Access to Medical Treatments (Innovation) Bill

Sarah Wollaston Excerpts

Friday 16th October 2015 Commons Chamber

[Dr Sarah Wollaston (Totnes) (Con)]

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

[Chris Heaton-Harris]

I shall come to that point in a moment.

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

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

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

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

[Chris Heaton-Harris]

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

The Royal College of Surgeons has stated:

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

[Dr Wollaston]

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

[Chris Heaton-Harris]

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

The Royal College of Psychiatrists has said that

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

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

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

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

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

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

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

Mr Smith believes:

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

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

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[Dr Sarah Wollaston (Totnes) (Con)]

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 the Member for Daventry (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 the hon. Member for Lewisham East (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.

[Mr Christopher Chope (Christchurch) (Con)]

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?

[Dr Wollaston]

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.

[Bob Stewart (Beckenham) (Con)]

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?

[Dr Wollaston]

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

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

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

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

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

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

[Chris Heaton-Harris]

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

[Dr Wollaston]

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

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

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

[Chris Heaton-Harris]

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

[Dr Wollaston]

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

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

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

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

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

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[Philip Davies (Shipley) (Con)]

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 the Member for Daventry (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 the hon. Member for Lewisham East (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.

[Dr Wollaston]

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.

[Philip Davies]

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.

[Dr Wollaston]

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 the Member for Daventry (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.

[Philip Davies]

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

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

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

Cancer Research UK stated in its consultation response:

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

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

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[Dr Wollaston]

rose—

[Philip Davies]

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

[Dr Wollaston]

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.

[Philip Davies]

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.

[Philip Davies]

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.

[Dr Wollaston]

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.

[Philip Davies]

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.

[Dr Wollaston]

rose—

[Philip Davies]

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

[Dr Wollaston]

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.

[Philip Davies]

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.

[Philip Davies]

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.

[Dr Wollaston]

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.

[Philip Davies]

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.

[Dr Wollaston]

rose—

[Philip Davies]

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

[Dr Wollaston]

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.

[Philip Davies]

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

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[Philip Davies]

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

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

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

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

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

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

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

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

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

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

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

[Dr Wollaston]

rose—

[Philip Davies]

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

[Dr Wollaston]

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.

[Philip Davies]

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.

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[Dr Wollaston]

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.

[Philip Davies]

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.

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[Philip Davies]

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”.—[Official Report, 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.

[Dr Wollaston]

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.

[Philip Davies]

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

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[Dr Wollaston]

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

[George Freeman]

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.

[George Freeman]

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 it 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 the hon. Member for Lewisham East (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.

[Dr Wollaston]

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 the Minister will accept that it is a genuine concern.

[George Freeman]

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.

[George Freeman]

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 the Member for Totnes (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.

[Dr Wollaston]

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.

[George Freeman]

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.

[Dr Wollaston]

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

[George Freeman]

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.

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[George Freeman]

I am grateful to the hon. Lady for clarifying that.

[Dr Wollaston]

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 notion that this is the way in which to achieve them.

The Minister has quoted two bodies that 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 notion 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?

[George Freeman]

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.