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Baroness O'Cathain: My Lords, the word "mischievous" is not right. I have obviously not discussed the allegation with my noble friend Lord Howe—the noble Lord has only just made it—but he is not one to be mischievous. Even I, reading the regulations, find them slightly difficult to understand. I am sure that my noble friend did not find them difficult, but I know, from his integrity, that he would not have sought to be mischievous.
Lord Clement-Jones: My Lords, of course I withdraw the word "mischievous" in those circumstances, and I understand the reason that the noble Baroness raised the issue. But, certainly, a plain reading of the regulations in relation to the Act does not produce the result that the noble Earl put forward in his opening speech.
A degree of folklore has surrounded this matter. I have found the debate extremely constructive. I believe that the contributions have been considerably more constructive than those in the debate in the other place. That debate was certainly not for the squeamish, as those who had the pleasure of reading Hansard will know.
Somehow the protection of personal information seems to have been set against the needs of medical research and public health, and so on. That seems to me to be an entirely false juxtaposition. The essence is to achieve a balance, and I believe that the regulations succeed in doing that.
My noble friend Lady Northover raised a number of issues for clarification by the Minister. I hope very much that he will give the assurances that have been sought. But the bottom line is that I do not consider that the regulations give what has been called "carte blanche" to the Minister.
As my noble friend pointed out, as the begetters of Section 60 of the principal Act in its current form, we start from the basis of Section 60 and the safeguards
that it provides. We have examined the regulations in detail and, subject to a number of key assurances which I hope the Minister will give, we are satisfied that the regulations are proportionate. We believe that the noble Earl's amendment will have a devastating effect on the regulations. Many uses of personal information other than for cancer disease registry purposes and communicable diseases are of crucial importance.I am sure that, quite apart from hearing some of the wise words of well-qualified noble Lords during the course of the debate, many of your Lordships will have received the briefing from the MRC. People have worked through examples with me. For example, the Gulf War-related research and the research relating to leukaemia in the area of Sellafield could not have been carried out with purely anonymised data. There has also been recognition of new variant CJD and its relation to the BSE epidemic.
There are many other aspects: for example, ways of reducing cot deaths; identification of adverse drug reactions; and, as the MRC says, identification of the healthcare needs of special groups in society, such as the elderly. A great number of areas would not be covered by the regulations if the amendment were carried. It is important that Regulation 5, which gives the Secretary of State powers, subject to considerable restriction, is agreed to.
I very much hope that the Minister will give the assurances that are sought, particularly in relation to the role of the PIAG and the publication of its report and decisions and the advice given, and so on.
I believe that the Minister needs to address what he believes "other risks to public health" are. With regard to the ordinary meaning of those words, it seems to me out of the question for mental health conditions to be covered by that wording. It is also important that the Minister clarifies the circumstances in which he will approve research under Regulation 5 and that he clarifies what type of advice he will take within the Department of Health, quite apart from the PIAG.
Apart from the medical profession, who else will be subject to the contractual duty of confidentiality? What type of contract does the Minister envisage will be entered into by, for example, civil servants and those who act with the various agencies which may process that information? What review process for the regulations will be followed by the Secretary of State in 12 months' time? Will it be an open and transparent process? Will there be an opportunity for debate?
There is also the very important issue of informing patients that their information has been processed. I believe that the Minister should spend some moments explaining how patients—or, at least, doctors—will be able to tag their medical notes in some shape or form so that it is clear that their information has been processed by researchers.
Finally, it is important that the Minister also gives an assurance about genetic information. It is important to know that there can be no question of genetic information being subject to the terms of these
regulations. Subject to those assurances, and to those sought by my noble friend Lady Northover, we on these Benches wholeheartedly support the regulations.9.45 p.m.
Lord Hunt of Kings Heath: My Lords, this has been a high level debate and recalls the long hours during which we debated Section 60 of the Health and Social Care Act in the previous parliamentary Session. I can assure the noble Earl, Lord Howe, that I agree with him. The relationship between the patient and the doctor is of critical importance. No one can be in doubt about the importance of patient confidentiality. Nor can anyone be in doubt that the NHS has a long way to go to get the matter absolutely right.
The noble Baroness, Lady Northover, suggested that for many years the NHS had been run along somewhat paternalistic lines, in which managers and clinicians made decisions about what they thought was best for patients with little or no input from patients and their families. We have to change that culture. That is why we published a statutory instrument last December to reform the way in which the NHS uses patients' confidential information. The issue raised by the noble Baroness, Lady O'Neill, of linkage and leakage is important in taking forward that strategy. Equally, we have to acknowledge that with the best will in the world, it will take time to implement those changes.
We simply cannot stop medical research or clinical audit or abandon all the valuable work on cancer that is taking place. We cannot forget or abstain from our responsibilities to monitor and to sustain public health, while we take the time that will be necessary to build systems and to devise ways of working that meet the standards that we now know should apply. In that context the noble Baroness, Lady O'Cathain, made a persuasive point.
