“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.]
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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I know that there were concerns that the list of specified organisations could become out of date.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
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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.
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 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.
12 pm
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.
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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.
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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.
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.
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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
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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).
12.15 pm
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
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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.
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
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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”.
“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.”
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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.
12.30 pm
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.
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Chris Heaton-Harris: I give way to my hon. Friend the guinea pig.
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
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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.
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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
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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.
12.45 pm
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 the Member for Bury St Edmunds (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
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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 the Member for Plymouth, Sutton and Devonport (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. The hon. Member for Central Ayrshire (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 the Member for Newton Abbot (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
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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
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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
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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.
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.
Responsible Innovation
Amendment made: 2, page 2, line 26, leave out clause 3 —(Chris Heaton-Harris.)
Effect on Existing Law
Amendment made: 3, page 3, line 19, leave out clause 4 —(Chris Heaton-Harris.)
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.
(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.)
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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)
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.)
1 pm
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.
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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
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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
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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.
1.15 pm
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
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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.
1.17 pm
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
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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.
1.21 pm
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.
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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.
1.23 pm
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
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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.
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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 right to him about the proposals and how we envisage the measure working.
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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 addressed that specifically when he writes to me, I would 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. That is why 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.
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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.
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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 form 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.
Bill accordingly read the Third time and passed, with amendments.
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Child Victims of Human Trafficking (Central Government Responsibility) Bill
1.45 pm
Mr Peter Bone (Wellingborough) (Con): I beg to move, That the Bill be now read a Second time.
I am delighted to follow my hon. Friend the Member for Daventry (Chris Heaton-Harris), who has piloted through such a successful Bill. I would like to pick up, in general terms, on what the Minister for Life Sciences said at the end of the previous debate, which is that it proves what Back-Bench MPs can do when they work together to achieve something. I want to talk about that a little more in relation to human trafficking and my Bill. It is only three clauses long, but it goes to the heart of the problem we have with human trafficking and modern-day slavery. However, I need to set it in the wider context of modern-day slavery and human trafficking.
Way back when I was first elected as a new Member of Parliament in 2005, the Labour party was in government, and at one of my constituency surgeries on a Friday I got a note through the door. It was anonymous, but the person who wrote it was a prostitute from Northampton who was very concerned at what was happening to young women who were being brought into this country—we now call it trafficking, but at that time people did not talk about it. I thus became aware of this issue and I then met someone called Anthony Steen, who at the time was Member of Parliament for Totnes—a most extraordinary person. He has changed the view of trafficking and modern-day slavery not only in this country, but across the whole of Europe. He formed the all-party group on human trafficking and modern slavery, and I was one of its officers.
At that time, the Home Office under the Labour Government did not really recognise that trafficking existed.
Mr Alan Campbell (Tynemouth) (Lab) indicated dissent.
Mr Bone: I am going back many years. [Interruption.] I am going to develop that point. I am not blaming anyone in particular other than the Home Office—of course, everyone will agree with that—and I am not really blaming the Home Office. It was just that people did not understand the issue. Indeed, if we went back to the days of what people might think of as traditional slavery, I am sure people would have denied it existed. It was only because of what William Wilberforce and others did that people got to know more and more about it. Indeed, I quite confess that when I came to Parliament, I had no idea about human trafficking or modern-day slavery, and I certainly did not think I was going to get wrapped up in trying to solve the problem.
Anthony Steen and a small number of us travelled all over Europe, to places such as Moldova—to places that, to be honest, I had not even heard of—and found out about this terrible, terrible crime being committed of people being trafficked across borders. In those days it was mainly for purposes of sexual exploitation, although it has now turned into labour exploitation.
