Oral Answers to Questions

Debate between Sarah Wollaston and George Freeman
Tuesday 5th July 2016

(8 years, 5 months ago)

Commons Chamber
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George Freeman Portrait George Freeman
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The hon. Gentleman will know that the Under-Secretary of State for Health, my hon. Friend the Member for Battersea (Jane Ellison), opened an exhibition on this topic yesterday and that the Chancellor recently put an extra £5 million into mesothelioma research. Through the National Institute for Health Research, the Government are committing to invest in that disease area. We are also committed to ensuring that we drive up both research and better treatment for such diseases.

Sarah Wollaston Portrait Dr Sarah Wollaston (Totnes) (Con)
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Prevention of ill health has to be given a higher priority if the NHS is to meet the challenges set out in the five year forward view. Central to that will of course be the childhood obesity strategy. Has the Secretary of State had any discussions with the Prime Minister about the strategy’s future? Is he in a position to take over the strategy should No. 10 become distracted?

Access to Medical Treatments (Innovation) Bill (Money)

Debate between Sarah Wollaston and George Freeman
Tuesday 3rd November 2015

(9 years, 1 month ago)

Commons Chamber
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George Freeman Portrait The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
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I beg to move,

That, for the purposes of any Act resulting from the Access to Medical Treatments (Innovation) Bill, it is expedient to authorise the payment out of money provided by Parliament of any increase attributable to the Act in the sums payable under any other Act out of money so provided.

The House debated the Access to Medical Treatments (Innovation) Bill on Friday 16 October, when it received its Second Reading. I pay tribute to my hon. Friend the Member for Daventry (Chris Heaton-Harris) for the huge amount of work that he put in to get the Bill to a point where it can enjoy majority support in this House and the other place, and for his open approach to dealing with all the stakeholders with an interest in it.

I want to reiterate what I said on Second Reading. Although the Government support the intention behind the Bill to promote access to medical innovation—an intention which sits four-square within my ministerial responsibilities—the mechanisms of any Bill need to be considered on their merits. We are neither supporting nor opposing this Bill, but working with those with an interest in it and the sponsors to do what we can to help to get it to a place where it could contribute to the landscape for medical innovation that we are putting in place.

This money resolution is not a signal of Government support or otherwise for the Bill; it is merely a convention of the House once a Bill has received its Second Reading. We have brought forward this resolution to allow the Bill to progress to Committee stage, reflecting that convention, and the will of the House for further debate.

Sarah Wollaston Portrait Dr Sarah Wollaston (Totnes) (Con)
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On a point of order, Madam Deputy Speaker. Is it in order for the Government to be neutral on a Bill if the payroll vote is whipped for that vote?

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George Freeman Portrait George Freeman
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I want to make two things absolutely clear. First, this Bill, in law, would have no impact at all on clinical research. We in the Department have been very clear about that. If it in any way changed the basis on which clinical research is regulated, it would be a very serious matter, because we lead the world in terms of our ethical and regulatory controls on research, and it is vital that we do not affect that.

Secondly, it would be a matter of very serious concern if this Bill were to undermine patient or public trust and confidence in our NHS, our research medicine and our clinical trials infrastructure. I flagged up on Second Reading the fact that I do have some concerns. Some of those relate to the way in which this debate is conducted, although I am not making any comment about the hon. Lady’s intervention. It is very important that we explain to people what this Bill does and does not do. If we mislead them, it is not surprising that we will get a lot of unnecessary fear. It is very important that we clarify that this has nothing to do with clinical research.

Sarah Wollaston Portrait Dr Wollaston
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Does the Minister accept, however, that the Association of Medical Research Charities, the Academy of Royal Medical Colleges, the British Medical Association, and an A to Z of other organisations involved with medical research are very clear that this does undermine participation in medical research? He should listen to those concerns and acknowledge that they are genuine.

George Freeman Portrait George Freeman
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Yes, indeed; I have listened. I acknowledged those concerns on Second Reading and said I was concerned about them. This is merely a debate about the Bill—there is no change in the law—and it is only this debate that is upsetting people at the moment. It is therefore very important that we carry it out in a way that makes it clear to them what this Bill does and does not achieve.

