Access to Medical Treatments (Innovation) Bill (Money)

National Insurance Contributions (Rate Ceilings) Bill (Programme) (No. 2) – in the House of Commons at 3:06 pm on 3rd November 2015.

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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 3:13 pm, 3rd November 2015

I beg to move,

That, for the purposes of any Act resulting from the Access to Medical Treatments (Innovation) Bill, it is expedient to authorise the payment out of money provided by Parliament of any increase attributable to the Act in the sums payable under any other Act out of money so provided.

The House debated the Access to Medical Treatments (Innovation) Bill on Friday 16 October, when it received its Second Reading. I pay tribute to my hon. Friend Chris Heaton-Harris for the huge amount of work that he put in to get the Bill to a point where it can enjoy majority support in this House and the other place, and for his open approach to dealing with all the stakeholders with an interest in it.

I want to reiterate what I said on Second Reading. Although the Government support the intention behind the Bill to promote access to medical innovation—an intention which sits four-square within my ministerial responsibilities—the mechanisms of any Bill need to be considered on their merits. We are neither supporting nor opposing this Bill, but working with those with an interest in it and the sponsors to do what we can to help to get it to a place where it could contribute to the landscape for medical innovation that we are putting in place.

This money resolution is not a signal of Government support or otherwise for the Bill; it is merely a convention of the House once a Bill has received its Second Reading. We have brought forward this resolution to allow the Bill to progress to Committee stage, reflecting that convention, and the will of the House for further debate.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health Committee

On a point of order, Madam Deputy Speaker. Is it in order for the Government to be neutral on a Bill if the payroll vote is whipped for that vote?

Photo of Natascha Engel Natascha Engel Second Deputy Chairman of Ways and Means

That is a matter for the Government, rather than for the Chair.

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 debate on Second Reading raised a large number of issues, which clearly need to be addressed and I have no doubt will be addressed in Committee. We cannot second-guess where that Committee will get to or the shape of any Bill that might subsequently return to the Floor of the House.

The costs associated with this Bill, were it to be implemented in its current shape, arise from the establishment and maintenance of a database by the Health and Social Care Information Centre. Early discussions on costing with the HSCIC, which is leading on the construction of a number of databases and data streams crucial to the operation of the NHS, have provided an indicative costing of between £5 million and £15 million for developing the database of innovative medicines that the Bill anticipates.

Photo of John Baron John Baron Conservative, Basildon and Billericay

My hon. Friend has implied broad Government support for the Bill. Can he provide any evidence to suggest that litigation is preventing doctors from innovating in medical science and practice generally? That is the premise on which the Bill is based.

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 a good point. That is the premise on which the Bill introduced by Lord Saatchi in the other place earlier in the year in the previous Parliament was predicated. My hon. Friend is right that it is a controversial proposition that fear of litigation for medical negligence is putting clinicians off innovating. The evidence that the Government received through the consultation was that some clinicians do feel that is a problem, but very few saw it as the principal problem or the principal obstacle. A number of clinicians made the point that several factors have acted in recent decades to slow down the rate of innovative prescribing and other procedures in surgery and elsewhere, not least increasing central control of procurement from NHS England, which puts in place very tight procurement guidelines, as well as a general sense of an increasingly litigious society, which is just one of a number of factors cited in an extensive range of barriers to innovation.

Photo of Philippa Whitford Philippa Whitford Shadow SNP Westminster Group Leader (Health)

Does the Minister not recognise the concern of the Association of Medical Research Charities and many within the profession about what the Bill opens up? The position when I started 30-odd years ago was that doctors could do what they liked. We have spent decades protecting people, slimming down the ethics paperwork to run trials, and I do not see that the Bill is necessary. I think it is dangerous. The problem is that people think it is about access to new drugs. It is not. Any drug that is licensed we can prescribe. This says that doctors can try what they like. That is quite scary.

