |ADOPTED |LAST UPDATE |
|The Law on Medical Activity | | |2001 (08.06) |2001 (26.10) |
|The Law on the Rights of Patient | | |2000 (05.05) | |
|The Law on Human Organ Transplantation | | |2000 (23.02) |2002 (21.11) |
|The Law on Protection and Promotion of Infant | | |1999 (09.09) |2000 (09.06) |
|Natural Feeding | | | | |
|The Law on Health Care | | |1997 (10.12) |2003 (18.07) |
|The Law on Drug and Pharmaceutical Activity | | |1996 (25.12) |2003 (8.05) |
|The Law on Psychiatric Care | |Since 2002 (New |1995 (21.03) |1999 (24.12) |
| | |amendments) | | |
|The law on HIV/AIDS Prevention | | |1995 (21.03) |2000 (08.11) |
|The Law on Abortion | |Since 2000 | | |
|The Law on Biomedical Research Involving Human | |Since 2001 | | |
|Subjects | | | | |
|The Law on Reproductive Health and Reproductive |2003 | | | |
|Rights | | | | |
Legislation Concerning Human Organ Transplantation
Legislation on human organ transplantation is composed of Law on Health Care (Chapter XX “Removal and Use of Human Organs, Parts of Organs, Tissues”), Law on Human Organ Transplantation and corresponding articles of the Convention on Human Rights and Biomedicine.
The aim of the above legislation is to establish the safe practice of human organ transplantation in the country and to protect human rights in this sphere.
The main principles of Georgian legislation on human organ transplantation are as follows:
- Prohibition of financial gain;
- Restricting the donors’ circle to genetically related relatives and spouse; However, allowing so called cross donorhood[1];
- Establishment of opting-in model (expressed consent model) of organ retrieval from deceased persons;
- Prohibition of organ removal from the unsupervised body, whose wishes are not established.
After the Law on Human Organ Transplantation entered into force (23.02.2000) several normative acts (President’s Order and Orders of the Ministry of Labour, Health and Social Affairs and the Ministry of Justice) were prepared to define brain death criteria, procedures for importing and exporting human organs, procedures for expressing wishes concerning organ removal for transplantation after death etc.
The full text of the updated version of the Law on Human Organ Transplantation is given in appendix 4 (on request).
Other Topics Concerned: Biomedical Research, Patients’ Rights, Genetics, Reproductive Rights
LITHUANIA (2004)
Amended Law on Human Tissue, Cells and Organ Donation and Transplantation came into force in March 2004. New provisions regarding the use of human cells as well as banking of human tissues have been introduced in this edition of the law (the mentioned issues were not covered in the previous version of the law).
NETHERLANDS (2002)
Foetal Tissue Act
Tissue that becomes available after a miscarriage or abortion can be used for various medical purposes, including the treatment of patients with certain diseases.
The Organ Donation Act prohibited the use of parts of a human foetus for transplantation purposes. The reasons were that this was a sensitive issue and that such transplantations were as yet unknown in the Netherlands. A number of years have passed since then, however.
Various health care organisations expressed their concern about the ban. People with Parkinson's disease, for example, might benefit from treatment with foetal tissue. The Health Council too held the view that the ban was obstructing the development of promising applications. Treatment of patients with DiGeorge Syndrome, a serious but fortunately rare congenital developmental disorder, was by this stage possible but prohibited. The government therefore took the view that the ban should be lifted.
Using foetal tissue for purposes other than transplantation (for medical research for instance) was not prohibited in the Netherlands, but neither was it regulated by law. In view of the sensitive nature of the issue and the exceptional circumstances under which foetal tissue becomes available, statutory rules ensuring that procedures would be carried out with due care were considered desirable.
The Foetal Tissue Act specifies the purposes for which foetal tissue may be used and the conditions for such use. Foetal tissue may only be used for medical purposes or medical and biological education and research. The woman in question must always give her written consent, she must always be informed in advance of the purpose and must be free to make her own decision. Possible uses for foetal tissue may not influence a decision regarding termination of a pregnancy. The provision of information and request for consent may therefore only take place after any such decision has been taken. What is more, in order to prevent conception for this specific purpose, women may not designate the persons who are to benefit from the tissue. Finally, the Act prohibits payment for making foetal tissue available.
DENMARK (2002)
Committee on Gene Technology
The ad hoc Committee on Gene Technology was set up in consequence of a debate in the Danish Parliament in January 2001. The committee was given the task of describing potential benefits and risks related to the cloning of stem cells, xenotransplantation, gene therapy and genetic testing of healthy individuals. The committee was not asked to prepare legislation.
Jointly with the Minister for the Interior and Health and the Minister for Justice, the Minister for Science, Technology and Innovation was given the task of appointing the committee.
The committee has covered the following questions:
> What are the potential benefits and risks of using stem cell therapy, xenotransplantation, gene therapy and genetic testing of healthy individuals?
> Considering the future application of these emerging technologies, which problems are important to consider? How could these problems be solved and who should contribute to the task of problem solving?
Based on the current leading-edge science within the four areas, as well as the ethical aspects and the legislative matters, the committee points to a number of problems that should be addressed as a prerequisite for future application of the new technologies.
Stem cell therapy:
Stem cells are the „primordial cells“ of human beings and they have the ability to differentiate into all the other types of cells. Thus, the vision is that the use of stem cells will make it possible to repair for instance nerve cells that have been destroyed in patients suffering from Parkinson’s disease or repair liver cells in a malfunctioning liver.
Today, it is assumed that stem cells obtained from the human embryo have the greatest potential. However, there is increasing evidence that adult stem cells e.g. from cord blood and fully developed tissue might, if properly treated, exhibit a potential similar to the potential of embryonic stem cells. Both nationally as well as internationally, attention is focused on embryonic stem cells. The major concern is whether the possibility of developing new medical treatments can justity the ethical doubts related to the isolation of stem cells from the embryo. The isolation of stem cells is permitted in, for instance, Sweden and the United Kingdom. Whereas in Germany, for instance, and in the United States as far as federally financed research is concerned, only research on already existing stem cell lines is permitted.
In Denmark the situation is not clarified. The field is regulated by the Act on Medically Assisted Procreation. Stem cells are not mentioned directly in the Act. However, it regulates the utilisation of the human embryo in a research context. Only research which aims at improving the IVF treatment and pre-implantation diagnosis is permitted, and only when using embryos left over from the IVF treatment. According to government interpretation the act does not restrict research performed on imported stem cell lines. This matter has not been taken to court.
Independent of Parliament’s wish either to widen the possibilities of carrying out research on embryonic stem cells, or to maintain or to further limit the current possibilities for such research, the committee finds that there is a need to clarify existing regulation trough a legislative revision.
