The “Saatchi bill” will allow responsible innovation in treatmentBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2771 (Published 15 April 2014) Cite this as: BMJ 2014;348:g2771
All rapid responses
The BMA’s Medical Academic Staff Committee shares many of the concerns expressed in the pages of the BMJ regarding the Medical Innovation Bill. We too are unaware of any doctors having come to the BMA for support because they feared litigation following an innovative treatment. As doctors in the United Kingdom continue to make tremendous advances in treatment, across all disciplines, it is clear to us that progress in medicine is not restricted by the threat of litigation. We believe that the current regime, operating under the so-called “Bolam” rules, ensures that there is ample scope for the individualised treatment that appears to be a key motivation behind the proposed legislation.
As doctors and researchers, however, we fear that the Bill itself is not neutral: it will damage medical research. Such research is best undertaken by teams of clinicians, supported by evidence and working closely with patients in a mutually beneficial relationship. The success of the relationship with patients both as participants in clinical trials and as providers of samples and data is built on trust. If doctors no longer needed to act in accordance with scientific or medical principles, and were free to discard any information or opinion which they considered irrelevant, they would rightly risk losing the trust of patients and with it their active participation in medical research.
The Bill does nothing to help doctors make informed decisions regarding an innovative treatment or ensure that a proper record is kept and shared of the outcomes of the innovation. An effective and well-supported network of clinical ethics committees would provide local professional support to doctors faced with the difficult decisions envisaged by the proponents of the Bill.
Innovation is best supported by having appropriately trained clinical staff, through strong clinical networks and by patient trust. Anything which strengthens these would be a valuable aid to further progress. The Medical Innovation Bill in its present form will have no positive effect in these essential areas.
Dr Peter Dangerfield, Co-Chair, Medical Academic Staff Committee
Professor Michael Rees, Co-Chair, Medical Academic Staff Committee
Professor David Katz, Deputy Co-Chair, Medical Academic Staff Committee
Dr Marcia Schofield, Deputy Co-Chair, Medical Academic Staff Committee
Competing interests: No competing interests
One day, after moving a bedside TV away from a mesmerised patient for the umpteenth time, we had a eureka moment. Are we missing a golden opportunity to educate our patient’s through the bedside TV screens they are exposed to 24 hours a day? With the NHS facing enormous pressures, faster rehabilitation of patient’s has never been more crucial. As junior surgical doctors working in a busy University teaching hospital, we spend a large proportion of time advising patients on how to expedite their discharge. Mobilise more, cough eat and drink, etc. Early mobilisation and maintaining adequate nutrition and hydration for example have all been shown to expedite discharge .
An example of advertising to a captive audience is used in the airline industry. To reduce DVT risk videos demonstrating exercises are shown in flight. Why can we not instigate this on our hospital screens? Could we not go a step further and advertise to encourage patients to eat well, keep hydrated, mobilise early and take deep breaths? We are currently investigating patient attitudes to this idea and how to bring other interested parties on board.
Michael Wall, vascular surgery specialist registrar, Matthew Rose, foundation doctor year 1, & Aaron Kisiel, foundation doctor year 1; Queen Elizabeth Hospital, Birmingham
 NHS Institute for Innovation and Improvement (2008) Enhanced Recovery Programme, Available at: http://www.institute.nhs.uk/quality_and_service_improvement_tools/qualit... (Accessed: 25/11/2013).
Competing interests: No competing interests
Sir Michael Rawlins clearly attempts to convey the sentiments behind what he, and many, feel are important aspects of medicine: progress in order to ‘benefit patients… and the furtherance of medical science.’ However it is with regret that his reasoning continually contradicts this overriding objective. 
1. The need for legislation
Sir Michael Rawlins accepts that ‘many doctors.. will have..tried.. to treat patients with novel interventions. He acknowledges only ‘anecdotal evidence’ of a reluctance.
Innovation is already a standard part of clinical practice where it is appropriate or required.
