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House of Commons

Friday 7 November 2014

The House met at half-past Nine o’clock

Prayers

[Mr Speaker in the Chair]

Fiona Bruce (Congleton) (Con): I beg to move, That the House sit in private.

Question put forthwith (Standing Order No. 163), and negatived.

Health and Social Care (Safety and Quality) Bill

Second Reading

9.34 am

Jeremy Lefroy (Stafford) (Con): I beg to move, That the Bill be now read a Second time.

This Bill is all about patients—their care and safety. My commitment to that comes directly out of the findings of the Francis report, particularly the second Francis report, following the public inquiry into the instances of dreadful care at the Mid Staffordshire NHS Foundation Trust in my constituency. The work of Cure the NHS, led by Julie Bailey, who challenged that care, and supported by a group of my constituents and those of my hon. Friend the Member for Stone (Sir William Cash), has brought us to today’s Bill.

Sir Robert Francis, in the letter to the Secretary of State for Health presenting his report, wrote:

“In introducing the first report, I said that it should be patients—not numbers—which counted. That remains my view. The demands for financial control, corporate governance, commissioning and regulatory systems are understandable and in many cases necessary. But it is not the system itself which will ensure that the patient is put first day in and day out. Any system should be capable of caring and delivering an acceptable level of care to each patient treated, but this report shows that this cannot be assumed to be happening.”

The Prime Minister, in his reply to the Francis report, said:

“Quality of care means not accepting that bed sores and hospital infections are somehow occupational hazards—that a little bit of these things is somehow okay. It is not okay; they are unacceptable—full stop, end of story. That is what zero harm—the jargon for this—means.”—[Official Report, 6 February 2013; Vol. 558, c. 281.]

The Prime Minister’s words captured the essence of this issue precisely.

Most of the Francis report recommendations have been accepted, and many have already been implemented. In addition, other very important decisions have been taken by my right hon. Friend the Secretary of State for Health, such as the appointment of chief inspectors of hospitals, general practice and social care. Those are already having a profound effect on improving the safety and quality of care that patients receive.

Our NHS, using the best medical science and skills, combined with professionalism and compassion, delivers extraordinary repair treatment and healing to the vast majority of its patients. Yet, it can also forget that and cause completely avoidable harm to sick patients. The Bill intends to reduce, and, I hope, eliminate, its ability

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to do that. The Bill arises out of a determination to ensure that what happened at Stafford, and indeed elsewhere, should not be repeated. It seeks to ensure that the focus on safety and quality of care we are seeing is not only maintained, but strengthened, and, most importantly, it seeks to ensure that it cannot be reversed. Of course, legislation on its own will not guarantee safe and high-quality care—leadership, culture and resources are all vital elements—but by making it clear in law what is expected of those providing health care, the Bill will go a long way to doing so.

First, the Bill, in clause 1, changes the Secretary of State’s power to a duty, moving from a “may” to a “must”, to ensure that all those providing health and social care make zero avoidable harm their target. Patient safety is therefore put at the top of the list of what must be inspected for. One important way of ensuring that patients receive the safe and high-quality care we would all wish to see is through better integration between services, both health and social care. That is why clauses 2, 3 and 4 seek to give an impetus to integration through the requirement for a single patient identifier and a responsibility to share information. Professional bodies play a vital role in improving safety and quality of care by setting standards.

Mr David Nuttall (Bury North) (Con): My hon. Friend will be aware of small concerns raised by the British Medical Association about some of the detail of his Bill. Is he confident that those will be able to be dealt with in Committee?

Jeremy Lefroy: I thank my hon. Friend who has shown a strong, keen and sincere interest in this Bill. Yes, I have just seen the BMA’s submission, and I recognise the concerns that have been raised. Those concerns should be listened to, addressed, and dealt with in detail in Committee. Perhaps what I am coming on to say will address some of them now. We must take extremely seriously the views of the BMA, which represents doctors.

As I was saying, professional bodies play a vital role in improving safety and quality of care by setting standards of practice and ensuring that high standards of conduct are maintained. Clause 5 and the schedule to it ensure that the professional bodies within the medical, nursing and care professions have the same overarching objectives that will benefit patients.

I propose to set out the context of the Bill and then to go into the detail of each of its three parts. In doing so, I will seek to address points that have been raised with me, especially whether we need legislation to achieve the aim of the Bill—patient safety and quality of care.

I am grateful to the team at the Department of Health that has helped in the preparation of the Bill and to the Minister, whose earlier proposals in his ten-minute rule Bill have informed the measures on the integration of services. I also thank the shadow Secretary of State and the Opposition health team for their interest in the Bill, the Chair of the Health Committee and other colleagues who have taken the time to discuss it with me, and to those in the health and social care professions who have contributed their thoughts.

I am also grateful to Ken Lownds whose work on patient safety has been fundamental to my work on this Bill and to my hon. Friend the Member for Stone who

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first called for a public inquiry and who has supported this work all along. I wish to thank my staff: James Cantrill, Pauline Ingall, Hetty Bailey, Alex Simpson, and Emily Mills, all of whom, but especially James and Pauline, have contributed in many ways. Above all, I wish to thank my wife, Dr Janet Lefroy, who has patiently discussed with me over many years the theory and reality of patient safety and care.

In 1863, in her preface to her notes on hospitals, Florence Nightingale wrote:

“It may seem a strange principle to enunciate as the very first requirement in a hospital that it should do no harm to the sick.”

That principle, extended to all health and social care services, lies behind the whole Bill, but particularly clause 1, to which I will now turn.

We are in a time where, quite rightly, there is increasing scrutiny of the safety and quality of care in our health and social care services. There are no accurate figures of how many people die avoidably while in the care of health or social care services in England. A recent study estimated that perhaps 12,000 people a year die from avoidable causes in hospitals alone. That is more than four times the annual number of deaths on roads in the UK. This is about not just those who die avoidably, but those who live but whose lives are profoundly affected by the avoidable errors—perhaps they are left with disability or mental scars. It is also about those who care for them who may have caused the avoidable harm and for whom it casts a shadow over their entire life.

In many cases, straightforward patient safety concern, procedures and practice would have protected both the patients and the members of staff from the consequences of avoidable harm. No patient wants to be harmed, and no one in the NHS would willingly harm them. The essence of zero avoidable harm is for the professionals and the organisations for which they work to convey to the patients, “We are health care providers because we want to treat and cure people. This is our contribution to humanity. We owe it to you, the patient, when you submit to our treatment not to harm you by being unprofessional, inattentive or negligent and also to have made all possible preparations in case we make an error so that it will not harm you. We will of course advise you of all risk inherent in what we are going to do for you.” When I speak of zero avoidable harm, that is the culture I mean.

These principles, procedures and practices for zero avoidable harm are in place in many hospitals and other care providers across the country, but they are neither universal nor standard. This is about not bureaucracy, but ensuring that health and social care has the same approach to safety as other activities in which safety is critical, such as air travel or the nuclear industry. Just last weekend, I noticed at one of the manufacturing sites in my constituency, which deals in chemicals, a board prominently displayed that said that the site had gone for more than 1,000 days without an accident. I fully acknowledge that health and social care is highly complex, and becoming increasingly so. But to those who use complexity as an excuse not to draw lessons from other professions that have had to make safety a priority, I would simply say: that is not good enough.

There is much excellent work going on in safety science, systematising and standardising many elements

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of health care, and indeed social care, to ensure that variability can be eliminated. Safety-critical sectors in the UK and elsewhere have for years been using what are called human factors to enable all staff to perform at their best, not only technically but also in communicating with patients and colleagues. Human factors are the key to building a culture of safety, or an open culture in which staff are able to speak up about safety—a just culture, in which blame is absent but fair accountability is the norm.