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 a series of interesting points. Her criticisms would perhaps apply more to the Bill introduced by Lord Saatchi in the other House. Let me confirm that this Bill has nothing at all to do with clinical research. It is to do with clarifying the freedoms that she is right to say that clinicians enjoy today. Clinicians are free to prescribe any treatment for their patients that they feel is appropriate on the basis of the clinical evidence.

The specific problem that the Government recognise, whether or not this Bill is the appropriate mechanism to deal with it, is that in order for clinicians to feel confident in making an innovative prescription or adopting an innovative procedure, the biggest barrier is the lack of information on what innovative procedures are out there already being used by other clinicians. It was with that in mind that the registry was originally proposed in the Bill introduced by Lord Saatchi in the other place. It was originally intended as a registry of innovative practices that clinicians adopted under the procedures in the Bill, which merely clarify the existing protections already afforded by medical negligence law. It was felt that that registry would be a helpful innovation in itself.

The Government’s view is that, as we build an infrastructure for the provision of information to clinicians to support off-label use of medicines and access to the latest information on innovative treatments, that registry could provide a much more interesting function of providing to clinicians, at the click of a mouse, an up-to-date registry of innovative medicines that are available and off-label and other treatments that other clinicians are already using. I want to stress that this Bill, which has a very different structure from the original Bill introduced by Lord Saatchi, has nothing to do with research at all. It is purely to do with supporting innovative prescribing by clinicians by providing them with information on innovations that they might consider.

Photo of Philippa Whitford Philippa Whitford Shadow SNP Westminster Group Leader (Health)

Does not this undermine our existing structures of clinical research? Those protect the patient through ethics and research being reviewed, whereas this allows a couple of doctors to say, “We’re going to give you liquorice for your cancer”, and that can get put on to a database. Many in the profession are anxious about this.

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 want to make two things absolutely clear. First, this Bill, in law, would have no impact at all on clinical research. We in the Department have been very clear about that. If it in any way changed the basis on which clinical research is regulated, it would be a very serious matter, because we lead the world in terms of our ethical and regulatory controls on research, and it is vital that we do not affect that.

Secondly, it would be a matter of very serious concern if this Bill were to undermine patient or public trust and confidence in our NHS, our research medicine and our clinical trials infrastructure. I flagged up on Second Reading the fact that I do have some concerns. Some of those relate to the way in which this debate is conducted, although I am not making any comment about the hon. Lady’s intervention. It is very important that we explain to people what this Bill does and does not do. If we mislead them, it is not surprising that we will get a lot of unnecessary fear. It is very important that we clarify that this has nothing to do with clinical research.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health Committee

Does the Minister accept, however, that the Association of Medical Research Charities, the Academy of Royal Medical Colleges, the British Medical Association, and an A to Z of other organisations involved with medical research are very clear that this does undermine participation in medical research? He should listen to those concerns and acknowledge that they are genuine.

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

Yes, indeed; I have listened. I acknowledged those concerns on Second Reading and said I was concerned about them. This is merely a debate about the Bill—there is no change in the law—and it is only this debate that is upsetting people at the moment. It is therefore very important that we carry it out in a way that makes it clear to them what this Bill does and does not achieve.

I am concerned that the passage of the Bill, the conduct of the debate, and any legislation that may survive the process of parliamentary scrutiny do not in any way undermine public or patient trust and confidence in clinical research or mainstream medicine. Were it to do so, I would be very concerned and the Government would be unable to support it. I have made it very clear to my hon. Friend the Member for Daventry that that is the No. 1 consideration, and as this is his private Member’s Bill, it is his task to get it to a point at which the Government would feel able to support it. Public trust and confidence in our NHS and in our clinical research infrastructure is crucial.

