The Medical Innovation Bill: alarmingly at odds with ‘do no harm’

The Medical Innovation Bill: alarmingly at odds with ‘do no harm’

Published in today’s The Lancet Oncology is an Editorial entitled ‘Undermining the Hippocratic Oath: the Medical Innovation Bill’. It follows the letter published in the Times this month signed by over 100 prominent oncologists opposing the Bill, in which they confirm that the current law of negligence does not obstruct innovation in any way.   They warn that the Bill protects ‘irresponsible experimentation’ with the ‘potential expense of causing serious harm and suffering’  and express dismay at the Bill ‘being promoted as offering hope to patients and their families when it will not make any meaningful difference to progress in treating cancer.’   The signatories to the letter; all top clinicians and researchers, add their names to the already overwhelming and categorical opposition to Lord Saatchi’s project.

‘These oncologists join almost every prominent British medical association in condemning the Bill.’ – Lancet Oncol 2014

The expert condemnation includes that voiced in the responses to the Department of Health consultation. These were clear and overwhelmingly negative, clarifying that no organisation had any evidence that litigation deterred responsible innovation and that the Bill would be a significant threat to proper clinical research, best practice and, crucially, patient safety.

Opposition has continued from the organisations and experts that have issued briefings to the Lords at each stage so far. Such briefings include those from the BMA, Sir Robert Francis QC, medical defence organisations and key patient groups and research charities.

As the Bill reached Committee Stage in the Lords last month, again briefing documents were issued by doctors’ representatives and defence bodies as well as numerous expert medical research and charitable organisations including the Motor Neurone Disease Association, Parkinson’s UK, Leukaemia and Lymphoma Research and The British Heart Foundation. These briefings were unequivocal in re-stating that the Bill is dangerous and unnecessary.

Cancer Research UK are one of many organisations that have spoken out against the Bill. The charity responded to the original Department of Health consultation, confirming that they  ‘have been unable to find evidence that fear of medical litigation is currently a barrier to innovation in cancer’   and stating

the most important mechanism for encouraging responsible innovation in the UK is to continue to build a thriving clinical research environment. There are a number of other mechanisms already in place that should be evaluated which, if further strengthened, could lead to significant improvements in medical innovation..’

This month, CRUK’s executive director of policy and information, remarked: “There is…a risk of unintended consequences” “These concerns lead us to conclude that there is no pressing need for this legislation.”

Indeed, no relevant body of opinion can find any evidence or reasoned justification for the Bill. The voices in support are those who believe the PR campaign, mounted by an advertising magnate legendary for his effective techniques in politics ‘Labour isn’t Working’ and other domains, such as campaigns run for Silk Cut and his contracts with pharmaceutical giants. His full-time team of journalists, PR and media experts include Dominic Nutt and Liz Scarff, whose USP is her previous experience of ‘crowdsourcing’ support through human interest stories and social media.

Those in objection are loud, clear, unspun and irrefutable: it would be a terrible mistake for this to recklessly proceed any further. It fails to address any real obstacles to innovation that may exist and persists with a demonstrably false notion that the law of negligence is a problem, real or perceived. It still is not, despite the campaign’s best attempts at instilling that perception.   Further, they have tried hard to perpetuate a false and dangerous notion that using untested treatments that may have no evidence base or backing at all would be a safe and useful alternative to a trial.

‘To pretend that the alternative is the provision of untested evidence on one or two individuals’ potentially biased judgement is not only disingenuous, it is harmful.’ – Lancet Oncol 2014

To carry on, despite such broadly unanimous and well-reasoned opposition and such severe concerns about the lives of real people, would be to broadcast how very misguided a project this has become.  This is not an issue that should be rushed in an attempt to pass botched legislation before the general election. This is serious; affecting real people, real lives, real children, real wives. As noted by The Lancet, the Bill’s alarmingly non-specific drafting is designed to affect all forms of medical treatment; its scope for patient harm and suffering dwarfing the volume of objection listed here.

Lord Saatchi should wind it down, consult properly and listen to the doctors who devote their lives to treating patients in the very best way they can and improving care for all. So far he hasn’t listened.  We all want innovation, we all want the best possible treatments and outcomes. The Bill isn’t an answer to this.

