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

The Money Resolution: Part 2 – Changing Common Law

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

On several occasions during the Money Resolution Debate on Chris Heaton-Harris’ Access to Medical Treatments (Innovation) Bill (AMTIB), the claim was made that the clinical negligence aspects to the Bill would either not change current law or at least provide patients with equal protection. To this end, George Freeman (a Government minister) said:

[the AMTIB’s negligence provisions] merely clarify the existing protections already afforded by medical negligence law (emphasis added) Source

He repeated this, even more explicitly, when he said:

the Bill, as we understand it — we have taken substantial legal advice — does not in any way change the law on medical negligence; we would struggle if it did. Rather, it sets out a clear pathway for doctors seeking to enjoy the freedoms that are already in law to make it very clear what the procedure would be (emphasis added) Source

Chris Heaton-Harris was equally clear about these issues. He stated:

The second part of the Bill, which I fully acknowledge is much more controversial, will give registered medical practitioners a supplementary method of demonstrating that they have acted responsibly while innovating. It closely mirrors the existing legal test, the Bolam test, that is used when clinical negligence proceedings reach the court stage. It brings the test forward and enables doctors to use it to demonstrate that they have acted responsibly before they enter the courtroom. It does not change the common law (emphasis added) Source

The purpose in doing so is to remove the fear of litigation from doctors who, according to the government, are dissuaded from innovating because they are worried about being sued if they do. As George Freeman told the House:

it is a controversial proposition that fear of litigation for medical negligence is putting clinicians off innovating. The evidence that the Government received through the consultation was that some clinicians do feel that is a problem, but very few saw it as the principal problem or the principal obstacle (emphasis added) Source

However, he also added this caveat:

I accept that if one were setting out a list of the biggest barriers to the uptake of innovation, fear of negligence would not be No. 1 on the list. However, it is equally true, as has been put to us during the consultation on this Bill, that it is a consideration Source

However, none of these claims can withstand scrutiny.

Does the AMTIB Change the Law or Weaken Patient Protection?

Unfortunately, the Bill does both of these things. The current law states that a doctor cannot be found liable in negligence if she can find a body of medical opinion that might have acted as she did in the circumstances (Bolam), and the evidence presented by that body is able to withstand logical analysis (Bolitho). The courts, due to Bolitho, have the ability to assess the content of any decision to innovate. The doctor also has to show that there is a body of other doctors that support her actions (although a failure to provide this does not automatically result in a finding that the doctor is negligent — it only permits the judge to do so).

Under the AMTIB, the doctor does not have to demonstrate that there is a body of other doctors who support her. Rather, if she can show that she has consulted one other doctor, regarding what that doctor thinks that other doctors would think, that is enough. This is both confusing and clearly a far less rigorous standard than that currently required. It replaces a requirement to have the support of a body of expert opinion to one where it is enough that one other doctor thinks that such a body might exist.

Moreover, the idea that the question of liability is brought forward to before treatment necessarily precludes assessment of the decision after it. Thus, the Bolitho element of the current test will consequently have to be dispensed with. Courts will therefore only be able to assess whether the doctor complied with the process of consultation contained in the AMTIB rather than the content of a decision to innovate.

It is also worth noting that section 4 of the AMTIB allows a doctor to rely on either the AMTIB test for negligence or the current common law (see in particular s.4(2)(a)). Two points stand out from this. First, the fact that the very text of the AMTIB sees the tests as separate grossly undermines the notion that the AMTIB merely clarifies rather than changes the common law. Secondly, this comes very close to allowing a doctor to choose which legal regime to be subject to. This would be extraordinary in any event, but given the Supreme Court’s landmark decision in Montgomery v Lanarkshire Health Board [2015] UKSC 11 this year, which emphasised the right of patients rather than doctors to make choices about their care, it is difficult to avoid to the conclusion that the AMTIB runs entirely against the current thrust of the common law.

The differences between the current law and the latest version of the AMTIB is discussed in more detail here: It’s Like Déjà Vu All Over Again

For an explanation of the current law (Bolam and Bolitho) see: Bolam, Bolitho and Patient Safety and Responsible Medical Innovation

For a critique of the effect of Montgomery v Lanarkshire on the Medical Innovation Bill (and the AMTIB as the negligence provisions are almost identical) see: When the Facts Change

Are Doctors Deterred From Innovating by a Fear of Litigation?