Photo of John Baron John Baron Conservative, Basildon and Billericay

May I add to the voice of my hon. Friend Dr Wollaston and suggest that not just the bodies she mentioned but many of the cancer bodies, charities and communities are very concerned about this Bill? Let me bring the Minister back to the issue of evidence. The pursuit of justice starts with evidence, and there is no evidence that litigation is deterring doctors from innovating. This Bill, in many respects, addresses a non-existent problem. If it is not necessary to legislate, it is necessary not to legislate.

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

As my hon. Friend knows, I have a lot of respect for his logic and his position, so let me be very clear again. As I tried to explain, I accept that if one were setting out a list of the biggest barriers to the uptake of innovation, fear of negligence would not be No. 1 on the list. However, it is equally true, as has been put to us during the consultation on this Bill, that it is a consideration. It is very important that the mechanism is proportionate to that obstacle. I think that that is the point he is really making, and I could not agree more. I signalled on Second Reading, and signal again now, that for the Government the most interesting part of this Bill is about access to information on innovative medicines and treatments for clinicians, who already have the freedom to innovate.

The second part of the Bill, as we understand it—we have taken substantial legal advice—does not in any way change the law on medical negligence; we would struggle if it did. Rather, it sets out a clear pathway for doctors seeking to enjoy the freedoms that are already in law to make it very clear what the procedure would be. People might say that these are fairly marginal improvements and ask whether they really merit the time of the House, but it is not for me to judge what is or is not an appropriate use of Parliament’s time. However, I do understand that my hon. Friend the Member for Daventry is trying to tackle, through a small measure, something that we all have an interest in, which is increasing access to innovative medicine.

The focus on provision of information that is reflected in the Bill’s new title and structure has the potential for an interesting mechanism. That is why we have looked at what the costs might be of putting such a database together. The figure that I have given is based on the understanding that further significant scoping work would be required were the Bill to become law, including consideration of the modification of existing coding systems to capture an innovation in medical notes, the data flow and the searching capability before the information centre—the HSCIC—was able to provide a robustly costed solution. Until proposed options and variables undergo additional policy refinement, including the development of a proper specification, it is not possible to offer a further estimate of supporting costs. The affordability of any specific proposal and future investment in technology more generally will also need to be considered in the light of the forthcoming spending review settlement, and the work of the National Information Board, which is putting in place a broader framework for the flow of information in the NHS.

Medical practitioners are already required to comply with the GMC and MBA guidance on record keeping, and the recording of an innovation for front-line staff is therefore based on existing practice. Thus no additional costs are foreseen for medical practitioners or their own organisation. Officials in the Department of Health are currently drafting an impact assessment to examine the estimated impact of the Bill and to understand better the likely costs and benefits of the proposals.

The database proposed by the Bill—should it survive parliamentary scrutiny—may ultimately improve the flow of information to clinicians on the range of innovative treatments that are already available. Those treatments might include off-label uses of medicines, about which the House is interested in connection with another Bill. In our view, the biggest barrier to the flow of information through the system is the lack of incentives or proper reward for innovation. That is to do with how we reward patterns of activity, rather than the promotion of health and healthcare. The lack of availability of data and information is one of the biggest barriers. Subject to whatever scrutiny and changes the Bill may undergo in Committee, we think that there is a potential prize worth winning, but I appreciate that the Committee will need to go through the Bill in some detail.

Photo of Justin Madders Justin Madders Shadow Minister (Health) 3:29 pm, 3rd November 2015

I will not detain the House for long, as my hon. Friend the shadow Health Secretary set out in detail our concerns about the Bill on Second Reading. I will say in summary that the Opposition believe the Bill to be at best unnecessary, and at worst a danger to patients.

The Bill is strongly opposed by a number of medical royal colleges, including the Royal College of Surgeons, the Royal College of Pathologists and the Royal College of Paediatrics and Child Health. There is strong opposition from several medical research charities, including Cancer Research UK, Alzheimer’s Research UK and the British Heart Foundation. There is also strong opposition from bodies such as the Wellcome Trust, the Patients Association and Action against Medical Accidents.

