Stop the Saatchi Bill

Driven by an extraordinary two-year PR campaign on social media and a supportive newspaper partner, this all started as Lord Saatchi’s Medical Innovation Bill, metamorphosed through several versions, and was resurrected under a new name by Chris Heaton-Harris, before finally clearing its last hurdle in the Lords this week to become the Access to Medical Treatments (Innovation) Act.
Pretty much the only thing they share is the word 'Innovation' in the title.

One day, it may be possible for politicians to ask the people who actually work in the medical field: what are the problems you face, and how can we help you overcome them?

One day, politicians may actually listen to the answers they receive, and thus try to tackle genuine problems rather than imagined ones.

One day, politicians, medics, researchers, lawyers, patient groups, charities, and the public, may work together to overcome the barriers to the development and provision of new treatments.

But it is not this day.

Read more: Not this day

It’s like déjà vu all over again…

Guest post by José Miola, Professor of Medical Law, University of Leicester.

So Chris Heaton-Harris MP’s Access to Medical Treatments (Innovation) Bill (AMTIB), the latest version of Lord Saatchi’s Medical Innovation Bill (MIB), was voted through its second reading today by 32 votes to 19. This was despite informed, intelligent comments from Heidi Alexander MP and Sarah Wollaston MP, which were completely ignored by the majority.

But that is not the focus of this post. In all honesty, it was always too much to ask that MPs who knew little about the law (I’m looking at you Philip Davies, who thought that the ‘v’ in between the parties’ names in cases was the number five conveyed as a Roman numeral) would see the Bills off at this point. So we now have the AMTIB going to Committee stage in the Commons, while the MIB remains parked in the Lords, ready to be resurrected if and when he feels that the time is right.

Rather, I was irked into writing this post by something that George Freeman, the health minister, said. In short, he tried to maintain the position — entirely erroneously, as Nigel Poole QC has repeatedly and eloquently demonstrated — that the MIB/AMTIB do not change the common law requirements that protect patients from negligent doctors. Those of us who object to the Bill — including the BMA, MPS, MDU, Sir Robert Francis QC and countless others — have frequently pointed out that this is not the case. It seems that we have to again. The part of Mr Freeman’s speech that, in my opinion, went too far was when he said this:

I reiterate that the Government are clear that the negligence provisions in the Bill do not provide any immunity to irresponsible doctors. It would be irresponsible for anyone to suggest that they do. I want to make that point very clearly from the Dispatch Box and to reassure her that in our view the Bill does not remove any of the current safeguards in place to protect patients’ safety. Our view is that the Bill does not apply a weaker test to a doctor’s decision to innovate than the existing law on clinical negligence. (Hansard, emphasis added)

The AMTIB, he said, does not apply a weaker test that would provide immunity to irresponsible doctors relating to decisions to provide innovative treatment, and it would be irresponsible to suggest otherwise. Chris Heaton-Harris also stated that his Bill’s framework was not a downgrade on the common law.

So, let’s look at this claim in more detail. The easiest way to disprove Mr Freeman and Mr Heaton-Harris’ assertion is to look at the protections provided by the common law, then compare them to those in his Bill. They are not, as we shall see, the same. Moreover, for the sake of completeness, I shall also compare the provisions of Lord Saatchi’s still live MIB.

The Common Law

I have described the common law position before on this website (see ‘Bolam, Bolitho and Patient Safety’), so I propose to describe it in the very briefest of terms. Readers who have followed the progress of the Bills will have heard a lot about the case of Bolam. Bolam states that a doctor is not guilty of negligence if she has acted ‘in accordance with a practice accepted as proper by a responsible body’ of medical opinion. This means that a doctor can avoid an action in negligence if she can show that there is a responsible body of other doctors who might have done as she did.

