The Medical Innovation Bill rears its head once more


By Catriona Stirling

Once upon a time, the British Medical Journal satirically asked what doctors could do if faced with a clinical problem for which there were no randomised controlled trials and no good evidence  (Isaacs, D., Fitzgerald, D. Seven Alternatives to Evidence Based Medicine. BMJ. 1999 Dec 18; 319(7225): 1618).

The suggested alternatives to evidence based medicine included eminence based medicine, in the practice of which, the more senior the colleague, ‘the less importance he or she place[s] on the need for anything as mundane as evidence’; eloquence based medicine, where ‘[t]he year round sun tan, carnation in the button hole, silk tie, Armani suit, and the tongue should all be equally smooth’, as ‘sartorial and verbal eloquence are powerful substitutes for evidence’; and vehemence based medicine, where ‘the substitution of volume for evidence is an effective technique for browbeating’ more timorous colleagues and convincing relatives of ability.

The much criticised Medical Innovation Bill (often referred to as the “Saatchi Bill”) has reared its head once more as a Private Members’ Bill in the new Parliamentary Session. It received its first reading in the House of Lords on 8 June 2015 and Lord Saatchi appears determined to keep trying to push it through Parliament, despite the vehement opposition that it has previously aroused. The House of Lords website lists a future motion to allow Standing Order 46 be dispensed with in relation to the Bill. If Lord Saatchi is successful in this motion, this would allow his Bill to pass through its remaining stages in the House of Lords in one day and move straight to the House of Commons.  

Although the Bill has previously been through many iterations, in an effort to meet criticisms which have been levelled at it, the version which received its first reading on 8 June is the same as the final version which passed the House of Lords in the last Parliamentary session.

It is worth reminding ourselves of the current law, and of how the Bill, in its most recent incarnation, would change that law. As will be apparent from this examination of the Bill, if it becomes law, it may result in some of the BMJ’s suggested alternative methods of practising medicine becoming a reality.


The Current Law

As readers will be aware, under the current law, the Bolam/Bolitho (“Bolam”) test determines whether medical treatment is negligent. Pursuant to this test, a doctor will not be negligent if his/her treatment would be supported by a reasonable body of medical opinion, so long as that opinion can withstand logical analysis. The reasonable body does not have to be a majority.

In other words, there may be a range of ways of treating a particular medical condition, which may all be supported by different, reasonable bodies of medical opinion. A doctor will only be deemed negligent if his/her chosen treatment would not be supported by any reasonable body of medical opinion.

Claimant lawyers will be aware that the Bolam test is often not a difficult hurdle for medical practitioners to overcome.   


Purpose of the Saatchi Bill

The Saatchi Bill aims to change the law in certain circumstances to make it easier for doctors to have a defence to a negligence claim if the treatment that they carry out harms a patient. Its purpose is stated to be ‘to encourage responsible innovation in medical treatment’( at Clause 1(1)).

If it becomes law in its present form, it will not be negligent for a doctor to depart from the ‘existing range of accepted medical treatments’ for a condition, if the decision to do so were taken ‘responsibly’ (Ibid at Clause 1(2)) even if the treatment followed would not pass the Bolam test.


Existing Range of Accepted Medical Treatments

There is no definition of ‘existing range of accepted medical treatments’ in the Bill. This is unhelpful, given that the exemption from Bolam for a decision taken ‘responsibly’ appears, on the face of the Bill’s wording, only to apply in relation to departures from that range.  

One might think that what the Bill means by an accepted medical treatment would be a treatment that would meet the Bolam test, i.e. which would be supported by a reasonable body of medical opinion. However, it appears that this may not be the case.

The Bill preserves common law rules as to negligence (Ibid at Clause 2). In other words, it preserves the Bolam defence in the case of departures from accepted medical treatment (as well as in cases where there is no such departure). Where Bolam applies, then there will be no need to show that a decision was taken ‘responsibly’ within the meaning of the statute; a doctor will have a defence to an allegation of negligence, without showing anything more.

If a departure from ‘accepted’ treatments were defined by reference to the Bolam test, then the Bolam test would have no application to such a departure. Does this mean that ‘accepted’ medical treatment cannot be defined by reference to the Bolam test, or does it merely reflect bad drafting? 

If ‘accepted’ medical treatment doesn’t mean supported by a responsible body of medical opinion, what does it mean? It presumably cannot be narrower than the range of Bolam-compliant treatment, so it must be wider. We have so far had little guidance to assist here.

Could we find patients in the future seeking to argue that a treatment which has gone wrong was an ‘accepted’ medical treatment and that Bolam should therefore apply, with a doctor (somewhat counter-intuitively) arguing that the treatment followed was not within the ‘accepted’ range and that he has a defence because his decision was taken ‘responsibly’ within the meaning of the legislation?

Such an argument by a patient would appear to be permissible on the current wording of the Bill and may be more likely to give him/her a remedy, as it may be harder for a doctor to show that the Bolam test is met than to show that a decision was taken responsibly.  

Take a hypothetical example of a patient with Cancer X. Cancer X is normally treated with Chemotherapy Drug Y at a particular dosage, but that treatment has proven to be ineffective in the particular patient’s case. What would cause a doctor’s treatment to move out of the existing range of ‘accepted’ medical treatments? Would trying a different, much higher than normal, dosage of the same drug be sufficient to amount to such a departure? Would trying a similar, but different, drug be sufficient? Or would it be necessary to depart entirely from chemotherapy treatment before the doctor is deemed to be departing from the existing range of accepted treatments, and exempt from the Bolam test?

