Health Service (Control of Patient Information) Regulations 2002

HL Deb 21 May 2002 vol 635 cc725-58

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 Sect ion 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 a II 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". With regard to communicable disease surveillance, the Public Health Laboratory Service's work to monitor infections such as E.coli and new variant CJD is clearly in the public interest. Dr Diana Walford, Director of the Public Health Laboratory Service has stated: 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". Professor Sian Griffiths, President of the Faculty of Public Health Medicine, said that there is, 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 he 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.

Earl Russell

My Lords, the Minister referred to the removal of addresses. One can see the argument for privacy. It is very strong. What about cases in which the research is into alleged cancer clusters? In that situation, is the address not a material circumstance to the research? How will that dilemma be resolved?

Lord Hunt of Kings Heath

My Lords, the noble Earl has raised an interesting question. There is no doubt that, in researching some issues, it would be important to consider precise geographical location. The noble Earl mentioned cancer clusters, but one might also want to examine the effects of living close to power lines or landfill sites, for which such information would be relevant.

There is a problem. Even if names and addresses are removed, a postcode might still serve to identify an individual in a rural area or with a rare condition. That is why one needs the kind of class support that is contained in the regulations.

Where the only reason for processing strong identifiers is to enable information from separate sources to be linked—for example, death registration details with health records—or to enable staff to go back to source data to validate information, class support may be required. Where there is a need to monitor the quality of care and treatment, which is vitally important in the overall monitoring of clinical outcomes, the class support in the regulations might help. I stress that class support will be provided only if it is clear that common law obligations cannot be met and that a key aspect of providing such support is the regulation of supported activity, requiring adherence to the code introduced by the regulations. Without support, an activity—whether it is the work of a cancer registry or a major MRC-sponsored research project—may be unable to continue or get under way.

Consultation again resulted in broad support for the proposals, and the Patient Information Advisory Group has agreed to monitor and assist with the process of approving applications for class support. I briefly referred to the approval process a moment ago. The advisory group has been asked to devise the approvals process and will have a central role in it. There have been calls for the advisory group, a body with advisory functions, to be given decision-making powers. That would require primary legislation to achieve and would be unnecessary and undesirable. It would be unnecessary because the Secretary of State has, in effect, delegated considerable power to the group and has every intention of acting on its advice. It would be undesirable because accountability should remain with the Secretary of State. We reached a similar conclusion in our debates only 12 months ago about Section 60, with its careful balance between many different issues.

There has been a certain amount of speculation about what the regulations may permit. Much of it is based on a somewhat exaggerated interpretation of the regulations, possibly because the safeguards in Section 60 have been overlooked. I shall take the opportunity of laying to rest some of the principal concerns. First, the regulations are driven by health service needs. The suggestion that Ministers may use the powers to snoop through health records is both offensive and untrue. A key requirement of the regulations is that only health professionals or those with equivalent obligations of confidentiality doing work for one of the medical purposes set out in the regulations are permitted access to confidential patient information. Ministers are not, nor are civil servants. It will be only health professionals or others bound by equivalent duties of confidence. That would almost certainly mean contractual obligations, tied closely to disciplinary action up to and including dismissal.

The purposes that may be supported include work on cancer, work on risks to public health, work to make records anonymous, work to identify and contact people to gain their consent, the analysis of geographical data such as postcodes, record linkage and validation, clinical audit and monitoring of healthcare provision. It will happen only if it is not reasonably practicable to rely on consent or anonymous data, only if items of information that identify patients are kept to the minimum and only if appropriate standards of security, transparency and commitment to improvement are met.

The regulations replace common law obligations with a code that, although permissive—or, in exceptional circumstances relating to cancer work or public health risks that may require disclosure of confidential information for supported purposes—is more prescriptive than the common law. The substitution of a regulatory code for the common law is an important safeguard for patients. The Data Protection Act 1998 served to enforce the common law duty of confidence, and it will, when the regulations are in place, serve to enforce adherence to the code.

The regulatory code is more direct and includes a power to fine those who fail to adhere to its requirements. Suggestions that the power to fine might be directed at doctors asked to disclose information for supported purposes are wide of the mark. Requirements could be imposed to support cancer work or the tackling of communicable disease—an epidemic—but it is extremely unlikely that a doctor would hesitate to comply in such circumstances. Regulations requiring the notification of certain diseases and infections have been in place for many years, and I am unaware of any doctor raising objections. Nor is it likely that a fine would be the appropriate response to non-compliance in such circumstances. I suspect that it might be an issue of professional misconduct to be discussed and considered by the General Medical Council.

I recognise that there has been concern about potential conflict arising for doctors between ethics and the law. The first point that I would like to make is that doctors have been disclosing information for those purposes for years, recognising the importance of the work that they support. It is only recently that awareness of the law has changed matters. Secondly, I will make it clear that, unless—exceptionally—a requirement to disclose is introduced, doctors are free to respect any objections that a patient may raise.

I shall be particularly interested to hear the reasons why the noble Earl, Lord Howe, has tabled his amendment. I have some concerns about the wording, particularly the use of the word "paramount", which is consistent with Section 60. However, I understand the need to get the balance right. I take seriously concerns about patient confidentiality, just as I take seriously the concerns of those who need access to patient information to do critically important health service work. Section 60 and the regulations get the balance right. They are for the good of the health service and, more importantly, serve the public interest. I commend the draft regulations to the House. I beg to move.

Moved, That the draft regulations laid before the House on 26th March be approved [25th Report from the Joint Committee].—(Lord Hunt of Kings Heath.)

8.15 p.m.

Earl Howe

rose to move, as an amendment to the above Motion, at end to insert, "subject only to Her Majesty's Government undertaking that they will protect the continuing work of cancer registries and protect the public from communicable diseases with the minimum infringement of patient confidentiality and that in all other circumstances patient confidentiality should remain paramount".

