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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 at least 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".
- "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 be 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 be 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 MMR 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 board. 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 be fulfilled. I therefore cannot support the amendment.
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