The Department of Health consultation on the 2014 stab at the Medical Innovation Bill received damning responses from legal experts, medical bodies, defence unions, research charities and patient groups alike.
Nevertheless, the Bill proceeded and was heralded as new and improved prior to its first and second readings in the House of Lords in June this year. Again, the expert consensus against the Bill was clear, strong and unequivocal.
Thereafter, the Bill morphed twice more into the version that went to committee stage in the House of Lords on 24 October 2014; it’s now at version 5 of its latest of numerous attempts.
This is not true but as we have seen with the campaign – perception is what matters, not truth.
Indeed, expert consensus is resolutely against the Bill; so much so that any government contemplating allowing such proceedings to become law would be somewhat failing in their duty of care – for it is so unthinkably wrong, arrogant and dangerous to push against such eminent, widely held opinion.
- APIL has placed it high on their political agenda under ‘Caring for Patients: addressing the misconceptions at the core of the Medical Innovation Bill’ and for the committee stage, published ‘Myth vs Reality’, concluding that there is no evidence that doctors are sued for trying innovative treatment or are deterred by the law, that the Bill would generate confusion, that there are other barriers, that the Bill does not contain what it is said to and that statements made by Lord Saatchi are highly misleading and damaging.
- The BMA has continued to oppose the Bill – reiterating that it is unnecessary, fails to support doctors and that rigid statute is inappropriate. The BMA ‘suggest that the bill is withdrawn and consideration given to identifying other means of increasing medical innovation’. The October parliamentary briefing can be read here, stating clearly that the current law and professional guidance allows for innovation and the latest drafts of the Bill are so far removed from the original intention behind it that it clearly should not proceed further.
- These views are echoed by the Medical Protection Society, who continue their opposition in recent publications and also issued a parliamentary brief and comment prior to committee stage.
- The Medical Defence Union also issued a new brief to parliament, setting out that the current law and ethical guidance is very clear and that the Bill introduces the potential for adverse consequences that do not currently exist.
- AvMA, Action against Medical Accidents, maintained opposition to the draft entering the committee stage, emphasising it is dangerous and misguided in their brief for 24th October.
- The Association of Medical Research Charities issued a briefing on the committee stage of the Bill, approved by the Medical Research Council, Academy of Medical Sciences, Wellcome Trust, Arthritis Research UK, Parkinsons UK, Leukaemia & Lymphoma Research, British Heart Foundation and Motor Neuron Disease Association. The AMRC briefing lists fundamental concerns with the Bill and the marshalled list of amendments, stating ‘we are concerned that the Bill risks subverting the frameworks currently in place to preserve patient safety. There may be unintended consequences for patients who could be at risk when receiving treatments for which the evidence base is not fully established, including treatments which could prove ineffective or harmful’ ‘We believe there is a need for better evidence to establish the main barriers to the development and utilisation of innovative medical treatments, and to clarify the best way to address this issue. We are also concerned that the Bill could introduce a degree of ambiguity to the law governing clinical negligence, potentially placing doctors at risk of further litigation.’ ‘ We are also concerned that the Bill may discourage patients and their clinicians from participating in clinical trials by encouraging the provision of novel treatments on an ad hoc basis, leading to a failure to develop the robust evidence of efficacy necessary to support wider adoption of innovations in the NHS.’
- Nigel Poole QC gave an interview that very clearly sets out what is so wrong with the Bill, available here.
- Likewise, Suzanne White, partner representing injured patients and bereaved relatives at Leigh Day & Co appeared on Sky News in the week running up to the committee stage – emphasising that this Bill is not an answer, doctors are not sued for innovating, patients will not benefit and the Bill fails to address any real barriers that may exist. Prof Colquhoun also appeared on TV voicing strong concerns against the Bill, its mistaken premise and reiterating that off-label prescribing is permitted under the current law.
- Media coverage has also included pieces in the Telegraph ‘The Saatchi Bill is dangerous and will bring nothing but harm’ and the Independent ‘So-called ‘Saatchi Bill’ under fire for unintended consequences’.
- Indeed in the Lords, a significant number of peers expressed serious concern during the 24th October stage.
Lord Turnberg: ‘I would hate to see the opening up of a bureaucratic and legal nightmare that Sir Robert Francis tells me he still has problems with…In my own field of gastroenterology I constantly tried novel treatments…I say as an aside that at that time I did not feel the need for a Bill of this sort to allow me to innovate when I already had ethics committees’ approval and the informed consent of my patients. I fear that I am not alone in wondering whether the Bill is necessary. When Action against Medical Accidents, for example, and a number of important medical bodies express doubts about the need for it, one begins to wonder.’ ‘I fear that the Bill’s wording leaves open to too great a degree the potential for harm by unorthodox, unregulated practitioners.’ ‘…it is for …vulnerable people, desperate to try anything, that we have to have in place processes and mechanisms to protect them from unethical practitioners who may take advantage of their vulnerability.’
