The National Health Service

Geoffrey Clifton-Brown Excerpts

Wednesday 23rd October 2019 Commons Chamber

[Matt Hancock]

That is a decision taken by the local NHS. The proposals that we are putting forward in law, for debate under this Queen’s Speech, are to change the regulations. We must absolutely get the best solutions for local patients, and I will address the hon. Lady’s point before taking some more interventions, because I want to refer specifically to the amendment tabled in the name of Opposition Members. Not only is it unnecessary, but it is counterproductive. It would do the opposite of what they say that they intend.

The Government believe—I think this is true across the House—in a publicly funded NHS that is free at the point of use according to need, not ability to pay. The Opposition say that they want a publicly provided NHS. I think what matters is what delivers best for patients, and let us look at this point of—

[Sir Geoffrey Clifton-Brown (The Cotswolds) (Con)]

Will my right hon. Friend give way on that point?

[Matt Hancock]

Let me explain my argument and then I will give way. What is not currently publicly provided? What about drugs and pharmaceuticals? Is the hon. Member for Leicester South really saying that only drugs manufactured by the NHS can be used in an NHS hospital? That is what his amendment says. Will he go and tell that to the patients who use Brineura, aspirin or cutting-edge cancer treatments? What about the new breakthrough announced this morning that could delay the onset of Alzheimer’s? My grandmother died with dementia, and his amendment would stop access to new drugs because he is against anything that is not publicly provided. The Government reject that ideology. What about other things that the NHS buys? Will he only buy pencils that are manufactured by the NHS? What about all those blasted fax machines? Is he suggesting that the NHS starts to manufacture its own fax machines? I want to abolish fax machines in the NHS; he wants to nationalise them.

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[Matt Hancock]

Yes, I entirely understand where my right hon. Friend is coming from, and he has been a tireless campaigner on this issue. On this point, I also want to welcome the cross-party approach set out by the hon. Member for Leicester South. This is an important thing to get right. Of course each decision for an individual patient has to be clinically-led; we cannot have MPs calling for specific clinical interventions, and I think my right hon. Friend and everybody else recognises that. But there is a problem in the system here, and I have asked the medical director of the NHS to lead the work to resolve the problem. We are working on it, and I look forward to meeting my right hon. Friend and others with an interest in this soon.

[Sir Geoffrey Clifton-Brown]

On behalf of my constituents, may I give a warm welcome to my right hon. Friend’s announcement this afternoon of extra funding to keep the A&E at Cheltenham open? My constituents already have to travel 25 miles to get to Cheltenham, and this announcement will be a huge relief to them.

[Matt Hancock]

I am delighted to have been able to give that assurance and I thank my hon. Friend for the work he has done.

Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019

Geoffrey Clifton-Brown Excerpts

Monday 7th October 2019 General Committees

[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

I beg to move,

That the Committee has considered the Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019, No. 1247).

It is a pleasure to serve under your chairmanship, Dame Cheryl. I am confident that we all share the intention to ensure that the high standards of food and feed safety and consumer protection that we enjoy in this country are maintained when the UK leaves the European Union. As my hon. Friend the Member for Winchester (Steve Brine) stated previously, this instrument and the original instrument, which it amends, seek only to protect and maintain those high public health and food safety standards. Changes are limited to the necessary technical amendments to ensure that the legislation is operable on exit day. I stress that no policy changes are made through these instruments and we do not have any intention of making any at this point.

This instrument amends a previous EU exit SI: the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019. Further clarity was required in setting out the authorisation process for approving products that can be used to remove surface contamination from products of animal origin. The clarification will ensure that the process is robust and can be applied clearly in assessing the risk in respect of new products.

This instrument needed to be in place to support the UK’s application for third-country listed status with the EU, so that the UK can continue to export animals and animal products to the EU. We anticipate that that is due to be voted on by the European Commission on 11 October.

This instrument has been made using the powers in the European Union (Withdrawal) Act 2018 to make necessary amendments to UK regulations to prevent, remedy or mitigate deficiencies in retained EU law that arise as a consequence of the UK’s withdrawal from the EU. The instrument was made on 9 September under the urgent “made affirmative” procedure, which was considered appropriate to meet the deadline for the European Commission’s third-country listing vote on 11 October.

As hon. Members know, the Government have made it clear that our priority is to seek a negotiated deal with the EU, but we are taking sensible action to ensure that we prepare for every eventuality. The UK’s third-country listing application was a particularly important part of our no-deal preparations. Third-country listed status guaranteed that the export of animal products and most live animals from the UK to the EU could continue. That market is worth approximately £5 billion to the UK annually.

I shall expand on the specific detail of the minor and technical changes made by the instrument. The primary purpose of this legislation is to refine an amendment to retained EU law made by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019. We considered that the regulation would benefit from further clarity in describing the authorisation process and the appropriate authority responsible for the process to approve substances that may be used to remove surface contamination from products of animal origin. Lack of clarity might affect implementation and has the potential to undermine the responsibilities for authorisation; this instrument rectifies that.

The new instrument makes it clear that the responsibility for approval of substances that may be used to remove surface contamination from products of animal origin rests with the Secretary of State for Health and Social Care and the appropriate Minister in each of the devolved Administrations. This measure introduces no substantive policy changes to what has already been successfully made and passed in Parliament in March 2019.

Food business operators are not permitted to use any substance other than potable water—or, where permitted, clean water—to remove surface contamination from products of animal origin unless that has been approved. This relates to business establishments that handle products such as meat, eggs, fish, cheese and milk and that do not supply to final consumers.

Currently, approval for such substances is given by the European Commission, but after EU exit this responsibility will be carried out by Ministers. The amendment to Regulation (EC) No. 853/2004 made by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 is being further amended to make it absolutely clear that Ministers will be responsible for prescribing the use of any other substances and that the process of consulting the food safety authority is retained. That decision will be based on independent food safety advice from the Food Standards Agency and Food Standards Scotland.

If after EU exit any additional substances are proposed to be approved for this purpose, they will be subject to risk analysis by the FSA, which has established a rigorous and transparent risk analysis process for assessment and approval of any such new substances. Any request for substance approval would be subject to thorough scientific risk assessment and risk management, before being put to Ministers for a final decision.

Let me be clear that neither this instrument nor the instrument it amends introduces any changes for food businesses in how they are regulated and how they run, nor does it introduce extra burden. The overall changes to the food hygiene regulations will ensure a robust set of controls, which will underpin UK businesses’ ability to trade domestically and internationally.

It is also important to note that we have engaged positively with the devolved Administrations throughout the development of this instrument. Further, this ongoing engagement has been warmly welcomed. The devolved Administrations in Wales and Northern Ireland have provided their consent for this instrument; the Scottish Government have been made aware of these regulations, but have not yet had the opportunity to scrutinise them.

I would like to stress that we would not normally make EU exit regulations under this Act, where the policy area is devolved in competence, without the agreement of all of the devolved Administrations. However, as I have explained, this is a very minor drafting change to the regulation, which the Scottish Parliament has previously agreed. Regrettably, the potential impact should the instrument not be in place before 11 October on the third-country listing vote does not constitute a normal situation and could affect the farming industry across the whole of the UK, including Scotland.

Finally, I draw the Committee’s attention to the fact that, in line with informal communications, which the Food Standards Agency has had with the Joint Committee on Statutory Instruments, the FSA will, in accordance with the terms of the free issue procedure, be making this instrument available free of charge to those who purchased the earlier exit SI, namely the Specific Food Hygiene (Amendment Etc.) (EU Exit) Regulations 2019.

The Government accept that this instrument should have been made available under the free issue procedure at the time it was first made, but that did not happen. That situation will now be remedied. I apologise for that oversight and confirm to the Committee that this will be corrected and the Food Standards Agency will, together with colleagues in the national archives, be taking action to ensure that anyone entitled to a free copy of the instrument under that procedure will, where appropriate, be able to apply for a refund or otherwise obtain a copy.

[Sir Geoffrey Clifton-Brown (The Cotswolds) (Con)]

Can my hon. Friend confirm that by laying this instrument the Government are demonstrating, beyond peradventure, that they will not tolerate any reduction in food safety standards as a result of the UK leaving the EU, contrary to what was asserted by some on television yesterday?

[Jo Churchill]

Indeed, that is so.

The action taken will allow one to obtain a copy of this instrument for free on request, in accordance with the usual terms of that procedure.

In conclusion, this instrument constitutes a minor—technical, but necessary—measure, to ensure that our legislation relating to food safety continues to work effectively after exit day. I urge hon. Members to support the amendment proposed, to ensure the continuation of effective food safety and public health controls. I commend the regulation to the Committee.

Budget Resolutions

Geoffrey Clifton-Brown Excerpts

Tuesday 30th October 2018 Commons Chamber

[Matt Hancock]

My hon. Friend is absolutely right, and we can only have a sustainable NHS if the social care system is also properly supported.

The social care Green Paper to be published later this year will set out the options to meet the unprecedented demographic challenge—and what a challenge. Some 70% of people in residential care homes now have dementia. The number of people with dementia is set to rise from 850,000 today to over 1 million in less than a decade. The number of people of working age in need of care is rising and is set to increase by almost half by 2035. Yet, despite these pressures, 83% of adult social care settings are now rated good or outstanding by the Care Quality Commission. That is the highest level since assessments began. As a society, we need to address the pressures on social care so that everyone can live in dignity and we can have a situation that is sustainable for the long term.

The Green Paper will bring forward a range of proposals to reform our social care system. I pay tribute to the excellent cross-party work of the Health and Social Care Committee and the Housing, Communities and Local Government Committee, which are helping to build a consensus behind potential solutions. This is exactly the sort of long-term cross-party work that we need to see, when fair-minded people from across the House come together to address the challenges of the future, and I will work with anyone from any party to get this right.

[Sir Geoffrey Clifton-Brown (The Cotswolds) (Con)]

I listened with care to my right hon. Friend’s very welcome remarks on yesterday’s “Today” programme about having parity of esteem between mental health and physical health, and I welcome the announcement in the Budget of £250,000 for children’s crisis centres. Sadly, people in society now have complex mental health problems at a younger and younger age. In order to make these policies work, will the Secretary of State ensure that there is a sufficient number of well trained staff in the NHS to deal with these mental health problems?

[Matt Hancock]

My hon. Friend is absolutely right; he has put his finger on an incredibly important point. As we spend £20 billion extra on the NHS, we are going to ensure that we train up and attract the people who are going to do the caring.

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[Mr Sheerman]

I hear what the hon. Lady says, but let us be serious. I recommend that she goes away and looks at a rather good book that I have recently read called “Reckless Endangerment: How Outsized Ambition, Greed, and Corruption Led to Economic Armageddon” by Gretchen Morgenson. Read it and learn it, because that was what we came through.

The Chancellor’s remarks yesterday did not really touch on many of the issues that affect my community. The fact is that we have a hospital in danger that suffers due to a private finance initiative scheme. All the Chancellor said was that Labour was responsible for PFI. I have been here long enough to know that the great charm offensive on PFIs was led by John Major. PFIs were the fashion among Members on all Benches. As Chairman of the Education Committee, I saw good PFIs and bad PFIs, but I also saw a lot of smart City types who danced rings around local authorities and local health authorities and gave them a rotten deal. That is the truth of PFIs—there were good ones and bad ones, but a lot of City spivs made a lot of money out of them. Nothing that the Chancellor said yesterday will rescue my local hospital and health trust from that burden.

[Sir Geoffrey Clifton-Brown]

Is the hon. Gentleman aware that 90% of all PFIs were signed under a Labour Government? Yesterday the Chancellor took steps to make sure that there will be no more.

[Mr Sheerman]

The Chancellor took no steps to help those parts of the country that are in trouble due to PFIs.

Watching the television and reading the papers, my constituents are not fooled: they know that what was left out yesterday was that whatever Brexit deal is struck, it will not be as good as staying in the European Union—that is the truth of it. I come here to represent my constituents, and I know that we are moving towards a disaster for their living standards, their health standards and everything else that will touch their lives over the coming years. This is a year of crisis. Just as we had the crisis of the great depression and the crisis in 2009, this will be the next crisis, and we need people at the Dispatch Box who will take on their role as leaders. I do not mean people such as the former Prime Minister and Chancellor who, when they lost the referendum, ran away from their responsibilities and from leadership. Where are they now? Writing for the Evening Standard I suppose, or writing their memoirs in their man caves.

Being in this House and representing our constituents is a grave responsibility. The job does not come and go—we do not want people who try a bit of time as Chancellor of the Exchequer and a bit of time as Prime Minister but then disappear. The great people who have been at that Dispatch Box are the people who have had values, showed leadership, and led this country in good time and in bad times. The fact of the matter is that we are heading for a very bad time indeed if we leave the European Union on bad terms, but that was not mentioned. The Chancellor of the Exchequer, at this time of crisis and impending disaster for our country, did not have the courage to mention Brexit more than once—that is the truth, and my constituents want me to say that today.

At this time of the year, I am, like many in the Chamber, wearing my poppy. I have just been reading a lovely new history about the first world war. The fact is that right in the middle of that war, everybody knew that it was unwinnable and that more and more young men were going to die. Of course, the real responsibility for the first world war lies with us—the politicians. Politicians failed the people of this country. German politicians failed their people, as did French politicians. It was politicians who did it, and they went on killing more and more young people. That was a failure of leadership, a failure of values, a failure of responsibility and a failure to make courageous decisions at the Dispatch Box. We are heading in that direction—not particularly into war, but into the most troubled times when our people will come out impoverished, miserable and unhappy. That will hurt their health, their education and their chance of a good life. For my part, I will do everything that I can to stop the disaster that those on the Government Benches have wished on our people.

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[Sir Geoffrey Clifton-Brown (The Cotswolds) (Con)]

I am grateful to have caught your eye in this important Budget debate, Mr Deputy Speaker.

I would like to begin by welcoming the Chancellor’s statement and recognising that UK public finances are in a much better shape than they were. Despite the narrative of negativity from the Opposition, the economic facts demonstrate a much more positive reality. I thought the Opposition might welcome the fact that average real wage growth in the public sector is now 3.1%—a 10-year high—or that the Chancellor is predicting an additional 400,000 people in work by 2023. That is on top of the 3 million extra jobs we have created in the last 10 years or so. But nothing came from the Opposition, except that they have 39 uncosted expenditure pledges. That is irresponsible public policy making.

As my hon. Friend the Member for Mid Norfolk (George Freeman) said, we need to build on the high-tech areas of our economy, such as AI, where we are world leaders. We need to ask ourselves why, when we can do the innovation in this country—for example, inventing the world wide web—large IT companies such as Google did not emerge in this country. We need to concentrate on the high-tech sectors of the economy. As my hon. Friend said, that is the way to build ourselves out of the debt created by previous Governments. We need to encourage more students from around the world—the brightest and the best—to come to our universities to study subjects such as computer sciences, so that our universities are at the world forefront of this much needed research.

We need to relentlessly pursue a growth strategy post Brexit. I was delighted that the Chancellor was able to release some of his cushion in this Budget. I hope that we get a deal; I am optimistic that we will get a deal and that this Parliament will pass it. We can then move forward, businesses that are currently shelving investment decisions will make those decisions and the economy will start to thrive.

One thing we can do in the post-Brexit era is to look carefully at the business rates system. I held an Adjournment debate on that earlier this month, in which I pointed out that business rates are not necessarily related to the ability to pay. There are some unfair quirks in the business rates system. For example, a business with a rateable value of under £12,000 gets small business rate relief, but if someone has two businesses with a rateable value of, say, £3,000 each, they get no small business rate relief for either of them.

I welcome the fact that the Government have put £900 million into the rating system, but again, that is a sticking plaster over a system that needs to be thoroughly reformed. I also welcome the fact that there is a third off business rates for retailers with a rateable value of up to £51,000 and a fund for the sustainable transformation of high streets.

Perhaps the most important thing that we need to look at in public services over the next few years is education. As I have alluded to, education is the way that we will be at the forefront of innovation in this country. I have campaigned over a number of years as part of the f40 group to ensure that my schools in Gloucestershire get fair funding. I welcome the additional £475 million for capital spending, but that does not address the current spending problems. In Gloucestershire, we have overspent by £3.2 million on the high-needs block of the education budget. As I mentioned in my intervention on the Health Secretary, that is unfortunately because our children are getting more and more complex health and other problems at an earlier age and need more special assistance in schools.

While I welcome the additional £1.3 billion put into education as a result of our manifesto commitment, it was predicated on the basis that secondary school children throughout the country were to get £3,800 under the fair funding formula. In fact, we will only be able to afford per pupil secondary school funding of £3,600 in Gloucestershire. That additional £200 per pupil would make a huge difference to my schools. I have to report to the House the sad fact that while we had a period of years when our schools in Gloucestershire were going from good to outstanding ratings, that has begun to drop back, which is of great concern.

