Access to Medical Treatments (Innovation) Bill

– in the House of Commons at 9:30 am on 16th October 2015.

Alert me about debates like this

Votes in this debate

Second Reading

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry 9:48 am, 16th October 2015

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.

Photo of David Nuttall David Nuttall Conservative, Bury North

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?

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.”

Photo of Edward Leigh Edward Leigh Conservative, Gainsborough

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?

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.”

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of Wendy Morton Wendy Morton Conservative, Aldridge-Brownhills

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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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 a fantastic idea, which so many cleverer minds than mine have conceived, as my own. 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.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health

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?

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of David Nuttall David Nuttall Conservative, Bury North

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?

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of Andrew Bingham Andrew Bingham Conservative, High Peak

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?

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of Edward Leigh Edward Leigh Conservative, Gainsborough

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?

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee 10:14 am, 16th October 2015

As with any book, we should not judge a Bill by its cover. All Members want to improve access to innovative medical treatments, but I sincerely believe that the Bill is not the right way forward. My hon. Friend Chris Heaton-Harris referred to a number of organisations, implying that they are in favour of the Bill, but he knows that the overwhelming majority of research and charitable organisations are ranged against it. It is opposed by the Association of Medical Research Charities, whose membership reads like an “A to Z” of expertise, including bodies such as Cancer Research UK, the Wellcome Trust—the list is very long, so I will not detain the House by reading it out. The Academy of Medical Sciences opposes the Bill, as does the Academy of Medical Royal Colleges, including all those he quoted in his speech.

The General Medical Council, the British Medical Association and the Patients Association oppose the Bill, and I direct my hon. Friend to their article in The Guardian. Action against Medical Accidents, and even the Association of the British Pharmaceutical Industry, oppose the Bill because of its unintended consequences. Legal experts, including Sir Robert Francis, firmly oppose the Bill. All those organisations oppose the Bill because it is unnecessary, it is unworkable, it would unravel important patient protections and, most importantly, it would have unintended and dangerous consequences for research.

I pay tribute to all the Bill’s sponsors and absolutely understand that they are motivated by very good intentions. I would love to sit down and work with them on how we genuinely improve access to innovative treatments. I hope they understand that I oppose the Bill because I sincerely believe that it is the wrong way forward.

The Secretary of State already has the power, as Heidi Alexander pointed out, to set up a register of innovative treatments, so we simply do not need that provision. We also do not need the heavy hand of legislation. We do need a register, but it needs to be set up by the research bodies themselves and to be adequately funded. We absolutely need transparency. There is a danger that we will misunderstand the science.

Photo of Christopher Chope Christopher Chope Conservative, Christchurch

My hon. Friend refers to the power of the Secretary of State to set up a system. When does she expect that to happen, and what is causing the delay?

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

My hon. Friend makes a good point. Principally, there are issues with funding and complexity. The Bill fails to recognise the science and the issues that a vast, sprawling database might cause. My hon. Friend the Member for Daventry referred to the desirability of the public being able to access a database and gave the example of male pattern baldness. There would be vast profits to be made by the quackery industry from male pattern baldness products. I envisage a vast, sprawling database of anecdotal treatments, and I am afraid it would act as free advertising for the quacks of this world. It is an invitation to quackery.

I started in medicine in the late ’80s and worked for a while in paediatrics. The prognosis for children with leukaemia was grim, but today most of the children diagnosed with the same conditions will survive and thrive, not because of access to a vast, sprawling database of unconnected, anecdotal treatments but because of the meticulous progress of medical research, whereby with thousands of people we compare existing treatments with innovative treatments and find out which are genuinely the best. Any single anecdotal treatment might be effective in one single patient, but that does not tell us whether, when applied to a population, it is better or not.

Another problem with the Bill is the danger that it would undermine medical research. In effect, it would give private clinics the opportunity to offer anecdotal treatments as a way of bypassing clinical trials. When individuals, and particularly parents, are desperate because they have a dreadful diagnosis, they are at their most vulnerable to the claims of individuals who say, for example, “Look at the database and see how it worked for Mr Smith.” They might be lured into thinking that was the best way forward. Someone in a very vulnerable place might be lured into not taking part in a clinical trial by the siren call of an anecdotal treatment recorded on a publicly accessible database. I am afraid that the Bill would undermine research, and that is why the vast majority of bodies are very unhappy about it.

My hon. Friend should reflect on all the concerns that have been expressed about the Bill, and think about how science moves us forward. We progress not by a series of anecdotal treatments but through a solid research community.

We need greater access to clinical trials. The searchable database set up by the National Institute for Health Research is a welcome step forward, but it is rather clunky. Patients need to be able to see very clearly what trials are available and be able to take part in them. There is progress, people are surviving today with treatments based on clinical trials that may have taken place 10 years ago and many go on themselves to take part in clinical trials that will benefit future generations. It is absolutely vital that we continue to support this approach.

Photo of Bob Stewart Bob Stewart Conservative, Beckenham

I thank my hon. Friend—a good friend—for giving way. Does she believe that there is no place for any sort of list whatsoever and that the system should be left as it is, or is she suggesting that a list could be made up? I understand all her inhibitions and worries about such a list, but should it be considered?

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

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.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health 10:30 am, 16th October 2015

I congratulate Chris Heaton-Harris on securing a place in the private Members’ Bills ballot and thank him for meeting me this week.

Sometimes in this place, we need to be careful what we wish for. The process of steering a private Member’s Bill through Parliament not only is time consuming, but can become very complicated. I suspect that, after the contribution of Dr Wollaston, the hon. Gentleman may be feeling that. I should probably be honest and warn him that my contribution may add to his headache.

The very fact that we are discussing the Bill means that we are having a vital debate about the critical issue of how we can improve patients’ access to innovative and effective treatments. In putting his case for the Bill’s Second Reading, the hon. Gentleman has demonstrated that he has the right intentions, but that is probably the best thing I can say.

Many people in this House will have been in the position of seeing someone they love dying too soon. In such situations, people want hope. I understand that. They want hope that there is a treatment or drug that offers a chance of survival or of extending life that little bit longer.

If I thought that this legislation would provide genuine, well-founded hope in a safe and sound manner, I would support it, but I am not convinced that it does. In truth, I am worried that it does the opposite. I am worried that unsafe treatments could be used on dying patients. I am worried that the Bill would muddy the waters for doctors who wish to innovate about the legal route to do so, that it would reduce participation in clinical trials and that it would reduce legal redress for patients with a genuine negligence claim.

In the few weeks that I have been in this job, I have approached the Bill with an open mind. I have met a range of experts, patient groups, royal colleges and charities. It is fair to say that they are overwhelmingly opposed to the Bill. I will put some of their concerns to the promoter of the Bill and to the Minister, who I understand is actively supporting it.

The first concern that has been put to me is that the Bill attempts to remedy a problem that does not exist. I will briefly quote a few of the experts in this area. The Academy of Medical Royal Colleges has said that

“the Bill rests on the false assumption that it is fear of litigation that is holding back innovation by doctors. There is simply no evidence that this is the case”.

The British Medical Association has said:

“We are not aware of any evidence to suggest that the threat of litigation inhibits innovation or that confusion exists amongst doctors over the circumstances under which they can deviate from standard practice.”

The Royal College of Surgeons has said that

“there is no evidence that doctors are deterred from innovating due to the threat of legal action.”

The Motor Neurone Disease Association has said that

“the Bill would not remedy the problem it is aimed at, for such a problem does not exist”.

Sir Robert Francis QC, who has done so much in recent years to make sure that the NHS is focused, rightly, on patient safety, has said:

“The law of negligence does not prevent responsible innovation and never has.”

I could quote many more people, but I have probably made my point. Why do the hon. Gentleman and the Minister think that all those experts are wrong and they are right? What evidence do they have that litigation, or the fear of litigation, is preventing new treatments or hampering doctors from innovating? Even if that were an issue, does the Bill provide a robust and safe mechanism to tackle it? I am not sure that it does, but I am willing to work with the hon. Gentleman and the Minister, and anyone else who is interested, to consider how we can work on a cross-party basis to address any potential barriers to innovation.

Before setting out why I do not believe that the Bill is the right approach, I will first deal with clause 2, which provides the Secretary of State with power to establish a non-statutory database of innovative medical treatments. As the hon. Gentleman said, the clause was included as a result of concerns that were rightly raised in the other place by Lord Hunt when the previous incarnation of this Bill was debated. Lord Hunt’s amendment to that Bill would have required the Secretary of State to establish a database, but such a requirement does not exist in this Bill. As currently drafted, the Bill gives the Secretary of State “power” to establish a database, but places no obligation on them to do so.

I also question whether clause 2 is needed at all. According to the House of Commons Library, section 254 of the Health and Social Care Act 2012 gives the Secretary of State power to direct the Health and Social Care Information Centre to establish a system for the collection or analysis of information. Will the Minister confirm whether the Secretary of State already has the power to establish a non-statutory database of innovative treatments without legislation?

The Bill gives no detail about how such a database might work, but is that not crucial? A database will be effective only if it is compulsory, regulated and quality controlled. For a database to work requires participants to be just as likely to register failure as success. Will there be a requirement to remove an innovation that is not effective from the database? Will the database be quality assessed or peer reviewed? Will it be used for marketing to patients? The Bill makes no reference to those crucial points.

