Off-patent Drugs Bill
George Freeman Excerpts(10 years ago)
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The Parliamentary Under-Secretary of State for Health (George Freeman)
I am delighted to have the opportunity to address the Bill. I start by congratulating my hon. Friend the Member for Cardiff North (Jonathan Evans) on bringing it before the House and raising this very important issue. As he has said, he and I have met Department officials and we very much agree on the Bill’s objective to promote off-label use of medicines. The only disagreement is on the mechanism to achieve that and whether the mechanisms proposed by the Bill are the right ones. That disagreement continues, and for that reason the Government want to work with my hon. Friend and the campaigners and charities that support the Bill to find a way to achieve our agreed aims.
I want to set out some of the background, outline my proposals and explain why the issue is not quite as straightforward as we would all like to think it is. If only we could legislate to get the right drugs into the right patients at the right time, the world would be a lot easier, but we are not able to do that.
Bob Stewart
Do I take it from what the Minister has just said that the Government support getting through the Second Reading as fast as possible?
George Freeman
Let me be clear. What I am saying is that the Government support the intention behind the Bill, which is to achieve greater use of off-label drugs in different indications, but we disagree with the Bill’s proposal for legislation to require the Medicines and Healthcare Products Regulatory Agency to license them. For reasons that I will set out, we do not think that is the problem or, therefore, that the proposal is the right solution. Nevertheless, I welcome the fact that the issue has been raised. It sits foursquare with my mission as the Minister with responsibility for life sciences. I am already working on it and am very keen to make sure that the active work streams I am pursuing embrace the intent behind the Bill.
I pay tribute to my hon. Friend the Member for Cardiff North for his work. The House has often debated this issue and I am well aware of the strength of feeling among Members of all parties about the importance of, and urgency involved in, getting both new and existing medicines to patients more quickly.
I should also like to take this opportunity to pay tribute to my hon. Friend for his service in this House. As he has said, this is his last year, and I am sure I speak for all of us in paying tribute to and thanking him for all he has done, not only in contributing to the quality of this institution, but in campaigning on this issue.
As my hon. Friend and others may know, I came to this House and my ministerial position after a career in biomedical research—a subject that is very close to my heart—so I am delighted to be able to discuss it and the Bill this morning. During my 15 years working in biomedical research, I saw first hand the serious challenges involved in bringing a new drug to market. I want to address how the landscape of drug development and discovery is changing; the profound way in which technology is changing what is possible; how the economics of 21st-century drug discovery are changing; and the resulting challenges and opportunities for us to do exactly what my hon. Friend seeks to promote, which is greater and more novel use of existing drugs for those patients who will benefit. I will then deal with the key points raised by him.
A rapid transition is taking place from a model of 20th-century drug development whereby the NHS, patients and the health system waited passively and all too patiently for the introduction of new drugs that had been tested, proven and developed with the claim that they would work and were safe for everybody. Over the past several decades, the regulatory barrier required to justify that claim has got higher and higher, as have the costs of developing drugs. On average, it typically takes 10 to 15 years and £1 billion to £1.5 billion to develop a new drug.
My hon. Friend referred to patent life. Members will know how the industry works, but it is worth repeating that, in order to justify the enormous sunk cost of the billions of pounds required to bring a new drug to market, the law provides for the inventor of a new drug to have a patent for 20 years. That mechanism ensures that those who successfully bring an innovation to market are able to get some exclusivity on sales, which allows them to pay for those sunk costs. When a drug becomes off-patent, the generics market kicks in and anybody can make the drug, provided it is made to the right standard and is safe, which allows all of us to benefit from that drug at a vastly reduced price. Indeed, one of the major challenges facing the sector is that, as the cost and time taken to develop a drug increases, the pharmaceutical industry’s pipeline of new drugs is not sufficient. The problem is referred to as the patent cliff, and the sector is going through a radical transition to try to deal with it.
The problem is that the more we know about genetics and the way in which different patients respond to different drugs and diseases, the more we realise that the blockbuster, one-size-fits-all drug that we have got used to the industry giving us is not what we need. What we need are drugs that are much more targeted at patients and their underlying genetic and pharmacokinetic profile. We want drug discovery to be driven by our increasingly sophisticated understanding of how different patients respond to different drugs and diseases.
Underlying that problem is an extraordinary opportunity for this country. In order to reorientate drug discovery around patients, we need an infrastructure that allows people to work in world-class research hospitals with access, at the very highest ethical and regulatory level, to tissues, biomarkers, electronic patient data and longitudinal cohort studies. Nowhere in the world is better equipped to lead that model of translational, personalised and stratified medicine than Britain with the NHS, and through my appointment the Government have signalled their commitment to exploit that opportunity.
We believe there is a real opportunity for the UK and the NHS to lead in the emerging field of stratified and targeted medicines, because no other territories in the world have our 50-year history of an integrated public health system, the records that go with it, its ethical and regulatory standards or its world-class centres of research excellence. If we embrace that model, using genomics and data to understand better how different patients respond, we will also be able to look back at the pharmacopoeia of known and existing drugs and re-profile them for use in particular patient groups, because it will have become clear that they will be effective for them.
My hon. Friend might be interested to know that the re-profiling of drugs is itself a major subsector of the life sciences sector. Whole companies, analysts and investors are devoted to mining the pharmacopoeia to find secondary uses, with the intention, of course, of re-patenting the secondary, novel use of an existing drug through tweaking the chemistry and providing the basis for a proprietary claim. Good luck to them—I wish them well—but what my hon. Friend and I want to see is the ability better to use that information in order to find existing drugs which, in their current form, would have a benign impact on a particular patient group. Doctors are perfectly free to use those drugs at the moment.
The truth is that whichever model of drug discovery we pursue, any drug has to be licensed as safe by the MHRA—or, in Europe, by the European Medicines Agency—and then NICE carries out a technology appraisal and makes a recommendation to the NHS about whether such a drug or device has a sufficient cost-benefit to be worth using. Despite all that, the decision on what to prescribe in the end rests, rightly, with clinicians. We cannot and should not legislate to tie clinicians’ hands. Rightly, it is up to clinicians to decide what to use for their patients.
I want to submit to the House and to my hon. Friend that the challenge does not relate to passing legislation to require the MHRA to license the new use of an existing drug, because the lack of a licence is not the restraining factor. In this landscape, the restraining factor is the lack of information for clinicians about off-label use. We need to encourage greater off-label use through NICE, and to have a culture within our health system that actively supports it. In a moment, I will talk about what we are doing and might do to encourage that.
I want to pick up the confusion that may exist about the difference between off-patent and off-label drugs. A drug is off-patent when its patent protection has expired, which means that anyone can produce an identical drug at their own cost. A drug is off-label when it can be used for a new indication for which it was not originally intended. However, clinicians are perfectly able to use drugs for off-label purposes: we do not require the MHRA to license drugs for such a reason, and many drugs are already used in that way.
Let me assure my hon. Friend and other hon. Members that, as the new Minister for life science, I have responsibility for the National Institute for Health Research, which underpins clinical research in the NHS with £1 billion a year. It looks not just at new drugs, although we are very good at that, but at the whole pharmacopeia and how existing medicines are used, and provides research on side effects, efficacy and outcomes for the MHRA and NICE.
We have created a new department at the heart of the Government to tackle precisely the issues that my hon. Friend has raised. I have been in post for only 100 days, but I want to talk about what we are doing to try to accelerate access for patients to new medicines, and to existing medicines with novel indications. I am sure that he is delighted to know that, as the hon. Member for Copeland (Mr Reed) reminded the House, my principal mission is to accelerate access to new drugs, including to new uses for existing drugs, for the benefit of NHS patients.
My hon. Friend the Member for Cardiff North was kind enough to refer to the Government’s commitment to the cancer drugs fund. He rightly identified that our real commitment is to ensure that if patients suffer because of NICE recommendations in relation to particularly expensive drugs, additional money is made available to prevent that from happening. The problem is one of health economics and NICE appraisals, rather than of licensing by the MHRA.
My hon. Friend made a very eloquent case, which I support, for the use of off-label drugs. We disagree not on the aim of promoting off-label use, but merely on the mechanism for doing so. As the Minister with responsibility for NICE, I am delighted to assure him and the House that we already have the power to instruct NICE to undertake technology appraisals. I hope that what I will say in a moment about how we intend to use that power and about the work we are doing on a series of ways to accelerate access to new drugs will reassure him that, far from our having any sense of complacency, we are bending our backs to consider every avenue in order to find value within the current pharmacopeia and to support clinicians actively embracing innovative uses of drugs.
It is for that reason that we have decided—controversially in some quarters—to support Lord Saatchi’s Medical Innovation Bill, which is in the House of Lords. It seeks to contribute to this landscape by making it clear in statute that clinicians have the freedom, and should be supported in using the freedom, to embrace innovative uses of both existing and new drugs in the treatment of cancer. His Bill is about making very clear that those freedoms exist, and that clinicians have a duty, under their Hippocratic oath, to explore every innovative opportunity that there is a good clinical basis for believing will be safe and to the benefit of their patients.
The truth is that the problem is as much cultural as legislative. That is the principal reason why the Government are not able to support this Bill, but very much support its aims. I want to say something about what we propose to do to achieve the progress that we all want more quickly and effectively.
So that there is no doubt, let me say that our position is basically that the Bill is not needed. Anyone can apply for a licence for a medicine, and doctors can already prescribe medicines for uses outside their licence, where that is in the best interests of their patients. Doctors do so every day: when they make such a judgment, it is safe, legal and right for them to do so if they feel that they have a basis for doing so.
The truth is that licensing gets a medicine licensed; it does not get it into clinical practice. Whether clinicians use the medicine is driven by NICE guidance, and doctors ultimately decide what is best for their patients. That is why pharmaceutical companies invest so heavily in promoting their products. In turn, NICE exists, as an independent source of advice in the NHS, to provide our clinicians with independent, world-leading advice on the cost-effectiveness and the clinical cost-benefits of new drugs.
If we want to accelerate the uptake of innovative medicines, I suggest that we focus our efforts on NICE guidance and on supporting our medical profession to adopt innovation. Our concern is that the Bill may, completely inadvertently, impede progress on that by making doctors feel that they should not use medicines except for their licensed indications, which is the opposite of the message that we want to send. I understand that that is not the intention of the Bill, but we believe that it might be an inadvertent side effect.
What are we doing? The Government believe that the real issue involves better informing and enabling clinicians to embrace new indications, not dealing with a supposed problem of licensing. We are taking steps with NHS England and NICE to support local drugs and therapeutics networks, and improve how they pick up new evidence and translate it into clinical practice. Indeed, one role of the NIHR is to gather data—that word again—on which drugs are working and on outcomes across the system, and to feed such information back into guidance that is continually updated.
We are also working with hospitals and GPs to support them to work together on delegated prescribing, and to consider how they can change clinical pathways to reflect the very latest evidence across the system. The truth is that we need more evidence about what is working, and we are now gathering that evidence through the NICE associates network and our contacts with local clinicians.
As I have explained to my hon. Friend in our meetings and conversations, we will set up a round-table discussion in the new year, alongside NHS England and NICE, to bring everyone together, review the evidence and agree a strategy and a timetable for action. I am more than happy to extend an invitation to him and those supporting his Bill, as well as Association of Medical Research Charities, to engage actively in that process and to help us to develop a strategy for achieving what we all want, which is the greater use of off-label medicines in areas where the evidence suggests that they can deliver patient benefit.
I can go further and confirm that that is part of a major piece of work that I am leading on how we can and should reissue and revise our guidance to NICE and the MHRA—and review our ambitions as a country in this 21st-century landscape—to make Britain genuinely the best model of patient-centred research. Through the NIHR and our NHS infrastructure, we want to be the best place in the world for people to come to and develop new medicines, or indeed new uses for existing medicines. We want specialist tertiary research hospitals with cohorts of data, to develop new models of commissioning through evaluation, and evaluation through commissioning—two sides of the same coin—so that we can get drugs to patients far quicker than under the traditional model of 10 to 15 years and the £1 billion drug development.
There are undoubted benefits to the use of off-label drugs where there is evidence about their safety, efficacy and side effects. Guidance from the MHRA and the GMC is clear that there is a hierarchy in the use of medicines. In treating patients, clinicians must first consider using a licensed medicine within its licensed indication. If that will not meet the patient’s needs, clinicians can consider a licensed medicine outside its licensed indication. Only if that is not suitable should they consider a medicine that is not licensed at all. A great many medicines can offer benefits to patients when prescribed outside their licensed indications—my hon. Friend has already mentioned tamoxifen and raloxifene for the prevention of familial breast cancer.
My hon. Friend also rightly identified that there can be delays and barriers to using off-patent drugs for new indications. The reasons for that are complex—if only they were so simple that we could solve them with one private Member’s Bill—and in part relate to reluctance by some clinicians to prescribe drugs for conditions for which they are not licensed. There are also issues about the system’s ability to pick up emerging evidence and translate it into new guidance and clinical practice, and about how hospital specialists and GPs can work together to achieve that, by adapting pathways where needed.
What the Bill seeks is already allowed. That is the key reason why, despite agreeing with the Bill’s aim that patients should have access to appropriate drugs, the Government are unable to support it. Medicines are already prescribed legally, safely and appropriately outside their licence indications to large numbers of NHS patients, both in hospitals and in general practice. No funding, legal or regulatory barriers in the system prevent patients from being prescribed a clinically necessary medicine that is not licensed for the treatment indicated. Indeed, doctors regularly prescribe drugs outside their licensed indications. For example, many medicines prescribed to children are unlicensed for paediatric use because historically they have not been formally trialled in children. Two key conditions must be met in such prescribing. First, the clinician must be satisfied that the unlicensed indication meets the clinical needs of the patient and that no suitable licensed alternative is available. Secondly, he or she must explain to the patient that the drug is not licensed, so that they are clear about that.
Evidence suggests that patients trust their clinicians, and that those who are suffering actively embrace research medicine and are keen to be made aware of available drugs that may be not have been originally licensed for that purpose, as long as there is good evidence for it and the clinician supports its use. That position is well established and supported explicitly in guidance to prescribers by the General Medical Council and the Medicines and Healthcare Products Regulatory Agency. Therefore, if a doctor chooses not to prescribe a medicine off label where one is indicated for the patient, that is unlikely to be simply because of the medicine’s licensing status. If a clinician believes that the lack of a licence prevents them from prescribing a drug, that is a different issue to which I will return in a moment.
Under the law regulating medicines, anyone can apply for a licence for a new use for an existing out-of-patent medicine. The Bill seeks to place that responsibility on the Health Secretary, so that he either takes steps to secure licences for off-patent drugs and new indications, or appoints a body to do so. In truth, licensing gets a medicine licensed, but it does not do what we want, which is get it into clinical practice. That requires clinicians to use and prescribe drugs, which is why we have NICE guidance.
