Published in the Solicitors Journal 6th January 2015
There has been much heat generated by the debate over the Medical Innovation Bill. Only recently, some described it as a ‘PR war’.
It is – or ought to be – no such thing, and I appeal for calm consideration on all sides.
For two years, Lord Saatchi, parliamentary counsel Daniel Greenberg and I have been talking to doctors, lawyers and patients about how best to encourage medical innovation in order to facilitate better, faster and safe discovery of more effective treatments for currently incurable diseases.
Indeed, we have held meetings with leading medical negligence lawyers and have adapted the Bill accordingly, and it has changed in light of the feedback and challenges given.
This feedback has been gratefully received, by the concerned parties mentioned, as well as former senior judges, politicians and former opponents.
Few would agree that the medical status quo is working well for patients with rare diseases for whom randomised clinical trials (RCTs) are not an option – often because there are few trials open to them, because the cohort numbers are insufficent to populate them.
But let me be clear. This is not in anyway a derogation of the importance of RCTs. Evidence-based medicine is the gold standard. And it is why we are still committed to logging on a central, open database all innovations under the Bill – so that incidental evidence can be built up and taken forward to full RCTs.
It is, however, a statement of what to many is obvious; RCTs are not the answer for every disease type and every patient. One size does not fit all.
An example – and there are many – how many trials are open in the UK to patients with aneuroendocrine tumour? The answer is one.
Putting aside the fact that the trial is not about researching a potential cure, but comparing two current treatments, neither of which will save lives, there is an exclusion list that rules out many patients.
I am one of them. Two years ago I was diagnosed with a nueroedocrine tumour. I had surgery. If it comes back, I will be excluded from this trial because I am an insulin-dependent diabetic.
In short, there is no trial available. This is the case for so many currently incurable diseases.
Under the Bill, a doctor can be given the necessary confidence, in appropriate cases, to investigate and, if appropriate, offer, an innovative treatment to such a patient outside an RCT.
However, the Medical Innovation Bill is only one of a raft of initiatives that either are – or should – be in play. No one – including Lord Saatchi – claims this Bill is the silver bullet.
As an aside, Lord Saatchi did once pose the question: ‘How can an Act of Parliament cure cancer?’ He answered his own rhetorical question thus: It can’t – but it will enable the men and women who will. It is a question that has unintentionally riled those who have allowed themselves to get angry about the Bill. I say again, this Bill is no cure-all, but is an important step forward.
What does the Bill do? In short it brings forward the Bolam test to a pre-treatment setting. Doctors wishing to avail themselves of protection under the Bill must build a responsible body of medical opinion prior to treatment, rather than hoping they can construct one after the event, if they are sued for negligence or threatened with disciplinary proceedings.
This is designed to give doctors and patients certainty and clarity at the point of treatment, and therefore the necessary confidence to proceed and innovate.
First, this does not mean a doctor must follow this procedure. Some doctors, especially high ranking ones in centres of excellence, may be confident to innovate now.
Others tell us they are not. This Bill is for them. Doctors will have a choice – to rely on Bolam or the Bill.
To defeat a claim of clinical negligence under Bolam, a healthcare professional is required to adduce evidence from respected peers within their speciality who agree with the standard of practice which is the subject of the action..
Under Bolam, a defendant doctor will not be deemed to have been at fault, providing his or her course of action is one that is professionally backed by appropriately experienced colleagues, even if certain other members of the medical profession may take an opposing view. The Bill requires the same, but in advance and with greater clarity.
There has been much made of the requirement in the Bill to ‘obtain the views of’ other doctors, rather than requiring their ‘agreement’ to proceed.
We considered introducing a requirement for agreement, and were persuaded against it by senior doctors. They were worried that being asked formally to approve a colleague’s proposed course of treatment would act as a deterrent, and doctors would feel reluctant to do so without having a complete history. However, they would be happy to feed in their own views, as they already do in many contexts.
As with the Bolam test now, a responsible body of medical opinion supports the treatment – unanimity is not required – so that no one consultee has a veto on a patient’s treatment,
Instead of consultation taking place after the event if the doctor is sued, under the Bill it will take place prior to treatment: views have to be obtained, and there is an express requirement to give effect to them in a reasonable way. The profession, and ultimately the courts, will give guidance on what that means in practice.
Doctors simply ignoring the views of experienced colleagues who were clearly opposed to the treatment could not expect protection under the Bill. And the same goes for doctors who simply surround themselves with ‘yes men’ to approve their proposed treatments.
But the Bill is more than a prosaic piece of putative legislation. The Bill also works on another level.
It will allow more doctors to consider innovating as a matter of course, rather than defaulting to procedures that are known not to work. In this respect, the Bill acts as an agent of culture change. It has also stirred welcome debate on how we can drive innovation in healthcare.
Some opponents say the Bill targets the wrong issue. To them I say two things: first, it is an answer to some of these issues. There is a culture of defensive medicine growing in the UK, fuelled in part by the explosion of medical negligence suits against the NHS. This Bill will help to moderate that, safely and sensibly.
Second, it is now for people of goodwill to use the space created in the media by this debate to offer solutions to the problems faced by patients, for whom evidence-based medicine is chimera, and who will die waiting in the queue for the never-to-happen clinical trial.
Dominic Nutt works with Lord Saatchi and Daniel Greenberg on the Medical Innovation Bill