Brain Tumours

Debate between George Freeman and Philippa Whitford

Monday 18th April 2016 Westminster Hall

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

I thank you, Ms Buck, and also your predecessor this afternoon, Sir Edward Leigh, for your excellent chairing of this debate. It has been a pleasure to serve under the leadership of both of you.

I echo many of the points made, not least those just made by the hon. Member for Denton and Reddish (Andrew Gwynne): today we have seen the House of Commons at its best, with strong cross-party support for those who put us here and who expect us to listen to them and work for them. I congratulate the Petitions Committee. One does not get to the Front Bench by rebelling against the Government very often, but I am proud that one of my first acts on arriving here as an MP was to vote for more Back-Bench powers, and I think that this is a great initiative. To see direct democracy in action, with the public petitioning the Government and bringing debates like this one, is—although challenging for us—a great thing.

I thank the Speaker for his support for the cause. I recently joined him at the Speaker’s Palace at a reception for Brain Tumour Research. He has quietly done a lot of work behind the scenes in support of that and other medical issues. I congratulate the hon. Member for Warrington North (Helen Jones) and thank her not just for her excellent speech, which framed and kicked off this debate, but for all the work she has been doing behind the scenes. Equally, my hon. Friend the Member for Castle Point (Rebecca Harris) has done extraordinary work behind the scenes to bring the subject to fruition.

It would be odious to pick out individual Members, but we have had some wonderful speeches. Having said that, I will mention my hon. Friend the Member for Hexham (Guy Opperman), who has spoken powerfully here and elsewhere. For those who are not aware, he collapsed with a tumour, which was luckily diagnosed quickly. It is a sign that Members of Parliament experience the things that we are sent here to deal with. The right hon. Member for Oxford East (Mr Smith) also spoke powerfully about his experience of diagnosis in his family, as did the hon. Member for Sheffield Central (Paul Blomfield). Disease does not respect party boundaries, and nor should we in tackling the issues that it throws up.

I want to mention Maria Lester, whose extraordinary campaigning work has fuelled much of the campaign and still fires behind the scenes, driving it with personal passion, energy and experience, as well as all the charities that have done and continue to do so much. Of course there is Cancer Research UK, but as is so often the case in my work, I see the work of the small charities, which survive on so little—on the contributions of patients and their loved ones, and on voluntary work: Brain Tumour Research, the Brain Tumour Charity, Marie Curie, the HeadSmart campaign, CLIC Sargent and Children With Cancer.

Most of all, I want to pay tribute to the patients and their families and loved ones whose experiences and whose pain drive this campaign and this issue. It is my great privilege as the Minister to see that across different disease areas, and today in the debate, and in your work, you are lifting a torch and joining a magnificent history of people who, through their suffering of disease, insist on our doing better and who drive campaigns and raise awareness, leading to increased funding. On behalf of all the right hon. and hon. Members who have spoken on your behalf, I want to say that you have spoken very clearly here today and I have heard you. As you know, Ms Buck—some people in the Public Gallery may not—Westminster Hall is often a magnificent forum for raising in the House issues of, shall we say, marginal interest in the House: important issues that do not command widespread support. Today we have seen this Chamber and the Public Gallery packed, and phenomenal interest online as well.

As the Minister for medical research, I know that what drives most patients when they experience a diagnosis is the knowledge—the reassurance—that their disease, their suffering and, in many cases, their death, will not be in vain. What people want is to know that their suffering will do some good, and through our extraordinary research and science infrastructure we are so often able to deliver on that promise. Most of the people I speak to say, “I just want to make sure that through my pain and suffering you are able to help prevent someone else’s; and if my experience of disease helps you to do that, I will have done some good.” I think that is the request that sits deeply underneath what has been said this afternoon.

There are many issues. There are issues to do with awareness, with research funding—clearly—with diagnosis and the care pathway, with treatment, whether surgery, chemo or radiotherapy, and with quality of life and aftercare. There is also a complex range of issues to do with the research, development, procurement and reimbursement pathway, with which I am dealing in a number of the reforms I am leading as Minister for Life Sciences.

