Access to Medical Treatments (Innovation) Bill

Chris Heaton-Harris Excerpts

Friday 16th October 2015 Commons Chamber

[Chris Heaton-Harris (Daventry) (Con)]

I beg to move, That the Bill be now read a Second time.

Not a day goes by without those practising medicine in our national health service innovating. Talk to any doctor, and especially any surgeon—in fact any registered medical practitioner—and they will show how they have been innovative and, in being innovative, how they have helped those they are trying to treat. The levels of innovation are, without doubt, inspiring.

Let me give an example to demonstrate what I mean. An eminent surgeon was telling me only the other day of how he had helped a patient who came to him with a particular stomach tumour. At the time of surgery, he found this tumour to be so large that if he had continued with his original plan of removing it, it would probably have killed the patient. This surgeon had just a few nights before read about a drug called Glivec. Glivec creates a mutation called C-KIT, common in chronic leukaemia, where it is a succeeding treatment. Reports appeared indicating that the type of tumour this patient had carried had the same sort of mutation, so rather than trying to remove the tumour, a bypass operation was performed to overcome the obstruction and allow the patient to take the drug.

When the surgeon put his patient on this drug, the tablets were tolerated. The tumour disappeared. Years later that patient occasionally visits his surgeon to say thank you for being innovative and saving his life. In fact, as that surgeon will confirm, there is only one thing wrong with what happened that day. There was no way of recording the innovation on a database that could share it with other surgeons preparing for a similar operation and show how it had worked.

[Mr David Nuttall (Bury North) (Con)]

Will my hon. Friend confirm that the doctor in that particular case would have had to obtain his patient’s consent before proceeding with that innovative treatment?

[Chris Heaton-Harris]

I believe that the decision was taken while the patient was unconscious, but there would then have been a conversation, absolutely, because the doctor would have acted responsibly, as would any surgeon.

This was a life-saving decision, but there was no simple, quick way to tell anyone about it and, in so doing, perhaps save someone else’s life. Earlier this year, when we in this place were getting excited and building up to some sort of election campaign, the House of Lords was passing Lord Saatchi’s Medical Innovation Bill. It passed through all its stages in the other place and, as with many Bills, ideas were refined and concepts were introduced in Committee, on Report and on Third Reading. One of the new ideas that was introduced into the Bill is the central idea that I have plagiarised for my Bill—namely, the introduction of a database for innovative treatments conducted by registered medical practitioners.

[Dr Sarah Wollaston (Totnes) (Con)]

Would my hon. Friend accept that such a database could be set up anyway, without this Bill, and that what is really needed if we are to record medical innovations is adequate funding? This does not require legislation.

[Chris Heaton-Harris]

I shall come to that point in a moment.

When this idea was introduced during the passage of Lord Saatchi’s Bill, it was not a novel one. Several of the royal medical colleges, among others, had already called for such a database. The Academy of Royal Medical Colleges has recently stated that it believes that there should be

“an explicit requirement for the results of an innovation to be properly recorded with the outcomes made available to clinical colleagues for scrutiny and learning…The Academy believes that this is an essential requirement.

The Association of Medical Research Charities has said of data collection:

“This is a key aspect of innovation since new interventions require an evidence base to demonstrate safety and efficacy and to ensure effective uptake in practice.”

[Sir Edward Leigh (Gainsborough) (Con)]

I am not opposed to my hon. Friend’s Bill, which he is presenting in a very effective way, but I want to ask him a question about scrutiny. Might not a bureaucratic procedure that required medical practitioners to put innovations on to a database prevent some of those innovations from being carried out in the first place because people would fear being called to account? Might that not hold people back?

[Chris Heaton-Harris]

I will continue, if my hon. Friend will allow me, because in the depths of my speech I shall come to that point and go into detail about how this will work. I am simply proposing to confer on the Secretary of State the power to establish this process, and I hope to be able to give my hon. Friend a detailed answer to his question in due course.

The Royal College of Surgeons has stated:

“The value of innovation is severely diminished if we cannot learn from it. Registration of the results of an innovative treatment, whether positive or negative, ensures that clinicians can consider the data to learn from mistakes or spread instances of good practice.”

[Dr Wollaston]

My hon. Friend has quoted a number of organisations. Does he accept that all those organisations oppose the Bill? He needs to make that explicit to the House. It is not fair to quote the Royal College of Surgeons, for example, without making it clear that it has explicitly opposed this Bill.

[Chris Heaton-Harris]

I would like to think I am making the point that although we all recognise that we need to encourage innovation in the NHS, and there is tons of it going on, it is not captured in a way that is easily spread throughout the NHS. All the royal colleges I am citing, which do not like parts of this Bill, do accept the concept of spreading innovation, which is something I am trying to do through this Bill.

The Royal College of Psychiatrists has said that

“a register that is available to other doctors would allow sharing of knowledge about a potential innovation and this would be beneficial.”

The Royal College of Physicians add to the list, by stating:

“Innovation relies on a culture of knowledge sharing and a collaborative environment that stimulates ongoing improvement.”

The concept of innovation being spread is welcome throughout the medical community, and I hope to capture it in this Bill. A way of encouraging and recording innovation, and spreading knowledge about it throughout medicine, is widely recognised by most of the royal colleges as being a solidly good thing.

That is also recognised by individual doctors, patients and families. It seems that most people know and understand that there is a need for a culture change in knowledge-sharing and the reporting of success and failure. In researching for my Bill, I was told a story by a dad named Alex Smith, and it is as follows:

“Four years ago, my wife Donna and I were told by a paediatrician to take our son Harrison, who had been diagnosed with Duchenne Muscular Dystrophy, home, love him, give him a good life, there’s nothing we can do, he’s going to die.

How is it possible that our specialist doctors and GPs were, AND STILL to this day are, not willing to try something to help save our son’s life?...every day something we all take for granted as simple as opening a jar is taken away from him, in the last month alone his ability to get off the floor unaided has almost left him and one day in the not-too-distant future his ability to breathe and his heart to beat will be taken away and we will lose him, way, way too soon.”

Mr Smith believes:

“With a robust framework to allow our doctors to innovate safely and responsibly and share that data, the chance to save this generation could become a reality.”

It therefore should come as no surprise that an idea that has been called for by so many worthy and excellent minds, including people such as Alex, Donna and Harrison, who are facing such horrendously difficult times, should be taken up by a legislator, especially given that for decades this simply has not happened.

[Wendy Morton (Aldridge-Brownhills) (Con)]

I am no clinician, but I am a patient, like many of us here. In today’s world, where we so often go on the internet to search for solutions, would it not make sense that when clinicians and the medical profession are seeking innovation, we do all we can not only to encourage them, but to share it, so that others in the medical profession have access to that information? That must, however, be done safely and in the correct manner.

[Chris Heaton-Harris]

I completely agree with my hon. Friend. The only surprise is that such a database of innovation does not already exist. Like generations of previous politicians, I therefore now rise to claim as my own a fantastic idea, which so many cleverer minds than mine have conceived. Thus, the first half of my Bill seeks to confer a power on the Secretary of State for Health to create a database of medically innovative treatments. I strongly believe that the creation of such a database will help to share ideas and spread good practice.

[Heidi Alexander (Lewisham East) (Lab)]

I asked the House of Commons Library whether the Secretary of State has this power already, and it suggested to me that section 254 of the Health and Social Care Act 2012 does give the Secretary of State the power to direct the Health and Social Care Information Centre to establish such a database. Does the hon. Gentleman accept that?

[Chris Heaton-Harris]

I am not sure I do. I would like to think that this Bill completely clarifies how this database can be set up and builds a foundation on which the Secretary of State can do such a thing. My Bill does not build this database; all it does is confer on the Secretary of State the power, which the hon. Lady talks about, to build such a database. If the Secretary of State for Health chose to use the power, it would only be after detailed consultation. However, as we would all expect, when given the opportunity to take a private Member’s Bill through into law, any Member of Parliament, myself included, would endeavour to consult widely on the matter in hand. Thus over the summer I have met pretty much everyone who has expressed an interest in this Bill—either for or against—to endeavour to allay any concerns about its content and direction of travel and to listen to what they have to say.

