Philip Davies (Shipley) (Con): I start by welcoming you to the Chair, Madam Deputy Speaker. It is an absolute pleasure to speak for the first time under your chairmanship on a sitting Friday, and it will be a great pleasure to do so again in the Fridays to come. I hope you enjoy it as much as I do. I congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on bringing forward this interesting Bill, on which we have had a good debate already. It would also be remiss of me not to welcome the hon. Member for Lewisham East (Heidi Alexander) to her position under the new regime in the Labour party. I am sure she will do a splendid job, and I wish her every success in doing it.
I have been contacted by constituents about the Bill, both in opposition to and support of it. It seems to polarise opinion; people seem to be either very for it or very against it in a way that is not always the case with Bills. I want to outline some of the points brought to my attention, many of them by my constituents. I understand that the Bill aims to help doctors to develop safely and responsibly innovative treatments and cures for cancer and other diseases, and that the rationale behind it, as my hon. Friend seemed to confirm, is that the promotion of such medical innovation could lead to the development of new cures and more effective treatments for patients.
To that end, the Bill has two aims: to provide a regulation-making power to enable the creation of a database of innovative medical treatments and to enable doctors to access information on this database; and to provide an option for doctors who innovate to take steps in advance to show that they are acting responsibly, not negligently—which deals with some of the concerns already expressed. It specifically states that it would not apply to the use of treatments in research, thereby keeping that distinction, but rather would support innovation in the treatment of individual patients, while preserving the existing common law safeguards for patients. By bringing forward the legal test of negligence to the point of treatment, it allows doctors to remove the barrier of the fear of litigation when using innovative techniques and working in a manner held as largely responsible. Those all strike me as worthy sentiments, and it is difficult to see why anyone would be against them in principle.
The Bill cannot be seen in isolation from its origin and progression in Parliament. As my hon. Friend made clear, the Bill stems from Lord Saatchi’s Medical Innovation Bill, introduced in the last Parliament, which, it is important to mention, arose from Lord Saatchi’s personal experience of losing his wife to a rare cancer. I think, therefore, that we can all appreciate, and should be mindful of, the Bill’s intention, which was to try and prevent that from happening to other people. It aimed to provide a standard for the legal position surrounding innovation, hoping, in theory, to encourage doctors to use innovative techniques, confident that their good intentions would not be lost.
In taking up issues with the NHS on behalf of constituents, I have often seen its fear of litigation. That might apply if I take up a complaint about one of my local hospitals—I have very good local hospitals, but of course everybody makes mistakes and things do not always go according to plan. Sometimes responses from the NHS can be very defensive, not because it does not appreciate that something has gone wrong, but because it fears the consequences of admitting that something has gone wrong. We should always do what we can to try to help the NHS from that fear of litigation. Anything seeking to do that would be very worthwhile.
Dr Wollaston: That is an entirely separate issue. Admitting when a mistake has been made is entirely separate from the fear of litigation, which is some cases can be very reasonable. If a doctor is putting forward an entirely bogus treatment and pretending that it could be helpful when it could in fact be more harmful than existing treatments, that is an entirely separate issue. I hope my hon. Friend will not conflate the two.
Philip Davies: I am rather surprised, given my hon. Friend’s background, that she has such little faith in doctors that she sees them wanting to peddle some bogus treatments. I was starting from the premise that the medical profession was far more responsible than that and would never seek to do that sort of thing. I certainly bow to my hon. Friend’s greater knowledge of the medical profession, but as I say, I was starting from the basis that her profession was nobler than she seems to indicate.
Dr Wollaston: Of course the overwhelming majority of the profession does behave responsibly, but the whole point about having protections in law is to accept that some would not behave responsibly. My hon. Friend the Member for Daventry (Chris Heaton-Harris) referred to hair loss, for example, which is a field where vast profits are to be made, and I am afraid some doctors might be tempted to behave irresponsibly.
Philip Davies: I take my hon. Friend’s point. She is an expert in her field in a way that I am not, and I certainly do not want to decry that. My perspective on the narrow point she raises, however, is slightly different. I would want to set the framework of the law for the overwhelming majority who are doing a good job. Let us try to find other ways to weed out those who are not doing so. Putting in place arrangements that apply to everybody in order to deal with the very small number of doctors about whom my hon. Friend speaks is probably the wrong way of going about it. I am happy to have this conversation with her in a different setting; I do not want to deviate too far from the Bill in going into how many doctors are noble and how many are chancers. I do not know the answer to that; perhaps my hon. Friend does, but I am not getting into that today.
