Dementia and Alzheimer’s Disease

Nick Thomas-Symonds Excerpts

Tuesday 12th April 2016 Westminster Hall

[Jim Shannon]

The hon. Gentleman is absolutely on the button on this issue. Very quickly on the figures, because stats can sometimes overawe us, it is estimated that by 2025 1.1 million people will have dementia and Alzheimer’s, and by 2051 2.1 million people will have the diseases. The numbers are enormous.

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

I congratulate the hon. Gentleman on securing this debate on such an important topic. On the increase in numbers, does he agree that some vital work is being done on mitigating the symptoms of Alzheimer’s, not least in many care homes and residential homes in my constituency? Equally, we have to focus on palliative care for people with Alzheimer’s at the end of their life.

[Jim Shannon]

I was going to come to that issue. I thank the hon. Gentleman for that intervention. It is not just about the diagnosis of dementia and Alzheimer’s, but about the follow-up, the path of care and how we help the whole way through. I will touch on some of those things later in my speech.

We must not abandon or diminish our efforts to find a cure. We have to take into account the reality we face and carefully plan for the future, so that all those with dementia and Alzheimer’s can get the care and support they so desperately need. As the hon. Gentleman said, that is the issue we have to address.

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[Jim Shannon]

My hon. Friend makes a salient point. He always hits on the issues that we should all be aware of.

I welcome the fact that the Government are developing a new carers strategy. I can only hope that this debate will raise awareness of the need for urgent and large-scale reform of the way in which the Government treat carers. I welcome the dementia-friendly communities strategy and the clusters of dementia groups. In my constituency we have a number of homes where patients with dementia and Alzheimer’s are looked after directly. I also have a dementia friends group who come together in the Church of Ireland church in Newtownards. They bring together all the people of Ards and North Down who want to participate. They give them art, they give them music and they give them a chance to interact, and it is marvellous what happens.

Briefly, I want to mention some of the things that happen in Northern Ireland. The Northern Ireland dementia strategy has a list of achievements to its credit in recent times, which I bring before the House to help the debate: £6.25 million in the Dementia Together Northern Ireland project; the appointment of dementia champions—perhaps the Minister will give us some thoughts about dementia champions in the whole of the United Kingdom, because things are happening, but I would like to hear about them.

[Nick Thomas-Symonds]

On dementia champions and dementia friends, will the hon. Gentleman join me in praising the wonderful work that is done by them, especially in providing sufferers with familiarity—the point made by the hon. Member for Belfast East (Gavin Robinson)? One of the ideas is to provide sufferers with things such as memory boxes to trigger the memory, which helps terrifically with this dreadful disease.

[Jim Shannon]

I thank the hon. Gentleman for his intervention.

National Minimum Wage: Care Sector

Nick Thomas-Symonds Excerpts

Wednesday 23rd March 2016 Westminster Hall

[Paul Blomfield]

I thank my hon. Friend for that intervention and I completely agree with her. I will illustrate that point further in my comments today.

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

My hon. Friend has talked about the delay and the lack of action since the previous debate. Is not one of the reasons for that the fact that, when investigations are launched into these matters, they take an inordinately long time?

[Paul Blomfield]

My hon. Friend is absolutely right. Indeed, arising from our last debate, six investigations were commissioned. I asked a parliamentary question about those investigations. They were launched in February 2015 and have yet to report. That is clearly a disgrace.

I was talking about the human stories in my constituency. I know of two local women who work for a care company that uses GPS technology to monitor when they arrive for and leave appointments. They told me their stories. The company monitors the time that they spend travelling; to be accurate, it monitors the distances that they are travelling, but it does not pay them for that time. Incidentally, the company also rips them off on the cost of travelling; it pays them 12p a mile for using their own cars, when Her Majesty’s Revenue and Customs assumes for its calculations that 45p a mile is a reasonable benchmark.

One of the women, Sharon, told me that it was not unusual for her to be out of the house at 6.15 in the morning and not return until 11 o’clock at night. She gets a break, but she is only paid for seven hours’ work, which is the time she is actually at appointments. Never mind how long it has taken her to get to an appointment or to travel between appointments. Consequently, a so-called “hourly” rate of £7.52 means that, according to Melanie, who works alongside Sharon:

“A 15-minute visit is worth £1.88”.

These women have even been refused payment for the time they have spent waiting for ambulances to arrive for people in their care. Why do they put up with that abuse? As Sharon told me:

“You get in a bit of a trap, because I actually do love the work.”

We should be ashamed that tens of thousands of people like Melanie and Sharon across the country, who look after our most vulnerable, are treated in that way simply because they care.

It also makes a mockery of our national minimum wage legislation. Let us be clear that it is a criminal offence knowingly not to pay the national minimum wage. However, the situation has not improved since we last debated this issue. In fact, there are signs—

Clinical Negligence Claims

Nick Thomas-Symonds Excerpts

Wednesday 9th March 2016 Westminster Hall

[Sir Edward Garnier (Harborough) (Con)]

I beg to move,

That this House has considered the Government’s proposals on fixed recoverable costs in clinical negligence claims.

Thank you, Mr Nuttall, for presiding over this very short debate. I thank Mr Speaker for granting it and my hon. Friend the Minister for being here to respond on behalf of the Government.

I should make it clear at the outset that, although I am a barrister in private practice, my work does not include clinical negligence cases, so I have no personal interest in this subject. I have, however, been approached by a number of solicitors from Leicestershire, the Leicestershire Law Society and the Law Society of England and Wales. They are concerned that the Government’s consultation on the fixed fee regime, which is being conducted by the Department of Health, has been delayed, although I understand that the Government intend to introduce a fixed recoverable cost regime in October. Those concerns are shared by a number of other solicitors’ firms, including Irwin Mitchell and Slater and Gordon, and organisations such as the Association of Personal Injury Lawyers, the Society of Clinical Injury Lawyers and the Bar Council. I am grateful to all of them for the assistance they have given me in preparing for this short debate.

Let me begin by placing my concerns in context. On the face of it, the Secretary of State’s statement, which has been trailed in the press—apparently, he is going to make a statement in the House of Commons this afternoon—confuses punishment, which is dealt with under criminal law, and civil law remedies, but no doubt he will make himself clearer this afternoon. Perhaps my hon. Friend the Minister can clarify that issue briefly this morning.

I accept that the Government do not have a bottomless purse. Taxpayers’ money is needed to pay for a huge range of public services, all of which compete for scarce resources at a time when the Chancellor is trying to balance the books and decrease public expenditure.

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

Will the right hon. and learned Gentleman give way?

[Sir Edward Garnier]

I will not give way.

