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What is the Medical Innovation Bill ?

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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


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What will the effect of the Bill be?

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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.

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Can it be used by anyone who wants to try new treatments, like homeopaths, for example?

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No. The Bill can only be used by qualified and registered doctors. The term ‘doctor’ is a legal one and homeopaths (for example) would not be protected by the Bill, if it became law.

You have to be a legally-recognised doctor. If not, the Bill doesn’t cover you.

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What difference will it make for patients?

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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.

 

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

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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.

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Why can’t doctors innovate at the moment?

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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.”

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

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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.

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Why do we need the bill?

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There is a lot of talk about breakthroughs in curing cancer and other diseases.

It is true there have been big breakthroughs; diagnoses of childhood leukaemia or breast cancer, for example, are no longer the near-certain death sentences they used to be.

But in many cancers and other diseases, too little progress has been made in recent decades.

For many cancers and other diseases, there are no treatments available other than surgery – no drugs, no chemotherapy, nothing.

In an ideal world, innovation would always be driven by full clinical trials. But, again, in the case of rare diseases often there are few trials taking place.

This is because there is not enough research funding for minority diseases, because there are not enough patients to run trials in the first place, or because drugs companies do not find it worth the money to run trials for diseases where there are too few patients and thus no realistic chance of making a profit.

Thus, the evidence base is small, and unlikely in many cases to grow sufficiently to drive new treatments.

We need more progress and we cannot only rely on full-scale clinical trials to drive progress – it’s just not happening, at least not across the board.

We need doctors who are creative and innovative who are ready to try new ideas and make things happen.

We also need to drive a culture of innovation. This Bill will encourage doctors to think that innovation is indeed possible. It will allow them to think about innovating.

 


 

Lord O'DonnellLord Gus O’Donnell on evidence based medicine speaking at the House of Lords committee stage 24th October 2014 .

“I am not a medic. I rise to speak because I think that this issue creates all sorts of problems and challenges in which my experience in public policy and economics can help…I think that this is an issue about evidence-based policy.

“We know that markets will not solve the issues that the noble Lord, Lord Saatchi, raises in the Bill.

“The incentive structures are such that the pharma companies will go for those areas where they can sell large amounts of drugs. Rare cases will be problems.

“One issue I have as someone who cares enormously about evidence-based policy—I gave a lecture at the Royal Statistical Society earlier this week on this, when I went on at length, which I will not repeat—is how you generate the right amount of data to handle this problem.

“I received a briefing from the BMA which said that there was no evidence to support such things. Of course there was no evidence; that is the whole point. We have to find ways to generate evidence.

“I strongly support the Bill. In that, I am with Sir Michael Rawlins, president of the Royal Society of Medicine and former head of NICE, who knows about the analysis, so I take the medic side as given.”

→READ: the whole text

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Can you give me an example?

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An example of where the Bill might be relevant is the case of a drug licenced for a specific cancer with a particular biological signature. There may be another, rare cancer with the same biological signature on which the drug might be effective. But without a full trial, costing millions and taking years, the drug will never be licensed for this secondary use.

In this case, the Bill would cover the doctor who wished to try the drug in conjunction with the less common cancer.

Some childhood cancers offer examples of where the Bill might be of use. Trials for treatments for adults are fairly common. But fewer trials happen for young people and children and therefore fewer drugs are licensed for use on children.

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Are there other reasons why we need the Bill?

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Yes. Defensive medicine is increasingly putting a brake on medical advances.

Doctors are rightly held to account for mistakes. However one effect of defensive medicine is to increase the pressure on doctors to stick to the standard treatment, to avoid anything risky, even if the standard treatment leads to the death of the patient.


Dr Max Pemberton -The fear of being sued is ruining modern medicine
Dr Max Pemberton -The fear of being sued is ruining modern medicine

Dr  Max Pemberton –  The fear of being sued is ruining modern medicine.

“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.”

→READ: Dr Max Pemberton’s full article in the Telegraph

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I’ve heard medical negligence lawyers argue that the law already protects patients.

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They are right – but they have entirely missed the point of the Bill.

Currently, the situation is this: if a doctor tried something new and it didn’t work and the patient decided to sue, the doctor could invoke what is known as the Bolam test.

