(8 years, 9 months ago)
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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.
Chris Heaton-Harris (Daventry) (Con)
Members may be aware that unlike the initial stages of my Bill, the journey of the Off-patent Drugs Bill promoted by the hon. Member for Torfaen (Nick Thomas-Symonds)—which is, coincidentally, further down on the Order Paper today—enjoyed widespread support from Members of this House, and outside this place among a whole host of charities and non-governmental organisations. My old colleague Jonathan Evans, a former Member of the European Parliament and the former Member for Cardiff North, introduced a similar Bill on these matters, which also gained widespread support. I have watched the progress of these Bills closely and read the briefings provided on them by several charities, and I could not help but notice the obvious links with my Bill and the importance of the subject it covers—increasing the use of effective off-label drugs.
The amendments that we are considering seek to work with the ideas of the Off-patent Drugs Bill and meet the same goal of spreading the use of off-label drugs. I am very grateful to the hon. Member for Torfaen for working with me, and others, so closely to include some of his very good ideas and thoughts in my Bill. He deserves a huge amount of credit for the work he has put into this, alongside the hon. Member for Central Ayrshire (Dr Whitford) and my hon. Friend the Member for Bury St Edmunds (Jo Churchill), who have been unbelievably strong champions of these issues.
The new clauses and amendments I am supporting do not reflect exactly the original Bill introduced by the hon. Member for Torfaen. That Bill sought to require the Secretary of State to seek licences for off-patent drugs in their new purposes. As the Government stated at the time, as the licensing authority in the UK, the Secretary of State cannot take up such a duty. However, that does not mean that a similar end result of increasing the use of such drugs cannot be achieved by other means. I very much hope that we can do so through this Bill.
Breakthroughs in research mean that several existing drugs have been found to be highly effective in treating conditions other than the ones for which they were originally produced. They potentially have huge life-saving effects and can alleviate the suffering of many people for many conditions. There are so many well-known examples. They were widely discussed on Second Reading of the Off-patent Drugs Bill, so I will not repeat all of them. The list includes the likes of tamoxifen and zoledronic acid, and of course the simple drug aspirin, which has so many other benefits in so many areas. The examples mentioned when we debated the hon. Gentleman’s Bill speak for themselves in showing us why his new clauses and amendments are so important.
As the hon. Gentleman has said in support of his Bill, doctors are nervous of prescribing off-label drugs. Even if a GP strongly believed in prescribing an off-label drug to a patient, they could well be put off. There are several reasons for that, and they were detailed in briefings circulated at the time. One is the matter of personal liability, which I will talk about in relation to other amendments. General Medical Council guidance shows that clinicians can currently prescribe off-label drugs, but that there are significant disincentives to do so. It states that a licensed treatment should be considered before an off-label or unlicensed treatment. It also indicates a greater level of responsibility for the doctor prescribing off-label, and therefore a potentially greater risk of liability, which would be a disincentive for a doctor in prescribing an off-label drug. Before a clinician has even started down this track, they are wary of picking an off-label medicine.
There is little incentive for a pharmaceutical company to pay for a licence when a drug can be manufactured generically. There is no incentive for any company to market the drug for a new indication, and there is no proper guidance for the use of such a drug. Without any stamp of approval, any marketing or any mechanism to provide guidance, there is nothing to encourage clinicians to use an off-label drug, other than their own medical knowledge.
Drugs without a licence for their second use are not marketed, so there is a lack of awareness, and the prescribing of them therefore varies when a new indication arises. There is no trusted and simple way to spread information about off-label drugs that are working. That means that some doctors may use the drug if they know of the indication, but lots may not. Without a system for sharing such information and spreading knowledge about these drugs, medical professionals deciding whether or not to prescribe them have to spend a huge amount of time reading the literature and undertaking research. The explicit mention, through the new clauses and amendments, of the inclusion of such drugs in the database will ensure that information about them is shared and reviewed, and that appropriate evidence is provided. By spreading awareness, the new clauses and amendments will therefore help to make prescribing more consistent.
On Second Reading of the Off-patent Drugs Bill, the hon. Member for Central Ayrshire said that experts in certain fields will prescribe many off-patent drugs whenever they feel it is necessary. For example, off-label prescribing is quite common in the treatment of secondary cancers. Experts in that area will have experience and will be aware of the evidence for use, but many other medical professionals will not be in such a position. If a drug is not in the “British National Formulary”, the dose cannot be checked.
When a clinician uses a drug every day or a specialist in a field sees conditions regularly, they know what works and what is best, and will therefore feel very comfortable in prescribing off-label. However, every medical professional is not an expert in every field. For the majority of the time, patients are not with such specialists. Their first point of call is not a clinical physician working in only one field, but a GP in their local practice or a nurse in their local surgery. I believe that the database has huge potential in helping to spread the knowledge and expertise required for better and further use of such drugs.
