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3 Apr 2003 : Column 1162—continued

6.19 pm

The Parliamentary Under-Secretary of State for Health (Ms Hazel Blears): I am grateful to the hon. Member for Galloway and Upper Nithsdale (Mr. Duncan) for raising in the House this evening the important question of patient safety. I join him in expressing my sadness at hearing about the tragic death of Tom Cooke, aged only 9 days.

The issues concerning the family and raised by the hon. Gentleman have been raised with the Department already. They have also been raised with the trust, which conducted a review of a number of issues that were raised by the family and which provided a report to the family on 8 May 2001. My officials have met Tom's mother and her representative and have worked to find a way forward to meet their concerns. The outcome of that discussion was an offer to set up a review that was independent of the trust concerned. The review would be conducted by an independent lawyer and would consider all the family's concerns—including their treatment by the trust before, during and after Tom's birth.

Although the review would have been conducted under the second stage of the NHS complaints procedure, the reviewer would have been entirely independent of the trust, with his or her final report being made to the chief executive and the board of the trust, as well as to the Department. Unfortunately, the proposal was rejected by the family. We were also unable to pursue an offer that was made by the chief executive of the trust to meet the family and their representative at the Department's offices to discuss the issues.

Mr. Duncan: I will try not to interrupt the Minister's flow. Does she accept that the independent inquiry that was offered was to be appointed by the chief executive of UBHT? There needs to be some avenue that is entirely independent of an errant trust; otherwise, how can patients trust the system?

Ms Blears: I understand that the offer was of an independent lawyer to review all the circumstances. That offer would have been a way forward, had it been accepted by the family, who could then have reported to the board allowing decisions to be made on the issues. The review would have been conducted in an entirely independent way. I am sure that we could have built in requirements to ensure that the review was independent. The offer remains open to the family. It is an avenue that I would urge the parties to pursue, because it is important that the issues are explored as fully as they possibly can be.

While discussions were going on to try to find a way forward, the family, through their lawyers, issued a pre-action protocol. That has the effect of staying proceedings under the complaints procedure, because we cannot pursue complaints or concerns using internal procedures at the same time as we are dealing with those same or related complaints and concerns by way of legal

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action. Now that we have the pre-action protocol, we cannot pursue the NHS complaints procedure—which is the procedure to use for dealing with matters in the health service.

There should however be no suggestion that the possibility of a review has been closed to the family. We have been entirely clear that the question of an independent review may be revisited to deal with any outstanding issues when any legal action has been concluded. There has been an allegation that negligence proceedings, if pursued, would deal only with some issues of concern to the family, and that there could be outstanding issues remaining. An independent review could pick up on any outstanding issues that were outwith the legal proceedings. It is entirely right and fair that that should be the case and that all the concerns that have been raised by the family should be investigated properly. That leaves open the question of the appropriate means of addressing a whole range of those concerns, but if there is going to be legal action, that legal action has to take place before we can see what issues outwith the legal action then need to be considered.

Mr. Duncan: Does the Minister accept that part of the reason for the pre-action protocol was to secure the information that the family needed from the files? That process is still not complete. The family still cannot be sure that they are in receipt of all the information that is being held—information that they are entitled to under the Data Protection Act 1998. They are entitled to information and that was part of the reason for instigating some of this action.

Ms Blears: It is right that the family, through their lawyers, should be able to pursue the information that they would need to prepare their case if they wished to embark on legal action. I do not know the individual circumstances of this case, but I want to say to the hon. Gentleman that the way in which he has presented this case today suggests that he has concluded that these matters have been investigated and decided. They have not been decided. I should be loth to conduct the debate with the sense that matters had been proven. The hon. Gentleman has used phrases such as "the matter was proved beyond doubt", or "the case is beyond doubt". Some of those matters have not been explored. The trust vigorously defends many of the allegations. I certainly do not know the truth about that individual case. Such matters will be explored through litigation, or properly investigated under the NHS complaints procedure or through the option of the independent review that was offered by the Department. I cannot say whether the allegations are proven. That is the basis on which I make my comments on the case.

It is right that I should point out that the trust concerned has an international reputation in the field of neonatal medicine and the care of children. In a recent review of clinical governance, undertaken by the Commission for Health Improvement, it was described as


with "good outcomes of care". Good-quality clinical governance has to be based on robust evidence-based medicine, as I am sure the hon. Gentleman agrees. That

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requires good research, and it is important that patients and their families understand the context in which such research takes place. I realise that that issue is of concern to the family.