Claimant lawyers may well seek to argue in such a case that the accepted treatment was chemotherapy, rather than a particular kind of chemotherapy, or Drug Y, rather than a particular dosage. There may, perversely, be a clear incentive for them to argue that an accepted treatment has been followed so that they can argue that Bolam applies to a defendant’s conduct. Of course, to succeed, they would still have to show that the treatment was unsupported by a reasonable body of opinion of medical opinion.


What makes a decision ‘responsible’?

Moving on from arguments about what is and isn’t within the existing range of accepted treatment, what will make a decision to use a medical treatment that is not currently within that range ‘responsible’?

The Bill gives a list of requirements with which a doctor must comply in order for his/her decision to depart from the existing range of accepted medical treatments to amount to a ‘responsible’ one and therefore defensible (Clause 1(3)).  

He/she must:

  1. Obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment.
  2. 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).
  3. Obtain any consents required by law to the carrying out of the proposed treatment.
  4. Consider:
    •  Any opinions or requests expressed by or in relation to the patient.
    • 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,
    • Any other matter that it is necessary for the doctor to consider in order to reach a clinical judgement.
  5. Comply with any professional requirements as to registration of the treatment under the provision of this Act with a scheme for capturing the results of innovative treatment (including positive and negative results and information about small-scale treatments and patients’ experiences).
  6. Take such other steps as are necessary to secure that the decision is made in a way which is accountable and transparent.

Stripped of the statutory language, what does the doctor actually have to do (other than convince himself of the merits of his/her own actions)? Not a great deal.

In relation to the opinion of other doctors, he/she has to speak to just one colleague about the treatment that is being proposed and ‘take full account’ of that colleague’s views. The colleague must be ‘appropriately qualified’. There is no requirement to speak to more than one doctor. It is not clear what taking full account requires, but it is plain that there is no need to obtain the agreement of the other (or any other) doctor.

There is also a requirement to get the patient’s consent to the proposed treatment, as there is with any treatment. It is difficult to see how there can be properly informed consent about an experimental treatment when there is unlikely to be much, if any, information about its risks and benefits.


Is this Bill desirable or needed?

The changes proposed to the law are not needed. They are also dangerous to patients.

The requirements set out for a decision to be deemed ‘responsible’ are largely procedural and administrative. They are not focused on the merits of the proposed treatment and require no demonstration of its merits to anyone other than the doctor wishing to experiment with a new treatment. They do not provide sufficient protection to patients from experimental treatment which is not in their best interests.

The new law would apply to all medical conditions, no matter how serious or minor, regardless of whether there are accepted and effective treatments already in existence and no matter whether there were already clinical trials of new treatments taking place; in the latter case, a doctor would effectively be able to bypass such trials by simply citing this legislation.

As many commentators have pointed out, it would therefore apply in situations far beyond the treatment cancers or other terminal diseases for which there is no known, effective treatment, although proponents of the Bill repeatedly cite only such situations when arguing in its support.

There is nothing in the Bill which requires a doctor to use any or all of any existing range of accepted medical treatments for a condition prior to, or alongside, using any experimental treatment. It is difficult to see why not. Surely any responsible medical practitioner would wish to at least try any existing treatment which may be effective, before, or while, trying a new treatment, or one whose effectiveness has not been proven?

Moreover, if a responsible medical practitioner wishes to try a new treatment on a patient, even if there is a paucity of evidence regarding its effectiveness (or potential for harm), one would expect him/her at least to have a sensible, logical and rational reason for wanting to try that treatment.

And if such a reasonable basis for trying the treatment existed (and any recognised treatments were being, or had been, tried), then one would expect to find support from a reasonable body of medical opinion for trying that new treatment. Indeed, one might ask why anyone would object in that situation. In that event, the Bolam test would be likely to be met and the exemption provided by this Bill would not be needed.   

The only new treatment that is not likely to be protected under the present law, is one which ignores existing, effective treatments, and which has no sensible, logical or rational basis

This can be contrasted with the position if this Bill becomes law, whereby all such ‘innovation’ would be protected, if the doctor had made his decision using the largely administrative procedure outlined, with no remedy for any harm suffered.

A Bill which allows such irrational and illogical experimentation to be carried out, while allowing no legal recourse by a patient, is unnecessary and undesirable. It would put patients at serious risk of harm.

If it becomes law, it will clear the way for many of the BMJ’s alternative methods of practising medicine to come to the fore.

A senior doctor wishing to experiment with a patient’s treatment will not need to concern himself with the need for evidence of the treatment’s effectiveness, but may rely on his own seniority and ideas of what he thinks best for the patient: eminence based medicine in practice.

Gaining a patient’s consent to experimental treatment and speaking to a (perhaps more junior) colleague about that treatment will allow ample opportunity for the practice of vehemence and eloquence based medicine, as doctors seek to persuade or browbeat patients into consenting to the proposed treatment and cow any objections from colleagues.

It is unfortunate that this once satirical vision may become reality. It is therefore to be hoped that this Bill can once more be stopped in its tracks before it reaches the statute book. However, given Lord Saatchi’s determination to proceed with it and apparently effective public relations campaign in support of it, it is likely that the Bill’s opponents need to prepare for a long fight ahead.