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

Bolam, Bolitho and Patient Safety

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

Anyone who is interested in the Medical Innovation Bill will have heard a lot about the ‘Bolam test’, which is the test for negligence used in English law.  The Bill team has been careful to state that the Bill does not modify it at all – but instead merely move its from after the treatment is given to before, so that the doctor knows the legal result of her actions before acting.  But what does this actually mean?

In this post I shall set out to explain what the Bolam test is, how English law currently operates to protect patient safety and how the Medical Innovation Bill does actually modify the test and strip away a key element of the law’s ability to shield patients from medical practitioners who are overconfident, merely wrong or quacks.

What is the ‘Bolam Test’?

The ‘Bolam test’ is the legal test for negligence that comes from the case of the same name (Bolam v Friern Hospital Management Committee) in 1957.  I do not propose to go into the facts of the case, but for those interested there are accounts of the case – a key one in medical law – in every medical law textbook.  Essentially, the judge in the case held that a doctor cannot be found liable in negligence if she can find a ‘responsible body of medical opinion’ (we shall return to the italicised word later) that might have done as she did in the circumstances (again – remember the italicised word).  In other words, if other reasonable doctors might have done as the defendant doctor did then the doctor is not negligent.

How Does It Work?

Note my use above of the words ‘might have done’.  It is not necessary for the defendant doctor to show that there are other doctors who have done what she did, only that, if they were in the same position, they might have done the same (see Simms v Simms).

If you think about it, this is a very low bar to clear.  The test became, essentially, a case of ‘get a couple of your friends to agree with you and you’re fine’.  Indeed, in a case in 1984 the House of Lords (what is now called the Supreme Court) held that it was not open to a judge – even though he wanted to – to find a doctor negligent because there were some other doctors who supported what he did (see Maynard v West Midlands Area Health Authority).

Indeed, a lot of people were very unhappy with this situation, for several reasons.  First, it essentially made doctors themselves the final arbiters of what was or was not negligent.  Moreover, it prevented judges from having any right of oversight.  They were not allowed to assess the expert evidence themselves, but instead their only role was to check whether or not it existed.  Secondly, this interpretation of Bolam was actually different to the way that it operated for all other professions.  For everyone else, be they ship captains, architects or solicitors, the courts reserved the right to examine the content of the expert evidence and, if it made no sense, still find negligence.

This was clearly too lenient, and did too little to protect patients.  Therefore, in 1997 the Bolam test was reinterpreted by the English courts.  In the case of Bolitho v City and Hackney Health Authority, the House of Lords held that it was open to the courts to find negligence even where the defendant doctor could provide some expert evidence on her own behalf.  However, it made it very clear that judges should only use this power in the ‘rare case’ that the evidence provided by the defendant’s experts was ‘unable to withstand logical analysis’.  In other words, Bolitho cannot be invoked where the judge simply prefers the claimant’s experts.  Rather, the judge has to be satisfied that the evidence or the reasoning behind it is so flawed that even though there might be a body of opinion supporting the doctor, it is not a responsible one – the word that I asked you to remember earlier in this piece.

So the law seeks to protect patients in two ways.  First, it asks the opinion of other doctors, to see if they might have done the same as the defendant did.  If they can find some to testify on their behalf, then that is strong evidence that they are acting responsibly.  This is Bolam.  But Bolitho then adds a second layer of protection.  It allows the judge to look at the evidence itself and assess whether it is logical.  In the very rare case that it isn’t, the judge can intervene and find negligence anyway.  This is the law today.

How Does the Medical Innovation Bill Affect This?

The Bill’s sponsors and backers say that the Bill does not affect Bolam.  Instead, they say, the timing of the Bolam test is shifted from being applied after the treatment is given (in other words, when the patient sues), to before the treatment is given.  This is because the doctor is forced by the Bill to ‘consult’ colleagues before she can make a decision to innovate that is protected by the Bill.  Once she has engaged in this process and done this, she cannot be found guilty of negligence.

In my opinion, there are two problems with this that mean that the Bill does, in fact, affect Bolam.  First, as I explained in my previous blog post on this website (‘The New Legal Advice’), a duty to ‘consult’ others is different from a duty to get their agreement.  The doctor can ‘consult’ colleagues by asking their advice but still reject it.  Therefore, while Bolam would require the support of a body of opinion within the medical profession, if enacted the Bill would protect doctors who cannot even gather that support.  This, at the very least, is a serious dilution of the Bolam test.

