Off-patent Drugs Bill

Paul Flynn Excerpts

Friday 6th November 2015 Commons Chamber

[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.

[Paul Flynn (Newport West) (Lab)]

rose—

[Peter Dowd (Bootle) (Lab)]

rose—

[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.

--- Later in debate ---

[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?

[Alistair Burt]

That is not the case.