I am concerned about the impact of the Bill on research, and particularly on participation in clinical trials. As the Minister will know, we are a world leader in clinical research, and we must be careful not to do anything that would put that status at risk. Last December the Minister said that he hoped that the forerunner to this Bill would develop into a form that

“the vast majority of medical opinion and respectable bodies in the medical field feel able to support”.—[Hansard, 9 December 2014; Vol. 589, c. 853.]

I am not sure we have got to that point.

Let me list some of the medical research charities opposed to the Bill: Alzheimer’s Research UK, the British Heart Foundation, Cancer Research UK, the Motor Neurone Disease Association, Parkinson’s UK, the Wellcome Trust. Is the Minister comfortable supporting a Bill that those experts say could have

“significant unintended consequences for medical research”?

Photo of Bob Stewart Bob Stewart Conservative, Beckenham

I presume that one fundamental reason why such bodies are against the Bill is that they are concerned that people who are without much hope would pin everything on something that could largely be quackery. Those poor devils will be encouraged to think that there is hope for them, when actually they should come to terms with the truth of their situation.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health

I think that is broadly the point, but it also goes back to what the hon. Member for Totnes said about the impact on participation in clinical research trials. It seems entirely possible to me that a doctor might choose to prescribe an innovative treatment, or a patient decide to take an innovative treatment, rather than enter a clinical trial. If a patient is faced with the choice of guaranteed access to a treatment or participation in a trial in which there is a 50-50 chance that they will not be part of the group receiving the innovative treatment, why would they choose to be part of the trial? I would be grateful for the Minister’s comments on that. Does he not accept that the arrangements for clinical trials, including as they do monitoring and ongoing data collection, provide a much better mechanism for evaluating new treatments and advancing medical progress than a situation that could become more pervasive as a result of the Bill?

If the concerns I have set out so far are not enough, let me now turn to my main concern about the Bill, which, if passed, could undermine a patient’s ability to hold doctors to account when things go wrong.

Photo of Dennis Skinner Dennis Skinner Labour, Bolsover

It is on this very subject that I am interested. I have had treatment for cancer and a heart bypass and countless other things, which is why I am still here. I have had to give permission to countless doctors for them to take action. What I can see here is that the doctor’s permission, which lists a lot of things they might or might not do, would also have to include a list of innovative treatments before I signed the document. It says on the document, say, that there is a 50% chance of having a stroke or a 5% chance that you might die. I remember saying to one of the doctors in Brompton hospital, after I had signed one for the fourth time, that I was down to even money. I would not even be even money if a list of innovative treatments was added to the ones I am already required to attend to. I cannot see, for the life of me, how the doctors could avoid having to put that on the document before a patient signed it. Believe me, it would frighten people to death.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health

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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health

The Bill would just confuse matters. The alternative approach outlined in the Bill would create uncertainty and undermine the mechanisms already in place to safeguard patients. Could this not lead to doctors being absolved from any liability for an experimental treatment if they follow the Bill’s standards, making it much harder for patients to redress malpractice? Sir Robert Francis QC has said it would

“deprive patients of remedies when mistreated by those who have no acceptable justification for what they have done.”

In conclusion, we are faced with deep and broad concerns, as expressed by patient groups, medical research charities and royal colleges, and I do not think we can ignore those voices. They include Action against Medical Accidents, which says the Bill is a threat to patient safety; the Association of Medical Research Charities, which says it

“may adversely impact on patients and medical research”; and the Royal College of Paediatrics and Child Health, the president of which simply says the Bill endangers the safety of infants and children. It would be irresponsible to support the Bill, which is why I will be opposing it, and I encourage other hon. Members to join me.

Photo of Philip Davies Philip Davies Conservative, Shipley 10:45 am, 16th October 2015

I start by welcoming you to the Chair, Madam Deputy Speaker. It is an absolute pleasure to speak for the first time under your chairmanship on a sitting Friday, and it will be a great pleasure to do so again in the Fridays to come. I hope you enjoy it as much as I do. I congratulate my hon. Friend Chris Heaton-Harris on bringing forward this interesting Bill, on which we have had a good debate already. It would also be remiss of me not to welcome Heidi Alexander to her position under the new regime in the Labour party. I am sure she will do a splendid job, and I wish her every success in doing it.

I have been contacted by constituents about the Bill, both in opposition to and support of it. It seems to polarise opinion; people seem to be either very for it or very against it in a way that is not always the case with Bills. I want to outline some of the points brought to my attention, many of them by my constituents. I understand that the Bill aims to help doctors to develop safely and responsibly innovative treatments and cures for cancer and other diseases, and that the rationale behind it, as my hon. Friend seemed to confirm, is that the promotion of such medical innovation could lead to the development of new cures and more effective treatments for patients.

To that end, the Bill has two aims: to provide a regulation-making power to enable the creation of a database of innovative medical treatments and to enable doctors to access information on this database; and to provide an option for doctors who innovate to take steps in advance to show that they are acting responsibly, not negligently—which deals with some of the concerns already expressed. It specifically states that it would not apply to the use of treatments in research, thereby keeping that distinction, but rather would support innovation in the treatment of individual patients, while preserving the existing common law safeguards for patients. By bringing forward the legal test of negligence to the point of treatment, it allows doctors to remove the barrier of the fear of litigation when using innovative techniques and working in a manner held as largely responsible. Those all strike me as worthy sentiments, and it is difficult to see why anyone would be against them in principle.

The Bill cannot be seen in isolation from its origin and progression in Parliament. As my hon. Friend made clear, the Bill stems from Lord Saatchi’s Medical Innovation Bill, introduced in the last Parliament, which, it is important to mention, arose from Lord Saatchi’s personal experience of losing his wife to a rare cancer. I think, therefore, that we can all appreciate, and should be mindful of, the Bill’s intention, which was to try and prevent that from happening to other people. It aimed to provide a standard for the legal position surrounding innovation, hoping, in theory, to encourage doctors to use innovative techniques, confident that their good intentions would not be lost.

In taking up issues with the NHS on behalf of constituents, I have often seen its fear of litigation. That might apply if I take up a complaint about one of my local hospitals—I have very good local hospitals, but of course everybody makes mistakes and things do not always go according to plan. Sometimes responses from the NHS can be very defensive, not because it does not appreciate that something has gone wrong, but because it fears the consequences of admitting that something has gone wrong. We should always do what we can to try to help the NHS from that fear of litigation. Anything seeking to do that would be very worthwhile.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

That is an entirely separate issue. Admitting when a mistake has been made is entirely separate from the fear of litigation, which is some cases can be very reasonable. If a doctor is putting forward an entirely bogus treatment and pretending that it could be helpful when it could in fact be more harmful than existing treatments, that is an entirely separate issue. I hope my hon. Friend will not conflate the two.

Photo of Philip Davies Philip Davies Conservative, Shipley

I am rather surprised, given my hon. Friend’s background, that she has such little faith in doctors that she sees them wanting to peddle some bogus treatments. I was starting from the premise that the medical profession was far more responsible than that and would never seek to do that sort of thing. I certainly bow to my hon. Friend’s greater knowledge of the medical profession, but as I say, I was starting from the basis that her profession was nobler than she seems to indicate.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

Of course the overwhelming majority of the profession does behave responsibly, but the whole point about having protections in law is to accept that some would not behave responsibly. My hon. Friend Chris Heaton-Harris referred to hair loss, for example, which is a field where vast profits are to be made, and I am afraid some doctors might be tempted to behave irresponsibly.

Photo of Philip Davies Philip Davies Conservative, Shipley

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 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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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 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.

Photo of Philip Davies Philip Davies Conservative, Shipley

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.

Photo of Philip Davies Philip Davies Conservative, Shipley

I cannot understand how it could be both, but perhaps my hon. Friend will explain that for me.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

On my hon. Friend’s first point about Cancer Research UK, let me be absolutely clear that it is opposed to the Bill. On the second point, what these bodies are all saying is that the Bill is unnecessary, but that if it is put in place, it would be dangerous. That would be the consequence of the Bill, and people think there are other ways of moving forward to improve access to innovative treatments.

Photo of Philip Davies Philip Davies Conservative, Shipley

I merely read out, word for word, Cancer Research UK’s response to the consultation; I can do no more than quote its words. I will take my hon. Friend’s point in that regard.

Photo of Christopher Chope Christopher Chope Conservative, Christchurch

If there is such widespread opposition to this Bill, why was it that the Saatchi Bill made such good progress in the other place during the last Parliament, when I understand it had the benign support of the Government?

Photo of Philip Davies Philip Davies Conservative, Shipley

My hon. Friend often asks me questions that I cannot answer. He has now asked another that I am not in a position to answer. I often think it is a mistake to give way to him; he is far too clever for my liking. Again, he has stumbled across something that I cannot answer. He raises a very good point, so perhaps we shall leave it hanging there for others to have a crack at later in the debate.

The Academy of Medical Royal Colleges said that it applauds the intentions of the promoters of the Medical Innovation Bill:

“The stated purpose of the Bill is to encourage responsible innovation in medical treatment, and accordingly to deter innovation which is not responsible. Those are aims which medical Royal Colleges would wholeheartedly support and welcome.”

That is an important point.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

The Academy of Medical Royal Colleges robustly rejects this Bill. Like me, it supports the intention of extending access to innovative medical treatments, but it is very clear that it opposes the Bill—and this House should oppose it, too.

Photo of Philip Davies Philip Davies Conservative, Shipley

I am perfectly happy for people to put their own gloss on what others are saying. That is their right. If I may be allowed to do so, I am merely quoting, word for word, the responses that people made. If my hon. Friend is saying that the Academy of Medical Royal Colleges should not have written that, she should take that up with the organisation. I am merely quoting what it wrote, which I thought was quite clear.

