Space Policy

Debate between Bob Stewart and George Freeman

Thursday 14th January 2016 Commons Chamber

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

I thank you, Madam Deputy Speaker, and the Speaker’s Office for granting the debate, and congratulate the Backbench Business Committee on securing it. I think it shows the House at its very best, capturing the mood of the nation and setting out an inspiring and challenging vision of how in the years ahead this country can do so much more in this exciting field.

As many hon. Members have said, the debate is timely. Major Tim Peake floats in orbit above us, looking down, and tomorrow he will conduct the historic and serious spacewalk. He is the first British European Space Agency astronaut and the first British astronaut to enter the international space station. The debate is also timely because of the sad passing of the iconic David Bowie, whose lyrics in so many ways provided a backdrop to my generation’s childhood and captured, at the time of the Apollo missions, the existential challenge and opportunity of pushing the boundaries of space, time and culture. That provides a rather extraordinary and unpredictable but moving backdrop to this moment in space.

[Bob Stewart]

I rise as the Member for the coolest constituency in the country. David Bowie lived and played in my constituency, and we are hoping that the bandstand where he played will be saved and restored properly. That is not happening at the moment.

[George Freeman]

I am glad that my hon. Friend the Member for Beckenham (Bob Stewart), David Bowie’s constituency, rose to speak at that moment.

This debate and story is about more than the space endeavour alone. It is about business—the UK space industry is an £11.8 billion industry, employing 35,000 highly skilled people. It is about extraordinary technology in optics, communications, rocketry and engineering. It is about an activist industrial policy and strategy, for which I am delighted to confirm our support, to encourage leading technologies and industry. I pay tribute to the work done by Paul Drayson and by my great friend and colleague David Willetts, now a Member of the other place, who in 2012 was instrumental with the Chancellor in securing the £80 million for the international space station, which was crucial to securing Tim Peake’s role in it, and in securing the money for the reaction engines programme, on which this country is leading.

This debate is also about science, not just in space, but solar and earth science. Taking in rocketry, engineering, climatology, optics and communications, this is a deep science project to inspire all. It is about women in science, as others have said. Dr Helen Sharman was the first British woman in space, and the Italian Samantha Cristoforetti was the first European Space Agency woman astronaut; she did inspiring work and has become something of a legend and a role model for girls and women in science. It is also about our perception and consciousness of our environment. The “Earth dawn” photo changed perceptions of the fragility of the Earth’s ecosystem.

The debate on space is also about geopolitics. Who, in the appallingly dark days of the cold war and intercontinental ballistic missile threats in which many of us grew up, could have imagined that we would now have an international space station in which Americans, Russians and people from across the world work together for the good of all? It is about defining a new common space for all and a new approach to our defence and security through common leadership. It is not a subject I get to speak much about at the Dispatch Box, but today’s debate makes it possible to talk about mankind’s destiny—the questing spirit deep in us all and in society to inquire, discover, imagine, explore and make possible whole new worlds and opportunities.

This debate is also about the power of ambitious, positive, global, purposive and internationalist leadership to inspire and unite to produce a better politics from us all. No one spoke better on that than JFK, in his inspiring inaugural address in 1960, when he famously said, on a frosty morning in Washington at the very height of the cold war,

“my fellow Americans: ask not what your country can do for you, ask what you can do for your country.”

He launched America on a mission of internationalism, and two years later, in his Apollo speech, announced that America chose to go to the moon not because it was easy, but because it was hard. He did so in the spirit of internationalism and of appeal to the best instincts of mankind. It is a beautiful thing, I think, that on the moon is left an inscription stating that mankind came to the moon in a spirit of freedom and peace. That mission captures so much that is best about our society and what we want to achieve.

It is for those reasons that the Prime Minister asked that we harness the inspirational power of Major Peake’s mission to inspire the next generation of scientists and engineers and to bring the country together. All of us found it difficult to avoid the excitement associated with the launch and arrival of the first British ESA astronaut at the international space station. We held celebration events in Edinburgh, London, Cardiff and Belfast, at discovery centres throughout the UK, and here in Parliament. The Science Museum in London attracted almost 11,000 visitors, and if the sheer exhilaration of the 5,000-plus primary schoolchildren at the museum translates into an increase in future sciences, Tim Peake’s mission will already have achieved its goal. In all, 35% of the viewing public watched the launch, and a further 3.8 million people watched the Soyuz spaceship dock with the international space station that evening.

Our Government are providing £3 million of support to the education and engagement programme associated with Tim Peake’s mission, and we have been lauded by the ESA as the country doing the most to invest in and promote educational outreach. We will measure whether the excitement inspires young people to take up STEM subjects—several Members rightly commented on that—and increases public understanding of and engagement with science through an evaluation study being undertaken by York University. It is the first such research since the Apollo effect study in the 1970s.

The Peake mission is possible because of a decision made at the 2012 European Space Agency Council of Ministers meeting by the then Science Minister, David Willetts, which resulted in the UK joining the international space station and the related European programme for life and physical sciences—ELIPS. The UK made a further investment at the Council of Ministers in 2014. The total investment, which exceeded £80 million, provides substantial value for money, giving UK scientists access to a laboratory that has cost others up to $100 billion and is testament to international collaboration in science. The three man crew on the Soyuz, which launched on 15 December, comprised Tim Peake, the American Tim Kopra and the Russian commander Yuri Malenchenko. It is early days, and evaluation of UK involvement is ongoing, but the current results are incredibly exciting.

