Off-patent Drugs Bill

Debate between Natascha Engel and Alistair Burt

Friday 6th November 2015 Commons Chamber

[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.

--- Later in debate ---

[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.