The second part of the common law test is found in Bolitho, where the House of Lords held that the word ‘responsible’ in the Bolam test meant that it was not enough to merely produce other doctors who might have done the same. Rather, the court had to be satisfied that the evidence presented by that body of opinion was able to ‘withstand logical analysis’. This means that they retain the ultimate authority to reject the evidence presented by the defendant’s ‘body of opinion’ and find negligence even where it exists.

So, the current law asks a doctor to produce other doctors who say that they would support the course of action taken by the defendant doctor (Bolam); in other words, that they might have acted in the same way as the defendant doctor did in the same circumstances. The court would then check that the evidence of the body of opinion relied upon was capable of withstanding logical analysis (Bolitho). This allows the court to assess the content of the evidence. It is important to patient safety that it can examine content, as this necessarily involves a detailed examination of the doctor’s conduct, with the cross-examination of experts from both sides by lawyers and the judge, and thus constitutes a rigorous examination of whether (in the case of treatment involving innovative procedures) a decision taken to innovate was based on sound medical principles that have the support of at least some other doctors.

Does the MIB Offer the Same Protection as Bolam?

The MIB framework, in contrast, provides a process for the doctor to go through. If it is completed, then the idea is that the doctor cannot be sued in negligence. The idea is to settle the question of liability forward before treatment, so that the doctor knows that she may proceed without fearing any subsequent litigation. This is made clear in the MIB team’s final briefing note to the last parliament:

The Bill achieves its aim — to encourage innovation — in a simple, safe and responsible way. Better still, it is modest and humble. 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. (Source, page 12, emphasis added)

This can only mean one thing: that a doctor who follows the procedure contained in the MIB cannot be sued. Of course, this would fit perfectly with the overall aim of removing the fear of litigation from doctors (which is the purpose of the Bill as Lord Saatchi identified the fear of litigation as the one and only barrier to innovation).

So, what does this framework require? The MIB (which can be found here) sets out the process in section 1(3).

The doctor must do the following:

(a) consult at least one other doctor who is appropriately qualified
(b) take their opinion into account in a way that a reasonable doctor would do
(c) obtain consent from the patient, and
(d) consider matters such as the risks and benefits inherent in the proposed treatment

As mentioned above, if they do this then the doctor cannot be found liable in negligence.

Comparing this with the common law, it is immediately striking that the doctor does not have to show a body of medical opinion in support of her actions. Rather, she can be immune from liability in negligence merely by consulting a single doctor and taking her opinion into account. If the other doctor agrees with the consulting doctor, then it will suffice to mount a successful defence to a negligence action so long as the doctor has ‘considered’ matters such as a risk/benefit analysis.

In short, the MIB does not offer the same protection as Bolam. The latter requires there to be a body of doctors in support of the actions of the defendant, while the MIB only requires that one person be consulted. It does impose a duty to ‘consider’ some matters but, as we shall see below, if the desire for legal certainty before treatment is to mean anything then the content of that consideration cannot be examined by a judge.

Does the AMTIB Offer the Same Protection as Bolam?

The AMTIB’s framework is almost identical to that of the MIB, with one exception:

Instead of a duty to consult at least one more doctor about what the consultee thinks, this has been changed to a duty to ‘obtain the views of one or more appropriately qualified doctors in 
relation to the proposed medical treatment, with a view to ascertaining 
whether the treatment would have the support of a responsible body of medical opinion’.

Perplexingly, this now requires a doctor to consult a single doctor, asking not what the consultee herself thinks, but rather (and confusingly) what the consultee thinks that other doctors think. This is, of course, still a downgrade on the protection provided by Bolam, as instead of having to find a body of medical opinion in support, a doctor need only find a single doctor who is of the view that one might exist.

Let us be clear about what this means: instead of a defence to negligence being available to a doctor who can show that a body of medical opinion would support her, here she merely has to find someone else who thinks that such a body might exist — irrespective of whether it actually does exist. In other words, doctors might receive immunity from negligence despite no such body of opinion existing, which is a standard that is far lower than that currently demanded.

