George Freeman outlines Government’s support for promoting medical innovation

George Freeman outlines the Government’s support for promoting medical innovation whilst not undermining its commitment to patient safety.

The Parliamentary Under-Secretary of State for Business, Innovation and Skills (George Freeman): 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 for quackery.

Dr Wollaston: 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: 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.

Jim Shannon (Strangford) (DUP): I apologise for not being in the Chamber at the beginning of the debate, Madam Deputy Speaker, but I did not realise that the business had moved on so fast. In the university in Belfast, we have developed some great partnerships in relation to finding new drugs. Nearby Belfast city hospital works together in partnership with the university to address the issue of innovation for new drugs and to address how best to utilise them and make them available. I know that the Minister is aware of that, but does he recognise that such a partnership—with Queen’s university, financed by big business, alongside the NHS in the form of Belfast city hospital—is a precedent for how to innovate?

George Freeman: 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.

Dr Wollaston: 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?

George Freeman: I will happily come on to the existing law and the protections within it.

Three weeks ago, I announced a major review of the landscape of innovative medicines development, which will involve a review of NICE and the Medicines and Healthcare Products Regulatory Agency. It will look closely at how we can develop a new landscape for the quicker development of innovation with patients in the NHS.

I reassure the House that the Government are committed in all this work to putting patient safety first and developing a landscape of evidence-based medicine. I have listened carefully to the concerns of my hon. Friends the Members for Totnes and for Cambridge. I reassure them that I and the Government take their concerns very seriously.

Lord Saatchi has identified the threat of litigation as a potential barrier to innovation. The purpose of his Bill is to set out a series of steps and a clearer legal framework that will make it less likely for doctors to be put off reasonable innovation because of the rather circular defence that the best treatment is one that is already well established. The intention of the Bill is to tackle the risk that the fear of clinical negligence could undermine the commitment of doctors to embracing innovation in the system. It does not claim to be a panacea or silver bullet to solve all our innovation challenges, but to be one measure in the broader landscape.

In Committee in the House of Lords, the Government supported Lord Saatchi’s amendments to the Bill, which added an objective test of responsibility to the doctor’s decision to innovate. The amendments exclude any doctors who act irresponsibly from enjoying the protections of the Bill.

The amended Bill provides a number of other safeguards for patients, including the requirement for doctors to take full account, in a responsible way, of the views of other appropriately qualified clinicians. My hon. Friend the Member for Totnes argues that that does not go far enough. I would be interested to hear the views of Members of the upper House who are more qualified than I am when they debate Third reading at the end of the week. The package of amendments is intended to ensure that there is expert peer review of any doctor’s proposal. Furthermore, it ensures that the doctor must act responsibly in taking account of that review, thereby applying an objective standard to their conduct. In addition, the Bill requires any doctor to consider the risks and benefits associated with the proposed treatment, alternative treatments and doing nothing. That provides a further safeguard.

Let me be clear that we do not want the Bill to prevent patients from taking doctors to court when there is a good reason to do so. Doctors who follow the steps set out in the Bill or the steps required in normal practice should be able to demonstrate more easily that they have acted responsibility, because they will have considered the necessary steps in advance of any innovation. However, by invoking the freedom to innovate that is set out in the Bill, one does not in any way avoid the scrutiny of the courts. Doctors will still have to justify their actions if any case is brought against them, just as they do now.

Dr Huppert: At the beginning of the Minister’s comments, he said that he and the Government were keen to ensure that this would not be a divisive issue, and that they would not progress with it if it became one. He now sounds like he is being very supportive of the Bill. Will he provide an assurance that if the Bill continues to have the vast weight of medical and legal expertise against it, whether that is expressed in the House of Lords or by the organisations that my hon. Friend the Member for Totnes mentioned, he will ensure that the Government do not back it?

George Freeman: 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.

Dr Wollaston: 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: 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.

Dr Huppert: The Minister is being very generous, although we do appear to have quite a lot of time. He talked about 170 responses. How many were supportive of the Bill and how many were not?

George Freeman: I do not have that information at my fingertips, but I will happily look into it and come back to my hon. Friend if I may.

Crucially, following the Committee stage, Lord Saatchi and the Government have continued to engage with peers and key stakeholders. Let me take this opportunity, on the question of the Government’s support, to reiterate that this is a private Member’s Bill. This is not a Government Bill. We are very supportive of the Bill’s aims and intent to promote a culture and regulatory framework that is supportive of innovation within the NHS, but it is equally important that we do not in any way damage or undermine public or patient confidence in research in this country and in the NHS. I stress that the Bill has not been given Government time. We are supportive of its principles, but it is very important that when it leaves the House of Lords, where it will have been subject to extensive scrutiny by very eminent medical and legal opinion, it comes to us in a format, even if not every single point is unanimously supported, that has the very strong support of our most senior lawyers and medics.

I want to close by highlighting the fact that the Bill has generated substantial interest, both in Parliament and outside. In many ways, if those concerns can be reflected in high-quality scrutiny and the tabling of amendments, we should be able to demonstrate that democracy works and end up with a Bill that both achieves the aims of Lord Saatchi and reassures those with concerns. I want to be clear that, as the Bill completes its passage in the House of Lords, I hope it returns to this House in a form that the vast majority of medical opinion and respectable bodies in the medical field feel able to support. It is not our intention to have a Bill that undermines public or patient trust in research medicine.

We cannot legislate for best practice; we can only legislate to support our front-line clinicians to do what they believe is best for their patients. At the heart of that is a sacrosanct duty of care that all clinicians share, and which the Bill does not in any way weaken or undermine. That duty is to do what is best for patients.

I want to close with some supportive quotes the Bill has received from a number of important people, lest the House should form the view that it is unanimously opposed, which is not the case. Dame Sally Davies, the chief medical officer, has said:

“I am confident that, with the amendments made in Committee stage, the Bill is safe for patients and has the potential to encourage responsible innovation.”

Sir Bruce Keogh, at NHS England, said:

“Encouraging innovation in medicine and protecting patients are both of vital importance. That is why I am pleased that amendments have been devised to address concerns about patient safety.”

Sir Michael Rawlins, president of the Royal Society of Medicine, said that the Bill will allow responsible innovation and treatment:

“I believe the use of the provisions in the draft Medical Innovation Bill will benefit patients, especially those with rarer diseases, and the furtherance of medical science.”

A letter to The Telegraph from 40 leading medical professionals, including David Walker, professor of paediatric oncology at Nottingham university and Riccardo Audisio, the president of the Association of Cancer Surgery, said the Bill

“legally protects doctors who try out innovative new techniques or drugs on patients when all else has failed. This Bill will protect the patient and nurture the innovator. It will encourage safe medical advancement, while at the same time deterring the maverick, thereby recalibrating the culture of defensive medicine. Finally, it will work with evidence-based medicine and provide new data that will inspire and support new research.”

I hope very much that that is the case and that when the Bill leaves the House of Lords, the vast majority of qualified senior opinion in this field is able to agree with it. It is absolutely our intention to support the Bill’s noble intent to promote medical innovation, but equally our intention is to not undermine in any way the Government’s commitment to patient safety or the duty of care that all clinicians share and owe to their patients.

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