2. The treatment?
‘Indeed these observations are arguably a form of “n of 1” trial.’
An n=1 trial is not ‘treatment’ of the individual, and would thus be governed by Directives and safeguarding measures. This is in line with comments from the Saatchi team ‘a wasted death’ . ‘a cure for cancer’, ‘benefits others’  reinforcing the coercion upon the public and in future upon vulnerable and desperate patients. This is not ‘innovative treatment’ but is more akin to therapeutic research, an outmoded phrase eliminated by the World Medical Association in 2000.
He later contradicts his support for n=1 and the Bill entirely:
'It is essential that the results..are placed in the public domain, whether or not they have succeeded. This would allow others not only to learn from such experiences but..to undertake formal research’, ‘Just because a particular intervention seems to have been effective in an individual patient it cannot be assumed that the results are generalisable. Further research in the form of one or more randomised controlled trials, or case series, will be needed to establish its effectiveness.
Risks and idiosyncratic responses are acknowledged here with emphasis that evidence must be collected, registered, shared and should lead to an RCT. This is however already the recommendation for innovative treatment in clinical practice, yet these requirements are remarkably absent from the draft legislation.
3. His understanding of the legal position
‘Several legal authorities have pointed out that departing from what is regarded as “established practice” or “the standard of care” leaves a doctor open to legal action for negligence. The definition of “the standard of care” .. was forcefully criticised by Elizabeth Butler-Schloss (sic) “The Bolam test ought not to be allowed to inhibit medical progress. And it is clear that if one waited for the Bolam test to be complied with to its fullest extent, no innovative work such as the use of penicillin or performing heart transplant surgery would ever be attempted.” ‘I was originally sceptical about the need for the bill but have been persuaded otherwise.. Firstly, it is clear from the comments of Butler-Schloss and other legal authorities consulted by Saatchi that there are serious legal impediments in civil law..’
The Medical Innovation Bill … proposes legislation stating that it would not be negligent for a doctor to depart from the existing range of accepted medical treatments for a condition, in carefully defined circumstances. These…. allowing for responsible innovation….include a plausible basis for the use of the proposed treatment and an assessment of the risks that could be reasonably expected to be associated with it.’
The legal position has been continually misrepresented in the Bill campaign and in articles supporting the Bill. If even Sir Rawlins can, naturally, trust in our law-makers to know the law of course the public, too, will be inclined to fall hook, line and sinker.
The case he has quoted here, as pointed out in responses, is Simms v Simms in which Baroness Butler-Sloss emphatically recognises the legal position – that Bolam is no obstacle to innovation. In this case she approved ‘innovative’ treatment for 2 patients with vCJD; a first-ever treatment with intracerebral infusion of Pentosan Polysulphate 
Indeed Bolam has never been an obstacle to innovation. Rawlins refers to departure from the standard of care and established practice as negligence. Here he has been undiscriminating in his acceptance of Lord Saatchi’s statements on the law, and clearly blends, confusingly, ‘the standard’ and ‘standards’. This has never been the case. The standard of care referred to in negligence is the lowest standard acceptable, below which would be negligent. It is not and never has been an ascribed standard procedure. The law guarantees a minimum level of competence.
In Bolam the directions were ‘in accordance with a practice accepted as proper…(by a reasonable body). Again, this does not say standard treatment. Rather, there is no negligence if practice is within the range of the acceptable, even if the majority would disagree.
Maynard  confirms that ‘failure to exercise the ordinary skill of a doctor (in the specialty) is necessary’ for there to be negligence. DeFreitas v O’Brien (1995) and other cases confirm that the opinion in support may be of only a very small, diametrically opposed body of opinion, but there will be no negligence if this is ‘responsible’. In Wisniewski v Central Manchester HA (1998) it is discussed that negligence is found only where the ‘views cannot be logically supported at all'.