So, it is entirely wrong to say either that the MIB and AMTIB preserve Bolam, or that they deliver as high a level of protection for patients from negligent doctors. But matters get even worse when we look at the position in relation to Bolitho.

Does the MIB Offer the Same Protection as Bolitho?

It will be remembered that Bolitho allows a court to assess the content of the medical evidence in support of the defendant doctor. However, the MIB cannot offer the patient this protection. By requiring, as I demonstrated above, that the question of liability is settled before treatment, the MIB by definition precludes any post-treatment analysis of the content of the decision by a court. Rather, all that the court can do is check that the process has been complied with.

If this were not the case, and the courts could assess the content of the decision to innovate despite the MIB process being complied with (and, as described above, find a doctor had made a negligent decision to innovate via Bolitho), then the whole point of the Bill — removing the fear of litigation from doctors — would be entirely lost as doctors would not be certain that they could proceed without the possibility of being sued.

Of course, this did not stop supporters of the MIB stating that it would be open to the courts to analyse decisions (see here, for example), despite the fact that doing so would undermine to the point of destruction the whole point of the Bill.

Does the AMTIB Offer the Same Protection as Bolitho?

In yesterday’s debate, Chris Heaton-Harris and George Freeman also tried to have this cake and eat it. First, Mr Heaton-Harris said this:

…the Bill 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 acting in the responsible way that he or she should be. (Hansard, emphasis added)

This suggests that it would be open to the court to assess the content of the doctor’s decision irrespective of their compliance with the process of the Bill.

But then Mr Freeman said this in the same debate:

[the Bill] sets out an agreed, statutorily approved procedure to reassure doctors that if they follow that procedure, they will be covered by existing negligence and liability protection that the Bill does not change in any way. (Hansard, emphasis added)

This, on the other hand, suggests that, as with the MIB, courts will not be able to review content rather than just process. The consequences of this are that it would be doctors (or, to be more precise, the treating doctor and her consultee) who would define whether her conduct was negligent, rather than the court. This removes the ability of independent oversight into medical conduct (in relation to the law of negligence — the GMC could still discipline the doctor, but the patient would remain uncompensated). Furthermore, it goes entirely against the thrust of the Supreme Court’s recent ruling in Montgomery v Lanarkshire Health Board [2015] UKSC 11, which emphasises that

…social and legal developments which … point away from a model of the relationship between the doctor and the patient based upon medical paternalism … Responsibility for determining the nature and extent of a person’s rights rests with the courts, not with the medical professions. (paras 79-81)

So should we believe Mr Heaton-Harris’ statement, or that of Mr Freeman? Well, the explanatory notes provided by the Department of Health with Mr Heaton-Harris’ consent in advance of the second reading today make it clear that it is Mr Freeman’s interpretation that is intended:

[the AMTIB] encourages responsible innovation by doctors in relation to the carrying out of medical treatment, by providing that a doctor is not negligent when departing from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly, in accordance with a series of steps set out in the Bill (Source, page 2)

Moreover, the House of Commons Library Briefing Paper shares this interpretation when it states that:

The Bill seeks to offer clarity for doctors in advance of offering innovative treatment about the steps that they need to take to demonstrate that the decision to innovate was taken responsibly, rather than requiring doctors to wait for this to be determined by a court at a later date if their actions are challenged (T Powell, House of Commons Library Briefing Paper, AMTIB 2015-6 (CBP7329, 13 October 2015, page 6)

It should be noted that this document also refers (at page 3) to following the Bill’s process as ‘reducing’ the risk of a successful action in negligence rather than necessarily eliminating it as the other quotes suggest. However, this can only be seen as an outlier given the basic tenet (innovation being stifled by fear of litigation) and purpose (removing that fear) of both the MIB and AMTIB.