I shall now explain the detail of clause 1. At the moment regulated activities, which are defined by clause 8(2) of the Health and Social Care Act 2008 as activity involving, or connected with,

“the provision of health and social care”,

are regulated through regulations that are made under section 20 of that Act. That section provides that the Secretary of State

“may impose in relation to regulated activities any requirements which the Secretary of State thinks fit”.

Such regulations

“may in particular make provision with a view to…securing the health, safety and welfare of persons for whom any such service is provided.”

So the Secretary of State has the power—a “may”—but not the duty—a “must”—to impose regulations regarding the safety of patients. The message that this could send out is that patient safety is not essential. Of course, Secretaries of State, and most recently heads of the Care Quality Commission, have made it clear that patient safety is of vital importance, but that did not apply at Stafford hospital or, indeed, in many other places.

Clause 1 of my Bill amends the 2008 Act by substituting the following for subsection (1) and part of subsection (2) of section 20:

“The Secretary of State must by regulations impose requirements that the Secretary of State considers necessary to secure that services provided in the carrying on of regulated activities cause no avoidable harm to the persons for whom the services are provided.”

So it is now incumbent on the Secretary of State specifically to require that those providing health and social care services cause no avoidable harm. The Care Quality Commission will therefore need to assure itself, when inspecting those providers, that they have the policy systems and procedures in place that tackle avoidable harm.

As the explanatory notes to the Bill state, current Care Quality Commission registration requirements, which the Government are introducing, which will introduce new fundamental standards of care, would not be changed as a result of clause 1, as the new regulations satisfy the new duty. But the clause ensures that those regulations could not be watered down in future to reduce the emphasis on patient safety.

The Bill defines harm as being avoidable,

“unless the person providing the service cannot reasonably avoid it (whether because it is an inherent part or risk of a regulated activity or for another reason).”

It may be argued—this is one of the concerns that have been expressed by the BMA—that it is impossible precisely to define avoidable harm in every instance, and therefore that we should not attempt to do so. However, the very fact that so many cases of avoidable harm, sometimes leading to death or other serious consequences, manifestly

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do occur is a reason to ensure that it receives the highest possible priority, even if there may be arguments over the definition at the very margins.

Some may understandably raise the concern that the desire to tackle avoidable harm might lead to professionals simply not taking any risks. The Bill covers that by excluding from the definition harm that cannot be reasonably avoided. As in many instances, a test of reasonableness, which is included in the Bill, is a sensible way to address that.

Instances of avoidable harm would include, for instance, operations being performed on the wrong limb; patients being left without adequate hydration or nutrition; patients being left alone in A and E for long periods without any attention; poor records resulting in the wrong drugs being administered; and neglect as a result of wards being staffed below safe levels. In my experience, and I am sure in that of other hon. Members, the vast majority of instances of avoidable harm would come under one of those, or similar, categories.

There would be no questioning whether such instances had arisen because professionals were afraid to take risks; they would come from poor clinical skills, faulty record keeping, inefficient administration or a lack of care and compassion. The fact that the instances of avoidable harm vary so much across the health and social care sectors in itself shows that the problem can be tackled. How many lives would be saved if all providers had the same standards as the best in class? That is why it is so important to address avoidable harm through legislation.

I now turn to clauses 2, 3 and 4. These clauses are about continuity of information, which must be used

“to facilitate the provision to the individual of health services or adult social care in England, and…in the individual’s best interests.”

Again, this is all about the patient. There are two provisions: the first is for use of a consistent identifier for a person by the provider of health or social care; the second is to ensure that relevant information is shared in support of people’s direct care by the introduction of a duty to share information. Both provisions are designed to help with the integration of health and social care, which is greatly needed and which the Government and the Opposition have said is essential for the future.

Before I turn to the details, I should like to quote from a letter sent to me by my constituent, Mrs Janet Powell, who was delighted to hear about the Bill. She describes two recent experiences of the lack of integrated information, explaining:

“After breaking her femur in November 2013, my mother was admitted to the Manor Hospital, Walsall. In February 2014, she was admitted to Stafford Hospital suffering from heart failure. In July 2014, she went to New Cross Hospital, Wolverhampton for her cataract operation. For each of these admissions, she has a different hospital number. We have had to repeat vital information about her medical conditions each time she has been dealt with by different teams.”

Mrs Powell’s mother was fortunate to have relatives who were able to be with her on each occasion and give the vital information about her conditions, but for many people that is not the case, and even if it were, the process would still be inefficient and leave open the possibility that vital information regarding the patient and their care would be omitted.

The requirement for the use of a consistent identifier would make the accessing of accurate and timely information about a patient’s condition much easier,

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but clause 2 stresses in proposed new section 251A(5)(a) to the Health and Social Care Act 2012 that the requirement to use a consistent identifier would apply only if it was

“likely to facilitate the provision to the individual of health services or adult social care in England, and…in the individual’s best interests.”

As one would expect, the Bill contains provisions for the identifier not to be used in certain circumstances, including when the individual objects or would be likely to object and when the information concerns the provision of services by an anonymous access provider—for instance, sexual health services. The Bill makes it clear that the professional must still comply with the Data Protection Act 1998 and with any common law duty of care or confidence.

The introduction of a duty to share information for an individual’s care and treatment—again, only if in the person’s best interests—is aimed at ensuring that medical records are shared appropriately between the professionals in the NHS and care sectors who are responsible for the care of the patient. That is especially important when patients move between organisations along their care pathway.

The 2013 Caldicott review of information governance, “To Share or not to Share”, found that a culture of anxiety prevents information from being shared between organisations and that the legislative landscape contributed to this, with staff saying that a risk-averse attitude to sharing was a barrier to sharing in caring for people. The review said that the duty to share information in such circumstances can be as important as the duty to protect patient confidentiality. Dame Fiona concluded that health and social care organisations should have the confidence to share information in the best interests of patients within the essential broader framework of protecting personal patient data. Again, the Bill will provide the same important safeguards as those in respect of the consistent identifier.

I do not for one moment pretend that these provisions alone will make fully integrated health and social care a reality, but I believe that they will certainly help to remove some of the obstacles.

The final part of the Bill—clause 5 and schedule 1 —sets out three objectives of regulation: public protection, maintaining public confidence in the professions and upholding standards. Again, the driver for this is the safety and care of patients.

The long title of the Bill states that it would

“make provision about the disposal of cases concerning a person’s fitness to practise a health or social care profession”.

That was indeed my intention. Some of the regulatory bodies have been frustrated by the limitations on their ability to deal with a person’s fitness to practise. However, I have subsequently learned that such was the level of detail required to introduce the provisions that they would have made the legislation too long and complex for a private Member’s Bill. This Bill therefore concentrates on the vital overarching duty to protect the health, safety and well-being of the public.

When the serious failures set out in the second Francis report were debated in the other place, the noble Lord Hill, then Leader of the House, said:

“the regulatory bodies in particular have difficult questions to answer. The Nursing and Midwifery Council and the General Medical Council need to explain why, so far, no one has been

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struck off. The Secretary of State for Health has today invited them to explain what steps they will take to strengthen their systems of accountability in the light of this report, and we will ask the Law Commission to advise on sweeping away the Nursing and Midwifery Council’s outdated and inflexible decision-making processes.”—[

Official Report, House of Lords,

6 February 2013; Vol. 743, c. 320.]

The Law Commission, to which we are greatly indebted, has produced an excellent draft Bill with an accompanying report, “Regulation of Health and Social Care Professionals”, dealing with these matters. It states:

“Given the importance of health and social care professionals regulation, it is a matter of some concern that its UK legal framework is fragmented, inconsistent and poorly understood.”

