Candour in Health Care

John Pugh Excerpts

Wednesday 1st December 2010 Westminster Hall

[Mr Robert Syms (Poole) (Con)]

It is a pleasure to serve under your chairmanship, Mr Gray. I start with an apology: I cannot possibly do justice in this debate to all those who have suffered as a result of mistakes made by the national health service. I know that a lot of people are paying attention to this debate, and I will do my best to make the case for a duty of candour in health care, particularly a statutory duty. That would be progress.

In the House, if an hon. Member makes a mistake, however outrageous, everybody thinks that it is fair enough as long as they apologise quickly. I want to put forward the arguments for why honesty is the best policy and why it is best to acknowledge that mistakes are made in medicine and in the health service. That is part of the medical process. If people inform relatives, put their hands up and say, “We made a mistake,” that is a far better way to proceed than what seems to have happened in the past.

I would like to thank Peter Walsh from Action against Medical Accidents for assisting me as I prepared for this debate. Over the next few weeks, Ministers are due to decide on their preferred option for honouring a commitment to require openness when things go wrong in health care. During the 2010 general election, the Liberal Democrat manifesto stated:

“We will: require hospitals to be open about mistakes, and always tell patients if something has gone wrong.”

I do not often quote from the Liberal Democrat manifesto, but it is probably important to do so under current circumstances and the coalition. That pledge was also included in the coalition programme for government:

“We will enable patients to rate hospitals and doctors according to the quality of care they received, and we will require hospitals to be open about mistakes and always tell patients if something has gone wrong.”

That has clearly been lifted from the Liberal Democrat manifesto. The White Paper, “Liberating the NHS”, stated:

“We will enable patients to rate hospitals and doctors according to the quality of care they received, and we will require hospitals to be open about mistakes and always tell patients if something has gone wrong.”

That shows consistency running from the original Liberal Democrat manifesto to the coalition programme for government and the White Paper produced by the Department of Health.

Those commitments have been widely interpreted and welcomed as going some way towards the introduction of a statutory duty of candour in health care. Such a move has been advocated for many years by patient groups and others, including the ex-chief medical officer, Sir Liam Donaldson. Recently, Ministers have made it clear that as well as the possible introduction of an explicit statutory duty of candour, they are also considering not altering or adding to the statutory regulations, but merely issuing new or refreshed guidance to existing regulations contained in the Care Quality Commission (Registration) Regulations 2009.

It is implied that that is more likely to be the favoured option because there is an extreme reluctance to add or alter statutory regulation. I will speak about those two options, with a view to encouraging support for the introduction of a statutory duty of candour. Action against Medical Accidents has campaigned on that matter for a number of years, and representatives from that charity met with a Health Minister to try to put forward their case about the right way to proceed.

Put simply, the situation is unacceptable. It comes as a shock to most people, particularly patients and members of the public, to know that health care organisations are in breach of no rules and will face no sanctions if they cover something up or decide not to inform a patient—or, in the case of a fatality, their relatives—that something went wrong during an operation or health care.

Probably more by accident than design, the current system tolerates cover-ups and denials. People ask how that can happen in a modern, ethical health service, and the vast majority of people would agree that honesty with patients and their relatives is a moral and ethical requirement. There is an abundance of guidance on the issue, and best practice dictates that honesty, or being open, is the only course of action.

We know that there are a million incidents in the national health service each year, about half of which cause some harm. Within those cases, there are many serious incidents, so it is a large problem. When something goes wrong, most people want someone to explain what happened to their relative, mother, father or daughter. In part, such behaviour is part of the professional code for individual doctors and nurses, and is recognised as a central component of an open and fair patient safety culture. However, the failure to be open and honest when things go wrong is not uncommon.

Although many trusts or PCTs do act openly, a significant minority tell patients nothing. Something must be done to provide parents and relatives with a flow of information and an honest approach. Patients and their families are unfairly denied crucial information about what happened during their health care procedure, and they may never learn the truth. If they do, they are often deeply traumatised by the initial dishonest response to something going wrong. It is not unusual to find people who have spent decades campaigning under difficult circumstances to find out what happened to one of their relatives.

If patients suspect that something has gone wrong but have to fight to get the truth, they lose all confidence in the health care system and are more likely to take legal and disciplinary action. The NHS and health care organisations have failed to develop a learning culture and the ability to learn from errors and make things safer. Instead, they have developed a culture of defence or denial; they do not want to see themselves in the newspapers.

