Heart valve ownership: legal, ethical and policy issues.
It is in the interest of parties to be able to test a defective explanted heart valve. This article identifies some of the relevant interests of patients (or their relatives), the manufacturers and society at large, and considers some of the legal issues involved in determining the ownership of valves in English law that arise from the varying nature of heart valves and the setting in which they are purchased and delivered. Ownership of explanted valves may vary according to whether the patient obtains the valve by private purchase, through the National Health Service, or through private health care insurance. It seems that, in the most common scenario (delivery via the National Health Service), the patient owns the valve (once implanted) by way of a gift, but that ownership revests to the health authority once the valve is explanted. The determination of ownership is, however, very complex. It is argued, however, that ownership does not automatically entail the right to test. So, even if it were determined that the patient (or the patient's estate) owned the valve, it would not follow that the patient had the right to control the testing of the valve or otherwise dispose of it. Close attention to the network of interests (both moral and socio-economic) in having explanted valves tested competently, suggests that it should be public policy to place custody of explanted valves (for the purposes of having them tested) in the hands of the Medical Devices Agency. This authority should be incorporated into regulation applying the European Community Medical Devices Directive.(ABSTRACT TRUNCATED AT 250 WORDS)
Beyleveld
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Sheffield Institute of Biotechnological Law and Ethics, University of Sheffield, United Kingdom.
Howells
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Longley
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D001344:Autopsy / Q000331:legislation & jurisprudence; D002201:Capital Expenditures / Q000331:legislation & jurisprudence; D004992:Ethics, Medical; D005062:European Union; D006350:Heart Valve Prosthesis / Q000191:economics / Q000592:standards; D006801:Humans; D007221:Industry; D007348:Insurance, Health / Q000191:economics / Q000331:legislation & jurisprudence; D007883:Legislation, Medical; D008422:Materials Testing; D009014:Morals; D010067:Ownership; D011050:Policy Making; D011475:Prosthesis Failure; D011640:Public Policy; D012959:Socioeconomic Factors; D013222:State Medicine / Q000191:economics / Q000331:legislation & jurisprudence; D006113:United Kingdom