The noble Earl said: My Lords, it is difficult to explain in a few minutes the full enormity of the regulations and to set out the long list of reasons why I tabled the amendment. However, I shall try my best.

With the warmest respect from those of us on these Benches, I say to the Minister that his speech puts a gloss on the statutory instrument that it does not deserve. Almost every argument that the Government have used to justify the provisions in the SI relies on part truth, wholesale omission and an absence of clarity on key points. My position can be summed up at the outset: I do not think that such an approach is satisfactory or acceptable for such a serious and sensitive matter. The least that Parliament is entitled to is clarity about what is in front of us. I hope that, when he comes to sum up, the Minister will comment fully on the points that I shall make.

I shall start with what, I hope, is a self-evident truth. The relationship between a doctor and his patient is founded on trust. A doctor cannot treat a patient properly unless he knows that he is being given all the material facts with complete frankness. Patients will be disposed towards such frankness only if they know that whatever is said in the doctor's surgery remains strictly confidential.

If there is a need for the doctor to disclose to a third party confidential information about the patient, there is one commonly accepted basis for him doing so: obtaining the patient's prior informed consent. Any proposals to deviate from the norm of strict doctor-patient confidentiality and informed patient consent require the tightest possible justification. In the statutory instrument we are considering we are offered two such justifications above all others. The first is that there is an overriding need for named patient data to be made available to cancer registries. The second is that named patient data are required for the control of communicable diseases and certain types of essential research.

Cancer registries perform an important, indeed, essential public service. I do not contend that their work should be threatened or brought to an end. It is, however, possible to have a debate about whether they could function satisfactorily if they were restricted to collecting data released with the informed consent of cancer patients. Much as I believe that more could be done to minimise the need for data about cancer patients to be disclosed in the absence of consent, I do not intend to argue that issue today.

Nor do I intend to argue against the proposition that named patient data are a necessary prerequisite for the proper surveillance of communicable disease. We are likely to hear from distinguished noble Lords opposite how vital the regulations are for the continued work of the Public Health Laboratory Service. Let there be no argument between us about that. The argument between us centres on different issues. The Government assert that the regulations respect the principle of informed consent; that they are tightly drawn; that they conform with human rights and other legislation; and that they are in patients' interests. I intend to show that none of those assertions holds water.

The Explanatory Memorandum states—and the Minister confirmed this today: The regulations will apply where confidential patient information is processed … in circumstances where it is either not practicable at the present time, or not appropriate, to seek the consent of the patient to whom information relates. Nothing in either the regulations or in the Health and Social Care Act 2001 draws that distinction. It is absolute bunk for the Government to assert that the regulations safeguard the principle of informed consent to the maximum possible extent: they ignore it.

Legally, neither a research ethics committee nor the Secretary of State is obliged to approve research applications only in circumstances where all efforts have been made to obtain patient consent or achieve anonymisation. No attempt is made in the regulations to make informed consent the preferred option for disclosures required for audit and analysis purposes.

The position is yet more open-ended, because not only is the patient's consent unnecessary, but also there is no need to notify the patient that identifiable data relating to him have been used in that way. In a speech to the King's Fund in January, the Secretary of State said, Above all else, for trust to thrive there has to be informed consent. Not a tick-in-the-box consent regime but consent that is based on discussion and dialogue. Where consent is actively sought and positively given". To put it bluntly, that is merely a lot of words. The regulations, in keeping with the Cabinet Office proposals for information-sharing, run in the opposite direction. It is not as if the information, once released, is to be confined to health professionals. Regulation 3(3)(c) makes it clear that anyone, employed or engaged by a Government Department or other public authority in communicable disease surveillance", may process—that is to say, gain access to—confidential patient information. That covers a huge range of people: public officials, statisticians, government employees, contractors and sub-contractors, none of whom need be health professionals. What information will they be entitled to? We do not know.

Regulation 3(1)(a) sets out one of the purposes of unconsented disclosure; namely, diagnosing communicable diseases. The sentence does not stop there; it continues: and other risks to public health". In other words, there is no limit to the type of confidential information that could be required. No wonder the RCN, the Royal College of General Practitioners, the Patients Association, the National Association of Nurses for Contraception and Sexual Health and the Mental Aftercare Association—to name only some—have expressed extreme concern about the regulations.

If, for example, sexual and mental health services are seen by the public as having even the potential to throw patient confidentiality to the four winds, they will run the risk of collapse. Patients will not trust them; some will refrain from using them and in so doing put their health at risk. One has to ask why the Government have seen fit to create uncertainty and doubt where there need be neither. The phrase, other risks to public health", adds nothing to the power to monitor communicable diseases, but opens the provision to misuse in respect of other illnesses.

Grave concern has also been expressed about the regulations' legality. Regulation 2(1)(e) provides for the processing of information for the purpose that it is required for the counselling and support of a person, yet section 60(5) of the Health and Social Care Act prohibits regulations on the processing of patient information.

Earl Russell

My Lords, will the noble Earl accept that when we last debated the issue no one would have considered discussing the symptoms of anthrax under risks to public health, whereas now we might do so; and that other such cases might occur in the future?

Earl Howe

My Lords, there is already a set of regulations enabling the Government to deploy emergency powers in the event of an outbreak of communicable disease. I do not know whether anthrax would be covered, but, if the noble Earl's point is valid, why have the Government chosen this course instead of making such conditions notifiable? That would have been the easy way round. It is not necessary to include a blanket phrase to catch every eventuality such as that in the regulations.

Section 60(5) of the Health and Social Care Act prohibits regulations on the processing of patient information for determining the care and treatment to be given to individuals. Counselling and support are a form of care. The regulations appear therefore to be ultra vires.