The Department of Health holds a small number of licences for anthrax vaccine in the case of national emergency, but the Government rightly view that very much as an exception. Our concern is that if the Secretary of State were to become a routine applicant, or instructed someone else to do that on his or her behalf, they might be open to accusations of interfering in the market and a conflict of interest. There might even be a case for claiming a conflict of interest between the Secretary of State’s role as an applicant competing in the medicines market, and their statutory role as overseer of the system. Ultimately, we worry that that could compromise the Secretary of State’s responsibility for the UK medicines licensing system, were they to become a regular applicant. The idea of a body set up by the Secretary of State to apply for licences does not seem proportionate to the scale or nature of the challenge. If the issues under consideration will not be resolved simply by granting more licences—I do not think they will—there is no need for such new bureaucracy.
We believe that the provisions on NICE in the Bill are unnecessary. The fact that NICE has recommended the unlicensed use of tamoxifen and raloxifene in its clinical guidance should reassure hon. Members on that point, and I stress that we are actively discussing that matter with NICE and wish to promote it. I know my hon. Friend is concerned about the level of uptake of those drugs, despite NICE’s approval, and by focusing on the NICE appraisal process and guidance with an associated legal funding requirement, the Bill seeks to remove a perceived funding barrier to the implementation of off-label drugs that are proven to be clinically and economically effective. However, we believe that in practice it is unlikely that drug costs will be the key factor determining prescribing behaviour, when we are talking about generic drugs that in many cases will cost a few pence a day.
The framing of NICE’s clinical guidelines reflects the strength of the underpinning evidence. For example, where evidence strongly supports the use of intervention, NICE often states that that should be offered to patients. On the other hand, where the evidence of benefit is less strong, NICE typically states that intervention should merely be “considered”. It is entirely appropriate that the uptake of NICE’s recommendations reflects the strength of the evidence base. For the two drugs mentioned by my hon. Friend and me, NICE concluded that the evidence strongly supports their use for women at high risk of breast cancer, but was less strong for women at moderate risk. As such, its recommendations are worded differently, depending on a woman’s risk levels. Specifically, and importantly, NICE states that the drugs should be “offered” to women at high risk, and “considered” for women at moderate risk.
The Bill would require the Secretary of State to ask NICE to appraise certain new indications for off-patent drugs, whether licensed or unlicensed, rather than issue any form of guidance. Again, the Government believe that that is unnecessary, as there is currently no legislative barrier to Ministers asking NICE to appraise drugs outside their licensed indication. We tend to do so only exceptionally where there is clear evidence that that is the right course of action—an example would be drugs used to prevent transplant rejection in children. More frequently, NICE looks at the off-label use of drugs in the context of its clinical guidelines across the whole care pathway. Guidelines are generally considered a more appropriate vehicle for guidance on off-label indications, as they can set use more clearly in context. The question of mandated funding is unlikely to be critical if the drugs concerned are older or lower cost generics. NICE recognises the primacy of the medicines regulator in matters of safety and efficacy, and liaises with the MHRA in developing any clinical guidance recommendations relating to off-label use.
Let me explain why I am concerned that supporting the Bill could be counter-productive. That is not my hon. Friend’s purpose or intent, but it is a possible accidental side effect. The Government are concerned that the Bill could lead to clinicians and patients being concerned that something is not right about the use of a medicine outside its licensed indication, and that clinicians may be deterred from prescribing a drug, and patients from taking it. As I have explained, off-label prescribing is safe, legal, and when it is the right clinical choice for the patient, that is the right thing for the clinician caring for them to do. Given the large amount of such prescribing that goes on in the NHS every day, seeking to license every drug for every indication or each potential combination would be a gargantuan task. In many cases, the formal evidence base may not exist in a form that would support a licensing application.
Access to medicines that are important to patient care could be impeded because we worry that we would be seen to have set a new higher threshold for their use. That is precisely the opposite of what the Bill is seeking to achieve. We are, however, keen to take proportionate action to investigate whether non-legislative improvements can be made to support the use of appropriate medicines and benefit NHS patients. I was struck by the opinion and evidence that has been presented on access to medicines, such as the potential issues in transferring care from a specialist to a GP.
I might add that such issues are in no way unique to unlicensed medicines’ use. There are areas where there is far too much variation in the use of licensed NICE-appraised medicines. We are working hard with the NHS to address that, but there is no single magic bullet.
George Freeman
I am not sure it is quite as simple as that. There is a significant and substantial ongoing series of discussions in the sector at the moment on issues such as the cancer drugs fund, specialist commissioning and whether we should be ring-fencing different medicines and therapeutic areas. The truth is, for reasons I described earlier, that the landscape is changing dramatically. I totally understand that charities that rightly support greater use of off-label medicines would like to think it is possible for us to legislate for these drugs to be put into use, but from the conversations I have had, it is apparent that clinical opinion is very varied. Nobody I have spoken to in the clinical profession wants the Government to go down the slippery road of starting to legislate for particular uses of particular drugs, which is effectively what this mechanism seeks to begin to do.
I commit today to working with NHS England, the MHRA, NICE and patient and professional groups to explore in depth the issues around the cultural challenges on unlicensed and off-label prescribing in general. We know that we need to look at the issue of clinical leadership. We need to take steps to improve how new evidence is translated into prescribing practice, and how hospitals and GPs work together and how that works within the care pathway. I am absolutely committed to doing what needs to be done and what can be done now within the existing system, and to looking at the evidence to ensure we adopt the approach most likely to succeed. Most trusts have robust governance arrangements set up to consider innovative treatments that clinicians may want to prescribe. A trust’s drug and therapeutics committee, or indeed the clinical ethics committee, provides an opportunity for doctors and pharmacists to explore the clinical and patient safety implications of doing so.
I am delighted to confirm that we have begun to work with NHS England and other stakeholders including NICE to get a handle on this and to accelerate the use of off-label drugs. I restate the invitation to interested Members to come and join the project. We are absolutely committed to looking at why there may be delays in translating new evidence and research into clinical practice, including why some clinicians are reluctant to prescribe drugs outside of their licensed indications when many others are not, and to consider what further arrangements might be put in place to assist in implementing new evidence into care pathways. This is a problem we face across the system, with variable uptake of NICE guidance. It is one of the central objectives of my new role in the Department of Health to drive consistency of uptake across the system.
I believe this offers the prospect of a more appropriate, sustainable and rapid approach to this problem that can apply to a range of different drugs and clinicians.
Mr Nuttall
The Minister has just used the word “rapid”. How quickly will these drugs become available?
George Freeman
I am not clear which particular drugs my hon. Friend is referring to, but let me answer in a generic way. I would like us to become a place where, instead of it taking 10 or 15 years and $1 billion to bring innovative drugs to market, we use the NIHR platform and our investment in genomics to become a country where for some cancers we could be getting drugs to the most needy patients through the early access to medicine scheme that I have been championing and that the Department launched earlier this year. Potentially, we could be getting drugs to patients five, six, seven or eight years earlier than would normally be the case through the traditional model of phase one, two, three, four.
Jonathan Evans
The drugs the Minister is talking about are new drugs. They are not a mechanism for using existing licensed drugs for which the patent has expired, which, under current circumstances, are not being prescribed to people who need them. That is what this debate is about.
George Freeman
I well understand that. The off-patent is a distraction; it is the question of off-label. The truth is that clinicians are free today to do it. My hon. Friend’s point about timing is very well made. I would merely say that at this stage, with the working party I am putting together and the strategy I would like us to launch—I would very much appreciate his input—I think we should be looking at setting some very clear goals and targets for speeding up that use. In particular, we should ensure that where there is evidence of an innovative and new use for an existing drug off label and there is good evidence to suggest it, we roll it out across the system. It is both the speed of first adoption and the speed of roll-out across the system.
This offers the prospect of a more appropriate and sustainable approach that can apply to a range of different drugs. We can use it to tackle this problem much more quickly and to get new drugs into use much more effectively. More specifically, we are looking to gather further evidence around potential barriers by focusing first on NICE’s updated guidelines on familial breast cancer, through the NICE associates network, and asking it further to promote its implementation. I will also ask NICE whether it would be prepared to use one of the patient decision aids it is piloting for further support.
To draw all the strands together and look at the issues at national level, we plan to arrange a national round table of the key stakeholders to be co-hosted by my Department with NHS England and NICE. We intend to use the initial meeting to identify what the various participant stakeholders might usefully do to help to address the cultural and clinical leadership issues and what other practical steps might help. The request I make to those who support the Bill is that we review the need for any further guidance or legislation in the light of that work when it has been completed. I am delighted to extend an invitation to my hon. Friend to be a part of that.
In conclusion, I very much appreciate the points that have been made today. I recognise the very real concerns that have led to the drafting of the Bill. I am absolutely committed to investigating and getting to the bottom of the reasons why new evidence is not being picked up and implemented consistently, as well as why some clinicians may be reluctant to prescribe in this way, and, crucially, the important role of NICE in supporting that with updated guidance. I am committed to doing so with the involvement of all interested parties.
The Government remain firmly of the view that improvement in this area can best be achieved through a combination of measures, and that resorting to legislation to demand regulatory measures is not a magic bullet. It will not solve the issues we believe are actually responsible for this problem, and it carries the risk of some serious and unintended consequences. It is for those reasons that the Government cannot support the Bill. However, I reiterate that we support the intention of promoting greater use of off-label medicines. We are committed to looking seriously at this and to launching a strategy and a work plan, with specific targets for increasing the rate of use of off-label medicines, with all the key agencies and to invite stakeholders in the sector, in particular medical research charities and the AMRC, to help us with that. New uses for existing drugs is something we actively support. The truth is that, as much as we would love to, we could not and should not go down the slippery road of starting to legislate for the use of medicines that should be, and are rightly, a matter for clinicians.
Jonathan Evans
I thank all who have contributed to the debate, including the Minister. In fact, other than the Minister everybody has spoken in favour of the proposition contained in the Bill. I am especially grateful to my hon. Friend the Member for Bury North (Mr Nuttall), who has been involved from the inception in supporting the Bill. I am grateful for the intervention of my hon. Friend the Member for Christchurch (Mr Chope), who has been such a source of great support in this process, which, even after 22 years, is relatively new to me. He, of course, is something of a Friday expert. I am also grateful to my hon. Friend the Member for Beckenham (Bob Stewart) for his interventions and his clear articulation of support for the Bill. Let me also thank the shadow Minister and those on the Labour Benches who have made it clear to me and to the charities their complete support.
The problem is that the Government take one view on the Bill, whereas charities, clinicians and others are saying that the current situation is unacceptable. It is not good enough to argue against going down the road of legislation, given that we already have a legislative process for licensing. For instance, it is the law that if a drug has not had a licence, it cannot be effectively marketed in the UK. The reason GPs often do not routinely prescribe life-saving medicines is that the rules in essence make it illegal to market them in that way. It is not surprising, therefore, that GPs, given that legislative background and the litigious world of the medical and legal profession, decide to avoid something unless it is licensed. It is not as though the charities sector has not provided the Department with a welter of information on why GPs are not doing it. The lack of licensing is at the core of it.
As the Minister knows, I respect him and his background career, and we have had several conversations about the Bill, but the proposition that passing the Bill would damage the current situation is simply laughable. I do not know who wrote that line for the Minister, but that proposition needs to be re-examined. Nothing in my Bill would cause a GP to say, “Well, actually, I was going to prescribe something, but I’m not going to now.” With due respect to him, that was the weakest of his arguments.
We heard earlier from the Labour Benches that several colleagues have received representations on the Bill from a wide coalition of charities covering a range of medical conditions. Yesterday, I spoke to several of my colleagues on a day trip to a constituency in southern England, and everyone spoke of having 50 or 60 constituents urging them to support the Bill and of being pleased to have received a response saying that the Government were speaking to me as the Bill’s promoter. Many people interpreted that to mean that the Government would be broadly supportive of the Bill.
For that reason, I am deeply disappointed to hear now that the Government are opposed to the principle of the Bill. I do not need to rearticulate its provision—it is a very simple Bill—but it says that in the absence of somebody applying for a licence, the Secretary of State has the duty to make that application or to appoint another public body to do it. Thereafter, the Bill makes provision for the drafting of regulations that present widespread opportunities for the Minister to address his concerns.
George Freeman
To clarify, we agree with the objective of the Bill, which, as I understand it, is to get greater off-label use of medicines for new indications, but we disagree about the mechanism. The Bill is very clear on the mechanism: it is to pass legislation to require the MHRA to issue licences. We believe that this is the wrong solution, but we are in alignment on the problem that needs to be solved.
Jonathan Evans
That is very helpful. I have always understood that a Second Reading debate is on the principle of the Bill; we then deal with the detail in Committee, and then we proceed to Report. Ever since I was first elected 22 years ago, that is how I have understood it to work. If my hon. Friend is saying, “We are not against the principle, but against the mechanism”, that is a reason to support the Bill on Second Reading and then to debate in Committee how we adjust it to take into account his concerns.
George Freeman
I congratulate my hon. Friend on making an extremely eloquent argument, but I cannot let that go. The point is that the principle to which we object is the passing of legislation to require the MHRA to issue licences. That is more than a vague guiding philosophy; it is the mechanism suggested, and that is why we are opposed to it. I genuinely believe we will make more progress in the next few months using my office and the organisations for which I am responsible, working with the supporters of the Bill, to drive forward these measures.
Jonathan Evans
So we are back to the Government being opposed to the principle of the Bill. It might have helped if Ministers had said, in response to those Members who wrote to them saying they were aware of my Bill, that they were opposed to the principle, as we have just heard from the Minister. Members were led to believe that the Government were not against the principle but were discussing these matters and that we might ultimately reach an accommodation. Now we understand that the Government are opposed to the principle.
The principle is one advanced by the clinician community and the AMRC and supported by editorials in leading newspapers in the UK this week. It is not surprising that almost every leading newspaper has urged the Government to pay attention to the arguments. The hon. Member for Copeland (Mr Reed) highlighted how people outside the House look at what we do here. As I said in my opening remarks, it is important that we pay attention to the clinician community and the AMRC. For that reason, I hope the House will support the Bill.
Question put, That the Bill be now read a Second time.
Health and Social Care (Safety and Quality) Bill
George Freeman Excerpts(10 years ago)
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The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)
I am delighted that this important Bill appears to have cross-party support. I strongly support it, as do the Government, and I pay tribute to the tireless commitment shown by my hon. Friend the Member for Stafford (Jeremy Lefroy) to the cause of public safety. I think that I speak for the whole House—although many Members are not present this morning—when I say that he has commanded all our respect in campaigning so tirelessly, with such good grace and diligence, and with cross-party support to ensure that the lessons of the appalling tragedy at Mid-Staffs are properly learned. He has demonstrated the integrity of that work again today, which is reflected in the degree of support for the Bill.
Let me begin by echoing the support that my hon. Friend expressed for Julie Bailey, my hon. Friend the Member for Stone (Sir William Cash) and Ken Lownds, all of whom have done a huge amount of work behind the schemes in support of the Bill and the wider cause of patient safety. My hon. Friend spoke extremely powerfully about the 4,000 unavoidable deaths and the many thousands more unavoidable incidents of harm. Such incidents will, of course, be avoidable if we are better equipped to track, monitor and collect data in the way that is proposed in the Bill, and to develop the culture of transparency and accountability for which it provides.