Which organisations, experts and groups have expressed opposition to the Bill?

  • Academy of Medical Royal Colleges
  • Academy of Medical Sciences
  • Arthritis Research UK
  • Association of Medical Research Charities
  • AvMA
  • Association of Personal Injury Lawyers
  • Academy for Healthcare Sciences
  • The British Heart Foundation
  • The British Medical Association
  • British Pharmacological Society
  • Cancer Research UK
  • The General Medical Council
  • Genetic Alliance UK
  • Good Thinking Society
  • HealthWatch UK
  • Kingsley Napley LLP
  • Leigh Day & Co
  • Leukaemia and Lymphoma Research
  • The Medical Defence Union
  • The Medical Protection Society
  • Medical Research Council
  • Motor Neurone Disease Association
  • NHS Health Research Authority
  • NHS Litigation Authority
  • NICE
  • The Nightingale Collaboration
  • Parkinson’s UK
  • The Patients’Association
  • Price Slater Gawn Solicitors
  • Royal College of General Practitioners
  • Royal College of Physicians
  • Royal College of Psychiatrists
  • Royal College of Radiologists
  • Royal College of Surgeons
  • Royal College of Surgeons, Edinburgh
  • Sense About Science
  • Wellcome Trust

Individuals include

  • Sir Ian Kennedy QC
  • Sir Robert Francis QC, Chair of the Mid Staffordshire NHS Trust Public Inquiries
  • Jose Miola, Professor of Medical Law and Ethics; Professor Richard Ashcroft, Professor Jonathan Montgomery
  • Dr Margaret McCartney, Professor Michael Baum; Professor Susan Bewley; Nick Ross, President of Healthwatch
  • Nigel Poole QC, Amanda Yip QC
  • Dr Clive Peedell and more than 100 oncologists and researchers
  • Many doctors speaking individually
  • Additional signatories to the letter in the Times, March 2014
  • Lord Robert Winston
  • Lord Turnberg
  • Baroness Masham of Ilton

Many more.

More than 100 leading cancer specialists sign letter in The Times opposing Bill

Letter published in The Times

13 November 2014

Dear Editor,

Lord Saatchi says he wants to make parliament find a cure for cancer. He condemns current cancer treatment as “the endless repetition of a failed experiment”. The reason for such “abject failure” is, he believes, the law of medical negligence. His Medical Innovation Bill seeks to protect doctors who offer treatment that no responsible body of medical opinion supports and would therefore be considered negligent under the current law.

We devote our professional lives to treating patients with cancer and advancing research that contributes to finding more effective treatments for cancer. We neither want nor need Lord Saatchi’s bill. We do not believe that it will help our patients or future patients. We are dismayed that the bill is being promoted as offering hope to patients and their families when it will not make any meaningful difference to progress in treating cancer.

The law of medical negligence does not hinder our work or prevent innovation. There have been significant advances across all the modalities of cancer treatment over recent decades. There was no call for this change in the law from the medical profession. The current law already allows us to use off label drugs and to try new treatments when they are in patients’ best interests.

We are concerned that rather than promoting responsible scientific innovation in the treatment of cancer, the Medical Innovation Bill will actually encourage irresponsible experimentation producing nothing more than anecdotal “evidence”, at the potential expense of causing serious harm and suffering to patients, their families and carers. Innovation is best carried out within the discipline of controlled clinical trials, not by individual doctors acting on a whim.

Yours sincerely,

Dr Clive Peedell, Consultant Clinical Oncologist, Co-chair NHS Consultants’ Association

Professor Ruth Plummer, Professor of Experimental Cancer Medicine, Director of Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care, Freeman Hospital, Newcastle

Professor Charles Swanton, Group Leader, Cancer Research UK London, Chair in Personalised Cancer Medicine at the University College London Cancer Institute

Prof Jonathan A Ledermann, Professor of Medical Oncology, Clinical Director, UCL Cancer Institute & Director, CR-UK & UCL Cancer Trials Centre

Professor Michael Baum, Professor Emeritus of Surgery and visiting Professor of Medical Humanities, University College London

