Off-patent Drugs Bill

Debate between George Freeman and Jonathan Evans

Friday 7th November 2014 Commons Chamber

[George Freeman]

I am not clear which particular drugs my hon. Friend is referring to, but let me answer in a generic way. I would like us to become a place where, instead of it taking 10 or 15 years and $1 billion to bring innovative drugs to market, we use the NIHR platform and our investment in genomics to become a country where for some cancers we could be getting drugs to the most needy patients through the early access to medicine scheme that I have been championing and that the Department launched earlier this year. Potentially, we could be getting drugs to patients five, six, seven or eight years earlier than would normally be the case through the traditional model of phase one, two, three, four.

[Jonathan Evans]

The drugs the Minister is talking about are new drugs. They are not a mechanism for using existing licensed drugs for which the patent has expired, which, under current circumstances, are not being prescribed to people who need them. That is what this debate is about.

[George Freeman]

I well understand that. The off-patent is a distraction; it is the question of off-label. The truth is that clinicians are free today to do it. My hon. Friend’s point about timing is very well made. I would merely say that at this stage, with the working party I am putting together and the strategy I would like us to launch—I would very much appreciate his input—I think we should be looking at setting some very clear goals and targets for speeding up that use. In particular, we should ensure that where there is evidence of an innovative and new use for an existing drug off label and there is good evidence to suggest it, we roll it out across the system. It is both the speed of first adoption and the speed of roll-out across the system.

This offers the prospect of a more appropriate and sustainable approach that can apply to a range of different drugs. We can use it to tackle this problem much more quickly and to get new drugs into use much more effectively. More specifically, we are looking to gather further evidence around potential barriers by focusing first on NICE’s updated guidelines on familial breast cancer, through the NICE associates network, and asking it further to promote its implementation. I will also ask NICE whether it would be prepared to use one of the patient decision aids it is piloting for further support.

To draw all the strands together and look at the issues at national level, we plan to arrange a national round table of the key stakeholders to be co-hosted by my Department with NHS England and NICE. We intend to use the initial meeting to identify what the various participant stakeholders might usefully do to help to address the cultural and clinical leadership issues and what other practical steps might help. The request I make to those who support the Bill is that we review the need for any further guidance or legislation in the light of that work when it has been completed. I am delighted to extend an invitation to my hon. Friend to be a part of that.

In conclusion, I very much appreciate the points that have been made today. I recognise the very real concerns that have led to the drafting of the Bill. I am absolutely committed to investigating and getting to the bottom of the reasons why new evidence is not being picked up and implemented consistently, as well as why some clinicians may be reluctant to prescribe in this way, and, crucially, the important role of NICE in supporting that with updated guidance. I am committed to doing so with the involvement of all interested parties.

The Government remain firmly of the view that improvement in this area can best be achieved through a combination of measures, and that resorting to legislation to demand regulatory measures is not a magic bullet. It will not solve the issues we believe are actually responsible for this problem, and it carries the risk of some serious and unintended consequences. It is for those reasons that the Government cannot support the Bill. However, I reiterate that we support the intention of promoting greater use of off-label medicines. We are committed to looking seriously at this and to launching a strategy and a work plan, with specific targets for increasing the rate of use of off-label medicines, with all the key agencies and to invite stakeholders in the sector, in particular medical research charities and the AMRC, to help us with that. New uses for existing drugs is something we actively support. The truth is that, as much as we would love to, we could not and should not go down the slippery road of starting to legislate for the use of medicines that should be, and are rightly, a matter for clinicians.

[Jonathan Evans]

I thank all who have contributed to the debate, including the Minister. In fact, other than the Minister everybody has spoken in favour of the proposition contained in the Bill. I am especially grateful to my hon. Friend the Member for Bury North (Mr Nuttall), who has been involved from the inception in supporting the Bill. I am grateful for the intervention of my hon. Friend the Member for Christchurch (Mr Chope), who has been such a source of great support in this process, which, even after 22 years, is relatively new to me. He, of course, is something of a Friday expert. I am also grateful to my hon. Friend the Member for Beckenham (Bob Stewart) for his interventions and his clear articulation of support for the Bill. Let me also thank the shadow Minister and those on the Labour Benches who have made it clear to me and to the charities their complete support.