The noble Earl, Lord Howe, asked about cancer registration, which I believe was answered by the noble Lord, Lord Turnberg, and the noble Baroness, Lady Finlay. He made a most persuasive case as to why complete sets of data are needed. That is critically important to the work of registries and researchers.
The noble Lord, Lord Soulsby, mentioned surveillance and epidemiological studies and the work that his Select Committee undertook into antibiotics. I acknowledge that vital work. It is clear from the evidence given by PHLS to the Patient Information Advisory Group that PHLS is making significant progress towards meeting the requirements of the Caldicott report, that it limits the use of patient identifiable data and that it uses pseudonymisation techniques wherever possible. It removes and destroys all patient identifiable information from its records after two to five years, with any departure from the norm justified in writing to the Caldicott guardian. I believe that it is right that we should acknowledge the progress being made by PHLS.
In his introductory remarks the noble Earl, Lord Howe, referred to some of his concerns about regulations and the way in which they were drafted.
Perhaps I can echo a point made by the noble Lord, Lord Clement-Jones. It seems to me that in focusing on the regulations he overlooked the overriding requirement of Section 60 of the Health and Social Care Act.Perhaps I may repeat myself. First, we are debating an affirmative order today. The Data Protection Act 1998 continues to apply. That activity has to be supported for a medical purpose. It must be to improve patient care or otherwise be in the public interest. Furthermore, there cannot be a reasonable practical alternative way of achieving the medical purpose. With that in mind there must be an annual review of any regulations laid. I believe that those are significant safeguards which need to be read alongside the regulations we are debating today.
The noble Earl, Lord Howe, raised the issue of why the phrase "other public health risk" is used in the regulation. He implied that we needed a tighter definition. It is, as noble Lords have suggested, impossible to know in advance what may constitute a risk to public health. The risks that we may face in the future are often unknowable today. Those working to monitor and safeguard public health must be free to act quickly and effectively when a new risk is detected. The alternative is to provide a long list of possible risks that would inevitably fall behind what is needed.
Noble Lords know that I am not fond of lists. With regard to the issue of emergency powers, the noble Earl, Lord Howe, suggested that because there were emergency powers one did not need that regulation. I think that he was referring to the notifiable disease regulations rather than emergency powers. In those regulations there is an out-of-date list of diseases. It suggests to me the problem always of lists. That is why the PHLS sought the flexibility to react to future risks.
The noble Earl, Lord Howe, also raised the question of whether counselling and support, as described in Regulation 2(1)(e)(ii) is consistent with Section 5 of the Act. I am advised that it is consistent. I am advised that both the Health and Social Care Act, and the Data Protection Act to which it closely relates, distinguish between a range of medical purposes, including diagnosis, preventive medicine and care and treatment. Analysis of risk for patients not yet diagnosed with a condition may support diagnosis and may lead to preventive medicine. Prior to a diagnosis being made, counselling and support are not the same as the care and treatment that may follow.
A person who has a number of relatives who have had cancer goes to see his doctor. As a result the doctor may contact the cancer registry. The registry may provide details of family history, normally after seeking consent but sometimes not when it is not practical. That person might receive counselling and support. But that would be before they had been possibly diagnosed and certainly before they had been treated. That is somewhat complicated. I should be happy to write in detail to the noble Earl, Lord Howe, on the matter.
So far as concerns genetics, of course I accept the point made by the noble Lord, Lord Clement-Jones. He will know that the Human Genetics Commission
reported on a number of important matters on 21st May. It states that it intends to monitor the use of the Section 60 powers and seeks to work with the Patient Information Advisory Group (PIAG) in relation to any application for personal genetic information. We very much support those discussions and would encourage PIAG to respond positively to the request for discussions from the Human Genetics Commission.The noble Earl, Lord Howe, also asked whether the power to fine people is in contravention of Article 6 of the European Convention on Human Rights. I am advised that it is not, because the Secretary of State must proceed through the courts. Those fined have an opportunity to defend themselves in court. Therefore, it is my advice that that matter satisfies the ECHR requirements.
I was asked by the noble Earl, Lord Howe, and the noble Lord, Lord Clement-Jones, how patients would know whether their confidential information had been used—for instance, would it be recorded on their records? Of course, patients must in general terms be informed about the use of information and its disclosure to satisfy the requirements of the Data Protection Act 1998. I can assure both noble Lords that guidance will be provided on how best to satisfy the requirements in relation to Section 60. NHS bodies will be advised to keep records of disclosures.
Turning to the questions raised by the noble Baroness, Lady Northover, I can assure her that the regulations do not apply only to NHS data, but to all confidential patient information. The regulations do not apply to Scotland or Northern Ireland, but we shall encourage officials to work with each other to encourage consistency of approach—consistent, as ever, with the principles of devolution, which I know that noble Lords on the Liberal Democrat Benches usually support to the full, except when it comes to teaching research in Wales.
The noble Lord, Lord Clement-Jones, answered most effectively the point raised by the noble Earl, Lord Howe. The noble Earl mentioned Regulation 3(3) relating to public health surveillance and whether the people allowed to process information would be engaged by government departments or other public bodies. Yes, the regulation does allow that, but the class of people who are allowed to process information is also limited by Regulation 7(2). That regulation ensures that confidential patient information can be processed only by those who are health professionals or under that a similar duty of confidentiality.
