Guest post by José Miola, Professor of Medical Law at the University of Leicester
The House of Lords considered the amendments to the Medical Innovation Bill on Friday 24 October. Many of their Lordships’ suggested changes — which would have done much to limit the damage inherent in the Bill — were simply rejected by the government and Lord Saatchi. In this post, I do not wish to consider the amendments themselves, or even the Bill as a whole. They have been expertly dissected by Nigel Poole QC here. Rather, what I want to emphasise is that the Lords, with one or two notable exceptions, do not seem to have yet realised two things about the Bill: first, that it necessarily lessens safeguards for patients; and, secondly but critically, that the Bill as enacted cannot work at all. In order to do this, though, we must first remind ourselves of what the law is, and then compare this to what the Bill will do.
In the main, I shall be referring to the words of their Lordships themselves in yesterday’s debate, all of which can be found here.
The Law of Negligence and What the Bill Provides
We have heard much about the Bolam test. Indeed, I have written about it in this website (here) and others such as Nigel Poole have done so here and elsewhere (here). The Lords are certainly aware of Bolam, and it was mentioned yesterday on several occasions by several Lords. However English law, as those of us who oppose the Bill have also noted, contains the dicta set out in Bolitho. Bolitho was not mentioned at all yesterday, and it is vitally important. As we shall see, though, Lord Saatchi and the government argue that it is also complied with.
For the benefit of those Lords still yet to understand, let me explain once again how the law of negligence operates in England.
Professionals, in order to avoid a charge of negligence, must act in a ‘reasonable’ fashion, and the test of ‘reasonableness’ asks a court to take two steps. The first is Bolam — where the court asks whether there are other professionals who might have done as the doctor in question did. It does not have to be all doctors, or even most doctors (in the case of DeFreitas v O’Brien  EWCA Civ 28, 11 out of over 1000 was deemed to be enough by the Court of Appeal). This provides professional validation and is reliant upon some colleagues providing evidence to support that doctor. However, we then have the second step provided by Bolitho. This tasks the court with assessing that medical evidence and checking that it is capable of withstanding logical analysis. Again, this has been extensively covered by me, Nigel Poole QC and others (see, for example, Responsible Medical Innovation, and my piece, Bolam, Bolitho and Patient Safety).
Now let us see how the Medical Innovation Bill compares. The proposed Section 1(3) of the Bill states that if the doctor meets its requirement of ‘responsible’ innovation, then she cannot be negligent. It defines ‘responsible’ innovation in this way:
1(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
So, let us compare the two.
Does the Bill Preserve Bolam?
We must begin by noting that professional validation is not required by the Bill. Instead, the doctor only needs to have consulted colleagues — there is no need to actually gain the agreement of anyone. Lord Turnberg spotted this, and his Amendment 7 was designed so that actual agreement from at least one colleague was required (see Columns 860–861 of the transcript).
This was rejected by Lord Saatchi, and Earl Howe (on behalf of the government). Lord Saatchi said that the latest version of the Bill (which is the one quoted above, which contains his latest amendments) already did this:
I believe that it is similar to my amendments in the sense that they both replace the existing conditions for the operation of the defence to negligence under the Bill with an alternative set of conditions. I understand that the noble Lord is trying to find a set of conditions that limit the opportunity for the Bill to be misused by quacks. As I have said, my amendments, proposed by Sir Bruce Keogh and the Secretary of State following consultation, have the same purpose. I hope that the noble Lord, Lord Turnberg, will therefore feel that those amendments address the fundamental concerns addressed by Amendment 7 and that he may feel able not to press it. (transcript at Column 864, emphasis added)
Earl Howe merely stated that he felt that Lord Saatchi had already answered that point (see Column 886).
My own view corresponds with that of Lord Turnberg, who responded to Lord Saatchi by again noting that:
The main difference is that his concentrates largely on taking account of the views of another expert, while mine suggests that we should obtain the agreement of at least one other expert, which should be recorded in the note. I think that that strengthens his amendment (at Column 886).
Put simply, consultation is different from agreement. Moreover, as I argued in my last post on this site (‘The Bill That Eats Itself’), the explanatory notes provided by the Bill team themselves notes that there will be circumstances where the consultees’ views may be disregarded.
I would ask anyone who disagrees with this view one simple question: can you point to any part of the Bill that mentions the word ‘agreement’ or requires it?
On the basis of this, I cannot come to any conclusion other than that Bolam is not required by the Bill. Rather, the Bill requires only consultation, which is something less than professional validation as it is possible to consult and still act contrary to the views of those consulted.
Does the Bill Preserve Bolitho?
As I mention above, Bolitho provides the additional — and crucial — safeguard that the courts can look at the evidence itself and check that it is capable of withstanding logical analysis. For those who think that this is a recipe for court interference, I would cite as evidence of the contrary the view of the Medical Defence Union (one of the two main bodies defending doctors from actions in negligence) that it has not seen one single case where a doctor has been sued for innovating.
