ACCESS TO MEDICAL TREATMENTS (INNOVATION) BILL

Justin Madders Excerpts

Wednesday 16th December 2015 Public Bill Committees

[The Chair]

Before we begin, I have a few preliminary announcements. Please switch all electronic devices to silent. Tea and coffee are not allowed during sittings. Hon. Members may remove their jackets if they so wish.

Today’s proceedings are relatively rare; this is a private Member’s Bill. Therefore, we will proceed in what used to be the time-honoured fashion—without a sittings motion and with our business governed by my selection of amendments and groupings and the decisions of the Committee.

In general, the choreography is like that in any other public Bill Committee. The Member with the lead amendment in a group kicks off. Then I propose the formal question. Then there is a debate on the whole group. Then the Member with the lead amendment responds and tells us whether they wish to withdraw the amendment or press it to a Division. We will deal with any votes requested on grouped amendments formally when we get to the lines of the Bill that they affect. That can be a little confusing, but I will seek to guide Members as we proceed. Then we move on to the next group or clause stand part debate as required.

There is no formal finishing time for this sitting— I was not looking forward to reading out those words. I hope that 4.30-ish will see us home, but we will see. Proceedings will be concluded either by us finishing our business and reporting the Bill or by a Member who has the floor—not intervening—moving the motion that the Committee do now adjourn. That is itself a debatable question, so there can be debate on that as well. If it looks like the Committee will not be able to complete its consideration of the Bill today, I will invite the Member in charge to move a sittings motion before any Adjournment.

Clause 1

Access to innovative medical treatments

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

I beg to move amendment 1, in clause 1, page 1, line 3, leave out from first “to” to “for” in line 5 and insert “provide”.

[The Chair]

With this it will be convenient to discuss the following:

Amendment 2, in clause 1, page 1, leave out lines 8 and 9.

Amendment 3, in clause 2, page 1, leave out line 17 and insert—

“(b) all of the positive and negative results of such treatments, and”.

Amendment 4, in clause 2, page 1, line 17, at end insert—

“(c) patient experiences of such treatments.”.

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[Justin Madders]

It is always a pleasure to serve under your chairmanship, Mr Streeter. I congratulate the hon. Member for Daventry on successfully progressing his Bill to Committee. I have not been in this place long, but I am aware that many private Members’ Bills fall well before this stage, so he deserves credit for clearing the hurdles placed in front of him so far. I also thank the hon. Gentleman for taking the time to meet me yesterday to discuss the Bill. I know from our conversation that he has put a huge amount of work into the Bill, and I am sure that even those who oppose it will have welcomed the opportunity that he has given to all the interested bodies to discuss it with him.

As I made clear during the debate on the money resolution, and as the shadow Secretary of State for Health, my hon. Friend the Member for Lewisham East (Heidi Alexander), set out in detail on Second Reading, Opposition Members believe that the Bill has been presented by the hon. Gentleman with the best of intentions, but we have serious reservations about some aspects of it. I will set those out in relation to our amendments 1 and 2, which we intend to press to a vote.

As I am sure the hon. Gentleman has been reminded on many occasions, the breadth of opposition to the Bill is extraordinary. It unites a huge number of professional bodies, royal colleges, charities and patients’ bodies. That opposition has been particularly strong in relation to clause 3 onwards, and we share the concerns about those clauses.

Our first two amendments relate to the introductory comments in clause 1, which sets out the purpose of the Bill. Amendment 1 would remove the words

“promote access to innovative medical treatments by… providing”

in lines 3 to 5 on page 1 and insert instead in line 5 the word “provide”. Amendment 2 would delete entirely lines 8 and 9. When combined together, and subject to what else is agreed today, those amendments would, we hope, remove entirely the provision in the Bill relating to what is described as “responsible innovation.” In our view, that provision is at best unnecessary, possibly counterproductive and at worst potentially dangerous. It is unnecessary because to date no evidence has been provided to suggest that the threat of litigation acts as an inhibitor on doctors innovating. A number of bodies have spoken on that point, as indeed have hon. Members at previous stages of the Bill.

I will give a few examples. The British Medical Association 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 Academy of Medical Royal Colleges 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 Royal College of Surgeons said that

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

Even Sir Robert Francis, QC, said:

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

As the hon. Member for Daventry will know, many have also made the same point that the current law is not an impediment to innovation, so this part of the Bill seeks to address a problem that we say simply does not exist. I am aware that some clinicians said in response to the Government consultation that that was a problem, but even the Minister conceded that very few saw it as the principal problem. If we are looking to break down barriers to innovation, a great many other factors mentioned in responses to that consultation could address the problem and are not set out in the Bill.

