Observations Medical Legislation

The “Saatchi bill” will allow responsible innovation in treatment

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g2771 (Published 15 April 2014) Cite this as: BMJ 2014;348:g2771

Re: The “Saatchi bill” will allow responsible innovation in treatment

One hesitates to disagree with Sir Michael Rawlins, but I am unaware of the evidence that law has ever been a driver of medical innovation in the past or in other jurisdictions. Doctors and surgeons have a long history of innovation, and it seems dangerous (if not reckless) to interfere with something that ‘works’. The logic of his article appears to be (a) there is no legal impediment to innovation now but (b) there is ‘anecdotal’ evidence of fear of law/lawyers, (c) therefore we need MORE law (as opposed to simple reassurance, clear information, and financial stimulation of innovative projects).

It is both an insult, and dangerous, for one rich persuasive individual with deep pockets, access and influence to tell the medical profession that it has not been innovative (enough) and that we need a Bill to help us do what we already do safely and legally. This is not a simple cultural debate - it is a category error for a grieving widower to suggest new law consequent to the sad fact that neither he, nor any medical practitioner, could stop his wife dying. Since when has law driven creativity, nuance, and shades of grey? Do law and regulation really drive up quality, or might they drive down to the lowest common denominator? In my world, we have examples of innovations that cause harms (1,2), but also of regulators not being able to police the safety of the industry thanks to challenges by lawyers working for very rich clinicians (3). Hype about ‘innovation’ is all, drives and is driven by commercial pressures and desperate clients, and it seems bizarre to accelerate this.

As medicine already has lots of laws, good practice, governance and the normal academic and clinical safeguards, there is no need to add more polish to the Bill of the sorts of ‘good’ things that happen anyway. Peer pressure is a powerful motivator of doctors – it’s more flexible and light touch to leave the ethical judgement about ‘good/ reckless’ to doctors in the ‘here and now’ than to try to capture this in law, that largely operates after the event.

What happened to "First of all, do no harm"? This Bill is not needed, it is not the right prescription for the wrongly thought through diagnosis. Bad doctors come up with treatments and then justify them. That is what Lord Saatchi is doing. The solution was found and now comes the justification. Starting a PR campaign and then finding lots of people agreeing might feel familiar and comfortable to him, but it really should carry no weight with us. It’s misleading to think ‘votes’ or even the ‘opinions’ of the great and good change scientific or medical facts. He really oughtn't be influenced by the agreement he and his Bill Team set out to find. Good scientists, innovators and lawyers pay a lot more attention to areas of weakness and disagreement.

The Bill just doesn’t make sense. Could Lord Saatchi desist now he has stirred up a great public discussion, and confirmed that there already is no legal impediment to innovation? If he set up a Medical Innovations Foundation that gave out financial largesse with all the ‘safeguards’ his Bill Team are trying to devise (like capturing and sharing results), this would be a great legacy and an upfront positive way of raising the bar of innovation and standards. In our normal professional and academic practice we look for unconscious biases, and make declarations of interest. We “follow the money” and ask “who benefits?”. The only people who can assuredly benefit from devising new law are barristers specialising in legislation or members of the ‘Bill Team’ driving this project.

References

1. Bewley S, Foo L, Braude P. Adverse outcomes of IVF. Br Med J 2011;342-3:d436
2. Vasireddy A, Bewley S. IVF is safe over 50 if it is not fatal. Am J Perinatol 2013;30:881-2
3. HFEA withdraws imposed 10% multiple birth rate target. http://www.embryonews.co.uk/blog/hfea_withdraws_imposed_10_multiple_birt... (last accessed 23rd April 2014)

Competing interests: Trustee, HealthWatch-UK "for treatments that work"

27 April 2014
Susan Bewley
Professor of complex obstetrics
Kings College London
Women's Academic Health Centre, 10th floor St Thomas' Hospital, Westminster Bridge Rd, London SE1 7NH
Click to like:
230