Access to Medical Treatments (Innovation) Bill
(8 years, 3 months ago)
Commons ChamberRead Hansard Text Read Debate Ministerial Extracts
Anne Marie Morris
I shall resume my comments on amendment 2, which would remove clause 3. The argument goes that innovation has fallen in recent years owing to the legal complexities and doctors fearing a negligence claim against them if something goes wrong. There is no evidence of this, according to the Medical Protection Society, the Medical Defence Union, the General Medical Council or various other medical bodies that have spoken out on the issue. They claim that the Bill needs to be completely rethought and that no amount of amendment would make it acceptable. I would like to think that the work that my hon. Friend the Member for Daventry (Chris Heaton-Harris) has done will go some way to meet the concerns expressed before Committee stage.
Those most likely to benefit from innovative medicine are likely to be those most in desperation. Those who have nowhere else to turn will often be allured by the carrot on the end of the proverbial stick, but we must make sure that the treatment is right for that particular person. The UK has a proud history of research through universities, research institutes, the private sector and, of course, the NHS. According to the UK Clinical Trials Gateway, there are currently 3,754 trials recruiting, and that does not include the innovation that goes on day to day in the NHS.
According to the Association of the British Pharmaceutical Industry, it can take over 12 years to develop a new medicine to the standards of quality, efficacy and safety that are laid down in legislation. It will typically cost £1.15 billion to do all the research and development necessary before a new medicine can be licensed for use. For every successful medicine, 25,000 compounds are tested, 25 of these in clinical trials, with five receiving approval for marketing. The pharmaceutical industry invests more in research and development than any other industry—£11.2 million is spent every day—and employs around 23,000 people in R and D. My hon. Friend the Minister for Life Sciences stated in September last year:
“Research and innovation in the NHS are critical for addressing ...challenges.”
I agree and therefore wholeheartedly support amendment 2.
Amendment 3, which would remove clause 4, was tabled by my hon. Friend the Member for Daventry, with the support of the hon. Member for Central Ayrshire (Dr Whitford) and my hon. Friend and neighbour the Member for Totnes (Dr Wollaston). It is important to address the legal aspects of the Bill and medical negligence. The common law test, which is the main test for medical negligence, has been around since 1957 and derives from the case of Bolam v Friern Hospital Management Committee. The Bolam test states that if a doctor reaches the standard of a responsible body of medical opinion, he is not negligent. This rule has served us well over the past 55 years and I believe it will continue to serve us well. However, if it needs to be amended, our judges are in a suitable position to do that. The 1997 case of Bolitho v City and Hackney Health Authority, where the courts refined the Bolam test, is a great example of our common law in action.
Although I am sure some will point out that the Bill does not explicitly change the Bolam test and clause 4(3) appears to address the concerns that were expressed about the Saatchi Bill, I worry that lawyers would still find a way around this. Why tempt fate to change something that is not broken? Judges and lawyers know where they stand with the common law, so maintaining the status quo will give both doctors and patients the protection they need from negligent treatment. If the removal of clause 3 is agreed to, it is right that clause 4 should also be removed as it would no longer be necessary, and the common law of negligence and the Bolam test can continue to operate effectively, as they have done for 55 years. I therefore support amendment 3.
Heidi Alexander
This group of amendments, and in particular those which leave out clauses 3 and 4, are very welcome and have my full support. I appreciate that making such extensive changes to a Bill at this stage is not easy, but the hon. Member for Daventry (Chris Heaton-Harris) has been true to his word, and has rightly decided not to proceed with these clauses in the face of strong opposition.
Members who were present on Second Reading will have heard some of the grave concerns expressed by medical royal colleges, research charities and patient groups. I think it would be fair to the hon. Gentleman if I say that those concerns, which I shared, were more about the unintended consequences of clauses 3 and 4, than about the stated aim of his Bill. However, the effect of these amendments, if they are passed, is that the sole purpose of this Bill is now to give the Secretary of State the power to establish a database. The hon. Gentleman knows that on Second Reading, along with many other hon. Members, I said that I believed the Secretary of State already had this power.
The Association of Medical Research Charities has said that primary legislation is not required to set up a database of innovative medical treatments. According to the House of Commons Library, section 254 of the Health and Social Care Act 2012 gives the Secretary of State power to direct the Health and Social Care Information Centre to establish a system for the collection or analysis of information. Indeed, in Committee, the Minister signalled his intention to introduce such a database, regardless of whether this Bill becomes law. He said at that time:
“If the Bill does not, for whatever reason, reach the statute book, I would happily proceed towards establishing such a database”.––[Official Report, Access to Medical Treatments (Innovation) Public Bill Committee, 16 December 2015; c. 22.]
With that in mind, I have to question whether what is left of this Bill is needed at all.
There also seems to be some confusion, even in the Minister’s own mind, about the purpose of the Bill. The Daily Telegraph claimed on 22 January that the Minister had told it that changes in the reworked Bill could help to cut the length of time it took to bring a new drug to market by a third, from 15 years to 10 years. Yet when my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders) received a written answer to a question on this very subject on 28 January, the Minister’s reply was:
“The Bill is not specifically designed to reduce the length of time it takes to bring a new drug to market”.
I would be grateful if the Minister clarified the apparent contradiction in those remarks. Having said all that, I support all the amendments in this group. Indeed, they represent a positive step forward in terms of the overall Bill.
George Freeman
The amendments seek to remove the part of the Bill that sought to take forward the original proposals put forward by Lord Saatchi to provide reassurance to clinicians that fear of negligence should not be a barrier to innovation. I want to say something about the Government’s position on this point, which, as the hon. Member for Lewisham East (Heidi Alexander) has said, has been a point of some contention.
The Government share the ambition that fear of negligence should not be a barrier to innovation. Indeed, we have looked carefully at the provisions of the original Saatchi Bill and of this Bill, and taken legal advice in order to be sure that the proposed mechanism would in no way change medical negligence law, and that is indeed the case. Notwithstanding that, I have also repeatedly made it clear that if the Bill’s provisions were to create confusion, undermine patient, public and clinician trust and confidence and trigger a lawyer-fest of discussion about whether the mechanism did or did not have that effect, it would have had the opposite effect to that which it was seeking. In those circumstances, the Bill could trigger more confusion about medical negligence.
My hon. Friend the Member for Daventry (Chris Heaton-Harris) has done a sterling job in the past few months to get round all the various parties and reassure them that, in law, the proposed mechanism does not change the legal framework for medical negligence. However, as he himself has candidly said, such has been the level of opposition—and indeed some misunderstanding, not least because there are three Bills on this subject in the House—that this proposal has started to have the opposite effect. As I said on Second Reading and elsewhere, we would never be able to support a Bill which, despite its intentions, undermined public and patient trust and confidence in our world-class medical and clinical research landscape. The fact that a coalition of lawyers, clinicians, patients and charities was concerned about the clause meant that it would inevitably have to be removed if the Bill was to receive any support from the Government. I congratulate my hon. Friend on doing his very best to develop the debate and, in the end, deciding that it would be better to remove the clause and focus on the areas on which there is agreement.
In accepting the amendments that remove the provisions on medical negligence from the Bill, it is worth pointing out that I do not want the hon. Member for Lewisham East to misrepresent my position on this. Both the chief medical officer and the NHS medical director had advised us that they believed the proposal was safe, and we had no fear that it would in any way endanger patient safety. The point is that if it triggers legal, political or patient concern, it is self-defeating.
As I have said repeatedly at the Dispatch Box, fear of negligence is just one concern in a whole field of barriers to the adoption of innovation. I do not believe that it is the biggest barrier; I never have. The biggest is the difficulty of getting information to clinicians on the busy frontline of our national health service on the pace, scale and volume of innovative medicines that are coming through the system. That is why I believe that my hon. Friend’s refocusing the Bill on that, and on the introduction of a new mechanism for getting information on off-label drugs and innovative medicines in development, is very helpful and powerful.
Heidi Alexander
Will the Minister tell us why it is taken him so long to reach this conclusion? Will he also be clear about the contact that his officials at the Department of Health might have had with the hon. Member for Daventry (Chris Heaton-Harris) or Lord Saatchi on previous incarnations of this Bill? It strikes me that the Department has supported this Bill for a number of months and years in its different incarnations.