Professor Iain McNeish, Professor of Gynaecological Oncology, Institute of Cancer Sciences, University of Glasgow

Professor John Radford, Professor of Medical Oncology, Institute of Cancer Sciences, The University of Manchester and the Christie NHS

Professor Tim Maughan, Professor of Clinical Oncology, CRUK/MRC Oxford Institute for Radiation Oncology, Gray Laboratories, University of Oxford

Professor Jeff Evans, Professor of Translational Cancer Research (Experimental Therapeutics) and Director of the Institute of Cancer Sciences, CR-UK Beatson Institute

Professor Anthony Chalmers, Professor of Clinical Oncology, University of Glasgow, Beatson West of Scotland Cancer Centre

Professor David Cameron, Professor of Oncology at Edinburgh University and Director of Cancer Services in NHS Lothian, Edinburgh, ECMC lead, lead for Scottish Cancer Research network

Professor Tim Meyer, Department of Oncology, UCL Cancer Institute

Professor Robert Coleman, Professor of Medical Oncology, Academic Unit of Clinical Oncology, Weston Park Hospital, Sheffield

Professor Daniel Hochhauser, UCL Cancer Institute, University College London

Professor Christian Ottensmeier, Consultant Medical Oncology, Professor in Experimental Cancer Medicine, Southampton University Hospitals and University of Southampton

Professor Matt Seymour, Professor of Gastrointestinal Cancer Medicine and Consultant Medical Oncologist, Leeds

Professor Richard Kaplan, MRC Trials Unit, University College London

Professor Richard Kennedy, Centre for Cancer Research and Cell Biology, Queen’s University Belfast

Professor William Steward, Professor of Oncology and Co-Director of Cancer Biomarkers and Prevention Group, Department of Oncology, University of Leicester

Professor Mark Middleton, Dept of Oncology, University of Oxford

Professor Chris Twelves, Deputy Director of Cancer Research UK’s Clinical Centre, St James’s Hospital, Leeds

Professor Gary Middleton, Professor of Medical Oncology, School of Cancer Sciences, University of Birmingham

Professor Tessa Holyoake, Professor of Experimental Haematology, University of Glasgow

Professor Anne L Thomas, Professor of Cancer Therapeutics, University of Leicester

Dr Robert J Jones, Consultant Medical Oncologist, Director, Cancer Clinical Trials Unit for Scotland (CaCTUS)

Dr Corinne Fairve-Finn, Honorary Consultant Clinical Oncologist, and Reader at the University of Manchester

Dr Richard Adams , Clinical Senior Lecturer, Institute of Cancer & Genetics, Cardiff

Dr Martin Forster, Clinical Senior Lecturer in Experimental Cancer Medicine and Consultant Medical Oncologist, UCL

Dr. Richard Baird, Academic Consultant in Experimental Cancer Therapeutics, University of Cambridge, Honorary Consultant in Medical Oncology, Addenbrooke’s Hospital

Dr Alan Anthony, Senior Lecturer and Oncology Research and Innovation Lead, St James’ Hospital, Leeds

Dr Richard Wilson, Reader in Cancer Medicine, Centre for Cancer Research and Cell Biology, Queen’s University Belfast, Clinical Director, N. Ireland Cancer Trials Centre and Network, Consultant Oncologist

Dr Rebecca Kristeleit, clinical senior lecturer and consultant medical oncologist UCL/UCLH

Dr Pippa G Corrie, Deputy Director, Cambridge Cancer Trials Centre, Consultant and Associate Lecturer in Medical Oncology, Cambridge University Hospitals NHS Foundation Trust

Dr Gerry Hanna, Senior Lecturer and Consultant in Clinical Oncology, Centre for Cancer Research and Cell Biology, Queen’s University, Belfast

Dr Emma Dean, Honorary Consultant in Experimental Medicine and Clinical Senior Lecturer University of Manchester, Christie Hospital, Manchester

Dr Ellen Copson, Associate Professor in Medical Oncology/Honorary Consultant Southampton Oncology Centre