Given the range and depth of concern, I do not understand how the Minister can be so comfortable in supporting the Bill, even though he contends that he is not supporting it. I ask him to reconsider the Government’s position. We will see very shortly whether the point made by Dr Wollaston is correct, and whether the Government are as neutral on the Bill as they state.

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. Gentleman will be familiar with the procedures of the House, but I just want to confirm that once the House has given a private Member’s Bill a Second Reading, the convention is that the Government, even when they robustly oppose it, always table a money resolution so that the Committee need not concern itself with that matter. Doing so is not a signal of Government support; it is absolutely in line with the convention of the House with all private Members’ Bills, whether we oppose or support them.

Photo of Justin Madders Justin Madders Shadow Minister (Health)

I am grateful to the Minister for his clarification. As I say, we shall see very shortly whether that is the case.

I understand that the part of the Bill to which the money resolution primarily relates will give the Secretary of State the power to set up a database. As the shadow Secretary of State set out on Second Reading, we consider that unnecessary because, under section 254 of the Health and Social Care Act 2012, the Secretary of State and NHS England have the power to direct the Health and Social Care Information Centre to establish and operate a system for the collection or analysis of information. I note that, in a recent letter to the shadow Health Secretary, the Minister said:

“Under section 254 of the Health and Social Care Act the Secretary of State has the power to direct the Health and Social Care Information Centre to establish and operate a system for the collection or analysis of information of a description specified in the direction.”

I understand the Minister’s argument is that he thinks it is appropriate to give the Secretary of State an express power, but I am not convinced by that and neither are many in the medical profession, including the Royal College of Surgeons.

We believe that the Bill attempts to address a problem, namely the fear of litigation, that simply does not exist and for which the profession have provided no evidence. There is a risk that it will undermine the methodical and reasoned approach to research that already exists. In the context of the £30 billion challenge that the NHS faces and the financial problems that are taxing us all, we note that the Bill may prove to be a step in the wrong direction. We will vote against the money resolution for the Bill, and we will no doubt see what the Government make of it when they have considered their research on the costs.

Photo of Chris Heaton-Harris Chris Heaton-Harris Conservative, Daventry 3:33 pm, 3rd November 2015

I thank the Government for introducing, as is the convention of this place, the money resolution on my private Member’s Bill.

Several colleagues have expressed their concerns about the Bill, as the Opposition spokesman has just done. I must say to them, and to the Association of Medical Research Charities and other bodies, that many of the briefings seem to relate to the previous iteration of the Saatchi Bill that went through three Readings in the other place and have not been changed for this Bill, even though this Bill is massively different from that brought forward by Lord Saatchi in the House of Lords.

The Bill has two elements. It proposes that a database of innovation be established for only registered medical practitioners to use when they innovate or depart from standard medical practice. As we have already heard, doctors and surgeons say that they regularly innovate.

Photo of Phillip Lee Phillip Lee Conservative, Bracknell

I would never question my hon. Friend’s intentions in this area, but the AMRC’s summary states:

“we do not see the need for this legislation and do not believe the Bill will achieve its aim of encouraging medical innovation.”

It goes on to say that

“this Bill…as it stands is unnecessary and may adversely impact on patients and medical research”.

That view is supported, among others, by Cancer Research UK, the British Heart Foundation and the Wellcome Trust. Does that not give him pause for thought before he proceeds with the Bill?

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

Yes, it does. I have talked to those organisations constantly from the conception of the idea of stealing these two ideas from the Saatchi Bill, and I will continue to talk to every organisation that wishes to talk to me about the Bill. If that was a bid to be on the Bill Committee to offer an alternative view and help me pick through the details of the legislation to ensure that it does what I intend it to do, I welcome my hon. Friend’s approach because a couple of people who would have added great value to the process and the Bill are not able to sit on the Committee.

