Off-patent Drugs Bill

Bob Stewart Excerpts

Friday 7th November 2014 Commons Chamber

[Jonathan Evans (Cardiff North) (Con)]

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

Only a handful of MPs are ever successful in the private Members’ Bill ballot, so I am delighted and honoured that, 22 years after I was first elected to the House, and now in my final year of parliamentary service, I have at long last joined this rather select group and have the opportunity to promote a Bill on such an important matter.

First, let me thank the Bill’s sponsors, and MPs from all parts of the House, who have shown such support and interest in my Bill. The passionate welcome it has received has been truly amazing, although not surprising given the challenges it addresses.

Just yesterday, the letter page of The Times led with a joint appeal to the Minister and the Government in favour of the Bill from the Association of Medical Research Charities, the Breast Cancer Campaign, Leukaemia and Lymphoma Research, Breakthrough Breast Cancer, the Alzheimer’s Society, the Multiple Sclerosis Society, Leukaemia Care, Breast Cancer Care and the Cure Parkinson’s Trust. I should particularly like to thank Jenny Goodare and Mia Rosenblatt of the Breast Cancer Campaign for all the help they have given me in introducing my Bill.

Why question access to off-patent drugs? The problem goes back many years and is caused by a gap in the licensing system. The system is set up on the basis that a pharmaceutical company that wants to market any new drug acts as the drug’s sponsor throughout the process. That is fine and clearly understandable when the company anticipates many years of patent protection for its new product, but the essence of the problem that my Bill addresses is that no mechanism is in place to ensure the routine availability of existing drugs where patent protection has expired and where the drugs may be clearly shown later to be clinically effective but in a new way and for a new purpose.

Every time previously licensed drugs are shown to be effective for a new purpose, a new licence is needed to certify the drug’s safety at whatever the dose may be and for that purpose, and it must then be authorised to be marketed for such use. However, if a drug is no longer patent protected, no organisation or individual will take on the role of seeking any necessary licence for that treatment, because, after the patent has expired, other drug companies can produce and market generic versions of the drug, so the price of the product is driven down through the simple expedient of competition. It follows that the incentive for any pharmaceutical company to act as an advocate or sponsor for an off-patent drug and apply for a new licence is lost.

The outcome of all this is that off-patent drugs that should be routinely available at extremely low cost effectively have no sponsor. Without a change in the system, no one is ever likely to make licence applications for off-patent drugs, even when they may be effective for new purposes. In fact, it remains illegal to advertise and sell such drugs for such purposes if the drug is not licensed. What this all boils down to is that off-patent, repurposed drugs are not routinely available on the NHS, despite minimal costs to the taxpayer and the clear, clinically proven health benefits.

We may hear mention today of the ability of general practitioners to prescribe a drug outside the terms defined by the licence, which is known as off-label prescribing—in fact, Madam Deputy Speaker, given our earlier experience today, we may hear a lot about that—but the reality in clinical practice is much more complex and there are many disincentives to prescribing off label. A small number of clinicians may well be comfortable prescribing drugs off label in certain limited circumstances, but we know from the chemoprevention example, which the Minister quoted in the earlier debate, that this is not happening on any substantial scale. We also know that the absence of a licence is deterring many clinicians and GPs from prescribing these life-saving drugs in their new indications. Medical charities and senior distinguished clinicians have said that it is just not good enough to rely on the promotion of better information about off-label indications between clinicians.

[Bob Stewart (Beckenham) (Con)]

Are off-patent drugs likely to be found in a chemist’s shop? Do chemists keep stores of these drugs?

[Jonathan Evans]

Invariably, such drugs have been licensed for other uses, but it transpires that they are being researched, as I will outline in my further remarks, and that research is showing that they can be used effectively in another way. The kernel of the problem that I am seeking to highlight is that, without licensing, they are not being used in that way.

A licence gives a clear indication to GPs that a drug is both safe and effective, so it is preferable that indications that could achieve such a licence are supported. We face an unacceptable situation where cost-effective drugs are not made routinely available for new and proven effective uses. Although a small number of people might be fortunate enough to get the drug, a far greater number with exactly the same condition, in exactly the same clinical circumstances but with a different GP, will not. That is the worst form of inequality.

I want to highlight one scandalous example of the failure, red tape and bureaucracy of our current licensing system. The passive approach to the flaw that I have highlighted has meant that, for all of 15 years, the chemoprevention drug tamoxifen was routinely available to women in the United States of America to prevent the development of breast cancer but not to thousands of women at risk here in the UK, not because the research evidence is any different in the United States of America and the UK but because under our licensing system there is just no one to request that this treatment should become routinely available. So for 15 long years nothing whatsoever happened, and thousands of women here in Britain were denied treatment that it has been clinically proven could have prevented the development of breast cancer in many cases.