It is true that there is no simple solution. It is true that there are lots of competing claims, believe me, on every pound that we spend. It is true that we all have responsibility. I worked in biomedical research for 15 years and none of the companies I ever worked with got anywhere close to working out how we get drugs over the blood-brain barrier. The brain is an extraordinary organ that sits in a privileged place in the body, and that makes it a difficult organ to treat and diagnose. In many ways, it is the last frontier of the extraordinary biomedical revolution we are living through. We have got to the point where we can pretty much take a heart out, strip it apart, replace most of the parts, put it back in and treat disease with an exquisite range of chemicals, but we are not at that stage yet with the brain.

It is equally true that we do not run the allocation of science and research spending on the basis of political lobbying—nor should we. We allocate the funding on the basis of applications, clinical excellence, need and academic excellence. But I believe it is also true that we are sent to this place to reflect the priorities of the people who put us here, and the debate has illustrated, in a loud, civilised, cross-party and non-partisan way, that there is an extraordinary call from people for the disease to be given higher priority. I believe that democracy is about people influencing us. I did not knock on 15,000 doors to come here and say, “We’re doing enough. We’re doing something, and that’s enough.” We need to do more, so I will today announce a package of measures that I hope will go some way to address the points that have been made.

[Dr Philippa Whitford]

Is not part of the problem that funding has been allocated on the basis of incidence—how often people get brain tumours—rather than on the basis of impact, as in the deaths caused and the life years lost?

[George Freeman]

The hon. Lady, with whom I work closely on a number of issues, makes an excellent point. There are a number of criteria that drive how funding is allocated, and that is one of the things we ought to look at. If I can get to the end of my speech, I will make some recommendations about how we might pick that up and look at it.

I want to announce today that the Government accept that we need to do more in this space, committing to a number of specific actions that reflect the concerns that have been raised, both here and in the Petitions Committee and the all-party group report. I suggest that I should convene in the Department of Health a task and finish group to examine a number of the issues that have been raised here today, and to ask a question. I do not believe that as a Government we are not doing enough. We have put £0.7 billion a year into the Medical Research Council, to do the deep science on the medical frontier. We have put £1 billion a year—ring-fenced—into the National Institute for Health Research’s clinical infrastructure. We are funding the genomics programme and putting £4 billion into digital health and the informatics that go around it. The question we should ask is: surely there is more we can do to help to make that resource and that infrastructure support this particular disease area? I will say a little more about why I think that case has been made and what we might do about it.

I will not repeat all the numbers—hon. Members have heard them—but about 4,000 brain cancer cases are diagnosed each year in this country, resulting in about 3,500 deaths a year. We all know that brain tumours are very complicated—there are about 130 different types of them—and the truth is that we do not know what causes most of these cancers. Old age is a risk factor, but as many hon. Members have said with great passion today, it is those children who are diagnosed who drive us. Four-hundred children a year are diagnosed, and we just do not understand or know exactly what is driving it. There are various hypotheses around genetic conditions and some exposures.

Unlike for most other cancers, brain cancer mortality rates have increased. According to figures from the Office for National Statistics, in the last 30 years the mortality rate for brain cancer has increased by 15% for men and almost 10% for women. Improvements in diagnostics and treatments have helped to improve short-term survival in adults, with around 49% of people diagnosed with brain cancer now surviving for at least a year, compared with around 25% 30 years ago. Long-term survival has also improved, with around 20% of people now surviving for five years or more, compared with around 10% 30 years ago. We have also recently seen an increase of more than 25% in GP referrals for magnetic resonance imaging for potential brain tumours, from about 30,000 to 50,000. Veterans of these issues will know that those are relatively small numbers over quite a long period, compared with the explosive pace of progress in a number of the other disease areas that we often discuss.

A number of Members have talked about early diagnosis, which is clearly absolutely key with this cancer, as with all cancers. Last year, a report by the independent cancer taskforce set out 96 recommendations, broadly covering six strategic priorities, including early diagnosis, and NHS England is working with partners to establish a new cancer programme to implement those recommendations. By the end of this Parliament, everyone referred with a suspected cancer will receive a definitive diagnosis or the all-clear within four weeks.