That this debate takes place only a week before the Budget underlies that point. I further accept that the vast majority of patients who visit a GP, an NHS surgery or a hospital leave satisfied with their treatment and the outcome, but very occasionally something goes wrong. In just over 3% of those cases an error caused by a negligent decision or act of omission by a clinician leads to a claim being made by the injured person against the NHS. Such cases can include, for example, birth injuries or misdiagnosed or mistreated illnesses. Of course, those are not deliberate actions by ill-motivated doctors or nurses, but negligent ones that lead to adverse consequences for the patient.

What does 3% mean numerically? In 2011-12, the NHS reported just under 420,000 so-called “adverse incidents causing harm”, of which 13,500, or just over 3.2%, resulted in a clinical negligence claim. In the following year, there were just over 458,000 such incidents and 16,000 claims, or about 3.5%. In 2013-14, there were just over 470,000 incidents and just under 18,500 claims, or 3.9%. In the great scheme of things, those numbers are small, but they represent permanently damaged or shortened lives, pain, suffering, heartache and anguish.

Of course, they also represent monetary expense to the claimant and the NHS. We should therefore aim to ensure justice and proper compensation for the claimant who has been injured, and protect the taxpayer from excessive and unnecessary expense in legal and medical experts’ fees.

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[The Parliamentary Under-Secretary of State for Health (Ben Gummer)]

This is a fascinating matter, which deserves a great deal of debate. We could discuss this interesting subject for many hours. I am grateful to my right hon. and learned Friend the Member for Harborough (Sir Edward Garnier) for condensing a complicated issue into a 15-minute, eloquent explanation of the problems that face us.

In addition to the reading that my right hon. and learned Friend has already done, I point him in the direction of the MBRRACE-UK—Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries across the UK—report into the quality of investigations into stillbirths and neonatal injuries and deaths in the NHS, which was published at the end of last year. Although it charts a significant improvement in the reduction of stillbirths and neonatal deaths over the past 20 years due to the advancement of science, it draws one very depressing conclusion, which is that the quality of investigations has not improved since the 1990s.

I admit immediately that there is not yet any clear, scientifically proved correlation between that and the fact that litigation costs have increased, but I hope that my right hon. and learned Friend will accept my initial submission, which is that there is not the evidence for one of his claims, that somehow the increase in litigation automatically leads to an improvement in investigation and, therefore, to an improvement in patient safety. I therefore suggest that one of the statements that he made in his very careful speech is not a full reflection of the truth that we are seeking to uncover.

My right hon. and learned Friend said that we should aim to achieve proper justice and proper compensation for the claimant, and that that is the endpoint of litigation —but it is only a partial endpoint. The first thing that we are trying to achieve is an understanding of what went wrong to ensure that that is immediately transmitted back into the service, so that we prevent such a clinical catastrophe from happening to another individual or family. That is exactly where the existing system does not work, because it militates against learning early in the litigation process. In many instances, it provides a definitive account only at the point of judgment. That is what we are seeking to change through our proposed reform.

[Nick Thomas-Symonds]

I am grateful to the Minister for giving way, and I congratulate the right hon. and learned Member for Harborough (Sir Edward Garnier) on securing the debate. I also declare that I am a non-practising door tenant at Civitas Law in Cardiff.

I accept the Minister’s point about the quality of investigation. Will he also agree that access to justice is itself crucial, particularly given that the Lord Chief Justice, Lord Thomas of Cwmgiedd, recently said that access to justice is now “unaffordable to most” and available only to the very richest?

[Ben Gummer]

I will turn to access to justice. I do not entirely accept the hon. Gentleman’s interpretation of the judge’s words.

In our proposed reforms, I intend to change the balance for the NHS Litigation Authority and for claimant lawyers to ensure that we get to a single version of the truth as early in the process as possible. I accept in its entirety my right hon. and learned Friend’s interpretation of the NHSLA’s performance in past years. I do so on the basis that many claimants have been immensely frustrated—as have the clinicians involved—by the length of time that trusts and the LA have had to respond to claims, the length of time it often takes to reach a resolution and the fact that there is often too much defence, delay and prevarication. At the same time, I have full confidence in the NHSLA’s current management, because I have seen a real determination to get to grips with the problems it inherited and change the authority into something far more fit for purpose.

I accept my right hon. and learned Friend’s contention that we need to change what happens with the NHSLA, but I posit that the existing costs regime encourages some claimant lawyers to stack costs in the early stage of a claim process rather than get to what we need to do: to establish a version of the truth agreed between all parties. I am not arguing that that is a deliberate and malicious intention, but that is how the system is constructed at the moment. Therefore, in attempting to reform how costs are settled between the NHSLA and claimants, we want to incentivise learning right at the beginning of the process, to ensure that it is as rapid as possible and that, if claimants have a fair claim, they receive justice and compensation as quickly as possible. Our interests are therefore entirely aligned.

That is why I say to claimant lawyers—I have said this privately to them on several occasions—that this is a genuine consultation. We are seeking to find out how best to reform a system that we all accept is not right. I therefore warn them against peremptory lobbying of Members of Parliament about a scheme that has not yet been determined. This is a genuine consultation, in which we will accept all their views, but they cannot—I hope they will not—proceed on a basis that could lay them open to accusations of pleading for special interests rather than trying to contribute to the consultation.

Access to Medical Treatments (Innovation) Bill

Nick Thomas-Symonds Excerpts

Friday 29th January 2016 Commons Chamber

[Nick Thomas-Symonds]

I echo what the hon. Member for Daventry (Chris Heaton-Harris) has said about the cross-party work, thanks to which the Bill is now in its current state. I again put on the record my thanks to him for his flexibility, and to the hon. Member for Bury St Edmunds (Jo Churchill) for her impassioned contribution.

I am delighted that amendments 10 and 13 have been agreed to, because it is extremely important to include off-label drugs in the Bill. I am very pleased by the Minister’s positive response to those amendments. I want, if I may, to make one request of the Minister. I did not press my new clause 5, on the accessibility of the licensing process. Will he write to me specifically about that? I would be extremely grateful for some clarification about precisely what the measure will be. Will he, in his closing remarks, confirm that he will do so?

I want to put on the record my thanks to the charity Breast Cancer Now, and particularly to Jenny Goodare of that charity, who has done a great deal of the facilitating work. I also thank my parliamentary assistant, Briony Robinson. Her father, who is in fact an oncologist, has also made a great contribution to all the work on the Bill.

Ultimately, the work that has been done, especially during the winter—I made the point earlier that no fewer than eight political parties were represented by those who signed new clause 1—demonstrates the very broad swathe of opinion both in the House and beyond. Whatever side of the House we sit on, we all come into politics to try to make a difference. I sincerely hope that what we have done today will make a significant difference.