Dr Alastair Greystoke, Senior Lecturer and Honorary Consultant in Medical Oncology,Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care, Freeman Hospital, Newcastle

Dr Paul Hatfield, Consultant Clinical Oncologist and Honorary Senior Lecturer, Leeds Cancer Centre, St James’s Institute of Oncology

Dr Mike Bayne, Clinical Director and Consultant Clinical Oncologist, Poole Hospital Cancer Centre, Dorset

Dr Chris Baughan, Consultant in Clinical Oncology and Care Group Lead, University Hospitals Southampton NHS trust

Dr Matthew Krebs, Clinical Senior Lecturer and Honorary Consultant in Experimental Cancer Medicine, Christie Hospital, Manchester

Dr Kevin Franks, Consultant Clinical Oncologist, St James’s Institute of Oncology, Leeds Cancer Centre, St James’s University Hospital, Leeds Teaching Hospitals NHS Trust

Dr Matthew Hatton, Consultant Clinical Oncologist Weston Park Hospital, and Honorary Senior Lecturer at the University of Sheffield.

Dr David Wilson, Consultant Clinical Oncologist, James Cook University Hospital, Middlesbrough

Dr Eleanor Aynsley, Consultant Clinical Oncologist, James Cook University Hospital, Middlesbrough

Dr Peter Dunlop, Consultant Clinical Oncologist, James Cook University Hospital, Middlesbrough

Dr David Landau, Consultant Clinical Oncologist, Guy’s and St Thomas’ NHS Foundation Trust, London

Dr John Frew, Consultant Clinical Oncologist, Northern Centre for Cancer Care, Freeman Hospital, Newcastle

Dr Toby Talbot, Consultant Clinical Oncologist, Royal Cornwall Hospitals

Dr Alison Humphreys, Consultant medical oncologist, James Cook University Hospital, Middlesbrough

Dr. Noelle O’Rourke, Consultant and Hon Senior Lecturer in Clinical Oncology, Beatson West of Scotland Cancer Centre

Dr Andrew Bates, Consultant Clinical Oncologist, Southampton

Dr Janine Graham, Consultant medical oncologist, James Cook University Hospital, Middlesbrough

Dr Jonathan McAleese, Consultant Clinical Oncologist, Belfast City Hospital

Dr Sophie Haney, Consultant Medical Oncologist, James Cook University Hospital, Middlesbrough

Dr Anna Gajewska, Associate Specialist, Palliative Medicine, Oncology Directorate Poole Hospitals FT

Dr Judith Cave, Consultant Medical Oncologist, Southampton General Hospital

Dr Luke Nolan, consultant medical oncologist, University Hospital, Southampton

Dr Yvette Drew, Senior Lecturer and Honorary Consultant Medical Oncologist, Newcastle University and Northern Centre for Cancer Care

Dr Syed Zubair, Consultant Medical Oncologist, James Cook University Hospital, Middlesbrough

Dr Maxine Flubacher, Consultant Clinical Oncologist, Poole Hospital

Dr Joe Davies, Consultant Oncologist, Dorset Cancer Centre, Poole Hospital NHS Foundation Trust

Dr Shahid Iqbal, Clinical Oncologist, Newcastle

Dr Nick Wadd, Consultant Clinical Oncologist, James Cook University Hospital, Middlesbrough

Dr Sheela Rao, Consultant Medical Oncologist, GI Unit, The Royal Marsden Foundation Trust, London

Dr Martin Eatock, Medical Director, Northern Ireland Cancer Network

Dr DebashisSarker, Senior Lecturer and Consultant in Medical Oncology

Dr Joanne Hornbuckle, Consultant and Honorary Senior Lecturer in Medical Oncology, Sheffield

Dr Jon Wadsley, Consultant Clinical Oncologist, Clinical Lead for Division 1 (Cancer) Yorkshire and Humber Clinical Research Network, Weston Park Hospital, Sheffield

Dr Julia McBride, Specialty Doctor Oncology, James Cook University Hospital, Middlesbrough

Dr Simon Pledge, Consultant Clinical Oncologist, Weston Park Hospital, Sheffield

Dr Joanne Lewis, Consultant Oncologist, Lead Neuro-science MDT and Lead Network Research CNS Tumours, Northern Centre for Cancer Care, Newcastle

