Access to Medical Treatments (Innovation) Bill

David Nuttall Excerpts

Friday 16th October 2015 Commons Chamber

[Chris Heaton-Harris (Daventry) (Con)]

I beg to move, That the Bill be now read a Second time.

Not a day goes by without those practising medicine in our national health service innovating. Talk to any doctor, and especially any surgeon—in fact any registered medical practitioner—and they will show how they have been innovative and, in being innovative, how they have helped those they are trying to treat. The levels of innovation are, without doubt, inspiring.

Let me give an example to demonstrate what I mean. An eminent surgeon was telling me only the other day of how he had helped a patient who came to him with a particular stomach tumour. At the time of surgery, he found this tumour to be so large that if he had continued with his original plan of removing it, it would probably have killed the patient. This surgeon had just a few nights before read about a drug called Glivec. Glivec creates a mutation called C-KIT, common in chronic leukaemia, where it is a succeeding treatment. Reports appeared indicating that the type of tumour this patient had carried had the same sort of mutation, so rather than trying to remove the tumour, a bypass operation was performed to overcome the obstruction and allow the patient to take the drug.

When the surgeon put his patient on this drug, the tablets were tolerated. The tumour disappeared. Years later that patient occasionally visits his surgeon to say thank you for being innovative and saving his life. In fact, as that surgeon will confirm, there is only one thing wrong with what happened that day. There was no way of recording the innovation on a database that could share it with other surgeons preparing for a similar operation and show how it had worked.

[Mr David Nuttall (Bury North) (Con)]

Will my hon. Friend confirm that the doctor in that particular case would have had to obtain his patient’s consent before proceeding with that innovative treatment?

[Chris Heaton-Harris]

I believe that the decision was taken while the patient was unconscious, but there would then have been a conversation, absolutely, because the doctor would have acted responsibly, as would any surgeon.

This was a life-saving decision, but there was no simple, quick way to tell anyone about it and, in so doing, perhaps save someone else’s life. Earlier this year, when we in this place were getting excited and building up to some sort of election campaign, the House of Lords was passing Lord Saatchi’s Medical Innovation Bill. It passed through all its stages in the other place and, as with many Bills, ideas were refined and concepts were introduced in Committee, on Report and on Third Reading. One of the new ideas that was introduced into the Bill is the central idea that I have plagiarised for my Bill—namely, the introduction of a database for innovative treatments conducted by registered medical practitioners.

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[Chris Heaton-Harris]

I am not sure I do. I would like to think that this Bill completely clarifies how this database can be set up and builds a foundation on which the Secretary of State can do such a thing. My Bill does not build this database; all it does is confer on the Secretary of State the power, which the hon. Lady talks about, to build such a database. If the Secretary of State for Health chose to use the power, it would only be after detailed consultation. However, as we would all expect, when given the opportunity to take a private Member’s Bill through into law, any Member of Parliament, myself included, would endeavour to consult widely on the matter in hand. Thus over the summer I have met pretty much everyone who has expressed an interest in this Bill—either for or against—to endeavour to allay any concerns about its content and direction of travel and to listen to what they have to say.

[Mr Nuttall]

Is it the case that the introduction of the database into this Bill is really in response to the concerns that were expressed in the other place when Lord Saatchi’s Bill was being debated? There were concerns that, if his Bill was allowed to go through without the database, there would be difficulties? Is that not the case?

[Chris Heaton-Harris]

Absolutely, my hon. Friend is completely right.

The Minister will be pleased to hear that I have been working closely with some of the excellent officials in his Department to ensure that there is a little more detail in the Bill specifically to deal with some of the concerns that have been raised with me. First, after a great deal of thought and research, I suggest that the database is held by the Health and Social Care Information Centre. The HSCIC has experience of dealing with big data, and although a number of details would have to be worked out, it seems that it would be the obvious place in the existing health infrastructure to hold such a database.

How the database would work would be detailed outside my Bill by those best placed to do so. However, it is envisaged that a registered medical practitioner, having consulted with his or her patient, would flag up on the patient’s notes that they were innovating. I recognise the pressure that medical practitioners are under, so I am determined that this database should not add much to their already heavy workload, and, hopefully, through this system it would not.