Access To Medical Treatments (Innovation) Bill

Debate between George Freeman and Philippa Whitford

Friday 29th January 2016 Commons Chamber

[George Freeman]

The hon. Gentleman makes two good points. This is, of course, UK-wide. One of the challenges, as a UK Minister, is to put in place a framework that will support this across the UK while respecting the different mechanisms in the devolved Administrations. I hope the Bill will provide a basis for a similar mechanism in areas where there are different formats. I believe that in Scotland, Northern Ireland and Wales, but particularly in Scotland and Northern Ireland, there is a hunger to do that. I believe the Bill will support those existing mechanisms.

[Dr Philippa Whitford]

We have moved on from talking about the BNF. I accept the comments about listing groups that would be considered in new clause 5. Does the Minister accept, however, that we still need to deal with the cascade of prescribing to ensure doctors are not forced to prescribe a licensed medicine, which is actually just a minimal moderation of an off-patent drug at a vastly expensive cost? That means we still need some kind of change to the licensing or short licensing process in the future.

[George Freeman]

The hon. Lady makes an important point about the classification of different drugs available to clinicians. Without detaining the House with too long a peroration on that classification, it is worth setting out that there is a clear cascade.

Clinicians can use unlicensed medicines in situations where, in their clinical judgment, and with patient consent, they believe it is the right thing to do. They are subject to all their usual professional undertakings. There are then off-label uses of drugs: drugs that do not have a licence for a particular indication but which the clinician, on the basis of evidence, is able to prescribe when they feel that evidence is compelling. The Bill now goes to the heart of that and will help to provide reassurance. For many clinicians, being able to click on a mouse with their patient and say, “For your condition there are one, two, three or no off-label medicines available for which NICE has looked at the evidence,” would be a powerful catalyst in helping to promote off-label use. There are generic drugs, which have been patented and brought to market, that are available at a heavily discounted open price.

There are then on-patent drugs, which have been brought to market and are still subject to a patent. The manufacturer has an exclusivity, which is the period in which their sunk costs in bringing the medicine to the system, can be reimbursed. That is an important protection to make sure we continue to have a thriving life science sector that can take the risks of investing in new drugs. Typically, new drugs take 15 years and £2 billion to develop. If there were no patenting mechanism, there would simply be no enthusiasm to do that research, which has a very high failure rate. In law, there is a key point of principle, which is that a licensed drug should be used first and that an unlicensed drug cannot be used purely on the basis of cost. That is a really important principle. An unlicensed drug can, however, be used on the basis of evidence. That is why the mechanism will allow NICE to look at the evidence and to signal to clinicians that they have the evidence basis on which to use the drug in an off-label indication.

One of the issues we have dealt with in discussions is the whole question of the European licensing of medicines. If we were to go down that route—I know the hon. Member for Central Ayrshire understands this—I can assure the House we would be here not just for weeks and months, but years. I am leading for the Government on reforming the European landscape of 21st medical research. The central role of protecting innovators’ sunk costs is really important to our life sciences sector, and the new clauses and amendments create a mechanism by which we can accelerate off-label use without running a coach and horses through that.

[Dr Whitford]

I accept the Minister’s points, but my concern remains that if in 10 years we have simvastatin in its current form versus a new name that is just a tweaked simvastatin at a thousand times the price, doctors will, under GMC rules, have to go for the one with the licence, as opposed to the off-patent one, even if it is in the BNF. I accept that the BNF mechanism will absolutely increase usage, but we still need to consider the longer term, given that in the future we might have huge numbers of off-patent drugs with new purposes.

[George Freeman]

The hon. Lady makes an interesting, important and useful point that I undertake to pick up in our consultation in response to the accelerated access review. The landscape will continue to change fast over the next few years. The Bill, as amended, will promote the greater use of off-label medicines. Crucially, the database mechanism, which, I reassure everybody, is very different from the original registry proposed in a precursor Bill—it is to make clinicians aware of what drugs are available—will generate data that will be incredibly powerful in helping the system to adapt and use the freedoms I hope to give it through the accelerated access review. That will ensure we are better and faster at getting these repurposed medicines into use.

I am delighted to say that the Government are happy to support amendments 10 and 13. Amendment 10 would set out in the Bill that its purpose specifically includes promoting access to the innovative use of licensed medicines outside their licence indications. It puts four square at the heart of the Bill the aims of the Off-patent Drugs Bill, which was promoted by the hon. Member for Torfaen (Nick Thomas-Symonds), and which, as hon. Members across the House have commented, had a lot of in-principle support. I am pleased, therefore, that we have found a form of words that moves it forward. At the heart of it, there is a clever protection for clinical sovereignty. We are not telling clinicians what they have to prescribe or putting in law a requirement that they prescribe in a particular way. We are giving them information on evidence-based off-label drugs. The feedback from clinicians so far is that it genuinely will help them to understand, promote and prescribe off-label uses.