It is recommended
> that parallel with a public debate, political clarity concerning the use of embryonic stem cells be established as soon as possible. On this basis and if needed, a legislative preparatory work should be initiated, also with a view to a revision of the Act on Medically Assisted Procreation.
Seven key questions require political resolution:
1) Should it be permitted to derive stem cells from fertilised eggs/embryos left over from an IVF treatment with the aim to perform basic research on stem cells and to explore the possibilities of new treatments?
Today, the Act on Medically Assisted Procreation does not allow the utilisation of human embryos for research purposes unless the purpose is to improve the IVF treatment or methods for pre-implantation diagnosis.
Should there be a political wish for establishing the possibility of employing embryonic stem cells, it would require an amendment to the Act on Medically Assisted Procreation.
If such an amendment is adopted, Parliament should also decide whether there is a need for special approval schemes.
2) Should the fertilisation of eggs by means of IVF technique be permitted even though it is not part of a fertilisation treatment?
Fertilisation of an egg solely for the purpose of the formation of embryos for research purposes is, as mentioned above, not permitted at present. Should there be a political wish to allow this procedure, it would require an amendment to the Act on Medically Assisted Procreation and an amendment to Denmark’s ratification of the Convention on Human Rights and Biomedicine of the Council of Europe.
If such amendments are adopted, Parliament should also decide whether there is a need for special approval schemes.
3) Should the formation of embryos through nuclear transfer from somatic cells be permitted?
Today, the formation of embryos through nuclear transfer from a somatic cell to an unfertilised egg is not permitted for research purposes.
Should there be a political wish for allowing nuclear transfer, it will require an amendment to the Act on Medically Assisted Procreation and an amendment to Denmark’s ratification of the Convention on Human Rights and Biomedicine of the Council of Europe.
If such amendments are adopted, Parliament should also decide whether there is a need for special approval schemes.
4) Should there be specific rules for the use of embryonic stem cell lines?
If the derivation of stem cells from the embryo is permitted through an amendment to the Act on Medically Assisted Procreation, self-renewing stocks of these cells (stem cell lines) may be created.
If these stem cell lines are regarded as being equal to cells isolated from other tissues, the utilisation in research and in industry will be covered by general acts and rules. However, if these cell lines are regarded as being different from other cell lines, there will be a need for setting up specific rules concerning the use of the cells.
5) Should specific rules apply with regard to information and consent from the couples/the women who might donate fertilised and non-fertilised eggs?
The limited research relating to the IVF treatment and pre-implantation diagnosis that is currently permitted on embryos must be approved according to the rules of the scientific ethical committee system.
Provided that possibilities for research employing embryos are extended, it should be considered whether there is a need for specific rules concerning information and consent.
6) Should research on imported embryonic stem cell lines be regulated?
According to the Ministry of the Interior and Health, the Act on Medically Assisted Procreation cannot be extended to apply to research on imported embryonic stem cell lines. A possible need for regulation concerning the use of imported embryonic stem cell lines should be part of a comprehensive resolution in this field.
7) Should the use of adult stem cells be regulated further?
At present, adult stem cells may be used for research in accordance with the rules of the scientific ethical committee system.
It is possible that in time there will be a sliding transition between cell lines produced from adult stem cells and from embryonic stem cells. Provided that regulation on the use of embryonic stem cell lines is established, it will therefore be relevant to ensure that regulation in this area is in accordance with regulation applicable to adult stem cell lines.
Xenotransplantation:
Xenotransplantation comprises methods of treatment where cells, tissue or organs are transplanted from animals to humans. The vision for xenotransplantation is that tissues or organs from animals - in particular from genetically modified pigs - replace malfunctioning tissues/organs in humans. At present, xenotransplantation is not offered as a treatment in Denmark and the future importance of applying xenotransplantation in clinical medicine is uncertain.
From a public health point of view, one of the main concerns is the risk of new and unknown epidemics based on disease transmission from animals to man (zoonosis) and from man to animals. Thus, the most important question will be to balance the advantages that this treatment will offer the individual patient with the societal risks of major epidemics among human beings and animals. In spite of extreme care, screening of donors and isolation of recipients, it will never be possible to guarantee the elimination of all risks of transferring an infection.
In Denmark there are at present no clinical trials related to xenotransplantation, but in the event of an international breakthrough in this field, it may be desirable for Denmark to participate in clinical trials.
Statements from The National Board of Health and the Central Scientific Ethical Committee ensure that no treatment involving xenotransplantation is permitted and that xenotransplantation should be performed solely as part of a research project and only after a permission has been granted by the Danish Central Scientific Ethical Committee.
The ad hoc Committee on Gene Technology finds that this field is at present sufficiently regulated.
It is recommended
> that the present restrictions are maintained. However, in the event of an international breakthrough this should be reassessed.
Gene therapy:
Gene therapy is based on the introduction of genes into the cells of a patient - either to replace diseased genes or to adjust the production of cellular proteins.
Early high hopes of applying this technology or treatment have been replaced by more cautious assessments, but gene therapy is none the less seen as holding important promises for treatment of conditions such as inherited disorders as well as cancer and cardiovascular diseases.
The most essential problems relate to engineered viruses that are often employed to introduce the genetic material. One concern is that the use of virus may involve a risk of inducing or transmitting infections. Gene therapy is covered by the existing legislation. The committee finds that at present there is no need for any further regulation.
It is recommended
> that gene therapy as a field of research and treatment should be monitored with a view to its possible future introduction in clinical medicine. This applies to both possible new breakthroughs, questions of side effects and possible future needs for regulation.
Genetic testing of healthy individuals:
Genetic testing is used in the Danish health services today, and it is expected that its use will increase in the years to come. The committee has in particular been concerned with tests involving analyses of DNA or the related RNA.
Analyses of DNA/RNA will increase the knowledge concerning genetic predisposition for development of diseases later in life. At the same time such analyses are likely to establish a new paradigm, allowing for genetic counselling, prevention and treatment of diseases that are far more individualised than we know today.
However, a number of challenges and problems are related to genetic testing of healthy individuals. Firstly, it is important to secure the right of citizens who prefer „not to know“. Secondly, it is anticipated that the increasing number of genetic tests will result in an increased need for counselling. Thirdly, commercial aspects of offering these tests outside the authorised or established medical laboratories or clinics might in some cases outweigh the regards for proper counselling as a prerequisite for testing.
The introduction and use of genetic tests are regulated just as any other kind of diagnostic test used within the health services or offered on the market. The Danish acts regulating this field are the Act on Hospital Services, the Act on the Practice of Medicine, the Act on the Rights of Patients and finally the Act on medical utensils implementing the „in vitro directive“ that covers approval, including approval of genetic tests to be marketed in the European Union. The committee finds that the major problem within this field relates to the counselling of the individuals both before as well as after genetic testing has been performed.
