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Inspection of Food from EU

Lord Hylton asked Her Majesty's Government:

Lord Hunt of Kings Heath: Information concerning the percentage of food originating from other member states of the European Union inspected at the point of destination in the United Kingdom is not held centrally.

Retail premises receiving such food are subject to random as well as programmed checks. The frequency and nature of programmed inspections are set out in Codes of Practice 8 and 9 issued under Section 40 of the Food Safety Act 1990. Random checks are undertaken in response to consumer complaints and for other reasons. The costs of these inspections fall to the local food authority.

Imports of meat and meat products from other member states of the European Union which are delivered to meat plants in the UK, licensed under the meat hygiene regulations, are subject to risk-based random checks by the Meat Hygiene Service (MHS) and by its equivalent in Northern Ireland. The MHS has been instructed to review levels of checking to allow for additional volumes of imports while British supplies are disrupted by the effects of the outbreak of foot and mouth disease. The MHS is also checking all consignments of imported carcass beef following the recent cases where specified risk materials were found to be attached to the meat. The costs of normal MHS services are charged to the plant operator.

National Diabetes Week

Lord Harrison asked Her Majesty's Government:

Lord Hunt of Kings Heath: The Government welcome National Diabetes Week, which each year helps to raise awareness of an important area of need.

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That is why we are developing a national service framework (NSF) for diabetes in England. The diabetes NSF will be published later this year for implementation from 2002. Its aim is to improve health outcomes for people with diabetes by raising the quality of services and reducing variations between them.

Wheelchairs

Baroness Darcy de Knayth asked Her Majesty's Government:

    What additonal funding has been made available for the supply of electrically powered indoor/outdoor wheelchairs and wheelchair vouchers since April 2000; and what managerial provisions there are to ensure that the funding is appropriately spent on wheelchairs and wheelchair vouchers; and[HL1990]

    What expenditure has been earmarked for the supply of electrically powered indoor/outdoor wheelchairs and for the issue of wheelchair vouchers in England for 2001-02, 2002-03, and 2003-04.[HL1991]

Lord Hunt of Kings Heath: From April 2000 the £14 million allocation for wheelchairs and vouchers was placed within health authority revenue baselines. The distinction on what can be spent on powered wheelchair and voucher schemes was removed so that users' needs can be met more effectively. Performance data on the continued progress of powered wheelchair and voucher schemes are collected on the Department of Health's common information core. We will continue to monitor the information carefully.

Baroness Darcy de Knayth asked Her Majesty's Government:

    What progress has been made in the supply of wheelchairs, indoor/outdoor powered wheelchairs and wheelchair vouchers since the publication of the Audit Commission's report Fully Equipped; and[HL2036]

    What is their response to the report on electrically powered indoor/outdoor wheelchairs and wheelchair vouchers, commissioned by the Department of Health from the York University Health Economics Consortium, and, in particular, to its recommendation that additional and ring-fenced funding should be given to the National Health Service to provide greater numbers of these essential mobility items to severely disabled people.[HL2037]

Lord Hunt of Kings Heath: The Fully Equipped report does not discuss the powered wheelchair or voucher schemes in detail as those initiatives had been the subject of the separate evaluation by the York Health Economics Consortium. The Audit Commission's recommendations on wheelchairs were directed at local services and auditors appointed by the commission carried out an overview of the wheelchair

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services at 45 trusts. A full study was then carried out in 38 of these, and individual reports given to the trusts for their local action.

After careful consideration of the York Health Economics Consortium's evaluation of the indoor/outdoor powered wheelchair and voucher scheme initiatives, we continued the overall allocation of £14 million for wheelchairs and vouchers, placing it within health authority revenue baselines which are increased annually. The distinction between what can be spent on powered wheelchair and voucher schemes was removed, so that users' needs can be met more effectively. We asked all services to continue to operate a voucher scheme which offers users a choice in having a wheelchair which meets their needs.

A new framework agreement for the supply of manual and powered wheelchairs was awarded by the NHS Purchasing and Supply Agency and began on 1 October 2000. This provides a wider choice of both manual and powered chairs is available through the NHS, including chairs made available through the voucher scheme.

We will continue to monitor provision of wheelchairs and vouchers to ensure that those who need it can benefit from this important service.