Amendment 13 seeks to clarify the definition in the Bill of innovative medical treatments to make it clear that it includes off-label and unlicensed medicines. I mentioned earlier the pace at which genomics and informatics were uncovering new uses for drugs—some have referred to it as finding diamonds in the dustbin. There are extraordinary applications among the existing pharmacopoeia of tens of thousands of drugs. We now realise that many of them have particular impacts and effects. That is all to the good. It is thanks to the power of our life sciences sector that we are beginning to uncover those, and the Bill will support that.

With those comments in support of amendments 10 and 13, I hope I have given hon. Members enough reassurance and that they feel able to withdraw or not press the probing new clauses. I will be happy, following Third Reading, to put in place, through the accelerated access programme, a clear plan for keeping on top of the system’s implementation and tracking the use of repurposed medicines. We will continue with the work we did with charities through the winter and with the very helpful discussions we had with the charitable sector, and the Department will look annually at the data and whether the landscape is changing, and if it is, we will keep that under review.

Space Policy

Debate between George Freeman and Philippa Whitford

Thursday 14th January 2016 Commons Chamber

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I beg to move,

That this House notes the scientific, cultural and technological opportunities arising from exploration of outer space and the significant contribution the space industry makes to the UK economy; further notes the increased public interest in space exploration resulting from Major Tim Peake’s mission to the International Space Station (ISS); welcomes the global co-operation that has led to the development of the ISS over the last forty years; takes note of the shortlist of airports and aerodromes that could host a UK spaceport published by the UK Government in March 2015; and calls on the Government to bring forward further advice and support for organisations considering developing such facilities so that they might be operational by the Government’s target date of 2018.

If hon. Members read the motion, they will see that it covers the incredible breadth and depth of the space industry and its amazing potential. I hope that that will be covered during the debate by Members from different parts of the United Kingdom. Some people are likely to stoop to using some fairly poor puns. At this point I would like to register the fact that I accept no responsibility for that. I lay the blame at the feet of the Prime Minister, who has stooped to using some pretty shocking puns at Question Time recently, something for which he needs to be penitent.

Some people who follow the media will be aware that our former First Minister, my right hon. Friend the Member for Gordon (Alex Salmond), has used as a travelling pseudonym the name of that famous captain of the USS Enterprise, but for a debate as important as this, I felt we should contact the real McCoy. I therefore have a message to the House of Commons from William Shatner:

“Space is one of the last known frontiers, mostly untouched by mankind and his politics. In opening a debate on this subject my hope is you take the tenets of Star Trek’s prime directive to universally and peacefully share in the exploration of it. I wish you all a wonderful debate. My best, Bill”.

As some people will have seen, we have also had a message on Twitter from George Takei—otherwise known as Mr Sulu—wishing us luck as we venture to the stars.

This is not a debate about fictional astronauts. We tried to get the debate on this day to honour a real astronaut, Major Tim Peake, who is currently in the international space station. We sought it today because tomorrow he will be making a spacewalk. Contrary to some slightly sloppy journalism, he is not actually the first British astronaut. That honour fell to Dr Helen Sharman from Yorkshire a quarter of a century ago, in 1991. I find it incredibly appropriate that, prior to that, she was a research chemist for Mars. [Laughter.] It’ll get worse.

However, Major Tim Peake is our first astronaut through an increased engagement with the European Space Agency. While Helen Sharman was on the Mir station, he is in the international space station, and tomorrow he will certainly be taking part in the very first British spacewalk. It will start, hopefully, at 11.30 GMT tomorrow morning. I would encourage all schools, children and youngsters of all ages to log on to principia.org or NASA TV on the internet, where it will be shown, as it truly is an historic moment. He has been tasked with changing regulators on the solar panels. As they are high-voltage regulators, the walk has to be carried out entirely on the dark side.