It was not until 2013 that the National Institute for Health and Care Excellence—NICE—eventually recommended the use of tamoxifen in the UK in its guidelines on the management of familial breast cancer, but that still stopped short of licensing, because of the flaw to which I have referred. As a result, the NICE guidance has proved insufficient to ensure equal access and there is no evidence that it has significantly changed clinical practice. The uptake of these treatments is lower and less uniform than if the drug were licensed. Furthermore, owing to the infrequency with which NICE guidelines are updated and their impact, this mechanism could not be widely employed to make off-patent drugs available, and I believe that the example of tamoxifen starkly confirms this.

[Jonathan Evans]

I am grateful to the hon. Gentleman for that contribution. If he will forgive me, I will not go further down the path of responding because of the point that he made at the end.

Sadly, all existing off-patent drugs that reduce the risk of people developing breast cancer fall into this category. The leading proven chemoprevention drugs are tamoxifen and raloxifene. These drugs, which reduce the risk of breast cancer developing in high-risk women by around a third, are not licensed for this purpose. With nearly half a million women in England and Wales eligible for these low-cost treatments, there is an urgent need to address the barriers to chemoprevention drugs being prescribed. The cost of tamoxifen is 6p a day; the cost of raloxifene is 61p a day. A third chemoprevention drug, anastrozole, originally developed as a hormone therapy, has been shown to reduce the risk of breast cancer developing by a half, and with fewer side effects. The evidence is there, but what action can be taken to ensure the routine availability of these treatments? The answer is none, or very little.

[Bob Stewart]

Without trying to talk out anything, may I say that I totally support what my hon. Friend is trying to do? Could NICE not do this sort of thing?

[Jonathan Evans]

My hon. Friend, yet again, anticipates another part of my remarks. The second part of my Bill is about giving a certain responsibility to the Secretary of State to encourage NICE to promote technology appraisals. I will deal with that in a little more detail in due course. He is quite right, but not exclusively: licensing is the major problem.

Major new research will be published in the next few months that provides evidence that bisphosphonates—drugs that were originally licensed for the treatment of bone fractures in adults with advanced cancer—are effective in the early stages of breast cancer in reducing the risk of the disease spreading to the bone in post-menopausal women. That analysis of phase 3 clinical trials is likely to show that, in post-menopausal women with early breast cancer, this therapy reduces the 10-year risk of breast cancer spreading to the bone by 34% and the risk of dying from breast cancer by 17%.

I should like us to reflect on that for a moment: a 17% reduction in the risk of women dying from breast cancer. What would be the cost of any new treatment that could deliver such results? It would probably be tens of thousands of pounds, and we would want to pay that for such impressive results. However, zoledronic acid, a type of bisphosphonate drug, can be given to post-menopausal women every six months for three to five years, and that can reduce the risk of breast cancer spreading to the bone by a third and the risk of death from breast cancer by a sixth, and it would cost less than 5p a day.

Yet bisphosphonates are off-patent drugs that are produced relatively cheaply by numerous pharmaceutical companies as generic drugs, as my hon. Friend the Member for Beckenham (Bob Stewart) mentioned earlier. It is therefore pretty certain that under the current flawed licensing system no organisation would seek a licence to use that treatment in preventing secondary breast cancer, even when the evidence is published, so the drugs will not be routinely available to the women who clearly need them.

I want to pay tribute to the distinguished breast cancer clinicians and researchers who have been speaking out about this issue for years. Sixteen of them wrote to The Times on the day of the Bill’s First Reading, stating:

“For some time it has been clear that there is a real barrier to licensing old drugs for new purposes, even when there is evidence that they are effective. This means that treatments which could bring real benefit to the lives of people and in some cases be life-saving, with minimal cost, are not routinely available”.

It is not just access to cancer treatments at stake; the current system will fail us for any medical condition in future if we do not correct the flaw. The Multiple Sclerosis Society makes it clear that strong preliminary evidence has shown that a number of repurposed medicines could be effective in the treatment of multiple sclerosis, but the UK currently lacks a system by which old drugs can be relicensed. In the past week the society wrote directly to the Minister in support of my Bill, in a letter co-signed by Professor Sue Pavitt, chair of the UK’s MS clinical trials network, and other leading specialists in the field. They cited the example of simvastatin, a drug originally licensed for treating high cholesterol that has been shown to be effective in slowing brain atrophy in secondary progressive MS by over 40%. Although final evidence from a phase 3 clinical trial is required to confirm those results, if successful that drug would address a significant unmet need, as there is currently no treatment that can slow or stop the deterioration seen in progressive MS.

The MS Society has pointed out that, given that simvastatin’s patent has expired, the treatment would require a licence in order to be made widely available on the NHS to people with multiple sclerosis, and it argues that the mechanism to achieve that just does not exist, despite the repurposing of previously licensed drugs being a fast and cost-effective way to provide new treatments. Those eminent clinicians and the MS Society strongly support my Bill and the mechanism it would create to provide access to medicines that could help tens of thousands of people with untreatable multiple sclerosis.