[Mr Nuttall]

Is it the case that the introduction of the database into this Bill is really in response to the concerns that were expressed in the other place when Lord Saatchi’s Bill was being debated? There were concerns that, if his Bill was allowed to go through without the database, there would be difficulties? Is that not the case?

[Chris Heaton-Harris]

Absolutely, my hon. Friend is completely right.

The Minister will be pleased to hear that I have been working closely with some of the excellent officials in his Department to ensure that there is a little more detail in the Bill specifically to deal with some of the concerns that have been raised with me. First, after a great deal of thought and research, I suggest that the database is held by the Health and Social Care Information Centre. The HSCIC has experience of dealing with big data, and although a number of details would have to be worked out, it seems that it would be the obvious place in the existing health infrastructure to hold such a database.

How the database would work would be detailed outside my Bill by those best placed to do so. However, it is envisaged that a registered medical practitioner, having consulted with his or her patient, would flag up on the patient’s notes that they were innovating. I recognise the pressure that medical practitioners are under, so I am determined that this database should not add much to their already heavy workload, and, hopefully, through this system it would not.

The Health and Social Care Information Centre already has in place a strong set of legal safeguards to protect privacy and confidentiality, which, again, makes it an ideal organisation to host the database. Clearly, privacy issues will be a core part of any consultation that takes place on the detail of the database.

Importantly, the Bill stipulates that outcomes, not just the process of innovation itself, will be on the database. Successes and failures would be recorded on an ongoing basis. There are a number of very, very good reasons for doing that. Of course sharing success is simple to explain. Sharing ideas is in itself a great idea. Letting others see that a treatment has been a success when that treatment might not be widely known is clearly helpful, perhaps even lifesaving. When we know that treatments can differ between NHS trusts and between individual surgeries, it seems clear that we should be encouraging a spread of the good innovation that comes from every individual medical practitioner, such as the surgeon I mentioned earlier and his use of the drug, Glivec.

We must also realise the potential of transparently sharing all outcomes of innovation—not just successes, but failures too. Critics of Lord Saatchi’s Bill were rightly concerned about “quackology”—their term, not mine. There are some doctors who sell to desperately sick people treatments that do not work and that, in some cases, are dangerous. Having a database on which the whole of the registered medical practitioner community can see what an innovation is and then watch the results come in removes quackology from the database in a stroke.

I might well be on the lookout for someone who can cure my male-pattern baldness. Undoubtedly, it would require an innovative treatment; some would say a miracle cure. Currently, there are many treatments on offer to people such as myself. Many adverts will offer me an innovative cure, but there is no way of checking on the successes or failures of the treatments on offer.

[Andrew Bingham (High Peak) (Con)]

My hon. Friend is making quite a powerful case. I do not wish to dwell on his receding hairline, but let me touch on the adverts that we all see for receding hairlines or whatever. Does he envisage an advert carrying a quality mark to say that the treatment is on the database with results that are proven, which would give it more credibility?

[Chris Heaton-Harris]

I am not particularly worried about what is going on up top, but what I would envisage is that if I wanted to get an extra bit of thatch put on I could go to my doctor, have a conversation with him and he would be able to look on the database and say, “There is nothing there. This is all pie in the sky, hokum pokum stuff and not worth going for.” The database gives people a way of checking on the success or failure of the various treatments on offer, and if innovations such as this miracle cure for baldness are not there at all, there must be questions to be asked.

Perhaps some of the treatments on offer do work, but I doubt that the quacks out there would want their supposed innovations placed under the spotlight of transparency in both practice and outcome that the database would offer. There is another much more compelling reason for having a database that records the outcomes of medical innovation, be they successes or failures. It is impossible to learn, to move forward or to spread best practice if innovation is conducted in a silo and if no one else in the health community knows what is going on.

[Sir Edward Leigh]

My hon. Friend and I are fellow Conservatives and we have battled over the years to stop more and more bureaucratic burdens being put on professionals. Our ethos is that we should trust professionals and if they have a good treatment, they will want to test it in their own time and put it on the database. What worries me is that if we have this great bureaucratic mechanism with piles and piles of untested information poured into it, although it might discourage good doctors it will not necessarily discourage quack practitioners. Does he see my point? How does he meet this Conservative objection to the Bill?

[Chris Heaton-Harris]

There are many elements to this genuine concern. My hon. Friend was the Chairman of the Public Accounts Committee and I served on that Committee for five years. We have seen plenty of IT action in the health service space that has not worked at all, but we have moved forward into a new era of big data and can now manipulate it sensibly and shrewdly. All that would be required from the medical practitioner would be a coding on the patient’s notes that would go into the system electronically. All the work would be done behind the scenes to make that visible to the rest of the registered medical practitioner community. Hopefully, it will mean a very small amount of work in exchange for a huge amount of best practice being spread across the NHS.

I have been reading a truly great book by the author Matthew Syed, which is called “Black Box Thinking”. Essentially, it makes the case for the database, for the recording of success and failure and for trying to encourage the reporting of failure so that lessons can be learned. To paraphrase, he basically says that it is rare for someone to come across “a eureka moment” without a huge amount of previous work. In fact, although most invention comes from innovation, most of it comes from innovation in tiny steps that occasionally build up to a large leap.

In a recent radio interview, the author said that healthcare needs a

“scientific mind-set that allows people to learn from their mistakes”

and to be “brutally honest about failure”. He said:

“For senior doctors, who have spent years in training and have reached the top of their profession, being open about mistakes can be almost traumatic. Society, as a whole, has a deeply contradictory attitude to failure.”

He went on:

“Preventable medical error is one of the biggest killers in the UK—when doctors make mistakes they are worried about litigation so they are not open about mistakes and they are made again and again.”

If preventable medical error was a disease, we would devote a whole medical specialty to dealing with it. Among the many causes of that disease would be fear and a culture of blame rather than learning that lead many doctors to conclude that the best option is not to be open about mistakes, which are then repeated again and again. As Matthew Syed says

“at a collective level…success can only happen when we admit our mistakes, learn from them, and create a climate where it is, in a certain sense, ‘safe’ to fail.”

So the database would do several important things. It should increase transparency in innovation, creating an even clearer trail of evidence which not only improves patient safety but encourages further innovation. It would, hopefully, encourage a culture of information sharing, spreading good ideas and also learning from less successful ones. Additionally, I want registered medical practitioners to know and feel confident that they can use the database to innovate and to discover the innovations of others, and this is partly behind clause 3.

I want to provide clarity and give confidence to doctors about how they can demonstrate that they have acted responsibly when innovating, while using the database or not. The second part of my Bill, therefore, does one thing: essentially, it brings forward what the medical community knows as the Bolam test. Currently, the Bolam test is applied only when proceedings have gone to court. However, bringing it forward to an earlier stage would allow a responsible doctor to take a series of steps to prove that they are being exactly that—responsible when providing treatment. This does not change common law. A doctor can continue to rely on the existing Bolam test before the court.

The Bill supplements the existing law; it does not replace it. The Bill will not stop a doctor being sued for clinical negligence. It simply allows a registered medical practitioner to demonstrate what their actions were and with whom they consulted. It gives a doctor that extra bit of confidence that they can prove that what they are doing is responsible and therefore not negligent. The Department of Health did a consultation on Lord Saatchi’s Medical Innovation Bill that revealed that some doctors do find the threat of litigation to be a block to innovation, although this view is not universally or widely held.

However, given that that engagement has identified that some respondents feel constrained from innovating, there is a case for addressing this through legislation. This Bill is aimed at reassuring those doctors, even if that is just an underlying fear, and to encourage the culture change I described earlier.

As Dr John Hickey told me:

“As a registered medical practitioner, a former NHS Trust Chairman and with 30 years’ experience in the field of legal medicine with the Medical Protection Society (the last five years as Chief Executive), I believe I am adequately qualified to comment on your Bill.

Over the last 30 years I have seen how doctors have increasingly practised defensive medicine both because of the fear of litigation and disciplinary action by their regulators; this defensiveness is not in patients’ best interests.