I am a member of the parliamentary space committee. We had the great opportunity to have a private tour of the “Cosmonauts” exhibition in the Science Museum, which I would recommend to anyone. The museum spent four years negotiating with Russia to bring incredible artefacts to this country—the space capsule of Tereshkova, uniforms of Gagarin and all sorts of pieces of hardware that even people in Russia did not know existed. What struck me as we went round the museum was the fact that, during points of incredible friction between Russia and the US and across the world, back channels always remained open. Co-operation always continued on the international space station. We have seen that in these few years of setting up the exhibition, during which we have had the Ukrainian crisis, Crimea and friction over Syria. If we can work so well together in space, it would be great if we could work a little bit better here on earth.

Any Members who were in the Chamber when I made my maiden speech will remember that I referred to Prestwick in my constituency as being on the shortlist for consideration as a space port. I remember that whenever I talked to anyone about that during the election, they would always just laugh, because in this country we think that space is for other people—the big boys: north America, Russia and maybe even China, but not us. That is something we have to change. We need to believe in what we can do, and I think Major Tim Peake’s mission will achieve that. We see the interest of school children and the Science Museum was packed on the day of the launch, and we had Members in this place watching it live on screen. We hope it will lead to an interest in STEM subjects—science, technology, engineering and maths—and an absolute belief in the space industry here in the United Kingdom.

The space industry is new, but the UK has a proud aviation history, which includes Rolls-Royce and supersonic flight. We need to take the next step and grasp that opportunity. The industry has changed over the past five years, and I applaud the decisions taken in 2010 that led to the formation of the UK Space Agency. It is now an industry with a turnover of £11.5 billion. It employs 35,000 people, three quarters of them in graduate jobs, and a third of its production is exports, but the vision of the Department for Business, Innovation and Skills is that it should grow to become a £40 billion industry. For that, we really need to take action.

If it was not a political decision, there should not really be any great doubt that the choice should be Prestwick. We already have almost everything that is needed. We have a runway that is touching 3 km. We are in a coastal position, to allow start-off over the sea. We have the northern air traffic control centre in our campus, which allows the planning of what will be some pretty clever management of airspace, and obviously we have relatively empty airspace. We are close to Glasgow University and Strathclyde technology catapults and we have, uniquely, an aerospace cluster on the airport campus. It contains BAE Systems, Spirit AeroSystems and many others, all of whom are interested in the idea of a space port.

Up the road from us is Clyde Space, which makes small CubeSats that are only a litre in size. Early communication satellites were weighed in tonnes and were the size of a double-decker bus, but the UK, through Surrey Satellite Technology, has led since the ’80s in producing satellites that are about the size of a fridge. That is a step change. It has been shown that if the cost of getting a satellite into space gets down to the tens of thousands, everyone is going to want one. We will have to look at regulating that, otherwise space will be full of junk, but it enables all sorts of possibilities. However, we do not have a domestic launch site. That is why the aim is to have a UK space port by 2018.

As well as all the physical attributes of Prestwick, 20 years of Met Office data show that, despite preconceptions, it has the clearest weather, compared with Newquay, which people would presume is the closest contender. Low cloud is suffered by Newquay 31% of the time and only 11% of the time at Prestwick. Less than 5 km visibility is suffered by Newquay 15% of the time and only 4% of the time at Prestwick. I live in Troon, which is next door, and I can vouch for the fact that we have a weird little weather system, locally known as the Prestwick hole. People can fly into it, drive into it or walk into it. They can be surrounded by thick cloud, but they will look up and see a large hole of pure blue sky. That is what has made Prestwick the clear weather airport for the United Kingdom for decades.

I call on the Minister to look not just at having one space port. I think this is an industry that will mushroom. We need to accept that all sorts of sectors will develop that we have not even thought about. It will diversify. This is a real industry. It is not about saying, “Beam me up, Scotty,” or fretting about the dilithium crystals that we see on the telly; it is a multi-billion pound industry. I call on the Minister to be imaginative, to be brave and to be boldly going where no Minister has gone before. [Hon. Members: “Ooh!”] Nearly done.

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

More!

[Dr Whitford]

Oh, I am sure the Minister will have about two hours more.

Prestwick was Scotland’s first ever passenger airport and it was founded by Group Captain David McIntyre, the first man to fly over Everest. That is the kind of imagination and drive we need. I call on the Minister to please be imaginative and to support the industry across the entire UK so that it can live long and prosper.