It describes the piecemeal growth of that regulation since the establishment of the General Medical Council in 1858, which has become a framework that

“is neither systematic nor coherent and contains a wide range of inconsistencies and idiosyncrasies.”

As part of its work, the Law Commission therefore proposed in recommendation 13 that an overarching duty to protect the public should be established in a single statute for all the regulatory bodies. The recommendation states:

“The main objective of each regulator and the Professional Standards Authority should be to protect, promote and maintain the health, safety and well-being of the public. The regulators and the Authority also have the following general objectives: to promote and maintain public confidence in the profession and to promote and maintain proper professional standards and conduct for individual registrants.”

It is that recommendation that will be given effect by clause 5 of my Bill.

It might reasonably be asked why we do not simply wait for the entire Bill, with all the details of changes to regulatory body powers, and introduce the overarching duty then. Let me be clear that I am a very strong advocate of introducing the Law Commission’s entire Bill at the earliest opportunity; indeed, I would urge the next Government to do so. However, I believe—this is supported by regulators who have written to me—that introducing the overarching duty to protect the public, together with maintaining public confidence in the professions and promoting and maintaining proper professional standards and conduct, is a very important matter. It should not be left any longer. The commission’s report explains why:

“fitness to practise panels have, in some cases, adopted an overly restrictive approach to the test of fitness to practise impairment… In particular, the concern is that in cases of clinical misconduct or deficient professional performance they are more likely to look at whether the instances of clinical misconduct or performance are remediable than to fully consider all of the factors, including the public confidence in the profession.”

It concludes:

“If this concern is correct, then we think that the panels in question have misunderstood the correct legal position—namely that regard must be had to all of the factors reflected in the objectives when deciding impairment, irrespective of the particular grounds being considered. Our intention is that the wording of the general objectives in the draft Bill and duties to have regard to them should help to clarify the existing legal position.”

I have enormous respect for the health care professions—in fact, three members of my closest family work in or are training for them. These professions have led the world in many ways. Indeed, hundreds of health

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care professionals are at this very moment showing their courage and commitment by volunteering to tackle the Ebola epidemic in west Africa. One of the most important things that we as legislators can do is to provide them with the framework they need so that poor practice will not be tolerated and the public will have the highest degree of confidence in them. Clause 5 will help to achieve this.

I said at the beginning that this Bill is all about patients. It will put safety at the heart of health care by making the Secretary of State responsible for bearing down on avoidable harm. It will help the vital integration of health and social care services, thereby improving both quality and safety by introducing a consistent identifier and a duty to share information. It will make it clear that the main objective of each regulator of the health care professions is the promotion, protection and maintenance of the health, safety and well-being of the public.

None of this will absolutely guarantee that the failure of safety and care described in Sir Robert Francis’s first report, and the failure of the NHS and regulators set out in his second, will not happen again. That depends on other things that cannot be legislated for, such as culture and leadership, and those that can, such as the commitment of resources. However, it is my belief and hope that it will make a recurrence much less likely. My constituents in Stafford, and those of my hon. Friends the Member for Stone, for Cannock Chase (Mr Burley) and for South Staffordshire (Gavin Williamson) will then know that all they have gone through over so many years will not have been in vain.

10.1 am

Mr David Nuttall (Bury North) (Con): I congratulate my hon. Friend the Member for Stafford (Jeremy Lefroy) on introducing this Bill. He has set out its content comprehensively, in great detail and with great clarity. I also congratulate him on having the foresight to include as one of the sponsors of the Bill my hon. Friend the Member for Mid Norfolk (George Freeman), who is now of course the Minister speaking for the Government on it. That was a smart move.

Perhaps everyone in this country sometimes takes our national health service for granted as something that is always there. Whatever the political arguments may be about the NHS, we all know that it is part of the bedrock of British society—part and parcel of the fabric of this country. In essence, it boils down to two things. First, there is the scientific element: the technical expertise of the scientists, the doctors, and the people who put the drugs together and study the biology of the human body and the interaction of drugs within it.

There is also the human side—the care side. When someone is ill, they rely on the scientists to come up with a solution, but sometimes there is no solution and the scientists say, “We’re sorry—we can’t help you.” Sadly, even after decades of advances, there are still all too many ailments that afflict the human condition. In those cases, and in those where people, for whatever reason, may be nearing the end of their lives, it comes down to the human touch—the care and the everyday things that are not really related to science at all, just to common humanity. Regrettably, as seen most notably in the constituency of my hon. Friend the Member for

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Stafford—the reasons have been well explored—sometimes that care is not there. I am not going blame A, B or C for what happened—whatever happened has happened and we are where we are. Terrible things have happened and care has not been up to standard—we all accept that.

What we must now consider is whether it is possible to redesign the regulatory framework in such a way as to try to reduce the risk of what has happened in the past ever happening again. I do not pretend that this Bill will achieve that 100%. My support for it is based not on that premise, but on the premise that, on balance, it will be an improvement.

The Bill’s first proposed provision for a duty—an obligation—to inspect care makes absolute sense. Millions of people outside this Chamber will, frankly, be amazed that that is not already the case. It would be entirely uncontroversial to enshrine in law that requirement of the NHS regulator.

Secondly, the proposal for a common identifier is common sense. When members of my own family have had to go into hospital—this has happened recently and, sadly, it happens on too many occasions—they tell me, time and again, “The only thing that really annoys me is that I constantly have to give information.” Surely a common identifier would save time for our NHS. I am pleased that the professional bodies support the proposal. There are one or two technical and minor concerns, and clause 2 goes a long way to dealing with them. I am sure that any further concerns can be dealt with in Committee.

On balance, this is a sensible Bill, which has been very carefully explained to us this morning. I wish it a speedy passage through this House and the other place.

10.8 am

Fiona Bruce (Congleton) (Con): May I begin by congratulating my hon. Friend the Member for Stafford (Jeremy Lefroy) on his Bill, which, if implemented, has the potential to provide significant improvements right across this country to the treatment and care of patients requiring medical assistance? Indeed, the improvements proposed by the Bill would have an immediate and real impact.

The national health service is an institution of which the whole nation can be proud. It serves our society with outstanding professionalism and admirable compassion. However, as a few specific, terrible instances have shown, there is room for improvement.

I salute my hon. Friend’s tireless work to do everything possible to ensure that this country never again experiences tragedies of the type reported from Mid Staffordshire hospital. Indeed, my hon. Friend’s constituents have cause to be extraordinarily proud of him as their elected representative and of the thoughtful, tireless and effective work he has done on their behalf in response to the issues raised at Mid Staffordshire hospital. I do not believe that any other Member could have worked harder for their constituents in this connection. He has raised their concerns in this House countless times.

The Bill is another carefully considered and utterly compassionate response—so characteristic of my hon. Friend—to those events. It is a focused, effective and, above all, practical proposal. It has one overriding focus: patient care. It deserves to be fully supported in its passage through the House. Its proposals are specific,

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realistic and immediately applicable. It will bring about real changes in the lives of real people right across the country at their weakest and most vulnerable moments.

As I have said, particular situations hit the headlines. Although they were extreme, the House must remember that they are part of a wider national picture. We must use the lessons to inform future policy, and the Bill does just that. It is all about patients and their care, and about promoting consistency across the country so that all patients are cared for safely, and are seen to be cared for safely, to an accepted and understood standard. The NHS is an institution that the British people own, fund and use, and it is right for us to be concerned about public confidence in the quality and safety of the care it provides.

I understand the concerns of those who say that the NHS cannot be run on the basis of public opinion—I will speak about that when I come to clause 5—but that does not negate the fact that public confidence in the NHS is an essential concern, not an optional extra. Indeed, an NHS or local hospital that loses the confidence of the public will quickly cease to be able to serve effectively the community for which it is designed.