I believe that your Bill, if approved by Parliament, would assist in meeting the concerns of clinicians treating such patients . . . I believe there are adequate safeguards in your Bill, particularly with respect to consent, to prevent the potential ‘quackery’ about which some of the critics of your Bill and Lord Saatchi’s previous Bill have expressed concern.”

I hope that my Bill is given the chance to fulfil the expectations of Dr Hickey, and many others who have contacted me to express their support for it.

I know that this Bill comes in the context of perhaps a new era in treatment, where patient choice is at the heart of decision making. Following on from the Montgomery v Lanarkshire ruling by the Supreme Court earlier in the year, I think it is fair to expect that all registered medical practitioners are now consulting their patients in a full and responsible manner and involving their patients in decisions about their ongoing treatment. So following these appropriate consultations a doctor might choose to innovate in the treatment of their patient and should feel confident to do so.

This Bill is not about research or about testing on patients. It is about harnessing the trust in the common law and the already well respected, tried and tested Bolam test. The Bill just provides clear steps to evidence Bolam, but before treatment takes place. It has always struck me as bizarre that although our national health service is constantly innovating, it rarely captures the innovative practice itself, let alone the results of that innovation. Out there right now in GP practices and in hospitals registered medical practitioners are innovating to help their patients. It is beyond belief that we fail to capture these innovations and allow others to understand and learn from them and then develop them to help others. That is the intention behind my Bill and I commend it to the House.

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[Dr Wollaston]

As my hon. Friend the Member for Daventry pointed out, many of these bodies would like to have such a register, but they would also like to be able to guide how it should look and to have it within the existing research framework.

The Bill suggests that doctors are not already innovating, and that this is about fear of litigation. The original Bill was based on the premise that fear of litigation was stopping innovation. In fact, the position is very clear if we read what a number of bodies have said. My hon. Friend quoted some individual examples, but the vast majority of opinion from the medical community and the research community is that, genuinely, it is not fear of litigation that stops innovation. Every aspect of this Bill is based on a false premise, I am afraid. I do not want to detain the House by reading out all the various quotes on why the fear of litigation does not stop innovation, but he will know that that is the case.

We face the danger of confusing the existing legal framework. Many have expressed their concern that we will end up with a sort of Heaton-Harris defence for those who have undertaken perhaps rather dangerous experimental treatments billed as innovation. My hon. Friend cited the case of the children who suffered from Duchenne muscular dystrophy, and that is very sad, but the Bill has an underlying assumption that all innovation is a good thing whereas the lesson of history is that it can be extremely dangerous and harmful. We need to be very careful about what we mean by innovation, and to accept that there are also very dangerous innovations. If, as a result of this well-intentioned Bill, we inadvertently end up with people being, in effect, experimented on by irresponsible doctors who are able to get off scot-free, we will have to come back to this place and amend it.

I would like to give my hon. Friend an example based on the case of somebody from my constituency who wrote to me to say that he was concerned that the Government were not doing enough with regard to experimental treatments. His specific example was a bogus treatment called GcMAF. The company promoting this entirely bogus treatment—it has a number of clinics in Europe and Guernsey—is very concerned that it cannot use it in this country because it is prevented from doing so by the current legislative environment. Well, jolly good. It puts out literature saying

“we state that if you have terminal stage 4…cancer, have not had chemotherapy, and you do the GcMAF protocol, you have an 80% chance of being cancer free in a year.”

That is the kind of claim that such doctors put out. In other words, the company is not only promoting its own product, but actively discouraging people from having a treatment that could help.

[Chris Heaton-Harris]

My hon. Friend is surely making the case for the database because successes and failures would have to be recorded. She would therefore be able to benchmark and see the evidence behind such a claim. A company cannot choose just to record successes on the database.

[Dr Wollaston]

I must say that I do not think my hon. Friend understands how this works. Companies will simply direct people to their successful treatments. Yes, they may have to record their failures as well, but it is only by comparing the results for bodies of patients having such treatments that people can see whether treatments are entirely bogus. This company cannot currently operate in the UK—quite rightly—and I am afraid that we would see this kind of bogus treatment.

My hon. Friend’s Bill would require doctors who want to undertake so-called innovative treatments to consult at least one other doctor. Seven doctors operate in the clinic concerned. We can see how, if a doctor is working in a clinic with others who are profiting from bogus treatments, it will be very easy for them to pop down the corridor and get one to agree that their bogus treatment is an absolutely fantastic treatment for cancer.

I am afraid that the Bill is based on a false premise, and such a randomly searchable database of unconnected treatments is very dangerous. In addition, if someone wants to start a trial of a new product but there are one or two examples on the database of the treatment not working, the Bill might inadvertently end up killing off a potentially useful treatment. Such things need to be established as part of a research trial. Databases that are randomly searchable by the public will be an absolute quacks charter.

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[Chris Heaton-Harris]

My hon. Friend will know—in fact, we had a meeting about this just before the Bill was first drafted—that I do not tackle research in the Bill; it is specifically excluded. She will know that learning from failure is one of the most important things people can do. She will know that she is describing doctors not acting responsibly, but my Bill does nothing to change the current position: if a doctor acts irresponsibly, the full weight of medical negligence legislation will still come down on top of them. She is painting a picture that simply will not and could not exist if the Bill comes into force.

[Dr Wollaston]

I am afraid that I disagree. My hon. Friend’s Bill would not allow us to learn from failure. We learn from failure through medical research. He says that it will not undermine medical research, but I have read him a long list—I am happy to read it out again—of members from across the entire research community who are deeply concerned that it will undermine research for the reasons I have set out.

If someone was absolutely desperate—as in the very tragic case of the family my hon. Friend cited—and was persuaded not take part in a clinical trial by an unscrupulous doctor, why would they do so? They would mortgage their house to go to such a clinic if it persuaded them to do so, thinking that it was their best hope of a cure. The fact is that that hope is likely to be dashed. They are best off going to an established research community.

The Bill will undermine recruitment to clinical trials. Although my hon. Friend does not mention medical research, very vulnerable people will end up circumventing genuine medical research. He will set back the progress of science, and when that comes to pass we will have to come back to the House to amend the legislation. I very much regret that he has been persuaded to take up this Bill. He knows of the long list of members of the research community who are profoundly opposed to it, for the reasons I have set out.

I urge the Government to be very clear that they support medical research and that they want genuinely to move forward on that basis. My hon. Friend the Minister is right to be looking at the accelerated access review. Let us use that review to look genuinely at the barriers to research and to getting products rapidly into use for NHS patients.

I urge colleagues to read the briefings on their desks from the entire research and medical community, and robustly to reject the Bill.

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[Heidi Alexander]

I am keen to find a way for doctors to innovate, but to do so using safe and effective treatments.

I was saying that the problem with the Bill is that it undermines a patient’s ability to hold doctors to account when things go wrong. The hon. Member for Daventry claimed that this is not Lord Saatchi’s Bill, but the wording of clause 3 is very similar to clause 1 of the previous Bill. Clause 3(2)(a) in today’s Bill requires a doctor to

“obtain the views of one or more...doctors”—

which, in practice, could mean just one doctor—

“with a view to ascertaining whether the treatment would have the support of a reasonable body of medical opinion.”

Will the hon. Gentleman confirm that that relies on someone’s interpretation of a “reasonable body”, as opposed to seeking a view from a responsible body directly? Does the Bill not boil down to one doctor who wishes to deviate from accepted medical treatments asking another doctor whether he or she thinks there is a reasonable body of medical opinion that would support such a treatment? As long as that second doctor perceives such an opinion to exist about support for the proposed treatment, this provides cover for the patient’s doctor to proceed. I cannot say that I am particularly convinced by that.

[Chris Heaton-Harris]

To allay that concern, the Bill states that nothing in it would override existing common law. All it aims to do is bring forward the step of the Bolam test, so that the doctor himself or herself can make a judgment at that time on whether he or she is doing something correctly. It does not stop clinical negligence cases coming forward; it just helps to prove that the doctor might or might not be acting in the responsible way that he or she should be.