Oral Answers to Questions

Debate between George Freeman and Philippa Whitford

Tuesday 5th January 2016 Commons Chamber

[George Freeman]

I pay tribute to the right hon. Gentleman. He is a Norfolk colleague and as Minister did a lot of work in this area. He raises an important point that as a society we need to think profoundly about how we integrate health and social care. As I say, the Government have made a £3.5 billion commitment from the new precept and the better care fund is a significant commitment, but he is right—we will have to go further. Through the devolution programme and the integration programme, we will have to develop more powers so that local health leaders and care council leaders can better integrate services to reduce unnecessary pressure.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

In Scotland, A&E performance is published weekly, but since June that in England has been published only every month and now after a six-week delay. Since that time, the performance in Scotland has risen and 96% of people were seen within four hours in Christmas week, which is a huge challenge, whereas the last data published for England were for October and show a figure below 90%. Do the Minister and the Secretary of State accept that to improve performance we need to return to more timeous and frequent analysis and publication?

[George Freeman]

I share the hon. Lady’s interest in data and in proper information. We need to be a little careful about Scottish figures. Over winter, England publishes three times more A&E performance measures than Scotland every week. We publish quality rankings on hospitals, care homes and GP surgeries, which Scotland does not. What we do not hear about in Scotland is A&E closures, A&E diverts, emergency admissions, general and acute beds—I could go on. It is dangerous to compare data that were not prepared on the same basis, but I share the hon. Lady’s enthusiasm, as does the Secretary of State, for information.

[Dr Whitford]

I am aware that the renewed strike call from junior doctors has actually been called in order to meet the new rules created by the Government’s own union laws and that negotiations are ongoing. To avoid an impact on hospital waiting times, what will the Secretary of State bring to the negotiating table to try to reassure junior doctors?

[George Freeman]

I am delighted to be able to announce—the hon. Lady might already have heard this—that the Secretary of State has appointed Sir David Dalton from Salford Royal to lead on that. I repeat the offer that the Secretary of State made this morning: we are very close to an agreement, so the right approach is not to strike, but to come to the table and reach it.

ACCESS TO MEDICAL TREATMENTS (INNOVATION) BILL

Debate between George Freeman and Philippa Whitford

Wednesday 16th December 2015 Public Bill Committees

[George Freeman]

I do not. I am politely winding my way round to saying that. However, the reasons are important. It is not that I object to amendments at all—I hope the Bill will be heavily amended in Committee to reach that nirvana of all the parties—but, because the clause is important and helps to clarify the Bill’s intention, I suggest that the amendments should not be pressed. However, we might work on a package of amendments on Report that tackle giving clinicians access to information about innovative medicines and the important points made by the hon. Gentleman.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

My concern about the Bill is that it seems to create a parallel system for something that we already have. We already have clear structures around litigation, defence and informed consent, which the Bill seems to bypass. If a doctor finds one other doctor who agrees with them, they can do what they like to somebody—they can go out and clip their privet hedge and give it to them: they are at the end of life and desperate, so they will try anything. That is really concerning.

The database would create a second information system that is not just about people reporting something. Someone might go to it in desperation, read about privet hedges and try that. That creates a separate system from the research system that has been developed over many years.

When I was a young doctor—sadly that was quite a long time ago—there was a paternalistic approach, in which the patient did exactly what the doctor told them. The thing is, when people are at the end of life or suffering from something for which we do not have an easy treatment, they are incredibly vulnerable, so we have a duty to protect them.

Part of the problem with the Bill is that it would create separate systems. Why should a doctor go through the entire system of pre-clinical research phases 1, 2 and 3, getting permission and getting things passed when, whatever their idea is, they can talk some wee lady into it and give it to them without any cover? That is quite frightening and would undermine our trials process.

There are things that could be improved. I agree with the Minister that some institutions have become rigid and defensive, thinking, “We don’t want you using that for anything else.” Out of the Bill we could get, as the Minister said, a database that talks about research that is going on that we could collaborate in, and what the findings and trial results are. Busy, front-line clinicians are often unaware of trials. In Scotland, we have the Scottish Breast Cancer Trials Group so that we flag up trials to people. There could be merit in that, but the idea that putting on a database something that I do to a patient, just randomly, somehow gives it credence is actually quite frightening.

