Abstract
Introduction
Chris Heaton-Harris MP seeks to introduce his private members Bill, the Access to Medical Treatments (Innovation) Bill (AMTIB). It had its committee stage on 16 December 2015. It now proceeds to report stage, on 29 January 2016. The AMTIB raises serious concerns for patients and doctors.
At the second reading he said The second part of my Bill, therefore, does one thing: essentially, it brings forward what the medical community knows as the Bolam test. Currently, the Bolam test is applied only when proceedings have gone to court. However, bringing it forward to an earlier stage would allow a responsible doctor to take a series of steps to prove that they are being exactly that—responsible when providing treatment. This does not change common law.
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At the second reading of the AMTIB, George Freeman MP, Minister for Life Sciences, said it “is in many ways different but trying to achieve the same ends” 2 as Lord Saatchi’s Medical Innovation Bill (MIB).
Interestingly, Lord Saatchi said of his MIB that the Bill achieves its aim—safe and responsible innovation—in a simple way. It moves the Bolam ‘responsible persons’ test from after the event to before the event. The result is that doctors are not obliged to speculate in advance about what might happen in a subsequent trial, and they can move forward with confidence, safe in the support of a responsible body of medical persons—in other words, the Bolam test brought forward. This crucial time change removes any uncertainty and ambivalence about what is or is not lawful medical innovation.
3
The AMTIB is a variant 4 of Lord Saatchi's MIB, which remains live in the House of Lords. Will they benefit patients and medical innovators? Do they change the common law? Will they remove uncertainty?
What is the problem?
During a debate about the MIB on 9 December 2014, George Freeman MP said Lord Saatchi has identified the threat of litigation as a potential barrier to innovation. The purpose of his Bill is to set out a series of steps and a clearer legal framework that will make it less likely for doctors to be put off reasonable innovation … The intention of the [MIB] is to tackle the risk that the fear of clinical negligence could undermine the commitment of doctors to embracing innovation in the system.
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The problems with the MIB (and consequently, with the AMTIB) have been neatly summarised by Dr Sarah Wollaston, Chairperson of the Commons Health Select Committee, and an ex-General Practitioner.
In a debate about the MIB in the House of Commons on 9 December 2014, she said Like books, one should never judge a Bill by its cover. Later this week, the Medical Innovation Bill reaches Report stage in the House of Lords, but I would like to demonstrate that it is fundamentally flawed in its premise, it is unnecessary, it removes essential protections for patients, and it increases the risks of their exposure to maverick doctors. I believe it will undermine not only patient safety but medical innovation and so will have precisely the opposite effect to that intended.
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Dr Wollaston’s concerns can be applied with equal force to the AMTIB.
Does a fear of litigation inhibit doctors from innovating?
At the second reading of the AMTIB, Mr Freeman said I reaffirm that the Department of Health’s consultation on the previous Medical Innovation Bill revealed that some doctors do find the threat of litigation to be a block to innovation, although that was not a universal view and I do not want to suggest in any way that it is the principal barrier.
The Government consulted on the MIB between February and April 2014. A summary of the consultation is set out in their July 2014 report. 7 Paragraphs 12–14 are instructive as to the weight of evidence against the premise of the MIB. In relation to the consultation process itself the report concluded “some of the statements made by supporters of the Bill (although not by DH) during the consultation period were misleading but received much publicity.”
A part of the remit of the NHSLA is to provide indemnity cover for legal claims against the NHS. Therefore, it will have the most complete data (going back 20 years, since its inception in 1995) on whether fear of litigation inhibits doctors from innovating. In their April 2014 response to that consultation, the NHSLA say that they do not have experience or evidence that doctors are deterred from innovation because of litigation. The consultation responses of many organisations have been helpfully collated here. 8 The imbalance between (very little) support for and (overwhelming) opposition to the central contention underpinning the MIB is striking, although the Briefing paper on the AMTIB fails to recognise this imbalance. 9
It is worth noting that all of the relevant bodies (NHSLA, MDU, etc.), when responding to the previous Government’s consultation on the MIB, were universal in their view that fear of litigation was not known to be an inhibitor to innovation. Where individual doctors expressed a fear of being sued to their representative bodies, those bodies responded that it was a training and education issue only.
A logical analysis of the available evidence is that fear of litigation does not inhibit doctors from innovating.