Dr Rhona McMenemin, Consultant Clinical Oncologist, Northern Centre for Cancer Care, Newcastle

Dr Joanne Parkinson, Associate Specialist Oncology, Poole Hospital Foundation Trust

Dr Mary Comisky, Consultant in Palliative Medicine, Northern Centre for Cancer Care, Newcastle

Dr Olly Donelly, Clinical Lecturer in Clinical Oncology, St James’s Institute of Oncology & Leeds Institute of Cancer and Pathology

Dr Rachel Cooper, Consultant Clinical Oncologist, St James’s University Hospital, Leeds

Dr David Bottomley, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Fiona Roberts, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Ganesh Radhakrishna, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Joji Joseph, Consultant Clinical Oncologist, Lead Clinician, York Teaching Hospital NHS Foundation Trust

Dr Katy Clarke, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Chris Fosker, Consultant Clinical Oncologist and Honorary Senior Lecturer, St James’ University Hospital, Leeds

Dr Peter Dickinson, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Bojidar Goranov, Oncologist, Northern Centre for Cancer Care, Newcastle

Dr Kate Sumpter, Consultant Medical Oncologist, Northern Centre for Cancer Care, Newcastle

Dr Christopher Jones, Consultant Medical Oncologist & Carcinoma of Unknown Primary Lead, Northern Centre for Cancer Care, Newcastle

Dr Caroline Lee, Consultant Clinical Oncologist, Sheffield Teaching Hospitals NHS Foundation Trust

Dr Mark Teo, National Institute Health Research, Academic Clinical Lecturer in Clinical Oncology, Leeds Institute of Cancer and Pathology, St James’ University Hospital, Leeds

Dr Pooja Jain, Consultant Clinical Oncologist, St James’ University Hospital, Leeds

Dr Martin Robinson, Reader and Honorary Consultant Clinical Oncologist, Academic Unit of Clinical Oncology (Cancer Clinical Trials Centre) , Weston Park Hospital, Sheffield

Dr Niladri Ghosal, Consultant Clinical Oncologist, Glan Clwyd Hospital, Rhyl

Dr Emma Dugdale, Locum Consultant Clinical Oncologist, Sir Robert Ogden Centre, Harrogate District Hospital

Dr Nicola Cresti, Consultant Medical Oncologist, Northern Centre for Cancer Care, The Newcastle upon Tyne Hospitals NHS Foundation Trust

Dr Nazia Mohammed, Consultant Clinical Oncologist, Honorary Clinical Senior Lecturer, Beatson West of Scotland Cancer Centre, Glasgow

Dr Paula Mulvenna, Consultant Clinical Oncologist, Chief Investigator QUARTZ Trial, Northern Centre for Cancer Care, Newcastle upon Tyne Hospitals NHS FT

Dr Kate Cardale, Consultant Clinical Oncologist, Leeds Teaching Hospitals NHS Trust

Dr Katie Spencer, Specialist Registrar in Clinical Oncology, Leeds Teaching Hospitals NHS Trust

Dr Maria Marples, Consultant/Honorary Senior Lecturer in Medical Oncology, St James’s University Hospital, Leeds

Dr Vanessa Gill, Consultant Clinical Oncologist, Clinical Oncology, St James’s Institute of Oncology, Leeds

Dr Michelle Kwok-Williams, Consultant Clinical Oncologist, St James’s Institute of Oncology, Leeds

Dr Emma Thomas, Consultant Clinical Oncologist, St James’s Institute of Oncology, Leeds

Dr Kathleen S. Dunn, Consultant Clinical Oncologist, Weston Park Hospital, Sheffield

Expert opinion unequivocal against the Medical Innovation Bill

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.

The PR approach however remains unchanged its earliest days, announcing that the Bill is well received and supported..

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.
  • 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.
  • 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.

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.’

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.