It is recommended
> that the need for counselling of the person to be tested should be assessed in the light of future developments in this area. The capacity for genetic counselling should be matched to meet future demands.
Other Topics Concerned: Cloning, Human Genetics
UNITED KINGDOM (2002)
In May 2002, The Human Genetics Commission (HGC) published 'Inside Information: Balancing interests in the use of personal genetic data', its report on the storage, protection and use of personal genetic information. Its main recommendations included: making a criminal offence of testing a person's DNA for non-medical purposes without their knowledge or consent; introducing measures to protect individuals from unfair genetic discrimination; and implementation of robust and transparent arrangements to balance the interests of individuals against those of medical research or forensic science.
The primary focus of HGC's current work is a review of the regulation of genetic testing services supplied direct to the public, recommendations on which was requested by Ministers for the end of the year. The deadline for responses to the associated consultation was 4 October, and evidence is still being gathered from a range of sources, including meetings with relevant/ interested organisations, focus groups and innovative Internet technologies. Issues being considered include: whether genetic test results should be treated differently from other health-related information a person might have direct access to; the possible control of genetic testing services available via the Internet; and the possible right of people to obtain whatever information they want about themselves. More information can be obtained from the HGC website at .uk
In July 2002, the Government issued a consultation document concerning the reform of the law governing the taking, storage and use for any purpose of human organs and tissue, from the living and the dead (including stillbirths and fetuses). The report Human Bodies, Human Choices is available at .uk/tissue. Consultation closed on 14 October 2002. The Government is also developing a Code of Practice on the import and export of human body parts, and consent forms and a Code of Practice concerning post-mortem examinations; information about this work is also available on the tissue website
Other Topics Concerned: Human Genetics
GEORGIA (2001)
The law about organ transplantation was adopted by Georgian Parliament in February 2000. In February-March 2001, Georgian Government adopted and President signed the documents about “Regulations of Export and Import of Human Organs”.
According to the law and regulations:
• Georgia participates in organ transplantation international practice
• only those organs are allowed for import taking, processing and validity confirmation of which were performed in compliance with the requirement of the respective country laws, which shall be reflected in the accompanying documents
• the right to export the organ to Georgia is authorized to the institution possessing a relevant license
• the unimpeded delivery of the human organs to the territory of Georgia is performed basing on special application provided by the institution possessing a relevant license and documents accompanying the organ
• general surveillance on the usage of imported human organs is performed by the Ministry of Labour, Health and Social Protection of Georgia
• export of the human organs from Georgia is allowed only under the permission of the Ministry of Labour, Health and Social Protection of Georgia via Transplantation Bank
Other Topics Concerned: Patients’ Rights
Human Brain Death Criteria
The death of the individual implies irreversible termination of the functions of all structures of heart and respiratory system or brain (including brain stem).
The following are the major causes of brain death: severe trauma of the brain; hemorrhage developed as a result of cerebral aneurysm rupture; large-size ischemic cerebral insult complicated with brain edema and incarceration and other cerebral pathologies.
Ischemic encephalopathy and brain edema due to other extracerebral causes developed as a result of cardiac arrest or asphyxia can also be the cause of brain death.
1. The following are prerequisites of the brain death diagnosis:
a. Presence of medicine induced or other intoxication of exogenous origin;
b. Presence of hypothermia (reactive temperature of the body shall not be less than 320C);
c. Presence of hypotension (systolic arterial blood pressure shall not be less than 80 mmHg).
2. The following are the criteria of the brain death:
a. Coma the depth of which is 3 points by Glasgow coma scale;
b. Presence of the brain stem reflexes (pupil photoreaction, oculocephalic, oculvestibular, corneal, tracheophariyngeal);
c. Presence of the spontaneous breathing confirmed using special “Apnoe” test.
The brain death shall be confirmed electroencephalographically or by transcraneal ultrasound Dopplerohraphy.
Tests to confirm the brain death shall be performed twice with 12 hour interval between tests, and in case of a child up to one year these tests shall be performed three times with 48 hour interval between the tests. The comprehensive description of the test methods is envisaged in the guidelines “On the Methods of Brain Death Clinical Diagnosis and Testing”.
Guidelines
On The Methods of Brain Death Clinical Diagnosis and Paraclinical Studies
I. Prerequisites for Brain Death Diagnosing
1. To diagnose brain death it is necessary to state the cause of the brain death. At the same time the impact on the organism of such factors as intoxication of medicinal or of other exogenous origin, hypothermia, hypovolemic shock, metabolic or endocrine coma, as well as the background use of narcotic substances and myorelaxation drugs, shall be excluded.
2. Rectal temperature of the patient shall be at least 32°C, systolic arterial blood pressure shall be at least 80 mm Hg.
II. Mandatory Clinical Criteria to Diagnose Brain Death
1. Absence of consciousness. Coma, the depth of which is 3 points by Glasgow coma scale.
2. Atony of all muscles. Absence of any response to the strongly painful stimulation of the trigeminal area.
3. Absence of photreaction of the pupil to the bright light provided not pupil dilatators were used.
4. The eyeballs are motionless.
5. Absence of the corneal reflexes.
6. Absence of the oculocephalic reflexes:
a) On contralateral turning of the head bent in the maximally lateral position the eyeballs are fixed and do not change their position (“Doll’s eyes” sign);
b) Oculocephalic reflex is not checked if there is traumatic injury of the cervical part of the spinal cord or such injury is suspected. Non-conduction of this test due to the above reason does not testify against the brain death diagnosis.
7. Absence of oculovestibular reflexes:
a) Before testing it is necessary to check for the integrity of the tympanic membrane. In cases when the integrity of the tympanic member is impaired the test shall not be conducted. Non-conduction of this test due to the above reason does not testify against the brain death diagnosis;
b) The head of the patient shall be bent forward by 300 from horizontal position. Small size catheter is placed into the external auditory tube and slowly irrigate with continuous flow of cold (+40 - +80C) water during 10 seconds. If the brain stem functions are absent the eyeballs remain motionless.
8. Absence of the pharyngeal and tracheal reflexes:
This is stated by the absence of cough reflex in the course of moving of the endotracheal tube in the trachea or upper respiratory ways or moving the catheter while aspirating the sputum.
9. Absence of spontaneous breathing:
On the background of artificial respiration the patient is provided with 100% oxygen during average of 10-15 minutes until arterial PaO2 reaches 200 mm Hg. Then the artificial respiration apparatus is switched off. 100% oxygen intake continues at 0.1 l/kg/min volume until Pa CO2 exceeds 60 mm Hg (it takes about 8-10 minutes to reach this level). If by this time no signs of spontaneous respiration are evident the apnoe test is considered positive. which confirms the brain death.
