Off-patent Drugs Bill Debate
Full Debate: Read Full DebateDepartment: Department of Health and Social Care
Alistair Burt
Main Page: Alistair Burt (Conservative - North East Bedfordshire)Department Debates - View all Alistair Burt's debates with the Department of Health and Social Care
Off-patent Drugs Bill
Alistair Burt Excerpts(9 years, 1 month ago)
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Dr Whitford
There is indeed a risk, as my QC expert has muttered. Part of the case would be that the doctor had prescribed an off-licence drug.
Experts in the field will prescribe many drugs that are off-patent for the treatment of secondary cancers. We are aware of the evidence, and we will use such drugs when we have the experience, but general practitioners will not. If a drug is not in the British National Formulary, they cannot check the dose, which might be different from the dose for the other usage.
We are seeing more and more non-doctor prescribers. We are seeing nurse prescribers and physio prescribers. We do not want to limit the use of future drugs that may be discovered by not sorting out the present position. It should not be beyond the wit of man. The NHS is surrounded by organisations, such as quangos, that could surely be used to deal with it.
The Minister for Community and Social Care (Alistair Burt)
Given the hon. Lady’s experience in this area, her presence in the House provides me with an opportunity that is too good to miss. Let me ask a question that goes to the heart of the reason for the Government’s concern about the Bill.
If I understand the hon. Lady correctly, it is not impossible to prescribe off-label if there is an indication that, say, the prevention of breast cancer may be aided by the use of tamoxifen. There is nothing to preclude that, although it may be difficult in the circumstances that she has described because of possible considerations of liability. Is she arguing that there should be no off-label prescribing because everything should be licensed, or not? I do not know whether it should be one or the other—[Interruption.] It is not a stupid question. We believe that if it is possible to prescribe off-label, the Bill is not necessary, but if it is not possible because of the difficulties that the hon. Lady has identified, perhaps that should not happen. Her experience is vital in this regard.
Dr Whitford
As I was trying to suggest, someone who is an absolute expert in a field will be comfortable prescribing off-label, because they are using the drug every day, and they know exactly what it does and how to use it. But our patients spend the majority of their time in primary care, and a GP, who is unable to look up and check the dose or indication, will be a little more uncomfortable. People who are non-consultants—those at staff grades, who are at other grades—will be less comfortable. We see that exactly in the prevention of breast cancer; this drug has not come on stream at the speed that would have been expected, because people are uncomfortable. There is certainly not enough protection to mean that nurses are going to prescribe a drug that is not licensed, and the vast majority of drugs do not have guidelines, so what the Minister describes is not a protection.
Alistair Burt
I just want to be sure about this. If I understand the hon. Lady correctly, that hesitation could apply to any off-label prescribing now, but off-label prescribing goes on—doctors and GPs do find the information and do it. I would not want to take the implication from her that off-label prescribing is wrong. It just needs the appropriate amount of information to make sure that it is right—otherwise, we do have to license everything.
Dr Whitford
When a drug is proven and is going to be in common usage, it should be licensed—otherwise, we are suggesting, “Why bother with licensing any drug?” We are talking about drugs that could make a big impact, but they will do that only if they are in common usage. Expecting doctors to face any potential that they are signing away their mortgage on their house by prescribing something is simply bizarre. Of course there is off-label prescribing as a drug develops, but once we have something with rock-solid evidence behind it, which we expect everybody of every grade and every profession within the NHS to use, we should give them the reassurance of licensing.
The Minister for Community and Social Care (Alistair Burt)
I thank the hon. Member for Torfaen (Nick Thomas-Symonds) for the way in which he introduced a Bill brought forward last year by my good friend Jonathan Evans. I thank all the right hon. and hon. Members who have made a contribution today.
The Government are in a difficult position. To take a position contrary to that of a breast cancer charity or a number of charities, and to resist action requested by a number of right hon. and hon. Members who speak with knowledge and passion, the Government must be pretty sure of their position and their actions. The hon. Gentleman has had a meeting with the Under-Secretary of State for Life Sciences, my hon. Friend the Member for Mid Norfolk (George Freeman), the charity and others, and he knows that the Government still do not support the Bill. I will defend that position.
No sensible Government would seek to resist people having access to drugs in any way. The reason for resisting what is proposed is that the Government believe that there is another pathway. However, I am also persuaded by what I have heard today and feel sufficiently uncomfortable about the current situation to know that this is not an end of the matter. I will resist the Bill today, but my advice to colleagues in the Department of Health will certainly reflect the mood of the House and what has been said.