The situation in England became even worse when the previous Government introduced the Care Quality Commission (Registration) Regulations 2009, which came into force in April 2010. That introduced a statutory requirement on health care organisations to report anonymously incidents that caused harm to the national incident reporting system. However, it did not include an equal requirement on the organisation to inform the patient or their relatives.

Therefore, an organisation is not currently in breach of the regulations if it covers up an incident from patients or relatives. It may be bad practice, but there is no real sanction as long as it sends an anonymous report to the system. An organisation will be ticked off if it does not send a report for the purposes of national measurement, but it will not be ticked off it fails to be open and honest with a patient or their relatives. Let me draw the Chamber’s attention to a document produced by Action against Medical Accidents entitled “The need for a statutory duty of candour in healthcare.” It is a good article for those who want to look at the more detailed requirements involved.

I pay tribute to my constituents, Derek and Joan Bye. As MPs, we deal with many constituents, but Mr and Mrs Bye have had to put up with a horror story following the death of their daughter, Helenor Bye, who died on 27 April 1978 in south Wales. There was a catalogue of medical errors. The parents were lied to, records were altered and their MP, John Morris, then the right hon. Member for Aberavon, held a debate in the House of Commons on 27 November 1979, volume 974, columns 1253-64. He called for a public inquiry, although that was turned down.

The situation was compounded by the fact that body parts were taken from Helenor Bye, some of which have been returned over the years. The last time body parts were received by the parents was in 2005. They have been through the most horrific period because of what happened to their daughter, what happened subsequently and, more importantly, because all along the line they felt that they were being lied to and that people were not being open and honest. Mr and Mrs Bye have become doughty campaigners for a more honest and honourable system of health care. They have also campaigned on their concerns about the drug Epilim. I cannot do justice to that campaign today, but if any journalist wants to know what can go wrong, I advise them to look at the case of Mr and Mrs Bye. They have had a very rough time.

Action against Medical Accidents calls for a change in the law and the introduction of a statutory duty of candour. It is called “Robbie’s law” because of the case of Robert Powell, who died on 17 April 1990, aged 10. His parents have campaigned for over 20 years to try and get justice. Similar things happened to them, such as changed medical records, and there was a catalogue of events, but they still do not feel that they have justice. Their campaign has continued under several Secretaries of State. The case is currently with the Welsh Assembly, and Mr and Mrs Powell are waiting to hear whether there will be a public inquiry into what happened to Robbie. Will Powell, who feels passionately about putting right what happened to his son and getting to the truth, has been a doughty campaigner for a long time. I pay tribute to him.

All the people whom we are talking about are, in their own way, fighting for the truth, not only to find out what happened to their loved ones, but so that such things do not happen again to someone else. This debate is about setting out a context and a better way of doing things, so that we have a much more honest and honourable system and families do not have to spend 10, 20 or 30 years going through absolute hell. Mr Bye told me that the start of the healing process is learning the truth and knowing what has happened to one’s relative. That is a very important point.

The Government have two options to consider. They can go for an explicit duty or for more guidance. Ministers often go down the guidance route. When the NHS constitution was being debated in the previous Parliament, the then hon. Member for Wyre Forest, Dr Richard Taylor, who served with me on the Health Committee, raised the issue of openness and whether we could go further down that route. He was informed by the then Minister of State, Mike O’Brien, “No, we can do it all through guidance,” yet guidance so far has not produced the results that we need.

Department of Health officials met representatives of Action against Medical Accidents and other stakeholders on 16 November 2010, when the two options were discussed in some detail. I shall go through the pros and cons of both. Option 1 is no new statutory duty but refreshed guidance in respect of the existing CQC regulations. The pros of that are that it would require no new legislation or change in the regulations.

[Dr John Pugh (Southport) (LD)]

Is not the difficulty with guidance the fact that guidance is already in place and any other guidance would simply reiterate what it says? Clearly, guidance by itself is not doing the trick in this case.

[Mr Syms]

The hon. Gentleman makes a very important point, because we have to change the whole culture of the national health service and I am not sure whether guidance will do that.

