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Deaf-Blind People

Mr. Baron: To ask the Secretary of State for Health what steps his Department is taking to ensure health staff have the relevant training to provide an effective service to deaf-blind people. [180203]

Mr. Hutton: NHSU, the organisation set up by the Department to establish a university for the national health service, is leading the development and delivery of disability equality and awareness training tools and resources as part of a wider disability learning and development strategy. An initial prototype learning programme, aimed at providing staff with a broad overview of disability awareness, will be ready for consultation in the autumn.

Delayed Discharge Charging

Mr. Baron: To ask the Secretary of State for Health how many chargeable days NHS trusts in England have reported since liability for delayed discharge charging came into effect; and what the total charging liability since this date is. [179590]

Dr. Ladyman [holding answer 21 June 2004]: Between 5 January 2004, when charging for delayed discharges was introduced and 28 March 2004, national health service trusts reported 58,724 days of delay to discharge because of patients awaiting social services.

Information on agreed legal liabilities for charging will be collected centrally at the end of the first six months of the scheme. The majority of councils have arranged local investment agreements with the NHS and will only pay charges for delays falling outside this agreement.

Departmental Vacancies

Mr. Lidington: To ask the Secretary of State for Health when he will publish his Department's vacancies survey for March. [180345]

Mr. Hutton: The national health service staff vacancy survey 2004 is due for publication in July 2004.

Domestic Violence

Sandra Gidley: To ask the Secretary of State for Health if he will make domestic violence training mandatory for all health professionals. [178809]

Mr. Hutton: Responsibility for professional education rests with the respective colleges and relevant professional bodies. The Department will support health professionals in establishing domestic violence policy, practice and training programmes in a number of ways. "Domestic Violence: A Resource Manual for Health Care Professionals", published in 2000, is being revised to include new material on training. In addition, the REFUGE therapists manual and training materials
 
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coming out of the University of the West of England pilot funded by the Department will be widely disseminated. Significant work has also been done by the national domestic violence health practitioners forum that will feed into the violence and abuse programme expert group on domestic violence for dissemination from April 2005. A national conference is planned for September 2004 which will provide the focus for all this work to come together as a resource for health professionals to enable them to access appropriate training.

Drug Applications

Paul Flynn: To ask the Secretary of State for Health what assessment he has made of the average (a) amount and (b) proportion of working days spent on scrutiny of new drug applications that is accounted for by examination of raw data from Phase 3 clinical trials. [179575]

Ms Rosie Winterton: Companies are required to submit, for review and assessment, summaries of all the clinical data and these are much more useful than the examination of the actual raw data for helping to determine the quality, safety and efficacy of products. The average amount of time spent by all assessors assessing a new drug is approximately 50 working days, only a small proportion of which is spent on review of raw data.

Drug Licensing

Paul Flynn: To ask the Secretary of State for Health what proportion of the fees charged for the licensing of a new drug is typically earmarked for post-marketing surveillance; and what his estimate is of the average amount payable for each new drug made available for that purpose. [179719]

Ms Rosie Winterton: Initial application fees for new drugs cover the work associated with the assessment and evaluation of an application prior to granting a marketing authorisation. Fees for post-marketing surveillance of authorised drugs are charged through an annual service fee for each live marketing authorisation. This service fee covers a number of activities, including enforcement, renewals and post-marketing surveillance activities and it accounts for around 36 per cent., of the Medicines and Healthcare products Regulatory Agency's annual budget.

The service fee is tiered according to the type of application, to reflect the increased post-marketing activity in newer drugs, compared to well established generic drugs. A newly authorised medicine attracts an annual service fee of £14,768, compared to £1,521 for an established prescription only medicine, or £275 for a general sale list product. Because the service fee covers a number of activities, it is not possible to estimate the amount available purely for post-marketing surveillance for each new product.

Paul Flynn: To ask the Secretary of State for Health what agreements exist between the Medicines and Healthcare Products Regulatory Agency and pharmaceutical companies that define (a) the basis on
 
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which drug licence fees are set and charged and (b) for what purpose fees may legitimately be used; and if he will publish them. [179720]

Ms Rosie Winterton: No agreements exist between the Medicines and Healthcare products Regulatory Agency (MHRA) and the pharmaceutical companies in relation to fees.

The Medicines Acts 1968 and 1971 require the MHRA to consult the pharmaceutical industry and other interested parties on any proposals to amend the Fees Regulations. Parliamentary approval is then required.

The MHRA is a Government trading fund and as such, is required to cover its full costs, in relation to the regulation of medicines, from user-fees. Fees paid to the MHRA may be used for purposes set out in the Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989 (SI 1989 No 684 amended by SI 1995 No 871), which specifies costs and activities which may be taken into account when setting fees for the MHRA. These include functions of the medicines advisory bodies, all functions relating to European and United Kingdom medicines regulations, enforcement of regulations and premises and equipment overheads.

MHRA fees are published and are available in the Library and on the MHRA's website.

Paul Flynn: To ask the Secretary of State for Health what proportion of the Medicines and Healthcare Products Regulatory Agency's fee income is allocated to post-marketing surveillance. [179721]

Ms Rosie Winterton: The proportion of income fees allocated to post-marketing surveillance by the medicines sector of the Medicines and Healthcare products Regulatory Agency for 2003–04 was approximately 30 per cent.

Paul Flynn: To ask the Secretary of State for Health whether the licensing authority has conducted an audit of the reliability of summaries of clinical data provided by pharmaceutical companies applying for new drug licence applications. [179722]

Ms Rosie Winterton: The Medicines and Healthcare products Regulatory Agency does scrutinise companies' raw data when considered necessary to ensure the reliability of summaries of clinical data. This may be done in various ways including looking at original patients' trial records, reviewing extensive listings of data and sometimes re-analysing the data.

Drug Rehabilitation (Crosby)

Mrs. Curtis-Thomas: To ask the Secretary of State for Health what action he is taking to reduce waiting times for drug rehabilitation in Crosby; what the budget is for the drug action team in Crosby in 2004–05; and how many people have been seen by the drug action team in each of the last three years. [177855]

Miss Melanie Johnson: The information requested is not available centrally. The Crosby area is covered by the Sefton drug action team, which is equivalent to the Sefton Metropolitan local authority area.
 
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The Government have invested substantial extra funding for drug treatment with the total pooled drug treatment budget increasing by over 100 per cent. since it was introduced in 2001–02. In 2004–05, the total pooled drug treatment budget allocation for the Sefton drug action team was £1,490,000, including young people's pooled drug treatment budget allocation, which is issued separately from the adult allocation.

The latest national waiting time figures show that additional funding has helped to reduce average waiting times for drug treatment from five to 11 weeks in 2001 to two to four weeks by April 2004.

A census of drug users in treatment was carried out in 2000 to estimate the number of drug users in England in contact with drug treatment agencies in 2000–01. The number of drug users reported as being in treatment in the Sefton drug action team area was 936. Data has been published in a statistical bulletin "Statistics from the Regional Drug Misuse Databases on drug misusers in treatment in England, 2000–01". This is available on the Department's website at http://www.publications. doh.gov.uk/public/sb0133.htm.

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