I gave the example on Second Reading of a surgeon who had innovated and saved the life of his patient, but who was unable quickly to communicate that to his peers as there was no comprehensive means of doing so. The database has been called for by many of the medical colleges, as is acknowledged in the briefings that my hon. Friend will have read. The database is important in spreading the best innovations, because it will include not just the successes of any innovation, but its failures. That will allow best practice to spread quickly and for other registered medical practitioners to learn from any innovation. It will not be available for patients to access and will be held by the Health and Social Care Information Centre, as we have just heard, which is where the money resolution directs the money towards.

The database will not cover research and will not hamper recruitment to clinical trials. Nothing in the Bill will allow doctors to bypass any process or requirement that has been set by their trust in relation to undertaking innovative treatments in the NHS, including the requirement to ensure that commissioners will fund any treatment that is not provided by the NHS. As we all know, individual innovation is incredibly important, but it is not a suitable substitute for medical research, which usually tests the efficacy of treatments in a systematic way. I hope that successful innovations will lead to systematic research projects as the evidence builds around a particular specialty and that they will thereby encourage more clinical trials.

The second part of the Bill, which I fully acknowledge is much more controversial, will give registered medical practitioners a supplementary method of demonstrating that they have acted responsibly while innovating. It closely mirrors the existing legal test, the Bolam test, that is used when clinical negligence proceedings reach the court stage. It brings the test forward and enables doctors to use it to demonstrate that they have acted responsibly before they enter the courtroom. It does not change the common law.

Photo of John Baron John Baron Conservative, Basildon and Billericay

I fully respect the good intentions behind the Bill and those of my hon. Friend. I suggest to him that his last point perhaps misses the more fundamental point that it is the fear of litigation that may deter doctors and medical professionals generally from innovating, and thereby put patients at risk. Does he accept that that is at least a valid concern?

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

I am not convinced that that is the case because doctors and registered medical practitioners innovate daily across the national health service. Litigation might be a consideration in the back of their minds, but they are all responsible doctors doing the best for their patients. I do not quite see my hon. Friend’s point.

Doctors have to demonstrate that they have acted responsibly and that remains the case under my Bill. If they have not acted responsibly, they will be subject, as they are now, to the full force of medical negligence law and bodies such as the General Medical Council.

I would argue that my Bill provides extra safeguards to protect patients from medics who peddle treatments that are dangerous or misguided. First, any doctor must act responsibly and in the best interests of his or her patients. They must also be able to demonstrate that they have done so—as they do now—if it gets to a court of law. Secondly, when an innovation is listed on the database, its successes and failures have to be listed. If a rogue doctor’s peers are able quickly to see the exact results of their innovation, would that doctor not be almost exposing themselves and their quackery to their peers?

My Bill has massively evolved from Lord Saatchi’s Medical Innovation Bill from which many of the criticisms levelled against it come. I have been working with the Department of Health, and others, to ensure that the Bill achieves its central aim, and I know that I have a long road ahead should the Bill get through Committee and its other stages. I fully intend to work with everybody who wishes to make suggestions and help constructively so that we can get to a point where we have a database of innovation that can help spread best practice across our NHS.

Photo of Philippa Whitford Philippa Whitford Shadow SNP Westminster Group Leader (Health) 3:40 pm, 3rd November 2015

There are many ways for a surgeon to share their experience if they have carried out an operation in the heat of the moment to save someone’s life. The “British Medical Journal” publishes things on a weekly basis and can share interesting cases. The danger of the Bill is that the database is being used as a fig leaf to make it sound like access to innovative treatments. Chris Heaton-Harris said that a doctor would have to prove that something was safe, but the first person prescribing liquorice for cancer has no method of proving that it is safe. That is the basis of research.

Phase 1 trials involve a small group of patients who fully consent to undergo treatment and know what they are taking on, based on pre-clinical research. Phase 2 is larger, and phase 3 involves multiple hospitals. We have that process to avoid a couple of doctors in a canteen saying, “That’s not a bad idea. I’ll back you if you back me”, and patients being given something dangerous. The Bill would not, of itself, undermine research in some way, but if patients and the public feel that they are guinea pigs for any old treatment that someone wants to have a bash at, that will undermine research.