Before I deal with the issues on patient safety that have been raised, I want to comment on several specific matters. First, there has been a suggestion that Tom Cooke was the subject of research without consent. That is an extremely important matter on which I cannot comment, as it is likely to come into any legal action. However, any treatment given to a child, including treatment given during a research trial, should be subject to the consent of a person with parental responsibility for that child. The Department of Health's guide on consent to examination or treatment makes it crystal clear that consent is a key requirement. I understand that, in this case, written consent was in fact given by both parents.

Secondly, the hon. Member suggested that social services involvement was inappropriate in this case.

Mr. Duncan: Before the Minister moves away from the research, will she confirm that no consent was given to the taking of the research video?

Ms Blears: I am not aware that specific consent was sought for particular elements of the research. My information is that written consent was given by both parents, but I do not know whether the different elements of the research were identified in the written consent; nor am I aware that it would be common practice to go through each such item when seeking consent. I am not in a position to provide the hon. Gentleman with that information. I am sure that an examination of the records would make clear the basis on which consent was sought and given. If there were an independent review of these matters, I am sure that point would be at the heart of the process.

I want to comment on the position of social services. Local authorities are responsible for decisions that they reach about individual children. Ministers cannot intervene in individual cases such as this, nor would it be appropriate for me to comment on cases involving social services that may become the subject of court proceedings, if that is indeed the route that the parents propose to take.

The Government and I appreciate that there can be serious consequences for an individual if allegations against him or her are unproven. Equally, that needs to be contrasted with the serious effects on children if allegations are not believed or not taken seriously. We all know of circumstances in which children's complaints have not been taken seriously, with terrible results. Although some allegations of abuse will inevitably be mistaken, misplaced, or even false and motivated by malice, we must never encourage a culture of non-interference, of turning a blind eye or passing by on the other side. We must not prevent people from speaking up and raising their concerns. Such matters need proper investigation, and to be confirmed—or not; and appropriate action should be taken. We must make sure that we listen both to children and to those who speak on their behalf.

The hon. Gentleman referred to the destruction of the video when the Department raised the matter with the trust. The Department was genuinely trying to find a

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way forward for the family, and wanted to establish whether it was possible to locate the video and a blanket that had belonged to Tom. The family specifically asked for the video of Tom not to be played again and to be passed to them with no copies left in existence. That message was relayed to the trust and, in fact, the video was deleted from the researcher's laptop.

The Department did not ask for that video to be destroyed; nor did we establish who owned it or whose decision it was to destroy it. Those issues have been discussed with Tom's mother, and they certainly could be included in any independent review. If Tom's mother or her adviser wants to make that matter the subject of a complaint, it can be pursued, but the Department certainly did not ask for that video to be destroyed; it was simply seeking a way to obtain it, so that it could be given back to Tom's mother, as she had requested.

The hon. Gentleman also referred to sharing information and said that, by making such a request, the Department could have been in breach of its duty of confidentiality to Tom's mother. Again, all the action taken by the Department in this case has been intended to try to find a way to resolve some of those very difficult issues for Tom's family in their relationship with the trust, but I do not think that a great deal of progress will be made until a review, investigation or litigation takes place to find out the truth of the allegations.

I want to reassure the House and the hon. Gentleman about how seriously the Department of Health views patient safety and about all the measures that have been put in place in the light of the Bristol report. After the Bristol report, we said that it was important to change

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the culture in the NHS, that there needed to be more openness and transparency, and that patients needed to be involved in the service, driving up standards.

The measures that have been put in place since the Kennedy report into the events at Bristol are very wide-ranging indeed. We have introduced new systems for patient and public involvement, patient advice liaison services, a new regulation for health care professionals to regulate the clinicians involved, the new independent inspectorate for the NHS, the National Patient Safety Agency, a new independent look at children's health services, and better leadership and modernisation in the service. There has been a real drive to ensure that we change that culture, because clinical governance, patient safety, openness and transparency are of the utmost priority in the health service.

Finally, I shall answer the hon. Gentleman's specific questions. He says that there is no independent mechanism to govern such disputes. Yes, there is: the NHS complaints procedure, which is the appropriate way to pursue such matters. I urge the hon. Gentleman and the family concerned to take that case forward. He asks how we can be sure that such things will not recur. We have not inquired into the facts, as I have explained, but all the measures taken following the Bristol report should ensure that we create a culture in which such matters can certainly be addressed, so that the NHS ensures—

The motion having been made after Six o'clock, and the debate having continued for half an hour, Mr. Speaker adjourned the House without Question put, pursuant to the Standing Order.



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