Draft Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2016

George Freeman Excerpts

Monday 25th April 2016 General Committees

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

I beg to move,

That the Committee has considered the draft Medicines and Healthcare Products Regulatory Agency Trading Fund (Amendment) Order 2016.

This technical amendment allows the Medicines and Healthcare Products Regulatory Agency to fund its work on e-cigarettes through fee income. The implementation of the tobacco products directive and the specific fee regime to cover regulatory activity undertaken by the MHRA are covered in separate legislation that has been laid before Parliament. The order affects only the MHRA, as it changes very slightly the terms on which the MHRA operates as a trading fund. As an accounting change, it is debated in the House of Commons, but not the House of Lords.

As I said, the fees themselves are the subject of separate legislation. However, the proposed fee levels for the coming year are £150 to notify a new product, £80 to notify a substantial modification to an existing product and a £60 annual fee per notified product starting from 1 April 2017. The fees are set at a level that will enable the MHRA to recover the cost of reviewing information on new products notified through the EU portal and of carrying out subsequent publishing and monitoring work. The fee levels will be reviewed during the first year and regularly thereafter in consultation with the e-cigarette industry, health advisory bodies and the public to ensure that they remain a proportionate and fair recovery of the cost of undertaking that work.

--- Later in debate ---

[George Freeman]

I thank the hon. Member for Ellesmere Port and Neston and the Opposition for their support for the measure, which I expected but which is none the less welcome. It is a sensible piece of legislation, and I am grateful for their support. I will answer the hon. Gentleman’s three questions, as well as those of the hon. Member for Newport West.

On terminology, the hon. Member for Ellesmere Port and Neston makes an important point. I am conscious of the need to keep well aligned the devolved Assemblies’ different work in this space. As the UK Minister for Life Sciences, I am conscious that the devolved Governments have their own responsibilities, and I have initiated an annual meeting with Ministers from the devolved Administrations to consider the sector. I will table the measure there and raise the point that he has made. I am not aware that it is a problem at the moment, but I think that his point was more about ensuring that it does not become one.

The hon. Gentleman asked about effectiveness. We intend, as part of our more general work on monitoring the effectiveness of the various campaigns against smoking, to ensure that the measure does not have any counter-effect. The Under-Secretary of State for Health, my hon. Friend the Member for Battersea (Jane Ellison), who has responsibility for public health, will lead on that, alongside her work on smoking more generally.

On the hon. Gentleman’s third question, I do not fear that the measure might normalise smoking. The evidence that we have received is that it should not, and there is no reason to expect that it will. I agree that we want to ensure that that does not happen.

The charges are not enormous, and they are perfectly in accord with charges across the rest of the medical device sector. For those who wonder what the statutory instrument is all about, it is about ensuring that vaping devices, which contain chemicals and a filament that vaporises liquid to create an inhalant, are properly regulated and monitored, and that the chemical inside is correct.

The hon. Member for Newport West asked whether I am concerned about the danger of the MHRA being distorted by commercial interests. I am not. I am not complacent about it, but wherever I go—in this country, in Europe or around the world—the MHRA is held up as an example of Britain at its absolute best. It is rigorous, it is science and evidence-based, and it is leading the debate on the regulation of 21st-century devices, drugs and diagnostics. In doing that, it is important that it is able to draw on the industry and best practice within it, but, as the Minister with responsibility for the MHRA, I assure Members that in its annual reviews, in my visits and in all my work with it, I see no evidence of undue leniency—if that is the word—with the industry. What I see is an organisation that is committed to regulating in a way that not only ensures that patient safety is paramount, but that helps the industry, on which we all rely for these drugs, devices and diagnostics, to bring them to market. I hope that it is not hostile to industry, but that it is, first and foremost—as, indeed, it is—completely committed to the rigorous implementation of the highest standards of patient safety.

I commend the statutory instrument to the Committee.

Question put and agreed to.

Brain Tumours

George Freeman Excerpts

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.

[Jim Shannon]

rose—

[George Freeman]

I will give way to the hon. Gentleman, because he is a doughty pursuer of mine.

[Jim Shannon]

I thank the Minister for his response. Will he set out the funding or help that he can give to universities? He knows I am very keen on that issue. Universities have put forward some very good medical initiatives and some new medications and medicines as well, and Queen’s University Belfast is one of those universities. Can we do more with universities, business and Government? If we can, we can find the cure, which would be a big step forward.

[George Freeman]

I think we can do more and I welcome this opportunity to praise the role of Queen’s University Belfast in this field; it is a centre of real excellence in cancer science.

The standard treatment by the end of this Parliament will be underpinned by a commitment of an extra £300 million from Government in diagnostics. Last June, the National Institute for Health and Care Excellence published updated guidance on cancer referrals, which will make it easier for GPs to think about the possibility of cancer much sooner and to refer people for tests more quickly. This guidance includes new recommendations about brain cancer in adults, children and young people.

We are investing substantially in research. That is not to say we are doing enough—I will come to that in a moment—but we are investing £1.7 billion every year in health research. I am delighted that in the last autumn statement my right hon. Friend the Chancellor ring-fenced our investment, despite some difficult public spending pressures. We spend £0.7 billion a year on the MRC and £1 billion a year on the NIHR’s clinical infrastructure across the NHS. Cancer research spend by the NIHR rose by over a third during the last Parliament to around £135 million a year. Most of that investment—around £115 million—is on infrastructure. The model is that industry and charity can then run research projects through that infrastructure—I will come back to that point in a moment. That investment supports translating scientific breakthroughs into benefits for patients.

Spend specifically on brain tumour research cannot currently be separated out from total spend data for the cancer research infrastructure. I can, reassuringly, share with colleagues the information that six of our 11 NIHR biomedical research centres are conducting brain tumour research, and that the NIHR clinical research network had 30 brain tumour research studies that were recruiting patients in 2015-16. The NIHR is also funding research programmes and fellowships. For example, the health technology assessment programme is funding a £1.4 million trial involving patients who have received surgery for atypical meningioma.

The other main Government fund for health is the MRC. Over the five years to 2014-15, the MRC spent £10.9 million on research into brain and pituitary tumours, which spans basic discovery science, translational projects and early clinical trials. Both the NIHR and MRC also fund the Clinical Practice Research Datalink—the CPRD —which shares data for research. Four brain tumour studies have been published using CPRD data.

I want to mention the important role of charities. Those that follow my work will know that I have recently opened the door and made what has been described as a bold, generous and comprehensive offer to the Association of Medical Research Charities to come to the top table in the new landscape of life science research co-ordination that I am putting place. Medical research charities in this country raise £1.4 billion every year for research, from the smallest charities on the high street to CRUK, which has now become a major strategic funder and shaper of cancer policy.

I welcome the work that the 18 major charitable and public funders of cancer research are doing in the UK through the National Cancer Research Institute. Through that work and the work that the NIHR is doing with research councils, increased brain tumour research investment by charities drives increased support by the NIHR. Here is the challenge: our system works on the basis of bids and of accelerated funding. Once funding starts to drive clinical and academic results, that generates more funding, which drives more research. The danger in that model is that, unless that initial critical mass can be achieved, things can get squeezed out.

We have invited a number of applications for experimental cancer medicine centre status over this funding period, which are funded by the NIHR and Cancer Research UK. I am delighted to be able to announce that, on behalf of the arm’s-length bodies, NHS England will next month publish an implementation plan for the cancer taskforce strategy, “Achieving world-class cancer outcomes”. As part of one of the specific recommendations in that strategy, Public Health England is investigating how we can use new and existing data sources to identify secondary cancers and cancer progression more generally, including for brain tumours.

I hope I have demonstrated that some progress is being made, but as I have said, I do not think that progress being made is a reason not to do more; I think hon. Members have made a powerful case that we should. We formally accept that more needs to be done. The case has been made that we need to look carefully at what we can do. As the report recommends, I will be asking the NIHR to look at publishing a national register that considers how we spend public funds across research of different disease areas and different organs by therapeutic area, not least because it is a powerful way of helping to draw in co-investment from industry and charities. I shall be raising those issues with the MRC and, having recently convened the NIHR Parliament day, suggesting that at next year’s NIHR Parliament day we come back with that register and that breakdown of information.

We should look at issues around earlier diagnosis. I am prepared to announce today that we should specifically include brain cancer in the Genomics England programme, which is dealing with rare diseases and cancers, to make sure that it is properly picked up, and to talk to NICE about the point made about its guidance procedures. To pull all this together, I want to suggest that I should convene a task and finish working group in the Department of Health to touch on other issues that have been raised, including data collection, trials, off-label drugs, research barriers and skills.

I am conscious that I need to leave the sponsor of the debate a few seconds to close, but I hope that colleagues will see in my response that I have tried both to give patients some hope that we are listening and to strike a blow for good democracy, as well as good medical research.

National Minimum Wage: Care Sector

George Freeman Excerpts

Wednesday 23rd March 2016 Westminster Hall

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

It is a pleasure to serve under your chairmanship, Mr Rosindell. I start by congratulating the hon. Member for Sheffield Central (Paul Blomfield) on bringing this debate to the House. It has been a very helpful opportunity to focus attention on this important area, and it gives me a chance, on behalf of the Government, to make clear our commitment to ensuring that this issue is properly dealt with. I know he is a robust champion of workers in the care sector, and I want to praise him for his work in representing them here today.

I also pay tribute to the right hon. Member for Oxford East (Mr Smith), the hon. Members for Brighton, Pavilion (Caroline Lucas) and for Hampstead and Kilburn (Tulip Siddiq) and others who have taken such an interest in this issue. Opposition Members may be surprised to hear me single out and congratulate Unison and the Resolution Foundation, which have done really good work on behalf of workers in the sector by shining a light on the complex issues and some of the completely unacceptable practices that have gone on for too long.

I take this opportunity to pay tribute to our nation’s 1.5 million care workers, who, as hon. Members have said, work tirelessly to provide invaluable support to some of our most vulnerable citizens. Without their support in caring for the frail, the disabled and the elderly, we simply would not be able to cope as a society with the pressures of an ageing population. Hon. Members are right that we must ensure care workers are treated fairly by their employers and receive the money to which they are legally entitled—and that is a priority area for the Government, for this Minister and for the Minister for Skills, my hon. Friend the Member for Grantham and Stamford (Nick Boles), who leads on this within the Department for Business, Innovation and Skills.

Perhaps I could take this moment to make it clear, lest anybody watching the debate is in any doubt, that this generation of Conservatives in government strongly supports the national minimum wage. We are very proud that we have gone further and introduced the national living wage, as well as increasing penalties from £5,000 per employer to £20,000 per employee, which last year saw one investigation lead to a fine of half a million pounds.

We have also increased the budget for compliance by 50% since 2010 and strengthened the naming and shaming provisions. Let me send the strong signal that we will not tolerate non-compliance with the national minimum wage. It applies across all sectors, and the nature of the work that these care workers do, in a fragmented, challenging and geographically difficult sector, is no excuse for non-compliance.

I want to make it clear that any employer who treats the Government’s commitment to this space with contempt needs to be very careful. I am very disappointed to see that the Business, Innovation and Skills Committee’s request for Mike Ashley from Sports Direct to come and give evidence has not been responded to. Let me take this opportunity to say that contempt for this area of law is not acceptable, and to welcome the recent court case in which Caroline Barlow successfully prosecuted MiHomecare. It led to the court ruling that she and, by implication, others should have been properly paid. I welcome that, and the signal should go out very clearly to businesses, councils and all those who employ the low-paid that they have to abide by their duties under the law.

[Mr Philip Hollobone in the Chair]

[Barbara Keeley]

Most Members here would agree with the Minister about Mike Ashley, I am sure, and would applaud the Chair of the BIS Committee and the Speaker for the way in which they are handling the situation.

The key point I want to make is this: although it is good that the Minister is proud of the Government’s policy on the minimum wage, does he not think that the Government should have funded that? Is not the key problem the one that I outlined: the 2% precept will only raise £1.6 billion, but my local council will need £2.7 billion just to deal with these pressures? We cannot get to a position in which those in the care sector can pay the minimum wage unless there is funding for it, and that is the Government’s responsibility.

[George Freeman]

I will come on to the funding of social care, which is a major issue that we all face as a society and will require some pretty deep thinking over the years ahead. I will also describe the extra money that the Government have put in. Although there is never enough money, we have made this priority very clear.