The first purpose of the Bill is to set in stone the priority of patient safety in NHS standards not just as a power but as a duty of the Care Quality Commission, as my hon. Friend has said. We have learned from the Francis report that patient safety is not an optional extra; it is essential and should be at the heart of good health care. The recognition of every single person’s dignity and value has characterised the proud history of the NHS and must always remain central to its practice, no matter what pressures it comes under on a wider scale.

The priority of safety in the work of the CQC will help to enshrine the dignity of individuals in a system that must inevitably focus on what is efficient in the wider structural picture. Putting safety first will ensure that it is not lost within bureaucracy and procedures. The nature of the NHS clearly means that health care professionals are always under all sorts of pressures to decide how they can most effectively allocate their resources of time, expertise and treatments.

Clause 1 will be a buttress to the rights and dignity of each and every individual within the larger picture. It will make sure that safety is one of the key non-negotiable factors that guide professionals and institutions as they make decisions. The clause acknowledges that there is no such thing as risk-free health care, and it allows for a certain margin when those providing the service cannot reasonably avoid risk. The responsibility that the clause will permanently place on health care professionals, institutions and those assessing the CQC should ensure that the recent tragedies in patient care are far less likely to happen in future. Ideally, no one in the House would want them to happen and to be reported again.

The second aim of the Bill relates to transparency and the integration of health care. A more integrated health care system must surely be a better system. It would promote shared expertise, shared learning and greater safeguards. The care provided for patients should reflect the fact that disconnected and fragmented health care is weak health care. These provisions will aid heath care professionals with regard to not just safety, but good practice across the board. I hope that it will simplify, rather than—as some fear—make more complex,

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the system of health care provision for patients. A consistent patient identifier and wider information sharing should create clearer channels for the integration of health and social care for individuals. This is the way of the future, particularly given the needs of our increasingly elderly population. I applaud my hon. Friend for those practical proposals.

As I have said, the NHS is a unique institution with a unique connection to the public. Public confidence is not an optional extra, but to achieve it requires transparency. I am sure that many health care professionals in the NHS will welcome greater transparency. The overwhelming majority of those who work in the NHS do an outstanding job, of which they—and we—can be proud.

The British Medical Association has certain concerns about the NHS number being used as a universal identifier, so I am pleased to highlight the fact that the Bill does not require any particular identifier to be used. The Bill seeks to promote the principle and merit of having an identifier, but which identifier is to be used can be left to the discretion of the Secretary of State, who I am sure will consult interested parties.

Provisions for sharing information in the Bill are also important. They will facilitate better health care treatment for every individual across all areas of their treatment, allow professionals to do a better job, and allow patients to know with confidence that those looking after them are fully informed about their care requirements before they provide treatment. Currently, patients cannot be sure that their medical and care history and priorities are being shared between professionals responsible for their care. My hon. Friend has cited cases where that has caused problems, which is no doubt typical of many.

Care must be taken to ensure that information is shared in a responsible way that upholds the privacy of the individual—that is critical. Questions of who information is shared with and how consent is assumed or obtained from patients are important, and there will be the opportunity to discuss such matters further in Committee. As the Bill rightly points out, patient data should not be shared where that is not appropriate, or in an unsafe manner—for example, where a person’s medical record contains confidential information about another person. Critically, the sharing of information must always be in the best interests of that person’s care and treatment. The Bill would not require the sharing of identifiable information for purposes other than direct care. As Dame Fiona Caldicott said:

“For too long, people have hidden behind the obscurity of the Data Protection Act or alleged rules of information governance in order to avoid taking decisions that benefit the patient. Personal data must be protected lawfully, but common sense and compassion must prevail.”

The third and final aim of the Bill is to ensure that the various health care regulators, including the Professional Standards Authority when making decisions on cases of conduct or misconduct, have consistent overall objectives in mind: the maintenance of public safety, public confidence in the relevant profession, and proper professional standards of conduct on the part of health care professionals. The proposals have not sprung up in a vacuum; they are consistent with recommendations in the Law Commission’s report, “Regulation of Health

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and Social Care Professionals”. It noted with concern the inconsistencies in the way different professional regulators assess individual fitness to practise. The relevant section of the Bill, recommended by experts, should ensure fewer examples of poor practice, and that it is properly addressed. Everyone—practitioners and regulators —should know the primary principles by which professional performance in the health care system is to be judged.

I understand that some professionals, and the BMA, are concerned that the link to public confidence could lead to an inappropriate link between volatile public opinion and the decision of regulators. Those are reasoned concerns but they underestimate the capacity of regulators to make appropriately sound judgments against set benchmarks. The legal position already requires attention to be paid to public confidence. The Law Commission’s report stated that

“the concern is that in cases of clinical misconduct or deficient professional performance they—”

that is the regulators, and for the benefit of the House I will elaborate a little on what “the regulators” means, because it is an extensive group of organisations—

“are more likely to look at whether the instances of clinical misconduct or performance are remediable than to fully consider all of the factors, including public confidence in the profession.”

The Bill addresses that concern.

Concerns that this will lead to inappropriate links between regulation and public opinion, perhaps especially as it relates to so-called scare stories in the press, should prove unfounded. Far from it: the Bill should encourage greater clarity and rigour in the grave task of regulators in assessing professional standards and promoting best practice. The impact of the Bill in this regard should not be underestimated. The extensive list of regulators—the bodies that regulate health and care professionals in the UK and will be affected positively by the Bill—includes: the General Chiropractic Council, the General Dental Council, the General Medical Council, the General Optical Council, the General Osteopathic Council, the Health and Care Professions Council, the Nursing and Midwifery Council and the General Pharmaceutical Council.

Jeremy Lefroy: I am most grateful to my hon. Friend for taking on the role of enunciating all the regulatory bodies. Does she agree that we would be wrong to downplay the great common sense of the British people when talking about public confidence? Public confidence in health care professionals, by any objective reasonable measure, is at a very high level and we do not just need to look at press headlines for that. Does she agree that, when it comes down to it, the British people have a huge amount of common sense and the profession should not be afraid of public opinion? It is very much on its side.

Fiona Bruce: I entirely agree. In saying what I have said, I in no way want to denigrate my hon. Friend’s intervention. I absolutely agree with him.

In closing, let me repeat my support for this profound and potentially far-reaching Bill. If passed, it would influence the life of every citizen in this country. Let me repeat my support for the excellent work my hon. Friend has done in bringing it to the House, and in working to drive up standards in the NHS, both locally in his constituency and nationally, and protect people

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across the country from a repetition of the sad and tragic events documented at Mid Staffordshire. The Bill will strengthen relationships between patients and health care professionals, and between the NHS and the public in general. It will help to lift confidence in the NHS even further. Most of all, it will help to ensure that every person who relies on the NHS in their most vulnerable moments will be safer wherever they live and whatever their condition. For that reason, I commend my hon. Friend’s Bill to the House.

10.22 am

Mr Jamie Reed (Copeland) (Lab): The House has a lot of business to attend to today. That said, this Bill deserves consideration in some detail. It clearly has widespread support across the House, including on the Opposition Benches, and from medical professionals across the NHS. Some groups have raised a number of concerns. I know that the hon. Member for Stafford (Jeremy Lefroy) will want to address them.

The Bill is made up of three key areas. Part one relates to provision of care that avoids harm. It requires the Secretary of State to bring forward regulations setting out the requirements on providers registered with the Care Quality Commission to ensure that the services they provide do not cause avoidable harm. Clearly, that is a principle we all support. All of us have learnt the lessons of what happened in the hon. Gentleman’s constituency and none of us wants to see that repeated in any part of our health economy or anywhere in our country. We want the very best care for our family and friends. Harm-free care should be something we all strive for at all times. We know that our doctors, nurses and other medical staff work incredibly hard, as Government Members have said, often in exceptionally trying circumstances. The Government—any Government—must do everything within their power at all times to support those professionals. That is surely beyond question.