Lord Pannick was concerned that the Medical Innovation Bill, as currently drafted with its requirement for consultation, would prevent the courts from assessing the content of any decision (as it now can), and only allow consideration of the process leading to it (the consultation). Thus, the Bill:
would define responsible innovation by reference to process; that is, obtaining and taking account of the views of others, considering the risks and benefits, and securing transparency. My concern is that this is insufficient because it says nothing about the substantive content of the decision of the doctor to innovate (at Column 868).
Earl Howe disagreed with this, and said that the proposed section 1(3) of the Bill uses the words ‘reasonable’ and ‘responsible’ on several occasions, and there are further mentions in the rest of the Bill. Therefore:
The steps that a doctor has to take under new Clause 1(3) include taking account of substantive factors as well as process. This includes taking full account in a responsible way of the views of one or more other doctors about the proposed treatment. In addition, the doctor must consider the risks and benefits of the proposed treatment as compared to other treatments and to not carrying out any treatments at all. This strays outside the realm of process (at Column 887).
This would seem to suggest that, perhaps, the intention is that Bolitho is complied with. Certainly, the words ‘reasonable’, ‘responsible’ and ‘respectable’ have long been known to lawyers as indicating that the courts should indeed assess the evidence. It is the bedrock of the decision in Bolitho itself.
So, does this mean that Bolitho is maintained as Earl Howe suggests? Unfortunately not — and the reason for that is that that there is no mechanism within the Bill for the court to undertake the review of the evidence that Earl Howe suggests is provided for by the Bill.
To explain this, we must remember that, as I explained in my last post, one of the key intentions of the Bill is to move the question of liability forward to before treatment. This was again mentioned by several of the Lords. Thus Lord Woolf stated that:
the Bill leaves the Bolam test intact. It is supplementing the Bolam test, and the importance of the fact that it is supplementing it is apparent in the fact that it states that if the doctor can comply with the Bill, he knows that he is safe and does not have to wait until the Bolam test has been applied to find out whether he is in danger (at Column 909)
Equally, Lord Saatchi said that:
as we all know—this is fundamental to the Bill—if the doctor is obliged to speculate in advance about what might or might not happen in a trial, that raises a very high degree of uncertainty. If it is possible for a doctor to move the Bolam test forward and comply with it in advance, which is what would happen as a result of the Bill becoming an Act of Parliament, that would enable the doctor to move forward with an innovation without the fear that a subsequent trial will find him guilty (at Column 909, emphasis added)
Finally, Earl Howe was of the same opinion:
my noble friend [Lord Saatchi] is proposing to bring the Bolam test forward, as he has clearly explained, so that the essence of the principle that the courts look at would apply in whichever course the doctor chose to take (at Column 890)
It is this particular effect of the Bill — bringing the question of determining liability forward — that means that it cannot work. This is because, if we settle the question of liability in negligence before treatment, then by definition it is not open to a judge to assess the evidence after the fact. Indeed, if a judge were to do so, then it would have the effect of completely undermining the entire point of the Bill — reassuring them that they cannot be sued.
On the other hand, if we accept this bringing forward of the question of liability, then it is not open for anybody to check whether the decision to innovate was taken responsibly or not.
In short, the two main planks that make up the Bill cannot work together. The Bill, as currently constituted, will have to choose between the safeguards and bringing the question of liability forward. It can’t have both.
So Where Are We Now?
Given that the purpose of the Bill is to reassure doctors, it might be expected that it will be the patient safeguards that will be compromised. As it stands today, that is precisely what the Bill does. Bolam is not complied with — despite the refusal of Lord Saatchi and Earl Howe to acknowledge it, consultation is not the same as agreement. Put it this way: I have read their arguments, and I have considered them carefully and with an open mind. I have complied with all of the procedures outlined in the Bill’s Section 1(3). So I have consulted them for their views. Yet I still disagree. Does this not prove my case? It also proves my case that Lord Saatchi has considered Lord Turnberg’s amendment and rejected it.
So, we know that a doctor can satisfy the process of the Bill despite not having the support of any of his peers (remember, as I said, that this possibility is explicitly recognised in the explanatory notes to Lord Saatchi’s own amendments). The next argument put forward is that the use of the words ‘reasonable’ and ‘responsible’ in the Bill allow for an assessment of the substance of the decision (as would be required by Bolitho).
However, as we have seen, the Bill not only provides no mechanism for this, but its entire raison d’être — bringing the question of liability forward — actively precludes any consideration of that substance by a court. In this sense, it is impossible for a court to apply Bolitho.
So we are currently in a situation where a doctor might proceed without the support of her peers, provide wrongheaded treatment that actively harms a patient, and there is no redress that the patient can seek. Something less than Bolam remains, and Bolitho is dispensed with in its entirety.
As Nigel Poole has already noted, Bolam already provides good doctors who have the support of some of their peers with a defence to a charge of negligence. What this Bill will do is provide bad doctors who do not have such support with a blanket immunity, and patients without protection.
Let us be very clear about this: by diluting Bolam and dispensing with Bolitho, the Bill proposes to remove the requirement that doctors act in a ‘reasonable’ fashion, and replaces it with one where all the doctor has to do is consult another one — there is not even a requirement to follow the advice gained.
How can that be a good way forward?