In Bolitho, risk:benefit and logicality are added into the revised Bolam test relating to the responsible body of medical opinion. In Bolitho we are told that this is an ‘’opinion…capable of withstanding logical analysis’’. The Bolitho ‘gloss’ contra illogicality thus seals the law: the responsible opinion is any that can be rational or justifiable. Reynolds v N Tyneside (2002) states the contrary practice or body of opinion must be defensible or logical.
In operation too we know that the law will reject ‘standard procedure’ when it is inappropriate: Hucks v Cole , NHS Trust v J (2006), AB v Leeds Teaching Hospital (2005)
This Bill was not based on an understanding of the law. This legislation is clearly not required.
1. Rawlins, M ibid. BMJ 2014;348
2. Saatchi, Medical Innovation Bill Launch
3. The Telegraph ‘This isn’t quackery it’s good practice’ 14.04.2014
4. Simms v Simms  EWHC 2734
5. Maynard v West Midlands RHA  1 W.L.R. 634
6. Hucks v Cole (1968)  4 Med LR 393
Competing interests: No competing interests
One hesitates to disagree with Sir Michael Rawlins, but I am unaware of the evidence that law has ever been a driver of medical innovation in the past or in other jurisdictions. Doctors and surgeons have a long history of innovation, and it seems dangerous (if not reckless) to interfere with something that ‘works’. The logic of his article appears to be (a) there is no legal impediment to innovation now but (b) there is ‘anecdotal’ evidence of fear of law/lawyers, (c) therefore we need MORE law (as opposed to simple reassurance, clear information, and financial stimulation of innovative projects).
It is both an insult, and dangerous, for one rich persuasive individual with deep pockets, access and influence to tell the medical profession that it has not been innovative (enough) and that we need a Bill to help us do what we already do safely and legally. This is not a simple cultural debate - it is a category error for a grieving widower to suggest new law consequent to the sad fact that neither he, nor any medical practitioner, could stop his wife dying. Since when has law driven creativity, nuance, and shades of grey? Do law and regulation really drive up quality, or might they drive down to the lowest common denominator? In my world, we have examples of innovations that cause harms (1,2), but also of regulators not being able to police the safety of the industry thanks to challenges by lawyers working for very rich clinicians (3). Hype about ‘innovation’ is all, drives and is driven by commercial pressures and desperate clients, and it seems bizarre to accelerate this.
As medicine already has lots of laws, good practice, governance and the normal academic and clinical safeguards, there is no need to add more polish to the Bill of the sorts of ‘good’ things that happen anyway. Peer pressure is a powerful motivator of doctors – it’s more flexible and light touch to leave the ethical judgement about ‘good/ reckless’ to doctors in the ‘here and now’ than to try to capture this in law, that largely operates after the event.
What happened to "First of all, do no harm"? This Bill is not needed, it is not the right prescription for the wrongly thought through diagnosis. Bad doctors come up with treatments and then justify them. That is what Lord Saatchi is doing. The solution was found and now comes the justification. Starting a PR campaign and then finding lots of people agreeing might feel familiar and comfortable to him, but it really should carry no weight with us. It’s misleading to think ‘votes’ or even the ‘opinions’ of the great and good change scientific or medical facts. He really oughtn't be influenced by the agreement he and his Bill Team set out to find. Good scientists, innovators and lawyers pay a lot more attention to areas of weakness and disagreement.
The Bill just doesn’t make sense. Could Lord Saatchi desist now he has stirred up a great public discussion, and confirmed that there already is no legal impediment to innovation? If he set up a Medical Innovations Foundation that gave out financial largesse with all the ‘safeguards’ his Bill Team are trying to devise (like capturing and sharing results), this would be a great legacy and an upfront positive way of raising the bar of innovation and standards. In our normal professional and academic practice we look for unconscious biases, and make declarations of interest. We “follow the money” and ask “who benefits?”. The only people who can assuredly benefit from devising new law are barristers specialising in legislation or members of the ‘Bill Team’ driving this project.
