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Kate Hoey: To ask the Secretary of State for Health (1) what records his Department holds on the anticipated range of charges to be levied by the Medicines and Healthcare Products Regulatory Agency for processing applications under the Traditional Herbal Medicinal Products Directive for (a) single ingredient products and (b) more complex products; and what assistance he plans to make available to small manufacturers to meet these charges; 
(2) if he will make it his policy urgently to survey specialist manufacturers of herbal remedies to identify the total likely cost burden of submitting dossiers for registration under the Traditional Herbal Medicinal Products Directive; and if he will make a statement; 
(4) how the proposed fee of £7,480 for processing applications for registration of complex herbal products under the Traditional Herbal Medicinal Products Directive has been calculated; and how many such fee payments the Medicines and Healthcare Products Regulatory Agency expects to receive annually; 
(5) how (a) the proposed fee of £1,496 for a single day inspection of a manufacturer of herbal products and (b) the fee of £1,266 for inspection of a wholesale dealer under the Traditional Herbal Medicinal Products Directive has been calculated; with what frequency such inspections are expected to be undertaken in relation to any one applicant for registration of products under the legislation; and how many of each such fee payments the Medicines and Healthcare Products Regulatory Agency expects to receive annually; 
(6) whether a full economic impact assessment has been undertaken and published on the proposed fee increases for applications for registration under the Traditional Herbal Medicinal Products Directive as set out in the Medicines and Healthcare Products Regulatory Agencys consultation letter of 17 October 2007; 
(7) if he will estimate (a) the anticipated fee income to the Medicines and Healthcare Products Regulatory Agency associated with the Traditional Herbal Medicinal Products Directive and (b) the net cost of processing the necessary applications. 
Dawn Primarolo: The registration scheme for Traditional Herbal Medicines was introduced in 2005 and the industry was fully consulted on how the scheme would work. The Department appreciates that for many companies moving from what was, for the main part, an unregulated environment into one where systematic standards need to be met does present significant challenges.
The Medicines and Healthcare products Regulatory Agency (MHRA) has therefore sought to minimise the impact as far as possible by, for example, making full use of the permitted transitional period, until 2011, for products that were legally on the market in April 2004. This allows companies time to prepare to meet the new requirements. In addition, the MHRA continues to have extensive discussions with the industrys herbal forum about the practical arrangements for implementing the directive, and has taken a wide range of practical measures to contain regulatory impact.
The MHRA is a trading fund and is fully funded by fees for its medicines regulatory work. It monitors costs against fees charged and reviews its fee levels annually. Fees are set, in accordance with Treasury guidelines, with a view to achieving cost recovery for each activity for which it sets a charge.
The agency published a consultation document (MIX 344) on 17 October proposing changes to the fees it charges in relation to the regulation of human medicines, including traditional herbal medicines, to take effect from 1 April 2008. Full details of all fees in relation to traditional herbal medicines are included in this letter. The MHRA also has provisions for easements of payment of certain capital fees by smaller companies. The consultation letter and details of provisions for smaller companies are available on its website:
The consultation letter includes a draft impact assessment relating to the whole package of fees changes proposed in the letter. The letter also specifically invites smaller companies to respond to the MHRA with details of the effects the proposals will have on their company. The consultation runs until 9 January 2008. The MHRA would particularly welcome responses from traditional herbal medicines companies to complete the impact assessment more fully.
Individual fees for the herbal medicines registration scheme, for applications and inspections, were subject to full consultation before they were set in 2005. The fees were based on an estimate of the amount of time it would take to undertake each of the activities and the costs of the relevant staff that would be required to undertake those activities. Applications that are more complex take longer to assess and can require staff with more experience to undertake the work. These costs are reflected in the fee charged. The proposed fee of £7,480 for processing applications for registration of complex herbal products containing two or more ingredients not previously assessed by the agency reflects the additional work that would be necessary when assessing ingredients for the first time. The MHRA, however, anticipates that only a minority of applications will fall into this category.
In setting its fees each year, the agency targets specific changes to fees according to the outcome of a rigorous costing model. The costing model is informed by anticipated unavoidable costs for the agency for the coming year as well as by performance and specific costs in each area of the agencys work. The fees for inspections for traditional herbal products are proposed to be increased by 9.7 per cent. for 2008-09 in line with the outcome from the costing exercise undertaken this year. Other fees in other areas of the agencys work are proposed to change by different amounts all with the intention of recovering full costs for those areas of work.
Inspections of herbal manufacturers are expected to take place when the application for the manufacturing licence is made and thereafter at least every three years. Based on experience with the scheme so far, the MHRA estimates that 10 inspections of this type might take place in 2008-09. MHRA is currently consulting on proposals for a risk-based inspection strategy which is intended to reduce the regulatory burden of inspections for compliant companies.
To ask the Secretary of State for Health what the monetary value was of the budget reductions
made by Hertfordshire Partnership Trust in the (a) 2007-08, (b) 2005-06 and (c) 2006-07 financial year. 
Mr. Walker: To ask the Secretary of State for Health what the percentage reduction was in the Hertfordshire Partnership Trust budget for the (a) 2007-08, (b) 2005-06 and (c) 2006-07 financial year. 