In short, this allows a doctor to bring a group of specialists into court to argue that the new treatment the doctor tried was acceptable.

However, this means that the doctor trying something new will be aware that if it goes wrong she or he could be sued and face a long investigation ending in a court case, with all the fear and stress that entails – even if s/he eventually wins.

The Bill brings this process forward. It requires that the doctor consult with qualified medical experts before undertaking the treatment.

If the doctor can’t, then the treatment is not covered by the Bill and should never be tried.

If the doctor consults with a panel of experts and obtains  a consensus of option from them and then in turn obtains the patient’s consent,  in accordance with the requirements of the Bill, then the doctor can carry on confidently without the threat of legal action.

A doctor who cannot demonstrate a consensus of opinion will not be able to rely on the protection of the Bill.

The clear requirement to consult is a legal definition and has a meaning within the legal sphere that differs from its common linguistic use. It is a definition derived from case law (see below example[i]).

→READ: What is the legal meaning of consultation?

Effectively, nothing changes, other than the Bolam test is brought forward to the clinical setting prior to treatment. It means the doctor can be safe and confident from the start.

In addition the Bill does not remove the Bolam test and if a doctor wishes to rely on that instead then they may.

Doctors aren’t lawyers. Our research has demonstrated that doctors are confused as to what they can and can’t do. So this Bill offers a clear, robust, transparent process for doctors to follow.

The Bill gives doctors clarity


 

Lord Woolf
Lord Woolf

“It is nonsense to suggest that the culture of litigation that now exists does not have a dampening effect on doctors.

“The doctors with whom I spoke when I conducted my inquiry made that clear, and doctors whom I have met in the course of my social life have equally made that clear.

“It is something that hangs over them. At the moment, the problem with the Bolam test is that it may provide them with protection when they get to court, but that is little comfort to doctors who have litigation going from stage to stage through the process to the courts, and whose lives are cast into the shadows by what is happening to them.

“It will be a great benefit that comes from this Bill, if that is removed by the open and transparent steps that it recommends.

Lord Woolf, Former Lord Chief Justice, former Master of the Rolls speaking at the second reading of the Medical Innovation Bill in the House of Lords, 27th June 2014.

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


 

[i] See, for example: R v Brent London Borough Council, ex parte Gunning (1985) 84 LGR 168 ; R v North and East Devon Health Authority, ex parte Coughlan [2001] QB 213, [108].” (R. (on the application of Compton) v Wiltshire Primary Care Trust [2009] EWHC 1824 (Admin) at para.104.); Agricultural, Horticultural and Forestry Industry Training Board v Aylesbury Mushrooms [1972] 1 W.L.R. 190 per Donaldson J.).


 

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If doctors were able to innovate in the past and the law hasn’t changed, what has and why do we now need the Bill?

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We have become more litigious. In the past four years the amount of money paid out by the NHS for medical negligence claims has doubled, reaching £1.2 billion in the last financial year.

And by the NHS’ own calculation on cases stacked against it pending court decisions, the NHS faces a bill of £24b – these are cases the NHS thinks it will lose in the coming years.

In these circumstances, doctors and hospital managers are less likely to step outside the standard procedures and try to find better ways to treat patients. The law doesn’t protect them.

This builds a deep culture of defensive medicine, such that innovation is not even considered as an option in many cases. Doctors become so used to standard procedures, they may not even think to push beyond failed standard procedures.

Of course, innovation happens. But the culture of innovation is dying. This law will encourage it and protect those who innovate sensibly.

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Why do you keep referring to ‘rare’ cancers or diseases?

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The Bill is for all doctors and all patients, irrespective of the condition or disease they present with. However, rarer conditions are a particular issue and one with which the Bill is most likely to help.

Standard procedures are based on what is called ‘Big Data’ and evidence-based medicine – that is, they are designed around what is known to work. At least that is the theory. And it is fine when it comes to common conditions, such as diabetes and broken legs, where there are many patients and where theories have been well-tested and proved.

But standard procedures based on rarer conditions, where the data and evidence is patchy is a problem. If there isn’t an evidence base for a disease, it makes innovation difficult – because there are not the numbers of patients available to develop new treatments.