Albert Owen
I am disappointed by what we have heard so far from the Minister. If he will not listen to me, will he listen to his hon. Friends on the Government Benches who have made a plea for the Bill to go through to Committee? He talks about difficult decisions, and the Prime Minister and his colleagues have been at the Dispatch Box saying that there are difficult decisions to take. I ask the Minister to take a difficult decision by doing a U-turn and supporting the Bill.
Alistair Burt
The difficult decision is to stick to the position that I believe to be correct. The onus is on me to explain why, in the face of the debate, I believe the Government’s position is right, and that is what I intend to do. I want to be very upfront about the situation. I have heard the debate very loudly, from colleagues on both sides of the House, and I have heard nothing that is not deeply felt and passionate. It is not always the case that something brought forward by a charity, and indeed advocated passionately by colleagues, is the answer. The difficult decision in government is often to say, “That is not the answer; this is the way forward.” We have all been in that position. I also understand the degree of concern about this—I listened carefully to the hon. Member for Central Ayrshire (Dr Whitford)—and I want to reflect on it.
In the time available before half-past 2—and I make it very clear that I will talk until then, because that is the procedure here—[Interruption.] Well, that is what I am following. In the time available I want to explain why the Government think that what is available to people now is access to the drugs. The most important message that I want to come out of this debate is not that drugs are not available, which I think is highly dangerous, but that treatment is available. If the message that comes out of this debate is that there is only one way forward for people, then there is only one way forward for hope, as colleagues have said, and that is through the Bill. I do not believe that is correct. If it stops anyone from seeking treatment because they think that doctors cannot or will not provide off-label, I think that is wrong. That is what I will set out, because that is the evidence we have.
Several hon. Members rose—
Alistair Burt
I will take interventions, but it is only fair to the House that I respond to the debate and answer some of the charges that have been made—[Interruption.] It is not disgraceful; it is the right answer.
Nick Thomas-Symonds
Will the right hon. Gentleman accept two points? First, he made clear his objections to the Bill, and they were firmly answered by the expertise of the hon. Member for Central Ayrshire (Dr Whitford). Secondly, the Government have had a chance to put forward a non-legislative solution to the problem in the past year, but they have completely failed to do so, so why is he still refusing to allow the Bill to proceed to Committee?
Alistair Burt
After I have dealt with the other interventions, I will deal with the actions since last year’s Bill.
Mark Durkan (Foyle) (SDLP)
We listened to a debate earlier in which we heard about many much-loved fictional characters. This Bill is about real people with real conditions and making real-life differences for them, and we are yet to hear a real argument against it. I remind the Minister of what he said at the conclusion of the last debate about not denying sunshine. Why is he acting as an agent of darkness on this Bill?
Alistair Burt
Because if the message that goes out from this debate is that there is only one way to get these drugs, and if people feel that they cannot get them because of what has been said here, that would be darkness indeed. That is not the truth. That is not the position.
Dr Whitford
I find it bizarre that the right hon. Gentleman says that we must not bring in this change because it would undermine access to other drugs, because that tends to suggest that we should not have any licensing at all. Why is he happy to have drugs licensed but also feels that we should have unlicensed drugs?
Alistair Burt
Because current medical practice appears to be that drugs are available on licence for indications that are already there, but it may then become clear that some drugs are also useful for things that were not previously indicated. If the patent position is as we have discussed, then no licence process is put forward and people can prescribe off-label, as they do in many cases. Accordingly, the system works with both. The Government’s worry about this Bill is that, because of the attention paid to what is being said, it will be suggested that there is some sort of prevention mechanism that does not enable people to get the treatment they need. I am very anxious to state that that is not the case, as I think the hon. Member for Central Ayrshire also said. These drugs can indeed be prescribed. That has to be the message.
Alistair Burt
I will give way, but then I want to set out what the position is rather than what it is believed to be.
Dr Whitford
As I said, there is still an implied risk to people, and those who are distant from the research will not do this. The only reason these drugs are not licensed is that it is not worth the company’s while. Surely letting the Bill go into Committee would allow us to iron out all the issues to the satisfaction of the Government.
Alistair Burt
The issue about licensing could apply to any off-label prescribing. What we are talking about for some would, in theory, have to apply to all, because there is a risk to everything. That suggests a provision of licensing for all, which is not where we are going. This matter is not closed—let us be quite clear about that. If this measure does not go through today, the matter is not closed.