One way in which the Chancellor has responded to public concern over IT companies such as Google and Facebook is to introduce a digital services tax. I agree with a little bit of what Opposition Members said—I think the tax is unambitious. If we look at the Red Book, we see that the tax is only 2% on profits, with a £25 million annual allowance, and it only covers relevant global revenues in excess of £500 million. The result is that hundreds, and maybe thousands, of relevant small and medium-sized IT companies around the world will be exempt from it. The tax is only predicted to raise £440 million by 2023-24. If we raised more from that tax, we would be able to put more money into schools. The Chancellor needs to look at that carefully. He introduced the diverted profits tax to start to deal with the issue of international companies not paying proper tax in the UK, but that has only raised £388 million this year.

Infrastructure is very important in this country, and I welcome the £25.5 billion for the roads programme. I desperately hope that that extra money will finally secure the construction of the missing link on the A417 in my constituency, for which I have campaigned for 15 years. The Chief Secretary is listening, and I hope I will get good news shortly. We have consulted on it, and we have a preferred route. All we are waiting for is the Government to announce which route they want.

Affordable housing is very important, and I welcome the extra £500 million for the housing infrastructure fund. I welcome the fact that a lot more money is going into housing. Providing housing is one of the most important things that we can do for our young people, and intergenerational fairness needs to be looked at. Low-paid public sector workers in my constituency, whether they be nurses or teachers, often cannot afford to live in the Cotswolds, and we need to look at more innovative ways of providing social housing for them.

Oral Answers to Questions

Geoffrey Clifton-Brown Excerpts

Tuesday 24th July 2018 Commons Chamber

[Stephen Barclay]

We will remain committed to attracting the brightest and best. The hon. Lady says that her area is “beleaguered”; I remind her that the Kent and Medway sustainability and transformation partnership received £101.2 million more than it received in the previous year.

[Sir Geoffrey Clifton-Brown (The Cotswolds) (Con)]

Nearly 10,000 EU citizens work in the social care sector, caring for some of the most vulnerable people in society. What steps is my hon. Friend taking to ensure that there will be no shortage of people working in that sector once we have left the EU?

[Stephen Barclay]

My hon. Friend has raised an extremely important point. The Home Secretary recently announced a settlement scheme to enable those staff from the European economic area to remain. However, it is also important for us not to scare EU nationals, and to point out that there are now 4,500 more non-UK EU nationals working in the NHS than there were two years ago, at the time of the referendum. There is often a sense that there are fewer, but that is not the case.

Digital Records in the NHS

Geoffrey Clifton-Brown Excerpts

Thursday 28th April 2016 Westminster Hall

[Geoffrey Clifton-Brown (The Cotswolds) (Con)]

I beg to move,

That this House has considered use of digital records in the NHS.

I am delighted to serve under your chairmanship, Mr Wilson, and grateful to you and Mr Speaker for the opportunity to debate this matter. I am delighted to see my hon. Friend the Member for South Basildon and East Thurrock (Stephen Metcalfe) in his place.

The issue of data is of transformative significance for the NHS. The health service has so many interactions with patients on a daily basis that it creates an enormous amount of health data that have a huge number of practical applications for those who know how to analyse the data correctly. With more patients being treated, more work being done on access to drugs, and massive breakthroughs in genomics and the study of rare diseases, the NHS must use IT effectively to digitise patient records and allow clinicians to harness the power of such valuable data. That is the essence of this debate.

My involvement in this subject area began through my late constituent, Les Halpin, who was diagnosed with the dreadful motor neurone disease in 2011. Les was one of the country’s foremost statisticians by profession, and a gifted mathematician with an inquisitive brain. He quickly realised that the numbers were stacked against him—when I first met him, he was absolutely clear that he had between a couple of months and a couple of years to live, about which he was absolutely stoical—and furthermore that the money spent on new drugs was widely out of kilter with the output.

Rather than take on the treatment of and research into MND directly, as that was already catered for by a number of non-governmental organisations, Les set his sights on tackling the system more widely. Understanding that the system he wanted to change was governed by the regulatory and political world, he began the Empower: Access to Medicine campaign. As a statistician, he knew better than anyone that it is information that furthers medical research. Empower taking on this debate is therefore the logical extension of his original work. Les died while on the waiting list for new treatments, for there had been no new treatment for MND for more than 20 years.

Through comprehensive engagement across Government, industry and the academic world, Empower helped to secure a major positive change for patients, known as the early access to medicine scheme. Working with a number of patient and medical campaign groups—Joining Jack, the Duchenne Children’s Trust and the Genetic Alliance UK, to name just a few—Empower hosted a summit in the House of Commons, at which the Department of Health launched its new early access scheme, with Empower’s support.

On 23 February, I hosted the parliamentary launch of Empower: Data4Health—my hon. Friend the Member for Bury St Edmunds (Jo Churchill) was present; perhaps other Members were as well—which is the next stage of this work and falls under the subject of this debate. The new campaign brings together politicians, clinicians and patients and calls for an NHS that uses state-of-the-art IT to collate and analyse health data to improve outcomes for patients. The campaign is a natural continuation of Les’s work, because it seeks to create an NHS that uses anonymised patient data to identify new treatments, effective new drugs and even repurposed drugs that can have major benefits for sufferers of rare or life-limiting diseases.

To my mind, there are three ways of deploying this IT effectively in the NHS—this is part of a wider debate, but it is worth mentioning here. First, with the right technology, data can be analysed for particular cohorts of disease sufferers to look for trends, monitor the effects of new drugs treatments and therapies and, ultimately, improve patients’ information about their own conditions, patient outcomes, and access to medicines or other treatments that are right for them.

Incidentally, we are seeing growing evidence of repurposed drugs being used to treat a variety of diseases that they were not originally intended for, with some success. For example, recent research suggests that some statins—drugs generally used to control cholesterol—can affect the treatment of brain tumours. Before such research can be turned into real treatment options for patients, we need to be able to use modern technology and digital records to flag where patients are receiving that treatment and look at the effects across a much larger cohort.

The potential offered by using IT to identify new treatments and trends could fundamentally change how the NHS operates. Indeed, the Science and Technology Committee recently reported that the value of big data to the health sector will equate to £14.4 billion by 2017. In fact, some consultants have found that efficiency savings between £16 billion and £66 billion could be generated in the NHS were the data deployed properly.

Once we start to use data, we can leverage the value of the intellectual property, which is created in a number of ways, by using it to incentivise GPs or clinicians to pursue certain treatment paths; by funding patient interest groups and other bodies; and, ultimately, by selling the IP to drug companies to speed up the development of new drugs. The whole thing then becomes a virtuous circle.

The second key benefit of IT and digital records is that they enable us to address the lack of co-ordination in the NHS. Clinicians will be able to monitor what is happening to a patient cohort for a particular disease across the country, rather than re-invent the wheel when approving treatment. Digital records will enable different teams to co-ordinate across one or a number of hospitals, synchronise appointments and ensure that all clinicians are fully informed of how their treatment is interacting with a patient. That should lead to the best possible outcomes for patients, and enable co-ordination across the health service.

Thirdly, patients will have more control over their own health information. In an age in which the use of medical self-diagnostic tools is on the rise, patients will be able to control—possibly remotely or at home—the data produced by the diagnostic machines; view them in whatever form they like; use them to inform their self-care; and feed them remotely, through IT, back to clinicians, who if necessary can modify the patient’s treatment. Treating people remotely will prevent unnecessary hospital visits and visits to clinicians.

Fourthly, once we start collecting data on patient outcomes, we will be able to drive processes within the NHS, identify things that are taking too long and work that is being duplicated, and ultimately save the NHS money on its day-to-day processes and tests. For example, we will be able to transfer huge amounts of data across different systems in the NHS. New patient tests are emerging almost weekly, which produce data that can be transferred across different parts of the NHS more efficiently. In those four ways, IT can transform the NHS.

Members from all parties, members of the public and clinicians have concerns about data privacy, and I would like to tackle that point head-on. I thought that some Members might be here to speak about their concerns about privacy and data protection. Some of those concerns are serious and legitimate; it is no use pretending that they are not. We all hear horror stories from our constituents about NHS trusts mishandling data, losing records and sharing inappropriate information. When this debate was granted, a member of the public contacted me to bring to my attention his experience of massive data breaches by one NHS trust, which is alleged to have consistently failed to adhere to data protection principles and to have hidden its failings from NHS England. Make no mistake: concerns about the handling of patient data are very real.

That member of the public highlighted that data protection breaches are regrettably already taking place. One of the purposes of this debate is to highlight the need for a national framework for digital records with built-in safeguards to protect patient privacy, and for genuine national accountability for trusts. We need to generate a debate on that subject. No patient record system is absolutely secure. Even the old-fashioned paper system is not absolutely secure, because it can leak: people can get into files, access the data and pass them on in an unauthorised way. With modern technology, we ought to be able to protect patient records.

Digital records may ring alarm bells with some patients, such as that member of the public, so it is imperative that the Government develop a comprehensive public information campaign on the enormous treatment benefits, which I have outlined, that health data can provide. We must convince the public that the benefits of the effective use of IT in the NHS far outweigh the potential obstacles and pitfalls that there may be along the way. We have the technology to keep patient data safe. A fear of errors should not paralyse progress on this issue.

There are some great examples of things happening across the country. For example, the Cystic Fibrosis Trust has done incredible work in putting together a patient registry of more than 99% of all cystic fibrosis sufferers. As I am sure all Members realise, cystic fibrosis is a horrible disease. Babies born with it cannot breathe properly and need continuous treatment for the whole of their often only too short lives. The first new-generation genotypic drugs are beginning to be introduced, and by using patient data to measure their effectiveness and possible side effects we can begin to make real progress on rare diseases such as cystic fibrosis.

The Cystic Fibrosis Trust operates a strict evaluation process, overseen by a committee of experts, to ensure that its registry data are used in line with patients’ consent. It is interesting that those with that debilitating disease realise the effect that IT can have and have willingly given permission for their data to be used in that way. That is an example of the importance of patient buy-in to IT patient records. Thanks to the Cystic Fibrosis Trust’s determination to promote and maintain its registry, we are seeing new treatments for particular strains of CF, which completely alleviate the dreadful symptoms that I outlined in young babies, who would otherwise die prematurely, and enable them to live a relatively normal life. Proper deployment of IT in a digital NHS would enable us to develop similar drugs for suffers of all sorts of rare and debilitating illnesses.

A shining example of what I am outlining is happening in Birmingham, where clinicians are trailblazing in this area. They are an example of what we hope will happen nationally. The University Hospitals Birmingham NHS Foundation Trust uses electronic patient records. Since 2011, all records have been electronic. Its commitment to innovation has allowed for some remarkable projects, such as Cure Leukaemia, which was established in 2003 to enable patients with blood cancer to access effective new treatments. In 2005, it helped to secure a £2.2 million grant to build the Centre for Clinical Haematology at the Queen Elizabeth hospital in Birmingham. It resulted in the development of the second-largest adult stem cell transplant programme in the United Kingdom. The impact of Cure Leukaemia and the Centre for Clinical Haematology in Birmingham is closely linked to the distinct make-up of the west midlands and the fact that they use IT in the way that we propose. With a population of 5.5 million and the most ethnically diverse catchment area in Europe, the west midlands offers access to the broadest possible data pool for drugs trials.

Over the past decade, Cure Leukaemia has funded a network of 15 specialist nurses, who work across the west midlands and administer pioneering drug treatments to leukaemia-suffering patients. The combination of the west midlands’ unique demographic and the network of well-supported nurses has enabled us to leverage millions of pounds-worth of pioneering drugs and give patients access to clinical trials for drugs not readily available in the rest of the NHS. Cure Leukaemia’s founder, Graham Silk, is also a member of the Empower: Data4Health campaign. Graham’s hope is that, one day, everyone will be able to benefit as he has from the amazing work being done with digital records in the west midlands.

The medical community see the advantages that digital records can bring to the NHS. The Royal College of Physicians believes:

“Fully digital patient records will bring benefits to the NHS, but to do so they need to be based on standards for the structure and content. Common standards are essential to enable interoperability between digital records in different care settings.”

The RCP goes on to list the benefits that digital records can bring, and I will take them in turn.

First, digital records have the potential to improve the quality of patient care. The people at the RCP believe that, with fully digital records, it will be

“easier for care professionals to bring together a person-centred view of the patient from all the disparate records held in different settings and over time. They believe digital records will improve communication between professionals in different care settings and that it will be easier to drive timely, relevant automatic clinical alerts. They believe that digital records can improve safety by reducing errors in transcription of paper documents and they are of the opinion that it will be easier for patients to access their records for self-care purposes”—

something I have already outlined.

The second major benefit comes in NHS quality improvement and research activities. That is very much the key theme of my speech today. The RCP states that digital records could provide:

“Much improved ability to carry out records-based research (with appropriate protection of confidential data and respect for those who wish to opt out)”—

my buy-in point—

“and support for the development of stratified medicine which enables doctors to provide patients with specific treatments according to individual needs. It requires the collection of genotype (information on an individual’s genetics) and phenotype (lifestyle and environmental information) from patients.”

The final benefit that the RCP highlights is the potential cost saving. With the NHS under increasing pressure, because of a variety of factors, the importance of opportunities to do more for less, while protecting patient outcomes, should not be dismissed. The RCP believes that the potential cost savings could come from reduced duplication of test orders and unsuccessful treatment, fewer errors and reduced time spent on searching for missing paper records.

I want to give a powerful example that really sums up what this is all about. Using IT and patient data to improve access to breakthrough treatments and personalised medicine is, fundamentally, about patients who are looking for answers and for some hope, not only for themselves, but for everyone in a similar situation. At this point, I want to mention a remarkable woman from my constituency, Christina Knudsen. Christina can explain her situation and her journey far more effectively than I ever could. If you will permit me, Mr Wilson, I will read the words she sent to me:

“The unusual aspect of my situation is that I am relatively young, midforties, and otherwise very healthy, sporty, have a positive mindset and have no cancer in my DNA. Where the illness originates from is a mystery (I personally believe it is from emotional stress from an unusually challenging childhood) and like many cancers, it seems to have been unprovoked. Unfortunately, we do not yet have a nationwide dataset of patients with ampullary cancer that could be used to cross-reference symptoms and treatments. This would, in my case, be a vital resource. It would not only allow doctors to help pinpoint the cause, but also make an informed decision on my treatment according to what has worked well with other patients who have suffered from the disease and who have similar attributes to me.

Ultimately, I am getting a feeling that I can turn this into something different. Perhaps I can use the situation in a positive way and be an inspiration to others. There’s no point in just going downhill with it, so I am slowly thinking that I could create a new reality around my predicament. One that would depend on my surviving this as best as possible, and showing the rest of the world that you can go through this and remain strong and positive, perhaps even overcome it. Apparently no one has beaten the particular cancer that I have, so why not try to reverse the statistics and make this into a first?”

Extraordinary! We can all agree that the drive to turn the experience of such a terrible illness into something positive for others, as Christina and Les have done, is the hallmark of someone truly heroic. When we think about the obstacles that we face in getting a fully digital NHS, and the potential pitfalls along the way, we need only think of Christina and Les, and the many patients like them who will benefit.

To conclude, effective use of digitisation in the NHS heralds the possibility of a complete transformation in how health services are delivered. This is one of those rare moments in human innovation when we could make a step change and deliver much more, for significantly less, on a permanent basis. We should, therefore, seize the opportunity with both hands, without delay.

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[Jo Churchill (Bury St Edmunds) (Con)]

It is a pleasure to serve under your chairmanship, Mr Wilson. I, too, congratulate my hon. Friend the Member for The Cotswolds (Geoffrey Clifton-Brown) on bringing this debate to the Chamber.

For me, data hold the key. As we move into new medical landscapes, comprehensive data sets hold vast possibilities for research and care, and we should harness and optimise their potential benefits, as my hon. Friend the Member for Twickenham (Dr Mathias) alluded to. I have been working with individuals, charities, researchers and clinicians to try to understand how to put patients at the centre of everything that is done with and for them.

Recent research by charities into patient responses shows that patients are keen for their data to be used. As my hon. Friend the Member for The Cotswolds mentioned, Data4Health was launched earlier this year. At its launch, we heard from a patient, Graham, whom my hon. Friend also mentioned. Graham was backed by a clinician, a researcher and a charity, and he spoke about his journey with leukaemia and how research had helped him get the most effective treatment. We also heard from the mother of the youngest patient to be diagnosed using cutting-edge genomics about how we are moving forward. What got those patients to a diagnosis and the correct care was a true understanding of their diseases. Data are a precious gift and we must take care to ensure that everything we do with them is in the patient’s best interest.

If we can speed up data sharing in something as simple as immunisation programmes, for example, it will be more effective. Vaccination coverage is necessary to ensure success, and at the moment data collection is, as a doctor described it to me, clunky in many areas. We still have paper records. Only recently we saw how integrated patient data might have saved a young child’s life. Patient safety and good data are therefore real and ever-present issues.