Regulation 8 provides that a person who does not comply with a requirement under the regulations may be subject to a civil penalty. The Secretary of State determines non-compliance and the level of penalty. Article 6 of the European Convention on Human Rights provides a list of procedural safeguards which apply in criminal proceedings. "Criminal" has its own meaning in ECHR law and can include charges which in UK law are regarded as civil. Lawyers have expressed to me the opinion that if the civil penalty in Regulation 8 is criminal under European law, as they believe it to be, none of the Article 6 safeguards is provided for and the regulations do not therefore comply with the Human Rights Act 1998.

The primary reason for my amendment is not to give expression to legalistic doubts but to emphasise in the strongest possible terms the primacy of a key principle of medical ethics and practice. The principle of confidentiality between doctor and patient is upheld for a good reason; the good of the patient. That principle has now been lost sight of.

The breadth and generality of the powers in the order mean one thing; the dignity and privacy of the individual is being subordinated to the administrative convenience of the NHS. That convenience extends to giving the Secretary of State the power to instruct any health professional to divulge individual patient data, even against the express wishes of the patient. It also extends to giving the Secretary of State a power, without due process of law, to impose a substantial fine on those who do not comply with the terms of the order. The practice within the NHS of free and easy sharing of medical records without consent, far from being prohibited, is instead being sanctified and legalised. I deplore that.

At the moment, patients in Britain are legally entitled to decide on who may and who may not have access to their personal medical records. With the approval of this order, that entitlement is being transferred to the Secretary of State. I believe that we cannot allow that event to pass without making the most emphatic possible statement in defence of patient choice and patient confidentiality. That is why I have tabled my amendment and it is for that reason that I beg to move.

Moved, as an amendment to the above Motion, at end to insert, "subject only to Her Majesty's Government undertaking that they will protect the continuing work of cancer registries and protect the public from communicable diseases with the minimum infringement of patient confidentiality and that in all other circumstances patient confidentiality should remain paramount".—(Earl Howe.)

8.30 p.m.

Baroness Northover

My Lords, Britain has had an outstanding record in clinical research since atleast the 1920s and that has been based on the use of patient information on a scale not easily achievable in other countries. The assumption which doctors made before the war was that any information about their voluntary hospital patients or their local infirmary patients could be used for research purposes. It was the same assumption which ran through the assumption that out-patient facilities needed no curtains, screening one patient from another. That ethos carried on into the NHS and yet that approach has enabled the disease registries to grow up and public health surveillance to take place.

That ethos has changed. Post Alder Hey, one cannot make such assumptions. Somehow, we have to balance the needs of society as a whole in terms of public health and protect the rights of individual patients to confidentiality. The Government brought forward a measure in the Health and Social Care Bill 2001 to try to clarify matters. Our concern then was that the Secretary of State was taking too much power into his hands. We put forward the proposal of a Patient Information Advisory Group to advise the Secretary of State on this matter and to which the Secretary of State must pay attention.

With the support of this House we prevailed and the Patient Information Advisory Group was established. Slowly, with no apparent sense of urgency of the matter, months passed while PIAG was set up. Despite the fact that the Act passed in the spring, the members of PIAG were not agreed until Christmas. It has had time to meet only twice prior to now.

Despite that, it has already made its mark. As we have heard, it considered five applications for approval under Section 60 of the Act, approved that from the Public Health Laboratory Service—I commend the noble Lord, Lord Turnberg, on the sterling work of his service—and that of the cancer registries. It turned down three others, including, I understand, one from the Department of Health itself as well as one from the Health and Safety Executive. Therefore, those who said to me last year that there was no point setting up the group because it would have no teeth have been proved wrong.

We seem to have given birth to a fine, flourishing bouncing baby which, like any other baby, shows every sign of having a major impact on those around it. And, continuing the metaphor, we must ensure that the baby is fed, watered and allowed to flourish because it has already played a vital part and must continue to do so.

We must recognise that we are in a period of transition. We need to promote a change of culture in the health service, and here GPs will surely play a key part, asking patients early on for permission to use information which no doubt will usually be very straightforwardly given. Of course, we need to develop to anonymise and pseudonomise data.

We do not yet know how the regulations will work out. Nevertheless, we know we need to move away from the paternalistic system which has held sway up to now. It was not some heavenly place where all was well. These regulations and the section of the Act which preceded them have been greeted with concern both from medical researchers, who feel fettered, distrusted and stymied in their research, and from those who are concerned about the rights and liberties of the individual and who feel that this trespasses on that. So perhaps a reasonable balance has been struck.

But let us look at their concerns. Medical researchers feel distrusted. They feel there is no certainty that the research they start can be continued if policy changes. They need stability, clarity and continuity. We should therefore keep open the possibility that there might in future need to be primary legislation to clarify this whole area. But of one thing I am certain: there would be no easy agreement on the shape of that legislation.

Meanwhile, they feel very strongly that these regulations must go through. Thus the Association of Medical Research Charities argues that, further delay by Parliament will lead to a loss of valuable data and research opportunities and have a negative effect on our efforts to improve human health". The GMC states that it supports the regulations as a temporary measure. Noble Lords who remember last year's debates will remember that the GMC was not happy until the Patient Information Advisory Group was set up. Cancer Research UK argues that: Since September 2002 cancer registration in this country has been at risk following guidance from the General Medical Council issued to doctors. Cancer Research UK believes that these draft regulations will help solve the problem in the short term and allow for incidences of cancer to be reported to the registries". We must pay attention to those views. We should and must bear in mind the enormous advances in understanding that have been promoted by researchers into medicine. We must also bear in mind that the past is not littered with court cases from aggrieved patients who have felt that their confidentiality has been abused. Far from it. We must remember that there is such a thing as society and that in some cases it is more important to look at society's needs than the apparent needs of an individual.

