Wednesday, 16 September 2015

Access to Medical Treatments (Innovation) Bill 2015

The Saatchi Bill has been "handed over" and is now in the Commons under a new name. Every criticism of the Saatchi Bill's attempt to change the law of negligence still applies. Indeed because the new version fails to recognise that the common law has moved on, the criticisms are even more valid.

I hope that sections 3 and 4 of this Bill will be defeated and that MPs will not have to explain to constituents deprived of justice when injured or bereaved by a negligent doctor, why they voted for it to become law.

Conservative MP, Chris Heaton-Harris has published a private member's bill soon to be introduced and then debated in the Commons. It is called the Access to Medical Treatments (Innovation) Bill. Lord Saatchi sought to introduce his Medical Innovation Bill in the last parliament. His website now says that he has "handed it over" to Mr Heaton-Harris (MIB website blog 14.9.15).

Lord Saatchi

Chris Heaton-Harris MP

The new AMTIB is in two parts. The first part concerns the creation of a data base. The second part adopts, with some minor changes, the core provisions of the Saatchi Bill. As a clinical negligence barrister I am not qualified to comment on the first part. I shall leave that to others, save to note that the definition of "innovative" treatment would not only include negligent treatments, but also  cupping, bleeding, draughts of mercury and other apothecaries' favourites.

The two parts have no logical or practical connection - they could form two separate bills. Sections 3 and 4, which copy the Saatchi Bill, could be removed in their entirety without affecting the substance of the rest of the Bill. MPs could support section 2 whilst rejecting sections 3 and 4.

Protecting Negligent Doctors

The object of sections 3 and 4 is to encourage responsible medical innovation by doctors.

The mechanism for encouraging innovation is to protect doctors who would now be found to have negligently injured their patients, from being liable to their patients. This would also protect their employers, including the NHS, from being sued.

The Bill provides that:

"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."

A doctor is negligent under the current law if he treats or manages a patient in a way in which no responsible body of (comparable) doctors would have acted (the Bolam test) or his actions are otherwise illogical or irrational (the Bolitho test). A doctor who treats a patient in a way which is irrational or which no other doctor would accept as responsible, will have been negligent. Under this Bill the law would change so that the doctor could not be found negligent if "the decision" was "taken responsibly".

So this Bill is intended to prevent doctors and their employers from being accountable when they have negligently injured or caused the deaths of their patients. Doctors who are not negligent do not need the Bill. Those who are, do and will seek to rely on it. That is my fundamental objection to it:an objection shared by patient groups including AvMA.

Just about every significant medical, medical defence and medical research body from the Royal Colleges to the MDU, told Lord Saatchi and the government that negligence litigation, and the fear of it, was not preventing doctors from innovating. Restricting negligence claims will not encourage responsible innovation. It will only serve to protect negligent doctors from being held accountable to their patients. Why deprive injured people of redress and why protect negligent doctors, when there will be no benefit for others through more innovation?

Confusion and Muddle

The Bill's provisions for what constitutes a responsible decision are muddled and confused:

  • As a minimum a doctor must first obtain the views of another doctor "with a view to ascertaining whether the treatment would have the support of a responsible body of medical opinion" and then take those views into account in a way in which any responsible doctor would. So the court's function will no longer be to determine whether a doctor's treatment has been negligent, but (take a deep breath) to decide whether a doctor has acted as any responsible doctor would have acted when taking into account the views of another doctor about whether any body of responsible doctors would support the treatment. Goodness me! If the Bill is intended to simplify the law and to provide more certainty for doctors, it has failed.

  • The provisions assume that it is the doctor that makes the decision to depart from the existing range of accepted treatments. As the Supreme Court recently emphasised in Montgomery v Lanarkshre Health Board, treatment decisions are made by patients, not doctors (save for emergencies or other similar circumstances): "The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments."  If a doctor is offering the patient an innovative treatment, then his/her role is advisory and "involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision."  

  • Official guidance on the Bill given to parliamentarians says that the intention is to "to reflect as closely as possible the steps under the current common law which a responsible doctor could be expected to take when innovating" It misses its target. The current common law requires that the treatment should be reasonable by the standards of a relevant body of medical opinion, and be rational. The Bill requires only that the doctor takes steps (by speaking to one or more other doctor) to ascertain whether (not to ensure that) the proposed treatment would have the support of a responsible body of medical opinion . 

  • Section 3(2)(c) of the Bill does provide that lawful consent must be obtained but Section 3(2)(d) merely requires a doctor to "consider any opinions or requests by the patient". Which is it to be? Either the Bill requires the doctor to comply with the current law on informed consent, or it requires doctors merely to take into account a patient's wishes. If this Bill is to pass it must at least be amended to make clear that doctors must obtain the informed consent of patients to any proposed treatment. Section 3(2)(d) muddies the waters and could be discarded if the need for informed consent is made clear in Section 3(2)(c).

  • The Bill should make clear that even if a decision to choose innovative treatment is properly made, that does not absolve the doctor from potential liability in relation to the delivery of that treatment. If the doctor negligently prescribes an over-dose of an innovative drug he/she should still be accountable, even if the decision to take the drug was "responsible" under the Bill.

Section 4 preserves the "Bolam" defence for doctors. It does not preserve the Bolam test as it is now applied by the courts. Under the Bill a patient could not choose to ask the court to apply the Bolam test rather than the provisions of sections 3 of the Bill. If the defence under the Bill is made out, the doctor will not be found negligent even if he would have been under the Bolam Test. Section 4 however provides the doctor with two defences - the current Bolam test and the new defence under the Bill.

The Bill will be heralded as a win/win provision but at its heart is an attempt to reduce the liability of doctors and their employers for negligence. It will not change the behaviour of the vast majority of doctors who are responsible, skilled and caring. Instead it will encourage irresponsible doctors, the quacks and the charlatans. The losers will be the injured and bereaved.

Mr Heaton-Harris says he wants feedback on his draft Bill - you can send it to him here

1 comment:

  1. I thought Montgomery would have put paid to this proposed law reform!!