My hon. Friend the Member for Totnes (Dr Wollaston) made the point that the Bill is unnecessary—the shadow Minister made the same point—and that there is no need for a legal requirement for medical innovation to be made, particularly when the current common law Bolam test is appropriate. Although it may not be popular, however, I believe it important to give serious consideration to this part of the Bill.
The Medical Innovation Bill, although criticised, showed an appetite for more legal work in the area of medical innovation. After a commitment from the Secretary of State for Health, the Medical Innovation Bill was put to consultation in the last Parliament. Many organisations shared their views, some of which have already been mentioned. I shall highlight a couple of those views because they are relevant to today’s Bill.
Cancer Research UK stated in its consultation response:
>“There is clearly patient and clinician demand for more innovation to help treat people with cancer. We do sometimes see exceptional responses to treatments from individual patients, and therefore want to be in a position to innovate. Cancer Research UK is supportive of efforts to bring innovative treatments to patients faster and to improve the uptake of innovative treatments in the NHS. Any new legislation seeking to promote innovation should be drafted to ensure doctors have to establish there is sufficient intellectual underpinning and safety data about a treatment before proceeding. There should also be appropriate consultation with other doctors in the same or a related field to ensure patients receive the best care at all times.”
I understood from previous contributions to this debate that Cancer Research UK was against today’s Bill, but it does not strike me from the response I have cited that it was opposed to it. It seems to me that it was looking for ways to bring about more innovation to help treat people with cancer. It seems to be open to the possibility that the Bill might be able to do that.
Chris Heaton-Harris: I fully admit that there are a number of critics of the Bill, but not so many critics of the central idea in the Bill. I welcome what the hon. Member for Lewisham East (Heidi Alexander) said about trying to work with those who are genuinely interested in spreading best practice and innovation across the NHS. If one of the Bill’s core features is widely welcomed, even by some of the harshest critics of its later parts, I put it to the hon. Lady that it is surely it is worth taking the Bill forward into Committee to examine the provisions in greater detail, when we could debate it with expert witnesses and others.
Philip Davies: My hon. Friend makes a very good point. A Second Reading is, of course, a debate of a Bill in principle, so that we can establish whether people object to it in principle. I have been somewhat confused by the voices in opposition to the Bill because I cannot work out whether they consider the Bill to be dangerous or unnecessary because what it proposes is already being done. It seems difficult to argue that it could possibly be both. Either the Bill’s provisions are already in place so there is nothing to be done, or the Bill is a terrible and dangerous thing.
Dr Wollaston rose—
Philip Davies: I cannot understand how it could be both, but perhaps my hon. Friend will explain that for me.
Dr Wollaston: On my hon. Friend’s first point about Cancer Research UK, let me be absolutely clear that it is opposed to the Bill. On the second point, what these bodies are all saying is that the Bill is unnecessary, but that if it is put in place, it would be dangerous. That would be the consequence of the Bill, and people think there are other ways of moving forward to improve access to innovative treatments.
Philip Davies: I merely read out, word for word, Cancer Research UK’s response to the consultation; I can do no more than quote its words. I will take my hon. Friend’s point in that regard.
Mr Chope: If there is such widespread opposition to this Bill, why was it that the Saatchi Bill made such good progress in the other place during the last Parliament, when I understand it had the benign support of the Government?
Philip Davies: My hon. Friend often asks me questions that I cannot answer. He has now asked another that I am not in a position to answer. I often think it is a mistake to give way to him; he is far too clever for my liking. Again, he has stumbled across something that I cannot answer. He raises a very good point, so perhaps we shall leave it hanging there for others to have a crack at later in the debate.
The Academy of Medical Royal Colleges said that it applauds the intentions of the promoters of the Medical Innovation Bill:
“The stated purpose of the Bill is to encourage responsible innovation in medical treatment, and accordingly to deter innovation which is not responsible. Those are aims which medical Royal Colleges would wholeheartedly support and welcome.”
That is an important point.
Dr Wollaston: The Academy of Medical Royal Colleges robustly rejects this Bill. Like me, it supports the intention of extending access to innovative medical treatments, but it is very clear that it opposes the Bill—and this House should oppose it, too.
