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 New Legal Advice

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

The Saatchi Bill team have in the last few days added some legal advice to the new version of the proposed Bill. It appears as Annex C in the briefing note, dated 10 June 2014.

The main issue, perhaps, is the continued misrepresentation regarding the way that the Bill interacts with Bolam and Bolitho (see The Saatchi Bill would not preserve the Bolam Test by Nigel Poole QC). However, there are two other issues that the published advice brings up that are worthy of note. The first relates to s.1(2), and whether the Bill provides a full defence to negligence, and the other to s.1(3) and the duty to consult. I shall consider each of these in turn.

With respect to s.1(2), there is continued confusion regarding exactly what effect the Bill has on the law of negligence. Does it provide a full defence? If so, does this mean that there is no provision for the courts to be able to critically examine the decision to innovate?

The legal advice published in Annex C is, in my view, problematic regarding the answer to these questions. The advice in relation to s.1(2) begins with the following: “the central proposition — responsible innovation is not negligent per se” (see the briefing note at page 22). This is similar to the wording of the explanatory notes on page 20 (that it is “not in itself negligent for a doctor to depart from standard practice where the decision to innovate is taken in accordance with a process which is accountable, transparent and allows full consideration of all relevant matters”).

On page 23, however, this is explained in the legal advice in the following way:

The policy at which the Bill is aimed is to remove the perception which appears to be held by some doctors and others, that a decision to depart from standard treatment for a condition is presumed to be negligent treatment unless the opposite is shown, and that it is therefore always safest to follow standard treatment even if it is known to be ineffective.

Therefore, s.1(2) “states that a decision to innovate is not per se negligent, and that what matters is why and how that decision was taken”.

Readers might not immediately notice the difference between the claim and the explanation — but there is one. The explanation — that responsible innovation is not “negligent per se” leaves room for a situation where a decision to innovate taken “responsibly” might still be considered negligent by a judge. We must assume that “responsibly” means ‘in accordance with the Bill’s requirements’. The explanation, however, takes a different view — it states that the decision to innovate is not negligent per se — what matters instead is “why and how that decision was taken”. The insinuation is that, should the decision be taken “responsibly”, then it will not be negligent.

This distinction is important, because under the latter interpretation so long as the Bill is complied with then it is not open to a judge to assess the content of the decision to innovate, only to check whether the Bill’s processes are complied with. Unfortunately, the wording of the new version of the Bill (in common with the wording used in all previous versions of the Bill), makes it clear that the latter interpretation is what is intended. Look at the precise wording of s.1(2):

It is not negligent for a doctor to decide to depart from the existing range of accepted treatments for a condition if the decision is taken in accordance with a process which is accountable, transparent and allows full consideration of all relevant matters. (emphasis added)

The italicised words are unequivocal. So long as the process is followed, it is not open to a judge to find a doctor negligent.

The legal advice does state at page 23 that what is “accountable” and what is “transparent” are to be “determined by the reader (including, but not limited to, the courts)”. However, I cannot actually see what this is based on. Certainly, it is not based on the wording of s.1(2) and it is just assuming that the courts would interpret it in this way. There are two reasons why we cannot presume that that will be the case. First, if the purpose of the Bill is to reduce uncertainty for doctors frightened of litigation, then such an interpretation does not do that. Indeed, it might be argued that the whole point of the Saatchi Bill is to remove precisely this fear of being second guessed by judges after the event. Secondly, and on a related note, such an power on the part of judges is inconsistent with the explanatory notes, which state at page 20 of the briefing note that the Bill “allows the test of whether innovation is negligent to be applied at the time when the doctor is deciding whether to innovate”. This would, it seems to be, suggest strongly that the Bill does not support the courts being able to find negligence where the Bill’s prescriptions have been complied with.

Given this, it is therefore absolutely vital that what the Bill requires of the process is rigorous, as it is the only mechanism for protecting patient safety. This is contained in s1(3), which states that the process “must include” the following:

(a) consultation with appropriately qualified colleagues, including any relevant multi-disciplinary team;
(b) notification in advance to the doctor’s responsible officer;
(c) consideration of any opinions or requests expressed by or on behalf of the patient;
(d) obtaining any consents required by law; and
(e) consideration of all matters that appear to the doctor to be reasonably necessary to be considered in order to reach a clinical judgment, including assessment and comparison of the actual or probable risks and consequences of different treatments.