We also think that the Bill is counterproductive. Even were it accepted that there was a problem, the Bill could increase litigation and uncertainty among doctors. On that point, Earl Howe said in response to a similar provision in the Medical Innovation Bill that it may be that overall litigation claims increase slightly as the legislation is tested. This Bill adds an extra layer of complexity that the law does not warrant. I would be interested to know whether the Minister has any views on the potential for extra litigation arising from the Bill. As we know, the law on medical negligence has been developed over many years, and I am not persuaded that the perceived benefits of the Bill are worth upsetting the certainty and stability that the settled law has brought.

Most significantly, we consider the clause to be potentially dangerous. That is not an attempt to cast aspersions on the hon. Member for Daventry, as I know he is genuinely trying to do his best, but we all know about roads paved with good intentions. To give an example, because “innovative treatments” is not defined in the Bill, it applies to all decisions to treat that are outside the range of accepted treatments. It therefore includes treatments that would currently be considered negligent, because negligent treatments are by definition outside the range of accepted treatments. That by itself is concerning.

The Bill requires the agreement of two doctors that a treatment decision would be supported by a responsible body of medical opinion, but it does not tell us how that agreement is to be reached. Is it a chat over a pint at the golf club? On any analysis, that is in no way comparable to a court finding on the basis of expert evidence that there was a responsible body of opinion that would have supported the treatment and that the treatment was rational and reasonable in all circumstances.

“Treatment” is defined in clause 5 to include “inaction”. For example, a patient might suffer from complications after bowel surgery. The patient having a fever and abdominal pain, the surgeon decides not to return them to theatre, but to continue with treatment of antibiotics and monitoring. In fact, the patient has a bowel perforation caused by the surgery and sadly dies. Under the current law, the court would find that no responsible body of surgeons would have delayed taking the patient to surgery within 24 hours. Had the surgeon done so, the patient’s perforated bowel could have been repaired and they would have survived. The court would find that the surgeon was negligent and that the negligence caused the patient’s death. The patient’s family would in those circumstances be compensated.

If the Bill becomes law, the surgeon might have a defence where there is none currently. Suppose he had consulted a colleague and asked whether he thought a responsible body of surgeons would not take the patient back to theatre, but would adopt a “wait and see” approach. If the colleague agrees, the surgeon could say that he had weighed up all the advantages and disadvantages, that he had the agreement of the patient to wait and see, rather than to go back to theatre, that he had gone through all the right steps under the Bill and that it was just that the decision was a bad one, which in fact no reasonable body of surgeons would condone. The Bill would give him a defence in such circumstances. If he had gone through the right steps under the Bill, by definition he could not be found negligent.

I am worried that the Bill will muddy the waters on the legal route for doctors who wish to innovate. I am worried that it will reduce patient participation in clinical trials. If patients are faced with the choice of guaranteed access to treatment or participation in a trial in which there is a 50:50 chance that they will not be part of the group receiving innovative treatment, why would they choose to be part of the trial? I am worried about the potential removal of legal redress for a patient with a genuine negligence claim. I am worried that unsafe treatments could be used on dying patients. Clause 1 should be amended to remove that provision from the Bill.

I will speak briefly to the other two amendments in the group. Amendment 3 replaces a paragraph that reads:

“the results of such treatments”,

and is intended to make it clear that we expect negative as well as positive results to be reported to prevent unsuccessful innovations being repeated, which would cause unnecessary suffering.

Amendment 4 would ensure that the information recorded on the database is as comprehensive as possible. In order to be a comprehensive record of the treatment, patient experiences need to be included. It may well be that the hon. Member for Daventry intends the Bill to be fairly general in its description of the database at this stage, in which case he may say that it is not necessary to have this level of prescription in the Bill. However, we believe that these are important details that should be set out now and included at this stage.

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

It is a pleasure to serve under your chairmanship, Mr Streeter. As the hon. Member for Ellesmere Port and Neston has just said, this is one of those Bills that has aroused a lot of interest. We have a number of issues to deal with in Committee and outside this room in further conversations.

I know that we are discussing specific amendments, but let me say briefly that I agree with much of what the hon. Gentleman said. Everybody accepts that the ambition of the Bill is noble: to promote innovation. Everybody in the health system accepts that innovation has been the lifeblood of medicine and of the NHS, and of this country’s leadership in medicine. The point of difference we need to focus on is the one he eloquently raised: identifying the barriers to adoption of innovation and the extent to which fear of negligence is one of them. If it is not, what is the barrier?