[Geoffrey Clifton-Brown]

My hon. Friend is extremely knowledgeable in this area. Is she aware of the campaign for the new-generation Bexsero meningitis B vaccine, which was developed by genomics? The NHS was the first health service in the world to allow two-month-old babies to receive that vaccine. The collection of data and the effectiveness of vaccines and drugs can put the NHS at the forefront of what is happening in the world.

[Jo Churchill]

Indeed, and there is a larger point than that: we also lead the world in life sciences, innovation and technology. The NHS is a critical resource; with patients’ permission, we have the ability not only to create great health for our nation, but to save money for our NHS and produce wealth for our economy. There is nothing not to like in that virtuous circle.

How much better would things be for people who go into hospital if the ambulance staff and paramedics who took them there could view their medication and understand their personal situation more fully, and therefore respond more appropriately and not waste precious time? As a doctor said to me, that is particularly important in caring for patients out of hours. Ringing other hospitals is sometimes not an option. Side effects can be worse for some patients than others, and we need to know why in order to target effective treatment. That would avoid waste and reduce the cost for individuals, their families and the system. My hon. Friend alluded to health economics studies that show potential savings ranging from as little as £16 billion to as much as £66 billion if data were deployed properly. We must grab this opportunity. The NHS needs to find cost savings, and we have an opportunity to drive the innovation that would deliver such savings.

That applies across the piece. I have just come from a debate on autism in the main Chamber, and one of the key points that was raised there was that health data are not adequate to link things up so that young children can have effective and timely diagnosis. As my hon. Friend mentioned, we had a powerful debate on meningitis in the House a few days ago, and we would benefit from data on that disease too. We also had a powerful and moving debate on brain tumours recently. Data on such issues should be linked, because the patient is an individual and how they respond to a drug or combinations of drugs is important.

Only this morning I spoke to Mike Burrows of the wonderful Salford lung study, in which a drug is put into a real-world environment and connected with databases so that all of a patient’s health needs can be tracked. The study looks at real life and can cope with all the different variables to see the effects that a drug might have on people. As we move into an environment in which co-morbidities are ever present in our ageing population, we can immediately see how someone who takes a drug for one condition and thereby receives a benefit for another will have their health enhanced.

GlaxoSmithKline is about to produce the results of that study, which will be interesting, but Mike said to me that it has been a winner for the local health service, and that is what is important. The GPs who have been involved have seen the benefits. The hardware alluded to by my hon. Friend the Member for Twickenham, which is so often lacking in the system, has been invested in and now, with the integration of the NHS and social care, we have the ability to optimise care for the patient, which is important. The Salford study covers a quarter of a million people, and the learning from it will be rolled out across the broader Manchester landscape as devolution takes place.

The Minister is in a unique position to see data as a solution. On many challenging issues in this data-rich system, we are information-poor. Variations lead to inconsistencies. He can implement the recommendations of the accelerated access review, spearheading how we can best put to use the lessons from large-scale studies such as the Salford study, the Birmingham study mentioned by my hon. Friend the Member for The Cotswolds and studies from right across London.

There is also much to be learned from some of the devolved areas. I have spoken at length about that with the hon. Member for Central Ayrshire (Dr Whitford), who is the Scottish National party’s lead on health. We have a lot of medical expertise to harness in my party and right across the House, so that we can concentrate minds and ensure that we take the right direction of travel.

Work is going on across the Richmond group and in the pharmaceutical industry. In this place, my hon. Friend the Member for Bath (Ben Howlett), who chairs the all-party group on rare, genetic and undiagnosed conditions, my hon. Friend the Member for North West Hampshire (Kit Malthouse), who chairs the all-party group on life sciences, and I, as chair of the all-party group on personalised medicine, are discussing how we can best develop a combined piece of work in this area, because collaborative approaches always give us the best results. There is a plethora of data in the system, but, as Chris Carrigan of the National Cancer Intelligence Network says, we must harness data effectively.

In this country we have some of the best science in the world. The areas of informatics and genomics will be game changers, allowing us to develop drugs in as little as five months instead of years. We need responsive systems. It is unlikely, if not impossible, that our clinicians will be able to keep up with cutting-edge research without the use of electronics. Last year, a multidisciplinary group looked at data sharing in genetics and concluded that the current arrangements are unsatisfactory.

If we understand why drugs work better on certain groups or in distinct geographical areas, they can be targeted effectively. That is particularly the case in the area of rare diseases. A young constituent of mine who has a condition called tuberous sclerosis and those who suffer from other conditions such as Duchenne muscular dystrophy, lupus or rare cancers are in cohorts that are too small to prove efficacy. If there are only a few suffers of such conditions throughout the country, the transferral of knowledge is difficult unless information is held centrally, but the data provide the key.

[Geoffrey Clifton-Brown]

I would not have intervened on my hon. Friend if we did not have plenty of time. She has developed the interesting theme of the benefit of the life sciences to our economy. She then explained how the better use of data can speed up the development of drugs. By doing that effectively at a time when global drugs companies are looking at where it is best to locate themselves, the NHS could encourage more of them to come to the United Kingdom to develop drugs. Would that not be a huge benefit?

[Jo Churchill]

It would. That is also part of the complex environment covered by the accelerated access review, the early access scheme that my hon. Friend mentioned and so on.

We now know what the landscape for the cancer drugs fund looks like going forward. I started my journey to this place on a personal note, speaking about personalised medicine as a campaigner back in 2010 after my second bout of cancer. My dream is that anybody will be able to have my data to learn what will prevent any of my four daughters from developing any of the cancers that I unfortunately have had in my lifetime. We need to take hold of patients’ ability to gift such data. Alongside that gift, we must drive an industry where we have the ability, the innovation, the technology and—quite frankly—the brains we need. Everybody comes here for our life sciences, to lead the world in that area, and we should grab that opportunity.

As I said, the cohorts are too small to prove efficacy. Unless we hold information in a central place, that creates a problem. As has been said, confidentiality is crucial. Strict safeguards and strong governance are a given, as my hon. Friend said. Confidentiality for participants involved in clinical research is well established, but most data are either aggregated or pseudonymised.

Speaking personally, if my data, particularly on cancer, can make one other person’s journey better than mine, it is a gift. I have spoken to Graham Silk about that, and he agrees, as do the many people I have campaigned with. As Christina and Les say, being the first to gift data makes someone feel that they have done something really special. Even if it gives someone with a complex disease to a small amount of additional time, we have given someone else a very special gift.

It is important that the risks are moderated, but we must also consider the benefits and what we can win. Many patient groups show involvement rates of getting on for 100% when people know that their information will go to others. My hon. Friend mentioned the cystic fibrosis group, which has an involvement rate of 98%. We need strong leadership to draw the strands together, a common understanding and a national agreement to optimise sharing in a safe, transparent and trustworthy way.

The risks and benefits of sharing data have to be explored, but those who talk only of the risks will miss the benefits. I would like to see a chief clinical informatics officer. I look to the Minister to lay out his vision for standardising, resourcing and futureproofing the system; drawing together the ongoing work; and achieving the momentum needed for greater data sharing to improve both the health and the wealth of our nation.

[Stephen Metcalfe (South Basildon and East Thurrock) (Con)]

It is a pleasure to speak in this debate, despite not thinking I would. I am actually a Parliamentary Private Secretary in the Department for Education, but I was asked to stand in this afternoon for the Minister, whose PPS could not be here. Suddenly I find myself for the first time ever keeping a holding pattern in advance of a Minister getting here. I suspect the confusion has arisen because the debate that was supposed to take place at 1.30 pm was cancelled, and this one was moved forward. I only discovered that this morning by spotting on the Order Paper that there was no debate other than this one. I suspect the Minister suffered the same problem.

[Geoffrey Clifton-Brown]

Given the way that my hon. Friend is handling his situation, I am sure it can only be a matter of time before he is elevated to ministerial status.

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[Stephen Metcalfe]

I thank my hon. Friend for those remarks; she is absolutely right. We have been talking about people suffering with rare conditions and about putting them together and spotting patterns, but tackling health inequality by comparing data from different parts of the country and by comparing, perhaps, people’s longer term histories is equally important. It may also help policy makers to find a way of developing a geographically stratified approach to tackling some of these health inequalities. Just moving on slightly, I think that part of why clinical commissioning groups were established was that they would allow doctors and clinicians locally to identify what was in the interests of the people they represented. Of course, using data to do that is vital, so I could not agree with my hon. Friend more.

[Geoffrey Clifton-Brown]

Before my hon. Friend moves away from the subject of healthcare, does he agree that we need to concentrate much more on preventive healthcare, rather than on the palliative treatment of health issues? Often early interventions, or even action taken to prevent a condition from occurring in the first place, can be far more effective for patients and more cost-effective for the NHS than treating symptoms once they have arisen.

[Stephen Metcalfe]

I agree completely. Prevention is always better. Sometimes we find that we have discovered the way of preventing something after it has been contracted—that may sound a bit confused. I am trying to say that if we have enough information in advance, we might be able to tell the right people how they might prevent themselves from getting a certain condition. We could identify them, identify the risk, inform them and hope that they do not then fall into the trap, as opposed to having found them with the condition and then saying, “If you had done this, you would have been able to prevent that particular condition.” My hon. Friend is absolutely right.

The wider benefits to the economy are the second, very important part of this. We have talked about the huge benefits and about making the United Kingdom—England— particularly with the fantastic NHS, the best place to develop, research, test and trial drugs, which has to be for the benefit of our constituents. If we have earlier access to new treatments, that can only be to the good. My hon. Friend used the excellent example of Cure Leukaemia in Birmingham and it sounds as though having that model rolled out across the country would be beneficial to many. I will certainly bring that particular aspect of my hon. Friend’s remarks to the Minister’s attention.

I shall start to wind up. We have to address a number of challenges to bring the ideas to fruition. When we talk about data, people get a little jittery. They think that we, as the authorities, are starting to collect information on them that they would not necessarily want collected, so the anonymising of data will be vital, as will ensuring that people understand how their data are used and how they can have access to their data and protect themselves.

[Geoffrey Clifton-Brown]

I emphasise to my hon. Friend that the most important thing that should come out of this debate is not the fact that data are a good thing—we all admit that—but that we need, from the Government, a way to push this forward. I and my hon. Friends have made a number of suggestions: there should be a public information campaign, common standards and perhaps a commissioner for data—or some such post—so that on a national basis we can really give this whole thing a push. Up till now, progress has been far too slow. We need to push things forward, so that we can really gain the benefits from it.

[Stephen Metcalfe]

My hon. Friend is completely correct; that is the key. It is about making sure that the Government put in place the correct mechanism not only to protect data but to give people confidence, and that is one of the biggest challenges that we face. I will make sure that is heard loud and clear.

The other big challenge is having the correct personnel to analyse the data. A major challenge for big data as a whole—not just in the clinical setting—is to have people who understand how the data work. Big data will be worth many billions of pounds to the UK economy over the next few years, and not just in the health sector, so we need to make sure that we have the right stream of well-trained, informed people coming through.

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

Thank you very much for making that point, Mr Wilson. It is a great pleasure to be here, and I am extremely disappointed not to have had notice that the debate had been brought forward. I am assiduous in attending these excellent debates in Westminster Hall, and on this subject more than any other. I will be having strong words with my office to ensure that I understand why the information was not communicated to me that the debate had been brought forward. I can only offer my apologies to hon. Members, all of whom know my passion for this subject. If there is any debate I would most want to have been at, it is this one, so please accept my apologies. I was alerted about six minutes ago that the debate had started, and I ran here. I cannot understand why this has happened, but I will happily look into it.

Thank you for the opportunity to respond to the debate, Mr Wilson. I start by congratulating the Backbench Business Committee on granting it and my hon. Friend the Member for The Cotswolds (Geoffrey Clifton-Brown) and the others who have spoken. I will say more in a minute about the points that they made, but it is incredibly timely to be having the debate now. I am grateful to the hon. Member for Bristol South (Karin Smyth) for her long list of questions, which I will do my best to plough through. If I miss anything, I will happily write to her to deal with it, particularly on one or two of the more detailed questions.

I genuinely thank my hon. Friend the Member for The Cotswolds for bringing this subject to the House. Although it perhaps is not a topic that is discussed down the Dog and Duck, many of the issues that it speaks to are discussed down the Dog and Duck—modern healthcare, research and the NHS’s role in helping to find new cures. My hon. Friend has been a doughty advocate of this subject in the House, not least in his advocacy of the Empower: Access to Medicine campaign on behalf of his late constituent, Les Halpin, who has been an inspirational figure to him and to many of us.

I also thank and pay tribute to my hon. Friend the Member for Bury St Edmunds (Jo Churchill), who has made a reputation very quickly in the House on the subject of medical research as a double cancer survivor herself and as a passionate advocate of how we can accelerate innovation in the NHS and harness the NHS as a catalyst for innovation and accelerated access to new treatments and drugs. My hon. Friend the Member for Twickenham (Dr Mathias) brings to the debate considerable professional expertise, as well as the passion with which she has spoken here this afternoon and elsewhere in the House.

The hon. Member for Bristol South gave a genuine signal of bipartisan, cross-party support for this broad agenda, which is extremely welcome. There are issues in the House on which it is entirely appropriate for the Government and the Opposition to knock seven bells out of each other. It is the Opposition’s job to oppose and ours to govern, and democracy would be ill served if we did not, but there are topics on which it is in the public interest that we seek agreement, and medical research is one of them. Indeed, in this Chamber on Monday of last week—it seems like a month ago—we had an incredibly packed debate, perhaps the most packed debate in Westminster Hall ever, on brain tumour research. The House was speaking with one voice, and I was delighted to be able to respond, surprise some and launch a working party to take forward the points that were made.

I thank the hon. Member for Bristol South for her signal of support in principle. That is heartfelt because this agenda—the use of data in a 21st-century health service to accelerate the search for cures and to prevent unnecessary suffering from tomorrow’s diseases and those that we do not have treatments for today—is precariously at risk from badly communicated policy and a media, public and political discourse that sometimes misses the detail of how data are actually being used. It is all too easy to jump on a bandwagon and launch a campaign to say, “No data to be used”. That would profoundly betray those who are suffering from disease today who want their experience to help to prevent disease tomorrow, and the pioneering clinicians, doctors, academics, researchers, charities and patients who have done so much to demonstrate the important role that data have to play in research. I therefore genuinely welcome the hon. Lady’s support in principle. I respect that that means she wants specific questions answered, and I will do my best to answer them.

I want to set the scene as to how and why the debate has come to a head, why the digitalisation of the health service and the use of data in health have become so topical, and why we have reflected that through the creation of this new ministerial role in the Department of Health. As the first Minister for Life Sciences, with responsibility for all of digital health and health data within the Department, I want to say something about the Government’s fundamental commitment to securing and safeguarding public trust and confidence as the bedrock of the digitalisation of the NHS. I will then say something about the commitments that we have made to that programme and the timetable and funding for it. I particularly want to pick up on the question of electronic health records, on which my hon. Friend the Member for The Cotswolds has rightly focused today’s debate, and how we see the electronic health record revolution in this Parliament and beyond transforming the three key pillars of the debate: individual care, system safety and performance, and research. When people ask why we need data, those three pillars are my first three answers.

I came to this agenda from the research end, after a 15-year career in biomedical research. In the past 15 years, the power of informatics—the power of applied computing—has come to transform how drugs are discovered. I am talking about individual data on the deep history of a patient’s journey through disease—their genomic predisposition, their clinical records and the way they react to different drugs—but also, on the other axis, about large-scale, anonymised cohort studies of patient experience. We can look, for example, at diabetes patients; why do 80% of UK diabetes patients respond in this way and not that way? A combination of large-scale, anonymised cohort studies and individual, in-depth personal patient histories can change, and indeed is changing, the way drugs are discovered.

I have seen with my own eyes in the industry how, in the last 10 years and even in the last five, work has very quickly come back to clinical assets and to starting the process of discovery with patients—with tissue, with data, with the clinical, human experience of disease. Understanding how different patients live with disease and respond to drugs is the starting point for research. The way the industry worked when I first joined it was that one would start with a theoretical, academic target for a possible drug and then go through an expensive 15-year process—it would now cost $2 billion—of long-term academic work followed by the pre-clinical stage and phase 1, 2, 3 and 4 trials, only to discover in about 80% of cases that the drug did not work in people. The industry is rapidly changing, to start with the experience of real people with real disease and to understand how disease takes hold in real people in real time.

One of the many benefits of this revolution is that we will reduce our dependence on animal tests. There will always be a need to involve animals in research, but we can reduce that need to an absolute minimum. The more we can start with data and an understanding of how particular patients respond, the more we can dramatically accelerate our search for both diagnostics and treatments.