Support for the MIB and AMTIB
Remarkably, especially given the time they have had to muster support, promoters of the MIB, and the AMTIB, have provided no objective evidence that fear of litigation inhibits doctors from innovating.
At the outset of Lord Saatchi’s media campaign to promote his MIB he quoted support from a handful of influential individuals including Lord Woolf, the former Master of the Rolls. However, when challenged to substantiate his claims Lord Woolf was unable to do so. 10 Dr Barton and Dr Powers, authors of Clinical Negligence, the leading text on both medical and legal aspects of the law of clinical negligence, are quoted as saying “The Bill's supporters have not provided any evidence that doctors are deterred from innovation by the threat of litigation,” and that “Parliamentary scrutiny requires solid evidence.” 11
Clinicians who initially came forward to offer support for the MIB have largely disappeared into the shadows. Sir Michael Rawlins appears to be the only senior doctor who continues publicly to support the MIB. However, his performance at the only public debate between supporters and opponents of the MIB on 4 March 2015 did not inspire confidence in justification for the MIB. A recording of the debate is accessible. 12
To date, the only published support for Lord Saatchi’s allegation that fear of litigation inhibits doctors has been anecdotal. Even that anecdotal support has waned as the content of the MIB and AMTIB have been publicly scrutinized. Quoting the personal view of a restricted number of individual doctors or patients, whilst ignoring the weight of the contrary views of bodies and organisations that represent the entire body of medical doctors practicing in the UK does not provide the expected level of impartiality for a proposed new Act of Parliament.
Opposition to the MIB
Overwhelming opposition to the MIB can be summed up by the view of the Medical Protection Society who have said We remain opposed to Lord Saatchi’s Medical Innovation Bill for many reasons. It would give false reassurances to doctors, confuse and hinder current responsible innovation and erode safeguards which protect vulnerable patients … Not only is it unnecessary but it will create confusion. As current law stands, doctors acting responsibly can innovate. Rather than confusing the law through a new piece of legislation, MPS calls for greater education around the present law.
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And that the MPS has been opposed to the Medical Innovation Bill from the beginning; we believe it is an unnecessary piece of legislation that has the potential to undermine safe and established routes of innovation and could damage the relationship between doctors and their patients.
14
Welsh assembly
On 3 February 2015, the Welsh Assembly debated the MIB. Mark Drakeford, Minister for Health and Social Services, said “The Welsh Government has grave concerns about this Bill and requested that the provisions within the Bill did not apply to Wales” and that “There was cross-party consensus in the Assembly that we should not consent to the Bill applying to Wales, with 54 votes to 0 voting with the [Welsh] Government, against the motion.” 15
Opposition to the AMTIB
The Royal College of Paediatrics and Child Health have published their view of the AMTIB. 16 The mission statement of the College is to “transform child health through knowledge, innovation and expertise.”
In a usually strong attack on the AMTIB the College makes clear that “This Bill is unnecessary but more importantly, poses a real danger to the safety of infants, children and young people in England and Wales.”
They go on to say The Bill will encourage irresponsible experimentation. Families, already at heightened susceptibility to the promise of miracle cures because of the illnesses of their children or loved ones, will be prey to at worst quackery and at best to the possibly strongly held but inadequately justified convictions of medical practitioners who do not know how, or do not wish, to test treatments objectively.
Further the College say What’s more, the Bill’s stated purpose of enabling practitioners to employ innovative treatments without fear of litigation is completely unfounded. There is no evidence to suggest that fear of litigation is a deterrent to a clinician’s use of innovative treatments. Doctors are already able to try new treatments under existing law.
If these quotes from organisations who represent, and support, doctors do not yet ring enough alarm bells, then there are very many more quotes from bodies and organisations who represent doctors, researchers, and patients, etc., helpfully brought together here. 17
Real barriers to innovation
Sir Hugh Taylor has been tasked by the current Government to Chair the Accelerated Access Review. He says finding new ways to get drugs, devices and diagnostics to patients faster is a very worthwhile task. Many benefits will flow from progress in this area: better treatment and health outcomes for patients; more cost-effective and affordable ways for the NHS to treat patients; and a more central role for research organisations and charities. This will also provide opportunities for business by getting their products to patients quicker, and a major boost for our economy and the country if we can become a world-leader in designing, developing and using innovative products.
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And NHS patients and their families deserve the quickest access possible to cost-effective new medical innovations, so it is a real privilege to be asked to lead this important review. By looking across the whole healthcare system I hope that we will be able to identify ways in which the latest advances in medicines and technologies can get from the lab to patients as quickly and safely as possible.
