| Previous Section | Back to Table of Contents | Lords Hansard Home Page |
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."
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",
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".
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",
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.
Next Section
Back to Table of Contents
Lords Hansard Home Page