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The NHS Innovation Bill

July 30, 2014

The Department of Health has just completed a consultation on a Bill to encourage medical innovation. In practice, what it deals with is experimental treatment, and as such will be of interest to PMI insurers and brokers. The Government will respond to comments shortly and then proceed to legislate. So where are we now and where might we be heading?

From a doctor’s perspective the current situation is covered by case law known as the “Bolam” test. In order to avoid a successful claim for negligence a doctor has to be able to demonstrate support for a treatment decision from a responsible body of medical opinion, and that the opinion is capable of withstanding logical analysis by the courts. This is also the test which a doctor’s own insurers would apply in the event of a liability claim. From a PMI perspective, many insurers exclude experimental medical treatment. The FOS has consistently ruled that when experimental treatment does go ahead, they must still pay the amount they would have paid for conventional treatment. These cases are rare and it seems like a sensible compromise.  

The new Bill argues that the effect of current case law is to reduce innovation because the further away a doctor moves from common procedures, the more uncertainty there is about how to show that the decision is responsible and not negligent; and that it is this lack of clarity that deters doctors from offering innovative treatment. The Bill expands the circumstances when a doctor can use experimental treatment beyond the Bolam test such that if the doctor is unclear if, or does not think, the proposed treatment would satisfy the Bolam test then the treatment can still go ahead if the decision is taken “responsibly”. Responsibly is then defined as if, in the doctor’s opinion, there are plausible reasons why the proposed treatment might be effective based on the relative risks that are, or can reasonably be expected to be, associated with the proposed treatment and other treatments; the likely success rates, in the doctor’s reasonable judgement of the proposed treatment and other treatments; the likely consequences, in the doctor’s reasonable judgement, of carrying out, or failing to carry out, the proposed treatment and other treatments; and the opinions or requests expressed by the patient.

Well that’s simple then! Not surprisingly there has been a lot of opposition to the Bill, especially a letter to the Times from Nigel Poole QC signed by many eminent people. They argue that the Bill seeks to remove that right of redress where a doctor has taken a decision to treat even when no other doctor would support the treatment actually given. They argue that the Bill does not adequately protect patients, in particular vulnerable patients whose conditions might lead them to look for obscure or untried treatments.

For me, Simon Denegri, Chair of the UK’s national advisory group on public involvement, and Director for public participation and engagement in research, makes the most telling public policy point: if the Bill is a serious attempt to boost medical innovation then would you really start here? There are many things that stand in the way of innovation and the testing of new ideas in the UK, but the inability of doctors to do ‘off-label innovation’ has never appeared that high on any list. The DH consultation document says that innovation helped by the new Bill could lead to major breakthroughs, such as a cure for cancer. Really? What it may do though is increase the volume of experimental treatment, good and bad; raise false hopes for many patients; and result in more PMI cases for the FOS to adjudicate on.

Written by Richard Walsh – first published in Cover magazine, 30 May 2014. (click here for Cover article )

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