I hope that the amendments I have tabled will be agreed by the House—I believe they represent common sense—and that the Minister will listen to Members who have tabled the other amendments and new clauses. Although some of them are probing amendments, a huge amount of effort has gone into all of them. He is aware of the time and cross-party work that has gone into getting the Bill to this point. That has basically been driven by the hon. Members for Torfaen and for Central Ayrshire, my hon. Friend the Member for Bury St Edmunds and, to a certain extent, me. I would like to think that we will have got to a certain place by the end of today’s sitting, and that we can all leave the Chamber feeling that we have done some good.
Jo Churchill (Bury St Edmunds) (Con)
I congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on his success in bringing the Bill so far. The fact that we have reached even this stage is no small testament to his hard work on the Bill, particularly the discussions about the removal of the areas of concern—clauses 3 and 4—and the fact that he has been gracious enough to allow me and the hon. Members for Torfaen (Nick Thomas-Symonds) and for Central Ayrshire (Dr Whitford) to badger or cajole him into allowing us to table new clauses 1 to 6, but specifically my new clauses 4 and 6.
The Minister was not in the Chamber on 6 November to hear the arguments of the Members who proposed and supported the Off-patent Drugs Bill. Since then, however, he has engaged with many of us, for which I thank him. We felt that his Department’s response simply was not correct. Doctors may have been able to prescribe medicines for uses outside their licence or off-label where that was in the best interest of their patients, as the guidance says, but they just did not do so, or at least not consistently throughout the medical profession or the field and irrespective of the patient’s postcode. The prescribing of such drugs is more common in oncology, paediatrics, pain management and palliative care, which adds to the lottery effect for the patient.
The need for an action plan for an off-patent drug pathway is undeniable. When there is a strong indication of effectiveness, their routine use for an alternative indication should be secured. For example, the use of bisphosphonates, which were originally developed to treat osteoporosis, are now commonly used by 36,000 women living with secondary breast cancer in this country. Those drugs have already been through phased trials. No one in this place is suggesting that the highest levels of safety should not be applied to drug research and licensing at all times, but efficacy should drive clinicians’ decision making.
Patients, too, have a voice on this issue. I found my patient’s voice after my second primary cancer, and I wanted to use it for the benefit of others. Here I am now asking the Minister—not for the first time—to use his position to find a way to unleash the potential of research in this country and to unblock the system for everyone. My oncologist told me that a second primary cancer was luck—bad luck, but just luck—and I hope that we can all improve the odds just a little bit today.
I believe in the power of patients, clinicians, charities and pharmaceuticals to do the right thing—to increase their knowledge for those whose daily lives are dominated by serious disease and debilitating illnesses, and to ensure that treatments exist to help them. Particularly in the area of off-patent repurposed drugs, they need to be supported by key players, such as NICE, the MHRA, NHS England and medical research charities.
I assure the Minister that it is not mere chance the new clauses and amendments are supported by Members from all four corners of our nation. It is to show solidarity with our constituents—north to south, east to west—who want a co-ordinated approach. One of the most frustrating things for patients is the clogged nature of our drugs pathway. It seems to be beyond us to get drugs licensed, whether repurposed or not, and to the patient in a timely way. I ask the Minister to provide a timeline to support any action that can be taken.
New clauses 2 and 3 would require the National Institute for Health Research to develop and introduce a mechanism for gathering and recording evidence. Last week, I was surprised to learn from Professor Bruce, a clinician at the NIHR working in the musculoskeletal biomedical research unit, that in 50 years only one drug has been licensed for the treatment of lupus. Sadly, that licensed drug has spent four years being considered by NICE and is not available for wider use. To avoid the heavy use of steroids for the condition, rituximab is often used—a drug that was originally developed for lymphoma and rheumatoid arthritis.
Dr Philippa Whitford (Central Ayrshire) (SNP)
I rise to support new clauses 1 to 3, 5 and 6 and amendments 10 and 13. The only reason new clause 4 does not stand in my name is that it relates to NHS England, which is outwith my purview.
People are well aware of my objections to clauses 3 and 4. Many Members in this House and medical voices outside the House have real concerns about the danger to patients of doctors having to convince only one colleague before trying a completely unproven approach. As well as the danger to patients, I feel that there is a danger to our clinical trials system. Why would someone go through applications, a year of paperwork and phases 1, 2 and 3, when they could just cut to the chase?
I pay tribute to the hon. Member for Daventry (Chris Heaton-Harris) for being willing to sit around a table with the Members who were named by the hon. Member for Torfaen (Nick Thomas-Symonds) and the Minister, and to start with a blank sheet of paper and work out how we could do something useful. It has been a great procedure. I welcome the fact that later in the day the hon. Member for Daventry will propose the removal of the clauses on innovative practice and litigation.
