Draft Health Service (Control of Patient Information) Regulations 2002

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If that is the case, it is necessary for the procedures under that article to be complied with. Such matters should be fully investigated. Do you have power to refer the instrument back to the Joint Committee on Statutory Instruments so that it can reconsider, in light of the matters that have arisen, first, the vires of the order and, secondly, its compatibility, as those are important matters?

The Chairman: I do not have the power to do as the hon. Gentleman requests. The instrument has already been considered by the Joint Committee on Statutory Instruments and it is now before us. The decision that I must make is whether to proceed with the debate or to suspend the Committee yet again. I am mindful of the time, however, and it is moving on. I remind members of the Committee that, while this is the only chance to debate the order, it must be brought before the House when a Division could be called. We must make progress. We are debating the regulations, not the primary legislation.

Mr. McLoughlin: On a point of order, Miss Begg. The order will go back to the Floor of the House only for a deferred vote. It cannot go back for debate. It is right that proper consideration be given to it. Yet until the new information comes before us in Committee, it is clear that we cannot give it proper consideration.

The Chairman: I take the hon. Gentleman's point.

Paul Farrelly (Newcastle-under-Lyme): Further to that point of order, Miss Begg. The correction has been around since May 2001. Opposition Members do not need to scurry around making spurious points of order. They should have done their homework. It should be said that some poor people are watching this Committee, and the antics of Opposition Members show the House at its worst. Tory Members, particularly the hon. Member for Chesham and Amersham, who is no longer in her seat, are chomping their socks off. That should be noted.

The Chairman: The Committee cannot adjourn unless it agrees to adjourn. We have had a Division on that matter and the Committee has agreed to continue. As we are eating into the limited time that

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the Committee has to debate the issue, we should continue.

Mr. Wilshire: On a point of order, Miss Begg. My hon. Friend the Member for Beaconsfield went to get information. He has now come back and the information may be relevant. I do not know if there are any lawyers on the Labour Benches—I admit that I did not check—but on our Benches there are at least three barristers, all of whom have raised the question of legality. As the barristers are in doubt, I urge you, Miss Begg, to give further thought to your suggestion to suspend the Committee, so that we can get the benefit of the advice of experts before we proceed with the debate.

Glenda Jackson (Hampstead and Highgate): Further to that point of order, Miss Begg. I find that point of order a gross insult to the power of the House. Members of the Committee are Members of Parliament, duly and democratically elected. Their previous job experience is utterly irrelevant to the decisions of the Committee. If Opposition Members are genuinely concerned that the legislation be properly scrutinised, they should not have wasted—quite deliberately—so much of our valuable time.

The Chairman: I should like the Committee to make some progress. That point of order could go on forever. The question will be put once the hour and a half is up. If we are to have any kind of debate, I must request that hon. Members do not make any more points of order.

Ms Blears: I was talking—if I can remember—about the second part of the regulations, which relates to class support. I should like to 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 activity requiring adherence to the code set out in the regulations. Without the legal support, activity, if it continues at all, remains unregulated and at risk. Consultation on this part of the regulations resulted in broad support for the proposals. PIAG has agreed to monitor and assist with the process of approving applications for class support, and will be involved daily in making sure that the system is robust and transparent.

There has been much speculation about what the regulations will permit, much of it based on a distorted or exaggerated interpretation of them. It is important that I lay to rest some of the concerns that have been raised. The regulations are driven by health service needs. The suggestion that they will be used by Ministers to snoop through people's records is both offensive and untrue. There are many limits to the purposes that the regulations may support, but a key requirement is that only health professionals, or those with equivalent obligations of confidentiality in their work, who are engaged in one of those purposes are permitted access to confidential patient information.

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The regulations replace common law obligations with a code that, although permissive of authorised disclosure of confidential information for supported purposes, is far more prescriptive than common law. It includes a power to impose a civil penalty upon those who fail to adhere to the code—that is, those who use information without setting up proper systems of security to make sure that that information is properly used. Suggestions have been made that the power to fine might be directed at doctors who are asked to disclose information. We do not intend that the regulations would make that the case. Potentially, if there were an epidemic, requirements could be imposed to tackle communicable disease. However, there are no plans to introduce such requirements—I put that clearly on the record. It is unlikely that a fine would be the appropriate response to non-compliance in such circumstances. If a doctor refused to disclose information during an epidemic, it would be more appropriate to complain to the General Medical Council or to examine professional responsibilities than to impose a civil penalty under the regulations, which is not their purpose.

Dr. Fox: Obviously, we have little time and we are probably addressing the most serious point of the regulations. The Minister said that there is no such intention, but the regulations do not say that. The Secretary of State can force any person or

    "persons employed or engaged for the purposes of the health service",

who could include any medical professional. The regulations do not contain guidelines on when the Secretary of State might wish to apply a penalty. The time, circumstances and the level of the fine are entirely at his discretion. There is no due process of law, which is guaranteed under section 6 of the Government's Human Rights Act 1988. The Minister's statement that the Government do not intend to use the regulations in a certain way does not help us to understand why we are passing law for not only communicable disease—as the Minister said—but for

    "the delivery, efficacy and safety of immunisation programmes"


    "adverse reactions to vaccines and medicines".

