Off-patent Drugs Bill

George Freeman Excerpts

Friday 7th November 2014 Commons Chamber

[The Parliamentary Under-Secretary of State for Health (George Freeman)]

I am delighted to have the opportunity to address the Bill. I start by congratulating my hon. Friend the Member for Cardiff North (Jonathan Evans) on bringing it before the House and raising this very important issue. As he has said, he and I have met Department officials and we very much agree on the Bill’s objective to promote off-label use of medicines. The only disagreement is on the mechanism to achieve that and whether the mechanisms proposed by the Bill are the right ones. That disagreement continues, and for that reason the Government want to work with my hon. Friend and the campaigners and charities that support the Bill to find a way to achieve our agreed aims.

I want to set out some of the background, outline my proposals and explain why the issue is not quite as straightforward as we would all like to think it is. If only we could legislate to get the right drugs into the right patients at the right time, the world would be a lot easier, but we are not able to do that.

[Bob Stewart]

Do I take it from what the Minister has just said that the Government support getting through the Second Reading as fast as possible?

[George Freeman]

Let me be clear. What I am saying is that the Government support the intention behind the Bill, which is to achieve greater use of off-label drugs in different indications, but we disagree with the Bill’s proposal for legislation to require the Medicines and Healthcare Products Regulatory Agency to license them. For reasons that I will set out, we do not think that is the problem or, therefore, that the proposal is the right solution. Nevertheless, I welcome the fact that the issue has been raised. It sits foursquare with my mission as the Minister with responsibility for life sciences. I am already working on it and am very keen to make sure that the active work streams I am pursuing embrace the intent behind the Bill.

I pay tribute to my hon. Friend the Member for Cardiff North for his work. The House has often debated this issue and I am well aware of the strength of feeling among Members of all parties about the importance of, and urgency involved in, getting both new and existing medicines to patients more quickly.

I should also like to take this opportunity to pay tribute to my hon. Friend for his service in this House. As he has said, this is his last year, and I am sure I speak for all of us in paying tribute to and thanking him for all he has done, not only in contributing to the quality of this institution, but in campaigning on this issue.

As my hon. Friend and others may know, I came to this House and my ministerial position after a career in biomedical research—a subject that is very close to my heart—so I am delighted to be able to discuss it and the Bill this morning. During my 15 years working in biomedical research, I saw first hand the serious challenges involved in bringing a new drug to market. I want to address how the landscape of drug development and discovery is changing; the profound way in which technology is changing what is possible; how the economics of 21st-century drug discovery are changing; and the resulting challenges and opportunities for us to do exactly what my hon. Friend seeks to promote, which is greater and more novel use of existing drugs for those patients who will benefit. I will then deal with the key points raised by him.

A rapid transition is taking place from a model of 20th-century drug development whereby the NHS, patients and the health system waited passively and all too patiently for the introduction of new drugs that had been tested, proven and developed with the claim that they would work and were safe for everybody. Over the past several decades, the regulatory barrier required to justify that claim has got higher and higher, as have the costs of developing drugs. On average, it typically takes 10 to 15 years and £1 billion to £1.5 billion to develop a new drug.

My hon. Friend referred to patent life. Members will know how the industry works, but it is worth repeating that, in order to justify the enormous sunk cost of the billions of pounds required to bring a new drug to market, the law provides for the inventor of a new drug to have a patent for 20 years. That mechanism ensures that those who successfully bring an innovation to market are able to get some exclusivity on sales, which allows them to pay for those sunk costs. When a drug becomes off-patent, the generics market kicks in and anybody can make the drug, provided it is made to the right standard and is safe, which allows all of us to benefit from that drug at a vastly reduced price. Indeed, one of the major challenges facing the sector is that, as the cost and time taken to develop a drug increases, the pharmaceutical industry’s pipeline of new drugs is not sufficient. The problem is referred to as the patent cliff, and the sector is going through a radical transition to try to deal with it.

The problem is that the more we know about genetics and the way in which different patients respond to different drugs and diseases, the more we realise that the blockbuster, one-size-fits-all drug that we have got used to the industry giving us is not what we need. What we need are drugs that are much more targeted at patients and their underlying genetic and pharmacokinetic profile. We want drug discovery to be driven by our increasingly sophisticated understanding of how different patients respond to different drugs and diseases.

