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,
(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.”
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,
(i) the Medicines and Health Products Regulatory Agency, and
(j) any other body or individual that the Secretary of State considers it appropriate.”
“( ) 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).
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 only command the confidence of the medical profession 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”.
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,
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.
I will speak first to amendments 8 and 9 and then turn my attention to amendment 15. As 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 amongst 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.
I congratulate my hon. Friend 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 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 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.
To develop a clinically focused community pharmacy service and for pharmacists to succeed in new care settings such as GP practices, we need better information sharing between community pharmacies and GP practices. We also need to make sure that there is a level playing field between the GPs and pharmacists who will be responsible for dispensing these medicines. The Bill refers to doctors not being negligent in prescribing off-label medical treatment if the GP’s decision is taken responsibly. I quite agree that patients’ safety must be paramount, and I congratulate the Government on their unwavering commitment to improving patient safety and the patient experience. GPs must therefore inform patients of the benefits of taking non-patented medicines and make them aware of any side effects.
I speak from personal experience. When I was 14, in 1974, I contracted shingles, which came perilously close to my eye. If it had got too close, I would have lost the sight in my right eye. I was put into the John Radcliffe eye infirmary, where doctors used me as a guinea pig to try out a new drug before it was put on the open market.
After they had tried it with me, they decided not to take it any further. After some while, I contracted regular migraines. I remember this incredibly well, for the simple reason that when my housemaster came to see me to make sure that I was all right, he turned up in the middle of David Lloyd’s maiden innings at Lords, when he scored 214 not out against India. Needless to say, I was more interested in listening to John Arlott on “Test Match Special” than in having a conversation with my housemaster, and I was positively delighted when he left.
I welcome the fact that doctors must show that they have taken the necessary steps to ensure that any decisions have been taken responsibly, including with regard to requests expressed by patients. However, if this rule is going to apply to doctors, it must also apply to pharmacists. When deciding to take a medicine, patients must be informed of the benefits but also of any side effects. Certainly, when I ended up having my shingles treatment, I was not aware of what the impact was going to be; my parents just made the decision for me. They are no longer alive, so I can no longer hold them accountable. However, GPs can only be struck off if they make a prescription error, while pharmacists can be sent to prison for doing exactly the same kind of thing. There must be some equality: we need a level playing field. We also need to make sure that any grievances can be considered.
I am going be slightly critical of the Government, I am afraid, because I have been campaigning on this issue for some while. The APPG had hoped that it might have been sorted through secondary legislation before the last general election, but I now understand that the Department of Health will delay introducing the necessary legislation until after the devolved Assembly elections and the new Executives and Governments have had a chance to bring in their own legislation. Legislation is unlikely to be introduced before the summer, so English pharmacists are dependent on legislation being passed for other pharmacists in Scotland, Northern Ireland and Wales—so much for a fair devolution deal. Will the Minister explain what practical steps are in place to safeguards patients’ safety and the exact timetable for when English pharmacists will not be reliant on the Welsh, Scottish and Northern Irish Assemblies? He may wish to write to me, rather than covering it today.
The Bill will allow the Secretary of State for Health to enable the Health and Social Care Information Centre to establish a database of innovative medical treatments and their outcomes. I would urge him to share that information with the pharmaceutical organisations as well. The Bill will allow other GPs to have access to the database, so where do pharmacists fit in? I argue that the database should not just be for GPs, but for other care professionals, such as pharmacists and perhaps even some local authorities, especially where they are dealing with social care issues.
Summary care records are an electronic summary of key clinical information about a patient—medicines, allergies, adverse reactions—sourced from GP records. It is hoped that all pharmacists will have access to it by autumn 2017. It is vital not to have the same kind of delay as has happened with the decriminalisation of prescription errors. The all-party group on pharmacy called for that in its document on the Government’s first 100 days. I argue that pharmacists should have access to the database of non-patented drugs and medicines.
I fully support the Government’s commitment to making sure that GPs share summary care records with other health professionals, such as pharmacists, but in so doing, they must ensure that patients are happy for their medical records to be shared with other health professionals. We must also ensure that insurance companies do not have access to such medical records. I would be grateful if the Minister wrote to me to explain what progress has been made and stating when pharmacies will have access to summary care records.
