Oral Answers to Questions
Debate between George Freeman and Sarah Wollaston(7 years, 10 months ago)
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George Freeman
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.
Dr Sarah Wollaston (Totnes) (Con)
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 George Freeman and Sarah Wollaston(8 years, 6 months ago)
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The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
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.
Dr Sarah Wollaston (Totnes) (Con)
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?
Madam Deputy Speaker (Natascha Engel)
That is a matter for the Government, rather than for the Chair.
George Freeman
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.
Dr Wollaston
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
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 George Freeman and Sarah Wollaston(8 years, 7 months ago)
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Dr Wollaston
How much of the litigation cost is related to complaints about innovative treatments?
George Freeman
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
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.
Dr Wollaston
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
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
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.
Dr Wollaston
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
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.
Dr Wollaston
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
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.
Dr Wollaston
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
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.