Medical Innovation Bill – key points

The latest expert news and views on the Medical Innovation Bill have been posted here at stopthesaatchibill.co.uk 

The Medical Innovation Bill is a private members bill introduced by Lord Maurice Saatchi. It has followed a tortuous route through parliament so far. Unusually, a No.2 bill procedure was used to introduce it into the Lords and the Commons simultaneously in 2012. This is rarely used and typically reserved for legislation that must be passed very quickly. Following much criticism, it was withdrawn from the Commons and a second draft was produced of the Medical Innovation (No.2) Bill to progress through the Lords.

Despite the unequivocal opposition voiced by leading organisations to the Department of Health consultation on the Bill, which closed in April 2014,  it has not been withdrawn. There has been no arrangement to consult upon what barriers to innovation actually are. Instead, the bill was ‘redrafted’ rapidly before publication of the (very negative) consultation responses.   Its second reading in the House of Lords occurred on 27 June  2014, following which it was redrafted again,  and again.  The Medical Innovation (No.2) Bill (fourth draft) – (HL Bill 4) went to Committee Stage in the House of Lords on 24 October 2014. Thirty nine amendments were tabled. A revised version has been produced with amendments, due to be discussed further and intended for Report Stage.

Lord Saatchi’s assertion is that the current law of negligence inhibits innovative practice and hinders progress in research and patient care. He defines negligence as deviation from standard procedure, and innovation as deviation.  He believes that by removing any threat of an action in negligence the Bill will encourage innovation and will empower patients to demand access to experimental treatments.

Expert organisations, individuals and representatives have strongly opposed the Bill in force, and maintain their opposition to its current draft. Those opposing include leading medical charities and research organisations, the BMA, the RCP, MDU, MPS, and Sir Robert Francis QC, legal expert and Chair of Mid Staffordshire NHS Trust Public Inquiries.

Key Points

  • The current law of negligence does not inhibit medical innovation.

The law of medical negligence is settled and well understood by judges, lawyers and doctors. The test of whether a doctor has been negligent was set down in the case of Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 and adapted in the case of Bolitho v City and Hackney HA [1998] AC 232.

The law is very flexible and allows for innovative treatment if a responsible body of medical opinion would support it, however small that body may be. A doctor is only negligent if no responsible body of medical opinion would support their treatment or if the support for the treatment has no logical or rational justification.

The current law therefore does not mandate adherence to a standard treatment. Innovative therapy, including off-label prescribing of medication, is used daily by responsible doctors, and this is expressly supported by considerable weight of case law, alongside professional and ethical guidance, such as that from the GMC.   The law does not impede innovation, and no organisation has any evidence that a false perception of the law manifesting a fear of litigation, impedes innovation. If anything does, the law is not it.

  • The Bill would remove the most fundamental patient protections.

The Bill would act to change the law to offer absolute protection for conduct falling so far below an acceptable level that it would be negligent.   Lord Saatchi proposes that doctors should have an immunity from being sued by patients who have been harmed by such treatment, establishing that such a doctor would not be negligent even if no other doctor at all would have supported the treatment or the reasoning behind it. Those patients harmed by what would now be regarded as treatment so unacceptable, illogical, irresponsible or unjustifiable that it is negligent would have no access to any form of redress, no matter how serious their injury or suffering.   The latest versions of the Bill have been written in terms that apparently apply to the conduct of treatment itself, not only the decision to treat, and to apply to all medical treatment for all conditions.

The Bill does not empower a patient. It does nothing to help access to treatment: barriers to which are entirely unrelated to the law of negligence. In doing nothing to increase or enable access to a treatment (albeit one that may harm) it operates in theoretical terms only, and focuses on something that will only remove rights and remove safeguards from patients.

  • The Bill would not help or benefit doctors.

The Bill would not be helpful for doctors. Doctors’ representatives, including the RCP, other Royal Colleges, the BMA, Medical Protection Society and Medical Defence Union, have voiced strong opposition.

The current law is very deferential to medical opinion and expertise. It allows consideration on an individual case basis, allowing for developments, rapid scientific progress new ideas and individual features, supporting the exercise of clinical autonomy. If clinical autonomy faces a challenge, it is not justifiably a legal one.  The law does allow for the oversight of peer support to maintain a good standard, prevent serious bias, guard against exploitative or simply terrible practice and thus maintain public trust in the profession, with a consequential benefit to each clinical encounter. This is rarely used, however this ability serves to protect and uphold the deferential position that the law follows, respecting medical opinion and progress.

