Explicit or presumed consent and organ donation post-mortem: does it matter?

In the last 25 years almost every West European country has enacted a transplantation law. During the preparation of these laws an important issue was whether to base the transplantation law on explicit or presumed consent regarding organ donation post-mortem. A common view of supporters of the presumed consent system is that it will result in more organ donors than the rule of explicit consent. In this article the difference between the different systems is further explored. For that purpose, the systems for post mortem donation in 10 West European countries will be discussed. Focus will be on the legal role of relatives within the consent process and finally on the role of relatives in practice. It will be argued that the difference between the two types of systems is less important than it seems to be at first sight.     

Postmortale Gewebespende in der Rechtsmedizin

After confirmation of death, tissues can be explanted from the deceased for transplantation purposes within a post-mortem period of 36 h (e.g. cardiovascular, musculoskeletal tissue and skin donations) or 72 h (cornea donation) in accordance with the donors’ wishes expressed while they were alive and depending on the medical and social history. In contrast, an organ donation can only be considered in cases of brain dead patients in whom the cardiovascular function is maintained. Multiple organ donors can also donate tissue although organ donation has priority. In contrast to organ transplantation, tissue transfer does not have to conform to any compatibility requirements, i.e. every donor can donate tissue for any recipient. While organ donation is organized centrally by the“Deutsche Stiftung Organtransplantation” (DSO, German Foundation for Organ Transplantation), tissue donation is not. The“Transplantationsgesetz” (TPG, German Transplantation Act) stipulates that the donor must be reported to the nearest tissue institution; however, this is often neglected due to ignorance of existing structures or not knowing the donor’s wishes. The following text describes the legal, medical and social prerequisites, the organization and process as well as transplantation indications for post-mortem tissue donation.     

Organ donation: a review of issues and laws.

Organ transplants sustain life and improve the quality of life for more than 18,000 patients in the United States each year, but many more await donor organs. All medical professionals need to understand organ donation and transplantation to provide patients and their families with accurate information. This article reviews the historical, social, legal and medical issues surrounding organ donation.     

Solid organ donation and transplantation

Medical imaging plays a key role in solid organ donation and transplantation. In addition to confirming the clinical diagnosis of brain death, imaging examinations are used to assess potential organ donors and recipients, evaluate donated organs, and monitor transplantation outcomes. This article introduces the history, biology, ethics, and institutions of organ donation and transplantation medicine. The article also discusses current and emerging imaging applications in the transplantation field and the controversial role of neuroimaging to confirm clinically diagnosed brain death.     

Launching the Greek forensic DNA database. The legal framework and arising ethical issues

Since the creation of the first national DNA database in Europe in 1995, many European countries have legislated laws for initiating and regulating their own databases.The Greek government legislated a law in 2008, by which the National DNA Database of Greece was founded and regulated. According to this law, only DNA profiles from convicted criminals were recorded. Nevertheless, a year later, in 2009, the law was amended to permit the creation of an expanded database including innocent people and children.Unfortunately, the new law is very vague in many aspects and does not respect the principle of proportionality. Therefore, according to our opinion, it will soon need to be re-amended.Furthermore, prior to legislating the new law, there was no debate with the community itself in order to clarify what system would best suit Greece and what the citizens would be willing to accept.We present the current legal framework in Greece, we highlight issues that need to be clarified and we discuss possible ethical issues that may arise.     

A proposal for an anonymous living organ donation in Germany

In Germany, living organ donation of paired and usually not regenerating organs is restricted by law to related individuals, as well as persons who 'obviously entertain an especially intimate personal relationship'. When this law was adopted in 1997, the intention of the legislator was to guarantee the free will of the donor and to exclude any trade of organs. Since then the transplantation of cadaveric organs has not increased. Additional organs were donated from living donors. However, for a number of reasons only a limited array of transplantation centers use living organ donation as a supply facing a steadily increasing number of patients with chronic renal failure. Living organ donation raises a variety of medical, ethical and legal questions. Although transplantation is a generally accepted therapeutic approach for impaired organ function, doctors do not promote it actively. Prospective donor-recipient pairs use the information obtained via internet and other sources before they contact the clinician. Doctors are hesitant to operate a healthy individual for allowing her or him to profit from this organ loss only emotionally or in an altruistic sense. Often a complex relationship between donor and recipient, as well as tissue incompatibility (ABO, HLA) may be additional reasons to restrain from carrying out living organ transplantation. To improve the chances for good organ function and better life quality of the patients we here propose a model for anonymous living organ donation with special reference to kidney transplantation.     

