Access to Medical Treatments (Innovation) Bill
Debate between Chris Heaton-Harris and Philip Davies(9 years ago)
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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.
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.
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.
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.