Alistair Burt
I will deal with these two interventions, and then, if colleagues do not mind, I will have to make progress.
Paul Flynn
I have long known the right hon. Gentleman and greatly respect him, but today the House has spoken on this with one voice, from both sides, with expert opinion and personal opinion. Only one voice has been silent in this debate, and that is the voice of the industry, the ABPI, which has an interest in its profits. Is its plea to keep its profits intact the only reason he is making this piffling objection to the Bill?
Alistair Burt
I have known the hon. Gentleman for a long time, and that last bit was rather unworthy of him. I have not seen anything from the ABPI, but having picked up this measure from my colleague, the Under-Secretary of State for Life Sciences, dealt with the evidence, as I have seen it, and had conversations with officials, I am perfectly convinced.
Peter Dowd
I have been sent here by my constituents, and the Minister said on his website, in response to a constituent regarding the Assisted Dying (No. 2) Bill:
“I believe that human life is intrinsically valuable and sacrosanct.”
I respect that view, but does he not agree that having rejected that Bill just a few weeks ago, this House has a responsibility, through this Bill, to facilitate, without reticence, access to medicines that would give practical and humane effect to the will of this House for those who have a terminal illness or for the prevention of that terminal illness?
Alistair Burt
Yes, of course. Why would a Government not wish to do that? I quite understand the hon. Gentleman’s point. I am trying to explain that that is exactly what happens now, and that to suggest otherwise carries a degree of risk.
Marcus Fysh (Yeovil) (Con)
Am I right in thinking that the Government’s position—it may from one point of view be a valid one that needs to be considered—is that what we are saying today does not affect the current prescription of off-patent drugs? I do not quite understand why the Government will not at least allow us the space to try to fix this Bill and try to make it law.
Alistair Burt
When I get a chance to make a little progress, I can explain to my hon. Friend why that is the case.
Mr Chope
I am grateful to my right hon. Friend, and I feel his pain. He says that he is concerned that he will not have sufficient time today to explain the Government’s position. In that case, why does he not allow this Bill to go into Committee, where he would have oodles and oodles of time in which to explain fully the Government’s position?
Alistair Burt
Because I still do not believe fundamentally that the passage of legislation is what is needed in order to reassure people that they have access to the drugs that they need.
Let me make a little progress and deal first with the concerns expressed by the hon. Member for Torfaen about what has happened since last year.
Alistair Burt
No, I will not on this occasion, because I have taken every intervention since I stood up and I cannot do my job unless I explain what people are concerned about.
As the Government promised when similar measures were discussed in the House this time last year, we held a round-table discussion bringing together some of the key stakeholders. We looked at what action short of legislation the Government could take.
Albert Owen
On a point of order, Madam Deputy Speaker, the Minister said earlier that, according to the procedure of this House, he is able to speak until 2.30 pm. I think that is incorrect. Can you give me some guidance? If the Minister sat down one minute before 2.30 pm, would my hon. Friend the Member for Torfaen (Nick Thomas-Symonds) be able to put the question so that we can have a vote and the democratic will of this House can be heard?
Madam Deputy Speaker (Natascha Engel)
The hon. Gentleman is absolutely right. That is not procedure, but it is the choice of the Front Bencher how long they speak for. He has put it on the record.
Alistair Burt
I am happy to be corrected in relation to procedure. The procedure of the House allows the Minister to speak until 2.30 pm. [Interruption.] I am not obliged to do so—that is correct—but I am choosing to do so because I believe that I would not be performing my duty if I were to allow a Bill that I think is wrong and potentially harmful to go through.
Alistair Burt
I am not going to take any further interventions; otherwise, I will take it that the House does not want to hear from me. I have to make some progress.
Carol Monaghan (Glasgow North West) (SNP)
How many people will die as a result of this?
Alistair Burt
Oh, shroud waving—thank you very much. That’s all we need.
On action flowing from last year, the Government had an extremely useful meeting that brought together the National Institute for Health and Care Excellence, Breast Cancer Now, the Cure Parkinson’s Trust and Cancer Research UK.
Mr George Howarth
On a point of order, Madam Deputy Speaker. Given the context of the Bill, do you not think that the use of the term “shroud waving” is at the very least inappropriate?