My great-grandfather, a rural vicar, said that he did not mind his congregation looking at their watches, but got very concerned when they started shaking them. I notice that my hon. Friend the Member for Daventry is just about to start shaking his watch. He is champing at the bit to ensure that he gets the Bill on to the statute book, and I will therefore conclude my remarks.
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 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.
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.
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.
It is always a pleasure to follow my hon. Friend 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.
We have talked about how the Bill might be able to help research, and there is a ton of innovation going on in the national health service at any given time. Sometimes spreading just a bit of extra knowledge and best practice can do the most amazing things. I guess the best example of innovative medical treatment that I have heard in all my stakeholder meetings was about a lady who, unfortunately, contracted mesothelioma, a sinister condition that can sit unnoticed for decades until it reveals itself. Its prevalence in our country is relatively high—in fact, we have the highest in the world—yet there has been very little research into finding a way to stop or even slow it. The story was given to me when I met the charity Mesothelioma UK, and it is about a lady I will call Emma —she has asked to be anonymised.
Emma was diagnosed five years ago with peritoneal mesothelioma, a cancer of the lining of the abdomen caused by exposure to asbestos. It is somewhat rarer than the version that attacks the lining of the lungs. She contracted it when she was married with two children and two grandchildren. Her first husband had been a building surveyor, and some of his work required him to be present at building demolitions. He remembers being present at one particular demolition when asbestos was found and removed. That was in the 1970s, when we were still being told that asbestos was safe and protective clothing was often not provided. Emma’s husband often returned home with dust all over his clothes, and it is thought that she ingested asbestos fibres during the washing of those clothes.
We now fast-forward to 2010, when Emma had just married her second husband and cancer was far from her mind. She was looking forward to a long and happy future. Her stomach had begun swelling, though, and she was putting on a bit of weight. After trying to diet, she decided to go and see her general practitioner. She was referred to a local hospital, and a few weeks later a scan revealed that she had peritoneal mesothelioma. She received five rounds of chemotherapy, with two drugs. I struggle to pronounce them, but if the House will forgive me, I will give it a go—they were pemetrexed and carboplatin. The side effects were extremely unpleasant, and she was given steroids to help take the edge off the worst of them. Unfortunately, the combination of drugs led to her contracting type 2 diabetes, but the cancer was held at bay for two years before it returned. Emma then received more chemotherapy with further rounds of those drugs, and once again the cancer was held at bay.
The disease returned in 2013, and once again funding was sought for pemetrexed. This time it was declined, on the basis that there was no evidence to support its use. Emma was offered palliative care, but was not offered the drug again. She was given none of the drugs that had helped her fight off the disease twice before. Her family therefore carried out their own research, as everybody in such circumstances does, and found a team of surgeons at a particular hospital who could do an operation called cytoreductive surgery. At their request, her oncologist referred her to a team of surgeons, who found her to be a suitable candidate and agreed to carry out the operation. The surgery took four surgeons eight and a half hours, during which they removed her ovaries, peritoneum and gall bladder—a whole host of organs. The surgery is carried out regularly in the United States of America.
Emma spent two weeks in hospital recovering and then returned home. That was two years ago, and she has told the charity:
“Yes I still get tired easily and I have to be careful what I eat, but hey, I am still here leading a meaningful life. I feel I have experienced the best and the worst of the NHS. The best because of the great care and amazing surgery I have experienced but the worst because of the withdrawal of certain chemotherapy funding on the basis of lack of evidence.”
Very few people are diagnosed with peritoneal mesothelioma—about 200 annually in the UK—so it is really hard to obtain evidence that certain drugs, such as those that Emma used and was in the end denied, could work. In July last year, NHS England withdrew its funding for the operation due to its apparent lack of success.
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.
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?
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.
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.
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.
“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”.—[Hansard, 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.
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?
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.
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.
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?
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.”
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?
I think 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.
I thank the hon. Lady for her explanation to my hon. and gallant Friend 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 Heidi Alexander.
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.
I shall deal with amendments 8 and 9, tabled by 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.
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?
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 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.