I am concerned that the passage of the Bill, the conduct of the debate, and any legislation that may survive the process of parliamentary scrutiny do not in any way undermine public or patient trust and confidence in clinical research or mainstream medicine. Were it to do so, I would be very concerned and the Government would be unable to support it. I have made it very clear to my hon. Friend the Member for Daventry that that is the No. 1 consideration, and as this is his private Member’s Bill, it is his task to get it to a point at which the Government would feel able to support it. Public trust and confidence in our NHS and in our clinical research infrastructure is crucial.

Access to Medical Treatments (Innovation) Bill

Debate between Sarah Wollaston and George Freeman
Friday 16th October 2015

(9 years, 2 months ago)

Commons Chamber
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Sarah Wollaston Portrait Dr Wollaston
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How much of the litigation cost is related to complaints about innovative treatments?

George Freeman Portrait George Freeman
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Most of the cases are a result of other contexts— as my hon. Friend will know, obstetrics is a big part of that—rather than innovation. I am happy to write to her with the actual figure as I do not have it to hand. My point is that the fear of litigation runs through the system.

I recently spoke to a senior paediatric consultant who is neutral about this Bill—he is neither a passionate advocate nor an opponent of it. He observed that over the past 20 or 30 years, a gradual conservatism has crept into clinical practice. When I asked what he thought drove that, he mentioned three things. First, ever tighter procurement control makes it harder to do things differently. Secondly, there is a subtly growing fear of negligence, and a lack of clear data information and guidance on what is available. Thirdly, many clinicians find it easier to stick to normal practice, and that is what the Bill seeks to tackle.

George Freeman Portrait George Freeman
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The hon. Lady makes an important point because it is difficult to quantify the impact of that fear. I have gone out of my way to make it clear that I do not think that issue is a primary concern, and that the organisational, cultural and financial barriers are higher concerns. That is partly what is difficult about the Bill. It gives the impression that fear of litigation is the big problem, whereas anecdotally I hear from leading clinicians—who, as I said, are not particularly for or against the Bill—that it is one of a number of issues in a complex landscape.

I am conscious of the time, so I will turn to the critical importance of patient and public trust and confidence in our clinical research infrastructure and NHS. The UK leads in clinical trials and in regulation through NICE, the Medicines and Healthcare Products Regulatory Agency, and our ethical framework. I am delighted that over the past four or five years we have made substantial improvements in recruiting more patients into trials. In 2014-15 the National Institute for Health Research—the jewel in the crown of NHS research—had 4,934 studies running, and last year we recruited 52 global first patients into trials. That is a key indicator of our leadership in the most innovative areas of medicine.

The MHRA has approved more than 80 first-in-human studies, and the NHS is becoming a leader in the forefront of that model of research, just as it was in the earlier part of the 20th century. It is also important to consider our leadership in regulation, ethics and approval, not least because those are major exports for this country. Over the next few decades, rapidly emerging economies will be looking for a lead from NICE, MHRA and our clinical trials infrastructure, and it is crucial to have a strong patient voice, and to maintain and develop patient trust. Central to my mission is to bring forward such development and put a stronger patient voice at the heart of our research landscape.

Patient empowerment through technology and access to innovation are key themes of our mission and work, and medical research charities have a huge role to play. In this new research landscape in which genomic information, patient data, records and medical histories become such key assets for research, the question is who will control that information. I think that we should build a policy landscape on the notion that such information and assets ultimately belong to the patient, and that the sovereignty of their relationship with their clinician should remain sacrosanct.

To answer an earlier question from the hon. Member for Lewisham East (Heidi Alexander), there is nothing in the Government’s plans to make such a database available to the public and drive the sort of quackery charter that I know the Chair of the Health Committee is worried about. We do not want to change the law that prevents pharmaceutical companies from talking to patients directly, and it is important that recruitment into clinical trials and access to innovation is done through patients and their clinicians.

