Guest post by José Miola, Professor of Medical Law at the University of Leicester
The Medical Innovation Bill has now received more amendments by Lord Saatchi, which now makes this the fourth version of the Bill.
The new amendments cover two principal issues: the process that the innovator has to go through in order for the decision to innovate to be considered ‘responsible’ and thus covered by the Bill, and the effects on the existing law.
In this blog post I shall set out what the amendments are, and argue that they still do not solve the inherent contradiction at the heart of the Bill — that it seeks to provide safeguards while effectively removing oversight. Moreover, as it currently stands the Bill is not internally consistent, as the duty to act responsibly cannot co-exist with the Bill’s insistence that the legality of a decision to innovate can be determined before the treatment takes place.
First, however, we must examine the amendments themselves.
The first of the amendments are a new section 1(3), which defines ‘responsible’ innovation. This definition is critical to the Bill because, it will be remembered, a ‘responsible’ decision to innovate cannot be negligent. The new section provides that:
(3) For the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition, the doctor must in particular—
(a) obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment,
(b) take full account of the views obtained under paragraph (a) (and do so in a way in which any responsible doctor would be expected to take account of such views),
(c) obtain any consents required by law to the carrying out of the proposed treatment,
(i) any opinions or requests expressed by or in relation to the patient,
(ii) the risks and benefits that are, or can reasonably be expected to be, associated with the proposed treatment, the treatments that fall within the existing range of accepted medical treatments for the condition, and not carrying out any of those treatments, and
(iii) any other matter that it is necessary for the doctor to consider in order to reach a clinical judgement, and
(e) take such other steps as are necessary to secure that the decision is made in a way which is accountable and transparent.
This essentially describes a process that the doctor will have to go through and, once she has done so, she cannot be found negligent.
Those who have been following the Bill’s progress will know that the Bill team have consistently argued that the Bill requires the ‘agreement’ of other doctors in order to be covered by the Bill. Those of us who oppose the Bill have, equally, consistently argued that it does not.
Again, the word ‘agreement’ is notable by its absence in the new version. Moreover, the guidance note that accompanies these amendments (available from the Bill’s website here) does not mention the word ‘agreement’ at all. What is required instead is consultation.
Thus, the guidance note states at paragraph 8 that the doctor must “obtain the views” of others, and that this provides safeguards because s.1(3):
requires the doctor to take full account of those views in a way in which a responsible doctor would be expected to do. This ensures that a doctor cannot ignore views, or give them minimal weight, unless there are reasonable grounds for doing so. This clause provides a critical safeguard in ensuring that there is expert peer review of the doctor’s proposal and that the doctor acts responsibly in taking account of that review (emphasis added)
This is true. However, this equally does not mean that the doctor is bound by the views of those that she has consulted. Indeed, this is acknowledged when the guidance says that the doctor can ignore or give minimal weight to views “where there are reasonable grounds for doing so”. In other words, it is clearly envisioned that there will be circumstances where the decision to innovate will be responsible and thus protected by the Bill even when the consulted parties disagree. The notion that agreement is required, then, can be seen to have been dispensed with.
Patients will be protected, according to the guidance notes, because the Bill (guidance notes para 6):
applies an objective test of responsibility to the doctor’s decision and prevents a doctor who acts irresponsibly from relying on the Bill
However, it is difficult to see how any test applied can be objective — and this is where we come to the inherent internal contradiction contained within the Bill. The only way that an objective test can be said to operate is if the decision can be reviewed by an external party. As we have seen above, the Bill does not intend that the doctor’s colleagues will have a right to veto the proposed innovation. This, in theory, leaves the courts. However, the Bill maintains its insistence that potential liability must be determined before the treatment takes place. To this end, the guidance notes state (at para 9) that the amendments:
reflect the policy intent of ‘bringing forward’ the Bolam test to before treatment is carried out.
It is not difficult to see the impossibility inherent in the Bill: if the decision regarding liability must be made before treatment is provided, then by definition it cannot be reviewed afterwards. Thus, the Bill still does not seem to provide a mechanism by which a poor decision (either with or without peer agreement) can be challenged after the fact if a patient is injured. This is the case even if there are, in retrospect, obvious flaws in the thinking behind the decision from the outset. If the court can intervene, then the ‘policy intent of bringing forward the Bolam test’ is necessarily lost.
In technical terms, the important patient safeguard in Bolitho that allows the court to assess medical decisions (that I described in my last blog post) remains excluded by the new version of the Bill. Given this, both the notion that the Bill does not remove currently available safeguards, and that (as the guidance states in para 5) “the Bill does not provide any protection to the doctor if the decision is implemented incompetently” quite simply cannot be supported.
The use (or not) of Bolam
The guidance maintains (in para 3) the Bill team’s consistent position that Bolam is unaffected. Thus, the new section 2 states that:
(1) Nothing in section 1 affects any rule of the common law to the effect that a departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion.
(a) where a doctor departs from the existing range of accepted medical treatments for a condition, it is for the doctor to decide whether to do so in accordance with section 1 or in reliance on any rule of the common law referred to in subsection (1);
(b) a departure from the existing range of accepted medical treatments for a condition is not negligent merely because the decision to depart from that range of treatments was taken otherwise than in accordance with section 1.
If a doctor can show that a responsible body of doctors would support her decision, then, she is still protected by the common law (subject to Bolitho, mention of which is of course notable by its absence in the guidance document).
The guidance continues by stating that doctors may choose whether to use Bolam or the Bill (para 4 and s.2(2)(a) of the Bill quoted above). But of course this then suggests that the Bill will protect doctors who cannot satisfy Bolam. In other words, the Bill must be intended to protect doctors who are unable to garner peer support. Otherwise, there is no point to the Bill as it would simply be a restatement of Bolam, which it explicitly states that it is not.
I must confess that I cannot understand how this is consistent with the traditional position of the Bill that peer review is vital — one that is again stated in the guidance document in para 8 where, as I quoted above, it stated that it ensures:
that there is expert peer review of the doctor’s proposal and that the doctor acts responsibly in taking account of that review
This is because there is only a point to the Bill if it protects doctors who disregard the opinion of that peer review. Put bluntly, it does not make sense. Again, it is worth noting that there is no mechanism in the Bill to allow for any review of a decision made.
If anything, this new set of amendments lays bare the fundamental problem with the Bill: if it is to allow increased certainty and protection to doctors, this must by definition come at the expense of safeguards for patients.
The Bill now seems to have got itself into a terrible mess, where its claims to provide safeguards simply cannot co-exist with the measures being put in place to provide peace of mind for doctors. It is worth restating the fact that, if the Bill’s aim of bringing decisions regarding liability forward, then Bolitho and indeed any form of post-treatment review of the decision is impossible.
What is worrying here is that even the safeguards previously claimed by the Bill team, such as the requirement for ‘agreement’ from other experts, are being watered down.
The new amendments do not improve the Bill, but they are useful insofar as they highlight how the Bill cannot really work.