It may help if I review how we got to be where we are today. In 1999, the national minimum wage came in. It was the first time that legislation had been introduced in the UK to ensure a minimum level of pay for virtually all workers. Its aim is to help as many low-paid workers as possible, end extreme low pay and ensure a level playing field for employers. We are absolutely clear that anyone who is entitled to be paid the national minimum wage or, from 1 April, the national living wage must receive it.

[Melanie Onn]

Will the Minister give way?

[George Freeman]

I will continue, if I may—I am under a tight time limit. The enforcement of the minimum wage is therefore essential to its success and we are committed to cracking down in every sector across the economy on employers who break the minimum wage law. Our approach is simple: through effective national minimum wage enforcement, we are able to support workers and businesses by deterring employers from underpaying their workers and removing the unfair competitive advantage that underpayment could bring.

[Mr Andrew Smith]

Will the Minister give way?

[George Freeman]

I will very briefly, but I am going to run out of time if Members keep intervening.

[Mr Andrew Smith]

Does the Minister not agree that those efforts would be very strongly buttressed if the power were taken under section 12 of the National Minimum Wage Act for mandatory statements showing compliance?

[George Freeman]

I will deal with the right hon. Gentleman’s points, with which I have a lot of sympathy, if I am given time to crack on.

Hon. Members have rightly raised the issue of non-compliance with the minimum wage in this sector. I want first to set out the measures that we are putting in place now and that we have put in place already, before touching on some things that we may go on to do in due course. HMRC responds to every complaint made by workers through the ACAS helpline. When a third party reports suspected non-compliance, HMRC evaluates the report and investigates the employer when there are grounds to do so.

Since HMRC began enforcing the minimum wage in ’99, it has identified more than £65 million in arrears. Between April and November 2015, HMRC took action against 557 businesses, clawing back over £8 million for 46,000 workers who had been illegally underpaid. That is already the largest amount of arrears identified in any single year since the national minimum wage was introduced and is possible as a result of the increased investment and extra measures we have put in place to support enforcement.

We are going further. The Prime Minister has committed to a package of measures that are currently being implemented that will build on Government action to date and strengthen the enforcement of the national minimum and living wage. First, we are increasing the enforcement budget from April 2016, demonstrating our ongoing commitment to ensuring that the hardest-working and lowest-paid people receive the pay that they are entitled to. HMRC will also continue to promote compliance with the law and respond when employers have got things wrong.

Secondly, the Government are further increasing the penalties that employers will have to pay when they break the law. From 1 April, the calculation will increase further, to 200% of the arrears that an employer owes. By increasing the penalties for underpayment of the national minimum wage, we intend that employers who would otherwise be tempted to underpay comply with the law and that working people receive the money they are legally due.

Furthermore, under changes being implemented through the Immigration Bill, we are creating a statutory director of labour market enforcement, who will set out a single set of priorities for the enforcement bodies across the spectrum of non-compliance. That should ensure a targeted approach that addresses problems and best helps victims.

Under the Immigration Bill, we are also creating a new type of enforcement order. That labour market enforcement undertaking will be supported by a criminal offence for non-compliance. We want to tackle employers who deliberately, persistently and brazenly commit breaches of labour law and fail to take remedial action. That cannot always be done satisfactorily through the repeated use of existing penalties or offences, which may lead to the continued exploitation of workers.

[Christina Rees]

I am grateful to the Minister for giving way. Will he provide examples of where that happens in the care sector? He is quoting a lot of statistics overall about the national minimum wage and recovery, but they are not specific to the care sector.

[George Freeman]

Perhaps I can come back to the hon. Lady on specific cases—I do not have them to hand. I just want to talk about what we are doing to deal with the issues that have been raised, but she makes an interesting point.

In the care sector, we have a particularly high incidence of workers who have not been paid the national minimum wage in the right way. Other sectors are hairdressing and retail, and there is some dispute about where the worst practice exists, but the care sector clearly has a major historical problem. That is in part attributable to the fact that many of the more complex rules on calculating working time are prevalent in the sector—for example, the calculation of travel and sleeping time. On those points, although I am sure that Members will appreciate that I cannot comment on individual cases, I want to restate the Government’s position: when workers are performing work under their contracts, they must be paid the minimum wage.

It is also worth noting that there is no perfect measure of non-compliance within the sector, and there is a possibility that current estimates of non-compliance overestimate work time and underestimate pay, because the information is reported by workers themselves. That is why we are continuing to work with the Low Pay Commission, the Office for National Statistics and others in order to improve our estimates and better understand the scale of the problem.

On the point that was mentioned by the right hon. Member for Oxford East (Mr Smith) and others, the Low Pay Commission’s proposals on transparency merit serious consideration, and we are looking at those and a number of its other recommendations. We are determined to continue to drive forward and send the very clearest signal to companies and employers that we are becoming less tolerant of non-compliance, and we want them to recognise that.

None the less, increasing compliance with the minimum wage in the sector remains a top priority for us and we are taking a number of steps to promote compliance and take stronger action against those who break the law. First, HMRC continues to focus on tackling non-compliance, but that activity is no longer reliant on worker complaints and instead targets employers with the highest risk of non-compliance, based on a range of intelligence and information. HMRC can now analyse information from, for example, other Departments, trade union representatives and the Low Pay Commission, and the evidence indicates that this targeted approach in the care sector is working. From April 2013 to January 2016, HMRC opened 443 cases in the social care sector and closed 308 of those. Of the 308 closed cases, underpayment of the national minimum wage was found in 32% of investigations—for total arrears of £442,000 to 3,000 workers, with penalties issued for a total value of £100,000.

Members have also raised the important issue of affordability within the sector, given the introduction of the national living wage. That pay rise for the lowest paid could be seen to be a threat in terms of increasing non-compliance. That is partly why we are taking steps to signal strongly our commitment to clamp down on it.

With an ageing society, social care funding is a major strategic issue for the country and this Government. We are engaging closely with all the relevant stakeholders on that issue to ensure that councils recognise the need to increase the price that they pay for care in order to cover costs and to reflect rising costs and, not least, the national living wage. That is partly why we are giving local authorities access to an extra £3.5 billion of new support for social care by 2020, to be included in the better care fund. Councils will also be able to introduce a new social care precept, allowing them to increase council tax by 2% above the existing threshold. Taken together, the new precept and the additional better care fund contribution mean local government has access to the extra funding that it will need to increase social care spending in real terms by the end of this Parliament.

[Barbara Keeley]

I thank the Minister for giving way again, but there is a two-year gap. There is nothing from the better care fund this year, only £100 million next year, and—as I said in giving the example from my local authority—the 2% social care precept only covers about half of what is needed. Nationally as well as locally, that is the problem and that is why the Local Government Association asked the Government to bring forward £700 million.

[George Freeman]

I understand. These things are never straightforward or simple. As the right hon. Member for Oxford East pointed out, a lot of creativity is required from councils and the healthcare sector. There is best practice across the country to ensure that health and care are better integrated. [Interruption.] It is all very well for Opposition Members to shake their heads as if this were an easy problem to solve. It is a problem we inherited from the last Government. I am trying to be reasonable in setting out our commitment to deal with it, but it should be remembered that we inherited the problem from the Members who are shaking their heads and suggesting that it is easily solved. I hope that the measures I have set out provide reassurance that we are taking the matter seriously.

Perhaps I may conclude by framing the central elements of the package that we are putting in place. We have toughened up the sanctions and made it easier to name and shame. We have now named 490 employers, raised over £1 million in penalties and recovered over £30 million in unpaid arrears. We are now running at a 94% rate of naming since our revisions to the code in 2013.

Several hon. Members made the point about four-year delays, including my hon. Friend the Member for Dudley South (Mike Wood). I think that that is completely unacceptable. Although we are seeing progress in the speed and rate at which investigations are being pursued, I will talk to the Minister for Skills to make sure the very strongest signal is sent to HMRC saying that we cannot tolerate such delays.

As I have signalled, we are seriously interested in looking at the Low Pay Commission’s recommendation on payslip transparency. It is important that employers are held to account and that employees, particularly when it comes to individual elements of time, can see clearly what time they are being paid for.

I want to highlight the fact that the advice available for employees is free and confidential and that we have introduced important measures to ensure that, when HMRC has information from a third party to carry out an investigation, it keeps the complainant’s identity confidential and that that should trigger a whole workforce investigation.

I also want to highlight the fact that HMRC offers a free service to any employee who believes they are not being reimbursed properly. HMRC also has powers to enforce the reimbursement of expenses. That gives me the chance to highlight the fact that all expenses properly incurred by care workers in the course of doing their duty, often in a sector that requires them to travel extensively across large areas, should be, must be and the Government expect will be, properly reimbursed.

I hope that that helps to set out the Government’s real commitment to tackling the issue. I again thank and congratulate the hon. Member for Sheffield Central on raising it and giving me the opportunity on behalf of the Government to set out how strongly we support cracking down on non-compliance.

[Paul Blomfield]

I congratulate you, Mr Hollobone, on the seamless and unnoticed way in which you assumed the Chair.

I thank all Members for their contributions, which are too numerous to cover in a couple of minutes. They have illuminated the scale of and damage caused by the problem. It is ironic that a sector that is supposed to be about care shows so little duty of care to its employees. To illustrate the cross-party concern, I cite the words of the hon. Member for Dudley South (Mike Wood) that something is very wrong indeed with national minimum wage enforcement in the care sector and that has to change.

I thank the Minister for the constructive way in which he has engaged with the debate and the issues that we have raised. I do not think he covered all the points that a number of us raised. I will write to him and I hope he will have an opportunity to get back to me on those.

I want to follow through on the Minister’s suggestion that the Government may take up the issue raised by the Low Pay Commission and Unison and to ask him to indicate—he can do so simply by nodding—that he is willing to meet me, the commission and Unison to discuss how we can move forward with implementation of transparency on payslips.

[George Freeman]

indicated assent.

[Paul Blomfield]

The Minister is nodding and I am pleased to acknowledge that we will be able to have such a meeting.

Question put and agreed to.

Resolved,

That this House has considered Government policy on enforcement of the national minimum wage in the care sector.

Oral Answers to Questions

George Freeman Excerpts

Tuesday 22nd March 2016 Commons Chamber

[Maggie Throup (Erewash) (Con)]

6. What progress the 100,000 Genomes Project has made on providing UK leadership for international developments in precision medicine.

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

Our groundbreaking 100,000 Genomes Project, which was announced by my right hon. Friend the Prime Minister as part of our 10-year life sciences strategy, represents the moonshot of medicine in making the UK the first nation on earth to sequence the entire genetic sequence of 100,000 genomes from NHS patients. Through our precision medicine strategy, the launch of 13 genomics medicine centres in the NHS, funding from Government and the precision medicine catapult, we are winning international plaudits and attracting inward investment, as a sign of our commitment to a 21st century NHS.

[Maggie Throup]

I recently visited the medical school in Nottingham where I saw the great work being carried out, including groundbreaking genomics work on identifying Alzheimer’s risk genes. What support is the Department providing to ensure that work is fully funded and expanded, so that the east midlands and the UK continue to be world leaders in the search for treatments and ultimately a cure for Alzheimer’s, based on our research?

[George Freeman]

I pay tribute to my hon. Friend, who had a distinguished career in the life science sector, including through setting up her own business. She is right to highlight the work at Nottingham University which, along with Leicester and Birmingham, represents something of an east midlands powerhouse. The Nottingham University Hospitals NHS Trust is part of the East of England NHS Genomic Medicine Centre, recruiting patients and becoming one of our hubs for NHS genomics medicine. In addition, we are actively supporting research into Alzheimer’s through our £1 billion a year National Institute for Health Research budget, the £150 million Dementia Research Institute and our dementia plan. I continue to lead conversations with dementia charities.

[Alex Chalk (Cheltenham) (Con)]

7. What progress the Government have made on achieving parity of esteem for physical and mental health services.

--- Later in debate ---

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

I thank the hon. Gentleman for raising this issue. Mesothelioma is a terrible disease from which more than 3,000 people die in this country every year. The Government are completely committed to supporting treatment, prevention and compensation. In the last three months my noble Friend Lord Prior has had a number of discussions with interested parties, and, as the hon. Gentleman will have noted, my right hon. Friend the Chancellor was able to announce £5 million of funding for a new mesothelioma research centre in last week’s Budget.

