Out of concern for the Government’s declared support for the Medical Innovation Bill (MIB), a member of the Stop the Saatchi Bill Alliance wrote to Earl Howe, Parliamentary Under Secretary of State for Quality in the House of Lords, seeking an explanation for this support in the face of overwhelming opposition from the medical profession. Earl Howe responded, but his response raises so many points of concern that we feel it appropriate to set out details of his letter with our commentary.
The Government’s position in support of the Bill makes no sense: it would appear that it is based on misconceptions about the Bill itself, as well as some rather faulty logic and assumptions. Here is the letter, paragraph by paragraph, with our comments below each.
Page 1, paragraph 2
The letter from the oncologists referred to is a letter to The Times newspaper from 100 leading oncologists, arguing that the Bill is not just unnecessary (as a fear of litigation is not preventing them from innovating), but will be actively harmful to patients. They join:
Even the two medical defence organisations are opposed to the Bill:
For many more, see What do doctors, lawyers and medical charities say?
We are not sure which ‘stakeholders’ the Government has talked to. We know that following the last session in the House of Lords, Lord Saatchi promised a round-table discussion, which apparently happened, but the Bill team has refused to reveal what was discussed, and even who was there. So much for transparency. But let us accept that there was contact with stakeholders, whoever they were.
Note the language in the letter: apparently they have been ‘reassured’ that there are patient safeguards in the Bill. We shall also leave the question of whether that is actually the case until later — it does come up again.
Rather, let us simply ask the question: if these stakeholders have been ‘reassured’, why have none of them changed their minds and voiced support for the Bill? Have any of them agreed with the Government’s position as a result of the ‘reassurances’? In the absence of any evidence of anyone changing their minds and supporting the Bill (again, we shall come on to the issue of evidence later), how can we assume that these reassurances have been accepted?
Page 1, paragraph 3
Lord Saatchi may indeed have identified the threat of litigation as a barrier to innovation, but he seems to be very much in the minority in this view. To be clear: in their responses to the Department of Health’s consultation regarding the Bill, none of the groups who would surely know if fear of the law was a problem agreed with Lord Saatchi.
Thus, the GMC said that they could find no evidence of this and said that the Bill was “unnecessary and undesirable”. Nor could the BMA find any such evidence. Neither the MDU or the MPS — who would also surely be contacted by worried doctors — said that they could either. Even the NHS Litigation Authority, which was set up in 1995 so has 20 years of experience, said that they had not seen this. Confirmation of this can be found in their responses to the consultation regarding the Bill.
So what evidence do we have that doctors are scared? The Government tells us that some doctors responded to the consultation saying that they had a fear of litigation. Equally, Lord Woolf has said that in his time as a judge he had seen several cases — although he cannot now point to any and says that he is now unlikely to be able to find any. But, at best, what we have here are some doctors who claim that they are scared (but have turned to neither their professional bodies or defence organisations for advice), and the vague recollections of a retired judge that he refuses to provide evidence for and does not see why he should have to do so.
Against that, we have the multitude of bodies listed above — representing all of the stakeholders involved — united in their view that this Bill is misguided. Thus, surely the answer is not to introduce legislation but to educate those doctors who are scared and reassure them that their fear is misplaced. It is worth re-emphasising the point here: not a single case has been provided as an example of a doctor being sued for innovating. The Government is supporting legislation based on a false premise.
Page 1, paragraph 4
Is this an admission that the safeguards were insufficiently stringent before? But whatever their previous merits, the amendments cannot ‘ensure’ patient safety. Under the MIB, provided a doctor complies with the correct process as set out within the Bill, that doctor can feel confident that they cannot be sued in negligence, no matter how much harm (or even death) they cause to a patient. This can only benefit those at and beyond the current boundaries of medical practice. Again, we return to this later.
Page 2, paragraph 1
Under the current law a doctor’s decision to treat a patient must be supported by a responsible body of medical opinion in that area of medicine (Bolam) and that opinion must be able to stand up to logical analysis (Bolitho); otherwise she could be held liable to compensate that patient in case of injury.
Let us be clear: the test in the MIB is certainly different from the one in the common law. The former deals with process, the latter the substance of the decision. Moreover, if by following the steps in the Bill the doctor is ‘not negligent’ (as the MIB provides), then by definition the court cannot assess the substance of the decision and find for the claimant. Thus, even if we accept that the Bill is basically bringing the Bolam test forward (which it isn’t), it most certainly dispenses with Bolitho. In this sense, it is simply not true that it does not remove the patient protection currently offered by the common law. Alternatively, if we accept what the Government and Lord Saatchi say that the courts are able to assess the substance of the decision under the Bill (which is impossible given the ‘not negligent’ phrasing within the Bill), then surely it fails to provide doctors with the reassurance that was mentioned earlier in the letter and is central to the Bill. In short, they cannot have it both ways and must compromise on one of the two purported pillars of the Bill: removing doctors’ fear of litigation and safeguards for patients.
What the Bill does, under specific circumstances, is to remove a patient’s right of redress (to be compensated) from a doctor who acts in a way that no responsible doctor would act, just by going through a defined process. It does not have to stand up to logical analysis. Logical analysis demands ‘proof of concept’. So, a doctor can try almost anything (that one other doctor doesn’t reject) and be safe in the knowledge that they cannot be sued. Therefore the Bill does remove a safeguard to protect patients. Despite what is said by the Bill supporters, the Bill has nothing to say about professional conduct; so doctors remain open to professional criticism and a misconduct charge. Nigel Poole QC has covered the difference between the Bill’s requirements and the Bolam test extensively:
- The Saatchi Bill would not preserve the Bolam Test
- Saatchi Bill – widening its reach and turning full circle (in particular the list of issues in point 5)
- Responsible Medical Innovation
— they are not the same.