I look forward to holding the Minister to the promises he has made. I have no doubt that the hon. Members for Bury St Edmunds and for Central Ayrshire (Dr Whitford) and I will continue to be rigorous in ensuring that that is the case. I just hope that the Minister will be ambitious in the measures he has said he will bring forward.

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[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

Nick Thomas-Symonds Excerpts

Friday 29th January 2016 Commons Chamber

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

I beg to move, That the clause be read a Second time.

[Mr Speaker]

With this it will be convenient to discuss the following:

New clause 2—Identifying evidence on off-patent repurposed drugs and passing to relevant bodies—

(1) The Secretary of State shall require the National Institute for Health Research to develop and introduce a mechanism for—

(a) gathering and recording existing evidence on off-patent, repurposed drugs, including clinical trial evidence, and

(b) passing this information to relevant bodies.

(2) The Secretary of State shall determine the relevant bodies under subsection (1) and may revise that determination from time to time.

New clause 3—Appraisal in new indications—

(1) Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall direct the National Institute for Health and Care Excellence (NICE) to conduct an appraisal in relation to the drug in its new indication.

(2) An appraisal under subsection (2) should include a cost-effectiveness analysis.

New clause 4—National commissioning policy for off-patent new drugs—

Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall require NHS England to produce and disseminate a national commissioning policy.

New clause 5—Accessibility of the licensing process—

(1) The Secretary of State shall require the Medicines and Healthcare products Regulatory Agency to consult key stakeholders about steps to be taken to make the licensing process more accessible to organisations or individuals other than pharmaceutical companies.

(2) For the purposes of subsection (1), key stakeholders shall include, but not be limited to—

(a) patient organisations,

(b) medical research charities,

(c) relevant academics, and

(d) the British Generic Manufacturers Association.

New clause 6—British National Formulary: inclusion of off-patent drugs—

The Secretary of State shall require NICE and the British National Formulary (BNF) to review their processes for registering off-label uses of repurposed drugs where there is strong evidence of their effectiveness.

Amendment 10, in clause 1, page 1, line 3, after “treatments” insert “(including treatments consisting in the off-label use of medicines or the use of unlicensed medicines)”

Amendment 13, in clause 5, page 3, line 44, at end insert—

“(1A) For the purposes of section 2(2), the kinds of medical treatment that may be innovative medical treatments include (amongst other things)—

(a) the off-label use of an authorised medicinal product, and

(b) the use of a medicinal product in respect of which no marketing authorisation is in force.

(1B) In subsection (1A)(a), the reference to the off-label use of an authorised medicinal product is a reference to the use of the product—

(a) for a purpose other than one for which its use is specified,

(b) in relation to a person who is not within a description of persons for whom its use is specified, or

(c) in any other way in which its use is not specified.

(1C) In this section—

(a) ‘authorised medicinal product’ means a medicinal product in respect of which a marketing authorisation is in force;

(b) ‘marketing authorisation’ and ‘medicinal product’ have the same meanings as in the Human Medicines Regulations 2012 (S.I. 2012/1916);

(c) ‘specified’, in relation to a medicinal product, means specified in its marketing authorisation.”

[Nick Thomas-Symonds]

These new clauses and amendments, which I support, relate to off-patent drugs. I think it would be useful for me briefly to set out the context in which they arise. The Off-patent Drugs Bill, a private Member’s Bill that I introduced—it was debated on Second Reading on 6 November—is a UK-wide Bill that would create a duty on the Government to make cheap drugs available when pharmaceutical companies had no incentive to do so. The problem, put simply, is that if a drug is shown to be useful for a new purpose after its original patent has expired, a pharmaceutical company has no financial incentive to sponsor that off-patent treatment through the processes normally used to license it and ensure its adoption on the NHS. Those off-patent or off-label treatments are certainly available at low cost. The issue is simply that although clinicians can of course prescribe them, they tend not to be prescribed consistently across the medical sector, or indeed geographically.

The Off-patent Drugs Bill ran out of time that day, but I think it is accurate to say that the Government supported its aims but not the mechanism it proposed. None the less, in recognising that there is a problem, and with a shared position on both sides of the House on the need to encourage greater consistency in off-label prescribing, a lot of work has since been done, and on a cross-party basis. I am proud that new clause 1 stands in the name of Members from no fewer than eight political parties. The concept of encouraging greater use of off-patent drugs, and indeed my Bill, have significant support across the House and outside. I pay tribute to Jonathan Evans, the former Member for Cardiff North, who first introduced such a Bill in 2014. His successor, the current Member for Cardiff North (Craig Williams), has also supported my Bill.

[Carolyn Harris (Swansea East) (Lab)]

I congratulate my hon. Friend on the excellent work he has done on the Off-patent Drugs Bill. Given the consensus across the House, does he agree that now is the time for a firm commitment from the Government on that Bill?

[Nick Thomas-Symonds]

I am grateful to my hon. Friend for that intervention. I hope to hear such a commitment today, so I look forward to what the Minister for Life Sciences has to say in that regard.

That wide support for my Bill was shared by medical research charities, NHS clinical commissioners in England, the British Medical Association, thousands of members of the public who wrote in, and four medical royal colleges. Indeed, 40 eminent clinicians wrote to The Daily Telegraph in support of my Bill.

Since then, I am pleased to say that there have been good attempts on both sides of the House to build on that good will in relation to off-patent drugs. I want to thank the hon. Member for Daventry (Chris Heaton-Harris) for the highly constructive and pragmatic way in which he has been willing to take the off-patent agenda forward when speaking about his private Member’s Bill. I thank the hon. Member for Bury St Edmunds (Jo Churchill), who brings a strong personal perspective to the debate. Her sense of what is good for patients has been highly constructive in the debates we have had over the winter months. The hon. Member for Central Ayrshire (Dr Whitford), who used to be a breast cancer surgeon—in fact, she still practises—has brought a great level of expertise and experience in recent months, for which we are extraordinarily grateful. I also pay tribute to the Minister, who has been extraordinarily generous with his time and that of his officials in order to try and take this agenda forward, and for that I am extremely grateful.

I want first to make a point about clauses 3 and 4. While there is something of a consensus around responsible innovation, I had strong concerns about those clauses, as did many across the medical profession who thought that they might encourage a more dangerous type of experimentation, if I may put it that way. Looking at the amendments tabled by the hon. Member for Daventry, I can see that his intention is to remove clauses 3 and 4 altogether, which would be a very welcome step. That would mean that the principal remaining part of the Bill relates to the database of innovative medical treatments. The hon. Gentleman’s amendments 10 and 13 would bring the off-patent concept firmly into the purpose of this Bill, and therefore into the database. A lack of data was one of the barriers identified to more consistent prescribing of off-label treatments. The amendments would be an extremely welcome step forward, because they would not only enshrine in law the off-label aspect, but bring the data into the database so that it became more widely and readily available, assisting clinicians on the frontline. I sincerely hope that the amendments will be positively received by the Minister.