My hon. Friend spoke about the concept of zero avoidable harm, which sits at the heart of the Bill, and spoke particularly powerfully about the culture of health and safety. In the aviation and nuclear industries, as we heard from the hon. Member for Copeland (Mr Reed), it is a culture that involves actively looking out for near misses, and actively welcoming the reporting of problems by staff members from top to bottom of an organisation as soon as they have been identified, that has enabled those industries to develop such exemplary health and safety records. One of the great lessons that emerges, loud and clear, from the Francis report is the need for a change of culture.
My hon. Friend referred to the science of safety and the elimination of variability from the system, and to the good work that is being done in this country, not least as a result of the Francis report. That is another example of an area in which the NHS is leading in global medicine. He also spoke of the importance of integrating information and data. His account of the journey made by his constituent Janet Powell as she helped to escort her mother across the health and care landscape will have resonated with many Members. It certainly resonated with me, because over the last 18 months I have been in a similar position, supporting my own mother through a journey from primary care to hospital care to community care in Norfolk. As many Members and many millions of carers outside will know from experience, it is often the carers, parents and loved ones of patients who are carrying the best information about the patient through the system. That information is often too slow and does not keep up with the patient on their journey.
My hon. Friend spoke very powerfully about the risk-averse attitude to sharing information. That is a problem, and the Government are committed to trying to tackle it. That is another reason why we are supporting this Bill. Key to that, as my hon. Friend touched on, are the recommendations of Dame Fiona Caldicott, and I am delighted that she has agreed to take a lead role and to accept the invitation of the Secretary of State to look at the safeguards we need to be putting in place across the whole of the NHS and Department of Health care and data provisions. That will help provide a strong degree of reassurance to both Members in the House and people outside that patient concerns about confidentiality are being met.
My hon. Friend also spoke very powerfully about his support for health care professionals, and I would like to put on record my support for his comments about the NHS staff who are in Africa on the front line of the fight against Ebola. We owe them all a huge debt of gratitude.
We also heard from a number of other Members who spoke very powerfully. My hon. Friend the Member for Bury North (Mr Nuttall) was kind enough to congratulate me on my role in managing to get the data-sharing measures included in this Bill. They were raised before this House in my ten-minute rule Bill, which fell, but I am delighted to see those measures picked up in this Bill.
My hon. Friend also spoke very powerfully about the NHS as a bedrock of British society, and I could not agree more. He made some interesting points, too, about the difference between the science of health care and the human and compassionate and cultural side of health care, which this Bill goes right to the heart of. That has always been a great strength of the NHS, which in its founding charter is a scientific and research-led organisation, and which has always put compassionate care at the very top of its mission.
My hon. Friend the Member for Congleton (Fiona Bruce) spoke very powerfully and again paid tribute to both the NHS and its staff. She also spoke about the importance of transparency and of there being public confidence in the data confidentiality aspects of this Bill and more generally across the health care system.
I was pleased by the tone and spirit of the speech of the hon. Member for Copeland and to hear that there is cross-party support for this Bill. Although parliamentary time is short in this Session, I think that with that support this Bill has every chance of reaching the statute book.
I was particularly pleased to hear the hon. Gentleman’s powerful—and personal—support for the importance of data sharing in 21st-century health care. He rightly highlighted Salford as a beacon of what can be achieved, and that stands as a tribute to the NHS in the north-west, which is leading the way in the use of informatics and medical data for both research and treatment.
The hon. Gentleman also spoke powerfully about his personal experience as a diabetic patient, and about his reliance now on data as a patient and his active embrace of telehealth and the use of smartphones. He also spoke very powerfully about how that is allowing him to have better control of his condition. Patient empowerment, through data and electronic health records and putting in place a landscape so that patient medical information flows with the patient and reflects the patient journey across the system, is key to both this Bill and the Government’s wider proposals for building the integration of health and care and a 21st-century model of the NHS in which health care moves from being something done to patients when the system is able to do it to a system in which active health citizens are empowered and enabled and encouraged to take more responsibility for their health care so they can drive through the system in the way that suits them.
We might not have a packed House here on this Friday morning, but we have certainly packed in the arguments. We have heard a lot of high-quality contributions. I want to talk about the thinking behind the Bill and answer some of the key questions that have been raised.
The need to maintain minimum levels of quality much more consistently was put into sharp focus by the landmark public inquiry report, published in February 2013, on the terrible, shocking and serious failings in the care provided at the former Mid Staffordshire NHS Foundation Trust. I think everyone in the House would accept that the subsequent Francis report shook the health system to its core. Francis’s call for a fundamental culture change across the entire health and social care system that would put patients first at all times still resonates loudly in this Chamber and throughout the health and care debate.
Sir Robert Francis QC, the chair of the inquiry, made a compelling call for action across six core themes: culture; compassionate care; leadership; standards; information; and openness, transparency and candour. That is a checklist that all of us who are involved in health care need to keep close at hand. The inquiry represented a watershed in our thinking on safe and better care. That in turn is driving a culture change across the NHS as we resolve never again to allow the system to fail patients and service users in the shocking way that it did.
The Government published their response to Robert Francis’s public inquiry on 19 November 2013. That response, “Hard Truths: The Journey to Putting Patients First”, demonstrates the Government’s commitment to creating a culture of openness, with greater accountability and a relentless focus on safety in an NHS that puts compassion at its heart. In response to the events at Mid Staffs, to Robert Francis’s recommendations and to Don Berwick’s excellent review of improving patient safety, the Government have already introduced a number of measures to improve safety. First, a new statutory of candour on providers will help to ensure that patients are given the truth when things go wrong and that honesty and transparency are the norm in every organisation. This new duty will be overseen by the Care Quality Commission. It will come into force for all NHS bodies soon and for other registered providers by April 2015. We expect staff to reflect the duty in their everyday activity.
An organisation is made up of its staff, and providers will be expected to implement the new duty through staff across their organisation. Training and education of staff will also support the establishment of an open culture. The General Medical Council, the Nursing and Midwifery Council and the other professional regulators will introduce a new explicit and consistent professional duty of candour, making clear a requirement to be open, whether the incident is serious or not.
Secondly, the Secretary of State announced in March a new Sign Up to Safety campaign, a platform on which all NHS organisations and patients can share, learn and improve ideas for reducing harm and saving lives. It was launched in June, and health care leaders have been invited to set out what their organisations will do to strengthen patient safety, including by producing a safety improvement plan. Sign Up to Safety aims to achieve much more than just the numbers of NHS organisations joining; it is about motivating participants actively to get involved. The campaign will go beyond institutions and seek to sign up as many individual NHS staff as possible, and everyone who chooses to join will commit to the new patient safety ambition.
In order to realise the Berwick report’s vision of the NHS as an organisation devoted to continual learning and improvement, NHS England and NHS Improving Quality have established a new national patient safety collaborative programme. This will spread best practice, build skills and capabilities in patient safety and improvement science, and focus on actions that can make the biggest difference to patients in every part of the country. The safety collaboratives will be supported systematically to tackle the leading causes of harm to patients. The programme will include establishing a patient safety improvement fellowship scheme to develop 5,000 fellows in a national faculty within five years.
We are absolutely committed to changing the culture of patient safety through investment in leadership. NHS England is now working with The Health Foundation to help develop proposals for a safety fellowship initiative. The NHS is on a transparency journey, through the NHS Choices patient safety section, to become completely open and transparent. More information about our local health services is now more publicly available than ever before. As well as using the information to drive improvements, it is vital that a patient or member of the public can easily find and understand what it says about their local health services.
In June, NHS Choices began publishing new and existing information in a new safety section, complementing the wealth of information available about our hospitals and wards. It specifically provides information on: nurse staffing levels, including at ward level; infection control and cleanliness; CQC national standards; whether the unit is recommended by staff to their relatives and friends; patients assessed for risk of blood clots; the response to patient safety alerts; and open and honest reporting. The NHS is one of the safest health care systems in the world but there is always scope to improve health care standards universally and reduce avoidable harm further. That is why the Secretary of State for Health set the ambition to reduce avoidable harm by half and save 6,000 lives over the next three years.
As well as the devastating effect that health harms can have upon patients, service users and, as hon. Members have mentioned, their carers and families, a recent report by Frontier Economics has estimated that poor care could be costing the NHS up to £2.5 billion every year. That is why the Government have thrown their full support behind this important Bill, which will do much to improve the safety of patients.
Jeremy Lefroy
I am grateful to the Minister for the argument he is developing. Does he agree that the Bill is vital for staff? They do not want to be involved in instances of avoidable harm; it preys on their minds and can blight their careers. If the institutions to which they belong are not seeking to avoid harm, it is often the professionals, rather than the institution, who carry the can, and that is not right.
George Freeman
As ever, my hon. Friend makes an incredibly powerful point. An institution is only as strong as the staff within it, and when an institution is not taking seriously an issue that the staff confront as a daily reality, it puts them in an impossible position. He rightly says that by changing the culture of the institution, NHS staff will be able to do their jobs more easily and with more confidence, safe in the knowledge that when they raise issues that may be of concern, whether or not there is in fact a risk, they will be welcomed and supported. That culture change is vital if we are going to turn things around in the way that we are committed to doing.
There are three key sets of provisions in the Bill: the ones that will mandate patient safety as a key requirement of CQC registration; the provisions ensuring the integration of data across the health and care pathway; and the provisions dealing with the regulation of professional standards. They represent real and significant steps to support and develop patient safety in the NHS, and we are delighted to support them. Let me deal with each of the three in turn.
On the CQC requirements to include safety, clause 1 is central to the Bill’s focus on safety and quality, and, in particular, the elimination of the avoidable harm that flows from the provision of poor care in health and adult social care services. Safety is paramount and must be the focus of care providers at all times. The experience at Mid Staffs underlines the importance of that and of what can happen when providers put other priorities before safety. The CQC’s role in protecting patients is vital, and safety and the avoidance of harm are key elements of the CQC’s regulation of providers, in two key ways. First, monitoring registered providers against safety requirements and taking enforcement action when the requirements are not met is central to the CQC’s objective to protect and promote the health, safety and welfare of people who use services.
Jeremy Lefroy
Does the Minister also agree that the Bill’s provisions, in seeking to get that focus right to the top and make it the responsibility of the Secretary of State, ensure that, right here in this House, patient safety is of the essence?
George Freeman
My hon. Friend makes another important point about the role of leadership in the culture change that we are seeking to drive. I believe all hon. Members would acknowledge the Secretary of State’s personal commitment to this crusade for patient safety, and it is symptomatic of the level of leadership that is required. If the leader—the accountable senior executive—in every trust and organisation in the NHS makes clear their personal commitment to this agenda, it helps to change the culture and to create the conditions in which the reporting of patient safety issues and concerns is welcomed and encouraged.
Safety is also a critical component of the CQC’s new inspection regime and one of the five key questions the chief inspectors ask when rating the quality of services. Currently, it is at the Secretary of State’s discretion as to whether registration requirements should cover safety of care. Clause 1 removes that discretion and instead places a duty on the Secretary of State to impose registration requirements about safety of care. We welcome that duty, because it absolutely fits with the Government’s wider commitment to putting patient safety right at the heart of our health and care system. The duty will cover all providers registered with the CQC across health and, importantly, adult social care, and will help ensure that no avoidable harm will come to patients and service users when they are being provided with a regulated service. It is important to say at this point that the duty will not place an obligation on the Secretary of State to ensure that care or treatment is risk-free—no Secretary of State could ever give that undertaking. Health care provision is of its nature a risky business and can be so. Chemotherapy, for example, saves lives but can have significant side effects. A test of reasonableness must be applied in assessing whether harm is avoidable. The registration requirements that are before Parliament do cover safety and will allow the CQC to take action against poor providers in a way that has not been possible up to now. The Government therefore welcome the clause, which reinforces what the regulations are seeking to achieve and will ensure that the key message of safety and harm reduction runs consistently through the CQC regulation, and across the system as a whole, for years to come.
Clauses 2 and 3 deal with the key changes requiring a common identifier and imposing the duty to inform other health care professionals along the care pathway. Far too often in the health care system, patients lead and their information follows and, particularly as patients migrate between primary, hospital and community care, they and often their loved ones are left driving the patient journey without access to the necessary information. Too often, the health care professionals do not have access to the very latest information on the treatment that their patient has received in another part of our health and care system. That is why we welcome the clauses.
Clauses 2 and 3 concern the sharing of information by providers and commissioners to support people’s direct care and treatment, as an essential part of the delivery of safe, effective and high-quality care. The sharing of timely, accurate and relevant information facilitates the provision of integrated care and treatment tailored to people’s needs and wishes, yet we know that that sharing does not always happen as it should. Anxiety about information governance and data protection can stifle the sharing of information between staff and organisations working together to care for an individual. Clauses 2 and 3 will require that providers and commissioners of publicly funded health and adult social care share the information which is so essential to the delivery of safe and high-quality care. That will relate only to the way in which information is shared by organisations directly involved in an individual’s direct care.
Clause 2 places a duty on providers and commissioners, within scope, to record and use consistent identifiers in people’s health and care records and correspondence. There is a requirement to include the identifier when sharing information with other organisations directly involved in that individual’s care. Clause 3—
Madam Deputy Speaker (Dame Dawn Primarolo)
Order. May I say to the Minister that he does not need to explain the whole Bill; the promoter has already done that. The Government have said that they support the Bill, so I am at a bit of a loss as to why the Minister does not appear to be giving us any new information, but is reiterating what has already been said. Perhaps he could clarify some things a bit more, but we do not need a commentary on every clause.
George Freeman
I completely understand, Madam Deputy Speaker, and I do not intend to give you a commentary on every line of the Bill; that happens in Committee. However, given that the Government are supporting this private Member’s Bill, I thought it was important that, as part of our wider commitment, I set out why and on what basis we are supporting it, and give some guidance to the House on where in Committee there may be differences and where and why the Government are taking the view that they are. None the less, I will heed your comments and ensure that I keep my remarks at an appropriate high level.
Madam Deputy Speaker
Order. I absolutely agree with the Minister. We would be interested to hear any qualifications from the Government and where they were, as that would give the House time to consider what will be occurring in Committee. I look forward to hearing him say that.
George Freeman
It is important to recognise that clauses 2 and 3 relate only to how information is shared by organisations involved in an individual’s direct care. My hon. Friend made the point that this Bill is solely focused on the needs of the patient; it is not in any way about the Government or the NHS seeking to collect information for any other purpose other than to ensure that patient care is first and foremost in the system.
Clause 3 places an express duty on direct care providers and commissioners of publicly funded health and adult social care. When providing care to an individual, organisations within scope would be required to ensure that the relevant information is shared with staff within their organisation, and also within other organisations along the care pathway, where it is in the individual’s best interests. That duty would apply only if it directly facilitated the individual’s care and if it was in his or her best interest. That will not only support the delivery of safe, effective and integrated care, but improve people’s experience of their care and support, sparing them the frustration of having to tell their story over and over again as they move along the care pathway.