As I said, I came to this agenda from the research end. Research has been significantly accelerated in this country over the past 20 or 30 years, for instance by the creation of the National Institute for Health Research and by the work of Professor Dame Sally Davies, the chief medical officer, in funding and setting up our clinical academic research centres. It is my great privilege to be the Minister responsible for that £1 billion-a-year infrastructure, and for the comprehensive biomedical centres that we have set up. For the past 15 to 20 years, there has been phenomenal use of data in tertiary research hospitals to drive research and improve care.

In many ways, the aim of the programme that I will discuss in a moment is to spread out the benefits of that advanced modern healthcare, and the embedding of research in clinical practice, to the rest of the national health service. For research purposes, the use of data is not an optional extra; it is an absolute fundamental. No researcher in the world would dream of trying to run a research programme without access to up-to-date data.

The programme is also about system safety and performance, and about individual care. If hon. Members have been to a GP clinic or a hospital recently, they will have quickly noticed that all the diagnostic devices and most pieces of treatment equipment are digital. Health is going digital. Conferences refer to digital health as if there were still analogue health, but health is going digital very fast, just like every other aspect of life. If the system is to give patients individual care, we have to digitalise it.

Any of us could, God forbid, clutch our chest, go down and need an ambulance. When the ambulance comes for me, I want the staff to have not a biro and a pad but an iPad. I want them to know my blood group, my allergies and my history when they get to me and when I go to A&E. Hon. Members might be amused that when I first gave a speech on this topic, I referred to a photograph outside my office in the Department of Health. It is an inspiring photograph of the NHS, there for us 24/7: a picture of a paramedic leaning out of an air ambulance over some remote island, probably in the Shetlands. A wave is breaking on the lighthouse, the poor patient lies in the heather waiting for the ambulance, and out of the air ambulance leans a paramedic holding a pad of paper and a biro. I said that when they come for me I want them to have an iPad, and the photograph was taken down within days of my speech, which was the first small sign of progress.

The important point is that we have set a target to ensure that electronic health records are used first in A&E, because that is where rapid response—getting the right drug to the patient—has the most dramatic effects. That is true across the care pathway. Most constituents say to me, “Mr Freeman, when I go from the GP to the hospital to the care home and back to the hospital, why do I have to repeat my diagnosis and my treatment history to the clinicians? Surely my patient record should follow, or even go ahead of me, through the system.” That point is very well made.

Most of my constituents desperately want individual care, so that the system knows who they or their loved ones are when they arrive. When somebody arrives at hospital after being referred by a GP, they want the hospital to know who they are, why they are there, what the referral was for and what the treatment is.

[Geoffrey Clifton-Brown]

The Minister has a huge knowledge of the subject, and I respect enormously what he is trying to do. One thing that has come out of the debate is that there is still a significant amount of public resistance to digitalising patient medical records. However, it is clearly in the interest of all of us. Those of us speaking in this debate are converted to the benefits of digital records. Will the Minister consider running a Government public information campaign showing the distinct benefits of digitalising patient medical records and how it can help the NHS? Will he also consider creating some form of post within Government to oversee the process—something like a health information commissioner—so that there is consistency right across the NHS as to how the digitalisation will be rolled out?

[George Freeman]

My hon. Friend makes an interesting point. I will come to our plans, and to the process and timetable for setting out the national data guardian’s recommendations on how we should proceed. I would expect that one of her recommendations will be about the importance of communicating to the public and patients why data are so important. As part of the annual National Institute for Health Research Parliament day that I launched, we might have a themed event focused on the power of data and why they are so key to a 21st century NHS.

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[George Freeman]

Thank you, Mr Wilson. Having arrived a little late, I was taking the opportunity to deal with the points that my hon. Friends and the hon. Member for Bristol South have made. I will do my best to expedite matters for you.

I want to make the point that the covenanting of public trust and confidence is completely central for the Secretary of State and me. We want to make sure that the public have faith and confidence that we are not in any way playing fast and loose, and I hope that the measures I have announced will go some way to underpinning that.

We have also gone further. People have been concerned about the selling of their data for purposes beyond healthcare—commercial purposes—particularly those that may prejudice their eligibility for healthcare. We have not only made it clear that that is unacceptable; we have made it illegal and imposed a substantial fine and penalty on it. We need to use data but we need to use them appropriately, and we need patients and the public to know that that is our commitment.

On the commitments that we have made, we have secured funding from the Treasury for the completion of the paperless NHS 2020 project, which the Secretary of State has set out in other speeches in some detail. It is a £4.2 billion funding commitment, and in the past few months, since the completion of the comprehensive spending review, officials in the Department of Health, in NHS England and in the Health and Social Care Information Centre—which I recently announced is to be renamed NHS Digital—have been working on a complex work plan for seeing this through. It comprises 26 workstreams in six domains, and we are very committed to making sure that this is properly managed with clear milestones and clear accountability procedures. The project is complex and some things will not go according to plan. We need to make sure that we are on top of that and bringing the very best levels of management to that project.

I want to cite one or two examples of where we are profoundly leading in this space. One is a project for which I have ministerial responsibility—the 100,000 Genomes Project, in which we are sequencing the entire genomes of 100,000 volunteer NHS patients, and combining those with hospital data to form the world’s first reference library for genomic medicine. All the information is consented, and the project represents a pioneering showcase of the use of data in 21st-century health research. We have also launched a genomic medicine service in the NHS through the 13 genomic medicine centres. We want the NHS to pioneer genomic diagnosis and treatment, particularly in cancer and rare diseases. It is a shining informatic and digital data programme as well as a genetic science programme.

I also want to highlight a project that I recently saw, which goes to the other end of the spectrum: the day-to-day management of disease. It is a diabetes service pioneered, to my great joy, by Litcham surgery in my constituency. It involves patients self-monitoring their blood sugar levels, and barcode and digital transmission of that information back to the GP practice. I went to see it in use. Patients go to the consultation and the nurse comes with their data, which is used to monitor their precise condition. That leads to the use of the very latest drugs in ever-more accurate precision dosing and comparative data across all participating GP clinics, which drives up standards. It is a brilliant example of data being used to improve care and the use of novel and precision medicines in the NHS.

[Geoffrey Clifton-Brown]

I alluded to that in my speech. The next stage on from that is for the individual patient to be able to access the data themselves, which I do not think they can in the example that the Minister cited. I think there have been cases where patients have hacked into the data to get the information for themselves so that they can then see what is happening to their own body and adjust the amount of a particular drug—insulin or sugar or whatever it happens to be—without having to have recourse to a nurse or even a hospital.

[George Freeman]

My hon. Friend makes an interesting point, as did my hon. Friend the Member for Twickenham. As part of this quiet revolution of patient empowerment, the clinicians I speak to actively want their patients to have the data and are encouraging them to have it. This is where the apps revolution comes into play, because that is one of the ways in which we are putting this information in the hands, laptops and phones of patients. He is absolutely right that care is improved, but we want to improve patients’ understanding of their condition and improve patient empowerment.

The other example I want to cite is an inspiring example set up at King’s College London by Professor Simon Lovestone: the case register information system in mental health and psychiatry, which is a difficult area of research, as colleagues know. It puts together patient records from across the 250,000-patient catchment area of South London and Maudsley and combines them with MRI brain scans, the digitisation of patient medical records and very complex drug histories in mental health, to build the world’s first reference database for trying to understand the causal mechanisms for complex psychiatric disorders. It has attracted phenomenal industry co-investment alongside the NIHR centre of excellence and is a shining example of how we can use information and data to drive both research and improved care.

On electronic health records, which are important and which this debate was focused on, the ultimate goal is to have a system in which our individual health records flow seamlessly across the system in advance of patients. That is the goal of the paperless NHS. We have set out a series of specific commitments—I can write to the hon. Members here about them—for this year, next year, 2018, 2019 and 2020. They set out clear targets for how the electronic health record will be used and brought to bear—percentages of penetration in A&E, in the ambulance service and then mainstream across the service.

My hon. Friend the Member for The Cotswolds makes an important point. We need to identify some early uses of electronic health records, which may not be comprehensive and universal, and put this benefit in the hands of patients as quickly as possible. One of my missions is to ensure that we get some basic but powerful uses of electronic health records in iPads, phones and devices, so that patients can see their experience beginning to improve today.

--- Later in debate ---

[Geoffrey Clifton-Brown]

I am very grateful for the opportunity to discuss what has, as I anticipated, turned out to be an incredibly important subject. Clearly, digital records will be transformational in the NHS and will hugely benefit patients; they could enable the NHS to do much more for less and make possible the quicker development of more drugs, particularly for terminal and rare diseases. The effect could be that drug companies would want to remain here to develop and research their drugs—they would have an environment in which they could do that.

I believe—this is where I started in the debate—that some of what the Minister has told the House this afternoon reveals amazing progress in the NHS, which a public information campaign could show. I bet that very few people know that their local pharmacy could have full electronic access to their patient records, so that they could go in and say, “I’ve got this problem,” and the pharmacist could answer, “I am able to access your patient records if you give me your NHS number.” I assume that is how it works. The pharmacist could then look at the data and say, “You have been on a particular drug, and for your condition you should go and see your GP,” or, “There is another drug that would suit you better.” That sort of decision making would keep more patients out of their GP surgery and A&E and would have a distinct impact on the NHS, because it would reduce costs. The whole tenor of the debate has been to show that the NHS can be transformed by better data use—as the Minister’s Parliamentary Private Secretary, my hon. Friend the Member for South Basildon and East Thurrock (Stephen Metcalfe), said—by being able to store data properly and get access to them at a later date.

The Minister will know that I have come to this issue from Empower’s access to information campaign, and the idea of its being possible to use the data across a particular cohort of patients. I used the example of the Cystic Fibrosis Trust, 98% of whose patients are on a data record base. It can use the data to begin development of the drug for the next strain of cystic fibrosis. That is the ideal way in which the system should work.

I am grateful for the opportunity to speak. The debate will go on. Perhaps once the Caldicott report is published, and when the Government have set out how they may go about the public information campaign and the new Information Commissioner is in place, it would be appropriate for the House to have another, similar debate. That could perhaps be on a more mainstream day, when more Members could participate. The subject is so important that we should not leave it here.

Question put and agreed to.

Resolved,

That this House has considered use of digital records in the NHS.

Meningitis B Vaccine

Geoffrey Clifton-Brown Excerpts

Monday 25th April 2016 Westminster Hall

[Ben Howlett]

I thank the hon. Gentleman for his intervention, and my condolences go to Mia’s family, because obviously anybody who is lost to this tragic disease is a loss overall, and it is horrendous what Mia’s family have had to go through; I have seen that with the family of my own constituent, and as MPs no doubt we have all seen that. There is a question around age, and I will come on to that shortly. Like Mia’s family, Lee Booth is calling for the Government to extend vaccinations up to the age of 11, and I think that we need to review some of the evidence today.

[Geoffrey Clifton-Brown (The Cotswolds) (Con)]

I congratulate my hon. Friend on leading this very important debate. I have been involved in this campaign for a considerable while. Does he agree that there is not an issue about the safety of the drug, because it is very safe—we know that because it has been used very safely on students in American universities—and that it is simply an issue of cost?

[Ben Howlett]

I thank my hon. Friend for his intervention; I am aware of his work in championing this cause, which he has done for a while. I very much hope that the Minister will consider that point when she makes her summation.

Although it is quite difficult for all of us as MPs to say this, throughout this debate we must of course keep at the back of our minds the fact that the NHS has finite resources. Everything that the NHS provides has an element of cost to it, and a life cost-benefit, too. However, along with many other Members, I worry that the long-term benefits of childhood vaccination and the life chances that vaccination can give to so many children are not being considered as much as they should be.

--- Later in debate ---

[Geoffrey Clifton-Brown (The Cotswolds) (Con)]

I am delighted to serve under your chairmanship, Mr Pritchard. I echo a feeling of sympathy for my hon. Friend the Minister, because in a sense she is the meat in the sandwich. Time after time she has to answer such debates, but, as she and the House know—the hon. Member for Foyle (Mark Durkan) certainly knows this, because he had an Adjournment debate on 7 July 2014 on this subject—there has been an ongoing campaign on this for a long time in the House.

My hon. Friend the Member for Bath (Ben Howlett) is right that meningitis B is a terrible disease that—as other hon. Members have said—comes on suddenly and, at least in the early stages, is often not recognised by health professionals, let alone parents. More publicity should be given to the disease so that people are aware of what to look for. Given that only yesterday I heard a public health advertisement to encourage parents to get their babies vaccinated against MMR, I am not sure why we should not have such a publicity campaign for meningitis B.

The Bexsero vaccine was first licenced by the European Medicines Agency on 1 January 2013. The Minister wrote to me in April 2014 and said that it would be rolled out for children under two months, with a one-off catch-up programme for children born between 1 May 2015 and 30 June 2015. I use that illustratively, because at that stage we did not know when the vaccine was to be introduced. The Minister will say that by 2017 all children under two years will be covered, but if the vaccine had been rolled out at the time of my Adjournment debate, in which we were urging the Minister to do that for all children under one, more children would have been covered. In that debate she said:

“Children aged less than five years are most affected by MenB…the peak of the disease is in infants aged 6 to 12 months.”

She went on to say that

“MenB is fatal for about one in 10 of those who develop meningitis…With early diagnosis and treatment, most people can make a full recovery”.

That is true. She also said:

“Incidence has been decreasing in recent years…but it is unpredictable and it could rise again quickly.”—[Official Report, 7 July 2014; Vol. 584, c. 137.]

The disease has an unfortunate habit of falling and rising in incidence, so it could very well start rising again. The Joint Committee on Vaccination and Immunisation set up a working party in 2013—I think in June—to look at vaccinating all children under one year. What has happened to that working party? Have we got the results yet?

This is an unfortunate issue, because as many hon. Members will know—particularly those who have had young children more recently than when my two were youngsters—we often have to take young children to the surgery anyway, so the costs to the NHS of administering the vaccine would be minuscule: just the cost of the drug. There is also a unit cost issue—if GlaxoSmithKline had to make more of the vaccines, presumably the price would come down. I urge the Minister to consider the anxiety that the disease causes and the vast number of people who signed the petition. It was the largest petition ever for such a debate, and I pay great tribute to the House for changing its procedures to introduce such interactive debates so that we can consider the concerns of large numbers of constituents on such issues. I originally got involved in the meningitis B campaign after my constituents, Dr and Mrs Turner, contacted me about their granddaughter, who sadly died from the disease, but it obviously concerns large numbers of constituents.

We should not consider this vaccine as just an issue of cost. We know that the drug is safe. It has been licensed since 1 January 2013 and in the United States, the student cohort at many universities received the vaccine at least two years ago, and it was also trialled in adolescents at a university in this country. It therefore appears to be safe, although the JCVI wants to look at that issue. I say as gently as possible to the Minister that we should not let this be purely an issue of cost. If we have a drug that works—we know it is effective—and it is simply an issue of cost, we should at least consider rolling it out to all babies under one year old and preferably to all children under five.

[Caroline Ansell (Eastbourne) (Con)]

My hon. Friend makes a powerful case for the drug’s safety. We just heard an agonising story from my hon. Friend the Member for Bury North (Mr Nuttall) about Charlie and his experience, so does he agree that the cost and suffering of those who survive men B should be factored into the consideration of a catch-up scheme?

[Geoffrey Clifton-Brown]

I entirely agree. I will ask the Minister to clarify this, because when I sat down she said sotto voce that it is one year, but my information is that, from when it started, it was for all those under two months of age on 1 September 2015, with a one-off catch-up programme for babies born between 1 May 2015 and 30 June 2015—those who were three or four months of age when the programme was launched. Therefore, while by now it may have nearly spread to one year, that was not the case when it was introduced. We should consider rolling it out definitely to those who are one year old today and preferably to those a little older as well.

I turn to the Department of Health’s cost-effectiveness methodology for immunisation programmes and procurement—the so-called CEMIPP, which is a dreadful acronym. The Minister will tell us that that looks at the life-cost issues, but those who contract meningitis and suffer long-term effects face not just the £30,000 to £40,000 of costs my hon. Friend the Member for Bury North (Mr Nuttall) mentioned, but considerable lifelong costs afterwards. The discounting rates, as hon. Friends have said, are particularly mean in that respect, so to look at the issue in the round we must look seriously at the cost to the public purse of not vaccinating. That route could show us more clearly that a roll-out to a larger cohort would be cost-effective.

[Neil Carmichael (Stroud) (Con)]

Meningitis Now is headquartered in my constituency. To follow on from my hon. Friend’s point, should we not think that prevention is better than cure? That should be the overall strapline to the debate.

[Geoffrey Clifton-Brown]

My hon. Friend is right. I pay tribute to the charity based in his constituency and to the other meningitis charity, because they have been campaigning for many years on meningitis B and all the other strains.

The point about rolling out the vaccine to the cohorts—I urge the Minister to go further than that—is that my understanding is that once someone is vaccinated for meningitis B with Bexsero, they are covered for life. Therefore, if more cohorts are covered by the roll-out, more of the population will be covered and the entire population will become less susceptible.