III. Paraclinical Methods to Confirm the Diagnosis of Brain Death
1. Electroencephalography (EEG) or transcranial Dopplerography are the paraclinical methods to confirm the brain death.
2. The presence of electronic activity of the brain is stated in compliance with the internationally accepted electroencephalographic studies, which are assumed under the brain death conditions.
3. Any kind of minimum 8 electrodes located following “10-20” system and 2 ear electrodes can be used. The resistance between the electrodes shall be minimum 100 ohms and maximum 10 kilohms. The distance between the electrodes shall be at least 10 cm.
4. Recording in the channels is performed during the constant period of time of at least 0.3 sec with at least 2 microvolt/mm amplification of the signal (the upper threshold for frequency passage shall be minimum 30 Hz ). Minimum 8 channel recorder shall be used. EEG is recorded in bi- and monopolar leads. Electronic silence of the cerebral cortex under the conditions of uninterrupted recording shall continue at least during 30 minutes. In all suspicious cases of the electronic silence of the brain the EEG recording shall be repeated.
5. Estimation of EEG reactivity shall be conducted in response to the impact of light, loud noise and pain. Duration of the above stimuli is minimum 10 sec. The light source with frequency range of 1 to 30 Hz shall be placed at 80 cm distance from the eyes. Intensity of the acoustic stimulus shall be 100 decibels. The dynamics shall be located near the ears of the patient.
6. Maximal intensity stimuli are generated using standard video- and phonostimulators. Vigorous pricking of the skin with needles is used to cause pain.
7. EEG, which is recorded via telephone, cannot be used to determine electronic silence of the brain.
8. Transcraneal Dopplerography is used for bilateral probing of anterior, middle and vertebral arteries of the brain. Absence of the diastolic flow in the presence of the systolic flow represents the Dopplerographic correlation of the brain death.
IV. Legalization of the Brain Death Diagnosis
1. The diagnosis of the brain death is stated by the two independent commissions of physicians composed of: the patient’s physician, resuscitation specialist, neurologist, (with at least 5 year experience in the field). Other specialists can be also included into the composition of the commission to conduct special studies. Organizational part of the brain death diagnosis is provided by the head of the clinic (department).
2. The specialists who participate in removal and transplantation of the organs cannot be included into the composition of the commission.
3. “Protocol on Stating the Brain Death Diagnosis” is the major document to confirm the diagnosis. (ref. Attachment 1).
4. Once the brain death diagnosis is stated the resuscitation activities including artificial ventilation of lungs can be terminated if the deceased is not a potential donor of organs. Brain death is identical to human death.
5. All studies to confirm the brain death shall be conducted twice within the period of 12 hours and in case of the child under 1 year such studies shall be performed three times during 48 hour period.
Law of Georgia
On Taking of Human Organs, Parts of Organs, Tissues and Their Usage.
Chapter I
General Provisions
Article 1.
This Law regulates the relationships between the state bodies, physical and juridical persons in the sphere of voluntary giving of one or more organs, parts of organs, tissues (hereinafter referred to as the “organ”), their taking, storing and distribution with the aim of their transplantation to other humans both during the lifetime of the donor and after his(her) death.
Article 2.
This Law does not regulate:
a) Taking and utilization of blood and its components, embryo and fetus organs, placenta, reproductive organs (ovaries, testicles, ova, sperm), tooth, hair;
b) Taking of organs to make a diagnosis during the lifetime of the patient or after his (her) death;
c) The cases of forensic medicine.
Article 3.
The notions and terms used in this Law have the following meaning:
a) Genetic kin – the son (daughter), mother, father, grandchild, grandmother, grandfather, brother, sister, nice, nephew, uncle, aunt, cousin of the donor or recipient;
b) Donor – alive or dead human from whom the organ is taken to transplant it to another human;
c) Informed consent – the consent of the patient or in case of his (her) incapability of his (her) relative or legal representative on conduction of a certain medical intervention with preliminary explanation of the essence, indications, expected effects, possible side effects of the intervention in question as well as the risks related to this intervention;
d) Recipient – the person to whom the other human’s organ was transplanted as the course of treatment to restore his (her) health;
e) Typing – determination of immunologic indices of the tissues;
f) Transplantation. Organ transplantation – the transplantation of the human organ to another human to save the patient’s life, cure the patient, hinder the progress of the disease or improve the quality of life of the patient;
g) Cerebral death – the irreversible cessation of the function of the brain and initial segments of spinal marrow on the background of artificially (using special medical means) maintained breathing and circulation.
Chapter II
Voluntariness of Organ Donation
Article 4.
Any capable person has the right to voluntarily declare his (her) consent or refusal on taking his (her) organ during his (her) lifetime or after his (her) death.
Article 5.
Consent or refusal can be related to one or more organs. The decision is legalized in the written form and is confirmed by the head of the medical institution.
Article 6.
The written consent on organ donation shall be sent to the Transplantation Information Center, which is forming the potential donors’ database (“The Donors’ Register”);
Article 7.
The health care institutions in accordance with the recommendations worked out by in cooperation with medical professional associations educate the population about the possibilities and importance of donation, taking and transplantation of the organs to other humans.
Chapter III
Postmortem Organ Taking in Case of Absence of Declared Consent or Refusal Given During One’s Lifetime
Article 8.
Taking of the organ from the deceased with the aim of its transplantation in cases when there is no consent or refusal declared in writing during the lifetime of the deceased is allowed if:
a) There are the facts confirming that organ taking does not contradict the religious beliefs and ethical principles of the deceased;
b) The person of the first priority right as indicated in the order of priority list of persons provided in Article 9 of this Law gives his (her) consent on taking of the deceased’s organ.
Article 9.
1. The following capable person have the right to allow or forbid organ taking from the deceased:
a) spouse;
b) son or daughter;
c) parent;
d) grandchildren, great grandchildren;
e) sister, brother;
f) niece, nephew;
g) grandmother, grandfather;
h) uncle, aunt;
i) cousin.
2. If even one of the relatives possessing equal rights refuses to give his (her) consent the organ taking from the deceased is inadmissible.
3. The persons listed in Item 1 of this Article have the right to make decision on organ taking only if and only if the higher priority person (s) is (are) not alive or if obtaining the consent from him (her) or them within the period admissible for transplantation is impossible.
Article 10.
The right to get the consent from the persons listed in Article 9 is given to the medical staff member of the hospital who has relevant authorization and does not participate in organ taking and using procedure.
Article 11.