Simply sharing is not enough. To realise fully the benefits of sharing information, it is vital that the information shared is accurate, relevant and timely. In order to provide safe and high quality care, especially where it is urgent or where multiple care teams are involved, information needs to follow the person, so that professionals can access the right information at the right time. Using a consistent identifier is essential to that aim, as it ensures that the information being shared relates to the right individual.
A number of people have asked about the common identifier. Clause 2 places a duty on the Secretary of State to make regulations that will specify the consistent identifier to be used. It is the intention of the Government that the prescribed identifier should be the NHS number.
The universal use of the NHS number is a long-standing priority of the Department. Ensuring that records include a person’s NHS number, especially when they move between providers on their care pathway, is vital to the safety and quality of care. A number of Members asked about our view of the appropriate identifier. We believe that consistent use of the NHS number will facilitate the co-ordination of care, reduce errors and support the integration of records.
Ensuring a reliable and seamless transfer of information is all the more vital when the patient is a vulnerable person. That vulnerable person could be an elderly patient with dementia and many complex needs, for whom large institutions can be difficult to navigate at the best of times. I must stress that these duties are strictly limited to sharing for direct care purposes, with only those organisations directly involved in the provision of care, and only where it is in the patient’s interests.
Let me be clear: this will not permit or require sharing of information for any other purpose. The duty would not apply where there were good reasons for it not to apply. Such reasons could include: when an individual objects to his or her information being shared, or to his or her NHS number being used; where the individual would be likely to object; or when an individual receives, or may receive, services, such as sexual health services, anonymously.
Jeremy Lefroy
Should this Bill command the support of this House on Second Reading, does the Minister agree that one thing we would need to consider in Committee is this real issue of the mixing up of personal information and patient information within records? How best that can be addressed will require quite a lot of discussion.
George Freeman
My hon. Friend makes an excellent point. As he is aware, there are a number of initiatives on data across the health and care system, which is why the Secretary of State has appointed Dame Fiona Caldicott to advise the Government and to look at the pilots that NHS England is currently running on the care.data programme. It is important that the data provisions of this Bill and the confidentiality provisions and guarantees are closely examined in Committee and that there is no confusion over the purposes for which the data provisions are being used, which are solely to do with patient safety.
Clause 4 creates a power for the Secretary of State to make regulations to exclude certain persons or their functions that would take them outside the scope of the new duties for continuity of information. The Government intend to make regulations that will exclude providers and commissioners of children’s social care and providers and commissioners of children’s health care within the Department for Education’s purview. Those exclusions will include local authorities and other organisations exercising educational functions and children’s social service functions, children’s homes and residential family centres, fostering and adoption support agencies and certain schools, nurseries and educational institutions. I am delighted to tell the House that the Department of Health and the Department for Education are working together to support information sharing and use of the NHS number, where appropriate, by those organisations.
The use of patient data can arouse significant public concern and controversy and lead to highly charged debates. The public rightly expect to see their data held securely and used only for their benefit. That sits full square at the heart of these proposals, which is why NHS England has taken back the care.data proposals to review, revise and pilot, and why we have appointed Dame Fiona Caldicott. The information-sharing provisions of this Bill are solely concerned with the sharing of information between health and care providers where it is in an individual’s direct care interests.
To summarise, the consistent patient identifier and information-sharing provisions will support three key things: better informed care decisions, leading to care and treatment being better tailored to people’s needs and preferences, and better health and care outcomes; safer care, with a reduced likelihood of errors, adverse events and sub-optimal care stemming from a lack of information;, and improved experience of care, with individuals being called upon less often to repeat their story, and having increased confidence that the person caring for them has all the information that they need.
Let me turn now to the third and final section of the Bill, which deals with the regulation for the Professional Standards Authority and the professional regulator. We welcome these clauses, which will bring in a consistent objective for the PSA and for the regulators of certain health and care professionals, including dentists, nurses, midwives and opticians.
That will ensure that public protection is at the heart of what the regulators do. This measure is about not changing what the PSA or the professional regulators do in relation to professional regulation, but ensuring a coherent, strategic approach by them in the performance of their functions. Patients and the public need to understand the role and purpose of the organisations that regulate our health professionals in order to have confidence in what the regulators do. Having clear and consistent objectives is vital to that.
Let me touch now on the automatic erasure provisions, which my hon. Friend said had been withdrawn. The intent of the policy is to enable the regulators automatically to erase from a professional register individuals tried and convicted of certain serious crimes. However, it would be necessary to amend the existing statutory framework for each of the regulators properly to achieve the policy and would result in a Bill that is much longer and more complex than is usually acceptable for a private Member’s Bill. In the light of that, and given the complexity of the drafting required to achieve the policy, we took the position that automatic erasure should not be taken forward.
Automatic erasure was one of the areas considered by the Law Commission in its review of the regulation of health professionals. The Government remain committed to legislating on this important issue at the earliest opportunity. We have explored all other possible legislative options for taking forward issues arising from that piece of work and therefore propose to take forward automatic erasure in a future parliamentary Session alongside other measures in response to the Law Commission’s review. The long title of the Bill, which sets its scope, specifically mentions the intention to provide for automatic erasure, but I believe that my hon. Friend the Member for Stafford has indicated his intention to table an amendment in Committee to remove that from the long title.
When I talk to people about the Bill, I am asked one or two key questions, which I believe those watching the debate will want to hear us answer, and which the hon. Member for Copeland has asked me to deal with. The first is, “Are my medical records already shared with others involved in my care?” Unfortunately, the sharing of information about one’s care is not as widespread in the system as it needs to be. Those who use the NHS the most often are often those who have the most to remember. It can be very frustrating for health professionals, and too often that lack of information is involved in the misdiagnosis and the mistakes that my hon. Friend the Member for Stafford spoke of.
The second question that we are often asked is, “Don’t these regulators already put patient safety at the heart of everything they do?” The CQC and the professional regulators are all there primarily to protect us. The measures in the Bill are not a reflection of any failure in that respect. However, these organisations are given legitimacy through legislation; their remit and ability to act are defined in law, and it is important, we believe, that their legislative basis is explicit about their respective roles and duties in public safety. It is not our intention that the Bill, if it becomes law, should result in a dramatic change to the way in which the regulators operate on a day-to-day basis. We know that they are already focused on patient safety. The Bill enshrines that focus and ensures that those organisations are never hindered in their important work.
The Bill is a big step forward. I urge hon. Members from both sides of the House to support it.
Later in the year, we shall publish a comprehensive update on achievements to date and the progress towards Sir Robert Francis’s vision of a system delivering safe, compassionate care.
The events at Mid Staffs were a shocking reminder of the systemic failings in patient safety and care that occur when the culture and practice of healthcare institutions cease to prioritise the human, the compassionate and the cultural aspects of health care. I am delighted to support the Bill, which fits very well with the Secretary of State’s crusade for accountability, transparency and patient safety. It complements the measures that we are putting in place, as a Government, to support patient empowerment, to integrate health and care, and to meet the need for seamless information that follows patients, rather than patients so often traversing the care pathway without that information to hand.
There are two other questions that I was—
Madam Deputy Speaker (Dame Dawn Primarolo)
Order. With respect to the Minister, I spoke to him nearly 15 minutes ago with regard to his comments on the Bill. He has now been speaking for 37 minutes to tell us how much the Government agree with the Bill. There are other Bills to be debated this morning. I tried asking the Minister very nicely and gently. Now I am saying to the Minister directly that it is not his job to use up time in the House. Could he please conclude what are the major points on the Bill?
George Freeman
Thank you, Madam Deputy Speaker. I have concluded my prepared remarks. I just want to deal, if I may, with the questions that were asked of me in the House.
Madam Deputy Speaker (Dame Dawn Primarolo)
With respect to the Minister, he should have integrated those into his remarks on the Bill, because I presume he was listening to the comments of the other speakers. He has now been speaking for nearly as long as the rest of the debate, and this is not really acceptable, Minister, given that there are other Bills to be debated this morning, and that this Bill seems to have the wholehearted support of the Department. The word succinct must be in the Minister’s mind, which means brief, and I will interrupt him again if he is not.
George Freeman
Thank you for that clarification, Madam Deputy Speaker. In that case, perhaps it would be appropriate for me to list the questions now and then deal with them by writing to Members.
There were important questions about the Law Commission, some of which I have addressed, but I will write more fully. The hon. Member for Copeland asked me about the duty of candour dropped under pressure from professionals. If he is happy, I will drop him a line on that. The hon. Gentleman also asked about the care.data issue. I think I have dealt with that in my comments, but he should feel free to contact me if there are any omissions. There were important comments about the BMA, Madam Deputy Speaker, which I am taking your guidance to mean I should not address. Its briefing arrived on my desk this morning, and obviously I will look at it very carefully and write to Members with our position on the concerns that it has raised, although I note that its report also seems to have a lot of support for the intent of the Bill.
Lastly, there was a question about making data sharing much more consistent. I want to confirm that the Department of Health is working with our partners, and will produce guidance to support compliance across the system.
On that basis, Madam Deputy Speaker, following your guidance, I express again our support for this important measure and resume my seat.
Non-Departmental Public Bodies (Triennial Reviews)
George Freeman Excerpts(10 years ago)
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The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)
I am today announcing the start of the triennial reviews of the National Institute for Health and Care Excellence (NICE), the Medicines and Healthcare Products Regulatory Agency (MHRA), the British Pharmacopoeia Commission (BPC), the Commission on Human Medicines (CHM), the Administration of Radioactive Substances Advisory Committee (ARSAC) and the Independent Reconfiguration Panel (IRP).
All Government Departments are required to review their non-departmental public bodies (NDPBs) at least once every three years. Due to the wide ranging reforms made by the Health and Social Care Act 2012, the Department was exempt from the first round of reviews in 2011-14. In order to ensure that the Department is an effective system steward and can be assured of all the bodies it is responsible for, we have extended the programme of reviews over the next three years to all of its arm’s length bodies and Executive agencies.
The reviews of the aforementioned bodies have been selected to commence during the first year of the programme (2014-15). The reviews will be conducted in two stages. The first stage will examine the continuing need for the function and whether the organisation’s form, including operating at arm’s length from government, remains appropriate. If the outcome of this stage is that delivery should continue, the second stage of the review will assess whether the bodies are operating efficiently and in line with the recognised principles of good corporate governance.
Oral Hormone Pregnancy Tests
George Freeman Excerpts(10 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Health (George Freeman)
I congratulate the hon. Member for Bolton South East (Yasmin Qureshi)—I pay tribute to her work—and my hon. Friend the Member for Enfield North (Nick de Bois) on securing the debate. I also congratulate the Backbench Business Committee. I did not rebel very often during my first four years in Parliament, but I am proud that one of my rebellions was in support of the Committee. The debates it brings to the House are often of the very highest quality, as today’s has again illustrated. I am delighted to have the chance to come to the Dispatch Box and speak on this important subject. I pay tribute to the victims’ association for its work, as well as to Marie Lyon, Jack Ashley and the many hon. Members who cannot be here today but take a very close interest in this issue.
I welcome the opportunity to update the House on the Department’s view of this important issue. I first want to assure all hon. Members that the current Government take very seriously the concerns that have been expressed. I want to take this opportunity to express my and other Ministers’ deepest sympathy to those who believe they have been affected by these products. I absolutely commit that this matter will receive the highest attention that it deserves, although hon. Members will appreciate that this is not an easy issue, given the many years—40-odd years—that have passed since the tests were first used.
We have heard some very powerful speeches from hon. Members on both sides of the House, and I want to highlight some of the points made. The hon. Member for Bolton South East spoke powerfully about the era of cover-ups. We have heard a lot in recent years about the cover-up of medical and sexual scandals—in Rotherham, Sheffield, Mid Staffs and, frankly, other areas—which have not been given the attention that they deserve. I suggest that we now need, and we are seeing, a new era of transparency, and that is all to the good. Medical professionals in the NHS and across the system have a duty of care and, like them, Ministers have a duty of care to the people we represent, and a duty of transparency as part of that.
My hon. Friend the Member for Aberconwy (Guto Bebb) spoke powerfully about his constituent Mrs Roberts and his experience of premature births in his family, and the hon. Member for Coventry North West (Mr Robinson) also spoke powerfully. My hon. Friend the Member for Enfield North made an important point about the trust that citizens and patients place in the medical profession and the health system. In return, we owe them a duty of trust and transparency. The hon. Member for City of Durham (Roberta Blackman-Woods) made an important point about how those involved in these cases need to receive some degree of closure and to know that the issue has been looked at properly.
My hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) spoke powerfully about her constituents. The hon. Member for Hayes and Harlington (John McDonnell) made an important point about the historical relationship between the pharmaceutical industry and the medical profession. Let me make this point very clearly: this Minister and this Front-Bench team are here to represent only one special interest group, and that is the patients whom the NHS, the health system and the Department are here to serve. I say that as someone who has come from the industry. We also heard powerful contributions from the right hon. Member for Sutton and Cheam (Paul Burstow) and the hon. Member for Airdrie and Shotts (Pamela Nash).
I want to deal with some of the key points made in those speeches. In particular, several hon. Members mentioned the difficulty caused by the lack of retention of medical records. I have personal experience of that. My father died when I was 19—a year after I had met him—and I was not able to get to the hospital or, later, to find out exactly how he died and what he died of. These days, our system is much better at recording information. This problem is one of the reasons why I believe we should support electronic patient records. Once records are recorded electronically, they are much easier to keep and track, so we would not have many of the difficulties that we face today. The Department is not aware of any documents requesting the destruction of papers or records. I am happy to make the commitment to review and action any papers that come to light.
I should point out for the benefit of the House that Dr Briggs, who is deceased, did not confess to falsifying any studies on hormone pregnancy tests.
It has been said that thousands of children were affected. The evidence on that is not clear and it is difficult to find accurate information. There have been various estimates at different times and the best estimate seems to come from the victims’ association. In 2009, it said that by October 1978 it had gathered information on more than 700 children who might have been affected, and that it had received additional responses and inquiries from other parents every time the topic received publicity. Despite the references to thousands of children, it is unclear how many we are dealing with.
I want to highlight an important quote from Dr Sarah- Jane Richards, who is a senior solicitor in medical negligence at Secure Law in Cardiff, that demonstrates that there is still a lack of clarity and no definitive proof of causality. She said that primodos patients need more definitive data, namely medical notes from several hundred subjects, to strengthen their case. She said:
“The facts are compelling… There are snippets of information which are extremely insightful—but at present, there is an abundance of circumstantial evidence and a great insufficiency of scientific evidence. That is a real hurdle when we see a health issue such as handicap, which happens to an unfortunate two per cent of the population anyway.”
Hon. Members would expect the Government to be guided by the best scientific advice, so I wanted to share that with the House.
I want to address a number of points that have been raised in this debate, in earlier debates and in the work of the all-party group, including the eight-year gap between the first reports of a possible danger and the circulation of an official warning; the continued prescribing of the pregnancy tests by doctors in the 1970s; the need for full disclosure of the documents held by the Department; and the need for an independent panel to examine those documents. I confirm that I will be happy to instruct the release of all information that is held by the Department on this case, and the setting up of an independent panel of inquiry. I will say more about that at the end of my remarks.