New clause 1 sets out an action plan for developing a pathway for off-patent repurposed drugs where strong evidence of their effectiveness in a new indication exists, with the aim of securing routine use. Put simply, this is an action plan with clear timeframes for progress. Again, this would be a welcome step forward.

New clause 2 would require the National Institute for Health Research to develop a mechanism for gathering and recording evidence on off-patent repurposed drugs, including clinical trials evidence, and passing it to the relevant bodies. The NIHR already has a dedicated horizon-scanning centre, but this would set up a dedicated stream for off-patent repurposed drugs to speed up getting them to the frontline and into routine use.

New clause 3 proposes that where there is strong evidence of effectiveness in a new indication, the National Institute for Health and Care Excellence should be directed to conduct a technology appraisal, including a cost-effectiveness analysis. While these drugs are extraordinarily cheap, some level of cost-effectiveness analysis would none the less be desirable, since to achieve routine commissioning, in England for a start, a persuasive business case clearly needs to be put to local hospitals and clinical commissioning groups.

New clause 4 is about having a national commissioning policy for off-patent drugs. It also requests that the Minister work with the devolved nations to produce something that is genuinely UK-wide. This has already happened in the case of NHS England working with Prostate Cancer UK to produce a commissioning policy for an off-patent repurposed drug called Docetaxel.

New clause 5 would make the licensing process more accessible. What would that mean in a practical sense? For example, an initial meeting where there is a discussion of the case and the likelihood of successful treatment could be free, a representative of patient organisations could be designated within the Medicines and Healthcare Products Regulatory Agency for patient organisations, and there could be a guidance document for non-pharmaceutical applicants.

--- Later in debate ---

New clause 6, which deals with the question of the “British National Formulary”, is very helpful in terms of giving me a chance to talk about the mechanism that I propose and have just touched on. I am reluctant to name the BNF explicitly in the Bill, not least because it is a commercial product that is not in my gift to control. There are no plans to change its format, but I would hate for us to have legislated for one particular mechanism of information and then find in a few years that it has changed in some way and is no longer appropriate. I am, however, very happy to give an undertaking at the Dispatch Box that we are actively exploring this option and have no reason to think it cannot work. NICE tells me it thinks there is a very good mechanism for it to use its existing powers for gathering evidence to pull together, as part of an evidence review, an evidence-based reassurance to clinicians that a drug has a legitimate off-label, off-patent use, and to include that in the appropriate registry. Today I think that would be the BNF, but that may change in due course.

[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.

--- Later in debate ---

[Nick Thomas-Symonds]

I am grateful to Members across the House for their contributions and to the Life Sciences Minister for his clear response to the six probing new clauses. I am pleased to hear that the Government will accept amendments 10 and 13. As I said in my opening speech, having off-label treatments in the Bill and the database will make a significant difference and help move things forward. I was also pleased with his reassurance to the hon. Member for Central Ayrshire (Dr Whitford) that we will continue to review the system, as, I hope, the number of off-label treatments and prescriptions increases.

In view of the Minister’s commitments and acceptance of amendments 10 and 13, I do not propose to press new clauses 1, 2 and 3. New clauses 4, 5 and 6 are in the names of the hon. Members for Bury St Edmunds (Jo Churchill) and for Central Ayrshire (Dr Whitford). I beg to ask leave to withdraw the motion.

Clause, by leave, withdrawn.

Clause 1

Access to innovative medical treatments

Amendment made: 10, page 1, line 3, after “treatments” insert

“(including treatments consisting in the off-label use of medicines or the use of unlicensed medicines)”—(Chris Heaton-Harris.).

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

We now come to amendment 1—

Cancer Drugs

Nick Thomas-Symonds Excerpts

Tuesday 19th January 2016 Westminster Hall

[Pauline Latham (Mid Derbyshire) (Con)]

I beg to move,

That this House has considered the removal of drugs from the Cancer Drugs Fund list.

It is a pleasure to serve under your chairmanship, Mr Streeter. I secured this debate to raise the case of a constituent and to allow other Members to discuss the effects that removing drugs from the Cancer Drugs Fund will have and, I suspect, the current consultation on the fund. The latest delisting of some drugs from the fund has happened since the last debate on cancer drugs, and I am sure that many Members have heard from constituents who have been affected.

In November, I was contacted by a constituent, Tina Spencer-Keyse, about her husband Graham, who in 2010, at 51, was diagnosed with myeloma, which is a rarer cancer caused by abnormal cells in the bone marrow, where all blood cells are made. Myeloma is a relapsing and remitting cancer, meaning that there are periods when the myeloma causes symptoms and complications and needs to be treated, followed by periods of remission or plateau, when the myeloma does not cause symptoms and does not require treatment. Because myeloma is relapsing and remitting, it is crucial that clinicians are always one step ahead of the disease and that there is a treatment option for the patient to receive when it returns, especially when other treatment options have already been used.

Until August 2015, Tina and Graham had hoped to use one further drug treatment available for myeloma. Pomalidomide, also known as Imnovid, is used to treat relapsed multiple myeloma patients who have received prior treatment regimens but for whom the disease has continued to grow and spread. Imagine how devastated the Spencer-Keyse family were to find out then that the drug had been removed from the list of drugs available through the fund. Following the delisting, there are no other licensed treatments available for myeloma patients in England. Patients have no other options once the drug they are currently taking fails. They have nowhere else to go. Imagine the frustration, and probably anger, that they and thousands of others feel when a drug that was available just months before is no longer available to them but is still being used by other patients who were prescribed it before the delisting. The situation is such that a doctor might see one patient in the morning and be able to continue prescribing a treatment yet see another patient with the same disease afterwards and not be able to do so, even when they know it could help.

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

It is a pleasure to serve under your chairmanship, Mr Streeter. I congratulate the hon. Lady on securing this important debate. Another example of a drug that has been delisted, causing similar frustration, is Abraxane, which is used in the treatment of advanced pancreatic cancer and was removed from the Cancer Drugs Fund in November. First, does she share my concern that although the delisting applies only to England, it causes worries across the rest of the UK as to whether the drug will become unavailable there, too? Secondly, although of course a consistent set of rules must be applied, one of the issues with pancreatic cancer is that 80% of patients are diagnosed when the cancer has already spread. Although Abraxane may only give a few weeks more life, those weeks may double life expectancy.