The Health and Social Care Information Centre already has in place a strong set of legal safeguards to protect privacy and confidentiality, which, again, makes it an ideal organisation to host the database. Clearly, privacy issues will be a core part of any consultation that takes place on the detail of the database.

Importantly, the Bill stipulates that outcomes, not just the process of innovation itself, will be on the database. Successes and failures would be recorded on an ongoing basis. There are a number of very, very good reasons for doing that. Of course sharing success is simple to explain. Sharing ideas is in itself a great idea. Letting others see that a treatment has been a success when that treatment might not be widely known is clearly helpful, perhaps even lifesaving. When we know that treatments can differ between NHS trusts and between individual surgeries, it seems clear that we should be encouraging a spread of the good innovation that comes from every individual medical practitioner, such as the surgeon I mentioned earlier and his use of the drug, Glivec.

We must also realise the potential of transparently sharing all outcomes of innovation—not just successes, but failures too. Critics of Lord Saatchi’s Bill were rightly concerned about “quackology”—their term, not mine. There are some doctors who sell to desperately sick people treatments that do not work and that, in some cases, are dangerous. Having a database on which the whole of the registered medical practitioner community can see what an innovation is and then watch the results come in removes quackology from the database in a stroke.

I might well be on the lookout for someone who can cure my male-pattern baldness. Undoubtedly, it would require an innovative treatment; some would say a miracle cure. Currently, there are many treatments on offer to people such as myself. Many adverts will offer me an innovative cure, but there is no way of checking on the successes or failures of the treatments on offer.

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[Mr David Nuttall (Bury North) (Con)]

As always, it is a great pleasure to follow my hon. Friend the Member for Shipley (Philip Davies), who has set out with his usual clarity the reasons why the Bill should receive the support of the House today. I too rise in support of the Bill.

I warmly congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on his success in coming second in the ballot for private Members’ Bills and on choosing such an important subject to bring before the House this morning. As we have seen, it is a Bill that is not without some controversy. Often, private Members’ Bills are technical and minor in nature and do not receive much public attention, but it is fair to say that this one very much has. It brings before the House—I think that I am right in saying that it is the first time that these issues have been debated on the Floor of the House—the issues that were considered in the other place when the Lords debated the Medical Innovations Bill, which was piloted through all its stages by the noble Lord Saatchi in the previous Parliament. I note, incidentally, that the noble Lord reintroduced his Bill on 8 June. I hope that he does not fear for the possible success of this Bill; perhaps he is just hedging his bets. I certainly hope that this Bill will proceed safely through this House and arrive in the other place.

The Bill builds on the work of Lord Saatchi’s Bill in that it deals, I think adequately, with some of the criticisms of it. The purpose of this Bill, as we have heard, is to promote the use by doctors of innovative medical treatments and it does that by allowing for the establishment of a database of such innovative medical treatments and by setting out the steps that doctors can take to demonstrate that they are acting responsibly in carrying out such treatments.

I have to admit at the outset that an impressive array of bodies have lined up either in outright opposition to the Bill or with at least some reservations about it. When I was considering the evidence, I had to take that into account. I had to decide whether in the light of that evidence I should simply go with the flow and decide that if all those people said that it is a bad thing, it must be a bad thing, or whether I should think about the other side of the coin. I did that, and on balance, I came down on the side of what I like to think of as my constituents’ view. I believe that the Bill has the potential to improve the lives of my constituents if they are struck down by a rare disease that means that they require innovative medical treatment.

It is appropriate to try to deal with the concerns that have been raised by so many eminent bodies in the medical world. As we have heard, last year, many organisations responded to the consultation on Lord Saatchi’s Bill. Like my hon. Friend the Member for Shipley, I shall try to deal with some of their concerns. The professional body for doctors, the British Medical Association, often described as the trade union for doctors, said in its consultation response to the Medical Innovation Bill:

“The BMA believes strongly in the value of innovation in medicine. Whilst the BMA would have concerns if the draft Medical Innovation Bill was to become law, if there was a need identified, we would support the exploration of other initiatives through which responsible, safe and effective innovation can be promoted to doctors.”