We have Bolam. We have a system and a definition of negligence and litigation. Creating these two parallels undermines the patient. How can they give informed consent if we are talking about something that has no work-up, no safety profile and no phase 1 trials? How do we ensure that we are not encouraging people to do that across the country? There are things that could be done with the Bill but, as it stands, I have grave concerns, as many other doctors do.

--- Later in debate ---

[George Freeman]

I thank and pay tribute to the hon. Member for Torfaen for his persistence and patience in working with all parties on this matter. Similar to the Bill we are discussing, his Bill touched on an ambition shared by colleagues across the House to promote greater off-label use of medicines. I have encouraged him and my hon. Friend the Member for Daventry has welcomed his commitment to try to work through this Bill to see whether we might be able to tackle some of the same objectives, which is an ambition I strongly support.

In this Bill, my hon. Friend the Member for Daventry has repositioned a much stronger focus on the database being a registry not for capturing innovations that medics might or might not think are reasonable to record, but for the provision of information to clinicians on licensed, unlicensed and off-label uses for innovative medicines that are currently being developed. That represents a powerful opportunity for us to strike a blow for getting clinicians access to drugs that are in development, in trials or in an early access to medicine scheme and to off-label drugs currently in use of which clinicians might be unaware.

I dream of the day when a clinician can talk to a patient, click on their electronic medical records to see their history, click on available treatments for patients of that profile and see, at the click of a mouse, what clinicians around the country are doing, including the numbers. That could then be used to help intelligent prescribing, using their best clinical judgment and their knowledge of the patient. There is an interesting opportunity for us to do something here.

Let me turn to the amendments. Amendment 7 seeks to make it explicit in the Bill that “treatments” includes access to off-patent drugs. I actually support that ambition. Lawyers at the Department of Health will tell me that it is otiose—a legal term meaning that it is not strictly necessary—but, as a pure democrat, I think that it would be helpful if we could find a way to make it clear that that is specifically what we want to achieve. I can list the reasons why a lawyer might say it is not a good use of legislation because it is already covered by the existing definition, which it is. I think it would be helpful to send a message that we explicitly want the database to promote off-label use. As the Minister responsible, I would happily take instruction in whatever mechanism from the House to go away and come back with a proposal on it.

Amendment 8 seeks to provide for the establishment of an arm’s length body to assist those seeking regulatory approval for off-patent drugs in a new indication. As the hon. Member for Torfaen is aware, we have talked about that at length. Although I understand the thinking behind it, I do not accept it. For those colleagues who have not been following this debate closely, the thinking is broadly that because an off-label indication does not have an applicant company with a patent and a commercial interest, there is nobody to promote its case, and to put together the data package, lobby for it and advocate for it through the system, and to ask NICE to look at it. Word has got round that, because of that absence of a commercial interest, those uses are not being properly looked into, and that if it had a licence clinicians would use those off-label indications.

I understand it, but I think that the logic is profoundly flawed for two or three reasons. First, the evidence is that even where off-label indications are well evidenced and even recommended by NICE, in which case there is clearly no barrier, uptake is patchy and in some places slow. That is not because of the absence of recommendations and data. In the example of the use of Tamoxifen as a preventative treatment for cancer, in fact, patients and clinicians decide not to use it, in many cases because of the side effects or because women prefer to have surgery. It is not due to the lack of a licence; it is because it is an off-label use and has different impacts on different patients, and patients always want to reserve the right. It is the same with the use of bisphosphonates. There are off-label treatments that are well evidenced and well supported and recommended by NICE. It is not about the absence of a licence.

Most profoundly, I worry that if we expected all off-label uses to have a licence we would inadvertently create a situation in which those off-label uses that did not have a licence would suddenly become questionable. I totally understand that is not the intention of the hon. Member for Torfaen. We might actually undermine our objective and end up in a situation in which we have to license every single off-label use in order to keep it legitimate, which would be the complete opposite of what my hon. Friend the Member for Daventry wants to achieve. I will come later to why the Secretary of State and I do not want to become the licensors of medicines.