However, on the other side there are questions. The system has clearly been too lax in the past and those who have been concerned about the rights of the individual are surely right to he concerned about the release of any information without informed consent. A system based on consent has to be the way forward.

We were concerned last year at the Secretary of State's powers in this area. That is why we fought so hard for the Patient Information Advisory Group and that is why we are so pleased that in the end we prevailed. We remain concerned about the role of the Secretary of State. It would be nice for all concerned, not least for the Secretary of State, to take him out of the equation. The role of the Secretary of State must be scrutinised to try to ensure that the process is as independent as possible and seen to be so.

I stated last year when we proposed the establishment of a statutory advisory committee that it should not sit muzzled in the background. The Secretary of State should refer any proposed regulations to the committee and the committee must make recommendations on them. If, after receiving the report of the committee, the Secretary of State lays before Parliament any regulations, he must accompany these with a copy of the committee's report and a statement showing the extent to which he has given effect to the committee's recommendations. If in any respect he has not given effect to its recommendations, he should give the reasons for his actions.

We did not get quite all of that, but the Minister assured us that the advice would be published and that he would say to what extent he had taken that advice. Well, yes, the advice was published—in a hard-to-find Department of Health website. Given that it would get out anyway, I do not see why it needed to be buried there. It is not adequate; it is not what we expected, and it is not what we expect in the future. I trust that the Minister can reassure us on the matter. His advice should be published in a more public form than simply on a Department of Health website, and should contain advice on what new regulations should he put forward and the reaction to government draft regulations, as well as to monitoring.

We also expect PIAG to meet with sufficient frequency to be able to give full consideration to applications and to form robust advice. Although the group has met only twice, it appears that it has managed to do that; however, we should like to know whether, having met only twice, the group felt that that was satisfactory.

We should like to know whether PIAG believes that the regulations are completely in keeping with its advice, and, if not, in what way.

I wish to be reassured that the expectation is that PIAG will continue to play a full and public part in this area. I am sympathetic to the idea that medical researchers need consistency, clarity and continuity if they are to undertake long-term projects. I ask that PIAG address that question to see if that too can be provided—within the need to evolve a more consensual approach.

I should like PIAG to report on how matters have operated when we come to review them next year, and to publish its findings to inform our debates.

Given that the regulations are meant to be temporary, until more permanent solutions are devised, I should like to know how the initial experience is to be evaluated and I urge that PIAG should have a key role to play here.

On some more general points, I should be grateful if the Minister would comment on how the regulations and the Information Commissioner's newly published guidance on the use and disclosure of medical data fit with each other. I should also like to know what steps the NHS is taking to anonymise data. These regulations relate to the control of information within the National Health Service. Does the Minister believe that the data protection rules adequately cover information generated outside the health service? Will he also explain how co-ordination will be pursued with the authorities of Scotland and Northern Ireland?

Will the noble Lord comment on the status of Regulation 5 on the granting of generic dispensations by classes of research, given that such detail has been given to cancer registries and public health bodies? What will be the circumstances under which the Secretary of State approves research under this regulation? What advice does he take, and does PIAG come fully into play?

Regulation 6 seems to imply that the Secretary of State has discretion to make, or not to make, an entry in the register. Please will the Minister clarify that? In addition, will the nation-wide clearing service data flows be applying for Section 60 permission?

In conclusion, we do not support the amendment in the name of the noble Earl, Lord Howe. The cancer registries and public health are covered in the regulations. We do not believe that the amendment can be justified, given the whole range of useful research that could be swept aside if it were to be passed. I point again to the fact that the Data Protection Act, the Health and Social Care Act and the Patient Information Advisory Group form part of a tightening, not a loosening, of procedures. There is no golden age to return to, except perhaps for researchers to pursue their researches unfettered, as they did previously—largely to the benefit of patients. We have to move forward and recognise the importance of research. We must not simply chuck out the baby with the bath-water as we seek to balance patients' rights and the public good.

For me, the Patient Information Advisory Group, approved by your Lordships last year and now in full operation, can help us through. The assurances that I seek from the Minister are mostly on the role that he anticipates it will play in the future.

8.45 p.m.

Lord Turnberg

My Lords, much of what the noble Baroness, Lady Northover, said resonates strongly with me—especially her reference to babies! It seems that almost everyone agrees with the two propositions that important research has to be done and that patients' trust and confidentiality should be protected. But therein lies the difficulty. Section 60 recommendations are attacked on the one hand by those who believe that confidentiality will be betrayed, and on the other by those who, like me, believe that research will be inhibited.

I must declare a number of interests as chairman of the board of the Public Health Laboratory Service, as scientific adviser to the Association of Medical Research Charities, and as vice-president of the Academy of Medical Sciences. So I am up to my neck in this area.

Getting the balance right has not been easy, but a balance has to be struck. I argued during the debate on the Bill last year that Section 60 procedures involved such a tortuous and prolonged process, with so many hurdles aimed at safeguarding patients' rights, that it effectively inhibited the research that it was designed to allow. I still believe that it is heavy-handed and bureaucratic, but now, at long last, we have the opportunity to agree that at least the specific types of research described in the regulations can be allowed to continue.

These regulations have not suddenly been dreamt up by officials out of the blue. They come at the end of a long vetting process: first, the Patient Information Advisory Group (PIAG), which has heavy legal, ethical and patient group representation on it and which has a keen interest in protecting patients' interests, has thoroughly reviewed the classes of research put to it. I understand that it turned down several proposals but accepted two which it thought so carefully constructed and safe that it could allow them to go to the next step of public consultation. The proposals were submitted to a long list of bodies and individuals for a period of consultation and, having survived that process, were recommended to the Secretary of State, and now to Parliament. It has taken eight months to arrive at this point—eight months during which some research, of which I could give a number of examples, has been delayed and frustrated, and public health, I believe, placed in jeopardy.