Underlying that problem is an extraordinary opportunity for this country. In order to reorientate drug discovery around patients, we need an infrastructure that allows people to work in world-class research hospitals with access, at the very highest ethical and regulatory level, to tissues, biomarkers, electronic patient data and longitudinal cohort studies. Nowhere in the world is better equipped to lead that model of translational, personalised and stratified medicine than Britain with the NHS, and through my appointment the Government have signalled their commitment to exploit that opportunity.

We believe there is a real opportunity for the UK and the NHS to lead in the emerging field of stratified and targeted medicines, because no other territories in the world have our 50-year history of an integrated public health system, the records that go with it, its ethical and regulatory standards or its world-class centres of research excellence. If we embrace that model, using genomics and data to understand better how different patients respond, we will also be able to look back at the pharmacopoeia of known and existing drugs and re-profile them for use in particular patient groups, because it will have become clear that they will be effective for them.

My hon. Friend might be interested to know that the re-profiling of drugs is itself a major subsector of the life sciences sector. Whole companies, analysts and investors are devoted to mining the pharmacopoeia to find secondary uses, with the intention, of course, of re-patenting the secondary, novel use of an existing drug through tweaking the chemistry and providing the basis for a proprietary claim. Good luck to them—I wish them well—but what my hon. Friend and I want to see is the ability better to use that information in order to find existing drugs which, in their current form, would have a benign impact on a particular patient group. Doctors are perfectly free to use those drugs at the moment.

The truth is that whichever model of drug discovery we pursue, any drug has to be licensed as safe by the MHRA—or, in Europe, by the European Medicines Agency—and then NICE carries out a technology appraisal and makes a recommendation to the NHS about whether such a drug or device has a sufficient cost-benefit to be worth using. Despite all that, the decision on what to prescribe in the end rests, rightly, with clinicians. We cannot and should not legislate to tie clinicians’ hands. Rightly, it is up to clinicians to decide what to use for their patients.

I want to submit to the House and to my hon. Friend that the challenge does not relate to passing legislation to require the MHRA to license the new use of an existing drug, because the lack of a licence is not the restraining factor. In this landscape, the restraining factor is the lack of information for clinicians about off-label use. We need to encourage greater off-label use through NICE, and to have a culture within our health system that actively supports it. In a moment, I will talk about what we are doing and might do to encourage that.

I want to pick up the confusion that may exist about the difference between off-patent and off-label drugs. A drug is off-patent when its patent protection has expired, which means that anyone can produce an identical drug at their own cost. A drug is off-label when it can be used for a new indication for which it was not originally intended. However, clinicians are perfectly able to use drugs for off-label purposes: we do not require the MHRA to license drugs for such a reason, and many drugs are already used in that way.

Let me assure my hon. Friend and other hon. Members that, as the new Minister for life science, I have responsibility for the National Institute for Health Research, which underpins clinical research in the NHS with £1 billion a year. It looks not just at new drugs, although we are very good at that, but at the whole pharmacopeia and how existing medicines are used, and provides research on side effects, efficacy and outcomes for the MHRA and NICE.

We have created a new department at the heart of the Government to tackle precisely the issues that my hon. Friend has raised. I have been in post for only 100 days, but I want to talk about what we are doing to try to accelerate access for patients to new medicines, and to existing medicines with novel indications. I am sure that he is delighted to know that, as the hon. Member for Copeland (Mr Reed) reminded the House, my principal mission is to accelerate access to new drugs, including to new uses for existing drugs, for the benefit of NHS patients.

My hon. Friend the Member for Cardiff North was kind enough to refer to the Government’s commitment to the cancer drugs fund. He rightly identified that our real commitment is to ensure that if patients suffer because of NICE recommendations in relation to particularly expensive drugs, additional money is made available to prevent that from happening. The problem is one of health economics and NICE appraisals, rather than of licensing by the MHRA.

My hon. Friend made a very eloquent case, which I support, for the use of off-label drugs. We disagree not on the aim of promoting off-label use, but merely on the mechanism for doing so. As the Minister with responsibility for NICE, I am delighted to assure him and the House that we already have the power to instruct NICE to undertake technology appraisals. I hope that what I will say in a moment about how we intend to use that power and about the work we are doing on a series of ways to accelerate access to new drugs will reassure him that, far from our having any sense of complacency, we are bending our backs to consider every avenue in order to find value within the current pharmacopeia and to support clinicians actively embracing innovative uses of drugs.