The second part of the Bill relates to the continuity of information and how it is shared between providers of care. For effective health care to be provided in the 21st century, data must be utilised as effectively as possible. I am sure the Minister shares that viewpoint. Macmillan Cancer Support has shown in north Trent that local data, when used effectively, can be used to redesign the follow-up care that colorectal cancer patients receive. On analysing the data, it discovered that more than a third of people who survived for more than five years had an additional, non-cancer complication such as type 2 diabetes or heart problems. By using these data—and, by extension, knowledge—it could better plan the future care of those patients. The principle of using complete data to identify patients’ needs must be applied more often to ensure that patients get the care they require. There are some tremendous examples of GPs in Salford deploying this care model. I urge Members to take a look at the innovative techniques being developed there.

I ask the House to indulge me for a moment. Like everyone, I understand how such data can lead to better patient outcomes. Two weeks before the last general election, as an undiagnosed type 1 diabetic, I was rushed to hospital—once again, I place on the record my gratitude to the West Cumberland hospital for saving my life—and now every day my life is governed by data:

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blood glucose readings, insulin ratios and so on. I want such data to be easily available to me: I want them on my smartphone, and I want them provided to pharmacists and GPs, to help me and others in my situation better to control the condition. Incidentally, such a huge innovation would also save the NHS a lot of money and improve outcomes for patients with a variety of long-term conditions. In that regard, the Bill is doing exactly the right thing.

I would be grateful if the hon. Gentleman could set out again how the Bill would make data sharing more consistent across the whole health service, because this is a challenge. Where individuals’ personal data are concerned, there are clearly issues of privacy to address. That debate rages across many sectors and is routinely discussed on and offline and in the House. I have been here almost a decade now—it is hard to believe—and issues of individual personal data have been discussed throughout that time. Nowhere is that felt more sharply than with medical data.

It was regrettable—and avoidable—that the Government failed with the care.data scheme, as it severely eroded public trust in how data protection matters are dealt with. I do not think that anybody would take issue with the principle that medical confidentiality should always be respected and protected. I hope the hon. Gentleman will outline what safeguards are in the Bill to ensure that only relevant patient data are shared. Sharing unnecessary information could undermine patient trust, particularly regarding the use of personal data, and, critically, could slow down treatment, which we do not want.

Jeremy Lefroy: I am grateful to the hon. Gentleman for setting out from personal experience how important this matter is. I can assure him that the aim of these provisions is to ensure that data are shared only for the care of individual patients. This is not about data collection, but about patient care and safety, for which, as he rightly says, data are often so important.

Mr Reed: I thank the hon. Gentleman for that response. We will drill down into this in Committee because it is important that we get the details absolutely right.

This is about the efficacy of the care provided, and if we do not get it right, we will be storing up trouble for the future. The sharing of relevant health information is already governed by professional obligation, as the hon. Gentleman will know from his marital circumstances, and the British Medical Association has said it would be unnecessary to replace that with a statutory framework without clear justification. I hope to hear some justification for a new framework. One of the lessons of my party’s time in office, and one of the lessons that should be learned by this Government, is that we need to take medical professionals with us. If we do not, we will put ourselves and patients in a difficult position. We can devise all the statutory and regulatory frameworks we want, but if we do not take medical professionals with us when we apply those strategies, we will be in difficulty.

The third part of the Bill relates to objectives for the regulation of health and social care professions. This part, and the draft order on the objective of the General Medical Council, amends the objectives of health and social care regulators and the Professional Standards Authority. Professional bodies such as the GMC and

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the BMA have differing views on the impact this will have in practice. The GMC states that while this Bill will not impact on the GMC per se,

“The newly worded statutory objectives in the draft order address the aim of protecting the public and set out clearly the importance of public confidence issues when deciding on appropriate action in the public interest.”

The GMC also believes that the Bill will align other regulators’ statutory purpose with their own. The BMA, however, believes that the now separate role of protecting the public while maintaining public confidence in the professions could lead to regulatory committees and panels punishing professionals who do not pose any threat to the public.

The details of this part will be subject to further scrutiny in Committee, but I would be grateful if either the hon. Member for Stafford or the Minister explained how this scenario articulated by the BMA could be avoided. Let me repeat that it is essential to take the medical professions with us on this, in view of the lack of appetite for the application of the Francis recommendations with regard to the individual duty of candour. I think this has been dropped because the medical profession did not believe it to be enforceable. The Government listened, but we should explore those concerns in greater detail.

It was disappointing that the Government did not bring forward in the Queen’s Speech a Bill to deal with the wider reform and regulation of health care professionals. An opportunity was missed, and I hope the Minister will explain why. Wider reform is clearly needed. The Nursing and Midwifery Council was disappointed not to see such a Bill in the Queen’s Speech and still says that wider legislative reform is needed. We must remember that this Bill is an essential component of the implementation of the Francis recommendations and that, without it, some of the important changes recommended by Robert Francis simply cannot take place. We support the superb efforts of the hon. Member for Stafford principally in that context. This is an issue that many in the professions wanted to see addressed by the Government in the Queen’s Speech. They should have brought forward a Bill, and it clearly cannot be through a lack of parliamentary time or because of a packed legislative agenda that no Bill has been introduced. I hope an explanation for that will be forthcoming.

Other issues need to be addressed. The principle of the Bill is one that we support and we will not divide the House on it. The details will be scrutinised further in Committee, and I hope that both the Minister and the hon. Member for Stafford will be able to deal with some of the issues I have raised.

Finally, although the Bill is an important step, cultural change in any organisation or profession is difficult and takes a long time to achieve. There is no magic bullet, as has been said, and we should always recognise that. I was grateful to the hon. Member for Stafford for mentioning the regulation of the nuclear industry, of which I have a lot of experience. I think I was the first person to introduce this regulatory example into this whole debate, and it is a very important comparison.

What is the point of the comparison? Effective regulation is an iterative process that relies on an effective partnership between the regulator and the regulated. Too often,

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regulatory bodies in a number of sectors can play cat and mouse or hide and seek with respect to those they regulate, which can have a serious, damaging and counter-productive effect. We are beginning to see that with Ofsted—the comparator often used nowadays for the Care Quality Commission. Of course we want to see education standards driven up; of course we want to see pupils receiving the best education in the world; and of course the pursuit of excellence must be constant and consistent. We must, however, consider what happens when regulators begin to damage the cause they exist to support. None of us wants to see the medical profession becoming as beleaguered as those other essential public servants in the teaching profession.

That said, public services exist first and foremost for the benefit of the public, not for the public servants—an essential principle. Iterative regulation is undoubtedly the way forward, as is demonstrated by the safety and performance improvements that have taken place in the nuclear industry over the past decade and a half. Those changes accompanied a major regulatory recalibration in the early part of this century. Cat-and-mouse, hide-and-seek regulations were actually making performance in the industry worse. Regulators should not wait for failure to occur and then seek to punish; they should work to prevent failure from occurring in the first place, and that requires a partnership between the regulator and the regulated.

There is a great deal in the principle of the Bill that unites the House. I am exceptionally grateful to the hon. Member for Stafford for all the work that he has done, and his Bill has the Opposition’s support.

10.35 am

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

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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,

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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

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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

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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

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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

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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

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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

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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

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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.

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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.

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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.

11.15 am

Jeremy Lefroy: With the leave of the House, Madam Deputy Speaker.

Should my Bill receive a Second Reading today, I shall take very clearly from this important debate the points raised by my hon. Friends the Members for Bury North (Mr Nuttall) and for Congleton (Fiona Bruce), the hon. Member for Copeland (Mr Reed) and the Minister, and I am grateful to them.

