ACCESS TO MEDICAL TREATMENTS (INNOVATION) BILL

Nick Thomas-Symonds Excerpts

Wednesday 16th December 2015 Public Bill Committees

Division 1

Ayes: 5

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Conservative: 9

Noes: 9

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Labour: 4
Scottish National Party: 1

[Nick Thomas-Symonds (Torfaen) (Lab)]

I beg to move amendment 7, in clause 1, page 1, line 3, after “treatments” insert,

“, including access to off-patent drugs in new indications,”

[The Chair]

With this it will be convenient to discuss the following:

Amendment 8, in clause 1, page 1, line 9, at end insert—

“(c) providing for the establishment of an arm’s length body to provide assistance to those seeking regulatory approval for off-patent drugs in new indications.”

Amendment 9, in clause 2, page 1, line 29, after “involves” insert—

“(a) the use of off-patent drugs in new indications where there is strong evidence for their effectiveness; and

(b) a departure from the existing range of accepted medical treatments for the condition”.

New clause 1—Licenses for off-patent drugs—

‘( ) The Secretary of State, or a body nominated by the Secretary of State, has a duty to seek licences for off-patent drugs in new indications where—

(a) there is no commercial incentive for a profit-making body to do so,

(b) there is robust evidence of its effectiveness in the new indication, and

(c) the drug meets NICE’s prioritisation criteria for Technology Appraisals.”

New clause 2—Appraisals for off-patent drugs—

‘( ) The Secretary of State has a duty to direct NICE technology appraisals or a suitable alternative, for off-patent drugs in new indications where—

(a) there is no commercial incentive for a profit-making body to do so,

(b) there is robust evidence of its effectiveness in the new indication, and

(c) the drug meets NICE’s prioritisation criteria for Technology Appraisals.”

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[Nick Thomas-Symonds]

It is a pleasure to serve under your chairmanship, Mr Streeter. I join in congratulating the hon. Member for Daventry, who cares a great deal about policy on this matter and is promoting this Bill with the best of intentions. I also congratulate him on his Bill surmounting the hurdles and reaching Committee stage.

Before I come to the amendments, I think it would assist to explain the background, because that will make them explicable in the context of the Bill. I was also drawn in the ballot for private Member’s Bills. The Second Reading of my Off-patent Drugs Bill took place on 6 November. I will quote from Hansard what I said that day to explain the purpose of that Bill.

“The Bill is a UK-wide Bill that creates a duty on the Government to make cheap drugs available when pharmaceutical companies have no incentive to do so. There is a problem: if a drug is shown to be useful for a new purpose after its original patent has expired, there is no financial incentive for a pharmaceutical company to sponsor that off-patent treatment through the processes that are normally used to license it, and to ensure its adoption on the NHS. Such off-patent treatments are usually available at low cost, but the current system is not set up to make them routinely available when they have been repurposed. Put simply, without a licence to act as a kitemark of safety, and a cost-effectiveness appraisal to give the NHS a mandate to provide it, there are multiple disincentives to treatments being prescribed, meaning that they are not routinely made available.” —[Official Report, 6 November 2015; Vol. 601, c. 1289.]

The Under-Secretary of State for Life Sciences has already spoken about barriers.

My Bill received a great deal of support, not just across parties but outside the House, including from 12 medical research charities, the umbrella body for the NHS clinical commissioning groups in England and the BMA. More than 10,000 members of the public wrote in support to their MPs in addition to the more than 20,000 who wrote to Jonathan Evans, the then Conservative Member for Cardiff North, in support of the same Bill the year before. Four medical royal colleges backed it and 40 eminent physicians wrote to The Daily Telegraph in support of the Bill.

In addition, the all-party parliamentary group on off-patent drugs, which I chair, held an evidence session on 15 October this year during which Pan Pantziarka, a repurposing specialist, spoke in favour of the mechanism that my Bill would have provided to deal with the problem. He said that the obtaining of a licence created “a whole cascade” of other events, including the updating of the British National Formulary, the updating of guidance and the fact that clinical commissioning groups would take further note of that treatment.

The amendments in this group, including new clause 1 and new clause 2, are in effect my Bill coming in via amendment to this Bill. New clause 1 would place a duty on the Secretary of State to seek licences for off-patent drugs in new indications, and new clause 2 relates to direction of NICE technology appraisals. The Minister has concerns about those aspects of my Bill, so with the amendments I have attempted to provide a series of options for discussion, but they are what I would call the strong version of what is essentially my Bill. The Minister takes a different view, but I remain of the view that they represent a better way of dealing with this matter. Otherwise, of course, I would not have promoted my Bill in the first place.

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[George Freeman]

The hon. Lady makes an excellent point, with the benefit of her front-line experience. It goes to the heart of why this Bill and that of the hon. Member for Torfaen mesh together. As she says, there are now clinicians on the frontline, nurses and others, making decisions and they need guidance. My only point of dispute is that a licence is a very heavy-handed form of guidance. I want to signal that I am actively and enthusiastically looking at ways of ensuring that front-line clinicians get the right guidance without creating a structure that requires the Department and Ministers to become the licensors of every off-label use. That is not least through the accelerated access review, about which I will be specific in a minute.