An argument can be made that the existing CQC regulations, backed up by clearer guidance, could be interpreted as making it a requirement to be open. For example, regulation 17 has been cited. It says that service users should be provided with adequate information and support in relation to their care or treatment. The guidance could clarify that that includes telling them if something has gone wrong. However, one of the cons is that, as the hon. Member for Southport (Dr Pugh) said, that would be in effect no different from the current situation. Such guidance and the existing regulations already existed when the policy to introduce a requirement was agreed. They were clearly not seen as sufficient then.

Given that the Department of Health was of the firm opinion previously that the existing regulations, even with the guidance alongside them, did not constitute a statutory duty to be open with patients when things go wrong—because at that stage they were not supporting a statutory duty—it is hard to see how that could be credible now.

Such a measure would be unlikely to be enforceable. Lawyers would no doubt have a field day if, given the above, the CQC tried to impose sanctions on a trust based on such a tortuous and dubious interpretation when the opportunity to be clear and specific had not been taken. Even if such a measure were enforceable, the CQC would be unlikely to give it a high priority, given the number of clear statutory obligations already spelt out in the regulations themselves, rather than developed by supporting guidance.

Option 1 would not have anything like the same impact as introducing a specific statutory duty, if it had any impact at all. The Department of Health would be trying to say, “This has always been the case, but we didn’t realise it and didn’t think it was important enough to make it clear.” That option would fail to deliver positive opportunities for sending a clear, unequivocal message about the importance of being open and would fail to support a major culture change. It would not deal with the bizarre situation whereby there has already been, since April 2010, a statutory obligation to report anonymously to the national incident reporting system patient safety incidents that cause harm, but there is no equal requirement to tell the patient or a relative. It would send the message that being open with patients is not important enough to justify a minor amendment to the regulations.

Option 2, which I prefer and think should be given serious consideration by the Government, is to introduce a specific statutory duty by amending the existing CQC registration regulations. That would send a clear, unequivocal message about the importance of being open, which would support and underpin other initiatives to develop a more open and fair culture. It would be enforceable. The CQC has confirmed that it would be practical for it to enforce such a measure. Of course, it would be a condition of registration with the CQC. It would have real impact: boards and management could not escape noticing the change or recognising the need to comply. At the moment, even when doctors or nurses want to be open with patients, sometimes the management of PCTs or of hospitals are less keen. We must send a clear message so that the whole organisation undergoes a major culture change in how it deals with patients.

Option 2 would balance out the existing statutory regulation where it is a statutory obligation to report anonymously patient safety incidents that cause harm but there is no equal requirement to tell the patient or a relative. It would not add to the regulatory burden on health care organisations, and I think that it would enjoy public confidence, which is a very important thing to have in this area. That option would be relatively easy to achieve. The con is that it would require a change in the regulations, so there would possibly be some legislation.

In my opinion, option 2 is the best way to go. It is not something that is supported only by a few oddbods; such a change has the support of many people, including many senior people in the medical profession. I know that there are concerns about compensation and litigation, but the evidence from the United States, where many insurers now do insist on a more honest system, is that when people receive an apology, they are less likely to sue. When they find out what happened to their relative, they accept that mistakes are sometimes made and they are less likely to pursue lengthy and costly legal action.

People are sometimes pushed into legal action by the sense of injustice that they feel when their relative has undergone harm or perhaps died in the course of treatment. They feel a sense of injustice and are then driven to take that action. Of course, many of the costs to the NHS are from the legal fees, not necessarily the money paid out in compensation.

I shall go through a list of some of those who would support a statutory duty of candour. I have already mentioned Sir Liam Donaldson, the ex-chief medical officer, who formally recommended a statutory duty in 2003. Harry Cayton, chair of the Council for Healthcare Regulatory Excellence, has also supported such a duty. The late Claire Rayner, who was a doughty campaigner on behalf of patients, and a former nurse, supported it. Professor Aidan Halligan, the former deputy chief medical officer for England, who is currently chief of safety at Brighton and Sussex University Hospitals NHS Trust, is completely supportive of the proposal. There is also Sir Graeme Catto, the immediate past president of the General Medical Council; Sir Donald Irvine, a past president of the GMC; Sally Taber, director of Independent Healthcare Advisory Services; Cure the NHS; Patient Concern; and Sufferers of Iatrogenic Neglect. There is broad support in the LINks—local involvement networks—organisation for the view that what has been described is an important thing to do.