Photo of Philip Davies Philip Davies Conservative, Shipley

I want to make some progress, but I will give way again to my hon. Friend.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

I must take issue with my hon. Friend because he is quoting very selectively from the report. When he has finished speaking, I urge him to go online and have a look at the detailed briefing on the Bill from the Academy of Medical Royal Colleges. It applauds the principle of improving access to medical treatment, but it is absolutely clear that it opposes the Bill.

Photo of Philip Davies Philip Davies Conservative, Shipley

I do not deny that. If the Academy of Medical Royal Colleges wants to shy away from any part of what I have said, the academy probably should not have written it in the first place. I did not write it on the academy’s behalf; the academy wrote it, and I have quoted it faithfully. People can make of it what they will, but what the academy said was that it

“applauds the intentions of the promoters of the Medical Innovation Bill…to encourage responsible innovation in medical treatment, and…to deter innovation which is not responsible. Those are aims which medical Royal Colleges would wholeheartedly support and welcome.”

That is what the academy has said. I did not say it on the academy’s behalf.

The Association of Medical Research Charities summarised its position as follows:

“We welcome the ambition of the Bill in seeking to address the important issue of encouraging medical innovation; innovation and its adoption can be low and slow in the NHS and there is much that can be done to improve this.”

Genetic Alliance UK said:

“There is much more that could and should be done to address the barriers that currently inhibit the adoption and integration of research and innovation into the NHS.”

The Royal College of Physicians said in its consultation document:

“The RCP strongly supports the aims of the Bill, and welcomes the debate and discussion around innovation that has occurred as part of the proposed Bill.”

Others will have different perspectives and will want to make other points as part of the consultation, but it seems clear to me, at least, that—as my hon. Friend the Member for Daventry said in his intervention, and as has been said even by those whom my hon. Friend the Member for Totnes says oppose the Bill—there is clearly something in the Bill that deserves further scrutiny in Committee.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health

Will the hon. Gentleman clarify exactly what he is quoting from? Is he quoting from the consultation responses provided by those organisations, or from the most recent briefings that were provided before the debate? It is well known that opinion among a number of organisations has hardened against the Bill.

Photo of Philip Davies Philip Davies Conservative, Shipley

I made it clear at the outset, but I am happy to make it clear again, that I am quoting from responses to the consultation. If those organisations want to shy away from any of those points, they are welcome to do so. As I have said, I am merely quoting what they said in response to consultation on Lord Saatchi’s Bill when these issues were first introduced.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

The point is that we all support the aim of improving access to innovative treatments; we simply do not agree that the Bill is the right way forward. Because my hon. Friend has quoted all those bodies, may I quote back to him the conclusion of the medical royal colleges? They will of course issue consultation responses that will be nuanced in relation to various points, but what we should look at is their conclusion, which could not be clearer:

“In conclusion, Medical Royal Colleges do not believe that the Bill should be supported.”

That is their position.

Photo of Philip Davies Philip Davies Conservative, Shipley

I think that my hon. Friend is slightly in danger of arguing against herself. She began her intervention by saying that all those bodies supported the principle behind the Bill, and it seems to me that that is really an argument for supporting its Second Reading. What we are discussing now is whether or not we agree with the principle of the Bill, and my hon. Friend has just said that all those organisations support that principle. She may well wish to scupper the Bill on Third Reading, or amend it in Committee so that it is to her particular taste, but, as I see it, announcing that everyone supports the principle behind the Bill is a call to arms for people to support its Second Reading.

Photo of Philip Davies Philip Davies Conservative, Shipley

I want to make some progress, but I will give way to my hon. Friend one final time.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

I thank my hon. Friend. He is being very generous. Can he not see, though, that supporting the principle of improving access to medical treatments is a completely different kettle of fish from supporting the mechanism whereby an individual Bill attempts to achieve that aim? In other words, it is perfectly consistent to say that one opposes the Bill robustly, as, indeed, did a long list of organisations and people, including research charities, medical royal colleges, Action against Medical Accidents and Sir Robert Francis. The list is huge. All those bodies state, robustly and clearly, that the Bill is not the mechanism to achieve those stated aims, and that is why the House should reject it.

Photo of Philip Davies Philip Davies Conservative, Shipley

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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of Philip Davies Philip Davies Conservative, Shipley

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.

Photo of Bob Stewart Bob Stewart Conservative, Beckenham

I came here to listen to my very good friend my hon. Friend Chris Heaton-Harris and to listen carefully to the debate. It seems to me that if Lord Saatchi’s Bill went into the sand and if this Bill does not make it into Committee and disappears, the one good thing that will come out of it is that the whole subject will be illuminated, and perhaps something good will come out of that. Therefore, the efforts of Lord Saatchi and my good friend the Member for Daventry will not be in vain. I hope very much that the medical authorities will look at this and think of it in that light.

Photo of Philip Davies Philip Davies Conservative, Shipley

I take on board my hon. Friend’s point. It seems to me that he was subtly saying he had come to listen to the speech of my hon. Friend the Member for Daventry rather than mine. I had hoped he had come to listen to my speech, but I am clearly mistaken.

Photo of Bob Stewart Bob Stewart Conservative, Beckenham

I must intervene. I always come to listen to my hon. Friend Philip Davies. I listen to him outside this hallowed hall and also inside it, and he is always well worth listening to.

Photo of Philip Davies Philip Davies Conservative, Shipley

My hon. Friend is very kind, although it would have been rather better if he had not had to be prompted to say that. Nevertheless, I will take those comments in the spirit in which I know my good friend intended.

Photo of Christopher Chope Christopher Chope Conservative, Christchurch

My hon. Friend has not responded to the intervention of my hon. Friend Bob Stewart. Surely the point is that if we want to discuss this in more detail in Parliament, the ideal opportunity for that is in Committee when it can have detailed scrutiny.

Photo of Philip Davies Philip Davies Conservative, Shipley

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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of Philip Davies Philip Davies Conservative, Shipley

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.

Photo of Philip Davies Philip Davies Conservative, Shipley

I was doing so well! However, I appear once again to have incurred the wrath of my hon. Friend.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

Not the wrath; I just want to point out to my hon. Friend that he is quoting selectively from the Royal College of Surgeons, which robustly opposes the Bill.

Photo of Philip Davies Philip Davies Conservative, Shipley

I am only quoting what the RCS has said. My hon. Friend might want to decry my statement, but the RCS’s overall conclusion on the merits of the Bill is a different issue. I am merely pointing out that it has stated that this could be a consequence of the Bill. People can draw their own conclusions from that. I would like to think that I have tried to be as even-handed as possible by outlining the potential benefits of the Bill as well as the other potential consequences. I have quoted organisations that have raised concerns. I am trying to be even-handed, whether my hon. Friend likes it or not—I suspect that she does not—and that is what the Royal College of Surgeons has said.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

Let me read some conclusions:

“we believe this law is unnecessary and potentially dangerous. It will absolve doctors from any liability for an experimental treatment if they followed the Bill’s low standards and will make it harder for patients to redress malpractice.”

That is the conclusion of the Royal College of Surgeons of Edinburgh and it is pretty clear.

Photo of Philip Davies Philip Davies Conservative, Shipley

That may well be that body’s conclusion as it stands, but my point is, as I have tried to make clear, that given that it can see there are potential benefits to the Bill, which I have expressed, in dealing with poor practice in the private sector, there is an argument for getting it into Committee to see whether we can make it a Bill that it wholeheartedly supports. That may or may not be possible, but it is certainly worth having a go, given that it has said clearly that the Bill has potential benefits.

Some medical organisations and groups have expressed their concern that the Bill will have an impact on the use of research clinical trials, but that should not be a sufficient reason to stop doctors using innovative treatments on an individual level. This should not be about one or the other—as I said, we should try to do both.

I was contacted, as I am sure many other Members were, by a concerned mother who is desperate for this Bill to pass so that it can benefit her young daughter, who suffers from a rare condition. As has been pointed out, the difficulty with rare diseases and conditions is that because they are so specific, research and clinical trials are not only costly, but very time-consuming. Many people suffering from these diseases do not have this time in finding a cure. The mother who contacted me explains that her daughter, Grace, is already awaiting the commencement of two clinical trials that may, in the long run, be able to help to treat her condition. Although she is appreciative of these movements, the mother explains that if, after the six-month or 12-month clinical trial, the drug is proven to be effective, her daughter will still not be able to have access to it for several years because of the lengthy approval system used by the National Institute for Health and Care Excellence. We should not forget that in a hurry. Although I do not doubt that the trial times and approval systems that new treatment methods must go through to be considered standard medical care are necessary in order to make sure they are safe, they are far too long for many people, given their particular illness.

Photo of Philip Davies Philip Davies Conservative, Shipley

Absolutely, this is too late for them. Therefore, patients may be willing to use innovative treatments, or even treatments that may be used elsewhere in the world but have not been approved in the UK, because in many cases they have nothing to lose. If that is the case, doctors should be allowed, and encouraged in many respects, to make informed choices on behalf of their patients.

During my research, I contacted NICE to ask for its opinion on the Bill, but it did not really have much of one. It responded by saying:

“NICE’S Chief Executive has met with Chris Heaton-Harris to discuss the Bill and will respond constructively to any further approaches for advice and comment”.

That was NICE’s comment on the Bill, so I am not sure whether NICE supports it or opposes it—I could not get anything further out of NICE. I hope it means that NICE will be happy to work with my hon. Friend the Member for Daventry to try to make the Bill a success, although it does not say that.

