Planet Insurance: Avoid off-label innovation

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Plans to encourage medical innovation are little more than experimental, writes Richard Walsh.

The Department of Health (DoH) 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, then proceed to legislate. So where are we now, and where might we be heading?

For doctors, the situation is covered by case law known as the ‘Bolam’ test. To avoid a successful claim for negligence, a doctor must 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 the test that a doctor’s own insurers would apply. From a PMI perspective, many insurers exclude experimental medical treatment. The FOS has consistently ruled that when experimental treatment goes ahead, they must still pay the amount they would have paid for conventional treatment. Such 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.

It says this lack of clarity 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 not sure the proposed treatment would satisfy the Bolam test, 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; .

Not surprisingly, there has been opposition, especially a letter to The Times from Nigel Poole QC signed by many eminent people. They argue 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 given.

They say the Bill does not protect patients adequately, in particular vulnerable ones whose conditions might lead them to look for untried treatments. For me, Simon Denegri, chair of the UK’s national advisory group on public involvement, makes the most telling public policy point: if the Bill is a serious attempt to boost medical innovation, would you 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 DoH consultation document says innovation helped by the new Bill could lead to major breakthroughs, such as a cure for cancer. Really? What it may do 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.

Richard Walsh is a fellow of SAMI Consulting, www.samiconsulting.co.uk

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