Non-standard Kidneys for Transplant: Medical Morality and the Law
* NIHR Biomedical Research Centre, Guy's and St. Thomas' NHS Foundation Trust and MRC Centre for Transplantation, King's College, London SE1 9RT, UK.Medical Law Review (Impact Factor: 0.65). 04/2013; 21(3). DOI: 10.1093/medlaw/fwt015
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.
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ABSTRACT: 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.
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ABSTRACT: This article will examine the problem of disease transmission through organ transplantation from a civil liability perspective. Both fault liability and strict product liability might be possible. These two types of liability will be compared, while applying them to the actions of the central parties involved in organ donation and transplantation, namely the physician/hospital, the donor and the organ exchange organisation. While product liability is generally an easier way to obtain compensation than fault liability, it might nevertheless place too heavy a burden on the transplant professionals.
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