[Alex Cunningham]

The British Lung Foundation has welcomed the £5 million that the Government have announced for a national mesothelioma centre, but when will those funds be released, and how will the Government ensure that funding for research is sustained in the years that follow?

[George Freeman]

We are engaged in active discussions with the various parties, including charities such as Cancer Research UK, and we have received some interesting submissions from some of the research institutes. Over the coming weeks, we will consider how best to put that £5 million from the Government to work in order to maximise inward investment and build UK leadership in this important centre.

[Mary Glindon (North Tyneside) (Lab)]

14. What steps he is taking to ensure that people with muscle-wasting conditions who require a cough assist machine have access to such a machine, commissioned in the community by their clinical commissioning group.

--- Later in debate ---

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

I am delighted to join my hon. Friend in that congratulation and to confirm the announcement in the autumn statement that the Government are committed to putting £4.8 billion of capital into the NHS every year through to 2021. That will include funding for proton beam therapy and for major new hospitals at Brighton and at Sandwell, in addition to our billion pounds a year for NHS research and our £700 million a year for medical research through the Medical Research Council.

[Alison McGovern (Wirral South) (Lab)]

The financial year ends next week. What does the Secretary of State expect the NHS provider budget deficit to be by then?

--- Later in debate ---

[Greg Mulholland (Leeds North West) (LD)]

Families with boys with Duchenne muscular dystrophy are anxiously awaiting the NICE guidance to be published next week. Can I get an assurance from the Minister that, with this drug already being licensed and available in 18 countries, if NICE approves it, NHS England will bring the funding forward very quickly?

[George Freeman]

The hon. Gentleman is a doughty campaigner. Although he tempts me to pre-empt the decisions of NICE, I cannot, and it would not be appropriate for me to do so. I am afraid that we will just have to wait for its decisions, which are rightly taken on the best clinical evidence.

[Amanda Milling (Cannock Chase) (Con)]

Hednesford is a dementia-friendly town, and I am pleased that my office team, who are based on Market Street in Hednesford, will be receiving dementia-friendly training next month. Does the Minister agree that we should be encouraging more towns to become dementia-friendly?

Oral Answers to Questions

George Freeman Excerpts

Tuesday 9th February 2016 Commons Chamber

[Amanda Solloway (Derby North) (Con)]

16. What progress the Government has made on integrating and improving care provided outside of hospitals.

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

I join you, Mr Speaker, in offering the Government’s congratulations to my hon. Friend the Member for Louth and Horncastle (Victoria Atkins) on her extraordinary success.

Tackling the long neglected integration of health and social care is a major priority for this Government. It is crucial to avoiding unnecessary hospital admissions, providing better care outcomes for the elderly and easing the pressure on our health economy from an ageing population. That is why we have set up the better care fund, providing funding of £3.9 billion—£5.3 billion if we include local funding; why my right hon. Friend the Chancellor has announced the social care precept, which will raise £2 billion; and why we have fully funded the NHS five year forward view integrated care pioneers and new models of care in 95 sites. That is more than Labour promised or ever did in its term of office.

[Victoria Atkins]

Thank you for calling me, Mr. Speaker. I must mention the team ably led by the hon. Member for Ealing North (Stephen Pound) and of course the hon. Member for Heywood and Middleton (Liz McInnes).

In areas with a high proportion of older residents, home aids and adaptations can help people live longer in their homes, which benefits them and can also help to ease pressure on the NHS and social care services. What steps are the Government taking to boost such support?

[George Freeman]

My hon. Friend makes an excellent point. The disabled facilities grant is our primary mechanism for supporting the most vulnerable patients. It is currently £222 million, and I am delighted my right hon. Friend the Chancellor has announced it will increase to £500 million by 2019-20. That will fund 85,000 adaptations and help to prevent 8,500 unnecessary hospital admissions.

[Amanda Solloway]

A recent study carried out by the Care Quality Commission found that there had been no notable improvement in mental health services outside hospitals. What steps are being taken to rectify that?

[George Freeman]

My hon. Friend makes an important point. It is right that the crisis resolution and home treatment teams were criticised in the recent CQC report for not providing adequate home treatment. That is why the Prime Minister announced in January that we are providing an extra £400 million in funding for those teams. It is also why, in the mandate, we recently required that NHS England not only agree but implement a plan to improve crisis treatment in all areas.

[Helen Jones (Warrington North) (Lab)]

Does the Minister now accept that the Government’s decision to slash funding to local authorities was disastrous for adult social care, as the Government were warned at the time it would be? Does he also accept that the social care precept, which the Government are allowing councils to levy, will raise the most money in those councils with the highest council tax base, not necessarily in those with the greatest need?

[George Freeman]

I would be concerned if that were true. The point is that we are facing extraordinary, exploding demand in our system. At the risk of sounding like a Monty Python sketch, what have the Government done, apart from launching the £3.9 billion better care fund and a £2 billion social care precept; fully funding the NHS five year forward view, with a front load of £3.5 billion; driving health devolution; and providing £4 billion for health technology? We are funding the integration of health and care in a way the last Labour Government never did.

[Barbara Keeley (Worsley and Eccles South) (Lab)]

That is really not true. Ministers are presiding over the hollowing out of social care, because their funding falls far short of what is needed. Some £4.6 billion has already been cut from adult social care, and the funding gap is growing at £700 million a year. The social care precept the Minister has just been talking about will raise £400 million a year, and the better care fund does not start until next year, when it starts at £105 million. Simon Stevens has called this “unresolved business”. When will Ministers face up to the fact that the Government’s figures just do not add up?

[George Freeman]

I think that that question could be taken more seriously, first, if the Labour party had tackled this issue in office and, secondly, if it had any suggestions. Let me summarise the pressure the system is under. Over the next 10 years, there will be a 22% increase in over-65s, and the number of people aged over 75 will rise by 90% in the next 20 years. We face extraordinary challenges. That is why we have announced the better care fund increases, why we have launched the social care precept and why we are driving devolution powers for local areas, which allow local health and care leaders to integrate. If this was as easy as Labour Members say, perhaps they would have done these things during their term in office.

[Mr Ben Bradshaw (Exeter) (Lab)]

8. What proportion of patients exercised their right to choose where to receive hospital treatment in each of the last three years.

Access to Medical Treatments (Innovation) Bill

George Freeman Excerpts

Friday 29th January 2016 Commons Chamber

[Heidi Alexander]

This group of amendments, and in particular those which leave out clauses 3 and 4, are very welcome and have my full support. I appreciate that making such extensive changes to a Bill at this stage is not easy, but the hon. Member for Daventry (Chris Heaton-Harris) has been true to his word, and has rightly decided not to proceed with these clauses in the face of strong opposition.

Members who were present on Second Reading will have heard some of the grave concerns expressed by medical royal colleges, research charities and patient groups. I think it would be fair to the hon. Gentleman if I say that those concerns, which I shared, were more about the unintended consequences of clauses 3 and 4, than about the stated aim of his Bill. However, the effect of these amendments, if they are passed, is that the sole purpose of this Bill is now to give the Secretary of State the power to establish a database. The hon. Gentleman knows that on Second Reading, along with many other hon. Members, I said that I believed the Secretary of State already had this power.

The Association of Medical Research Charities has said that primary legislation is not required to set up a database of innovative medical treatments. According to the House of Commons Library, section 254 of the Health and Social Care Act 2012 gives the Secretary of State power to direct the Health and Social Care Information Centre to establish a system for the collection or analysis of information. Indeed, in Committee, the Minister signalled his intention to introduce such a database, regardless of whether this Bill becomes law. He said at that time:

“If the Bill does not, for whatever reason, reach the statute book, I would happily proceed towards establishing such a database”.––[Official Report, Access to Medical Treatments (Innovation) Public Bill Committee, 16 December 2015; c. 22.]

With that in mind, I have to question whether what is left of this Bill is needed at all.

There also seems to be some confusion, even in the Minister’s own mind, about the purpose of the Bill. The Daily Telegraph claimed on 22 January that the Minister had told it that changes in the reworked Bill could help to cut the length of time it took to bring a new drug to market by a third, from 15 years to 10 years. Yet when my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders) received a written answer to a question on this very subject on 28 January, the Minister’s reply was:

“The Bill is not specifically designed to reduce the length of time it takes to bring a new drug to market”.

I would be grateful if the Minister clarified the apparent contradiction in those remarks. Having said all that, I support all the amendments in this group. Indeed, they represent a positive step forward in terms of the overall Bill.

[George Freeman]

The amendments seek to remove the part of the Bill that sought to take forward the original proposals put forward by Lord Saatchi to provide reassurance to clinicians that fear of negligence should not be a barrier to innovation. I want to say something about the Government’s position on this point, which, as the hon. Member for Lewisham East (Heidi Alexander) has said, has been a point of some contention.

The Government share the ambition that fear of negligence should not be a barrier to innovation. Indeed, we have looked carefully at the provisions of the original Saatchi Bill and of this Bill, and taken legal advice in order to be sure that the proposed mechanism would in no way change medical negligence law, and that is indeed the case. Notwithstanding that, I have also repeatedly made it clear that if the Bill’s provisions were to create confusion, undermine patient, public and clinician trust and confidence and trigger a lawyer-fest of discussion about whether the mechanism did or did not have that effect, it would have had the opposite effect to that which it was seeking. In those circumstances, the Bill could trigger more confusion about medical negligence.

My hon. Friend the Member for Daventry (Chris Heaton-Harris) has done a sterling job in the past few months to get round all the various parties and reassure them that, in law, the proposed mechanism does not change the legal framework for medical negligence. However, as he himself has candidly said, such has been the level of opposition—and indeed some misunderstanding, not least because there are three Bills on this subject in the House—that this proposal has started to have the opposite effect. As I said on Second Reading and elsewhere, we would never be able to support a Bill which, despite its intentions, undermined public and patient trust and confidence in our world-class medical and clinical research landscape. The fact that a coalition of lawyers, clinicians, patients and charities was concerned about the clause meant that it would inevitably have to be removed if the Bill was to receive any support from the Government. I congratulate my hon. Friend on doing his very best to develop the debate and, in the end, deciding that it would be better to remove the clause and focus on the areas on which there is agreement.

In accepting the amendments that remove the provisions on medical negligence from the Bill, it is worth pointing out that I do not want the hon. Member for Lewisham East to misrepresent my position on this. Both the chief medical officer and the NHS medical director had advised us that they believed the proposal was safe, and we had no fear that it would in any way endanger patient safety. The point is that if it triggers legal, political or patient concern, it is self-defeating.

As I have said repeatedly at the Dispatch Box, fear of negligence is just one concern in a whole field of barriers to the adoption of innovation. I do not believe that it is the biggest barrier; I never have. The biggest is the difficulty of getting information to clinicians on the busy frontline of our national health service on the pace, scale and volume of innovative medicines that are coming through the system. That is why I believe that my hon. Friend’s refocusing the Bill on that, and on the introduction of a new mechanism for getting information on off-label drugs and innovative medicines in development, is very helpful and powerful.

--- Later in debate ---

[Heidi Alexander]

Will the Minister tell us why it is taken him so long to reach this conclusion? Will he also be clear about the contact that his officials at the Department of Health might have had with the hon. Member for Daventry (Chris Heaton-Harris) or Lord Saatchi on previous incarnations of this Bill? It strikes me that the Department has supported this Bill for a number of months and years in its different incarnations.

[George Freeman]

I am absolutely delighted that the hon. Lady has asked me that question, because it gives me the chance to deal with this matter directly. I am surprised at her question, in an age in which people want the Government to work in a cross-party way and to support private Members’ Bills and enable Back Benchers to get business through, and I have gone out on a limb to work in a cross-party vein. Sadly, however, the hon. Lady seems stuck. I thought this morning might have been a day on which to celebrate that joined-up work. Let me deal with the specific points that she has raised.

