Where are we heading? The legality of human body transplants examined.

In this article the authors examine the legality of human body transplantation under the current state of medical knowledge. The article first analyzes under what conditions an experimental medical procedure may be legitimately performed under international and national law. Then it examines the legal requirements for prior ethics approval and considers the possible civil and criminal liability claims and disciplinary sanctions that may arise if such a procedure would fail. Subsequently, it applies this analysis to investigate whether body transplants would currently be legally allowed. The authors conclude that it is very unlikely that prior ethics approval would be obtained, and emphasize that physicians are likely to be found liable for medical malpractice if body transplantation is performed. If body transplantation results in the death of the patient, the physicians involved would run a considerable risk of being held criminally liable for negligent homicide. The participating physicians also risk severe disciplinary sanctions for professional misconduct, with a real possibility that they will be suspended or even banned from medical practice for life.

Protection of Human Beings Trafficked for the Purpose of Organ Removal: Recommendations.

This report presents a comprehensive set of recommendations for protection of human beings who are trafficked for the purpose of organ removal or are targeted for such trafficking. Developed by an interdisciplinary group of international experts under the auspices of the project Trafficking in Human Beings for the Purpose of Organ Removal (also known as the HOTT project), these recommendations are grounded in the view that an individual who parts with an organ for money within an illegal scheme is ipso facto a victim and that the crime of trafficking in human beings for the purpose of organ removal (THBOR) intersects with the crime of trafficking in organs. Consequently, the protection of victims should be a priority for all actors involved in antitrafficking activities: those combating organ-related crimes, such as health organizations and survivor support services, and those combating trafficking in human beings, such as the criminal justice sectors. Taking into account the special characteristics of THBOR, the authors identify 5 key stakeholders in the protection of human beings trafficked for organ removal or targeted for such trafficking: states, law enforcement agencies and judiciary, nongovernmental organizations working in the areas of human rights and antitrafficking, transplant centers and health professionals involved in transplant medicine, and oversight bodies. For each stakeholder, the authors identify key areas of concern and concrete measures to identify and protect the victims of THBOR. The aim of the recommendations is to contribute to the development of a nonlegislative response to THBOR, to promote the exchange of knowledge and best practices in the area of victim protection, and to facilitate the development of a policy-driven action plan for the protection of THBOR victims in the European Union and worldwide.

Anonymity and live-donor transplantation: an ELPAT view.

Anonymity of donors or recipients in living-donor transplantation is a complex issue and practice varies widely. There are compelling arguments for maintaining anonymity of both parties before unspecified donor transplantation and specified indirect transplantation. After transplantation, there are still good reasons to avoid disclosure of identities. Although anonymity could be lifted if both parties explicitly request it, there are significant, potentially negative consequences of such an approach. Both donor and recipient should be counseled regarding these, and transplant teams should consider the considerable financial and psychosocial costs if problems are encountered as a result of contact. Given the recent rise in the number of unspecified living-donor transplants and through paired exchange schemes, it is vital that data are collected regarding the effects of maintaining or revoking anonymity after transplantation.

Living organ donation practices in Europe - results from an online survey.

In Europe, living organ donation (LOD) is increasingly accepted as a valuable solution to overcome the organ shortage. However, considerable differences exist between European countries regarding frequency, practices and acceptance of donor-recipient relations. As a response, the Coordination Action project 'Living Organ Donation in Europe' (www.eulod.eu), funded by the Seventh Framework Programme of the European Commission, was initiated. Transplant professionals from 331 European kidney and liver transplant centres were invited to complete an online survey on living kidney donation (LKD) and living liver donation (LLD). In total, 113 kidney transplant centres from 40 countries and 39 liver transplant centres from 24 countries responded. 96.5% and 71.8% performed LKD and LLD respectively. The content of the medical screening of donors was similar, but criteria for donor acceptance varied. Few absolute contraindications for donation existed. The reimbursement policies diverged and the majority of the donors did not get reimbursed for their income loss during recovery. Large discrepancies were found between geographical European regions (the Eastern, the Mediterranean and the North-Western). As a result of this survey we suggest several recommendations to improve quality and safety of LOD in Europe.

New classification of ELPAT for living organ donation.

In the literature, varying terminology for living organ donation can be found. However, there seems to be a need for a new classification to avoid confusion. Therefore, we assessed existing terminology in the light of current living organ donation practices and suggest a more straightforward classification. We propose to concentrate on the degree of specificity with which donors identify intended recipients and to subsequently verify whether the donation to these recipients occurs directly or indirectly. According to this approach, one could distinguish between "specified" and "unspecified" donation. Within specified donation, a distinction can be made between "direct" and "indirect" donation.

'Vague Oviedo': autonomy, culture and the case of previously competent patients.

The paper examines the ethical and legal challenges of making decisions for previously competent patients and the role of advance directives and legal representatives in light of the Oviedo Convention. The paper identifies gaps in the Convention that result in conflicting instructions in cases of a disagreement between the expressed prior wishes of a patient, and the legal representative. The authors also examine the legal and moral status of informally expressed prior wishes of patients unable to consent. The authors argue that positivist legal reasoning is insufficient for a consistent interpretation of the relevant provisions of the Convention and argue that ethical argumentation is needed to provide guidance in such cases. Based on the ethical arguments, the authors propose a way of reconciling the apparent inconsistencies in the Oviedo Convention. They advance a culturally sensitive approach to the application of the Convention at the national level. This approach understands autonomy as a broader, relational consent and emphasizes the social and cultural embeddedness of the individual. Based on their approach, the authors argue that there exists a moral obligation to respect the prior wishes of the patient even in countries without advance directives. Yet it should be left to the national legislations to determine the extent of this obligation and its concrete forms.