In recent years, we have become aware of a major disaster at Stafford hospital. It has affected not one or two people, but hundreds of them. Of course, it has been the subject of much debate, many statements in the House and a lot of real concern, but had there been a statutory duty of candour, the management of Stafford hospital would not have been able to get away with the poor standards of treatment and nursing and the fact that many hundreds of people lost their lives. Such a duty is a very important and practical measure, and if the NHS is to mean anything to the people of this country, being open and honest with those who have suffered as a result of what are sometimes unavoidable accidents is the best way to proceed.

There are clear benefits to introducing a statutory duty, and there is an historic opportunity in that regard. I listened to my right hon. Friend the Secretary of State talking over the weekend about more transparency. Introducing such a duty would be a brave step, because all the advice from people in the Department of Health would be, “Careful, Minister. Don’t do anything that might have long-term costs.”

However, in the modern age—an age of freedom of information, when thousands of documents appear on the internet—it is not unreasonable that a cornerstone of the NHS in this century should be that people are up-front and honest, and tell the truth when something goes wrong. Things inevitably do go wrong—not necessarily deliberately, but simply because that is the way of the world and medical science. People can then understand what has happened to their relatives.

As my constituent Mr Bye said, “The start of the healing process after the loss of a loved one is to know the truth of what happened.” It is a very poor thing if Governments cannot tell the truth. One has to acknowledge that truth has not always been the essential component of the NHS that it should be. I propose that the Government give serious consideration to a statutory duty of candour, because that is the best protection for those who use the health service and for higher standards. The best protection is that all of us believe in honesty in public life.

--- Later in debate ---

[Tom Brake]

I am sure that Mr Powell will be listening carefully to what is said and reading the remarks in Hansard later. That family have played a major role in bringing this issue to our attention and are working with AvMA to promote what they hope will become Robbie’s law.

The MPS has provided information that I think works against its case. Its research shows that, at the moment, a third of doctors are not prepared to be open and honest when an accident occurs. If so many doctors feel constrained from or concerned about being open when an accident has occurred, it supports the case for a culture of candour. The MPS also refers to states in the United States where there is a duty of candour and where it perceives that there may be a difficulty in enforcing the duty. In his remarks, my hon. Friend the Member for Poole made it clear that the Care Quality Commission has confirmed that it could and would enforce a statutory duty, and would be in a position to do so, if that were part of its regulations.

Another issue that the MPS raised, which we need to respond to, is that the proposed duty would not include near misses. It is arguing against the duty of candour, but at the same time saying that it would be a problem if near misses were not included. I understand that there is a general agreement that, although it might the norm for near misses to be reported to the patient, there would be discretion in cases in which reporting a near miss might cause unnecessary harm. There is recognition that the near miss issue needs to be addressed carefully.

One important fact is that, whether it is a duty or a requirement, it must apply to all health care organisations. If there was one thing in the coalition agreement that was slightly remiss, it was the fact that it referred only to hospitals, but there is a wider health body that we need to include. I am sure that the Minister will clarify in her response that the duty of candour, or the requirement, would need to apply not only to the patient but, sadly, if the patient has died as a result of the accident, more widely to include family members. It should not be strictly restricted to the person who had the misfortune of suffering the accident.

[Dr Pugh]

My hon. Friend mentions hospitals, but does he not accept that there are severe diagnostic failures at primary care level? Failures to refer can seriously imperil life, so they, too, need to be encompassed in the duty of candour.

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[Dr John Pugh (Southport) (LD)]

I thank the hon. Member for Poole (Mr Syms) for introducing this important and timely debate and for putting the Government’s dilemma so succinctly and accurately. I also pay tribute to my hon. Friend the Member for Carshalton and Wallington (Tom Brake), who has done as much as anybody in this place to raise the issues of a duty of candour and patient rights.

I do not know whether anybody caught Ian Hislop’s programme about do-gooders on the BBC this week, but in it he described the creation of the journal The Lancet. It was set up by a young doctor, who, among other things, wished to expose some of the deficiencies in the appalling surgical practices at that time. He was greeted with wholesale acrimony from much of the medical profession and he was successfully sued. That shows that there is resistance in most businesses and professions to acknowledging error.

In an excellent book published some time ago, the sociologist Erving Goffman suggested that people in all organisations—whether in health, business, teaching or policing—have a vested interest in supporting their colleagues, playing as part of a team and working together to minimise the reputational loss that their organisation can suffer. He analysed in particular detail how that can happen in health services right across the world, although it must be said that such things do not always happen for bad reasons. People have duties of loyalty to colleagues and a genuine concern for the organisation to which they belong—for its reputation and, where admitting to errors might seriously imperil it, for its very survival.