In its 2014 response to the consultation on that Bill, the AMRC, the Association of Medical Research Charities, a national organisation made up of 137 leading research and medical charities from across the UK that, incidentally, spends about £1.3 billion a year on research, welcomed the ambition of the Bill but was concerned about its unintended consequences. In February this year, it welcomed the idea proposed in the other place about the importance of collecting data. I am pleased to note that the Bill we are considering today appears to address that concern by establishing a database to collect the results of innovative medical treatment.

Without wanting to create confusion, I want to refer to another body that raised concerns, another AMRC—not the Association of Medical Research Charities this time, but the Academy of Medical Royal Colleges, a body that comprises 20 medical royal colleges and faculties from across the UK and Ireland. It agrees with the idea that research and innovation are vital to the NHS, but does not support the Bill as a whole because, in its words, it is not clear what it is trying to achieve.

It is therefore a considerable challenge for my hon. Friend the Member for Daventry and those of us who support the Bill to demonstrate the need for it. To put it simply, I believe that it will provide access to innovative treatments to best meet a patient’s desires and needs when other treatments might not achieve the best results. People might well ask why we need the Bill now. The law on medical negligence has not changed for decades and in those decades medical innovations have been made. The law might not have changed much, but society certainly has—it is more informed, less deferential and more litigious. The number of lawsuits filed against the NHS has doubled in five years and last year’s pay out, which has also doubled in that time, was £1.2 billion. The Treasury provision for claims against the NHS has now reached £26 billion, so it is no surprise that doctors increasingly feel frightened of being sued and therefore, understandably, feel less likely to be able to innovate.

It is worth noting that back in 2013 the Health Service Journal stated:

“It is a popularly held view that the NHS is resistant to innovation. Despite several laws and policy directives and many successful examples of innovative approaches resulting over the years, the NHS is still seen to a late adopter of innovation—inventive but not creative.”

I believe that the Access to Medical Treatments (Innovation) Bill has the potential to counter that problem by putting innovation on a statutory footing.

NESTA, the independent charity in the UK that works to increase innovation in the UK, considered the whole question of innovation in the healthcare system in its 2014 report, “Which doctors take up promising ideas?” It highlighted the early adoption of drugs by general practitioners since 2010 to treat conditions such as diabetes, chronic constipation in women and deep vein thrombosis as well as to prevent stroke in patients with atrial fibrillation as an alternative to warfarin. The study also found that 86% of doctors found out about other innovative treatments from other doctors. It is a crucial component of this Bill that it places a responsibility on any doctor wishing to undertake innovative treatment to talk to another doctor about the proposed treatment.

NESTA’S report also recommended that there should be clear instructions on innovation to encourage early adoption, which is what I believe that the Bill aims to do, to provide reassurance, and to provide instructions to doctors to allow them to adopt life-saving treatments only when it would be in the best interests of their patients. The Bill would extend and encourage the idea sharing that is already going on between doctors and give them confidence in that process.

One of the key objections made by bodies such as the BMA was the “unproven threat” of litigation against doctors. In the summer, it was reported in the press that between 2010 and 2013 there was a 64% increase in the number of complaints to the UK medical regulator, the General Medical Council, and a 42% increase in the number of doctors struck off or suspended from the UK medical register. Let me make it clear that I believe that patient safety must be paramount. It is right that patients have access to our world-class justice system if, sadly, things go wrong. It is, however, a curious observation to make that there is an “unproven threat” of litigation when the bill for legal fees paid out over clinical negligence claims in 2013-14 was £259 million, with many believing that there is an increasing culture of litigation.

The Royal College of Ophthalmologists expresses a common view:

“Without unequivocal GMC and NICE support, ophthalmologists are understandably concerned that they may be assuming unacceptable personal liability by using a unlicensed drug when a licensed alternative exists … Consequently, patients may not be getting treatment when they need it and not getting the best results.”

Of course, the Bill must not be seen as a licence to experiment on patients, which is one of the more sensational claims I have seen about the Bill. I believe it clearly preserves the existing safeguards of the common law, which protect the patient while giving the doctor the option to take steps to demonstrate that the action they have taken has been taken responsibly before carrying out any innovative treatment.