Madam Deputy Speaker
I think what is happening is that the Chamber is getting very passionate and very heated. Members on both sides of the House ought to calm down the debate a bit. We are discussing very serious matters and we are being watched not just by people in the House but by people outside the House as well. I think all of us need to calm down a little bit.
Alistair Burt
I withdraw the remark immediately and apologise to the hon. Member for Glasgow North West (Carol Monaghan).
I am seeking to find a bit of space to explain, in the face of a House that plainly does not accept it, why the Government hold their position. I am very anxious to convey it, because I believe there is a risk that people outside will take the view that something is preventing people from getting access to drugs that they may want. I think that that position is wrong, and that is why I want to make clear the Government’s position.
Since last year, the Government have had a series of meetings with the people involved. We have received input from the MS Society and the General Medical Council. It is clear from the conversations the Government have had that this is a very complex area with a number of factors at play, including easy access to robust evidence for prescribers; information about licensing status and what it means; and clear and more accessible information for researchers and charities on how to get research findings into the system and through to licensing, if that is the approach they wish to follow. What is also clear is the genuine commitment to work together to make those things happen and to investigate whether there are other non-legislative improvements that can be made to support appropriate medicines use and benefit NHS patients.
We know that there are issues with access to medicines, but they are in no way unique to unlicensed or off-label medicines use. There are areas where there is far too much variation in the use of licensed, NICE-appraised medicines, and we are working hard with the NHS to address that, but there is no single magic bullet. The measures before us today are more likely to impede access than to facilitate it. What is more, they would be of benefit to only one medicine, one condition and one group of patients at a time.
We are committed to working with NHS England, the Medicines and Healthcare Products Regulatory Agency, NICE, the GMC, the all-party group on off-patent drugs, and patient and professional groups, to address the issues that the round-table group identified. MHRA, NICE and the GMC are committed to working together to improve the understanding of the differences in licence status and how clinicians can practically work with that. The GMC is preparing a topic for its website to dispel myths and confusion about off-label prescribing and to explain how its guidance applies. NICE and the GMC are also considering further joint work to support clinicians in discussing and sharing knowledge.
As doctors may prescribe unlicensed medicines where it is necessary to do so to meet the specific needs of individual patients, and given that patients need sufficient information to allow them to make an informed decision along with their doctor, NICE is looking at making more use of patient decision aids further to support implementation of its clinical guidelines, to help individuals work through the pros and cons of different treatment options.
We are looking at how we might provide better information to help researchers and other stakeholders know how they can propose subject matter for NICE’s clinical evidence summaries and for updates to NICE guidance. NICE will be working with the “British National Formulary” to ensure that off-label uses are included where there is robust evidence to support them and that they are presented in a standard way to help clinicians to use them.
We are committed to working with the research community to set out the pathways and options for bringing research evidence to the attention of clinicians more systematically. This will involve working with a number of bodies in the research community, including the Association of Medical Research Charities, and I know there is a commitment to do so. The outcomes of the accelerated access review will also feed into that.
Let me say a little on the detail of why I do not think the Bill is the right way forward and about what is the best way forward. The Government do not support the Bill, just as the then Government did not support the virtually identical measure introduced by Jonathan Evans last year. I want to be absolutely clear about why that is the case: when it comes to the primary objective, which is to make sure that our NHS can treat everyone according to the most up-to-date and robust evidence, the hon. Member for Torfaen and I are in complete agreement. However, legislating in this way is not the way to achieve that goal.
There are clear benefits in using licensed drugs based on evidence about their safety profile, side effects, efficacy and so on. The guidance from the Medicines and Healthcare Products Regulatory Agency and the General Medical Council is clear that a licensed medicine being used within its licence indications should be the first choice for patient care, and that is exactly as it should be. However, the guidance also makes it clear that clinicians are free to use their clinical judgment to treat their patients with a licensed medicine used outside its licensed indication—off-label prescribing—or, indeed, an unlicensed medicine where such a medicine is the best clinical choice for the patient or there is no licensed medicine to meet the particular need. In fact, the guidance from the MHRA and the GMC sets out a hierarchy of medicine use.
Paul Flynn
The right hon. Gentleman prays in aid the MHRA, which is entirely funded by the pharmaceutical industry. Why does he not confess that he has taken this cruel and unfair stand of following what the industry has told him to maximise its profits and put patients last?
Ian Blackford
On a point of order, Madam Deputy Speaker. Will you give us some guidance? Given the feelings being expressed throughout the Chamber, what can we do to move a closure motion so that the views of the House can be expressed properly in this debate?