Turning to the off-patent drugs proposals, 6 November was a very frustrating day in this House. Every single Member who spoke from the Back Benches spoke in favour of the Off-patent Drugs Bill, but the time ran away during the Minister’s response—not the Minister who is here today. That debate showed the appetite across the House to get something done on off-patent drugs.
The hon. Member for Bury St Edmunds (Jo Churchill) has explained most of what I was going to explain. There is still the issue that while specialists are steeped in the evidence and used to using drugs off label, those who are not are less sure. There is no automatic place where they can check a dose or an indication. Sometimes, it is the general practitioner who does not carry it through. We have had lots of discussions in this House about the changes in the NHS and the evolution to multidisciplinary teams out in the community. That means that there are far more non-medical prescribers. The further someone is from the expert prescriber, the less comfortable they are. They do not have easy access to somewhere they can check when they think, “Is that just my bad handwriting or is that really what I mean?” That is what new clause 6 on the BNF could achieve.
The BNF is used by everyone and is on every desk in the NHS. As the hon. Member for Bury St Edmunds said, people can either check a drug that they have had a letter about from the hospital or look something up when they think, “I don’t have anything for this. What exists?” We will also discuss that when we come to the database proposals. I welcome the fact that the database has been changed from being a registry of people doing their own thing to a place where information is shared.
On new clause 5, which I tabled, although the inclusion of off-patent drugs in the BNF will achieve the sharing of information and will, in a sense, give them a slightly informal kite mark, I feel that it is important to look eventually at providing a licence. The reason for my concern relates to the drug simvastatin, which is used all over the place to control people’s cholesterol and has been found to be useful in multiple sclerosis—a disease that plagues many people and causes a lot of suffering, and for which, frankly, we do not have a lot to offer. That drug is incredibly cheap, but if a company decides to tweak a little molecule of it, call it something else and put it out as a new wonder-drug for multiple sclerosis, we will be having debates in Westminster Hall about a drug that costs fifty grand and that the NHS cannot afford. Under General Medical Council rules, the cascade is still that a doctor must prescribe a licensed drug over an unlicensed or off-label one, regardless of cost. If a doctor was faced with fifty grand for simvastatin-new versus sixpence for the simvastatin we all know, they would have no choice, and we would be right back in the same position—relentlessly discussing the NHS’s access to drugs.
The drugs we are talking about are already safe. They have had a patent and been used for so long that they are now off patent, which means that they have been around for a decade. We know their side effects, the common dosages and what to look out for. They should not have to start at point zero of the licensing process. We need a short licensing system, so that patient groups, academics, charities and the British Generic Manufacturers Association can say, “We think there is something useful here.” We have put provisions in new clauses 2 and 3 for the NIHR and NICE to have capacity in their systems to provide a funnel for evidence on such drugs.
These drugs are not developed by big pharma, so there are not huge costs that have to be recouped. The purposes of them are usually found by academics and clinicians, so pharmaceutical companies should not make a massive profit out of them. The benefit should be that the NHS can afford them and patients can access them. We have many debates about access to medical treatments in the House, usually in Westminster Hall and usually about drugs that are eye-wateringly expensive. In this case we are talking about drugs that are proven and cheap. We need to come up with a system that makes them accessible to patients.
I commend the Minister for the time, that, as others have said, he has given the four of us around a few tables, hammering these provisions together. I hope that we will be supported in working them through and actually doing some good for the NHS and our patients.
Anne Marie Morris (Newton Abbot) (Con)
It is with great pleasure that I rise to speak in support of this important Bill, introduced by my hon. Friend the Member for Daventry (Chris Heaton-Harris), and the amendments he has tabled. Specifically, I rise to support amendment 13. I am sure that the hon. Member for Torfaen (Nick Thomas-Symonds) will be disappointed that his private Member’s Bill did not make it to Committee stage, but I hope that he is happy to see some of it included in this Bill.
I had my reservations about the Bill as it stood originally, and I have reservations about some of the amendments, but I believe that amendment 13 will increase the use of off-label drugs in a safe and secure way. Those drugs can often be a cheaper and quicker way to tackle a disease, as they do not have to go through the rigmarole of being developed and licensed, which can take many years and many billions of pounds. NICE states that an unlicensed medicine is one that
“does not have a UK marketing authorisation and is not expected to do so in the next 2 years”,
whereas an off-label medicine is one
“with an existing UK marketing authorisation that is…used outside the terms of its marketing authorisation”,
and for which
“it is not expected that the existing UK marketing authorisation will be extended to cover this use in the next 2 years.”