And it means, also that less research is carried out because no one wants to spend a millions of pounds researching drugs into rare diseases for which the market is small. Also, it is harder to recruit scientists to investigate rare diseases, for which funding is hard to come by.

Big diseases tend to carry the day. This relegates the rarer conditions into a scientific and medical backwater with doctors left able only to repeat their failures.

This is why we need to free doctors to innovate, safely, with and for patients.


Harrisons Fund
Harrisons Fund

“In our case the risk of doing nothing is not nothing, the risk of doing nothing is fatal.

“Fatal every single time. You never survive this.

“What we are not willing to do is assume the risk of doing nothing.

“If a potential therapy shows promise of stabilisation or improvement over what would be expected without any treatment, and it shows safety, then patients and parents should be given a choice to try it with long-term studies taking place concurrently.

“Because, at the end of every discussion and assessment of a therapy, we must never lose sight of the reality that the risk of having Duchenne far outweighs the risk of most potential treatments.”

Alex Smith runs Harrisons Fund, a charity that funds research into Duchenne Muscular Dystrophy – a 100% fatal condition with no cure.

→WATCH: Alex speak at the House of Lords.

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Surely evidence-based medicine, derived from proper clinical trials is the only safe way to develop and test new treatments?

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Clinical trials remain the gold standard and the Medical Innovation Bill does not in anyway undermine the process nor the concept of the clinical trial – which does remain the best way to deliver new treatments.

Further, those involved with the Bill say clearly that patients with cancer and other diseases for which treatment options are limited should seek to get on a trial.

However, there are few trials for the many rarer cancers and other diseases – and 54% of all cancers are rare cancers.

There are often not enough patients with the right medical profile to run such trials. They are expensive and fundraising efforts and resources tend to support the bigger, more common cancers and diseases.


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 says:

‘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.

‘…The Saatchi Bill would do this, by protecting individual doctors who try new, licensed but untrialled treatments, on patients who have consented to such treatment outside of a formal trial. This cannot be – and isn’t – a license for the maverick doctor acting alone.’

READ: The full article from Professor Walker

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How would the Bill help here?

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Cancer research trials tend to focus on identifying and blocking single molecules with targeted new drug therapies. However, tumours in rarer cancers may have the same molecular signatures and the drugs developed for some common cancers may have relevance for rarer cancers with the same signatures.

So, a drug trialled and passed for one cancer cannot be used for another cancer – because it isn’t licensed for it, even though it is likely to be safe and may be effective. In this case, the Bill would protect a doctor wishing to use this new, safe drug for another cancer.

When the result of the innovation is known – and if it is a success, then this may inspire a more formal clinical trial. It will provide evidence that there is something worth investigating.

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But for the Bill to work, surely you must ensure doctors collect the results of their innovations for others to see and apply.

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Recognising the importance of collecting evidence and data from innovative treatments, the Bill team is committed to working with Oxford University who have agreed to develop a method of data collection and sharing which arise from the Bill.

Specially, following feedback from the consultation, we are committed to including an obligation on doctors that they must register innovative interventions and outcomes – including negative results – in order to be protected by the Bill.

There are some concerns, however, that this may put an added bureaucratic burden on doctors and therefore obstruct innovation.

So we are working with stakeholders including the Department of Health, to work out a way to introduce a register of innovation without burdening doctors with cumbersome administrative duties.

It has been the subject of much discussion – in particular with eminent, very senior and well respected medical Lords as the Bill works it’s way through the House of Lords.

We will keep the website updated with the latest developments.

 

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If a doctor wants to do something differently, must s/he always go through this process?

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No. The doctor can decide to go through the process or to rely on the law as it stands now (common and case law).

Also, there will be times when the process is not appropriate – for example in a trauma case when a surgeon needs to take fast action to save a life. Taking time out to consult and consider options would be unhelpful.

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Who is this Bill for?

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This Bill is for medical doctors – it will protect those who want to find new and better ways of caring for their patients and finding better ways to treat patients.

It is for the courts – current law is ambiguous and leads to uncertainty. The current law does not define clearly what good, or bad, practice is in regards to innovation. It causes doubt among judges and doctors. This Bill brings clarity.