We should place these regulations in perspective. They apply to a very limited set of circumstances. Despite much of what has appeared in the press about the lack of constraints on confidential information, the constraints are clear and considerable—some might argue, too considerable.

The regulations do not apply to the vast majority of research where consent can and indeed has to be obtained— there is no getting away from that—or where data cannot be attributed to any individuals; that is, the patients are anonymous. Indeed, among the many criteria which applications to the PIAG have to fulfil is a full explanation of why consent cannot be obtained or why the data cannot be made anonymous. Both have to be fully justified. That is the base-line from which all else follows. So we have a very limited but very important sub-set of research activities to which the regulations apply; namely, research where consent or anonymity cannot be obtained or guaranteed.

The other constraints apply to the question of who can do the research, and how, and who can handle the data—points to which I shall return. The particular classes of activity covered in the regulations are research depending on cancer registries and the work of the PHLS in tracing sources of outbreaks of infectious disease.

I shall give examples of the sort of work that would be covered by the regulations. The first relates to research on data derived from patients sometime in the past when it is no longer possible to locate those patients to seek their consent because they have moved or died. Even setting about finding those patients to obtain their consent is not possible because a researcher is not allowed access to names or addresses even to seek consent. The finding that cancer of the lung was associated with smoking would not have been possible without Sir Richard Doll being able to refer back to patients with lung cancer to ask about their smoking habits.

If today researchers wanted to pursue the idea that patients with cancer of the colon ate certain foods that might have contributed to their cancer, they would only be able to do so if the regulations are passed. The researchers would also require the additional approval of a research ethics committee, as they have always had to do.

Another example is PHLS work, where workers have to trace the sources of outbreaks of infectious disease, where speed is of the essence. Laboratory staff detecting an infection should be able to alert the PHLS and consultants in communicable disease control immediately—not be constrained by having to seek the consent of patients, who may not be easily reachable. Hitherto, no one in their right mind objected to the sharing of that type of information among professionals with strict codes of confidentiality. While as an individual patient, I am keen to make sure that my confidences are protected, I am equally clear as an individual member of the public that I want to be protected from infectious disease and I want safe, rapid and effective systems to be in place.

In the important field of post-immunisation surveillance, it may be suspected that a rare or unusual disease is attributable to some vaccine or other. Gulf War syndrome or autism and M MR always rear their head. It has been possible to exclude a causal relationship between them. There are several other examples of surveillance which are not research but which are threatened unless we pass the regulations.

Much has been made of the powers of the Secretary of State. I can leave it to my noble friend the Minister to defend the Secretary of State. Confidential information about patients cannot be demanded by the Secretary of State. Confidential data can only be handled by professionals with a duty of confidentiality—and, in the context of research, only after research ethics committee approval. It seems unlikely that an ethics committee would give the Secretary of State approval. The thought of the Secretary of State demanding to see case notes beggars belief and would not be allowed under the regulations. Nor would any of his officials be permitted to see them.

Without the regulations, it would not even be possible to process information about patients so that they could no longer be identified—to anonymise the data. If the regulations are not passed, that would have the perverse effect of inhibiting the process by which patients' identities could be protected.

Many of us have been sent papers warning of the dangers to patients of passing the regulations. Can anyone point to a patient or a member of the public who has ever been harmed in any way by researchers using data from cancer registries or the work of the PHLS in its efforts to detect sources of outbreaks? I doubt it. Such activities will undoubtedly be threatened if we do not agree to the instrument.

Much as I dislike the bureaucratic path we had to take to reach this point, now that we are here it is vitally important to accept the proposals. I hope that we can make the process more workable. To reject the regulations would put a block on research by research ethics committees. Microbiology labs would be unwilling to report infections. The public would hardly be able to understand why we had compromised their safety.

The noble Earl's amendment would take us right back to where we were before debating Section 60 during the passage of the Bill. The amendment would immediately obviate the possibility of other epidemiological research on any data held in disease registries—all of which would, under the current circumstances provided for in the regulations, have to be vetted by PIAG set up specifically for the purpose of examining such cases thoroughly, using the strict criteria previously discussed.

The possibility of linking Rey's syndrome—a nasty and unusual disease in children—with aspirin ingestion would have been made impossible. The prospect of finding a possible but as yet unknown environmental or infectious cause for rare childhood illnesses such as leucodystrophy would be obviated. There are many other examples.

Although Section 60 is tedious for researchers, it is a thorough process. Coupled with the need for research ethics committee approval, it provides strong safeguards for patients. It is difficult to know what could take its place as a more thorough process if we are to allow any such research to be undertaken. It would be a sad, bad day for medical research and patients if we took the route proposed in the amendment.

9 p.m.

Baroness Finlay of Llandaff

My Lords, the noble Lord, Lord Turnberg, has dealt most eloquently with the issues surrounding research, so I shall not revisit them. The noble Baroness, Lady Northover, dealt with the Patient Information Advisory Group. I shall confine my remarks to cancer intelligence and surveillance units and medical ethics.

It is important to note that the cancer registries that appear to be the focus of some of the debate have been desperate for a statutory instrument to be introduced. The problem that these units have faced in recent years is that they have not been able to obtain complete data. I am most grateful to Dr John Steward for providing me with the confidentiality policy of The Welsh Cancer Intelligence and Surveillance Unit. I declare an interest, as Dr Steward is employed by the same NHS trust as me—which is the guardian of the cancer registry for Wales.