Charities will have an increasingly important role. Cancer Research UK leads in much of this area, and many smaller charities are becoming strong advocates for their patients and collecting data. With the rise of apps and digital technologies, charities will soon create portals for patients to get involved in research communities, and work with industry and academics to drive and accelerate innovation.

Sarah Wollaston Portrait Dr Wollaston
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Does the Minister accept that all the bodies he has referred to, as well as the Association of Medical Research Charities, the Academy of Medical Sciences and the Academy of Medical Royal Colleges, have expressed concern that the Bill could undermine recruitment to clinical trials? That is an important point and I hope the Minister will accept that it is a genuine concern.

George Freeman Portrait George Freeman
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I was addressing that point to make it clear that I and the Government take strongly the need to ensure that the Bill does not undermine patient support in any way. I have heard some of those concerns, and if the Bill goes to Committee it is important to address them. It is also crucial to protect and support the sovereignty of clinicians to look after their patients, and to do as much as possible to try to liberate them from the burden of unnecessary bureaucracy and excessive targets. We must remind clinicians that they have freedoms in law and a vocational mission to do whatever they think is best for their patients.

On safeguards and protections let me make three important points about the Bill. I have taken advice from counsel, and I will respond to a number of questions raised by colleagues. As currently drafted the Bill provides no change to existing protections on medical negligence, and that is important. It sets out the power to create a database, and a mechanism to make clear to clinicians how they can demonstrate compliance with existing legal protection—the Bolam test has been referred to—and allow innovations to be recorded for the benefit of other clinicians and their patients. Importantly for the Government, that does not change existing protections on medical negligence, and it is crucial to understand that. Secondly, the Bill does not change our gold standard regulatory and ethical framework for clinical research. The Bill is not about research; it is about reinforcing freedoms for clinicians and how they prescribe. I will return to the detail of that in a minute.

George Freeman Portrait George Freeman
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That is an important question. The Bill does not change the legal framework on negligence; it merely seeks to clarify matters for those doctors who understand that they have the freedom to innovate but fear that current understanding in law about the test is not clear enough. It sets out an agreed, statutorily approved procedure to reassure doctors that if they follow that procedure, they will be covered by existing negligence and liability protection that the Bill does not change in any way. The hon. Lady’s second point is about whether people understand that, and whether there is a risk of the Bill inadvertently triggering fear. That is an important point, and it behoves everyone to ensure that we discuss it in the right way.

I have been shocked by some—not all—of the briefings, one of which referred to this being a “concentration camp” or a “Mengele” charter. Such unhelpful language triggers unhelpful media interest and will alarm patients completely unnecessarily. All the provisions in the Bill reinforce and endorse existing safeguards on the use of data and regulatory protection.

Time is short, but I want address the concerns that have been raised by hon. Members across the House. My hon. Friend the Member for Daventry gave a powerful speech and my hon. Friend the Member for Totnes (Dr Wollaston) made a number of interventions. There were contributions from my hon. Friends the Members for Beckenham (Bob Stewart), for Gainsborough (Sir Edward Leigh), for Bury North (Mr Nuttall) for Shipley (Philip Davies) and for Aldridge-Brownhills (Wendy Morton), and the hon. Members for Lewisham East and for Bolsover (Mr Skinner). I would like to take the opportunity to welcome the shadow Secretary of State to her post. I value hugely her offer to work on the Bill in a cross-party spirit and to deal with the issues raised. If the Bill goes to Committee, that will be an important offer. I am certainly happy to take it up and see, in a cross-party spirit, whether we can help to ensure that it does not trigger the doubts that she and other hon. Members have expressed concern about.

I want to address the specific concerns raised by my hon. Friend the Member for Totnes. She is a very distinguished Chairman of the Health Committee, as well as a doctor. For those reasons, they merit proper scrutiny and attention. I apologise to her if I am unable to deal with all of her concerns, but I will try to address them all.

