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The Human Transplantation ( Wales) Act became law in Wales in September 2013. The Act aims to increase deceased donor organ and tissue donation in Wales by introducing a 'soft opt-out' system to replace the previous requirement of express 'appropriate' consent under the Human Tissue Act 2004. Adults dying in Wales (with certain exceptions) will be 'deemed' to consent to donation, unless evidence of their objection is produced, and a duty is imposed on Ministers to promote transplantation and inform the public through awareness campaigns about how to choose the deemed status or opt out. Although a welcome development, these campaigns may obscure the effects of deemed consent, especially in the context of generally rising UK donation rates. There may also be problems of legal interpretation and of integration with the 'opt-in' laws in the rest of the UK. In the absence of any statutory duty to retrieve all lawfully donated organs, the apparently restricted influence of donor relatives is likely to remain effectively dominant. [ABSTRACT FROM AUTHOR]

Advances in kidney transplantation over the past six decades have been impressive, but have not eliminated the significant variability in outcome related to donor organ quality. Organ shortage means that, in addition to ‘standard’ deceased donor kidneys (SD), ‘non-standard donor’ (NSD), ‘expanded criteria donor’, or ‘marginal’ kidneys, which fail to meet standard criteria and are often associated with less good outcomes, are now being transplanted into selected recipients as a means of increasing the donor pool. A similar, but less-documented, practice has developed in living donation. This article outlines the clinical rationale and ethical argument underpinning the use of such donor kidneys and examines their legal status in the UK, which we claim remains largely undefined and untested. While it is probable that the general principles governing medico-legal consent and liability also apply to organ donation, the special circumstances of donation, notably the inadequate supply of donors and the emphasis on a ‘gift relationship’, make it difficult to know how far existing medico-legal precedents can or should apply. The non-standard status of deceased donor organs creates potential problems for the validity of ‘appropriate consent’ to donation required by statute. It may also be relevant to the use of interventions intended to optimise deceased donor organ quality. Furthermore, the SD/NSD distinction in clinical practice may produce unexpected legal effects. For example, the recent UK Regulations 2012, which bring into force the EU Directive on standards of quality and safety of human organs intended for transplantation, could produce a negative legal restraint on the use of NSD kidneys. There is an urgent need for clarification of the effect of using NSDs in areas such as recipient and donor consent, liability for negligence, and the law of product liability. Some argue that the need for non-standard organs results from society's failure to compel the retrieval of all suitable standard organs from the deceased as a community resource. However, the Human Tissue Acts of 2004 and 2006 (Scotland), which govern organ donation and transplantation in the UK, expressly require individual consent or authorisation in the decision to donate. This emphasis on individual autonomy appears to chime with prevailing public opinion. However, the sense of medico-legal security gained by uncritical observance of the existing law and of directives published under its authority may be an obstacle to the development of a system which adequately meets the needs of recipients while safeguarding donor autonomy. [ABSTRACT FROM AUTHOR]

The article discusses the laws and misconceptions with regards to directed and conditional organ donations of deceased donors. It cites the Human Tissues Act of 2004, the establishment of the Human Tissue Authority (HTA) and the National Health Service (NHS) Blood and Transplant Organ Donation and Transplantation Directorate (NHSBT ODT). It mentions the remarks about organs as public resources that can be distributed in behalf of the state through the NHSBT ODT while others favor donor autonomy to respect the wishes of living donors.

The issue of directed donation of organs from deceased donors for transplantation has recently risen to the fore, given greater significance by the relatively stagnant rate of deceased donor donation in the UK. Although its status and legitimacy is explicitly recognized across the USA, elsewhere a more cautious, if not entirely negative, stance has been taken. In England, Wales and Northern Ireland, the Human Tissue Act 2004, and in Scotland the Human Tissue (Scotland) Act 2006, are both silent in this regard. Although so-called conditional donation, donation to (or perhaps withheld from) a specific class, has been outlawed as a product of guidance issued by the Secretary of State for Health issued in the wake of the controversial incident occurring in the North of England in 1998, its intended application to 'directed' donation is less certain. Directed and conditional donations challenge the traditional construct of altruistic donation and impartial (equitable) allocation in a very immediate and striking fashion. They implicitly raise important questions as to whether the body or parts of the body are capable of being owned, and by whom. This paper attempts to explore the notion of donor ownership of body parts and its implications for both directed and conditional donation. [ABSTRACT FROM AUTHOR]