The Bioethics Convention of the Council of Europe and organ sharing for transplant recipients in Scandinavia

Even though organ transplantation is often life saving, the lack of donor organs is limiting the number of transplantation procedures. In small countries, like the Scandinavian countries, the small population level highlights this problem of organ availability which is further complicated by the fact that the utilisation of available organs may be prevented by histoincompatibility between the host and donor. This problem can only be solved by sharing both medical information and organs across countries. In Scandinavia, an organ sharing program (Scandiatransplant) was initiated between Denmark, Finland, Iceland, Norway and Sweden in the late 1960's long before the establishment of European Economic Area and the expansion of the European Union in Northern Europe. Even though trade in human organs is prohibited by international conventions, medical procedures and services that are associated with transplant activities are such services whose "free movement" within the Union is guaranteed by the Convention of Rome. These services can thus be offered across the national borders for remuneration. The potential impact of the conventions of the Council of Europe on transplantation services and organ sharing programs within European Union will be discussed.     

A review of Greek law on human cloning

The creation of Dolly, a cloned lamb from adult cells was a major scientific breakthrough, which opened new avenues for many research fields such as reproductive medicine, transplantation and biotechnology. However this achievement brought to public attention the theoretical possibility of human reproductive cloning. Inevitably heated debate occurred on several ethical and legal consequences of the prospect of human cloning. At the present time there is no legal framework in any country to respond to this challenge in a pragmatic way in order to protect human rights and at the same time to allow science to work for the best interests of mankind. Greece is a European Union country with its own traditions, history, culture and beliefs but without political and legislative experience in the handling of medical and biotechnological matters. This paper aims to discuss the legal issues likely to be raised by the prospect of human reproductive cloning in relation to the current state of the Greek legal system.     

Organ donation and transplantation

Medical imaging plays a key role in many aspects of organ donation, procurement and transplantation. Imaging techniques are used to confirm a diagnosis of brain death, measure organs, assess potential donors and recipients, and evaluate the success of surgery. This article offers an overview of organ donation and transplantation. After completing this article, readers will: Understand what U.S. laws apply to organ donation and which organizations play a part in the transplant process. Describe methods for determining death. Explain how organs are procured and allocated. Describe the role medical imaging plays in organ donation and transplantation. Discuss the controversies surrounding organ donation.     

Organ transplantation programme: an overview of the present situation

An ever-increasing demand for organs for transplantation has failed to keep pace with their availability. Social, religious and legal restrictions on the one hand and technological developments on the other have further worsened the existing shortage of organs. A correct definition of the 'moment of death', a more humane approach in breaking the news of death to relatives and de-linking the request for donation from the announcement of death may all go a long way in enhancing organ donation and procurement for needy patients. In India, the Transplantation of Human Organs Act was passed in 1994 to regulate the removal of organs from the living as well as the dead. However, it has certain fallacies. This paper reviews the various criteria in use to define the 'moment of death' around the world and with reference both to the Transplantation of Human Organs Act 1994 and the urgent need for organ retrieval in the present day paucity of donors.     

Anonymity in connection with sperm donation

Since Sweden abolished anonymity in connection with sperm donation in 1985, a number of other countries have followed suit. A legal provision still exists in Denmark to the effect that the donor must be anonymous. Arguments given in a Danish context against retaining the present scheme involving anonymous sperm donation will be discussed. The biggest problem with sperm donation seems to be non-disclosure. Current and important arguments in favour ofabolishing anonymity are that it sends out a clear signal that non-disclosure is unacceptable and that, in principle, all citizens should have access to the information available about themselves. However, the arguments can be criticised both from theoretical (legal) and several practical (medical) points of view. A substantive alternative to abolishing anonymity might be to inform parents about avoiding non-disclosure--and to design information material for the children, to support the parents.     