There are two things that we must discuss very seriously in Committee. The first is justification of all the clauses. I believe they are justified, for the reasons that I set out in my earlier remarks; I will not rehearse them again. Secondly, we must discuss the details, particularly around privacy. With that, Madam Deputy Speaker, I thank you very much for your indulgence.

Question put and agreed to.

Bill accordingly read a Second time; to stand committed to a Public Bill Committee (Standing Order No. 63).

Stephen Doughty (Cardiff South and Penarth) (Lab/Co-op): On a point of order, Madam Deputy Speaker. I am sorry to detain the House briefly. You may be aware that the shadow Home Secretary has asked the Home Secretary to make a statement on the publication of the Wanless report on whether the Home Office misplaced files relating to child sex abuse allegations, and yet the Home Secretary has so far declined to say that she will. This morning the media are reporting details from the Wanless report. Madam Deputy Speaker, I wanted to ask you whether, after the bungling of the child sex abuse inquiry, you think it would be appropriate and wise, given the seriousness of this, for the Home Secretary to make an oral statement on Monday, so that the House is able to have complete transparency on the important issues around the Wanless report?

Madam Deputy Speaker (Dame Dawn Primarolo): That is not a point of order for the Chair today. I understand that the Wanless report is to be published. I am sure that those on the Treasury Bench heard the hon. Gentleman’s points very clearly. It is open to him to pursue that subsequently if he is not satisfied with the response, but it is not a point of order for me today.

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Off-patent Drugs Bill

Second Reading

11.18 am

Jonathan Evans (Cardiff North) (Con): I beg to move, That the Bill be now read a Second time.

Only a handful of MPs are ever successful in the private Members’ Bill ballot, so I am delighted and honoured that, 22 years after I was first elected to the House, and now in my final year of parliamentary service, I have at long last joined this rather select group and have the opportunity to promote a Bill on such an important matter.

First, let me thank the Bill’s sponsors, and MPs from all parts of the House, who have shown such support and interest in my Bill. The passionate welcome it has received has been truly amazing, although not surprising given the challenges it addresses.

Just yesterday, the letter page of The Times led with a joint appeal to the Minister and the Government in favour of the Bill from the Association of Medical Research Charities, the Breast Cancer Campaign, Leukaemia and Lymphoma Research, Breakthrough Breast Cancer, the Alzheimer’s Society, the Multiple Sclerosis Society, Leukaemia Care, Breast Cancer Care and the Cure Parkinson’s Trust. I should particularly like to thank Jenny Goodare and Mia Rosenblatt of the Breast Cancer Campaign for all the help they have given me in introducing my Bill.

Why question access to off-patent drugs? The problem goes back many years and is caused by a gap in the licensing system. The system is set up on the basis that a pharmaceutical company that wants to market any new drug acts as the drug’s sponsor throughout the process. That is fine and clearly understandable when the company anticipates many years of patent protection for its new product, but the essence of the problem that my Bill addresses is that no mechanism is in place to ensure the routine availability of existing drugs where patent protection has expired and where the drugs may be clearly shown later to be clinically effective but in a new way and for a new purpose.

Every time previously licensed drugs are shown to be effective for a new purpose, a new licence is needed to certify the drug’s safety at whatever the dose may be and for that purpose, and it must then be authorised to be marketed for such use. However, if a drug is no longer patent protected, no organisation or individual will take on the role of seeking any necessary licence for that treatment, because, after the patent has expired, other drug companies can produce and market generic versions of the drug, so the price of the product is driven down through the simple expedient of competition. It follows that the incentive for any pharmaceutical company to act as an advocate or sponsor for an off-patent drug and apply for a new licence is lost.

The outcome of all this is that off-patent drugs that should be routinely available at extremely low cost effectively have no sponsor. Without a change in the system, no one is ever likely to make licence applications for off-patent drugs, even when they may be effective for new purposes. In fact, it remains illegal to advertise and sell such drugs for such purposes if the drug is not licensed. What this all boils down to is that off-patent,

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repurposed drugs are not routinely available on the NHS, despite minimal costs to the taxpayer and the clear, clinically proven health benefits.

We may hear mention today of the ability of general practitioners to prescribe a drug outside the terms defined by the licence, which is known as off-label prescribing—in fact, Madam Deputy Speaker, given our earlier experience today, we may hear a lot about that—but the reality in clinical practice is much more complex and there are many disincentives to prescribing off label. A small number of clinicians may well be comfortable prescribing drugs off label in certain limited circumstances, but we know from the chemoprevention example, which the Minister quoted in the earlier debate, that this is not happening on any substantial scale. We also know that the absence of a licence is deterring many clinicians and GPs from prescribing these life-saving drugs in their new indications. Medical charities and senior distinguished clinicians have said that it is just not good enough to rely on the promotion of better information about off-label indications between clinicians.

Bob Stewart (Beckenham) (Con): Are off-patent drugs likely to be found in a chemist’s shop? Do chemists keep stores of these drugs?

Jonathan Evans: Invariably, such drugs have been licensed for other uses, but it transpires that they are being researched, as I will outline in my further remarks, and that research is showing that they can be used effectively in another way. The kernel of the problem that I am seeking to highlight is that, without licensing, they are not being used in that way.

A licence gives a clear indication to GPs that a drug is both safe and effective, so it is preferable that indications that could achieve such a licence are supported. We face an unacceptable situation where cost-effective drugs are not made routinely available for new and proven effective uses. Although a small number of people might be fortunate enough to get the drug, a far greater number with exactly the same condition, in exactly the same clinical circumstances but with a different GP, will not. That is the worst form of inequality.

I want to highlight one scandalous example of the failure, red tape and bureaucracy of our current licensing system. The passive approach to the flaw that I have highlighted has meant that, for all of 15 years, the chemoprevention drug tamoxifen was routinely available to women in the United States of America to prevent the development of breast cancer but not to thousands of women at risk here in the UK, not because the research evidence is any different in the United States of America and the UK but because under our licensing system there is just no one to request that this treatment should become routinely available. So for 15 long years nothing whatsoever happened, and thousands of women here in Britain were denied treatment that it has been clinically proven could have prevented the development of breast cancer in many cases.

It was not until 2013 that the National Institute for Health and Care Excellence—NICE—eventually recommended the use of tamoxifen in the UK in its guidelines on the management of familial breast cancer, but that still stopped short of licensing, because of the flaw to which I have referred. As a result, the NICE guidance has proved insufficient to ensure equal access

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and there is no evidence that it has significantly changed clinical practice. The uptake of these treatments is lower and less uniform than if the drug were licensed. Furthermore, owing to the infrequency with which NICE guidelines are updated and their impact, this mechanism could not be widely employed to make off-patent drugs available, and I believe that the example of tamoxifen starkly confirms this.

Graeme Morrice (Livingston) (Lab): I entirely agree with what the hon. Gentleman has said so far. Indeed, I want to lend my personal support to his private Member’s Bill and wish him well on its Second Reading. Several dozen of my constituents have contacted me in support of the Bill and specifically asked me to come along today to represent them in the Chamber and to vote for the Bill on Second Reading if, indeed, there is a vote. I certainly hope that his Bill is not talked out.

Jonathan Evans: I am grateful to the hon. Gentleman for that contribution. If he will forgive me, I will not go further down the path of responding because of the point that he made at the end.

