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

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Latest draft Bill published: 2nd June 2014

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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.

 

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 and their responsible officer. 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.

 

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

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.

 

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.

 

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

The process will be as follows.

The patient’s medical doctor will be obliged to discuss the patient’s case with specialists and experts, normally within their own hospital or clinic, seeking consensus from them about the best course of action for the patient.

This group of experts is often called the ‘multi-disciplinary team’ or MDT.

It may be decided that the standard procedure is not going to be effective and that offering the patient an innovative treatment that deviates away from standard procedures is a good thing to do.

If the group of specialists and experts all agree, the doctor must then also go to what is known as their ‘responsible officer’.

(A responsible officer oversees the process of revalidating a doctor, a process which happens every five years – without which the doctor cannot continue to practice. In the case of the Medical Innovation Bill, the responsible officer becomes another check on the process by which a doctor gets agreement to innovate).

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.

If the MDT or the responsible officer do not agree that the new treatment should be offered, the doctor will not be confident that the Bill will protect the innovation proposed, and will have to rely on the existing common law Bolam test or decide not to proceed.

 

Why can’t doctors innovate at the moment?

They can, and many do. But many also tell us they fear it. Therefore, at best, innovation is patchy.

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. So, a doctor who follows the standard procedures for, say, late stage ovarian cancer will be protected by the law, even if, as is likely, his or her patient dies.

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?

 

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 negligent treatment 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 MDT, the responsible officer and the patient recognize that and sign up to that, then the doctor cannot be sued. But the Bill does not protect the doctor from poor performance.

 

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 leukemia 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, 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, 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.

 

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.

 

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. This is driving up the cost of payouts by NHS trusts to patients. The cost is increasing annually. This Bill does not aim to stop this. But one effect of this 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.

 

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 allows the doctor to try to get the agreement of a body of 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 gets the agreement of a panel of experts, plus the responsible officer and the patient, then the doctor can carry on confidently without the threat of legal action.

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.

Furthermore, 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.

 

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.

 

Don’t most hospitals already have multi-disciplinary teams? If so, what’s the big deal?

Yes, many hospitals already take difficult and challenging cases to an MDT for discussion. It is widely acknowledged as being ‘best practice’. The difference is that the Bill, if passed, will give doctors legal protection from being sued – if, and only if they follow a process which includes the MDT, the responsible officer, any other appropriate experts and the patient.

The good news is that the Bill doesn’t impose a new process on hospitals and doctors.

 

What if a hospital doesn’t have an MDT?

A medical doctor seeking to innovate within the strictures of the Medical Innovation Bill will need to obtain the opinions of senior clinicians with relevant qualifications and expertise, be that from within their own hospital, or elsewhere – from other hospitals or clinical settings, for example. If they don’t – or can’t – they will not be able to be confident that the Bill protects them and they will either have to rely on the existing common law Bolam test or determine not to proceed.

 

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.

 

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. 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.

 

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.

 

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

Yes. This is true. The Medical Innovation team is committed to including an obligation to collect and share data – including of negative results – as an amendment to the Bill. During the consultation process many feedback on this point and it is a message we have heard and with which we agree.

 

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

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.

 

Who is this Bill for?

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.”

 

What is innovation?

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.

 

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

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.

 

Is the Medical Innovation Bill dangerous?

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.

The Bill sets a far higher test than laws such as the Mental health Act or the Abortion Act, which require only two doctors to sign off on sectioning a patient or authorizing a medical termination.

The Medical innovation Bill requires the involvement of a full multi-disciplinary team, the patient and the responsible officer.

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 agreement. This is why the Bill stands squarely against the maverick and the quack.

 

How much will the Bill add to the health budget?

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

 

Who has written the Bill?

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. The Department of Health ran the recent consultation into the Bill and the results have been used to refine and strengthen the Bill.

 

Why has Lord Saatchi created the Medical Innovation Bill?

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 gynecological 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.

 

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

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.

 

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

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.

Where can I download the Bill?

Download and read the guide and new (draft) Bill – published June 2nd 2014

 *Get the Facts updated to reflect new draft of the Bill June 2nd 2014

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