The traditional way for these women—we call them women, but in many cases they were actually young girls, way under the age of 18—in very poor countries
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such as Moldova to be trafficked would be for somebody of their own age, quite often a female, to befriend them. They would then tell them there was a job in Belfast, say, in a restaurant—this is from a true case, from one of the dependencies of the old USSR. These women would come over expecting to work in a restaurant—and there was, indeed, a genuine restaurant. Because of the free movement rules in the European Union and Schengen, they would not be checked, but could come straight across Europe and into this country, and although I really do not want to make a European Union point, I will. Years and years ago, a long time before all this stuff appeared in the press, we warned that while free movement might have many advantages, it was certainly of great advantage to the traffickers, because there was very little chance of their being caught.
This is what would happen. The girls would arrive, all happy, looking forward to—in this case—a job in a restaurant in Belfast, and looking forward to a better life, more money, and excitement. Those girls never actually made it to the restaurant. They were locked up in a terraced house in Belfast. I say “locked up”. One would expect the lock on a bedroom door to be on the inside, but in houses such as that one they were on the outside, so that the young women could be locked in.
Andrew Griffiths (Burton) (Con): I know that my hon. Friend could not resist making the Europe point. Will he explain something to me? I entirely understand his point about Schengen, but how did the girl manage to travel from the Schengen area to the United Kingdom without being stopped at the border?
Mr Bone: My hon. Friend has made a good point. Years ago, before I came to this place, I ran a travel business which had an operation in Florida, and I would quite often fly over there with new members of staff who were young girls. So there was a middle-aged man taking two or three young women across to America. Every time we arrived, we were stopped at immigration, and the women were taken away and interviewed to establish whether this was a genuine operation and I was not actually trafficking people. We used to get parents to write letters, and so on. But those immigration authorities did a proper, thorough job.
As for our borders, citizens of the European Union have a right to come here. It was not as though those girls were breaking any immigration rules. This is not about immigration at all. They had an absolute right to come into this country, because they were EU citizens. I have always argued that, in obvious cases like that, we should be much more willing to take people to one side and find out whether the operation is genuine or not. The trouble with this operation, however, was that it looked as though it was genuine because the girls were going to a Belfast restaurant to work.
I think that about 70 young women went through that process, and were locked into the terrace house. I do not want to use the word “rape” lightly but they were, in effect, being raped repeatedly. They were not in a position to escape, they were not giving permission, and there was no question of their earning any money. Eventually, those young women were rescued. In that instance we did something really well, but I am afraid that we are still doing something rather poorly.
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When I was a member of Anthony Steen’s group, I discovered that there was a Government-funded centre in London—it was, in fact, funded by the Ministry of Justice—which was run by a left-wing organisation. All the trafficked victims were supposed to be accommodated in 24 beds, which is laughable, because there were so many more victims than 24. There was quite a big row about it at the time, and it is to the Government’s credit that they changed the policy. They took the money away from that organisation and gave it to the Salvation Army. They said, “Work with all sorts of different agencies around the country, religious and non-religious, and they will give you added value. If Newcastle, for instance, already has a hostel that is able to look after trafficked victims, why not give it some money, and then you will have that added value.”
The system worked terrifically well. The money started with £1 million, and despite the huge economic downturn that we have experienced, that amount has increased to, I believe, about £3 million. Adult victims of human trafficking are really well looked after. We must remember that an 18-year-old girl who has gone through this trauma cannot be just put in a house; they have to be looked after. The trauma is enormous and they must overcome that. We do that really well, and the Government, and the Prime Minister in particular, should take great credit for it. The Prime Minister has shown great courage on the human trafficking issue, but the problem comes with how children are looked after; they do not go into that system, and that is what I am trying to solve with this Bill.
The Parliamentary Under-Secretary of State for Refugees (Richard Harrington): I feel I should say at this stage that Anthony Steen’s operation is based in Watford in my constituency, and I am very familiar with it. I was going to say this as part of my concluding remarks but, time being as it is, I felt I should say now that not just he but all the different umbrella groups in the anti-trafficking field are housed in the building above Watford Junction station, so I see him quite a lot. I know my hon. Friend is part of that, and Sir John Randall introduced me to him in the first place, and I think it is a wonderful organisation.