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

My question follows on nicely from the point made by the hon. Member for Stroud (Neil Carmichael) in his intervention about the long-term costs. I first came across this issue at a reception held by Meningitis Now. I commend that charity and the Meningitis Research Foundation for their excellent work. In terms of special educational needs, long-term costs can come in when a child reaches 12 or 13 and it becomes apparent that they are not developing at the same rate as other children. All sorts of educational implications should be factored into the long-term costs.

[Geoffrey Clifton-Brown]

I could not agree more. That is why the CEMIPP group study should look at not only the medical costs but the educational costs, the cost of carers and so on. There are considerable costs to the public purse. We tend, under our democratic system, to be quite short-termist in our view of such matters. I am involved at the moment in work on drugs for cystic fibrosis, to which exactly the same issues apply. After the considerable cost at the outset, there is a lifelong benefit to babies from getting such drugs. If we are going to carry out a cost-benefit analysis for the meningitisusb B vaccination, that is what we should consider.

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

I agree with the vast majority of what the hon. Gentleman says. In actual fact, it was not possible to trial Bexsero in humans because this is such a rare condition, and therefore we do not yet know whether the immunity will be for life.

[Geoffrey Clifton-Brown]

I am extremely grateful to the hon. Lady. The benefit of these debates is that we always have a professional on hand who can give us the last word on the subject. My sister is a GP and would no doubt have given me that same advice.

I am grateful for the chance to speak in this debate. This is a tragic disease with tragic consequences. I urge the Minister to go further, and faster in rolling out a good, safe vaccine that will give immunity to a larger section of the population.

[Several hon. Members rose—]

--- Later in debate ---

[Dr Wollaston]

I thank my hon. Friend. In fact, I will take us back even further by mentioning Ben Franklin, who said that

“an Ounce of Prevention is worth a Pound of Cure.”

He was referring to fire services in Philadelphia, of course, but the principle still stands.

In paying tribute to all who have brought us to where we are today, we should remind ourselves that vaccination is becoming increasingly complex to develop. Bexsero is being developed through reverse antigen mining and is extraordinarily expensive. That is why we have to consider cost-effectiveness, because in a system where finances are limited, what might be displaced if a new intervention is funded? In other words, we in this House and beyond have a responsibility to ensure that the money we spend can save as many lives as possible, and to consider that in the round.

That is why it is important to take account of the work of the Joint Committee on Vaccination and Immunisation in making its incredibly difficult decisions and judgments. It is absolutely important that we allow the JCVI to carry out its work without undue political interference. The role of this House is, of course, to raise awareness and to hold the Government to account for the way in which—and the framework under which—the JCVI operates. However, our role must never be to lean directly on members of that committee in the very difficult decisions that they make. I pay tribute to the JCVI—to Professor Andrew Pollard and his team—for their work. Their decisions are extraordinarily difficult, and they need to apply the science with a combination of judgment and sensitivity. It is absolutely right that we regularly review the criteria that they are able to take into account.

I thank the Minister for her letter today confirming that the cost-effectiveness methodology for immunisation programmes and procurements working group, or CEMIPP—it may need a catchier title—is going to publish its work in full. Perhaps she will say whether she has now received that report. It is absolutely important that the principle of transparency applies, so that we can all be clear about the decision-making process.

I support Members who have said that we should review the so-called discounting rate if it means that, as my hon. Friend the Member for Faversham and Mid Kent (Helen Whately) has pointed out, by the time someone is in their 20s, effectively no account is taken of them. It clearly seems reasonable that we apply the same principle that is applied to public health decision making in the NICE methodology, with its lower discount rate, so that we can take full account of that situation. It is also right for the House to reflect on views beyond this place by thinking, for example, about the social costs. I do not wish to repeat the many important points that have been made about that today.

The JCVI’s independence is absolutely vital. We in this House are not in a position to make judgments about the effectiveness and safety of vaccination. We have to rely on experts, and we are very grateful to them for their work. However, one thing that we have to do is hold the Secretary of State to account for implementing the decisions of the JCVI in a timely manner and for the time that it takes to carry out the negotiations on the cost of vaccines.

I would like to make a further point, which I do not think Members have brought up today. The level of variation in the roll-out of existing vaccinations needs to be looked at. During the Health Committee’s current inquiry into public health, we have been hearing evidence about the difficulty that public health professionals and directors of public health have in being able to access the data and information that they need to tell them where the gaps are in the roll-out of vaccination. Perhaps the Minister will update the House on where we are in that regard, because it clearly cannot make sense that artificial barriers have sprung up between those who are responsible for implementing the programme and those who are delivering it on the ground. It would be helpful to have an update on that issue.

It is also absolutely right that the House holds the Minister to account on what is being done to follow up the work that is happening on sepsis. As she will know, early diagnosis is critical. Although we want to focus on the number of cases that we can prevent, we cannot prevent them all, so we must also focus on early diagnosis and intervention and on ensuring that we have the right pathways in hospitals, so that the time it takes from the moment someone enters a hospital until they receive life-saving antibiotic therapy is kept to a minimum. Perhaps the Minister will update us on that.

[Geoffrey Clifton-Brown]

I hesitate to intervene on my hon. Friend, especially as she is such an expert on this subject, but as I understand it, Bexsero was licensed by the European Medicines Agency on 1 January 2013. It was not introduced in this country until more than two and a half years later, and people will have died of the disease in the interim. Does my hon. Friend not think that is too long a process when the argument is not about the safety of the drug but purely about the price? Something needs to change. The negotiation with the drugs companies needs to be done in a different way.

[Dr Wollaston]

I agree that there needs to be a better and faster procedure for negotiating about cost, but we cannot get away from cost, because, as I mentioned, cost-effectiveness is not an abstract concept. It means asking, could we save more lives by spending the same amount of money differently? If the cost of the drug is exorbitantly high, would it be better to invest the money in, for example, early diagnosis and intervention? Those complex decisions should not be made by politicians. Politicians and the public should be part of the process that sets the guidelines and advises the committee, but it is not for this House to make those decisions, although I absolutely agree that of course it would be better if the negotiations could be done more quickly.

I end where I began, by paying tribute to the very brave families for the evidence that they gave. I hope that the Minister will do everything in her power to ensure that we reach decisions as quickly and as fairly as possible.

[Philip Davies in the Chair]

--- Later in debate ---

[Jane Ellison]

I have only had initial conversations with Public Health England about the shape of the campaign, but I can assure my hon. Friend that the officials and the other people working on this campaign will look very carefully at what has been said today, and at some of the ideas that hon. Friends and other Members have put forward, and of course they will take all those points into account.

[Geoffrey Clifton-Brown]

I fear that I am becoming the bane of the Minister’s life over this issue, so I apologise, but I am grateful to her for giving way. One of the issues that I raised in my speech was the unit cost. As I understand it from her reply today, she does not think that there is a case yet for rolling vaccination out to children under five. Would she undertake to keep this matter under review, and would she also undertake to ensure that the JCVI, or Department of Health officials, will continue to have discussions with GlaxoSmithKline on what the drop in the unit cost might be if all these extra vaccinations were given to under-fives?

[Jane Ellison]

I can assure the whole House that the JCVI keeps that under constant review. It is not something that is occasionally dusted off and looked at every four or five years. The committee looks at all the factors that go into making the relevant decisions. When the factors that contribute to its decision making change, it looks into them. I have already given the House the assurance that the JCVI will keep that under careful review. The Select Committees heard directly from Professor Pollard and had that assurance from him. However, I will draw the JCVI’s attention to the concerns raised in this debate and the huge level of interest in the matter in the House and among the wider public.

As came out in the evidence that the JCVI gave to the Health Committee and the Petitions Committee, under the current cost-effectiveness criteria, the men B vaccination programme was only just cost-effective even for infants on JCVI’s final analysis, but we did not shy away from introducing it because we know how devastating meningitis can be and how important protecting children from it is to parents. That is why we became the first country to have a programme of using Bexsero. Many other countries have asked experts to consider men B vaccine programmes, but because the cost-effectiveness is so borderline, to date only Ireland has recommended a programme. I understand that it will start in the autumn, using the same criteria as the UK’s programme. We are leading the way in protecting our children from men B.

As I draw my remarks to a close, I want to reiterate Members’ thanks. I appreciate the fact that so many Members have expressed their thanks to Professor Pollard and the JCVI for the complex and important work that they do. That also goes for the many clinical experts who give us their expertise on which to make these enormously difficult decisions.

A and E and Ambulance Services

Geoffrey Clifton-Brown Excerpts

Thursday 18th December 2014 Commons Chamber

[Mr Hunt]

My hon. Friend is absolutely right. One of the most heartbreaking things is to see someone with advanced dementia arriving in an A and E department. People do not know anything about their medical history and the best care that they need, and it becomes very difficult for the hospital to discharge them in that situation. Having proper personalised care wrapped around those individuals will normally mean that hospital is not the best place for them to go. Indeed, to echo the comments that have already been made, the key to that is knowing where they would like to die. Very often it is not hospital, so we need to be much better in that regard.

[Geoffrey Clifton-Brown (The Cotswolds) (Con)]

Will my right hon. Friend examine the discharge situation in Gloucestershire Royal hospital? We had an instance this week of which he may be aware of clinically fit patients not being able to be discharged. We have some excellent community hospitals in Gloucestershire. Will his Department examine that problem to ensure that all branches of the NHS—the acute trust, the care services trust and the commissioning group—work closely together to avoid that problem becoming a real issue in the new year?

[Mr Hunt]

I thank my hon. Friend for championing care for his constituents. Let me reassure him: I had a meeting on that very issue on Monday. It is important that the NHS community care sector plays its role alongside the social care sector in making effective discharge possible.

Meningitis B Vaccinations

Geoffrey Clifton-Brown Excerpts

Monday 7th July 2014 Commons Chamber

[Geoffrey Clifton-Brown (The Cotswolds) (Con)]

Thank you, Mr Speaker, for giving me the opportunity to raise the important matter of meningococcal B—or MenB—vaccines in this short debate. I also thank the Under-Secretary of State for Health, my hon. Friend the Member for Battersea (Jane Ellison), for kindly responding on behalf of the Government. I appreciate that I have dragged her to these green Benches at a time when she might well be negotiating with the drugs companies and it might be difficult for her to respond to every one of my points. Nevertheless, she will understand that I must make them on behalf of my constituents and other members of the public.

There will be a number of hon. Members in this House with constituents whose lives have been affected by meningitis B. I have constituents who have had to deal with the suffering and loss caused by meningitis B, which is why I am here today further to raise the need for a national roll-out of the vaccination. My constituents, Dr and Mrs Turner, who are here today, tragically lost their 19-year-old granddaughter on new year’s day this year. As you are aware, Mr Speaker, their granddaughter, Emily, and her parents are constituents of yours. Emily’s uncle is a constituent of my hon. Friend the Member for North Wiltshire (Mr Gray).

Meningitis B is a comparatively rare disease, with about 1,800 cases in the UK each year. According to the charity Meningitis UK, however, many thousands of people die as a result of contracting the illness. The infection progresses rapidly and can lead to permanent disability or death within 24 hours of the symptoms becoming evident. That is sadly what happened to Emily. One in 10 people who contract the infection will tragically die despite the treatment that is available today. Of those who survive, one in five will have devastating life-long disability such as brain damage, hearing loss or limb damage.

Infants under the age of one year are disproportionately affected by meningitis B, with the number of cases peaking at the age of about five to six months. However, there is unfortunately another peak during late adolescence when students mix at university. Those are the two age groups that are most likely to contract meningitis B and the fact that there is another peak later in life highlights the need for a vaccine during infancy to protect people from lifelong suffering from this potentially devastating disease.

Parents up and down the country were given a sense of hope when in January 2013 a vaccine was licensed in the UK as well as in Europe and the US. The Bexsero vaccine was developed by the drug company Novartis and protects against approximately 73% of the different strains of meningitis B with apparently limited side effects. That was obviously very welcome, but there have been extremely long and costly delays in implementing any vaccination programme. The vaccine was turned down by the NHS after being considered by the Joint Committee on Vaccination and Immunisation.

The passion felt by many members of the public that the vaccination should have been implemented straightaway has resulted in various petitions urging the Government to do so. The charity Meningitis Now, which I heartily and sincerely congratulate on its constant campaigning, delivered a petition of 36,000 signatures to Downing street. My constituents organised a petition of around 5,000 signatures and I had great pleasure in presenting that petition to Parliament earlier this evening.

[Jim Shannon (Strangford) (DUP)]

I thank the hon. Gentleman for giving way and for bringing this matter forward for consideration. Meningitis B numbers have halved in the past 25 years, but there is no room for complacency. Some of my constituents have experienced devastating effects from meningitis, so, as the MP for Strangford, my issue is whether the hon. Gentleman feels that the vaccine, when it becomes available, should be available to the whole of the United Kingdom of Great Britain and Northern Ireland.

[Geoffrey Clifton-Brown]

I am grateful to the hon. Gentleman for his intervention. As I shall discuss later, this is obviously a big and costly undertaking for the NHS. As I am sure the Minister will mention later, there are delicate negotiations to be had, but if we start with babies—preferably babies under the age of 12 months—and then roll it out to students, the whole population will eventually have been vaccinated. Perhaps that will take too long, and once we have vaccinated those cohorts of the population, we might be able to find the money later to vaccinate other cohorts, but let us start, for goodness’ sake. In particular, vaccinating young babies would be an important start.

In my view, and in the view of many others, the Bexsero vaccine should have been rolled out immediately. Doing so could have prevented around 600 cases of meningitis B, and the associated 200 deaths between January 2013 and now. Although there have been delays in rolling out this vaccine on a national scale in the UK, it has been available privately since December 2013 for parents able to pay the high price, and it has been used across several university campuses in the United States. I am sure the House would agree that it is unsatisfactory that where a vaccine has been licensed and is available for use, only those who can afford to pay can get it.

[Ms Margaret Ritchie (South Down) (SDLP)]

I congratulate the hon. Member for The Cotswolds (Geoffrey Clifton-Brown) on achieving this debate on an extremely important subject that impacts on many of our constituents. I have been tabling questions to the Minister about this. Does the hon. Gentleman agree that the most important issue is the time scale for the roll-out of this vaccine? I agree that the important age cohort is infants, and that vaccination should be rolled out to other age groups later.

[Geoffrey Clifton-Brown]

I thank the hon. Lady for her intervention. The key thing that we want to hear from the Minister tonight is an honest assessment of when the roll-out of the vaccine is likely to happen. That information will be particularly important to parents of young babies.

Within the announcement that there would be vaccine as part of childhood immunisation, the Department for Health stated that the Bexsero vaccine would be made available—I quote from a letter dated 25 April 2014 to me from the Minister—

“subject to it being made available by the manufacturer at a cost-effective price”.

That is the crunch point, as that will be a very large cost to the national health service, and the Minister needs to negotiate a good low price so that immunisation does not become prohibitively expensive. If anyone would like to see a copy of that letter, they should email me at [e-mail] and I will willingly send them a copy. I am told that I am not allowed to deposit it in the Library, otherwise I would do so.

There are three things that I would like to ask the Minister to do. First, what does her Department consider to be a “cost-effective price” for something that will save many lives in the future? Surely it is impossible to put a monetary value on young lives. I urge her not to base her decision solely on how much the vaccine will cost, but to look at the hugely positive effects that implementing a vaccine will have, especially when one considers the trauma that parents have to go through and the devastating pain of losing a young child suddenly within 24 hours. Indeed, there are large costs associated with not vaccinating, as it is estimated that every case of MenB which leads to a severe disability will cost the Government £2 million to £3 million during the life of that child.

Secondly, the announcement made in March confirmed that the vaccine would be introduced only for infants at two months old, with a limited catch-up period for babies up to four months. Given that, as I said earlier, cases peak at around five or six months and the illness remains most common in babies under one year, I urge the Minister to consider implementing the vaccine for all infants under one year old at the time of introduction, to ensure that we protect as many babies as possible. In her response tonight could the Minister inform me of the difference in cost between providing the vaccine for all two-month-old babies, with a catch-up for all four-month-old babies at the time of introducing the vaccine, and the cost of providing it for all 12-month-old infants? I appreciate that she might not have those figures this evening. If she does not know the figures, I would be grateful if she would undertake a cost-benefit analysis of vaccinating all 12-month-old babies and let me have the figures. That would be helpful.

Thirdly, as I said earlier, there is another peak of individuals contracting meningitis B during late adolescence, as my constituent’s granddaughter sadly did. At university, people’s lifestyle is totally different; they mix and get different germs, and unfortunately that seems to mean that they are more susceptible to this dreadful meningitis B. There is therefore a strong case for a roll-out of Bexsero to university students to prevent the spread among that age group. As I have said, some campuses in the US have already administered the vaccine to stop outbreaks of meningitis across the student body. When evaluating the costings, will the Minister please embark on a cost-benefit analysis of providing the vaccine to all 18-year-olds in full-time education?