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The Accelerated Access Review Interim Report prepared by Sir Hugh Taylor20,21 describes the real inhibitors to innovation in medicine. A full list of the barriers to innovation that he identified can be found here. 22 On 1 October 2015, Sir Hugh Taylor also authored an article 23 on the barriers to accessing transformative health technology; he has not identified fear of litigation as being one of those barriers.
It is unarguable that both the MIB and the AMTIB are based on a false premise; fear of litigation does not inhibit doctors from innovating in medicine. So what will the Bills actually do?
Database of innovative treatments
The only substantive difference between the MIB and the AMTIB is that Clause 2 of the Access to Medical Treatments (Innovation) Bill provides for a database of innovative treatments. This is missing from the MIB. However, section 254 (1) of the Health and Social Care Act 2012 states “The Secretary of State or the Board may direct the Information Centre to establish and operate a system for the collection or analysis of information of a description specified in the direction.”
It is generally agreed that Section 254 (1) of the Health and Social Care Act 2012 already provides the Secretary of State with the power that Chris Heaton-Harris MP seeks to provide in Clause 2 of the Access to Medical Treatments (Innovation) Bill, thereby rendering his Clause 2 unnecessary.
Responsible innovation
Clause 3 of the Access to Medical Treatments (Innovation) Bill, and Clause 1 of the Medical Innovation Bill attempt to deal with “responsible innovation”. I will not discuss these clauses in detail in this article. For a full dissection of the flawed basis of, and approach to, the “problem” originally identified by Lord Saatchi, I commend the comprehensive review by Professor Jose Miola, School of Law, University of Leicester. 24
Moving Bolam forward?
During the second reading of the AMTIB Chris Heaton-Harris said that the [AMTIB] states that nothing in it would override existing common law. All it aims to do is bring forward the step of the Bolam test, so that the doctor himself or herself can make a judgment at that time on whether he or she is doing something correctly. It does not stop clinical negligence cases coming forward; it just helps to prove that the doctor might or might not be [my emphasis] acting in the responsible way that he or she should be.
Lord Saatchi made similar claims about his MIB. 25 A new law that “might or might not” do anything does not add clarity or certainty; quite the opposite.
However, Chris Heaton-Harris went on to say that “The test of responsibility in the Bill is intended to be the nearest possible equivalent to the Bolam test.” The only way for a Court to interpret the “nearest possible equivalent” as meaning “the same as” would be for a claim for clinical negligence to be argued in front of a Judge. This would fail to provide the clarity and certainty underpinning the AMTIB, as cases are likely to end up in Court (with all of the uncertainties that brings), after the innovative treatment has been used.
The accepted definition of the Bolam test (formulated in the High Court in 1957) is that a doctor “is not guilty of negligence if he has [my emphasis] acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.” 26 Although the actions in question are referenced to what was, or ought to have been, known at the time, the test is posed retrospectively.
Clause 3 (2) (a) of the AMTIB, obtaining the view of another doctor “in relation to the proposed treatment with a view to ascertaining whether the treatment would [my emphasis] have the support of a responsible body of medical opinion” is posed prospectively. How could anyone responsibly assess in advance whether the proposed innovation would have such support without reliable and reproducible data on the outcome of that innovative treatment?
Firstly, to apply the Bolam test prospectively, a doctor could only act responsibly if they follow an established practice because “a departure from the existing range of accepted medical treatments” amounts to testing and cannot accord with an accepted practice, even where there is more than one accepted practice.
Secondly, asking, potentially, a single colleague for a view on whether the proposed innovative treatment would pass the Bolam test is a step removed from, and not the same as, applying the Bolam test. I suggest that the AMTIB does not bring the Bolam test forward; the AMTIB bypasses it.
The evidence does not support the view that the MIB and the AMTIB will maintain the current legal position. Both the MIB and the AMTIB are not Bolam compliant. As such they amend the current law to the detriment of an avoidably injured patient.
Bolitho analysis
There is another fundamental – perhaps fatal – flaw in the analysis behind the MIB and the AMTIB. The promoters of both Bills have failed adequately to take into account the case of Bolitho, 27 a case which was decided by the House of Lords (as was) after the Bolam decision. Bolitho decided that, effectively, a body of medical opinion must be capable of withstanding logical analysis.