Philip Davies: I am perfectly happy for people to put their own gloss on what others are saying. That is their right. If I may be allowed to do so, I am merely quoting, word for word, the responses that people made. If my hon. Friend is saying that the Academy of Medical Royal Colleges should not have written that, she should take that up with the organisation. I am merely quoting what it wrote, which I thought was quite clear.
Dr Wollaston rose—
Philip Davies: I want to make some progress, but I will give way again to my hon. Friend.
Dr Wollaston: I must take issue with my hon. Friend because he is quoting very selectively from the report. When he has finished speaking, I urge him to go online and have a look at the detailed briefing on the Bill from the Academy of Medical Royal Colleges. It applauds the principle of improving access to medical treatment, but it is absolutely clear that it opposes the Bill.
Philip Davies: I do not deny that. If the Academy of Medical Royal Colleges wants to shy away from any part of what I have said, the academy probably should not have written it in the first place. I did not write it on the academy’s behalf; the academy wrote it, and I have quoted it faithfully. People can make of it what they will, but what the academy said was that it
“applauds the intentions of the promoters of the Medical Innovation Bill…to encourage responsible innovation in medical treatment, and…to deter innovation which is not responsible. Those are aims which medical Royal Colleges would wholeheartedly support and welcome.”
That is what the academy has said. I did not say it on the academy’s behalf.
The Association of Medical Research Charities summarised its position as follows:
“We welcome the ambition of the Bill in seeking to address the important issue of encouraging medical innovation; innovation and its adoption can be low and slow in the NHS and there is much that can be done to improve this.”
“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.
Dr Wollaston: The point is that we all support the aim of improving access to innovative treatments; we simply do not agree that the Bill is the right way forward. Because my hon. Friend has quoted all those bodies, may I quote back to him the conclusion of the medical royal colleges? They will of course issue consultation responses that will be nuanced in relation to various points, but what we should look at is their conclusion, which could not be clearer:
“In conclusion, Medical Royal Colleges do not believe that the Bill should be supported.”
That is their position.
Philip Davies: I think that my hon. Friend is slightly in danger of arguing against herself. She began her intervention by saying that all those bodies supported the principle behind the Bill, and it seems to me that that is really an argument for supporting its Second Reading. What we are discussing now is whether or not we agree with the principle of the Bill, and my hon. Friend has just said that all those organisations support that principle. She may well wish to scupper the Bill on Third Reading, or amend it in Committee so that it is to her particular taste, but, as I see it, announcing that everyone supports the principle behind the Bill is a call to arms for people to support its Second Reading.
Dr Wollaston rose—
Philip Davies: I want to make some progress, but I will give way to my hon. Friend one final time.
Dr Wollaston: I thank my hon. Friend. He is being very generous. Can he not see, though, that supporting the principle of improving access to medical treatments is a completely different kettle of fish from supporting the mechanism whereby an individual Bill attempts to achieve that aim? In other words, it is perfectly consistent to say that one opposes the Bill robustly, as, indeed, did a long list of organisations and people, including research charities, medical royal colleges, Action against Medical Accidents and Sir Robert Francis. The list is huge. All those bodies state, robustly and clearly, that the Bill is not the mechanism to achieve those stated aims, and that is why the House should reject it.
Philip Davies: It is not for me to advise other Members how to pursue their own agendas. My hon. Friend is a wonderful exponent of ways of implementing her views, but my advice to her, for what it is worth—which she may think is not a great deal—is that if she wants to see more innovation in medicine, as she said at the beginning of her speech, but does not believe that the Bill is the right way forward, she should support its Second Reading and then seek to amend it in Committee so that it achieves the innovation that she would like to see. We shall then review the matter on Third Reading, and she can decide at that point whether the Committee stage has delivered to her what she feels would be a useful way of getting more innovation into the NHS. It seems to me bizarre that someone should stand up and say, “I want to get more innovation into the NHS”, and then block on Second Reading—and this is the principal point of the Bill—any attempt that might actually facilitate the introduction of improved innovation into the NHS. But that is just the way I see the matter; it is up to individual Members to pursue their agendas in the way that they see fit.
Chris Heaton-Harris: I believe that the Bill should go into Committee, because it is an evolution: it is a process that we are going through in trying to get the position right. The Royal College of Physicians says that it “generally welcomes” the first part of the Bill, which enables the Secretary of State for Health to establish a database of medical treatments. However, it issues plenty of caveats in respect of how the detail should run. Those should be discussed in Committee, and that is where I want the Bill to go.