One final point on this: David Nuttall MP suggested in the debate that Bolitho was preserved by s.3(5) of the AMTIB, which states that ‘Nothing in this section permits a doctor to carry out treatment for any purpose 
other than the best interests of the patient’. The concept of best interests is designed for decisions regarding the treatment of patients who cannot make decisions for themselves, and thus not appropriate for the task that he assumes that he is asking it to perform. More fundamentally, s.3(5) requires only that the purpose of the treatment is the best interest of the patient. In other words, the purpose should not be research or anything other than a desire to make the patient’s condition better by providing the treatment. It does not relate to the adequacy of the content of a decision to innovate. If that it the intention, then s.3(5) needs to be significantly reworded.

Thus we can see that Bolitho is necessarily dispensed with by both Bills, as the courts will only, at best, be able to assess whether the doctor has complied with the process contained in the Bills rather than the content of a decision to innovate. If this does not occur, then doctors will still fear post-treatment reviews of their decisions and will thus not be free from the fear of litigation. Moreover, given that what the Bills require is at least different from the common law, doctors would be faced with years of uncertainty as the courts struggled to settle the law as demanded by new legal framework (Nigel Poole QC has eloquently discussed this here: Access to Medical Treatments (Innovation) Bill 2015). The BMA agrees, arguing in its briefing note on the AMTIB that

…the common law also requires, as per the judgment in Bolitho, that the decision to provide treatment is logically defensible. This is absent from the Bill as drafted and therefore represents a weaker form of protection for patients than that described in the common law. We believe this section of the Bill risks creating unnecessary confusion over the circumstances under which doctors are able to pursue “innovative” treatments. This would not only be counter-productive to the Bill’s aim of encouraging innovation but could also have implications for patient safety.

Conclusion

Both the MIB and AMTIB frameworks constitute significant downgrades on the current common law position. Bolam is watered down: it does not take a legal expert to see that requiring the support of a ‘body of professional opinion’ is more onerous than needing to consult a single colleague (MIB) or a single colleague about whether she thinks that other doctors would be supportive (AMTIB).

Bolitho, meanwhile, cannot survive if the two Bills’ philosophy is to be implemented. Put simply, if the purpose is to introduce legal certainty before treatment, then assessment after treatment by a court must be explicitly precluded as long as the doctor can show that she has followed the process. The steps taken to reach the decision, rather than the decision itself, will be all that the court will be able to assess, and that is substantially less than offered by the current law. Irresponsible doctors will be able to provide legal immunity to each other by consulting amongst themselves, and the courts will be powerless to stop bad decisions that harm patients by at least giving patients redress in negligence.

Let me provide an example: Dr A believes that, rather than chemotherapy, an injection of a ‘nutrients, minerals and substances’ concoction would help with patients’ cancer. She consults with her colleague (a partner at a private clinic), who agrees that it would be a good alternative. The injections are given, and all of the patients die within weeks (except one, who stops the ‘treatment’ after a short period of time). Currently, the courts could intervene to at least provide compensation in negligence. But within the MIB/AMTIB framework, given that Dr A had consulted a colleague, if she had also obtained the consent of the (desperate) patients and ‘considered’ the risks and benefits — let us assume that she genuinely believed that the concoction would work — her patients would be unable to sue in negligence. This is because the process had been followed, and Bolam and Bolitho emasculated.

A case with similar facts occurred in Australia in 2013 (Medical Board of Australia v Boyd [2013] WASAT 123).

The notion that the MIB and AMTIB do not affect patients’ rights quite simply cannot be supported. Moreover, let us remember that so far not a shred of evidence has been provided to show that a fear of litigation is hampering innovation. These significant downgrades on the law’s ability to safeguard patient safety are therefore being pushed through parliament to solve a problem that has not been shown to exist. It will not help responsible doctors, who are innovating and are already protected by the law. Instead, it will help the irresponsible practice without injured patients being able to obtain compensation for their injuries.

Mr Freeman may wish to reconsider just who is being irresponsible.

These issues are explored in more detail in relation to the MIB in my peer reviewed article published by the academic journal Medical Law InternationalBye Bye Bolitho? The Curious Case of the Medical Innovation Bill.