Mr. Lansley: To ask the Secretary of State for Health when, and on what terms he permitted Hillingdon Primary Care Trust to access the suppliers under the Framework for External Support for Commissioning. 
Mr. Bradshaw: Hillingdon Primary Care Trust (PCT) issued tender documentation to a range of relevant suppliers on 2 June 2007 following approval by the PCT board. The PCT has been in discussion with the Department regarding the strengthening of its commissioning functions as part of its organisational recovery programme and the PCT is piloting the Framework for procuring External Support for Commissioners, which was available to PCTs from 31 May 2007.
|Count of finished admission episodes where the strategic health authority of treatment was the five London SHA's: Data for national health service hospitals, England, 1996-97 to 2005-06|
|Data year||Finished admission episodes|
1. Primary care trust (PCT) and strategic health authority (SHA) data quality.
PCT and SHA data was added to historic data-years in the HES database using 2002-03 boundaries, as a one-off exercise in 2004. The quality of the data on PCT of treatment and SHA of treatment is poor in 1996-97, 1997-98 and 1998-99, with over a third of all finished episodes having missing values in these years. Data quality of PCT of GP practice and SHA of GP practice in 1997-98 and 1998-99 is also poor, with a high proportion missing values where practices changed or ceased to exist. There is less change in completeness of the residence-based fields over time, where the majority of unknown values are due to missing postcodes on birth episodes. Users of time series analysis including these years need to be aware of these issues in their interpretation of the data. The SHA's used to define Greater London were:
Q04 North West London Strategic HA
Q05 North Central London Strategic HA
Q06 North East London Strategic HA
Q07 South East London Strategic HA
Q08 South West London Strategic HA
2. Ungrossed Data
Figures have not been adjusted for shortfalls in data (i.e. the data are ungrossed).
3. Assessing growth through time
HES figures are available from 1989-90 onwards. During the years that these records have been collected by the NHS there have been ongoing improvements in quality and coverage. These improvements in information submitted by the NHS have been particularly marked in the earlier years and need to be borne in mind when analysing time series. Changes in NHS practice also need to be borne in mind when analysing time series. For example a number of procedures may now be undertaken in outpatient settings and may no longer be accounted in the HES data. This may account for any reductions in activity over time.
4. Finished admission episodes
A finished admission episode is the first period of in-patient care under one consultant within one health care provider. Please note that admissions do not represent the number of in-patients, as a person may have more than one admission within the year.
Hospital Episode Statistics (HES), The Information Centre for Health & Social Care
Death certificates record the place where a person dies, but not where any infections may have been acquired. It is not possible from the information on a death certificate to know whether an infection was acquired in the hospital or other place where a patient died. Patients are often transferred between hospitals, nursing homes and other establishments and may have acquired infections in a different place from where they died.
ONS does not receive information on 'healthcare-acquired infections' but special analyses of deaths involving two infections that are often associated with healthcare, MRSA and Clostridium difficile, are undertaken annually by ONS for England and Wales.
The most recent figures were published in reports in Health Statistics Quarterly 33 in February of this year. This publication is available in the House of Commons library.
|Table 1: Number of death certificates where (a) methicillin-resistant Staphylococcus aureus( 1) and (b) Clostridium difficile( 2) was mentioned, England and Wales, 1996-2005( 3,4)|
|(a) MRSA||(b) Clostridium difficile|
|(1) Identified using the methodology described in Griffiths C, Lamagni TL, Crowcroft NS, Duckworth G and Rooney C (2004). Trends in MRSA in England and Wales: analysis of morbidity and mortality data for 1993-2002. Health Statistics Quarterly 21, 15-22. (2) Identified using the methodology described in Office for National Statistics: Report: Deaths involving Clostridium difficile: England and Wales, 2001-2005. Health Statistics Quarterly 33, 71-75. (3) Data are for deaths occurring in each calendar year.|
(4) Deaths involving Clostridium difficile can only be identified using the Tenth Revision of the International Classification of Diseases (ICD-10). This has been used by ONS for coding mortality from 2001 onwards and in 1999 for a bridge coding study. Data are therefore not available for 1996-98 and 2000 when the Ninth Revision of the ICD was in use.
Mr. Spring: To ask the Secretary of State for Health when he expects to receive the recommendations of the Independent Reconfiguration Panel on hospitals in West Suffolk; and when he expects to make his final decision on changes to services in the West Suffolk area. 
Mr. Ivan Lewis: The Independent Reconfiguration Panel will report back to the Secretary of State (Alan Johnson) on hospitals in West Suffolk by the end of December. Until the Independent Reconfiguration Panels report is received it is not possible to speculate as to when a final decision will be made.
Mike Penning: To ask the Secretary of State for Health how many people in the South Hertfordshire Primary Care Trust area have been diagnosed with (a) chronic bronchitis and emphysema and (b) pneumoconiosis on the most recent date for which figures are available. 
Mr. Bradshaw: This information is not held centrally but may be available directly from the Chairman of NHS Direct NHS trust. However, the Department does collect monthly data on the percentage of calls that NHS Direct answers within 60 seconds. Following a major transformation programme last year, NHS Direct have improved their performance and are meeting their target, set in June 2007, to answer 95 per cent. of calls within 60 seconds.
|Calls answered within 60 seconds|
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