The first concern is that the Bill is based on a false premise, which is that doctors are afraid to innovate because of fear of litigation. I reaffirm that the Department of Health’s consultation on the previous Medical Innovation Bill revealed that some doctors do find the threat of litigation to be a block to innovation, although that was not a universal view and I do not want to suggest in any way that it is the principal barrier. This Bill is aimed at reassuring those doctors who feel unable to innovate due to concerns about litigation. It sets out a series of steps that doctors can choose to take when innovating, to give them confidence that they have acted responsibly. I read the Bill again this morning and I am happy to highlight some of the key protections in it.

Sarah Wollaston Portrait Dr Wollaston
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Will the Minister clarify that the vast majority of medical bodies feel that it is not a barrier to innovation, and that there are some important points where we need to protect patients from irresponsible innovation? We have to accept that there is a risk inherent in going down a route that would make that possible.

George Freeman Portrait George Freeman
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My hon. Friend makes an important point about public trust, and patient safety and confidence. I do not want to detain the House by reading the relevant provisions in the Bill. I think my hon. Friend has tried, during the summer, to draft a Bill that deals with a number of those concerns. She makes the important point that if the Bill is inadvertently undermining public trust and confidence, that is in itself a problem. That is partly a function of how people discuss it and it is regrettable that the Bill has generated the level of antagonism it has, but she makes an important point that we should look at those specific measures and ensure we tackle the issues and concerns that leading doctors have raised.

Sarah Wollaston Portrait Dr Wollaston
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My initial point was whether the Minister would accept that the overwhelming number of respondents felt that fear of litigation was not the barrier?

George Freeman Portrait George Freeman
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I made the point earlier that the barriers to access of innovation are much broader than the fear of litigation, and I am happy to reinforce that.

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George Freeman Portrait George Freeman
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I am grateful to the hon. Lady for clarifying that.

Sarah Wollaston Portrait Dr Wollaston
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Perhaps the Minister will give me an opportunity to clarify my position as well. I shall robustly oppose the Bill’s Second Reading. As the Minister has said, we all support the principles and aims of the Bill, but many of us robustly reject the notion that this is the way in which to achieve them.

The Minister has quoted two bodies that he says support the Bill, one of which disagrees with half of it. Does he accept that the Association of Medical Research Charities, the Academy of Medical Sciences, the Academy of Medical Royal Colleges, the British Medical Association, the General Medical Council, the Patients Association, Action against Medical Accidents, and even the Association of the British Pharmaceutical Industry—as well as legal experts such as Sir Robert Francis—all oppose the Bill? It reads like an A to Z of opposition. All those bodies would work with the Government if the Bill were given a Second Reading, but they robustly reject the notion that this is the right way in which to achieve its aims. Does the Minister accept that list, and does he accept that, according to the vast majority of opinion, this is the wrong way forward?

George Freeman Portrait George Freeman
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I well accept that views on the merits of this Bill are divided, not least for the reasons I have highlighted in my speech. Some of the commentary on it, referring to it as the Mengele Bill for example, has played a very damaging part in misrepresenting—[Interruption.] I can show the hon. Member for Lewisham East the briefing after the debate if she would be interested.

It is important that colleagues decide for themselves whether to vote for this Bill. My own view, and the Government’s view, is that it is seeking to address a matter of public policy that we share in terms of promoting access to innovation. The measures in the Bill may not be quite perfect; it would not be the first Bill to be in that situation, and I dare say many of our proudest legislative breakthroughs going right back to the 18th and 19th centuries started in a format that possibly did not command unanimous support. I would have thought it is worth us debating this further in Committee, but I reiterate that if we cannot get a Bill into a position where it clearly has, and reinforces, public and clinician support from our world-leading expertise in research medicine and clinical practice, and if it any way undermines patient trust and confidence, it would be retrograde.

I think this Bill is trying to do something laudable, however; I think my hon. Friend the Member for Daventry is trying to do something laudable. This is a complex field, and the Government are trying to put in place the right measures, and I thank him for raising it—and I thank you, Madam Deputy Speaker, for allowing me to respond in full.