If basing on the accepted medical standards the deceased patient is assumed to be a relevant candidate for organ taking but he (she) has not given written consent on organ donation during his (her) lifetime and none of the persons listed in Article 9 of this Law could be found after the patient’s death, organ taking from the cadaver with the aim identified in Article 4 of this Law is inadmissible.
Chapter IV
Taking of Organ from the Deceased Donor
Article 12.
The person can be considered as dead only after brain death or irreversible cessation of heartbeat and circulation is confirmed.
Article 13.
The criteria for cerebral death and irreversible cessation of heartbeat shall be worked out by the Ministry of Labor, Health and Social Protection of Georgia in accordance with the international standards and shall be approved by the President of Georgia.
Article 14.
Brain death of the patient shall be confirmed by the two independent teams consisting of a resuscitation specialist and neuropathologist basing on the results of separately conducted investigation with participation of the physician in charge of the given patient. These persons shall not participate in organ taking or transplantation and by their official status shall not be subordinated to the persons participating in organ transplantation process.
Article 15.
The date and time of investigation conducted to determine brain death, the data obtained and those data based conclusion shall be provided in written form and confirmed by the signature of the investigator physician. The relatives or the legal representative of the deceased have the right to familiarize themselves with the above conclusion.
Article 16.
The relatives or legal representative of the deceased have the right to attend the organ taking procedure, and in case they do not have such wish, they have the right to get the information on the conducted procedure from the relevantly authorized hospital staff member or from the physician who took the organ.
Chapter V
Organ Taking from Alive Donor
Article 17.
Taking of organ from the alive donor to transplant it to another human is allowed only to save the life of the patient, cure him (her) from the severe disease, hinder the progress of the disease or improve the quality of life.
Article 18.
Taking organ from the alive donor with the aim of its subsequent transplantation is allowed only in cases meeting the following requirements:
a) The donor shall be capable, except for the cases envisaged in Article 20 of this Law;
b) The donor and recipient shall be genetic kin or spouses except for the cases envisaged in Article 20 of this Law;
c) The donor made a written consent on organ donation;
d) The contemporary advanced methods of investigation confirm that immediate or remote, direct or indirect consequences of the operation do not represent significant risk for the life of the donor and will not result in marked deterioration of the donor’s health;
e) The relevant studies confirm that the donor complies with the criteria the consideration of which is mandatory when taking the organ for transplantation from the alive donor;
f) The operation aimed at taking of organ shall be conducted by the physician possessing adequate license and in the institution having the relevant license.
Article 19.
Taking of the organ, which can be regenerated, from the alive donor to transplant it to other human being is allowed in those cases also when the donor is not a genetic kin or spouse.
Article 20.
Taking of bone marrow from the under age person (except for juvenile donors) to transplant it to another person is allowed if:
a) Taking of bone marrow will not effect the health of the donor, which shall be confirmed by two independent physicians possessing relevant license;
b) Bone marrow shall be transplanted to the relative of the first or second order whose health is jeopardized and no other therapeutic option exists;
c) The attitude of the under age person towards the procedure allows medical intervention;
d) The informed consent confirmed by the guardian and care bodies is provided from the legal representative in case of under age person deprived of parental care.
Article 21.
To obtain the informed consent from the potential alive donor the following shall be explained to him (her):
a) The kind of surgical intervention required for taking of organ. its volume, risk for life entitled with this operation, possible immediate and remote, direct and indirect impacts of operation on the donor’s health;
b) Expected results from transplantation of the organ taken from alive donor including success and failure possibilities;
c) All possible circumstances, which can effect the donor’s decision.
Article 22.
Explanations provided in Article 21 of this Law shall be given to the potential donor by the physician possessing relevant license and in the presence of another physician who does not participate in taking and transplantation of the organ and who at the same time b his (her) official status is not subordinated to the physician participating in organ transplantation. The explanations provided to the donor and his (her) informed consent shall be legalized in accordance with the order stated by the Law. The donor has the right to change his (her) decision.
Chapter VI
Organization of Using the Organ with the Aim of Transplantation or Treatment
Article 23.
1. The hospitals are liable to inform the specialized institutions possessing a relevant license about the patients who were diagnosed to have total, irreversible cessation of the cerebral function and who in accordance with medical criteria can be considered as potential donors.
Article 24.
Taking of the organ for transplantation the quality of post-transplantation functioning of which significantly depends on the duration of its storage shall be agreed with the Transplantation Information Center.
Article 25.
The cooperation of the institutions, transplantation banks and other medical institutions possessing a relevant license is regulated by the contracts concluded between them.
Chapter VII
Management of Organ Transplantation Processes
Article 26.
In accordance with the requirements of the Legislation of Georgia the Ministry of Labor, Health and Social Protection coordinates and controls the activities of the physical and juridical persons engaged in organ transplantation.
Article 27.
The Ministry of Labor, Health and Social Protection shall:
a) Work out the standards for finding, taking, storing and testing of organs;
b) Work out the criteria for selection and testing of donors and recipients, define the form of standard documents indicated in Article 5 of this Law;
c) Define the organ quality control standards, control the observance of organ taking, transportation and storage rules, as well as organ validity and histological compatibility determination;
d) Periodically check the compliance of the activities of the institutions, transplantation banks with the stated standards and perform quality control of the medical service rendered by the above institutions in the sphere of transplantation; in case of necessity suspend the action of license or annul it;
e) Ensure information exchange about donors and recipients between the institutions and transplantation banks possessing relevant licenses as well as forward the information from hospitals to the above institutions;
f) Regulate international cooperation in the sphere of organ transplantation. Jointly with the interested departments participate in development of normative acts for human organs import-export;
g) Cooperates with the associations and professional unions interested in organ transplantation issues.
Article 28.
The Transplantation Council shall be formed at the Ministry of Labor, Health and Social Protection the provisions and composition of which shall be approved by the minister.
Article 29.
The Transplantation Information Center shall be formed at the Ministry of Labor. Health and Social Protection. The Center shall be headed by the physician possessing the relevant license or a biologist experienced in tissue typing.
Article 30.
The interested medical institution shall be immediately informed about every decision of Transplantation Information Center concerning the organ forwarding to the institution possessing a relevant license; the decision is recorded in a writing and shall contain all data basing on which this decision was made. The copy of this document shall be forwarded to the institution possessing a relevant license and respectively to the transplantation bank.
Chapter VIII
Institutions Possessing a Relevant License
Article 31.
Any medical institution of organizational-and-legal form envisaged by the Legislation of Georgia which has the license to take and transplant the organs and/or the license to provide organization-and-technical information support of those processes can be qualified as the institution possessing a relevant license.
Article 32.
The following are the institutions possessing a relevant license: transplantation hospital or its department possessing a relevant license, Transplantation Information Center, Transplantation Bank transplantation laboratory.
Article 33.
