§ Mr. HardyTo ask the Secretary of State for Health if she will ensure that there will be no delay in approving the drug beta-interferon as a treatment of multiple sclerosis if the current trials suggest that this drug could be useful; and when she expects trials to be completed.
§ Mr. SackvilleThe licensing authority has always sought to ensure that there is no delay in approving any drug application. The Medicines Control Agency is now arguably the fastest assessing authority for new drugs in the world. In addition, the MCA has a fast-track procedure for considering new drugs which might offer significant public health benefits. However, in the consideration of any drug application, the licensing authority has to be satisfied as to the efficacy, safety and quality of the product before marketing.
Beta-inteferons, to be used in the treatment of multiple sclerosis, fall into a category of products which, as from 1 January 1995, will be considered through the new European licensing procedures. Such products will be granted European approvals through the so-called "centralised procedure". The Council regulation 2309/93 defines the time frame within which applications must be considered through the procedure. Applicants are required to provide data to support the safety, quality and efficacy of the product. If the clinical trials and the other data presented by the company are satisfactory and meet European requirements, then a marketing authorisation will be granted.
Because of commercial confidentiality, information on the progress of clinical trials cannot be provided.