Right at the beginning, I said that I supported the aim of Lord Saatchi’s Bill to tackle the issue, such as it is, of medical fear of negligence if it is getting in the way of innovation. Indeed, we made it clear that we supported the aims of the Off-patent Drugs Bill, but not the mechanism involved. We also made it clear that we supported the aim of the Bill introduced by my hon. Friend the Member for Daventry to promote access to information about innovative medicines. I am surprised that the hon. Lady cannot get away from wanting to criticise that attempt. I believe that it is a good thing that we have reached joined-up consensus today on a package of amendments.

The hon. Lady should not believe everything that she reads in the papers. The article in The Daily Telegraph to which she referred talked about the accelerated access review, which I am leading and which I would like to think she welcomes and supports. My comments on speeding up the pace at which we can get innovative medicines to patients were in connection with that. I read the piece too, and it was misleading because it gave the impression that I thought this Bill would have the effect that I want the accelerated access review to have. I was merely making the point that the Bill in its current form could support the wider accelerated access review and the landscape that I am trying to put in place.

[Heidi Alexander]

I should like to state for the record that it has never been the Opposition’s desire to play political games with this Bill. We have always been concerned about what is in the best interest of patients, and I would like to make that point clear to the Minister and place it on record.

[George Freeman]

I am grateful to the hon. Lady for that clarification; it is most welcome.

I want to deal with the point that the hon. Lady and one or two others have made about the necessity of the Bill, given the powers that Ministers already have in relation to data. The Health and Social Care Information Centre, created under section 254 of the 2012 Act, can collect data, but there are restrictions on who it can disclose those data to. The Bill will enable disclosure to doctors, which could be limited by using just section 254. The 2012 Act also contains specific provisions relating to the HSCIC having a role in establishing other databases, so this approach is more in keeping with the general approach in the legislation.

The Bill might not pass in its current form, as it still has to go to the House of Lords. However, the point I made in Committee was that although I support the intention of that database provision, the law regarding the use of data in the NHS is complex and difficult, as Members know well. If the House wants the database to be created, having a Bill that makes very clear what it wants the database to do and requires Ministers to come back with proposals for it would be extremely helpful. In conclusion, I support these amendments.

Amendment 1 agreed to.

Clause 2

Database of innovative treatments

Amendment made: 11, page 1, line 18, leave out from beginning to “involves” in line 19 and insert

“In this section, “innovative medical treatment” means medical treatment for a condition that”.—(Chris Heaton-Harris.)

[Heidi Alexander (Lewisham East) (Lab)]

I beg to move amendment 8, page 2, line 20, at end insert—

“(b) the General Medical Council,

(c) the British Medical Association,

(d) the Association of Medical Research Charities,

(e) the Royal Colleges,

(f) the Academy of Medical Sciences,

(g) the Medical Research Council,

(h) the National Institute for Health and Care Excellence,

(i) the Medicines and Health Products Regulatory Agency, and

(j) any other body or individual that the Secretary of State considers it appropriate to consult.”

--- Later in debate ---

[Chris Heaton-Harris]

Soon to be right honourable—I shall try to get her promoted to that position. I am sure there are some Privy Council positions awaiting on the Labour Benches.

I completely understand where the hon. Lady is coming from in trying to ensure the widest range of consultation on, actually, pretty much anything. Forget this Bill; when the NHS does something, it should try to interact with stakeholders who have direct and indirect concerns. As it stands, the list in her amendments looks like a preferred list of consultees, although I have a range of concerns about the listing, the order and so on. Given the way we have gone about this Bill—there has been a great deal of understanding and working together—I would like to think that when my hon. Friend the Minister answers this point and indicates what the Secretary of State would do with the power, how he would consult and which groups he would consult with, the hon. Lady will perhaps consider not pressing her amendments, in the full knowledge that there will be the widest possible consultation, should this Bill become law.

[George Freeman]

I shall deal with amendments 8 and 9, tabled by the hon. Member for Lewisham East (Heidi Alexander), and amendment 15, which I tabled on behalf of the Government. I shall also deal with some of the important points that Members have raised.

I have to say that I am not here every Friday, but I think that today’s debate is setting a high standard, both in terms of the issues that are being raised and the way in which it is being conducted. I hope that those who take a close interest in the Bill and are watching the debate are observing the cross-party nature of our discussion of some very important issues.

I thank the hon. Member for Lewisham East for her support for the spirit of cross-party working. The sector needs to be confident in the knowledge that the House is paying close attention to the issues that underlie the Bill—issues relating to data, informatics, genomics, drug trials and research—in a cross-party spirit. As the hon. Lady knows, in the course of my work I have paid tribute to the last Labour Government’s pioneers, Lord Drayson and David Sainsbury, who did so much to create the Office for Life Sciences. I think the debate reflects that spirit, and I welcome the hon. Lady’s restatement of her support for it.

I also welcome amendments 8 and 9, which specify and flag the importance of a wide group of consultees. I entirely agree with the principle of the amendments. Indeed, I would go further and include a range of patients’ groups, charities and others. I give the hon. Lady—and the House—a commitment, which I am happy to put in writing, that I will seek to involve all the organisations on her list, and indeed others, in the consultation that will take place following the Bill’s enactment.

As an experienced parliamentary operator, the hon. Lady knows that including lists of organisations in a Bill is always a mistake, because in the end it creates more problems than it seeks to resolve. However, I will happily write to all the bodies that she has mentioned, and to all Members as well, with a list of those who I think should be involved in the consultation.

[James Morris (Halesowen and Rowley Regis) (Con)]

I know that the Bill is specifically about access to medical treatments, but, as chair of the all-party parliamentary group on mental health, I know that there is a growing need for the ability to share information about both drug-based and non-drug-based interventions in mental health care. Has any consideration been given to the sharing of information about mental health care in particular, and how would that fit into the framework of the Bill?

[George Freeman]

My hon. Friend has made a typically interesting and important point. I pay tribute to his work on mental health.

In no area of pharmacology and pharmaceuticals is drug discovery, drug use and prescribing more complex than in mental health. One of the projects on which I worked before entering the House was at the Institute of Psychiatry at King’s College London, where Professor Simon Lovestone has pioneered the use of informatics and data to integrate research into mental health conditions and the compiling of patient records information, MRI scans and, latterly, genomic information, to assist understanding of both the causes of disease and the way in which different patients respond to different drugs. As my hon. Friend will know, mental health care involves a wide range of very complex and, in some cases, very powerful drugs, and information about how those drugs work and how different patients respond is therefore crucial. I certainly want to ensure that we do not exclude mental health from the Bill’s provisions.

I tabled amendment 15 in connection with clinical research, an issue that received much attention during the Bill’s earlier stages. When—before these amendments were tabled—the Bill made provision for medical negligence, the Government were determined to ensure that none of its provisions would in any way undermine the United Kingdom’s world-class and world-rated landscape for the regulation of clinical trials. So the previous Bill contained a provision stating that nothing in it applied to clinical research. Now that my hon. Friend the Member for Daventry (Chris Heaton-Harris) has tabled amendments to remove the clauses dealing with medical negligence so as to create instead a Bill focused purely on the provision of data on innovative medicines to clinicians, I suggest that we remove that exclusion of clinical research and make sure that the database—now that it has nothing to do with negligence—actually covers drugs in research. That would make sure that we do not preclude the inclusion of drugs in clinical trials that clinicians may want to recommend to their patients or investigate their patients’ eligibility for.

--- Later in debate ---

[George Freeman]

May I share in the sense of relief? I, too, congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris). As others have said, it is no mean feat to steer a private Member’s Bill through this House. For all sorts of very good reasons, there are many obstacles to doing so. The process is designed to ensure that only those Bills that command a majority, if not unanimous support, and that clearly address something that the House feels is a priority make it on to the statute book. He has achieved something remarkable in getting this far, although he is right to emphasise that he has only come this far and that the Bill now goes on to the upper House. I pay tribute to his work. Everybody here has acknowledged the quiet, careful, considerate decency and tenacity with which he has got around and listened to people.

I genuinely believe that the Bill will be a powerful mechanism in the new landscape of personalised and precision medicines that we are developing in this country. It will help busy clinicians on the frontline of our health and care sector by making easily available at the click of a mouse information on innovative medicines—both new medicines and innovative uses of existing medicines—that they can prescribe or recommend to their patients.

It is a pleasure to have reached this point, having embarked—somewhat bravely, some of my officials might have said—on a process of supporting the intentions behind three Bills that the House has considered over the past 18 months. I have been determined to work with Back Benchers to reach a solution that the House and the Government could support.

The Bill captures the spirit of two others: the Bill tabled in the other House by Lord Saatchi, which was intended to promote a culture of innovation and innovative medicines in our health system, and the Off-patent Drugs Bill tabled by the hon. Member for Torfaen (Nick Thomas-Symonds), which was intended to promote greater use of off-label and repurposed medicines. My hon. Friend the Member for Daventry intends to promote greater access to information. I pay tribute to all three people, because their work in initiating their Bills has led to the House reaching unanimity.

I thank and pay tribute to the hon. Member for Central Ayrshire (Dr Whitford). Ministers do not always agree strongly with Scottish National party Members, but it is nice to be able to do so on this occasion. She brings to the House a lot of expertise in her field as a medical specialist, and she has played an important role in bringing the Bill to this point. I also thank my hon. Friend the Member for Bury St Edmunds (Jo Churchill), who brings her own experience of surviving cancer and a passion for the subject. The Members I have mentioned and others who have spoken today and in earlier debates have brought us to a much better place, with a Bill that commands and deserves respect and support.

I want to say something about Lord Saatchi, who commenced the debate on this subject. Passing legislation through Parliament is always a messy business. The anti-slavery campaigners took years, and all sorts of legislation that we can look back on with great pride had previously fallen at various hurdles. It takes tenacity to make things happen. This is not the same Bill as Lord Saatchi’s and it does not tackle the issue that he wanted to tackle of some clinicians fearing negligence cases, but I believe that it tackles the central issue that he was trying to address by creating a culture that promotes greater use of innovative medicines. I believe that he has secured, in his way, a legacy for his late wife Josephine that he can be proud of.

Lord Saatchi and Members who have spoken today have become part of a growing movement of patients, charities and campaigners who want us to accelerate access to innovative medicines. I often hear demonstrations from my window in the Department of Health, with patients sometimes chaining themselves to railings. I have yet to hear a demonstration asking us to take longer to regulate and assess drugs and bring them to market. Indeed, the demonstrations that I have heard in the past year have been by patients asking for quicker access to medicines. Mothers whose children have rare diseases have been asking why we are not moving more quickly to bring genomically and infomatically targeted medicines to their children. I have taken part in more debates on this subject than on any other in the past year.

I want to mention a number of people who, appropriately, have been referred to today, including the late Les Halpin. He founded Empower: Access to Medicine with a passion that his death would not be in vain and that his experience of dying from a rare disease would inspire and motivate others to invest more in research and accelerate innovative medicines being brought to patients. The campaign, which was started for him, is continuing to grow and build support for the agenda that we have discussed today.

Graham Hampson Silk has also been mentioned. Ten years ago, he was given four years to live, but because of the extraordinary work of NHS clinicians and NIHR researchers at the Birmingham Institute of Translational Medicine, led by the inspired Professor Charlie Craddock and supported by Cure Leukaemia, Graham is alive. He is using his life to campaign for quicker access to innovative medicines. He is alive because Charlie Craddock got him access to a drug that was in research in America, raised money and flew Graham to the States, and then got the drug into the Institute of Translational Medicine. In fact, that institute has pulled into the greater midlands area more than £20 million of free drugs in trials.

I should mention Emily and a number of the other mothers who have been to my office on a number of occasions in the past six months to discuss muscular dystrophy and Duchenne. The extraordinary progress of our medical community in genomics and informatics unlocks new treatments, but the mothers and fathers of children with rare diseases look on with frustration that we are unable to get the insights to benefit their children and families more quickly. As the first Minister for Life Sciences, I am driven every bit as much by their advocacy, passion and commitment.

The truth is that a lot of people are not interested in this space until they get a diagnosis or until someone in their family gets a diagnosis, at which point people become very interested in research, data and genetics. I am very pleased that their names and a number of others have been mentioned. My hon. Friend the Member for Daventry has struck a small blow in the march of that army for accelerated access to innovative medicines.