And most of all it is for us – patients. Most of us have been touched by ill health, by cancer and rare or hard to treat diseases. And those of us who haven’t been, almost certainly will be, one day.

It will allow us to go to our medical doctor and say: “Have you tried everything? Is there anything new out there? Something that is not standard procedure? I would like you to try it – you can, you know, because of the Medical Innovation Bill.”

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What is innovation?

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Innovation is anything that is not standard procedure, anything new, anything designed to improve results, find better treatments and cures for patients compared with standard procedures.

Innovation does not have to be anything spectacular. It might be a slightly different surgical technique, or using a different combination of drugs, or a different dose – and it might be doing nothing.

The history of innovation often revolves around the individual clinician who has an idea, who is inspired to try something new, who has seen a pattern that others have missed and who bucks the trend.


Lord Mackay
Lord Mackay

Former Lord Chancellor Lord MacKay has said of those calling for a definition of innovation within the Bill that:

“…the word ‘innovation’ is a straightforward word in the English language. … if we want simplicity, we should go for perfectly clear English words. “Innovation” is one of them.

“To define it other than that which is not the standard procedure, is to risk limiting it and it is for doctors to decide what is innovation and whether to apply the bill to their proposed procedure.”

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Isn’t it the case that we are winning the ‘war on cancer’ already?

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It is true that there have been huge advances in some cancer treatments, including breast and blood cancers. But the majority of cancer deaths are from so-called ‘rare’ cancers. Such cancers, individually, account for a relatively small number of deaths. But together, they account for the majority of cancer-related fatalities. Indeed, one in six of us will die from a so-called ‘rare cancer’.

There have been few advances in most of them. And for many there simply are no treatments, other than the surgeon’s knife.

In many cases, going through standard procedures, when the standard procedures are ineffective is a painful demonstration of Einstein’s theory of insanity – doing the same thing over and over and expecting different results.

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Is the Medical Innovation Bill dangerous?

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No – quite the opposite.

Not only will it encourage better treatments and advance medical science, with the consent of patients, it will isolate the maverick, the eccentric and the snake oil salesman who act alone.

As things stand now, under the current law, a doctor wishing to innovate could, in theory, act alone. This Bill will stop this happening.

No doctor wishing to use the Bill can do so without specialist collegiate support. This is why the Bill stands squarely against the maverick and the quack.

Indeed, the intention clause of the Bill, which sets out what the bill is intended to achieve, explicitly states that: “The purpose of this [Bill] is to encourage responsible innovation in medical treatment (and accordingly to deter irresponsible innovation).


 

→LISTEN: Sir Michael Rawlins – BBC Radio 4 Today programme, June 2nd 2014.

 

Sir Michael Rawlins
Sir Michael Rawlins

Sir Michael 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

“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,” adds Sir Michael.


Lord Kakkar - Medical Innovation Bill
Lord Kakkar – House of Lords committee 24th October 2014

Lord Kakkar – House of Lords committee 24th October 2014 Professor of Surgery at University College London and member of the General Medical Council, speaking at the House of Lords committee on 24th October 2014.

“I was initially anxious about the fact that there were insufficient safeguards. The approach that I wished to adopt was one that I know has been considered but has been also dismissed.
‘I have, however, become reassured by the process under the supervision of the Medical Director of the NHS, Sir Bruce Keogh.

“He has consulted widely among the profession and I believe that the amendments in the name of the noble Lord, Lord Saatchi, particularly Amendments 12 and 16, bring us to a place where appropriate safeguards have now been introduced.

“I hope that they will be judged sufficient to provide the protection that all responsible and reasonable clinical practitioners would want in a Bill of this nature.”

→READ and WATCH: the full House of Lords commitee stage debate

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How much will the Bill add to the health budget?

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Nothing. The Bill is cost-neutral. It encourages innovation. That’s it.

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Who has written the Bill?

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The idea of the Bill was conceived by Lord Saatchi.

The Bill was written by Daniel Greenberg, a specialist lawyer, called a Parliamentary draftsman, who is an expert in legislation.

 

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Why has Lord Saatchi created the Medical Innovation Bill?