First, I want to set the scene, because it is complex and difficult. I know that Members will be interested. As Members are aware, we have in the United Kingdom an agency whose sole responsibility is to ensure that all medicines in the UK work and are acceptably safe. That role is underpinned by robust legislation and guidance. In fact, we lead the world in medical regulation. However, we were not always this fortunate. In the late 1950s, when this story has its roots and hormone pregnancy tests were introduced, there was no legislation on the use of medicines in the UK, believe it or not. Unfortunately, it took the thalidomide tragedy in the early ’60s to highlight that serious deficiency, which now seems extraordinary to everyone in the House. Although sweeping changes to the legislation were made as a result, culminating in the Medicines Act 1971, by that time, hormone pregnancy tests were widely used.
The Committee on Safety of Medicines, to which my hon. Friend the Member for Enfield North referred, was first established as the Committee on Safety of Drugs in 1963 and took on its later incarnation in 1971. I will refer to it henceforth as the committee. Not long after the committee was established, a study was published by Dr Gal that suggested that there was a link between the use of oral hormone pregnancy tests and birth defects. The study was reviewed by the committee, but considered to be methodologically flawed. At that time, the committee was not aware of other evidence to support such an effect. Nevertheless, the committee undertook its own study to investigate the matter further. Over the next few years, a number of studies were published, but the evidence for an association remained limited and the findings inconsistent. The committee carefully evaluated all new evidence as it emerged and, in 1978, concluded that
“to date there is no proof of the existence of a causal relationship between the use of hormonal pregnancy tests and congenital abnormalities”.
As a result of the campaigning of my hon. Friend the Member for Enfield North and other hon. Members, earlier this year the Under-Secretary of State for Health, my hon. Friend the Member for Central Suffolk and North Ipswich (Dr Poulter) commissioned the Medicines and Healthcare Products Regulatory Agency—the lead regulator—to review all the key evidence on this issue and produce a report on its findings, which I believe hon. Members have been sent. The report has also been posted on the MHRA’s website.
Based on studies published between 1960 and 2013, the MHRA’s view is that the results are inconsistent, with some finding no association, some a weak association, and some a strong association. Its conclusion is that the data do not provide conclusive evidence of an association between hormone pregnancy tests and birth defects. As hon. Members will appreciate, the Government have a duty to ensure that they are acting at all times on the best advice available from specialist agencies set up to advise them, which in this case is the MHRA. I believe that in commissioning the report, the Government have listened to and acted on the concerns that have been raised about this drug.
What I believe makes the conclusion difficult to accept is that several studies did show an association that was statistically significant and, of course, many people have visible defects and feel that their lives have been damaged by these drugs. However, there are good reasons why both those observations do not yet constitute the proof that a causal association exists—proof that hon. Members and citizens would expect the Government to acquire before taking action.
As hon. Members will know, it is always exceptionally difficult to know for sure that a medicine taken by a mother during pregnancy is responsible for a defect in the child. It is almost impossible to know whether the condition would have developed regardless of whether the medicine had been taken, and that is especially true for birth defects, which are relatively common and occur in up to four in every 100 live births.
With the studies there is an added complexity in that a statistically significant association is not necessarily the same as a causal association, because limitations in the design of the studies may mean that the results are not reliable. Examples of that include poor recording of what was prescribed by doctors—that, I am afraid, has been all too common; another reason for the digitalisation of health records—as well as biased recall of what was taken by sufferers, the preferential prescribing of pregnancy tests for women who were at higher risk of a difficult pregnancy in the first place, and a number of other complicating factors.
One of the key concerns of the hon. Member for Bolton South East related to the eight-year gap between the publication of the first study finding a link and the committee alerting doctors to a potential risk. Although I appreciate that that may seem an unacceptable delay, it is worth remembering that such a charge assumes that the committee believed there was a causal association. However, the report that I referred to previously suggests that that is not the case, and that the committee at no time considered those pregnancy tests to be responsible for the observed birth defects.
Despite that, in 1969, just two years after Dr Gal’s study was published, the committee took the precaution of asking companies to stop promoting the tests to doctors. As more evidence was published and alternative methods of diagnosing pregnancy became available, the committee considered there to be no reason to use the hormonal methods anymore, and advised doctors of that in 1975. As Members may know, despite the committee’s warnings it became apparent that doctors were still using those outmoded tests, so it issued a further alert in 1977.
At this point I remind the House that guidance provided by the General Medical Council gives doctors in the United Kingdom the freedom to prescribe any medicine if they judge it to be in the best interests of their patient, and they take responsibility for their prescribing decisions. In that respect, I believe the evidence suggests that the committee acted in a proportionate and responsible way given the evidence before it—that is the only test that we can apply at this point.
Pamela Nash
The Minister said that the committee had to issue a further warning in 1977. I appreciate what he says about responsibility being with the GP, but why would a GP prescribe those pregnancy tests if they knew and were clear that they were dangerous? Is it the responsibility of the committee that it did not communicate that danger aptly enough?
George Freeman
Unfortunately, as I have been trying to explain, in our system the sovereignty for prescribing lies with clinicians. Guidance can be issued and we would expect GPs to comply with it. Today that is more often the case, but we are dealing with a period when things were different. I cannot at this point tell the hon. Lady why a number of GPs did not comply with the guidance provided, but it was given very clearly.
Hon. Members have asked that the Department fully disclose all documents on hormone pregnancy tests held between 1953 and 1978. While I support that request, I remind the House that we are talking about an era that mostly predated medicines legislation and companies were not required even to submit evidence to support the efficacy, quality and safety of their products—extraordinary though that may seem to us today. As a result of that, and the fact that the pregnancy tests were withdrawn from use more than 35 years ago, the Department holds very limited information and what it does hold is already in the public domain. That said, I am happy to confirm to the House this afternoon that I will instruct that all relevant documents held by the Department be released.
The MHRA will of course review any new data that emerge as a matter of priority and seek independent expert advice as needed. I am happy to go further and confirm to the House that I will instruct an independent review of the papers and all the evidence. I suggest that that be carried out by the Medicines for Women’s Health Expert Advisory Group, which exists to advise the Department on such matters. It comprises independent members who are experts in their field, and I am happy to take submissions from colleagues to ensure that the association is properly represented and has a chance to give evidence.
Mr Robinson
I apologise for not being in my place for the Minister’s opening remarks. The news that the Minister has just announced is very encouraging and will help to bring closure and reassurance. I am sure that no Member, including my hon. Friend the Member for Bolton South East (Yasmin Qureshi), will want to press the motion to a Division now. I thank the Minister for his reply and the positive note that he has struck.
George Freeman
I am grateful for the hon. Gentleman’s comments and I hope that the House has taken what I have said this afternoon in the spirit in which it is intended. I am open to representations from the victims’ association and to ensure that the inquiry panel addresses all its concerns.
I assure hon. Members that Ministers in the Department will continue to monitor the evidence closely and to work with hon. Members and the victims’ association, so that if there is any reason to believe in a causal link, appropriate steps can be taken quickly. I pay tribute to the hon. Member for Bolton South East for initiating this debate, and I thank the Backbench Business Committee for providing the time. I am grateful for the tenacious advocacy of Members and many people outside, including many who cannot be with us today. We stand on the shoulders of others. Whatever the cause of the appalling disabilities that some people have suffered, their suffering still exists, and I look forward to co-operating in any way I can to try to shed light on the issue and bring the all-important closure in an era of transparency, so that lessons can be learned and this never happens again.
Yasmin Qureshi
I thank all the hon. Members who have spoken in the debate today. I particularly thank all the members of the all-party parliamentary group on primodos, all those who signed my early-day motion and everybody who participated in the petition that was presented to No. 10 Downing street. I also thank the association.
I should also mention a couple of other people. My hon. Friend the Member for Hayes and Harlington (John McDonnell) mentioned Valerie Williams, who campaigned on this issue many years ago. When my constituent Nichola Williams first contacted me I went to see her at her home. At first glance, she appeared to have nothing wrong with her. It was only on talking to her that I found out about all the internal damage that she has.
The campaigners have found a raft of documents that I went through with my researcher and my office. We thought that something was very wrong and that there had been a miscarriage of justice, and that is why we started the campaign. I am glad that after two years we have finally received an undertaking from the Government that they will appoint an independent panel to look not only at the documents held by the Department, but all the documents that we have. We have a lot of information that we think shows a medical and legal cover-up.
On the causal link, the Minister said that the victims’ association will be consulted. Every lady who took primodos said that it was the pregnancy during which they had taken that drug that resulted in abnormalities in children. Other children those same ladies went on to have were perfectly healthy—in those pregnancies, no primodos had been taken. This is important research and it needs to be looked at.
The Minister said that the numbers of victims may not be in the thousands. It is fair to say that as the campaign has gone on over the past two years, with limited coverage and publicity in my local newspaper and in the national media, I have received letters and e-mails from more and more people coming forward and saying, “This is what happened to us.” I think there are a lot more people out there. Perhaps this is something the independent panel can look at, because we think there are many more people who are unaware of what is happening.
I thank the Minister for what he has said at the Dispatch Box, which is that he will release and look at the documents, set up an independent panel, work with the victims’ association and also look at our documents.
George Freeman
What we might do is set up an expert working group and invite one or two patients’ representatives from the victims’ association to sit on it. If hon. Members are happy, I will write around with a suggestion for how we might do that. I want to just remind the House that those from the Medicines for Women's Health Expert Advisory Group are independent experts in their field. They currently advise the Commission on Human Medicines on issues relating to medicines for women’s health. All members must fully disclose any conflicts of interest and are disbarred from any discussions of issues where they hold a personal interest. I think the House can therefore be confident that these are independent experts. If we set up an expert working group and have patients on it, that should give the House confidence that victims’ and patients’ voices will be properly heard.
Yasmin Qureshi
I thank the Minister for that reassurance. I am sure that those from the victims’ association who are watching the debate will be reassured too.
I thank the Minister again for what the Department has offered to do. We hope it will be done speedily and that there will be a resolution. As we know, many of the victims are now approaching their 40s and 50s. Their medical conditions are worsening and some have died. It is important that they understand what has been happening. They have never, ever asked for this—they have never even suggested it—but perhaps after the investigation we could think about some kind of financial settlement or compensation. As I have said, this is something that I am saying. I think that that would be only fair after all their suffering.
Finally, I have spoken in the Chamber from time to time, but today is the first time that, when I came into the Chamber, I got a little butterfly in my stomach. It reminded me of when I was a barrister before I became a Member of Parliament. I would have that feeling when going into court for a special case of particular significance. When I came in I almost felt that I was going to present a legal case to ask for—
Oral Answers to Questions
George Freeman Excerpts(10 years, 1 month ago)
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Mr Dave Watts (St Helens North) (Lab)
6. What assessment he has made of the potential effect of the Transatlantic Trade and Investment Partnership on NHS services.
The Parliamentary Under-Secretary of State for Health (George Freeman)
The Government’s aim and my central mission as the new Minister for life sciences is to accelerate access for NHS patients to the very latest diagnostic devices and drugs by making the UK the best place in the world in which to develop innovative treatments. The US is a world leader in medical technology and TTIP will help NHS patients get faster access to those innovations. Let me be clear: the treaty excludes the NHS from binding commitments. Parliament will retain sovereignty over how we organise and fund our health system and NHS England is free to decide how best to commission NHS services in the clinical interests of local patients, as it does today.
Caroline Lucas
I thank the Minister for his answer and I welcome him to his new post. If his assurances were remotely credible then surely the British Medical Association would not have called for health to be excluded from TTIP entirely. Will the Minister confirm that under the investor-state dispute mechanism, US corporations will be able to challenge our national health policy decisions for ad hoc arbitration tribunals and potentially sue us for millions of dollars in damages for loss of profit in the event of any moves to reverse the coalition’s privatisation agenda and bring the NHS back fully into public hands?
George Freeman
No, I will not confirm that, but the hon. Lady does not have to take it from me. She can take it from the people who are doing the negotiations. The US chief negotiator confirms that the United States has no provision in its trade agreements on health. The EU chief negotiator says:
“I wish… to stress that our approach to services negotiations excludes any commitment on public services, and the governments remain at any time free to decide that certain services should be provided by the public sector.”
Mr Watts
Before the election, there was a promise that there would be no top-down reorganisation of the NHS. Given the concern of the Opposition and the BMA, will the Minister meet the BMA to work out how we can get a cast iron assurance that these TTIP talks will not be used to privatise the NHS?
George Freeman
I will happily meet the BMA, but such a request is a bit rich coming from a Labour party that legislated to introduce competition in the health service and to pay private sector providers 11% more, which is now illegal under the Health and Social Care Act 2012. Let me be clear about this, and I can be no clearer than the Labour member of the all-party group for TTIP, who said that
“my direct discussions with the EU’s chief negotiator have helped produce an EU promise to fully protect our health service…TTIP could have no impact on the UK’s sovereign right to make changes to the NHS.”
Stephen Hammond (Wimbledon) (Con)
I am grateful to the Minister for confirming that these negotiations will have no effect on NHS services and how they are provided. With his life sciences hat on, will the Minister also confirm that this treaty gives us a real advantage as UK companies will be able to compete in the American market?
George Freeman
My hon. Friend makes an excellent point. As well as providing a £10 billion boost to the economy, which I am surprised to see that the left is not in favour of, and securing 13 million jobs in the EU, this treaty also helps our NHS pioneers and innovators and our UK life science companies generate revenue for this country from our innovations in health care in the world’s biggest health care market.
Chris Heaton-Harris (Daventry) (Con)
Is it not the case that free trade agreements have always grown the economies that have contracted within those agreements, and a growing economy can only benefit the NHS in the future?
George Freeman
My hon. Friend makes an important point. The truth is that we cannot have a strong economy without a strong NHS, and we cannot have a strong NHS without a strong economy. In a modern society, health and wealth go hand in hand, which is why this treaty, with the safeguards that we have secured, is good for Britain and good for NHS patients.
Keith Vaz (Leicester East) (Lab)
Some 3 million people with diabetes have not received their full health checks, and 630,000 people have diabetes but do not know about it. Will the Minister give us an assurance that nothing in this deal will affect the ability of people to have free diabetes tests?
George Freeman
The last time I checked the TTIP negotiations do not make any specific provision for access to those services within the NHS. All I can do is remind the right hon. Gentleman that over the course of this Parliament, we have invested another £12 billion, hired more doctors and nurses and increased the provision of diagnostics in the NHS. This treaty does not affect that.
Sir Tony Baldry (Banbury) (Con)
Will my hon. Friend confirm that there is absolutely no requirement in TTIP for this or any future Government to open NHS health care services to further competition and private sector provision, and that TTIP will have no effect on the ability of local NHS commissioners to decide who delivers services to patients?
George Freeman
I can absolutely provide that guarantee. UK sovereignty on health is not in any way threatened by TTIP. As I have already told the House, safeguards on this are being built in by both the American and the European negotiators. As my right hon. Friend points out, clinical commissioning decisions in the NHS will rightly remain with the clinical commissioning groups, which include the people who are closest to the patients.