Mr Bone: I am very grateful for the Minister’s intervention, and I am very grateful that we have this particular Minister at the Dispatch Box, because I know he has worked with Anthony Steen and John Randall on this issue, and I greatly appreciate that.
The Government have done exceptionally well. John Randall is, of course, one of our ex-colleagues in this House. I remember that in the Corridor upstairs we had what we called an exhibition, but it was a role play about human trafficking and his son played a trafficker—very convincingly, as well—and that brought home to Members just how under the radar this situation is.
Mr Steve Reed (Croydon North) (Lab): When the POPPY project, which I believe was the organisation the hon. Gentleman was talking about, lost its funding, some of the successor organisations were criticised for putting rescued women in mixed-sex hostels, which was deeply inappropriate.
Mr Bone:
There was a big row about the POPPY project and I am broad-brush about this: I think the Salvation Army operation has been a huge success, and
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I am absolutely convinced that no other country in Europe looks after rescued adult victims of human trafficking better than ours, and we can be very proud of that.
Let me rewind a bit to when I was traipsing around Europe with Anthony Steen. He is a man it is impossible to say no to; I have seen him blag his way into all sorts of establishments that we had no right to be in, and he did so fearlessly. In some places he talked to traffickers and took great personal risks. His influence is what drives me to continue this fight on this particular issue.
At that time, back in 2005, there was a Council of Europe convention on human trafficking. The COE is a very good body. It brings together 47 countries in Europe. The idea is that if we can get something through the COE that everyone agrees with, it is a really good standard. What happened to this convention happened when a Labour Government were in power, but I am absolutely not blaming the Labour Government because it equally would have happened if a Conservative Government had been in power at that time because of the way people looked upon human trafficking: we could not even get the convention signed. Then, after lots of pressure, the convention was signed, and then that turned out to be no use because until it is ratified, it does not come into force, so then we had a fight on that and it was eventually ratified.
Many of the things that were then discussed became part of the Modern Slavery Act 2015, such as tougher penalties for traffickers, quite rightly. There was originally a problem with the hurdle that had to be mounted to prosecute traffickers. The Crown Prosecution Service had decided that in order to get successful prosecutions, it would have to go for lesser charges. That was sorted out; traffickers can be jailed now for 14 years. Tougher border controls are hugely important, too, because I do not want to be punishing traffickers and rescuing victims, as I do not want them to be victims in the first place. There is a lot to do in Europe on that, but obviously, our border control is important. In a wonderful example of co-operation, the Metropolitan police and the Romanian police worked together and broke up a notorious gang and saved many people from being trafficked. Police operations all come down to intelligence and working together across Europe.
Mr Christopher Chope (Christchurch) (Con): Does my hon. Friend accept that there is not just an issue with border controls, but a lot of concern about forged documents and passports? There is a report in today’s press that the United States is thinking of withdrawing its visa waiver scheme for some European countries—for example, for Belgium—because there are up to a million forged EU passports in circulation.
Mr Bone:
My hon. Friend is quite right that this is not, as I have portrayed it, just a European Union issue. I wanted to use that example because I did not want to get into the arguments about immigration and migration control. People from the EU have the right to be here and can be trafficked, but of course human traffickers operate across the world. Traffickers bring people in from Nigeria, and use all sorts of terrible things to keep them in prostitution. If someone were in a town and forced into prostitution, one would think that there would be ways for them to escape, and there probably are, but they are under acute mental pressure. They may
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be told that their parents will be killed or that their children will be harmed. If they come from Nigeria—this may seem strange to us—voodoo spells may be used. All those things have to be dealt with, and we are beginning to deal with them. The problem of forged passports is important.
I do not accept what the Home Office used to say, which is that if we create a safe environment for people who have been trafficked, it will be a pull factor. That is complete and utter rubbish. People can come in and claim asylum anyway. They do not need to pretend to be trafficked; there is no advantage to that at all, and I really reject the idea. There are more slaves today across the world than there were in Wilberforce’s time; it is just that we do not see them on the docks. Great credit should go to the Government for what they have done in this regard.