Sadly, all existing off-patent drugs that reduce the risk of people developing breast cancer fall into this category. The leading proven chemoprevention drugs are tamoxifen and raloxifene. These drugs, which reduce the risk of breast cancer developing in high-risk women by around a third, are not licensed for this purpose. With nearly half a million women in England and Wales eligible for these low-cost treatments, there is an urgent need to address the barriers to chemoprevention drugs being prescribed. The cost of tamoxifen is 6p a day; the cost of raloxifene is 61p a day. A third chemoprevention drug, anastrozole, originally developed as a hormone therapy, has been shown to reduce the risk of breast cancer developing by a half, and with fewer side effects. The evidence is there, but what action can be taken to ensure the routine availability of these treatments? The answer is none, or very little.

Bob Stewart: Without trying to talk out anything, may I say that I totally support what my hon. Friend is trying to do? Could NICE not do this sort of thing?

Jonathan Evans: My hon. Friend, yet again, anticipates another part of my remarks. The second part of my Bill is about giving a certain responsibility to the Secretary of State to encourage NICE to promote technology appraisals. I will deal with that in a little more detail in due course. He is quite right, but not exclusively: licensing is the major problem.

Major new research will be published in the next few months that provides evidence that bisphosphonates—drugs that were originally licensed for the treatment of bone fractures in adults with advanced cancer—are effective in the early stages of breast cancer in reducing the risk of the disease spreading to the bone in post-menopausal women. That analysis of phase 3 clinical trials is likely to show that, in post-menopausal women with early breast cancer, this therapy reduces the 10-year risk of breast cancer spreading to the bone by 34% and the risk of dying from breast cancer by 17%.

I should like us to reflect on that for a moment: a 17% reduction in the risk of women dying from breast cancer. What would be the cost of any new treatment

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that could deliver such results? It would probably be tens of thousands of pounds, and we would want to pay that for such impressive results. However, zoledronic acid, a type of bisphosphonate drug, can be given to post-menopausal women every six months for three to five years, and that can reduce the risk of breast cancer spreading to the bone by a third and the risk of death from breast cancer by a sixth, and it would cost less than 5p a day.

Yet bisphosphonates are off-patent drugs that are produced relatively cheaply by numerous pharmaceutical companies as generic drugs, as my hon. Friend the Member for Beckenham (Bob Stewart) mentioned earlier. It is therefore pretty certain that under the current flawed licensing system no organisation would seek a licence to use that treatment in preventing secondary breast cancer, even when the evidence is published, so the drugs will not be routinely available to the women who clearly need them.

I want to pay tribute to the distinguished breast cancer clinicians and researchers who have been speaking out about this issue for years. Sixteen of them wrote to The Times on the day of the Bill’s First Reading, stating:

“For some time it has been clear that there is a real barrier to licensing old drugs for new purposes, even when there is evidence that they are effective. This means that treatments which could bring real benefit to the lives of people and in some cases be life-saving, with minimal cost, are not routinely available”.

It is not just access to cancer treatments at stake; the current system will fail us for any medical condition in future if we do not correct the flaw. The Multiple Sclerosis Society makes it clear that strong preliminary evidence has shown that a number of repurposed medicines could be effective in the treatment of multiple sclerosis, but the UK currently lacks a system by which old drugs can be relicensed. In the past week the society wrote directly to the Minister in support of my Bill, in a letter co-signed by Professor Sue Pavitt, chair of the UK’s MS clinical trials network, and other leading specialists in the field. They cited the example of simvastatin, a drug originally licensed for treating high cholesterol that has been shown to be effective in slowing brain atrophy in secondary progressive MS by over 40%. Although final evidence from a phase 3 clinical trial is required to confirm those results, if successful that drug would address a significant unmet need, as there is currently no treatment that can slow or stop the deterioration seen in progressive MS.

The MS Society has pointed out that, given that simvastatin’s patent has expired, the treatment would require a licence in order to be made widely available on the NHS to people with multiple sclerosis, and it argues that the mechanism to achieve that just does not exist, despite the repurposing of previously licensed drugs being a fast and cost-effective way to provide new treatments. Those eminent clinicians and the MS Society strongly support my Bill and the mechanism it would create to provide access to medicines that could help tens of thousands of people with untreatable multiple sclerosis.

The treatment of Parkinson’s disease could greatly benefit from the Bill. I know that Tom Isaacs, president and co-founder of the Cure Parkinson’s Trust, has

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written to the Minister in the past week to point out clearly the charity’s full support for the Bill. Tom has said:

“Parkinson’s may not be a death sentence, but at the moment it is a life sentence. There is increasing evidence that a number of off-patent drugs have the ability to slow, stop or reverse our condition. Under these circumstances, the ability for patients to have a clearly defined way to make these medications accessible is now imperative.”

I think that it is now appropriate to turn to the detail of the Bill, given that the Minister might do so, Madam Deputy Speaker. To address the anomaly I have outlined, the Bill introduces a new advocate—the Secretary of State or a body appointed by him—for off-patent, repurposed drugs in the existing UK licensing system. The advocate would have to act in the public interest, and in circumstances where no other body had taken on the role of seeking a licence. The level of evidence required to trigger the advocate to seek a licence for an off-patent drug in a new indication would have to be significant. The treatments referred under the mechanism would be required to meet exactly the same standards for a licence for any other treatment, so nobody is lowering the bar in the licensing process. The Bill does not seek to make any unproven treatments available to patients; it simply seeks to address a clear market failure in the current system and to allow proven drugs to be considered for a licence after their patents have expired.

Clinicians have also suggested the supplementary provision in the Bill for NICE to appraise off-patent drugs in new indications where these are unlicensed—the point made earlier by my hon. Friend the Member for Beckenham, who sadly is no longer in his place. It is anticipated that that exceptional route would be used rarely. Regulations would outline the specific and significant standards that would need to be met before the provision was triggered. Although it may already be possible under existing legislation for NICE to appraise drugs for an unlicensed indication, the Bill would simply place a duty on the Secretary of State to direct NICE to conduct a technology appraisal for an off-patent drug in a new indication that satisfies the evidence threshold.

The Minister has stated publicly:

“The Government firmly believe that cost-effective, clinically appropriate drugs and devices should be routinely available to NHS patients.”—[Official Report, 1 September 2014; Vol. 585, c. 141.]

I recognise and applaud the admirable steps that this Government have taken to improve access to new cancer treatments. The cancer drugs fund has been established for England and now has a budget of £280 million a year. It is an incredible scheme that has improved access to treatments for thousands of patients in England, and I have seen for myself the disadvantages that my constituents have faced by not having an equivalent fund in Wales.

On the CDF, we are currently spending millions on new treatments, so why not improve access to treatments that cost just pennies but that we know can save or improve lives? In future there will be drugs for other conditions, including Parkinson’s, multiple sclerosis, breast cancer and Alzheimer’s, that could benefit from the Bill. We cannot wait 15 years longer than other countries for our constituents to get these treatments, as happened with tamoxifen, and then tolerate a postcode lottery in their availability to our constituents.

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Mr Christopher Chope (Christchurch) (Con): I congratulate my hon. Friend on bringing forward this brilliant Bill. If it does not succeed today, it will certainly succeed in future, because it seems to be based on unanswerable logic. Can he explain why he thinks the Government are against it?

Jonathan Evans: It will be for my hon. Friend the Minister to make the Government’s case, although I certainly hope that he will not be lengthier than I am being in endeavouring to make my case.

It is simply not acceptable to sit back and hope for the best: we will let our constituents down by taking such a stance. I have heard it said that the Bill is not necessary and that better information for GPs and clinicians may be the answer, but the reality is that addressing the licensing flaw in the current system, as I have outlined, is the only way to tackle the issue effectively.