George Freeman
I am absolutely delighted that the hon. Lady has asked me that question, because it gives me the chance to deal with this matter directly. I am surprised at her question, in an age in which people want the Government to work in a cross-party way and to support private Members’ Bills and enable Back Benchers to get business through, and I have gone out on a limb to work in a cross-party vein. Sadly, however, the hon. Lady seems stuck. I thought this morning might have been a day on which to celebrate that joined-up work. Let me deal with the specific points that she has raised.
Right at the beginning, I said that I supported the aim of Lord Saatchi’s Bill to tackle the issue, such as it is, of medical fear of negligence if it is getting in the way of innovation. Indeed, we made it clear that we supported the aims of the Off-patent Drugs Bill, but not the mechanism involved. We also made it clear that we supported the aim of the Bill introduced by my hon. Friend the Member for Daventry to promote access to information about innovative medicines. I am surprised that the hon. Lady cannot get away from wanting to criticise that attempt. I believe that it is a good thing that we have reached joined-up consensus today on a package of amendments.
The hon. Lady should not believe everything that she reads in the papers. The article in The Daily Telegraph to which she referred talked about the accelerated access review, which I am leading and which I would like to think she welcomes and supports. My comments on speeding up the pace at which we can get innovative medicines to patients were in connection with that. I read the piece too, and it was misleading because it gave the impression that I thought this Bill would have the effect that I want the accelerated access review to have. I was merely making the point that the Bill in its current form could support the wider accelerated access review and the landscape that I am trying to put in place.
Heidi Alexander
I should like to state for the record that it has never been the Opposition’s desire to play political games with this Bill. We have always been concerned about what is in the best interest of patients, and I would like to make that point clear to the Minister and place it on record.
George Freeman
I am grateful to the hon. Lady for that clarification; it is most welcome.
I want to deal with the point that the hon. Lady and one or two others have made about the necessity of the Bill, given the powers that Ministers already have in relation to data. The Health and Social Care Information Centre, created under section 254 of the 2012 Act, can collect data, but there are restrictions on who it can disclose those data to. The Bill will enable disclosure to doctors, which could be limited by using just section 254. The 2012 Act also contains specific provisions relating to the HSCIC having a role in establishing other databases, so this approach is more in keeping with the general approach in the legislation.
The Bill might not pass in its current form, as it still has to go to the House of Lords. However, the point I made in Committee was that although I support the intention of that database provision, the law regarding the use of data in the NHS is complex and difficult, as Members know well. If the House wants the database to be created, having a Bill that makes very clear what it wants the database to do and requires Ministers to come back with proposals for it would be extremely helpful. In conclusion, I support these amendments.
Amendment 1 agreed to.
Clause 2
Database of innovative treatments
Amendment made: 11, page 1, line 18, leave out from beginning to “involves” in line 19 and insert
“In this section, “innovative medical treatment” means medical treatment for a condition that”.—(Chris Heaton-Harris.)
Heidi Alexander (Lewisham East) (Lab)
I beg to move amendment 8, page 2, line 20, at end insert—
“(b) the General Medical Council,
(c) the British Medical Association,
(d) the Association of Medical Research Charities,
(e) the Royal Colleges,
(f) the Academy of Medical Sciences,
(g) the Medical Research Council,
(h) the National Institute for Health and Care Excellence,
(i) the Medicines and Health Products Regulatory Agency, and
(j) any other body or individual that the Secretary of State considers it appropriate to consult.”
Mr Deputy Speaker (Mr Lindsay Hoyle)
With this it will be convenient to discuss the following: amendment 9, page 2, line 20, at end insert—
“(6A) Regulations under subsection (1) may not be made unless the Secretary of State is satisfied that the regulations have the approval in principle of—
(a) the HSCIC,
(b) the General Medical Council,
(c) the British Medical Association,
(d) the Association of Medical Research Charities,
(e) the Royal Colleges,
(f) the Academy of Medical Sciences,
(g) the Medical Research Council,
(h) the National Institute for Health and Care Excellence,
(i) the Medicines and Health Products Regulatory Agency, and
(j) any other body or individual that the Secretary of State considers it appropriate.”
Amendment 15, in clause 5, page 4, line 1, leave out subsection (2) and insert—
“( ) References in section 2 to medical treatment include references to treatment carried out for the purposes of medical research (but nothing in section 2 is to be read as affecting the regulation of medical research).”
This amendment makes it clear that the database for which clause 2 provides may contain information about treatments carried out for the purposes of medical research (including, for example, in the context of a clinical trial).
Heidi Alexander
Setting aside the fact that I question whether what is left of the Bill is necessary, if the database is to be created, it is important that we get its design right. The Association of Medical Research Charities has expressed concern that the database might adversely impact patients and medical research. For such a database to be effective, it will need to be appropriately regulated and quality controlled. I believe that it can command the confidence of the medical profession only if it is developed in consultation with it. With that in mind, amendments 8 and 9 deal with the bodies that the Secretary of State must consult and get approval from before introducing regulations establishing a database of innovative treatments.
As the Bill stands—this is set out in clause 2(1)—to make those regulations the Secretary of State need only consult the Health and Social Care Information Centre. Restricting the statutory consultees to only one organisation seems highly restrictive and is inconsistent with the Bill’s explanatory notes, which state:
“The detailed design of the database would be consulted upon with professional bodies and organisations.”
Amendments 8 and 9 would make the legislation clearer on which bodies should be consulted.
I note that the Minister was unable to support similar amendments tabled in Committee because he felt that the list was “not exhaustive”. Indeed, he went on to say:
“Although it represents a helpful list of consultees, such a provision would need to include many more organisations. While I understand the intention behind the amendment, restricting the process would not be helpful”.
The hon. Member for Daventry (Chris Heaton-Harris) then said:
“I know from my consultation on the Bill with stakeholders that we would need longer lists than those in the amendments.”––[Official Report, Access to Medical Treatments (Innovation) Public Bill Committee, 16 December 2015; c. 22-23.]
With those constructive comments in mind, I have included in the list a provision allowing the Secretary of State to consult
“any other body or individual that the Secretary of State considers it appropriate to consult.”
I know that there were concerns that the list of specified organisations could become out of date. However, given that these regulation-making powers would likely be used only once—to create the database—I do not believe that concern is wholly justified. Indeed, if the Minister, or any hon. Member, believes that an inappropriate organisation is on the list set out in my amendments, I would be keen to know which organisation they feel should not have a say in the creation of the database.
I hope that these important amendments will address the concerns raised in Committee and that hon. Members will now be able to support them, because they will ensure that we get the design of the database right.
Anne Marie Morris
I will speak first to amendments 8 and 9 and then turn my attention to amendment 15. As the hon. Member for Lewisham East (Heidi Alexander) explained, amendments 8 and 9 would add a whole host of bodies—I think that I counted eight—that the Secretary of State must consult before making regulations under subsection (1). This relates to the conferring of functions on the Health and Social Care Information Centre in connection with the establishment, maintenance and operation of a database. The hon. Lady has talked articulately about why the two amendments should be made, but I have some concerns.
My main concern, despite everything the hon. Lady said, is that adding all these organisations that the Secretary of State must consult will just add to the complication of the database. The amendments not only ask the Secretary of State to consult, but ask that all these organisations approve the regulations. Adding these extra organisations will just add to the confusion about who is policing the system. Is the consent of all those organisations needed before a treatment can be removed, or can it be removed just by the Health and Social Care Information Centre? If a complaint is made about what is on the database, does it go to the Secretary of State, the NHS or the Health and Social Care Information Centre, or does it have to be put in front of all those organisations again?
I understand that the hon. Lady might not have all the answers to my questions and that these issues go deeper than just her amendments, but I do not think that adding extra layers of consultation will help to simplify the Bill or make it any easier to implement the database, which, if put together correctly, could do much good and help many people across the country and, potentially, the world. I do not support amendments 8 and 9, because I believe that they will add unnecessary complications to the database and impede the good work that it could well achieve.
Amendment 15 has been tabled by the Minister, who has spoken eloquently throughout these debates. Including references to treatments carried out for the purposes of medical research will enhance the database, because it will allow the inclusion of clinical trials and other forms of medical research. Including medical research in the Bill will hopefully help to address the UK DUETS database. Mr Deputy Speaker, you will be glad to hear that that is not a database of UK singers who perform together; it is the database of uncertainties about the effects of treatment. It publishes treatment uncertainties from a wide range of people, including patients, clinicians and research recommendations, among others. By including medical research on the database, hopefully we can remove a few more treatment uncertainties from the database or, on the flip side, identify treatment uncertainties with greater ease and therefore tackle them head-on.