The inclusion of off-label use classes in the database as innovative medical treatments will allow the medical profession to see where off-label use has been effective, even if it is at the other end of the country. However, we must be careful not to place off-label uses on a pedestal and allow people to cling on to false hope. They are the most vulnerable people in our society, often looking for any treatment that may help them, but we must ensure that any drug that is prescribed off label is used responsibly and ethically. I believe that the database will help by allowing doctors to see what is effectively a large sample trial that gives them more information on a particular treatment. I therefore support amendments 13 and 10.
Mrs Flick Drummond (Portsmouth South) (Con)
I thank my hon. Friend the Member for Daventry (Chris Heaton-Harris) for bringing this important private Member’s Bill before the House and for his work in ensuring that all parties agree with it. It seems that a lot of work has gone into it by Members throughout the House, and as someone who was not part of those discussions, I am grateful to them for doing that work for everybody else.
The NHS benefits from one of the most rigorous health technology assessment organisations in the world, which provides clear and robust evidence of the clinical benefits of new interventions. However, the introduction of innovative treatments is complex, not straightforward, and the difficulty for the life sciences industry in getting new treatments to the market means that UK patients are often the last to see the benefits of new innovations in their disease area.
Heidi Alexander (Lewisham East) (Lab)
I congratulate the hon. Member for Daventry (Chris Heaton-Harris) on navigating the Bill to this stage. His pursuit of legislation in this area has sparked an important debate on the Floor of the House about how we can improve access to innovative treatments.
I welcome the opportunity to speak on this group of amendments, and I support the broad thrust of all of them. I commend the hon. Member for Bury St Edmunds (Jo Churchill) for her speech and the contribution that she has made—she spoke with great knowledge and passion.
I am particularly pleased that my hon. Friend the Member for Torfaen (Nick Thomas-Symonds) has tabled new clauses on the important issue of off-patent drugs and off-label uses, which he has championed. I was sorry to see his Bill fall on Second Reading in November and hope we can make more progress with the Government today.
Improving access to off-patent drugs so that people, no matter where they live or by whom they are being treated, are offered well-evidenced treatments that might not be routinely commissioned, is an ambition shared by many in the House, regardless of political persuasion. The Minister shares those objectives. Over the past few weeks and months, he has worked with key stakeholders and discussed the issue with them.
I express my support for new clause 1, which requires the Department of Health to produce 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 their routine use in such an indication. I hope the Minister can commit to such an action plan and put forward a clear timetable for progress, which is long overdue. I also hope he can offer the House reassurance on the proposals in new clauses 2 to 6, all of which have merit and deserve proper consideration by the Government.
Mr Speaker
Order. The hon. Lady had wished to contribute but toddled out of the Chamber at the appropriate moment. I would have called her but did not because she was not here. Does she still wish to speak?
Rebecca Harris
Very briefly, Mr Speaker.
I support the Bill and commend all those who have worked towards it in the many iterations it has been through in this House and the other place—I can see that Members of the other place are taking an interest in our proceedings today.
I am chairman of the all-party parliamentary group on brain tumours. Brain tumour research has desperately lagged behind other areas of cancer research, and we desperately need to find new sources of treatment. Sadly, brain tumour is still the biggest cancer killer of the under- 40s—children and young adults. The Bill could be a great step forward in the sharing of information.
I commend the Minister, as all hon. Members have. Without wishing to sound too toadying, we have a Minister who is committed to taking forward progress on research in a way that we have not seen previously.
It should be pointed out that the NHS is a superb innovative organisation that does huge amounts of research. We do not hear that said often enough of the NHS. From my point of view, the most important bit of the Bill is the database, which will mean we can take forward the research we do in the NHS so that people can have access to information—not just patients, but clinicians, who might not know as much as we or they would hope. I very much hope the Bill makes progress.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
It is a great pleasure to take part in the debate and to support a package of amendments that have been agreed by Members on a cross-party basis over the past few weeks and months. Very often in private Members’ business, the Government take the view that the intentions are fine but the mechanism is flawed, and that the Government legislate while MPs raise issues. However, with this Bill, we have struck a blow for joined-up thinking and cross-party working in pursuit of patients’ interests—I will say more about that on Third Reading.
With my hon. Friends the Members for Daventry (Chris Heaton-Harris) and for Bury St Edmunds (Jo Churchill), and the hon. Members for Torfaen (Nick Thomas-Symonds) and for Central Ayrshire (Dr Whitford), and with the help of Opposition Front Benchers, we have managed to deal with three Bills with which the House has been preoccupied in recent months—the Bill initiated by Lord Saatchi, which looked to change the culture of innovation; the Bill introduced by the hon. Member for Torfaen, which promoted the use of off-patent repurposed drugs; and this Bill, introduced by my hon. Friend the Member for Daventry, which seeks to promote access to innovative medicines. With the package of amendments we have agreed, we will end up with a Bill that moves forward on those three areas of concern for Members in all parties of the House. Today is a rare and rather wonderful moment because the amendments are supported by every party in the House—I cannot speak for the United Kingdom Independence party because I have not heard anything from it, but all other parties support the Bill.