Why is this Bill necessary? As we have heard, one main criticism of the Bill has been that it is unnecessary: the status quo does not currently prevent or discourage doctors from innovating, and therefore this change will not encourage further responsible innovation. The Royal College of Surgeons of Edinburgh stated:

“As existing Clinical trial regulations provide a safe and patient centred framework for innovation, there is no evidence that doctors are being deterred from testing new drugs and treatments. None of the medical Royal Colleges, patient groups or research charities have evidence that litigation, or the fear of litigation, is preventing new treatments or hampering doctors from innovating. The overwhelming experiences of our members and fellows leads us to believe that an additional, parallel structure for innovation is unnecessary”.

I hope my hon. Friend the Member for Totnes is happy with my quoting from that passage and does not claim that it is a selective quote. I am trying to be even-handed in respect of the points that people are making.

That point made by the RCSEd is echoed by other medical groups, and these points are clearly valid, but my hon. Friend, too, should be even-handed in accepting that for every organisation suggesting there is no need for these changes, probably just as many organisations and doctors support the Bill. Let us take just one. Dr Max Pemberton was reported in The Daily Telegraph in 2012 as supporting the Medical Innovation Bill and writing:

“It is a tragic indictment of modern medicine that innovation is too often jettisoned in favour of the status quo—not because it is in the patient’s best interest, but because of the fear of being sued. This defensive medicine is at the heart of so much clinical practice now.”

Furthermore, in its consultation response to the Medical Innovation Bill, the NHS Health Research Authority stated:

“We recognise that the fear of litigation may influence behaviours of clinicians”.

That shows not that every doctor who does not use innovative methods takes that approach because of a fear of litigation, but instead that it may be a possible cause for some doctors. I am not advocating that every doctor in the NHS is concerned about the fear of litigation, because to do so would be absurd, but although litigation may not be a huge barrier to some innovative treatments within the NHS, to totally disregard it as a problem, as many critics have done, is not justifiable. There is clearly sufficient concern about litigation for it to need addressing.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health

What assessment has the hon. Gentleman made of the survey by the Royal College of Physicians on the views of a range of clinicians about the barriers to innovative treatment? When asked, 70% said funding was the issue, 69% said that applying for funding requires too much effort and 69% said that their employer would not grant them the time they need to assess the benefits of carrying out that innovative treatment. If a fear of legal action is so serious, why does it not appear in those survey results?

Photo of Philip Davies Philip Davies Conservative, Shipley

When the survey says that employers are not allowing people to carry out the innovation, the shadow Minister may have not appreciated why that may be the case. One reason may be the fear of litigation. She should not take it that just because it was not mentioned expressly it is not one of the factors involved in why some employers do not want that innovation to be performed by their employees. She perhaps ought to have asked: why do the employers not want to give them the time to do it? She may well find that the fear of litigation is one of the reasons.

In his speech to the Lords, Lord Saatchi summed up his Bill using the words of Professor Norman Williams, President of the Royal College of Surgeons:

“Protect the patient: nurture the innovator”.—[Hansard, House of Lords, 27 June 2014; Vol. 754, c.1450.]

Perhaps, therefore, this Bill is necessary in order to reassure doctors; society has become more and more litigious over the years. We even have a specifically assigned part of the NHS to deal with the cases of medical negligence claims—the NHS Litigation Authority. I am sure that if litigation was not an issue within the NHS, we would not need an NHS Litigation Authority, whose role is to manage and help resolve claims against the NHS. Despite resolving 96% of claims out of court, in order to keep legal costs low, the most recent information shows that in 2014-15 annual expenditure on NHS clinical negligence claims was £1.2 billion. For total liabilities, the figure is £28.6 billion, £16.1 billion of which is included to cover claims that have not yet been reported. These figures have increased year on year, showing that we live in a more litigious society. Between the financial years 2010-11 and 2013-14 the amount of new clinical claims rose year on year by 6%, 10.8% and 17.9% respectively. The amount has almost doubled since 2009-10, moving from 6,652 new clinical claims to 11,945 in 2013-14, and even non-clinical claims have risen from 4,074 to 4,802 in the same time. In stark contrast, the outstanding liabilities bill for 2013-14 was £26.1 billion, which was the equivalent to almost a quarter of the annual health budget for the same year. In July, the Triennial Review of the NHS Litigation Authority spoke of

“A significant challenge to the NHS LA in managing litigation on behalf of the NHS is the rising growth in clinical negligence claims.”

With a spending round forecast for 2015-16 of £1.4 billion, a 35% increase, and projections up to 2018-19 of £2.1 billion in spending on claims, it is clear that projections show that the litigation culture will continue to grow. An unintended consequence of this litigious culture is surely to act as a deterrent to medical innovation. We must therefore ensure that no doctor with the knowledge to help a patient should be deterred by fear of litigation.

It is also significant to point out that some of the most fearsome critics of this Bill have been medical negligence lawyers. However, we must be assured that they are not speaking out with vested interest—for example, how it might affect their business. In 2010-11, the NHS Litigation Authority reported total legal costs to be £257 million, £200 million of which was paid to claimant lawyers. That is a significant point to note and explains why they might be so opposed to this Bill.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

There tends to be an assumption in this debate that all innovation is a good thing. Some medical innovations turn out to be extremely dangerous and irresponsible. We need protections in law to protect patients from unscrupulous doctors. The reason Action against Medical Accidents and the Patients Association oppose this Bill is that they recognise that it will unravel some very important protections that are in place. We need to proceed with great caution.

Photo of Philip Davies Philip Davies Conservative, Shipley

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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

What my hon. Friend 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?

Photo of Philip Davies Philip Davies Conservative, Shipley

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.

Photo of David Nuttall David Nuttall Conservative, Bury North 11:47 am, 16th October 2015

As always, it is a great pleasure to follow my hon. Friend 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 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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of David Nuttall David Nuttall Conservative, Bury North

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.

Photo of Philip Davies Philip Davies Conservative, Shipley

My hon. Friend is setting out a very good case. Does he accept, though, that the concerns of some of my constituents that I outlined are valid, and that in Committee we should look at ways in which they can be dealt with if necessary? We should not just accept the Bill in its current state; we should look to see whether we can improve it in Committee.

Photo of David Nuttall David Nuttall Conservative, Bury North

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.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry

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.

Photo of David Nuttall David Nuttall Conservative, Bury North

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.

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health 12:27 pm, 16th October 2015

It is a great pleasure, Madam Deputy Speaker, to serve under your stewardship today. I am usually to be found in my constituency on a Friday, unlike some colleagues who are more often here on Fridays, and it is a great pleasure to be able to debate private Members’ business and respond to this very important debate on this very important subject.

I congratulate my hon. Friend Chris Heaton-Harris, who has had a very busy summer trying to work with the huge number of people who have taken an interest in this Bill to try to get it to a place where it can command majority support. He has been tireless in that work. He will know from this debate that there is more to do, but I know he has the appetite for it. That is not least because he and many Members across the House often see from their constituency mailboxes, as well as from their own family experiences, the great pressure there is from patients, particularly those with a diagnosis for which there is no known treatment, for us in Government to do everything we can to accelerate access to the growing range of innovations. I am privileged to be the Minister responsible for the sector that is bringing those innovations to us.

I want to pay tribute to one or two other colleagues in this House and in the other place. The noble Lord Saatchi built up the original momentum and head of steam with his Bill in the other place during the previous Parliament. My hon. Friend has sought to develop that in his Bill, which is in many ways different but trying to achieve the same ends.

My hon. Friend Mr Robertson has been a vocal supporter of the great campaigner Les Halpin, who was diagnosed with a terminal disease and launched the Empower: Access to

Medicine campaign. They have both been very vocal in supporting not only this Bill but the wider innovation agenda.

I also want to take this opportunity to pay tribute to the patients who suffer from terminal and untreated diseases, as well as their families, carers and loved ones. As the Minister for Life Sciences, it often falls to me to sign off very difficult decisions by NICE and NHS England. In the past six to nine months, I have met many people who are passionate about those of us in government and in Parliament doing everything we can to accelerate access to innovation. For all those reasons, this debate is timely and important.

An awful lot of points have been raised both this morning and in the months leading up to the Bill’s Second Reading, and I will deal as substantially as I can with the issues to which the Bill has given rise. I want to say something about the wider context in which the Bill seeks to accelerate innovation, not least the things the Government are already doing. I want to say something about the problem and, indeed, the opportunity for the UK and for patients and the NHS. Some colleagues have hinted at the ambiguity in their minds about the problem the Bill seeks to solve, so I want to shed some light on what I think the problem is that we are trying to solve. Before one legislates, it is never a bad thing to be clear about the problem.

I then want to say something about the importance of public support for and patient trust in our clinical research and medical landscape. We lead the world in medical research: the NHS in the UK is globally recognised as a leader and we set the gold standard in ethical, regulatory and other aspects of clinical research. It is absolutely vital that the Bill reinforces and supports that, and does not in any way, with or without reason, alarm or undermine public trust and confidence in our NHS and our research infrastructure. To that end, I also want to look at some of the protections proposed by the Bill and the safeguards that are already in place, to address some of the key concerns raised, to highlight where the Bill is supported and to set out the Government’s position.

I will start by addressing the context. Colleagues have touched on the UK’s glorious history in medical innovation —from amputation in the 18th and 19th centuries to penicillin, bypass surgery, transplantation, the discovery of DNA and pioneering discoveries on genomics and digital health. Barely a month goes by without this country making another significant step forward in biomedical science. On any indicator, but particularly on the numbers of patents and learned papers, we punch well above our weight. We are the global leader on medical science and research per capita.