Clinical trials are vital if we are to put our NHS resources into the right treatments. They can help find out how to prevent illnesses, detect and diagnose illnesses or treat illnesses. The earlier we can do that, the more lives we can save, so I support any move to increase clinical trials, which I believe this amendment will do. It is my belief—I am sure that my hon. Friend the Minister will correct me if I am wrong—that his amendment will also increase knowledge of clinical trials among clinicians by adding them to the database. Sir Francis Bacon said that “knowledge is power”, and I do not believe that is any less true when it comes to medicine and saving lives. I fully support the Minister’s amendment.
Oliver Colvile (Plymouth, Sutton and Devonport) (Con)
I congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on introducing this Bill. Let us hope that it has a successful outcome later. I should remind you, Mr Deputy Speaker, that I am the Government’s pharmacy champion and vice-chairman of the all-party pharmacy group. Consequently, the majority of my comments will be based very much on pharmacists as dispensers of medicines that will include off-label ones.
I enter into the debate with some trepidation having listened to the hon. Member for Central Ayrshire (Dr Whitford), who was incredibly well-informed and very persuasive. I hope that my comments will be practical and constructive. I want to concentrate on the data-sharing of summary care records, as well as information to do with these medicines, and the decriminalisation of pharmacists for dispensing errors. I hope that the Minister can clarify his position on some of this stuff when he winds up.
Mr Deputy Speaker (Mr Lindsay Hoyle)
The hon. Member for Daventry (Chris Heaton-Harris) may have to shake his watch a little longer. I call Jo Churchill.
Jo Churchill
I spoke earlier about the new clauses we tabled, but I did not emphasise my own need for us not to paralyse the database. It is vastly important, given the wider horizon of genomics and informatics, and we have not even touched on how it could accelerate the whole system and improve patient outcomes significantly. We need to put patients at the front and centre of the process, and allow enough flex for the system to be the best and the database to be the finest in the world. We have the finest scientists, the greatest charities and some of the best academic minds at our disposal.
The database may also revolutionise the life sciences industry, to which my hon. Friend the Member for Newton Abbot (Anne Marie Morris) has just referred. That industry generates 1% of our export market from one drug. The power for this billion-pound industry to grow and to improve health—not only in our own country, but across the world—has to be seen to be believed. It costs upwards of £1 million to take a drug to market. What on earth would incentivise a company to do that if it could not get some sort of payback? We must not tie the hands of the people who can find the answers. Many such companies start as micro-companies, spun off from the great universities of our country, but many of them fail in what they call “death valley”. Our health system needs to modernise, digitise and reform to collect, collate and use our health data in the right way.
I believe that clinical trials are vital. I would take part in one, as a dear friend of mine recently did, to give other people a better chance of beating their disease. That is why we must not constrain the database in a way that, like a straitjacket, would completely constrict the industry and academia. At the same time, we must maintain the rigour in dealing with science for which our country is so famed. I believe that the power behind that science is patient data, and every patient holds an answer. With the support of clinicians and charities, and with a strong sense of purpose from the Government, I want data to be used for the benefit of patients. I will stand here and make my point over and again for these five years if we wreck the ability for a database to be a power for good in this Chamber today.
Dr Philippa Whitford
I wonder whether the hon. Lady will clarify what she is saying. The database that is referred to in the Bill will share information on drugs and trials that ought to be available to anyone, whether a pharmacist, a GP or a doctor. It is simply about information sharing. Is she referring more to a database of patient information from which we can learn in the future? Obviously, that is outwith the scope of the Bill, but it has been held back by the various data challenges that have been faced.
Jo Churchill
I apologise. Yes, I have confused the two, because I really believe that if we are not careful, what we do today will have an effect on our ability to bring that second broader database to fruition, which would give us the information we need to drive the trials, the life science industry and so on. Databases need to be fit for purpose. I could not have put it better than the hon. Lady did. We want the database that we are talking about today to be fit for purpose, but we do not want to put too many constraints or too much rope around it if that will stop us moving forward with clinical trials and with the whole area of genomics and patients.
I want every life to mean or have meant something. A patient should be able to choose to give knowledge as their legacy. Data hold the answers—the answer for my constituent whose two-year-old had a brain tumour; the answer for a family I know who have diabetes in several generations; the answer for a family member whose humour is tested by Parkinson’s that attacks his body. Personalised medicine should be a reality. As was pointed out in a paper yesterday, we are doing great things with CRISPR—clustered regularly interspaced short palindromic repeats—and across the piece.
Like me, every patient is somebody’s parent, partner, child or friend. That must not be forgotten. If the database we are discussing allows for information to be given that is appropriate to the individual, with care taken by the clinician right through the pipeline, it has to become a force for good. We should not wrap it up in too many constraints, but should allow it to develop. We must allow the Under-Secretary of State for Life Sciences to give us a lead in how to proceed in this field in the most effective manner.
The use of data offers the possibility to accelerate medical trialling from seven to two years and to link research together to find new insights. My glasses are not rose-tinted. I would want assurances about the use of my data, as any sensible person would. I want the recommendations of the accelerated access review to be implemented. The use of health data will be central to solving this country’s health challenges, not least in terms of cost, and its economic challenges. Our medical future will be uncertain unless we unleash the potential of information about patients for patients. I therefore support the Minister’s proposal.
Chris Heaton-Harris
It is always a pleasure to follow my hon. Friend the Member for Bury St Edmunds (Jo Churchill). Her knowledge and the way she goes about her business in the Chamber on this subject mean that it is always worthwhile to listen to her. What she says is powerful and she beats a trail that many will follow. She will get to the place she wants to get to eventually. I am very hopeful that this process today is one step along the way. I hope she gets some comfort from the fact that she is beginning to open doors, open minds and, in this case, open up information to registered medical practitioners about a host of treatments that they might not have known existed.
First, I will deal with what I perceive to be a Government amendment, amendment 15, which was tabled by my hon. Friend the Minister. I will then deal with the amendments tabled by the hon. Member for Lewisham East (Heidi Alexander).
Mrs Drummond
That was a very moving story about Emma. Does my hon. Friend envisage that the database will include international research and data from around the world?
Chris Heaton-Harris
Strangely enough, the Bill confers only a general power on the Secretary of State to provide such a database, and stakeholders and practitioners want clarification on how the database will operate and what sort of thing it might contain. Ideally, in the future, perhaps we could include what my hon. Friend suggests—who knows?—but the Bill confers a very simple power on the Secretary of State at this point in time. The very simple answer is, as it stands, no.
Mrs Drummond
My hon. Friend mentions that Emma got her treatment from the United States, where there is a lot of innovation and research. Would it not be great if we could expand that database to include research from around the world?
Chris Heaton-Harris
Yes, but in responding to amendments 8 and 9, which were tabled by Her Majesty’s loyal Opposition, I know that, when the Secretary of State and the Minister choose to use the power conferred on them in the Bill, they will confer far and wide on how the database is set up and used. Perhaps my hon. Friend will have an opportunity at that time to put her point in the consultation on how wide and extensive the database should be.
I mentioned Emma’s story because it was about evidence sharing within our existing system, which every single Member would like. Of Emma’s treatment, the NHS stated that it could not find evidence to approve the effectiveness of the operation that saved Emma’s life, and then withdrew funding for it. However, in its consultation on the matter, the NHS did not talk to the surgeons at the hospital where Emma was treated. There is a general point. I could tell hundreds if not thousands of stories in which a simple flow of information and data, or innovation or other things in our NHS, could improve the quality and type of care that is given to patients.
Amendment 15—the Minister’s amendment—states:
“References in section 2 to medical treatment include references to treatment carried out for the purposes of medical research (but nothing in section 2 is to be read as affecting the regulation of medical research)”.
That is an important amendment because it signals the Government’s intention to use the database wisely when it comes to dealing with research. Research has come on in leaps and bounds, meaning that a huge number of new treatments are coming into our NHS through clinical trials and innovative ideas everywhere in the system.