Going back to the Council of Europe situation, a good convention was eventually signed and ratified. One thing we wanted for the protection of people who have been trafficked was the appointment of a rapporteur —I would say a commissioner because the word rapporteur sounds far too “European Union” for my liking. We had a long battle on that with the Government. By this time, we were in the coalition Government. A cross-ministerial group was appointed, which was complete rubbish. We knew that by how many times the Ministers bothered to turn up. It was a complete farce. We had a battle on that. MPs from both sides of the House and from all parties—the hon. Member for Foyle (Mark Durkan) was a great support—called Westminster Hall debates to put pressure on Ministers and to ask lots of questions. That all followed on from what Anthony Steen did.
When I first came to the House, Anthony Steen was the only person doing anything, and then everybody started to realise that there was a problem. People may think that the Government make all their decisions in Downing Street and that we are just here to tick the boxes, but it was not like that, and we proved that with the previous Bill. On human trafficking, it was absolutely not like that. Private meetings went on and so on. We finished up with a Modern Slavery Act 2015, which increased the penalties for trafficking, toughened border control and improved the rights of victims to prove that they were victims, which is a complicated thing, but we did not deal with the situation of child victims. We dealt with victims, but forgot that there was a huge loophole.
Members will recognise that probably every week in their constituency advice surgeries, they have someone in front of them who is clearly in need of help and social care. The problem is that the health service says the person needs social care and the local council says the person needs social care, but they blame each other for not funding it. I will develop the argument a little later.
Adult victims of human trafficking are a central Government responsibility, that of the Ministry of Justice. Unbelievably, children who are victims of human trafficking finish up in local authority homes and, bizarrely, are indirectly the responsibility of the Department for Education. How that works I have no idea. In fact, it does not work.
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I do not know of any legislation in which we deliberately set out to treat adults better than children. I return to my example of the 18-year-old who was tricked into coming to Belfast and started off in the restaurant but finished up in a terraced house. It must be an horrendous experience to be repeatedly raped, and many of those people come from countries in central Europe that are deeply religious.
Mr Steve Reed: The hon. Gentleman is making a powerful case against what is going on, but is he aware that, according to the police, the most common route by which men who want to abuse women find them is through classified ads—small ads—in local newspapers? Does he agree that Government organisations and publicly funded bodies should seek to exert pressure on those newspapers to abandon carrying such adverts by withdrawing state funding if they refuse to do so?
Mr Bone: I am grateful to the hon. Gentleman for raising that important point. It is interesting that the front of the paper will damn human trafficking, and the back of the paper will advertise it. That used to be true, but now advertising tends to be on the internet.
There has always been an argument—I take no view on this—that if prostitution is banned, as has happened in Sweden, human trafficking will stop, and if prostitution is legalised, if I may use that term, as in the case of Holland, there will be human trafficking galore. The truth is, as the record shows, that it does not matter—there is human trafficking in Sweden and there is human trafficking in the Netherlands. People feel very strongly about the issue of prostitution, which is quite right, but to say that if it is banned, it will stop human trafficking does not meet the facts. We have to accept that whatever happens, we will have to deal with human trafficking.
The slight worry about the Swedish model is that because it happens underground, there is even less likelihood of prostitution being detected and the girls may be subject to even worse treatment than where prostitution is open. I have no view on that, other than to say that the evidence is clear that trafficking carries on in both countries.
Returning to the Belfast situation, human trafficking is usually discovered by members of the public. Neighbours who live in the street suddenly realise that there are a lot of men going into the building at all hours and they never see the people who live there. So they report it to the police and the police raid the property and rescue the girls, at which point the support kicks in, which is what my Bill deals with. The problem is that although those girls might be rescued, the 70 who went before have been moved on.