People inside organisations often recognise that mistakes will happen in their organisations. I have worked in the teaching profession all my life, and I have not always been very overt about my colleagues’ deficiencies, even when that sometimes has involved people suffering from alcoholic intoxication when they should not. There are therefore circumstances in which people cover up. There is also probably a belief in many organisations that the internal resolution of problems is the best way to proceed.

However, there is a huge downside; confidence is eroded by simply taking such a path. Worse still, false confidence persists; in other words, there are palpable and demonstrable errors in organisations, but nobody finds out about them until it is too late. Errors remain uncorrected, and poor performance is undeterred or, in some cases, it worsens.

That is where the duty of candour fits in, because it will, on a voluntary or simply a request basis, lessen the problems. There is an enormous amount of evidence not only that patients want the NHS to be candid with them, but that the NHS finds it hard to be candid. The Department of Health itself spoke of a culture of denial in the NHS—denial about error and, more seriously, about negligence.

No one believes that things will necessarily improve if nothing is done. No willing provider entering the frame will find it easier to be more candid than NHS organisations; in fact, they might have other motives for covering up. They might be answerable to others apart from members of the public, such as shareholders and the like. There is therefore a genuine concern to get things right.

Every Member of the House of Commons has probably come across a case, or several cases, where they feel that things have gone badly wrong. In my intervention on my hon. Friend the Member for Carshalton and Wallington, I mentioned primary care. A young man in my constituency—he was a relative of a friend of my daughter’s—went to his GP five times to complain of listlessness, a lack of energy and so on. He was brushed off with suggestions that he needed more rest and less stress. He was told that he perhaps had glandular fever, but no blood test was done. Eventually, when one was done, it was discovered that he had late-stage leukaemia. My children attended his funeral. That clearly was a failing.

I am also familiar with the ongoing case in my constituency of a TV soap star with a disabling condition that was brought on by receiving the wrong diagnosis and the wrong treatment. Similarly, I had the long-running case of a lorry driver with severe hypertension who was prescribed Viagra for other complaints, even though Viagra increases blood pressure. The thought of a lorry driver being prescribed a drug that can imperil not only him but members of the public is quite disturbing.

A woman in my constituency was falsely diagnosed with cancer and treated for it until, on the spur of the moment, she decided to request a check of the X-rays. Staff then found that the X-rays that they had been using, and which they had assumed were correct, were those of another person. That woman had spent a year in absolutely harrowing circumstances. More disturbingly, we do not know whose X-rays were assigned to her. Presumably, that person was not given the treatment that this woman was wrongly given.

Each of those cases leads to a prolonged complaints procedure, involving the ombudsman and the Care Quality Commission. In other cases, as other Members have indicated, there have been accusations that records have been altered. The whole process is inordinately cumbersome and difficult. To some extent, it exists because there is no candour where candour would probably be the solution.

On top of that, there are the systemic failures—the Mid Staffordshires, the Bristol heart babies and so on. To be fair, the Government recognise that this all comes with the territory of running the modern health service, and they are, to some extent, endeavouring to deal with the problems. Lots of things are going on, and we all want to applaud and support what the Government are doing on quite a few issues. We also applaud the previous Government for having initiated some of these things.

Incident reporting has got better, which is wholly desirable. Complaints are monitored, which is good and a move wholly in the right direction. There is more intensive recommending of procedures. The NHS is more of a learning body than it ever used to be; good practice is disseminated, while bad practice is identified and controlled. There is a general beefing-up across the piece of NHS guidance—particularly to the secondary care sector—about things not to do, things that will help and things that will avoid mishap.

Right across the profession, there is a constant stressing of professional ethics, as spelt out by the General Medical Council or whoever. In the past few days, we have had the phenomenon of publicising outcomes, with efforts by Dr Foster and, presumably, the Department of Health to see that outcomes are properly tracked.

[Mr Syms]

It is interesting that it is sometimes non-NHS organisations such as Dr Foster, rather than the NHS itself, that put their finger on the things that go wrong. The NHS is a wonderful organisation generally, but most of my constituents would be surprised that there is not a duty of candour already. One reason why we have not got one is that we find out that we do not only when we actually have a problem.