Philip Davies: My hon. Friend has made a very fair point.
I now want to say something about the medical innovation database provision, which is one of the main differences between the Medical Innovation Bill and the Bill that we are discussing. Clause 2 provides for the Secretary of State to make regulations enabling the Health and Social Care Information Centre to establish a database containing information about innovative medical treatments and their outcomes. As a layman, I consider that to be a significant and fundamental part of the Bill. A central database recording all innovative treatments strikes me as a useful tool from which doctors can learn when tailoring medical treatments for their patients. Again, I speak as a layman, but I think that the creation of a system to enable that knowledge to be shared is a logical step towards medical innovation.
Having said that, I should add that the proposal is not without its worrying aspects. I wanted to raise them earlier, but the interventions from my hon. Friend the Member for Totnes delayed me. One of the main criticisms of clause 2 comes from the Royal College of Surgeons of Edinburgh, which states:
“The proposed database could only be effective if it is compulsory, regulated, has robust quality assurance and be journal-led, ethically framed and rigorously peer reviewed. It will also require an honest culture in which participants are just as likely to register failures as successes”.
The clause provides for the Health and Social Care Information Centre to specify what information should be recorded and how it should be assessed. More experienced people than me will be able to note what standards and specifics need to be recorded to make the database useful and usable. It is certainly not for me to make any suggestions. The database will also be designed in consultation with professional bodies and organisations.
The clause contains the important provision that the database will cover all individual patient innovations, not only those in respect of which doctors have chosen to rely on the steps in the Bill to demonstrate that they have acted responsibly. It is a significant inclusion, as it means that the database will include and cover all treatments and their outcomes—both positive and negative —that take place in England. That is my understanding of the clause, but if my hon. Friend the Member for Daventry wants to correct any misunderstandings, he is welcome to do so. Therefore, this national database not only spreads the knowledge of successful innovations, but also has the benefit of ensuring that innovative treatments that do not work, or perhaps have harmed patients, are not repeated by other clinicians. That should go some way towards reassuring those with concerns. It will also, therefore, create a standard practice that all innovative medical treatment should be recorded in this database, which can be a useful tool for other doctors to draw information from when they are doing their own innovation.
Bob Stewart: I came here to listen to my very good friend my hon. Friend the Member for Daventry (Chris Heaton-Harris) and to listen carefully to the debate. It seems to me that if Lord Saatchi’s Bill went into the sand and if this Bill does not make it into Committee and disappears, the one good thing that will come out of it is that the whole subject will be illuminated, and perhaps something good will come out of that. Therefore, the efforts of Lord Saatchi and my good friend the Member for Daventry will not be in vain. I hope very much that the medical authorities will look at this and think of it in that light.
Philip Davies: I take on board my hon. Friend’s point. It seems to me that he was subtly saying he had come to listen to the speech of my hon. Friend the Member for Daventry rather than mine. I had hoped he had come to listen to my speech, but I am clearly mistaken.
Bob Stewart: I must intervene. I always come to listen to my hon. Friend the Member for Shipley (Philip Davies). I listen to him outside this hallowed hall and also inside it, and he is always well worth listening to.
Philip Davies: My hon. Friend is very kind, although it would have been rather better if he had not had to be prompted to say that. Nevertheless, I will take those comments in the spirit in which I know my good friend intended.
Mr Chope: My hon. Friend has not responded to the intervention of my hon. Friend the Member for Beckenham (Bob Stewart). Surely the point is that if we want to discuss this in more detail in Parliament, the ideal opportunity for that is in Committee when it can have detailed scrutiny.
Philip Davies: My hon. Friend makes a good point. I have not heard anything so far today to suggest that the Bill should not at least go into Committee for further scrutiny, and perhaps even for some improvement, if I may be so bold as to suggest that may be possible. I do not think I have heard anything today that suggests the Bill should be stopped in principle on Second Reading. I hope that my hon. Friend the Member for Totnes will appreciate, however, that I am also trying to be balanced in setting out some of the concerns that have been expressed, perhaps so they can be considered if we do get into Committee, which would be a useful exercise.
Another concern raised by some of my constituents is that the database may compromise patients’ anonymity. Innovative medical treatments will be applied on a case-by-case basis with a specifically honed technique for one particular individual. The fear is that a degree of detail will be needed in the register, which would end up compromising a patient’s anonymity. That is a valid concern, and protections would need to be put in place to ensure all information is stored securely within the database to protect anonymity. However, that may be at the cost of using innovative treatments. There may well be a tension between those two factors.