The frustrating thing about this is that the gangs that do the human trafficking are the same people who do drugs and guns. They know that human trafficking is a better deal because once drugs have been used, they are used up, but a girl can be sold on, time and again. I will tell the House about something that used to happen at Gatwick airport. A girl would come through border control and be met by someone. They would sit in a coffee shop and other men would bid to buy her. That was happening a few years ago.
What frustrates me—I have had this argument with the Government—is that we put a huge amount of resources into fighting drugs and guns but only a tiny
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amount into fighting human trafficking. That needs to be addressed. We need to put more money into police intelligence operations, because that is how they discover where the gangs are. When we break these gangs up, we are breaking up the drug and gun gangs at the same time. These are not nice people. They are extremely evil. Also, there are often family organisations involved.
Let us say that some girls come over from Hungary. They come across Europe without any border checks and into this country without any border checks. They arrive in Belfast and work in a restaurant for perhaps two days before being put into prostitution. The argument the traffickers use is to tell the girls that they have to do this to pay back the debt—a made-up amount—that they have incurred in being brought over to this country. This is patently evil.
It is difficult for me to imagine the trauma that these young women go through, but it is absolutely awful. Many of them have never had sex before. There is a case on record of young girls being brought together in a house by a Russian gang for the purpose of human trafficking and one of them refusing to do as she was told. You know what? They executed that person in front of the rest of the girls. Should we not be putting more money into dealing with these people? I think we should.
Let me talk about the problem as I see it. I really want to praise Members on both sides of the House, and particularly the Prime Minister, for what we have already done on human trafficking and modern slavery. The Modern Slavery Act 2015 would not have become an Act if the Prime Minister had not made it a priority. We did so much, but we missed this one thing and, my goodness, it is the old problem of central Government, local authorities and empires.
Let us take as an example a 19-year-old girl who, having been rescued, is looked after by the Salvation Army. In due course, she will become a responsible citizen of this country. But what happens to a 15-year-old child who has never had sex with anyone before but is now being repeatedly raped? What trauma is she going through? Thankfully, the police rescue her, but what is their duty at that point? They have to hand her over to the local authority. There is no requirement for the local authority to recognise her as having been trafficked. It just treats her like a missing or homeless child. There is no special care for her, and that is wrong. These children have been traumatised. They have not simply run away from home because they have had an argument; they have been through the most brutal experience and they need specialised care.
A few years ago I submitted a freedom of information request to all councils to see what they could tell me about children who have been trafficked. Most of them could tell me nothing, because they did not bother to record them, but some did make an effort and were much better. The frightening thing was that the majority of those children had been re-trafficked within about a week, probably to the same evil gang. What happened to those children when they were back in the hands of those horrible people? I presume that they were beaten up and tortured before being put back into that lifestyle and then sold on to somewhere else in the country.
The first problem is that we do not know what happens to those children. That should be the responsibility of Government, and certainly of local government, as I have argued. I just do not accept that children who have
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had such a terrible time can be put into local government control. Even the best foster carers, unless they know about human trafficking, cannot possibly deal with them.
I rarely leave this place, because I think that MPs should be here when Parliament is sitting, but I did go to the Philippines with Anthony Steen. The Philippines has a great problem with trafficking, but it deals with child victims so much better than we do. They are put in a safe home, where they could never be discovered, and they are looked after by female staff and they go to school. I had the privilege of meeting a young women—she was then 21—at her wedding. When she was younger she had been trafficked and repeatedly raped, so she had come through on the other side. I also met someone who had just gone into the system. The poor girl was blind and had had the most horrible existence. The great advantage of that system was that those girls would never be re-trafficked.
We can learn from that example. To the Government’s credit, Barnardo’s has run a similar pilot scheme, which I think has been a huge success. However, that is where we come up against a problem. Central Government do not want to take on another responsibility and extra cost —that is the attitude we come up against—and local government does not want to lose part of its empire. Come on, Government; that is patently absurd. There is no extra cost, because someone is supposed to be looking after those children. Why not make it the responsibility of the Ministry of Justice? We should treat those children the same way we treat adults by having safe homes for them around the country. There is a huge problem with inter-Department squabbling and budgeting, but I argue that we must put all that to one side and do for those children what we do for adults. How can it be Government policy that child victims of human trafficking are treated worse than adult victims?
