Access to Medical Treatments (Innovation) Bill

Heidi Alexander Excerpts

Friday 16th October 2015 Commons Chamber

[Chris Heaton-Harris]

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

[Heidi Alexander (Lewisham East) (Lab)]

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

[Chris Heaton-Harris]

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

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[Heidi Alexander (Lewisham East) (Lab)]

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

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

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

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

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

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

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

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

The British Medical Association has said:

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

The Royal College of Surgeons has said that

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

The Motor Neurone Disease Association has said that

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

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

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

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

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

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

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

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

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

I am not sure we have got to that point.

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

“significant unintended consequences for medical research”?

[Bob Stewart]

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

[Heidi Alexander]

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

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

[Mr Dennis Skinner (Bolsover) (Lab)]

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

[Heidi Alexander]

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

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

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

which, in practice, could mean just one doctor—

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

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

[Chris Heaton-Harris]

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

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[Heidi Alexander]

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

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

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

“may adversely impact on patients and medical research”;

and the Royal College of Paediatrics and Child Health, the president of which simply says the Bill endangers the safety of infants and children. It would be irresponsible to support the Bill, which is why I will be opposing it, and I encourage other hon. Members to join me.

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[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.

[Heidi Alexander]

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

[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.

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[Philip Davies]

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

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

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

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

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

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

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

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

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

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

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

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

[Heidi Alexander]

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

[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.

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[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.

[Heidi Alexander]

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

[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.

[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.

[Heidi Alexander]

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

[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.

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[George Freeman]

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

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

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

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

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

[Heidi Alexander]

Does that power not exist under section 254 of the Health and Social Care Act 2012?

[George Freeman]

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

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

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

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

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

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

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

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

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

[Heidi Alexander]

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

[George Freeman]

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

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

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

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

(c) obtain any consents required by law”,

including

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

(ii) the risks and benefits”

and to

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

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

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

Members have asked whether the Bill will allow doctors to prescribe untested medicines. It is important to make it clear that the Bill does not change existing medicines legislation, which permits the use of unlicensed medicines —tested or untested—prescribed by physicians on their own responsibility, subject to all their own professional tests, regulatory conditions and the law. This will be based on what they believe, in their own professional clinical judgment, is right for their patients. If there is an unmet medical need, there is clearly more scope for clinicians to innovate.

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

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

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

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

The Royal College of Physicians has said that it

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

--- Later in debate ---

[Heidi Alexander]

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

[George Freeman]

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