There has been some discussion about this, with many of us who believe that the Bill is misconceived arguing that the Bill’s requirement that the doctor proposing innovation “consult” with others does not impose a rigorous enough standard — as it leaves open the possibility of the doctor consulting, meeting unanimous opposition and being able to carry on anyway. The Bill’s proponents have consistently taken the opposite view, arguing that instead the Bill requires agreement from others.

For example, in the Daily Telegraph on 26th January 2014, Lord Saatchi himself wrote (of the second draft of the Bill), that “the agreement of other senior medical experts” would be required (M. Saatchi, “Lord Saatchi Bill: We Must Liberate Doctors to Innovate”, Daily Telegraph, 26th January, 2014). Similarly, Dominic Nutt wrote in March (also about the second version of the Bill) that “[i]t would be a legal requirement for the doctor to get the approval of a panel of senior doctors for any innovative treatment” (D. Nutt, “Saatchi Bill: The Fight to Win Hope for the Seriously Ill”, Daily Telegraph, 31st March 2014).

It is true that these quotes relate to the previous version of the Bill but, if anything, the new version waters down the requirements. Once again: look at the wording of the Bill quoted above. Is there anything there that requires “agreement” or “approval”? There is not.

This, at least, has been clarified by the legal advice in the briefing note. It transpires that, for s.1(3)(a) at least, “[t]his is a duty to consult — it does not give colleagues a veto” (briefing note page 24). In other words, to put it bluntly, we were right — there is no specific legal duty to gain agreement or consensus. The Bill’s legal advice does continue by saying that this is a high threshold, and that:

it requires full communication, allowance of proper time to respond, and through and open-minded consideration of any responses received … A doctor who does not receive consensus support from colleagues consulted under the Bill is unlikely to feel confident in relying on the protection of clause 1(2) – and that is precisely the policy of the Bill (briefing note page 24, emphasis added).

Nevertheless, just as with s.1(2), this relies on judges interpreting s.1(3) in this way, and there is nothing in the actual wording that mandates or even suggests that agreement or approval. With respect to s.1(2), the legal advice suggests that notification means that Responsible Officers (ROs) might themselves create procedures to stop doctors from providing innovative treatments that the RO does not approve of. However, this would only mean an internal disciplinary procedure against the doctor — it would not allow the patient a means of legal recourse.

Equally, the legal advice suggests that s.1(3)(c)’s requirement that the patient’s views are considered means that innovation is not possible without the consent of the patient. This, according to the legal advice in Annex C, is because patient empowerment is at the heart of the Bill. I would agree that innovation without permission would not be covered by the Bill — but for a different reason. I would argue that if the doctor does not disclose that the treatment is innovative, the patient’s consent would be invalid. Given that the Bill expressly states that the law relating to consent still applies, the doctor would not be protected.

Overall, then, what does the legal advice add? In short, not a huge amount. It would strike me as being close to wishful thinking to suggest that s.1(2) is not intended to be interpreted as providing a full defence to a charge of negligence to a doctor who complies with the provisions in s.1(3). Indeed, if there is not a blanket immunity for such doctors, then the Bill’s claim to change the time where legal liability is determined to before the treatment is provided cannot be supported. If courts can retrospectively declare doctors negligent, this central plank of the Bill falls flat on its face.

Equally, the admission that s.1(3) does not require agreement or approval by other doctors is important. Of course, this was always the intention – otherwise there is no point to the Bill, since according to the Bill team such a doctor would comply with Bolam and not need the Bill’s protection. The Bill, as Nigel Poole makes clear, is intended for doctors who do not pass the Bolam test, and this necessarily means that they have no support. If the approval of agreement of other doctors is envisioned as being needed, this should be made clear and explicit in the Bill.

In short, I am not sure that the legal advice matches the wording of the Bill and its stated intentions.

Due to this, I remain troubled by it.