Progress in transplantation outcomes depends on continuing research into both donor and recipient factors that may enhance graft and patient survival. A system of licencing for transplantation research, introduced by the Human Tissue Act 2004, which separates it from the transplantation process (then exempt from licencing), has damaged this vital activity by a combination of inflexible interpretation of the 2004 Act and fear of criminal liability on the part of researchers. Now, following the European Union (EU) Directive (2010) on standards of quality and safety of human organs intended for transplantation, new UK Regulations have been drafted, which are intended to implement it. These Regulations impose a compulsory licencing system, similar to that for research, on the whole transplantation process. This goes beyond what is required by the Directive and may even have an inhibitory effect similar to that already seen in research. Initial draft Regulations went further, imposing criminal sanctions for breaches. However, following a public consultation process, the Department of Health (DH) has recently stated that, as a result of the overwhelming view of respondents that the proposed licencing system was unnecessary, all sanctions under the final Regulations are now decriminalised, with the sole exception of operating without a licence. While this does not eliminate the negative effect of licencing, it does suggest an awareness of the DH that excessive regulation unnecessarily harms the transplantation process. An opportunity thus arises for the Human Tissue Authority (the regulatory body for both the new licences and research licences under the 2004 Act) to end the current illogical and harmful separation of transplantation and transplantation research by ensuring that all centres licenced for organ donation, retrieval and transplantation are also fully licenced for related research. [ABSTRACT FROM AUTHOR]

This manuscript reports on a landmark symposium on the ethical, legal and technical challenges of xenotransplantation in the UK. King's College London, with endorsement from the British Transplantation Society (BTS), and the European Society of Organ Transplantation (ESOT), brought together a group of experts in xenotransplantation science, ethics and law to discuss the ethical, regulatory and technical challenges surrounding translating xenotransplantation into the clinical setting. The symposium was the first of its kind in the UK for 20 years. This paper summarises the content of the expert lectures showcasing the progress which has been made in xenotransplantation including-the history of xenotransplantation, advances in gene edited animals and progress towards clinical xenotransplantation. We then set out the ethical and legal issues still to be resolved. Finally, we report the themes of the roundtable discussion highlighting areas of consensus and controversy. While the detail of the legal discussion was directed towards the UK, the principles and summary reported here are intended to be applicable to any jurisdiction seeking to implement clinical xenotransplantation., Competing Interests: Competing interests: David Ayares is the chief scientific officer of Revivicor, Inc. David Cooper Consultant to eGenesis Bio, Cambridge, MA, USA. Jayme Locke receives grant salary support from Lung Biotechnology PBC, a subsidiary of United Therapeutics., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Advances in modern medical technology have gone so far that it is now possible for machinery to keep people alive. To some extent this has led to a misperception in society that death can almost always be postponed because life-sustaining extracorporeal machinery of some sort or another, for example a dialysis machine, can prevent it. However, for some, being kept alive connected to a dialysis machine for four hours three times a week does not represent or even come close to an existence or quality of life they consider valuable. It may even cause unnecessary distress. This may be because they have reached a point at the end of their lives where they would like the focus of their treatment or care to become that which enables them to live as well as possible until they die. In these circumstances treatment and care should properly be that which enables the supportive and palliative care needs of both patient and family to be identified and met throughout the last phase of life and into bereavement. Identifying and acknowledging the importance of such a paradigm shift in the delivery of healthcare, and above all facilitating it, includes taking on the responsibility, incumbent upon us all, to address the ethical issues that are brought into focus. In this paper, I examine some of these issues. I consider the ways in which underlying theoretical ethical principles have informed the development of professional guidance and highlight the dynamic relationship this guidance has with the law. Finally, I demonstrate the ways in which it can be usefully applied to inform and assist clinical decision-making. Key challenges for BAME groups are addressed., (© 2014 European Dialysis and Transplant Nurses Association/European Renal Care Association.)