§ Paul FlynnTo 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 WintertonInitial 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 FlynnTo 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 1546W 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 WintertonNo 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 FlynnTo 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 WintertonThe 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 FlynnTo 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 WintertonThe 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.