[Dr Pugh]

Dr Foster is probably doing what the Government will eventually get around to doing, and it will presumably prompt the Government to do that more expeditiously.

In some cases, private organisations may find it slightly easier than the Department of Health to progress such matters, but a lot of internal consultations and procedures will need to take place. Such organisations do not need to be answerable for how they treat the bodies within the NHS. A recent key development is the Government’s willingness to ensure immunity for whistleblowers, and to encourage whistleblowing when appropriate. That is a good thing, but there is evidence that whistleblowers still take genuine risks. For instance, they may not be sacked or redeployed, but they may experience difficulties getting employment elsewhere in the health service. I know of cases in which genuine whistleblowers have regretted the professional outcome that has resulted.

Such Government measures are self-evidently to the good, but they are not the same, equivalent to or a substitute for a duty of candour. Frankly, not all errors will be reported and not all complaints will get bottomed out. As others have said, guidance is ignored, professional ethics can be flexibly interpreted, and outcomes, whether published by Dr Foster or others, often come too late or are too general for individual cases. As I pointed out, although whistleblowers may have temporary immunity, that may not last. The Department of Health spoke of a culture of denial; but if such a culture exists, it needs to deal with it.

The argument against a statutory duty of candour—that, in a sense, the simple duty to be open with patients or relatives when requested is otiose or redundant—is not sustainable. It cannot be used as a genuine reason for Government reticence or hesitation. I therefore ask why the Government are hesitating when they are going ahead with so much else. A duty of candour is a disincentive to cover up, and it takes away the risk for whistleblowers.

Statutory duties are important. I give a parallel example. Local authority reporting officers, usually directors of finance, have the job of identifying when a council is spending money in a reckless and improvident way. They have always been in that position, but prior to there being a statutory duty to show the council the red card they were often bullied by the political establishment. As a result, they unwillingly had to consent to the deployment of council resources in ways that were reckless. Without a statutory duty, the same sort of thing can happen in health institutions. People can be put under a lot of pressure, and unless they can say, “But I have the statutory duty to report this,” they will find themselves in appreciable difficulties.

If we all believe in transparency—and we do at the moment—the duty of candour must be part of it. It keeps patients informed of their genuine situation. It is entirely in line with what the Secretary of State says again and again—it is a good quote, which I paraphrase, about no action being done to me without my consent. That is the gist of what he says. Why, then, do we hesitate, given the coalition agreement? The Liberal Democrats are clearly on board, and many Conservative Members genuinely support it. Indeed, the coalition agreement is emphatic.

I have the perception that somewhere in the background in the Department of Health the voice of Sir Humphrey can be heard. Just as the Minister is about to initiate a statutory instrument on the subject, someone in the civil service—I do not accuse the permanent secretary—says, “That is a very brave decision, Minister.” The Minister is thus persuaded that his decision may not be as positive as appeared at first sight.

If one thinks about it, a candid admission of error or, worse still, of negligence is intrinsically damaging and potentially expensive. I have seen stats suggesting that the potential damage to the NHS, if every person who had a complaint pursued it legally to the nth degree, might be a bill of something like £10 billion. That is half of the internal savings that the NHS needs to make.

However, the stats also show that litigation costs against the NHS are far less than that. The unnerving feeling inside the Department of Health is that if it goes for a statutory duty—I believe that it should—that picture might change dramatically, as the number of complaints that end up in successful and expensive litigation mushrooms.

[Tom Brake]

Does my hon. Friend agree that, because the information is now in the public domain, another consequence might be that the number of accidents will reduce because people will take the necessary action to ensure that such things do not happen?

[Dr Pugh]

One sincerely hopes so. I was a member of the Committee that considered the NHS Redress Act 2006, which I believe is not yet in force. The sort of thinking suggested by my hon. Friend was behind that Act, but the same forces that are delaying the duty of candour are probably responsible for delaying its implementation. I cannot recall there being much dissent among the parties as to the merits of that legislation. The idea was that complaint costs would reduce if we had an open policy of admitting errors, patients surrendering none of their legal rights but simply being given the apology and the explanation that they wanted.

As the hon. Member for Poole said, people who wish to pursue a complaint against the NHS if they believe that their treatment has gone wrong are not looking for money. They are looking not only for an explanation and an apology; they are looking for an assurance that whatever happened to them or their relative will not happen to others.