[Mr Gary Streeter (in the Chair)]

Order. Interventions must be brief.

ACCESS TO MEDICAL TREATMENTS (INNOVATION) BILL

Nick Thomas-Symonds Excerpts

Wednesday 16th December 2015 Public Bill Committees

Division 1

Ayes: 5

---

Conservative: 9

Noes: 9

---

Labour: 4
Scottish National Party: 1

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

I beg to move amendment 7, in clause 1, page 1, line 3, after “treatments” insert,

“, including access to off-patent drugs in new indications,”

[The Chair]

With this it will be convenient to discuss the following:

Amendment 8, in clause 1, page 1, line 9, at end insert—

“(c) providing for the establishment of an arm’s length body to provide assistance to those seeking regulatory approval for off-patent drugs in new indications.”

Amendment 9, in clause 2, page 1, line 29, after “involves” insert—

“(a) the use of off-patent drugs in new indications where there is strong evidence for their effectiveness; and

(b) a departure from the existing range of accepted medical treatments for the condition”.

New clause 1—Licenses for off-patent drugs—

‘( ) The Secretary of State, or a body nominated by the Secretary of State, has a duty to seek licences for off-patent drugs in new indications where—

(a) there is no commercial incentive for a profit-making body to do so,

(b) there is robust evidence of its effectiveness in the new indication, and

(c) the drug meets NICE’s prioritisation criteria for Technology Appraisals.”

New clause 2—Appraisals for off-patent drugs—

‘( ) The Secretary of State has a duty to direct NICE technology appraisals or a suitable alternative, for off-patent drugs in new indications where—

(a) there is no commercial incentive for a profit-making body to do so,

(b) there is robust evidence of its effectiveness in the new indication, and

(c) the drug meets NICE’s prioritisation criteria for Technology Appraisals.”

--- Later in debate ---

[Nick Thomas-Symonds]

It is a pleasure to serve under your chairmanship, Mr Streeter. I join in congratulating the hon. Member for Daventry, who cares a great deal about policy on this matter and is promoting this Bill with the best of intentions. I also congratulate him on his Bill surmounting the hurdles and reaching Committee stage.

Before I come to the amendments, I think it would assist to explain the background, because that will make them explicable in the context of the Bill. I was also drawn in the ballot for private Member’s Bills. The Second Reading of my Off-patent Drugs Bill took place on 6 November. I will quote from Hansard what I said that day to explain the purpose of that Bill.

“The Bill is a UK-wide Bill that creates a duty on the Government to make cheap drugs available when pharmaceutical companies have no incentive to do so. There is a problem: if a drug is shown to be useful for a new purpose after its original patent has expired, there is no financial incentive for a pharmaceutical company to sponsor that off-patent treatment through the processes that are normally used to license it, and to ensure its adoption on the NHS. Such off-patent treatments are usually available at low cost, but the current system is not set up to make them routinely available when they have been repurposed. Put simply, without a licence to act as a kitemark of safety, and a cost-effectiveness appraisal to give the NHS a mandate to provide it, there are multiple disincentives to treatments being prescribed, meaning that they are not routinely made available.” —[Official Report, 6 November 2015; Vol. 601, c. 1289.]

The Under-Secretary of State for Life Sciences has already spoken about barriers.

My Bill received a great deal of support, not just across parties but outside the House, including from 12 medical research charities, the umbrella body for the NHS clinical commissioning groups in England and the BMA. More than 10,000 members of the public wrote in support to their MPs in addition to the more than 20,000 who wrote to Jonathan Evans, the then Conservative Member for Cardiff North, in support of the same Bill the year before. Four medical royal colleges backed it and 40 eminent physicians wrote to The Daily Telegraph in support of the Bill.

In addition, the all-party parliamentary group on off-patent drugs, which I chair, held an evidence session on 15 October this year during which Pan Pantziarka, a repurposing specialist, spoke in favour of the mechanism that my Bill would have provided to deal with the problem. He said that the obtaining of a licence created “a whole cascade” of other events, including the updating of the British National Formulary, the updating of guidance and the fact that clinical commissioning groups would take further note of that treatment.

The amendments in this group, including new clause 1 and new clause 2, are in effect my Bill coming in via amendment to this Bill. New clause 1 would place a duty on the Secretary of State to seek licences for off-patent drugs in new indications, and new clause 2 relates to direction of NICE technology appraisals. The Minister has concerns about those aspects of my Bill, so with the amendments I have attempted to provide a series of options for discussion, but they are what I would call the strong version of what is essentially my Bill. The Minister takes a different view, but I remain of the view that they represent a better way of dealing with this matter. Otherwise, of course, I would not have promoted my Bill in the first place.

--- Later in debate ---

[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.

--- Later in debate ---

[The Chair]

Our timing is good. We might have a Division downstairs shortly, so we have plenty of time for Mr Thomas-Symonds to respond.

[Nick Thomas-Symonds]

I am grateful to both the hon. Member for Daventry and the Minister for Life Sciences for their reassurances. Having spent 11 years as a lawyer, I know that while certain things may be otiose, the more explicit one can be in a Bill such as this, the better it is and the more reassurance that is given. That is important.

It is important that off-patent drugs are on the face of the Bill; I do not think the Minister has any objection to that, from what I heard. His reassurance about specifically asking the accelerated access review to look at the matter is much appreciated. On new clause 2, if the role of NICE technology appraisals could be made explicit in the Bill, that would be extremely helpful.

I am very willing to take up the Minister’s offer to sit down and look at this issue with me and to work constructively. On the basis of the reassurances I have been given, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Amendment proposed: 2, in clause 1, page 1, leave out lines 8 and 9—(Justin Madders.)

Question put, That the amendment be made.

World Prematurity Day

Nick Thomas-Symonds Excerpts

Tuesday 24th November 2015 Westminster Hall

[Chris Heaton-Harris (Daventry) (Con)]

I beg to move,

That this House has considered World Prematurity Day.

It is a pleasure to serve under your chairmanship, Mr Hollobone. This subject does not get enough attention in this place, or indeed in the media. In the previous Parliament—in a Westminster Hall debate and elsewhere—I raised the subject of stillbirth, as I have a very good friend who suffered possibly one of the worst stillbirth events that I have ever heard of. I asked lots of questions in this place on that subject, including at Prime Minister’s questions, because I truly believe that we need to raise awareness of these matters. I worked very closely with Sands and with a charity called Bliss, whose strapline is,

“for babies born too soon, too small, too sick”.

Those organisations really care passionately about neonatal issues.