I want to say something about the landscape in which the Bill will land, the leadership that the UK is showing to create that landscape and the changes that will benefit patients and our NHS. The truth is that the traditional model of drug discovery is breaking down in front of our very eyes—the very long, 15-year, $2 billion process by which traditional pharmaceutical products are developed and brought to patients. That is too long for the industry and patients, and it is too expensive. Increasingly, the breakthroughs in genomics and informatics mean that drugs can be developed for specific patient groups around specific genetic biomarkers with much greater precision and be brought into the system much more quickly. They do not have to go through 15 years of randomised control trials when there is a genomic biomarker that guarantees they will work in certain patients and informatics to support that claim. That allows us to get medicines into targeted groups much more quickly.

That quiet revolution, which the UK is seeking to develop through our various initiatives, is principally driven by two transformational technologies: genomics and informatics. Genomics allows us to understand the cause of so many diseases—in many cases, the cause is inside the cells in our bodies—and to understand, at scale, why different patients respond to different drugs and why they respond to different diseases in different ways. It also allows us to centre our research on the experience of real patients with real diseases in real time.

Allied with informatics, that allows us to use the NHS to look at huge datasets of patients over the past 20 or 30 years, which is an incredibly powerful resource. Large-scale anonymised data allow us to identify patterns. When we re-analyse the data, we find that many of the drugs that have failed in traditional drug discovery, which could happen because of a side effect, a serious side effect or a death in the late stage of trials when the drug is trialled in the largest number of people, are dream drugs for a small sub-segment of the population. Part of that revolution is about allowing us to identify which patients would have responded much more quickly, which cuts down the time, cost and risk for companies in developing and thus reducing the price. It also cuts down the time that patients have to wait and to have more accurate dosing—we can get the right drug in the right dose to the right patients more quickly.

[Mr Peter Bone (Wellingborough) (Con)]

I put on the record my thanks to my hon. Friend the Member for Daventry (Chris Heaton-Harris) for his success in driving the Bill through. I have heard only today that a constituent of mine is getting a treatment for prostate cancer earlier because of the Minister’s intervention. I am sure that that is part of what the Government are driving. I wanted to thank him for that while I had the opportunity.

[George Freeman]

My hon. Friend is very kind. I thank him for his comment and am very pleased to hear that news.

We are putting in place various initiatives to support the new agenda, and seeing the beginnings of some successes. On the request made by the hon. Member for Torfaen, I will be happy to write to him about the proposals and how we envisage the measure working. There is quite a lot of work to be done on how the process of using a NICE evidence review to assess the evidence for an off-label claim. I am not prevaricating for any reason other than that I do not want to pre-empt that work, which we are getting on with.

[Nick Thomas-Symonds]

I am grateful to the Minister for that. New clause 5 was also about easier access to the licensing process itself, on which I made a few suggestions on Report. If the Minister addresses that specifically when he writes to me, I will be very grateful.

[George Freeman]

I will happily come back to the hon. Gentleman on licensing. We have discussed this at some length, but I am happy to confirm the situation. There is a very strong legal set of constraints on how we handle licensing, but I will happily write to him to confirm the position.

I would like to respond to the request, by the hon. Member for Lewisham East (Heidi Alexander) from the Opposition Front Bench, to take very seriously the design of the database. I agree. We need to make sure it works well. Datasets are already available, but we need to connect them up better to give clinicians the right information they need. I am absolutely happy to give an undertaking to engage very closely with the medical profession, and all who have taken an interest in the Bill, to ensure this measure has the intended effect. I also give an undertaking to the House that I want to put the patients’ voice right at the heart of this and to invite the Association of Medical Research Charities and others, as we put the proposals together.

I want to take up the point raised by my hon. Friend the Member for Wellingborough (Mr Bone) and update the House on the range of initiatives, which the database will sit in the middle of, that we are putting in place. As the landscape for drug discovery changes profoundly, the Government are intent on making sure the country leads in this new model of personalised, targeted, patient-led research, moving from a world in which a drug is traditionally developed around a notional theoretical target that is normally developed in an academic laboratory and then, if it is lucky, put through a process to raise money and be spun out or partnered. That original target is turned into a drugable target that a pharmaceutical company can make a drug against. The early synthetic chemical compounds are tested against vast libraries. With luck, they are taken through pre-clinical testing and extensive in vitro and in vivo testing. They then go “over the wall” as the industry refers to it, into development to phase 1, phase 2, phase 3 and phase 4 trials, through MHRA and European Medicines Agency safety approval, to NICE for health economic approval and then to the NHS to decide how to best use the drug.

That landscape still works for many drugs and is still the conventional system in which drugs are developed. In truth, however, the breakthroughs in genomics and informatics mean we can, and are, developing a different landscape. The Government are investing in the cell therapy catapult and the precision medicine catapult so that we lead in academic research, working with industry partners on the new model of personalised and precision medicine. It is why we set up the biomedical catalyst to support quick funding for small companies and academic groups developing key technologies in this space.

It is why I am delighted that we announced, in the autumn statement, ring-fenced funding for the Medical Research Council and the other research councils. That budget is now £700 million a year for leading research around the UK. It is why we confirmed the £1 billion-a-year commitment to the National Institute for Health Research, an embedded clinical research network at the heart of our NHS all around the country that is the jewel in the UK crown, and the establishment of the NIHR Office for Clinical Research Infrastructure, allowing innovators internationally to come in and work in our research hospitals. The progress of NIHR means we now have over 200 industrial studies on new medicines in the UK. We are increasing year-on-year the number of patients enrolling on clinical trials, including, importantly, first-in-man and first-in-patient studies. The UK is now going back up the international league for drugs having their first exposure to people, here in the NHS and the NIHR.

It is why, on informatics and genomics, we launched the Genomics England programme. In 2012, the Prime Minister announced that we would be the first nation on earth to sequence 100,000 entire genomes—those of NHS patients—and link them with their hospital records. The project has captured the world’s imagination—I have called it the NASA of 21st biomedicine—and triggered phenomenal academic and industrial investment in the UK. It is already driving new diagnostic insights into rare diseases and insights into how we can use existing medicines better.

It is also why we have invested in the clinical practice research datalink and the aggregating of the NHS’s long-term cohort studies. These are phenomenal resources for research. Before coming to the House, I was involved in one, funded by the MRC and Cancer Research UK, that involved 250,000 women at risk of ovarian cancer. As a part of that, we collected blood, tissue, genomic and medical record information. I am proud that, after the academic study was finished, a group of medics at University College London, along with MRC Technology, UCL Ventures and CRUK, used that database to form a company called Abcodia Ltd, an ageing biomarker company. The database contains biomarkers that allow us to diagnose not just cancers but a range of diseases in ageing women much earlier. The scale of that dataset allows us to lead.

My hon. Friend the Member for Daventry mentioned Professor Simon Lovestone, at King’s College London, who led the world in the use of informatics and integrated medical records in mental health and who has now gone to Oxford University to pioneer that work. The Government are investing in genomics and informatics because it is a transformational technology that is changing the way drugs are developed.

I want to entice the House to think about where this might go and the direction the Bill points us in. This new world is coming fast. The first genome to be sequenced, 10 years ago, cost £10 billion. It now costs $5,000 and can be done in 24 hours. Not least because of the leadership of Genomics England, it will soon be possible to do it in minutes for a few pounds and pence. That will allow the NHS, when patients arrive with cancer, rare diseases and, increasingly, any disease, to identify the right genomic diagnostic and profile the right treatment and drug much more quickly. When a patient arrives, whether at a GP practice, hospital or clinic, we will, in due course, be able to do a quick and easy genomic diagnosis.

Thanks to the Bill, front-line clinicians will be able much more quickly to identify innovative drugs from which their patients might benefit. That will not happen overnight; it will not happen by Easter; it will not happen by the end of this parliamentary Session, but it is a quiet revolution of 21st century medicine that we are leading, and data and information sit right at its heart. My hon. Friend has taken three Bills that were generating more heat than light, crystallised their essential purpose, which was noble and well-intended, and brought them together in one Bill. I hope that it will be treated in the Lords in the way that this debate and cross-party consensus invite and that it will not be significantly re-amended, not least because, if it is, it will probably run out of time to reach the statute book.

Many people comment that the House spends too much time doing yah-boo politics for its own sake. Today, we have struck a blow for joined-up government and parliamentary process. It is wonderful to see MPs from all mainstream parties—I have not heard anything from UKIP—in support of a measure that offers real benefits for patients and front-line clinicians, without undermining the latter’s clinical sovereignty over patients. It is about giving them information, so that they can make the exquisite clinical judgment we all want them to make. I am happy to commend the Bill to the House and to congratulate all those involved, and I am delighted to have done my bit to help strike a blow for joined-up government.

[Chris Heaton-Harris]

On a point of order, Madam Deputy Speaker. Would it be in order for me to thank Abigail Bishop-Laggett, my member of staff who has worked so hard on getting the Bill to this point?

Access To Medical Treatments (Innovation) Bill

George Freeman Excerpts

Friday 29th January 2016 Commons Chamber

[Rebecca Harris]

Very briefly, Mr Speaker.

I support the Bill and commend all those who have worked towards it in the many iterations it has been through in this House and the other place—I can see that Members of the other place are taking an interest in our proceedings today.

I am chairman of the all-party parliamentary group on brain tumours. Brain tumour research has desperately lagged behind other areas of cancer research, and we desperately need to find new sources of treatment. Sadly, brain tumour is still the biggest cancer killer of the under- 40s—children and young adults. The Bill could be a great step forward in the sharing of information.

I commend the Minister, as all hon. Members have. Without wishing to sound too toadying, we have a Minister who is committed to taking forward progress on research in a way that we have not seen previously.

It should be pointed out that the NHS is a superb innovative organisation that does huge amounts of research. We do not hear that said often enough of the NHS. From my point of view, the most important bit of the Bill is the database, which will mean we can take forward the research we do in the NHS so that people can have access to information—not just patients, but clinicians, who might not know as much as we or they would hope. I very much hope the Bill makes progress.

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

It is a great pleasure to take part in the debate and to support a package of amendments that have been agreed by Members on a cross-party basis over the past few weeks and months. Very often in private Members’ business, the Government take the view that the intentions are fine but the mechanism is flawed, and that the Government legislate while MPs raise issues. However, with this Bill, we have struck a blow for joined-up thinking and cross-party working in pursuit of patients’ interests—I will say more about that on Third Reading.

With my hon. Friends the Members for Daventry (Chris Heaton-Harris) and for Bury St Edmunds (Jo Churchill), and the hon. Members for Torfaen (Nick Thomas-Symonds) and for Central Ayrshire (Dr Whitford), and with the help of Opposition Front Benchers, we have managed to deal with three Bills with which the House has been preoccupied in recent months—the Bill initiated by Lord Saatchi, which looked to change the culture of innovation; the Bill introduced by the hon. Member for Torfaen, which promoted the use of off-patent repurposed drugs; and this Bill, introduced by my hon. Friend the Member for Daventry, which seeks to promote access to innovative medicines. With the package of amendments we have agreed, we will end up with a Bill that moves forward on those three areas of concern for Members in all parties of the House. Today is a rare and rather wonderful moment because the amendments are supported by every party in the House—I cannot speak for the United Kingdom Independence party because I have not heard anything from it, but all other parties support the Bill.

We have three groups of amendments to get through so I will try to be brief in dealing with the specific points, many of which have previously been raised and discussed. I should take this opportunity to pay tribute to and thank my officials who, over the past three to six months, have tirelessly worked with Members on both sides of the House in an unusual way to help to draft amendments that we can all support. I thank them for their diligence in doing so.

Broadly, the intention of the package of amendments is to introduce off-label repurposed medicines in the Bill, and to put it four square at the heart of the agenda. As the hon. Member for Torfaen said, I wholeheartedly supported the intention of his Bill and its predecessor, but not the mechanism. We now have a mechanism that will work.

I appreciate that the new clauses are probing and that hon. Members are seeking my reassurance on how the Government will take things forward. New clause 1 is a request for an action plan. Nobody seriously thinks that we should put an action plan in the Bill, but let me set out my commitment and that of the Government to pursuing this agenda with time and rigour. As I have said in other places, the truth is that the world of drug discovery is changing profoundly. The transformational power of genomics and informatics create a wholly new opportunity both to discover new medicines and target them at individual patients much more quickly, and to discover repurposed uses of existing drugs in a way that we have not been able to do previously. The 100,000 Genome Project, which the Government have initiated and funded, has already begun to identify existing drugs that have uses in indications that were not hitherto known. The pace at which new drugs are being developed and discovered is increasing, which is a credit to the creativity of the sector.