It is worth noting that no cancer registry has breached the confidentiality of the information entrusted to it. There is no history of irresponsible registries but of registries desperate to obtain data and validate them. In recent years, pathology laboratories became frightened of disclosing diagnostic data on specimens, fearing that they would be in breach of the law. Consequently, 5 to 10 per cent of data were lost to registries. In addition, the ability to quality assure the data that were being notified was also lost. There is a need to cross-check clinical data against the histological diagnosis from pathology laboratories. That quality control makes sure that the data held by the registries are as accurate as they can be. Without that accuracy, the information that flows from the registries potentially becomes less meaningful. Some information might almost be meaningless. Registries strive hard to obtain complete sets of data that are as accurate as possible. They need information such as postcode data to identify and track clusters.

Registries have several key roles. They are not just repositories of descriptive statistics. Registries are able to inform commissioning by providing comparable data between different parts of the country and varying patterns of disease occurrence. They are able also to monitor outcomes. Registries have a major role in public protection and patient care, directly and indirectly.

We have heard a lot about the focus on research. It is important to remember that cancer registries provided vital information for the entire revision of cancer services under the Calman-Hine report. I declare an interest, as I had the honour of serving on that group.

The legal safeguards are very tight. The data are subject to all the safeguards of personal health information that apply to medical records, including the moral and ethical responsibilities of health professionals, contractual obligations and legal requirements. All registry staff cover all of this at induction and sign an undertaking in their contracts of employment to protect the privacy of the record and abide by the policy. Any visiting academic staff must sign an honorary contract as well. Their ordinary NHS contracts are not adequate. They have to re-declare their commitment to confidentiality. The director and the deputy are registered medical practitioners, and the director is the Caldicott guardian as well as data custodian. It would be serious professional misconduct if there were even a hint of a breach of individual confidentiality in relation to a registry.

A principle of implied consent has been used to obtain data for the registry. It takes a lot of time for a patient to consent to any procedure, and patients who are struggling to come to terms with their diagnosis find it very difficult to take additional information on hoard. However, I am unaware of any patient's information being disclosed against their will when they have said they do not want that information disclosed to a registry. In the case of the trust, patients are informed that there is a registry in Wales. Moreover, printouts from the registry are not secret but are in the public domain. Patients who want to see the cancer statistics can see the ones published by their local registry. The statistics available to the profession and the commissioners are also available to the public.

There are direct benefits to patients in cancer registration. These relate to assuring and improving the quality of care and treatment, monitoring and protecting public health, managing and planning services as well as the matters that we have already heard about in academic research and teaching. The cancer registry itself is a closed office, always under lock and key. The computerised database is secure and subject to the same security policy. Encryption would be welcomed, but the NHS number or other code which could be encrypted as a universal identifier to track and cross-reference data without directly linking it to the patient's name and address is not widely available. However, everyone expects that that will be available eventually.

Finally, I turn to the issue of ethics which has been alluded to by the noble Earl, Lord Howe. He is quite right to state that confidentiality and trust are paramount within the context of a consultation. However, trust does not relate only to the information disclosed by the patient to the doctor; it is based also on the patient's awareness that the doctor is working in the patient's best interests. Patients trust that they are receiving the best care available and in the competence of the professional they are seeing. They also trust that the professional will refer them to someone else if that person is better equipped or more competent to look after them.

There are five key principles within medical ethics, and confidentiality comes under the principle of autonomy. Other principles are beneficence and non-maleficence—to do good and not to do harm— which are joined and are self-explanatory. We should also consider the principle of justice, as there is a tension between justice in relation to the individual and the healthcare professional's duty to the whole population and to other patients and potential patients. The scope of a decision and its impact on others is another consideration.

These regulations are called for by those who are trying desperately to maintain registries. Evidence from across the United Kingdom has already made it clear that, without such provision, data quality will continue to decline rather than improve, and the general principles of justice and scope will not he fulfilled. I therefore cannot support the amendment.

Baroness O'Cathain

My Lords, I rise reluctantly and briefly to support the regulations. I am reluctant to support the regulations because I have huge respect and admiration for the work and total integrity of my noble friend Lord Howe. Moreover, the debate has revealed the enormous professional knowledge of noble Lords who have spoken. I shall speak not so much as a rank outsider, but as someone who, like everyone else, is involved in health issues.

I believe that we are in danger of addressing this overall issue from the outlook of the 1950s and 1960s. Way back then, people were utterly reluctant even to mention the fact that they had TB in the family because it was regarded as a disease born of poverty, unsanitary conditions and had nutrition. Similarly, cancer was rarely mentioned in the 1970s; it was the big C. My own mother contracted cancer in 1970 and, to her dying day in 1977, never acknowledged the fact. However, the world has moved on a little. I know from personal experience that those suffering from diseases such as TB, cancer and stroke wish more than anything to share information with others so that others may benefit from their experience and from potentially helpful research. They also want to help in the search for a remedy to the disease afflicting them.

Anecdotally, I am one of those who is in the very fortunate position of being the only family member not, so far, to have been struck by cancer. After having four primary cancers in five years, my sister rather wryly said, "Dena, perhaps you ought to go and be tested for the Li-Fraumeni Syndrome which obviously is genetic in our family". I asked what good that would do me. Would I commit hari kari and take my own life, or get into a total depression? I was struck by my sister saying that she wanted people to know about her situation. The more people who know about the effects of the disease the better.

Closer to home was my late husband who suffered a massive stroke about 13 years ago and who died last year. I know that had he been able to contribute to the knowledge—sadly, he could not as he was unable to speak since the stroke happened—he would have been in the forefront of allowing any data about his condition to be made known, so that research could benefit.

We have tried to develop our intellectual attitude from the time when my mother would not say the word "cancer" through to the rest of my family. As I said, my remarks are very personal and anecdotal.