The aim of this database is to provide clinicians, at the click of a mouse, with information on innovative medicines in trials that their patients may be eligible for, innovative off-label uses of drugs that that there is evidence for, and unlicensed medicines in early access to medicines schemes that, with patient and clinical consent, their patients may be eligible for. I hope that amendment 15 is uncontroversial; it is consequent on the changes my hon. Friend has put forward.
I want to pick up a number of the points raised by hon. Members. My hon. Friend Jo Churchill spoke with real passion and authority on this. In case colleagues in the House or those watching are not aware, she is herself a very courageous double survivor of cancer—a survivor of cancer twice—and speaks with real authority on the power of research and data, and on why we need urgently to develop this new landscape to support the speedier adoption of medicines. I pay tribute to her resourcefulness, and look forward to her challenging me and haranguing me to move faster on the mission we share of accelerating the adoption of innovative medicines.
My hon. Friend made an important point about the centrality of patient voice in this debate, and I want to make sure that, in our consultation, we put patient voice right at the heart of the landscape and this measure. This week I convened and chaired a summit with the Association of Medical Research Charities, who now spend £1.4 billion a year on research in this country—they are a giant in the landscape—which puts them up there with the very largest companies in the world. My offer to them is to come to the top table and help to shape this landscape for the faster adoption of innovative medicines. Indeed, by putting the patient voice and experience—in many cases best expressed by the great research charities—at the heart of this, we can strike a blow for both empowering patients and accelerating innovation.
My hon. Friend made an important point about building into this provision for consultation enough flexibility to work with an ever-wider group of people. She was passionate on the importance of data as the oil that flows through this 21st century research engine.
My hon. Friend Oliver Colvile was eloquent on the important role of pharmacists. I will take him up on his offer to write to him with a detailed answer on the issues to do with devolution that he raised, but I also want to pick up his point about not forgetting the importance of pharmacists as prescribers. One of our central objectives in this digitisation of electronic health records in order to allow 21st century individual care, patient safety and research is to make sure that we are getting information to all those who prescribe. Dr Whitford, who spoke earlier but has had to return to Scotland, has been passionate about the importance of this database allowing nurses, pharmacists and others who are not perhaps leaders in research to have access to information on innovative medicines. So my hon. Friend’s point about the importance of pharmacies is well made. He also highlighted the importance of confidentiality and of having a patient’s trust and confidence. It is for that reason that the Secretary of State and I commissioned, and will shortly be receiving, the National Data Guardian, an independent report from Dame Fiona Caldicott. The report advises us on the use of data in the NHS and how to ensure that our systems are the best in the world for protecting patient confidentiality. It also helps us to shift from a system that is currently reliant on paper and cardboard to one that allows electronic information between primary, community and hospital providers, through an integrated patient record, to support individual care, patient safety, system performance and, crucially, research.
That brings me on to my hon. Friend Anne Marie Morris who was very eloquent about the importance of our research landscape in the UK. Our life sciences industry is a sector that is worth between £50 billion and £60 billion. The digital and genomic sectors are growing fast, not least because of the initiatives that we have tried to take through the life science strategy. We are leading in genomics and informatics, and rapidly becoming a global hub for this new model of research.
I am delighted that, in the autumn statement, we confirmed a £1 billion a year funding commitment for the National Institute of Health Research, which is the jewel in the crown of this landscape. Embedded in the NHS, the institute allows us to lead in this new world of data and genomic-informed research.
In the creation of Genomics UK, we are the first nation on Earth to sequence the entire genome of 100,000 patients, all of whom have volunteered and consented. In that project, we are setting the very highest standards of data protection. Genomics England Ltd is up and running and sequencing genomes and combining with clinical data to form the world’s first reference library for genomic information. We are also setting the standard in ensuring that no individual data can be sold or transferred—we are talking about a reference library, not a lending library. Genomics England will then support the NHS with information on traits that might determine disease, new insights into diagnostics and treatments.
As hon. Members have hinted, this space is moving very fast. Some of the extraordinary things that I get to see as Minister speak to the pace of that development. Recently, at Genomics England, I saw an analysis done at speed of a patient with a rare disease that had hitherto been undiagnosed. The diagnosis was achieved when large computer power was applied to the genomics database, identifying the very genomic trait that had predisposed the patient to the rare disease, which, in this case, allowed us to identify a treatment. Funnily, it was an off-label use of an existing drug that had already been in use in that indication.