The claim that the Department of Health’s Consultation found that doctors are deterred from innovating by the threat of litigation is also, at best, not entirely reflective of the findings. The DoH’s response to the consultation (see here) on page 11 identified only BASO (a membership organisation for surgical oncologists) as a group that said that they did have examples of doctors being deterred from innovating by a fear of litigation, as well as some individuals. Moreover, while ‘a small number’ of respondents identified both a particular innovation and a potential treatment, there were ‘none where a doctor described him- or herself personally as deterred’. Moreover, the DoH noted at page 12 that

many of the respondents who said “no” were medical bodies, including the Academy of Medical Royal Colleges and the Royal Colleges of Pathologists, of Physicians, of Physicians and Surgeons of Glasgow, of Radiologists, and of Surgeons of Edinburgh

Others included the Medical Defence Union, as well as the following (listed on page 13):

  • medical research charities (including Cancer Research UK, Leukaemia & Lymphoma Research, the Motor Neurone Disease Association, the Muscular Dystrophy Campaign, Parkinson’s UK, Prostate Cancer UK and Target Ovarian Cancer);
  • other bodies active in research and science (including the Academy of Medical Science, the Medical Research Council, the Wellcome Trust, and the British Pharmacological Society);
  • bodies primarily concerned with patients (including Action against Medical Accidents, Genetic Alliance UK and the Teenage Cancer Trust);
  • NHS England, the NHS Litigation Authority and the National Institute for Health and Care Excellence (NICE).

To these bodies we can even add patients’ groups such as the Patients’ Association and AvMA. Given that the medical, medical protection, patient and research communities do not think that a fear of litigation is a problem at all, the justification for tampering with law that is not, after all, an obstacle, is removed.

Furthermore, the only evidence relied upon by supporters of the Medical Innovation Bill and AMTIB (other than to say that litigation costs the NHS a lot of money, without even attempting to say how much of that cost relates to innovative practice) comes from Lord Woolf, who said that he had, as a judge, experience of such cases.

However when challenged by Dr Anthony Barton, co-author of an authoritative clinical negligence book, to name actual cases, Lord Woolf was unwilling and unable to provide any at all, and demanded that Dr Barton take him at his word.

See: When Harry Met SaatchiSolicitors Journal, Former Lord Chief Justice unable to substantiate argument for Medical Innovation Bill and Solicitors Journal, Huzzah! Lord Woolf has Written a Book But Still Dodges the Question

It is also clear that the law does not actually act as a barrier to the provision of innovative treatment, as can be seen by the courts’ authorisation of the treatment of patients with vCJD with treatment never before attempted in the UK (see Simms v Simms [2002] EWHC 2734 (Fam)); the treatment of ‘Ebola nurse’ Pauline Cafferkey with experimental drugs (see here), and the recent news that Layla Richards (a child with cancer) has been treated with experimental genetic therapy at Great Ormond Street hospital (see here).

So, what we can see is that there is no proof of an actual problem to solve. Indeed the NHS Litigation Authority, who would certainly know if doctors were being sued, stated that it knew of not one single case where a doctor had been sued for innovating.

See: J. Miola, ‘Bye Bye Bolitho: The Curious Case of the Medical Innovation Bill’ (2015) Medical Law International — free version available here

Therefore, if there are some doctors who are dissuaded from innovating due to a fear of litigation — and no evidence has been presented that this is the case to any significant degree — this fear is misplaced, as there is no evidence at all of any litigation regarding responsible innovation.

Given all of this it is imperative that the AMTIB does not lessen patient protection. Yet, as we have seen, this is far from the case and the AMTIB does offer patients far less protection than the current common law.

Conclusion

It should be remembered that this proposed change in the law is all in order to solve a problem that does not exist. Nobody has been able to provide a single example of an innovative treatment that was responsibly provided and resulted in the doctor being sued. Nor is there any strong evidence of a fear of litigation preventing innovation — and indeed almost all of the key stakeholders explicitly state that the problem does not exist.

As mentioned above, if some doctors do fear litigation then that fact alone is insufficient reason to change the law. The law does not actually prevent innovative practice (a view shared by the BMA and Sir Robert Francis QC amongst others — see here). Doctors who fear that which they have no reason to fear should therefore be educated regarding what the current law actually provides and allows them to do.

Indeed a reduction in patient safety — an inevitable consequence of the AMTIB, which is significantly different from the current law — is not the answer. Even the Government acknowledge this. As George Freeman himself noted:

The second part of the Bill [concerning negligence], as we understand it … does not in any way change the law on medical negligence; we would struggle if it did (emphasis added) Source

Given this commitment, and the fact that the AMTIB clearly does modify the law, we would ask that the government act according to its word and withdraw at least the negligence aspects of the Bill which, according to the Royal College of Paediatrics and Child Health, ‘poses a real danger to the safety of infants, children and young people in England and Wales’.