Patient Safety and Medical Innovation

Debate between Sarah Wollaston and George Freeman
Tuesday 9th December 2014

(10 years ago)

Commons Chamber
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George Freeman Portrait The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman)
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I thank my hon. Friend the Member for Totnes (Dr Wollaston) for securing this Adjournment debate and giving the House, albeit only a few of us, the chance to debate what is, I agree, a very important issue that is the subject of live discussion in another place. I also thank my hon. Friend the Member for Cambridge (Dr Huppert) for his comments.

My hon. Friend the Member for Totnes is a tireless campaigner for good health care and good medicine, as Member of Parliament for Totnes, as a member of the medical profession, and as Chair of the Health Committee. I very much welcome her contribution. I will first deal with the points that she made, then set the scene and provide a little context about the Government’s view of this Bill, and then close with what I hope may be some reassurance about our commitment to patient safety.

My hon. Friend made a number of important points, which I repeat merely to signal that I have heard them loud and clear. She said that the Bill might risk creating a carte blanche, or open door, situation as an inadvertent side effect of unjustified and unsubstantiated claims. My hon. Friend the Member for Cambridge mentioned homeopathy and other non-evidence-based forms of medicine. My hon. Friend the Member for Totnes highlighted the danger of relying too heavily on the protection of a clinician merely seeking the endorsement of a fellow clinician. Implicit in her concern is the fact that most of us could probably find one person in life to support our own prejudices, however well intentioned.

My hon. Friend highlighted the risk of unethical approaches and the danger of back-door promotions, which none of us wants to see. On the danger of undermining public and patient trust in clinical trials, she knows that I am passionate about achieving precisely the opposite. We are very proud in this country that more and more of our patients are enrolling in clinical trials. The NHS is running a fabulously successful programme of promoting research medicine, and this year the numbers are up by 24% or 25%. That is good for patients, good for NHS research, and good for our life sciences sector.

My hon. Friend has highlighted the danger of accidental errors across the system today. We live with that risk, but I hear her point that it would be a disaster if the Bill inadvertently made errors more likely, rather than less. She also raised concerns about the Bill not promoting evidence-based medicine or requiring claims to be based on clear patient benefit. She made a specific point about the Cancer Act 1939, which I will follow up and deal with by letter, if I may.

Most concerning of all, my hon. Friend ran through a very long list of medical and health organisations that she described as being opposed to the Bill. I will look into that following the debate because—I will say more about this in a moment—we do not want the measure to be divisive or to alienate or undermine the consensus about the importance of good medical research in the UK and the NHS. I take that point seriously. My hon. Friend flagged up the letter from 100 oncologists that appeared in newspapers recently. Since that was published, there have been a number of discussions about—and, indeed, amendments tabled to—the Bill in the Lords. I want to have a look and make sure which, if any, of those concerns are extant as the Bill completes its passage through the Lords. I will say more about that in a moment.

My hon. Friend the Member for Cambridge endorsed those comments. I note in particular his comments about the importance of evidence-based medicine. As with so many issues that we deal with in this House, a good test is to ask: would I apply this to myself? Certainly, for myself and my family, I am a strong believer in evidence-based medicine. I am a believer in innovation as well, but my hon. Friend made an important point. I particularly enjoyed his mention of the politician’s syllogism: “We must do something; this is something; ergo, we should do it.” I assure him that that is not in any way the reason for the Government’s benign support for the Bill’s principles and the case it seeks to make to promote innovation. I align myself hugely with his comments about not wanting to open the door to quackery.

Sarah Wollaston Portrait Dr Wollaston
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Lord Saatchi has said that 20,000 people support his Bill, but if people are asked whether they are in favour of medical innovation, they are likely to answer yes, and if the same people are asked whether they are likely to support medical anecdotes, I think they are likely to say no. Sometimes the answer depends on the question being asked.

George Freeman Portrait George Freeman
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I am sure my hon. Friend is right. She makes an excellent point about the nature of the question having an impact on the answer one gets. I have repeated the concerns because they bear repetition and are important, and I want to signal that I am taking them seriously.

