§ Lord Northfield
asked Her Majesty's Government:
What are the time limits imposed by EC Directives on the processing of applications for marketing authorisations for medicinal products in the case of those which are not referred to advisory committee; what number and percentage of abridged applications were not referred to an advisory committee in the most recent twelvemonth period for which figures are available; what number and percentage of such applications were dealt with outside the EEC time limits; and what steps are being taken to improve the situations.
§ The Parliamentary Under-Secretary of State, Department of Health and Social Security (Baroness Trumpington)
Article 7 of Economic Community Directive 65/65 states that member states shall take all appropriate measures to ensure that the procedure for granting an authorisation to place a proprietary medicinal product on the market is completed within 120 days of the date of submitting the application and that, in exceptional cases, this time limit may be extended for a further 90 days. Under Article 4(c) of Directive 75/319/EEC these limits are exclusive of the time taken by companies to reply to queries from the licensing authority or to make representations. There is no distinction in the directives for applications referred to an advisory committee.
In 1985, the number of abridged applications for which product licences were granted without reference to an advisory committee was 565, or 88 per cent. The number of such applications dealt with in 1985 where 286WA the gross time (that is, including time taken by companies to reply to requests for further information or to make representations) exceeded 120 days was 263, or 46 per cent., and the number where the gross time exceeded 210 days was 164, or 29 per cent. I regret that it is not possible at present, without disproportionate cost and delay to applications, to indicate the extent to which these figures are reduced when account is taken of the time awaiting replies or representations from companies, as provided for in the directives.
During 1985, a record number of product licence applications was received from industry as well as many applications under the new licensing scheme for parallel imported medicines; following staff departures, there were also a number of professional staff still in training. Because of such pressures over and above other urgent work, such as that on adverse reactions, the average time taken to deal with applications by the specialist professional and administrative staff in the Medicines Division of DHSS has inevitably risen. We have taken, and shall take, all possible steps, within overall limits of Government money and manpower, to increase efficiency and reduce time taken to consider applications. But since the right to apply for licences and variations to licences, is open-ended, the matter is not—as the EC directive recognises—wholly within the department's control.