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But won’t the Bill deny patients who have been harmed the right to sue and get compensation?

No.

A doctor who harms a patient through bad practice or who makes a mistake can still be sued.

Bad doctoring is still bad doctoring and a mistake that courses damage, remains a mistake.

The difference will be in cases where an innovative treatment is agreed to and tried and where the consequences cannot be known in advance.

As long as the doctor concerned and the doctors with whom he or she consults and the patient recognise that and sign up to that, then the innovating doctor cannot be sued.

But the Bill does not protect the doctor from poor performance.

Why can’t doctors innovate at the moment?

They can, and of course many do. But many also tell us they fear it.

For cancers and other diseases with large patient groups trials exist.

But this isn’t the case for every disease.

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

Professor David Walker,  Professor of Paediatric Oncology Faculty of Medicine Health Sciences, University of Nottingham explains:

“There will never be enough trials, they take time and money, there are rarely trials for the less common diseases.

“So when patients are in a situation with “nowhere else to go” and if there is no trial for which they are eligible, they need to be able to try treatments that might work, based upon the best judgment of their medical advisors.

“We need to allow them to try such new drugs that may be applicable and collect that experience to inform the next generation of trials.”

→READ: There will never be enough trials

Innovating can be a high-risk enterprise, which many doctors seek to avoid.

There is a culture in the NHS that drives clinicians to stick to what are known as ‘standard procedures’. These are the prescribed norms of practice for any given illness.

Sticking to these gives the clinician protection in law in the event of a negligence claim – irrespective of whether the standard procedures are effective or not.

A doctor who, knowing his patient has little chance of survival, tries something new, even with the patient’s permission, may risk being taken to court or to a disciplinary tribunal, if the patient or their family later decides to sue or complain.

So, why try something new? Why innovate – when it is safer to stick to the well – worn path, even when that path leads to the death of the patient?


 

Prof Stephen Kennedy - Medical Innovation Bill
Prof Stephen Kennedy

Professor Stephen Kennedy, clinical director of women’s services at Oxford University NHS Trust, told the Independent on 13th October 2013 he supports Lord Saatchi’s Bill because he said doctors are more risk averse in a more litigious culture, where they face being disciplined by the General Medical Council if they do not conform to standard practice.

“Doctors are afraid of being struck off for not following standard practice and they are afraid of how innovation is seen by the general public,

“The problem is particularly acute for rare cancers. What do you do when confronted with a patient with a rare cancer where the evidence base is not strong or when there is no evidence?”

READ: the full article in the Independent


 

Professor Andy Hall
Professor Andy Hall

Professor Andy Hall, Associate Dean of Translational Research at Newcastle University and an expert on bone cancer, said:

“There have been major advances in some areas, but in others it has been agonisingly slow, and we are still left with treatments that are extremely blunt instruments.

“Take, for example, bone cancer. Treatment frequently involves amputation and extremely toxic chemotherapy. Lord Saatchi’s Bill draws attention to the need to innovate when the prognosis of an individual patient is poor.”

How will it work, practically speaking? What is the so-called ‘correct process’?

The process, as currently laid out in the bill, is as follows.

The doctor wishing to innovate will need to obtain the views of other medical doctors and seek consensus from them about the best course of action for the patient.

→READ: What is the legal meaning of consultation and consensus?

Should those doctors not support the planned innovation, the innovating physician will not be able to rely on the bill.

The option – and it will only be an option – must then be explained carefully to the patient.

This includes explaining the risks. In some cases this may mean explaining that the risks are unknown – especially when the treatment on offer is new.

The patient will always have the option to go through with standard procedures, or consent to the innovative treatment.

Patient consent is a requirement of the Bill.

The bill is still changing, as it proceeds through Parliament and therefore this process may be subject to amendment.

We will keep you updated.

What difference will it make for patients?

It will free your doctor to consider new treatments and ideas, safely and responsibly, with your consent.

So when standard treatments are exhausted, you and your doctor can then consider what other options may be available, if any.

 


“The Bill seeks to support doctors who endeavour to act in the best interest of their patients without the fear from litigation.

“It deters from irresponsible experimentation but encourages a much needed attitude change of innovation in the provision of care to cancer patients.”