Dr Philippa Whitford
Although people who work in an academic unit will be very aware of trials—a lot of trials are UK-wide, but European Organisation for Research and Treatment of Cancer trials are Europe-wide and occasionally there are worldwide trials—people who work in district general hospitals, where there might be greater numbers of certain types of patients, are often less aware. Adding a listing of trials under any disease topic or area of clinical practice could be helpful in attracting clinicians to say, “I am aware that you can access a trial in Birmingham or Manchester.” The measure might promote trials to the busy clinician who is not directly involved in academic research.
Chris Heaton-Harris
I thank the hon. Lady, and I completely concur. I can foresee great benefits for those in the outer reaches of the NHS who do not necessarily come across information about many of the trials that are taking place. One of the biggest criticisms of the original formulation of my Bill was the fear in connection with getting people on to clinical trials. I would like to think that we have not just overcome that issue, with the amendments we are discussing and the latest version of the Bill, but have gone some way along the line to help improve the ability of registered medical practitioners to have knowledge of such trials. I completely concur with the hon. Lady’s point. We have innovation everywhere, so there is a real purpose behind having a database, regardless of whether the Minister has had the ability to set one up before now.
On research, Lord Winston made a very important point particularly well in the other place on Second Reading of the Mesothelioma Bill. He stated:
“There is no question that in the field of treatment there is a great deal of research.”
He had a list of a number of chemotherapeutic agents that were being looked at, saying:
“In recent years I can count at least 10 or 11”.
He then went on to name them. They are impossible for me to pronounce, so I will not do so here today. He said that,
“there are various combinations of those therapies with other well-known mitotoxic agents. These have included trials”.
He went on to say:
“Other treatments have been researched: of course there is surgery…and there are now attempts to try to reduce the tumour inside the lung membranes.”
He spoke about three trials that Cancer Research UK is conducting to emphasise the wide range of “stuff”, as he put it, that is going on.
“One is some work with HSV1716, which is a virus that acts against dividing cancer cells. It comes from the herpes virus…a very good example of where we might make a breakthrough in treatment. Then there is a different strand of research with ADI-PEG 20, which in combination with other drugs such as cisplatin affects a particular amino acid in the chain of cell division”—
which could prevent cancer cells from multiplying.
“That has been specifically targeted for the treatment of mesothelioma. A compound, GSK3052230, developed by GSK, is I think about to enter phase 3 trials very shortly. That attacks the FGFR1 gene, and therefore stops cancer cells growing.”
This is where he makes the point exactly:
“There is now an increasing emphasis on understanding that, if we are going to improve outcomes for patients with a variety of different cancers, and other chronic long-term conditions, we need to move away from a generalised approach to managing disease towards personalised, precision medicine”.—[Official Report, House of Lords, 20 November 2015; Vol. 767, c. 395-7.]
Medicine is going to change. Research is going to change. Spreading the information about that across our NHS, and how quickly we can do that and learn from success and failure in our NHS, is a very, very important matter.
Anne Marie Morris
Does my hon. Friend believe that personalised medicine should become a reality over the next little while and not a research project, and that unless we have freedoms within the database we will never have the knowledge to find out that we can truly have personalised medicine?
Chris Heaton-Harris
I truly believe that personalised medicine will become a reality. I would like to think that a database would aid the spread of knowledge about how individual medicines are being used and who they might affect in different ways, so yes, I nearly completely agree with my hon. Friend.
Dr Whitford
I have two small points. First, personalised medicine, particularly for breast cancer, has been evolving for years. Right from when we could tell whether a cancer fed on the female hormone oestrogen or not, we were targeting the treatments towards patients. We have been moving that way and it will accelerate.
I know it is not the subject of the Bill, but I hope that the accelerated access review will consider in general how we get drugs to patients—a subject that we debate relentlessly in Westminster Hall. I see a negative feedback loop coming from among colleagues who used to be trialists, such as myself. We registered patients and did all the work to take part in research, but when the drugs were finally made available, the NHS could not afford them. We need a totally different way of accessing those drugs. The companies want to sell them, and we and patients want them.
Chris Heaton-Harris
The hon. Lady speaks with way more experience and knowledge than I do, but from everything I found out during my research for the Bill, I completely concur.
Oliver Colvile
Does my hon. Friend also recognise that an enormous amount of research is taking place in many of our medical schools, especially Peninsula medical school in my constituency and the one in Exeter?
Chris Heaton-Harris
Clinical research and innovation is happening across our NHS every day. Would it not be wonderful if every registered medical practitioner could see what was going on, without too much effort or work, by tapping into a database and getting a better understanding of the picture around them?
This is the crux of the matter. Treatments are not what they used to be; there is not a one-size-fits-all policy. As medicine progresses and personalises even further, the mind boggles trying to imagine the sheer number of treatments that will be available in our NHS in the future. How can we expect every clinician to know about all the possible treatment routes? How can we not, therefore, provide them with somewhere to record them and their outcomes?
As Lord Giddens stated in the debate I mentioned earlier, we are experiencing a digital revolution. Given how far technology has come in our lifetimes and what is now possible, we can truly say we are living through a different age of digital capability. It is moving at such a pace that we struggle to keep up with it ourselves. It is not unfounded to say we might be living through a period of unparalleled innovation in medicine and other frontier areas of science more generally. Thanks to the strides in treatment and the speed of technological development, we have an opportunity to create and record life-saving data like never before. It is surprising that we do not have such a database already. The Bill sends an unambiguous political signal to the Government that we would like them to get on with it.
The Bill defines innovation as a situation where a doctor departs from the existing range of accepted medical treatments for a condition. This will be well understood by doctors, who are best placed to know whether treatments are acceptable and responsible. The definition of what can go on the database is deliberately wide because I want the Minister to have as wide an ambit as possible.
I want quickly to mention another stakeholder I met, Nutricia, a company dealing with advanced medical nutrition. It kindly welcomed the Bill:
“This Bill marks an opportunity for patients managing a range of diseases and conditions to get access to the most innovative medical care, and to actively support their inclusion in patient pathways in an on-going manner. This should not simply be confined to pharmaceuticals, as patients can benefit from innovation across a range of sectors, for example medical nutrition.”
Medical nutrition—otherwise known as medical foods—describes a special category of foods designed to meet the needs of patients whose disease or health concern requires medically determined nutritional support. Medical nutrition is a scientifically formulated food that is available in many different formats. Applications can range from those with rare conditions, such a child who inherits a metabolic condition meaning that the consumption of a specific amino acid commonly found in normal foods can lead to brain damage, right through to people with common cancers who may as a consequence lose weight rapidly and be at risk of malnutrition for a period of time. Nutricia was therefore keen that we maintained the widest possible definition for how the database could be used.
Medical nutrition also provides benefits in the treatment pathways of other diseases, including various cancers, strokes, cerebral palsy and pressure ulcers. Nutricia has stated that,
“we must seek to streamline the adoption of innovative care of all kinds—not just pharmaceuticals—so that clinicians have a resource which will mean that there are no more missed opportunities, and patients have every available chance to manage their condition.”
Bob Stewart (Beckenham) (Con)
I am very ignorant compared with a lot of people in this Chamber, so my question is probably a question from a fool. I do not mean it to be, but when I go to a doctor and they are sitting in front of a computer, I make the assumption that if they have a question, they go into the computer and get an answer. Am I wrong in saying that cannot or does not happen, and would this new list work much better?
Chris Heaton-Harris
I will give way to the hon. Member for Central Ayrshire, who will give a much more informed answer.
Dr Philippa Whitford
I think the hon. Member for Beckenham (Bob Stewart) has a much greater admiration for what a computer on a desk can access at that moment when a GP has a 10-minute appointment. What they are actually looking at is the patient’s records. They also have the ability to prescribe, but to track something down they would have to shut those systems down and go into something else, as with searching the internet. They cannot do that live, in front of a patient, and that brings up an important point. If the new system is meant to be used live, in front of patients, it will have to interact with the NHS computer systems, which someone can literally click on and use to look things up relatively easily, in the way we look things up in the BNF at the moment.
Chris Heaton-Harris
I thank the hon. Lady for her explanation to my hon. and gallant Friend the Member for Beckenham (Bob Stewart).
It is important that doctors are aware of the changing methods by which care is being delivered. Innovation in the delivery of care must be recognised in the tapestry that is our wonderful national health service. I fully welcome the Minister’s amendment to my Bill. It makes it more worth while. The improvements we are making to the Bill today are dramatic, but they have not come out of thin air; they have come from a great deal of work. A great deal of thought has gone into them, which I very much appreciate.