The hon. Gentleman made an important point about the risk of even well-intentioned attempts to clarify having an inadvertent effect of generating a festival for lawyers, to debate whether or not the Bill could potentially have any effects other than those that Parliament intended. I certainly agree with him that if that were to happen it would be unhelpful.

The point of the clause, as I understand it, is to clarify for those who fear that the existing protections on negligence create a burden of proof that is unclear in law and thus create a de facto barrier to innovation, a clear process that in no way changes the current provisions of medical negligence law. I can confirm that one of my main preoccupations has been to ensure that we in no way inadvertently or deliberately change that protection. We have had counsel look at that very carefully, and we have been advised that this would in no way change the basis of medical negligence law.

The Bill simply seeks to create a procedure that would provide clinicians with comfort that by pursuing that they are simply pursuing what is currently best practice under existing medical negligence provisions. I take the hon. Gentleman’s point that, if it creates any significant uncertainty and thus inadvertently creates confusion, it will have the opposite effect to that it was seeking, which is to clarify the process.

The hon. Gentleman touched on the importance of need, and I will return to that point later because it goes to the heart of where the Committee ought to help get the Bill. He also touched on safety. I want to address that profoundly, because my No. 1 concern as a Health Minister is patient safety. I join him in paying tribute to my hon. Friend the Member for Daventry for taking the wide interest of the House in the subject and seeking to come up with a measure that can satisfy all parties. He has done a magnificent job of moving us on.

As I have said on the record at the Dispatch Box on more than one occasion, if the Bill, despite its best intentions, undermined patient safety or significantly created the perception that patient safety had been undermined, that would be very damaging for the UK and for the NHS. As the Minster responsible for getting more medical and clinical research into the UK, I cherish this country’s hard-won reputation for setting the highest standards in research medicine. I would be concerned if the Bill specifically, deliberately or inadvertently harmed that.

The chief medical officer has said that she supports the Bill. From a safety point of view, I take a lot of comfort from that. Sir Bruce Keogh has said that he is absolutely sure that the Bill is safe in terms of patient safety, which has been our No. 1 criterion. I think that it would be fair to say that although Sir Bruce Keogh says that the Bill is safe, he does not necessarily lie awake at night longing for it to be passed. He shares some of our concerns about the avoidable but none the less quite predictable outcome of the Bill having the opposite effect to the one intended. From a safety point of view, I am absolutely sure, as a Minister, that the Bill will in no way interfere with current medical negligence practice and that it is merely an attempt to clarify the existing protections available to patients and clinicians.

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On amendment 4, which refers to patient experiences of such treatments, when the hon. Member for Ellesmere Port and Neston and I had our conversation, I said I thought it was not required. The Bill is wide enough to cover patient experience in the databases, including information about treatments and results. Actually, the purpose of the Bill is to confer a power on the Secretary of State to consult widely on covering all such matters when he decides to act on that conferred power, so I do not think that the amendment is required at this stage. If the hon. Gentleman feels the need to press the amendment or to re-table it on Report, I will willingly work with him to get the words correct, so that he is satisfied with the wording and its purpose. For now, I ask him to withdraw his amendment.

[Justin Madders]

On amendments 3 and 4, I am happy to work with the hon. Gentleman and, if necessary, table an amendment on Report. I take what he says about this being a conferring Bill, but I think it was important for us to place on record our views about the importance of patient experience. We can have further conversations on that, and if we consider it necessary we will re-table those amendments. However, we will press amendments 1 and 2 to a vote.

I appreciate what the Minister said about the need to focus on innovation barriers. There is something in what he said about it being a cultural issue—there is no doubt about that. I do not think, however, that a piece of legislation of this nature is the right way to tackle that cultural issue. As I said in my opening comments, the Bill carries the risk of unintended consequences. We can all work together to try to tackle some of the barriers, but the Bill is not the way to do it.

Of course, the Minister has had the benefit of legal advice that I have not had on the impact on existing medical negligence law, but I am sure all members of the Committee have seen the representations from Nigel Poole QC, who is the leading authority on clinical negligence in this country. His view is that the Bill does make changes. We cannot get into a debate about who is right or wrong about that, but I focus on what the Minister said about how, even if the Bill only changes the perception of patient safety, that is important in itself. That alone is reason for us to pause and look again at the Bill, and that is why I will press amendments 1 and 2 to a vote.

[Chris Leslie]

To be absolutely clear on the effect of the amendments, as I read them, amendments 1 and 2 would delete the provisions about access to innovative treatment, but would retain the creation of the database. Have I got it right?

[Justin Madders]

Yes, my hon. Friend is absolutely correct. That is why we spent some time talking about those issues. They are really at the heart of the concerns.