The Bill will probably not make progress today, but I hope that the principle behind it will be considered seriously. Before concluding my remarks, I will go through the Bill so that hon. Members understand it. It contains only three clauses. Clause 1 amends section 17 of the Children Act 1989 so that children who have been trafficked are no longer the responsibility of the local authority. Clause 2 sets out a duty to provide for child victims of human trafficking—it basically states that we should treat them the same way as we treat adults. Clause 3 deals with the formalities.
While I would like this Bill to move into Committee and to the Lords and become an Act of Parliament, I know that in reality it will not, but I hope that by airing the issue I have moved things forward. Given that we have a Minister who is known for his caring and compassionate attitude, a Government who really have done things about human trafficking, and an Opposition who wholeheartedly support improving things for victims of human trafficking, surely we could all work together. This has been a cross-party movement; the APPG was of course cross-party. It would be a crowning moment, and a recognition of what Anthony Steen did, if in due course the principle of child victims of human trafficking being a responsibility of central Government became a reality.
2.20 pm
Sarah Champion (Rotherham) (Lab):
I give huge congratulations to the hon. Member for Wellingborough (Mr Bone), who for a very long time has been an
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incredible campaigner on this issue. It is absolutely to his credit that we are debating this Bill, and I wish we had longer to go through it, because it deserves that.
Human trafficking remains a significant and growing problem. It is estimated that there are 20,000 modern-day slaves in this country alone—a terrifying statistic. Members on both sides of the House share a determination that we should do everything that we can to end trafficking, and particularly to support the victims—including children, who are so often overlooked. Recent figures from the National Crime Agency demonstrate all too clearly the scale of the task. In 2014, 3,309 potential victims of human trafficking were reported, of whom 732 were children. That is the highest number since we started recording the figures, and it represents a 22% increase on the number of child victims of human trafficking reported in the previous year.
The impact of exploitation on child victims of trafficking cannot be overstated. I am grateful to the hon. Gentleman for giving some examples. Of the identified child victims in 2014, 32% were trafficked for sexual exploitation. Among trafficked girls, the figure rose to 49%. The exploitation of trafficked children leaves them with highly complex needs that are not being met by current provision. However, despite my concerns, I cannot support the notion of central Government having responsibility for a particular group of children. Transferring this responsibility would leave trafficked children outside mainstream provision of care, which may potentially be discriminatory. Furthermore, I am concerned that it could lead to an even more fragmentary response for victims.
I served on the Modern Slavery Bill Committee, where we heard moving testimony about the dangers faced by trafficked children—in particular, the risk of re-trafficking. Research has shown that 60% of trafficked children in local authority care go missing; most are never found again. Trafficked children who go missing are highly likely to be returned to exploitation. That children identified by the authorities should be allowed to disappear without trace is both shocking and indicative of a failing system.
Despite the passing of the Modern Slavery Act, there has been very little change in the delivery of support to child victims. Only one section of the Act was specifically designed to improve the response to child victims—the introduction of child trafficking advocates—and this is yet to be enacted. In Committee, the Minister clearly recognised the need to implement the provisions as soon as possible, and pointed out that the Government had begun the trial prior to the necessary legislation being passed. It is therefore concerning that despite the passage of the Act and the successful completion of the trial, the Government have delayed the introduction of child trafficking advocates, instead opting to conduct further testing of the model. The need for independent advocates has been accepted by the Government, and the proposals have been trialled and positively evaluated. It is vital, therefore, that the Government now proceed without further delay to implement the scheme nationally.
The Modern Slavery Act was a historic piece of legislation, and the Government should be commended for the commitment they have shown to ending human trafficking, but the task remains incomplete. I urge
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them to do everything they can to ensure that child victims of trafficking receive the support they so desperately need.