The illusions promoted by the introduction of such legislation would not help doctors. The perceived, illusory, shift of power further to the patient is set in a landscape of media hype, misinformation, increased expectation and demand, and with no resources, funding or infrastructure in place the likeliest outcome is patient dissatisfaction or harm. The increased pressure from patients and pharmaceutical companies would leave a doctor, in an office with bureaucracy propping up the ceiling, hands tied by purse strings and tape, in an untenably fraught position.

The Bill does nothing to support doctors in responsibly innovating, obtaining funding, access or time to effectively conduct appropriate activities; it merely promotes an unrealistic expectation from patients while adding to a bureaucratic nightmare for the doctor. There would be a significant increase in legal action, and doctors would be drawn into it. In treating a patient, the doctor may breach a number of professional regulations, while facing increased scrutiny for adverse events by virtue of decreased liability across the board, even for pharmaceutical products.

More doctors would face legal scrutiny and a potential litigation process, alongside an increased likelihood of regulator investigation or sanction for individuals. It would be a legal disaster with attempts in res ipsa, or a failure to treat,  loss of a chance, judicial reviews and considerable other legal challenge, including criminal liability. The scope for satellite litigation around the bill’s operation is significant and has the potential to continue for years, increasing confusion, adding barriers, damaging doctor-patient interaction and obstructing best practice.

  • The Bill would not advance scientific progress.

Many examples from recent history have shown that permitting access to a ‘treatment’ that may have no beneficial effect at all delays the acquisition of evidence required to determine its effects. It is an archaic and inappropriate model to promote in today’s era. Scientific progress is rarely linear and newer treatments are not always better, and rapid use with decreased critical evaluation is both inappropriate and reckless. Genome sequencing, and fields such as pharmacogenomics and concurrent rapid advances allow for precision in rationalising a treatment strategy for an individual.

Responsible decisions and compassionate access to treatments or potential treatments are supported by the current law, and if this is the Bill’s aim, it is unnecessary. It serves to obstruct the trials process and diminish available evidence, putting people at serious risk of harm, without progressing their care or advancing medical knowledge. No data generated would be of benefit to anyone, and the concept fails to address real areas that may assist in advancing progress, such as removing rather than adding bureaucracy; providing funding and support. Research and trials access and networks could be widened, not shut down. This would increase access to accurate data and meaningful, reliable information and encourage rapid advancement and adoption of effective treatment strategies without unacceptable risks of harm, suffering or hastened death.  It would promote a form of very high risk, reckless experimentation on patients, or dishonest exploitation at its worst, without the need for any evidence of benefit or any logical rationale with protection from a claim in negligence.

  • All key expert organisations oppose the Bill.

There is no evidence of claims in clinical negligence occurring following innovative treatment, and no evidence in support of the assertion that doctors do not innovate for fear of litigation. Instead there is a wealth of opposition; from doctors’ representatives, legal and defence bodies, patient organisations and medical research groups and charities, alongside notable experts including Lord Winston and Sir Robert Francis QC.

Key concerns are that it is founded on a clear misunderstanding of the law, it is a severe threat to patient safety, it is put forward by non-experts who fail to understand the clinical position and complexities and fail to recognise serious risk to patient groups, it applies to all patients, conditions and treatments and it fails to address anything that may in fact support doctors and enable access to more treatment or innovation appropriately.  It further fails to consider extremely important issues of quality of life, wellbeing, patient trust and the subtlety and complexity of illness experience and decision making.   Instead it expressly permits the use of drugs or therapeutic techniques where there is no known efficacy and no evidence base at all. It would also permit treatment where it is not logically or rationally justifiable. This would benefit pharmaceutical companies financially through the use of unused drugs and patent extensions, but may cause significant harm to the patients being ‘treated’.

Furthermore, any amendments to the Bill do not address the fundamental aspects that this legislation is  unacceptably dangerous, poorly targeted and is unnecessary when both current law and professional guidance support innovative treatment.