[George Freeman]

Before the hon. Gentleman decides how he wants to proceed, I wanted to welcome the commitment my hon. Friend the Member for Daventry made to withdraw if we cannot reach agreement and to second my offer to sit down and work with members of the Committee and others to see whether we can get a package of amendments. I am rather less worried about other bits of the Bill from a Government point of view, but this bit is in many ways the best bit of the Bill. This is a very different Bill from the original Saatchi Bill, in that it focuses—perhaps not strongly enough for the hon. Gentleman—on getting information to clinicians on the innovative medicines that are out there. Funnily enough, it is the bit of the Bill I would most like us to keep. I reiterate that I am happy to work with members of the Committee, and to get officials to help us try to get the Bill into a better place, if that helps us to avoid an unnecessary Division.

--- Later in debate ---

[Justin Madders]

I am afraid that I do not have the confidence that we will be able to get the Bill to a place where we can agree. The widespread concern among all the royal colleges says to me that we need to start again, and that is why I will press the amendment to a vote.

Question put, That the amendment be made.

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Database of innovative treatments

[Justin Madders]

I beg to move amendment 5, in clause 2, page 2, line 20, at end insert—

‘(b) the General Medical Council,

(c) the British Medical Association,

(d) the Association of Medical Research Charities,

(e) the Royal Colleges,

(f) the Academy of Medical Sciences,

(g) the Medical Research Council,

(h) the National Institute for Health and Care Excellence, and

(i) the Medicines and Health Products Regulatory Agency.’

[The Chair]

With this it will be convenient to discuss amendment 6, in clause 2, page 2, line 20, at end insert—

‘(6A) Regulations under subsection (1) may not be made unless the Secretary of State is satisfied that the regulations have the approval in principle of—

(a) the HSCIC,

(b) the General Medical Council,

(c) the British Medical Association,

(d) the Association of Medical Research Charities,

(e) the Royal Colleges,

(f) the Academy of Medical Sciences,

(g) the Medical Research Council,

(h) the National Institute for Health and Care Excellence, and

(i) the Medicines and Health Products Regulatory Agency.’

[Justin Madders]

I will be briefer on these amendments.

The clause deals with the creation of the database, which we consider unnecessary, because the Secretary of State already has the relevant power under section 254 of the Health and Social Care Act 2012. Even if there is a difference of opinion and the clause remains in the Bill, we want to broaden the number of bodies that the Secretary of State must consult. We think the list in the amendment is comprehensive, whereas, as the Bill stands, to make regulations under clause 2, the Secretary of State need consult only the Health and Social Care Information Centre. The explanatory notes to the Bill state:

“The detailed design of the database would be consulted upon with professional bodies and organisations”,

from which we take some comfort, but we feel that it is better to be clear in the Bill about the wider range of bodies to be consulted.

Amendment 6 would insert a proposed new subsection (6A) requiring the Secretary of State to seek approval for regulations from the bodies on the same list, in essence, as in amendment 5, but with the addition of the HSCIC. It is about having approval in principle, as well as the details and mechanics of the database.

We are not making a complicated point, but we are putting on record our wish for a broader selection of groups to be consulted.

[George Freeman]

I will be brief. Following our earlier conversation about the database provisions, I emphasise that they are the part of the Bill that the Government most strongly support. The database is not envisaged as it was in the predecessor Bill—if I may call it that—as a registry for recording ad hoc innovations by clinicians, but as a fundamental database to give all clinicians access to information on innovative medicines, including off-label uses of medicines and medicines that are either unlicensed but in use, as in the early access to medicines scheme, or in clinical trials, in which a patient might be eligible to enrol. The clause gives the Secretary of State the power to make regulations conferring functions on the HSCIC, the body that develops and puts into place databases such as the one we are discussing, in connection with the establishment, maintenance and operation of the database for innovative medical treatments.

I am pleased that my hon. Friend the Member for Daventry proposed the database for recording such treatments and for getting information on them out to clinicians. The measure is important in the promotion of innovation. Crucially, the measure would give doctors the ability to search the database for innovations, so the position is very different from that under the Bill introduced in the House of Lords last year, which proposed a database as a registry on which innovative doctors could log what they had done. The database proposed in this Bill is completely different, which is why I strongly support it.

The database could result in better care and health outcomes for patients and a faster uptake of new treatments, and it could support our work to make Britain a world-leading centre for innovative medicines. The pace of progress in genomics and informatics is profoundly changing the way in which new drugs are developed, but our databases and systems information have not kept up, so that is among the things that are being considered under the accelerated access review. While the Secretary of State might already have the legal power to create a database, the Bill helpfully sets out that provision may be made to give instructions to HSCIC to create a specific database, which I would welcome. If the Bill does not, for whatever reason, reach the statute book, I would happily proceed towards establishing such a database, but it would be helpful if the provision were set out clearly in legislation.

