Stop the Saatchi Bill

Driven by an extraordinary two-year PR campaign on social media and a supportive newspaper partner, this all started as Lord Saatchi’s Medical Innovation Bill, metamorphosed through several versions, and was resurrected under a new name by Chris Heaton-Harris, before finally clearing its last hurdle in the Lords this week to become the Access to Medical Treatments (Innovation) Act. Pretty much the only thing they share is the word 'Innovation' in the title.

One day, it may be possible for politicians to ask the people who actually work in the medical field: what are the problems you face, and how can we help you overcome them?

One day, politicians may actually listen to the answers they receive, and thus try to tackle genuine problems rather than imagined ones.

One day, politicians, medics, researchers, lawyers, patient groups, charities, and the public, may work together to overcome the barriers to the development and provision of new treatments.

But it is not this day.

Read more: Not this day

Perception and Reality

Re-blogged with permission from Perception and Reality by Nigel Poole QC

“In democratic politics, perception is reality” wrote Lord Saatchi in The Telegraph earlier this year. In his days in advertising and PR he learned all about the power of the word and of the image. We can all remember the line, “Labour Isn’t Working” and the images of slashed purple silk used to promote Silk Cut cigarettes, campaigns which won Saatchi and Saatchi many plaudits and awards.

He is now using those skills to promote a change in the law which he claims will help doctors find a “cure for cancer”. Virtually every article he has written about his Medical Innovation Bill details his own wife’s treatment for cancer and his painful bereavement. His grief is to be respected but his response to those who have the temerity to oppose the bill is not. Supporters of the bill do not have a monopoly of suffering. Just because an opponent chooses not to make public their own private suffering, it does not mean that they are “complacent” or uncaring.

Words do indeed matter. The problem for Lord Saatchi is that judges in court are not interested in how a bill was promoted in the media before it was passed or how it was perceived by the public or politicians — they are interested in the words of the statute itself.

Strangely, the Medical Innovation Bill does not even define “innovation” or “innovative treatment. I have asked the Saatchi Bill team and various champions of the bill to explain what they mean by “innovative treatment” but they either cannot or will not answer.

The stated purpose of the bill is to encourage responsible medical innovation but it seeks to do so by introducing a cultural change whereby patients are prevented from suing doctors who harm them by departing from the existing range of “accepted treatments“. This exemption could hardly have been drafted more widely. It applies to:

All patients — children and adults, those with capacity and those without.

All conditions — mental or physical, trivial or life-threatening, acute or chronic, curable or incurable.

All treatments — emergency or elective, surgical, medical, conservative or invasive.

All doctors — GPs and specialists, neurosurgeons and cosmetic surgeons, those in the NHS and those in private practice. Those who believe in evidence-based treatment. Those who have adopted alternative therapies.

And it applies to negligent treatment which no responsible doctor would have given, otherwise there would be no point in the Bill. I am not convinced the definition of negligent treatment is that which falls outside the existing range of “accepted treatments” — the Bolam test is whether treatment was in accordance with a reasonable body of (relevant) medical opinion, it is not a test of what exists as a “standard” or even “accepted” treatment. In any event the Bolitho test exists to allow the courts to scrutinise whether the treatment decision was logical and rational.

When is a treatment “accepted” and when is it a departure from accepted treatment? “Accepted” by whom, by how many and in what manner? Is a small variation from an established treatment, a departure? There is no central register of “accepted treatments”so how will a Judge determine whether any particular treatment was an “accepted” one or not? If Lord Saatchi and his team cannot answer these questions, what chance is there for a doctor contemplating a decision to treat? Or a patient bringing a claim in negligence?

And then there is the wording of the provision requiring a doctor who departs from accepted treatments to make the decision to do so “responsibly”. Under the bill the doctor has to “obtain the views” of another doctor who is expert and experienced in treating patients with the condition in question and to take those views into account in a way in which any responsible doctor would do. So, would any responsible doctor take into account whether the other doctor was a close colleague or business partner, had not seen the patient, had not seen the patient’s notes, had given a generic view rather than one specific to the particular patient, had not put his views in writing, had no experience and expertise in the particular proposed treatment, or was not a “senior” doctor”? The bill is silent on these important matters. If a cosmetic surgeon in private practice asks his business partner what he thinks of the proposed treatment over a beer in the pub, and he takes those views properly into account, has he complied with the bill’s requirements? If not, why not?

Again the Saatchi Bill team appears confused itself as to these requirements. As I write, its website still includes a piece on the legal meaning of “consult” — a word which does not appear in the bill since Lord Saatchi’s amendments were accepted. Elsewhere even after those amendments, the bill’s supporters have claimed that the bill requires doctors to “build a consensus of support” for the proposed treatment amongst other doctors or that a panel of senior doctors has to approve the treatment. Those are interesting readings of the words of the bill but not readings a Judge would be likely to accept!

My colleagues wonder why I am opposing this bill since it is likely to lead to more not less litigation. Many cases of alleged medical negligence will potentially involve examination of the Saatchi defence as well as the Bolam/Bolitho test (if the Saatchi defence fails, then the court will have to go on to consider the Bolam/Bolitho test of negligence). The wording of the bill raises far more questions than answers. Doctors will be less clear as to the law. Patients will be well-advised to ask every doctor who is giving them treatment whether they are proposing “accepted treatment” or not. If not, what steps has the doctor taken to obtain the views of other doctors? Cases are likely to take longer to resolve. Patients whose lives have been ruined by negligent medical treatment, or those who have lost loved ones, will not lightly accept that a doctor reasonably took into account the views of another if the end result was the provision of treatment which no responsible body of doctors would consider acceptable. The issue of consent to treatment will become even more complex, since it will involve providing more information to the patient about the process leading to the decision to treat.

Lord Saatchi has certainly stirred up debate. Not all of it has been edifying but what has emerged, I believe, is a consensus that the focus of attention should not be on the law of negligence but in improving the governance of clinical trials and of the regulatory process. If Lord Saatchi were to propose a commission to look into ways in which to promote responsible medical innovation, then his name could become associated with real and lasting progress.

Updated: 17 November 2014