Ms Margaret Ritchie (South Down) (SDLP)
For the avoidance of any doubt, given that health is devolved to Northern Ireland, what assurances can the Minister give us that not just the UK Government, but the devolved Administrations, will be safeguarded from the investor-state dispute settlement mechanism?
George Freeman
The treaty’s provisions apply to the whole United Kingdom, so it will be for the delegated authority of the people of Ulster and their Administration to give effect to the treaty locally.
Tim Loughton (East Worthing and Shoreham) (Con)
2. What safeguards are in place for the sustainability of NHS facilities when clinical commissioning groups contract out local services.
Jason McCartney (Colne Valley) (Con)
11. When the third stage of the review into the closure of surgery at Leeds children’s heart unit will be published.
The Parliamentary Under-Secretary of State for Health (George Freeman)
Safe, compassionate care is an absolute priority for the Government. Publication of the Verita reports regarding the Leeds paediatric cardiac unit is a matter for NHS England. The reports are due to be published on 28 October, and copies will be placed on the NHS England website.
Jason McCartney
Constituents and clinicians continue to tell me that the children’s heart surgery unit goes from strength to strength, provides high-quality care, and has the full confidence of NHS England. Does the Minister sympathise with patients, families and clinicians who have faced uncertainty because of the delay of the third stage of the review?
George Freeman
Yes, I absolutely sympathise: I understand how important this is to local patients and their parents. As my hon. Friend knows, NHS England’s review of children’s heart surgery goes back a very long way—to the Bristol royal infirmary issues in the 1980s—and I know that Leeds and Newcastle Members are actively engaged on it. I can say that there is no immediate threat to any congenital heart surgery unit. NHS England has held a drop-in session with all MPs, and I encourage Members to make representations to the consultation on the national review.
Greg Mulholland (Leeds North West) (LD)
The reality is that NHS England has made a mess of this. I hope that it will finally apologise when the third stage of the review is published. On the process that we have now, will my hon. Friend confirm that it is an open and fair process that will allow all units, including Leeds, to reach the important standards that we want for all our units?
George Freeman
My hon. Friend makes an important point. This is a matter for NHS England to deal with. I have made inquiries to ensure that the process is being followed as it should be. As I say, there is no immediate threat. The issues around the provision of congenital heart disease services are not limited to Leeds. NHS England is conducting a nationwide review of congenital heart services, which will look at the whole of life care pathways available across the country. The truth is that congenital heart diseases are often very serious illnesses affecting life expectancy and quality of life for patients, who will expect NHS England to put in place the very highest quality care and service available.
Mr Graham Allen (Nottingham North) (Lab)
12. What contribution his Department is making in support of the health objectives of the rebalancing project on dental checks for three-year-olds, foetal alcohol syndrome and lung screening for people over 60.
Stephen Mosley (City of Chester) (Con)
T7. Healthwatch England recently released a report, “Suffering in silence”, that found that almost two thirds of people felt that their complaint about the NHS was not taken seriously and half ended up not receiving an apology or even hearing the word “sorry”. What action is my hon. Friend taking to ensure that complaints are taken seriously in the NHS?
The Parliamentary Under-Secretary of State for Health (George Freeman)
My hon. Friend makes an excellent point. Following the appalling systemic abuse and neglect described in the Francis report, our response, set out in “Hard Truths”, focused relentlessly on hearing the patient voice, learning tough lessons on patient safety and care, and, in particular, the creation of the new independent chief inspector of hospitals, who is looking closely at all complaints. The health ombudsman has increased its caseload and we are also taking measures to display information on how to complain in every hospital and ward across the country.
Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
Will the Secretary of State join me in paying tribute to Eilish Hoole, who sadly passed away in July from ovarian cancer. She was only 47 and the mother of five children. Following her diagnosis of late-stage ovarian cancer she campaigned tirelessly in Parliament with Target Ovarian Cancer, which led to the recent successful pilot of the awareness campaign in the north-west. Will the Secretary of State commit to roll that out to the rest of the country so that other women in her position get to see their children grow up?
Sepsis (Preventable Deaths)
George Freeman Excerpts(10 years, 1 month ago)
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The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)
It is a great pleasure to serve under your chairmanship, Sir Edward. I congratulate my hon. Friend the Member for Truro and Falmouth (Sarah Newton) on securing this debate, and I thank her for bringing this issue to the House. I also thank the hon. Member for Coventry South (Mr Cunningham) for his helpful and supportive interventions. This is a chance to discuss an important issue. I know that the lack of colleagues here today is not a sign of disinterest; it is merely because the House is on a one-line Whip. I pay tribute to my hon. Friend for her campaigning work on the issue and her co-chairmanship of the all-party parliamentary group on sepsis, which is doing important work to raise the profile of this urgent condition.
Let me say at the outset that the information and case studies in the reports by the all-party parliamentary group and the parliamentary ombudsman make for sobering reading. I extend my regret and sympathy to the families affected by these preventable deaths, particularly the family of Sam Morrish. Every preventable death is a tragedy from which we must learn. I pay tribute to the important campaigning work of his family and others to improve sepsis care and treatment across the NHS.
We entirely accept that more can and should be done to address sepsis, paying particular attention to the points raised in the reports by the ombudsman and the all-party group. I am grateful to my hon. Friend for sharing the key points of her speech in advance. I will do my best to deal with all of them in the time available, but I hope that she will indulge me. If the clock beats me, I will write to her and deal with them all clearly in writing.
Colleagues should be in no doubt that the Department takes its responsibilities on sepsis very seriously indeed. In fact, sepsis is one of the few issues on which three departmental ministerial colleagues each have a specific responsibility for overseeing action. I take my hon. Friend’s point about the need for co-ordination, and I will pass it on. The Under-Secretary of State for Health, my hon. Friend the Member for Central Suffolk and North Ipswich (Dr Poulter), covers sepsis management in hospitals, and the Under-Secretary of State for Health, my hon. Friend the Member for Battersea (Jane Ellison), has responsibility for sepsis management in the community. In the House of Lords, Lord Howe covers sepsis management in hospitals.
Although I am standing in for my hon. Friend the Member for Central Suffolk and North Ipswich, who is indisposed this morning, coincidentally, only last week, when we went to the US to visit pioneering clinical innovators in the life sciences, one issue that we discussed was the early detection of sepsis through greater use of digital technology in community health care. Early diagnosis in that first hour is crucial. It is one of many areas in which investing in new technology, particularly data technology, provides a much higher chance of early intervention and thus of preventing complex and costly downstream complications. Point-of-care diagnostics are a crucial part of that, and I am mindful of that in my work on innovation.
Hon. Members will appreciate that although the Department is accountable to Parliament for health care, the delivery of that care is the responsibility of NHS England, the executive non-departmental public body responsible for overseeing the running of the NHS; Ministers no longer run the NHS. NHS England works with NHS staff, patients, stakeholders and the public to improve health outcomes for people in England. We hold NHS England to account through the mandate, which sets out its priorities. I am glad to say that sepsis is incorporated in the patient safety and premature mortality provisions of the mandate.
We all agree that we will have the greatest impact by focusing our efforts on improving the clinical management of sepsis by health care providers and ensuring a consistently high standard in sepsis care across the whole system. We are doing so through a range of initiatives, including better education and training in recognising the warning signs of sepsis; ensuring that trends in sepsis are monitored —that is where data become important—raising the profile of sepsis in the community; and ensuring collaborative working across the whole system.
In the period between the publication of the ombudsman’s report in September last year and of the all-party parliamentary group’s report in June this year, we made significant progress. For example, we have mandated that Health Education England must include sepsis in its work to improve the training and education of health care professionals. We have also ensured that sepsis is included as a key patient safety priority in the NHS business plan for 2015-16.
The NHS outcomes framework sets out the indicators that are used to hold the NHS to account for the outcomes that it delivers through commissioning health services. Sepsis is captured in the overarching indicator measuring potential years of life lost from causes considered “amenable to health care”—a clumsy phrase, but it is a statement of the importance attached to the condition. Reducing the number of deaths from sepsis is specifically included in that indicator.
NHS England is considering the range of commissioning levers that it will put in place for 2015-16. The commissioning for quality and innovation payments framework is one option. I cannot comment further at this point as internal discussions are ongoing, but we are conscious of the interest in a specific lever on sepsis.
NHS England has also initiated work to develop a consistent methodology for a robust, retrospective case-note review of deaths in hospital. That is part of further work to develop the NHS outcomes framework, which will offer a way of establishing much more accurately how many deaths are attributed to sepsis, identifying any shortcomings in sepsis care management and feeding any improvements into local practice. That work is expected to be completed by 2016 and rolled out thereafter.
Regarding paediatric care, a children’s sepsis summit is planned for tomorrow—15 October—as I am sure my hon. Friend is aware. It will bring together a range of national experts and key personnel from the south-west, particularly those involved in the review of the tragic case of Sam Morrish, to share learning and to set the direction for further work on the timely recognition and treatment of children with sepsis.
Furthermore, NHS England has developed a webinar series to promote greater awareness among clinicians of the actions to be taken to treat patients who are critically ill. Sepsis clearly features in this “deteriorating patient as a medical emergency” campaign; the first webinar in the series covered sepsis and was held on 17 September.
Regarding the timely recognition of sepsis, we fully endorse the work carried out by NHS England’s surgical services patient safety expert group, its children and young people patient safety expert group and the safety board of the Royal College of Physicians to roll out the “sepsis six” guidelines, to which my hon. Friend referred and which were produced in collaboration with Dr Ron Daniels. That has led to the development of a series of clinical toolkits for health professionals, which were launched by the UK Sepsis Trust.
To support the implementation of existing resources and guidance on sepsis, such as the sepsis six and the paediatric sepsis six, NHS England issued a stage 2 patient safety alert. I am advised that that alert has been cascaded to all trusts, social care providers, community providers and, via area teams, to GPs and public health directors in all local authorities.
Wider work to further the sepsis agenda includes initiatives to combat antimicrobial resistance more generally. While some might argue that there is a tension between limiting the inappropriate use of antibiotics to reduce the incidence of antimicrobial resistance and the provision of early antibiotics in cases of suspected sepsis, we would argue that those activities are complementary and do not cut across each other. The key issue is the appropriate use of antibiotics, which is common to both agendas, as each requires the appropriate use of antibiotics for the right patients at the right time.
It is also important to note that we have strengthened and updated a key resource on the appropriate use of antibiotics. This guidance, called “Start smart—then focus”, was originally published in 2011. We are currently consulting on an update, which is due to be published shortly. The resource has been updated to refer explicitly to sepsis and to draw particular attention to the need to act promptly
“between the onset of sepsis-related hypotension and the administration of appropriate antibiotics”.
Equally importantly, it focuses on the need to initiate effective antibiotic treatment
“within one hour of diagnosis in patients with life-threatening infections”.
It also sets out clear guidelines on the need to review the clinical diagnosis within 48 to 72 hours and to make a clear plan of action when additional information becomes available, such as new microbiological, radiographic or clinical data.
Let me turn to another point raised by my hon. Friend in the all-party group’s report, which is the need to establish robust pathways to deal with sepsis. That is an absolutely key objective, which NHS England has been developing in conjunction with the UK Sepsis Trust. The action includes the development and publication of toolkits for acute medical units and emergency departments. The toolkits, which were published in September, identified organisational standards for the acute management of sepsis in both locations.
I understand that the UK Sepsis Trust is working with NHS England to establish sepsis exemplar sites and to recognise publicly those providers that excel at the processes and behaviours that improve the early detection, diagnosis and delivery of interventions to patients. The sepsis exemplar standard initiative is to be welcomed, as it encourages joined-up thinking between health care units, which will help to strengthen further the provision of seamless care for critically ill patients.
The programme is expected to include three phases. The first phase is the accreditation of excellent emergency departments, which will identify departments with traditionally strong links with primary care, pre-hospital systems, acute admission units and critical care, and which have demonstrated willingness and drive to improve sepsis care and an engagement with sepsis-related audits, changing improvement strategies and improving data collection.
The second phase is the accreditation of further health care units. Following the pilot testing for emergency department standards, and building on lessons learned in creating those standards it will involve the development of accreditation plans for other health care units, such as ambulance trusts, in-hospital critical care outreach or sepsis teams and acute medical units prior to expansion in other areas. The final phase is the assigning of exemplar unit status as part of our commitment to demonstrate best practice.
I turn to the National Institute for Health and Care Excellence, which my hon. Friend mentioned and for which I have ministerial responsibility. Of course, we recognise that we need to support NHS colleagues in addressing sepsis with the provision of comprehensive and up-to-date guidelines, so in April we asked NICE to develop such guidelines to aid the recognition, diagnosis and management of severe sepsis. These guidelines are under development and will be comprehensive and thorough. They are scheduled to be published no later than July 2016, but I very much hope they will be published earlier than that.
Sarah Newton
At the Public Administration Committee hearing, frustrations were demonstrated by Committee members, which I certainly share, about the fact that a “90% good” NICE guideline would begin to save lives and that the time that NICE is taking to get this guideline 100% right is allowing preventable deaths to continue. I urge my hon. Friend the Minister to go back to NICE and say that, while it is important that whatever it does is excellent and should be based on the best available evidence, in the meantime the delays in developing guidance are costing lives.
George Freeman
My hon. Friend makes an excellent point, which I will pick up. NICE rightly prides itself on making thorough health assessments, but it is equally important that we get the right guidance out quickly. I will raise her point with NICE.
I will touch on data collection, because we will also fund work by Public Health England to improve the data collection mechanisms in emergency departments. Awareness raising is also important, and there are two key initiatives in that regard. First, the “Sign Up to Safety” campaign was launched by my right hon. Friend the Secretary of State in June. It has a three-year objective to halve avoidable harm in the health care system and to save 6,000 lives. It is for everyone in the NHS, and will include information on sepsis.
The second initiative to publicise sepsis will be part of Public Health England’s work on this year’s European antibiotic awareness day on 18 November. Social media messages will highlight the importance of the appropriate use of antibiotics, to ensure that they are effective for the treatment of infections such as sepsis, and there will be a number of other measures as part of that campaign.
We have also commissioned work to revise the code of practice in the Health and Social Care Act 2008 on infection prevention and control to strengthen provisions on the diagnosis, treatment and management of multi-drug resistant infections and severe sepsis. That code will be used by regulators such as the Care Quality Commission and Monitor as part of their inspection regime.
Finally, I will touch on the world sepsis declaration, which sets a number of targets. We are not in a position to sign up to the declaration, but we support the intention behind it and we are considering supporting it in future.
In conclusion, I thank my hon. Friend for bringing this matter to the attention of the House this morning and for giving us a chance to raise awareness of this important issue. I hope that the measures that I have scuttled through at speed give some indication of the concerted effort given to treating this important condition, not only by the Government but by NHS England, Public Health England, NICE and other agencies, to try to get on top of it. Above all, we owe the families of those patients who have lost their lives as a result of sepsis nothing less than a robust and comprehensive response to the threat that sepsis poses. For their sake, and for all patients who entrust their care to our health care services, we are determined to ensure that lapses in the recognition and treatment of sepsis are minimised, and the provision of safe patient care remains paramount.