While the information stored in the database should only be accessible by doctors, it will need to remain confidential aside from access for medical purposes and, ultimately, it should be the patient’s choice whether to use an innovative treatment that will be recorded for medical purposes. Furthermore, in an age when we want more doctors to spend more time with patients and not at their desks, we need to be careful to ensure that the register does not become overwhelming to the point where doctors are put off from using innovative techniques for the sake of the amount of paperwork and red tape that would accompany it. The Academy of Medical Royal Colleges said
“current experience in the NHS show that establishing an effective register for far more standard procedures is a complex task. Establishing and maintaining a register of innovations would be a costly and potentially burdensome and bureaucratic task.”
My hon. Friend the Member for Totnes made that point. That is another factor that needs to be considered
when the database is created. Of course the database and the information gathered should be rigorously checked and regulated. However, that is not always easy when doctors are already busy.
Overall, I believe this clause, originating from an amendment to Lord Saatchi’s Bill, is one of the key clauses. For rare diseases such as some cancers there is a lack of published evidence on which to rely when determining treatments to try. It is also widely regarded that some methods used to treat some types of cancers have remained similar for many years, with only slight modifications to the techniques. With this in mind, a database that allows knowledge to be stored and accessed at a doctor’s level will be not only desirable but probably essential for allowing doctors to innovate responsibly. It will encourage a culture of knowledge sharing, which, importantly, will include both successes and failures. This is a vital part of the Bill, and indeed I do not see how the power to innovate can move forward without the inclusion of a database recording the results of these treatments. I therefore commend my hon. Friend the Member for Daventry on including this clause.
We need to look at what we consider to be a responsible innovative treatment. Clause 2(2) states that a treatment is regarded as
‘innovative’ if it involves a departure from the existing range of accepted medical treatments” for a condition. We can therefore assume a wide scope to cover the cases that should be recorded in the new database.
However, concerns have been raised regarding the distinction between innovation and research. While clause 5(2) specifically states that this Bill does not apply to medical research, some medical organisations have raised concerns as to how this would work in reality. The Academy of Medical Royal Colleges states:
“We do not understand the distinction between ‘individual patient innovation’ and ‘research’. The distinction seems false and potentially dangerous. As a college president stated ‘Innovation without research isn’t innovation, it’s more often just advertising’.”
Although the Bill uses the two in harmony, it is important to raise these points and for them to be considered in Committee.
One of the main differences that separates the two is that this legislation allows doctors more freedom to modify and specifically cater treatments towards the individual they are treating. That is very important and worthwhile. Although they will not be finding a brand new cure for cancer, it allows doctors to cater treatment plans more specifically to the patient’s needs and wishes. Many patients will benefit from that, and often would prefer it.
We have discussed the Bolam test. By working from the current common law Bolam test, the Bill identifies the steps a doctor can take to show that they have acted responsibly before innovating. The common law Bolam test is defined as the test “used to determine the standard of care owed by professionals to those whom they serve, e.g. the standards of care provided to patients by doctors.”
Established from the case Bolam v Friern hospital management committee in 1957, it shows that if a doctor acts in accordance with a responsible body of medical opinion, he or she will not be negligent. Subsequently this standard of care test was amended—the
Bolitho amendment—to include the requirement that the doctor should have behaved in a way that “withstands logical analysis” regardless of the body of medical opinion.
This determination of whether a professional’s actions or omissions withstand logical analysis is the responsibility of the court. The Bill, through clause 3, aims to reflect as closely as possible the steps under the current common law which a responsible doctor could be expected to satisfy when innovating. However, clause 3 has caused specific concern for many of my constituents and I would like to raise some of their concerns today.
Most groups and individuals from the medical profession seem to be satisfied with the current Bolam test as a standard for regarding medical innovation, with the Royal College of Surgeons regarding it as “adequate”, so there are concerns that, instead of clarifying the legal position, clause 3 will confuse the current mechanism for judging responsible innovation.
Subsection (2)(a) requires a doctor to
“obtain the views of one or more appropriately qualified doctors in relation to the proposed medical treatment, with a view to ascertaining whether the treatment would have the support of a responsible body of medical opinion”.
