The Medical Innovation Bill

7 August 2014

The second draft of Lord Saatchi’s Medical Innovation Bill was introduced in the House of Lords on 5 June 2014.  It is still a Private Members Bill, and so the introduction was effectively a paper exercise, with no debate.

Lord Saatchi has published a briefing note in which he describes how his Bill “…is about ensuring that every patient knows that everything is being done that can reasonably be done to give him or her a chance of life.”

This is not an unreasonable proposition, but neither is it a new one – arguably it has been around since at least the 5th Century BC, when Hippocrates thought it might be a good idea for physicians to take an oath to observe the code of professional behaviour.  No doubt the founders of the NHS had something similar in mind, and I would hope that still pertains.

The second draft of the Bill is an improvement, in that it makes it clear that it does not seek to do away with the protections afforded by the existing common law of negligence.  Nevertheless, the reasoning behind the bill is just not sound enough, and if it becomes law, healthcare is likely to get worse, not better.

Medical innovation is, of course, a good thing.  Life is precious, and illness is cruel, and one of the highest human instincts is to try and find ways to alleviate suffering.  Lord Saatchi faced a tragic bereavement, and it is admirable that he is trying to help others.  However, with law, as with medicine, we should “first do no harm”, and I am afraid that this well intentioned Bill, will not pass that test.  On the contrary, vulnerable people are likely to suffer if it becomes law.

Lord Saatchi wants to enable patients “to demand that every possible route” should be available to prolong life and improve its quality.  He discusses a culture of conservatism, and a fear of litigation amongst doctors which, he claims, act as a barrier to innovation.

His solution to this conundrum is a type of light touch regulation whereby doctors wishing to innovate are encouraged to follow a semiformal means of obtaining approval for innovative treatment.  For example, the doctor “…may decide to hold minuted telephone conversations with one or more respected colleagues…” and the hospital “may have put in place a system for cascading proposals to other disciplines… in which case she (the doctor) will comply with that procedure”.  Note the use of the word “may”.  In law this usually means not mandatory, so the doctor will have a choice about whether or not to comply with this safeguard.

The doctor will not have to use any special form for recording this process, but the intention is that she will present the patient with a signed copy of the audit trail which will supposedly enable the patient to give properly informed consent.

To the lay observer this might seem like a sensible and reasonable approach which cuts out some of the stifling bureaucracy that the NHS is known for, but unfortunately it is just not that simple.  How can a sick and vulnerable person – possibly with a terminal illness – be in a position to make an informed choice about untested medical treatment?

In any event we already have well developed and effective systems that allow innovation, whilst at the same time protecting both doctors and patients. Medical innovation is happening all of the time, and on a huge scale.   Academic departments of medicine, scientific researchers, pharmaceutical companies, giant commercial organisations and small charities are working for changes which continually filter thorough to clinicians and patients.

Good innovation is based upon well-structured research which in turn is based upon carefully managed data.  Improvements in medical science are only worthwhile if they are conducted under the aegis of scientific and ethical guidelines which validate those innovations, and tell the public that they will be safe and beneficial.

This cannot be anything other than complicated and careful.  Although Lord Saatchi’s Bill is not limited to cases involving potentially fatal illnesses, it has to be remembered that every patient is vulnerable, and competent clinicians will already want to do all that they can to alleviate suffering.

Busy clinicians may be involved in research projects, but for the most part, clinical care and medical research are very different things.  Similarly, the expectation for patients must be that only fully validated and authorised medical treatment will be offered.

The presumption behind Lord Saatchi’s Bill is that patients are missing out, and that innovative and effective treatments are being denied, largely because doctors are worried about being sued.  In my opinion, and with respect to Lord Saatchi, this presumption is supported by little more than the type of journalism that attacks the so called “health and safety culture”.

Similarly, the Bill does not really acknowledge that innovation is also experimentation.  A few years ago a doctor suggested that there was a link between autism and the MMR vaccine.  He was an ambitious innovator, and no doubt well intentioned.  Nevertheless, his views were subsequently discredited, and his innovation became something of a medical scandal, because many parents refused to have their children vaccinated.

The clinical relationship between doctor and patient is at real risk of compromise if it also involves the development of medical science.  Whether motivated by the desire to reduce suffering, or to further a medical career, a treating doctor who seeks to innovate in the context of the clinical relationship runs the risk of creating a situation in which the wellbeing of the patient is not the only consideration.

Lord Saatchi tells us that the initial responses to the Bill include a small minority who are in opposition, which is comprised in part of medical negligence lawyers.  I am not entirely sure what is meant by this, but, for the avoidance of doubt, I would like to say that opposition from the legal profession is not based upon self-interest.  Lord Saatchi focuses upon the law of negligence, which I spend most of my time working with, and contrary to what he apparently believes, the law in this area is very clear and straightforward.  Moreover, it gives sensible protection to doctors, and to patients.

In my view, Lord Saatchi’s Bill will make things worse for both groups.  Vulnerable patients and their families, many of whom will be dealing with life threatening illnesses, will be put in a situation whereby they are asked to sign up for treatment that has not been properly tested and validated.  Conversely, doctors, perhaps those who are looking after terminally ill patients will be faced with families who threaten to sue them for breach of statutory duty if the doctor doesn’t try “every possible route” to prolong life that this Bill seeks to empower patients to demand.

Clinical negligence lawyers are very familiar with claims by bereaved families who are concerned that the clinicians looking after the deceased did not do everything that they should have.  Sometimes such claims are well founded, but one unforeseen consequence of this Bill might be to create statutory support for such claims. Therefore doctors may find themselves sued both in negligence and in breach of statutory duty.

Leaving aside the professional reputations that might be built or destroyed, and the millions that might be made or lost, medical innovation can have three outcomes. It can help the patient, it can make no difference whatsoever, and it can hurt the patient.  The last point should never be forgotten, and that it is why it has to be done carefully.

The same is true of innovation in the law, and whilst Lord Saatchi’s motivations cannot be criticised, I am afraid that his Bill is in fact most likely to make things worse.

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