As the guidance notes make clear, if another qualified doctor expresses reservations, those would have to be taken into account or, quite appropriately, the prescribing doctor could be found negligent. I do not believe that this Bill is simply a “get out of jail free” card for negligent doctors. It does not override the Bolam test, which was first set out in the leading 1957 case of Bolam v. Friern Hospital Management Committee. In that case Justice McNair said in his judgment that a doctor

“is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”.

Therefore, a doctor would be negligent under the current law if they treat or manage a patient in a way in which no responsible body of doctors would have acted. That test was extended to include a requirement that they must also act in a logical manner, which is called the Bolitho test, established in the case of Bolitho v. the City and Hackney Health Authority.

I believe the Bill contains the appropriate reassurances that doctors cannot use it to run roughshod over the existing law. The necessary reassurance is contained in particular in clause 3(5), which explicitly states:

“Nothing in this section permits a doctor to carry out treatment for any purpose other than the best interests of the patient.”

To ram home that point clause 4(1) clearly states:

“(1) Nothing in section 3—

(a) affects any rule of the common law to the effect that a departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion, or

(b) is to be read as limiting the circumstances in which any such rule of the common law may be relied on”.

I do not believe, therefore, that the Bill would limit redress in the event of negligence. A doctor would still be negligent if they acted in a way that was not in the best interests of their patient. However, the Bill would put into legislation a workable framework to allow responsible innovation where that would serve the best interests of the patient when a conventional treatment or lack of treatment might not meet the same goal.

I turn to the concerns of the Royal College of Surgeons, a professional membership organisation and a registered charity, which exists to advance surgical standards and improve patient care, with 20,000 members in the UK and abroad. That body has issued a parliamentary briefing on the Bill and one of its concerns is:

“The wording of the Bill confers the decision-making power on the doctor rather than the patient. There is a risk it misunderstands the doctor-patient relationship.”

The RCS may think there is such a risk, but having read the Bill and the guidance notes I fail to see that. As I have mentioned, the Bill clearly states the importance of the doctor acting only in the best interests of the patient and consideration being given to the patient’s views.



Clause 3(2) states:

“For the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition, a doctor must in particular . . .

(c) obtain any consents required by law to the carrying out of the proposed treatment”.

The guidance notes for clause 3 clarify that that means that

“the Bill does not affect the legal requirement for a doctor to obtain a patient’s informed consent to any treatment proposed”.

It could not be clearer. The Bill does not affect that legal requirement for a doctor to obtain the informed consent of a patient. Indeed, only this year in the Supreme Court was the issue of consent and a patient’s understanding of treatment considered in the case of Montgomery v. Lanarkshire Health Board, when it was held that it would be a mistake to view patients as uninformed, incapable of understanding medical matters, or wholly dependent on information from doctors. It was said that an adult of sound mind was entitled to decide which of the available treatments to undergo, and their consent must be obtained before treatment is undertaken. Doctors are under a duty to take reasonable care to ensure that their patients are aware of any material risks involved in proposed treatment, and of the reasonable alternatives available.

This seems to be in accordance with guidance from the General Medical Council which, as one would expect, provides lengthy guidance on the question of consent and outlines the steps a doctor should take to communicate in

“clear, simple and consistent language”

to a patient and to work on the presumption that patients have the capacity to make decisions about their own care.

The RCS is also concerned that

“the emphasis in the Bill is on proving the doctor’s decision was responsible. Courts are not asked to deal with whether a patient’s treatment has been negligent.”

I do not understand that comment. It seems to me that the courts would clearly be invited to deal with the question of negligence if something went wrong and the patient could establish that the necessary steps had not been taken by the doctor. I cannot see how the courts would not be asked to deal with whether a patient’s treatment had been negligent. As I hope I have demonstrated, the Bill makes it clear that it does not seek to override the law on negligence. The focus is all about providing a framework in which a doctor can act responsibly.

NESTA’s 2014 report found that 73% of GPs surveyed said that they would be most likely to collaborate with other doctors when adopting innovations. Therefore, three out of four doctors—the vast majority—are already familiar with talking to their peers and working with them in a collaborative manner in this area. The requirement for consultation is simply what for them would be the natural course of action.