Professor Ahmed Ashour Ahmed
Professor Ahmed Ashour Ahmed

Professor Ahmed Ashour Ahmed, Professor of Gynaecological Oncology,  Consultant Gynaecological Oncology Surgeon and Scientist, University of Oxford

 

 

 


 →WATCH: Debbie Binner, mother and campaigner who lost her 18 year old daughter to Ewings Sarcoma.

“Once Chloe only had 6 months left to live, how could any radical potential new treatment, actually I’d prefer innovative rather than radical, have been defined as too risky or too dangerous. These words risky, dangerous, are utterly meaningless in this context.

“What if doctors tried something different, something new, something promising. Chloe might well have died anyway, and I accept that, but surely what she would have left behind would have been more clinically valuable for other children, for other teenagers.”

Debbie is speaking at the House of Lords.

 

What will the effect of the Bill be?

Medical doctors, patients and judges will have much greater clarity as to what is negligent and dangerous practice by clinicians and what is careful and reasonable innovation.

This will have two effects.

1/ It will allow good doctors who have the best interests of their patients at heart to innovate safely and responsibly, with the consent of the patient as long as they follow the transparent and accountable procedure that the Bill requires.

Doctors relying on the Medical Innovation Bill will know in advance that as long as they have followed the clear procedures of the Bill they will be protected from negligence claims in regards to the innovative medical intervention they have undertaken.

2/ It will expose mavericks and quacks.

Doctors will be required to follow the accountable and transparent procedure laid out by the Bill – which includes consulting with a multi-disciplinary team of senior medical experts.  It will therefore clearly expose the doctor who acts alone and in a reckless way.

Courts will therefore be able to adjudicate on good and bad clinical behaviour. A doctor who follows the correct process will be protected, allowing and encouraging responsible and measured innovation to take place, with the patient’s consent.

A doctor who does not go through the correct procedure and acts alone, as a ‘maverick’ can be clearly and easily identified.


→READ: Dr Max Pemberton – Why I back the pioneer Lord Saatchi

 

Dr-Max-Pemberton---why-I-back-the-pioneer-Lord-Saatchi“It is a tragic indictment of modern medicine that innovation is too often jettisoned in favour of the status quo for fear of legal action. Defensive medicine is at the heart of so much clinical practice today, but the Bill – if accepted into law – would deftly excise this, leading the way for doctors to feel free to strive for medical advancement.

“This doesn’t mean that doctors would have free rein to experiment on a patient – they would still be bound by professional guidance and their duty of care would remain to their patient. Nor would it mean that the Bill would become a substitute for proper clinical trials.

“But what it does mean is that, in cases where the evidence is shaky, wanting or not yet clear, the Bill would set out a code by which doctors could try alternatives. It would provide a legal framework by which doctors, in discussion with their patients, could try off-label drugs or a device, treatment or intervention that might have some clinical data supporting it, but has yet to be fully proven.”


Professor Dean Fennell, Chair of Thoracic Medical Oncology, University of Leicester speaks at the House of Lords about why he feels the Medical Innovation Bill could help advance treatments.

Professor Fennell specialises in mesothelioma, a rare cancer most commonly caused by exposure to asbestos.

What is the Medical Innovation Bill ?

The Medical Innovation Bill is designed to help medical doctors innovate new treatments and cures safely and responsibly for cancer and other diseases.


Lord Woolf
Lord Woolf

“At the moment, the doctor’s hands are tied – by concerns about professional reputation and potential negligence claims,” says Lord Woolf.

“That needs to change.”

Lord Woolf, Former Lord Chief Justice, former Master of the Rolls.

He was the first Lord Chief Justice to be President of the Courts of England and Wales.


Sir Michael Rawlins
Sir Michael Rawlins

“The Saatchi Bill will allow responsible innovation.” says Sir Michael Rawlins.

“From trying out things in individual patients, that can lead onto research and benefit thousands of other patients.”

Sir Michael Rawlins is Chair of Medicines and Healthcare Products Regulatory Agency, former chairman for National Institute for Health and Clinical Excellence (NICE) and President of the Royal Society of Medicine