It is for that reason that we have decided—controversially in some quarters—to support Lord Saatchi’s Medical Innovation Bill, which is in the House of Lords. It seeks to contribute to this landscape by making it clear in statute that clinicians have the freedom, and should be supported in using the freedom, to embrace innovative uses of both existing and new drugs in the treatment of cancer. His Bill is about making very clear that those freedoms exist, and that clinicians have a duty, under their Hippocratic oath, to explore every innovative opportunity that there is a good clinical basis for believing will be safe and to the benefit of their patients.

The truth is that the problem is as much cultural as legislative. That is the principal reason why the Government are not able to support this Bill, but very much support its aims. I want to say something about what we propose to do to achieve the progress that we all want more quickly and effectively.

So that there is no doubt, let me say that our position is basically that the Bill is not needed. Anyone can apply for a licence for a medicine, and doctors can already prescribe medicines for uses outside their licence, where that is in the best interests of their patients. Doctors do so every day: when they make such a judgment, it is safe, legal and right for them to do so if they feel that they have a basis for doing so.

The truth is that licensing gets a medicine licensed; it does not get it into clinical practice. Whether clinicians use the medicine is driven by NICE guidance, and doctors ultimately decide what is best for their patients. That is why pharmaceutical companies invest so heavily in promoting their products. In turn, NICE exists, as an independent source of advice in the NHS, to provide our clinicians with independent, world-leading advice on the cost-effectiveness and the clinical cost-benefits of new drugs.

If we want to accelerate the uptake of innovative medicines, I suggest that we focus our efforts on NICE guidance and on supporting our medical profession to adopt innovation. Our concern is that the Bill may, completely inadvertently, impede progress on that by making doctors feel that they should not use medicines except for their licensed indications, which is the opposite of the message that we want to send. I understand that that is not the intention of the Bill, but we believe that it might be an inadvertent side effect.

What are we doing? The Government believe that the real issue involves better informing and enabling clinicians to embrace new indications, not dealing with a supposed problem of licensing. We are taking steps with NHS England and NICE to support local drugs and therapeutics networks, and improve how they pick up new evidence and translate it into clinical practice. Indeed, one role of the NIHR is to gather data—that word again—on which drugs are working and on outcomes across the system, and to feed such information back into guidance that is continually updated.

We are also working with hospitals and GPs to support them to work together on delegated prescribing, and to consider how they can change clinical pathways to reflect the very latest evidence across the system. The truth is that we need more evidence about what is working, and we are now gathering that evidence through the NICE associates network and our contacts with local clinicians.

As I have explained to my hon. Friend in our meetings and conversations, we will set up a round-table discussion in the new year, alongside NHS England and NICE, to bring everyone together, review the evidence and agree a strategy and a timetable for action. I am more than happy to extend an invitation to him and those supporting his Bill, as well as Association of Medical Research Charities, to engage actively in that process and to help us to develop a strategy for achieving what we all want, which is the greater use of off-label medicines in areas where the evidence suggests that they can deliver patient benefit.

I can go further and confirm that that is part of a major piece of work that I am leading on how we can and should reissue and revise our guidance to NICE and the MHRA—and review our ambitions as a country in this 21st-century landscape—to make Britain genuinely the best model of patient-centred research. Through the NIHR and our NHS infrastructure, we want to be the best place in the world for people to come to and develop new medicines, or indeed new uses for existing medicines. We want specialist tertiary research hospitals with cohorts of data, to develop new models of commissioning through evaluation, and evaluation through commissioning—two sides of the same coin—so that we can get drugs to patients far quicker than under the traditional model of 10 to 15 years and the £1 billion drug development.

There are undoubted benefits to the use of off-label drugs where there is evidence about their safety, efficacy and side effects. Guidance from the MHRA and the GMC is clear that there is a hierarchy in the use of medicines. In treating patients, clinicians must first consider using a licensed medicine within its licensed indication. If that will not meet the patient’s needs, clinicians can consider a licensed medicine outside its licensed indication. Only if that is not suitable should they consider a medicine that is not licensed at all. A great many medicines can offer benefits to patients when prescribed outside their licensed indications—my hon. Friend has already mentioned tamoxifen and raloxifene for the prevention of familial breast cancer.

My hon. Friend also rightly identified that there can be delays and barriers to using off-patent drugs for new indications. The reasons for that are complex—if only they were so simple that we could solve them with one private Member’s Bill—and in part relate to reluctance by some clinicians to prescribe drugs for conditions for which they are not licensed. There are also issues about the system’s ability to pick up emerging evidence and translate it into new guidance and clinical practice, and about how hospital specialists and GPs can work together to achieve that, by adapting pathways where needed.

