Monday, 13 October 2014

Responsible Medical Innovation

The Medical Innovation Bill will shortly be in Committee stage in the House of Lords. Lord Saatchi has tabled amendments to produce a consolidated bill. Using all his PR experience he has persuaded most of the media (so far) to take a wholly uncritical look at his proposals.

The bill's purpose is to promote medical innovation. It targets clinical negligence law as being, in Lord Saatchi's view, the obstacle to innovation.  Clear evidence from representative bodies such as the BMA, the Academy of Royal Medical Colleges, the NHS Litigation Authority, the MDU and others, that litigation and the fear of litigation are not barriers to innovation has been ignored.

The bill has nothing to say about the regulation of new medicines and devices, about research protocols, professional regulation or funding. Its sole focus is on clinical negligence litigation.

The Current Law

The law of medical negligence is settled and well understood by judges, lawyers and doctors. The test of whether a doctor has been negligent was set down in the case of Bolam-v-Friern Hospital Management Committee [1957] 1 WLR 582 and adapted in the case of Bolitho-v-City and Hackney HA [1998] AC 232.

A doctor is not negligent if he provides treatment to a patient which is supported by a responsible body of medical opinion, even if there are other bodies of medical opinion who would not support it. A doctor is only negligent if no responsible body of medical opinion would support their treatment or if the treatment had no logical or rational justification. If that negligent treatment harms or kills the patient then the patient or their family will be entitled to compensation.

Hippocrates - Do No Harm

The current law does not mandate adherence to a standard treatment.  The Bolam test is flexible and allows for innovative treatment if a responsible body of medical opinion would support it. Clinical negligence law has not halted the incredible advances which have been made in medical practice over the past five decades since the Bolam decision.

The Medical Innovation Bill

The great majority of doctors providing innovative treatment are not negligent. They act in accordance with a responsible body of medical opinion and give treatment which has a rational basis. The Medical Innovation Bill is not intended to affect them.

Instead, the bill seek to change the way the law treats the small minority of doctors who are negligent and who do not act in accordance with a responsible body of medical opinion or who provide treatment which has no rational basis.  Lord Saatchi proposes that those negligent doctors should have an immunity from being sued by patients harmed by their treatment. In short, the bill's recipe for promoting responsible medical innovation is to protect negligent doctors from being sued.

Under Clause 1(2) of the bill a doctor providing treatment would no longer be negligent even if his treatment had no support from any responsible body of medical opinion, indeed even if no other doctor at all supported the treatment. The patients of those doctors will not be entitled to compensation however seriously they are harmed.

I want to be guinea pig 

The bill is heralded on the BBC news website and elsewhere as allowing doctors to give unlicensed drugs to dying patients. Elsewhere it has been said that the bill will allow doctors and patients to experiment with untested treatments. This claim involves several misconceptions.

First, doctors are already permitted to use unlicensed drugs on patients. The GMC guidance on doing so says it is common practice.

Second, the bill is not targeted at patients for whom "standard" treatments have failed, or who have a terminal illness. It applies to all treatment which departs from the existing range of accepted treatments. 

Third, the bill itself does not permit treatment which is purely for experimental purposes - the treatment must be in (what the doctor believes is) the best interests of the patient. If a treatment is "untested" how will the doctor know that it is in a patient's best interests. In other words, the bill does not allow anyone to become a guinea pig, the doctor cannot experiment but must act in the best interests of the patient, not in the interests of research. The doctor will have to rely on tests of the drug to obtain fully informed consent and to determine whether it is in the patient's best interests to give it. This is, in effect, the current position.

Fourthly, at present the only people who could sue a negligent doctor for providing experimental treatment would be the patient, or, if they died, their loved ones. If a doctor says to you that they cannot give a treatment for fear of being sued, they mean being sued by you! A patient who gives fully informed consent to an experimental treatment and who makes it clear they will not sue if something goes "wrong" will have a difficult time in court if they later bring a claim. Of course if the doctor misled them about the risks and benefits, or made a negligent error when administering the treatment, then that would be a different matter. The bill is not intended to affect those cases.

Fifthly, Lord Saatchi says his bill is intended to promote responsible not irresponsible medical innovation. Responsible medical innovation ought to be founded on a relationship of trust between doctor and patient. Why would any patient want to allow their doctor to provide them with treatment which had no rational basis or which no other doctor would support? 

Sixthly, the bill will not provide funds for treatment. Unless the NHS provides the drug or other treatment, a patient will have to pay for it. The bill will not unlock NHS funds for widespread experimentation. 

Finally, experimentation is useful only if it is carried out in a controlled manner where evidence is shared and lessons learned. In contrast this bill will allow individual doctors to carry out experimental treatment outside controlled trials and with no obligation to share information.

New Requirements

In seeking to protect negligent doctors from being sued, the consolidated bill will impose various requirements which are likely to affect all doctors. In response to concerns that the bill would expose vulnerable patients to harm from maverick doctors, the amendments now proposed set out a labyrinth of new procedural requirements. 

The consolidated bill requires that a doctor providing treatment outwith the existing range of accepted treatments must obtain the views of an appropriately qualified doctor and take full account of their views in a way in which any responsible doctor would be expected to take into account such views; that they consider 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 treatments for the condition, and not carrying out any of those treatments, and any other matter that is necessary to consider in order to reach a clinical judgment; and that they take such other steps as are necessary to secure that the decision is made in a way which is accountable and transparent. 

So unclear are these requirements that they are highly likely to lead to more litigation and more red tape. 

No comments:

Post a Comment