Access To Medical Treatments (Innovation) Bill

Nick Thomas-Symonds Excerpts

Friday 29th January 2016 Commons Chamber

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

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

[Mr Speaker]

With this it will be convenient to discuss the following:

New clause 2—Identifying evidence on off-patent repurposed drugs and passing to relevant bodies—

(1) The Secretary of State shall require the National Institute for Health Research to develop and introduce a mechanism for—

(a) gathering and recording existing evidence on off-patent, repurposed drugs, including clinical trial evidence, and

(b) passing this information to relevant bodies.

(2) The Secretary of State shall determine the relevant bodies under subsection (1) and may revise that determination from time to time.

New clause 3—Appraisal in new indications—

(1) Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall direct the National Institute for Health and Care Excellence (NICE) to conduct an appraisal in relation to the drug in its new indication.

(2) An appraisal under subsection (2) should include a cost-effectiveness analysis.

New clause 4—National commissioning policy for off-patent new drugs—

Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall require NHS England to produce and disseminate a national commissioning policy.

New clause 5—Accessibility of the licensing process—

(1) The Secretary of State shall require the Medicines and Healthcare products Regulatory Agency to consult key stakeholders about steps to be taken to make the licensing process more accessible to organisations or individuals other than pharmaceutical companies.

(2) For the purposes of subsection (1), key stakeholders shall include, but not be limited to—

(a) patient organisations,

(b) medical research charities,

(c) relevant academics, and

(d) the British Generic Manufacturers Association.

New clause 6—British National Formulary: inclusion of off-patent drugs—

The Secretary of State shall require NICE and the British National Formulary (BNF) to review their processes for registering off-label uses of repurposed drugs where there is strong evidence of their effectiveness.

Amendment 10, in clause 1, page 1, line 3, after “treatments” insert “(including treatments consisting in the off-label use of medicines or the use of unlicensed medicines)”

Amendment 13, in clause 5, page 3, line 44, at end insert—

“(1A) For the purposes of section 2(2), the kinds of medical treatment that may be innovative medical treatments include (amongst other things)—

(a) the off-label use of an authorised medicinal product, and

(b) the use of a medicinal product in respect of which no marketing authorisation is in force.

(1B) In subsection (1A)(a), the reference to the off-label use of an authorised medicinal product is a reference to the use of the product—

(a) for a purpose other than one for which its use is specified,

(b) in relation to a person who is not within a description of persons for whom its use is specified, or

(c) in any other way in which its use is not specified.

(1C) In this section—

(a) ‘authorised medicinal product’ means a medicinal product in respect of which a marketing authorisation is in force;

(b) ‘marketing authorisation’ and ‘medicinal product’ have the same meanings as in the Human Medicines Regulations 2012 (S.I. 2012/1916);

(c) ‘specified’, in relation to a medicinal product, means specified in its marketing authorisation.”

[Nick Thomas-Symonds]

These new clauses and amendments, which I support, relate to off-patent drugs. I think it would be useful for me briefly to set out the context in which they arise. The Off-patent Drugs Bill, a private Member’s Bill that I introduced—it was debated on Second Reading on 6 November—is a UK-wide Bill that would create a duty on the Government to make cheap drugs available when pharmaceutical companies had no incentive to do so. The problem, put simply, is that if a drug is shown to be useful for a new purpose after its original patent has expired, a pharmaceutical company has no financial incentive to sponsor that off-patent treatment through the processes normally used to license it and ensure its adoption on the NHS. Those off-patent or off-label treatments are certainly available at low cost. The issue is simply that although clinicians can of course prescribe them, they tend not to be prescribed consistently across the medical sector, or indeed geographically.

The Off-patent Drugs Bill ran out of time that day, but I think it is accurate to say that the Government supported its aims but not the mechanism it proposed. None the less, in recognising that there is a problem, and with a shared position on both sides of the House on the need to encourage greater consistency in off-label prescribing, a lot of work has since been done, and on a cross-party basis. I am proud that new clause 1 stands in the name of Members from no fewer than eight political parties. The concept of encouraging greater use of off-patent drugs, and indeed my Bill, have significant support across the House and outside. I pay tribute to Jonathan Evans, the former Member for Cardiff North, who first introduced such a Bill in 2014. His successor, the current Member for Cardiff North (Craig Williams), has also supported my Bill.

[Carolyn Harris (Swansea East) (Lab)]

I congratulate my hon. Friend on the excellent work he has done on the Off-patent Drugs Bill. Given the consensus across the House, does he agree that now is the time for a firm commitment from the Government on that Bill?

[Nick Thomas-Symonds]

I am grateful to my hon. Friend for that intervention. I hope to hear such a commitment today, so I look forward to what the Minister for Life Sciences has to say in that regard.

That wide support for my Bill was shared by medical research charities, NHS clinical commissioners in England, the British Medical Association, thousands of members of the public who wrote in, and four medical royal colleges. Indeed, 40 eminent clinicians wrote to The Daily Telegraph in support of my Bill.

Since then, I am pleased to say that there have been good attempts on both sides of the House to build on that good will in relation to off-patent drugs. I want to thank the hon. Member for Daventry (Chris Heaton-Harris) for the highly constructive and pragmatic way in which he has been willing to take the off-patent agenda forward when speaking about his private Member’s Bill. I thank the hon. Member for Bury St Edmunds (Jo Churchill), who brings a strong personal perspective to the debate. Her sense of what is good for patients has been highly constructive in the debates we have had over the winter months. The hon. Member for Central Ayrshire (Dr Whitford), who used to be a breast cancer surgeon—in fact, she still practises—has brought a great level of expertise and experience in recent months, for which we are extraordinarily grateful. I also pay tribute to the Minister, who has been extraordinarily generous with his time and that of his officials in order to try and take this agenda forward, and for that I am extremely grateful.