The Government do not support amendment 5 because it is not exhaustive. Although it represents a helpful list of consultees, such a provision would need to include many more organisations. While I understand the intention behind the amendment, restricting the process would not be helpful, but I would be happy to write to members of the Committee about our approach. I undertake to write to all the relevant organisations and to ensure that they are consulted, but I am old enough and ugly enough to know that well-intentioned lists of statutory consultees can quickly become out of date. They can create weird anomalies whereby parties that really have nothing to say are statutory consultees, yet those who have a lot to say are not. I am happy to discuss what other steps we can take to ensure that those who, rightly, need to be informed about the Bill and the mechanisms it proposes are properly informed.

The Government do not support amendment 6 for the same reason—because the list is not exhaustive—but I will be happy to put in a place an alternative mechanism to ensure that those parties listed the amendment and others are properly informed. I would not want to put in law a list of consultees that we might well need to amend quite quickly. I, for one, do not want to find myself back in Committee considering a statutory instrument to amend a list of statutory consultees established by a well-intentioned proposal, so I hope that the hon. Member for Ellesmere Port and Neston will withdraw the amendment.

[Chris Heaton-Harris]

Obviously, I agree with the Minister, and I have discussed the matter with the shadow Minister. I know from my consultation on the Bill with stakeholders that we would need longer lists than those in the amendments. I hope that the hon. Member for Ellesmere Port and Neston will agree to the Minister’s generous offer and therefore withdraw the amendment.

[Justin Madders]

Our debate has shown that a well-intentioned proposal might have unintended consequences, so I accept what the Minister and the hon. Member for Daventry say about the need for comprehensive lists. I think that the lists in the amendments are pretty comprehensive, but I accept that other bodies might emerge or feel that they should be included. I am happy to work with the hon. Gentlemen to ensure that we reflect the intention behind the amendments, yet do not create additional work a few years down the line because we have to amend the legislation. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 2 ordered to stand part of the Bill.

Clauses 3 to 5 ordered to stand part of the Bill.

Clause 6

Extent, commencement and short title

Question proposed, That the clause stand part of the Bill.

[George Freeman]

On a point of order, Mr Streeter. This may be a point of order, although I stand to be corrected.

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[George Freeman]

I would like briefly to add my thanks to you, Mr Streeter, for chairing the Committee.

We have had a constructive discussion with all parties represented on the Committee, with some front-line advice from clinicians. I thank my hon. Friend the Member for Daventry for his clear offer. I pay tribute to him for the clarity of that offer. The Government are concerned that this Bill, with the noblest of intentions, is still not in a place where it has widespread support from all parties. A Bill that elicits concerns and opposition from both industry and charities, patient groups, lawyers and the General Medical Council is a Bill whose nobility of purpose is not yet reflected in unanimity of support.

I am grateful to my hon. Friend, and I know that he is keen to get the Bill to a point where it can be distinguished from a predecessor Bill that generated a lot of heat and some opposition. I genuinely believe he is trying to get to that point, particularly on the database provisions. I urge him to keep his foot to the pedal, particularly on the negligence provisions, on which we have a bit more work to do. I repeat that if a well-intentioned Bill has the inadvertent effect of undermining patient and public trust in the world-class status of our research medicine and clinical trials, it will be self-defeating and I would find it impossible to support. However, we have a chance to avoid that.

I thank you for your excellent chairmanship of the Committee, Mr Streeter, and add my thanks to the officials sitting on both sides of you, who have guided us through this process. I hope we can get to a point where we can go back to the House on Report and say that this Committee has managed to rescue a noble cause and, with the help of my hon. Friend the Member for Daventry, put forward a proposal we can all support.

[Justin Madders]

May I start by thanking you, Mr Streeter, for your chairmanship of the Committee? I hope that this is the first of many times we will meet in such a situation. I also thank the Minister and the hon. Member for Daventry for the open way in which they took on board our concerns. I, along with my hon. Friend the Member for Torfaen, will be pleased to accept any offers to help get the Bill into a shape where it has the support of not only Members of all parties, but, most importantly, the greater medical community. The hon. Member for Daventry is a beacon of optimism in that respect, given the level of concern that remains, but we shall try. The Minister is right that we do not want to put into law something about which there is such widespread concern, but we shall see where we get to on Report.

Question put and agreed to.

Bill accordingly to be reported, without amendment.