1. Bewley S, Foo L, Braude P. Adverse outcomes of IVF. Br Med J 2011;342-3:d436
2. Vasireddy A, Bewley S. IVF is safe over 50 if it is not fatal. Am J Perinatol 2013;30:881-2
3. HFEA withdraws imposed 10% multiple birth rate target. http://www.embryonews.co.uk/blog/hfea_withdraws_imposed_10_multiple_birt... (last accessed 23rd April 2014)
Competing interests: Trustee, HealthWatch-UK "for treatments that work"
Saatchi law has been drafted with the noblest of intentions and if the letter of law is implemented in the spirit of the proposers, it would be particularly welcomed by terminally ill, mentally competent, consenting, adult cancer patients.
But I have my concerns; in particular, I am keen to see the legal minds reconcile the bill with the provisions of various EU directives on medicinal products. All new ‘medicines for human use’ in European Union are now subject to mandatory EU directives. (1).
As stated by MHRA on its website, the EU 'Directive 2001/83/EC relating to medicinal products for human use' takes precedence over Medicines Act in UK. (2).
I also cannot see the distinction between an ‘innovative treatment’ and a ‘research treatment’ and how this bill can side step the provisions of EU DIRECTIVE 2001/20/EC on clinical trials, notwithstanding the explicit support for clinical trials by the proposed law . (3).
Any medicinal product for human use, innovative or otherwise, needs authorisation from MHRA before it can be legally prescribed in UK. Perhaps the BMJ could invite MHRA to comment on the provisions of the proposed bill.
1. European Commission: Public health - Medicinal products for human use. URL: http://ec.europa.eu/health/human-use/index_en.htm (Accessed 26 April 2014).
2. MHRA (Medicines and Healthcare Products Regulatory Agency : An introduction to UK medicines regulation.URL : http://www.mhra.gov.uk/Howweregulate/Medicines/index.htm (Accessed 26 April 2014).
3. DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034... (Accessed 26 April 2014).
Competing interests: As member of the NHS England-Cancer Drugs Fund (CDF) panel, on occasions, I have approved licensed cancer medicines for unlicensed conditions. http://www.england.nhs.uk/ourwork/pe/cdf/
The team behind Lord Saatchi's campaign have provided no emperical evidence to support their contention that the fear of clinical negligence stifles innovative treatment. The proposed Bill also provides no protection for vulnerable patients (eg children, those without mental capacity etc) who are potentially open to manipulation by a maverick clinician. There is no need for this Bill, as drafted. If enacted it will cause serious problems for the medical profession. It should be rejected.
Competing interests: I am a solicitor who specialises in cliams for clinical negligence
The Bill as drafted provides an almost blanket protection to a clinician to try out out a treatment or management on a patient, whilst providing no counter balancing protection to that patient. If that patient is a child or without capacity then they are especially open to POTENTIAL abuse by the clinician. Lord Saatchi emphasises the position of a terminally ill patient, but the law must take into account all patients. Although drafted to make a point this article (http://www.injuredpatientclaims.co.uk/2014/04/dr-maverick-i-presume/ ) encourages the reader to look at the issue from a different angle. There is no empirical need for this Bill. It should be rejected.
Competing interests: I am a lawyer who specialises in clinical negligence
We apologise sincerely to Sir Michael Rawlins for failing to credit him with one of his important recommendations.
Competing interests: No competing interests
The “Saatchi Bill” has the stated purpose to “encourage responsible innovation in medical treatment (and accordingly to deter innovation which is not responsible)”. The consultation document on the bill recognizes that malpractice litigation induces a culture of defensive medicine: medical practice based on fear of legal liability rather than on patients’ best interests.
Defensive medicine can take two forms. Positive or assurance behavior results in medical services of marginal or no healthcare value e.g. unnecessary tests.[2 3] Negative or avoidance behavior manifests in preference for low risk interventions or inaction in situations of uncertainty.[2 3 4] Interestingly, tort law reform in the USA appears to have done little to assuage doctors’ fears, and has been associated with small or no change in practice patterns.