[Nick Thomas-Symonds]

That has been the difference between myself and the Minister in this debate for a number of months. The aim surely has to be to get consistency both across different medical sectors and prescribers in terms of off-label use. The big problem, as the Minister is aware, has been inconsistency.

There is an argument, and the Under-Secretary of State for Life Sciences made the point, about licences being heavy-handed. However, there would at least be consistency. We must find a way through that provides such consistency.

[George Freeman]

The hon. Gentleman makes a good point, up to a point, because one needs to preserve clinical freedoms and clinicians need to be free to make the right decision for their patient. However, I appreciate that the point he is making, principally, is that we do not want pockets of enlightened use of off-label drugs, perhaps because a group of clinicians has access to the information or works in a research hospital, for example. We want patients to have access across the whole system. That is why the ambition to use, and the possibility of using, the database in the Bill could be powerful.

Amendment 8 seeks to provide for the establishment of an arm’s length body to assist those seeking regulatory approval for off-patent drugs in a new indication. The Government do not support the amendment. As I have said, we support the objective, but we do not support that mechanism. The Medicines and Healthcare Products Regulatory Agency, for which I am responsible, already provides advice to people who want to apply for marketing authorisations.

We have no plans to fund an additional arm’s length body, and I do not believe that it would be helpful. However, I am happy to ask the accelerated access review team to look specifically at the question of how we could promote the use of off-label medicines, and to give recommendations to that effect, and, if that is not possible in the next few weeks, as the team finalises its recommendations, to take action as a review and come back on that specifically.

I would happily sit down with the hon. Member for Torfaen and the promoter of the Bill to see whether we can agree a form of words. I am signalling my willingness to amend the Bill to make the ambition very clear, but I cannot accept the amendment. I do not want to go back to the Secretary of State tonight and tell him, “Great news, Secretary of State! You and I have now become the licensors of off-label medicines and will be putting together regulatory and litigation packages. We are going to set up a pre-clinical office.” It is not what he and I are here for, mainly because we are here to drive and protect patient safety.

It is for others to bring forward drugs and for us to regulate them. It would be a profound and fundamental conflict of interest if we were to take that on. Off-label use of medicines is widespread in the system today, particularly in paediatrics, without the need for licences. I do not accept that licensing is the right mechanism, but I happily accept that we should put into the Bill the fundamental objective of promoting off-label use.

[Nick Thomas-Symonds]

The Minister is entirely right on paediatrics. There is also quite widespread off-label use in anaesthetics, but of course that shows the problem, because there is pretty consistent use in those two areas but not in other medical specialisms, which is of course the point.

[George Freeman]

It is a point well made by the hon. Gentleman.

It could be argued that strictly speaking the wording of the Bill makes amendment 9 unnecessary, but I have quite a lot of sympathy with it, in the spirit of my response to amendment 7. Again, I wanted to offer the possibility of sitting down with the hon. Gentleman and officials to see whether we could reach a wording to bring before hon. Members to capture the ambition of giving effect to greater off-label use.

Currently, all innovative treatment falls within the scope of the Bill, including not only innovative medicines but the innovative use of existing medicines. However, given the level of interest in and the particular challenge with off-label drugs—the subject elicits particular interest, not least with some patient groups—it could be powerful to make that more explicit.

With regard to new clause 1, I reiterate that, as the licensing authority for the United Kingdom, the Secretary of State cannot become a routine applicant for licences. Neither would it be appropriate for the Government to take on responsibility for bringing medicines to market, which is a requirement of marketing authorisation holders. If my right hon. Friend the Secretary of State was responsible for nominating a body to undertake the role, that would still place him in far too close a proximity to the state of being a licence applicant, and would conflict with his responsibility to oversee and ensure the quality of the system. I encourage the hon. Gentleman not to press the new clause, but I am very open to seeing whether we can put a package together on Report.

The Secretary of State already has the power—a power he delegates to me, for this purpose—to direct NICE to carry out a technology appraisal where appropriate, but new clause 2 would turn that freedom into a binding obligation for NICE to carry out an appraisal where the use of an off-patent drug might be better addressed by a different NICE product. I understand the ambition behind the new clause, and I am happy to work on the wording of the Bill, but that mechanism is too restrictive and too binding. It would put the Secretary of State and me in a difficult situation.

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[The Chair]

Our timing is good. We might have a Division downstairs shortly, so we have plenty of time for Mr Thomas-Symonds to respond.

[Nick Thomas-Symonds]

I am grateful to both the hon. Member for Daventry and the Minister for Life Sciences for their reassurances. Having spent 11 years as a lawyer, I know that while certain things may be otiose, the more explicit one can be in a Bill such as this, the better it is and the more reassurance that is given. That is important.

It is important that off-patent drugs are on the face of the Bill; I do not think the Minister has any objection to that, from what I heard. His reassurance about specifically asking the accelerated access review to look at the matter is much appreciated. On new clause 2, if the role of NICE technology appraisals could be made explicit in the Bill, that would be extremely helpful.

I am very willing to take up the Minister’s offer to sit down and look at this issue with me and to work constructively. On the basis of the reassurances I have been given, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Amendment proposed: 2, in clause 1, page 1, leave out lines 8 and 9—(Justin Madders.)

Question put, That the amendment be made.