Even if some sort of amendment is tabled that would alleviate such a concern – we on this website advocate at the very least an explicit requirement that actual agreement is required in s.1(3) – my second concern is that, by definition, Bolitho’s safeguards are discarded.  S.1(2) of the Bill makes it clear that  doctor who abides by the process outlined in s.1(3) is ‘not negligent’; and remember also that the Bill is intended to shift Bolam to before treatment is given.  This means, by definition, that the court’s ability to scrutinise the decision to innovate is removed.  The only role for the court will be to act as a rubber stamp, checking that the consultation process has been complied with.

In these two ways it is clear that, despite the suggestions to the contrary, the Bill does affect the common law.  The second change – the discarding of Bolitho – cannot be the subject of an amendment without fundamentally altering the very purpose of the Bill, which is to allow doctors to be sure that they cannot be sued before they try to innovate.

Why Is Discarding Bolam and Bolitho a Problem?

 The safeguards in Bolam (requiring peer support) and Bolitho (allowing court oversight) are critical as they exist to safeguard patient safety.  It must be remembered that the law already allows responsible innovation, as the GMC, BMA, Academy of the Royal Colleges and MDU have pointed out in their responses to the consultation document.  The safeguards exist not to allow liability in negligence for doctors who have peer support and whose innovations are based on good science – and it is noticeable that not one single example has yet been put forward of such innovation being litigated.  Rather, they exist to allow patients to gain compensation if they have been injured as a result of irresponsible innovation.  This does not just include quackery, but also instances where the doctor is overconfident, insufficiently mindful of the patient’s interests or simply makes a scientific mistake.  It is here that Bolam and Bolitho come into their own in helping to assess the doctor’s behaviour.

In relation to Bolam, if a doctor cannot obtain the support of her colleagues then it is vital that a court should be able to ask the simple question: ‘why not?’  If other doctors consider the science to be faulty, or the risk not worth taking, then surely this is a very important consideration when deciding whether that decision to innovate was indeed responsible.  For every doctor who is a misunderstood genius who is years ahead of her time, in situations where there is no peer support there will be another 100 who have made a mistake or have been reckless with the patient’s welfare.

Bolitho is just as important.  When the House of Lords decided the case in 1997 it was seen as marking a sea change where the courts saw a responsibility to protect patients from a profession that had been able to set its own legal standard.  I will provide an example of Bolitho being used by the courts to show how it is right that courts should have the final say.  After the scandal at Bristol Royal Infirmary, it transpired that in many hospitals around the country it had been the common practice to remove some organs from dead babies to use for research.  This was done without the knowledge or consent of the parents, who in some cases buried their children without their hearts.  The case of AB v Leeds Teaching Hospitals NHS Trust concerned three parents in Leeds whose children had had organs removed without their consent by the hospital during the post mortems.  The judge noted that this was a universal practice within the medical profession, and that the reason for it was a concern not to distress the parents rather than malice.  He also agreed that the doctors involved were conscientious.  Nevertheless, he also said that such a practice was not justifiable and had caused more distress to the parents, and used his right – under Bolitho – to compensate the parents and show that this practice was not to be continued.

Sometimes a profession can become insular.  This is not a trait limited to the medical profession, but an outside set of eyes can ensure that practices remain tight and proper.  It is in part for this reason that Professor Sir Ian Kennedy, who chaired the inquiry into the Bristol scandal, and Sir Robert Francis QC, who led the inquiry into the Mid-Staffordshire scandal recently, oppose this Bill. (“Damning Report by Sir Robert Francis QC“) They feel, as I and the others on this website do, that the role of the courts in protecting patients – which is what Bolitho gives – cannot be discarded without seriously compromising patient safety.  Under the Bill, the court would lose the right to question medical practice if it were supported by other doctors, and under the current Bill doctors would not even need that.  What would happen if a doctor were to innovate irresponsibly, based on bad science, and injure a patient?  Under the Bill as it stands there would be no way for the court to intervene.

Yet this is necessarily what this Bill will do.  As a consequence, patients will be less, not more, safe, because the Bill is trying to correct a problem (innovation being stifled by the fear of litigation) that no medical organisation believes exists.  In other words, this Bill seeks to remove important safeguards for patients to correct a problem that is not there.

That is one of the reasons why I and the others who write on this website oppose this Bill.