The Government place a very high priority on the promotion of medical innovation, not least because the context of our economy and the very urgent challenges faced by our health service demand that we significantly increase the pace at which we adopt innovation. The “Five Year Forward View” by the chief executive and the management team of NHS England, which landed on the Government’s doormat a year ago, powerfully sets out the scale of that challenge.

By the end of this Parliament, demand for healthcare will be rising fast. There are 1 million more pensioners in 2015 than there were in 2010, and there will be 1 million more in 2020, while thousands of people are now living to over 85. Those who heard the piece on Radio 4 this morning will know that we now have thousands of people living to over 100. Indeed, we have the oldest citizen of the globe in Britain: she is 114 today. Such a situation is a magnificent tribute to the extraordinary advances of our biomedical, life science and medical sector, but it of course creates added pressures on our health system because in the last decades of life our health demand rises exponentially.

The NHS has set out that, as a result of that rising demand and of the obesity and dementia epidemics in our society, health will require an extra £30 billion by the end of this Parliament. NHS England has stated that it can deal with £22 billion of that through the profound adoption of innovation to change care pathways —keeping people out of hospital, diagnosing earlier, treating smarter and embracing digital, genomic and a range of other technologies—but it has also stated that the NHS will need more money. I am delighted to be a Minister in a Government who immediately said we would put in the necessary money.

We will earn some of that money, not least through our leadership in the medical innovation and life sciences space. That is why the Prime Minister, the Chancellor and leading Ministers in the former coalition Government set out in 2011 the UK’s groundbreaking life science strategy. The Prime Minister launched it in December 2011, and it is now my great privilege to be the Minister with responsibility for its implementation. At the heart of the strategy is the belief that by profoundly integrating our NHS healthcare delivery system with our research and innovation sector we can achieve a win-win-win situation: we can improve healthcare productivity by embracing new technologies; we can do so in a way that drives investment into the UK; and we can make this country as much a leading pioneer in the research, development and commercialisation of life and health science research in the 21st century as it was in the 20th century.

As the Minister for Life Sciences in the Department of Health in combination, for the first time, with the Department for Business, Innovation and Skills, my mission is clear: to accelerate the uptake of innovation in our health system and to unleash the power of our health system as a research engine. Essentially, the model is based on two cylinders of support. We have traditionally supported our life science and healthcare innovation sector through BIS, with a set of policies on investing in deep science, translational infrastructure and skills, but we have now decided that in the 21st century we must integrate that with our health service. The second cylinder is the health system, which is pumping in access to data on the genome or tissues and to our £1 billion a year clinical research infrastructure. Just as importantly—this brings us to the nub of the Bill—it is accelerating the uptake of innovation in our health service. That is my mission and that of the Department of Health’s directorate of innovation, growth and technology, which the Government created at the same time as they set up my ministerial role.

Innovation is an urgent priority for this Government and, indeed, for all western Governments tackling the profound healthcare challenges caused by growing demand. That is why, during the past five years and during this Parliament, the NHS has made it such a priority. As other colleagues have mentioned, the essence of the strategy is set out in the NHS report on “Innovation, Health and Wealth”, which captures the mission I have described and sets out a huge range of initiatives designed to drive the uptake of innovation across the system. You will be relieved to hear, Madam Deputy Speaker, that I will not list those initiatives, because there are a huge number of them, but I reassure the House that we are monitoring their delivery closely. We have launched the innovation scorecard, and through the digitisation of CCG scorecards, we will shortly build in an uptake of innovation metric, so that patients and users across the system can begin to see from heat maps which CCGs or parts of our NHS are the most innovative.

The fundamental challenge remains that to be a competitive life and health science research economy and to drive innovation into our health system in the way we need, we must take a more profound approach to tackle the challenges and barriers. That is why I launched the accelerated access review last year, which seeks to address three important questions at the heart of this agenda. There is a new landscape because the model for the development of drugs is undergoing a profound change. The 20th-century model is very silo-ed: there is deep research on a drug in universities; it is spun out to companies, if they are lucky; it is funded and acquired by a pharmaceutical company, if they are lucky; and there is a 15-year development pathway—the average drug takes more than $2 billion and 15 years to develop—before it is brought back to the oh-so-patient patient waiting at the end of the chain. Our strategy recognises that that is too long and too expensive for patients, the industry and the NHS.

That problem is also an opportunity, because the profound advances in genomics and informatics mean that we are getting to a point where we no longer have to take that amount of time to de-risk the development pathway. In an era when a genomic biomarker can predict which patient will respond to a drug and which cohorts of patients will develop certain variations of a disease, we can dramatically accelerate the development of drugs and our ability to get innovations to patients in a way that hugely reduces the cost and the risk.

We are asking three questions at the heart of the accelerated access review, which a number of colleagues have asked about. First, what can we do to make it easier and quicker for innovators outside our health system to get clinical validation in the NHS? That would unleash not only the power of our £1 billion-a-year clinical research infrastructure, but the power of our NHS, which treats millions of patients every month, to act as an innovation platform, day in, day out.

Secondly, how do the new technologies of genomics and informatics change the way in which NICE and the regulators can assess, reimburse and work out the health economics in respect of innovations in the new landscape? When a drug comes to the system with a companion diagnostic and has an absolute guarantee of working in certain patients on the back of a genomic biomarker, it profoundly changes the way in which NICE is able to assess the drug. It unlocks the possibility of targeting drugs much more quickly at the right patients and changing the way in which we reimburse. We will be able to reimburse on the basis not of an average quality of life adjusted year, a notional price or a calculation of the health economic benefit for the average patient, but of real value in our health economy for different patient groups who respond in different ways to different drugs. Just as NICE took the lead in the 20th-century model of health economics, I want it to lead in the 21st century and to embrace the new technologies.

Thirdly—and this goes to the heart of the space in which the Bill is positioned—what can we do, when we have a proven innovation, to reduce the barriers to rolling it out across the system? The NHS has a mixed track record on innovation. On the one hand, it has pioneered brilliantly, particularly in our specialist tertiary research centres, innovations that have changed global medicine, some of which I have listed. On the other hand, we have been poor at rolling out innovations in our own system across the breadth of the country. Improving that is a key ambition of the AAR.

The Bill comes in the context of our asking what we can do to incentivise the uptake of best practice across the NHS. I will say a little more about the difference between innovation and research in a moment. The Bill’s focus on supporting 21st-century medics to be more aware of what is available to them when prescribing and its insistence on their sovereignty and freedom in making clinical judgments as professionals are important and helpful.

The glorious history of medical innovation has relied on profound scientific breakthroughs, some of which I have listed, but it also contains a long-standing pattern of unpredictable and accidental innovations, many of which have been profound and have delivered substantial benefits to patients. The discovery of penicillin was an observational accident by an inquiring mind. More recently—you may well know about this, Madam Deputy Speaker—Viagra was developed as a heart treatment and the discovery of the benefit that it is now used for was completely accidental. The company in question discovered that none of the sachets of the drug that it had sent out to patients for the trial, some of which are normally returned at the end of the trial with a medical form, were returned. That was quite striking to the company and when it asked why they had not been returned, it discovered that the drug had a completely different benefit, which led to its being relicensed and becoming the popular drug that it is today. Again, that completely accidental discovery has benefited millions of patients. It is important to understand that accident and observation have always played a powerful role in our leadership of life sciences and research.

I will have a go at defining the problem and the opportunity that the Bill rightly tries to address. I do not for a minute pretend that it is simple, as has been highlighted in this debate. If the Bill goes into Committee, I suspect that this is something that the Committee will want to look at. I suggest that we should be looking at three or four issues. The first is the barriers to the uptake of innovation in our health system. There are a number of barriers and I will not delay the House with a long exposition of them all. Suffice it to say that they are in part organisational, in part financial and in part cultural.

The most profound barrier to the uptake of innovation is that innovating in our health system normally requires the permission of an awful lot of people—not always clinical permission, but purchasing permission and procurement permission. As the health service rightly seeks to drive procurement efficiencies and control spending, we often inadvertently make it harder for people to innovate with treatments.

The biggest barrier in terms of substantial innovation in care pathways tends to be that the person who is asked to make the initial investment in a preventive treatment or any new treatment is often not the person on whose budget the benefits of improved treatment or outcomes will fall. The AAR is looking at that silo-ed budgeting and other organisational, financial and cultural barriers to the uptake of innovation in the system.

Procurement is an important factor. As part of Lord Carter’s review of procurement in the NHS and the Department’s efficiency drive, we are looking at how we can use the single purchaser advantage of the NHS to drive up procurement efficiencies and at how we can make it easier for front-line clinicians to innovate by making procurement decisions that drive efficiencies into their own local health economy, at whatever scale that is.

There is a barrier to innovation in respect of data. Information on innovative treatments and their benefits and on the improvements that different parts of the system are able to deliver is not always allowed to flow through our health system. Even today, there are huge differentials of efficiency and clinical outcome in different therapeutic areas that are not properly picked up or measured. That is part of what the programme of accountability and transparency that the Secretary of State and I are running through the CCG monitoring exercise and My NHS is intended to tackle.

Quite soon, we think that patients will want to click on My NHS and ask us the right questions, such as, “Why is my mother’s clinical outcome in Norfolk three or four times better or worse than my mother-in-law’s clinical prospects in London?” I do not for a minute seek to denigrate Norfolk’s health service—it is doing magnificently well—but my point is that there are regional variations. We want the public and patients to be aware of them and to ask their CCGs, the Government and their health professionals why they are there and what can be done to tackle them.

