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17 Dec 2002 : Column 783Wcontinued
Information on whether individuals live within the health authority delivering treatment, for drug users presenting to residential rehabilitation, in the six month period ending 31 March 2001, is given in the table. Whether health authority (HA) of treatment and health authority and/or NHS Regional office (RO) of residence
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were the same for drug users presenting to residential rehabilitation during the period 1 October 2000 to 31 March 2001.
|Number of users||810||100|
|Same HA of treatment||256||32|
|Different HA of treatment but same RO||339||42|
|Resident outside RO of treatment||105||13|
1. The data are from the Department of Health Regional Drug Misuse Databases
2. Percentages do not sum to 100 due to rounding.
Mr. Hutton [holding answer 12 December 2002]: National health service foundation trust status will only be made available to high performing three-star acute and specialist NHS trusts. The application process will entail an independent financial review in which applicants will need to clearly demonstrate a track record of good financial management and be financially viable.
Dr. Gibson: To ask the Secretary of State for Health (1) what representations have been received from consumers and patient organisations as part of the HGC consultation on regulation of genetic testing services supplied direct to the public; and whether these organisations favoured (a) statutory regulation and (b) a voluntary industry code; 
(3) when the HGC will be making recommendations to Government as a result of the consultation on regulation of genetic testing services supplied direct to the public; 
(4) if he will place in the Library the responses of the (a) Advertising Standards Agency, (b) British Embassies from Canada, Holland, Japan and the US, (c) DTI Policy Advisor on Internet Regulation, (d) Information Commissioner, (e) Medical Devices Agency, (f) Medical Research Council and (g) Occupational Health Advisory Committee to the HGC consultation on genetic testing. 
Ms Blears: The Human Genetics Commission (HGC) consultation on genetic testing services supplied direct to the public closed in October 2002. HGC is analysing the responses and is conducting additional public surveys. HGC plans to publish its report and recommendations to Ministers early in 2003. It will also
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publish all of the non-confidential responses received during consultation and copies will be placed in the Library.
HGC has now received written responses from 42 organisations and 22 individuals. Approximately 14 written responses and four oral evidence sessions were from consumer and patient groups. Of these, six favoured statutory regulation for at least some tests and three favoured voluntary codes. Of the written responses from all sources that expressed a view, none favoured no action, 11 favoured voluntary codes for some types of tests, 24 favoured a mixture of voluntary codes and statutory restrictions and 13 favoured statutory restrictions for some types of test.
Ms Blears: Central data on genito-urinary medicine (GUM) clinic waiting times are available only for patients referred by general practitioners. GUM is an open access service and the vast majority of patients self-refer and therefore these data do not provide an accurate picture of waiting times for these services. One of the action points in the sexual health and HIV strategy implementation action plan is to develop a waiting times indicator for GUM and work on this is already under way. However, we are aware that there are pressures on GUM clinics which have led to long waiting times for some services. We have therefore invested over #5 million this year to improve capacity and reduce waiting times.
Mr. Hutton [holding answer 2 December 2002]: Over 20,000 national health service staff were involved in the 'Shifting the Balance of Power' (StBOP) reorganisation. 95 health authorities were replaced by 28 strategic health authorities, and in order to keep valuable skills and experience in the NHS, all staff involved in the reorganisation were given a 12-month guarantee of employment up to 31 March 2003.
However, due to a variety of factors, it was recognised that some staff might not be able to gain suitable alternative employment in the NHS. These staff have been allowed to take early retirement or redundancy prior to 31 March 2003. Since April 2002, there has been one redundancy and 20 early retirements that have taken place among the former health authority chief executives.
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Ms Blears [holding answer 16 December 2002]: A decision on the reconfiguration of acute services in East Kent could not be made while the Judicial Review of the process was under consideration. Now the judgment has been made Ministers are in a position to consider Kent and Medway Strategic Health Authority's recommendation. I cannot, at this time, give the hon. Member an indication of when that decision will be made.
Ms Blears: Amendments 9 and 11 proposed by the European Parliament in relation to the draft Directive on Traditional Herbal Medicinal Products would have the effect of allowing applications for traditional use registrations where individual active herbal ingredients had had traditional use but there was not evidence of traditional use of that particular combination. Elsewhere, within the proposed Directive, applicants are required to supply evidence of the traditional use of the specific combination and member states may refuse applications if the data on traditional use is insufficient. The amendments would therefore probably have limited effect.
Our overall view on this issue is that active medicinal ingredients, herbal or otherwise, can interact causing adverse reactions and we would have concerns on public health grounds about combinations where safety was supported neither by tests and trials (as would apply in the case of a marketing authorisation) nor by evidence of long usage. In some cases one or more herbal ingredient in a combination could reasonably be regarded as non active, for example where included for taste or colour, and in that situation non active ingredients need not have been used as part of the traditional combination.
It is likely to be possible to demonstrate traditional use of a great many herbal combinations. During continuing negotiations, and subsequent implementation if the Directive is agreed, we will look for ways to ensure that the regulatory impact of demonstrating traditional use of combinations is contained to the necessary minimum.
Amendments 9 and 11 also follow through a concept introduced in Amendment 6 which has the effect that classification of a product as a herbal medicinal product would depend on the active ingredients being present at a pharmacologically active level.
We have some concerns about the proposal as drafted. There is an existing definition of a medicinal product in Directive 2001/83/EC. We would not wish to change that definition in relation to one category of medicinal product only (herbal medicines), in relation to an issue, (levels of pharmacological activity) that is a generic one, relevant to all medicines. Second, the amendment does not address the regulatory position of products which, under the existing definition, are classified as medicinal products by virtue of their presentation. Third, the dividing line between
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pharmacologically active and non pharmacologically active levels may be difficult to determine for many herbal substances.
Our top priority in relation to the definition of a medicinal product in the ongoing negotiations on the review of Directive 2001/83/EC is to resist the provision, originally proposed by the European Commission, that would give precedence to medicines legislation for any product which fell within the definition of a medicinal product, even if that product was already regulated under other sectoral legislation. This proposal could have lead to many more products being classified as medicines. From the outset of negotiations we have argued vigorously against this proposal, seeking to enlist the support of other member states and Members of the European Parliament. We are therefore pleased that the European Parliament has not supported the Commission's original proposal and we will continue to argue for its deletion from the proposals.
We also recognise that there are differences in member states' interpretation of the current definition of a medicinal product in relation to products close to the borderline of medicines and other regulatory regimes. We are therefore open to constructive dialogue, whether domestically or in a European forum, on this issue. We intend to discuss further the implications of these proposed amendments with the United Kingdom herbal sector in order to inform our negotiating position.
Ms Blears: Any website reported to the Medicines Control Agency, which appears to be in breach of regulations regarding advertising, sale and supply of medicines is investigated. The agency works closely with other Government Departments and law enforcement authorities, both in the United Kingdom and abroad, in an effort to identify and take action where appropriate.
There is evidence that some unlicensed herbal medicinal products, whether sold via the internet or in other ways, may be of poor quality and in some cases may pose a threat to public health. Subject to the successful conclusion of negotiations, the proposed directive on traditional herbal medicinal products would provide a regulatory regime which should allow the public to choose from a wide range of herbal remedies made to assured standards of safety, quality and information. In turn this would make it possible for the public to be given much clearer advice than is currently possible about how to avoid unregulated herbal medicines which may pose a risk to health.
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