The process by which the doctor obtains the view, in Clause 3 (2) (a), of (at least) one other doctor must withstand logical analysis. Consideration of Clause 3 (2) (b) of the AMTIB where a doctor must “take full account of the views obtained under paragraph (a) (and do so in a way in which any responsible doctor would be expected to take account of such views)” must, under Bolitho principles, be an objective analysis, such that the two doctors (in Clause 3 (2) (a)) are excluded from making that analysis. The additional steps under the AMTIB must be open to a Bolitho analysis.
Additionally, it is clear from the Judgment of Lord Browne-Wilkinson in Bolitho that “it was for the Court, not for medical opinion, to decide what was the standard of care required of a professional” and “the Court has to be satisfied that the exponents of a body of opinion relied upon can demonstrate that such opinion has a logical basis” and that where “it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the Judge is entitled to hold that the body of opinion is not reasonable.” A Bolitho analysis of the steps taken under the MIB/AMTIB can only be carried out retrospectively, independently of the actors, and by a Court. Therefore, the two doctors would be second guessing the independent and retrospective view of a Judge.
Responsible innovation?
Let us consider three possible scenarios. Doctor A consults Professor B about an innovative treatment, which he wishes to offer to Patient C for condition Y.
Scenario 1
Patient C has Condition Y, which is uncontrolled by Drug 1. There are other drugs (Drugs 2, 3, and 4) for condition Y, which have not been fully tested in combination. Doctor A wishes to try a combination of the drugs. Doctor A sought the view of Professor B who agreed that a combination of drugs for Condition Y would be supported by a responsible body of opinion. A short, simple note of the telephone conversation between them is written in Patient C’s notes. Doctor A tries Drugs 1 and 2 in combination, within their therapeutic range. Condition Y remains uncontrolled. Doctor A ultimately offers a combination of Drugs 1, 2, 3, and 4 at the same time, and at top of their therapeutic range. Those drugs interact and cause patient C an avoidable injury.
Currently, no responsible body of medical opinion would support use of all four drugs in combination at the same time, at the top of their therapeutic ranges. In that case, Dr A is likely to be found to have negligently caused an avoidable injury, and Patient C is compensated.
Under the proposed law Doctor A will seek to raise a Saatchi Defence (that they complied with the relevant sections of the MIB/AMTIB), preventing Patient C from being compensated; even though the brief note did not record details of the agreement to the specific proposed combinations or doses, of the drugs.
Scenario 2
Patient C has Condition Y which is uncontrolled by drugs known to help the condition. Doctor A sees that Professor B has written a case report about use of Drug 2 for a patient with Condition Y; the published results were inconclusive.
Professor B has an interest in repurposing Drug 2 to treat Condition Y. He (negligently) advises Doctor A that use of Drug 2 for Condition Y would be supported by a responsible body of medical opinion. Professor B is aware that unpublished evidence does not show a benefit to patients of using Drug 2 for Condition Y. Patient C suffers an avoidable injury shortly after taking Drug 2.
Currently, no responsible body of medical opinion would support use of Drug 2 for Condition Y. In that case, Dr A is likely to be found to have negligently caused an avoidable injury, and Patient C is compensated.
Under the proposed law Doctor A will seek to raise a Saatchi Defence (preventing Patient C from being compensated), where no responsible body of medical opinion would support Professor B even though Doctor A acted responsibly.
Scenario 3
Patient C has Condition Y. It is uncontrolled by all of the known treatments. Mrs D (Patient C does not have capacity) produces a Google printout of a treatment offered in Timbuktu. Mrs D is insistent that Doctor A try it. Doctor A needs to write up another case report to complete their MD, before being ready for a teaching hospital appointment. Professor B knows a doctor who offers it, and is told that it works, with no obvious side-effects. He relays this information to Doctor A, feeling that it would be supported by a responsible body of opinion. Doctor A explains what is known about the proposed treatment to Mrs D. She is keen to accept the risks, to Patient A, as explained to her by Doctor A, who administers the Timbuktu treatment. Patient C dies, Mrs D benefits under Patient C’s Will, and Doctor A writes up a case report.
Currently, no responsible body of medical opinion would support use of the Timbuktu treatment. In that case, Dr A is likely to be found to have negligently caused Patient C’s death.
Under the proposed law Doctor A will seek to raise a Saatchi Defence (having complied with her responsibilities under the AMTIB), preventing compensation being paid to the estate/any eligible beneficiaries.