We have three groups of amendments to get through so I will try to be brief in dealing with the specific points, many of which have previously been raised and discussed. I should take this opportunity to pay tribute to and thank my officials who, over the past three to six months, have tirelessly worked with Members on both sides of the House in an unusual way to help to draft amendments that we can all support. I thank them for their diligence in doing so.
Broadly, the intention of the package of amendments is to introduce off-label repurposed medicines in the Bill, and to put it four square at the heart of the agenda. As the hon. Member for Torfaen said, I wholeheartedly supported the intention of his Bill and its predecessor, but not the mechanism. We now have a mechanism that will work.
I appreciate that the new clauses are probing and that hon. Members are seeking my reassurance on how the Government will take things forward. New clause 1 is a request for an action plan. Nobody seriously thinks that we should put an action plan in the Bill, but let me set out my commitment and that of the Government to pursuing this agenda with time and rigour. As I have said in other places, the truth is that the world of drug discovery is changing profoundly. The transformational power of genomics and informatics create a wholly new opportunity both to discover new medicines and target them at individual patients much more quickly, and to discover repurposed uses of existing drugs in a way that we have not been able to do previously. The 100,000 Genome Project, which the Government have initiated and funded, has already begun to identify existing drugs that have uses in indications that were not hitherto known. The pace at which new drugs are being developed and discovered is increasing, which is a credit to the creativity of the sector.
That sets the backdrop for the creation of my post and the accelerated access review that I have launched. As all hon. Members know, I am committed to putting in place a landscape that accelerates the use of NHS resources to support research. When we launched the strategy, the Prime Minister said that every patient should be a research patient and that every hospital should be a research hospital. We are determined to ensure that the daily footprint of diagnosis and treatment is used more intelligently to support research.
The accelerated access review is looking at that in a lot of detail and is an extensive piece of work. Colleagues have referred to the interim report—the final recommendations are due to arrive on my desk at Easter. I am very happy to give a commitment that, in our response to that report, we will pick up the points made in the debate and in the Bill on ensuring that we look at repurposing and off-label uses of existing drugs as much as we look at innovative medicines.
In new clauses 2 and 3, hon. Members are probing me to give details on how the National Institute for Health Research and the National Institute for Health and Care Excellence can put into practice the mechanism that we have discussed. On new clause 2, there are very open mechanisms currently for applications to the NIHR to research existing medicines. The NIHR—I am delighted that we have reconfirmed our £1 billion a year funding for it—conducts research every year into existing medicines, and there is a clear process for that. It would not be appropriate to legislate in a Bill to tell organisations that are subject to the Haldane principle, which is sacrosanct for the Government, what to do. We want research to be led by that principle, but I am happy—I will say more about this in a moment—to ensure that, through the process, we explore mechanisms for ensuring the NICE can look at evidence and develop evidence-based guidance on off-label medicines, so that doctors are aware of which drugs are being used in an off-label indication.
On new clause 3, I am delighted to confirm that, after discussions, NICE is now looking at ways to collect evidence on repurposed medicines. It is looking at taking evidence and how it could use, through its existing evidence review process, evidence on repurposed medicines specifically. I have asked whether we might be able to put a mechanism in place to find a way to somehow put that into the “British National Formulary”. I would not want to put that mechanism into the Bill, because we need the freedom to evolve the mechanism and to get it right. I hope that is a helpful reassurance.
Nick Thomas-Symonds
I would just like to make two points. First, the “British National Formulary” is UK-wide. Secondly, and just to probe the Minister further, is he able to give an approximate timeframe for when he thinks the process might be complete?
George Freeman
The hon. Gentleman makes two good points. This is, of course, UK-wide. One of the challenges, as a UK Minister, is to put in place a framework that will support this across the UK while respecting the different mechanisms in the devolved Administrations. I hope the Bill will provide a basis for a similar mechanism in areas where there are different formats. I believe that in Scotland, Northern Ireland and Wales, but particularly in Scotland and Northern Ireland, there is a hunger to do that. I believe the Bill will support those existing mechanisms.
Dr Philippa Whitford
We have moved on from talking about the BNF. I accept the comments about listing groups that would be considered in new clause 5. Does the Minister accept, however, that we still need to deal with the cascade of prescribing to ensure doctors are not forced to prescribe a licensed medicine, which is actually just a minimal moderation of an off-patent drug at a vastly expensive cost? That means we still need some kind of change to the licensing or short licensing process in the future.