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[Philip Davies]

I take my hon. Friend’s point. She is an expert in her field in a way that I am not, and I certainly do not want to decry that. My perspective on the narrow point she raises, however, is slightly different. I would want to set the framework of the law for the overwhelming majority who are doing a good job. Let us try to find other ways to weed out those who are not doing so. Putting in place arrangements that apply to everybody in order to deal with the very small number of doctors about whom my hon. Friend speaks is probably the wrong way of going about it. I am happy to have this conversation with her in a different setting; I do not want to deviate too far from the Bill in going into how many doctors are noble and how many are chancers. I do not know the answer to that; perhaps my hon. Friend does, but I am not getting into that today.

My hon. Friend the Member for Totnes (Dr Wollaston) made the point that the Bill is unnecessary—the shadow Minister made the same point—and that there is no need for a legal requirement for medical innovation to be made, particularly when the current common law Bolam test is appropriate. Although it may not be popular, however, I believe it important to give serious consideration to this part of the Bill.

The Medical Innovation Bill, although criticised, showed an appetite for more legal work in the area of medical innovation. After a commitment from the Secretary of State for Health, the Medical Innovation Bill was put to consultation in the last Parliament. Many organisations shared their views, some of which have already been mentioned. I shall highlight a couple of those views because they are relevant to today’s Bill.

Cancer Research UK stated in its consultation response:

“There is clearly patient and clinician demand for more innovation to help treat people with cancer. We do sometimes see exceptional responses to treatments from individual patients, and therefore want to be in a position to innovate. Cancer Research UK is supportive of efforts to bring innovative treatments to patients faster and to improve the uptake of innovative treatments in the NHS. Any new legislation seeking to promote innovation should be drafted to ensure doctors have to establish there is sufficient intellectual underpinning and safety data about a treatment before proceeding. There should also be appropriate consultation with other doctors in the same or a related field to ensure patients receive the best care at all times.”

I understood from previous contributions to this debate that Cancer Research UK was against today’s Bill, but it does not strike me from the response I have cited that it was opposed to it. It seems to me that it was looking for ways to bring about more innovation to help treat people with cancer. It seems to be open to the possibility that the Bill might be able to do that.

[Chris Heaton-Harris]

I fully admit that there are a number of critics of the Bill, but not so many critics of the central idea in the Bill. I welcome what the hon. Member for Lewisham East (Heidi Alexander) said about trying to work with those who are genuinely interested in spreading best practice and innovation across the NHS. If one of the Bill’s core features is widely welcomed, even by some of the harshest critics of its later parts, I put it to the hon. Lady that it is surely it is worth taking the Bill forward into Committee to examine the provisions in greater detail, when we could debate it with expert witnesses and others.

[Philip Davies]

My hon. Friend makes a very good point. A Second Reading is, of course, a debate of a Bill in principle, so that we can establish whether people object to it in principle. I have been somewhat confused by the voices in opposition to the Bill because I cannot work out whether they consider the Bill to be dangerous or unnecessary because what it proposes is already being done. It seems difficult to argue that it could possibly be both. Either the Bill’s provisions are already in place so there is nothing to be done, or the Bill is a terrible and dangerous thing.

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[Philip Davies]

It is not for me to advise other Members how to pursue their own agendas. My hon. Friend is a wonderful exponent of ways of implementing her views, but my advice to her, for what it is worth—which she may think is not a great deal—is that if she wants to see more innovation in medicine, as she said at the beginning of her speech, but does not believe that the Bill is the right way forward, she should support its Second Reading and then seek to amend it in Committee so that it achieves the innovation that she would like to see. We shall then review the matter on Third Reading, and she can decide at that point whether the Committee stage has delivered to her what she feels would be a useful way of getting more innovation into the NHS. It seems to me bizarre that someone should stand up and say, “I want to get more innovation into the NHS”, and then block on Second Reading—and this is the principal point of the Bill—any attempt that might actually facilitate the introduction of improved innovation into the NHS. But that is just the way I see the matter; it is up to individual Members to pursue their agendas in the way that they see fit.

[Chris Heaton-Harris]

I believe that the Bill should go into Committee, because it is an evolution: it is a process that we are going through in trying to get the position right. The Royal College of Physicians says that it “generally welcomes” the first part of the Bill, which enables the Secretary of State for Health to establish a database of medical treatments. However, it issues plenty of caveats in respect of how the detail should run. Those should be discussed in Committee, and that is where I want the Bill to go.

[Philip Davies]

My hon. Friend has made a very fair point.

I now want to say something about the medical innovation database provision, which is one of the main differences between the Medical Innovation Bill and the Bill that we are discussing. Clause 2 provides for the Secretary of State to make regulations enabling the Health and Social Care Information Centre to establish a database containing information about innovative medical treatments and their outcomes. As a layman, I consider that to be a significant and fundamental part of the Bill. A central database recording all innovative treatments strikes me as a useful tool from which doctors can learn when tailoring medical treatments for their patients. Again, I speak as a layman, but I think that the creation of a system to enable that knowledge to be shared is a logical step towards medical innovation.

Having said that, I should add that the proposal is not without its worrying aspects. I wanted to raise them earlier, but the interventions from my hon. Friend the Member for Totnes delayed me. One of the main criticisms of clause 2 comes from the Royal College of Surgeons of Edinburgh, which states:

“The proposed database could only be effective if it is compulsory, regulated, has robust quality assurance and be journal-led, ethically framed and rigorously peer reviewed. It will also require an honest culture in which participants are just as likely to register failures as successes”.

The clause provides for the Health and Social Care Information Centre to specify what information should be recorded and how it should be assessed. More experienced people than me will be able to note what standards and specifics need to be recorded to make the database useful and usable. It is certainly not for me to make any suggestions. The database will also be designed in consultation with professional bodies and organisations.

The clause contains the important provision that the database will cover all individual patient innovations, not only those in respect of which doctors have chosen to rely on the steps in the Bill to demonstrate that they have acted responsibly. It is a significant inclusion, as it means that the database will include and cover all treatments and their outcomes—both positive and negative —that take place in England. That is my understanding of the clause, but if my hon. Friend the Member for Daventry wants to correct any misunderstandings, he is welcome to do so. Therefore, this national database not only spreads the knowledge of successful innovations, but also has the benefit of ensuring that innovative treatments that do not work, or perhaps have harmed patients, are not repeated by other clinicians. That should go some way towards reassuring those with concerns. It will also, therefore, create a standard practice that all innovative medical treatment should be recorded in this database, which can be a useful tool for other doctors to draw information from when they are doing their own innovation.

--- Later in debate ---

[Philip Davies]

My hon. Friend makes a good point. I have not heard anything so far today to suggest that the Bill should not at least go into Committee for further scrutiny, and perhaps even for some improvement, if I may be so bold as to suggest that may be possible. I do not think I have heard anything today that suggests the Bill should be stopped in principle on Second Reading. I hope that my hon. Friend the Member for Totnes will appreciate, however, that I am also trying to be balanced in setting out some of the concerns that have been expressed, perhaps so they can be considered if we do get into Committee, which would be a useful exercise.

Another concern raised by some of my constituents is that the database may compromise patients’ anonymity. Innovative medical treatments will be applied on a case-by-case basis with a specifically honed technique for one particular individual. The fear is that a degree of detail will be needed in the register, which would end up compromising a patient’s anonymity. That is a valid concern, and protections would need to be put in place to ensure all information is stored securely within the database to protect anonymity. However, that may be at the cost of using innovative treatments. There may well be a tension between those two factors.

While the information stored in the database should only be accessible by doctors, it will need to remain confidential aside from access for medical purposes and, ultimately, it should be the patient’s choice whether to use an innovative treatment that will be recorded for medical purposes. Furthermore, in an age when we want more doctors to spend more time with patients and not at their desks, we need to be careful to ensure that the register does not become overwhelming to the point where doctors are put off from using innovative techniques for the sake of the amount of paperwork and red tape that would accompany it. The Academy of Medical Royal Colleges said

“current experience in the NHS show that establishing an effective register for far more standard procedures is a complex task. Establishing and maintaining a register of innovations would be a costly and potentially burdensome and bureaucratic task.”

My hon. Friend the Member for Totnes made that point. That is another factor that needs to be considered when the database is created. Of course the database and the information gathered should be rigorously checked and regulated. However, that is not always easy when doctors are already busy.