With people becoming ever more inclined to look for someone to blame when things do not turn out how they had hoped, and therefore with the threat of legal action increasing, it must be right that this House looks across the board at ways of making the vital work that our doctors do easier. I believe that allowing for responsible innovation as a means of treating patients who wish to receive such treatment is a positive way to help them.

A further concern from the BMA is that it believes doctors can already innovate as much as they need to. It states:

“The BMA has received anecdotal reports from members that funding requests for innovative treatment are submitted and approved, often on condition that the results will then be distributed, adding to the wider body of medical knowledge.”

I think that the very use of the word “anecdotal” suggests that we need a much greater degree of standardisation of approach. As far as I can see, that is precisely one of the problems that the Bill seeks to address: the fact that, at present, there is no standard basis for the recording of innovative medical treatments.

I am pleased to see that one of the changes in the Bill, compared with Lord Saatchi’s Medical Innovation Bill, is the establishment and maintenance of a database, to be held and managed by the Health and Social Care Information Centre, because I believe that will provide an additional method of evidence-building for doctors. I note that the Royal College of Surgeons has suggested that a clinical society might instead manage the database, if it is limited to one area of medicine. Although that suggestion might warrant further examination, I have a couple of concerns about it.

First, taxpayers’ money has gone into the establishment of the Health and Social Care Information Centre, which is an executive non-departmental body under the care of the Department of Health. It is the national provider of information, data and IT services for commissioners, analysts and clinicians in the health and social care sector, so it seems to me to be the ideal body to carry out that function. I have no doubt that taxpayers would expect it to carry out that work.

Secondly, I believe that there are considerable advantages in having a single database that doctors can consult, as the Bill proposes, rather than several. A database that shares innovative medical treatments would help improve the spread of best practice. The Government’s competitiveness indicator report showed that medicines in the third year after launch were used in the United Kingdom at a level that was, on average, only one third of the average usage in the comparator countries, which included France, Germany and the United States. I believe that the creation of the database would go some way towards closing that gap.

The Academy of Medical Royal Colleges has expressed a concern that the database would be a substitute for research and might even sidestep clinical research. I take the view that the purpose of the database, which is to be a collection of reports on individual innovative treatments outside conventional methods, would not have that consequence. The academy has also expressed concerns about the complexity of establishing a database and maintaining confidentiality. There is no doubt that the confidentiality of medical records is something that we must all take seriously. However, I do not believe that just because something is complex is grounds for us not doing it at all. I appreciate those concerns, given the roll-out of the care.data scheme, but the database proposed in the Bill would be very different. It would be much smaller in scope, in terms of the number of people it would relate to, than the care.data scheme, which has the records of virtually everyone, unless they have opted out.

The Royal College of Surgeons accepts the need for research to be made available, but it does not see the need for the database proposed in the Bill. It states:

“Surgeons in England have been the first in the world to publish their individual outcomes from surgery. We support this level of transparency in all areas of surgery including research and innovation. The College expects all researchers conducting trials, including those we directly support, to register the trial in a publicly accessible database. However, we do not see the need for a new database of innovative treatments in surgery. A number of audits in surgery already exist and it is unclear what different data this additional database would cover. It would be helpful for the Government to clarify what data it envisages collecting under this Bill”.

I am sure that the Minister will cover that in his remarks later today. I believe that most patients who benefit from a particularly innovative treatment, especially if they are the first to benefit, would have no objection to their treatment being recorded anonymously.

The Royal College of Surgeons also states:

“We believe the Secretary of State already has the power to establish a non-statutory database of innovative treatments without legislation.”

Well, if that is the case, there is nothing in the Bill for it to worry about. What is clear is that if the Secretary of State does have that power, he has not used it. Indeed, I believe that there is scope to strengthen the Bill, if it proceeds to its later stages, to clarify when the establishment of the database can be expected.

The NHS’s 2011 publication “Innovation: Health and Wealth” lamented

“brilliant examples of pioneering work”

so often being “isolated examples”. As a principle of furthering innovation, therefore, surely gathering evidence in the database would be helpful to medical advancement. If treatments look like they are working, it must be right that the public and, of course, doctors know about it.

