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Rosie Cooper: To ask the Secretary of State for Health how many people worked in the Cheshire and Merseyside strategic health authority, including Southport and Ormskirk hospital trust; and what the staff costs were (a) in October and (b) at its inception. [26377]
Mr. Byrne: The information requested on staff costs is not held centrally. Information on all national health service staff by selected group, for Cheshire and Merseyside strategic health authority by organisation, as at 30 September 2002 and 30 September 2004 has been placed in the Library.
Mr. Burstow: To ask the Secretary of State for Health on what basis she exercises her discretion to release information covered by commercial confidentiality for reasons of public accountability; and if she will list the occasions on which she has exercised this discretion in each of the last five years. [29747]
Jane Kennedy: In considering any decision to disclose confidential information the commercial sensitivity of that information is assessed on a case by case basis at the time the request for disclosure is made, against the criteria set out in the Freedom of Information Act (2000). The Freedom of Information Act 2000 became effective on 1 January 2005.
The information requested on the release of such information is not readily available and could be obtained only at disproportionate cost.
Mike Penning: To ask the Secretary of State for Health if she will list the 10 highest-paid employees in her Department; what the (a) job title and (b) salary including bonuses is of each; and whether the individual concerned is (i) a civil servant and (ii) a contractor in each case. [27431]
Jane Kennedy: The information requested is shown in the following table.
Mr. Hollobone: To ask the Secretary of State for Health (1) what long-term safety and efficacy data the Department makes available on insulin analogues; [28665]
(2) what research she has evaluated on the clinical effects of the use of insulin analogues by insulin-requiring diabetes patients; [28671]
(3) what assessment has been made of the safety of NovoRapid for use in children; and what assessment she has made of the post-marketing data available in this respect. [28676]
Jane Kennedy:
All new drugs applications, including insulins such as Novorapid are evaluated by the commission on human medicines (CHM), formerly the committee on safety of medicines (CSM) which advises the Licensing Authority as to whether a marketing
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authorisation should be granted. The applicant includes, in their submission, results of clinical trials conducted in the proposed indication for which the licence is sought. The first marketing authorisation for the recombinant human insulin was granted to NovoNordisk on 9 June 1982. This application was considered by the expert biologicals sub-committee of the CSM, in March 1982 and subsequently by the main committee. The application for a new drug substance such as recombinant human insulin would have been scientifically and medically reviewed to ensure it satisfied the criteria for safety, quality and efficacy. Medicinal products, including human or animal insulin, will not be granted a marketing authorisation unless supporting data have been provided to demonstrate that the quality, safety and efficacy are satisfactory for the intended use. The type of clinical development programme, clinical trial data, that should support the registration of new medicinal products for the indication treatment of diabetes mellitus is detailed in European guidance documents, for example, notes for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus. CPMP/EWP/1080/00. These are read in conjunction with other pertinent European and International (ICH) clinical guidelines. The marketing authorisation applications are evaluated by the CSM before they are granted.
Data from clinical trials submitted at the time of licensing examined the safety and efficacy of the human insulin analogues (insulin glargine, insulin aspart, insulin detemir, insulin lispro and insulin gluisine) in diabetic patients treated for up to 12 months. A summary of the available data submitted in support of the licence applications for many of the insulin analogues is made publicly available in the form of a European Public Assessment Report.
The longer term safety of the use of human insulin analogues in routine clinical practice is monitored by the Medicines and Healthcare products Regulatory Agency (MHRA). Any possible new safety issue to emerge is evaluated and, if necessary, product information for prescribers and patients is updated to reflect the new data.
As with all medicines, reports of suspected adverse drug reactions (ADRs) to insulin analogues are collected by MHRA and CHM through the spontaneous reporting scheme, the Yellow Card scheme. A summary of the ADRs that have been received in association with a medicine, including insulin analogues, is available on the MHRA's website.
Kitty Ussher: To ask the Secretary of State for Health what the expenditure of East Lancashire NHS Trust on NHS services was in each of the last five years for which figures are available. [28005]
Mr. Byrne:
The information is not available in the format requested. However, information relating to the total operating expenses is shown in the table.
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Sarah Teather: To ask the Secretary of State for Health how many people have been prosecuted under the Health Act 1999 for wrongful claims of free prescriptions in London in each year since 2000. [16904]
Jane Kennedy: Since August 2001, a penalty charge system has been in place in respect of those falsely claiming exemption to national health service pharmaceutical charges. Since its introduction in August 2001, 160,000 penalty notices have been issued. The total amount recovered to date is £2,950,000. These figures are national and are not broken down into regions as requested. This is done through the civil courts as criminal prosecution of offenders would not be a cost-effective way of dealing with such high volume but low-value frauds.
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