Overall, I believe this clause, originating from an amendment to Lord Saatchi’s Bill, is one of the key clauses. For rare diseases such as some cancers there is a lack of published evidence on which to rely when determining treatments to try. It is also widely regarded that some methods used to treat some types of cancers have remained similar for many years, with only slight modifications to the techniques. With this in mind, a database that allows knowledge to be stored and accessed at a doctor’s level will be not only desirable but probably essential for allowing doctors to innovate responsibly. It will encourage a culture of knowledge sharing, which, importantly, will include both successes and failures. This is a vital part of the Bill, and indeed I do not see how the power to innovate can move forward without the inclusion of a database recording the results of these treatments. I therefore commend my hon. Friend the Member for Daventry on including this clause.

We need to look at what we consider to be a responsible innovative treatment. Clause 2(2) states that a treatment is regarded as

“‘innovative’ if it involves a departure from the existing range of accepted medical treatments”

for a condition. We can therefore assume a wide scope to cover the cases that should be recorded in the new database.

However, concerns have been raised regarding the distinction between innovation and research. While clause 5(2) specifically states that this Bill does not apply to medical research, some medical organisations have raised concerns as to how this would work in reality. The Academy of Medical Royal Colleges states:

“We do not understand the distinction between ‘individual patient innovation’ and ‘research’. The distinction seems false and potentially dangerous. As a college president stated ‘Innovation without research isn’t innovation, it’s more often just advertising’.”

Although the Bill uses the two in harmony, it is important to raise these points and for them to be considered in Committee.

One of the main differences that separates the two is that this legislation allows doctors more freedom to modify and specifically cater treatments towards the individual they are treating. That is very important and worthwhile. Although they will not be finding a brand new cure for cancer, it allows doctors to cater treatment plans more specifically to the patient’s needs and wishes. Many patients will benefit from that, and often would prefer it.

We have discussed the Bolam test. By working from the current common law Bolam test, the Bill identifies the steps a doctor can take to show that they have acted responsibly before innovating. The common law Bolam test is defined as the test

“used to determine the standard of care owed by professionals to those whom they serve, e.g. the standards of care provided to patients by doctors.”

Established from the case Bolam v. Friern hospital management committee in 1957, it shows that if a doctor acts in accordance with a responsible body of medical opinion, he or she will not be negligent. Subsequently this standard of care test was amended—the Bolitho amendment—to include the requirement that the doctor should have behaved in a way that “withstands logical analysis” regardless of the body of medical opinion.

This determination of whether a professional’s actions or omissions withstand logical analysis is the responsibility of the court. The Bill, through clause 3, aims to reflect as closely as possible the steps under the current common law which a responsible doctor could be expected to satisfy when innovating. However, clause 3 has caused specific concern for many of my constituents and I would like to raise some of their concerns today.

Most groups and individuals from the medical profession seem to be satisfied with the current Bolam test as a standard for regarding medical innovation, with the Royal College of Surgeons regarding it as “adequate”, so there are concerns that, instead of clarifying the legal position, clause 3 will confuse the current mechanism for judging responsible innovation.

Subsection (2)(a) requires a doctor to

“obtain the views of one or more appropriately qualified doctors in relation to the proposed medical treatment, with a view to ascertaining whether the treatment would have the support of a responsible body of medical opinion”.

This implies that the innovating doctor need only rely on an interpretation of a responsible body, and need not gain the support from a responsible body itself. In practice this might not be a problem, however, as the Bill specifically states that those supporting views must be obtained from “appropriately qualified doctors”—that is, those with appropriate expertise and experience in dealing with patients with the condition in question. It may therefore be taken that the doctor is qualified in the relevant field, which would provide reassurance. It is this clause that many of my constituents are concerned about, however.

This brings me to another point that was raised by my hon. Friend the Member for Totnes. Some of my constituents fear that the database could be used as a tool by quacks, crooks and charlatans, giving them the flexibility to use devious experimental treatments. Indeed, that concern has been echoed by the Royal College of Surgeons, which claims, in reference to clause 3(2)(a):

“This sub-clause could also provide post-hoc justification for an unethical treatment from a doctor asserting s/he sought the view of one other doctor.”

We must be sure, therefore, that appropriate safeguards are in place to protect patients from such doctors. I do not think that many of them exist, but I do not know. My hon. Friend the Member for Totnes and I might have some disagreement about that. The important point is that there needs to be a safeguard, because it is inevitable that some such doctors will exist.

[Chris Heaton-Harris]

Those safeguards do exist. A doctor has to act responsibly, and if he does not do so, the full weight of the GMC and the law will come down upon him. That situation will not change at all as a result of my Bill.

[Philip Davies]

I take my hon. Friend’s point, and we should recognise the work of the General Medical Council in ensuring that high quality people are in the profession.

Much of the debate has rightly focused on the impact that the Bill would have on doctors and the medical profession, and on whether it would give them further freedom to innovate or whether it could be misused. However, it seems to me as a layman that much of the focus should also be on the patient. Ultimately, it is the patients who will bear the consequences of this legislation. Many of my constituents, on both sides of the debate, have contacted me to offer opposing views on the effects the Bill would have on patient safety. Some are concerned that it would move the focus from determining whether a patient’s care had been negligent to whether the doctor’s decision had been responsible.

However, the Bill would provide another layer of protection for patients in that the assessment would be carried out before the innovative treatment took place. By following the steps of the common law test, the doctor would obtain the views and support of a responsible body of medical opinion before innovating, so that they could be confident in the knowledge that they had support and would thus not be found negligent. This would of course provide reassurance to the doctor administering the innovative treatment, but more importantly, it would also be in the patient’s interest. Patients could therefore be satisfied about the treatment plan they were undergoing. Any innovative treatment plan must, by definition, come with concerns, but at least the patient could be assured that the doctor had satisfied legal and sound tests to show that the proposed treatment was responsible.

The Bill also sets out that during their research enquiries, the doctor must act and record views in a responsible manner. Therefore, if an appropriately qualified doctor were to consult on the proposed innovative treatment and express reservations about it, the innovating doctor could not disregard those reservations without being found negligent. That is an important point that should not be forgotten. Presumably, the powers of the GMC could kick in at that point to deal with any parts of the medical profession that we might not be altogether pleased with. My hon. Friend the Member for Totnes should not discount the fact that this legislation could highlight some of those cases and bring to account certain people who are hidden from such exposure at the moment. The aim of these provisions is to preserve the existing safeguards of the common law for the patient while giving the innovating doctor the additional choice of taking steps to show that they have acted in a responsible manner prior to innovating, thus aiming to encourage most doctors to do so without fear of litigation.

It is also important to touch on the possibility of unintended consequences. On Fridays, we often debate Bills that have a worthy sentiment behind them—indeed, that applies to most of the Bills that we discuss on Fridays—but they often turn out to be accompanied by unintended consequences. Some of the potential unintended consequences of this Bill have been raised with me by my constituents. One such concern is that the Bill could inadvertently undermine the work of clinical trials or discourage patients from participating in clinical trials, instead leaving doctors to focus on individuals on a case-by-case basis.

Clinical trials, by definition, test methods that aim to be of general benefit in combating a disease collectively—that is, they aim to find a common solution that can work with all, or nearly all, patients. The concern is that if doctors are encouraged to use innovative treatments when treating their individual patients, this could harm the development of research and clinical trials, as they may bypass the need for a regular clinical trial, leaving innovation to develop on an individual level. That seems to be a reasonable point for my constituents to have raised.

Having said that, the proposal could provide an opportunity to enhance the work of clinical trials and research. I hope that my hon. Friend the Member for Daventry will look further in Committee at any unintended consequences, and determine what, if anything, needs to be done to the Bill to prevent any harm from being done to clinical trials. It could boost clinical trials, but there is the potential for both consequences, and we must ensure that it results in a good conclusion rather than a bad one.

If a doctor were to use an innovative treatment on a patient that seemed to be successful, and subsequently recorded it on the medical database, a larger-scale clinical trial could be established to determine whether the treatment provides an inclusive solution for the disease or is suitable only for that individual. I hope that such a complementary consequence will occur as a result of the Bill, and that the understandable concerns of my constituents will be unfounded. The Bill does not create the climate for innovative treatment to begin. Doctors already have the freedom to innovate in individual cases, and that has not yet caused any difficulties or concerns for researchers or clinical trials, so there is no reason why it should do so in the future.