There have been a number of questions today about the fear of litigation. The Government’s consultation on the original Medical Innovation Bill highlighted some concerns about litigation. One difficulty is that much of the early reporting and discussion on that Bill created the impression that that was the problem that it sought to highlight. Of course, the picture is more subtle, difficult and complex than that, but it is worth highlighting that, as a number of colleagues have pointed out, the cost of clinical negligence claims to our health service is substantial. The latest figures that I have to hand state that in 2012-13, 10,000 claims were made and the payments totalled £1.2 billion. It is true that many of those claims related not to innovation, but to obstetrics and other standard procedures. However, the NHS is conscious of that bill and in most of our hospitals and other institutions, there is an acute awareness that we live in an ever more litigious society. Heaven forbid that we should ever become like America, where litigation is a daily routine in the health system, but we need to be aware of the risk. There is a legitimate fear among clinicians of doing anything that might trigger a reasonable or unreasonable claim for litigation.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

How much of the litigation cost is related to complaints about innovative treatments?

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

Most of the cases are a result of other contexts— as my hon. Friend will know, obstetrics is a big part of that—rather than innovation. I am happy to write to her with the actual figure as I do not have it to hand. My point is that the fear of litigation runs through the system.

I recently spoke to a senior paediatric consultant who is neutral about this Bill—he is neither a passionate advocate nor an opponent of it. He observed that over the past 20 or 30 years, a gradual conservatism has crept into clinical practice. When I asked what he thought drove that, he mentioned three things. First, ever tighter procurement control makes it harder to do things differently. Secondly, there is a subtly growing fear of negligence, and a lack of clear data information and guidance on what is available. Thirdly, many clinicians find it easier to stick to normal practice, and that is what the Bill seeks to tackle.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health

The Minister and Chris Heaton-Harris have referred to anecdotal remarks about fear of litigation being a barrier to medical innovation. Can the Minister set out his evidence that that is a widespread concern and genuinely prevents doctors from innovating and prescribing new treatments?

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

The hon. Lady makes an important point because it is difficult to quantify the impact of that fear. I have gone out of my way to make clear that I do not think that issue is a primary concern, and that the organisational, cultural and financial barriers are higher concerns. That is partly what is difficult about the Bill. It gives the impression that fear of litigation is the big problem, whereas anecdotally I hear from leading clinicians—who, as I said, are not particularly for or against the Bill—that it is one of a number of issues in a complex landscape.

I am conscious of the time, so I will turn to the critical importance of patient and public trust and confidence in our clinical research infrastructure and NHS. The UK leads in clinical trials and in regulation through NICE, the Medicines and Healthcare Products Regulatory Agency, and our ethical framework. I am delighted that over the past four or five years we have made substantial improvements in recruiting more patients into trials. In 2014-15 the National Institute for Health Research—the jewel in the crown of NHS research—had 4,934 studies running, and last year we recruited 52 global first patients into trials. That is a key indicator of our leadership in the most innovative areas of medicine.

The MHRA has approved more than 80 first-in-human studies, and the NHS is becoming a leader in the forefront of that model of research, just as it was in the earlier part of the 20th century. It is also important to consider our leadership in regulation, ethics and approval, not least because those are major exports for this country. Over the next few decades, rapidly emerging economies will be looking for a lead from NICE, MHRA and our clinical trials infrastructure, and it is crucial to have a strong patient voice, and to maintain and develop patient trust. Central to my mission is to bring forward such development and put a stronger patient voice at the heart of our research landscape.

Patient empowerment through technology and access to innovation are key themes of our mission and work, and medical research charities have a huge role to play. In this new research landscape in which genomic information, patient data, records and medical histories become such key assets for research, the question is who will control that information. I think that we should build a policy landscape on the notion that such information and assets ultimately belong to the patient, and that the sovereignty of their relationship with their clinician should remain sacrosanct.

To answer an earlier question from Heidi Alexander, there is nothing in the Government’s plans to make such a database available to the public and drive the sort of quackery charter that I know the Chair of the Health Committee is worried about. We do not want to change the law that prevents pharmaceutical companies from talking to patients directly, and it is important that recruitment into clinical trials and access to innovation is done through patients and their clinicians.

Charities will have an increasingly important role. Cancer Research UK leads in much of this area, and many smaller charities are becoming strong advocates for their patients and collecting data. With the rise of apps and digital technologies, charities will soon create portals for patients to get involved in research communities, and work with industry and academics to drive and accelerate innovation.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

Does the Minister accept that all the bodies he has referred to, as well as the Association of Medical Research Charities, the Academy of Medical Sciences and the Academy of Medical Royal Colleges, have expressed concern that the Bill could undermine recruitment to clinical trials? That is an important point and I hope that the Minister will accept that it is a genuine concern.

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

I was addressing that point to make it clear that I and the Government take strongly the need to ensure that the Bill does not undermine patient support in any way. I have heard some of those concerns, and if the Bill goes to Committee it is important to address them. It is also crucial to protect and support the sovereignty of clinicians to look after their patients, and to do as much as possible to try to liberate them from the burden of unnecessary bureaucracy and excessive targets. We must remind clinicians that they have freedoms in law and a vocational mission to do whatever they think is best for their patients.

On safeguards and protections let me make three important points about the Bill. I have taken advice from counsel, and I will respond to a number of questions raised by colleagues. As currently drafted the Bill provides no change to existing protections on medical negligence, and that is important. It sets out the power to create a database, and a mechanism to make clear to clinicians how they can demonstrate compliance with existing legal protection—the Bolam test has been referred to—and allow innovations to be recorded for the benefit of other clinicians and their patients. Importantly for the Government, that does not change existing protections on medical negligence, and it is crucial to understand that. Secondly, the Bill does not change our gold standard regulatory and ethical framework for clinical research. The Bill is not about research; it is about reinforcing freedoms for clinicians and how they prescribe. I will return to the detail of that in a minute.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health

The Minister says that the Bill does not change the law on medical negligence but sets up an alternative pathway or framework. Does he accept that that could confuse matters?

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

That is an important question. The Bill does not change the legal framework on negligence; it merely seeks to clarify matters for those doctors who understand that they have the freedom to innovate but fear that current understanding in law about the test is not clear enough. It sets out an agreed, statutorily approved procedure to reassure doctors that if they follow that procedure, they will be covered by existing negligence and liability protection that the Bill does not change in any way. The hon. Lady’s second point is about whether people understand that, and whether there is a risk of the Bill inadvertently triggering fear. That is an important point, and it behoves everyone to ensure that we discuss it in the right way.

I have been shocked by some—not all—of the briefings, one of which referred to this being a “concentration camp” or a “Mengele” charter. Such unhelpful language triggers unhelpful media interest and will alarm patients completely unnecessarily. All the provisions in the Bill reinforce and endorse existing safeguards on the use of data and regulatory protection.

Time is short, but I want address the concerns that have been raised by hon. Members across the House. My hon. Friend the Member for Daventry gave a powerful speech and my hon. Friend Dr Wollaston made a number of interventions. There were contributions from my hon. Friends the Members for Beckenham (Bob Stewart), for Gainsborough (Sir Edward Leigh), for Bury North (Mr Nuttall) for Shipley (Philip Davies) and for Aldridge-Brownhills (Wendy Morton), and the hon. Members for Lewisham East and for Bolsover (Mr Skinner). I would like to take the opportunity to welcome the shadow Secretary of State to her post. I value hugely her offer to work on the Bill in a cross-party spirit and to deal with the issues raised. If the Bill goes to Committee, that will be an important offer. I am certainly happy to take it up and see, in a cross-party spirit, whether we can help to ensure that it does not trigger the doubts that she and other hon. Members have expressed concern about.

I want to address the specific concerns raised by my hon. Friend the Member for Totnes. She is a very distinguished Chairman of the Health Committee, as well as a doctor. For those reasons, they merit proper scrutiny and attention. I apologise to her if I am unable to deal with all of her concerns, but I will try to address them all.

The first concern is that the Bill is based on a false premise, which is that doctors are afraid to innovate because of fear of litigation. I reaffirm that the Department of Health’s consultation on the previous Medical Innovation Bill revealed that some doctors do find the threat of litigation to be a block to innovation, although that was not a universal view and I do not want to suggest in any way that it is the principal barrier. This Bill is aimed at reassuring those doctors who feel unable to innovate due to concerns about litigation. It sets out a series of steps that doctors can choose to take when innovating, to give them confidence that they have acted responsibly. I read the Bill again this morning and I am happy to highlight some of the key protections in it.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

Will the Minister clarify that the vast majority of medical bodies feel that it is not a barrier to innovation, and that there are some important points where we need to protect patients from irresponsible innovation? We have to accept that there is a risk inherent in going down a route that would make that possible.

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

My hon. Friend makes an important point about public trust, and patient safety and confidence. I do not want to detain the House by reading the relevant provisions in the Bill. I think my hon. Friend has tried, during the summer, to draft a Bill that deals with a number of those concerns. She makes the important point that if the Bill is inadvertently undermining public trust and confidence, that is in itself a problem. That is partly a function of how people discuss it and it is regrettable that the Bill has generated the level of antagonism it has, but she makes an important point that we should look at those specific measures and ensure we tackle the issues and concerns that leading doctors have raised.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

My initial point was whether the Minister would accept that the overwhelming number of respondents felt that fear of litigation was not the barrier?

