HC Deb 27 June 1990 vol 175 cc247-8W
Mr. Ashley

To ask the Secretary of State for Health if he will give consideration to adopting in the United Kingdom the United States Food and Drug Administration's system of publishing summary basis of approval reports when a product licence is given to a pharmaceutical drug.

Mrs. Virginia Bottomley

The Commission of the European Community (EC) suggested publication of a summary basis of approvals in proposals for a future licensing system for licensing in the EC. Further proposals are expected from the Commission soon and we shall consider these carefully. Section 118 of the Medicines Act 1968 currently prohibits disclosure of information obtained for the purposes of the Act.

Mr. Ashley

To ask the Secretary of State for Health if he will request all pharmaceutical companies to inform the Committee on Safety of Medicines when they withdraw a licence application to the United States Food and Drug Administration for a drug which has a British licence and to give the reason for the withdrawal.

Mrs. Virginia Bottomley

There are standard provisions attached to every product licence granted to a medicinal product in the United Kingdom. These provisions require the licence holder to inform the licensing authority of any information that casts doubt upon the continued validity of the data which was submitted for the purpose of the assessment of safety, quality and efficacy of any medicinal product to which the licence relates. Licence holders are also required to provide details of adverse reaction reports received worldwide by them. These statutory requirements provide sufficient safeguards to ensure that the licensing authority and the Committee on Safety of Medicines are informed of all relevant issues relating to a licensed medicinal product by the pharmaceutical company holding the licence.

Mr. Ashley

To ask the Secretary of State for Health if he will make public all discussions in the Committee on Safety of Medicines on matters pertaining directly to patients' health.

Mrs. Virginia Bottomley

The deliberations of the Committee on Safety of Medicines (CSM) are confidential. Information on potential problems with medicines is sent regularly to all prescribers by means of CSM's "Current Problems" bulletin; in the case of major drug safety hazards the professions are alerted by means of a letter from the Chairman. Other means of publicity may be used when necessary. Drug prescribing information arid guidance is also available from a number of other sources, for example the British National Formulary, which the Department issues free to all doctors twice yearly.

Mr. Ashley

To ask the Secretary of State for Health if he will introduce legislation requiring the Committee on Safety of Medicines to consider whether or not a drug is more efficacious than other drugs already on the market before it grants a product licence.

Mrs. Virginia Bottomley

There are no plans to amend section 19(2) of the Medicines Act 1968 which requires the licensing authority to leave out of account any question of relative efficacy.

Mr. Ashley

To ask the Secretary of State for Health if he will make it his policy to request the Committee on Safety of Medicines, whenever there is a withdrawal of a licence application to the United States Food and Drug Administration for a drug which has a British licence, to re-evaluate the safety evidence.

Mrs. Virginia Bottomley

The licensing authority would consult the Committee on Safety of Medicines (CSM) the event of important new information being made available in relation to a medical product which was licensed in the United Kingdom. Withdrawal of a licence application made to the United States Food and Drug Administration could occur for a number of reasons. In the United Kingdom holders of product licences for medicinal products are required to inform the licensing authority of any information that casts doubt upon the continued validity of data which were submitted for the purpose of the assessment of safety, quality and efficacy of the licensed product. Licence holders are also required to provide details of adverse reaction reports received by them.

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