NICE has issued their response to the consultation: NICE Response
The Royal College of Physicians already encourages innovation and finds, together with medical protection bodies, no real evidence, anecdotal or otherwise, that fear of litigation deters doctors from responsible innovation. It does however set out some recommendations for improvement in this area and notes the key factors which may arise as barriers to innovation and would thus be more suitably addressed as areas of focus for any future, careful improvements. The RCP also note in their response that there is no legal barrier to responsible innovation in the present law or guidelines.
The GMC state ‘we are concerned that legislation which aims to clarify and encourage good practice in terms of when medical innovation is responsible could have the opposite effect as well as unintentionally weaken the principles which we regard as fundamental to safe, effective patient care. We take the view, therefore, that legislation is both unnecessary and undesirable.’
The members of the British Pharmacological Society oppose the Bill and its rationale. BPS Response
The Academy of Medical Royal Colleges has issued their opposition in a statement following the consultation closure, enclosing their consultation response- see below
This is an enormous body of medical, expert opinion collaboratively responding to the Bill, clearly aghast at the suggestions therein:
‘We have not seen any evidence that suggests litigation or the possibility of litigation is deterring clinicians from innovative practice’ ‘We are therefore concerned that the Bill will not actually deter innovation which is irresponsible and may indeed have the opposite effect’. ..’the Bill could inadvertently undermine the undertaking of proper clinical trials.’ Noting that ‘informed consent, which can be difficult enough when a body of evidence has accumulated following clinical trials, becomes much more difficult when there is little evidence to support innovation.’
The BMA Response may be read here:
The BMA summary states: ‘this Bill should not become law.. is .. unnecessary, risks removing important protections for patients and could encourage reckless practice, with attendant risks for patient safety.’
The Wellcome Trust, Medical Research Council and Academy of Medical Sciences oppose the Bill.
They have ‘significant concerns’ feeling ‘there is a degree of disconnect’ and stating ‘patients could be at risk of receiving treatments for which the evidence base is not well established, including treatments which could prove ineffective or even harmful.’ They identify many concerning aspects of the Bill.
The British Dietetic Association has opposed the Bill. The Academy for Healthcare Science, the overarching body for the 50,000 Healthcare Scientists working across the NHS, opposes. AHCS Response here
Professor of Complex Obstetrics Susan Bewley, Professor of Surgery Michael Baum, Professor of Bioethics Richard Ashcroft and GP and Author Dr Margaret McCartney in her response and writing in the BMJ, haveall joined an expert opposition to the Bill.
Expert Legal Opinion
Sir Robert Francis QC responded to the consultation, acknowledging the flawed legal basis and significant risks. His response can be read in full here:
Many QCs, Solicitors, APIL, Leigh Day & Co, Irwin Mitchell, Kingsley Napley and other legal organisations are resounding in their opposition of the Bill. The defence organisations the MDU and MPS strongly oppose the Bill. MPS Response.
It is clearly not just lawyers opposing this Bill. The Good Thinking Society strongly opposes. The Nightingale Collaboration strongly opposes the Bill. Junior doctors and medical students disapprove – they don’t want to practice in the broken environment that would be created by the Bill, one dubbing the campaigning Orwellian.
It is opposed by many, many doctors, research experts and medical professionals: and, importantly, by the public, patients and charities.
Charities and Patient Associations
CRUK, supporting clinical studies on which over 35,000 patients are enrolled, having ‘consulted with both patients and clinicians, including the Chairs of the National Cancer Research Institute Clinical Studies Groups’ is against the Bill.
The AMRC Response from the Association of Medical Research Charities does not support the Bill.
HealthWatch who promote fair tests of health treatments and quality information for the public and health care professionals, are against the Bill.
The Patients Association responded in opposition of the Bill.
The MND Association state the following:
‘It is only after very serious consideration that we have decided that we cannot support the Bill, and must recommend to the Government that it does not legislate as proposed.’