The Joint Committee on Vaccination and Immunisation has recommended a study to inform its decision on whether to recommend a vaccine for adolescents as the second most at-risk group of people. In her letter to me of 25 April, the Minister told me that the Department is

“considering how best to proceed with this”.

I urge her to instigate the study as soon as possible to prevent any further delays. Once it has been decided how to develop the study, people must be recruited to it as soon as possible, and once the results are available, they should be presented to the JCVI without delay, so that a recommendation can be made quickly. Only with speedy action and decisions can we prevent any more unnecessary deaths and suffering as a result of meningitis B in this group.

I would like to end where I started. Thousands of families suffer from the devastating effects of meningitis B, but we now have a preventive vaccine, which is fantastic news. The vaccine has been licensed for 18 months without being rolled out by the NHS. That delay has had a devastating effect on families of individuals who have contracted the infection and died or become seriously disabled. Now that the JCVI has given a positive recommendation for roll-out of the vaccine, that should happen swiftly. I urge the Minister to conclude rapid negotiations with Novartis. I ask the drug company to enter those negotiations with the Government in a spirit of good will, so that we can get this vaccine rolled out as quickly as possible. I also urge the Minister to consider expanding the current proposal of vaccination to include children up to one year old and adolescents, so that we cover all high-risk groups.

It is now possible to prevent further tragedies similar to that of Emily and thousands of others. We have experienced too many delays already. Let us end those delays, make quick progress, and find ourselves in a situation in which parents are confident that their child will be safe from the devastating effects of this dreadful infection. Every day’s delay is a potential life lost. Please will the Minister act as quickly as she can?

[The Parliamentary Under-Secretary of State for Health (Jane Ellison)]

I congratulate my hon. Friend the Member for The Cotswolds (Geoffrey Clifton-Brown) on securing this debate on the meningococcal B—or MenB, as I think we will call it—vaccination. It is a hugely important topic to which he has done great justice. Obviously, this is a very topical public health issue. He is not alone in this House in having had constituents who have felt the devastating effects of MenB, and he put his case passionately; I certainly respect that. Of course, we recognise the devastating impact that MenB disease can have, and Members have described it. It is often known among clinicians and parents as a parent’s greatest fear.

Children aged less than five years are most affected by MenB. As my hon. Friend mentioned, the peak of the disease is in infants aged 6 to 12 months. MenB is fatal for about one in 10 of those who develop meningitis and/or septicaemia. With early diagnosis and treatment, most people can make a full recovery, but around a tenth of survivors have major physical or neurological disabilities, including amputation, deafness, epilepsy and learning difficulties, so it is truly devastating. It is, thankfully, relatively uncommon, with an average of about 1,000 cases per year in England and Wales over the last decade. Incidence has been decreasing in recent years, as was alluded to in an intervention, but it is unpredictable and it could rise again quickly. That is why the advent of a vaccine that could provide protection against MenB is so welcome.

If the House will indulge me, I will go over the history of the investigation into the vaccine and the work of the Joint Committee on Vaccination and Immunisation. It is worth noting for the record that the JCVI is an independent departmental expert committee that provides scientific advice to inform policy making. It is a statutory standing advisory committee for England and Wales under the National Health Service Act 1977. It has no statutory basis for providing advice to Ministers in Scotland or Northern Ireland, although Health Departments in those countries may choose to accept the committee’s advice or recommendations, and they generally do.

In anticipation of a MenB vaccine being developed and licensed, the JCVI began work to consider a possible MenB immunisation strategy in 2010. The MenB vaccine Bexsero, manufactured by Novartis, was licensed by the European Medicines Agency in January 2013. The JCVI’s work before that date enabled it to provide advice at the earliest opportunity, so it is not quite right to say that there has been a great delay. The work had begun in anticipation to try to get us ahead of the situation. The JCVI looked to base its recommendations on the best available evidence for efficacy and cost-effectiveness.

Following the licensing of the vaccine, my right hon. Friend, the Secretary of State for Health requested a recommendation from the JCVI on the use of a MenB vaccine under the provisions of the Health Protection (Vaccination) Regulations 2009, which provide the basis for the public’s right of access to national immunisation programmes in the NHS constitution. The Secretary of State has a statutory duty to implement a recommendation from the JCVI on a new immunisation programme, so far as reasonably practicable, where cost-effectiveness has been demonstrated.

The Secretary of State and my predecessor, my hon. Friend the Member for Broxtowe (Anna Soubry), subsequently met to discuss the MenB vaccine with the national meningitis charities Meningitis Now and the Meningitis Research Foundation. Like my hon. Friend the Member for The Cotswolds and other Members in previous debates, I pay tribute to those charities for their excellent work.

The JCVI published an interim position statement on the MenB vaccine for consultation in July 2013 to assist it in making a complete assessment of the available evidence. That interim statement did not recommend a national immunisation programme because of uncertainties about the vaccine’s effectiveness and cost-effectiveness. In response to its consultation, the JCVI received new and recently published evidence on the MenB vaccine. The JCVI also considered comments and queries received in response to its interim position statement. Many of those comments and queries followed similar lines to those raised by my hon. Friend and made the same points on the severity of the impact on children who survive MenB. All the evidence and submissions led to further detailed analysis of the cost-effectiveness of a MenB immunisation programme.

Having considered the outcome of the further analysis at its meeting in February 2014, the JCVI recommended on 21 March that there should be a carefully planned national MenB immunisation programme for infants, starting at the age of two months. The JCVI made it clear that that recommendation was subject to the vaccine being available at a cost-effective price lower than the list price of £75 a dose.

There was some rather inaccurate media reporting when the JCVI’s recommendation was published that suggested that external influences might have led the JCVI to change from the position in its interim statement. The JCVI is an independent committee that greatly values its independence, so I remind Members that, in response to its consultation, the JCVI received new and recently published evidence and relevant comments that led to further analysis and the recommendation that the programme should be cost-effective subject to vaccine price. That is why the JCVI’s position shifted; there was no question of external interference.

[Geoffrey Clifton-Brown]

I am grateful for the way in which my hon. Friend is presenting her reply. From what she has said so far, the only issue seems to be the cost-effectiveness of the vaccine. Will she give any indication of when the cost-effectiveness issue is likely to be resolved so that a roll-out can begin for two-month-old babies, with a catch up for four-month-old babies?

[Jane Ellison]

Rather frustratingly, for me and for my hon. Friend—he alluded to this in his speech—I am not in a position to answer that, because to do so would be to pre-empt the stage we have reached with the issue. What I can say is that this country has world-leading vaccination programmes and a great deal of experience in planning them and rolling them out very effectively. I can assure him that all our experience would be brought to bear in a positive way at that stage. I cannot pre-empt either the timing or the price, but he can be assured of the expertise that sits behind the UK’s vaccination programme.

The Government welcomed and accepted the JCVI’s recommendation and hope that the UK will be the first country in the world to launch a national immunisation programme for MenB. As I have just said, that would continue our successful track record in providing a world-leading national immunisation programme.

I acknowledge that some people might say—I would not blame them—that cost-effectiveness should not be an issue when talking about a vaccine to protect very young children from a potentially fatal disease. However, it is important to consider cost-effectiveness so that money spent on new immunisation programmes does not use finite NHS funds that would otherwise provide more overall benefit to the wider population if spent on other treatments or services. We all recognise that those decisions are not easy, which is why so much expert thought and careful consideration go into them.

My hon. Friend asked when immunisation would start, and I have explained that we are not in a position to comment on that, but we are in a position to draw on great expertise when we face that issue. As I have said, the JCVI recommended that a MenB vaccine be introduced but only at a cost-effective price, below the list price published by Novartis. Therefore, the first essential step is to agree a cost-effective price for the vaccine with the manufacturer. We want to agree that with Novartis as soon as possible so that children can benefit from the vaccine, but we need to ensure NHS funds are used effectively, as I have explained. We must also follow due process on spending approvals within the Government before launching any procurement. That is quite a complex process involving a detailed business case.

We see the onus as being on the manufacturer to respond positively to the JCVI’s recommendation so that we can purchase the vaccine at a price that represents good value for money for the NHS. If we can obtain the vaccine at a cost-effective price, the introduction of the new vaccination programme would need to be carefully planned with the manufacturer and the NHS so that parents can be confident of a sufficient and sustainable supply of vaccine, with arrangements in place in the NHS for it to be provided and for clear information to be given to parents to enable them to make an informed choice.

I hope that it will give my hon. Friend some reassurance to know that last year the NHS introduced three new vaccination programmes and another one was rescheduled, which demonstrates that that is something we can do. That large expansion in the national immunisation programme was unprecedented. We must ensure that the NHS is fully equipped to be able to deliver another programme safely before introducing it. We hope to be able to start the procurement process soon and to purchase the vaccine at a cost-effective price.

My hon. Friend asked about adolescents. The JCVI’s advice was that research was needed on the effectiveness in adolescents of preventing transmission of infection. I am aware of the cases on US campuses to which he alluded. The Department is considering how best to commission the necessary work. If I have any update on that situation, I will write to interested Members after the debate. In addition, I will give an update on where we are in the process as soon as I am in a position to do so. If the procurement is successful, we will be in a position to make firm plans for the introduction of the new MenB immunisation programme. At that point I will be able to say a lot more. I accept that it is frustrating that I cannot say as much as he would like.

I thank my hon. Friend for raising this incredibly important subject. All of us, as constituency MPs, and certainly those of us who are Health Ministers, are extremely aware of the importance that many parents place on this subject and the fear that MenB raises for some many people. He was right to ask me to come to the House and address the subject, even if I cannot do so in quite as much detail as he would like. I look forward to updating the House in due course and will do my very best to ensure that I keep all interested Members fully up to date as we progress with this important process.

Question put and agreed to.

Genetic Medicine

Geoffrey Clifton-Brown Excerpts

Thursday 13th June 2013 Commons Chamber

[George Freeman (Mid Norfolk) (Con)]

Thank you, Mr Deputy Speaker, for your patience—and that of the House—in waiting for me to raise this important subject at this time of the week. I also thank the Minister for her presence. I pay tribute to her long interest in this subject, her work at the Department of Health on cancer, screening and public health—she is a tolerant and fair-minded advocate of public health in the Members’ Tea Room—and her interest in the difficulties of the early onset of dementia. I was struck the other day by her moment at the Dispatch Box, when she was greeted with extraordinary affection in the House, which was a sign of the great respect and affection in which she is held and the respect for the work she does.

My interest in this debate comes from a family interest in cancer—an interest that I know is shared by many in the House and across the country. Few families have been untouched by the disease, which is increasingly understood to be a genetic disease. I lost my father and my mother-in-law to cancer, and, as the parent of two children, take a close interest in something that I might have inadvertently passed on to them. I also have an interest because I come to this House after a 15-year career in biomedical research and speak in my role as Government adviser on life sciences, taking a deep interest in how current breakthroughs are changing the assumptions on which we base public policy.

For the purposes of giving some background and declaring an interest, I want to explain what I did in those 15 years. I spent four years running a predictive toxicology business, which looked at drug compounds and analysed their likely toxicology and efficacy in different patient groups. I also spent six years in translational medicine, working with academic health science centres up and down England and Scotland, helping to set up the Scottish translational medicine research institute and working at University college London on the cardiovascular institute and at King’s Health Partners on dementia. I was delighted two years ago to be given the chance to support the Government as life sciences adviser. I stress that I have no ongoing commercial interest in the sector. For the purpose of clarity, I draw the House’s attention to my entry in the Register of Members’ Financial Interests. It details historical investments, including a very small shareholding in GlaxoSmithKline, which has been passed down through our family since my grandfather met the founder and decided that the then baby milk business might have a good future.

[Geoffrey Clifton-Brown (The Cotswolds) (Con)]

Foresight!

[George Freeman]

Indeed. The register also shows a very small shareholding in a women’s cancer diagnostics joint venture business that I helped to set up with Cancer Research UK and UCL Partners.

This is a topical debate. We have seen in the newspapers recently the news of Angelina Jolie’s decision to have a double mastectomy, having received a diagnosis of a high chance of developing breast cancer based on the most well-known and acknowledged genetic test, the BRCA mutation. The widespread coverage in the press of her decision has been helpful in raising public awareness, as have the powerful and moving descriptions of the thinking behind her decision and of her husband’s support for her.

Only yesterday in The Times we saw the news of the NHS cancer registration service launching a project to bring together all the available data on the 350,000 types of cancer across the 50-million-patient database in Britain. Over the past month, we have also seen the launch of Cancer Research UK’s contribution to the global alliance on sharing genomic and clinical data. Topically, there is also an ongoing battle in the American Supreme Court involving Myriad Genetics and the ownership of the BRCA gene.

I believe that the revolutions in translational medicine, in experimental medicine and in the personalisation of medicine are a huge force for good. They raise a number of important issues, some of which we might touch on in the debate. By way of illustration, I want to share with the House a couple of stories illustrating how I came to see that force for good in practice.

The first involves a project at King’s Health Partners in south London, led by Professor Simon Lovestone, who is a pioneer in clinical research into psychiatric disorders, particularly dementia. The project is funded by the National Institute for Health Research, and I congratulate the previous Government on putting in place that infrastructure, which we have developed and continued. Professor Lovestone and his team have developed a case register information system, which is a portal for data for the whole of the South London and Maudsley NHS mental health trust, involving 250,000 patients. It brings together all the information, anonymised and in large datasets, on medical records and clinical histories and on the often complex drug histories involved in treating mental health, along with MRI brain scans, to create a powerful database for the purpose of shedding light on the mechanisms of action and the clinical drivers of early-onset and late-onset examples of the disease.

The portal is now being used by researchers on campus for purely academic work, alongside researchers from industry who, quite fairly, pay substantial amounts of money to King’s Health Partners in order to use the facility. They often find themselves working alongside leading-edge researchers. As a result, King’s Health Partners has signed up to a number of collaborations with industry to work on some very expensive drug programmes. That is an example of how data can accelerate academic research and bring academic and industry researchers together in pursuit of a common cause.

The other company that I want to mention is the joint venture set up by UCL Partners called Abcodia. It is based around a database of 250,000 women who are at risk of gynaecological cancer. It was funded by Cancer Research UK and the Medical Research Council over 20 years, but at the end of the academic study, the database was sitting gathering dust. It is now being used as a powerful database to provide all sorts of screening and diagnostic molecular biomarker services, and is helping to identify the biomarkers that predict and are implicated in the onset of gynaecological cancer. It is also a powerful database for all the diseases of ageing in women, many of which are the same in men. It is a powerful tool for understanding the molecular biomarkers and the drivers for the early onset of a whole range of late-life diseases.

These databases are incredibly powerful, and across the NHS and across our university academic health science centres, they are being run under very high standards of ethical and regulatory regimes and with very strong patient consent. One lesson is that where clinician scientists work with patients to do basic and clinical research, patients and the research charities that work with them are hugely supportive of this revolution in genetics and computing.

More than 10 years ago we sequenced the human genome. It was a massive global collective effort, which took several decades and several hundred million pounds to achieve. It now costs about $1,000 to sequence the entire genome of one of us, and it takes no less than 24 hours—and those numbers are falling fast.

[Geoffrey Clifton-Brown]

My hon. Friend is to be congratulated on the widely respected work he is doing as a Government life sciences adviser; he really is doing a fantastic job. I congratulate him, too, on securing this debate. I think he is aware of the campaign of my constituent, Les Halpin, to accelerate the use of drugs in the NHS in carefully controlled circumstances on a trial basis for people with terminal illnesses. With the sort of conditions my hon. Friend has been talking about, if we could change the protocol in the medical profession and harness our innovative bio-sciences sector, we could become a world leader in the development of new drugs.

[George Freeman]

My hon. Friend makes an excellent point, and I pay tribute to his advocacy, on behalf of his constituent Les Halpin, of the access to medicines campaign. We have plans to continue to help support it. My hon. Friend’s point is important, and the point that Les Halpin has made is that people like himself with a terminal disease actively want the opportunity to take part in trials and research so that their disease and suffering will not be in vain. My hon. Friend speaks powerfully on behalf of his constituent and on behalf of those with other diseases who share that view.

The truth is that this revolution of translational personal lives medicine is all about the end of the one-size-fits-all blockbuster model of drug discovery and development. The more we know about disease, the more we discover the genetic predispositions of disease and how different patients respond in different ways both to drugs and to the onset of disease. We discover that what was yesterday one cancer is today three or four and tomorrow will be 30 or 40. This is breaking down the size of markets and requiring a whole new model of research around patients. It puts patients right at the heart of the research process. That is challenging for hospitals and for companies, but ultimately, I believe—we are seeing the evidence—it is good for patients, leading to quicker innovation and quicker access to drugs. It is also good for our life sciences sector. It is a win-win, which is why the Government were right to describe the report on the subject as “health, wealth and innovation”. The three do indeed go together.

