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Earl Howe: I am grateful to the Minister for his comments. Pharmacists have two sets of concerns. One is: will the clause prejudice the ability of community pharmacists to run their businesses effectively? If that ability is prejudiced, clearly they feel that there will be a resulting diminution in patient care. The second concern is: will the clause force pharmacists into disclosing patients' specific data against their ethical obligations and without the informed consent of the patients? The Minister has made some reassuring comments on the former issue. I hope that the consultation with the professions will iron out any concerns that remain.

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The Royal Pharmaceutical Society is currently preparing a draft framework for the mutual disclosure of information between the society and health authorities, PCGs and PCTs. I believe that that work will inform the discussion that the department will no doubt wish to have with them. I thank the Minister for his reply and beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 297 to 298A not moved.]

Lord Hunt of Kings Heath moved Amendment No. 299:

    Page 67, line 16, after "prescribed" insert "NHS".

On Question, amendment agreed to.

[Amendment No. 299A not moved.]

Lord Hunt of Kings Heath moved Amendment No. 300:

    Page 67, line 26, at end insert "NHS"

On Question, amendment agreed to.

[Amendments Nos. 300A to 303 not moved.]

Earl Howe moved Amendment No. 304:

    Page 67, line 37, at end insert "and the Secretary of State shall not exercise the power to make regulations under this section in a manner which hinders or restricts the ability of a relevant practitioner to use health information for the purpose of providing safe and effective services to patients.

(4) In this section 'relevant practitioner' means--
(a) a pharmacist within the meaning of the Medicines Act 1968; or
(b) an appropriate practitioner within the meaning of Section 58 of that Act."

The noble Earl said: I beg to move Amendment No. 304. Patient medication records are vital to pharmacists in helping patients to use their medicines effectively and restrictions on their use could therefore thwart the Government's medicine management objectives. Restrictions could also impede pharmacists from supporting general practitioners through the provision of advice on the quality and cost-effectiveness of their prescribing. Likewise, regulations regarding the use of patient information could potentially make it harder for the Government to achieve their objectives on the electronic transfer of prescriptions from GP surgeries to pharmacies and the prescription pricing authority.

The Government's pharmacy strategy, Pharmacy in the Future, pledged that by 2004 GPs would be able to send prescriptions electronically to the pharmacist. To quote a Department of Health press release of last December:

    "significant benefits for patients are expected, including fewer trips to the GP surgery to collect repeat prescriptions and an end to illegible and incomplete prescriptions".

Without access to anonymised patient information, software developers are likely to find it more difficult to develop this important new technology. I can see that, because the Government are seeking such wide-ranging powers to restrict the use of patient

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information, there could potentially be damaging and unforeseen consequences for those involved in the delivery of front-line patient care, and the amendment would help to ensure that the powers exercised by Ministers were more limited and that pharmacy, which is perhaps the best known public-private partnership involved in the delivery of healthcare, was able to continue to work in the interests of patients. I beg to move.

Lord Hunt of Kings Heath: Let me make it clear that the Government have no intention of stopping health professionals, including community pharmacists, from providing safe and effective services. However, there are several points to put on the record here.

First, the amendments which the Government have tabled to restrict the scope of subsection (1), and which have been agreed, should reassure pharmacists that regulations could not be made under that subsection which would affect the provision of unaffected services to patients.

The second point is that regulations under subsection (3) can be made only in the interests of improving patient care or in the public interest. I cannot see that it would be in the public interest to undermine the provision of safe and effective services to patients. However, superimposed on that is the issue of the use of identifiable patient information by pharmacists and other health professionals. Pharmacists and other health professionals should surely start from the position that as long as information provided in confidence is held in a form that identifies individual patients, it is confidential and would normally only be disclosed to a third party with the informed consent of the patient concerned.

The only exception to this position is where there is a requirement in law to disclose information or where, in very rare circumstances, the public good from the disclosure outweighs the patient's right to confidentiality. This requirement for consent arises out of common law obligations of confidentiality, but beyond those obligations, which lawyers no doubt would be happy to debate for many days, the Government believe that informed consent is the only basis for sustaining a relationship of trust between patients and health professionals.

As I have said already, we fully recognise that current practice may not live up to that standard. We need to change current practice. Clause 67 provides a lifeline for activity that cannot, for good and demonstrable reasons, make the required changes swiftly. All the bodies that represent pharmacists--and I am aware of the issues they raise--will be welcome to apply for the support provided by Clause 67 if they feel that is justifiable.

Earl Howe: I am sure that pharmacists will find that reply very helpful and I thank the Minister for it. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 304A to 305ZB not moved.]