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Lord Saatchi’s wife, Josephine Hart, died in July 2011 from a form of ovarian cancer.

Moved by grief, taxed by the treatment his wife had to endure and shocked by the lack of progress made in treating and curing gynaecological cancers, Lord Saatchi sought to act.

He felt that more progress needed to be made and could be made in finding new treatments for cancers and other diseases and conditions.

His research discerned that one brake on progress was the fear doctors have of trying new techniques where old techniques have failed.

This fear is a result of law suits which can be brought against doctors who deviate from standard procedure. All innovation is, by definition, deviation. The law protects those who tread the well-worn path and can punish those who don’t.

Watch this overview on the Medical Innovation Bill by the BBC from January 2013.

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Lord Saatchi is a Conservative. Is this Bill party political?

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No. This Bill is not party political.

We are reaching out to politicians and the media across the political spectrum.

There is no enemy, no baddy, no political agenda – other than to help doctors find new and better treatments and cures for diseases.

 

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I’ve heard Lord Saatchi and others talk about the Bill ‘changing medical culture’. What does this mean?

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Over time, the Bill will, we believe, encourage innovation and in turn support the development of better treatments and cures for all manner of diseases, conditions and cancers.

It will foster a spirit of innovation, which will advance medical science and discovery in the interests of patients.

At the same time it will act against the maverick and the snake oil salesman. The Bill will be a catalyst for change.

 

Lord Kakkar - Medical Innovation Bill
Lord Kakkar – Medical Innovation Bill

Lord Kakkar, Professor of Surgery at University College in London and a member of the General Medical Council said at the House of Lords Committee stage 24th October 2014

‘…this is a vitally important Bill to drive forward the practicalities of innovation in clinical practice. I hope that it will also drive forward a positive culture of putting innovation at the heart of all clinical thinking.’

 

 

Earl Howe - Medical Innovation Bill
Earl Howe – Medical Innovation Bill

Lord Earl Howe, Parliamentary Under Secretary of State for Quality said at the House of Lords Committee stage 24th October 2014

‘…We have silos of innovation and forward-thinking practice throughout the health service. The challenge has been to spread that innovative behaviour more widely and for the diffusion of innovative treatments to become second nature to the health service. It is a cultural issue.’

Read the full text of the House of Lords committee debate in Hansard.

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Where can I download the latest version of the Bill?

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You can read the latest version of the Bill on our About page.

You can also follow all the activity on the Bill direct from the Parliament website here.

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Who are the Medical Innovation Bill team and how are they funded?

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We are a small, part-time team of three funded personally by Lord Saatchi.

Daniel Greenberg
Daniel Greenberg

Daniel Greenberg  I am a barrister who specialises in legislation. For 20 years I wrote laws as a member of the Office of the Parliamentary Counsel in 36 Whitehall, London.

Now I consult as in-house Parliamentary Counsel in the Parliamentary Team at Berwin Leighton Paisner BLP, where I advise on statutory interpretation, the legislative process and machinery of government.

I also have a legislative drafting and training practice in the UK and abroad.  I have published and edited a number of books and articles including Craies on Legislation, and I am the General Editor of Westlaw UK Annotated Statutes and Insight Encyclopaedia.  I am also the Editor of OUP’s Statute Law Review, the editor of two legal dictionaries and an adviser to the Oxford English Dictionary.

Dominic Nutt
Dominic Nutt

Dominic Nutt was a former local and national print journalist. In 1999 he became a communications specialist and worked for aid agencies including Save the Children and Christian Aid.  He covered humanitarian and man-made disasters, including famines, floods and earthquakes and the wars in Iraq, Afghanistan, Somalia and Lebanon. He has contributed pieces to The Guardian, Express, Telegraph and BBC Radio 4 – many from overseas. He is a campaigner for the marginalised, fighting for human rights and justice. Dominic is now director of his own communications agency CNC Ltd .

Liz Scarff
Liz Scarff


Liz Scarff is Director of Fieldcraft Studios – an agency working on the intersection of social-media, technology, media and social change.  A former national journalist she has produced pioneering social media and digital projects for the world’s leading charities and organisations including Save the Children, UNESCO, Marie Curie Cancer Care, Oxfam and Sightsavers. Her hybrid storytelling & media / campaigning projects have, among other things, raised much needed funds for a food crisis in West Africa and driven global awareness of maternal mortality.