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

It is a pleasure to serve under your chairmanship, Mr Hollobone. I warmly congratulate the hon. Gentleman on securing this very important debate. I have received a number of emails about the debate, including from a constituent, Samantha Evans, whose son Dylan was born in the 27th week of pregnancy. Across the emails I have had, there is a wonderful sense of how great the care provided by the NHS to premature babies is. I absolutely praise that, but suggest that perhaps in policy development in future, it might be useful to look at what support can be provided to the parents of premature babies.

[Chris Heaton-Harris]

I thank the hon. Gentleman for his intervention. He is absolutely right, and I will come on to that later. I, too, have had a lot of contact from my constituents on this issue. In fact, at my very first surgery—or advice centre—as a Member of Parliament back in 2010, a lady called Catherine Allcott came in, and it is through her that I got involved with the charity Bliss. I asked whether she would mind if I read out a couple of paragraphs about what happened to her and why this issue is so important to so many parents such as her and her husband, Nigel. She very kindly agreed, so to set the scene for Members, I will read out Catherine and Nigel’s story.

Their twins, Luke and Grace, were born in the early hours of the morning of 4 May 2006, at 26 weeks’ gestation. The twins’ premature birth caused serious health problems, including brain bleeds, suspected meningitis, necrotising enterocolitis and heart problems. Although Grace is now a happy, healthy child, sadly, Luke died nearly four months after being born. Catherine tells me:

“One of the things we found hardest to deal with at that time was the fact that there was often only one nurse in the NICU”—

the neonatal intensive care unit—

“usually to three or four babies.”

She was on the unit so much because of the issues she was experiencing and because she felt so uneasy about that situation, and that is why she has been involved ever since.

Catherine says:

“When I was there sometimes I would have to help the nurse on duty by running into the next room to fetch help. I often wondered what happened when I wasn’t there. When the nurses would tell me not to spend so much time on the unit, what was I to do? Tell them I didn’t trust them with so many babies to look after?”

She goes on to say:

“As a committed campaigner for high quality neonatal care I am saddened to think that in ten years very little has changed in terms of staffing units safely and effectively. How many babies have died or now endure life changing illnesses because there simply weren’t enough nurses to care for them appropriately, and what cost is that to the NHS?”

Catherine’s story is really significant. She took me on to the Gosset ward—the neonatal ward—in Northampton general hospital. I was told by a junior doctor who works there that it has all completely changed; it has been refitted and is a much nicer space. There is no doubting the passion and the care that the staff on the ward give, but equally, there is no doubting the pressure that they are under and the fact that we can help to improve the conditions for them.

World Prematurity Day takes place on 17 November every year—we have just missed it, but this was the closest time to World Prematurity Day that I could get for the debate. The day is aimed at raising awareness of the issues facing premature babies. It is co-ordinated by a global coalition of charities and groups, including Bliss, each year.

The global statistics are quite astonishing: 15 million babies are born prematurely worldwide each year—that is 29 babies every minute, and one in 10 of all babies born—and in the UK, that equates to nearly 60,000 babies born prematurely each year. Bliss estimates that 113 babies who need specialist care to help them survive and thrive are born every year to parents living in my constituency. About 61 of those babies are born prematurely, at under 37 weeks’ gestation. Those born at under 32 weeks’ gestation are considered very pre-term. Those babies are born before they are fully developed and often spend the longest time in neonatal care.

Obviously, most premature births have no clear cause, whereas others are induced due to medical necessity. There is evidence that risk factors for premature birth include smoking, drinking alcohol, substance abuse, low or high maternal age, infection, high blood pressure and multiple births. There is lots of research—although we could always do more on this subject—showing that socio-economic factors also have an impact.

I want to underline the fact that prematurity is a global issue, which is why we have World Prematurity Day. It is the world’s biggest cause of death for young children. Of the 15 million babies that are born prematurely worldwide each year, more than 1 million do not survive. We are fortunate in the UK to have the resources to care for all babies born prematurely, but there is a long way to go before babies and their parents are given the best possible chance.

Oral Answers to Questions

Nick Thomas-Symonds Excerpts

Tuesday 17th November 2015 Commons Chamber

[Ben Gummer]

My hon. Friend makes her point extremely well. A seven-day NHS will operate only if it works across all areas of care. That is why the local integration of care and health services is part of our wider vision for the NHS. I urge her to look, when it is published, at Professor Sir Bruce Keogh’s report on urgent and emergency care, which envisages precisely the sort of joined-up care that will ensure people receive the correct attention at the correct level and do not therefore go to hospital when they can be dealt with in primary care settings.

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

On the Friday before last, a Minister stood at the Dispatch Box and talked out my private Member’s Bill, the Off-patent Drugs Bill, which would have provided a mechanism for improved clinical outcomes by making repurposed drugs more consistently available across the country. The Minister for Community and Social Care said that the Government would consider an alternative pathway. What is that pathway and when will it be implemented?

[Ben Gummer]

As I am sure the hon. Gentleman knows, my hon. Friend the Under-Secretary of State for Life Sciences is fully committed to the ambition expressed in the hon. Gentleman’s Bill. My hon. Friend feels that the mechanisms do not work, but has set up a working party to ensure that that ambition can be taken forward. I know that he would welcome full engagement with the hon. Gentleman to make sure that that happens.

Off-patent Drugs Bill

Nick Thomas-Symonds Excerpts

Friday 6th November 2015 Commons Chamber

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

I beg to move, That the Bill be now read a Second time.

It is an honour to be drawn in the ballot and to bring forward a private Member’s Bill on such a key issue. My grandmother, who inspired me to go into politics, died of breast cancer, and it is poignant for me that this Second Reading debate takes place in the week that would have been her birthday.

I am grateful to those who have sponsored this Bill, and to Members from across the House who have supported it. I thank the former hon. Member for Cardiff North, Jonathan Evans, whose Off-patent Drugs Bill was debated last year, and his successor, the hon. Member for Cardiff North (Craig Williams), for his support for this slightly refined version of the Bill. I thank my constituents for all their support, and I also thank Jenny Goodare from Breast Cancer Now for her help in preparing the Bill.

The Bill is a UK-wide Bill that creates a duty on the Government to make cheap drugs available when pharmaceutical companies have no incentive to do so. There is a problem: if a drug is shown to be useful for a new purpose after its original patent has expired, there is no financial incentive for a pharmaceutical company to sponsor that off-patent treatment through the processes that are normally used to licence it, and to ensure its adoption on the NHS.

Such off-patent treatments are usually available at low cost, but the current system is not set up to make them routinely available when they have been repurposed. Put simply, without a licence to act as a kitemark of safety, and a cost-effectiveness appraisal to give the NHS a mandate to provide it, there are multiple disincentives to treatments being prescribed, meaning that they are not routinely made available.