The pace of the development of electronic health records in some parts of our NHS is extraordinary, and the advantages are very powerful. I recently visited the Norfolk and Norwich hospital where the nurse on the pharmaceutical drug round in the ward was using an electronic prescribing system. She was absolutely passionate about the power of it to ensure that she gets the right dose, to cut out mistakes, to allow her to monitor her patients’ response, and to drive up the accuracy and precision of prescribing. It also drives up the use of data on patients’ response to different drugs to allow the system to improve the way that we prescribe.
I recently visited McLaren healthcare group, which is working with the NHS. It provides informatics to the entire Formula 1 fleet, taking 400 data points per second off every Formula 1 car. It leads the world in the handling of massive datasets for insights. It is working with the NHS at Birmingham children’s hospital to provide wireless telemetry for constant data feed monitoring with individualised algorithms for children in post-operative cardiac recovery units. I saw toddlers liberated from cables, wires and huge machines that go ping beside their bed, and the look on their parents’ faces as the children with huge scars on their chest toddle off happily to the playroom, knowing that all the nurses have in their pockets a device that will ping at the slightest statistical outlier that individually shows whether the child is experiencing any sort of side effect or incident. The system allows the nurses to be absolutely certain that they can provide the right care. This is a stunning application of informatics and the beginning of personalised medicine. The ability to create much better information flows on the innovative drugs that are available is one part of that landscape.
Patient safety and confidentiality are the Government’s absolute priority. We have to make sure that the revolution in informatic medicine and the digitisation of healthcare, which offers such extraordinary benefits for individual care, system safety and research, carries and deserves to carry patient trust and confidence. That is why we eagerly await Dame Fiona Caldicott’s report, due imminently, on how best we should take forward consent and make sure that we allow this quiet revolution in medicine to progress and the NHS to lead it in a way that our patients can have trust and confidence in.
A number of colleagues have spoken about the new field of personalised or precision medicine. This country is leading in the field. I had the extraordinary privilege in January last year of being invited to talk to the White House health policy team, which wants to know what we are doing on our precision medicine catapult, on genomics and on informatics. In the past year we saw the US launch a very ambitious programme in precision medicine, many of whose initiatives were initiated here in the UK.
For that reason I have launched the accelerated access review to look at how we can better integrate and speed up our landscape for the adoption of innovative medicines using information on genomics and informatics, so that NICE and NHS England have more freedom to target particular treatments at the right patients.
The traditional silos in the R and D pathway are changing and breaking down. We have traditionally talked about medical research, which goes on in universities, academic research and clinical research at a later stage into particular treatments in development. There is something emerging called research medicine, which is the learning of insights daily from the treatment of patients and the diagnosis of patients. The NHS is a potential world superpower in the application of research medicine, because no other organisation in the world has that diagnostic and treatment footprint day in, day out.
This Bill is a small measure that sits in that emerging landscape for making sure that we build an intelligent healthcare system that can use data on innovative drugs and treatments and, increasingly, data on how different types of patients respond to different drugs, to better target not least off-label medicines—repurposed medicines —to particular patients. Those are smaller markets, niche markets, which are very challenging for the large-scale pharmaceutical industry, which is built up on the model of one-size-fits-all blockbuster drugs, but incredibly exciting for our patients and for the charities and some of the smaller companies developing targeted therapeutics.
It is for that reason that the vision at the heart of the life science strategy is, as the Prime Minister put it when we launched it,
“every hospital a research hospital. Every patient a research patient”, so that the NHS is able to fulfil the dream of its founders, captured not least by Nye Bevan and in the original mandate—to be an organisation that uses the collectivisation of health assets for the prevention of suffering for the next generation.
I hope that, with the reassurances about consultation, the House will support the hon. Lady in not pressing amendments 8 and 9. I will happily follow up on the commitments that I have made to make sure that all her suggested consultees are included and others too. I hope the House will support amendment 15, which seeks to remove the exemption for clinical research so that clinicians will have access under the Bill to drugs in clinical research that their patients may be eligible for.
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.