This implies that the innovating doctor need only rely on an interpretation of a responsible body, and need not gain the support from a responsible body itself. In practice this might not be a problem, however, as the Bill specifically states that those supporting views must be obtained from “appropriately qualified doctors”—that is, those with appropriate expertise and experience in dealing with patients with the condition in question. It may therefore be taken that the doctor is qualified in the relevant field, which would provide reassurance. It is this clause that many of my constituents are concerned about, however.
This brings me to another point that was raised by my hon. Friend the Member for Totnes. Some of my constituents fear that the database could be used as a tool by quacks, crooks and charlatans, giving them the flexibility to use devious experimental treatments. Indeed, that concern has been echoed by the Royal College of Surgeons, which claims, in reference to clause 3(2)(a):
“This sub-clause could also provide post-hoc justification for an unethical treatment from a doctor asserting s/he sought the view of one other doctor.”
We must be sure, therefore, that appropriate safeguards are in place to protect patients from such doctors. I do not think that many of them exist, but I do not know. My hon. Friend the Member for Totnes and I might have some disagreement about that. The important point is that there needs to be a safeguard, because it is inevitable that some such doctors will exist.
Chris Heaton-Harris: Those safeguards do exist. A doctor has to act responsibly, and if he does not do so, the full weight of the GMC and the law will come down upon him. That situation will not change at all as a result of my Bill.
Philip Davies: I take my hon. Friend’s point, and we should recognise the work of the General Medical Council in ensuring that high quality people are in the profession.
Much of the debate has rightly focused on the impact that the Bill would have on doctors and the medical profession, and on whether it would give them further freedom to innovate or whether it could be misused. However, it seems to me as a layman that much of the focus should also be on the patient. Ultimately, it is the patients who will bear the consequences of this legislation. Many of my constituents, on both sides of the debate, have contacted me to offer opposing views on the effects the Bill would have on patient safety. Some are concerned that it would move the focus from determining whether a patient’s care had been negligent to whether the doctor’s decision had been responsible.
However, the Bill would provide another layer of protection for patients in that the assessment would be carried out before the innovative treatment took place. By following the steps of the common law test, the doctor would obtain the views and support of a responsible body of medical opinion before innovating, so that they could be confident in the knowledge that they had support and would thus not be found negligent. This would of course provide reassurance to the doctor administering the innovative treatment, but more importantly, it would also be in the patient’s interest. Patients could therefore be satisfied about the treatment plan they were undergoing. Any innovative treatment plan must, by definition, come with concerns, but at least the patient could be assured that the doctor had satisfied legal and sound tests to show that the proposed treatment was responsible.
The Bill also sets out that during their research enquiries, the doctor must act and record views in a responsible manner. Therefore, if an appropriately qualified doctor were to consult on the proposed innovative treatment and express reservations about it, the innovating doctor could not disregard those reservations without being found negligent. That is an important point that should not be forgotten. Presumably, the powers of the GMC could kick in at that point to deal with any parts of the medical profession that we might not be altogether pleased with. My hon. Friend the Member for Totnes should not discount the fact that this legislation could highlight some of those cases and bring to account certain people who are hidden from such exposure at the moment. The aim of these provisions is to preserve the existing safeguards of the common law for the patient while giving the innovating doctor the additional choice of taking steps to show that they have acted in a responsible manner prior to innovating, thus aiming to encourage most doctors to do so without fear of litigation.
It is also important to touch on the possibility of unintended consequences. On Fridays, we often debate Bills that have a worthy sentiment behind them—indeed, that applies to most of the Bills that we discuss on Fridays—but they often turn out to be accompanied by unintended consequences. Some of the potential unintended consequences of this Bill have been raised with me by my constituents. One such concern is that the Bill could inadvertently undermine the work of clinical trials or discourage patients from participating in clinical trials, instead leaving doctors to focus on individuals on a case-by-case basis.
Clinical trials, by definition, test methods that aim to be of general benefit in combating a disease collectively—that is, they aim to find a common solution that can work with all, or nearly all, patients. The concern is that if doctors are encouraged to use innovative treatments when treating their individual patients, this could harm the development of research and clinical trials, as they may bypass the need for a regular clinical trial, leaving innovation to develop on an individual level. That seems to be a reasonable point for my constituents to have raised.