This is not declaring an interest, but I am chairman of our local surgery support group, which has nothing to do with supporting patients, but which is intended to support doctors so that they can assess the facilities available to enable them to conduct their business. I have not consulted them on this because I have come to the debate with my eyes, ears and mind open. They would be at the forefront in saying that we must do whatever we can do to advance the knowledge of those diseases and how they affect people genetically, in clusters, because of lifestyle, or whatever, and that we must give that information to the research bodies.

I declare an interest that I have been involved with the Imperial Cancer Research Fund, which is now subsumed into the new organisation, Cancer Research UK, which is headed by the noble Baroness, Lady Hayman. I am willing that organisation and anyone involved in it to succeed. We are becoming much more open.

Those of us who are not suffering from cancer at the moment, although I know that there are Members of this House who have done so, would be much more open. We would say, "I don't mind my medical record being available, but I am not too sure that I want it named". That is the issue. We should keep names from the information. There was a question earlier about postcodes, which are unnecessary. If local GPs and consultants can verify that there is a certain number of cases of prostate cancer, strokes, TB, and so on, that will help the people doing the research in the relevant agencies.

I support the regulations and I am sorry to tell my noble friend that I cannot support his amendment.

Lord Rea

My Lords, I believe that the regulations should be passed as they stand, benign though the amendment moved by the noble Earl, Lord Howe, appears to be, as always. Your Lordships will remember the debates that we had on what have became Sections 60 and 61 of the Health and Social Care Act 2001 as the previous Parliament drew to a close.

The role of the of the Patient Information Advisory Group, or PIAG as it is now called, created by that Act is vital. Section 61 states that the Secretary of State shall seek and have regard to the views of the Advisory Group". We have already heard that in three out of five cases, the Secretary of State has listened to its views and has not allowed certain projects to go ahead. Other noble Lords, especially my noble friend Lord Turnberg, and the noble Baroness, Lady Finlay, described the need for patient information for cancer registration and for monitoring and controlling infectious diseases. The amendment would allow data to be used for those purposes, but, if it were carried, all other use of patient information for research would become largely unobtainable, even if it had the approval of PIAG.

The United Kingdom has an outstanding pioneering record in epidemiology, which depends largely on having the kind of patient information that would be permitted by the regulations, but denied by the amendment.

Earl Howe

My Lords, the point of that part of the amendment is that patient consent should be sought if such research were in prospect. It is not to deny research; but patients should consent to personal and identifiable information being disclosed.

Lord Rea

My Lords, my noble friend Lord Turnberg explained how much information cannot be obtained because the patient may have died or moved to an unobtainable or unknown address. Information about them may still be vital to the completion of research. Much of that research, for instance, is now available from the reports of the Registrar General and/or the Office for National Statistics. I refer to mortality and morbidity data which provide such details as place of residence—we have discussed whether that should be a house address or a postcode—social status and occupation at the time of death or of the episode of illness of the patient concerned. If the regulations are rejected, some data collected in general practice and in other specific surveys would become unlawful to collect and use.

Epidemiology started as a tool for identifying and controlling infectious disease. It is now a vital method of determining the association of the chronic noninfectious diseases, which cause the majority of deaths and the greatest burden of morbidity in the community—I am talking about heart disease, stroke, diabetes and hypertension—with other variables which may be important in their causation, for instance, their relation to smoking, social class and other factors such as residence and type of housing or district. Such associations increase our understanding of the aetiology of those diseases and their prevention. If the regulations are rejected, the record linkage mechanism first set up by Professor Donald Acheson in Oxford (which is vital in this kind of research) will be endangered.

The professor of cardiovascular epidemiology at St George's, Peter Whincop, says (in a letter to me): Without satisfactory implementation of the regulation; most epidemiological research of the sort that has been so beneficial in the past will become increasingly difficult or impossible". I understand that my college, the Royal College of General Practitioners, opposes the regulations. I can understand that because the college may feel that the role of the general practitioner is to be the guardian of individual patients' rights and confidentiality. However, I have the advantage, which I think that the chairman of council of the Royal College of General Practitioners does not have, of having worked both as an epidemiologist and as a GP. I submit that the gain to patients as a whole by continuing the research that the regulations will allow far outweighs any theoretical advantage which might be gained by individual patients by rejecting the regulations or by accepting the amendment.

9.15 p.m.

Earl Russell

My Lords, I do not think that I shall surprise the Minister if I say that the Patient Information Advisory Group is of considerable importance to these Benches. The idea was based on the model of the Social Security Advisory Committee. That is something which I do know something about.

There are several essential qualities about the Social Security Advisory Committee. The first is its professional integrity and independence. I think we all agree that the Patient Information Advisory Group has cleared that hurdle with flying colours, to the universal applause, I believe, of all those concerned.

The other conditions concern the way in which the Government handle that body. The important matters as regards the Social Security Advisory Committee are, first, that all proposed regulations in the area that its remit covers are laid before it for consideration and consultation before they are laid before the House. The second is that its comments are submitted to the Secretary of State and that the regulations, if they appear, are published with the Social Security Advisory Committee's report and the Secretary of State's reply to it so that when we go into the Printed Paper Office, when a social security regulation within the relevant area is to be considered, we can pick up in one handful the regulation, the advisory committee's comments and the Secretary of State's reply.

That is what we understand by publication. Publication means that you have to be able to get it in the PPO. Publication on a website is really not good enough, first, because certain noble Lords—I am perfectly proud to confess that I am one—are incapable of getting access to anything on a website, and, secondly, when something is published on a website, so far as I know, there is no means of discovering that publication has taken place.

I shall listen to the Minister's reply on precisely those points very carefully. It was said when the bishops were turned out of this House that they that hated the bishops hated them worse than the devil and that they that loved them loved them not so well as their dinner. I am more interested in the Minister's reply than I am in my dinner.

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 he 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. Rut 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 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 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 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.

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 OD 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 PH LS 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.

