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271WH Candour in Health Care 1 DECEMBER 2010 Candour in Health Care 272WH [Mr Robert Syms] 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,

273WH Candour in Health Care 1 DECEMBER 2010 Candour in Health Care 274WH 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. 9.50 am Tom Brake (Carshalton and Wallington) (LD): It is a pleasure to serve under your chairmanship this morning, Mr Gray. I congratulate my hon. Friend the Member

273WH<br />

Candour in Health Care<br />

1 DECEMBER 2010<br />

Candour in Health Care<br />

274WH<br />

given the number of clear statutory obligations already<br />

spelt out in the regulations themselves, rather than<br />

developed by supporting guidance.<br />

Option 1 would not have anything like the same<br />

impact as introducing a specific statutory duty, if it had<br />

any impact at all. The Department of Health would be<br />

trying to say, “This has always been the case, but we<br />

didn’t realise it and didn’t think it was important enough<br />

to make it clear.” That option would fail to deliver<br />

positive opportunities for sending a clear, unequivocal<br />

message about the importance of being open and would<br />

fail to support a major culture change. It would not deal<br />

with the bizarre situation w<strong>here</strong>by t<strong>here</strong> has already<br />

been, since April 2010, a statutory obligation to report<br />

anonymously to the national incident reporting system<br />

patient safety incidents that cause harm, but t<strong>here</strong> is no<br />

equal requirement to tell the patient or a relative. It<br />

would send the message that being open with patients is<br />

not important enough to justify a minor amendment to<br />

the regulations.<br />

Option 2, which I prefer and think should be given<br />

serious consideration by the Government, is to introduce<br />

a specific statutory duty by amending the existing CQC<br />

registration regulations. That would send a clear,<br />

unequivocal message about the importance of being<br />

open, which would support and underpin other initiatives<br />

to develop a more open and fair culture. It would be<br />

enforceable. The CQC has confirmed that it would be<br />

practical for it to enforce such a measure. Of course, it<br />

would be a condition of registration with the CQC. It<br />

would have real impact: boards and management could<br />

not escape noticing the change or recognising the need<br />

to comply. At the moment, even when doctors or nurses<br />

want to be open with patients, sometimes the management<br />

of PCTs or of hospitals are less keen. We must send a<br />

clear message so that the whole organisation undergoes<br />

a major culture change in how it deals with patients.<br />

Option 2 would balance out the existing statutory<br />

regulation w<strong>here</strong> it is a statutory obligation to report<br />

anonymously patient safety incidents that cause harm<br />

but t<strong>here</strong> is no equal requirement to tell the patient or a<br />

relative. It would not add to the regulatory burden on<br />

health care organisations, and I think that it would<br />

enjoy public confidence, which is a very important thing<br />

to have in this area. That option would be relatively<br />

easy to achieve. The con is that it would require a<br />

change in the regulations, so t<strong>here</strong> would possibly be<br />

some legislation.<br />

In my opinion, option 2 is the best way to go. It is not<br />

something that is supported only by a few oddbods;<br />

such a change has the support of many people, including<br />

many senior people in the medical profession. I know<br />

that t<strong>here</strong> are concerns about compensation and litigation,<br />

but the evidence from the <strong>United</strong> States, w<strong>here</strong> many<br />

insurers now do insist on a more honest system, is that<br />

when people receive an apology, they are less likely to<br />

sue. When they find out what happened to their relative,<br />

they accept that mistakes are sometimes made and they<br />

are less likely to pursue lengthy and costly legal action.<br />

People are sometimes pushed into legal action by the<br />

sense of injustice that they feel when their relative has<br />

undergone harm or perhaps died in the course of treatment.<br />

They feel a sense of injustice and are then driven to take<br />

that action. Of course, many of the costs to the NHS<br />

are from the legal fees, not necessarily the money paid<br />

out in compensation.<br />

I shall go through a list of some of those who would<br />

support a statutory duty of candour. I have already<br />

mentioned Sir Liam Donaldson, the ex-chief medical<br />

officer, who formally recommended a statutory duty in<br />

2003. Harry Cayton, chair of the Council for Healthcare<br />

Regulatory Excellence, has also supported such a duty.<br />

The late Claire Rayner, who was a doughty campaigner<br />

on behalf of patients, and a former nurse, supported it.<br />

Professor Aidan Halligan, the former deputy chief medical<br />

officer for England, who is currently chief of safety at<br />

Brighton and Sussex University Hospitals NHS Trust,<br />

is completely supportive of the proposal. T<strong>here</strong> is also<br />

Sir Graeme Catto, the immediate past president of the<br />

General Medical Council; Sir Donald Irvine, a past<br />

president of the GMC; Sally Taber, director of Independent<br />

Healthcare Advisory Services; Cure the NHS; Patient<br />

Concern; and Sufferers of Iatrogenic Neglect. T<strong>here</strong> is<br />

broad support in the LINks—local involvement<br />

networks—organisation for the view that what has been<br />

described is an important thing to do.<br />

In recent years, we have become aware of a major<br />

disaster at Stafford hospital. It has affected not one or<br />

two people, but hundreds of them. Of course, it has<br />

been the subject of much debate, many statements in<br />

the House and a lot of real concern, but had t<strong>here</strong> been<br />

a statutory duty of candour, the management of Stafford<br />

hospital would not have been able to get away with the<br />

poor standards of treatment and nursing and the fact<br />

that many hundreds of people lost their lives. Such a<br />

duty is a very important and practical measure, and if<br />

the NHS is to mean anything to the people of this<br />

country, being open and honest with those who have<br />

suffered as a result of what are sometimes unavoidable<br />

accidents is the best way to proceed.<br />

T<strong>here</strong> are clear benefits to introducing a statutory<br />

duty, and t<strong>here</strong> is an historic opportunity in that regard.<br />

I listened to my right hon. Friend the Secretary of State<br />

talking over the weekend about more transparency.<br />

Introducing such a duty would be a brave step, because<br />

all the advice from people in the Department of Health<br />

would be, “Careful, Minister. Don’t do anything that<br />

might have long-term costs.”<br />

However, in the modern age—an age of freedom of<br />

information, when thousands of documents appear on<br />

the internet—it is not unreasonable that a cornerstone<br />

of the NHS in this century should be that people are<br />

up-front and honest, and tell the truth when something<br />

goes wrong. Things inevitably do go wrong—not necessarily<br />

deliberately, but simply because that is the way of the<br />

world and medical science. People can then understand<br />

what has happened to their relatives.<br />

As my constituent Mr Bye said, “The start of the<br />

healing process after the loss of a loved one is to know<br />

the truth of what happened.” It is a very poor thing if<br />

Governments cannot tell the truth. One has to acknowledge<br />

that truth has not always been the essential component<br />

of the NHS that it should be. I propose that the Government<br />

give serious consideration to a statutory duty of candour,<br />

because that is the best protection for those who use the<br />

health service and for higher standards. The best protection<br />

is that all of us believe in honesty in public life.<br />

9.50 am<br />

Tom Brake (Carshalton and Wallington) (LD): It is a<br />

pleasure to serve under your chairmanship this morning,<br />

Mr Gray. I congratulate my hon. Friend the Member

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