Relay kidney transplantation in Korea--legal, ethical and medical aspects

Living kidney transplantations constitute the majority of kidney transplantations in Korea. Recently, relay kidney transplantation, which is a modified form of both 'exchange transplantation' and 'living anonymous donation', has become at issue. After a living anonymous donor makes the initial donation, the next donor, who is related to the first recipient, makes the second donation; the third donor, who is related to the second recipient, makes the third donation; and so on. In relay kidney transplantation, organ trafficking, coercion of donation, assessment order, breach of agreement, and recipient burden should be evaluated with respect to ethical, legal and medical considerations. Despite these problems, a non-governmental body, the Korean Organ and Tissue Donor Program, has been promoting relay kidney transplantations to address the shortage of cadaveric kidney donations. Acceptance of the method of relay kidney transplantation requires the institution of supplementary measures to minimize the related problems.     

Practical experience in post-mortem tissue donation in consideration of the European tissue law

In consequence of the European guidelines of safety and quality standards for the donation, retrieval, storing and distribution of human tissues and cells the purpose of tissue transplantation was implemented into German legislation in May 2007. The law came into effect on August 1st 2007 considering of the European rules. The Institutes for Legal Medicine of the University of Frankfurt/Main and the University Medical Center Hamburg-Eppendorf developed a model for tissue retrieval. The Institute of Legal Medicine (I.f.R.) at the University Medical Center Hamburg cooperates with the German Institute of Cell and Tissue Replacement (Deutsches Institut für Zell—und Gewebeersatz DIZG). Potential post-mortem tissue donors (PMTD) among the deceased are selected by standardized sets of defined criteria. The procedure is guided by the intended exclusion criteria of the tissue regulation draft (German Transplant Law TPG GewV) in accordance with the European Guideline (2006/17/EC). Following the identification of the donor and subsequent removal of tissue, the retrieved samples were sent to the DIZG, a non-profit tissue bank according to the tissue regulation. Here the final processing into transplantable tissue grafts takes place, which then results in the allocation of tissue to hospitals in Germany and other European countries. The Center of Legal Medicine at the Johann Wolfgang Goethe-University Medical Center Frankfurt/Main cooperates since 2000 with Tutogen, a pharmaceutical company. Harvesting of musculoskeletal tissues follows corresponding regulations. To verify the outcome of PMTD at the I.f.R. Hamburg, two-statistic analysis over 12 and 4 months have been implemented. Our results have shown an increasing number of potential appropriate PMTD within the second inquiry interval but a relatively small and unvaryingly rate of successful post-mortem tissue retrievals similar to the first examination period. Thus, the aim of the model developed by the I.f.R. is to increase the number of PMTD retrievals and, furthermore, to avoid any conflict of interest between organ and tissue donation.     

Abortion under Greek law: parental consent for a minor's abortion

As medical abortion becomes more widely used and available in Greece, several issues are emerging and require clarification. Health care providers often face a dilemma when dealing with an adolescent requesting abortion. Parents' consent is mandatory before delivering any kind of treatment to minors. However, as it appears in the case presented here, the circumstances are not always straightforward. A critical review of the Greek legal framework in relation to the current social context is attempted through an interesting case aiming to elicit potential defects of the law that should be addressed by the legislator.     

Bio-medicolegal guidelines and protocols: survey and future perspectives in Europe

The preservation of uniqueness and the enhancement of the value of evidence in legal medicine is based on the implementation and development of a “quality management system,” which includes a continuous education of specialists, the introduction and application of guidelines and protocols, as well as mechanisms of internal quality control. This ongoing process shows differences with regard to various fields of knowledge such as forensic genetics, toxicology, forensic pathology or forensic psychiatry, especially if different European countries are compared. To get an overview on the development of legal medicine in different European countries, a questionnaire was developed and sent to representatives of 42 European countries to verify the existence of bio-medicolegal guidelines and protocols. A National Society of Legal Medicine is established in 27 out of 32 countries (84%) which could be included in the final analyses. In 25 countries (78%), a specialisation is necessary as a prerequisite of inclusion in a national register, and 30 of the countries (94%) have guidelines in at least one field of legal medicine. The most common guidelines concern forensic pathology (in the fields of professional qualification and sudden death), forensic toxicology (driving under the influence of drugs and substance testing) and forensic genetics (paternity testing and personal identification). The findings of this study show that comparison is possible and can be a basis for further consensus in the European medicolegal community. The process of harmonisation of the medicolegal autopsy rules in Europe initiated in 1990 was a first step on this way. Further consensus is necessary and might be gained by developing European guidelines for each field within the subdisciplines, based on a standard European Guideline Format.     

