§ Mr. Hunterasked the Secretary of State for Social Services if he will outline the consultative and investigative process which takes place before the withdrawal of a medically prescribed drug; and if he is satisfied with these processes.
§ Mr. Kenneth ClarkeUnder section 28 of the Medicines Act 1968 the licensing authority can revoke a product licence for a number of reasons.
Where we propose to revoke a licence, we are required by the law to consult a statutory advisory committee, for example, the Committee on Safety of Medicines. If that committee proposes to endorse revocation, the licence holder has the right to make representations to that committee either in writing or at an oral hearing. If the committee confirms its advice, the licence holder has the right to make further representations either orally or in writing to the Medicines Commission. After the committee, or the commission if it is involved, has offered its advice to us, we make a decision on the revocation of the product licence.
We can also suspend a licence without consultation for an initial period of three months with immediate effect. We use this procedure in cases of urgency where there is an immediate and serious safety hazard associated with the product. We always follow up suspension by a proposal to revoke that licence.
I am reviewing these procedures because they can be time consuming in cases where patient safety is in issue.