That sets the backdrop for the creation of my post and the accelerated access review that I have launched. As all hon. Members know, I am committed to putting in place a landscape that accelerates the use of NHS resources to support research. When we launched the strategy, the Prime Minister said that every patient should be a research patient and that every hospital should be a research hospital. We are determined to ensure that the daily footprint of diagnosis and treatment is used more intelligently to support research.

The accelerated access review is looking at that in a lot of detail and is an extensive piece of work. Colleagues have referred to the interim report—the final recommendations are due to arrive on my desk at Easter. I am very happy to give a commitment that, in our response to that report, we will pick up the points made in the debate and in the Bill on ensuring that we look at repurposing and off-label uses of existing drugs as much as we look at innovative medicines.

In new clauses 2 and 3, hon. Members are probing me to give details on how the National Institute for Health Research and the National Institute for Health and Care Excellence can put into practice the mechanism that we have discussed. On new clause 2, there are very open mechanisms currently for applications to the NIHR to research existing medicines. The NIHR—I am delighted that we have reconfirmed our £1 billion a year funding for it—conducts research every year into existing medicines, and there is a clear process for that. It would not be appropriate to legislate in a Bill to tell organisations that are subject to the Haldane principle, which is sacrosanct for the Government, what to do. We want research to be led by that principle, but I am happy—I will say more about this in a moment—to ensure that, through the process, we explore mechanisms for ensuring the NICE can look at evidence and develop evidence-based guidance on off-label medicines, so that doctors are aware of which drugs are being used in an off-label indication.

On new clause 3, I am delighted to confirm that, after discussions, NICE is now looking at ways to collect evidence on repurposed medicines. It is looking at taking evidence and how it could use, through its existing evidence review process, evidence on repurposed medicines specifically. I have asked whether we might be able to put a mechanism in place to find a way to somehow put that into the “British National Formulary”. I would not want to put that mechanism into the Bill, because we need the freedom to evolve the mechanism and to get it right. I hope that is a helpful reassurance.

--- Later in debate ---

[Nick Thomas-Symonds]

I would just like to make two points. First, the “British National Formulary” is UK-wide. Secondly, and just to probe the Minister further, is he able to give an approximate timeframe for when he thinks the process might be complete?

[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.

Vulnerable Adults: Transport

George Freeman Excerpts

Thursday 21st January 2016 Commons Chamber

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

I congratulate the hon. Member for Salford and Eccles (Rebecca Long Bailey) on securing this debate and thank her for allowing me, on behalf of the Government, to put the record straight on some important issues relating to funding for care generally and for this group of vulnerable patients in particular. I will start by setting the scene of how our reforms have changed the way in which funding is provided, and I will then address some of the detailed local issues in Salford.

The way we look after some of our most vulnerable people is a benchmark of how civilised we are as a society. For that reason, the Government have tried, in a very difficult funding round, to make sure that funding for the most vulnerable is protected and ring-fenced. We understand that everybody in the country is tightening their belts to pay off the debts that previous generations and Governments have left us, but we have tried to be as careful as possible and to make sure that we protect the most vulnerable in our society who have no choice and are completely reliant on public services. That is why, through the Care Act 2014, we now have a reformed care system that is already leaving local authorities in a better position to meet the care needs of their people as they see best and to target resources at those who most need them.

Councils now have greater flexibility to arrange care, as well as to give greater choice and control to individuals. We have given councils freedom on how to use the money they receive and allowed them to work with their residents to decide how best to arrange their spending, based on local priorities and need. I am not pretending for a minute that local government has not faced real pressures on its finances over the past five years. However, when local authorities account for a quarter of the Government’s entire public spending budget, it is only right that local government must find its share of the savings that we all need to make to reduce the deficit we inherited from the Labour Government in 2010. It is a tribute to local government across the country, including Labour councils, that the vast majority of them have managed to deliver more with less. It was good to hear the hon. Lady acknowledge that there was fat in the system in 2010, and that councils could do a lot to deliver more for less. Many councils have indeed done so.

[Angela Rayner]

I want to reiterate that I welcome the fact that Tameside is a pilot area for the Government’s proposed integrated care model. I mentioned the figures earlier, including the forecast £20 million deficit in Tameside general hospital’s budget. Does the Minister not think that that will completely undermine the fantastic and innovative work such areas are trying to do to ensure that people who need care can get it in the right place and at the right time? These savage cuts undermine all the proposals for an integrated care model.

[George Freeman]

If the hon. Lady had asked her question in slightly more moderate terms, I might have been able to agree, but when she talks about “savage cuts” completely undermining any progress on integration, I cannot agree with her. That extreme language does not tally with the rather better numbers—I am not pretending that there are not challenges, because there are—but I will come to them in a minute.

[Barbara Keeley]

Will the Minister give way?

[George Freeman]

I will give way briefly, but I want to answer the questions that have already been asked.

[Barbara Keeley]

Like my hon. Friend and constituency neighbour the Member for Salford and Eccles (Rebecca Long Bailey), I want to talk about Salford. It was one of the last authorities in the country that managed to hold on to moderate eligibility for social care, but the cuts that my hon. Friend spoke about mean that we have had to move from moderate to substantial. There is not the funding in the system that the Minister is outlining.

[George Freeman]

I will come on to the numbers for Salford. I rang Salford this morning to get the very latest numbers, and they make quite interesting listening.

Let me just set the scene on the settlement. In the context of the tough public sector finances, we listened to local government and took steps to protect social care services. In the spending review, we reflected that by introducing a 2% social care precept to the council tax for authorities with social care responsibilities. It is ring-fenced: it has to be spent on social care. The precept could mean up to £2 billion of additional funding for social care by 2019-20, which would be enough to support more than 50,000 people in care homes or 200,000 people in their own homes. In addition, we have secured a further £1.5 billion by 2019-20 through extra funding for the better care fund, which brings that funding to a total of £5.3 billion. Those resources are secure, and they are in the hands of local authorities.

Let me turn to transport for disabled people in Salford. Rightly in my view, the provision of social care and the question of how to meet local need are very much matters for the local authority, as I think hon. Members would agree. That is at the heart of this issue. I understand that Salford City Council has decided that the transport needs of people who require support to get to local day care and respite care services can best be met, in the patients’ interests, by closing the in-house passenger transport unit and providing suitable alternatives for individuals.

I also understand from the local authority that a significant number of parents and carers have commented on how much better the arrangements are because they can individualise journey times. Instead of having to wait and then sit on the council bus to get to services, going on very long routes, the vast majority of users are getting a much more personal and bespoke service. It means that the users of the service do not spend significant amounts of time on transport, which used to result in some of them arriving at a day centre or home upset, agitated, delayed and frustrated.

The council has worked hard to resolve the concerns that have been expressed by care users and their families. Having spoken to the council this morning, I understand that all have now accepted the new arrangements. Indeed, the director of adult social services at Salford City Council has told me that he considers the change to be

“a success both in terms of outcomes for individuals and in delivering a saving to the council budget.”

[Rebecca Long Bailey]

The Minister is quite right in what he says. The ability of my local authority to do more with less has been extremely amazing, but the fact remains that the review of special needs transport would not have occurred to this extent had the funding not been taken away. I do not dispute that it is right to review the service and the needs of individuals on an ongoing basis, but it should not have been done in such a forthright and extreme way. That would not have occurred had the funding not been taken away.

[George Freeman]

I am not sure what the question was. It is interesting that the hon. Lady is saying that the review was the right thing to do and the service has improved, but the rationale for doing it was wrong. I beg to differ. If the rationale that we have to deliver more for less leads good councils, in this case Salford, to find a better way to deliver services that uses less money and provides a better service, that is good. It is exactly what we want councils across the country to do.

For far too long, local government has been hidebound by receiving far too much of its funding from central Government. For me, as a localist, it is anathema that the majority of local government spending comes from central Government. That is why we have begun the process of seriously rebalancing the funding settlement by providing more powers and freedoms locally to raise money that can be spent on locally agreed priorities. The social care precept and the retention of business rates locally are powerful things for which many of us have campaigned for years.

If Salford uses the full social care precept flexibility that we have just provided, it could raise £7.6 million in 2019-20. That will be on top of Salford’s additional income from the better care fund of £10.5 million in 2019-20.

This is not about cuts. It is about a Labour council making prudent decisions that not only improve the way in which services for vulnerable people with disabilities are delivered, but do so in the most cost-effective way. The council’s prudence extends to its decision to nearly double its non-ring-fenced reserves from £29.7 million in 2010 to £56.5 million at the end of 2014-15. I will just say that again: the council doubled its reserves to £56.5 million over the course of the coalition Government.

[Barbara Keeley]

The Minister is being rather complacent in the way that he is responding to this debate. Salford City Council has announced this week that it is having to use its reserves for flood victims, when the Prime Minister will not even apply to the EU solidarity fund for funds. On the point that the Minister makes about social care, the Prime Minister heard this week from the Conservative leader of Essex County Council, who pleaded with him to bring the money forward. The Minister is talking about money for 2019-20. We have to get through the time until then. The money is back-loaded and it is not enough. The situation is risky and uncertain because the money will be provided so late. I should tell him that council leaders are very worried about 2017-18.

[George Freeman]

I will take the question as being, what do I think about that statement? The hon. Lady is right that the funding ramps up, but she is not right in saying that it does not come on stream until 2020. Indeed, I have looked at the figures for Salford. The money that will go to Salford from the better care fund will be £1.1 million in 2017-18, £6.1 million in 2018-19 and £10.5 million in 2019-20. Similarly, the precept will rise over the course of this Parliament, depending on Salford’s decisions on raising it.

Salford’s reserves have gone from being £29.7 million in 2010 to £56.5 million. Those reserves are public money that is there to be used prudently. In this period when we are all having to make sure that our children do not inherit ever more debts, I do not think the fact that Salford City Council is having to dip into its reserves to ensure that it is able to provide services—which, remember, are costing less but delivering better quality—is the savage crisis that the hon. Lady referred to.

[Rebecca Long Bailey]

I invite the Minister to visit the city of Salford. He will see the extent of the damage that this Government have done to local authority services. It is not just social care that is experiencing a large funding gap. Salford is experiencing a large-scale regeneration and is coming out of its post-industrial decline, but all that is at risk. He made the fantastic comment that we have increased our reserves, but there is much more that needs to be done in Salford.

[George Freeman]

I would happily welcome the chance to debate more widely the economic regeneration of Salford, which I hugely welcome. Since the floods have been mentioned, may I extend my sympathy, and that of the Government, to those who have been affected? However, this debate is on transport for vulnerable adults and when I spoke to Salford Council this morning, it told me that all those affected—I believe there are 200 families—are happy with the new service and believe that it is providing a better service for vulnerable adults in Salford.

The hon. Lady has cleverly used the debate to make wider points about the Government’s approach to care, which is perfectly within her rights. I have tried to deal with them. She says that we are underfunding local government, but in the recent comprehensive spending review, local government made clear to central Government that it foresaw a shortage of £2.9 billion that it was worried would not be met. That is why we gave local government a funding settlement of £3.5 billion, to ensure that the shortage we were warned about was properly met. We went further and gave local government the right to raise up to what will equal £2 billion in 2020 to fund that care gap, and a four-year settlement so that it can plan ahead—one of the other key asks. We have put an extra £1.5 billion into the better care fund, which now totals £5.3 billion for the integration of health and care.

The plea may go up that that is not enough, but money does not grow on trees and we can only fund what we can from our strongly recovering economy. However, I do not believe that that fits the pattern of “savage cuts” described earlier. I merely repeat that if the picture that the hon. Lady painted about transport for vulnerable people in Salford were true, I would be very concerned. However, when I spoke to the Labour-run council, it told me that it believes it is delivering better services at a more efficient cost, and that all those in the families involved have settled and are happy with that. The council’s reserves are up substantially on where the Labour Government left them, to the extent that over the next one or two years, while the extra money that we have put in comes on stream, it will have those reserves that it built up during the coalition Government. I simply do not recognise the picture of savage cuts and austerity that the hon. Lady presents.