When considering the unintended consequences, we must also consider the unintended positive consequences, such as the one highlighted by the Royal College of Surgeons. It has stated:

“We…believe the Bill could potentially help to prevent poor practice in the private sector where decisions to try unconventional treatments are, in some rare instances, taken without adequate evidence or support from a multi-disciplinary team (MDT decision-making is less common in the private sector).”

Passing the Bill, and setting a more robust legal framework, would automatically set a precedent in the medical community for the procedures that would be expected to be followed when using innovative treatments.

--- Later in debate ---

[Philip Davies]

I do not think that anyone would disagree with my hon. Friend. Everybody is concerned about patient safety. I have stated at length some of the concerns that my constituents have raised about, for example, anonymity and safety. I hope that all those points will be considered by my hon. Friend to see whether anything further needs to be done in Committee. No one disagrees with that, but saying that we cannot have a Bill that does not protect patient safety is probably not the same as my perspective.

[Chris Heaton-Harris]

What my hon. Friend the Member for Totnes (Dr Wollaston) has to answer is what provision she would put in place to recognise failure of innovation. If this database is not the right way forward, what is?

[Philip Davies]

I do not propose to be the central hub of a three-way conversation involving my hon. Friends. I am sure that they are perfectly capable of sitting down in the Tea Room afterwards and going through this in some detail with each other, and they can leave me alone. They do not need me to speak on their behalf. We will leave the three-way conversation there, and I will press on.

Finally, I wish to raise the accelerated access review, which my hon. Friend the Member for Totnes mentioned. In 2014, an external review of the development, assessment and adoption of innovative medicines and medical technologies—the accelerated access review—was announced. This is expected to make recommendations to Government on speeding up access for NHS patients to cost-effective, innovative medicines, diagnostics and medical technologies. Some medical organisations have said that they wish to wait to see the recommendations of this review before implementing changes to rules around innovating treatments. I think that was the main thrust of the speech of my hon. Friend the Member for Totnes. The Royal College of Surgeons said:

“The Government’s consultation on the Accelerated Access Review recently closed and this is likely to prove a more productive route for identifying ways to encourage innovation.”

However, in an article earlier this year, my hon. Friend the Minister for Life Sciences—just to prove that I do read his articles—linked this Bill specifically to the Government's accelerated access review. He stated:

“The Medical Innovation Bill highlighted some of the important issues and obstacles to the adoption of innovation in the NHS. The growing pressure from patients and medical charities for faster access to innovation, and the potential of the NHS as a world beating research ‘engine’ in 21st century life and health science creates an opportunity for the UK to deliver benefits for patients, NHS and economy. This is the aim of my accelerated access review of NHS adoption of medical innovation. I look forward to working with Chris Heaton Harris to help him shape a Bill to help unlock this exciting opportunity.”

I look forward to the Minister’s comments in due course, but it seems to me that, rather than the accelerated access review being an alternative or something different from this Bill, the thinking is that these two things can go hand in hand with each other, and that one does not contradict the other.

Although the AAR is expected to report recommendations back to Government at the end of the year, its briefing specifically lists

“barriers that currently prevent the uptake of transformative healthcare within the NHS and the healthcare industry.”

Three areas are specifically mentioned: insufficient skills to adopt innovation; lack of leadership support for innovation; and lack of accountability for innovation. Those are just three points I have picked out from the list of areas identified for recommendations by the AAR. It seems that it is those issues that my hon. Friend’s Bill aims to target and it is therefore within the scope of what the AAR is trying to achieve.

In conclusion, this Bill attempts to provide leadership and support for innovation by setting a precedent that innovation should be encouraged and nurtured. It specifically pinpoints accountability by providing doctors with a test to satisfy prior to the beginning of any innovative treatment in such a way that satisfies doubts that the innovating is of a responsible nature. Finally, and most significantly, it sets a base for sufficient skills to adopt innovation by providing a database from which other doctors can work together and learn.

Ultimately, this Bill is not only for doctors; it must and should focus on the patients it affects. Although doubts are cast over whether the regulation to ensure innovating treatments are created responsibly, we must also consider the principle that responsibility can be satisfied before the innovating treatment is administered, thus reassuring the patient as well as the doctor. There is also a compelling argument that those patients who want innovative treatments—they may not be able to wait for lengthy research and approval systems—should be given the option to use innovative treatments. Those treatments should not be withheld because a doctor fears litigation. The patient should always be at the centre of what we do, and we should provide legislation that allows them to use the medical treatments of their choice that have that doctor approval.

I commend my hon. Friend for introducing this Bill, because he has hit on something that matters to a great deal of people. I have constituents on both sides of the argument. There are legitimate concerns, but I have heard nothing today that does not persuade me that this Bill should go forward from its Second Reading. I hope that some of the concerns that I have outlined today will be considered by my hon. Friend in Committee and that we end up with a Bill that is welcomed by those who support it and that deals with all the concerns that have been raised.

[Mr David Nuttall (Bury North) (Con)]

As always, it is a great pleasure to follow my hon. Friend the Member for Shipley (Philip Davies), who has set out with his usual clarity the reasons why the Bill should receive the support of the House today. I too rise in support of the Bill.

I warmly congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on his success in coming second in the ballot for private Members’ Bills and on choosing such an important subject to bring before the House this morning. As we have seen, it is a Bill that is not without some controversy. Often, private Members’ Bills are technical and minor in nature and do not receive much public attention, but it is fair to say that this one very much has. It brings before the House—I think that I am right in saying that it is the first time that these issues have been debated on the Floor of the House—the issues that were considered in the other place when the Lords debated the Medical Innovations Bill, which was piloted through all its stages by the noble Lord Saatchi in the previous Parliament. I note, incidentally, that the noble Lord reintroduced his Bill on 8 June. I hope that he does not fear for the possible success of this Bill; perhaps he is just hedging his bets. I certainly hope that this Bill will proceed safely through this House and arrive in the other place.

The Bill builds on the work of Lord Saatchi’s Bill in that it deals, I think adequately, with some of the criticisms of it. The purpose of this Bill, as we have heard, is to promote the use by doctors of innovative medical treatments and it does that by allowing for the establishment of a database of such innovative medical treatments and by setting out the steps that doctors can take to demonstrate that they are acting responsibly in carrying out such treatments.

I have to admit at the outset that an impressive array of bodies have lined up either in outright opposition to the Bill or with at least some reservations about it. When I was considering the evidence, I had to take that into account. I had to decide whether in the light of that evidence I should simply go with the flow and decide that if all those people said that it is a bad thing, it must be a bad thing, or whether I should think about the other side of the coin. I did that, and on balance, I came down on the side of what I like to think of as my constituents’ view. I believe that the Bill has the potential to improve the lives of my constituents if they are struck down by a rare disease that means that they require innovative medical treatment.

It is appropriate to try to deal with the concerns that have been raised by so many eminent bodies in the medical world. As we have heard, last year, many organisations responded to the consultation on Lord Saatchi’s Bill. Like my hon. Friend the Member for Shipley, I shall try to deal with some of their concerns. The professional body for doctors, the British Medical Association, often described as the trade union for doctors, said in its consultation response to the Medical Innovation Bill:

“The BMA believes strongly in the value of innovation in medicine. Whilst the BMA would have concerns if the draft Medical Innovation Bill was to become law, if there was a need identified, we would support the exploration of other initiatives through which responsible, safe and effective innovation can be promoted to doctors.”

In its 2014 response to the consultation on that Bill, the AMRC, the Association of Medical Research Charities, a national organisation made up of 137 leading research and medical charities from across the UK that, incidentally, spends about £1.3 billion a year on research, welcomed the ambition of the Bill but was concerned about its unintended consequences. In February this year, it welcomed the idea proposed in the other place about the importance of collecting data. I am pleased to note that the Bill we are considering today appears to address that concern by establishing a database to collect the results of innovative medical treatment.