Community Hospitals
George Freeman Excerpts(10 years, 2 months ago)
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I congratulate my hon. Friend the Member for Dover (Charlie Elphicke) on securing this debate and on his tireless work on this matter and the wider subject of social engagement and community ownership of public resources. I pay tribute to his work in his constituency, particularly on securing the future of the Victoria hospital in Deal.
Several hon. Members who are not here at this well attended debate, such as my hon. Friend the Member for Thirsk and Malton (Miss McIntosh) and my right hon. Friend the Member for Berwick-upon-Tweed (Sir Alan Beith), continue to support their local community hospitals through their constituency and parliamentary work. I extend my thanks to all hon. Members. It is wonderful to see so many of them here today representing their own community hospitals and the wider cause.
We have heard a range of excellent contributions from a distinguished and committed group of hon. Members, including two doctors—the Chairman of the Select Committee on Health, my hon. Friend the Member for Totnes (Dr Wollaston), and my right hon. Friend the Member for North Somerset (Dr Fox)—and my right hon. Friend the Member for North West Hampshire (Sir George Young), my hon. Friends the Members for Stroud (Neil Carmichael), for Congleton (Fiona Bruce) and for Maldon (Mr Whittingdale), and the hon. Members for Upper Bann (David Simpson) and for Strangford (Jim Shannon).
We have heard some important reasons why community hospitals and local health care facilities matter so much, and I will highlight and reinforce them. We have heard strong views about the invaluable role of community hospitals, clinics and local health centres in our communities; about the benefits of community engagement and patient voices in health care that flow from them; about the potential for community hospitals to be hubs of social care, intermediate care and recovery beds; and about the role of community hospitals in easing pressure on expensive clinical and bed space in our acute hospitals. Some colleagues have made the point that big is not always best in health care. We have also heard about the importance of integrating social care and health care, which is a Government priority, as is the role of local centres in facilitating that; the impact of reconfiguration on recruitment; the important role of community hospitals in providing respite care beds; and the strength of patient support and community voice in support of hospitals.
We have heard some important examples of imaginative new thinking in Dover, Maldon, Andover, Congleton and elsewhere, and of the risk of fundraising being channelled to the big, the professional and the remote by excessive bureaucracy and complexity. We also heard an important point about transparency and evidence-based, jargon-free language in consultations, the absence of which militates against the small, voluntary and local community.
I want to start by signalling that all Ministers in the Department of Health acknowledge absolutely the great benefits that community health care, hospitals and health centres provide to our communities. I will speak about the role we foresee them playing and highlight how our NHS reforms are changing the NHS in a way that should help to support more local and community facilities, putting in place specific protection for community hospitals. I will try to address some of the specific points that have been raised, and if time prevents me from doing so, I will write to colleagues to deal with points that they have raised.
We should remind ourselves about what community hospitals are and why they matter so much. They are local hospitals, units or centres providing an appropriate range and format of accessible health care facilities and resources. There are around 300 in England and they are overwhelmingly owned by NHS trusts, foundation trusts and NHS Property Services Ltd. Where they are wholly owned by the NHS and are needed for service delivery, they will remain in NHS ownership and will not be sold for profit. The sustainability of a community hospital is down to the decision making of local NHS commissioners, regardless of who owns the hospital.
Community hospitals can be invaluable assets that make it easier for people to get care and treatment in their community, as we have heard, closer to where they live. They allow large hospitals to discharge patients safely into more appropriate care, freeing up hospital beds for people who need them urgently, and they allow many patients to avoid travelling to large hospitals altogether, providing a wide range of vital services, from minor injury clinics and diagnostic services to intensive rehabilitation.
Therefore, people are often very protective of their local hospital, and with good reason. In many cases, they deliver a range of essential services, as well as providing employment for local people and often space for community groups and associated members of what one might call “the health big society”. It is understandable that community hospitals are fiercely defended and inspire such loyalty, and that support for local facilities is a sign of the growing appetite for the quiet revolution of patient empowerment and health citizenship at the heart of our vision of a 21st-century health service. That is why everything we are doing in central Government is designed to support local clinicians and patients to change and shape their local NHS for the better, making improvements to primary and community services to suit local needs.
As a result of the Health and Social Care Act 2012, PCTs have been abolished and responsibility for commissioning services has, as we know, moved to clinical commissioning groups and local clinicians are now in control. CCGs are free to commission services that they judge provide the best care and outcomes for their patients and free to work out which services are needed and where they should be located to best meet local needs. With strong local patient and clinician input, the CCGs will also be able to decide which providers are in the best position to offer those services. They—and, I am delighted to say, not the Ministers at the Department of Health or officials at NHS England—will determine whether a community hospital remains open and what services it should provide.
With the abolition of PCTs in April 2013, ownership of a significant number of community hospitals changed. Some were transferred to local NHS trusts and NHS foundation trusts. Other hospitals went to NHS Property Services, the Department of Health-owned property management company. I know some hon. Members—some not here today—have concerns about some of those transfers, which I want to touch on. I want to make it clear that the conditions applying to those transfers mean the hospitals will not be closed unless commissioners determine that they are no longer fit for purpose. As with all decisions about local patient services, it is absolutely right that those decisions are taken locally, taking account of local views.
Sometimes tough decisions need to be taken. Buildings become tired and inefficient. New and better treatment, diagnostics and technological innovations are transforming the way in which health care is delivered, and, of course, communities grow and evolve. It is understandable that sometimes old infrastructure, though much loved by the community, cannot always keep up with the community’s needs. It is right then that commissioners explore how services can continue to be delivered efficiently and accessibly to patients.
That could mean decommissioning a hospital, in part or wholly, and moving some services even closer to the community. It could mean extra investment to modernise and develop existing community hospital centres, such as the development of the new Buckland hospital in the constituency of my hon. Friend the Member for Dover. These are tough decisions about meeting the changing health needs of the local community in the decades to come and it is absolutely right that they should be taken locally, driven by what is best for local people.
I am well aware that some hon. Members have been asked by their constituents about promoting community ownership of hospital assets in order to save at-risk or surplus hospital and clinical space, and I emphasise that all NHS property decisions are driven by clinical decision making by the CCG, and not the other way round.
First, under statutory provisions, while a building is needed to deliver NHS services, no NHS organisation will be allowed to sell it off, so there is no question of useful NHS property being transferred outside the NHS. The commissioners decide that, not the providers. At the same time, that means that a community-owned company is unable to own the freehold of operational NHS property.
Secondly, current Government policy is that property that is surplus to the NHS and the wider public sector should normally be sold by auction or competitive tender. In such cases, a community-owned company would have the opportunity to bid for the property along with other interested parties, but there is no guarantee that the community-owned company’s bid would be successful. However, if they were successful, we need to be clear that it would be in circumstances where NHS commissioners would have already decided that the site is no longer required for health service delivery. It would therefore no longer be operated as an NHS community hospital, but that is not to say an alternative community use could be found for the site. I think that is a key point. We will not necessarily be helping our constituents in advocating community ownership where commissioners have taken a decision to decommission services at particular site.
In conclusion, I want to highlight that the Government and Ministers are absolutely committed to greater diversity, choice and local community influence in our modern NHS. We have taken steps to secure the sites of community hospitals and make sure they are used for the benefit of their community where there is an ongoing use for them. However, the lifespan of those hospitals is solely down to the decisions made locally by clinicians and service providers—the people qualified to make those decisions. That is the best thing for the hospitals themselves, and it is certainly the best thing for the communities we serve.
If my hon. Friends or any other hon. Members have raised specific concerns that I have not addressed or highlighted in my earlier comments, please—
Mr Whittingdale
Just before the Minister sits down, I accept that decisions will be made locally, but I raise again the specific proposal that I suggested was under consideration, of obtaining a new hospital as a benefit of the development scheme. Although that is to be locally determined, it would help enormously if the Minister could at least smile on it and encourage that kind of thinking. If he would like to write to me once he knows a little more about it, I would be very grateful to him.
George Freeman
I am very grateful to my hon. Friend for flagging that point up. It was concealed within my list of exciting and imaginative bold thinking, but I did hear him and I would be very interested to pick that up. I invite him to write to me with the details.
The vision at the heart of our NHS reforms is of an NHS freed from the 20th-century model of health care in which health has been something done to the people we serve when government deems it appropriate, with the shape of health driven from the top down, to a model of 21st-century health care in which services are shaped by local priorities and greater freedoms to innovate and differentiate, combining the local, the personal and the voluntary with the general, the central, the specialist and the world-class. Exciting breakthroughs in diagnostics, remote sensing, e-health and telehealth, and in non-invasive new surgical and informatics technologies are driving new models of integrated health and social care. I believe that it is one in which local community-based hospitals, clinics and health centres will play a key role in the next century.
Aerospace Industry
George Freeman Excerpts(10 years, 2 months ago)
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The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)
It is an absolute pleasure to start my Front-Bench work in Westminster Hall under your chairmanship, Mr Hollobone. I congratulate my hon. Friend the Member for Mid Worcestershire (Sir Peter Luff) on securing this debate. I also want to take this opportunity to pay tribute to his work on this sector and on industrial strategy more generally, in what has been a very distinguished career in this House and in Government. From our work over the past few years, he knows that I share his passion for making sure that we use every pound of Government money to support a wider, more balanced long-term economic growth agenda for this country. This debate has played an important part in highlighting those issues.
My hon. Friend has raised a number of excellent points about the civil aerospace sector in the UK: the role of innovation in driving long-term growth; whether the current strategy is sufficient to rise to the international competitive challenge; how we can improve linkages between the defence sector and the space sector; whether both we and the supply chain sufficiently understand the views of the major US players; the case for improving export support; the need to support companies in the supply chain, both small and large; whether the approach to skills is adequate; and the importance of maintaining the momentum of the AGP.
We have also heard important contributions from my hon. Friends the Members for Aldershot (Sir Gerald Howarth), for Burnley (Gordon Birtwistle) and for Tewkesbury (Mr Robertson), from the hon. Members for East Antrim (Sammy Wilson), for Strangford (Jim Shannon) and for Alyn and Deeside (Mark Tami) and from the shadow Minister. There is a strong consensus in the room on the importance of the sector and its need for cross-party support. I will strive to respond to all the points raised as best I can in the time available. If I fail to do so, I will write to Members to deal with points in detail.
The Government know well that the aerospace industry is vital for the UK economy. It is one of our key industrial sectors and, like the life sciences sector, a key driver of long-term growth. I was struck by the recent figures from ADS showing that since 2011 the sector has grown by 14%. That is a real success story for the UK and something we should be rightly proud of. There is a huge opportunity for the UK to benefit from the forecast growth in aerospace, with forecast demand for 29,000 new passenger aircraft, valued at over $4 trillion, between now and 2032.
The sector has achieved so much, through a combination of good management, a skilled, innovative work force, supportive trade unions and long-term Government policy. The recent aerospace sector strategy provides long-term stability for the UK. It is particularly important for sectors such as aerospace and the life sciences that we lay out a programme for long-term support to secure investment.
The Aerospace Growth Partnership, set up in 2010, was designed to transform the way in which Government and industry work together. The AGP led on developing the industrial strategy published in 2013 and is now taking forward its implementation. It is not something that we can take for granted. In early meetings with the aerospace industry’s business leaders, it was striking that our national success is dependent on investment in research and technology. The UK’s No. l position in Europe was built on heavy investment in the ’70s and ’80s. However, over the years, public funding reduced significantly, resulting in some of our research capability going overseas, followed, inevitably, by some manufacturing jobs. That had to be addressed. It was through those honest, frank conversations that the seeds were planted for what became the aerospace industrial strategy.
It quickly became apparent that there was a need for Government to operate strategically over the long term. For critically important sectors such as aerospace, that is essential. For example, all hon. Members here will know that the Airbus A320 family was launched in 1984 and first flown in 1987, and is still selling strongly in 2014, with over 6,000 delivered so far and an order backlog of 1,200. Like the other sectors for which the Government have set out industrial strategies, the aerospace sector has long-term product development time scales that last well beyond a single Parliament and require a stable environment where industry and Government pull in the same direction. In that context, I warmly welcome the shadow Minister’s comments.
At the heart of the industrial strategy was a commitment to set up the Aerospace Technology Institute and for industry and Government to invest £2 billion over the next seven years in new technology and manufacturing—the largest and longest commitment on aerospace in a generation, creating funding certainty through to the end of the next Parliament, to give industry the certainty it needs to invest in the UK. It is a new way of working that avoids the piecemeal, ad hoc, hand-to-mouth approach of the past. It matches industry time scales that allow new technology to be developed and harnessed into game-changing products.
I am pleased to say that industry and Government have made good progress in setting up the Aerospace Technology Institute. Key posts have been filled, the office has been established in Cranfield and the institute has been fully operational since the beginning of April. A key part of the ATI’s work in the months ahead will be to develop a technology strategy for the UK that will take into account the international competitive challenge of which my hon. Friend the Member for Mid Worcestershire spoke.
We have wasted no time in putting that work to good use. To strengthen critical parts of infrastructure, we have already committed £60 million to the manufacturing technology centre in Ansty and £15 million to upgrade wind tunnels in research organisations. In total, we have announced well over £300 million of collaborative research projects, involving companies of all sizes working alongside academic and research institutions. Over 100 UK companies and 26 universities are now involved across the UK.
Knowing that long-term research funding is available gives business the confidence to invest. I was delighted at the announcement at Farnborough air show that Airbus will develop a new version of the A330, which will exclusively feature the new Rolls-Royce Trent 7000 engine. With over 120 orders already, the new aircraft will support jobs in Airbus, Rolls-Royce and the wider supply chain.
I turn now to skills, another issue raised by my hon. Friend. A big success story has been the jointly funded initiative to create an additional 500 masters-level postgraduate places. Last year, as planned, 100 bursaries were awarded; this year we have awarded a further 200 bursaries and the remainder will be awarded next year. I am delighted to report that industry has just opened up a portal on the Talent Retention Solution website so that bursary holders can link up with companies of all sizes.
I can also report that industry has submitted a bid through the AGP to the Government’s employer ownership programme to tackle its priority skills needs. It includes actions to boost apprenticeship numbers, and improve early career opportunities and the flow of high-level skills into the sector. That bid, for over £10 million of public funding, will leverage in additional investment by industry. I will take the opportunity to set out my support—as my hon. Friend invited me to—for the flagship apprenticeships and the STEM programme, which he talked of earlier.
Mr Laurence Robertson
Will the Minister be so kind as to look into any possible effect that the changes in funding of apprenticeship schemes might have on the industry—not necessarily now?
George Freeman
That is an important point. I will be delighted to look into it and come back to my hon. Friend.
We have also opened a dialogue with industry about the potential to create a national college for aerospace to help the sector tackle its long-term skills needs. My hon. Friend the Member for Mid Worcestershire also mentioned the importance of promoting women in science, technology, engineering and mathematics. I pay tribute to him for his campaigning work on increasing the flow of STEM skills into the economy and increasing the number of women working in STEM jobs. As in the life sciences, that is a key strategic priority for the future of our country. I want particularly to take the opportunity to support the STEM ambassador scheme.
