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The Medical Innovation Bill, introduced by Lord Saatchi and commonly referred to as the “Saatchi Bill”, has passed the House of Lords and is about to be debated in the House of Commons.
Lord Saatchi has been confident of his aim for the Bill: “I intend to cure cancer, you see. I mean to do it. I expect to do it.” The reason we do not have a cure for this and other diseases, he asserts, is because doctors are prevented from innovating by restrictive law and the fear of litigation. He intends to alter the law to remove that fear, while preserving patient safety.
However, the Bill has met strong criticism, including observations that it is unnecessary, that it misunderstands the law, that it jeopardises patient safety, that its scope is so broad that it would cover treatment for any condition, however minor, even if effective treatments already exist, and that it may “strike at the heart of evidence based medicine” and undermine clinical trials. For these reasons, it is opposed by virtually every major medical, medical protection, patient and research organisation, including the GMC, BMA, MDU, MPS, the Academy of the Royal Colleges, the Wellcome Trust, the MRC and Cancer Research UK. Now the National Assembly for Wales have unanimously rejected it as well.
As opponents of the Bill ourselves, we believe that each one of the above criticisms should mean – if it worthy of any further parliamentary time at all - that the Bill is subjected to the most rigorous scrutiny. However, there is a distinct possibility that it will pass through the Commons during its second reading on 27th February and then into law, unless at least one MP objects.
In this article, we argue that this fast-track passage would be inappropriate. We do so not by reference to any of the criticisms already noted, even though each would be sufficient basis on its own, but because of a hitherto under-recognised issue in relation to the Bill. Essentially, the Bill contains an internal inconsistency that is so fundamental that, structurally, it does not work – even on its own terms. The two pillars on which the Bill rests - removing the fear of innovation from doctors and patient safeguards - are mutually exclusive in the way they are constructed in the proposed legislation. Thus, if it has one protection it cannot have the other.
The current law – Bolam and Bolitho
Anyone following the Bill will no doubt be familiar with the current law, and a lengthy description is outside the scope of this article but, in essence, in order to win a case in negligence the plaintiff must demonstrate that the doctor has not acted ‘reasonably’. This has a two-part test. First, the court will assess whether the doctor has acted in a way that other doctors might have done in the same circumstances. This is the Bolam test, which ascertains whether such a body of medical opinion exists. The second step is to ask, if there is such a body, whether the evidence presented by it can withstand logical analysis. This is the test in Bolitho. If the doctor can provide evidence from such a body, and it can withstand logical analysis, then the doctor cannot be liable in negligence. If she is unable to provide evidence then it is open to the judge to find liability, although this is not compulsory as the judge can still find that the doctor acted reasonably in the circumstances. The test is well known, and well tested in the courts.
What Does the ‘Saatchi Bill’ Do?
The Bill states that, for departure from “the existing range of accepted medical treatments”, a doctor is not negligent so long as the process described in the Bill is complied with. In other words, it provides immunity from liability in negligence and indeed any professional requirements, but only if the process is followed. It is then described as containing safeguards to protect patients being treated under the bill.
Therefore, the Bill rests on two central pillars: peace of mind for doctors and safeguards for patients. In relation to the former, this is purportedly achieved by attempting to bring the question of liability forward so that it is determined before treatment. As the Bill’s website notes,
[b]y following the process set out in the Bill, doctors can be confident that a decision to depart from standard practice will be upheld as responsible by the courts, the regulatory bodies and others.
The Bill’s fundamental philosophy is that if it can move the determination of potential liability forward then doctors can innovate safe in the knowledge that they cannot be sued or disciplined later. Thus, the bulk of the Bill relates to the process that the doctor must undertake in order for the proposed innovative treatment to be labelled ‘responsible’ and the doctor consequently to be safe. This includes “obtaining the views” of at least one other doctor (s.1(3)(a)), taking “full account” of those views in a way that reasonable doctors would do (s.1(3)(b), obtaining consent from the patient (s.1(3)(c)), considering the patient’s views (s.1(3)(d)(i)) and risks and benefits of the proposed treatment (s.1(3)(d)(ii)).
Note the conditional language: doctors must obtain views and take them into account, which falls short of requiring agreement, a point now admitted by the Bill’s creators. Amendments to the bill aimed at resolving this point have all been rejected by Lord Saatchi or the government (supporting the bill), on the basis that the doctor being consulted should not be expected to take on a burden of responsibility for what is envisaged to be a very informal discussion, often without reference to details of the case or the patient’s notes. This informal level of oversight is intended to replace the tests in Bolam and Bolitho.