Without wanting to create confusion, I want to refer to another body that raised concerns, another AMRC—not the Association of Medical Research Charities this time, but the Academy of Medical Royal Colleges, a body that comprises 20 medical royal colleges and faculties from across the UK and Ireland. It agrees with the idea that research and innovation are vital to the NHS, but does not support the Bill as a whole because, in its words, it is not clear what it is trying to achieve.

It is therefore a considerable challenge for my hon. Friend the Member for Daventry and those of us who support the Bill to demonstrate the need for it. To put it simply, I believe that it will provide access to innovative treatments to best meet a patient’s desires and needs when other treatments might not achieve the best results. People might well ask why we need the Bill now. The law on medical negligence has not changed for decades and in those decades medical innovations have been made. The law might not have changed much, but society certainly has—it is more informed, less deferential and more litigious. The number of lawsuits filed against the NHS has doubled in five years and last year’s pay out, which has also doubled in that time, was £1.2 billion. The Treasury provision for claims against the NHS has now reached £26 billion, so it is no surprise that doctors increasingly feel frightened of being sued and therefore, understandably, feel less likely to be able to innovate.

It is worth noting that back in 2013 the Health Service Journal stated:

“It is a popularly held view that the NHS is resistant to innovation. Despite several laws and policy directives and many successful examples of innovative approaches resulting over the years, the NHS is still seen to a late adopter of innovation—inventive but not creative.”

I believe that the Access to Medical Treatments (Innovation) Bill has the potential to counter that problem by putting innovation on a statutory footing.

NESTA, the independent charity in the UK that works to increase innovation in the UK, considered the whole question of innovation in the healthcare system in its 2014 report, “Which doctors take up promising ideas?” It highlighted the early adoption of drugs by general practitioners since 2010 to treat conditions such as diabetes, chronic constipation in women and deep vein thrombosis as well as to prevent stroke in patients with atrial fibrillation as an alternative to warfarin. The study also found that 86% of doctors found out about other innovative treatments from other doctors. It is a crucial component of this Bill that it places a responsibility on any doctor wishing to undertake innovative treatment to talk to another doctor about the proposed treatment.

NESTA’S report also recommended that there should be clear instructions on innovation to encourage early adoption, which is what I believe that the Bill aims to do, to provide reassurance, and to provide instructions to doctors to allow them to adopt life-saving treatments only when it would be in the best interests of their patients. The Bill would extend and encourage the idea sharing that is already going on between doctors and give them confidence in that process.

One of the key objections made by bodies such as the BMA was the “unproven threat” of litigation against doctors. In the summer, it was reported in the press that between 2010 and 2013 there was a 64% increase in the number of complaints to the UK medical regulator, the General Medical Council, and a 42% increase in the number of doctors struck off or suspended from the UK medical register. Let me make it clear that I believe that patient safety must be paramount. It is right that patients have access to our world-class justice system if, sadly, things go wrong. It is, however, a curious observation to make that there is an “unproven threat” of litigation when the bill for legal fees paid out over clinical negligence claims in 2013-14 was £259 million, with many believing that there is an increasing culture of litigation.

The Royal College of Ophthalmologists expresses a common view:

“Without unequivocal GMC and NICE support, ophthalmologists are understandably concerned that they may be assuming unacceptable personal liability by using a unlicensed drug when a licensed alternative exists … Consequently, patients may not be getting treatment when they need it and not getting the best results.”

Of course, the Bill must not be seen as a licence to experiment on patients, which is one of the more sensational claims I have seen about the Bill. I believe it clearly preserves the existing safeguards of the common law, which protect the patient while giving the doctor the option to take steps to demonstrate that the action they have taken has been taken responsibly before carrying out any innovative treatment.

As the guidance notes make clear, if another qualified doctor expresses reservations, those would have to be taken into account or, quite appropriately, the prescribing doctor could be found negligent. I do not believe that this Bill is simply a “get out of jail free” card for negligent doctors. It does not override the Bolam test, which was first set out in the leading 1957 case of Bolam v. Friern Hospital Management Committee. In that case Justice McNair said in his judgment that a doctor

“is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”.

Therefore, a doctor would be negligent under the current law if they treat or manage a patient in a way in which no responsible body of doctors would have acted. That test was extended to include a requirement that they must also act in a logical manner, which is called the Bolitho test, established in the case of Bolitho v. the City and Hackney Health Authority.

I believe the Bill contains the appropriate reassurances that doctors cannot use it to run roughshod over the existing law. The necessary reassurance is contained in particular in clause 3(5), which explicitly states:

“Nothing in this section permits a doctor to carry out treatment for any purpose other than the best interests of the patient.”

To ram home that point clause 4(1) clearly states:

“(1) Nothing in section 3—

(a) affects any rule of the common law to the effect that a departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion, or

(b) is to be read as limiting the circumstances in which any such rule of the common law may be relied on”.

I do not believe, therefore, that the Bill would limit redress in the event of negligence. A doctor would still be negligent if they acted in a way that was not in the best interests of their patient. However, the Bill would put into legislation a workable framework to allow responsible innovation where that would serve the best interests of the patient when a conventional treatment or lack of treatment might not meet the same goal.

I turn to the concerns of the Royal College of Surgeons, a professional membership organisation and a registered charity, which exists to advance surgical standards and improve patient care, with 20,000 members in the UK and abroad. That body has issued a parliamentary briefing on the Bill and one of its concerns is:

“The wording of the Bill confers the decision-making power on the doctor rather than the patient. There is a risk it misunderstands the doctor-patient relationship.”

The RCS may think there is such a risk, but having read the Bill and the guidance notes I fail to see that. As I have mentioned, the Bill clearly states the importance of the doctor acting only in the best interests of the patient and consideration being given to the patient’s views.



Clause 3(2) states:

“For the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition, a doctor must in particular . . .

(c) obtain any consents required by law to the carrying out of the proposed treatment”.

The guidance notes for clause 3 clarify that that means that

“the Bill does not affect the legal requirement for a doctor to obtain a patient’s informed consent to any treatment proposed”.

It could not be clearer. The Bill does not affect that legal requirement for a doctor to obtain the informed consent of a patient. Indeed, only this year in the Supreme Court was the issue of consent and a patient’s understanding of treatment considered in the case of Montgomery v. Lanarkshire Health Board, when it was held that it would be a mistake to view patients as uninformed, incapable of understanding medical matters, or wholly dependent on information from doctors. It was said that an adult of sound mind was entitled to decide which of the available treatments to undergo, and their consent must be obtained before treatment is undertaken. Doctors are under a duty to take reasonable care to ensure that their patients are aware of any material risks involved in proposed treatment, and of the reasonable alternatives available.

This seems to be in accordance with guidance from the General Medical Council which, as one would expect, provides lengthy guidance on the question of consent and outlines the steps a doctor should take to communicate in

“clear, simple and consistent language”

to a patient and to work on the presumption that patients have the capacity to make decisions about their own care.

The RCS is also concerned that

“the emphasis in the Bill is on proving the doctor’s decision was responsible. Courts are not asked to deal with whether a patient’s treatment has been negligent.”

I do not understand that comment. It seems to me that the courts would clearly be invited to deal with the question of negligence if something went wrong and the patient could establish that the necessary steps had not been taken by the doctor. I cannot see how the courts would not be asked to deal with whether a patient’s treatment had been negligent. As I hope I have demonstrated, the Bill makes it clear that it does not seek to override the law on negligence. The focus is all about providing a framework in which a doctor can act responsibly.

NESTA’s 2014 report found that 73% of GPs surveyed said that they would be most likely to collaborate with other doctors when adopting innovations. Therefore, three out of four doctors—the vast majority—are already familiar with talking to their peers and working with them in a collaborative manner in this area. The requirement for consultation is simply what for them would be the natural course of action.

With people becoming ever more inclined to look for someone to blame when things do not turn out how they had hoped, and therefore with the threat of legal action increasing, it must be right that this House looks across the board at ways of making the vital work that our doctors do easier. I believe that allowing for responsible innovation as a means of treating patients who wish to receive such treatment is a positive way to help them.

A further concern from the BMA is that it believes doctors can already innovate as much as they need to. It states:

“The BMA has received anecdotal reports from members that funding requests for innovative treatment are submitted and approved, often on condition that the results will then be distributed, adding to the wider body of medical knowledge.”

