The Medical Innovation Bill: why Saatchi was wrong

Lord Saatchi introduced the Medical Innovation Bill which recently failed to progress through the House of Commons. It has been stopped (fortunately) by a Liberal MP.

On the face of it the Bill seemed desirable. It arose in part out of the particularly tragic personal circumstances Lord Saatchi and his family faced.  We can have nothing but sympathy for those.  But sympathy is not the basis on which law should be made.

The Bill was not actually able to promote responsible innovation, which was the intention. Nobody believes that there was anything other than good intent on the part of those who drafted and pursued the Bill. However, the Bill’s affect would in fact have been to promote irresponsible experimentation. It was not supported by any leading medical organisation or representative and that was because it was badly drafted and actually unnecessary.

The Bill was designed to fill in a gap which did not exist. It provided that medics could use innovative treatments in cases where the patient consented. However the law already allows that. In appropriate circumstances, with the right consents – not just the patient’s but also a review by medical and managerial staff – innovative treatment takes place all the time. There are endless oncology patients on trials of innovative drugs, all lawfully proceeding on the basis of informed consent and proper review. These are not drugs that have been banned. They are trials available to people at the more profound stages of cancer which are being made available. There is plenty of innovation in the NHS and there is plenty of innovation in the private sector (although less well regulated).

The problem with the Bill was that it was designed to minimise the scrutiny of the treatments from other qualified medical staff. It was supposed to cut down on the red tape but, from my discussions with consultants working in the NHS, when innovative treatment is required, the red tape can be dealt with fairly quickly. When there is an urgent situation that needs resolution, the NHS can move quicker than people would anticipate. But it does not move quickly at the expense of patient safety. There are proper meetings, reviews and discussions about the merits of the treatment that is being proposed and the likely outcome.

Lord Saatchi apparently felt that these detailed reviews were not particularly necessary. A patient could simply agree with the doctor, so long as one other doctor had reviewed the matter, and proceed with the treatment. It is certainly true that Lord Saatchi envisaged that the patient would give full consent. However if somebody is, for example, in the advanced stages of cancer, that consent is simply that this may be the last chance. But even if the treatment extends life, it may not extend the quality of life and for some people in terminal care, that is as important as the length of the life that they have left.

Robert Francis QC, who reported on the Staffordshire Hospital, confirmed that he thought the Bill exposed vulnerable patients to unjustified risks. It also deprived them of remedies when mistreated. It changed the legal test in respect of innovative treatment. It redefined what would be deemed negligent so that patients who were given bad, unnecessary or unhelpful treatments would be unable to get compensation.

Innovative treatments are generally good for the NHS and for healthcare generally. Medicine is a fast-moving profession and innovation is a fundamental part of its development. This does not, however, mean that innovation should take place at all costs, in all circumstances, regardless of the potential consequences. In essence, the mechanism proposed by the Bill for the review of innovative treatment was so marginal as to be completely ineffective. There were no proper safeguards in the Bill and it represented a significant risk to patients.

It is possible that the Bill may come back in another form. Lord Saatchi is perfectly entitled to regroup, redraft and re-submit something. The newspapers are reporting that the Labour Shadow Health Secretary wonders why it was stopped. Anyone with common sense and an ability to understand the issues which have been very easily and quickly identified by medical practitioners would know. The Bill was flawed – fundamentally flawed. It is good that it has been stopped in its tracks.

All recent reports regarding the NHS have identified potential dangers and difficulties as a result of failures in funding or management or staffing or a combination of all three. The NHS does not need to relax its rules. It needs to provide more safeguards to patients and more care. We do not need and the medical profession does not want, a licence to experiment. It wants to be able to innovate and it can do that perfectly well under the current system.

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