HC Deb 03 November 1987 vol 121 cc693-5W
Mr. Gale

asked the Secretary of State for Social Services what steps he intends to take to ensure that when considering the safety of drugs, the effect of drug overdoses is brought within the scope of the Medicines Act.

Mr. Newton

When assessing an application for a product licence under the Medicines Act, the licensing authority and the Committee on Safety of Medicines are concerned primarily with the safety, quality and efficacy of the medicinal product when taken at recommended doses for the relevant indications. Where appropriate, however, close account is taken of the adequacy of warning statements, including guidance in the event of overdosage, in the data sheets, product particulars and labelling of medicinal products. We have no plans to change these arrangements.

Mr. Gale

asked the Secretary of State for Social Services if he will ensure that consultation takes place between the Committee on Safety of Medicines and drug companies before notices are formally issued under section 28 of the Medicines Act.

Mr. Newton

Before seeking the compulsory revocation or variation of a product licence under section 28 of the Medicines Act, it is normal practice for the licensing authority to consult the licence holder with a view to obtaining agreement to a voluntary change. Where the licensing authority proposes to take formal action under that provision to suspend, revoke or vary a product licence in relation to safety, quality or efficacy, the provisions of schedule 2 to the Medicines Act 1968 will apply. These include the right of the licence holder to make oral or written representations to a section 4 committee, such as the Committee on Safety of Medicines, and, if necessary, thereafter to the Medicines Commission before action is taken. The licensing authority can, however, suspend a product licence with immediate effect for up to three months in the interests of safety, further suspension being subjected to the process described in schedule 2. Informal consultation may not be possible in such circumstances.

Mr. Gale

asked the Secretary of State for Social Services what steps he is taking to reduce delays in the processing by the Committee on Safety of Medicines, of applications by drug companies that will lead to the introduction of new and available treatments for a variety of conditions.

Mr. Newton

The special study of the medicines division of the Department by Dr. J. Evans and Mr. P. Cunliffe, which I announced in March this year, is considering ways of reducing the time taken in the processing of new drug applications. We hope to receive their report early in the new year. Increases have been made to the full-time professional staff which supports the Comittee on Safety of Medicines. We are also introducing more information technology. The recently introduced EC requirement for expert reports to be included in all applications should lead to improvements in the quality and comprehensiveness of applications by pharmaceutical companies and this will facilitate quicker processing.

Mr. Gale

asked the Secretary of State for Social Services if he is satisfied with the benefit-risk ratio applied to the Committee on Safety of Medicines; if the same criteria will be applied to treatments for AIDS as for other conditions; and what groups of conditions qualify for fast-track processing.

Mr. Newton

The Committee on Safety of Medicines has to balance the risks and benefits on a case by case basis in the light of professional judgment. The level of acceptable risk will clearly vary according to circumstances, for example where conditions are life threatening, such as AIDS, compared with other less serious conditions. I am satisfied that the committee is well constituted to provide expert advice to the licensing authority on licensing decisions. Normally all licence applications are assessed in strict chronological order of the date of receipt. "Fast-tracking" means that the application is considered out of turn; it does not mean that normal standards are lowered. A product licence application may be fast-tracked when there are compelling reasons for believing that the product would provide a major therapeutic breakthrough in the treatment of patient for indicated conditions.

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