Tag Archives: Health

The Medical Innovation Bill will support evidence-based medicine

Prof Walker - Medical Innovation Bill
Prof Walker – Medical Innovation Bill

One of the key tenets of the Medical Innovation Bill is that it will oblige doctors to record and share the results of incidental medical innovations in the Medical Innovation Register.

This applies to both positive and negative results.

→READ: About the Medical Innovation Bill Register

As such, the Bill will begin to build data around innovations in a way never before seen in this country.

We know that medical innovation already happens – though this bill will encourage more innovation by setting a clear process for doctors to follow that will ensure patient safety and offer the doctor legal clarity.

But currently, there is no register for innovation, no database, no record of success or failure.

Medical Innovation Bill - Oxford University
We are working with Oxford University to produce an open access database of treatments and outcomes under the Bill.

So no one can replicate those successes and avoid the failures.

Recording such data would also allow doctors and researchers to follow up on promising new therapies.

Dr David Walker, professor of paediatric oncology at the University of Nottingham says:

“If evidence started to amass under the Medical Innovation Bill, that a treatment works then it would support the establishment of new trials.

“Historically medicine has a large number of situations where new treatments have been developed by repurposing drugs for a new indication.

“Currently this step is hard to make as people say that although the drug exists, is licensed, it cannot be used off license if there is no evidence as it would be  wasting money that could be spent on licensed drugs for licensed indications.

“This is particularly damaging for people with rare conditions where research is rare – this applies to cancers in particular.

“In childhood 60% of all drugs are off licenses many of our strongest treatments are a product of off license development or repurposing of drugs.”

The Medical Innovation Bill would could speed this process of re-purposing drugs up thereby enabling treatments to get to patients quicker.

Prof Walker added that this would create a system where the recording of pre-trial results of therapeutic innovation would become “a recognised and appreciated step in the drug selection process, particularly in rare conditions.”

“It could help to reduce the risks of failed trials”

→READ: About the Medical Innovation Bill Register

Dr David Walker is a Professor Paediatric Oncology
Children’s Brain Tumour Research Centre
Faculty of Medicine and Health Sciences
University of Nottingham

Medical Innovation Bill – adjournment debate

George Freeman during Bill Adjournment debate
George Freeman, MInister for Life Sciences, speaking during the adjournment debate

Yesterday December 10, 2014 Sarah Wollaston MP was granted leave to hold an adjournment debate on the Medical Innovation Bill.

The Bill team were also invited to meet Dr Wollaston earlier in the week to discuss the Bill. We thank her for that meeting and for requesting the debate.

During the debate Dr Wollaston raised several important points about the Bill, which could formally come to the Commons in early January.

The points revolve around patient safety and scientific rigour – issues which have been raised by senior doctors and lawyers in the House of Lords and which have been discussed with peers in committee and in bilateral meetings with Lord Saatchi, health ministers Earl Howe, George Freeman and Department of Health lawyers and officials.

On the back of these meetings, amendments have been laid which address the issues raised, and they will be further debated on Friday (December 12) in the Lords.

Edit: This debate has now taken place. Read here.

Chief Medical Officer Dame Sally Davies and NHS chief Sir Bruce Keogh, who has inputted into the Bill himself, remain satisfied that the Bill is robust, safe and will enhance, not hinder scientific research.

Summing up in favour of the Bill, Minister George Freeman said:

‘I want to close with some supportive quotes the Bill has received from a number of important people, lest the House should form the view that it is unanimously opposed, which is not the case.


Dame Sally Davies, the chief medical officer, has said:

“I am confident that, with the amendments made in Committee stage, the Bill is safe for patients and has the potential to encourage responsible innovation.”


Sir Bruce Keogh, Medical Director of the NHS, said:

“Encouraging innovation in medicine and protecting patients are both of vital importance. That is why I am pleased that amendments have been devised to address concerns about patient safety.”


Sir Michael Rawlins, president of the Royal Society of Medicine, said that the Bill will allow responsible innovation and treatment:

“I believe the use of the provisions in the draft Medical Innovation Bill will benefit patients, especially those with rarer diseases, and the furtherance of medical science.”