[Rebecca Long Bailey]

I am quite concerned about the Minister’s comments. I spoke to the council this week and received similar comments, including notification that large numbers of the families were happy with the new service—I outlined that in my speech. I also highlighted that the council was aware that some families are not happy with the amended service, and it continues to work with them to try to reach a sensible conclusion on the matter. That is why I have raised this issue in the Chamber today.

[George Freeman]

I am delighted that we close on a point of unanimity: we agree that Salford council is doing a good job and has managed well the issue of transport for vulnerable adults. I was merely dealing with the wider points that the hon. Lady sought to make about the Government’s more general approach to care, to which it is my duty to respond. I welcome the work that Salford council is doing to look after its most vulnerable citizens, and I hugely support it in that. The Government’s vision is to give councils more freedoms and funding to provide for local people in the way that they see fit; in that way, all councils can do what Salford has done and deliver more for less.

Question put and agreed to.

Cancer Drugs

George Freeman Excerpts

Tuesday 19th January 2016 Westminster Hall

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

It is a pleasure to serve under your chairmanship, Mr Streeter. I congratulate my hon. Friend the Member for Mid Derbyshire (Pauline Latham) on securing this debate and I thank her for the chance to discuss these important issues, which I know are important to various Members who cannot be here this afternoon. I thank colleagues of all parties who have spoken. It was particularly powerful to hear the personal perspective of my hon. Friend the Member for Bury St Edmunds (Jo Churchill), who is a cancer survivor. I pay tribute to the work of Myeloma UK, Cancer Research UK, Macmillan and the other charities that have done, and continue to do, so much work looking after patients and supporting policy and research. As colleagues know, I am passionate that charities should have a bigger role to play in policy making. I have opened the Department’s door and invited them to come to the top table.

Few families in the country are untouched by cancer, and I am no different. My father died of throat cancer when I was 19, 18 months after I had met him. My mother-in-law died of myeloid leukaemia a few years ago. The family, like so many families, had to watch her go from a wonderful and healthy, vibrant grandmother to a corpse in 12 to 15 months. It is a tragedy when it happens, but the truth is that our generation has lived through the most extraordinary advances in cancer. Certainly in my childhood it was a death sentence. One sat in the back of cars as a child and heard parents discussing in hushed tones that somebody had a cancer diagnosis, which meant they would die. Now that has changed: 2 million people live with cancer and it has become a treatable disease. In some cases, it has become a preventable disease. That is why it is such a pleasure to see my hon. Friend the Member for Bury St Edmunds here. Many others in the country today work and live with cancer. It is a stunning tribute to the success of our life sciences sector and our academic and clinical scientists.

My hon. Friend the Member for Mid Derbyshire talked about Tina and Graham and their experience of cancer. We should always remember—I do every day—that at the heart of difficult policy decisions there are people living with the disease. As constituency MPs and parliamentarians we need to bring that personal perspective to policy making. Certainly as a Minister I try to do that. My hon. Friend highlighted the trauma experienced by patients who, at diagnosis, think they will be eligible for a drug but find they have been caught by the timing of the CDF review, which means that the drug is tantalisingly taken away from them. We can all sympathise with that. As in all Administrations, when change comes, somebody normally gets caught at the point of change and it is very difficult. My hon. Friend also made a powerful point about data being crucial, and I accept that we need to do better on data. I have picked out those comments, but we have had excellent comments from across the House.

I want to set the context before dealing with specific questions. In the past 20 or 30 years, we have seen incredible transformations in biomedical research and in our ability to develop new treatments and diagnostics. My own 15-year career in biomedical research saw us go from the early days of genetics to extraordinary abilities to drive diagnosis and personalised therapy. One looks at Herceptin for breast cancer, a genomic biomarker theranostic partner drug. We have guaranteed that it works in patients who have that genetic biomarker. This is the future: much more genomic targeting of drugs. Genomics and informatics are transforming the way in which drugs are developed.

I arrived in the House of Commons six years ago. As a Government adviser on life sciences, I supported the Prime Minister in putting a life sciences strategy in place that built on the previous Government’s good work. We set out an ambition for the NHS to become not only a passive recipient of new therapies, but an active partner in the development of them, making available our genomic and informatics leadership and our clinical research, which is at the heart of the life sciences strategy: two cylinders pumping together, with the NHS not just as a purchaser but a partner in development.

Although we have had phenomenal revolutions in genomics and informatics and in the pace of discovery—pioneered in cancer, which is why cancer has led with this pressure on our funding mechanisms—they give rise to great challenges: rising costs of treatment; ever more expensive drugs; smaller patient catchments, which puts a coach and horses through the traditional model of reimbursement; and the end of a one-size-fits-all blockbuster model of drug discovery, which is what NICE was originally set up to deal with. Those are very big challenges and I am putting policy responses in place. However, they are also big opportunities. As the world’s only integrated comprehensive healthcare system, nowhere is better equipped in the world to unleash the power of genomics and informatics for public good. I believe Nye Bevan would be banging the table today and saying, “The NHS was about the collective use of our health assets to prevent disease. Come on! Let’s harness the extraordinary ability of our NHS,” which is what we are doing.

As we reform the way in which NICE works, there is an opportunity for us to take the lead in the development of these new drugs and new specialised therapies, and to pioneer new models of reimbursement as well. It will not happen overnight—that is the honest truth—but it will happen over the next few years. That is why we have set out a 10-year strategy, and I am absolutely honoured and privileged to be at the beginning of a five-year Parliament as the Minister for Life Sciences with a chance to drive the reforms through. That is at the heart of the accelerated access review that I have launched, which I will talk about in a moment.

I urge everyone to recognise that the Government are not complacent. We have put £250 million extra into Genomics England. We are the first country on earth to do, at scale, full genome sequencing in cancer and rare diseases. Rare cancers are particularly well served. We have led on data and informatics for research in the NHS, often at a high political price, but it is essential if we are to drive this forward. We have set up the precision medicine catapult, the cell therapy catapult and the £700 million Crick Institute. We have protected, increased and ring-fenced science budget increases. We have announced and secured a multi-billion pound drugs budget, and more on that will be announced shortly. We have set up the rare diseases consortium, the accelerated access review, the early access to medicines scheme and a £1.2 billion commitment to the Cancer Drugs Fund, so I hope colleagues will acknowledge, as some have, that we are serious about trying to both invest in and reform this space.

The Cancer Drugs Fund was set up with strong leadership from the Prime Minister. Because of the progress in cancer putting pressure on NICE’s systems, NICE’s clinically led, world class, independent advice rejected many of the new cancer therapies that did not fit well with its scoring system, so the Prime Minster said that we must make the money available to make sure cancer patients do not suffer while we reform the system. The fund is now £1.2 billion; another £340 million was invested this year. Some 84,000 people have received life-extending drugs that they would not otherwise have got.

[Andrew Gwynne]

The situation is worse than described. There were drugs that NICE had approved, but the primary care trusts refused access to those treatments.

[George Freeman]

The hon. Gentleman makes an interesting point about the balance of responsibilities between NICE and NHS England. The system was set up so that NHS England is statutorily bound by NICE’s recommendations. Part of the problem in recent years has been that even treatments approved by NICE can take up to two, three and in some cases five years to be rolled out across NHS England. Much as we all love the NHS, we accept—even the NHS accepts—that there is a problem with patchy roll-out. That is also to do with data, which various colleagues have touched on.

[David Mowat]

The Minister used the words “world class” in respect of NICE, but said that its scoring system was such that drugs did not get authorised, and that many that the drugs fund includes were not authorised by NICE. Those two things do not seem to be consistent. Should we not look carefully at what NICE’s criteria are, as they have done in Scotland, and make them more appropriate?

[George Freeman]

The answer is yes. That is why I have set up the accelerated access review, which is doing precisely that. NICE is heavily involved in contributing to setting up the reforms, giving it new flexibilities and changing the way we adopt, assess and reimburse new medicines. I meant that NICE is recognised internationally. Indeed, other countries follow its health technology assessments, and its methodology and protocols. The challenge now is to update them for a world of genomics and informatics, with a much more targeted and precision medicine landscape. I accept that in that context we are not yet world class—we have more to do—but NICE is a world class organisation. Given the chance to update its systems, I believe it will lead the world in that field.

In the autumn statement we fully funded the NHS’s five-year forward view, including its cancer strategy, with a commitment to £10 billion extra per year by 2020. We frontloaded that with £6 billion, as was asked for, to allow it to make the investments necessary to modernise. That is a half-trillion pound commitment to spending on the NHS over this Parliament, so I gently point out to the shadow Minister, the hon. Member for Denton and Reddish (Andrew Gwynne), that to describe that as a cut is testing the admirable elasticity of the English language.

On the importance of NICE and independent, clinically led decision making, much as at times like this I yearn to reach for a big lever, pull it, make a decision and send hon. Members out dancing and cheering and send patients home happy, I think we all understand that it is right that such decisions are not taken by MPs or Ministers; they must be taken by clinicians, based on the very best evidence from the very best independent advice. That is how this system works: NICE makes an independent judgment using the very best systems available to it. I take the point made by my hon. Friend the Member for Warrington South (David Mowat) that that needs to be, and it is being, updated to give NICE more flexibility to reflect the challenges of precision medicine—treatments that have a very definable, predictable response in a very small number of patients. NICE’s advice goes to NHS England, which makes the clinical judgment about treatment protocols. It is right that the Cancer Drugs Fund is based on that clinical decision making.

Nevertheless, there is an anomaly. Although we expect NHS England to be guided by NICE, in one therapeutic area, with the best of intentions, we have created a fund that sits at the end of the process, so that NHS England has a fund to buy drugs that NICE has said no to. That is an anomaly in the system. The point of the review is to take the CDF commitment to fund earlier, so that NICE can use it as an assessment fund to enable it to look earlier in the process at new drugs that are coming on stream and then give NHS England advice. That is in keeping with our general policy of opening up a space between research and medical practice in which we use data from the front-line treatment of patients and from the system to inform our procurement and reimbursement system.

Rather than “finger in the air” theoretical models of health-economic benefits, we are within touching distance of a system that is able to use real data in realtime from real patients with real diseases to drive real models of cost-benefit and health economics, and we are trying to wire the system in order to deliver that exciting prize. Members will understand that, where funding is finite—£1.3 billion is a big commitment, but it is finite—the system must re-prioritise which drugs it purchases. That is difficult for those who are in the process of getting a diagnosis and expecting a treatment that is then withdrawn, but I stress that no patient who is in receipt of a treatment that is withdrawn has that treatment withdrawn from them specifically. If they are getting a drug, they continue to get it.

My hon. Friend the Member for Mid Derbyshire mentioned pomalidomide, a drug used to treat relapsed myeloma. The CDF clinical panel looked at it, reviewed it, and, based on its independent, best-in-class assessment, the score was too low so the panel recommended that it not be approved. As I understand it, NICE is currently looking at other treatments for multiple myeloma, including panobinostat. I checked with NICE before the debate, and can say that final guidance on that treatment for that condition is imminent.

I remind Members that any patients receiving drugs continue to be treated, and that no drug will be removed if it is the only proven therapy available on the NHS. Sometimes in debates such as this we give the impression that we are taking away a drug, patients will stop getting it, and patients who have no other treatment will be left without treatment. That is not what happens. We should remember that there is an individual funding request mechanism—the IFR—for patients with exceptional conditions that are not met by other drugs. That is there specifically so that if any constituents have a unique claim on clinical exceptionality, their clinicians can make that case.

I should highlight the fact that two new drugs were approved in the previous CDF round. We sometimes forget that new drugs are being approved. We do not get requests for debates in Westminster Hall to congratulate the system on their approval, but it is worth mentioning them. The system approved panitumumab for bowel cancer and ibrutinib for cell lymphoma. Those approvals have been widely welcomed by patients and charities in the relevant sectors. I am delighted that, through the early access to medicine scheme that we introduced last year, which, with patient consent and their clinician’s approval, enables unlicensed drugs to be fast-tracked, we have now got pembrolizumab through, tested, into patients and purchased by NHS England several years earlier than would have been the case. That is a precursor of what we want to do much more widely through the accelerated access review.