[Dr Whitford]

I accept the Minister’s point about Tamoxifen. There are certainly other reasons why patients do not take it. As we move into an era of more and more non-medical prescribers—nurses and professions allied to medicine—those people are going to be a lot less comfortable prescribing unlicensed drugs that are not in the “British National Formulary”. Those people are made to sign a liability form and they are simply not going to do that. We are moving patients out into the community. The idea that they will come to a specialist every eight weeks for a prescription is not practical.

Access to Medical Treatments (Innovation) Bill (Money)

Debate between George Freeman and Philippa Whitford

Tuesday 3rd November 2015 Commons Chamber

[George Freeman]

My hon. Friend makes a good point. That is the premise on which the Bill introduced by Lord Saatchi in the other place earlier in the year in the previous Parliament was predicated. My hon. Friend is right that it is a controversial proposition that fear of litigation for medical negligence is putting clinicians off innovating. The evidence that the Government received through the consultation was that some clinicians do feel that that is a problem, but very few saw it as the principal problem or the principal obstacle. A number of clinicians made the point that several factors have acted in recent decades to slow down the rate of innovative prescribing and other procedures in surgery and elsewhere, not least increasing central control of procurement from NHS England, which puts in place very tight procurement guidelines, as well as a general sense of an increasingly litigious society, which is just one of a number of factors cited in an extensive range of barriers to innovation.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Does the Minister not recognise the concern of the Association of Medical Research Charities and many within the profession about what the Bill opens up? The position when I started 30-odd years ago was that doctors could do what they liked. We have spent decades protecting people, slimming down the ethics paperwork to run trials, and I do not see that the Bill is necessary. I think it is dangerous. The problem is that people think it is about access to new drugs. It is not. Any drug that is licensed we can prescribe. This says that doctors can try what they like. That is quite scary.

[George Freeman]

The hon. Lady makes a series of interesting points. Her criticisms would perhaps apply more to the Bill introduced by Lord Saatchi in the other House. Let me confirm that this Bill has nothing at all to do with clinical research. It is to do with clarifying the freedoms that she is right to say that clinicians enjoy today. Clinicians are free to prescribe any treatment for their patients that they feel is appropriate on the basis of the clinical evidence.

The specific problem that the Government recognise, whether or not this Bill is the appropriate mechanism to deal with it, is that in order for clinicians to feel confident in making an innovative prescription or adopting an innovative procedure, the biggest barrier is the lack of information on what innovative procedures are out there already and being used by other clinicians. It was with that in mind that the registry was originally proposed in the Bill introduced by Lord Saatchi. It was originally intended as a registry of innovative practices that clinicians adopted under the procedures in the Bill, which merely clarify the existing protections already afforded by medical negligence law. It was felt that that registry would be a helpful innovation in itself.

The Government’s view is that, as we build an infrastructure for the provision of information to clinicians to support off-label use of medicines and access to the latest information on innovative treatments, that registry could provide a much more interesting function of providing to clinicians, at the click of a mouse, an up-to-date registry of innovative medicines that are available and off-label and other treatments that other clinicians are already using. I want to stress that this Bill, which has a very different structure from the original Bill introduced by Lord Saatchi, has nothing to do with research at all. It is purely to do with supporting innovative prescribing by clinicians by providing them with information on innovations that they might consider.

[Dr Whitford]

Does not this undermine our existing structures of clinical research? Those protect the patient through ethics and research being reviewed, whereas this allows a couple of doctors to say, “We’re going to give you liquorice for your cancer”, and that can get put on to a database. Many in the profession are anxious about this.

[George Freeman]

I want to make two things absolutely clear. First, this Bill, in law, would have no impact at all on clinical research. We in the Department have been very clear about that. If it in any way changed the basis on which clinical research is regulated, it would be a very serious matter, because we lead the world in terms of our ethical and regulatory controls on research, and it is vital that we do not affect that.

Secondly, it would be a matter of very serious concern if this Bill were to undermine patient or public trust and confidence in our NHS, our research medicine and our clinical trials infrastructure. I flagged up on Second Reading the fact that I do have some concerns. Some of those relate to the way in which this debate is conducted, although I am not making any comment about the hon. Lady’s intervention. It is very important that we explain to people what this Bill does and does not do. If we mislead them, it is not surprising that we will get a lot of unnecessary fear. It is very important that we clarify that this has nothing to do with clinical research.