George Freeman
The hon. Lady makes an important point about the classification of different drugs available to clinicians. Without detaining the House with too long a peroration on that classification, it is worth setting out that there is a clear cascade.
Clinicians can use unlicensed medicines in situations where, in their clinical judgment, and with patient consent, they believe it is the right thing to do. They are subject to all their usual professional undertakings. There are then off-label uses of drugs: drugs that do not have a licence for a particular indication but which the clinician, on the basis of evidence, is able to prescribe when they feel that evidence is compelling. The Bill now goes to the heart of that and will help to provide reassurance. For many clinicians, being able to click on a mouse with their patient and say, “For your condition there are one, two, three or no off-label medicines available for which NICE has looked at the evidence,” would be a powerful catalyst in helping to promote off-label use. There are generic drugs, which have been patented and brought to market, that are available at a heavily discounted open price.
There are then on-patent drugs, which have been brought to market and are still subject to a patent. The manufacturer has an exclusivity, which is the period in which their sunk costs in bringing the medicine to the system, can be reimbursed. That is an important protection to make sure we continue to have a thriving life science sector that can take the risks of investing in new drugs. Typically, new drugs take 15 years and £2 billion to develop. If there were no patenting mechanism, there would simply be no enthusiasm to do that research, which has a very high failure rate. In law, there is a key point of principle, which is that a licensed drug should be used first and that an unlicensed drug cannot be used purely on the basis of cost. That is a really important principle. An unlicensed drug can, however, be used on the basis of evidence. That is why the mechanism will allow NICE to look at the evidence and to signal to clinicians that they have the evidence basis on which to use the drug in an off-label indication.
One of the issues we have dealt with in discussions is the whole question of the European licensing of medicines. If we were to go down that route—I know the hon. Member for Central Ayrshire understands this—I can assure the House we would be here not just for weeks and months, but years. I am leading for the Government on reforming the European landscape of 21st medical research. The central role of protecting innovators’ sunk costs is really important to our life sciences sector, and the new clauses and amendments create a mechanism by which we can accelerate off-label use without running a coach and horses through that.
Dr Whitford
I accept the Minister’s points, but my concern remains that if in 10 years we have simvastatin in its current form versus a new name that is just a tweaked simvastatin at a thousand times the price, doctors will, under GMC rules, have to go for the one with the licence, as opposed to the off-patent one, even if it is in the BNF. I accept that the BNF mechanism will absolutely increase usage, but we still need to consider the longer term, given that in the future we might have huge numbers of off-patent drugs with new purposes.
George Freeman
The hon. Lady makes an interesting, important and useful point that I undertake to pick up in our consultation in response to the accelerated access review. The landscape will continue to change fast over the next few years. The Bill, as amended, will promote the greater use of off-label medicines. Crucially, the database mechanism, which, I reassure everybody, is very different from the original registry proposed in a precursor Bill—it is to make clinicians aware of what drugs are available—will generate data that will be incredibly powerful in helping the system to adapt and use the freedoms I hope to give it through the accelerated access review. That will ensure we are better and faster at getting these repurposed medicines into use.
I am delighted to say that the Government are happy to support amendments 10 and 13. Amendment 10 would set out in the Bill that its purpose specifically includes promoting access to the innovative use of licensed medicines outside their licence indications. It puts four square at the heart of the Bill the aims of the Off-patent Drugs Bill, which was promoted by the hon. Member for Torfaen (Nick Thomas-Symonds), and which, as hon. Members across the House have commented, had a lot of in-principle support. I am pleased, therefore, that we have found a form of words that moves it forward. At the heart of it, there is a clever protection for clinical sovereignty. We are not telling clinicians what they have to prescribe or putting in law a requirement that they prescribe in a particular way. We are giving them information on evidence-based off-label drugs. The feedback from clinicians so far is that it genuinely will help them to understand, promote and prescribe off-label uses.
Amendment 13 seeks to clarify the definition in the Bill of innovative medical treatments to make it clear that it includes off-label and unlicensed medicines. I mentioned earlier the pace at which genomics and informatics were uncovering new uses for drugs—some have referred to it as finding diamonds in the dustbin. There are extraordinary applications among the existing pharmacopoeia of tens of thousands of drugs. We now realise that many of them have particular impacts and effects. That is all to the good. It is thanks to the power of our life sciences sector that we are beginning to uncover those, and the Bill will support that.
With those comments in support of amendments 10 and 13, I hope I have given hon. Members enough reassurance and that they feel able to withdraw or not press the probing new clauses. I will be happy, following Third Reading, to put in place, through the accelerated access programme, a clear plan for keeping on top of the system’s implementation and tracking the use of repurposed medicines. We will continue with the work we did with charities through the winter and with the very helpful discussions we had with the charitable sector, and the Department will look annually at the data and whether the landscape is changing, and if it is, we will keep that under review.