That goes way beyond the description that the Minister gave, which was—no doubt, accidentally—misleading to the Committee.

Ms Blears: I have no intention of misleading the Committee. I am attempting to make the circumstances in which the regulations will be used very clear. Penalties will be imposed on people who go outside the scope of the regulatory code.

Mr. Hawkins: On a point of order, Miss Begg.

The Chairman: I remind the hon. Gentleman what I said about time wasting and the limits of my power.

Mr. Hawkins: This is an entirely fresh point.

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While I listened to the Minister, a question occurred to me that arose from a serious recent case. Some of our most reputable national newspapers alleged that no lesser person than the Prime Minister and his press secretary had used incorrectly and obtained improperly medical information about a constituent of my right hon. Friend the Leader of the Opposition.

The Chairman: Order. There must be a point of order.

Mr. Hawkins: The point of order to you, Miss Begg, is a question of privilege. Is the Minister saying that people who could be the subject of the regulations could include the Prime Minister and his press secretary if they improperly disclosed medical information about a patient, as they did recently about a constituent of my right hon. Friend the Leader of the Opposition? Is that not a question of privilege?

The Chairman: If it is a question of privilege, the hon. Gentleman should write to the Speaker because that is the proper procedure in such cases.

Ms Blears: If I return to the substance of what is supposedly before the Committee, it might be useful.

It was suggested that the regulations fail to comply with the European convention on human rights. I stress that the Government are sympathetic to those who are worried about patients' rights, and we want to put that at the centre of everything we do. We have taken legal advice on the implications of the convention, and we have gone further than meeting our bare legal obligations. We have built in carefully a range of comprehensive and stringent safeguards that ensure that tests of necessity and proportionality underpin each and every use of the section 60 power.

The introduction of the code means that we will have a more stringent set of rules than we ever had under common law.

Mr. Heald: Will the Minister give way?

Ms Blears: I want to explain this to the Committee because it is very important.

The regulations support only seven medical purposes, which are: work on cancer; work on risk to public health; work to anonymise records, which will increase confidentiality; work to identify and contact people in order to gain their consent so that we can go through proper process; analysis of geographical data to identify links between disease and neighbourhoods; work to record linkage between data to allow the validation of information; and clinical auditing and monitoring of healthcare provision. Those are the only purposes approved under the regulations. The medical purposes are tightly drawn and that is what the regulations are for.

Not only do the applications have to relate to the seven medical areas, permission will be granted only where it is not reasonably practicable to gain consent, which presents another hurdle. One has to fit one of

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the seven areas and then say that it is not reasonably practicable to gain consent. Permission will be granted only in cases in which authorised staff are health professionals or have equivalent duties of confidence, and only when appropriate standards in respect of security and transparency are met.

There is also a commitment to improvement. Every review that goes on will say, "How much further are you? How much progress have you made in anonymising your data, and in gaining consent?" There is real momentum behind the regulations to drive forward the issue of confidentiality and ensure that we have every possible safeguard in the system. Wherever it is absolutely necessary to use confidential information for matters of public health and to make sure that we have access to information that benefits future generations of patients, it is allowed to be used to protect the staff from the risk of personal litigation and exposure.

This is a complex matter of balancing the hugely important private interests of individuals with the public interest in matters of public health and communicable disease. We must ensure that we put in place a system that recognises the reality of what goes on in the national health service today. We can all pretend that the situation in the past 30, 40 or 50 years has been wonderful and confidentiality has never been breached. Hon. Members who know what has been happening in the NHS for decades, will know that confidentiality has gradually been eroded. The regulations put confidentiality and informed consent back at the centre of the whole health service. It is not just talk—the regulations are detailed and provide a proper statutory and regulatory framework. I genuinely believe that the issues raised about whether the regulations are a proportionate and necessary response to the problem meet the two important tests of necessity and proportionality.

I should like to stress that we have established a statutory independent watchdog—the PIAG. Members of that group have been immersed in some very technical and complex work and they have done an excellent job in ensuring that they balance the interests of patients. Members include Dr Michael Catchpole who is a consultant in public health medicine and deputy director of the Communicable Disease Surveillance Centre of the Public Health Laboratory Service; Professor Sir Cyril Chantler, chairman of the General Medical Council standards committee; Dr. Tricia Cresswell, a consultant in public health medicine; Mrs Helen Darrocott, head of professional ethics at the Royal Pharmaceutical Society of Great Britain; and Professor Andrew Haines, Dean of the London School of Hygiene and Tropical Medicine.

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Prepared Wednesday 15 May 2002