Finally, and briefly, let me turn to amendments 8 and 9, in the name of the right hon. Member for Lewisham East (Heidi Alexander).
Chris Heaton-Harris
Soon to be right honourable—I shall try to get her promoted to that position. I am sure there are some Privy Council positions awaiting on the Labour Benches.
I completely understand where the hon. Lady is coming from in trying to ensure the widest range of consultation on, actually, pretty much anything. Forget this Bill; when the NHS does something, it should try to interact with stakeholders who have direct and indirect concerns. As it stands, the list in her amendments looks like a preferred list of consultees, although I have a range of concerns about the listing, the order and so on. Given the way we have gone about this Bill—there has been a great deal of understanding and working together—I would like to think that when my hon. Friend the Minister answers this point and indicates what the Secretary of State would do with the power, how he would consult and which groups he would consult with, the hon. Lady will perhaps consider not pressing her amendments, in the full knowledge that there will be the widest possible consultation, should this Bill become law.
George Freeman
I shall deal with amendments 8 and 9, tabled by the hon. Member for Lewisham East (Heidi Alexander), and amendment 15, which I tabled on behalf of the Government. I shall also deal with some of the important points that Members have raised.
I have to say that I am not here every Friday, but I think that today’s debate is setting a high standard, both in terms of the issues that are being raised and the way in which it is being conducted. I hope that those who take a close interest in the Bill and are watching the debate are observing the cross-party nature of our discussion of some very important issues.
I thank the hon. Member for Lewisham East for her support for the spirit of cross-party working. The sector needs to be confident in the knowledge that the House is paying close attention to the issues that underlie the Bill—issues relating to data, informatics, genomics, drug trials and research—in a cross-party spirit. As the hon. Lady knows, in the course of my work I have paid tribute to the last Labour Government’s pioneers, Lord Drayson and David Sainsbury, who did so much to create the Office for Life Sciences. I think the debate reflects that spirit, and I welcome the hon. Lady’s restatement of her support for it.
I also welcome amendments 8 and 9, which specify and flag the importance of a wide group of consultees. I entirely agree with the principle of the amendments. Indeed, I would go further and include a range of patients’ groups, charities and others. I give the hon. Lady—and the House—a commitment, which I am happy to put in writing, that I will seek to involve all the organisations on her list, and indeed others, in the consultation that will take place following the Bill’s enactment.
As an experienced parliamentary operator, the hon. Lady knows that including lists of organisations in a Bill is always a mistake, because in the end it creates more problems than it seeks to resolve. However, I will happily write to all the bodies that she has mentioned, and to all Members as well, with a list of those who I think should be involved in the consultation.
James Morris (Halesowen and Rowley Regis) (Con)
I know that the Bill is specifically about access to medical treatments, but, as chair of the all-party parliamentary group on mental health, I know that there is a growing need for the ability to share information about both drug-based and non-drug-based interventions in mental health care. Has any consideration been given to the sharing of information about mental health care in particular, and how would that fit into the framework of the Bill?
George Freeman
My hon. Friend has made a typically interesting and important point. I pay tribute to his work on mental health.
In no area of pharmacology and pharmaceuticals is drug discovery, drug use and prescribing more complex than in mental health. One of the projects on which I worked before entering the House was at the Institute of Psychiatry at King’s College London, where Professor Simon Lovestone has pioneered the use of informatics and data to integrate research into mental health conditions and the compiling of patient records information, MRI scans and, latterly, genomic information, to assist understanding of both the causes of disease and the way in which different patients respond to different drugs. As my hon. Friend will know, mental health care involves a wide range of very complex and, in some cases, very powerful drugs, and information about how those drugs work and how different patients respond is therefore crucial. I certainly want to ensure that we do not exclude mental health from the Bill’s provisions.
I tabled amendment 15 in connection with clinical research, an issue that received much attention during the Bill’s earlier stages. When—before these amendments were tabled—the Bill made provision for medical negligence, the Government were determined to ensure that none of its provisions would in any way undermine the United Kingdom’s world-class and world-rated landscape for the regulation of clinical trials. So the previous Bill contained a provision stating that nothing in it applied to clinical research. Now that my hon. Friend the Member for Daventry (Chris Heaton-Harris) has tabled amendments to remove the clauses dealing with medical negligence so as to create instead a Bill focused purely on the provision of data on innovative medicines to clinicians, I suggest that we remove that exclusion of clinical research and make sure that the database—now that it has nothing to do with negligence—actually covers drugs in research. That would make sure that we do not preclude the inclusion of drugs in clinical trials that clinicians may want to recommend to their patients or investigate their patients’ eligibility for.
Heidi Alexander
I have listened carefully to the debate on this group of amendments. Although I know that the hon. Members for Bury St Edmunds (Jo Churchill) and for Newton Abbot (Anne Marie Morris) have concerns about creating excessive bureaucracy, I think those concerns are somewhat overstated. The Bill already requires consultation before regulations are made. I am seeking to ensure that the appropriate organisations are able to have their input into the process. However, in the spirit of cross-party working for which the Minister has developed a fondness this morning, I beg to ask leave to withdraw my amendment 8 and not to press amendment 9.
Amendment, by leave, withdrawn.
Clause 3
Responsible Innovation
Amendment made: 2, page 2, line 26, leave out clause 3 —(Chris Heaton-Harris.)
Clause 4
Effect on Existing Law
Amendment made: 3, page 3, line 19, leave out clause 4 —(Chris Heaton-Harris.)
Clause 5
Interpretation
Amendments made: 4, page 3, line 40, leave out “this Act” and insert “section 2”.
Amendment 12, page 3, line 42, leave out paragraph (b).
Amendment 13, 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.”’—(Chris Heaton-Harris.)
Amendment 15, page 4, line 1, leave out subsection (2) and insert—
‘( ) References in section 2 to medical treatment include references to treatment carried out for the purposes of medical research (but nothing in section 2 is to be read as affecting the regulation of medical research).”—(George Freeman.)
This amendment makes it clear that the database for which clause 2 provides may contain information about treatments carried out for the purposes of medical research (including, for example, in the context of a clinical trial).
Madam Deputy Speaker (Natascha Engel)
We now come to amendment 5. With the leave of the House I will put the questions on amendment 5, 6 and 14 together.
Chris Heaton-Harris
On a point of order, Madam Deputy Speaker. I was under the impression that amendment 5 would be called only if amendment 15 was not carried. Please could you give me some clarification on that point?
Madam Deputy Speaker
The hon. Gentleman is right; we will take amendments 6 and 14 together.
Amendment made: 6, page 4, line 3, leave out ‘this Act’ and insert ‘section 2’.—(Chris Heaton-Harris)
Clause 6
Extent, commencement and short title
Amendment made: 14, page 4, line 8, leave out ‘Sections 1 to 5’ and insert ‘Sections 1, 2 and 5’.—(Chris Heaton-Harris.)
Third Reading
Chris Heaton-Harris
I beg to move, That the Bill be now read a Third time.
It is a tiny bit of a relief to get to this point in the proceedings. I guess I should start by thanking a number of people, the first of whom is the inspiration for this Bill. As I explained in my Second Reading speech, I followed in some detail what Lord Saatchi had been doing in another place, especially when his Bill reached its Report stage and Third Reading, and I thought some of his ideas were very much worthy of legislation in this place. Unfortunately, the inspiration for his Bill was the terrible loss that he suffered, but I would like to think that what we have done here today will be a true and lasting legacy for him to remember his wife by.
I should also like to thank the Under-Secretary of State for Life Sciences and all the officials in the Department who have given me advice—nearly always constructive and helpful—especially a gentleman called Peter Knight, who very kindly hosted a round-table for a whole host of organisations, and anyone else who was interested. It was only the people who were being really stroppy about the Bill who refused to come. He kindly explained what the database could and should be doing, and what its potential was, which alleviated a huge amount of concern. He also enlightened a number of people on the direction of travel that we were taking. I thank my hon. Friend the Minister and all his officials for their help and understanding.
