By Professor Jo Samanta - Reader in Medical Law at Leicester De Montfort Law School writes about the Medical Innovation Bill (Saatchi Bill) and the law.
Post-hoc scrutiny of medical innovation is inadequate
The publicity around Lord Saatchi’s Medical Innovation Bill has put innovative therapy high on the political and public agenda.
I broadly support the Bill, and think there needs to be a clear balance between the risks of innovation and patient safety.
It is my view that the Bill can be fine-tuned to meet this challenge. In a paper recently published in the Journal of Medical Ethics – Quackery or quality: the ethicolegal basis for a legislative framework for medical innovation – I, along with my co-author, argue that a regulatory framework is needed to allow a full consideration of the applicability of innovation, prior to the proposed treatment taking place.
In this blog I focus on the issue of pre-treatment scrutiny of proposed innovative treatment, rather than post-hoc scrutiny and of the issue of valid patient consent to innovation.
The vociferous debate over the recent Medical Innovation Bill introduced in the UK by Lord Saatchi is testament to the continuing relevance of innovation for contemporary healthcare provision.
The Bill has been criticised by some, with suggestions that the proposed legislation is unnecessary and might even promote quackery.
However, this criticism is perhaps too harsh, since innovation has often been the impetus for a range of diagnostic and therapeutic developments in medical science.
Legislation would permit doctors to deploy medical innovation optimally for the benefit of patients and within a legitimate assurance framework.
INADEQUACY OF POST HOC SCRUTINY
As yet there is no formally established quality assurance framework for proactive evaluation of innovative therapy in respect of its applicability, or suitability, prior to delivery.
The existing pathways tend to be post hoc review through litigation, regulatory or disciplinary processes, or local procedures such as root cause analysis, serious incident review, or clinical audit.
These ‘after the event’ mechanisms are unsatisfactory, since they are usually predicated on some form of adverse outcome.
The Bill seeks to encourage ‘responsible innovation’ on the basis that doctors will not be prima facie negligent for deciding to depart from the existing range of accepted treatment if their decisions are transparent and accountable and all relevant matters have been considered fully.
For an action in negligence, the question for the court will be whether the doctor has breached the standard of care expected in law.This is based on the Bolam test with the Bolitho proviso that the decision withstands ‘logical analysis’.
Both these tests could be problematic in the context of innovative practice. A standard for responsible innovation that is defined by legislation would carry the force of law, provide clarity for the de jure limits of innovative practice, and offer protection against improper experimentation on patients.
Innovative therapy falls between two highly regulated areas: standard medical treatment and clinical research.
The regulatory mechanism of post hoc review is largely unsatisfactory. In the presence of terminal or incurable illness, patients may be vulnerable to a greater or lesser degree and might not be best placed to assess the risks and benefits of potential innovations adequately, particularly if they believe they have nothing left to lose.
It has been argued that since the decision-making process is based typically on an individual doctor–patient axis, a clear framework is needed for appropriate regulation.
Innovative therapy includes departures from standard medical therapy, which may lack an evidence base or a demonstrable safety profile. The primary purpose of innovation must be to benefit the individual patient.
I hold that legislation of medical innovation would be beneficial. Legislation would provide a legal standard for responsible innovation, define the boundaries of acceptable medical conduct in this area, and provide the basis for legal protection of patients (many of whom could be highly vulnerable) against wrongful exposure to inappropriate therapies (at best) or unwarranted experimentation (at worst).
I propose that the Bill could be further refined through a two-stage test for embarking on responsible innovation, by creating mandatory requirements for ongoing oversight accountability, and by placing patient-centred care at the heart of the statute with an emphasis on consent and compassion. There is need for fine-tuning between empathetic care, innovation and regulation in order to get the balance right.
Another argument against the Bill has been around the concern that vulnerable patients are not able to consent validly to innovative treatments.
Valid consent is a necessary precursor for therapeutic treatment of competent patients and raises particular challenges in the context of innovation.
The human instinct to cling to hope together with a dearth of alternative options might mean that duress of circumstances can interfere with the validity of apparent consent.
The potential vulnerability of those who seemingly have ‘nothing to lose’ is recognised in international guidance for research participants with incurable and life-limiting conditions.
Nevertheless, while circumstances such as these may well affect freedom of choice, it is wrong to conclude that this inevitably compromises autonomous choice.
The possibility of well- intentioned beneficent medical paternalism needs to be guarded against and further strengthens the argument for legislation.
Professor Jo Samanta is Reader in Medical Law at Leicester De Montfort Law School. Her primary research focus is on end-of-life decision making. She is the lead author of Medical Law – Palgrave Law Masters and is Chair of the Business and Law Faculty Human Research Ethics Committee. ENDS