Access to Medical Treatments (Innovation) Bill (Money)

John Baron Excerpts

Tuesday 3rd November 2015 Commons Chamber

[George Freeman]

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

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

[Mr John Baron (Basildon and Billericay) (Con)]

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

[George Freeman]

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

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[George Freeman]

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

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

[Mr Baron]

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

[George Freeman]

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

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

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

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

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

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[Chris Heaton-Harris]

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

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

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

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

[Mr Baron]

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

[Chris Heaton-Harris]

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

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

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

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

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[Mr John Baron (Basildon and Billericay) (Con)]

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

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

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

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

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

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

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