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Is the proposed new law on medical innovation necessary?

The British medical Journal once asked, satirically, what doctors could do if faced with a problem for which there were no controlled trials and no good evidence.

They suggested alternatives to evidence based medicine and ironically referred to it as “eminence based medicine”. Reference was made to “the more senior the colleague the less importance he or she places on the need for anything as mundane as evidence”.
Eloquence based medicine was defined as where “the 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”.
Vehement based medicine was defined as “the substitution of volume for evidence is an effective technique for browbeating more timorous colleagues in convincing relatives….”.
The much criticised medical innovation bill has reared its head again recently. Lord Saatchi appears determined to keep trying to push it through parliament despite vehement opposition that it that it has aroused.

The current law.
Under the current law legal tests set down by substantive case law heard in our higher Courts determines whether medical treatment is legally negligent. A doctor is not deemed negligent if his/her treatment would be supported by a reasonable body of medical opinion so long as that opinion can withstand logical analysis.
In other words there may be a range of ways of treating a particular condition which may all be supported by different reasonable bodies of medical opinion. A doctor will only be deemed negligent if his or her chosen treatment would not be supported by any reasonable body of medical opinion.
Claimant lawyers are aware that this test is not often a difficult hurdle for medical practitioners to overcome in order to defend themselves.

What is the intended purpose of the medical innovation bill?
This aims to change the law in certain circumstances to make it easier for doctors to have a defence to a claim if the treatment that they carry out harms a patient. Its purpose is stated to be “to encourage responsible innovation in medical treatment”.
If it becomes law 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” even if the treatment followed would not pass the existing legal test described above.
There is no definition of “existing range of accepted medical treatments” in the bill. This is unhelpful given that the exemption from the current legal test appears to only apply to departures from that range of treatments.
For a practitioner to show that his or her decision is “responsible” the proposed new law has a number of requirements but stripped of the statutory language it would seem that the doctor does not actually have to do a great deal other than convince himself/herself of the merits of his or her own actions.
In relation to the opinion of other doctors he/she has to speak to just one colleague about the treatment and take “full account” of that colleagues views. There is no requirement to speak to more than one doctor.
The patients consent must be obtained. It is difficult to see how properly informed consent can be obtained about an experimental treatment where there is unlikely to be much if any information about the risks and benefits.

Is the new law desirable or necessary?
The changes proposed to the law are not needed. It has been argued by many authoritative lawyers and medical practitioners that the new changes are potentially dangerous to patients.
The requirements set out for a decision to be deemed responsible do not provide sufficient protection.
There is nothing in the new law requiring a doctor to use any or all of any existing accepted medical treatments before using any experimental treatment. It is difficult to see why not.
The existing legal test would protect a medical practitioner if they are able to find support from a reasonable body of medical opinion for trying the new treatment. The existing legal requirements and test would be likely to be met in such circumstances and the additional exemption provided by this new proposed law is not necessary.
The only treatment that is not likely to be protected under the present law is one which would ignore existing effective treatments and which has no sensible, logical or rational basis. Why anyone would want to extend the provisions of existing law to enable such a treatment to proceed is highly questionable.
Any law which allows 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.
It is arguable therefore that a senior doctor wishing to experiment with a patients treatment will not need to concern himself with the need for evidence of the treatments effectiveness but may rely on his own seniority and ideas of what he thinks best for the patient; eminence based medicine in practice.
It is unfortunate that this once satirical view may become a reality. It is therefore to be hoped that this bill can be once more stopped in its tracks before it reaches the statute book.

Posted in: Personal Injury

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