Lord Clement-Jones

My Lords, I do not want to prolong the debate, but such a situation cannot arise under the regulations. If it did, it would be a breach of the regulations under Regulation 7(2) and a breach of the Act. That is as plain as the writing on the paper.

Earl Howe

My Lords, we shall have to agree to differ. That is not my interpretation and not the legal advice I have received.

My noble friend Lord Soulsby referred persuasively to the monitoring of communicable disease. I listened carefully to his remarks. The existing communicable disease legislation requires named data so that the occurrence and clusters of disease can be identified, investigated and controlled. It overrides the doctor's duty of confidence. My contention to the Minister and the tenor of my reply to the noble Earl, Lord Russell, was that that provision could be extended to conditions such as E.coli, MRSA and CJD, with any unforeseen additions made subsequently by order. I still do not see why that model is not possible.

The Minister referred to the PAIG. The noble Baroness, Lady Northover, wants to give it teeth; the noble Lord, Lord Turnberg, placed great emphasis on it as a safeguard. I have nothing but the highest respect for its members. It is interesting to note that one of its key recommendations in relation to this measure was that the department should establish a publicly available register of all activities approved under the class support arrangements, yet under Regulation 6(4) the Secretary of State has the option to decide not to make public entries in the register.

The Government are clearly capable of a pick-and-mix approach to the PAIG's advice.

Lord Hunt of Kings Heath

My Lords, perhaps I may place on the record that it is the Secretary of State's intention to publish all such approved applications in the register.

Earl Howe

My Lords, I am pleased to hear that, but I do not understand why there is a provision in the regulations appearing to provide for exceptions.

Lord Hunt of Kings Heath

My Lords, I am grateful to the noble Earl for giving way. My understanding is that the flexibility in the regulations is more about the amount of information which can be provided rather than the relevant information as regards the entries. The entries will be in the register, but the discretion relates to the amount of detail that is provided.

Earl Howe

My Lords, again, I am grateful to the Minister. That comment is extremely helpful and reassuring.

I say to the noble Baroness, Lady Finlay, on the subject of cancer registries that the range of purposes for disclosure, detailed at Regulation 2(1), is very wide. It goes well beyond activities for which cancer registries may require information and covers practically every use which might be made of patient information. The effect of such widely drawn provision is to remove patient rights in relation to storage and use of information about them in any NHS or similar data base. I believe that that is of concern.

I spoke of the wide scope of the regulations. The phrase "other risk to public health" is without constraint. There is a carte blanche element elsewhere. Section 4(a) coupled with Regulation 5(b) provides a general purpose for linking data from different sources identifiably for its own sake. I do not fully understand why that has been permitted.

Every so often there is a defining moment in the life of this House when it is right to stand up for basic principles. This is one such instance. I am proposing that we challenge the Government to abide by the precepts which their own Ministers repeatedly articulate. However, I have listened carefully to noble Lords, not least the noble Baroness, Lady O'Neill, the noble Lord, Lord Turnberg, my noble friend Lord Soulsby and all noble Lords who have spoken. I note with due seriousness what the Minister said about the wording of my amendment and in particular the last part of it.

Let there be no misunderstanding about the amendment. As it stands, it is not fatal to the regulations. It was not designed to be fatal. In tabling the amendment in such a form, my main hope was that it might commend itself to noble Lords generally and to the Government and that the Minister might feel able to give me the undertakings that I seek. As he will know, those matters are of immense importance to many people outside the House. It is no part of my purpose to frustrate the operation of the regulations. I am well aware of the immediate damage that would be done to cancer registries and to disease monitoring if the regulations were to be overturned.

It would be possible for us to go through the lobbies and vote on my amendment. However, I would rather reach a consensus with the Government. The Minister appeared to indicate that as regards the first part of my amendment he would have no difficulty about giving me the undertaking I am seeking. His difficulty lies in the second part of the amendment. I therefore have a proposal to put to him. If he will consent to give me an undertaking that the Government will protect the continuing work of cancer registries and protect the public from communicable diseases with the minimum infringement of patient confidentiality, and if furthermore he will undertake that in the early part of the next Session of Parliament he will take a suitable opportunity to report back to the House on the operation of the regulations, on the progress that the Government are making on their plans to minimise the need for unconsented disclosure in all areas of activity covered by the order, and on the whole issue of safeguarding patient confidentiality, I in turn undertake that I will not press my amendment to a vote.

Lord Hunt of Kings Heath

My Lords, I am grateful to the noble Earl. Before responding to his invitation, perhaps I may say that the issue that he has raised makes a persuasive case for the regulations. They establish a clear framework in which the use of such information is very clearly set out.

We discussed the issue of civil proceedings. But the point of the regulations lies not only in the fact that they allow the use of such information under certain circumstances; they also lay down a clear set of rules under which such information can be used, and they go on to list an enforcement procedure under which proceedings can be taken against those who abuse their position and do not follow the rules.

The consultation paper that we produced in December on implementing the confidentiality strategy provides the right framework to take the NHS forward into a situation where we deal better with the issue of patient confidentiality. We are developing a code of practice for the NHS which it is our intention to publish during the summer. I am sure that all of us are united in wanting to make sure that 'the NHS conducts itself properly in these areas.

As regards the noble Earl's request that I report back to noble Lords on the operation of the regulations and on the progress being made in the area of patient consent, I am happy to agree. It would be extremely useful if, late this year and early in the next Session, we have a further debate on these issues. I am very happy to agree to that suggestion.

Earl Howe

My Lords, that brings our debate to a very satisfactory conclusion. I thank the Minister very much indeed for agreeing to my suggestion. There is nothing more for me to do other than to beg leave to withdraw my amendment.

Amendment, by leave, withdrawn.

On Question, Motion agreed to.

House adjourned at twelve minutes past ten o'clock.