Most of all, however, I would like to thank the hon. Members who are in the House today. I was a Member of the European Parliament, and I guess we have Europeanised the system here. I am not a great European—I like to consider myself a decent Eurosceptic—but there are some practices in the place where I used to work that enable you to listen to people on all sides of an argument, and that allow you to evolve and learn from their better experience and knowledge and put that into your own work. I want to thank the hon. Members for Torfaen (Nick Thomas-Symonds) and for Central Ayrshire (Dr Whitford), and of course my hon. Friend the Member for Bury St Edmunds (Jo Churchill), who is an unbelievable force of nature. I am sure that she will make waves for the Minister if he does not stick to some of the promises he has made today. I also thank Her Majesty’s loyal Opposition, who all the way through this process have been willing to engage with me, to listen and to criticise, completely and correctly. I therefore thank the hon. Members for Lewisham East (Heidi Alexander) and for Ellesmere Port and Neston (Justin Madders).
Where we have got to now is not a bad place. I have received a briefing from Empower, which is one of the charities that is keen to ensure that patients get the best treatment. I will quote from its briefing, because this is not something I would ever say about myself. It states:
“We are particularly pleased by the ingenious step of absorbing Nick Thomas-Symonds’ Off-Patent Drugs Bill into the amendments. Mr Heaton-Harris’ database of innovation combined with off-patent access to medicines is a hugely positive step forward, and one Empower fully supports.”
The briefing included a note from Graham Silk, a gentleman who was doing some media on this yesterday, having joined Empower’s drive for spreading innovation. He said:
“I was diagnosed with leukaemia in 2001, and I’m still here today because of medical research facilitated by the patient data of the leukaemia community. I was one of the lucky ones by being in the right place at the right time. But we need to start taking luck out of the equation by spreading this information faster and wider. This database could have the power to do just that.
Indeed the drug that saved my life has already shown early promise in other conditions, the off-patent provisions in the Bill could also see patients granted access to a far broader set of treatments which would really open up our health system.
I am looking forward to continuing Les Hatpin’s legacy”—
Les was the power behind Empower—
“by working with Parliament, policy makers, and frankly anyone who will listen, to see our health service modernise and digitise to the benefit of patients.”
Jo Churchill
That clearly encapsulates what we need to be doing: putting the patient at the centre, backed up by a charity, such as that leukaemia charity, and supported by clinicians. We could not want a more virtuous situation.
Chris Heaton-Harris
I completely concur with my hon. Friend. I would like to think that Graham, when he looks at our proceedings today, will be pleased at where we have got to, and the process by which we have got here, and is looking forward to his wishes becoming fact.
There have been some questions about whether the database is required at all. I will talk about this gently, because I do not want the cross-party consensus to break down at such an important moment in proceedings. I know—I have learned a huge amount in this process—that there are many mechanisms already available for sharing treatments, but they are far from being available to all medical practitioners, and in my view they are insufficient. Besides that, there is no comprehensive database of treatments that are not regulated under the Medicines and Healthcare Products Regulatory Agency; there are just many smaller ones, such as registries for specific diseases or databases for particular regions.
For example, the most recent figure I could find for the total number of registers used by medical professionals is from 2002. Back then the Department of Health commissioned a report into disease registers in support of the White Paper, “Saving Lives: Our Healthier Nation”. The report found that there were well over 200 registers in existence in England. The number of disease registers already in existence in England was obviously large, although possibly larger than was generally appreciated. Even though the review was not exhaustive, it identified about 250 registers. The report stated:
“We would not be surprised if there were more than 400 specific registers in existence in England.”
That rendered the situation on data collection at best confusing, and at worst it makes finding evidence and navigating through that data almost impossible. I hope that the database set out in the Bill will provide clarity through the vast web of registries, information and data that already exist and help clinicians find evidence for innovative treatments simply and quickly.
That is particularly important today, because research has come on in leaps and bounds, meaning that a huge number of new treatments are coming into the NHS and innovative ideas are everywhere. There is great potential for what this could do. South London and Maudsley NHS Foundation Trust has developed a computer system that allows it to carry out research using the information from the trust’s clinical records. The system is known as the clinical record interactive search system, and it is anonymised. It is hoped that it will make a very real and positive difference to future treatments and care. The system allows clinicians and researchers at the hospital to look at real life situations in large quantities. This makes it easier to see patterns and trends such as what works for some and does not work for others. For example, case registers have been used extensively in mental health research, which was commented on earlier. Recent developments in electronic medical records and in computer software to search and analyse these in an anonymised format have the potential to revolutionise this research tool. The case register has been hailed as representing a new generation of this research design, building on a long-running system of fully electronic clinical records and allowing for in-depth analysis of data while preserving anonymity through technical and procedural safeguards.
Historically, medical records of some kind have always been kept. In keeping with the tradition of careful, methodical scientific observation, they have frequently been developed into disease registers through which the incidence, course and health service use of specified diseases can be monitored and investigated. In the context of changing social, political, professional and technological factors, a large number of psychiatric registers were constructed throughout the 20th century. However, owing to the expense of maintenance, often then carried out manually, the limited information available, which relied on data sheets completed by clinicians in addition to their routine workload, the practical difficulties of monitoring data quality, and limited funding, many of these programmes closed, and a vast amount of the information collected, which could have been useful, was lost.
Now we live in a time in which rapid technological advances and other developments over the past decade have led to new possibilities for the development of data-sharing. With electronic clinical records increasingly complementing handwritten notes, large volumes of clinical information are contained in an electronic format. The possibility of what we can do with this is unbelievably exciting. So far, we have not really harnessed the data that we already have. There is so much potential to make great changes, and this Bill is a tiny pigeon step in the right direction.
There has obviously been a huge amount of interest in this Bill from a whole host of groups. Some have concluded that the database is not needed, some have concluded that it is a good idea, and some have raised a number of questions about it. I would like specifically to thank the Association of the British Pharmaceutical Industry for its briefing on my Bill, which was circulated to Members of Parliament this week. It states its concern that the Bill will promote the prescription of unlicensed medicines and says that that is worrisome because there is hierarchy of risk involved with prescribing off-label and unlicensed medicines that makes unlicensed treatments the more risky route. It is completely correct. Promoting the prescription and use of these treatments when that is best thing to do for patients, is, I would like to think, exactly the sort of information that the Bill will share around the place to enable people to do the best thing.
With the amendments tabled today, the Bill promotes treatments in clinical trials, which are by their very nature unlicensed, as well as off-label drugs, other licensed but perhaps underused or very new treatments, and other unlicensed treatments. Clearly, it will not change the fact that, under MHRA guidance, more risk is involved when using unlicensed drugs. This, rightly, will remain the case, as these drugs have not received regulatory approval and are not yet deemed safe for use. No guidance or law of liability is changed at all by this Bill, with the tabled amendments. However, the Bill will spread information behind how these drugs are being used and allow responsible registered medical practitioners to access more information, much more quickly, to make better decisions for themselves.
The ABPI also wrote that the database undermines the UK medicines regulatory system and gives doctors the ability to prescribe unlicensed or off-label medication. As I have said, that is perhaps not terribly bad, but I would like to think that we are not undermining any regulatory system. The Bill simply does not contain provisions that would do so. I want to give the ABPI some help with its questions, and I would like to think that this debate—the points made by the Minister about how he will use the power, and those made by hon. Members on both sides of the Chamber underlining the cross-party nature of the provisions—shows that the Bill is worthy to be sent by this House to the other place and that it will do patients, registered medical practitioners and our NHS the world of good.
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.
Anne Marie Morris
I once again congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on bringing forward the Bill. I am sure I will not be the first to tell him what a feat it is to get a Bill through this House, with all its complexities, to Third Reading. Clauses 1 and 2 will give many people throughout the country hope that there is a cure for many well-known and not so well-known diseases. The database will make it much easier for clinicians up and down the country to find them and provide a better quality of life for many people.
I commend my hon. Friend for the time he has put into the Bill, and the effort he has made to obtain cross-party support on a number of issues. His work with the hon. Member for Torfaen (Nick Thomas-Symonds) to include some of the provisions of his Off-patent Drugs Bill is to be commended. Although I did not support all the hon. Gentleman’s amendments, I do believe, as I stated on Report, that amendments 10 and 13 will help many people to live healthier and happier lives for years to come. I therefore congratulate him on his contribution to this Bill.