Her work has won awards from the Guardian Digital Innovation Awards, Social Buzz awards and has been featured in the Guardian, Mashable, TEDX, and Telegraph among others. She regularly speaks on social and digital media.

Crowdfunding for rare cancer trials

In 2012 /2013 Liz Scarff and Dom Nutt worked pro-bono to crowdfund £2 million to fund a trial at Uppsala University into a potential cure for neuroendocrine tumours – a rare type of cancer. Without the crowdfunded money  a trial for this potential treatment would never have gone ahead.

This project has been showcased at TEDMED and featured in the FT, Nature Magazine, Guardian among others.

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The Bill has been amended many times – why?

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The Bill is going through the usual Parliamentary process and amendments are part of that process.

The original bill was drafted by the Medical Innovation Bill team with input from senior figures in the medical and legal profession. It was then taken on by Jeremy Hunt, the Secretary of State for Health.

His team amended it and put it up for public consultation.

New amendments were then drafted in by Sir Bruce Keogh the Medical Director of the NHS on behalf of Jeremy Hunt, in light of the consultation feedback.

Further amendments were added by peers during the committee stage in the Lords on October 24 and more are likely as the Bill moves through the Parliamentary process.

We will keep the website updated with the latest developments.

→FOLLOW: All stages of the Bill on its Parliamentary page. You can also sign up for email alerts.

→READ: What is the passage of a Bill?

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Does the Bill apply to mental health?

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The Medical Innovation Bill applies to all areas of medicine.

However as defined in the Bill a doctor cannot give any treatment without patient consent and the Bill does not change the law on what treatments may and may not be given to patients without consent.

So if a patient were detained under section 2 or 3 of the Mental Health Act, and thus being detained and treated without consent a doctor would not be able to give innovative treatment without consent.

The Bill does not change the law about what treatment can or should be given to persons suffering from mental illness (in particular, the issue of “appropriate” medical treatment under section 3(4) of the MHA 1983).

So the Bill could apply to determine whether a decision to exercise a discretion to depart from standard practice in the treatment of mental illness was negligent: but it does not determine whether the doctor has a discretion in the first place, in terms of the law applying to mental illness.

The Bill also expressly does not change the law as to the need for consents, as to which there are of course particular considerations in relation to mental illness.

The Bill expressly limits itself to treatment that in the opinion of the doctor, having consulted appropriately qualified colleagues, is in the best interests of the patient himself or herself: so there is no question of the Bill being relied upon to use patients suffering from mental illness as opportunities to experiment for the purpose of scientific research.

 The provision of treatment will have to be justified, exactly as in the case of non-innovative treatment, both in terms of the risk-benefit analysis for the patient and in terms of the laws addressing the provision of treatment to those suffering from mental illness.

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Why is research specifically excluded from the Bill?

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It is vital that the Bill does not facilitate reckless experimentation nor allow patients to be used as laboratory mice.

The bill excludes the use of treatment specifically as just research. It allows only for treatment that is in the best interests of the patient.

However, this does not stand as an obstacle to the furtherance of medical knowledge.

In trying novel treatments in the best interests of the patient it is likely that new and successful ways of treating diseases will emerge.

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Does the Bill falsely promising ‘miracle cures’ for all patients?

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The Bill does not offer false hope.

It is for the doctor to manage the expectations of the patient.

However, hope is not a bad thing. consider trying novel treatments and encourages a patient to read and research and if, between the doctor and patient it is decided that it is worth innovating, then that is a good thing – and arguably better than the false hope a doctor gives when offering standard treatments that are known to fail.

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Did the Medical Innovation Bill team work with the Department of Health on one consultation – or were there two, as some opponents claim?

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A: There was one consultation. 

This has been confirmed in a letter to Lord Saatchi from Health Minister Earl Howe on  22 January 2015 in which Lord Howe states: “It was agreed in advance with the Department views captured through the online petition and embeddable web form would be considered.” See letter in full below.