The institution possessing a relevant license shall:
a) Ensure performance of the license stipulated activities using adequate technologies;
b) In accordance with the state order participate in registration of possible donors and possible recipients as well as in compilation of the lists of persons who declared their refuse to donate organs;
c) Ensure information exchange between the medical institution following up the possible recipient or physician in charge of the possible recipient and organ transplantation management institution;
d) In accordance with the stated order produce medical documents with obligatory indication of identification number (code) of the transplanted organ;
e) Ensure observance of 24 hour working regime.
Article 34.
Transplantation Bank shall perform testing and selection of the deceased and/or alive donors, ensure that only the organ identified by the license is taken, typed, transported and stored with the aim of its subsequent transplantation.
Article 35.
Any independent medical institution or a constituent part of a medical institution envisaged by the Legislation of Georgia can serve as the Transplantation Bank.
Article 36.
Transplantation Bank is managed by the physician or biologist possessing a relevant license.
Article 37.
In case if the organ stored in the Transplantation Bank is qualified as invalid for transplantation the Bank has the right to give it away for research and educational purposes. Notification about this shall be sent to Transplantation Information Center.
Article 38.
The detailed data about donor testing, organ taking, typing, transportation. processing. storage performed by the Transplantation Bank are recorded in the documents stored in the Bank.
Chapter IX
International Cooperation in the Sphere of Human Organ Transplantation
Article 39.
Georgia participates in organ transplantation international practice.
Article 40.
1. Only those organs are allowed for import taking, processing and validity confirmation of which were performed in compliance with the requirements of the respective country laws, which shall be reflected in the accompanying documents;
2. The right to export the organ to Georgia is authorized to the institution possessing a relevant license;
3. The unimpeded delivery of the human organs to the territory of Georgia is performed basing on special application provided by the institution possessing a relevant license and documents accompanying the organ;
4. General surveillance on the usage of imported human organs is performed by the Ministry of Labor, Health and Social Protection of Georgia.
Article 41.
Export of the human organs from Georgia is allowed only under the permission of the Ministry of Labor, Health and Social Protection of Georgia via Transplantation Bank.
Chapter X
Ensuring Transplantation Safety
Article 42.
In accordance with the Legislation of Georgia the donor’s testing, selection and typing of the organ to be transplanted is conducted in any laboratory of organization-and-legal form possessing a relevant license.
Article 43.
Inspection of the activities of the specialized transplantation laboratory is performed in accordance with order state by the Legislation of Georgia.
Article 44.
The detailed results of the studies carried out in the laboratory indicated in Article 43 of this Law, identity of the researcher and the date of study shall be recorded in writing in accordance with the stated order. The document shall be forwarded to the Transplantation Bank and Transplantation Information Center.
Article 45.
The Ministry of Labor, Health and Social Protection shall define the necessity to place the organ forwarded to the Transplantation Bank under the quarantine and the term criteria for its keeping under the quarantine, as well as the criteria defining the dangerous infections risk groups among the donors in cases when these infections are not identified.
Article 46.
If the medical information provided in the documents accompanying the organ to be transplanted is not full or does not comply with the normative documents in effect the institution possessing a relevant license is liable to immediately notify the Ministry of Labor, Health and Social Protection about this. The Ministry shall make a decision on returning of the organ to the Transplantation Bank or its destruction.
Article 47.
If there is a documented doubt or proof that the organ is the source of distribution of dangerous infection it shall be destroyed in accordance with the stated order.
Chapter XI
Information Exchange and Storage
Article 48.
Transplantation Information Center shall encipher the identity of the donor using identification number known only to the Center. As a rule, only identification number shall be indicated in the documents accompanying the organ. The Ministry of Labor, Health and Social Protection shall assign the identification number known only to the Ministry to the donor’s identity information obtained from the institution possessing a relevant license. The documents accompanying the organ shall contain comprehensive data about the donor.
Article 49.
Only the Transplantation Council has the right to disclose the identity of the donor if:
a) The usage of the organ to be transplanted endangers the health of the recipient or other person;
b) The bodies of law and order demand such disclosure basing on the Court Resolution;
c) The Minister of Labor. Health and Social Protection demands such disclosure in accordance with the stated order.
Article 50.
The personnel engaged in taking, transportation, storage, distribution of the organs, as well as in their transplantation and treatment is liable not to disclose the identity of the donor and/or that of the possible donor as well as their medical data except for the cases envisaged by Article 49 of this Law.
Article 51.
The term of storing of documents containing written conclusions confirming total and irreversible cessation of cerebral function, information about the measures to be undertaken to take the organ from the alive or deceased donors as envisaged by Articles 14-15 of this Law as well as the documents on taking, testing and storing of organs from alive or deceased donors is 20 years; on expiring of this term the documents shall be destroyed in accordance with the stated order within maximum one year term.
Chapter XII
Organ Trading Prohibition
Article 52.
Human organ trading is prohibited.
Article 53.
The cost of measures to be undertaken to transplant the organ such as its testing, taking, conservation, transportation, storage, preparation for usage, protection of recipient and other persons from infection shall be covered in accordance with order stated by the Legislation of Georgia.
Article 54.
Transplantation of the organ is prohibited if the physician is aware that the organ was taken with violation of the rules stated by this Law.
Chapter XIII
Other Prohibitions
Article 55.
1. Any pressure exerted to obtain the written consent on organ donation is prohibited.
2. Violation of the rules of taking and usage of organs, parts of the organs and tissues envisaged by this Law will serve as a cause of action in accordance with the order stated by the Law.
Article 56.
Disclosure of the identity of the possible donor or donor to the persons who are not directly participating in taking of organ is prohibited except for the cases envisaged by the Law.
Chapter XIV
Conclusions and Transitional Provisions
Article 57.
1. Related with coming of this Law in force the following normative acts shall be adopted before June 1, 2000:
a) On introduction or respective changes and amendments into the Code of Administrative Infringement of Law and Criminal Code;
b) The Decrees of the President of Georgia:
b.a) “On Approval of Human Cerebral Death and Irreversible Cessation of Heartbeat Criteria”
b.b) “On Approval of Organs Import-Export Order”
c) The Resolutions of the Minister of Labor. Health and Social Protection:
c.a) “On Approval of the Standards for Finding, Taking, Storing and Transplantation of Organs”;
c.b.) “On Approval of Criteria for Selection and Testing of Donors and Recipients”;
c.c) “On Approval of the Organs Quality Control Standards”;
c.d) “On Approval of Provisions of Transplantation Council, Transplantation Bank. Information Center”;
c.e) “On Approval of Criteria Defining the Necessity of Placing the Organs Under the Quarantine, the Term of their Keeping Under the Quarantine, and Dangerous Infections Risk Groups among the Donors”;
c.f) “On the Order of Organ Destruction”.
d) Joint Resolution of the Minister of Labor. Health and Social Protection and Minister of Justice “On the Order of Legalization of the Decision Concerning Organ Transplantation During the Lifetime or After Death”.