I want to set the scene in terms of the Government’s commitment to patient safety, the context in which innovative medicines are being developed, and the changes in the sector that are challenging some of the traditional methods of drug development. I will then address some of the specific points that my hon. Friends the Members for Totnes and for Cambridge have made and say something about the Government’s position on the Bill.

The Government’s response to the Mid Staffordshire NHS Foundation Trust public inquiry, led by Sir Robert Francis, “Hard Truths: The Journey to Putting Patients First”, demonstrated beyond any doubt, I hope, the Government’s absolute commitment to creating a new culture of openness, compassion and accountability and a renewed focus on patient safety right at the heart of the NHS.

The truth is that the NHS is one of the safest health care systems in the world. I am delighted to report that, in the recent Commonwealth Fund report comparing the US health care system with those of 11 other nations, the UK came top. However, there is always scope to improve health care standards universally and to reduce avoidable harm further. That is why the Secretary of State set the ambition this June, at the launch of the Sign up to Safety campaign, to reduce avoidable harm by half and save 6,000 lives over the next three years.

We have put patient safety right at the heart of the Government’s agenda for health. For that reason, I am delighted that the Government are actively supporting the Bill on patient safety sponsored by my hon. Friend the Member for Stafford (Jeremy Lefroy). The Bill has several important provisions on the use of data to drive safety across the system and to ensure transparency and accountability in health outcomes.

Why do we need to look at mechanisms for promoting innovation? My hon. Friend the Member for Totnes was kind enough to signal her awareness that the Government—particularly me, as the first Minister for life sciences—have taken an active role in trying to promote it. The reason is that we face a challenge in the field of drug discovery and development, as well as in medical technology generally. There is a challenge and an opportunity.

The challenge is that the more we know about disease, genetics and data—the datasets at our disposal in the NHS, and the history of drug reactions and the way in which patients respond to diseases differently—the more we realise that patients respond to the same disease or the same drug in different ways, and that those ways can often be predicted. These insights are beginning to change the way in which drugs are developed.

Increasingly, we do not need the one-size-fits-all, blockbuster drugs that we have traditionally expected the industry to bring us after long, slow, protracted and increasingly expensive clinical trials and randomised, double-blind trials. Of course, those trials have a strong part to play in our system, but the more we know about the nature of disease and the extraordinary breakthroughs that our biomedical and life sciences sector is making, the more the agenda shifts to designing around patients, as well as around tissues, data and genomics. That is why the Government are so committed to shifting our policy landscape to support the extraordinary role that our NHS can play globally. It is a uniquely well positioned, integrated national health care system, with extraordinary leadership in genomics and informatics, which the Government are actively supporting.

My hon. Friend made the point that the randomised, double-blind trial has given medicine great service in the 20th century, and I agree. As we move further into the 21st century and see the transformational power of new technologies, it is equally true that the system of expecting the industry to go away and spend 10 to 15 years, and an average of £1.5 billion, to develop a new drug—many of them fail in late-stage clinical trials, because of some toxic side effect in one patient or a few small number of patients—is leading to a crisis in the industry and in the pipeline for new drugs and new treatments, and to patients increasingly suffering because we cannot give them innovative medicines.

Part of the agenda for this Government and all western Governments is to look at how to accelerate the way in which our health systems support research and to bring innovative medicines, as well as devices, diagnostics and other innovations, to benefit patients more quickly.

George Freeman Portrait George Freeman
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The hon. Gentleman makes an important point. I want to take this opportunity to pay tribute to the work being done in that cluster at Queen’s. I am delighted to say that I will be coming in the new year to support it and to show, as the UK Minister, that there are great clusters in Scotland, Northern Ireland and Wales. I very much look forward to that visit.

The truth is that the landscape is changing. Part of the challenge that we all face is to find ways to accelerate earlier access to innovative treatments for patients, and earlier access for those developing innovative drugs, devices and diagnostics to our health system, so that we can more quickly design innovations that are more targeted and personalised. We are seeing the first genuinely personalised cancer therapies and drugs that, in the unfortunate event that one is diagnosed with cancer, can be designed around one’s genetic profile. I was at a seminar on that development this morning. It is changing the landscape of drug development. We are keen to ensure that we benefit from it in the UK and that we use every mechanism in the NHS to support it.