To boost the pool of potential engineers, the Government are making a series of interventions across the spectrum, within vocational and higher education and with employers. In response to Professor Perkins’s review, we are putting in £30 million for employers to address engineering skills shortages in sectors, £18 million of investment in a new elite training facility at the Manufacturing Technology Centre in Coventry and £250,000 of seed funding to encourage children in schools to consider engineering careers through the Tomorrow’s Engineers initiative. In addition, last year my right hon. Friend the Member for Havant (Mr Willetts) announced a £400 million boost for English universities to promote science and engineering —a £200 million fund from Government that will be matched by universities on a one-to-one basis.
The Government cannot tackle this agenda alone: engineering employers, the profession and educators need to work together with Government to increase the supply of engineers in the UK. Companies such as QinetiQ, based in the constituency of my hon. Friend the Member for Mid Worcestershire, are taking a leading role through initiatives such as the 5% Club.
The AGP is also working to increase the competitiveness of our supply chain. The ambitious Sharing in Growth programme is part of that work and a great example of how the sector is raising the capability of our aerospace suppliers, mainly at mid-cap and smaller business level. Sharing in Growth is an ambitious £120 million performance improvement programme tailored to the specific needs of the participating companies. The programme is backed with £50 million from the regional growth fund and aims to secure or create up to 3,000 UK jobs. The Aerospace Growth Partnership has also created the National Aerospace Technology Exploitation Programme, a £40 million programme backed by £23 million from the advanced manufacturing supply chain initiative, to help smaller companies innovate and expand.
I will also pick up on my hon. Friend’s comments on Boeing. Although Boeing was not a formal part of the Aerospace Growth Partnership, given that it has no civil manufacturing presence in the UK, we have made it clear that initiatives coming out of the AGP, such as R and D funding, are open to Boeing when working with UK suppliers.
As time is running short, I shall conclude by touching on the issue of the Washington state tax breaks. I am pleased my hon. Friend has taken this opportunity to set out a balanced description of the WTO disputes. We continue to work with EU counterparts and I will be happy to write to him in detail on that ongoing work.
My hon. Friend also touched on the importance of links between the civil and defence aerospace sectors. Again, I will write to him in detail, but I emphasise that the Government are looking at that crucial area.
I conclude by highlighting once more the work the AGP has done and congratulating it on what it has achieved so far. It is already beginning to make a difference, which was summed up in a recent interview in The Sunday Telegraph with Fabrice Brégier, CEO of Airbus, who said—I will not use a French accent:
“I must say the UK has an approach which is to support industry, to support the economy and to be very pragmatic…We would like at times for other parts of Europe to have the same pragmatism and support.”
The signs are that there is increasing confidence in investing in the UK, and we are seeing fantastic new aerospace facilities. In less than four months, we will all be in election mode, but the best test of all this work will be if we can maintain sufficient unity of purpose. Today’s debate has suggested that that unity does indeed exist, which is important and to the benefit of us all.
Clinical Technology Appraisals (NICE)
George Freeman Excerpts(10 years, 2 months ago)
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The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)
May I say what a pleasure it is to start my role on the Front Bench under your careful guidance tonight, Mr Speaker?
I pay tribute to my hon. Friend the Member for Lancaster and Fleetwood (Eric Ollerenshaw) for his tireless campaigning on this subject, his leadership in the House and his work on the all-party group on pancreatic cancer. He has been a tireless campaigner on behalf of patients affected by pancreatic cancer, which is a terrible disease. I know that the subject is very close to his heart, having been affected by the tragic loss of his partner from pancreatic cancer. I applaud him and pay tribute to him for the work he has done. I pay tribute to all the patients and charities who are so active in this area, and I assure him and all those affected that we want to see the best possible outcomes for all NHS patients and loved ones, including those with pancreatic cancer. As is so often the case, the impassioned advocacy of patients and their loved ones forces the system to address the priorities of the patients whom we are all here to serve.
It is vital for people, especially those affected by long-term and life-threatening conditions, to have access to new and promising treatments. That is one of my key priorities in my new role. I well understand how disappointing it is for patients and carers when NICE does not recommend a particular drug or treatment for which they have held out such hope. A central part of my mission as the UK’s first Minister for life sciences—an opportunity that reflects the Government’s commitment and the Prime Minister’s personal commitment to this agenda—is to accelerate the discovery, design and adoption of new drugs in the NHS, making the UK the best place in the world to discover and design 21st-century health care technologies.
My hon. Friend raised a number of important points that I want to address. In particular, he asked whether the appraisal process of the National Institute for Health and Care Excellence is fit for purpose and spoke about the time that is taken over the approval of new drugs and the importance of the cancer drugs fund. He made a number of specific references to treatments, not least to Abraxane. I will reflect on those references and write to him so that I have time to address his substantive points.
I will start by taking a step back to reflect on the context in which NICE works, including the pressures and opportunities that the extraordinary pace of biomedical discovery is unlocking. In an age when so many new drugs and treatments are being discovered because of the extraordinary success of our scientists and our life sciences industry in bringing innovation to the market, and in a world in which more people are living longer and in which our resources are under ever more sustained pressure, it is no surprise that we hear with increasing frequency stories of new drugs and of NICE’s decisions to restrict their use to smaller groups of patients.
As my hon. Friend is all too aware, we, like other Governments across the globe, face a great challenge to ensure that every pound of health service money is well spent on effective treatments. The NHS does not have an infinite budget. As we make significant advances in these areas, which in turn will bring more treatment options, the demands on those resources will increase. The discovery of new treatment options is great news, but it brings new challenges. That is particularly relevant to cancer, for which a number of new high-cost drugs have arrived in recent years. Some of those, despite their cost, offer only marginal improvements in quality and length of life. I recognise, as my hon. Friend pointed out, that for patients who are dying, a few extra months provide precious extra time for them and their loved ones. The challenges is to find an equitable way of dealing with the difficult ethical, medical and economic judgments that we have to make. That is where NICE fits in.
Over the years, this country has, through NICE, led the way in developing an evidence-based assessment system to determine how drugs and treatments are best used in the NHS. Initially set up in 1999, NICE has played an invaluable role in providing internationally respected guidance to the NHS on the clinical and cost effectiveness of drugs and treatments. Those are difficult decisions to make. NICE reaches its final decision on the use of a particular technology only after careful and thorough consideration of all the available evidence and following extensive consultation with stakeholders.
The Government firmly believe that cost-effective, clinically appropriate drugs and devices should be routinely available to NHS patients. That is why NHS commissioners are legally required to fund treatments that are recommended by NICE’s appraisals, why the right of patients to NICE-recommended drugs and treatments is enshrined in the new NHS constitution, and why we are acting to promote the rapid uptake of NICE-recommended drugs in the NHS. Many thousands of people in England have, as a result, benefited from the treatments that are recommended by NICE, including for cancer. I am pleased to note that so far this year, NICE has recommended five new cancer drugs on the basis that they are clinically effective and cost effective.
However, the rapid development of breakthroughs in genomics, informatics and new diagnostics means that NICE’s processes will have to adapt. Since it was established in 1999, NICE’s internationally renowned technology appraisal process has evolved constantly to meet new challenges. I am confident that it will continue to do so—it will need to if it is to keep its place at the vanguard of international health technology assessment.
The UK and NICE led the world in the late 20th century in pioneering the health economics of drug discovery. However, the breakthroughs in genomics and clinical informatics are transforming the way in which drugs are discovered and are allowing us increasingly to design drugs around patients and their tissues, data and genomic and phenotypic history. That is unlocking a new era of targeted and, ultimately, personalised medicine. Drugs may be designed for patients in whom we know they will work. That will allow us to change the way in which we procure and provide reimbursement for drugs—from payment on performance to outcome-based payments.
We are at the dawn of an exciting new age of more accurate, effective, specific and targeted medicines. We no longer expect to give every drug to every patient. We do not expect the industry to bring drugs to us that can be proven to work in every single patient. We will be able to unlock huge efficiencies in the NHS’s £12 billion drugs budget through a much more targeted model of medicine, and it will mean a radically different mission for NICE in the coming years. Accelerating this country’s leadership in that area is central to my appointment, and I am delighted to be able to take the opportunity to spell that out.
I note my hon. Friend’s concerns about the length of time that it can take for new drugs to be made available. I very much recognise that as both a core barrier to making the UK the best place in the world to develop new medicines and a great opportunity. I should like to speak a little about a particular case that illustrates the importance of early access.
I recently met, and got to know, a leukaemia and lymphoma patient who was diagnosed 10 years ago with chronic myeloid leukaemia. He was in his early 40s and had a young family, and he was given about three years to live—10 years ago. He is alive today because he was one of just three patients placed on a clinical trial by his oncologist at the university of Birmingham hospital back in 2001. The trial, of Glivec, now one of the most commonly used CML drugs, was his lucky break. He was one of the first patients to receive a groundbreaking new treatment, giving him an extra decade with his young family and now a clean bill of health and a life that he is using as a pioneering campaigner for the revolution of targeted medicine.
Of course, it is important that any new medicine is shown to be effective and safe before it is used routinely within the NHS, but I believe that we need to do much more to help the patients in the direst need to access pioneering drugs more quickly so that luck does not come in to it. That is why the Prime Minister and I have committed to the early access to medicine scheme, which we launched earlier this year. That UK-only scheme addresses unmet need on an unlicensed or off-label basis for patients with life-threatening or seriously debilitating conditions who do not have adequate alternative treatments, by supporting access to very promising new treatments long before we would normally expect to receive them through the usual approval process. We have much more work to do, but I am pleased to see that the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency, is now starting to receive applications for the scheme. I am also pleased to say that pioneering life science companies have pledged their support and made applications to the European Medicines Agency’s adaptive licensing pilot. NICE has also been involved in discussions on both those initiatives, along with NHS England, to ensure that licensing decisions translate into patient access. The central aim of the early access to medicines scheme is to create a new fast-track runway to get a new generation of innovative medicines to the patients for whom there is no alternative treatment, to give them a chance and some hope that their suffering might help to prevent suffering for future generations.
My hon. Friend also raised the important issue of the length of the NICE appraisal process. I appreciate how important it is, when new drugs are licensed, that the NHS has good guidance on their use as quickly as possible so that clinicians can make the best possible use of them. In drug discovery, time is money, and accelerating assessment and approval is the single most important reform that we have to make. I am absolutely committed to it. In fact, I met NICE’s chief executive and chair today to highlight that point. For me, tonight’s debate marks the beginning of a conversation about the new model for NICE and our work with it on that model. NICE is an independent organisation, and it is not for me to second-guess what its final proposals will look like, but we have made it clear in the terms of reference that the end of life will continue to be given important consideration. There will certainly be no unlawful discrimination.
I mentioned genomics. Genomic technologies are allowing us to make groundbreaking discoveries about how disease works, how different patients become susceptible to different diseases and how we can diagnose disease earlier, treat it and ultimately prevent it. That is why the Prime Minister and I recently announced a £300 million investment to make the UK the world leader in genomic medicine. For the first time in the world, 100,000 full human genomes from volunteers will be sequenced by 2017. It is the most ambitious project in biomedicine in the world, and it is a world first. The development of genomically informed medicine will lead to faster diagnosis, with knowledge based on genomic technologies being used to better target treatments and get the right patients the right treatment faster than is possible today. I do not think it is an exaggeration to say that it has the potential to transform how we evaluate medicines, the benefits they deliver, who they deliver them to and how effectively. It will help bring to an end the averaging of outcomes, which sits at the heart of the current NICE model, allowing us to work out how to give the right drugs to the right patients much quicker than is currently possible.
My hon. Friend mentioned the cancer drugs fund and the benefits that it has brought to many patients and their loved ones. More than 55,000 patients have benefited from the fund since October 2010, and I am delighted to be able to confirm that the Prime Minister, the Secretary of State for Health and I are all committed to the renewal of the fund. Indeed, we announced last week that an additional £160 million would be made available to the fund through to March 2016, which will allow patients to continue to receive the extra drugs that are right for them.
We also announced plans for NHS England, NICE, charities and industry to work together to improve the way cancer drugs are commissioned. We must make better use of the cancer drugs fund to generate better data on new drugs, so that we can address the uncertainties that so often affect early clinical trial evidence, and help NHS patients and clinicians to understand the real world value of those drugs—indeed, today I met Harpal Kumar from Cancer Research UK to discuss that point. I note my hon. Friend’s concerns about future access to cancer drugs, and will carefully consider with NHS England what arrangements should be put in place for the fund in the longer term.
Central to this quiet revolution is patient empowerment, and 21st-century health care will move from being something in the 20th century that was done to patients by the Government when they deemed it appropriate, to something that 21st-century citizens will be entitled to and empowered to take more responsibility for themselves. In access to research and drugs, access to outcomes data, and people’s ability to shape their health choices, we are committed to accelerating that quiet revolution.
Ensuring patients have more say in how their care is delivered and embedding choice are key themes in the Health and Social Care Act 2012, and I intend to accelerate that in the field of health care technology. This quiet revolution is what the Government’s life science strategy sets out to frame and accelerate. That is why we have created a new Office for Life Sciences, bringing together officials from the Department of Health, the Treasury, and the Department for Business, Innovation and Skills. There is a new directorate in the Department of Health to accelerate innovation, and a new ministerial post, which it is my honour to hold. A package of other measures will help to make the UK in the 21st century once again what we were in the early 20th century—the world leader in medicines discovery.
Twenty-first century health care is being utterly transformed by breakthroughs in genetics, informatics, diagnostics and the new field of targeted medicine. It will transform the way we design and procure new medicines, and the way that NICE assesses their costs and benefits. I intend to ensure that this country seizes the opportunity for the benefits of our children, so that Britain is once again the best place in the world to discover new medicines and to be treated by them.
I congratulate my hon. Friend again on his advocacy and the important issues he has raised tonight, and I will write to address his specific points in detail. I look forward to working with him and the many other groups in Parliament and outside who are increasingly active in that space, to ensure that his partner, and many hundreds of thousands of others like him, have not died in vain.
Question put and agreed to.
Patient Safety
George Freeman Excerpts(10 years, 5 months ago)
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Mr Speaker
Order. For the benefit of the public—it is important that they find our proceedings intelligible—I should say that these exchanges are taking place because an urgent question was submitted and because I granted it. That is the beginning and the end of the matter.
George Freeman (Mid Norfolk) (Con)
After the shocking events at Mid Staffs under the last Government, I would like to congratulate the Secretary of State on his crusade for accountability and transparency as the best disinfectant, as shown by his support for whistleblowers and for 4,000 additional nurses. Does he agree that the collection, monitoring and day-to-day use of data on health outcomes is absolutely key? I welcome his Minister’s support for measures in my ten-minute rule Bill, now adopted and sponsored by me and my hon. Friend the Member for Stafford (Jeremy Lefroy).
Mr Hunt
I am happy to do that, and I would particularly like to congratulate my hon. Friend on the insight he has brought with regard to the power of data. In one example of why this is so important, the latest figures showed 43 or 44 people dying in the NHS because of medication errors, but if the person giving the medication had been able to see the patient’s entire prescription history, those horrific tragedies might have been avoided. That is why proper sharing of data is so important.