‘Some people who promote such treatments are misguided, mistaken about their efficacy, or motivated by the prospect of monetary gain without any regard for the safety or wellbeing of people with MND. While there are some potential new treatments for MND in development, there are also numerous unproven treatments that have been developed and marketed, outside orthodox research and clinical channels…all of these unproven treatments could be made available via the provisions of the Bill’
‘It is the bedrock of medical ethics that treatments must be both safe and efficacious, and these principles serve well to strike a balance that allows scientifically proven new treatments to be promoted without making it easy to exploit vulnerable people with a serious illness. We fear that the provisions of this Bill could undermine this position, and unintentionally open the door to the exploitation of people’
‘Furthermore, the evidence presented for change in the consultation paper is unconvincing’
‘The Bill would not remedy the problem it is aimed at, for such a problem does not exist: uncertainty around the law or fear of litigation do not.. dissuade doctors from trying new treatmentsIt is certainly the case that such factors are not at all the reason for the lack of curative treatments..’
‘Indeed, we believe that the current legal position offers an appropriate balance between latitude for doctors and safeguards for patients
‘(The Bill does) not appear to offer any safeguard against the inappropriate or exploitative use of unproven treatments’
‘In the face of legislation which could open the way for, and .. encourage, people with terminal illnesses to take significant risks with their health, it should be remembered that people who live with such illnesses can achieve a quality of life sufficient to make life worth living.’
‘We are very concerned’
To apply Bolitho, there is no responsible body and no logical way that this can be supported. The Bill was misconstrued, dangerous and indefensible from the outset. No responsible body of medical or ethical opinion would support the Bill. It should have ‘a survival rate of zero’ and be withdrawn with immediate effect.
Additionally here are those listed on Nigel Poole QC’s blog at 26 April, plus many others expressing objection via twitter:
As at 26 April 2014 the following have agreed this statement: Suzanne White, Partner on behalf of Leigh Day Solicitors, Professor Michael Baum, Emeritus Professor of Surgery, UCL and past President of the British Oncology Association, Peter Walsh, CEO Action against Medical Accidents, Matthew Stockwell, President, Association of Personal Injury Lawyers, Stephen Webber, Chairman of the Society of Clinical Injury Lawyers, Catherine Collins, Chair of England Board, The British Dietetic Association Keith Isaacson, Chairman, HealthWatch, Alan Henness, Director, The Nightingale Collaboration; Laura Thomason, Good Thinking Society, Margaret McCartney, GP, author and broadcaster; Professor John McLachlan, Professor of Medical Education, Durham University, Professor Richard Ashcroft, Professor of Bioethics, QMUL, Professor David Curtis, Honorary Professor of Psychiatry; Kate Rohde, Partner, Kingsley Napley LLP, Edwina Rawson, Partner, Field Fisher Waterhouse LLP ; Dr Simon Taylor QC, Amanda Yip QC, William Waldron QC, Henry Whitcombe, Barrister, Dr David Nicholl, Consultant Neurologist, Les Rose, Clinical Research Consultant, Dr Darren Conway, Solicitor; Benjamin Dean, Orthopaedic Registrar, Nuffield Orthopaedic Centre, Oxford, Richard Borrett, Barrister; Lindy Williams, Paula Ashton, Azalea Read, Diane Lyall, Solicitor, Jack Skellington, Roger Fisken, Consultant Physician, Steve Cornforth, lawyer, author and blogger, David Hills, Michelle Beckett, Killian Garvey, Peter Novakovich, Lucy Barker, James T Randall, Jo Brodie, Nicola Jenkins, Caroline Aspinwall; Adam Gyulani-Lancaster, Mark Slater, Partner PSG Solicitors, Tabatha James, David Ratcliffe, S Hart, Ben Harris, Kiri Shala, Roy Omond, David Brims, Andrew Buckley, Robert Kane, Jonathan Hartley, Robert Kane, Darryl Allen QC, Alan Lodge, John Bates, Geoff Silva, David Marshall, Sandra Patton, Muiris Lyons on behalf of Stewarts LLP, Dr Fiona Hamilton, Hamish Morrin, Angelina Curtis, Dr Peter English