From Feb 2014 – April 2014 the Department of Health ran a public consultation on an earlier draft version of the Medical Innovation Bill. You can read the report here.

Following the consultation and taking feedback on board the Bill was presented to the House of Lords. It has since been robustly debated and amended. In particular an open access database of all treatments under the Bill, both positive and negative is now included in the Bill. The Bill passed to the House of Commons on 23rd January 2015.

The Bill team met the Department of Health (DoH) several times to discuss the Medical Innovation Bill consultation and the best way to make it accessible for as many people as possible.

At those meetings, the DoH made it clear that it wanted a strong response from the public and professional bodies alike.

Accordingly the Medical Innovation Bill (MIB) team and the DoH agreed and proposed to and set up various channels by which individuals, patients, doctors and organisations could respond.

Some of these channels would be managed by the DoH and others by the MIB team. Our combined effort working to drive a big response to the consultation.

These channels included open public events (held in Leeds, London and Cardiff), the standard DoH hosted online response platform, online conversations through, for example, DoctorDot.Com, a dedicated Department of Health email address (standard practice) and a written address to which people could send their own thoughts.

The DoH also suggested they host twitter chats via WeNurses, which they have done for other consultations – although this never happened. Another channel by which people could respond was an embeddable widget that allowed people to respond either positively or negatively to the consultation and leave an in-depth comment if they wished. And a petition on Change.org  that also enabled people to leave a comment if they wished.

Both the widget and the Change.org petition sent responses directly to the DoH. The widget captured expressions of opinion both in favour of the Bill and against. Neither the widget or the petition responses were intercepted, manipulated or changed by the MIB team.

The DoH team made it clear, by prior agreement, that all responses, received through any of the above channels, were both desired and welcome whether they answered all questions fully, or whether they were direct emails, or conversations designed to capture sentiments and views in a less structured way.

By prior agreement with the DoH the MIB Bill team set up and managed the embeddable widget and the Change.org petition. After the consultation closed even though the DoH should have received all the response in real time direct from the widget and the change.org the MIB team also sent all the of consultation responses received via these two channels in one consolidated email along with a detailed description of the pre-agreed methodology.

This approach, that is using multiple channels to respond to a consultation, has many historic precedents and is not new.


Examples of previous Department of Health consultations where responses have come from multiple channels.

Example 1: Consultation of standardised packing of tobacco products: Summary Report July 2013

Extract from Chapter 2 pg 8

‘Campaign responses. A number of campaigns were run that encouraged multiple respondents to answer only a handful of consultation questions (many campaigns only addressed whether standardised packaging of tobacco should be introduced or not). These responses used identical template documents (typically postcards, emails or letters), a single letter signed by multiple people or were received in the form of a petition.2 In total, 665,989 responses were received in this category.’

The two campaigns that provided these responses were run by Cancer Research UK and Tobacco Free Future.

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/212074/Summary_of_responses_to_consultation_-_standardised_packaging_tobacco.pdf

Example 2: Consultation of the future of tobacco control – December 2008

Extract from Pg 8:

In total, more than 96,000 responses were received. The majority of these were pre-written postcards or e-mail campaigns. 

The phrasing was often generic, for example, “I support measures to protect our children from tobacco marketing.” 

http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_091384.pdf


The DoH team agreed the above approach at a meeting with the full DoH team and the MIB team (Dominic Nutt, Liz Scarff and Daniel Greenberg).

The details were fleshed out and agreed in depth on a subsequent meeting with the DoH digital communications team with Dominic Nutt and Liz Scarff a few days later, again at the DoH office in London.

This has been confirmed in a letter to Lord Saatchi from Health Minister Earl Howe on  22 January 2015 in which Lord Howe states: “It was agreed in advance with the Department views captured through the online petition and embeddable web form would be considered.” See letter in full below.

It has been wrongly claimed that the MIB team was wrong to state those responses were part of the consultation and has intentionally mislead the public and media by stating this.

However,  the MIB team’s statements have been substantiated by Earl Howe’s letter. All responses, through all channels, were together, in unison with the DoH and in express and advance agreement and encouragement by the DoH.

It was in the clear and mutual interests of the DoH and the MIB teams to work together to gather opinion and was part of the ‘one team’ philosophy developed by the DoH and the MIB team.