It has taken decades to get to our current level of safety, checks and balances. That has been streamlined, and single ethical permissions are carried out once for the whole country, and then recognised in all health boards and areas. That has made things a lot easier, but it is crucial that patients who sign up to a treatment know that there has been a degree of rigour before they are given that drug.

If someone is bleeding to death in the middle of the night, of course a surgeon can innovate because every operation is slightly different, but we are talking about access to medical treatment that will predominantly involve drugs that have not had sufficient pre-clinical work. That is of concern to research charities and the royal colleges—I am a member of the Royal College of Surgeons—because of patient safety. The absolute concern is not even the secondary impact on research; it is the impact on patient safety and people finding that they are being given something totally unproven.

Photo of Andrew Slaughter Andrew Slaughter Shadow Minister (Justice)

The hon. Lady is making a good point, and I agree with everything she says. As a lawyer rather than a doctor, I think the problem with the Bill is that—unintentionally, I am sure—it also undermines carefully constructed juris- prudence on clinical negligence, and it is dangerous for that reason.

Photo of Philippa Whitford Philippa Whitford Shadow SNP Westminster Group Leader (Health)

Of course the Bill is well-intentioned, and its title will attract support from people who think that it means getting access to drugs to which we do not currently have access. It is not that any doctor can prescribe anything—we cannot. We can prescribe drugs that are licensed and recognised, and have a basic safety profile. In Westminster Hall we often debate access to expensive, innovative, brand new treatments, but that is not about our right as a doctor to prescribe them; it is about who will pay for them because some of those drugs are expensive. As the Minister has said, that would still be an issue. In what sense would a commissioning group have evidence to allow a doctor to prescribe a drug that has absolutely no basis, but that would have to be funded?

The Bill is basically a bit of a mess. What problem is it trying to answer? People think it means that they will get earlier access to new drugs, but drugs should be taken forward on the correct path to protect patients and doctors. Doctors need to know that what we are doing is right, and not some random thing that has been on a database after somebody tried something once and it seemed to work. We know that there are placebo and random effects.

Photo of Maria Caulfield Maria Caulfield Conservative, Lewes

I support everything the hon. Lady has just said. I was a research nurse in cancer care for more than 10 years. We observed good clinical practice standards, and the standards of the Medicines and Healthcare Products Regulatory Agency and the FDA, because mistakes happened. Those safeguards are in place for a reason. The No. 1 reason is to protect the patient.

Photo of Philippa Whitford Philippa Whitford Shadow SNP Westminster Group Leader (Health)

I did my MD thesis in the late ’80s on the use of monoclonals in breast cancer, which was then totally blue-sky thinking. What became Herceptin was found at that time. I remember speaking at a conference in America where people presented their research. At that time, they thought they had to put a toxin on the back of an antibody to make it work. They were using ricin, which was used in the Bulgarian umbrella murder, and—surprise, surprise—almost all their patients died. They got around that in America by going to Mexico and to prisons. It is not the case that everything a doctor thinks might work will be good for patients. We have developed a safe system over decades and we give it away at our peril.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health Committee 3:46 pm, 3rd November 2015

I rise to oppose the money resolution because this is bad legislation. It is unnecessary and could undermine essential protections for our patients. That is why an A to Z of medical royal colleges and research charities oppose the Bill, as does Action against Medical Accidents, the British Medical Association and so on—the list goes on. This is the time at which the House must bring the legislation to an end.