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

I made the point earlier that the barriers to access of innovation are much broader than the fear of litigation, and I am happy to reinforce that.

Photo of Steven Baker Steven Baker Conservative, Wycombe

The Minister will know that in the treatment of wet AMD Lucentis costs £700 an injection and Avastin £60. Does he think the Bill could help clinicians use Avastin to treat wet AMD, thereby saving the NHS, I understand, some £84 million?

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

My hon. Friend is quick to leap on to a very important point. The answer is no, because in law we have an important provision to protect people who invest billions of pounds in developing new innovations. Clinicians are free to use alternative off-label drugs where there is evidence they work, but not on the basis of cost. We have a presumption in law that where a drug is licensed or on patent for a particular indagation, which is the protection for the company that has invested to bring the drug to market, we allow an alternative to be used only where there is clinical evidence, not on cost grounds. The price falls dramatically when drugs come off patent and the generics industry picks them up. There is price protection for a short period of patent life to create the incentive for people to make the extraordinary investments up front. We then get the benefit of cheap drugs through the generics sector.

Photo of Steven Baker Steven Baker Conservative, Wycombe

The Minister raises a critical point. I am concerned that cost grounds do matter and that some people might be going without early treatment for wet AMD, because they cannot, for a range of reasons, access Avastin. My concern is that people might be going untreated for wet AMD at a point when the relevant drug, Avastin, might help them more than Lucentis at a later stage.

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

My hon. Friend makes an important point. The NICE clinical guidance to NHS England, after carrying out a health technology appraisal, is binding. NHS England has a duty to implement it across the system. There is an issue about how quickly different parts of the NHS implement guidance and how quickly innovative drugs are rolled out. Another Bill going through the House will be looking at what can be done to support the use of off-label drugs. My position on that is that the most profound barrier to the adoption of off-label drugs is in fact information for clinicians on the clinical benefits of an off-label indagation. It is the clinical evidence that provides the basis on which they are perfectly free at the moment to use alternative drugs.

Let me address the other points raised by my hon. Friend the Member for Totnes, the Chairman of the Select Committee. She expressed concern that the Bill would undermine research and clinical trials. That is an important point. I stress that the Bill, as drafted, does not cover clinical trials, which are regulated by the MHRA and the HRA from a scientific, safety and ethical viewpoint. Rightly, the Bill does not stray into that regulatory environment. I confirm that we would be concerned if it did. It does not relate to formal clinical research, only to clinicians’ duties to their care of individual patients. If the database is got right, we think it could contribute to the sum of healthcare knowledge by collecting information on innovations and their success or not.

My hon. Friend said that she fears the Bill would do more harm than good. I merely point out that the chief medical officer for England supported the final version of the Medical Innovation Bill, which ran out of time in the House of Lords at the end of the previous Parliament. The national clinical director for NHS England confirmed that he had no concerns about patients’ safety with regard to that Bill. Hon. Members may debate whether the Bill is needed, but it is really important to understand that we are clear that the Bill in no way damages patient safety. The test of responsibility under the Bill is intended to reflect absolutely the requirement of the Bolam test, which has been the gold standard for decades. I highlight that a doctor has to obtain any consents required by law when taking a decision to part from the existing range of medical treatments. The Bill expressly provides that a doctor must have regard in particular to the requirements of patient safety. Under both existing common law and the Bill, the doctor would need to show that they had acted responsibly. There is absolutely no escape for a negligent doctor under the Bill. The Bill seeks to give doctors access to the database as a source of learning—doctors, not patients. We hope that if the database has got right it could help to drive both innovation and information through the system.

My hon. Friend set out some concerns about safeguards for patients. I reiterate that the Government are clear that the negligence provisions in the Bill do not provide any immunity to irresponsible doctors. It would be irresponsible for anyone to suggest that they do. I want to make that point very clearly from the Dispatch Box and to reassure her that in our view the Bill does not remove any of the current safeguards in place to protect patients’ safety. Our view is that the Bill does not apply a weaker test to a doctor’s decision to innovate than the existing law on clinical negligence.

My hon. Friend raised points about the rigour of the database, which I will come on to in a moment. A number of other concerns have been raised. I want to run quickly through, in two batches, the concerns about the database and about negligence and legal protections. Colleagues have asked whether there is really a need for legislation for a database. I confirm that the Bill gives power to the Secretary of State to confer functions on the Health and Social Care Information Centre in relation to the establishment of a database. Legislation enables provision to be made for the disclosure of information from the databases, ensuring that the HSCIC has the necessary powers to disclose information and that appropriate safeguards are in place. Were the Bill to become law, we would obviously consult on regulations setting out the detail of how the database would be constructed.

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

The hon. Lady might be surprised to know I do not have that section right in front of me, but I will happily come back to her. The Bill would allow a database to be created for specific purposes. It is not for me to judge the merits of the wording of different private Members’ Bills, but this would not be the first such Bill to command the authority of the House and then to be rewritten to put into effect the ambitions it sets out. I think, however, that the Bill goes a lot further than the existing powers in requiring us to consider a database with specific functions linked to providing a mechanism of statutory protections for clinicians under existing law. We understand what it is trying to achieve, although it is complex in that it does not change the legal protections but merely sets out a particular runway in which clinicians can have confidence.

Questions have been asked about how the database will work. As I have said, if the Bill becomes law, we will want to consult on regulations, but it is intended to be principally for the use of medical practitioners, not patients. We would not support the Bill if it were to be a database—my hon. Friend the Chair of the Select Committee expressed concern about that point—providing support for companies, quacks and unregulated providers to contact patients directly and to validate illegitimate innovations. It is for clinicians to record the innovations that they, in their professional judgment, have decided to adopt. We would envisage the database being used to flag a treatment as innovative, meaning it would be coded and picked up by the HSCIC, allowing us to form a national database.

Questions have been asked about who would submit information to the database. As with all data provisions, patient confidentiality will absolutely be protected. I would envisage the detail of who could access information, and in what circumstances, being a source of substantial discussion, if and when we came to pass regulations. I stress, however, that it would not be used by patients. We could not support that.

Questions have also been asked about who would determine which groups could get information. It is designed for clinicians, the HSCIC and regulators. At the moment, a doctor passing information to the HSCIC is bound by the common law duty of confidentiality and their professional obligations. The HSCIC would need to be satisfied that any disclosure was in accordance with the law, including the Data Protection Act 1998.

Hon. Members asked about funding. The exact level of grant in aid required would be subject to additional scoping by the HSCIC, and if the House decided to proceed, we would need to come back with the details. Hon. Members also asked whether the treatments in the database would be flagged with some kitemark or advert. The Government would oppose this being used as a marketing tool. Such flagging by means of kitemarks, being regulated differently, would not be appropriate. We want a database focused on helping doctors to see what other clinicians have decided is an appropriate treatment. We would see the database not as a process of quality assurance, but as a way for doctors to learn from and see transparently what other doctors have decided is an appropriate treatment.

I turn quickly to the negligence and regulatory questions. Colleagues have asked whether the negligence provisions provide another way for doctors to carry out research, circumventing the usual safeguards. The answer is an emphatic no. The Bill would apply not to research, but only to individual treatment decisions, as clarified in clause 5(2). Research is highly regulated—rightly so—by the Health Research Authority and the MHRA. Research studies cannot go ahead without ethical approval overseen by the HRA, and research that involves clinical trials and the investigation of medicinal products must be thus authorised. The Bill is concerned with innovations in individual treatments by clinicians. The results of an innovation might trigger further research—I think my hon. Friend the Member for Daventry envisages the database triggering questions such as, “Well, if one or two clinicians think this is an appropriate innovation, shouldn’t we look at whether it might be more widely applicable?”—but that would then take it into the more formal jurisdiction of a research application.

Hon. Members asked whether the Bill would relate to clinical trials. It is important to note that it does not cover clinical trials, which are regulated by the MHRA and the HRA. We would not want the Bill to stray into that territory and risk undermining that international gold mark of UK clinical trials infrastructure. It has been asked whether innovation is just the same as research. I strongly believe they are not the same thing, although they are often confused. They are closely related, but they are not the same thing. Research is highly regulated; innovation is the application of different ways of practising medicine, which clinicians have always done. That is partly what makes it hard to regulate and why the Bill has raised the questions it has.

Hon. Members asked whether patients would be asked for their consent before being given an innovative treatment. Yes, patients would have to give their consent. There is no change to the law of consent, which requires patients to provide informed and voluntary consent to any treatment offered. Colleagues have also asked whether the Government support the Bill in the light of the concerns raised by the medical profession about its impact on patient safety. I will confirm the Government’s position in a moment, but we believe it is an important and timely debate for the reasons I have set out, and we support the intentions behind the Bill. My hon. Friend has engaged with those who have raised concerns, and if the Bill goes to Committee, issues raised today would need to be tackled, but in the view of the Government and parliamentary counsel it does not undermine the current law on clinical negligence.

It has been asked in the House this morning and in the run-up to the debate whether the Bill is safe for patients. I again repeat that the Bill does not remove any of the current safeguards on patient safety. The test of responsibility in the Bill is intended to be the nearest possible equivalent to the Bolam test. It simply seeks to provide clarity via a mechanism by which doctors can be sure they are complying with that test.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health

As I understand it, the current test requires a doctor to seek the advice and medical opinion of a responsible body, while the arrangements in the Bill require them to seek someone else’s view on whether such a responsible body holds an opinion about the safety of treatment. I think those two things are slightly different. Does the Minister share that concern?

