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Lord Lucas: My Lords, before the noble and learned Lord sits down, does he share my noble friend Lord Waddington's interpretation of his Motion?
Lord Williams of Mostyn: My Lords, the Motion is perfectly plain. The instruction is, by 8th July, to make recommendations—and I underline the following words—"for approval by the House, as to the implementation of the Report".
All this rests with the House.
7.57 p.m.
Lord Denham: My Lords, I am grateful to the noble and learned Lord for what he has said. My main concern in this was seeing that the conventions of the House were not disturbed. The two that particularly worried me over this matter were: first, that a take note Motion had an instruction tacked on to it, which has never been done before and is certainly against the spirit of the Companion; and, secondly, it had never been done before and I thought it dangerous to do it on this occasion to set a time limit for the Procedure Committee.
It has been a very friendly debate on the main topics of the report. I do not think that I managed to get a great deal of support among my noble friends and others who spoke to my particular worry over the time limit and the Procedure Committee. I think in that case it would probably be unwise for me to divide the House without support going across the debate. So, I beg leave to withdraw my amendment.
Amendment, by leave, withdrawn.
On Question, Motion agreed to.
Health Service (Control of Patient Information) Regulations 2002
8 p.m.
The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath) rose to move, That the draft regulations laid before the House on 26th March be approved [25th Report from the Joint Committee].
The noble Lord said: My Lords, we have returned time and time again in this Chamber to debate how to get the balance right between medical confidentiality and the need to conduct medical research and epidemiological studies. Striking a balance between individual rights and the interests of society more generally is an issue of the greatest importance.
There can be no doubt of the importance of patient confidentiality. We must also be clear that confidential patient information is currently used by the health service to support a wide range of purposes. Those extend well beyond the information sharing needed to support care and treatment. They certainly extend well beyond what patients understand to be the case. Without understanding, there cannot be consent.
The Government are committed to openness and to developing relationships between service providers and service users based on trust, partnership and informed consent. We must recognise that that represents a considerable challenge. For many years, the NHS has been run along paternalistic lines, with managers and clinicians making decisions about what is best for patients with little or no input from patients and their families.
Confidential medical records have been rightly seen as a valuable resource—to be protected, yes, but also to be exploited for the wider public good. Indeed, much good has come from that. We need to bring services in line with the expectations of patients, with the requirements of law and with the high standards that we have set as our goals. We need to put in place systems and processes that support the scientific community and deliver a public good while respecting patients' rights and preferences.
But it is important to acknowledge that it will take time to implement those changes. We cannot simply stop medical research or clinical audit, abandon all the valuable work on cancer that is underway or leave aside our responsibilities to monitor and sustain public health while we take time out to build systems and devise ways of working that meet the standards that we now know should apply. We have yet to determine whether we can support every key activity through consent procedures or new anonymisation techniques. This may not be the case—some very important work may always need the support that the regulations provide. I know that a number of noble Lords who work in medical research fields already believe that to be the case and would prefer stronger support than the regulations provide. But it is only right that every activity is robustly tested clearly to establish genuine need. That itself will take time.
So we have to manage change in a way that supports essential activity while the building blocks for improvement are put in place. We cannot risk some of the most important health service work programmes grinding to a halt because they are unable at present to meet required standards. We also do not think it appropriate for NHS staff, who are working hard in the interests of us all, to bear the burden of knowing that they are working without a robust basis in law for what they do.
Those were the key reasons for including Section 60 in the Health and Social Care Act 2001. I remind your Lordships that Section 60 is intended largely as a transitional measure. It will allow essential NHS activities that rely on access to confidential patient-identifiable information to continue while the NHS devises procedures to satisfy the obligations of confidentiality—obligations that we fully accept should apply. Section 60 is driven by health service requirements, with support being provided only to those who can demonstrate both justification and need.
It may be helpful if I summarise the requirements and safeguards introduced by the Health and Social Care Act 2001. They were as follows. Use of the power provided must be approved by Parliament through the affirmative procedure. The Data Protection Act 1998 continues to apply. The activity supported must be a medical purpose. The activity must aim to improve patient care or otherwise be in the public interest. There must be no reasonably practicable alternative way of achieving the medical purpose—with this in mind, there must be an annual review of any regulations laid. An independent statutory watchdog must be created: the Patient Information Advisory Group.
It is important to bear in mind all those provisions, as the safeguards and requirements introduced through the regulations add to and complement those in the Act. The Patient Information Advisory Group, in particular, has proven to be a conscientious and demanding group, as noble Lords who have read its published advice will be aware. That is a good thing. The group will play an increasingly important and visible part in the work to set things right in respect of confidentiality and consent in the health service.
The group has considered six applications for Section 60 to date and, having also taken note of the responses generated by wider consultation, advised that support be offered to two of them. I shall turn to those in a moment. However, the group also advised the Secretary of State that an application on behalf of all disease registers was too broad in its application and that applications by the Health and Safety Executive, by a renal register and on behalf of a major research project were not clear on the issue of why consent could not be obtained. We have followed the group's advice and rejected those applications.
We are confident that the advisory group will not support any activity that has not been fully justified on the grounds that it is of benefit to patients and the public and that the support of Section 60 will be provided only where it is truly needed.
I turn to the regulations. They are essentially in two parts. The first part outlines two specific areas of work that require access to patient-identifiable information where, through consultation and consideration by the independent Patient Information Advisory Group, it has been demonstrated that common law requirements for consent cannot currently be met. The two areas are: the work carried out by cancer registries to monitor the incidence of cancer and measure mortality and survival rates; and work to tackle risks to public health such as the communicable disease surveillance and prevention undertaken by the Public Health Laboratory Service and other contributing agencies.
I am sure that the House will agree that those are important activities that we should support. Reporting on the future of cancer research, the Science and Technology Select Committee in another place stated in March that,
- "unless legislation is put in place swiftly, medical research will be irretrievably damaged".
- "These regulations are essential if we are to avoid compromising public health. If our current surveillance systems are damaged, then there is a real danger of unnecessary cases of infectious disease and even deaths".
- "a clear public health justification for the practice of effective communicable disease surveillance".
The second part of the regulations, usually referred to as class support, outlines a small number of potential justifications for limited access to confidential information where it is likely to be impractical to gain consent. The proposals were developed primarily by the Medical Research Council in relation to the needs of researchers and others of whom they have become increasingly aware. Class support is therefore intended to support medical research, but will also be of great value to those engaged in epidemiology and the audit of the care that the NHS provides. The need for such limited support is service-wide and each and every example could not realistically be brought before this House.
Instead, it is proposed that responsibility for approving class support should rest with the Secretary of State, guided appropriately by the independent Patient Information Advisory Group. I will say a little more about the approval process in a moment, because I know that it has been a cause of concern.
Specifically, class support may enable staff to access records in order to remove names and addresses and other identifying details. In the near future, electronic records will be able to do that automatically, but that is not currently the case. The expertise to select
appropriate research subjects and the resources effectively to anonymise records are often simply not available locally.
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