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Lord Clement-Jones: I shall digest what the Minister said about the appeal procedure. I am heartened by what he said about giving reasons and the discussions taking place with the BMA. I seek his assurance that organisations representing patients' interests will also be consulted in that process. As I understand it, there has been no discussion with them to date in this area and it would be valuable.

Lord Warner: I take the noble Lord's point.

Baroness Noakes: I asked about consultation on the provisions in the regulations for changing doctors. I said that the National Association of Citizens Advice Bureaux is particularly keen that patients' groups should be involved in drawing up the regulations. Can the Minister say something about that?

Lord Warner: There will be consultation on the regulations.

Baroness Noakes: I am grateful to the Minister for that. As I said, it is regarded as important by patients' groups. I thank the Minister for the assurances he gave. I look forward to the amendment he will bring forward on Report and I shall read carefully what he has said. I believe he has answered many, if not all, of my points but, in view of the time, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 447 not moved.]

Lord Warner moved Amendments Nos. 447A to 447C:

    Page 88, line 18, leave out from "individual" to end of line 23 and insert "falling within section 28D(1)(bc) above"

    Page 88, line 36, leave out "and "section 17C employee"" and insert ", "section 17C employee" and "Article 15B employee""

On Question, amendments agreed to.

Earl Howe moved Amendment No. 448:

    Page 88, line 44, leave out from beginning to end of line 14 on page 89.

The noble Earl said: Proposed new Section 28T sets out the provisions governing payments under the GMS contract. I have tabled this probing amendment to find out what is meant by subsection (3)(a), (b) and (d) in particular. Paragraph (a) appears to cover targets and paragraph (b) schemes and scales of payment that are unspecified. It would be helpful to hear what these may comprise.

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A great deal of money for the GMS contract is targeted towards quality and outcomes. How are the targets to be set, what will they be and who will police them? The Minister will by now realise that I am suspicious of targets because, unless they are clinically based, they are likely to lead to skewed priorities which may not necessarily be in the interests of patients. I make an exception for public health targets such as vaccinations, but if the targets are not public health-related, my suspicions return.

Paragraph (d) covers conditions. The only example of such a condition given in the Explanatory Notes is payments for seniority, which seems a very odd basis on which to make payments as it has nothing to do with either competence or quality of outcomes. It would be helpful if the Minister could explain the implications and meaning of these proposals in a little more detail. I beg to move.

Baroness Barker: I shall speak briefly to Amendment No. 449, which echoes the words of the noble Earl, Lord Howe. We, too, feel great disquiet that a target system is based on treatments or proportions of treatments that are delivered rather than health outcomes. We think that could cause quite severe difficulties not only for medical practice but for the nature of the doctor-client relationship.

The BMA is concerned that if exceptional reporting systems are not in place for all target payments, there could be a skew. As the noble Earl, Lord Howe, said, the GMS contract contains several pages detailing the making and achievement of payments. There is a very complex points system under which GP practices are to be rewarded, precisely to improve the numbers of treatments given. We do not see that that can be justified by itself in clinical outcomes. If a patient chooses not to have vaccinations or immunisations, what does that do to the GP practice in question?

Lord Warner: Perhaps I could deal first with Amendment No. 448. The power in proposed Section 28T is needed to implement the national agreement that was reached between the NHS Confederation and the GPC. Subsection (3) sets out how the power to make directions may be exercised. It makes it clear that payments may be determined by reference, for example, to the meeting of standards. In this way, it provides for the quality and outcomes framework. This framework represents, for the first time, that the NHS will significantly reward general practices for the quality of care delivered to patients. It recognises and rewards their clinical professionalism, not just the number of patients on their list.

It is not a series of targets for GPs. The contract does not include a required level of achievement. The framework is voluntary—it is based on best academic evidence. It was proposed by the BMA, which negotiated and agreed it with NHS employers.

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Subsection (3) also allows for directions to be made that take effect from a date earlier than the direction where this would overall be favourable to the contractor. This may be used, for example, where negotiations to review payments conclude that new or revised payments should be backdated to the beginning of a year. This has been essential in the past and the power will doubtless be used again. Sometimes these payments are about new services that will deliver benefits to patients, such as vaccinations. I do not think that patients or the profession would wish to see that power amended.

