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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.

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.

 

How would the Bill help here?

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.

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

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

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

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.

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?

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.

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

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.).


 

Are there other reasons why we need the Bill?

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

Can you give me an example?

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.

Why do we need the bill?

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