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.).
Chris Heaton-Harris
On a point of order, Mr Deputy Speaker. I am unsure of the process. What happened to amendment 13?
Mr Deputy Speaker
It comes later. It is about three pages further on in the dossier. It has not been lost, and we will be coming to it, so the hon. Gentleman can rest assured. It is there.
Chris Heaton-Harris
I beg to move amendment 1, page 1, leave out lines 7 to 9.
Mr Deputy Speaker
With this it will be convenient to discuss the following:
Amendment 11, page 1, line 18, in clause 2, leave out from beginning to “involves” in line 19 and insert
“In this section, “innovative medical treatment” means medical treatment for a condition that”.
Amendment 2, page 2, line 26, leave out clause 3
Amendment 3, page 3, line 19, leave out clause 4
Amendment 4, page 3, line 40, in clause 5, leave out “this Act” and insert “section 2”
Amendment 12, page 3, line 42, in clause 5, leave out paragraph (b)
Amendment 5, page 4, line 1, in clause 5, leave out “this Act” and insert “section 2”
Amendment 6, page 4, line 3, in clause 5, leave out “this Act” and insert “section 2”
Amendment 14, page 4, line 8, in clause 6, leave out “Sections 1 to 5” and insert “Sections 1, 2 and 5”
Chris Heaton-Harris
I just thought I would check about amendment 13, Mr Deputy Speaker. This whole experience has been a steep learning curve when it comes to procedure in the House. Perhaps we have invented a few things on the side as well, given how we have gone about our business here. I do not want to speak too soon, but if we could conduct all our health debates in the positive and constructive tone that has characterised these debates and the process behind the Bill, we might improve our heath service in leaps and bounds, rather than getting caught up in unnecessary politics. But that is where we are.
My amendments 1, 2 and 3 would remove, among other provisions, two clauses on clinical negligence. I want to talk about the reasons for their removal and the original idea behind the clauses. As right. hon. and hon. Members who have been following the progress of my Bill will know, many of the ideas in it came from Lord Saatchi’s Medical Innovation Bill in another place. Those ideas have not had the smoothest of journeys in this place. I have been regularly reminded by hon. Members—I thank those here today—and others outside this place that these clauses have not enjoyed the support of stakeholders.
Such concerns have been around since before the Bill was even drafted. Unfortunately, the echoes of those concerns haunted the first mention of the word “innovation” in the clause, and I decided from conversations I have had that those concerns could not be quelled in time. Throughout the process, I was clear that I wanted to listen to everybody with something to say on this matter. I have met and read the briefings of everyone who has contacted me wishing to share their views, and I hope it has been evident that I have been up front, honest and very clear about my intentions. I tried to solve the concerns of Members and the medical community who believed the clause would have negative and unintended consequences. That is why I tabled these amendments.
I hope that this process reflects favourably on Parliament and shows how a piece of possible legislation can evolve with a huge amount of stakeholder engagement and with parliamentary opinion taken on board. Since the beginning, I have focused on the sharing of good practice and transparency—and, indeed, on the failures of treatments through a database. Those ideas are reflected in clause 2 and have received much support.
I wanted to maintain the camaraderie built up around the Bill and have been unable to find the support I needed for the more controversial clauses, 3 and 4. Clause 3 sets out the steps that a doctor would need to take to show that he or she had acted responsibly using the Bill. They were intended to reflect the steps that a responsible doctor could be expected to take under common law when innovating. In relation to a proposed treatment, clause 3 would require the innovating doctor to
“obtain the views of…appropriately qualified doctors”
with
“appropriate expertise and experience in dealing with patients with the condition in question.”
Clause 4 expressly preserves the common-law Bolam test, the key precedent for judging whether a doctor has acted negligently.
The two clauses received strong opposition, which I will not go into too much. However, I worked closely with many officials from the Department of Health, and I want to thank them, because I had read the briefings that were so adamant in saying how dangerous parts of the Bill would be, so it was nice to have some of the best and brightest legal and parliamentary counsel remind me again and again that they viewed them as perfectly safe and did not see them as a danger to patients.
Dr Philippa Whitford
Does the hon. Gentleman understand the danger of undermining our clinical trials systems, in that, using the Bill, a doctor would have to convince only one colleague before they could go ahead and try something completely new? The recent tragedy of the patient who died while taking part in a phase 1 trial shows the need for steps and procedures to reduce the risk.
Chris Heaton-Harris
The hon. Lady knows that I would obviously have preferred to retain clauses 3 and 4, but I have to agree with her: the body of opinion stands on her side of the argument, not mine, so the simple answer is yes.