Lord Pannick recognised the need to ‘ensure the protection of vulnerable and often desperate patients and their families’ and expressed a number of significant concerns.
Lord Winston said ‘I feel that the whole of this Bill will increase lack of clarity and promote uncertainty on the part of patients, which is something that really concerns me. I must also say that, as it stands, I believe that the Bill is quite dangerous’ ‘I have to say that never once have I looked over my shoulder and thought that there might be a risk of litigation as a consequence of my innovating’
‘I believe that the noble Lord is mistaken ….Had the noble Lord, Lord Saatchi, along with his noble friend the Minister of Health, decided to focus on certain other aspects, I would have argued that some of the permissions for research ethics would have been a very important issue to look at. They are increasingly inhibitory. I would also cite some of the problems that have arisen out of the Human Tissue Act 2004, which was introduced by a Labour Government. There is a number of other issues that could have been looked at, such as the fitness to practise regime of the GMC…’
‘I have to say to the noble Lord, Lord Saatchi, that, unlike him, I have tangled with innovation throughout my life. I have had sleepless nights; I have had trembling hands when facing patients who might die because I knew that I had to take a decision on the spur of the moment that might make the difference between life and death’
Baronness Masham of Ilton, acknowledging the duty to try to improve the Bill, emphasised serious concerns: ‘The Royal College of Surgeons of Edinburgh said it retained its belief that the Bill presents a notable threat to patient safety and so should not become law. It said it shared the view of Sir Robert Francis QC, who said that the Bill “is actually dangerous for patients because it proposes safeguards which are illusory” meaning things that seem to be true, but are actually false.’
Lord Giddens: ‘it is highly important that this Bill …covers the question of whether perverse consequences could arise and whether the Bill could therefore end up subverting some of its own intentions.’
Lord Cormack: ‘ It has been said that the real poor of the 21st century are those without hope, but there is a worse condition and that is to have false hopes..’ I believe that if we are to legislate on this front we need to get the best possible Bill to become an Act of Parliament and speed must not be the only criterion we take into account when we are legislating on such a complex issue.’
Baroness O’Neill of Bengarve: ‘We do not wish to put in so much process that we successfully stifle the very innovation that it is the purpose of the Bill to achieve’ ‘Finally…there is a bit of a difference between reasonableness and proportionality. They tend to come as twins. I am entirely in favour of reasonableness but proportionality suggests that you have at the back of your mind enough data to say what is proportionate and what is not.’
Baroness Wheeler: ‘After Second Reading, the Minister for Health…acknowledged the Government’s support for the principles of the Bill but emphasised that the amendments were necessary “to ensure it does not: put patients at risk; deter good and responsible innovation; place an undue bureaucratic burden on the National Health Service; or expose doctors to a risk of additional liabilities”…’There is an extremely worrying potential for conflict of interest here…Sir Robert Francis QC points to the problem that arises from the choice of the appropriate qualified doctor to consult resting entirely with the doctor wanting to offer a new treatment… There is also concern among a number of stakeholder groups that pharmaceutical companies could put undue pressure on doctors to try out potentially dangerous treatments, and this concern will also need to be addressed. Concerns remain that the involvement and consent of patients to untested innovative treatments are not more explicitly in the Bill…’
Additional remarks included: Lords Winston and Turnberg on cancer surgery ‘There is a problem there with the structure of the Bill as it presently stands.’ ‘The surgical aspects of the Bill are quite tricky.’
Lord Kirkwood of Kirkhope: ‘This changes how the regulator approaches a complaint, as far as I can see. As I know from previous experience, the General Medical Council has very clear, long-established systems for determining how complaints are lodged and how fitness-to-practise procedures are put in hand. It is very carefully controlled. Do I understand that the proposed new clause in Amendment 29 would merely—if I can put it that way—give the doctor against whom the complaint was alleged the choice of one of these channels of defence in relation to any complaint made against him by the regulator? I am still not clear as to whether I understand this properly’
Lord Turnberg: ‘I am sorry to interrupt the Minister’s flow. Does he not think that that is confusing for doctors in an emergency situation, wondering which route to take and about the options at that stage, rather than just getting on with the job? Earl Howe: Personally, no, I do not—although my noble friend may choose to address that point. I believe that what initially motivated my noble friend to introduce the Bill was a perception on his part that there are doctors out there who are afraid to innovate, and perhaps afraid to innovate even on the spur of the moment, for fear of being litigated against.’
- What the Lords Missed – Professor José Miola
In addition to the agreement from experts in medical research, medicine, surgery, patient care, doctors’ representatives and defence unions that the Bill is unnecessary and dangerous, the expert opinion against the Bill is overwhelming.