In each scenario would Doctor A be able successfully to make out a “Saatchi Defence” to a claim for clinical negligence? Possibly, possibly not; it will depend on the specific facts in each case. But that is my point. Until a Court has had an opportunity retrospectively to analyse the circumstances of each case, by reference to the wording of the MIB or the AMTIB, then there can be no certainty or clarity for doctors or patients.
During the second reading of the AMTIB Chris Heaton-Harris said that “I want to be clear that this Bill in no way changes patients’ rights to claim for negligent treatment.” Chris Heaton-Harris is wrong. There will be situations where a Saatchi Defence will be successful (thus avoiding compensating an avoidably injured patient), where that patient would be compensated under the current law. Therefore, it will remove a right of redress for some patients.
Any new law will be used by lawyers to try to benefit their client, whether patient or doctor. Until the Courts have interpreted each word, phrase, paragraph, etc., it is not possible to say with any kind of certainty what the effect of (parts of) that new law will be.
The future?
A new law that seeks to solve a problem that doesn’t exist will potentially open a Pandora’s Box of unintended, and unwanted, consequences. All responsible doctors can currently innovate (subject to other constraints, as identified by Sir Hugh Taylor and others) without fear of being sued for negligence. They do not need either the MIB or the AMTIB. The very few doctors who are unable, currently, to justify their innovative treatment, and who cause an avoidable injury, are likely to use the MIB/AMTIB to protect themselves (to the detriment of an avoidably injured patient). This group of doctors will be expanded by the inattentive, the gullible, quacks, mavericks, and charlatans of the medical world. In some cases, they will get away with it.
Over time and as a settled interpretation of the new law develops, a doctor may be prepared to push the boundary in interpreting and applying the criteria set out in the Bill, for an innovative treatment. There is potentially a lot of money to be made from new or repurposed drugs and other healthcare innovations. It is foreseeable that, at some point, a Court will deny that doctor a Saatchi Defence. Their patient will then be compensated. This will encourage more lawyers to review other scenarios where a Saatchi Defence has been used. Judicial interpretation of the law may change over time, as cases come before the Courts (as is likely to happen). Floodgates for a potential new type of claim may open. The knock-on effect is that many other potentially innovating doctors will become more risk-averse and decline to offer other (worthy) innovative treatments under this new law, out of a genuine fear that the Saatchi Defence will not protect them, and may actively be used to try to sue them.
I expect that in the longer term either Bill will lead to an increase in litigation. This will actively inhibit innovation, the precise opposite of what the Bills are intended to achieve.
Conclusions
Provided they comply with its requirements, the MIB/AMTIB seeks to provide innovating doctors with a new protection from being sued for clinical negligence, by an injured patient. The fundamental problem is that the “error” identified by Lord Saaatchi, one of the World’s leading, and most successful, marketeers, which the MIB and the AMTIB seek to correct – that fear of being sued prevents doctors from innovating – does not exist. Indeed, the truth is that since the dawn of time innovation has been at the heart of medicine.
If you give a doctor a new protection, then you necessarily take a protection away from the patient. Therefore, the MIB/AMTIB will remove a right for a negligently (as assessed under the current law) injured patient to be compensated, by providing a new protection (the Saatchi Defence) to a maverick doctor, based on this false premise.
This amendment to the law will not benefit patients and, in the longer term, will not benefit doctors or medical research. The position has been set out by Professor Neena Modi, President of the Royal College, who says of the MIB Let me be clear. The Royal College of Paediatrics and Child Health is a strong proponent of clinical research to bring innovation into the care of sick children. The UK has envied strengths in clinical research, developed through recognition that it is a prime means to advance patient care. This Bill will set back such progress.
In other words, it will have the opposite effect of the intention behind the Bill.
Like books, do not judge these Bills by their covers. Neither Bill succeeds in providing clarity of the law, legal certainty, protection to patients or to act to nurture innovators. Sir Hugh Taylor’s interim report concludes, effectively, that Lord Saatchi is wrong. Patients, doctors, and taxpayers would benefit if Parliamentary time was redirected to solving a real problem, rather than an imagined one. It is time for both the MIB and the AMTIB to be consigned to the innovation bin, as the repetition of a failed experiment.
Footnotes
Acknowledgments
I am grateful to Professor Jose Miola for looking at an early draft of this article.
Declaration of conflicting interests
The author declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author received no financial support for the research, authorship, and/or publication of this article.