Having said that, the proposal could provide an opportunity to enhance the work of clinical trials and research. I hope that my hon. Friend the Member for Daventry will look further in Committee at any unintended consequences, and determine what, if anything, needs to be done to the Bill to prevent any harm from being done to clinical trials. It could boost clinical trials, but there is the potential for both consequences, and we must ensure that it results in a good conclusion rather than a bad one.
If a doctor were to use an innovative treatment on a patient that seemed to be successful, and subsequently recorded it on the medical database, a larger-scale clinical trial could be established to determine whether the treatment provides an inclusive solution for the disease or is suitable only for that individual. I hope that such a complementary consequence will occur as a result of the Bill, and that the understandable concerns of my constituents will be unfounded. The Bill does not create the climate for innovative treatment to begin. Doctors already have the freedom to innovate in individual cases, and that has not yet caused any difficulties or concerns for researchers or clinical trials, so there is no reason why it should do so in the future.
When considering the unintended consequences, we must also consider the unintended positive consequences, such as the one highlighted by the Royal College of Surgeons. It has stated:
“We…believe the Bill could potentially help to prevent poor practice in the private sector where decisions to try unconventional treatments are, in some rare instances, taken without adequate evidence or support from a multi-disciplinary team (MDT decision-making is less common in the private sector).”
Passing the Bill, and setting a more robust legal framework, would automatically set a precedent in the medical community for the procedures that would be expected to be followed when using innovative treatments.
Dr Wollaston rose—
Philip Davies: I was doing so well! However, I appear once again to have incurred the wrath of my hon. Friend.
Dr Wollaston: Not the wrath; I just want to point out to my hon. Friend that he is quoting selectively from the Royal College of Surgeons, which robustly opposes the Bill.
Philip Davies: I am only quoting what the RCS has said. My hon. Friend might want to decry my statement, but the RCS’s overall conclusion on the merits of the Bill is a different issue. I am merely pointing out that it has stated that this could be a consequence of the Bill. People can draw their own conclusions from that. I would like to think that I have tried to be as even-handed as possible by outlining the potential benefits of the Bill as well as the other potential consequences. I have quoted organisations that have raised concerns. I am trying to be even-handed, whether my hon. Friend likes it or not—I suspect that she does not—and that is w
Dr Wollaston: Let me read some conclusions:
“we believe this law is unnecessary and potentially dangerous. It will absolve doctors from any liability for an experimental treatment if they followed the Bill’s low standards and will make it harder for patients to redress malpractice.”
That is the conclusion of the Royal College of Surgeons of Edinburgh and it is pretty clear.
Philip Davies: That may well be that body’s conclusion as it stands, but my point is, as I have tried to make clear, that given that it can see there are potential benefits to the Bill, which I have expressed, in dealing with poor practice in the private sector, there is an argument for getting it into Committee to see whether we can make it a Bill that it wholeheartedly supports. That may or may not be possible, but it is certainly worth having a go, given that it has said clearly that the Bill has potential benefits.
Some medical organisations and groups have expressed their concern that the Bill will have an impact on the use of research clinical trials, but that should not be a sufficient reason to stop doctors using innovative treatments on an individual level. This should not be about one or the other—as I said, we should try to do both.
I was contacted, as I am sure many other Members were, by a concerned mother who is desperate for this Bill to pass so that it can benefit her young daughter, who suffers from a rare condition. As has been pointed out, the difficulty with rare diseases and conditions is that because they are so specific, research and clinical trials are not only costly, but very time-consuming. Many people suffering from these diseases do not have this time in finding a cure. The mother who contacted me explains that her daughter, Grace, is already awaiting the commencement of two clinical trials that may, in the long run, be able to help to treat her condition. Although she is appreciative of these movements, the mother explains that if, after the six-month or 12-month clinical trial, the drug is proven to be effective, her daughter will still not be able to have access to it for several years because of the lengthy approval system used by the National Institute for Health and Care Excellence. We should not forget that in a hurry. Although I do not doubt that the trial times and approval systems that new treatment methods must go through to be considered standard medical care are necessary in order to make sure they are safe, they are far too long for many people, given their particular illness.
Bob Stewart: Too late.
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.
Dr Wollaston: There tends to be an assumption in this debate that all innovation is a good thing. Some medical innovations turn out to be extremely dangerous and irresponsible. We need protections in law to protect patients from unscrupulous doctors. The reason Action against Medical Accidents and the Patients Association oppose this Bill is that they recognise that it will unravel some very important protections that are in place. We need to proceed with great caution.