The problem is that the Government take one view on the Bill, whereas charities, clinicians and others are saying that the current situation is unacceptable. It is not good enough to argue against going down the road of legislation, given that we already have a legislative process for licensing. For instance, it is the law that if a drug has not had a licence, it cannot be effectively marketed in the UK. The reason GPs often do not routinely prescribe life-saving medicines is that the rules in essence make it illegal to market them in that way. It is not surprising, therefore, that GPs, given that legislative background and the litigious world of the medical and legal profession, decide to avoid something unless it is licensed. It is not as though the charities sector has not provided the Department with a welter of information on why GPs are not doing it. The lack of licensing is at the core of it.

As the Minister knows, I respect him and his background career, and we have had several conversations about the Bill, but the proposition that passing the Bill would damage the current situation is simply laughable. I do not know who wrote that line for the Minister, but that proposition needs to be re-examined. Nothing in my Bill would cause a GP to say, “Well, actually, I was going to prescribe something, but I’m not going to now.” With due respect to him, that was the weakest of his arguments.

We heard earlier from the Labour Benches that several colleagues have received representations on the Bill from a wide coalition of charities covering a range of medical conditions. Yesterday, I spoke to several of my colleagues on a day trip to a constituency in southern England, and everyone spoke of having 50 or 60 constituents urging them to support the Bill and of being pleased to have received a response saying that the Government were speaking to me as the Bill’s promoter. Many people interpreted that to mean that the Government would be broadly supportive of the Bill.

For that reason, I am deeply disappointed to hear now that the Government are opposed to the principle of the Bill. I do not need to rearticulate its provision—it is a very simple Bill—but it says that in the absence of somebody applying for a licence, the Secretary of State has the duty to make that application or to appoint another public body to do it. Thereafter, the Bill makes provision for the drafting of regulations that present widespread opportunities for the Minister to address his concerns.

[George Freeman]

To clarify, we agree with the objective of the Bill, which, as I understand it, is to get greater off-label use of medicines for new indications, but we disagree about the mechanism. The Bill is very clear on the mechanism: it is to pass legislation to require the MHRA to issue licences. We believe that this is the wrong solution, but we are in alignment on the problem that needs to be solved.

[Jonathan Evans]

That is very helpful. I have always understood that a Second Reading debate is on the principle of the Bill; we then deal with the detail in Committee, and then we proceed to Report. Ever since I was first elected 22 years ago, that is how I have understood it to work. If my hon. Friend is saying, “We are not against the principle, but against the mechanism”, that is a reason to support the Bill on Second Reading and then to debate in Committee how we adjust it to take into account his concerns.

[George Freeman]

I congratulate my hon. Friend on making an extremely eloquent argument, but I cannot let that go. The point is that the principle to which we object is the passing of legislation to require the MHRA to issue licences. That is more than a vague guiding philosophy; it is the mechanism suggested, and that is why we are opposed to it. I genuinely believe we will make more progress in the next few months using my office and the organisations for which I am responsible, working with the supporters of the Bill, to drive forward these measures.

[Jonathan Evans]

So we are back to the Government being opposed to the principle of the Bill. It might have helped if Ministers had said, in response to those Members who wrote to them saying they were aware of my Bill, that they were opposed to the principle, as we have just heard from the Minister. Members were led to believe that the Government were not against the principle but were discussing these matters and that we might ultimately reach an accommodation. Now we understand that the Government are opposed to the principle.

The principle is one advanced by the clinician community and the AMRC and supported by editorials in leading newspapers in the UK this week. It is not surprising that almost every leading newspaper has urged the Government to pay attention to the arguments. The hon. Member for Copeland (Mr Reed) highlighted how people outside the House look at what we do here. As I said in my opening remarks, it is important that we pay attention to the clinician community and the AMRC. For that reason, I hope the House will support the Bill.

Question put, That the Bill be now read a Second time.