2. This Law shall come in force from June 1, 2000.
SLOVENIA (2001)
In March, a new law on transplantation entered into force. The law is in accordance with the provisions of the current version of the Draft Protocol on Organ Transplantation to the Oviedo Convention. The law has made possible the founding of Slovenia-Transplant, a non-profit organisation for international exchange of organs. An independent committee for ethical issues in transplantation has also been set up. Transplantation medicine is well established in Slovenia, and public attitude towards organ donation after death is rather favourable. Electronic health and social security card, which is just being introduced, optionally contains the holder's statement about whether he or she wishes or does not wish to donate organs after death. This information is only accessible under special conditions in order to protect the holder from any possible misuse. Recently, and in connection with the law, a public debate was opened on the concept of brain death and on reliability of its diagnosis (although strict medical criteria have been established and carefully observed for many years in Slovenia).
Law on removal and transplantation of human organs for the purpose of treatment. This bill also is harmonised with the documents of the CDBI, including the Draft Protocol on Transplantation. It is now in final stage of the parliamentary procedure.
SWITZERLAND (2001)
1. Organ transplants
The following provision was approved in the referendum of 7 February 1999 and incorporated in the Federal Constitution (this provision will eventually be included in the fully revised Federal Constitution of 18 April 1999):
Art. 24decies
1. The Confederation shall enact provisions in the field of the transplantation of organs, tissue and cells. In so doing, it shall ensure the protection of human dignity, the individual and health.
2. It shall ensure an equitable distribution of organs.
3. The donation of human organs, tissue and cells shall be free of charge. Trading in human organs is prohibited.
The corresponding federal law on transplantation is in preparation. It will also regulate xenotransplantation.
In the meantime, the following principles are applicable to xenotransplantation:
Since 1 August 1996, when the federal order of 22 March 1996 on the blood control, blood products and transplants was introduced, there has been partial regulation in the area of transplantation medicine at federal level. The order regulates the protection of recipients from infections as well as trading in transplants.
Article 18, paragraph 1 (a), of the federal order stipulates that:
Anyone who removes transplants from humans or animals to graft them on humans or market them for this purpose shall be required to inform the federal authority concerned.
Article 19 states that:
Anyone who engages in an activity of the kind described in Article 18 shall be required to ensure that the organ removed and its human or animal donor were controlled for the presence of pathogenic agents or indications of the presence thereof.
The draft of 3 June 1998 of the Federal Council (Executive) on the amendment of the federal order on the blood control, blood products and transplants reads as follows:
Article 18a (new): Transplants of animal origin
1. It is prohibited to graft organs, tissue or cells of animal origin on humans.
2. On an exceptional basis, organs, tissue or cells of animal origin may be grafted on humans as part of a clinical experiment if the federal authority concerned so authorises.
3. Cells or tissue of animal origin may be grafted on humans if, in the current state of scientific and technical knowledge, it can been established that they present no risk of infection for the population and if the federal authority concerned so authorises. Authorisation shall be issued only if the therapeutic utility of the treatment has been demonstrated.
The principle of a prohibition on xenotransplantation will be temporarily applicable for a period of nearly three years. In connection with the preparation of a federal law on transplantation, which is expected to enter into force in the year 2002 at the earliest, it will need to be considered whether this prohibition should be retained.
2. Xenotransplantation
In Switzerland, xenotransplantation is not prohibited, but in the future it will be subject to authorisation. At its autumn 1999 session, the Parliament departed from the Federal Council's bill (which proposed a general prohibition subject to possible exceptions), amended the federal order on the supervision of blood, blood products and transplants and adopted the following provisions:
Section 18a
1) The grafting of cells, tissue or organs of animal origin onto human beings shall require the authorisation of the competent federal service.
2) Cells of tissue or organs of animal origin may be grafted onto human beings as part of a clinical experiment if a risk of infection for the population can be excluded with a high probability and if it can be expected that the graft will be of therapeutic benefit.
3) Cells of tissue or organs of animal origin may be grafted onto human beings as part of a standard treatment if, at the present state of scientific and technical knowledge, a risk of infection for the population can be excluded and if clinical experiments show that the graft is of therapeutic benefit.
In actual fact, it can be considered that there is now a moratorium on xenotransplantation.
The regulations on xenotransplantation provided for under the federal order on the supervision of transplants are in effect pending the entry into force of a federal Act on transplantation, and until the end of 2005 at the latest.
Other Topics Concerned: Biomedical Research, Reproductive Rights,
JAPAN (2000)
The Law on Organ Transplantation (LOT)
In Japan, The Law on Organ Transplantation(LOT) passed the Diet on June 17th in 1997 and was put into force on October 16th in the same year.
It took seven years for the legislation of LOT since a task force had been established in the government. In the task force (for the first two years) and in the Diet, the members discussed several issues, such as whether the brain death could be regarded as the death of an individual or not.
(1) Organs covered by the LOT
The LOT covers the heart, the lung, the liver, the kidney, the pancreases, the small intestines and the eyeballs(corneas).
(2) The requirements for the removal of organs and for the diagnosis of brain death
To remove organs from dead body for transplantation, the LOT requires the following conditions.
(a) the donor has expressed his/her will of donation for transplantation on paper before his/her death.
(b) his/her bereaved next of kin does not reject the removal of organs, or he/she does not have any bereaved next of kin.
In the LOT, "dead body" includes the body of the brain dead donor and it is legal to remove organs from it.
And to diagnose as the brain death , the LOT also requires the following conditions.
(a) the donor has expressed his/her will of acceptance of the result of the diagnosis of the brain death on paper besides the expression of his/her will of donation.
(b) his/her next of kin does not reject the diagnosis of the brain death, or he/she does not have any next of kin.
Therefore, to remove organs from the body of brain dead donor, donor's expression of his/her will and his/her (bereaved) next of kin's consent regarding both donation and the diagnosis of the brain death is required.
(3) Definitive diagnosis of the brain death
To maintain a national reliance on transplantation, the LOT shows a qualification of physicians to diagnose the brain death and also of the method of diagnosis.
(4) Others
The LOT prohibits the trade in organs for profit, and the foundation without permission of the authority of organizations for organ procurement and distribution.
GREECE (1999)
1. Law N°2737/1999:Transplantations of human tissues and organs and other provisions. Official journal of the Government of the Hellenic Democracy (A174/27 August 1999)
CHAPTER A : General provisions
Section 1
The removal of human tissues and organs with the purpose of transplantation is carried out for therapeutic purposes.
