Access to Medical Treatments (Innovation) Bill

Bob Stewart Excerpts

Friday 16th October 2015 Commons Chamber

[Dr Wollaston]

My hon. Friend makes a good point. Principally, there are issues with funding and complexity. The Bill fails to recognise the science and the issues that a vast, sprawling database might cause. My hon. Friend the Member for Daventry referred to the desirability of the public being able to access a database and gave the example of male pattern baldness. There would be vast profits to be made by the quackery industry from male pattern baldness products. I envisage a vast, sprawling database of anecdotal treatments, and I am afraid it would act as free advertising for the quacks of this world. It is an invitation to quackery.

I started in medicine in the late ’80s and worked for a while in paediatrics. The prognosis for children with leukaemia was grim, but today most of the children diagnosed with the same conditions will survive and thrive, not because of access to a vast, sprawling database of unconnected, anecdotal treatments but because of the meticulous progress of medical research, whereby with thousands of people we compare existing treatments with innovative treatments and find out which are genuinely the best. Any single anecdotal treatment might be effective in one single patient, but that does not tell us whether, when applied to a population, it is better or not.

Another problem with the Bill is the danger that it would undermine medical research. In effect, it would give private clinics the opportunity to offer anecdotal treatments as a way of bypassing clinical trials. When individuals, and particularly parents, are desperate because they have a dreadful diagnosis, they are at their most vulnerable to the claims of individuals who say, for example, “Look at the database and see how it worked for Mr Smith.” They might be lured into thinking that was the best way forward. Someone in a very vulnerable place might be lured into not taking part in a clinical trial by the siren call of an anecdotal treatment recorded on a publicly accessible database. I am afraid that the Bill would undermine research, and that is why the vast majority of bodies are very unhappy about it.

My hon. Friend should reflect on all the concerns that have been expressed about the Bill, and think about how science moves us forward. We progress not by a series of anecdotal treatments but through a solid research community.

We need greater access to clinical trials. The searchable database set up by the National Institute for Health Research is a welcome step forward, but it is rather clunky. Patients need to be able to see very clearly what trials are available and be able to take part in them. There is progress, people are surviving today with treatments based on clinical trials that may have taken place 10 years ago and many go on themselves to take part in clinical trials that will benefit future generations. It is absolutely vital that we continue to support this approach.

[Bob Stewart (Beckenham) (Con)]

I thank my hon. Friend—a good friend—for giving way. Does she believe that there is no place for any sort of list whatsoever and that the system should be left as it is, or is she suggesting that a list could be made up? I understand all her inhibitions and worries about such a list, but should it be considered?

[Dr Wollaston]

As my hon. Friend the Member for Daventry pointed out, many of these bodies would like to have such a register, but they would also like to be able to guide how it should look and to have it within the existing research framework.

The Bill suggests that doctors are not already innovating, and that this is about fear of litigation. The original Bill was based on the premise that fear of litigation was stopping innovation. In fact, the position is very clear if we read what a number of bodies have said. My hon. Friend quoted some individual examples, but the vast majority of opinion from the medical community and the research community is that, genuinely, it is not fear of litigation that stops innovation. Every aspect of this Bill is based on a false premise, I am afraid. I do not want to detain the House by reading out all the various quotes on why the fear of litigation does not stop innovation, but he will know that that is the case.

We face the danger of confusing the existing legal framework. Many have expressed their concern that we will end up with a sort of Heaton-Harris defence for those who have undertaken perhaps rather dangerous experimental treatments billed as innovation. My hon. Friend cited the case of the children who suffered from Duchenne muscular dystrophy, and that is very sad, but the Bill has an underlying assumption that all innovation is a good thing whereas the lesson of history is that it can be extremely dangerous and harmful. We need to be very careful about what we mean by innovation, and to accept that there are also very dangerous innovations. If, as a result of this well-intentioned Bill, we inadvertently end up with people being, in effect, experimented on by irresponsible doctors who are able to get off scot-free, we will have to come back to this place and amend it.

I would like to give my hon. Friend an example based on the case of somebody from my constituency who wrote to me to say that he was concerned that the Government were not doing enough with regard to experimental treatments. His specific example was a bogus treatment called GcMAF. The company promoting this entirely bogus treatment—it has a number of clinics in Europe and Guernsey—is very concerned that it cannot use it in this country because it is prevented from doing so by the current legislative environment. Well, jolly good. It puts out literature saying

“we state that if you have terminal stage 4…cancer, have not had chemotherapy, and you do the GcMAF protocol, you have an 80% chance of being cancer free in a year.”

That is the kind of claim that such doctors put out. In other words, the company is not only promoting its own product, but actively discouraging people from having a treatment that could help.

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[Heidi Alexander (Lewisham East) (Lab)]

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

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

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

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

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

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

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

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

The British Medical Association has said:

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

The Royal College of Surgeons has said that

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

The Motor Neurone Disease Association has said that

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

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

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

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

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

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

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

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

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

I am not sure we have got to that point.

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

“significant unintended consequences for medical research”?

[Bob Stewart]

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

[Heidi Alexander]

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

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

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[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.

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[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.