Experiments for the ELIPS and subsequent experiments undertaken on the space station are selected on the basis of science excellence, which plays to UK strengths. We sometimes forget that this is a massive international set of experiments up in space. In the most recent competition, the UK won more than 10% of awards for experiments, although UK involvement in the space station is at about 5% of costs, so we are punching above our weight. About 40 to 80 scientists across the UK are involved.

Space is not just about national exploration; it is about critical national infrastructure and services, such as weather forecasting, satellite navigation and satellite television. Space-based technologies are used for tackling many global challenges. Satellites can assist with tackling illegal fishing, efficient urban and rural land use, resource management, safe implementation of autonomous vehicles, and myriad further uses underpinning new technologies and new markets. For example, over half the essential climate variables needed to understand climate change derive from our satellite observations.

The UK space sector is undoubtedly a massive and growing success story. There are real prospects for the young people inspired by Tim Peake and the Rosetta mission to work in our very strong and vibrant space economy in the future. It is currently worth more than £11.8 billion to the UK economy. That is growing at about 8% a year, which is three times faster than the average non-finance sector. It is characterised by an incredibly highly skilled workforce of more than 37,000 people, half of whom hold at least a first degree. Those direct jobs each support more than two jobs in the wider economy. The sector has a general value added per job of £140,000, three times higher than the UK average.

To reflect the strategic and economic importance of the sector, my right hon. Friend the Secretary of State for Business, Innovation and Skills launched the national space policy on 13 December to coincide with the Peake mission. It showcases how deeply space now impacts on our daily lives, not least in the field of satellite data and information. It describes how the sector is a unique, strategic national capability which delivers science and innovation, national security, essential public services and prosperity. The policy spells out how the UK Space Agency has brought together the roles and responsibilities of 17 different Government organisations and other partners, such as research councils and Innovate UK which are involved with space.

Space-based activity is a long-term endeavour with international collaboration, industrial co-investment, skills development and considerable planning at its heart. Stability and certainty are important, and the national space policy is the Government’s expression of our long-term commitment to seeing it through and to putting in place a policy landscape to support that investment.

The UK’s involvement in space ranges from fundamental underpinning research into the origins of the universe, to understanding and protecting our planet, through to supporting the research that leads to UK companies launching entirely new multimillion-pound telecommunication satellites. Some 25% of the world’s telecommunication satellites are substantially built here in the UK. Satellites operated under the disaster charter and earth observation data procured commercially were critical to effectively targeting the response efforts on the ground in the recent floods.

This is an exciting time for space. In 2016 the UK will be building the main experiment on the Plato mission that will search for new earths orbiting other stars, in pursuit of answers to the profound question about life elsewhere in the universe, and will precipitate key contracts for UK companies. We look forward to a major European Space Agency Council of Ministers meeting in November/December 2016, where we will negotiate to ensure that the UK continues to play an influential part and benefits fully from European Space Agency programmes. The programmes that we are looking forward to in particular include the UK-led biomass experiment that will calculate the capacity of the world’s forests to store carbon. As well as improving our ability to control climate change, this offers a considerable opportunity as UK companies are poised to win contracts to provide the craft that will host the experiment in orbit.

2017 will see the launch of the joint European-Japanese BepiColombo mission which will set out on a voyage to Mercury, using a very efficient ion drive electric propulsion engine manufactured by UK firm Qinetiq.

In the field of space flight, through companies such as Clyde Space and SSTL, the UK has become a leader in the manufacture of smaller satellites and has largely secured cost-effective launch by arranging “piggy-back” launches with larger satellites in a competitive launcher market which is not yet sustainable but is growing fast. This is connected to the growth of commercial constellations of tens or even hundreds of low-cost small mass-produced satellites that can provide ubiquitous communications across the globe or near real-time imagery from low earth orbits.

Indeed, we believe that commercial space flight is a market which, when combined with the emerging trend to use large constellations of small satellites, could provide a cumulative economic benefit to the UK of £20 billion by 2030. This will provide new and long-term manufacturing and service jobs and will stimulate high tech growth. This includes exciting developments such as single-stage to orbit launchers, the engines for which are being pioneered by Reaction Engines, a rapidly growing company in Oxfordshire.

This is the context for the UK to explore having a launch capability. We believe there is at least a two-stage process to achieving it. The first part of our ambition is for the UK to become the European hub for commercial space flight and related space sector technologies. The initial focus is on creating the necessary legislative and regulatory framework that will enable commercial suborbital space flights alongside existing civilian and military airspace operations. Alongside this, it is the Government’s intention to select a preferred location for a UK spaceport that will be capable of operating horizontal commercial spaceplanes. We are closely examining what this process will look like, to ensure that it is fair, transparent and robust.

We will seek to draw on established Government approaches to appraisal and will ensure that the preferred location meets a number of key criteria—that it can deliver a spaceport technically capable of operating horizontal commercial spaceplanes, that it will be commercially viable, that it can ensure the safety of the uninvolved public, and that it takes into account the potential environmental impacts of the spaceport and will deliver local and national economic growth. These criteria are likely to form the core of any selection process, though we have not settled on the final criteria.

Off-patent Drugs Bill

Debate between Bob Stewart and George Freeman

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.