Tuesday, 9 June 2015

When the facts change....

Lord Saatchi may be seeking to re-introduce his Medical Innovation Bill unchanged, but the common law he blames for preventing a cure for cancer, has moved on.

In January 2015 the House of Lords sent the Medical Innovation Bill to the Commons. The Bill sought to provide doctors with a defence to clinical negligence claims brought by their patients.

In March 2015 the Supreme Court gave judgment in Montgomery v Lanarkshire  Health Board [2015] UKSC 11. This important case developed the common law of clinical negligence in relation to the issue of consent. It has clarified how the law of negligence affects the doctor-patient relationship.

In June 2015, following the general election, Lord Saatchi has re-introduced the Medical Innovation Bill to the House of Lords, and has proposed that a parliamentary device be used to avoid debate of the Bill in the Lords.

The (new) Bill may be  identical to the (old) Bill as it was in January 2015, but the law it seeks to improve upon has changed. As was once famously said, "When the facts change, I change my mind. What do you do, sir?"



Lord Saatchi has always sought to justify his bill on the grounds that doctors are uncertain about the law of negligence, scared of being sued and therefore opt for conservative rather than innovative treatment. Well, all they need to do is to read the judgment of Lords Kerr and Reed (with whom the other Justices agreed) in Montgomery and in particular the passage beginning at paragraph 81.

Lord Saatchi needs to acknowledge that the law on informed consent has been reviewed and developed by the Supreme Court since his bill was last before parliament


The Bill expressly preserves the law of consent to treatment: "the doctor must ... obtain any consents required by law to the carrying out of the proposed treatment". I presume that the intention is therefore to preserve the common law requirement that doctors should obtain patients' informed consent to treatment. Certainly Lord Saatchi has never stated otherwise. However, he needs to acknowledge that the law on informed consent has now been carefully reviewed and developed by the Supreme Court. The doctor's role is to provide the patient with material information on which they can make an informed decision about treatment. It is not the doctor's "decision" to provide treatment (save in certain circumstances referred to below), it is the patient's decision to elect and consent to undergo a certain treatment. The following extracts from the judgment make this clear:


81. ... the law ..., instead of treating patients as placing themselves in the hands of their doctors (and then being prone to sue their doctors in the event of a disappointing outcome), treats them so far as possible as adults who are capable of understanding that medical treatment is uncertain of success and may involve risks, accepting responsibility for the taking of risks affecting their own lives, and living with the consequences of their choices. 

82.  In the law of negligence, this approach entails a duty on the part of doctors to take reasonable care to ensure that a patient is aware of material risks of injury that are inherent in treatment. ... [there is a]  fundamental distinction between, on the one hand, the doctor’s role when considering possible investigatory or treatment options and, on the other, her role in discussing with the patient any recommended treatment and possible alternatives, and the risks of injury which may be involved. 

83. The former role is an exercise of professional skill and judgment: what risks of injury are involved in an operation, for example, is a matter falling within the expertise of members of the medical profession. But it is a non sequitur to conclude that the question whether a risk of injury, or the availability of an alternative form of treatment, ought to be discussed with the patient is also a matter of purely professional judgment. The doctor’s advisory role cannot be regarded as solely an exercise of medical skill without leaving out of account the patient’s entitlement to decide on the risks to her health which she is willing to run (a decision which may be influenced by non-medical considerations). Responsibility for determining the nature and extent of a person’s rights rests with the courts, not with the medical professions.


It is the patient's decision, not the doctor's, whether to undergo treatment


The Medical Innovation Bill puts the doctor at the centre of the decision making process.

"s.1(2) It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly."

But as the Supreme Court has said, it is the patient's decision, not the doctor's, whether to elect to undergo treatment. The doctor's role is to enable the patient to make an informed decision.

The Bill does not reflect the law as has been clarified by the Supreme Court since the House of Lords last had a chance to debate the Bill. It sets out what steps a doctor has to do to take the decision responsibly rather than what steps a doctor has to take to allow the patient to make an informed decision.

"s.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 (a) ....."

There are circumstances when a doctor, rather than a patient, makes a treatment decision: in an emergency for example. There may also be rare cases where there is a so-called "therapeutic exception" to the rule that the patient should be fully informed of material risks. In debate in parliament, Lord Saatchi made it clear that the Bill was not intended to apply to emergency cases. Clearly it is designed for elective treatment - where the doctor and patient have time to discuss the risks and benefits of treatment options.

Some will object that in reality it is doctors that make the treatment decisions. The way a doctor informs a patient of the risks and benefits of treatment options will produce the desired response. However, the Supreme Court has said loud and clear that medical paternalism is dead.

Of course the ideal of unfettered patient choice is a myth. There are funding, regulatory and systemic restraints on patient choice. But within those constraints, the patient is sovereign.

I have always opposed this Bill but it is now clearer than ever that it is based on a misconception about the doctor-patient relationship and about who makes the decisions about treatment. Ironically it is the common law Lord Saatchi has condemned for maintaining the status quo, that has developed. It is the Bill that is stuck in the past.



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