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

The hon. Lady raises an interesting point. I am just looking at clause 3(2):

“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—

(a) 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,

(b)take full account of the views obtained…(and do so in a way in which any responsible doctor would be expected to take account of…),

(c) obtain any consents required by law”,

including

(d)(i) any opinions or requests expressed by or in relation to the patient,

(ii) the risks and benefits” and to

(e) take such other steps as are necessary to secure that the decision is made in a way that is accountable and transparent.”

Let me repeat that we would not even countenance supporting the Bill if its intention were in any way to change the basic test of clinical professionalism to which every clinician is subject. They remain subject to all the professional safeguards of the GMC and other regulatory bodies and clinical negligence law. The Bill merely seeks to put in place one particular mechanism on which doctors can rely to be clear that the innovation they propose is in accordance with the law. There is a danger of thinking of that if this Bill ever became law, it would be the last and final word on the area of medical innovation. It would absolutely not be; it is a small contribution to a vast canon of common law and practice that—importantly for the Government—does not change.

Counsel’s advice to us has been very clear that the negligence provisions provide no immunity to irresponsible doctors. Under both existing common law and this Bill’s provisions, doctors will need to show that they have acted responsibly. There will be no escape for a negligent doctor.

Members have asked whether the Bill will allow doctors to prescribe untested medicines. It is important to make it clear that the Bill does not change existing medicines legislation, which permits the use of unlicensed medicines

—tested or untested—prescribed by physicians on their own responsibility, subject to all their own professional tests, regulatory conditions and the law. This will be based on what they believe, in their own professional clinical judgment, is right for their patients. If there is an unmet medical need, there is clearly more scope for clinicians to innovate.

Finally, I was asked whether the Bill will prevent patients from making a claim if they receive negligent treatment. No. I want to be clear that this Bill in no way changes patients’ rights to claim for negligent treatment. We are completely committed to ensuring that patients are safe and protected. On the occasions when, regrettably, things go wrong and treatment has been given negligently, it is absolutely right that patients are entitled to seek compensation. It is essential that any new legislation or any amendments to the Bill do not put patients at risk in any way. If a doctor carries out a procedure negligently, they would not be protected by this Bill, as is made clear in clause 4(3).

In conclusion, let me highlight that although substantial concerns have been raised—my hon. Friend the Member for Totnes has expressed some of them this morning—it is true to say that there has been support for the Bill. The “Empower: Access to Medicine” campaign has said:

“This new Bill provides a real opportunity to renew the focus on patients’ rights to try innovative medicines within a reasonable risk framework. Empower: Access to Medicine has long advocated appropriate access, for some patients, to certain medicines earlier in the clinical trials process. Chris Heaton-Harris’ new Bill provides a real opportunity to make that ambition a reality.”

It is particularly supportive of the accelerated access review that I am running. A number of colleagues have suggested that we look at the Bill in the context of those recommendations that will shortly arrive on my desk.

The Royal College of Physicians has said that it

“generally welcomes the first part of the Bill to enable the secretary of state…to establish a database of medical treatments. However, the RCP strongly recommends that the medical and research communities should lead in developing the database.”

If the Bill became law, it is very important for that to happen. I understand that the RCP has particular concerns about the second half of the Bill.

Let me also highlight what was said in the extensive discussion of the Medical Innovation Bill, which was launched in the other place. The chief medical officer, Dame Sally Davies, said that she was

“confident that, with the amendments made in Committee stage, the Bill is safe for patients and has the potential to encourage responsible innovation.”

She was referring to the provisions in the second half of the Bill. Sir Bruce Keogh, clinical director of NHS England said, in connection with the same provisions in the former Bill:

“Encouraging innovation in medicine and protecting patients are both of vital importance. This is why I am pleased that amendments have been devised to address concerns about patient safety.”

Sir Michael Rawlins, president of the Royal Society of Medicine said that the Medical Innovation Bill would

“allow responsible innovation in treatment...I believe that the use of the provisions in the draft Medical Innovation Bill will benefit patients, especially those with rarer diseases, and the furtherance of medical science.”

I appreciate that there are real issues of contention and debate, but I wanted to highlight the views of eminent people on both sides of the debate, of which the House should be cognisant.

I was particularly struck by the comments of the hon. Member for Lewisham East. At the end of the last Parliament, her predecessor as shadow Health Secretary said, interestingly, that he was “disappointed” that the Liberal Democrats had withdrawn their support for the Bill. He said that

“there should at least have been some cross-party talks about this”,

and I was glad to hear the hon. Lady echo that view this morning. He went on to say:

“The Bill was heavily amended and extra safeguards put in, and I worry a little bit that those who are opposed to it don’t realise that it is actually quite a different Bill now.”

He said that for parents whose children suffered from untreatable diseases and had no hope, the Bill was “about opening up hope”, and added:

“It is often parents who struggle to get their voice heard”.

In the other place, although some peers had concerns about the Bill, a number of others supported it. I have a list in front of me, which shows that the numbers were equal on both sides. It also shows that some pretty eminent peers supported the Bill: Lord Kakkar, Lord Patel, Lord Ribeiro, Lord Mackay, Lord Woolf, Baroness Gardner, Lord O’Donnell, Baroness Butler-Sloss and Lord Blencathra. Those are all eminent people in their fields. I am not suggesting for a minute that there is not a debate, but I think it is a genuine debate, which is, after all, what the House is here to provide.

The Government support the intention of the Bill to promote innovation, to reinforce existing medical negligence law, to promote the dissemination of information on innovations, to protect and reinforce the sovereignty and the freedom of clinicians to vary and innovate treatment in their interests of their patients, and to promote the use of identification and data on innovation as critical to 21st-century healthcare. We are—and I am— very concerned to ensure that the Bill promotes, rather than undermines, patients’ and doctors’ trust in the legal and regulatory framework for innovation, to ensure that it fits into the wider landscape and framework for innovation that I—along with various bodies—am putting in place, and to ensure that it reflects and supports the growing discussion about research medicine and innovation.

The House has many and varied ways of improving the lot of our citizens, and private Members' Bills are one important way. As you well know, Madam Deputy Speaker, we Ministers are normally sceptical about the virtues of private Members' Bills, and jealously guard our, and the Government’s, unique monopoly on legislative virtue and competence; but I believe that when a Bill—such as this Bill—seeks to do something that we support, even if the mechanics proposed may not yet be perfect, there is a strong argument for it to proceed to a Committee stage and be subjected to detailed scrutiny. I hope that the Bill is given such a hearing in Committee. The hon. Member for Lewisham East has signalled her willingness to work on a cross-party basis to try to get the Bill into a shape that will address the concerns that have been expressed, and I was delighted to hear my hon. Friend the Member for Totnes make a similar offer.

Photo of Heidi Alexander Heidi Alexander Shadow Secretary of State for Health

I am slightly worried that the Minister is ascribing to me words that I have not used. I have indicated a willingness to work on a cross-party basis to address the barriers to innovation, but, as the Minister will have heard me say in my speech, I have very serious reservations about the Bill, and I intend to oppose it today.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health and Social Care Committee

Perhaps the Minister will give me an opportunity to clarify my position as well. I shall robustly oppose the Bill’s Second Reading. As the Minister has said, we all support the principles and aims of the Bill, but many of us robustly reject the motion that this is the way in which to achieve them.

The Minister has quoted two bodies who he says support the Bill, one of which disagrees with half of it. Does he accept that the Association of Medical Research Charities, the Academy of Medical Sciences, the Academy of Medical Royal Colleges, the British Medical Association, the General Medical Council, the Patients Association, Action against Medical Accidents, and even the Association of the British Pharmaceutical Industry—as well as legal experts such as Sir Robert Francis—all oppose the Bill? It reads like an A to Z of opposition. All those bodies would work with the Government if the Bill were given a Second Reading, but they robustly reject the motion that this is the right way in which to achieve its aims. Does the Minister accept that list, and does he accept that, according to the vast majority of opinion, this is the wrong way forward?

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

I well accept that views on the merits of this Bill are divided, not least for the reasons I have highlighted in my speech. Some of the commentary on it, referring to it as the Mengele Bill for example, has played a very damaging part in misrepresenting—[Interruption.] I can show the hon. Member for Lewisham East the briefing after the debate if she would be interested.

It is important that colleagues decide for themselves whether to vote for this Bill. My own view, and the Government’s view, is that it is seeking to address a matter of public policy that we share in terms of promoting access to innovation. The measures in the Bill may not be quite perfect; it would not be the first Bill to be in that situation, and I dare say many of our proudest legislative breakthroughs going right back to the 18th and 19th centuries started in a format that possibly did not command unanimous support. I would have thought it is worth us debating this further in Committee, but I reiterate that if we cannot get a Bill into a position where it clearly has, and reinforces, public and clinician support from our world-leading expertise in research medicine and clinical practice, and if it any way undermines patient trust and confidence, it would be retrograde.

I think this Bill is trying to do something laudable, however; I think my hon. Friend the Member for Daventry is trying to do something laudable. This is a complex field, and the Government are trying to put in place the right measures, and I thank him for raising it—and I thank you, Madam Deputy Speaker, for allowing me to respond in full.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry 1:31 pm, 16th October 2015

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 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.

The House divided:

Ayes 32, Noes 19.

Division number 79 Alcohol Harm and Older People — Access to Medical Treatments (Innovation) Bill

Aye: 32 MPs

No: 19 MPs

Ayes: A-Z by last name

Tellers

Nos: A-Z by last name

Tellers

Question accordingly agreed to.

Bill read a Second time.