On Amendment No. 449, I have to say that the United Kingdom has one of the most successful vaccine programmes in the world, with high levels of uptake. This has been achieved by the hard work of GPs and enforced by a system of targeted financial incentives. This is for the good of the public's health.

The target payments scheme incentivised levels of uptake; it protects children not only individually but collectively in the wider community, especially those for whom immunisation is contra-indicated. Removing the target payments would have an unpredictable effect on vaccine uptake levels, but it is more likely to be adverse than advantageous to the public health. It could well perpetuate coverage that is insufficient for the protection of the wider community.

The new contract makes it clear that we will be discussing with the BMA how we can use the target payments more effectively in a way that meets general practitioners' concerns and encourages even higher uptake levels, protecting children from potentially life-threatening diseases. It is also worth noting that the BMA negotiated and agreed the directed enhanced service specification for childhood vaccinations in the contract. That includes the existing target payments. Aside from a potentially adverse effect on public health, the amendment would cut across part of the deal that GPs voted on and undermine our ability to deliver the contract agreement.

Earl Howe: I am grateful to the Minister for his full reply. He once again shed light on the clause, as I hoped that he would. I shall study his remarks and beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 449 not moved.]

Lord Warner moved Amendment No. 449A:

    Page 89, line 30, at end insert—

(1) A general medical services contract must contain provision requiring the contractor or contractors to comply with any directions given by the appropriate authority for the purposes of this section as to the drugs, medicines or other substances which may or may not be ordered for patients in the provision of medical services under the contract.
(2) A direction under this section must, subject to subsection (3), be given by regulations.

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(3) A direction under this section may be given by an instrument in writing where it gives effect to a request made in writing to the authority making the direction by a person who is a holder of a Community marketing authorization or United Kingdom marketing authorisation in respect of the drug, medicine or other substance to which the request relates.
(4) A direction under this section given by an instrument in writing may be varied or revoked by a further direction under this section (whether given by an instrument in writing or by regulations).
(5) In this section—
"appropriate authority" has the same meaning as in section 28T above;
"Community marketing authorization" and "United Kingdom marketing authorisation" have the meanings given by regulation 1 of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144)."

The noble Lord said: Government Amendments Nos. 449A, 457B and 464ZF are made in response to the Delegated Powers Committee report. They make it clear that directions in respect of the drugs, medicines, and other substances that may or may not be ordered for patients will be made by regulations, except where there is a request from a holder of an EU or UK marketing authorisation and the directions give effect to that request. In that case, directions may be given in an instrument in writing.

Any decision to restrict the availability of the medicines on GP prescription is taken only following a period of public consultation. We consult the manufacturer. Additionally, we consult professional representatives, patient representatives and other organisations with an interest to take into account as wide a range of views as possible. We do not intend to alter the arrangements. The consultation document would explain the rationale behind each proposal, including the available evidence on clinical and cost-effectiveness, if appropriate.

The relevant EU legislation is the so-called transparency directive, which obliges the Secretary of State to give a statement of the reasons for introducing a restriction based on objective and verifiable criteria. In addition, if there are expert opinions on which the decision is based they should be sent along with the decision. Those procedures safeguard the interests of patients and manufacturers.

I trust that these amendments and clarifications satisfy the concerns that have been expressed. I beg to move.

Lord Clement-Jones: In view of the hour, I do not propose to speak at length on Amendment No. 457A, which was tabled in my name. Suffice it to say that there are very good arguments against the selected list today, versus the time when the selected list was introduced under the 1977 Act. I intend to return to those arguments at a later stage.

Earl Howe: I thank the Minister for responding positively to the recommendations made by the Delegated Powers Committee on the issue of non-prescribable drugs and the regulatory procedure that

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should govern them. Amendment No. 459 was designed to flag up the issue, and I have no objection to what the Government are now proposing.

On Question, amendment agreed to.

[Amendments Nos. 450 to 455 not moved.]

Lord Grocott: I beg to move that the House do now resume.

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Moved accordingly, and, on Question, Motion agreed to.

House resumed.

        House adjourned at six minutes before five o'clock.

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