title: Quackery or quality: the ethicolegal basis for a legislative framework for medical innovation.
abstract: Innovative therapy is a matter of recent public interest, particularly following Lord Saatchi's Medical Innovation Bill. The purpose of the Bill is to encourage responsible innovation in medical treatment. We argue for the need to achieve a balance between the risks of medical innovation and patient safety considerations. We make the case for statutory regulation of medical innovation on the basis of responsible innovation, choice and patient-centred care. At the heart of regulation of medical innovation is care delivered by a process which is accountable, transparent and allows full consideration of all relevant matters. This paper proposes a two-stage test (to assess applicability of medical innovation as well as suitability for the choice of intervention to be undertaken). It is suggested that this model would provide safeguards for patients as well as define limits for doctors in the context of innovative therapy. Implementation and application of such therapy must be underpinned by due process and governance oversight, which could be provided through context-specific professional peer review. A combination of these ethicolegal principles would permit responsible medical innovation and maximise benefit in terms of therapy and patient-centred care.
authors.affiliation: Law School, De Montfort University, Leicester, UK.
authors.forename: Jo
authors.initials: J
authors.lastname: Samanta
authors.affiliation: Department of Rheumatology, University Hospitals of Leicester NHS Trust, Leicester, UK.
authors.forename: Ash
authors.initials: A
authors.lastname: Samanta
mesh_terms: D006801:Humans; D061214:Patient Safety / Q000331:legislation & jurisprudence* / Q000592:standards; D018802:Patient-Centered Care / Q000941:ethics* / Q000331:legislation & jurisprudence*; D011781:Quackery / Q000517:prevention & control; D035703:Therapies, Investigational / Q000941:ethics*; D006113:United Kingdom
keywords: Clinical Ethics; Decision-making; Legal Aspects; Negligence