→DOWNLOAD: Letter to Lord Saatchi from Department of Health Final

Letter-from-Department-of-Health-to-Lord-Saatchi-re-consultation

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Is the Bill a new legal requirement on doctors, previously untested in the courts?

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No, this is not new – the Medical Innovation Bill is simply bringing forward the existing Bolam test and turning it from a hypothetical exercise into a real one.

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Is the Medical Innovation Bill different from the current legal requirement that a decision to treat is one which would be supported by a responsible and rational body of medical opinion?

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It is a practical application of the existing hypothetical test which asks doctors to imagine what colleagues’ views would be, but not to ask them unless and until the matter comes to trial.

Under the Medical Innovation Bill the doctor will actually ask colleagues for their opinion at the point of treatment.

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If a doctor makes out the Saatchi Defence, will this stop a judge applying either of the Bolam or Bolitho tests to find that doctor to have been negligent?

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If a doctor has satisfied the reasonableness and responsibility requirements of the Bill, the Bolam and Bolitho tests will have been applied and satisfied at the point of treatment, so there will be no opportunity for lawyers to hire doctors to go into court and re-argue the issue in the hope of forcing a settlement from a risk-averse NHS budget-manager.

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Does the Bill require that the other doctor is independent from the treating doctor?

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 GMC guidance or hospital protocols will help doctors to identify appropriate consultees; and will strike a balance between independence and relevant knowledge.

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Why is there is no requirement that the other doctor must agree to or support the proposed treatment. The doctors may disagree.

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The views must be recorded in the patients’ notes – no doctor who receives only negative responses will be safe in relying on the Bill.

To intentionally use known, supportive doctors and to exclude intentionally dissenting experts would be unreasonable and would expose the doctor to a claim of negligence.

No doctor who receives only negative responses will be safe in relying on the Bill.

However, the Bill does not allow one, single, dissenting doctor to effectively veto a novel treatment for which there is otherwise a clear consensus among other experts.

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When relying on the Bill must medical experts who are offering their views to the doctor who is treating the patient actually see the patient?

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It is often most efficient and effective for doctors to discuss the principles of treatment without examining each others’ patients.

This is not new and already happens currently.

Doctors will decide for themselves what information they need in order to offer views on treatment, and whether they need to see the patient – as is the case now.

GMC guidance or hospital protocols will also be relevant.

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The Bill is introduced into the House of Commons

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The Medical Innovation Bill has today been introduced into the House of Commons as a Private Member’s Bill by Chris Heaton-Harris MP.

This is now his Bill and already he has changed the title to: “Access to Medical Treatments (Innovation) Bill”.

Lord Saatchi said: “It is wonderful news for patients that the bill has moved forward to the next stage. The House of Commons will bring great expertise to the scrutiny of the bill.”​

Here’s how we got to today.

The Bill was taken through the House of Lords by Lord Saatchi, supported by the government health minister in the Lords, Earl Howe.

It was debated, amended and passed by the Lords and handed over to the House of Commons for MPs to debate and amend.

However, it was halted before it got to the Commons by the then Liberal-Democrat health minister Norman Lamb. (He was able to do this under the coalition agreement the Lib-Dems had with the Tory leadership – allowing them to veto discussion of Bills in the Commons).

We then had the general election – so the Bill ran out of time.

Where are we now?

First of all, all the amendments made in the House of Lords, which won over the support of the Lords, remain.

Second, there is much more time available now for MPs to debate the Bill. We are not faced with a looming general election and we are at the beginning of the new Parliament. This means that MPs can debate and amend the Bill.

We know that government ministers support the Bill, as does Labour’s shadow health Minister Andy Burnham. So, it has a good chance.

But there is, as you know, genuine opposition from some medical bodies, including Royal Colleges and the BMA. Many have changed their positions over the past two years and we hope we can persuade them to change their minds back again to supporting the Bill, as it develops.

Lord Saatchi listened to his colleagues in the Lords and amended the Bill and now MPs will have their say – and through them, so will all those – patients, doctors and lawyers – who have an opinion.

This is democracy and we hope all will join the debate and make this Bill a success.

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