Sarah Wollaston Portrait Dr Wollaston
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Does the Minister accept that a doctor who uses such innovative treatments within the NHS is protected under existing law and that we do not need new legislation to make them available to patients?

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George Freeman Portrait George Freeman
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I am merely trying to set out a balanced review of the arguments. In closing my speech, I will give an assurance that I hope will satisfy my hon. Friend on that point.

On protection, under existing common law and in the Bill doctors must show that they have acted responsibly. They cannot simply go through the motions and seek advice from an inappropriate source as that would not be “responsible”, which is the key test in the Bill and common law. Even if doctors follow the steps in the Bill when deciding to adopt an innovative treatment, they might still carry it out negligently and be subject to a negligence claim in the same way. When something goes wrong it is right that patients are free to seek compensation, and that will continue to be the case. The Government do not want any undermining of protection for patients against clinical negligence.

My hon. Friend the Member for Totnes made a point about the Bill not requiring doctors to seek the prior agreement of an appropriately qualified doctor, and instead being required only to take account of their views. I would not want the Bill to give a carte blanche to quackery or non-evidence based medicine. The Bill requires a doctor to take full account of the views of at least one appropriately qualified doctor, just as any responsible doctor would be expected to do, and they would not be able to ignore certain views or give them minimal weight by just “noting” them unless there were reasonable grounds for doing so. All doctors will be bound by the core and primary duty of responsibility and care to their patients. If the Bill were to require the explicit agreement of another doctor to innovate—that is one suggestion made in the other place—we are worried that that would open the possibility of a new negligence action against the countersigning doctor and lead to more confusion. We would not be able to give the countersigning doctor any certainty about their legal position, and they would not be able to rely on provisions in the Bill.

My hon. Friend made a point about undermining confidence in clinical trials. Although the Bill has raised awareness of innovation in medical treatment, it does not confer additional rights on patients to demand innovative treatment. It will still be for the doctor to decide the most appropriate course of treatment in discussion with their patient and using their best professional clinical judgment. Nothing in the Bill allows doctors to bypass any processes or requirements set by their trust when undertaking innovative treatments in the NHS, which includes ensuring that the commissioner would fund the treatment if it is to be provided within the service.

Individual innovation is important but no substitute for medical research and testing the efficacy of new treatments in a systematic way. A large part of my work is about ensuring that we use all of our £1 billion a year for the National Institute for Health Research infrastructure in the NHS, to ensure—as the Prime Minister set out in his speech when launching our life science strategy—that every willing patient is a research patient and every hospital a research hospital, and that we learn from evidence that we develop daily in our interaction with patients. Lord Saatchi and Ministers are determined that doctors should learn from innovative medicine as we go along, and a large part of the NIHR and our data programme is about ensuring that we pick up and track innovations and outcomes more accurately across the system.

Sarah Wollaston Portrait Dr Wollaston
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Does the Minister accept that that cannot happen under the Bill, and that those things will remain a series of unlinking anecdotes? In medical science and for the safety of patients no one will be able to track whether there were unintended consequences or benefits, and it will not advance the cause of medical innovation whatsoever.

George Freeman Portrait George Freeman
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I would be interested to see the Bill once it has completed its passage through another place and ensure that it contains adequate provision for evidence-based medicine, and that, by encouraging innovation, we are not in any way encouraging medicine that is not supported by the best evidence available.

My hon. Friend spoke about consultation. The Department of Health carried out a full consultation on the issues raised in the Bill, which ran from February to April this year. It was delighted to receive 170 responses to that consultation, making clear a range of opinions. Responses came from a range of audiences, professional bodies, patients and clinicians. Four regional public consultation events were also held. Lord Saatchi attended those events and it was in no small part thanks to his involvement that a number of changes were made to strengthen the oversight mechanisms in the Bill. At every stage, the Department of Health has engaged with Lord Saatchi to develop amendments to align the policy of the Bill with the legal and expert clinical advice we have taken, including from Sir Bruce Keogh.