However, it is still worth repeating one point again: the Bill by definition removes the right of the court to assess the content of a decision (as it can under Bolitho). If the courts retained this right, then the Bill would be pointless as the fear of litigation would not be removed from doctors, who would not know their legal position before treatment was provided. If the courts lose this right, then the Government’s position that patient safeguards are not eroded cannot be maintained. This has been covered here: Bolam, Bolitho and Patient Safety.
Page 2, paragraph 2
This is only a meaningful statement if the definition of ‘responsible’ is robust. As we have seen above, that is not the case. Quite simply, the MIB states that if a doctor follows the process described in the Bill, then she is not negligent. The definition of ‘responsible’ therefore relates to process rather than substance. This is a departure from the current law, and a clear lessening of patient protection. It also explains why patient groups oppose the MIB.
Page 2, paragraph 3
As we shall see below, even the Government now accepts that these requirements do not include a duty to gain the agreement of the consultee. Moreover, it is also notable that dissenting views from consultees do not have to be recorded.
Also, remember that the doctor is NOT negligent if she has followed the process of the Bill. So first of all we have a situation where two charlatans agreeing with each other would satisfy the process contained within the Bill. Furthermore, as mentioned above, if the judge can still look at the substance of the decision to innovate even where there is agreement, then the Bill’s essential purpose — freeing doctors from the fear of litigation — is lost.
Moreover, the test simply cannot be objective. The innovative doctor selects the other doctor whose views she takes account of. As the innovating doctor does not have to detail any doctor that says ’no’ to the treatment (and it could be doctor number five who is the first doctor not to object to the innovative treatment) then the test is completely subjective. The innovating doctor determines, under the MIB, whether they are (not) negligent.
Page 2, paragraph 4
This is a new position for the Government and the Bill team to take, and a radical departure from that previously held by them. Indeed, the previous position has been to rubbish any claims that agreement was not required within the Bill.
More seriously, when Lord Turnberg raised this precise issue in the House of Lords, Lord Saatchi himself told him that the Bill did require agreement. Lord Turnberg said:
He should make sure that other doctors looking after that patient who have an interest in that patient will agree with him and he should have the agreement of another expert in the field. He should have not just consulted that person but obtained their agreement.
See also: What the Lords Missed.
Lord Saatchi replied:
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.
But we now know that this is not the case. Rather, it appears that there was never an intention to require the agreement of another doctor, despite the frequent and strident declarations to the contrary. Furthermore, the reason given here is that the consultee must be protected from litigation. It has even been admitted that the Bill team envisions situations in which the consultee is not provided with all of the available information.
Opposition to the Bill is unsurprising when the patient safeguards involve ‘consultation’, based on limited information, which is so informal that the consultee can take no responsibility at all for the decision made. Essentially, each doctor indemnifies the other, leaving the patient without protection or redress.
Page 2, paragraph 5
Page 3, paragraph 1
The Government’s position here is that a doctor does not have to record an adverse view from a colleague, because this might mean ‘putting himself in a risky position’. This surely cannot be accepted. If the decision is ‘responsible’, then the doctor has nothing to fear. If it is not, then the Government’s position seems to be that it is better for this to be covered up and for the innovative treatment to proceed rather than the doctor being too scared to innovate or have to answer for the decision afterwards if it injures the patient. Again, this highlights that patient safeguards come below indemnifying doctors on the Bill’s list of priorities.
Page 3, paragraph 2
The purpose of the law is to protect patients from harm caused by truly negligent, bad, reckless doctors and charlatans. Such individuals may well lack professional integrity, as history so vividly confirms. By failing to close an obvious loophole in requiring consultees to act reasonably the Government leaves all patients exposed to serious harm and removes the oversight provided by the current law. Is the Government’s position really that there should be no legal duty for consultees to act reasonably at all? This is particularly concerning when by giving agreement they also indemnify the consulter.
Page 3, paragraph 3
The conditional and hopeful language is telling here. While temporarily increased litigation is, of course, a risk with any new statute, the whole point is that this particular Bill is trying to solve a problem that quite simply does not exist (and even then does so in an incredibly flawed manner). It is worth remembering at this point that there has not yet been a single example of litigation about innovation presented. If the law is not a barrier, then the answer is education (which will not increase litigation in the short, medium or long term) rather than legislation that almost certainly will.
Page 3, paragraph 4
The whole notion that all that the Bill does is ‘move the Bolam test forward’ has already been debunked several times (see, for example, The new amendments – the Bill that eats itself). But, if the purpose of the Bill is merely to restate the law, then is there really a point in using legislation rather than education to do so? The law is settled, and if there is a small minority who are fearful of it — a minority not including any of the stakeholding organisations or the doctors who we really want innovating such as the 100 senior oncologists — then they should be reassured that they have nothing to fear as long as they act reasonably.
The problem with the Bill — as some of the discussion above has highlighted — is that on the basis of claims that are entirely unsupported, all patient protections will be removed from the law. An unlimited number of patients are left exposed to serious harm or death to solve a problem of perception that does not exist.
It is no wonder that there is not a major organisation that supports the Bill, and we are disappointed that the Government has failed to take this into account in its position.