Some great medicines have been developed through the use of off-label treatment, and I believe that they will continue to be developed, even without the new clauses that the hon. Gentleman tabled. I do not profess to be an expert in the field of off-label treatment, but I know that drugs such as infliximab, adalimumab and methotrexate are now regularly used in the treatment of Crohn’s disease and ulcerative colitis, having previously been used to treat rheumatoid arthritis and cancer. The use of those treatments has come on leaps and bounds over the past 10 years, and that in an environment where, it is claimed, doctors are scared to innovate. As I have stated, I do not profess to be an expert in these matters, but I do know that many doctors communicate not just countrywide, but across the boundaries of diseases, and learn from each other. The database that the Bill establishes will allow that to be achieved with much greater ease.
A member of my office staff has been fortunate enough to benefit from the drugs that I have just mentioned. Indeed, he informs me that he was one of the first people, if not the first person, to be given the drug adalimumab to treat Crohn’s disease. He was prescribed it in Southampton back in 2007, when it was not licensed for use in children. Had the doctors not taken innovative steps to prescribe a medicine that had not yet been licensed, he would not have had such a fulfilling life—something that many of us take for granted. That is just one example, and I am sure that Members across the House have many more examples of doctors using innovative medicines to help out constituents and loved ones with all manner of diseases. I am therefore delighted to support the Bill on Third Reading and the great work my hon. Friend the Member for Daventry has done to get us here.
Heidi Alexander
It is a pleasure to follow the hon. Member for Newton Abbot (Anne Marie Morris) and my hon. Friend the Member for Torfaen (Nick Thomas-Symonds).
In opening this debate on Third Reading, the hon. Member for Daventry (Chris Heaton-Harris) said that it was something of a relief to get to this stage. I have to say that I agree with him. I congratulate him on getting his private Member’s Bill through to its Third Reading. His commitment to the Bill has ensured that the crucial issue of improving access to innovative treatments and medicines has been debated in detail on the Floor of the House, which is a good thing.
I am conscious that we have already spent considerable time today debating a Bill that is now relatively straightforward, so I will keep my remarks brief. In short, the amendments that have been made today have made the Bill safer and have focused it on the area that the hon. Gentleman feels most passionately about—namely, the power to create a database.
Although I still question whether legislation is needed to give the Secretary of State this new power, the Bill is a vast improvement on what it was previously, and I will not oppose its Third Reading. I am sure that the other place will take a keen interest in scrutinising the Bill, as it has had extensive debates on this subject in the past and, indeed, on similar private Members’ Bills.
I urge the Minister to think very carefully about the design of the database. Even if he does not wish to broaden the list of statutory consultees, I hope that he will engage with the medical profession and other stakeholders to ensure that he gets the database right.
I congratulate the hon. Member for Daventry once more on navigating the Bill to this stage and on taking account of the very real concerns that I and many others have expressed to him.
George Freeman
May I share in the sense of relief? I, too, congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris). As others have said, it is no mean feat to steer a private Member’s Bill through this House. For all sorts of very good reasons, there are many obstacles to doing so. The process is designed to ensure that only those Bills that command a majority, if not unanimous support, and that clearly address something that the House feels is a priority make it on to the statute book. He has achieved something remarkable in getting this far, although he is right to emphasise that he has only come this far and that the Bill now goes on to the upper House. I pay tribute to his work. Everybody here has acknowledged the quiet, careful, considerate decency and tenacity with which he has got around and listened to people.
I genuinely believe that the Bill will be a powerful mechanism in the new landscape of personalised and precision medicines that we are developing in this country. It will help busy clinicians on the frontline of our health and care sector by making easily available at the click of a mouse information on innovative medicines—both new medicines and innovative uses of existing medicines—that they can prescribe or recommend to their patients.
It is a pleasure to have reached this point, having embarked—somewhat bravely, some of my officials might have said—on a process of supporting the intentions behind three Bills that the House has considered over the past 18 months. I have been determined to work with Back Benchers to reach a solution that the House and the Government could support.
The Bill captures the spirit of two others: the Bill tabled in the other House by Lord Saatchi, which was intended to promote a culture of innovation and innovative medicines in our health system, and the Off-patent Drugs Bill tabled by the hon. Member for Torfaen (Nick Thomas-Symonds), which was intended to promote greater use of off-label and repurposed medicines. My hon. Friend the Member for Daventry intends to promote greater access to information. I pay tribute to all three people, because their work in initiating their Bills has led to the House reaching unanimity.
I thank and pay tribute to the hon. Member for Central Ayrshire (Dr Whitford). Ministers do not always agree strongly with Scottish National party Members, but it is nice to be able to do so on this occasion. She brings to the House a lot of expertise in her field as a medical specialist, and she has played an important role in bringing the Bill to this point. I also thank my hon. Friend the Member for Bury St Edmunds (Jo Churchill), who brings her own experience of surviving cancer and a passion for the subject. The Members I have mentioned and others who have spoken today and in earlier debates have brought us to a much better place, with a Bill that commands and deserves respect and support.
I want to say something about Lord Saatchi, who commenced the debate on this subject. Passing legislation through Parliament is always a messy business. The anti-slavery campaigners took years, and all sorts of legislation that we can look back on with great pride had previously fallen at various hurdles. It takes tenacity to make things happen. This is not the same Bill as Lord Saatchi’s and it does not tackle the issue that he wanted to tackle of some clinicians fearing negligence cases, but I believe that it tackles the central issue that he was trying to address by creating a culture that promotes greater use of innovative medicines. I believe that he has secured, in his way, a legacy for his late wife Josephine that he can be proud of.
Lord Saatchi and Members who have spoken today have become part of a growing movement of patients, charities and campaigners who want us to accelerate access to innovative medicines. I often hear demonstrations from my window in the Department of Health, with patients sometimes chaining themselves to railings. I have yet to hear a demonstration asking us to take longer to regulate and assess drugs and bring them to market. Indeed, the demonstrations that I have heard in the past year have been by patients asking for quicker access to medicines. Mothers whose children have rare diseases have been asking why we are not moving more quickly to bring genomically and infomatically targeted medicines to their children. I have taken part in more debates on this subject than on any other in the past year.
I want to mention a number of people who, appropriately, have been referred to today, including the late Les Halpin. He founded Empower: Access to Medicine with a passion that his death would not be in vain and that his experience of dying from a rare disease would inspire and motivate others to invest more in research and accelerate innovative medicines being brought to patients. The campaign, which was started for him, is continuing to grow and build support for the agenda that we have discussed today.
Graham Hampson Silk has also been mentioned. Ten years ago, he was given four years to live, but because of the extraordinary work of NHS clinicians and NIHR researchers at the Birmingham Institute of Translational Medicine, led by the inspired Professor Charlie Craddock and supported by Cure Leukaemia, Graham is alive. He is using his life to campaign for quicker access to innovative medicines. He is alive because Charlie Craddock got him access to a drug that was in research in America, raised money and flew Graham to the States, and then got the drug into the Institute of Translational Medicine. In fact, that institute has pulled into the greater midlands area more than £20 million of free drugs in trials.
I should mention Emily and a number of the other mothers who have been to my office on a number of occasions in the past six months to discuss muscular dystrophy and Duchenne. The extraordinary progress of our medical community in genomics and informatics unlocks new treatments, but the mothers and fathers of children with rare diseases look on with frustration that we are unable to get the insights to benefit their children and families more quickly. As the first Minister for Life Sciences, I am driven every bit as much by their advocacy, passion and commitment.
The truth is that a lot of people are not interested in this space until they get a diagnosis or until someone in their family gets a diagnosis, at which point people become very interested in research, data and genetics. I am very pleased that their names and a number of others have been mentioned. My hon. Friend the Member for Daventry has struck a small blow in the march of that army for accelerated access to innovative medicines.
I want to say something about the landscape in which the Bill will land, the leadership that the UK is showing to create that landscape and the changes that will benefit patients and our NHS. The truth is that the traditional model of drug discovery is breaking down in front of our very eyes—the very long, 15-year, $2 billion process by which traditional pharmaceutical products are developed and brought to patients. That is too long for the industry and patients, and it is too expensive. Increasingly, the breakthroughs in genomics and informatics mean that drugs can be developed for specific patient groups around specific genetic biomarkers with much greater precision and be brought into the system much more quickly. They do not have to go through 15 years of randomised control trials when there is a genomic biomarker that guarantees they will work in certain patients and informatics to support that claim. That allows us to get medicines into targeted groups much more quickly.