What the Bill seeks is already allowed. That is the key reason why, despite agreeing with the Bill’s aim that patients should have access to appropriate drugs, the Government are unable to support it. Medicines are already prescribed legally, safely and appropriately outside their licence indications to large numbers of NHS patients, both in hospitals and in general practice. No funding, legal or regulatory barriers in the system prevent patients from being prescribed a clinically necessary medicine that is not licensed for the treatment indicated. Indeed, doctors regularly prescribe drugs outside their licensed indications. For example, many medicines prescribed to children are unlicensed for paediatric use because historically they have not been formally trialled in children. Two key conditions must be met in such prescribing. First, the clinician must be satisfied that the unlicensed indication meets the clinical needs of the patient and that no suitable licensed alternative is available. Secondly, he or she must explain to the patient that the drug is not licensed, so that they are clear about that.

Evidence suggests that patients trust their clinicians, and that those who are suffering actively embrace research medicine and are keen to be made aware of available drugs that may be not have been originally licensed for that purpose, as long as there is good evidence for it and the clinician supports its use. That position is well established and supported explicitly in guidance to prescribers by the General Medical Council and the Medicines and Healthcare Products Regulatory Agency. Therefore, if a doctor chooses not to prescribe a medicine off label where one is indicated for the patient, that is unlikely to be simply because of the medicine’s licensing status. If a clinician believes that the lack of a licence prevents them from prescribing a drug, that is a different issue to which I will return in a moment.

Under the law regulating medicines, anyone can apply for a licence for a new use for an existing out-of-patent medicine. The Bill seeks to place that responsibility on the Health Secretary, so that he either takes steps to secure licences for off-patent drugs and new indications, or appoints a body to do so. In truth, licensing gets a medicine licensed, but it does not do what we want, which is get it into clinical practice. That requires clinicians to use and prescribe drugs, which is why we have NICE guidance.

The Department of Health holds a small number of licences for anthrax vaccine in the case of national emergency, but the Government rightly view that very much as an exception. Our concern is that if the Secretary of State were to become a routine applicant, or instructed someone else to do that on his or her behalf, they might be open to accusations of interfering in the market and a conflict of interest. There might even be a case for claiming a conflict of interest between the Secretary of State’s role as an applicant competing in the medicines market, and their statutory role as overseer of the system. Ultimately, we worry that that could compromise the Secretary of State’s responsibility for the UK medicines licensing system, were they to become a regular applicant. The idea of a body set up by the Secretary of State to apply for licences does not seem proportionate to the scale or nature of the challenge. If the issues under consideration will not be resolved simply by granting more licences—I do not think they will—there is no need for such new bureaucracy.

We believe that the provisions on NICE in the Bill are unnecessary. The fact that NICE has recommended the unlicensed use of tamoxifen and raloxifene in its clinical guidance should reassure hon. Members on that point, and I stress that we are actively discussing that matter with NICE and wish to promote it. I know my hon. Friend is concerned about the level of uptake of those drugs, despite NICE’s approval, and by focusing on the NICE appraisal process and guidance with an associated legal funding requirement, the Bill seeks to remove a perceived funding barrier to the implementation of off-label drugs that are proven to be clinically and economically effective. However, we believe that in practice it is unlikely that drug costs will be the key factor determining prescribing behaviour, when we are talking about generic drugs that in many cases will cost a few pence a day.

The framing of NICE’s clinical guidelines reflects the strength of the underpinning evidence. For example, where evidence strongly supports the use of intervention, NICE often states that that should be offered to patients. On the other hand, where the evidence of benefit is less strong, NICE typically states that intervention should merely be “considered”. It is entirely appropriate that the uptake of NICE’s recommendations reflects the strength of the evidence base. For the two drugs mentioned by my hon. Friend and me, NICE concluded that the evidence strongly supports their use for women at high risk of breast cancer, but was less strong for women at moderate risk. As such, its recommendations are worded differently, depending on a woman’s risk levels. Specifically, and importantly, NICE states that the drugs should be “offered” to women at high risk, and “considered” for women at moderate risk.

