Oral Answers to Questions

Debate between Nick Thomas-Symonds and George Freeman

Tuesday 5th July 2016 Commons Chamber

[Nick Thomas-Symonds (Torfaen) (Lab)]

Happy 68th birthday to the NHS and thank you to its creator, Labour’s Aneurin Bevan.

According to research by the British Lung Foundation, the mortality rates for lung disease have not improved over the past 10 years. Will the Secretary of State take a lesson from the Welsh Government, which have put in place a specific strategy and delivery plan to tackle the issue?

[George Freeman]

The hon. Gentleman will know that the Under-Secretary of State for Health, my hon. Friend the Member for Battersea (Jane Ellison), opened an exhibition on this topic yesterday and that the Chancellor recently put an extra £5 million into mesothelioma research. Through the National Institute for Health Research, the Government are committing to invest in that disease area. We are also committed to ensuring that we drive up both research and better treatment for such diseases.

Access To Medical Treatments (Innovation) Bill

Debate between Nick Thomas-Symonds and George Freeman

Friday 29th January 2016 Commons Chamber

[Nick Thomas-Symonds]

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

[George Freeman]

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

Access to Medical Treatments (Innovation) Bill

Debate between Nick Thomas-Symonds and George Freeman

Friday 29th January 2016 Commons Chamber

[George Freeman]

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

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

[Nick Thomas-Symonds]

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

[George Freeman]

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

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

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

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

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

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

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

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

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

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

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

ACCESS TO MEDICAL TREATMENTS (INNOVATION) BILL

Debate between Nick Thomas-Symonds and George Freeman

Wednesday 16th December 2015 Public Bill Committees

[George Freeman]

The hon. Lady makes an excellent point, with the benefit of her front-line experience. It goes to the heart of why this Bill and that of the hon. Member for Torfaen mesh together. As she says, there are now clinicians on the frontline, nurses and others, making decisions and they need guidance. My only point of dispute is that a licence is a very heavy-handed form of guidance. I want to signal that I am actively and enthusiastically looking at ways of ensuring that front-line clinicians get the right guidance without creating a structure that requires the Department and Ministers to become the licensors of every off-label use. That is not least through the accelerated access review, about which I will be specific in a minute.

[Nick Thomas-Symonds]

That has been the difference between myself and the Minister in this debate for a number of months. The aim surely has to be to get consistency both across different medical sectors and prescribers in terms of off-label use. The big problem, as the Minister is aware, has been inconsistency.

There is an argument, and the Under-Secretary of State for Life Sciences made the point, about licences being heavy-handed. However, there would at least be consistency. We must find a way through that provides such consistency.

[George Freeman]

The hon. Gentleman makes a good point, up to a point, because one needs to preserve clinical freedoms and clinicians need to be free to make the right decision for their patient. However, I appreciate that the point he is making, principally, is that we do not want pockets of enlightened use of off-label drugs, perhaps because a group of clinicians has access to the information or works in a research hospital, for example. We want patients to have access across the whole system. That is why the ambition to use, and the possibility of using, the database in the Bill could be powerful.

Amendment 8 seeks to provide for the establishment of an arm’s length body to assist those seeking regulatory approval for off-patent drugs in a new indication. The Government do not support the amendment. As I have said, we support the objective, but we do not support that mechanism. The Medicines and Healthcare Products Regulatory Agency, for which I am responsible, already provides advice to people who want to apply for marketing authorisations.

We have no plans to fund an additional arm’s length body, and I do not believe that it would be helpful. However, I am happy to ask the accelerated access review team to look specifically at the question of how we could promote the use of off-label medicines, and to give recommendations to that effect, and, if that is not possible in the next few weeks, as the team finalises its recommendations, to take action as a review and come back on that specifically.

I would happily sit down with the hon. Member for Torfaen and the promoter of the Bill to see whether we can agree a form of words. I am signalling my willingness to amend the Bill to make the ambition very clear, but I cannot accept the amendment. I do not want to go back to the Secretary of State tonight and tell him, “Great news, Secretary of State! You and I have now become the licensors of off-label medicines and will be putting together regulatory and litigation packages. We are going to set up a pre-clinical office.” It is not what he and I are here for, mainly because we are here to drive and protect patient safety.

It is for others to bring forward drugs and for us to regulate them. It would be a profound and fundamental conflict of interest if we were to take that on. Off-label use of medicines is widespread in the system today, particularly in paediatrics, without the need for licences. I do not accept that licensing is the right mechanism, but I happily accept that we should put into the Bill the fundamental objective of promoting off-label use.

[Nick Thomas-Symonds]

The Minister is entirely right on paediatrics. There is also quite widespread off-label use in anaesthetics, but of course that shows the problem, because there is pretty consistent use in those two areas but not in other medical specialisms, which is of course the point.

[George Freeman]

It is a point well made by the hon. Gentleman.

It could be argued that strictly speaking the wording of the Bill makes amendment 9 unnecessary, but I have quite a lot of sympathy with it, in the spirit of my response to amendment 7. Again, I wanted to offer the possibility of sitting down with the hon. Gentleman and officials to see whether we could reach a wording to bring before hon. Members to capture the ambition of giving effect to greater off-label use.

Currently, all innovative treatment falls within the scope of the Bill, including not only innovative medicines but the innovative use of existing medicines. However, given the level of interest in and the particular challenge with off-label drugs—the subject elicits particular interest, not least with some patient groups—it could be powerful to make that more explicit.

