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Mr. Lansley: To ask the Secretary of State for Health what the (a) budget of the Medical Research Council and (b) the NHS research and development budget has been in each year since 199798 in (i) real and (ii) nominal terms. [63109]
Jane Kennedy: The information requested is shown in the table.
Mr. Sheerman: To ask the Secretary of State for Health what average time it has taken for an application for (a) a new and (b) a variation of a medicine to be approved by the Medicines and Healthcare products Regulatory Agency. [49842]
Jane Kennedy:
The most recent full-year figures for new medicines approval times by the Medicines and Healthcare products Regulatory Agency (MHRA) are for 200405. These show an average approval time, from receipt of the application to grant of the licence, of 288 calendar days. This period however includes the time taken by applicants to supply any necessary new or correcting information following the initial assessment
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of their application. When this is taken into account the actual number of net working days taken by the MHRA reduces to an average of 122 days.
For the relatively small number of completely new medicines, for example those containing new drugs and with the potential for meeting unmet medical needs in major diseases, the MHRA, during the same period, has maintained its record of assessing these in under 40 days.
For all types of variations to product licences, whether straightforward or complex, and again in the most recent full year for which figures are available, 200405, the average time taken to approve, from receipt of the application to grant of the variation, was 67 calendar days. This includes time taken waiting for the company to provide any further information needed.
More recent figures show a lengthening of assessment and approval times. For example, for the first seven months of 200506 (April to October) the approval time for new product licences had increased to 153 net working days or 404 gross calendar days.
These exceed the MHRA's assessment and approval target times and it is well aware of the impact this is having on pharmaceutical company business. This lengthening of assessment and approval times has been caused by a combination of adverse factors including increases in workload, difficulties in recruiting professional assessment staff, especially medically-qualified staff, and transitional implementation problems during the introduction of a new information management system.
The MHRA is taking a number of steps to improve service levels. These include organisational restructuring, additional recruitment, re-training of staff, voluntary schemes for extended working hours, and information system performance enhancements.
Mr. Sheerman: To ask the Secretary of State for Health what assessment she has made of the methods used by the Medicines and Healthcare products Regulatory Agency to approve new medicines. [49844]
Jane Kennedy: The Medicines and Healthcare products Regulatory Agency (MHRA) approves new medicines for marketing in the United Kingdom and is required to follow procedures set out in European legislation. The basis of its licensing decisions is its assessment of the data provided by companies attesting to the quality, safety and efficacy of their new product. This assessment is carried out by professionally qualified and experienced staff in the fields of medicine, toxicology, pharmacy and other scientific disciplines relevant to the product under review. The MHRA is a benchmark agency within the European Community for the quality of its assessments and processes and is recognised as a leading player in European medicines licensing.
The MHRA assessment process and decision-making is supported by internationally recognised technical guidelines and, where necessary, by external expert advice.
The MHRA's business procedures are subjected to internal and external audit as part of its risk management and corporate governance procedures. The MHRA's directors and managers are required to
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keep their processes under constant review and to strive to make year-on-year efficiency and effectiveness improvements.
Anne Main: To ask the Secretary of State for Health what the level of pre-existing debt is within the NHS; what her Department's plans are for reducing it; and if she will make a statement. [61123]
Jane Kennedy: The overall audited net national health service deficit position for 200405 was around £250 million. This represents around 0.4 per cent. of overall NHS resources. At 200506 month six, the NHS was forecasting a net deficit of £620 million. This forecast deficit amounts to less than 1 per cent. of the funding available.
We are taking action with the minority of organisations that are underperforming to ensure that the position improves and financial balance is restored in the NHS by the end of 200607.
For the organisations with the biggest problems we have sent in financial and management specialists (turnaround teams) to help the organisations address their problems of poor financial management.
The turnaround teams will support the NHS in identifying opportunities to deliver services with greater cost-effectiveness and to make financial savings. They will help the local NHS ensure that the NHS delivers both its key targets and financial balance.
Mr. Evans: To ask the Secretary of State for Health how much the NHS has spent per head of the population in (a) Lancashire and (b) Ribble Valley in each year since 1997. [63198]
Mr. Byrne [holding answer 18 April 2006]: The information is not available in the format requested. However, the following table shows expenditure per capita by all relevant health authorities, strategic health authorities (SHA) and primary care trusts (PCTs) within the current Lancashire and Cumbria SHA area.
John Hemming: To ask the Secretary of State for Health what the expected (a) turnover, (b) fixed capital costs as a proportion of turnover, (c) fixed costs and (d) financial out-turn is for each NHS hospital trust for 200506. [62509]
Jane Kennedy: The information requested on turnover, fixed capital costs as a proportion of turnover and financial out-turn for 200506 for each national health service trust has been placed in the Library.
The turnover and forecast out-turn position for 200506, as submitted by both NHS trusts and primary care trusts at the mid-year point (month six), is available in the Library. Copies of this information is also available on the Department's website at:
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