As with any new piece of legislation, we must be mindful of the cost to the public purse. That is one of the areas where I believe we still need more information at this stage. We do not yet have any real sense of what the financial implications would be, although I note that a full impact assessment is promised before the Bill goes to Committee. NHS England has forecast an annual cost increase for drugs in specialised services of 11%, rising from £2.4 billion in 2013-14 to £4.5 billion in 2019-20. I sincerely hope that the impact assessment will give some estimate of the impact that increased use of innovative treatments will have, for example on drug expenditure in the longer term.

I also believe that the impact assessment should consider what effect the Bill would have on the early access to medicines scheme, which was not in operation when the Medical Innovation Bill was first debated. The scheme allows patients to access medicines at an earlier stage in their development, following a risk-benefit assessment and subject to ongoing data collection.

A lot has been said about this Bill being potentially dangerous for patients. Yet doctors are currently prevented from carrying out reckless or dangerous treatments by the risk of proceedings being taken against them—either civil proceedings or, in the worst cases, criminal proceedings. Nothing in the Bill makes that risk any less likely. All the safeguards that are in place in law at the moment would simply remain in place.

[Chris Heaton-Harris]

I completely underline what my hon. Friend is saying. If a doctor is acting responsibly, they have nothing to fear; if they are acting irresponsibly, this Bill does not help them, and they will suffer the consequences of their actions.

[Mr Nuttall]

I am grateful that the sponsor of the Bill agrees with me on this, because it is the key point of the whole debate. Those who oppose the Bill have alleged that it will somehow put patients at risk. If that were the case, I would not be supporting it. I am supporting it because having read it carefully, and having considered all the evidence and all the views of all the professional bodies that are ranged against it, I have come to the conclusion that patients would have all the safeguards after the Bill has been passed that they do now.

The Bill has the potential to increase and improve the range of medical treatments available to my constituents.

[Philip Davies]

My hon. Friend is setting out a very good case. Does he accept, though, that the concerns of some of my constituents that I outlined are valid, and that in Committee we should look at ways in which they can be dealt with if necessary? We should not just accept the Bill in its current state; we should look to see whether we can improve it in Committee.

[Mr Nuttall]

I am grateful to my hon. Friend. The arguments are finely balanced. As he said, he has constituents who support the Bill and constituents who are against it. If the Bill receives its Second Reading, as I hope it will, the concerns of those who have reservations about it, and those who go further and are outright opposed to it, can be considered in detail in Committee and, if possible, reflected and taken into account by way of appropriate amendments at that stage or on Report.

[Chris Heaton-Harris]

I assure my hon. Friend and all other Members who have spoken, and everybody I have been in consultation with to get the Bill to this stage, that should it get through its Second Reading, I will continue to consult, to listen, to talk to and to take advice from all organisations with an interest to make sure that we take into account and deal with as many as possible of the concerns outlined by him, by other hon. Friends, and by Opposition Members.

[Mr Nuttall]

I hope that my hon. Friend’s intervention will go some way towards satisfying the concerns of those who are opposed to the Bill.

From what we have heard, there seems to be a general acceptance of the principle in the Bill that there should be greater access to medical innovation. Even looking at the views of the various medical bodies—an impressive array, as I said—the best interpretation is that some are outright opposed and others are ambiguous. Either way, they all share the view that medical innovation is a good thing. It seems to me that the devil is in the detail. I hope that my hon. Friend’s confirmation that if the Bill proceeds he will be generous in speaking to people and looking at all possible ways of dealing with their concerns will persuade the House to give it a Second Reading.

Research and innovation are crucial to the continued success of healthcare. The NHS faces increasing demands: a growing population with an increasing lifespan, which is a good thing; an increase in its own capability, fuelled by advances in knowledge, science and technology; and ever-increasing expectations from the public it serves. We should not shy away from new ideas that put the patient first and offer chances that they may not otherwise have. This Bill will increase the likelihood of life-saving solutions being found where they did not previously exist. It will mean more choice for patients—for my constituents. It will provide doctors with a mechanism to enable them to use innovative treatments giving them the best possible chance to do what they do best—help patients. I support the Bill and trust it will receive its Second Reading.