With regard to new clause 1, I reiterate that, as the licensing authority for the United Kingdom, the Secretary of State cannot become a routine applicant for licences. Neither would it be appropriate for the Government to take on responsibility for bringing medicines to market, which is a requirement of marketing authorisation holders. If my right hon. Friend the Secretary of State was responsible for nominating a body to undertake the role, that would still place him in far too close a proximity to the state of being a licence applicant, and would conflict with his responsibility to oversee and ensure the quality of the system. I encourage the hon. Gentleman not to press the new clause, but I am very open to seeing whether we can put a package together on Report.

The Secretary of State already has the power—a power he delegates to me, for this purpose—to direct NICE to carry out a technology appraisal where appropriate, but new clause 2 would turn that freedom into a binding obligation for NICE to carry out an appraisal where the use of an off-patent drug might be better addressed by a different NICE product. I understand the ambition behind the new clause, and I am happy to work on the wording of the Bill, but that mechanism is too restrictive and too binding. It would put the Secretary of State and me in a difficult situation.

Fibromyalgia

Debate between Nick Thomas-Symonds and George Freeman

Wednesday 1st July 2015 Westminster Hall

[George Freeman]

My right hon. Friend is an outspoken advocate for addressing such needs in Wales, in health as in other issues. He will know that pain centres in England are distributed evenly, but they are a devolved matter in Wales and the other devolved Administrations. I will happily write to the relevant people in Wales to highlight the importance of this condition and what we are trying to do in England, and to encourage them to adopt similar best practice. I cannot vouch for their response and, as in other areas, it is a matter for the local Assembly, but I will happily pick that up.

In addition to the specialised pain services that are available, a number of NHS trusts provide dedicated fibromyalgia clinics, such as that at the Royal National hospital for rheumatic diseases in Bath. That clinic offers expert support and advice, as well as a fibromyalgia coping skills programme to facilitate self-management. Some constituents of my hon. Friend the Member for Reading West have raised concerns about the co-ordination of their care; I reassure him and them that improving care and support for people with long-term conditions, and improving the co-ordination of that care, is a central ambition of this Government, as reflected in our mandate to the NHS.

[Nick Thomas-Symonds]

Is there not also a social aspect to this—the issue of sufferers being able to support each other? I am delighted to hear the Minister’s point about co-ordination, because improving co-ordination is crucial to such support being more widely and more consistently available across the UK.

[George Freeman]

The hon. Gentleman makes an important point. Such co-ordination is happening across different therapeutic areas. Charities have a role in providing a strong voice for patient empowerment. Patient networks, increasingly including social media, allow us to advance the voice of disease sufferers in research, treatment and patient support. I am delighted by the news of today’s amalgamation of the two charities, which can only be a good thing for developing wider understanding and a patient voice in new treatment pathways.

We want everyone with a long-term condition— around 15 million people—to be offered a personalised care plan that sets out their needs and preferences for care. Martin McShane, who is responsible at NHS England for improving outcomes for long-term conditions, and Peter Kay, the national clinical director for musculoskeletal care, are working hard to make that happen. I will ensure that the points raised today are passed on to them as part of that work.

My hon. Friend the Member for Reading West mentioned research. Nationally, the Department of Health has substantially increased overall medical research investment from £885 million a year in 2010 to the more than £1 billion allocated for 2015-16. The usual practice of the Department’s National Institute for Health Research, for which I am responsible, is not to ring-fence funds for expenditure on particular topics but to invite and assess research proposals in all areas. Although no fibromyalgia projects are currently funded by the NIHR, the European Commission is contributing nearly €6 million to a project seeking better ways of treating chronic pain, including fibromyalgia. I look forward to the results after the project ends in 2018, and I urge hon. and right hon. Members who are present, FMA UK and the patients it represents to feed their comments into that project and to welcome the results.

We are considering further ways to showcase the world-class research funded by the NIHR, and we are working in this place, and with the public and charities, to drive accountability. I am working with the NIHR to put together a parliamentary open day to allow Members such as those who have spoken today to see where the £1 billion a year is spent, and to work with charities and patient groups on making applications.

A number of colleagues on both sides of the House have talked about discrimination in the workplace, which is a serious concern for people both in my hon. Friend’s constituency and in local fibromyalgia support groups. It is completely unacceptable if patients with long-term conditions are misrepresented as malingerers at work. Historically, we have seen that happen with other conditions, and as research and understanding of the disease develop, we need to be aware that people who present with conditions that are not well understood may be suffering from diseases that have yet to be properly diagnosed. People with long-term disabling conditions are rightly protected from discrimination in the workplace under the Equality Act 2010. Where a disability, such as one arising from a long-term condition, has been established, the Act requires employers to make reasonable adjustments to ensure that the disabled are not placed at a substantial disadvantage compared with their non-disabled colleagues. Failure of an employer in that regard could amount to direct disability discrimination under the Act.

My hon. Friend and a number of others spoke about the establishment of a network of specialist fibromyalgia clinics. We are aware of a number of dedicated fibromyalgia clinics across the UK, including the UK’s leading centre at the Royal National hospital for rheumatic diseases in Bath, but I will write to Martin McShane, the head of long-term conditions at NHS England, to ask whether more formal networks can be established and whether, with the support of active patients and charities, there is more we can do to develop such groups and to help them to support research on developing new treatments and pathways.

I genuinely thank my hon. Friend for his tireless constituency work to raise this issue, and I congratulate him on securing this debate. So much medicine begins with the small voice of misunderstood patients who get together through charities to promote research, raise the profile of a disease in this place and elsewhere, build a head of steam, bid for research projects—the NIHR stands open and ready to receive bids—and build cross-party support. I have no doubt that, in the years to come, this work, this discussion and this topic will come to be seen as one of those occasions when the more we come to understand a condition, the more we drive research on cure and diagnosis and the more we improve treatment across the NHS. I warmly welcome his leadership in bringing fibromyalgia to the House’s attention today.

Question put and agreed to.