Further, the risks and benefits of the proposed treatment must be ‘considered’, though there is nothing to specify the adequacy of that consideration: it requires mere consideration irrespective of the content of that reflection. According to s.1(2), if a doctor goes through this process then the treatment is deemed to be “responsible”, and the doctor is “not negligent”. In this way, the doctor is supposed to be reassured whether she is liable in negligence before treatment begins and need not fear litigation or professional sanction. It is designed to be easy to achieve, because innovation is assumed to be necessarily a good thing that is worthy of being encouraged, and the individual doctor decides which law applies to her when she makes the decision to treat.
At the same time, patients have to be protected, and the second central pillar is that of patient safety. English law has long recognised the words ‘reasonable’, ‘responsible’ and ‘respectable’ as allowing courts to intervene: a body of opinion in support of the defendant can be defined as ‘unreasonable’, ‘irresponsible’ or ‘not respectable’, in acknowledgment of the normative nature of the words. This is the very basis of Bolitho. The Bill’s drafters have stated that this robust system of judicial scrutiny will remain. They have highlighted the fact that the Bill’s own wording contains various references to ‘reasonable’ behaviour, and that the Bill states that it will only support ‘responsible’ innovation. However, the latter assertion is somewhat questionable, as the definition of ‘responsible’ in the Bill relates to the following of a set of procedural steps in deciding to treat, rather than an examination of the content of a decision (as Bolitho requires). The Bill’s website notes that once the process in the Bill is complied with (before treatment) there will be “no opportunity” for anyone to review the decision afterwards.
In short, then, the Bill provides legal indemnity to doctors who fulfil its criteria for ‘responsible’ innovation. It does not do anything other than this. It does not seek to address any issues relating to access to treatments. Nor does it consider issues of funding. Indeed, it does not empower doctors to do anything that they cannot already do. This is problematic, given that while a fear of litigation has not been identified by any major organisation as being a barrier to innovation, the other factors mentioned above have. It can therefore be said that the Bill seeks to solve a problem that does not exist.
But, even more troublingly, the Bill is even unsuccessful in achieving its own aims.
The Problem With the ‘Two Pillars’
Eagle-eyed readers will already have noted the structural problem with the Bill as it is currently drafted, and it is so fundamental that it means that – even if the Bill addressed a genuine issue in an appropriate way - it is fatally flawed. Put simply, the two central pillars are constructed in a way that makes them mutually exclusive. The Bill claims both to settle the question of liability before treatment, and to allow judges to assess not just the process but the content of the decision afterwards. But, of course, this is impossible. If we move the Bolam test forward so that the doctor can proceed knowing that she will not face legal sanction, then this actively precludes judicial scrutiny of anything other than the process involved in reaching the decision. Conversely, if the courts are able to assess the content of the decision after the fact, then no doctor can act secure in the knowledge that they are legally safe.
In this way, we can see that the Bill cannot simultaneously provide peace of mind for doctors and safeguards for patients. Let's imagine a doctor follows the procedure set out in the Saatchi Bill: he consults a fellow doctor at the same practice, the doctor does not agree with the treatment, but after due consideration the doctor proceeds. The patient suffers harm as a result. Now, if that patient is able to sue retrospectively then clearly the Bill safeguards patients but it does not safeguard doctors. On the other hand, if the patient is not able to sue, then the Bill has safeguarded doctors but it has not protected patients.
The question therefore arises: which pillar does the Bill prioritise? In our view, it clearly prefers protecting doctors rather than patients. Indeed, the concept of bringing the issue of liability forward was the intent of the Bill. Moreover, it is important to remember that the basis of the Bill is the notion that the law impedes innovation, and therefore the purpose of the Bill is to free doctors from the law. This was reflected in the fact that, in the version of the Bill sent by the Department of Health for consultation, doctors were explicitly “not negligent” even if they suspected or knew that there were no other doctors who would support the proposed treatment.
There are two principal issues highlighted here. First, the Bill is internally inconsistent to the point of being fundamentally flawed in its construction. The patient safeguards cannot operate if the ‘key objective’ of moving the question of liability forward is achieved, and vice versa. Given that the point of the Bill is the protection of doctors, and the Bill is pointless if any other interpretation is adopted, we must conclude that the legislative intent is to prioritise doctors rather than patients. It remains to be seen what the courts will do, but this inconsistency necessarily means more litigation. This is already ironic in a Bill that is supposed to be about reducing litigation. It is fatal when one considers that no serious stakeholder – all of those listed in the opening paragraph of this paper and many others including the NHS Litigation Authority – is of the opinion that a fear of litigation is impeding innovation.
Given this, we are moved to disappointment that this Bill has been allowed any parliamentary time at all, but note that it would be a tragedy if it were passed without the Commons giving it full scrutiny. We would ask MPs, in the strongest possible terms, to attend on 27th February and ensure that this scrutiny takes place.