Presumed consent in the law of the Russian Federation on transplanting organs

In this article, the author defines and discusses various concepts of consent in relation to organ transplantation. Beginning with the law of the Russian Federation, he highlights the benefits and shortcomings of basic provisions and parameters of consent in Russian law. The situation is some other countries is reviewed from a comparative aspect. With the object of making transplantation more widespread, liberal interpretations of the rules are to be encouraged.     

Medically assisted human reproduction: the Greek view

Medically assisted human reproduction is a controversial issue that has attracted heated debate over the last two decades. In December 2002 the Greek Parliament passed a law with major social and scientific impact: the Medically Assisted Human Reproduction Act 3089/02. This law establishes the parameters of so-called surrogate motherhood, protects the anonymity of semen donors and sets the legal framework through which a woman's artificial fertilization after her husband's death is allowed. This article aims to discuss the legal ramifications of medically assisted human reproduction and especially the moral and social issues concerning the introduction of surrogate motherhood in Greece.     

Das neue deutsche Gewebegesetz unter Berücksichtigung des TPG-Gewebeverordnungsentwurfs hinsichtlich praktischer Umsetzung der postmortalen Gewebespende

Background

In the course of the European guidelines (2004/23/EC, 2006/17/EC and 2006/86/EC) and necessary subsequent corrections, a new law on tissue donation and retrieval for the purpose of transplantation was implemented in the German legislation in May 2007. The law came into force on August 1st 2007. The law regulates safety and quality standards for the donation, retrieval, storing and distribution of human tissues and cells. In anticipation of this new tissue law, the Institute for Legal Medicine (I.f.R.) of the University Medical Center Hamburg-Eppendorf developed the model for a tissue retrieval unit in 2006 already.

Methods

The I.f.R. developed, in collaboration with the German Institute of Cell and Tissue Replacement (Deutsches Institut für Zell- und Gewebeersatz DIZG); a model allowing for identification of potential Post Mortem Tissue Donors (PMTD) among deceased applying defined criteria. The procedure is supplemented by the intended exclusion criteria of the tissue regulation draft (TPG GewV) in accordance with the European guideline (2006/17/EC).

Results

In 14% of deceased eligible for PMTD tissue donation was effectuated thanks to the application of the criteria. The retrieved tissue was then sent to the DIZG, a non-profit tissue bank with a licence for further processing. This final processing into transplantable tissue then resulted in the allocation to hospitals in Germany and other EU countries.

Discussion

Our results up to now show a relatively small number of PMTD in comparison to the big amount of deceased within the Hamburg area. The aim of the model developed by the I.f.R. is to increase the PMTD and to avoid any conflict of interest between organ donation and tissue donation.     

Confidentiality of health information in Greece,the birthplace of Hippocrates

It is a doctor's duty to observe the rules of professional secrecy strictly by refraining from disclosing voluntarily to any third party information concerning a patient, that he has learned in the course of his professional practice. Greece is a European Union country with its own tradition, history, culture and beliefs but without political and legislative experience in the statutory handling of medical matters. This paper aims to give emphasis to the obligation of confidence in the area of medical practice and to discuss the legal issues likely to be raised in relation to the current state of Greek legal order.     

Without discrimination for religion,race, or gender

The transplantation of organs, which at first sight appears to be just a technical medical procedure, is, first and foremost a sociocultural action that gives expression to existential perceptions. In Israeli society, as in most western societies the donation of the body or parts of it, is interpreted as possible at a societal level, and not as a gift from one individual to another. The medical achievement inherent in organ transplantation brings forward the relationship between the body, death and society. The moment the body ceases to function biologically, its position within the social entity is examined. The donation of organs evinces the acceptance of the idea that the personal body belongs to the society which sanctions the transition of the private body into organs that become national assets. This research is a first attempt to study the motives of people from Muslim society, who donated organs of their dear ones. The ability of these people to enter into a system of exchange flows from a tacit assumption by all of them that the action is approved by their social group. This paper presents the concepts of death and of the body that enable donation in general and the donation of the Muslim population in particular.