I want first to make a point about clauses 3 and 4. While there is something of a consensus around responsible innovation, I had strong concerns about those clauses, as did many across the medical profession who thought that they might encourage a more dangerous type of experimentation, if I may put it that way. Looking at the amendments tabled by the hon. Member for Daventry, I can see that his intention is to remove clauses 3 and 4 altogether, which would be a very welcome step. That would mean that the principal remaining part of the Bill relates to the database of innovative medical treatments. The hon. Gentleman’s amendments 10 and 13 would bring the off-patent concept firmly into the purpose of this Bill, and therefore into the database. A lack of data was one of the barriers identified to more consistent prescribing of off-label treatments. The amendments would be an extremely welcome step forward, because they would not only enshrine in law the off-label aspect, but bring the data into the database so that it became more widely and readily available, assisting clinicians on the frontline. I sincerely hope that the amendments will be positively received by the Minister.

New clause 1 sets out an action plan for developing a pathway for off-patent repurposed drugs where strong evidence of their effectiveness in a new indication exists, with the aim of securing routine use. Put simply, this is an action plan with clear timeframes for progress. Again, this would be a welcome step forward.

New clause 2 would require the National Institute for Health Research to develop a mechanism for gathering and recording evidence on off-patent repurposed drugs, including clinical trials evidence, and passing it to the relevant bodies. The NIHR already has a dedicated horizon-scanning centre, but this would set up a dedicated stream for off-patent repurposed drugs to speed up getting them to the frontline and into routine use.

New clause 3 proposes that where there is strong evidence of effectiveness in a new indication, the National Institute for Health and Care Excellence should be directed to conduct a technology appraisal, including a cost-effectiveness analysis. While these drugs are extraordinarily cheap, some level of cost-effectiveness analysis would none the less be desirable, since to achieve routine commissioning, in England for a start, a persuasive business case clearly needs to be put to local hospitals and clinical commissioning groups.

New clause 4 is about having a national commissioning policy for off-patent drugs. It also requests that the Minister work with the devolved nations to produce something that is genuinely UK-wide. This has already happened in the case of NHS England working with Prostate Cancer UK to produce a commissioning policy for an off-patent repurposed drug called Docetaxel.

New clause 5 would make the licensing process more accessible. What would that mean in a practical sense? For example, an initial meeting where there is a discussion of the case and the likelihood of successful treatment could be free, a representative of patient organisations could be designated within the Medicines and Healthcare Products Regulatory Agency for patient organisations, and there could be a guidance document for non-pharmaceutical applicants.

--- Later in debate ---

New clause 6, which deals with the question of the “British National Formulary”, is very helpful in terms of giving me a chance to talk about the mechanism that I propose and have just touched on. I am reluctant to name the BNF explicitly in the Bill, not least because it is a commercial product that is not in my gift to control. There are no plans to change its format, but I would hate for us to have legislated for one particular mechanism of information and then find in a few years that it has changed in some way and is no longer appropriate. I am, however, very happy to give an undertaking at the Dispatch Box that we are actively exploring this option and have no reason to think it cannot work. NICE tells me it thinks there is a very good mechanism for it to use its existing powers for gathering evidence to pull together, as part of an evidence review, an evidence-based reassurance to clinicians that a drug has a legitimate off-label, off-patent use, and to include that in the appropriate registry. Today I think that would be the BNF, but that may change in due course.

[Nick Thomas-Symonds]

I would just like to make two points. First, the “British National Formulary” is UK-wide. Secondly, and just to probe the Minister further, is he able to give an approximate timeframe for when he thinks the process might be complete?

[George Freeman]

The hon. Gentleman makes two good points. This is, of course, UK-wide. One of the challenges, as a UK Minister, is to put in place a framework that will support this across the UK while respecting the different mechanisms in the devolved Administrations. I hope the Bill will provide a basis for a similar mechanism in areas where there are different formats. I believe that in Scotland, Northern Ireland and Wales, but particularly in Scotland and Northern Ireland, there is a hunger to do that. I believe the Bill will support those existing mechanisms.

--- Later in debate ---

[Nick Thomas-Symonds]

I am grateful to Members across the House for their contributions and to the Life Sciences Minister for his clear response to the six probing new clauses. I am pleased to hear that the Government will accept amendments 10 and 13. As I said in my opening speech, having off-label treatments in the Bill and the database will make a significant difference and help move things forward. I was also pleased with his reassurance to the hon. Member for Central Ayrshire (Dr Whitford) that we will continue to review the system, as, I hope, the number of off-label treatments and prescriptions increases.

In view of the Minister’s commitments and acceptance of amendments 10 and 13, I do not propose to press new clauses 1, 2 and 3. New clauses 4, 5 and 6 are in the names of the hon. Members for Bury St Edmunds (Jo Churchill) and for Central Ayrshire (Dr Whitford). I beg to ask leave to withdraw the motion.

Clause, by leave, withdrawn.

Clause 1

Access to innovative medical treatments

Amendment made: 10, page 1, line 3, after “treatments” insert

“(including treatments consisting in the off-label use of medicines or the use of unlicensed medicines)”—(Chris Heaton-Harris.).

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

We now come to amendment 1—