Ian Blackford
claimed to move the closure (Standing Order No. 36), but the Deputy Speaker withheld her assent and declined to put that Question.
Alistair Burt
The guidance says that in treating their patients, clinicians must first consider using a licensed medicine within its licensed indication. If that will not meet their patient’s needs, they can consider a licensed medicine outside its licensed indication, and only if that is not suitable should they consider using a medicine that is not licensed at all. We know that a great many medicines can offer benefits to patients when prescribed outside their licensed indications.
Alistair Burt
Not at the moment, because this point is absolutely crucial to put on the record.
Prescribing in that way is part and parcel of normal, everyday clinical practice, as the hon. Member for Central Ayrshire confirmed. It is very common in prescribing for children and in treating some forms of pain. Most doctors, particularly GPs, will do it every day in their clinical practice. That has already been covered in relation to tamoxifen and raloxifene for the prevention of familial breast cancer. As was rightly identified by the hon. Member for Torfaen, the issue is compounded when drugs come off patent and new evidence suggests that they would be appropriate in the treatment of new indications.
The hon. Gentleman has gathered a lot of support for the Bill, but it does give the impression that such drugs are not being made available to patients. It also suggests that licensing is required to make these drugs available for patients, and that a NICE technology appraisal is required as well.
Alistair Burt
If the hon. Gentleman is happy to say that that is not the impression given, I am pleased to correct what I said.
Nick Thomas-Symonds
I never said that the drugs were not available. I said that they could theoretically be prescribed, but that it did not happen consistently by sector or across the country. That is what I said. It is on the record.
Alistair Burt
In that case, I am more than happy to again let the message go out from the Chamber today that these drugs are available and can be prescribed. Where it is clinically appropriate, they should be prescribed. Seeking this legislation will not change that availability.
Members of the House are doing a highly effective job of bringing their constituents’ concerns to the attention of Ministers and asking our help to resolve this issue. We are not aware of colleagues bringing examples of people who have been refused treatment. It is vital to know if there is evidence of people being refused treatment. As I said, the clinician’s letter that the hon. Member for Torfaen read out was wrong. Unless there is a clinical reason for not supplying the drug, there is nothing to prevent the doctor from doing so.
Dr Philippa Whitford
I simply make the point that we are now not just talking about doctors prescribing. It is unrealistic to expect physiotherapists and nurses to prescribe drugs off licence. It just will not happen.
Alistair Burt
I understand that point. We want more people to have prescribing powers and the information that they have will be vital.
A number of our exchanges have raised the questions of what information there will be and how easy it will be for clinicians to access it. We maintain that such access will be possible. The Access to Medical Treatments (Innovation) Bill will assist that still further.
Matthew Pennycook (Greenwich and Woolwich) (Lab)
The Minister has been exceptionally generous in giving way. I hold him in very high regard personally. However, given the weight of evidence that has been brought to the Chamber, he is doing himself a disservice. I appeal to him personally, as someone who has constituents who would benefit from the Bill, to allow it to go to Committee.
Alistair Burt
I certainly did myself a disservice with a silly, offhand remark. I entirely accept that. It is not like me and I apologise.
The stance that I am taking as the Minister representing the Government is that I do not believe this is the right vehicle to achieve what Members want. I am also concerned—
Nick Thomas-Symonds
On a point of order, Madam Deputy Speaker. With the greatest of respect to the Minister, he has had a bit more time since the last point of order and it is quite clear that he has run out of arguments and is now talking to the clock. I beg to move that the Question on closure be put.
Alistair Burt
The reason I said earlier that I would go on until 2.30 and beyond is that I have not even begun to deal with the licensing arguments and the problems—[Interruption.] Hon. Members just said that I had run out of arguments, but I have not even covered the difficulty of the Secretary of State being put in the position of being the regulator and someone who applies for licences. There are plenty more arguments that need to be put and I think that we will run out of time.
Antoinette Sandbach
Given the Minister’s clear support for the principles behind the Bill, will he agree to meet the various organisations to see whether there is a non-legislative means of achieving the aims of the Bill?
Alistair Burt
I am certain that the Under-Secretary of State for Life Sciences will meet people soon at my request to carry on our discussion. It is clear that the House is not in any way comfortable with the Government’s position in resisting this Bill, so before the matter is considered again it is essential that the Government look at it further. If a message had gone out from the House that there was only one way for people to get access to the drugs they need, that would be wrong—