A letter to The Telegraph from 40 leading medical professionals, including David Walker, professor of paediatric oncology at Nottingham university and Riccardo Audisio, the president of the Association of Cancer Surgery, said the Bill

“legally protects doctors who try out innovative new techniques or drugs on patients when all else has failed. This Bill will protect the patient and nurture the innovator. It will encourage safe medical advancement, while at the same time deterring the maverick, thereby recalibrating the culture of defensive medicine. Finally, it will work with evidence-based medicine and provide new data that will inspire and support new research.”

I hope very much that that is the case and that when the Bill leaves the House of Lords, the vast majority of qualified senior opinion in this field is able to agree with it. It is absolutely our intention to support the Bill’s noble intent to promote medical innovation, but equally our intention is to not undermine in any way the Government’s commitment to patient safety or the duty of care that all clinicians share and owe to their patients.’

→Read: The full text in Hansard 



Telegraph: The fear of being sued is ruining modern medicine by Dr Max Pemberton

Dr Max Pemberton writes about why he supports Maurice Saatchi’s Medical Innovation Bill in the Telegraph.


By doctor and Telegraph journalist Max Pemberton

Published 9th December 2012

Read in the Telegraph.

Doctors are too scared to deviate from evidence-based medicine and innovation is being stifled.

In recent years there has been a seismic shift in the way that doctors practise. The mantra that young, fledgling doctors repeat to themselves endlessly is “evidence-based practice”. On the face of it, this seems sensible. Of course doctors should only prescribe or recommend treatments for which there is a clear, empirical evidence base. Modern medicine is founded on the principles of scientific inquiry; a hypothesis is put forward, tested and proved or disproved. But, as any doctor will tell you, in real life things are a lot messier than that, and nowhere more so than in cancer management.

Here, evidence is not always as clear and decisive as we would wish it to be. When I worked on a paediatric cancer ward a few years ago, I remember being struck by how little evidence was available to support many of the treatments that were at the clinicians’ disposal. While evidence-based practice is noble in theory, in reality, it’s simply not always realistic, given the complex nature of cancer when its multiple variables, contributing factors and idiosyncrasies are taken into account. This is what makes medicine as much an art as a science.

But worryingly, while doctors know that evidence-based medicine is not always the best choice for treating their patients, they have, in recent years, become increasingly scared of deviating from the standard treatments available to them, even if these don’t appear to be working. One man is trying to change this. Maurice Saatchi, the advertising guru who sits in the House of Lords, last week launched his Medical Innovation Bill, with the specific aim of changing the current culture within medicine that makes doctors fearful of the new and untested. I give it my wholehearted support because I despair at the way medicine is heading.

It’s a tragic indictment of modern medicine that too often innovation is jettisoned in favour of the status quo – not because it’s in the patient’s best interest, but because of the fear of being sued. This defensive medicine is at the heart of so much clinical practice now. Several factors have coalesced to create an environment whereby evidence-based medicine is something to hide behind, rather than simply a gold standard to inform decision-making.

The seeds of this defensiveness were sown in the medical profession’s consciousness following the fall-out from the Harold Shipman case. One of the unintended consequences of the regulation that came in as a result was that, suddenly, doctors and what they did for their patients was under incredible scrutiny. It was no longer assumed that the doctor would, de facto, have the patient’s best interests at heart. The authorities became increasingly suspicious of doctors and what they got up to behind the closed doors of their surgeries. A culture of fear crept into the medical profession. This was against the backdrop of the insidious creep of the compensation culture and the rise of the no-win no-fee lawyer.

Also, as hospitals have become run increasingly like businesses, so a new ruling class has emerged from within health care – the managers. They tend to be wary of any innovation or deviation from protocol that might expose the hospital to litigation risk. With often little or no experience of health care at the coalface, they struggle to grasp the speed, daring and courage needed for medical innovation. So they hide behind protocols and policies and mete out punitive consequences for any clinician who deviates from them. Protocols have solidified into monolithic rules – not to help patients but so they could be waved across a courtroom to defend the hospital against complaints.