Philip Davies: I do not think that anyone would disagree with my hon. Friend. Everybody is concerned about patient safety. I have stated at length some of the concerns that my constituents have raised about, for example, anonymity and safety. I hope that all those points will be considered by my hon. Friend to see whether anything further needs to be done in Committee. No one disagrees with that, but saying that we cannot have a Bill that does not protect patient safety is probably not the same as my perspective.
Chris Heaton-Harris: What my hon. Friend the Member for Totnes (Dr Wollaston) has to answer is what provision she would put in place to recognise failure of innovation. If this database is not the right way forward, what is?
Philip Davies: I do not propose to be the central hub of a three-way conversation involving my hon. Friends. I am sure that they are perfectly capable of sitting down in the Tea Room afterwards and going through this in some detail with each other, and they can leave me alone. They do not need me to speak on their behalf. We will leave the three-way conversation there, and I will press on.
Finally, I wish to raise the accelerated access review, which my hon. Friend the Member for Totnes mentioned. In 2014, an external review of the development, assessment and adoption of innovative medicines and medical technologies—the accelerated access review—was announced. This is expected to make recommendations to Government on speeding up access for NHS patients to cost-effective, innovative medicines, diagnostics and medical technologies. Some medical organisations have said that they wish to wait to see the recommendations of this review before implementing changes to rules around innovating treatments. I think that was the main thrust of the speech of my hon. Friend the Member for Totnes. The Royal College of Surgeons said:
“The Government’s consultation on the Accelerated Access Review recently closed and this is likely to prove a more productive route for identifying ways to encourage innovation.”
However, in an article earlier this year, my hon. Friend the Minister for Life Sciences—just to prove that I do read his articles—linked this Bill specifically to the Government’s accelerated access review. He stated:
“The Medical Innovation Bill highlighted some of the important issues and obstacles to the adoption of innovation in the NHS. The growing pressure from patients and medical charities for faster access to innovation, and the potential of the NHS as a world beating research ‘engine’ in 21st century life and health science creates an opportunity for the UK to deliver benefits for patients, NHS and economy. This is the aim of my accelerated access review of NHS adoption of medical innovation. I look forward to working with Chris Heaton Harris to help him shape a Bill to help unlock this exciting opportunity.”
I look forward to the Minister’s comments in due course, but it seems to me that, rather than the accelerated access review being an alternative or something different from this Bill, the thinking is that these two things can go hand in hand with each other, and that one does not contradict the other.
Although the AAR is expected to report recommendations back to Government at the end of the year, its briefing specifically lists
“barriers that currently prevent the uptake of transformative healthcare within the NHS and the healthcare industry.”
Three areas are specifically mentioned: insufficient skills to adopt innovation; lack of leadership support for innovation; and lack of accountability for innovation. Those are just three points I have picked out from the list of areas identified for recommendations by the AAR. It seems that it is those issues that my hon. Friend’s Bill aims to target and it is therefore within the scope of what the AAR is trying to achieve.
In conclusion, this Bill attempts to provide leadership and support for innovation by setting a precedent that innovation should be encouraged and nurtured. It specifically pinpoints accountability by providing doctors with a test to satisfy prior to the beginning of any innovative treatment in such a way that satisfies doubts that the innovating is of a responsible nature. Finally, and most significantly, it sets a base for sufficient skills to adopt innovation by providing a database from which other doctors can work together and learn.
Ultimately, this Bill is not only for doctors; it must and should focus on the patients it affects. Although doubts are cast over whether the regulation to ensure innovating treatments are created responsibly, we must also consider the principle that responsibility can be satisfied before the innovating treatment is administered, thus reassuring the patient as well as the doctor. There is also a compelling argument that those patients who want innovative treatments—they may not be able to wait for lengthy research and approval systems—should be given the option to use innovative treatments. Those treatments should not be withheld because a doctor fears litigation. The patient should always be at the centre of what we do, and we should provide legislation that allows them to use the medical treatments of their choice that have that doctor approval.
I commend my hon. Friend for introducing this Bill, because he has hit on something that matters to a great deal of people. I have constituents on both sides of the argument. There are legitimate concerns, but I have heard nothing today that does not persuade me that this Bill should go forward from its Second Reading. I hope that some of the concerns that I have outlined today will be considered by my hon. Friend in Committee and that we end up with a Bill that is welcomed by those who support it and that deals with all the concerns that have been raised.