I say to colleagues, let us take this opportunity to act and deliver real change for those affected by cancer, multiple sclerosis, Alzheimer’s, Parkinson’s and so many other conditions. That is what the charities supporting them, and the senior clinicians specialising in treating them, are asking for. If we take forward this Bill, we can save and improve lives. If we tinker at the margins, we will not. For those who really want change, who really want people in this country to have access to the best treatments available, the answer is before us and it is clear. A legislative solution is necessary. By passing this Bill, we have an opportunity to change and save our constituents’ lives. I hope that we take it.

11.38 am

Mr Jamie Reed (Copeland) (Lab): I congratulate the hon. Member for Cardiff North (Jonathan Evans) on introducing this excellent and concise Bill, which Opposition Members support wholly. I will keep my remarks brief, because I think that there is plenty of time for us to do the business with the Bill this morning.

The principle of the Bill is one that the Labour party supports. We must do all we can to ensure that patients have timely access to safe drugs. As the hon. Gentleman has pointed out, the Bill would benefit very many people indeed. There is no doubt that the subject of off-patent drugs needs to be debated and, more importantly, requires action from this House. Now that we are aware of the issue, it would be remiss of us not to do something about it. We will support this Bill to ensure that people who are at risk of, or have been diagnosed with breast cancer, multiple sclerosis, Parkinson’s disease, Alzheimer’s, leukaemia and many others—as well as all those who may be diagnosed with any of these conditions in future—have access to treatments that they would otherwise be denied: treatments that are effective and low cost, and change lives.

I hope that the Government are also going to support this potentially life-saving—as the hon. Gentleman pointed out, life-changing—Bill. The Minister himself has stated that a central part of his mission

“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”,

and for Britain to be

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“once again the best place in the world to discover new medicines and to be treated by them.”—[Official Report, 1 September 2014; Vol. 585, c. 141-144.]

That is an aim we all share. We have our work cut out, but it is achievable.

Existing drugs can demonstrate great benefits but do not have licences under which to be marketed, meaning that access to them is low. Often a repurposed drug offers the best hope of a step change in treatment and therefore should not be forgotten or deprioritised. The views of clinicians on this issue have been exceptionally powerful. I will quote just a few. Harking back to the previous debate, we should listen to medical professionals when they are giving us advice that is, frankly, beyond dispute. Professor Anthony Howell, professor of medical oncology and research director of the Genesis breast cancer prevention centre at the University Hospital of South Manchester NHS Foundation Trust, says:

“Clinically-proven therapies to reduce the risk of breast cancer developing and spreading could bring a step change in breast cancer survival rates, but without the Bill we will not see a step change in the availability of these treatments.”

Professor Robert Coleman, Yorkshire cancer research professor of medical oncology at Sheffield cancer research centre, says:

“Repurposed bisphosphonate drugs could significantly reduce the risk of breast cancer spreading, and ultimately killing women, and would cost the NHS very little. However, without the Bill we are unlikely to see the wholesale change in prescribing behaviour that would be required to make these drugs routinely available.”

Dr Jeremy Chataway, consultant neurologist at the National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust, and St Mary’s hospital, Imperial College Healthcare NHS Trust, says:

“There are currently re-purposed medicines that have shown strong preliminary evidence that they could be effective in the treatment of multiple sclerosis (MS), however the UK is currently lacking a system by which old drugs can be re-licensed for new purposes. This Bill would create a mechanism to potentially provide access to medicines that could help tens of thousands of people with untreatable MS.”

It is also powerful to see that, as the hon. Member for Cardiff North pointed out, the Bill is supported by a whole spectrum of medical charities: the Association of Medical Research Charities, the Breast Cancer Campaign—I praise it for its absolutely phenomenal work on the Bill—the Multiple Sclerosis Society, Cure Parkinson’s Trust, Breakthrough Breast Cancer, Breast Cancer Care, Leukaemia CARE, the Alzheimer’s Society, the Teenage Cancer Trust, and Leukaemia & Lymphoma Research. All agree that we have a one-off opportunity to change the law and would like the results of research to be translated into clear, demonstrable, deliverable patient benefit.

We are talking about clinically proven drugs that cost virtually nothing but could bring a step change in survival rates. Zoledronic acid costs less than 5p a day per patient and could reduce the risk of death from breast cancer in post-menopausal women by 17%. This Bill is not about bringing untested drugs forward for use in the NHS—it is about ensuring that the drugs that can benefit patients, but in which pharmaceutical companies have no commercial interest, are available to treat myriad conditions and bring real patient benefits.

We must remember, though, that drugs are not the only tool to fight these conditions. With specific regard to cancer, we must ensure that bringing new drugs

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through is not to the detriment of patient access to radiotherapies and surgeries. We should remember that it is crucial that patients can get tested quickly if cancer is suspected. That is why a future Labour Government will guarantee that NHS patients will wait no longer than one week for cancer tests and results by 2020. Labour supports the principle behind the Bill, and we will support its Second Reading.

There is something else to consider. This Bill provides a simple remedy to an obvious and avoidable problem. It is underpinned by irresistible logic. To thwart it would represent an act of vandalism. Right now, our country is facing a collective nervous breakdown. Faced with internal separation and separation from the European Union, fear and loathing stalks this septic isle. Every day, people ask themselves, “What is the point of politics? What is the point of Parliament?” Unless we act to address these legitimate concerns, this place will drift towards not only irrelevance but illegitimacy. The purpose of each of us in this House, on both sides, is to make better the lives of the people who sent us here. That is our principal aim. I urge Members in all parts of the House, and the Government, to do what we were sent here to do—act to make life better and to demonstrate that Parliament, and politics, can work.

11.44 am

Mr David Nuttall (Bury North) (Con): I congratulate my hon. Friend the Member for Cardiff North (Jonathan Evans) on bringing this fairly short, but very important, Bill before the House. I am delighted to be named as one of its sponsors. I have to say that I am perhaps the least well qualified of them all. My right hon. Friend the Member for North Somerset (Dr Fox) and my hon. Friends the Members for Bracknell (Dr Lee) and for Totnes (Dr Wollaston) are all real doctors. The fact that they are real doctors and have felt it appropriate to lend their names to this Bill is, in itself, something of which the House should take careful note.

This Bill is required because when a drug whose patent has expired is found to be effective in treating a different condition from that for which it was originally licensed, doctors are reluctant to prescribe it because it is not licensed for its new use. As I understand it, the Bill would put the onus on the Secretary of State to take steps to secure licences for clinically proven off-patent drugs for their new use when no other body has taken on that role.

In essence, the Bill would put an end to a postcode lottery. Patients are left in limbo. Until they go to their GP, they do not know whether they are registered with a GP who is prepared to take this risk. The Bill would remove that postcode lottery and give security to millions of patients. If the process has been followed and the drug licensed for its new use, whichever GP they are registered with will have the confidence and security of being able to prescribe it for its new use.

I am pleased to say that the Bill has the support of many charities: the Association of Medical Research Charities, the Breast Cancer Campaign, Leukaemia & Lymphoma Research, Breakthrough Breast Cancer, the Alzheimer’s Society, the Multiple Sclerosis Society, Leukaemia CARE, Breast Cancer Care, and the Cure

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Parkinson’s Trust. That is a wide range of charities, all of which, for their own individual reasons, can see the sense of having a new procedure in place to bring back to life drugs that are found to be of new use but are off-patent.

The Bill also has the support of many of my constituents. I thank all those who have taken the time and trouble to write to me personally to express their support for the Bill and to urge me to continue to support it. I am delighted to do so.

Bob Stewart: A lot of us have received letters from constituents, including me, and I am absolutely delighted that we are here to support the Bill and get it through as fast as possible.

Mr Nuttall: I am grateful to my hon. Friend for that intervention.

This Bill will cut through the red tape that exists at the moment. It aims to get drugs off the shelves and into the hands of the patients who need them. I hope it receives the wholehearted support of this House.

11.49 am

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

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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.

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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

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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

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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.