I acknowledge to the noble Earl, Lord Russell, and to the noble Baroness, Lady Northover, that the compromises and agreements that we reached after our debates about the establishment of a statutory advisory group have been well founded. The noble Earl, Lord Russell, spoke at every stage of the passage of the Health and Social Care Act 2001 of the model of the Social Security Advisory Committee. He is right. The PIAG has shown professionalism and integrity. The Government have also shown their good faith by listening to the advice of the PIAG.
I accept that we could do better in terms of ensuring that the work that they do and the advice that they give enters the public domain more effectively. I give an assurance to the House that I will discuss that with officials and the chair of the PIAG. It is in the interests of all those involved, whether they take the view that the regulations are draconian or that they are far too bureaucratic, that the advice of the PIAG is given the fullest publicity. I accept the point raised by the noble Baroness, Lady Northover, that not only must the papers be as accessible as possible, we must ensure that the PIAG annual report is full and readable. Again, I will ensure that that matter is discussed with the chair of the advisory group.
I know that my noble friend Lord Turnberg and the noble Baroness, Lady O'Neill, have made some telling points about the needs of the research community. I hope that they will be pleased about the certainty that the regulations will allow. I also understand that they feel that the time taken to approve the regulations has been too long and their worries about research blight. But I am convinced that the advisory group had to get it right. We took time to appoint the group, but we have appointed first-rate people as a result. Now that we have a proper framework and there is greater certainty, I hope that the research community will understand why it has taken so long to process the first applications.
The noble Baroness, Lady Northover, asked about the overlap between the regulations and the Information Commissioner's guidance. Officials have worked closely with the commissioner on the guidance and on other projects, including the confidentiality code of practice for the NHS. The commissioner's guidance makes numerous references to the regulations, explaining how they fit in with data protection provisions. That issue is covered.
I was asked by my noble friend Lord Turnberg and the noble Baroness, Lady Northover, about how the Secretary of State would approve class support. I can reassure the House that the Secretary of State has asked the advisory group to determine the approval process for class support. The PIAG has agreed to an active role in establishing the criteria for determining whether support should be provided and, most importantly, has agreed to scrutinise directly, at least in the initial stages, applications for disclosure of information with class support. There may be other points to which I feel that I cannot respond. I shall follow them up by letter. Important matters of fact and principle have been raised.
I turn to the amendment proposed by the noble Earl, Lord Howe. If the amendment were accepted, it would leave researchers, epidemiologists and those needed to monitor and audit the quality of care without support. I acknowledge that the noble Earl accepts the importance of work on cancer and communicable diseases, and I have no argument with him about that. However, the noble Baroness, Lady O'Neill of Bengarve, made a telling point about the amendment. It attempts to rewrite the primary legislation that provides for the regulations by seeking an undertaking that patient confidentiality should be paramount in all
circumstances other than in work on cancer and communicable diseases. The entire point of the legislation is to face up to the fact that much vital work cannot meet the standards of confidentiality that we know we must apply and about which we must do something. If the amendment were accepted, it would close the door on support of any other activity.Section 60 provides a power to set aside the requirements of confidentiality in specific and controlled circumstances, replacing them with, essentially, a regulatory code. Undertaking in this context to treat patient confidentiality as paramount does not seem to me to be wise.
Anyone who takes the time to examine the regulations and to consider the work already undertaken by the advisory group will see the high standards and the commitment to improvement that are required when support is provided. I fear that if we were to accept the noble Earl's amendment, we would have confusion about the interpretation of common law, and those left out in the research community would be in a worse state than they are, even with a process that many of them consider to be rather complicated and bureaucratic.
I hope that in my response I have shown that I regard patient confidentiality as being of great importance and that the Government recognise, in the paper published in December, that the NHS must do more to ensure that it gets this right. In the mean time, we must allow work in important areas relating to cancer, public health and clinical audit to continue with the support and security that the regulations will allow, knowing that the work has been thoroughly vetted by an advisory group that has shown itself to be extremely robust, and which in its rejection of the majority of the applications that it has received, has shown itself to be no easy turnover. I often talk about balance. In relation to Section 60 and these regulations, I believe that we have achieved a balance that is sensible, workable and, above all, in the public interest.
10 p.m.
Earl Howe: My Lords, this has been a useful debate. I thank all noble Lords who have taken part and the Minister for his reply. I cannot claim that all my concerns have been allayed, but perhaps I may pick up one or two points.
I turn to the limits of confidentiality. The noble Lord, Lord Clement-Jones, took issue with my assertion that the regulations permit non-health professionals to gain access to patient information. He cited Regulation 7(2). A short anecdote might illustrate my concern. I know of someone who was employed as a temp for £5 per hour processing highly sensitive, fully identified patient records at a local firm. The relevant health authority employed him; I shall not say which one. There was no credible security or supervision over that individual. I ask whether such a situation is acceptable and what is in the regulations to prevent that happening again.
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