The current climate has resulted in a loss of professional autonomy and transmogrified doctors into tick-box automatons, no longer guided by guidelines but strangled and suffocated by them. Mavericks used to flourish in medicine, but they have now been stamped out – branded unacceptable variables of unpredictable risk.

All of this has coalesced to mean that the fear of being sued has ruined modern medicine. It’s not good for the doctors, who are constantly questioning what they do and don’t do – not on behalf of the patient, but because they fear having to justify what they are doing in front of cross-examination. And it’s not good for patients, who are denied the chance of cutting edge, untested and unlicensed treatments when they have little or nothing to lose. Things that might be in the patients’ best interests are not pursued, meaning that nothing moves forward for them, or indeed future generations.

It’s this that the Saatchi Bill is designed to address. Its origins lie in Lord Saatchi’s devastation as he watched his wife, the novelist Josephine Hart, die of ovarian cancer last year. He has managed to turn his grief and sense of loss into something that has the potential to bring untold benefit to future sufferers.

The drafting of the Bill, Lord Saatchi explains, is designed to safely advance the freedom of doctors to innovate and strive for advancement, rather than simply accept the status quo because it means that no one can sue them. This doesn’t mean that doctors will have free rein to experiment on a patient. They are still bound by professional guidance and their duty of care still remains to their patient. But what it does mean is that, in cases where the evidence is shaky or wanting, or is not yet clear, the Bill sets out a code by which doctors can try alternatives. In this way, it actually offers the patient more security than they have at present because it provides, for the first time, a robust legal framework to encourage responsible innovation in diagnosis and treatment.

One in three of us will get cancer. If the survival rates are going to improve, doctors must be free to innovate, and this is what Lord Saatchi’s Bill does. I hope our politicians can see this, too.

→READ in the Telegraph: Dr Max Pemberton writes about why he supports Maurice Saatchi’s Medical Innovation Bill in the Telegraph.

Supporting innovation – exposing the maverick

The Saatchi Bill will make it much easier for doctors to innovate safely in the interests of their patients.

At the same time, it will expose the doctor who wishes to exploit their patient, preying on them and their vulnerability in order to attempt a reckless experiment.

Doctors will not be protected by the Saatchi Bill unless they go through a rigorous and specific process to ensure that the attempted innovation is the right course of action for the patient.

As the draft Bill states in paragraph 2 (3a) a doctor wishing to try a new treatment – for example in the case where standard treatments aren’t working – must consult a body of senior and relevant medical experts and get their consent.

The doctor must also record their opinion, including and dissenting voices.

The decision of the panel of experts must then be presented to the patient – including any contrary opinions if there are any – and the patient must of course also agree to go through with the innovative treatment.

Finally, the note of the opinions must then be attached to the patient’s consent form as a permanent record.

Only then will the doctor be legally covered by the Bill.

The Bill imposes a much higher standard of consent than other health legislation.

For example in order to section a patient, the Mental Health Act requires the signatures of only two doctors.

Currently, it is easier now for a doctor to indulge in reckless experimentation and maverick medicine, than it will be if the Bill becomes law.

As it now stands – without the Saatchi Bill – a doctor can attempt to persuade a vulnerable patient to embark on a dangerous treatment path.

This is so because the doctor technically doesn’t need to refer to a panel of experts before trying the non-standard procedure. He or she can act alone.

So, the Medical Innovation Bill supports and encourages reasoned innovation – and exposes the maverick.

Lord Woolf: Former Master of the Roles and Lord Chief Justice:

[The Bill] could give confidence to medical practitioners engaged in the field of treatment of cancer that in appropriate circumstances they could safely recommend and implement a course of treatment, or non-treatment , which some, or indeed the majority of their professional colleagues, might regard as unorthodox.

I have come to this conclusion because it is, in my view, undoubtedly the case that there is insufficient certainty as to the course which courts will adopt in this country at the present time when faced with an allegation that a medical practitioner’s treatment of a patient was inappropriate because of its innovative nature.

[There is] a risk that the present state of the law could inhibit the proper development of treatment of particular cancers.

Any way of avoiding this by legislation, in my opinion, should be welcomed. I would therefore hope that in the Lords, at any rate, your Bill will be well received.

About Lord Woolf