I am concerned at the selective misquoting of a number of bodies. Many of the medical royal colleges have objected to being selectively misquoted during debates on the Bill. I will quote from just one of the royal colleges; the president of the Royal College of Physicians, Jane Dacre, would like to put the college’s views on the record. She says:

“The RCP does not support the progression of the Access to Medical Treatments Bill through Parliament. The primary objective of the Bill to create a parallel innovation process may result in unforeseen consequences that negatively impact on patient safety. The Bill may further undermine and overcomplicate the established existing process for conducting innovation, damaging the UK’s innovation process. As the RCP has previously stated prior to previous readings of the Access to Medical Treatment Bill and the Medical Innovation Bill it is unclear how the legislation will improve upon the existing innovation process or address the real barriers to conducting innovation. The RCP does not support the Bill’s progress through Parliament.”

We should also be clear that the Minister does not need the legislation in order to introduce the processes that all hon. Members would support to facilitate communication between research bodies about genuine innovations. We need to simplify the processes by which patients understand which research trials are out there from which they could benefit. When I started in medicine 24 years ago, many of the children I treated for leukaemia were dying. Children today with the same conditions survive not as a result of a series of unconnected, anecdotal, have-a-go treatments, but because of the medical research that built the foundation for the treatments from which they now benefit.

Our patients and our constituents want to contribute to research that benefits future generations, but they cannot do so through an unconnected database of anecdotal treatments. A series of anecdotes does not constitute evidence. We need to be careful of that. I thank my hon. Friend Chris Heaton-Harris. He has good intentions, but I simply do not agree with the Bill.

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Health), Shadow DUP Spokesperson (Transport), Shadow DUP Spokesperson (Equality) 3:49 pm, 3rd November 2015

I, too, have concerns about the Bill introduced by Chris Heaton-Harris. I agree in principle about the need for quick, easy and affordable access to effective treatments for patients, and new developments and initiatives that improve access to innovative treatments should be encouraged so long as they do not have a negative impact on patient safety. Dr Wollaston made that point, as did other Members.

Questions and concerns have been raised by a number of prominent UK charities—the British Heart Foundation, Prostate Cancer UK and Alzheimer’s Research UK, to name but a few. We must be careful not to confuse intention with outcome. The main concern is the potential risk to medical research, and the Association of Medical Research Charities, which represents a large number of prominent and well respected medical charities, has expressed concern that

“the bill may inadvertently act to discourage patients from participating in robust research studies”.

That is important, and we must be clear that we are concerned about introducing legislation that has perhaps not been fully thought out.

Further concerns include the vagueness of certain definitions in the Bill. For example, what exactly can be described as “accepted medical treatments”? Well respected UK charities in the sector have expressed concern about the vagueness of that definition, and it is just one of many concerns.

The Bill is loose and it is not definitive. It is also unclear. With great respect to the hon. Member for Daventry, we need to go back to the drawing board with this one. In addition to concerns about unintended consequences, there is the question of whether the Bill is really necessary. I reiterate my support for innovation as a principle—it should be encouraged and welcomed—but I want the House to note the comments that many hon. Members have made today and be mindful of the concerns that have been raised, because we do not want the Bill, however well intended, to have unintended negative consequences.

Photo of John Baron John Baron Conservative, Basildon and Billericay 3:51 pm, 3rd November 2015

I, too, wholly support the purpose of the Bill and the good intentions behind it, but I am opposed to the Bill itself. I declare an interest as chair of the all-party group on cancer.

Parliamentary scrutiny demands evidence. The Bill is based on the false premise that doctors are somehow deterred from innovating because of a fear of being sued for negligence. I am not aware of any evidence to support that. Doctors can and do innovate without the proposed law. The innovative response to the Ebola crisis was one example of that. Lord Woolf, a leading supporter of the Bill in the other place, wrote in The Daily Telegraph in April 2014:

“What I do know about, from sitting as a judge, are the cases where doctors are sued for negligence because they have innovated in the treatment they offer, rather than following generally accepted medical standards.”

A member of the public then questioned him and asked him to produce evidence of such cases, to which he replied:

“I am not prepared to be cross-examined further”.