I remind the House, though, that there was a decent and honourable purpose behind clauses 3 and 4. Dr John Hickey, the former head of a primary care trust, contacted me to say that,
“as a registered medical practitioner, a former NHS Trust Chairman and with 30 years’ experience in the field of legal medicine with the Medical Protection Society (last five years as Chief Executive), I believe I am adequately qualified to comment on your Bill.”
He went on to say:
“Over the last 30 years I have seen how doctors have increasingly practised defensive medicine…because of the fear of litigation and disciplinary action by their regulators; this defensiveness is not in patients’ best interests.”
In fact, it may interest Members to hear that, in reading the debates on the Bill introduced by the hon. Member for Torfaen (Nick Thomas-Symonds) and the recent debate on the Mesothelioma (Amendment) Bill, I have seen much stated that supports the action I wanted to take in clauses 3 and 4 to reassure doctors who fear litigation. For example, the British Medical Association’s parliamentary brief for the Second Reading of the Off-patent Drugs Bill stated that there were
“two barriers to the use of off-patent drugs in a new indication: 1) Clinicians’ confidence in prescribing: clinicians take on a personal and professional liability if they prescribe an off-patent drug in a new indication”,
and therefore they require reassurance. The brief goes on:
“GMC guidance also indicated a greater level of responsibility for the doctor prescribing off-label and therefore potential greater risk of liability which would be a disincentive for a doctor prescribing off-label drugs”.
That is a simple statement of the purpose of clauses 3 and 4: to give doctors a supplementary way to assure themselves that they are doing the right thing where they might want to do something they believe to be in their patients’ best interests, in a fully evidenced, responsible and honest way.
Similarly, the Multiple Sclerosis Society’s brief on the same subject states:
“Guidance from the General Medical Council is clear that a doctor takes on an extra level of personal liability when prescribing off-label, which would be a significant disincentive to prescribing”.
Breast Cancer Now says that, because of personal liability,
“doctors can be unwilling to prescribe drugs for new purposes, even where…clinical evidence is strong”.
As Lord Freyberg stated in the mesothelioma debate in the other place,
“The fastest way to save lives is to see if the drugs for common cancers work on the rarer ones as well, given the shared mechanism of disease across cancer. This is off-label research and until we fix the issue of liability, as advocated by the noble Lord, Lord Saatchi, we will continue to send thousands, like my sister, to an early grave.”—[Official Report, House of Lords, 20 November 2015; Vol. 767, c. 407.]
There was therefore plenty of reason and evidence to support clauses 3 and 4, but I guess politics is all about being pragmatic, and I believe that the provisions that we have already discussed are worthy in themselves of inclusion in a sensible Bill, because they will do some positive things. It is therefore with some reluctance, as I am sure the House will understand, that I have decided to table these amendments, which strike the elements relating to clinical negligence from my Bill.
Anne Marie Morris
I support my hon. Friend’s amendment 2, which would remove clause 3—the responsible innovation clause—from the Bill. I know that his heart was absolutely in the right place when he first put the Bill before the House; however, I am glad he has tabled the amendment, as I am sure the majority of us, if not all of us, are present in the Chamber to ensure that the rest of his Bill, particularly the provisions dealing with the database, gets through.
I have received briefings from all manner of medical bodies, as I am sure all colleagues have, stating that the Bill would do more harm than good for patients. A letter signed by nine different medical bodies, including the Academy of Medical Royal Colleges, the British Medical Association and the Patients Association, says that
“this Bill will actually harm good innovation by weakening patient protection, adding unnecessary bureaucracy and undermining good scientific practice.”
By removing clause 3, amendment 2, along with amendment 3, will allay those fears. There will no longer be any fears about doctors using quackery, as some people outside the Chamber have put it. Instead, there will merely be a database, set up by the Secretary of State, who may by regulation confer functions on the Health and Social Care Information Centre, although I note that the hon. Member for Lewisham East (Heidi Alexander) has tabled amendments seeking to change who the Secretary of State has to consult before making any regulations.
At a constituency level, a number of concerns have been raised with me by those in the healthcare sector who believe this Bill, or at least this clause, would do more damage than good. There was a misconception among some people that it remained a carbon copy of Lord Saatchi’s Medical Innovation Bill, which was introduced in the last Parliament. Although my hon. Friend’s Bill is indeed similar to Lord Saatchi’s, the amendments he has tabled will completely dispose of any similarity at all. Innovation sounds like such a good idea. To most people in the street, it sounds like a marvellous thing and therefore taking “innovation” out of the Bill must be a bad move. However, innovation must be achieved through the correct means and must not pose any danger to patients.
The argument goes that innovation has decreased in recent years owing to the legal complexities and doctors’ fears of negligence claims against them if something goes wrong. There is no evidence of that, according to the Medical Protection Society, the Medical Defence Union, the General Medical Council and various other medical—
Debate interrupted.