Prior to the NHS Redress Act 2006, we looked hard at the costs of litigation in the NHS. Yes, it cost the NHS a lot of money; and, yes, something could have been done to reduce it. The really depressing thing, however, was that the bulk of the money went into the lawyers’ pockets on either side. The NHS is not about helping to boost lawyers’ profits.

The 2006 Act seemed to offer an alternative to litigation, which everyone would support, but the nagging fear in the Department of Health was that it would become a platform for litigation—that if someone admitted a fault it might be a sound basis for taking legal action. Are those fears well grounded? I believe that we do not precisely know, but we all have our own feelings on the subject. People cite the Michigan case in the United States, where they went outright for a duty of candour, and litigation costs to the health service have declined.

The duty of candour is not something that can be piloted, and once it has been done one cannot withdraw it. To go ahead with it is almost an act of faith. I am very keen on the concept of evidence-led policy, but I see evidence-led policy debates taking place in the Department of Health. If we go ahead with a statutory duty of candour—and I firmly believe that we should—it will be a statement about what sort of NHS we want.

I conclude by quoting Sir Liam Donaldson, the former chief medical officer for England. He said,

“To err is human, to cover up is unforgivable”.

Regardless of the risks, I doubt whether the Government want to do what is unforgivable.

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[The Parliamentary Under-Secretary of State for Health (Anne Milton)]

It is a pleasure to serve under your chairmanship for the first time Mr Gray congratulate my hon. Friend the Member for Poole (Mr Syms) on securing this debate. As Chairman of the Regulatory Reform Committee, he is no doubt acutely aware of some of the issues that exist around regulation, not least those that exist around the duty of candour. His humility and recognition of the impossible task that we face here today—to truly reflect the pain and suffering of those who have suffered as a result of medical harm—does him considerable credit.

We take candour and openness in the NHS extremely seriously. Everybody does, because it is a vital issue. As anyone who has ever been treated knows, a health care system is not just about how quickly someone is seen or how quickly their stitches come out; it is also about trust. Trust is fundamental—between patients, the patient’s family and health care professionals—and we must do everything we can to ensure that that trust is upheld.

As my hon. Friend may be aware, one of the early references to a statutory “duty of candour” was included in “Making Amends”, a 2003 report, which I know hon. Members have referred to. It was a consultation paper from the then chief medical officer, Liam Donaldson, and it set out proposals for reforming the approach to clinical negligence in the NHS, suggesting

“a duty of candour requiring clinicians and health service managers to inform patients about actions which have resulted in harm”.

The paper also proposed to foster an environment of openness and honesty among all NHS staff; it encouraged “integrity”, which is a word that we perhaps do not use often enough, and it proposed exempting those who report adverse events or medical errors from disciplinary action, unless there are serious extenuating circumstances. It is a key belief of the coalition, and I would hope all Members of the House, that the focus should be on the performance of the organisation rather than on penalising individuals who bring matters of concern out into the open. The hon. Member for Southport (Dr Pugh) has already mentioned whistleblowing. I think that the point is that this debate is not necessarily about the protection of whistleblowers or a right to whistleblow; it is perhaps about a duty to whistleblow.

It is important to note the good work that is currently being done to promote candour. The previous Government should be congratulated for providing staff with advice and support to help them to communicate with patients, their families and carers following harmful incidents. The Health Act 2009 requires all NHS organisations to be aware of the NHS constitution, which places a duty on NHS staff to acknowledge mistakes, apologise for them, explain what happened and put things right. The professional codes of practice for doctors and nurses contain a similar duty.

As somebody who trained as a nurse and worked in the NHS for 25 years, I think that professional codes of practice and professional standards are not talked about often enough. We look for someone to blame: we look for the organisation to blame; we look for the board to blame, and we look for the chief executive to blame. What we do not talk about is individual professional standards and I feel particularly strongly that we need to do everything that we can to raise those standards right up.

The National Patient Safety Agency has been running its own campaign to promote candour in the NHS, as the hon. Member for Leicester West (Liz Kendall) said. That campaign, entitled “Being Open”, is a long-term process rather than a short-term push. It encourages the provision of verbal and written apologies to patients, their families and carers; it promotes continual communication with those involved in incidents, and it requires thorough record-keeping of all “Being Open” discussions and documents.

However, we all know that still more needs to be done, as hon. Members have said and as I know myself from my own constituency casework; I have a number of people who have continually fought to try to get the truth about what happened to their relatives. The recent White Paper, “Liberating the NHS”, states that

“we will require hospitals to be open about mistakes, and always tell patients if something has gone wrong”.