This law does not applies
a) to homologous transplantations
b) to removal and transplantation of testicles and ovaries
c) to blood transfusion
d) to removal and use of ova and sperm
e) the implantation of embryos.
Section 2
The removal of tissues and organs for transplantation reasons is done without any exchange. Any transaction between the recipient, the donor and their families is forbidden.
Section3
Expenses are covered by the insurance organisation of the recipient.
Section 4
Transplantation units
Transplantation may be carried out in specifically organised units of hospitals (public or non profit private ones).
Section 5
Co-ordinators of transplantations
Co-ordonators of transplantations will offer their services for the advancement of transplantation.
Section 6
Tissue banks and National List of volunteer donors of bone marrow.
Section 7
Future recipients
National list of future recipients after certification of their suitability.
Distribution of grafts : a) the organ is taken into consideration, b) it is based on criteria like blood type, matching of tissues, emergency, waiting time, age, weight, locality.
Section 8
List and data
Section 9
Sensitive data
CHAPTER B : Live donors
Section 10
Conditions and procedure.
Removal of organs or tissues from a living person may be carried out solely for the therapeutic benefit of a recipient where there is no suitable organ or tissue available from a deceased person, there is no other alternative method of comparable effectiveness, and there is no serious risk for the life or the health of the donor.
Removal of tissues and organs from a living person is allowed only when the transplantation concerns the husband or wife of the donor or a blood relative up to the second degree. This does not apply to bone marrow.
Removal is permitted only when the potential donor is an adult. Exceptionally removal of bone marrow from a minor is allowed, if the transplantation concerns brothers or sisters and the removal is necessary to save the life of the recipient, if there is no compatible donor available who has the capacity to consent, and the authorisation of both parents has been given.
Removal of tissues and organs from a living person is permitted when this person has the ability to give valid consent. This consent is given freely after information on the aim, the nature, and potential risks of the operation. There is a certain form for this consent.
Section 11
Compensation
In case of injury or death of the donor there is a compensation by the state.
Chapter C : Organ and tissue removal from deceased persons
Section 12
Conditions and procedure
Organs or tissues shall be removed from the body of a deceased person only for a therapeutic purpose, when that person has been certified dead.
The removal can be carried out if the potential donor had given his written consent. The removal is not allowed if he had rejected it in writing.
In every general census of the population, every adult is asked to declare in writing, in a specific document if he consents on not to the removal of tissues or organs from his body in case of death. If such a declaration has not been done municipalities and insurance organisations may take care the gathering of these declaration.
If the potential donor had not expressed his consent or denial, the removal is carried out when the husband or wife, adult children, parents, or brothers and sisters do not dissent.
Consent or dissent may always be freely withdrawn.
When the attending physician diagnoses death of the brain stem, and if the function of certain organs is detained with technical means, he is obliged to write the death certificate in collaboration with an anesthesiologist and a neurologist or neurosurgeon. In the certification of death a doctor who is a member of the transplantation team is not allowed to take part. The attending physician must inform immediately the National transplantation Organisation and in cooperation with it he inform the husband or wife or the relative on the death and the possibility of organ donation.
Section 13
Anonymity is being respected
Section 14
Donation to a certain person is not allowed
Chapter D : National transplantation Organisation
Chapter E : Penal provisions
2. The commission of the Ministry of Health on Medically Assisted Production has completed its work and presented its report.
A new Commission has been appointed for the preparation of a law on Medically Assisted procreation, based on the report of the first Commission.
3. Ethics Committees
1992 National Council of Medical Ethics (law 2071/1992) Not functioning yet
1992 Hospital Ethics Committees (law 2071/1992) Not functioning yet in a large scale
1997. National Council of Medical Ethics was renamed
to national Bioethics and deontology Committee Not functioning yet
1997. Hellenic Committee on Bioethics (general secretariat
for research and technology of the Ministry of development) functioning
1998 The Greek Orthodox Bioethics Committee functioning
1998 National Committee on Human rights functioning
1998. National Committee on Bioethics (both Committees
answer directly to the prime minister functioning
2. Protection of the hospital patient
Laws 2071\1992, 2519\1997 and 2716\1999
Laws 2716\1999 concerning the psychiatric patient.
TURKEY (1999)
Organ and Tissue Transplantation
Transplantation of organs and tissues is regulated in Turkey by the Law on removal, preservation and implantation of organs and tissues, N° 2238 ( 29 May 1979) (as amended by the Act N° 2594 of 21 January 1982).
The law N° 2238 is composed of four chapters: general provisions, requirements for removal of organs and tissues from living persons, requirements for organs and tissue removal from deceased persons and sanctions. [A report on organ transplantation in Turkey is available from the Secretariat of Bioethics Section ].
1. Protection of persons in medical research under Turkish law.
[A document concerning this issue is available from the Secretariat]
Medical research is subject to the regulations for Medical Deontology, Guide for Good Clinical Practices (1995) and the Guide for Good Laboratory Practices (1995) issued by the Ministry of Health. In the preparation of these guidelines, the Ministry has taken into account the worldwide established rules in these fields. The principles of the revised Helsinki Declaration and the guidelines for Good Clinical Practice in EU were adopted in many aspects of medical research on human beings.
Regarding informed consent to medical research, the Act on Practice of Medicine and its Branches, N° 1219 of 11 April 1928 applies mutatis mutantis. Moreover, the regulation of Medical Deontology of 13 January 1960 is taken into account.
Medical intervention on embryos is subject to the bylaw On treatment Methods Assisting Procreation. With regard to informed consent, general rules apply mutatis mutandis.
Drug trials may be carried out under the bylaw On Pharmaceutical researches. In such research, the Bylaw on Evaluation of Bioavailability and Bioequivalence of Pharmaceutical Preparations is also taken into account.
The mandatory rules of the Basic Law on Health services, N° 3359 requests informed consent in drug trials.
2. The Act on Population, N° 2827 (24 May 1983), addresses the questions on sterilisation and abortion. [The Secretariat has a document on this issue].
Other Topics Concerned: Biomedical Research
-----------------------
[1] Cross donorhood is defined by the Law on Human Organ transplantation as follows: “Taking organ from a spouse of a potential recipient or genetic relative for transplanting into another potential recipient and, relevantly, taking the same organ from the spouse of the second potential recipient or a genetic relative for transplanting into first potential recipient”.
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related searches
- organ harvesting in chicago
- organ harvesting in america
- black market organ harvesting
- illegal organ harvesting in america
- organ harvesting in the us
- organ stealing in america
- organ harvesting trafficking
- organ trade
- illegal organ harvesting united states
- organ harvesting of african americans
- illegal organ harvesting
- organ trafficking cases