The treatment of Parkinson’s disease could greatly benefit from the Bill. I know that Tom Isaacs, president and co-founder of the Cure Parkinson’s Trust, has written to the Minister in the past week to point out clearly the charity’s full support for the Bill. Tom has said:

“Parkinson’s may not be a death sentence, but at the moment it is a life sentence. There is increasing evidence that a number of off-patent drugs have the ability to slow, stop or reverse our condition. Under these circumstances, the ability for patients to have a clearly defined way to make these medications accessible is now imperative.”

I think that it is now appropriate to turn to the detail of the Bill, given that the Minister might do so, Madam Deputy Speaker. To address the anomaly I have outlined, the Bill introduces a new advocate—the Secretary of State or a body appointed by him—for off-patent, repurposed drugs in the existing UK licensing system. The advocate would have to act in the public interest, and in circumstances where no other body had taken on the role of seeking a licence. The level of evidence required to trigger the advocate to seek a licence for an off-patent drug in a new indication would have to be significant. The treatments referred under the mechanism would be required to meet exactly the same standards for a licence for any other treatment, so nobody is lowering the bar in the licensing process. The Bill does not seek to make any unproven treatments available to patients; it simply seeks to address a clear market failure in the current system and to allow proven drugs to be considered for a licence after their patents have expired.

Clinicians have also suggested the supplementary provision in the Bill for NICE to appraise off-patent drugs in new indications where these are unlicensed—the point made earlier by my hon. Friend the Member for Beckenham, who sadly is no longer in his place. It is anticipated that that exceptional route would be used rarely. Regulations would outline the specific and significant standards that would need to be met before the provision was triggered. Although it may already be possible under existing legislation for NICE to appraise drugs for an unlicensed indication, the Bill would simply place a duty on the Secretary of State to direct NICE to conduct a technology appraisal for an off-patent drug in a new indication that satisfies the evidence threshold.

The Minister has stated publicly:

“The Government firmly believe that cost-effective, clinically appropriate drugs and devices should be routinely available to NHS patients.”—[Official Report, 1 September 2014; Vol. 585, c. 141.]

I recognise and applaud the admirable steps that this Government have taken to improve access to new cancer treatments. The cancer drugs fund has been established for England and now has a budget of £280 million a year. It is an incredible scheme that has improved access to treatments for thousands of patients in England, and I have seen for myself the disadvantages that my constituents have faced by not having an equivalent fund in Wales.

On the CDF, we are currently spending millions on new treatments, so why not improve access to treatments that cost just pennies but that we know can save or improve lives? In future there will be drugs for other conditions, including Parkinson’s, multiple sclerosis, breast cancer and Alzheimer’s, that could benefit from the Bill. We cannot wait 15 years longer than other countries for our constituents to get these treatments, as happened with tamoxifen, and then tolerate a postcode lottery in their availability to our constituents.

--- Later in debate ---

[Mr David Nuttall (Bury North) (Con)]

I congratulate my hon. Friend the Member for Cardiff North (Jonathan Evans) on bringing this fairly short, but very important, Bill before the House. I am delighted to be named as one of its sponsors. I have to say that I am perhaps the least well qualified of them all. My right hon. Friend the Member for North Somerset (Dr Fox) and my hon. Friends the Members for Bracknell (Dr Lee) and for Totnes (Dr Wollaston) are all real doctors. The fact that they are real doctors and have felt it appropriate to lend their names to this Bill is, in itself, something of which the House should take careful note.

This Bill is required because when a drug whose patent has expired is found to be effective in treating a different condition from that for which it was originally licensed, doctors are reluctant to prescribe it because it is not licensed for its new use. As I understand it, the Bill would put the onus on the Secretary of State to take steps to secure licences for clinically proven off-patent drugs for their new use when no other body has taken on that role.

In essence, the Bill would put an end to a postcode lottery. Patients are left in limbo. Until they go to their GP, they do not know whether they are registered with a GP who is prepared to take this risk. The Bill would remove that postcode lottery and give security to millions of patients. If the process has been followed and the drug licensed for its new use, whichever GP they are registered with will have the confidence and security of being able to prescribe it for its new use.

I am pleased to say that the Bill has the support of many charities: the Association of Medical Research Charities, the Breast Cancer Campaign, Leukaemia & Lymphoma Research, Breakthrough Breast Cancer, the Alzheimer’s Society, the Multiple Sclerosis Society, Leukaemia CARE, Breast Cancer Care, and the Cure Parkinson’s Trust. That is a wide range of charities, all of which, for their own individual reasons, can see the sense of having a new procedure in place to bring back to life drugs that are found to be of new use but are off-patent.

The Bill also has the support of many of my constituents. I thank all those who have taken the time and trouble to write to me personally to express their support for the Bill and to urge me to continue to support it. I am delighted to do so.

[Bob Stewart]

A lot of us have received letters from constituents, including me, and I am absolutely delighted that we are here to support the Bill and get it through as fast as possible.

[Mr Nuttall]

I am grateful to my hon. Friend for that intervention.

This Bill will cut through the red tape that exists at the moment. It aims to get drugs off the shelves and into the hands of the patients who need them. I hope it receives the wholehearted support of this House.

[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.