It is no coincidence that one reason for the delay that was referred to earlier is that I am very keen for the CDF review to be done at the same time as the accelerated access review. Had we not done that, colleagues would have been saying to me, “How ridiculous, Minister, that you have reviewed the Cancer Drugs Fund and closed it before you have received the recommendations of the accelerated access review this spring.” I wanted to ensure that we are building a landscape that is logical and fit.

[Sir Oliver Heald]

Does my hon. Friend the Minister accept that it is worth while to look at the difference between a condition that goes from diagnosis to death over, say, 18 months, where an extra two months of life is proportionately quite small, and one of these very fast-acting cancers, such as pancreatic, where a person gets only six months and giving them an extra two would be very important in allowing them to settle their affairs and come to terms with the world?

[George Freeman]

My hon. and learned Friend makes an important point. I urge colleagues, as elected representatives, to make such points to NHS England through the CDF review, which closes on 11 February. We represent 70,000 or 80,000-odd people, so it is appropriate to make the point that for different diseases there is a big difference between the benefits of extra time for patients.

In the limited time I have left, I want to touch on some of the questions that came up. Colleagues asked about performance measures for data. It is important that we use the data from the CDF better. We are introducing measures to ensure that the contracts for 2016-17 specify that trusts that do not submit complete datasets will be penalised. One hundred per cent. of trusts are now submitting data, so we have closed that door. Some of the horses may have bolted, but we are getting properly on top of the data.

My hon. Friend the Member for Mid Derbyshire asked first about a draft treatment pathway for multiple myeloma. NHS England advises that that is currently in the process of being finalised. It has been the subject of public consultation and is being revised to take account of the comments received and the potential impact of treatments that have been removed from the CDF. The treatment pathway is due to be published in 2016. Secondly, on individual funding requests, NHS England does publish data on its website, including the number of individual funding requests for each drug on the national CDF list. Thirdly, on the issue of penalties for failing to produce data, we have built specific performance measures into the systemic anti-cancer therapy database.

My hon. Friend also mentioned multi-drug treatment cost reductions. It would not be appropriate for me to comment on NHS England’s individual commercial discussions with companies, but I can say that I am actively looking at ways to integrate better the Department of Health negotiators with NHS England commissioners through the accelerated access programme, so that we can get the benefit of time, cost and risk reductions in the pathway in more enterprising pricing mechanisms. I am confident that there is interesting progress to be made in that space.

I am aware that it is traditional for the Minister to leave a little time for the Member who secured the debate to wind up. I have around 15 questions that I have not had the chance to answer, so with your permission, Mr Streeter, I will write to the Members who contributed to the debate. I close by reiterating our commitment, as a Government, to get on top of the issues that have been raised. I hope that Members can see that, as the first Minister for Life Sciences, I am making progress in the direction that has been highlighted.

Cambridgeshire CCG and UnitingCare Partnership

George Freeman Excerpts

Monday 18th January 2016 Commons Chamber

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

I congratulate the hon. Member for Cambridge (Daniel Zeichner) on securing the debate and thank the Members who are present, including my hon. and learned Friend the Member for North East Hertfordshire (Sir Oliver Heald)—I know that he has an interest in the matter—for attending. I also pay tribute to all those working on the frontline in the NHS in East Anglia, particularly at this time of year, when pressures are at their greatest.

As the hon. Gentleman has described, the contract between Cambridgeshire and Peterborough CCG and UnitingCare Partnership has very recently been terminated. I need to say right away that NHS England has launched an investigation into the circumstances surrounding the contract. Its terms of reference are to establish, from a commissioner perspective, the key facts and root causes behind the collapse of the contract in order to draw out any recommendations and lessons to be learned. I understand that the CCG is also undertaking a review, as is right and proper.

We should let the NHS complete that process. I hope that nothing I say today can be taken as an assumption that Ministers have in any way prejudged the outcome of that process. Clearly there are different views about what has happened, and I want to wait for the reports of the reviews before deciding what, if anything, needs to be done, either by the NHS or by the Government. Once the reports are published, Ministers will be briefed on their conclusions. I am happy to invite the hon. Gentleman to that meeting, although I cannot say today exactly when it will take place. I know that he is in regular contact with his local NHS, and I encourage him to keep that up.

The core scope of services in the contract with UnitingCare was acute unplanned hospital care for older people—those 65 and over—older people’s mental health services, older people and adult community services and a range of supporting voluntary sector services. The underlying principle was to create an integrated care pathway between all these services. The UnitingCare service model was designed by local clinicians during the procurement process and had a high degree of local health and social care support. Its detail and assumptions were subsequently ratified by two independent auditors. It was designed to: join up services around the patient and reduce service fragmentation; to focus on better outcomes for patients and carers, rather than activity levels; to invest in out-of-hospital services in order to better address the needs of a rapidly ageing and growing population; and to deliver £170 million of savings to the local health economy by 2020 by reducing inappropriate emergency admissions to hospital and inappropriate A&E attendances.

UnitingCare began introducing those new services with an investment of £5.4 million over the first six months of the financial year. They included a number of important local improvements, such as: care based around neighbourhoods, with 17 neighbourhood teams working closely with GPs; access to specialist services, with neighbourhood teams and the support of four integrated care teams to offer more specialist care; a 24/7 helpline, called OneCall; urgent care and support, with joint emergency teams to assess and treat people most at risk of admission to hospital; health and wellbeing, with voluntary organisations working together; a single view of the patient record, called OneView, providing professionals with a summary of all information about a person’s health; and a health analytics service to target interventions at those most at risk of admission.

To achieve those improvements, a contract was needed between the provider and the CCG. The main components of the contract were: a new framework for improving outcomes; a new contracting approach to align incentives in a better way; a five-year contract term; and a new lead provider, UnitingCare. It was therefore a high-value contract; it had a total value of around £800 million. Having taken legal advice, the CCG went to open procurement, using a standard three-stage process—pre-qualification, an invitation to submit outline solutions, and an invitation to submit final solutions. The CCG prospectus set out the CCG budget and the evaluation criteria. It was a contract entered into in good faith. This included submitting bids within the CCG budget. The CCG budget incorporated forecast population growth, an acuity factor, and QIPP—quality, innovation, productivity and prevention—savings for each year.

In 2014, there was in some quarters, as the hon. Gentleman said, concern that the process was “stealth privatisation”. Clearly no one, on any objective criteria, would agree that that was the case; it was merely, as he said, a service reconfiguration placed with a not-for-profit company set up by local health providers. The boards of Cambridge University Hospitals NHS Foundation Trust and Cambridgeshire and Peterborough NHS Foundation Trust held the firm belief that only by introducing radical change led by the NHS would the local health economy under the CCG become viable for patients, staff and the respective trusts across the region. For that reason, they decided to submit a joint bid and, following commercial and legal advice, opted to create a limited liability partnership to fulfil the role of prime vendor, as required by the CCG.

The CUHFT and CPFT consortium was appointed as preferred bidder at the end of September 2014. In October, it formed UnitingCare LLP to hold the contract. The strategic projects team was appointed as procurement adviser to the CCG through a competitive process and its role was to manage the procurement process. The strategic projects team is a specialist unit hosted by the Arden and Greater East Midlands commissioning support unit, which has substantial experience in managing complex procurements. The CCG also appointed legal advisers, Wragge Lawrence Graham, and financial advisers, Deloitte, to support the procurement process.

Much information about the costs of the current services, staffing details and timescales could not be provided by the CCG to UnitingCare until it was at preferred bidder stage. As a result, UnitingCare’s bid was heavily caveated and based on assumptions. To illustrate this point, at the time of preferred bidder award status, there were 71 outstanding clarification questions from the procurement process. The contract signed between the CCG and UnitingCare also included several protection clauses to be utilised in the event of the financial distress of either party. Subsequent to contract signature, additional clauses were agreed that allowed for the rapid exit of the contract in the event of the financial destabilisation of either party. With these protections in place, trust boards, the CCG and Monitor allowed the contract to be signed in November 2014 and for the necessary mobilisation activities to facilitate service commencement on 1 April 2015.

There were clear improvements in patient care. For example, in November 2015 emergency admissions for over-65s reduced by just short of 8% compared with the previous year and by 9% when taking into account population growth; admissions of more than two days’ duration for people over the age of 65 reduced by 14%; and A&E attendance reduced by 3.2% when taking into account population growth. However, in December the contract was terminated by mutual agreement.

[Lucy Frazer (South East Cambridgeshire) (Con)]

As my hon. Friend says, there were advantages to this project and it produced good outcomes. If it is a good concept, will the Department of Health support the services that so need to be provided?

[George Freeman]

My hon. and learned Friend makes an excellent point. The service is currently being continued, albeit by the CCG rather than through the company that was created for the purpose. As she says, the reforms that were put in place were the right reforms. Indeed, they were led by local clinicians and designed with that in mind.

[Sir Oliver Heald (North East Hertfordshire) (Con)]

In Royston we have the Royston NHS and social care hub, which will include beds as well as other services. Does my hon. Friend agree that there is no reason at this stage for people to become anxious that the difficulty with the contract will lead to any change in the quality of services that are planned for the future?

[George Freeman]

That is right. As both questions have highlighted, the change in the care pathway is being pursued by the CCG and there is no reason for patients—the users of the system—to fear any dramatic change to the service. The remaining issue is the residual issue of how the contract came to be put in place. The dispute between the parties is about their different conceptions of the financial and contractual situation. I do not want to prejudge the investigations, but the service reforms will continue.

The final decision to terminate was taken after extensive discussions between the CCG, UnitingCare, Cambridge University Hospitals NHS Foundation Trust, Cambridge and Peterborough NHS Foundation Trust, NHS England and Monitor. Prior to escalation to NHS England and Monitor, the CCG, CUH and CPFT worked hard to try to reach a resolution locally.

[Daniel Zeichner]

Could the Minister enlighten me on the role played by Ministers in that final decision? Did they know it was happening? Who ultimately terminated the contract?

[George Freeman]

As I will come on to say, due process was followed in the correct way. One of the reasons for listing all these acronyms is so that the hon. Gentleman can be reassured that the right bodies carried out their due diligence. I do not believe that there was any reason for Ministers to be concerned at any point until the dispute between the parties became clear. Indeed, the reforms had been generated locally by clinicians and an accountable CCG led by clinicians. As the questions I have been asked have illustrated, the reforms were and remain very sensible. This is a better care pathway, with improved outcomes.

The issue is contractual and relates to a dispute between the parties about liabilities in the contract. As I have said, I do not want to prejudge the ongoing investigations, the point of which is to work out what should have been done differently. I can absolutely reassure the hon. Gentleman and the House that we are hungry to learn any lessons from that commissioning experience. We need novel commissioning. We need commissioners around the country to look into different ways of commissioning the reforms to our integration of health and care, and lessons need to be learned when it goes wrong. I emphasise that this was a contract between the parties. As I have said, the Department is looking forward to the reviews and wants to hear the lessons that others can learn.

The CCG has now taken over all relevant contracts with providers that were previously held by UnitingCare, to ensure that there is no service disruption to patients and carers. In addition, the CCG and CPFT, which employ the majority of the affected staff, have worked closely together to ensure that frontline staff are clear that, while the contractual model has now changed, the service model remains in place.

Of course, I agree with hon. Members that it is a matter of extreme concern that the new arrangements lasted barely six months. That is not ideal. We need to work out how the parties got it wrong and what mistakes were made. There are questions for the reviews to address. For instance, there is the question of why, given full procurement and assurance of the process, the result fell so far short in practice, along with other associated questions.

To describe modern commissioning as back-door privatisation is wilfully to misrepresent what is going on. These are clinician-led improvements to the care pathways, and I do not believe that most service users would consider it privatisation. We are talking about two public sector organisations coming together to form a company for the purposes of jointly commissioning care pathway innovation put together by clinicians in the local CCG. If Labour considers that privatisation, it has a serious problem, because most people would consider it enlightened commissioning for modern care pathways. This is a contract issue. The parties to the contract did not get it right, and we are keen to understand why and what can be done to make sure it does not happen again. I want those answers as much as the hon. Gentleman, and I repeat my invitation, to him and other hon. Members with an interest, to meet in due course to learn the lessons and make sure that the benefits of commissioning for integration go ahead without the contractual errors that have bedevilled this project.

Question put and agreed to.