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1.30 a.m.

Baroness Northover moved Amendment No. 305A:

    Page 68, line 36, leave out subsection (8) and insert--

"(8) Without prejudice to the operation of provisions made under subsection (4)(c), regulations made under this section may not make provision for, or in connection with, the processing of prescribed patient information--
(a) in a manner inconsistent with any provision made by, or under, the Data Protection Act 1998 (c. 29); or
(b) in a manner which may inhibit research for medical purposes and the publication and dissemination of the results of such research."

The noble Baroness said: In moving this amendment, I shall speak also to Amendments Nos. 305B, 307 and 321A. I am grateful for the assistance I have received from the King's Fund which is the leading independent think tank on health policy in Britain.

As soon as this Bill was published it was immediately apparent that this clause in particular gave the Secretary of State powers that were too wide. The delegated powers committee recognised that and requested that Clauses 67(1) and 67(2) be subject to the affirmative resolution procedure. Given the wide concerns from all sides, I sought the help of the King's Fund in seeking a way through. The amendment proposed here is supported by many to whom I have spoken in the medical research community as well as the GMC. I trust that the Minister will give very serious thought to the proposals. I know the Minister has promised to set up an advisory committee but he or any successor could just as easily disband it.

The amendment to subsection (8) is designed to allay fears that the wide powers of the Secretary of State to make regulations could be used to inhibit research that was critical of the Government. Subsections (9) to (17) set up an advisory committee as a watchdog for the Secretary of State when making regulations. It extends to the first two sections of this clause in relation to anonymised data and, therefore, could ensure that there is no encroachment here into medical or academic research.

The wording of the provisions related to the committee is based on a streamlined version of the well established Social Security Advisory Committee set up by the Social Security Administration Act of 1992. Having been established by statute, its position is secure. Flexible provision can be made regarding its membership. Its central role is to report on regulations thereby ensuring that the Secretary of State has put in front of him or her authoritative views from people representing the most interested groups. In addition, the process ensures that if the Secretary of State decides against the committee's recommendations that must become public and the Secretary of State must give reasons for his or her actions.

This amendment sets up a statutory advisory committee and takes out of the hands of some unknown future Secretary of State powers that cause

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concern on all sides of this debate. Given the weight of support for this amendment across the spectrum, I commend it to your Lordships. I beg to move.

Lord Hunt of Kings Heath : The amendments now to be considered have been grouped together because they have an effect on the whole of Clause 67, not just the first or second parts. Amendment No. 305A seeks to ensure that regulations laid under Clause 67 cannot be made where to do so would inhibit research for medical purposes, and the publication and dissemination of such research. I believe that to be an unnecessary constraint, much as I admire the King's Fund.

The amendments that we have put forward to limit the use of the power provided by subsection (1) leave no scope now for that power to be used to inhibit research or the dissemination of results. Further, the power provided by subsection (3) can only be used for medical purposes that are in the interests of improving patient care, or in the public interest. The actual criteria that will be used to govern the use of that power are likely to be tighter still. We have assembled a working group drawn from patient and professional interests to advise on the matter. But the basic safeguards built into the clause are already substantial and have been approved by the information commissioner. I should also like to draw the Committee's attention to the requirement for all regulations made under the clause to be laid before both this Chamber and the other place, and approved by resolution.

Amendment No. 305B would require the creation of a new statutory body to provide advice, which it is suggested should be published whenever regulations under Clause 67 are being considered. Amendment No. 321A is consequential to that requirement. The establishment of an expert group is something to which the Government are already committed in respect of the power provided by subsection (3). I am sure that that is a very sensible step to take. However, we remain unconvinced of the need to put the advisory group on a statutory footing.

As we explained at some length during the Bill's progress in another place, the power provided by subsection (3) is intended largely to provide transitional support for important activity until, and not beyond, the time when there is a reasonably practical alternative way of sustaining the activity, whether it be through the gaining of valid consent or through anonymisation or pseudo-anonymisation. The creation of a new body would require further legislation to repeal it in a few years' time when the intention is to move away as quickly as we can from reliance on Clause 67 for all but a few residual activities. We do not consider that that would be a an appropriate way of obtaining the advice that we need.

I know that the noble Earl, Lord Howe, might ask me about the sunset clause. The issue here is that there are clearly uncertainties in terms of the duration of the transitional stage. Many of the issues that depend upon our ability to move from it relate to technology and some of the other difficult areas that must be

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confronted. I believe that that makes a sunset clause difficult. However, that does not detract from the general argument that this is to be seen as a transitional phase. For that reason, I do not wish to accept the amendments.

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