In the UK, a claim for medical negligence is likely to succeed if the doctor fails the venerable Bolam test i.e. if the doctor’s action (or inaction) is not supported by any responsible body of his peers. The Bolitho exception - the action must withstand logical scrutiny - seeks to ensure that pervasive negligence is not condoned. But, it is critical to make the distinction between decision-making and execution of the decision. The Department of Health espouses the model of shared decision-making (SDM), and GMC guidance (2008) has equated consent with SDM (Consent: patients and doctors making decisions together). For litigation on inadequacy of consent, the Bolam test (was the information-disclosure consistent with that of a responsible body of doctors?) has been hotly challenged by the “prudent patient” test (was the information sufficient to satisfy a body of patients?) and a “subjective” test (was information tailored to the requirements of that individual patient?).
It is very likely that doctors, even those who are familiar with the legal doctrine on informed consent, will find comfort in the Bolam standard. For, how is a doctor to know the information requirements of a hypothetical body of “prudent patients”? Moreover, the “subjective” test leaves the doctor vulnerable to the self-serving hindsight of dissatisfied patients, who might claim that information was not “tailored” to their requirements. In the current era of Evidence Based Medicine (EBM), decision-making is increasingly driven by practice policies and guidance. Most guidance comes with the disclaimer that the recommendations are not universal and should be interpreted in the light of individual circumstances. Nonetheless, doctors feel legally vulnerable if they contravene common practice[7 8]; safety is perceived to lie in “standard” decisions that do not need special justification.
Good medical practice is hampered if doctors do not make non-standard decisions that are in the best interest of an individual patient because of fear of litigation. Uncertainty in medicine must be acknowledged. The Saatchi Bill recognizes the issue but confuses the central tenets of good medical care – EBM combined with SDM – with innovation and progress. Of course, innovation is important, but the distinction from research is very fine and should be left to local “new procedure” and ethics committees. On the other hand, statute is needed urgently to clarify the requirements for informed consent – so that doctors can responsibly make appropriate decisions for individual patients – and the Bill should be modified to address this goal.
1. Rawlins MD. The “Saatchi bill” will allow responsible innovation in treatment. BMJ 2014;348.
2. Kessler DP, Summerton N, Graham JR. Effects of the medical liability system in Australia, the UK, and the USA. Lancet 2006;368(9531):240-6.
3. Studdert DM, Mello MM, Sage WM, DesRoches CM, Peugh J, Zapert K, et al. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA 2005;293(21):2609-17.
4. Feess E. Malpractice liability, technology choice and negative defensive medicine. Eur J Health Econ 2012;13(2):157-67.
5. Thomas JW, Ziller EC, Thayer DA. Low costs of defensive medicine, small savings from tort reform. Health Aff (Millwood) 2010;29(9):1578-84.
6. Jackson E. Consent I: Understanding. In Medical Law. Text, Cases and Materials. 2 ed. Oxford: Oxford University Press, 2010.
7. Mehlman MJ. Medical practice guidelines as malpractice safe harbors: illusion or deceit? J Law Med Ethics 2012;40(2):286-300.
8. Hurwitz B. How does evidence based guidance influence determinations of medical negligence? BMJ 2004;329(7473):1024-28.
9. Montori VM, Brito J, Murad M. The optimal practice of evidence-based medicine: Incorporating patient preferences in practice guidelines. JAMA 2013.
Competing interests: No competing interests
It has been drawn to my attention, since responding to the criticisms of my paper, that Lord Woolf - the former Master of the Rolls and Lord Chief Justice - has an article published in today's (24th April) Daily Telegraph explaining his reasons for supporting the Saatchi Bill. As my learned friends would say, "I rest my case".
Competing interests: No competing interests