I would like to take this opportunity to congratulate the Minister and the Department on the work they are doing in pursuit of the life sciences strategy, particularly on the £100 million cancer genomics project. That provides an extraordinary opportunity for Britain to sequence the genomes of 100,000 patients and combine that information with the clinical data—one of the world’s most precious resources in our NHS—creating a global hub that would put Britain right at the forefront of unlocking this field of cancer genomics.

I pay tribute, too, to the work of the research charities, which do extraordinary work driving funding and research, but also in advocating some of the changes that need to be made. In the time available, I will not be able fully to go through all the information I have received, but the Minister and I may be able to pick up some of the points afterwards.

I do want to say that Cancer Research UK has done a huge amount of work in this field, setting out a very clear analysis of what it wants to see happening—support for NHS provision of genetic tests for inherited cancer risk, improving existing molecular diagnostic services for cancer and strong support for the 100,000-patient cancer genome project.

The Prostate Cancer UK charity—you will remember, Mr Deputy Speaker, the moustache that I sported in the autumn in support of the Movember campaign—has highlighted the fact that nearly 35,000 men are diagnosed with prostate cancer every year and that 215,000 of us are living with the disease. By 2030, it will be the most common cancer in the UK. One in eight men will get prostate cancer at some point in their lives. The genetics of prostate cancer is well behind that relating to other diseases and needs to be accelerated as it is not as well understood. However, recent developments in understanding the genetics of prostate cancer have been crucial to driving up survival rates and showing the potential for future improvements in treatment.

Breast Cancer UK is investing substantial sums in the study of genetics, and the Breast Cancer Campaign has already provided £10 million. It has highlighted the role of Angelina Jolie’s recent decision in drawing public attention to the importance of genetics in providing earlier diagnosis and better treatment.

The Alzheimer’s Society has raised some interesting points. In many respects, Alzheimer’s is the toughest of the blockbuster diseases for us to crack, and it is becoming increasingly apparent that it is one of those diseases that we will not crack through the magic discovery of some drug. What is needed to beat this disease is a completely new model: a massive collective effort by patients and researchers using data and online tools such as PsychologyOnline. The Alzheimer’s Society has said that genetic testing may cause difficulties in some cases. A genetic defect cannot be repaired, effective treatment to slow the disease is not yet available, and the society fears that some premature genetic testing may trigger inappropriate responses.

Genetic Alliance UK has set out a detailed response to the debate, and has issued some important calls. In particular, it has called for the explicit inclusion of genetic testing in NHS England service specifications for all services that may utilise genetic testing. It has also called for investment in research that will help to elucidate the findings of whole genome sequencing and exome sequencing for clinical use, so that the benefits of the technology will be available to patients as soon as possible; for recognition of the importance of clinical genetic services as a resource for single-gene conditions; and for the linking of the commissioning of companion diagnostics with the stratified medicines for which they indicate patient response.

I have referred elsewhere to an Arab spring of health care. I believe that the current revolution—the stratification, targeting and, ultimately, personalisation of therapy, which cancer therapy is leading but in which other therapeutic areas are rapidly making progress—is all about patient empowerment. That applies both to someone like Les Halpin, who was mentioned by my hon. Friend the Member for The Cotswolds (Geoffrey Clifton-Brown)—someone who has a terminal disease, and wants to play his part in ensuring that others do not suffer in the same way—and to much younger patients with an easier diagnosis who want a chance to play their part in research. The aim is to give patients better access to information about their disease, and to earlier treatment. All the research findings show that patients on research programmes respond better, have better outcomes, and appreciate and enjoy—if that is the right word—the process.

There is also an Arab spring of disease charity involvement. Our disease charities are raising ever larger sums, and playing an ever bigger role. Movember, which was started five years ago by two Kiwis who raised $500, has now raised $23 million, and is the world’s biggest prostate cancer charity. It is using the internet and driving social media, establishing research committees, and setting standards for prostate cancer research all over the United Kingdom. The power of computing in genetics is transforming the way in which we conduct medical research.

Lord Saatchi’s Medical Innovation Bill, which is currently in another place but is coming our way, raises a number of the issues to which I have referred. It makes a powerful case for adapting regulations so that clinicians are no longer bound to stick to protocols that they do not believe will be effective. We need to make it easier for clinicians to innovate and to adopt new medicines and new treatments when they think there is a reasonable chance of a better outcome, without in any way undermining their duty to put patients’ interests first.

A number of other campaigns are coming our way. One of my reasons for initiating the debate was to give the Minister a chance to respond to some fairly specific policy questions. They cannot all be answered this evening, but let me present a few of them. Who owns the rights to genetic data, the rights to DNA—that issue has been highlighted by the Supreme Court’s ruling against Myriad Genetics—and the rights to clinical data? Some interesting work done in the other place suggests that, ultimately, we need to establish the idea that the data are ours. Your medical records are yours, Mr Deputy Speaker, and mine are mine. If we put patients at the heart of this, we will build a framework for consent and for enlightenment, which will be all to the good.

Who has the right to be tested, and when tested, what rights do they have to counselling? I want to reiterate that this has nothing to do with the insurance scare stories we sometimes read about in the press. I call again for the insurance moratorium to be extended. This is not about in any way wanting to undermine the ability of those who have had testing to receive health insurance. The point of this revolution is that it is about empowerment. It is about empowering patients actively to seek, and take, more responsibility for their health care earlier in their life, not penalising those who do that. There are also some important questions to be asked about how we open up the NHS to allow greater access to the types of medical breakthroughs that will fundamentally change the way we treat illness and disease in our society.

I am delighted to give the Minister some time to set out the Government’s support both for this important and emerging field and, as the Prime Minister said in his speech in December 2011 launching the life sciences strategy, for the inspiring vision that every patient in the NHS will be a research patient.

Terminal Illness (Access to Medicines)

Geoffrey Clifton-Brown Excerpts

Wednesday 23rd January 2013 Westminster Hall

[Geoffrey Clifton-Brown (The Cotswolds) (Con)]

May I thank you, Mr Caton, and Mr Speaker for allowing me to hold this important debate today and particularly my hon. Friend the Minister for being here to respond? I am pleased to introduce this debate on such an important subject. A number of people have worked hard on this issue for a long time, and I am glad that their work has now come to fruition in this debate. The debate is on access to medicine for people with terminal illness, which is a subject that I and others have wanted to raise.

Ensuring that people with a terminal illness have access to medicine should concern us all. Unfortunately, such illnesses will affect many people, including many people in Westminster Hall today. It is unacceptable that so many people, when they are diagnosed with an illness, find that no drugs are available to help them to overcome their condition.

I hope that it is an area of common ground that we need to speed up the development and availability of drugs to treat life-threatening illnesses. The current testing and development process is too long, cumbersome and expensive. The Minister and I would agree on that, although we may differ slightly about what needs to be done about it.

A recent report from the Office of Health Economics found that, on average, it takes five years after the launch of a new drug for it to win approval from the National Institute for Health and Clinical Excellence. That amount of time can be more than doubled when added to the time taken for a new drug to go from the development stage through to phase 3 and beyond. It is also very expensive, incurring costs of more than £1 billion, and it can take more than 10 years to bring a new drug to market.

The impetus for this debate came from a meeting I had with one of my constituents, Les Halpin, in Portcullis House last year. The way in which Les set out his views on drug development inspired me to do all that I can for him and his campaign. He convinced me that a great deal of political pressure needs to be applied, to ensure that change is made.

Sadly, Les was diagnosed with motor neurone disease in May 2012. He has a doctorate in statistics, and following his diagnosis, he began to conduct a huge amount of research and talked to as many experts as he could to

“understand the disease that is probably going to kill me.”

Indeed, Les had an interview on BBC Radio Gloucestershire this morning and he was barely audible. However, we have kept in constant contact since we met, and I admire his bravery.

Les told me that, equipped with his research, he began to understand MND better than many medical professionals, which is not surprising given his intellectual ability. The internet is a resource that enables many patients, especially those who suffer from a rare disease, to do the same type of research to some degree. Les poses the question on behalf of patients in similar situations:

“Why should they not be allowed to make informed decisions about their treatment?”

MND is an example of a rare disease for which there is no cure. It is a horrible disease, involving—over a period—all the organs of the body shutting down, leading inevitably to death. About 5,000 people in the UK suffer from MND; one in every 100,000 or so people will be diagnosed with it each year. The condition affects twice as many men as women.

The outlook for people with MND is very poor. People with limb-onset MND will live for three to five years, and people with bulbar-onset and respiratory-onset MND will live for even less time—probably two to three years—but slightly more fortunately, people with other less common types of MND can live for much longer and some people have lived with MND for decades; for example, the physicist Stephen Hawking, who was diagnosed with MND more than 40 years ago.

One medication, called riluzole, can extend the lifespan of some people with MND, but it has a very limited effect; on average, it only extends life expectancy by about three to six months. The drug was developed more than 20 years ago, and in the subsequent years, no new drug for MND has been developed or approved. So the real purpose of the debate is to highlight the lack of new drug development for people with rare and life-threatening diseases.

Having applied his statistical approach to the problem and having talked to leading experts from around the world, Les has concluded that it is very probable that it will require more than one drug to treat MND effectively. The problem is that clinical drug trials normally only test a single drug, which ignores the possibility that, as with the treatment of HIV, a cocktail of more than one drug is required. That is the key. Reform of how we develop, test and approve drugs is therefore crucial. Les sums it up in his own words:

“Imagine a world where MND patients worldwide have access to drugs at this stage of testing—they are proven safe for humans, and possibly known to be efficacious in other neurological diseases, just not for MND specifically. Patients are given the freedom to choose which drugs they think might help them; the process is monitored, and patients and doctors alike can report on their effects. Data is stored centrally, and thus can be analysed to determine the effects of individual drugs and of drug combinations. Ideally this requires some way of objectively measuring the progress of the disease—something which has not been possible in the case of MND in the past.

However, huge strides have been made recently in determining biomarkers for MND—measurable characteristics that reflect the progress of the disease. Biomarkers are also being developed or are available for other rare diseases that would benefit from this approach. Once a volume of data has been collected from thousands of patients worldwide, this can then be analysed and used to inform future research into these diseases, and influence investment from pharmaceutical companies.”

To his immense credit, Les has initiated a campaign to bring focus to such issues. It is called Empower: Access to Medicine and is designed to provide a new platform to open up the debate about the lack of drug development for patients with rare or life-threatening conditions. I am proud to be a trustee of the campaign, which is now a registered charity.

The campaign has already sought out the views and ideas of a range of respected individuals and organisations. For example, Dr Richard Barker, director of the Centre for the Advancement of Sustainable Medical Innovation, has rightly remarked that

“opening up the discussion around the lack of availability of effective drugs for rare and life-threatening diseases is a vital first step on the path towards accelerating new innovative drugs.”

I hosted an event in the House last June to enable a wide range of such people to meet Les and discuss his thoughts. I was particularly grateful to Lord Howe for meeting Les on the same day to discuss his thoughts in more detail.

As a patient-led movement, I believe that the Empower: Access to Medicine campaign has a real role to play in bringing all the stakeholders together. Also, I echo the words of Baroness Masham in a debate in the other place on 20 November last year, when she said that the campaign is

“a unique one, created for patients by patients. It is a powerful voice, rarely heard, but one that I believe could have a real impact on how pharmaceutical companies, regulators, politicians and the general public view drug development.”—[Official Report, House of Lords, 20 November 2012; Vol. 740, c. 1785.]

I will now take a few minutes to raise some of the issues that I believe require consideration by the Minister and her officials.

All drugs can have side effects. It is only through a full understanding of the efficacy of a drug or treatment that a patient can make an informed decision about what they want. From my conversations with Les, I have been struck by the fact that, for patients with life-threatening illnesses, the risk ratio—this is an important point—of “doing nothing”, as Les puts it, is hugely significant. Patients should have the ability to access all information on a drug, even if the risk of adverse effects or failure is great.

The director of Genetic Alliance UK, Dr Alastair Kent, sums it up well:

“Given that there is no such thing as a completely safe drug, the issue becomes one of establishing whether or not the anticipated health gains for patients are sufficient to outweigh the risks inevitably associated with prescribing a powerful (and potentially somewhat toxic) medicine to a patient with a serious and possibly life limiting disease.

Traditionally the evaluation”

of drug safety

“has been made by committees of experts—scientists, ethicists, clinicians etc sitting without patient and family input to their processes in order to reach a conclusion about whether or not patients can be allowed to take the risk. While it is clear that these experts have an important contribution to make, patients and families are”

in these days of openness and information

“increasingly demanding a say in this decision making process.”

The real kernel of the debate is that we address the risk aversion that can too often hold back the development of a new drug. Professor Sir Peter Lachmann, a former president of the Academy of Medical Sciences, and professor of immunology at the university of Cambridge, has argued that risk aversion has

“led to a false perception that most prescription drugs on the shelf are almost entirely safe. Unfortunately this is not (and never will be) the case. This misconception has meant that when things do go wrong people often, if understandably, look for someone to blame. This blame normally involves litigation; and that normally involves significant cost.”

In a recent article for QJM: An International Journal of Medicine, Professor Lachmann sets out his argument in more detail, and I warn Members that this bit of my speech is slightly legalistic. He focuses on the change in legislation in the 1980s, when the Consumer Safety Act 1978 was supplanted by the Consumer Protection Act 1987, which introduced the European product liability directive into UK law. In Professor Lachmann’s view, under the Consumer Safety Act, if a patient agreed to take a medicine that they knew had not been fully tested and thereby assumed the risk themselves, that prohibited any claim by them if some harm later materialised. Unfortunately, the Consumer Protection Act changed that, by introducing a system of strict liability, under which a person or company is legally responsible for the damage or loss caused by their acts or omissions, regardless of culpability.

Professor Lachmann rightly concluded that it is often the fear of litigation that drives a great deal of the regulation of medicines and, therefore, a significant amount of the cost behind drug development. Let us not forget that the cost of new drugs is also preventing small and medium-sized enterprises in the life sciences sector—many of them in our constituencies—from developing in the way that they should.

Professor Lachmann sets out four solutions, and I should be grateful to the Minister if she considered them carefully. First, we should abolish strict liability in this area and replace it with liability based on negligence. Secondly, we should revise the definition of negligence, so that in deciding whether it was negligent to seek to develop a new drug, account is taken of the consequences of doing nothing, as well as the consequences of trying to do something. Thirdly, we should change the law on waivers, so that any patient who is prepared to try a new medicine, with the risk that it may have unknown side effects, is at liberty to do so. Finally, we should, at least in this area, abolish the no win, no fee arrangements.

I was pleased to introduce Les to Lord Howe at a meeting in the Department of Health last June. I should therefore be grateful to the Minister if she set out the latest progress on the early-access scheme, which was first mentioned in the life sciences strategy published in 2011. As Lord Willis of Knaresborough said in the other place recently, the scheme could allow earlier access to drugs than the current regime permits. That is promising, but will the Minister confirm that the Government aim for the scheme is to produce just two to five new drugs a year? What can the Government do to significantly scale that up?

I would appreciate an update on adaptive licensing. There are different interpretations of what it means; but, in essence, it is a more flexible and streamlined approach to research and, I hope, the licensing of new drugs. One objective of the European Medicines Agency is to pilot a new approach along those lines, and my hon. Friend the Minister is to be commended for her decision to bid to host the pilot. Will she therefore outline the latest situation and what plans the Government have to ensure that the UK continues to take a lead on this issue?

I turn now to the report by the Select Committee on Health on NICE. The report, published on 16 January, touched on issues that are highly relevant to the debate. The Committee was highly critical of the delay in setting out precisely what a value-based pricing system for drugs entails. I share its concern, yet the section of the report focusing on research data and access to clinical trial data troubled me most. It is deeply concerning that drug companies have been allowed to withhold information about drug trials. Members should think about that for a minute. If a drug is developed, but it has unwarranted side effects and does not do the job it is supposed to, no one will know about research. Other drug companies will come along, do exactly the same research all over again and will have exactly the same problems. Surely, therefore, it is in everyone’s interests that the information is published.

I therefore fully support the Committee’s recommendation that there should be a professional and legal obligation to ensure that all regulators, including NICE, have access to all available research data about the efficacy and safety of new pharmaceutical products. Stephen Whitehead of the Association of the British Pharmaceutical Industry summed it up well when he told the Committee:

“negative trials often give you as much information that is helpful as positive trials.”

Few people would disagree with the Committee’s argument that it should be neither legal nor ethical to withhold research data about pharmaceutical products that are in clinical use. The Department will respond to the Committee’s report in the coming weeks, and I urge the Minister to reflect on this issue, even if she cannot say anything about it because her response to the Committee is still pending.