That quiet revolution, which the UK is seeking to develop through our various initiatives, is principally driven by two transformational technologies: genomics and informatics. Genomics allows us to understand the cause of so many diseases—in many cases, the cause is inside the cells in our bodies—and to understand, at scale, why different patients respond to different drugs and why they respond to different diseases in different ways. It also allows us to centre our research on the experience of real patients with real diseases in real time.
Allied with informatics, that allows us to use the NHS to look at huge datasets of patients over the past 20 or 30 years, which is an incredibly powerful resource. Large-scale anonymised data allow us to identify patterns. When we re-analyse the data, we find that many of the drugs that have failed in traditional drug discovery, which could happen because of a side effect, a serious side effect or a death in the late stage of trials when the drug is trialled in the largest number of people, are dream drugs for a small sub-segment of the population. Part of that revolution is about allowing us to identify which patients would have responded much more quickly, which cuts down the time, cost and risk for companies in developing and thus reducing the price. It also cuts down the time that patients have to wait and to have more accurate dosing—we can get the right drug in the right dose to the right patients more quickly.
Mr Peter Bone (Wellingborough) (Con)
I put on the record my thanks to my hon. Friend the Member for Daventry (Chris Heaton-Harris) for his success in driving the Bill through. I have heard only today that a constituent of mine is getting a treatment for prostate cancer earlier because of the Minister’s intervention. I am sure that that is part of what the Government are driving. I wanted to thank him for that while I had the opportunity.
George Freeman
My hon. Friend is very kind. I thank him for his comment and am very pleased to hear that news.
We are putting in place various initiatives to support the new agenda, and seeing the beginnings of some successes. On the request made by the hon. Member for Torfaen, I will be happy to write to him about the proposals and how we envisage the measure working. There is quite a lot of work to be done on how the process of using a NICE evidence review to assess the evidence for an off-label claim. I am not prevaricating for any reason other than that I do not want to pre-empt that work, which we are getting on with.
Nick Thomas-Symonds
I am grateful to the Minister for that. New clause 5 was also about easier access to the licensing process itself, on which I made a few suggestions on Report. If the Minister addresses that specifically when he writes to me, I will be very grateful.
George Freeman
I will happily come back to the hon. Gentleman on licensing. We have discussed this at some length, but I am happy to confirm the situation. There is a very strong legal set of constraints on how we handle licensing, but I will happily write to him to confirm the position.
I would like to respond to the request, by the hon. Member for Lewisham East (Heidi Alexander) from the Opposition Front Bench, to take very seriously the design of the database. I agree. We need to make sure it works well. Datasets are already available, but we need to connect them up better to give clinicians the right information they need. I am absolutely happy to give an undertaking to engage very closely with the medical profession, and all who have taken an interest in the Bill, to ensure this measure has the intended effect. I also give an undertaking to the House that I want to put the patients’ voice right at the heart of this and to invite the Association of Medical Research Charities and others, as we put the proposals together.
I want to take up the point raised by my hon. Friend the Member for Wellingborough (Mr Bone) and update the House on the range of initiatives, which the database will sit in the middle of, that we are putting in place. As the landscape for drug discovery changes profoundly, the Government are intent on making sure the country leads in this new model of personalised, targeted, patient-led research, moving from a world in which a drug is traditionally developed around a notional theoretical target that is normally developed in an academic laboratory and then, if it is lucky, put through a process to raise money and be spun out or partnered. That original target is turned into a drugable target that a pharmaceutical company can make a drug against. The early synthetic chemical compounds are tested against vast libraries. With luck, they are taken through pre-clinical testing and extensive in vitro and in vivo testing. They then go “over the wall” as the industry refers to it, into development to phase 1, phase 2, phase 3 and phase 4 trials, through MHRA and European Medicines Agency safety approval, to NICE for health economic approval and then to the NHS to decide how to best use the drug.
That landscape still works for many drugs and is still the conventional system in which drugs are developed. In truth, however, the breakthroughs in genomics and informatics mean we can, and are, developing a different landscape. The Government are investing in the cell therapy catapult and the precision medicine catapult so that we lead in academic research, working with industry partners on the new model of personalised and precision medicine. It is why we set up the biomedical catalyst to support quick funding for small companies and academic groups developing key technologies in this space.
It is why I am delighted that we announced, in the autumn statement, ring-fenced funding for the Medical Research Council and the other research councils. That budget is now £700 million a year for leading research around the UK. It is why we confirmed the £1 billion-a-year commitment to the National Institute for Health Research, an embedded clinical research network at the heart of our NHS all around the country that is the jewel in the UK crown, and the establishment of the NIHR Office for Clinical Research Infrastructure, allowing innovators internationally to come in and work in our research hospitals. The progress of NIHR means we now have over 200 industrial studies on new medicines in the UK. We are increasing year-on-year the number of patients enrolling on clinical trials, including, importantly, first-in-man and first-in-patient studies. The UK is now going back up the international league for drugs having their first exposure to people, here in the NHS and the NIHR.
It is why, on informatics and genomics, we launched the Genomics England programme. In 2012, the Prime Minister announced that we would be the first nation on earth to sequence 100,000 entire genomes—those of NHS patients—and link them with their hospital records. The project has captured the world’s imagination—I have called it the NASA of 21st biomedicine—and triggered phenomenal academic and industrial investment in the UK. It is already driving new diagnostic insights into rare diseases and insights into how we can use existing medicines better.
It is also why we have invested in the clinical practice research datalink and the aggregating of the NHS’s long-term cohort studies. These are phenomenal resources for research. Before coming to the House, I was involved in one, funded by the MRC and Cancer Research UK, that involved 250,000 women at risk of ovarian cancer. As a part of that, we collected blood, tissue, genomic and medical record information. I am proud that, after the academic study was finished, a group of medics at University College London, along with MRC Technology, UCL Ventures and CRUK, used that database to form a company called Abcodia Ltd, an ageing biomarker company. The database contains biomarkers that allow us to diagnose not just cancers but a range of diseases in ageing women much earlier. The scale of that dataset allows us to lead.
My hon. Friend the Member for Daventry mentioned Professor Simon Lovestone, at King’s College London, who led the world in the use of informatics and integrated medical records in mental health and who has now gone to Oxford University to pioneer that work. The Government are investing in genomics and informatics because it is a transformational technology that is changing the way drugs are developed.
I want to entice the House to think about where this might go and the direction the Bill points us in. This new world is coming fast. The first genome to be sequenced, 10 years ago, cost £10 billion. It now costs $5,000 and can be done in 24 hours. Not least because of the leadership of Genomics England, it will soon be possible to do it in minutes for a few pounds and pence. That will allow the NHS, when patients arrive with cancer, rare diseases and, increasingly, any disease, to identify the right genomic diagnostic and profile the right treatment and drug much more quickly. When a patient arrives, whether at a GP practice, hospital or clinic, we will, in due course, be able to do a quick and easy genomic diagnosis.
Thanks to the Bill, front-line clinicians will be able much more quickly to identify innovative drugs from which their patients might benefit. That will not happen overnight; it will not happen by Easter; it will not happen by the end of this parliamentary Session, but it is a quiet revolution of 21st century medicine that we are leading, and data and information sit right at its heart. My hon. Friend has taken three Bills that were generating more heat than light, crystallised their essential purpose, which was noble and well-intended, and brought them together in one Bill. I hope that it will be treated in the Lords in the way that this debate and cross-party consensus invite and that it will not be significantly re-amended, not least because, if it is, it will probably run out of time to reach the statute book.
Many people comment that the House spends too much time doing yah-boo politics for its own sake. Today, we have struck a blow for joined-up government and parliamentary process. It is wonderful to see MPs from all mainstream parties—I have not heard anything from UKIP—in support of a measure that offers real benefits for patients and front-line clinicians, without undermining the latter’s clinical sovereignty over patients. It is about giving them information, so that they can make the exquisite clinical judgment we all want them to make. I am happy to commend the Bill to the House and to congratulate all those involved, and I am delighted to have done my bit to help strike a blow for joined-up government.
Chris Heaton-Harris
On a point of order, Madam Deputy Speaker. Would it be in order for me to thank Abigail Bishop-Laggett, my member of staff who has worked so hard on getting the Bill to this point?
Madam Deputy Speaker (Natascha Engel)
That is a very nice comment, but not a point of order.
Question put and agreed to.
Bill accordingly read the Third time and passed, with amendments.