I have a letter from a clinician dated 15 October 2015 that I have permission to read out—the personal details have been redacted. He says he was contacted by a lady because she was advised that she had a high risk of breast cancer, and that raloxifene, which is an example of a drug that would benefit from the Bill, could be prescribed to help to prevent it. The key passage in the letter states:

“Unfortunately, I am unable to prescribe this as it is not licensed with this indication.”

[Interruption.] The Minister shakes his head, but I am quoting directly from a letter written by a clinician only in the past few weeks. That affects real people and has had a great impact on somebody’s life.

The Bill proposes a Government responsibility to step in and address that market failure in the public interest. Part 1 of the Bill introduces the duty of the Secretary of State to seek licences for off-patent drugs in new indications. The idea is to make those cheap, off-patent drugs routinely available. The president of the Royal College of Surgeons of Edinburgh recently said that, at the moment, there is significant variation, leading to variation of access across the UK.

There are barriers to the drugs being regularly available. Lack of awareness is a problem, but it is not all about that. General Medical Council guidance states that licensed treatment should be considered before an off-label or unlicensed treatment. In addition, GMC guidance is clear that a doctor takes on an extra level of personal liability when prescribing off-label.

[Carolyn Harris (Swansea East) (Lab)]

A Government spokesman was quoted in The Independent this week saying that the only thing general practitioners need is more information. Does my hon. Friend agree that that was both unhelpful and ill-informed? Deluging GPs with yet more information is certainly not productive.

[Nick Thomas-Symonds]

My point is precisely that it is about more than information.

A licence for off-patent drugs would make a big difference. The all-party parliamentary group on off-patent drugs, which I chair, met on 15 October and took evidence from experts across the board. Pan Pantziarka, a repurposing specialist, said that granting a new licence triggers a “whole cascade of things”: the British National Formulary gets updated, clinical commissioning groups and specialist bodies take note, and guidance is updated. He said that, without that, we are dependent on doctors reading the literature and prescribing off-label, and that that is not the solution we want.

Sir John Burn, professor of clinical genetics and a non-executive director of NHS England told our inquiry:

“The other problem is making decisions in a short time scale—we haven’t got time to look at the bundle of evidence presented. The whole point of the licensing process is to distil that for the physician”

[Anne Marie Morris (Newton Abbot) (Con)]

Will the hon. Gentleman clarify something for me? Under his proposed scheme, when a drug gets relicensed, what will the impact be on pricing? When a drug goes off-patent, one benefit is that it effectively becomes cheaper because any company can manufacture it, which is clearly a benefit for the NHS. With relicensing, is there a risk that the company will effectively re-price, landing the NHS with extra costs?

[Nick Thomas-Symonds]

I do not accept that that is a risk of the Bill. As the hon. Lady knows, the drugs are available for pennies a day. Under the Bill, the Government would step in to address a market failure. The Bill will not have the impact that she believes it will have. She makes a reasonable point, but it is not one that will arise under the apparatus and structure proposed by the Bill.

The alternative to the Bill—I firmly believe that if this Government do not do this, a future Government will have to legislate—is to continue to encourage more off-label prescribing. Even if that were desirable, very little has happened. In a letter dated 2 November, the Royal College of Physicians states:

“As there has been no meaningful progress on a non-legislative solution to this issue, we believe that your Bill is an important first step towards expanding access to these vital drugs.”

The proposal was debated a year ago and we have had a year to see whether there is a non-legislative solution to the problem.

The Bill has incredibly wide support across the professional spheres. I apologise in advance for not naming every charity that supports it.

[Christina Rees (Neath) (Lab)]

The Bill has the support of a huge number of medical research charities, which lead the way in research on the use of repurposed drugs. Currently, there is no route to market for off-patent drugs in new indications. Does my hon. Friend agree that the Bill will fix that anomaly?

[Nick Thomas-Symonds]

I agree entirely with my hon. Friend. Twelve medical research charities back the Bill; the NHS clinical commissioners in England back the Bill; and the British Medical Association backs the Bill. More than 10,000 members of the public have written to their MP in support of it. That is in addition to the 20,000 who wrote last year to the former Member for Cardiff North. Four of the medical royal colleges support the Bill. Forty eminent clinicians wrote in recent weeks to The Daily Telegraph to support the Bill. It has incredibly wide support across parties and among the professions.

[Albert Owen (Ynys Môn) (Lab)]

I congratulate my hon. Friend on the Bill and pay tribute to Jonathan Evans, a thoughtful Member of Parliament who introduced a Bill in the previous Parliament. In addition to the long list of experts that my hon. Friend has quoted, I am sure he has had other lobbying letters. I had one from a multiple sclerosis sufferer. He eloquently put his case and said: “Please be there to give us hope.” Does my hon. Friend agree that the Bill will give us hope for cures for the future?

[Nick Thomas-Symonds]

I agree entirely with my hon. Friend.

[Liz McInnes (Heywood and Middleton) (Lab)]

We are talking about people who support the Bill. The Association Of the British Pharmaceutical Industry says that it supports the principle of the Bill, but that it is concerned that it could discourage the development of new medicines. Does my hon. Friend agree that the Bill in no way precludes the normal process of research and development for the manufacture and discovery of new drugs?

[Nick Thomas-Symonds]

I agree entirely with my hon. Friend. Repurposing is becoming increasingly common. Approximately 10% of the Brain Tumour Research portfolio is in repurposed drugs. For the Cure Parkinson’s Trust, the figure is 50%, and for the Alzheimer’s Society it is 13.6%. My hon. Friend makes a powerful point.

[Liz Saville Roberts (Dwyfor Meirionnydd) (PC)]

The debate is poignant for me. Breast Cancer Now is very supportive of the Bill, and my best friend and the mother of my goddaughter is currently in hospital recovering from her second treatment for breast cancer in 10 years. I should like to take the opportunity to say this. Christine Lennon, the most organised, capable and scary of my friends: we all want you home as soon as possible. [Hon. Members: “Hear, hear.”]

Some 850,000 people suffer from dementia, and that number is likely to increase to 1 million in 10 years’ time. The matter raised by the Bill is relevant to 20% of the drugs that the Alzheimer’s Society support, and it claims that the Bill will enable it to work on off-patent drugs. Does he agree that that is very significant, given that the disease affects so many people?

[Nick Thomas-Symonds]

On the second part of the hon. Lady’s intervention, I entirely agree that it would assist the Alzheimer’s Society. On the first part, I am sure the whole House wishes her best friend a speedy recovery.