The ongoing consultation on the NHS constitution is another opportunity to strengthen patient rights and enshrine them in law. In particular, I urge the Government to seize the opportunity offered by the consultation to give more weight to individual patient choice and to allow patients greater freedom to determine what existing and new medical treatments they undertake. Will the Minister say when the Government will respond to the consultation on the NHS constitution and whether any proposed changes to it will be approved by Parliament?

I want now to move to a slightly different issue, because it would be relevant to mention the accessibility of end-of-life care. If it were not for the fantastic work that nurses and others do, many people who have had an experience similar to that of Les would have suffered a great deal more than was necessary. Some 73% of people, when they reach the terminal stage of an illness, want to die at home, surrounded and comforted by their family and friends, and it is a dismal fact that only 27% are currently able to do so. Access to a community or specialist nurse is a requirement for those who want access to medicine but who are unable to self-administer. This is a twofold problem, which can be solved only when adequate time is spent on the issues of access to medicine and end-of-life care.

I hope that the debate will ensure that these issues remain firmly on the agenda of my hon. Friend and her fellow Ministers. Many colleagues, from all parties and in both Houses, have taken a keen interest in these and related issues. Through his Medical Innovation Bill, my noble Friend Lord Saatchi seeks to address the issues that hold back innovative practice in the treatment of patients with life-threatening conditions. He has spoken movingly of his experience and that of his wife in this regard.

If the debate can in any way contribute to that process, it will be a fitting legacy for Les Halpin and his excellent campaign. Several people have asked me what the debate is all about, and the answer is simple: how would any of us who, God forbid, might develop a terminal illness gain access to an effective medicine? In future, what we need are not terminal illnesses, but treatable illnesses.

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[Jim Shannon]

Those are the sort of responses we hope to hear, because they show that the Government are working. The Minister, as we knew she would, has come up with a practical, physical response, and is doing the things that we have been hoping will come out of the debate. I thank her for initiating the process she outlined, and for moving things forward.

I am pleased to support the hon. Member for The Cotswolds in his cause of drawing attention to motor neurone disease, cancer and other illnesses, so that a treatment path will not be simply a step along the road to the end of life, but may enhance the quality of life. Perhaps a successful treatment path can be developed. According to Empower: Access to Medicine,

“Speeding up the development and availability of drugs that treat life-threatening diseases would benefit everyone in society.”

I believe that too. Everyone present will know people whom new drugs could help. The current testing and development process is long, cumbersome and expensive. In fact, a recent report by the Office of Health Economics found that it takes five years, on average, after the launch of a new drug, to win NICE approval. That time scale can be more than doubled when the time taken for a new drug to go from the development stage through to phase 3 and beyond is added. As an example, no new drug has been approved for motor neurone disease since riluzole was approved 20 years ago. Are we happy to sit back and rely on that one drug, or should there be more research? We need more research; we need to fund it, and we need it to be made possible.

Currently, pharmaceutical companies do not have a financial incentive to invest in developing new drugs for rare or “orphan” diseases—I am being careful in my terminology—because of the small number of the population who are affected and the high and uncertain costs of the drug development process. The drug regulatory regime is therefore clearly having a significant impact on those with life-threatening and rare diseases.

Just yesterday, the shadow Secretary of State held a meeting on special commissioning. Five speakers introduced the issues. The gentleman who spoke on cystic fibrosis said that drugs are available only in certain parts of the United Kingdom. He is worried that we are setting an imbalance, which I have taken up with my colleague back home, Edwin Poots, the Minister of Health, Social Services and Public Safety, to ensure that cystic fibrosis drugs are available to sufferers when they need them not only in England, but in Northern Ireland, Scotland and Wales.

The panel hosted by the shadow Secretary of State outlined the need for drugs allocation. There was a guy representing HIV patients, and 100,000 people in the United Kingdom are receiving HIV drugs to prolong their life. The man who spoke yesterday has lived for 20 years with the drugs that are available, but are those drugs available across the whole United Kingdom?

[Geoffrey Clifton-Brown]

I am extremely grateful to the hon. Gentleman for making those extremely good points. The point he makes about cystic fibrosis crystallises the health service’s dilemma. A small drug company came to me the other day, and told me that it has developed an absolute cure for a certain type of cystic fibrosis if it is caught very early in life. The problem is that the drug will have to be administered for life, and the life cost of the drug for the very small number of people whom the drug will absolutely cure, and whose quality of life it will improve, is £180,000. That is why his remarks on the need to drive down the cost of developing drugs in this country are so important.

[Jim Shannon]

I thank the hon. Gentleman for his constructive intervention. I take his comments on board, and I believe the Minister has a willing ear, too.

[Geoffrey Clifton-Brown]

My hon. Friend the Minister reminds me sotto voce that I was corresponding with her, and I am extremely pleased to say that she has approved the drug I mentioned. So that small number of people will now have an absolute cure.

[Jim Shannon]

If this goes on much longer, I would want the Minister to reply to every Westminster Hall debate, because we have asked for two things and got them both, which is good news.

I will now illustrate the need for drugs for three categories of people. The first category is those with dementia. There has been debate in the House and in the papers over the past week on dementia treatment. In Northern Ireland, we do not have the highest diagnosis rate for dementia in the United Kingdom, but at 63% the diagnosis rate is high. The support services are perhaps not as equal to that as they should be, which we will take up with the Minister to see how we can improve.

The facts are that some 370,000 people have not yet been diagnosed for dementia treatment—first it is diagnosis, and then it is drugs—so there is a combination of how the health system works best. People are given drugs including Aricept, which reduces symptoms and slows progression. The drugs might not always cure the ailment or disease, but they certainly can improve life and make it a wee bit more amenable.

The second category is cancer, and there will not be a family in the whole country that has not been touched in some way by cancer. The Government have set up what they refer to as a “fast track” for cancer patients. There is some indication that the fast track is perhaps not working in the way that it should, but the Government have a £750 million cancer strategy, which plays a key role. As with dementia, the strategy is diagnosis, early intervention and prevention through all the surgeries and clinics across the United Kingdom.

The third category is breast cancer. A new breast cancer drug has had some coverage in the press over the past few weeks. The Minister has been tremendous in her response to our points, and perhaps she could give us some indication of how that drug will be made available to those with breast cancer. The drug has the potential to prolong life. The papers have said that, for some people, the drug can prolong life for 20 years. Such drugs must be available if that is the case. I am keen to hear how that will go.

It is long past time to take active steps to ensure that terminally ill patients or patients with life-threatening conditions are not simply given a form of end-of-life care—it has to be more than that—but are treated for their conditions. New drugs and medications should be actively sought, instead of accepting a diagnosis of illness as a death sentence.

The hon. Member for The Cotswolds mentioned hospice care. We are fortunate to have so many organisations, and if I name some, I will leave some out, so I am not going to name any. They all do tremendous work. The hospice care those organisations deliver to the person who is dying or recuperating and the help they give to families is tremendous. We owe them a lot.

I support the hon. Gentleman in this debate, and I am disappointed there are not more people here, because it is a debate that affects us all. Our constituents would be keen to ensure that we are involved in this debate.

We have been fortunate this morning to have very positive responses from the Minister, and I look for more. What steps are this Government, and our Government in Northern Ireland, taking to ensure that another five years are not lost and that we can make a change to bring hope, instead of despair, to those who refuse to accept a one-size-fits-all diagnosis and who wish to have access to the best drugs available at a price we can afford and that delivers more treatment and care for everyone?

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[Mr Jamie Reed (Copeland) (Lab)]

It is a pleasure to be called to speak under your chairmanship again, Mr Caton.

I extend my sincere thanks to the hon. Member for The Cotswolds (Geoffrey Clifton-Brown) for securing this important, emotive and timely debate. He laid out the issues in a compelling fashion, complemented by the testimony of other Members from across the House. The debate comes a day after my right hon. Friend the shadow Secretary of State held a specialist commissioning summit in the House to discuss some of the very issues before us today.

When dealing with terminal illnesses, it is important to recognise all of the lives affected by terminal and degenerative illness. It is important that stories and experiences of those with such diseases inform our debate, so that we do not focus purely on statistics. Behind every statistic is an individual and a family with real human issues that wear no party colours, and they may have no interest in our party colours. I am sure that all hon. Members have experience of constituents who have suffered from such debilitating illnesses and realise the importance of doing whatever we can whenever we can to improve their access to treatments that could improve their quality of life. I express my most sincere best wishes to those people dealing with terminal conditions today, and to their families, carers and everyone whose lives they touch.

I also praise the constituent of the hon. Gentleman, Mr Halpin, for the work that he does to highlight the issue and to push for improvements and greater access to drugs to improve palliative care. Today’s debate is proof that this place can be influenced by the public and by individuals—individuals can make a difference. We must look at what we can do to improve access to medicines and we must continue to explore ways and methods to encourage the synthesis of new drugs and to make those available to patients as soon as possible, while also maintaining the fundamental focus on patient safety, as has been said. That is a fine balance to strike and I look forward to learning how the Minister plans to address it.

Making new, safe and effective treatments available to all patients who require them must be the end goal, but it cannot be an isolated goal. We must look at ways to increase the availability of already licensed drugs and we must look at non-drug-based treatments as well, which can vastly improve the quality of life for patients in need. A number of charities have expressed a view that a move to adaptive licensing of drugs could benefit patients. The European Medicines Agency suggests:

“Adaptive Licensing seeks to maximise the positive impact of new drugs on public health by balancing timely access for patients with the need to provide adequate evolving information on benefits and harms”.

It must be recognised that adaptive licensing would bring a number of benefits, such as encouraging pharmaceutical industries to develop new drugs and to bring them into service quickly. It is suggested that new drugs could be available after phase 2 testing, the main focus of which is safety rather than efficacy.

There are, however, a number of issues with that approach. After phase 2 testing, drugs might be expected to be safe for human consumption, but the efficacy of any drug would still not be proven. Going on to prove efficacy at stage 3 could raise some ethical and personal difficulties. At present, a phase 3 trial is needed to demonstrate that any drug is effective. Under adaptive licensing, would those with early access be classified as part of a conventional phase 3 trial? If early access formed part of a conventional phase 3 trial, would existing trial guidelines be maintained for the use of data received on early access recipients? Clearly, ethical and personal issues would arise from both questions.

First, how can the efficacy of one drug be compared with that of another, existing drug, or with a placebo? Using blind tests in which one drug is administered to one group, and another drug or placebo is administered to another group would raise ethical issues. Doctors might knowingly deny access to a drug that has been proven to be effective because of the chance that a new drug could also be effective. Secondly, on a personal level, how could we be sure that patients are fully comfortable with and aware of the risks of taking medicines before they are fully approved under the current system? I acknowledge the point made by the hon. Gentleman about the patient being in charge of the choices with which they are presented, and more fundamentally in charge of their own treatment and destiny.

We must be careful not to suggest that adaptive licensing is risk-free and the only logical solution to a problem. Patients participating in early adoption of medicines might have better access, but there would be clear and obvious risks. That is not to say that we should discourage the synthesis of drugs that are less effective than those that already exist. The development of drugs is clearly a highly precise science, but the application and treatment of medicines sometimes resembles an art form. For some patients, the most effective available drugs are useless and, for want of a better phrase, less effective drugs could be invaluable.

I raise these issues not because we should oppose the introduction of adaptive licensing, but because we must fully explore the ramifications of introducing a change on this scale, and I look forward to hearing how the Minister plans to tackle these delicate and fine issues. We must also understand what it would mean for our life sciences and our research and development capability in the UK, but first and foremost, and fundamentally, what it would mean for patients and patient choice.

In the spirit of this debate, we should look at ways to improve care and provision of other types of available treatment, such as care facilities in communities, and assistance for patients at home. The care a patient receives does not depend solely on the medicines they receive, although clearly that is hugely important, and we should continue to explore ways in which that can be widened.

It must be noted that, as other hon. Members have said, very few drug options are available to people with terminal illnesses such as multiple sclerosis and motor neurone disease. As well as doing everything we can to speed up the development of new drugs while protecting patients’ well-being, we should explore other methods of treatment for those with terminal illnesses. We must all acknowledge that the NHS is always changing as society changes. The art of drug and medicine application demands a more bespoke and tailored patient experience and more wide-ranging treatments.

The principle behind adaptive licensing is commendable, and one that anyone would find difficult to oppose. It would ensure better access to drugs, but it would not necessarily alter things that much. As has been said, pharmacology recycling bins are filled with trials for promising new medicines that ultimately proved to be ineffective or even dangerous. Loosening access to trial drugs requires greater peer reviewing of early data and methodology to ensure patient safety.

There is a strong argument for allowing more off-label prescribing of drugs that have already passed safety tests. They could be an option open to doctors and patients if they are believed to be effective in treating a condition they were not originally intended for, and I would be extremely interested in hearing what the Minister has to say about that. Even if adaptive licensing was adopted now with a robust system of safeguards in place to protect the well-being of patients, those with terminal illnesses would not start to see improved access for a number of years. We are all aware that drug manufacturing does not happen overnight.

One of the harsh realities of debates such as this is that changing regulations today will not benefit patients tomorrow or the day after. What we need right now is improved care for those with terminal illnesses, and support for their carers. Improved facilities offering specialised care would go some way to improving patients’ quality of life, as would earlier, faster diagnosis of terminal conditions. All Members of Parliament have heard of cases of suffering that could have been prevented, and diagnosis that could have been earlier, resulting in a better experience for patients and their families.

Access to drugs may vary throughout the country and that cannot be tackled by a fractured system. That is a huge concern as we move towards April and beyond. I hope the Minister will explain how she can guarantee that a clinical commissioning group in Cornwall meets the same standard in access to medicine as a group in Cumbria. Adaptive licensing would improve access to drugs, but not without risks, and I hope the Minister will be able to outline a safe and secure framework that could be put to the House for greater scrutiny. At this stage, not enough research has been done to guarantee that access to drugs can be expanded through adaptive licensing without exposing patients to ineffective and potentially dangerous drugs. I hope that much more work will be done to show that a patient’s well-being and quality of life can be protected while ensuring that more drugs are made available.

[Geoffrey Clifton-Brown]

The hon. Gentleman has touched on an important matter than has not yet arisen in this debate: the possibility of different protocols for prescription of medicines by different clinical commissioning groups. My gentle suggestion to the Minister is that it would be unacceptable if the new system developed a postcode lottery whereby people in some areas had access to a new drug, but people in others did not.

[Mr Reed]

I thank the hon. Gentleman for his contribution. He is entirely right, and I do not believe that any hon. Member in the House would want that. Many of us have seen and read accounts of the problem he illustrates, and we must not hasten any further move towards that. We should all seek to address such issues as and when they occur.

The hon. Gentleman intervened just as I was coming to the end of my remarks, and I look forward to hearing the Minister’s response.

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[Anna Soubry]

I cannot give a short answer in this debate, but that is important and it has been raised by a number of hon. Members. On that basis, I will ensure that a proper and full written response is given, both to the hon. Gentleman and all other hon. Members—I suspect that my hon. Friend the Member for Southport and the hon. Member for Strangford will also be interested in the answer. All present will certainly get a written answer to that, because it is an important point; clarity is clearly being sought, and it will be given.

Returning to NICE, once effective new drugs are brought to market, it is important, as we all know, that they are made available to the patients who will benefit most from them on terms that represent value to the NHS—that means, of course, value to the taxpayer. NICE has played an important role in that by providing robust, evidence-based guidance to the NHS on drugs and treatments. In the great majority of cases, NICE now publishes draft or final guidance on significant new drugs within a few months of their launch. In 2011, for drugs appraised using its single technology appraisal methodology—the methodology used for the great majority of new drugs—NICE issued draft or final guidance an average of four months after the date of market authorisation. The end-of-life flexibilities introduced into NICE’s appraisal process from 2009 have allowed a number of important drugs for terminal illnesses affecting a small number of patients to be made available on the NHS.

The NHS constitution sets out patients’ rights to medicines positively appraised by NICE, underpinned by a statutory funding direction. In December 2011, the NHS chief executive’s report, entitled “Innovation, Health and Wealth”, introduced a NICE compliance regime to help to ensure that medicines approved by NICE are made available on the NHS quickly and consistently. Furthermore, since the cancer drugs fund started operating in October 2010, more than 25,000 patients have received cancer drugs that they would previously have been denied. Our priority is to give NHS patients better access to effective and innovative medicines. That is why we will move to a system of value-based pricing for new branded medicines from January 2014, following the end of the current pharmaceutical price regulation scheme.

[Geoffrey Clifton-Brown]

I am grateful to the Minister for giving way, because I sense that she is coming to the end of her speech. Could she comment on two aspects that I raised? The first is the early access to medicines scheme. Quite rightly, the current licensing scheme is intended to eliminate all risk, but could there not be a system whereby, for people with a terminal illness, a drug might be given a provisional licence on a fully informed patient basis so that it could be trialled by those people, perhaps for the benefit of others coming along afterwards? Secondly, could she comment on the issue of strict liability—the legal liability for drugs of this sort being given, which makes it very difficult for people to use such techniques?