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Baroness O'Neill of Bengarve: My Lords, the hour is late and I do not want to say much. However, the statutory instrument reminds me of the countryman leaning on the gate when the city slicker in his smart car came by and asked the way to the farm and, after much reflection and some chewing on the grass, the countryman replied, "If I were you, I would not start from here".

We have here a statutory instrument which on the surface assigns great powers to the Secretary of State. I have listened with great care to this debate and have read the previous debate, and I can see that in many ways those powers are greatly circumscribed. I am also aware that in recent months many medical researchers have told me how uncertain they were about the data that they can use and transmit to others. I was, therefore, enormously tempted by the amendment proposed by the noble Earl, Lord Howe. It is simple, and that is tremendously appealing. It makes confidentiality the primary, paramount principle.

I want to say why, nevertheless, it is not an acceptable direction in which to go. It is not because of the cancer registries or communicable diseases, which the amendment addresses. The most fundamental reason is that I doubt whether informed consent can be a feasible general principle in public health. It is the fundamental principle in clinical ethics, in the clinical encounter. It never has been the fundamental principle in public health, where we have always had to look to other principles of legitimation. We cannot ask each individual whether he or she approves the current standards for water monitoring and for many other facilities. So public health has to be taken in a different way. I fear that an attempt to reintroduce informed consent as the crucial principle at every stage in matters of public health is likely to lead us back to the rather formulaic and inadequate conceptions of informed consent, or merely pro forma conceptions, that used to obtain.

What I greatly regret about this statutory instrument is that nowhere would one guess what are the two major public concerns in this area. I anticipate that they centre round the issues of linkage and leakage. After all, the linking of different kinds of data is what this is all about. That, of course, is why we cannot simply use the principle of informed consent at every stage. If we are to anonymise data, someone first has to look at them before they can be anonymised in the way that is required for a particular study. But data linkage raises legitimate public concern. Bioinfomatics develops rapidly all around us. I very much hope that the Minister will be able to confirm that we shall hear

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from the advisory group what view it takes of different forms of data linkage in the health field, because they are important.

I turn to data leakage, by which I mean data percolating to those who are not properly privy to it, who have perhaps not signed the requisite confidentiality agreement. We should not fool ourselves that this is completely absent when data take the form of hand-written records in old manila files on hospital trolleys. But it is rather easier when they are recorded electronically. I therefore hope that we shall hear a great deal more about the way in which the advisory group will deal with data linkage and data leakage.

That is where we are. We are at that gate. We are not on the high road into the town in which the regulation of the use of health information is a totally clear matter. With some regret, I support this statutory instrument.

Lord Soulsby of Swaffham Prior: My Lords, I rise to speak in favour of the need to advance surveillance and the epidemiology of infectious disease, especially when that pertains to public health and the betterment of the individual within the public health framework. My concern derives from the experience of the House of Lords' Select Committee on resistance to antibiotics, which I had the honour to chair. First, the committee reported that we had had an alarming experience in that investigation; and, secondly, we identified a lacuna in the public health service as regards the level of surveillance and epidemiological studies, pertaining to antibiotic resistance.

As a general statement, we believed that surveillance of disease provides the information on which basic policies are made, and by which those policies are assessed on their effectiveness. On antibiotic resistance, the committee emphasised that much of the evidence was not available at the time; namely, three years ago. I would be particularly concerned should there be any compromise of the present surveillance mechanisms in the United Kingdom that are largely in the province of the Public Health Laboratory Service. In fact, we strongly recommended in our report that the PHLS be funded more for that very purpose—its surveillance capability—and, in particular, to support the study of the distribution of disease associated with antibiotic resistance.

As has been mentioned by other noble Lords, we have a series of notifiable diseases reportable under a variety of Acts; for example, the Public Health (Control of Disease) Act 1984 and the Public Health (Infectious Diseases) Regulations 1988. Of course, we are not talking about that legislation tonight, but it means that reporting and surveillance is neither new nor unrealistic in the United Kingdom. I do not believe that anyone challenges that situation, or the fact that we need such measures. In all of these matters the PHLS works on a confidential and, I believe, an anonymised information basis. That is the way that it should be. To my mind, it would be a very serious compromise to the health control agencies in this

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country if additional hurdles were placed in the way of public health management. It is right that such information should not serve to undermine a patient's right to confidentiality.

In the diagnosis of a patient's illness, we all realise that certain tests and laboratory diagnoses are necessary; indeed, they serve part of the patient's confidential clinical record. Either immediately—or, some time later, after the episode of illness—that information may prove valuable to certain areas of study. These often provide valuable input to the surveillance and control of various contagious diseases.

As has been mentioned, it would be difficult, if not impossible, to go back to each individual because that patient may have moved home, or may no longer exist. However, the study of information derived from that case could be particularly valuable. Indeed, there have been quite a number of instances where, had that been done, certain diseases that spread locally and then nationally could have been contained. I believe that much of this can be accomplished by what is known as "generic" permission from patients; namely, that, on clinical examination, his or her medical data could, under the normal conditions regarding a patient's right to confidentiality, be used to great effect. I believe that the vast majority of patients would willingly give their consent, based on the betterment of healthcare in general.

There is a point to be made about anonymity, although it can be over-stressed. It may be that complete anonymity may be detrimental to the acquisition of further knowledge. For example, anonymity with respect to territorial information may be detrimental to sorting out whether there is a local or general problem or to establishing whether an issue is associated with human behaviour, human location or human diet and so on. The issue of anonymity must be treated with care in view of the potential by which disease entities can be analysed and the intricacies of modern epidemiology laid forth. The issue becomes more complicated as we introduce molecular epidemiology, whereby samples that may have been gathered months or years previously may be brought into consideration to unravel the difficulties of understanding the relevant disease. The issue is somewhat complex and cannot be dealt with at the source of the original infection; namely, the patient who goes to his doctor or is in hospital. Informed consent is obviously important in relation to the use of information. However, a wider issue, such as that involving a generic agreement with the patient, is important.

Having said what I have said, it is with great regret that I cannot support the amendment moved by my noble friend Lord Howe.

9.30 p.m.

Lord Clement-Jones: My Lords, I shall not detain noble Lords for long. I want briefly to support the position adopted by my noble friend Lady Northover in relation to the regulations. It may be my connection

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with cancer charities over the years that makes me find the comments of the noble Earl, Lord Howe, uncharacteristically disproportionate. His description of the enormity of the regulations was surprising.

The noble Earl said that it was bunk to assert that the regulations safeguarded personal information. I very strongly disagree with him in that respect. I believe that they are proportionate and that the PIAG got it right in terms of what should go forward. Much of what the noble Earl said proceeded on that false premise. He suggested that processing confidential information does not need to be done by a medical professional. I refer him to Regulation 7(2), which makes it clear that the qualification is designed entirely to give "equivalent" protection.

I hear the noble Earl's interpretation of the ultra vires nature of Regulation 2(1)(e)(ii), in relation to Section 60(5) of the principal Act. Anyone reading that Act, unless one was being mischievous, would find it very difficult to interpret it in the way that the opponents of the regulations have put forward. An enormous amount of folklore has sprung up around the regulations.

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