Given the time restraints, I will touch on just one benefit that the Bill would have. zoledronic acid, a type of bisphosphonate, was originally used to treat bone fractures in advanced cancer and osteoporosis, but it can also reduce by 28% the risk of breast cancer spreading to the bone in post-menopausal women. If it were routinely available to 34,000 women, it could save 1,000 lives a year, at the cost of about 5p per day per patient. That is precisely the kind of benefit the Bill could bring.

[Dr Rupa Huq (Ealing Central and Acton) (Lab)]

My hon. Friend talked about cost. Does he agree with my constituent, Elena, of west Ealing, who wrote to me on this subject to say that it would help MS sufferers in particular and that

“it is crucial that affordable treatments are used to their full potential particularly at a time when NHS resources are stretched. The Bill will tackle this issue head on and stand to benefit hundreds of thousands of people in Ealing and beyond.”?

[Nick Thomas-Symonds]

I agree entirely with my hon. Friend. It is precisely that kind of benefit that the Bill would bring.

[Rachael Maskell (York Central) (Lab/Co-op)]

Today, a constituent of mine, Mark Hamilton, is laying to rest the ashes of his father, who lost his life very suddenly in September. Had these drugs been available then, he might well be with us today. Is that not why it is so important that the Bill proceeds to its next stage?

[Nick Thomas-Symonds]

I am grateful for that intervention, because the Bill could have a positive impact on the lives of many people. That is why it should move forward.

This is a common-sense solution to an acknowledged problem. There is even a precedent for it. The Secretary of State, who is not in his place, but whom I am sure will be ably represented by the Minister, is the licence holder for a chemotherapy drug called Erwinase. It is manufactured by a state-owned pharmaceutical company called Porton Biopharma Ltd, which was established in July and in which the Secretary of State is the sole shareholder. There is, therefore, a precedent for the type of intervention I am talking about to deal with this market failure. The Bill will bring enormous benefits to people. It is a sensible solution to the problem.

[Chris Stephens (Glasgow South West) (SNP)]

I congratulate the hon. Gentleman on bringing the Bill before the House. A constituent of mine, Tracey Hardie, is a cancer survivor, but this is not just about her; it is about other people, and those who have survived cancer are very supportive of the Bill.

[Nick Thomas-Symonds]

The hon. Gentleman is absolutely right. The Bill could really assist people out there in the country, which is why it should proceed.

[Anne Marie Morris]

The hon. Gentleman has not talked about the consequences for off-label drugs. I do not think that anybody would disagree with using good drugs for alternative purposes. Most of the concerns I have heard about the Bill are around the methodology and the process and the impact on off-label drugs. At the moment, drugs not on the agreed list can be prescribed, and I would be concerned if there was any threat to the ability to do so.

[Nick Thomas-Symonds]

With respect, that is precisely what the Bill seeks to do. We are talking about drugs that have been on patent for a particular purpose and that have a licence in that indication, but which also have another purpose. At the moment, theoretically, they can be prescribed off label, but that simply does not happen consistently across different spheres of medicine or across the country. The letter I read out from the Royal College of Physicians, dated 2 November, made that exact point.

The Bill is a common-sense solution that commands support across parties, in different spheres of the medical profession and from other stakeholders, and I commend it to the House.

--- Later in debate ---

[Alistair Burt]

I will take interventions, but it is only fair to the House that I respond to the debate and answer some of the charges that have been made—[Interruption.] It is not disgraceful; it is the right answer.

[Nick Thomas-Symonds]

Will the right hon. Gentleman accept two points? First, he made clear his objections to the Bill, and they were firmly answered by the expertise of the hon. Member for Central Ayrshire (Dr Whitford). Secondly, the Government have had a chance to put forward a non-legislative solution to the problem in the past year, but they have completely failed to do so, so why is he still refusing to allow the Bill to proceed to Committee?

[Alistair Burt]

After I have dealt with the other interventions, I will deal with the actions since last year’s Bill.

--- Later in debate ---

[Alistair Burt]

I am happy to be corrected in relation to procedure. The procedure of the House allows the Minister to speak until 2.30 pm. [Interruption.] I am not obliged to do so—that is correct—but I am choosing to do so because I believe that I would not be performing my duty if I were to allow a Bill that I think is wrong and potentially harmful to go through.

[Nick Thomas-Symonds]

rose—

[Alistair Burt]

I am not going to take any further interventions; otherwise, I will take it that the House does not want to hear from me. I have to make some progress.

--- Later in debate ---

[Alistair Burt]

Not at the moment, because this point is absolutely crucial to put on the record.

Prescribing in that way is part and parcel of normal, everyday clinical practice, as the hon. Member for Central Ayrshire confirmed. It is very common in prescribing for children and in treating some forms of pain. Most doctors, particularly GPs, will do it every day in their clinical practice. That has already been covered in relation to tamoxifen and raloxifene for the prevention of familial breast cancer. As was rightly identified by the hon. Member for Torfaen, the issue is compounded when drugs come off patent and new evidence suggests that they would be appropriate in the treatment of new indications.

The hon. Gentleman has gathered a lot of support for the Bill, but it does give the impression that such drugs are not being made available to patients. It also suggests that licensing is required to make these drugs available for patients, and that a NICE technology appraisal is required as well.

[Nick Thomas-Symonds]

I did not say that.

[Alistair Burt]

If the hon. Gentleman is happy to say that that is not the impression given, I am pleased to correct what I said.

[Nick Thomas-Symonds]

I never said that the drugs were not available. I said that they could theoretically be prescribed, but that it did not happen consistently by sector or across the country. That is what I said. It is on the record.

[Alistair Burt]

In that case, I am more than happy to again let the message go out from the Chamber today that these drugs are available and can be prescribed. Where it is clinically appropriate, they should be prescribed. Seeking this legislation will not change that availability.

Members of the House are doing a highly effective job of bringing their constituents’ concerns to the attention of Ministers and asking our help to resolve this issue. We are not aware of colleagues bringing examples of people who have been refused treatment. It is vital to know if there is evidence of people being refused treatment. As I said, the clinician’s letter that the hon. Member for Torfaen read out was wrong. Unless there is a clinical reason for not supplying the drug, there is nothing to prevent the doctor from doing so.

--- Later in debate ---

[Alistair Burt]

I certainly did myself a disservice with a silly, offhand remark. I entirely accept that. It is not like me and I apologise.

The stance that I am taking as the Minister representing the Government is that I do not believe this is the right vehicle to achieve what Members want. I am also concerned—

[Nick Thomas-Symonds]

On a point of order, Madam Deputy Speaker. With the greatest of respect to the Minister, he has had a bit more time since the last point of order and it is quite clear that he has run out of arguments and is now talking to the clock. I beg to move that the Question on closure be put.

[Hon. Members]

Hear, hear!