I think that the very use of the word “anecdotal” suggests that we need a much greater degree of standardisation of approach. As far as I can see, that is precisely one of the problems that the Bill seeks to address: the fact that, at present, there is no standard basis for the recording of innovative medical treatments.

I am pleased to see that one of the changes in the Bill, compared with Lord Saatchi’s Medical Innovation Bill, is the establishment and maintenance of a database, to be held and managed by the Health and Social Care Information Centre, because I believe that will provide an additional method of evidence-building for doctors. I note that the Royal College of Surgeons has suggested that a clinical society might instead manage the database, if it is limited to one area of medicine. Although that suggestion might warrant further examination, I have a couple of concerns about it.

First, taxpayers’ money has gone into the establishment of the Health and Social Care Information Centre, which is an executive non-departmental body under the care of the Department of Health. It is the national provider of information, data and IT services for commissioners, analysts and clinicians in the health and social care sector, so it seems to me to be the ideal body to carry out that function. I have no doubt that taxpayers would expect it to carry out that work.

Secondly, I believe that there are considerable advantages in having a single database that doctors can consult, as the Bill proposes, rather than several. A database that shares innovative medical treatments would help improve the spread of best practice. The Government’s competitiveness indicator report showed that medicines in the third year after launch were used in the United Kingdom at a level that was, on average, only one third of the average usage in the comparator countries, which included France, Germany and the United States. I believe that the creation of the database would go some way towards closing that gap.

The Academy of Medical Royal Colleges has expressed a concern that the database would be a substitute for research and might even sidestep clinical research. I take the view that the purpose of the database, which is to be a collection of reports on individual innovative treatments outside conventional methods, would not have that consequence. The academy has also expressed concerns about the complexity of establishing a database and maintaining confidentiality. There is no doubt that the confidentiality of medical records is something that we must all take seriously. However, I do not believe that just because something is complex is grounds for us not doing it at all. I appreciate those concerns, given the roll-out of the care.data scheme, but the database proposed in the Bill would be very different. It would be much smaller in scope, in terms of the number of people it would relate to, than the care.data scheme, which has the records of virtually everyone, unless they have opted out.

The Royal College of Surgeons accepts the need for research to be made available, but it does not see the need for the database proposed in the Bill. It states:

“Surgeons in England have been the first in the world to publish their individual outcomes from surgery. We support this level of transparency in all areas of surgery including research and innovation. The College expects all researchers conducting trials, including those we directly support, to register the trial in a publicly accessible database. However, we do not see the need for a new database of innovative treatments in surgery. A number of audits in surgery already exist and it is unclear what different data this additional database would cover. It would be helpful for the Government to clarify what data it envisages collecting under this Bill”.

I am sure that the Minister will cover that in his remarks later today. I believe that most patients who benefit from a particularly innovative treatment, especially if they are the first to benefit, would have no objection to their treatment being recorded anonymously.

The Royal College of Surgeons also states:

“We believe the Secretary of State already has the power to establish a non-statutory database of innovative treatments without legislation.”

Well, if that is the case, there is nothing in the Bill for it to worry about. What is clear is that if the Secretary of State does have that power, he has not used it. Indeed, I believe that there is scope to strengthen the Bill, if it proceeds to its later stages, to clarify when the establishment of the database can be expected.

The NHS’s 2011 publication “Innovation: Health and Wealth” lamented

“brilliant examples of pioneering work”

so often being “isolated examples”. As a principle of furthering innovation, therefore, surely gathering evidence in the database would be helpful to medical advancement. If treatments look like they are working, it must be right that the public and, of course, doctors know about it.

As with any new piece of legislation, we must be mindful of the cost to the public purse. That is one of the areas where I believe we still need more information at this stage. We do not yet have any real sense of what the financial implications would be, although I note that a full impact assessment is promised before the Bill goes to Committee. NHS England has forecast an annual cost increase for drugs in specialised services of 11%, rising from £2.4 billion in 2013-14 to £4.5 billion in 2019-20. I sincerely hope that the impact assessment will give some estimate of the impact that increased use of innovative treatments will have, for example on drug expenditure in the longer term.

I also believe that the impact assessment should consider what effect the Bill would have on the early access to medicines scheme, which was not in operation when the Medical Innovation Bill was first debated. The scheme allows patients to access medicines at an earlier stage in their development, following a risk-benefit assessment and subject to ongoing data collection.

A lot has been said about this Bill being potentially dangerous for patients. Yet doctors are currently prevented from carrying out reckless or dangerous treatments by the risk of proceedings being taken against them—either civil proceedings or, in the worst cases, criminal proceedings. Nothing in the Bill makes that risk any less likely. All the safeguards that are in place in law at the moment would simply remain in place.

[Chris Heaton-Harris]

I completely underline what my hon. Friend is saying. If a doctor is acting responsibly, they have nothing to fear; if they are acting irresponsibly, this Bill does not help them, and they will suffer the consequences of their actions.

[Mr Nuttall]

I am grateful that the sponsor of the Bill agrees with me on this, because it is the key point of the whole debate. Those who oppose the Bill have alleged that it will somehow put patients at risk. If that were the case, I would not be supporting it. I am supporting it because having read it carefully, and having considered all the evidence and all the views of all the professional bodies that are ranged against it, I have come to the conclusion that patients would have all the safeguards after the Bill has been passed that they do now.

The Bill has the potential to increase and improve the range of medical treatments available to my constituents.

[Mr Nuttall]

I am grateful to my hon. Friend. The arguments are finely balanced. As he said, he has constituents who support the Bill and constituents who are against it. If the Bill receives its Second Reading, as I hope it will, the concerns of those who have reservations about it, and those who go further and are outright opposed to it, can be considered in detail in Committee and, if possible, reflected and taken into account by way of appropriate amendments at that stage or on Report.

[Chris Heaton-Harris]

I assure my hon. Friend and all other Members who have spoken, and everybody I have been in consultation with to get the Bill to this stage, that should it get through its Second Reading, I will continue to consult, to listen, to talk to and to take advice from all organisations with an interest to make sure that we take into account and deal with as many as possible of the concerns outlined by him, by other hon. Friends, and by Opposition Members.

[Mr Nuttall]

I hope that my hon. Friend’s intervention will go some way towards satisfying the concerns of those who are opposed to the Bill.

From what we have heard, there seems to be a general acceptance of the principle in the Bill that there should be greater access to medical innovation. Even looking at the views of the various medical bodies—an impressive array, as I said—the best interpretation is that some are outright opposed and others are ambiguous. Either way, they all share the view that medical innovation is a good thing. It seems to me that the devil is in the detail. I hope that my hon. Friend’s confirmation that if the Bill proceeds he will be generous in speaking to people and looking at all possible ways of dealing with their concerns will persuade the House to give it a Second Reading.

Research and innovation are crucial to the continued success of healthcare. The NHS faces increasing demands: a growing population with an increasing lifespan, which is a good thing; an increase in its own capability, fuelled by advances in knowledge, science and technology; and ever-increasing expectations from the public it serves. We should not shy away from new ideas that put the patient first and offer chances that they may not otherwise have. This Bill will increase the likelihood of life-saving solutions being found where they did not previously exist. It will mean more choice for patients—for my constituents. It will provide doctors with a mechanism to enable them to use innovative treatments giving them the best possible chance to do what they do best—help patients. I support the Bill and trust it will receive its Second Reading.

--- Later in debate ---

[Chris Heaton-Harris]

Even though there has been some negativity, this has been a very positive debate. I have enjoyed trying to work with various colleagues and all the royal colleges—the list of organisations, actually, that my hon. Friend the Member for Totnes (Dr Wollaston) read out—and I hope that if the Bill has its Second Reading, I can continue to try and work with them, because I think the aspiration and concept behind the Bill, of spreading best practice and innovation quickly throughout our national health service, has widespread support. If this Bill is not the right mechanism, as I said earlier I am very willing to work in Committee to amend and change and to get to the point where I would like to think I could allay any concerns. So I thank everybody for their contributions, give them that assurance, and commend this Bill to the House.

Question put, That the Bill be now read a Second time.