Access to Medical Treatments (Innovation) Bill (Money)

George Freeman Excerpts

Tuesday 3rd November 2015 Commons Chamber

[The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)]

I beg to move,

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

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

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

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

[Dr Sarah Wollaston (Totnes) (Con)]

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

[Madam Deputy Speaker (Natascha Engel)]

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

[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.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

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

[George Freeman]

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

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

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

[Dr Whitford]

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

[George Freeman]

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

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

[Dr Wollaston]

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

[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.

[Justin Madders (Ellesmere Port and Neston) (Lab)]

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

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

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

[George Freeman]

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

[Justin Madders]

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

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

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

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

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

--- Later in debate ---

[George Freeman]

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

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

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

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

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

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

Question put.