Lord Woolf did not cite a single case to support his position. Surely the pursuit of justice starts with evidence. With respect, that sort of judicial paternalism has no place in the modern world. Nowadays, the public expect and deserve better. I am informed by the joint editors of the leading text “Clinical Negligence” that they are not aware of any such cases. Doctors are sued for poor practice, not for innovative practice.

The supporters of the Bill need to provide evidence that doctors are being sued for innovative practice. They need to identify the cases in which that is happening. There cannot be any informed debate until they provide that information. So far, they have not produced any shred of evidence to support their position. The Bill addresses a non-existent problem. If it is not necessary to legislate, then it is necessary not to legislate. Moreover, there is a duty not to pass bad law. This Bill, like the Medical Innovation Bill before it, proposes law that is not only unnecessary but would turn out to be bad.

Photo of Andrew Slaughter Andrew Slaughter Shadow Minister (Justice) 3:54 pm, 3rd November 2015

I will be brief. Chris Heaton-Harris may be beginning to think that he had a lucky Friday when he got the Bill a Second Reading. When one looks at it in detail, it has a number of flaws.

Action against Medical Accidents, a reputable organisation that I have worked closely with, has stated:

“We believe that the proposed changes would have serious unintended consequences such as lowering protection for patients and patient safety”— a point a number of Members have dealt with—

“causing confusion about the law which could hamper rather than help medical innovation; and leaving patients who have been harmed as a result of what currently would be deemed negligent treatment with no redress.”

It is the last of those points that concerns me. Many leading QCs in the field of medical negligence have also raised concerns about it. If people have been injured by negligent medical treatment, they must have redress. That redress was substantially withdrawn in the Legal Aid, Sentencing and Punishment of Offenders Act 2012. It is only right that we are clear that we want to preserve it, not only for the individuals involved but because standards of medical practice are enhanced and improved if they are attacked on the rare occasions when they fall below standard. For those reasons, I oppose the money resolution.

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 3:55 pm, 3rd November 2015

It is not for me to defend this private Member’s Bill, promoted by my hon. Friend Chris Heaton-Harris, but I want to deal with two or three points that have been raised in connection with the Government’s view of clinical research and patient safety, both of which are very important.

Dr Whitford made an impassioned plea that patient safety not be undermined. I reiterate that the Bill will in no way have any impact on our clinical research approvals and ethical regulatory infrastructure, which are world-class and a much prized jewel in our crown. The Bill merely—by saying merely, I do not mean to undermine its potential impact—deals with freedoms to prescribe innovatively, which already exist and are enjoyed by clinicians. It is important that everyone understands that doctors are already free to prescribe medicines. They have sovereignty in prescribing treatment to their patients where they believe there is good clinical evidence.

The hon. Lady made a point about the importance of evidence. The part of the Bill that the Government think is of particular interest is the mechanism for accelerating the giving of evidence to clinicians on currently available innovations—both innovative medicines and the off-label innovative use of existing medicines. It is worth bearing in mind the House’s interest in accelerating off-label use through the provision of information. Patient safety and patient protection are absolutely key, and we will do nothing, and allow nothing, that undermines that.

My hon. Friend Dr Wollaston raised a range of concerns. They are all legitimate, but I think the place to address them is in Committee. I reiterate that nothing in the Bill will interfere in any way with UK clinical research infrastructure.

In response to the point that Justin Madders made about whether the Government support the Bill, let me be very clear: the Government neither oppose nor support the Bill. We are prepared to work with the Bill’s sponsors to get it to a place where it supports the environment that we want to see.

On testing the will of the House, I can assure the hon. Gentleman that the Government always support money resolutions, even on Bills to which they are blatantly opposed. That is the convention, so he will be testing and proving nothing other than that we will stick to the convention of always supporting the money resolution to a Bill.

Question put.

The House divided:

Ayes 281, Noes 227.

Division number 108

See full list of votes (From The Public Whip)

Aye

No

Question accordingly agreed to.