It is quite simple: we expect the NHS to admit to errors; apologise to those affected, and ensure that lessons are learned to prevent errors from being repeated.

In one year, the NPSA receives notification of more than one million incidents. Most of those incidents result in no harm and we welcome the high level of reporting. However, the incidents that result in harm obviously cause distress and anguish for the patients and families involved. In those cases, it is even more important that the lessons are learned and that organisations are open with those who have been affected.

[Dr Pugh]

I want to ask about the future of the NPSA. If it is going to be brought within the national commissioning body, will a Chinese wall be established between the NPSA and the other operations of that body? It crosses my mind that risks can allegedly be increased or decreased by commissioning decisions themselves.

Under those circumstances, the NPSA has got to be free to impute itself, as it were, if the national commissioning body is going to be part and parcel of the same organisation. So, can the Minister assure me that there will be no conflict of interest when the NPSA is placed within the national commissioning body, which may itself—through its commissioning procedures—be one of the risk factors?

[Anne Milton]

The hon. Gentleman is absolutely right. That is terribly important. It is not only important to have Chinese walls and be seen to be separate; it is important to be separate. I will come to that point in detail in a minute.

Measuring openness is not as straightforward as measuring reporting. We welcome high levels of reporting, as they are an indicator of an open and supportive culture of patient safety, but there are still reasons why people within the NHS and organisations shy away from openness. Without a doubt, professionals who strive for excellence are reluctant to admit errors. The higher up the tree one is, the harder it is to say, “I’ve made a mistake.” All of us face that issue in our professional lives.

People may have unfounded concerns about possible admissions of liability, even though apologising when something has gone wrong is not in any way an admission of liability. The fine line between the two sometimes prevents people from saying what relatives want to hear: “I am so sorry this happened.” That is not necessarily saying, “I have made a mistake.” It is such a shame when professionals resort to a defensive stance, often encouraged by myths about where liability lies. Also, at times, they may fear reprisal, blame and even bullying.

We are considering options for introducing a requirement for openness and will make a decision in due course. The hon. Member for Southport felt that we were hesitating, and was concerned about possible evidence of Sir Humphreys in the Department. We are considering, not hesitating. It is important to get it right. Members have discussed the three options, but I will run through them quickly and mention a few relevant issues.

The first option is using what is in the existing Care Quality Commission registration requirement regulations. It is already mandatory for NHS trusts to report all serious patient safety incidents. We could also require organisations to demonstrate that they have met the openness requirement, which would not require new legislation. It makes sense to use existing means to detect and investigate trusts that are not as open as they should be. The counterargument is that that approach is not specific enough, and that the wording of the guidance would need to be made more explicit. We have seen many cases in which guidance has failed.

The second option involves introducing a new legal, statutory duty of openness explicit within the CQC regulations. That would send a clear signal about the importance of openness and provide patients and campaigners with a single clear duty that they could use to demand full disclosure. However, the Government want to create new legislation only when absolutely necessary, although when necessary, it should be done. We would need to ensure that any new legislation or new approach was not counter-productive. We want to make it easier for staff to come forward; we do not want new legislation to have unintended consequences.

The third option involves incorporating an openness requirement into the new NHS contractual, performance and commissioning processes, to which the hon. Members for Leicester West and for Southport referred. It certainly appears possible to pursue openness through the new commissioning arrangements. For instance, it could be written into standard NHS commissioning board requirements that providers commit to being open. The hon. Member for Leicester West asked whether the NHS commissioning board would have time to take a role on patient safety. In many ways, safety underpins all commissioning decisions. Any decision on any service commissioned should have safety wrapped around it. That is fundamental.

As with any complex matter, each of the options has its pros and cons. It is imperative that a decision on the issue is not rushed. I reassure the hon. Lady that campaigners and organisations have good access to officials within the Department, and I am sure that all their views will have been taken into account when a decision is made, because we are aware of the importance of getting it right. It is terrible to think that the first duty of the NHS is to do no harm. Safety wraps around everything that we do.

The hon. Lady also mentioned the decision to abolish strategic health authorities. I understand that SHAs are the performance managers of trusts, yet that did not help in Staffordshire. In many ways, bringing commissioning decisions closer to the patient within general practice will mean that decisions about care and its consequences rest where they should.