Baroness Darcy de Knayth asked Her Majesty's Government:

    When they expect to issue national minimum standards for National Health Service wheelchairs in England, as recommended by the Audit Commission in its report on disability equipment and services entitled Fully Equipped.[HL2038]

Lord Hunt of Kings Heath: The specific recommendation in the Audit Commission report Fully Equipped was for local reviews of current service standards for delivering wheelchairs and the introduction of local proposals to deliver incremental quality improvement programmes. Subsequently, a full study of the wheelchair service in 38 trusts has been carried out by auditors appointed by the Audit Commission and reports have been provided to the individual trusts. The Department of Health will have further discussions with the Audit Commission.

Herbal Remedies: Traditional Medicines Directive

Lord Colwyn asked Her Majesty's Government:

    What progress is being made by the Medicines Control Agency in discussions at the European Commission Pharmaceutical Committee in relation to the proposed traditional medicines directive; and what assessment they have made of the likelihood of those discussions leading to a directive that would meet the Government's objective of securing, in European law, a safe home for herbal remedies currently marketed under Section 12 of the Medicines Act 1968 as medicines not requiring a product licence; and [HL2042]

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    What steps they are taking to ensure that the provisions of the proposed European traditional medicines directive do not restrict or compromise the ability to continue to market in the United Kingdom herbal products which are currently legitimately on the market as either (a) herbal medicines exempt from licensing under Section 12 of the Medicines Act 1968, or (b) food; and [HL2043]

    What steps they are taking to ensure that the proposed European traditional medicines directive does not impose upon traditional herbal remedies a technical compliance regime based upon criteria established in the Medicines Directive 65/65 and related legislation for pharmaceutical products; and [HL2044]

    When they expect the Medicines Control Agency to submit written comments to the European Commission following discussions on the proposed traditional medicines directive at the European Pharmaceutical Committee meeting on 5 April; and whether they will publish those comments; and [HL2045]

    Whether the provisions of the proposed European traditional medicines directive will unduly limit product innovation and development in natural remedies. [HL2046]

Lord Hunt of Kings Heath: In discussions with herbal interest groups, the Medicines Control Agency (MCA) has reached a wide measure of consensus that the current regulatory arrangements which permit unlicensed herbal remedies under Section 12(2) of the Medicines Act 1968 do not provide adequate safeguards for the public: there are no specific standards for the safety and quality of individual products under this regime, and there are inadequate arrangements for providing the public information about the use of the product.

The UK comments on the second draft of the directive on traditional medicinal products were set out in a letter from the MCA to the European Commission dated 30 April 2001. The response took account of points made by a range of herbal interest groups in their continuing dialogue with the MCA on this issue. Copies of the letter have been placed in the Library.

Although work is still at a relatively early stage, we are encouraged by progress on the draft directive. We expect that if negotiations are successful, this legislation would provide systematic regulatory arrangements for a wide range of traditional herbal remedies of the kind currently sold and supplied under Section 12(2).

Any systematic updated regulatory regime for traditional herbal remedies is likely to place greater constraints on companies than is currently the case with the weak regulatory arrangements for unlicensed herbal remedies. A potential advantage for companies, however, is the greater confidence the public could have in the safety and reliability of these products. The draft directive would not affect products which are not classified as medicines.

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We take the view that traditional herbal remedies properly classified as medicines should be appropriately regulated within a medicines regime. Standards should be consistent with those applying to other licensed medicines, including the many herbal medicines which have received a marketing authorisation under Directive 65/65/EEC. We also wish to ensure that relevant regulatory requirements developed for traditional medicines are in practice applied in a way that is appropriate to the nature of the specific product under consideration.

The current draft directive includes several features which would have the effect of containing the burden of regulatory requirements: for example, the possibility of a positive list of traditional medicines where in certain defined circumstances the safety of the

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product and the requirement to demonstrate traditional usage could both be accepted as met without the applicant presenting evidence and the possibility of simplified quality dossiers for defined categories of traditional medicines.

On product innovation, a key feature of the proposed directive is that the usual requirement for medicines to demonstrate efficacy would be replaced by a requirement to show evidence of traditional use. There will need to be continuing discussions about many aspects of the detailed contents of the directive. Our starting point, however, is that where companies are seeking to bring a new medicine, natural or otherwise, to the market the normal route should be through demonstration of the product's safety, quality and efficacy.



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