The Bill would require the Secretary of State to ask NICE to appraise certain new indications for off-patent drugs, whether licensed or unlicensed, rather than issue any form of guidance. Again, the Government believe that that is unnecessary, as there is currently no legislative barrier to Ministers asking NICE to appraise drugs outside their licensed indication. We tend to do so only exceptionally where there is clear evidence that that is the right course of action—an example would be drugs used to prevent transplant rejection in children. More frequently, NICE looks at the off-label use of drugs in the context of its clinical guidelines across the whole care pathway. Guidelines are generally considered a more appropriate vehicle for guidance on off-label indications, as they can set use more clearly in context. The question of mandated funding is unlikely to be critical if the drugs concerned are older or lower cost generics. NICE recognises the primacy of the medicines regulator in matters of safety and efficacy, and liaises with the MHRA in developing any clinical guidance recommendations relating to off-label use.

Let me explain why I am concerned that supporting the Bill could be counter-productive. That is not my hon. Friend’s purpose or intent, but it is a possible accidental side effect. The Government are concerned that the Bill could lead to clinicians and patients being concerned that something is not right about the use of a medicine outside its licensed indication, and that clinicians may be deterred from prescribing a drug, and patients from taking it. As I have explained, off-label prescribing is safe, legal, and when it is the right clinical choice for the patient, that is the right thing for the clinician caring for them to do. Given the large amount of such prescribing that goes on in the NHS every day, seeking to license every drug for every indication or each potential combination would be a gargantuan task. In many cases, the formal evidence base may not exist in a form that would support a licensing application.

Access to medicines that are important to patient care could be impeded because we worry that we would be seen to have set a new higher threshold for their use. That is precisely the opposite of what the Bill is seeking to achieve. We are, however, keen to take proportionate action to investigate whether non-legislative improvements can be made to support the use of appropriate medicines and benefit NHS patients. I was struck by the opinion and evidence that has been presented on access to medicines, such as the potential issues in transferring care from a specialist to a GP.

I might add that such issues are in no way unique to unlicensed medicines’ use. There are areas where there is far too much variation in the use of licensed NICE-appraised medicines. We are working hard with the NHS to address that, but there is no single magic bullet.

[Mr Chope]

I am listening intently to what the Minister is saying. Is he concerned that he has not persuaded a whole host of clinicians and medical charities of his case?

--- Later in debate ---

[George Freeman]

I am not sure it is quite as simple as that. There is a significant and substantial ongoing series of discussions in the sector at the moment on issues such as the cancer drugs fund, specialist commissioning and whether we should be ring-fencing different medicines and therapeutic areas. The truth is, for reasons I described earlier, that the landscape is changing dramatically. I totally understand that charities that rightly support greater use of off-label medicines would like to think it is possible for us to legislate for these drugs to be put into use, but from the conversations I have had, it is apparent that clinical opinion is very varied. Nobody I have spoken to in the clinical profession wants the Government to go down the slippery road of starting to legislate for particular uses of particular drugs, which is effectively what this mechanism seeks to begin to do.

I commit today to working with NHS England, the MHRA, NICE and patient and professional groups to explore in depth the issues around the cultural challenges on unlicensed and off-label prescribing in general. We know that we need to look at the issue of clinical leadership. We need to take steps to improve how new evidence is translated into prescribing practice, and how hospitals and GPs work together and how that works within the care pathway. I am absolutely committed to doing what needs to be done and what can be done now within the existing system, and to looking at the evidence to ensure we adopt the approach most likely to succeed. Most trusts have robust governance arrangements set up to consider innovative treatments that clinicians may want to prescribe. A trust’s drug and therapeutics committee, or indeed the clinical ethics committee, provides an opportunity for doctors and pharmacists to explore the clinical and patient safety implications of doing so.

I am delighted to confirm that we have begun to work with NHS England and other stakeholders including NICE to get a handle on this and to accelerate the use of off-label drugs. I restate the invitation to interested Members to come and join the project. We are absolutely committed to looking at why there may be delays in translating new evidence and research into clinical practice, including why some clinicians are reluctant to prescribe drugs outside of their licensed indications when many others are not, and to consider what further arrangements might be put in place to assist in implementing new evidence into care pathways. This is a problem we face across the system, with variable uptake of NICE guidance. It is one of the central objectives of my new role in the Department of Health to drive consistency of uptake across the system.

I believe this offers the prospect of a more appropriate, sustainable and rapid approach to this problem that can apply to a range of different drugs and clinicians.

[Mr Nuttall]

The Minister has just used the word “rapid”. How quickly will these drugs become available?

[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.