2.24 pm
The Parliamentary Under-Secretary of State for Refugees (Richard Harrington): I, too, pay tribute to my hon. Friend the Member for Wellingborough (Mr Bone) not just for putting forward and speaking for the Bill, but for all the work he has done. As I said when he kindly took an intervention from me, the work that Anthony Steen has done and is still doing is particular pertinent for me, since it is impossible for anyone to end up at Watford Junction station without seeing his operation there.
I am very short of time, so I will get straight to the point. My hon. Friend’s proposal is that the Government should take over dealing with the trafficking of children by placing it under national control in a national organisation, rather than the current situation of dealing with it locally through local authorities. Our contention is that that is not the best way to deal with it. I am afraid I cannot accept his assertion that children are, to use his expression, treated worse than adults.
We have set a clear expectation on local government in caring for children who are trafficked or unaccompanied by making important revisions to the statutory guidance for local authorities. The guidance is clear that unaccompanied asylum-seeking children and child victims of human trafficking are some of the most vulnerable children in the country and that placement decisions
“should take particular account of protecting the child from any continued risk from traffickers, and from a heightened risk of going missing.”
We have also published strengthened statutory guidance on children who run away or go missing from home or care. The guidance clearly sets out the steps that local authorities and their partners should take to prevent children from going missing and to protect them when they do.
The Government have strengthened multi-agency arrangements for co-ordinating and sharing intelligence in relation to vulnerable victims. Such multi-agency safeguarding hubs—or MASHs, as they are called—are being set up across the country and are helping to share information about and to co-ordinate more effectively in safeguarding children and vulnerable adults from harm.
Mr Bone: Will the Minister give way?
Richard Harrington: I will give way, but I have very little time.
Mr Bone: I am sorry that the Minister does not have more time. What he says is really good news, but as the hon. Member for Rotherham (Sarah Champion) said, 60% of such children are re-trafficked. Despite what the Government are doing, local government is therefore failing.
Richard Harrington: I am afraid I do not accept what my hon. Friend says about children who go missing. I am happy to discuss that with him separately. [Interruption.] We do not know.
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I briefly want to mention one point made by the hon. Member for Rotherham (Sarah Champion) in her very thoughtful speech. I agree with her about bringing in officials to be advocates for such children, but the Home Office is being very careful. It has very recently been decided that further trials are needed. That the result of prevarication, as though the Government do not want to act, but because of a fear of not getting it right. We have a one-off chance to do this. The Minister for Children and Families, who is very interested in this subject, is in the Chamber, for which I thank him.
A lot of work is under way. It is not as though the Government are oblivious to the issue. It is most important that children at risk of trafficking and those who have been trafficked do not fall outwith the system or are treated separately from adults. We must continue to deliver at this pace, because the Government will not tolerate the exploitation of any child, whether they are from the UK or foreign-born.
The question my hon. Friend the Member for Wellingborough has asked us is whether we can achieve that aim by transferring responsibility for victims of child trafficking from local to central Government. We believe that that is not the answer, because the work in progress to care for such victims better meets the standards required for vulnerable individuals. We are giving it a lot of resource and doing the work to beef it up—for example, our help for unaccompanied children in Kent—which demonstrates the Government’s commitment. There is a ministerial implementation taskforce to consider child protection, so we are not oblivious to the issue.
I have made a careful note of the very good points made by my hon. Friend, but I am afraid that the Government cannot agree to his Bill becoming law for the reasons I have explained. That does not mean that this debate is a spurious use of time, or that he has not made very interesting and relevant points. I hope he does not find it disrespectful that I have to say, reluctantly, that the Government cannot accept his core proposal. He has been in this House for a long time and will understand that it is not possible for us to do so, but he was right to use this opportunity to air the issue. I am sure that some of the points that he raised will be discussed again in the House and be taken into consideration. For that reason—
2.30 pm
The debate stood adjourned (Standing Order No. 11(2)).
Ordered, That the debate be resumed on Friday 11 March.