HC Deb 08 November 1995 vol 265 cc1000-1W
Mr. Galbraith

To ask the Secretary of State for Scotland if he will make it his policy to restrict the use of beta-interferon to controlled trials; and if he will make a statement. [41509]

Lord James Douglas-Hamilton

Currently there are no marketing authorisations—product licences—for beta-interferon in the United Kingdom but approval has been given for clinical trials to test the efficacy of beta-interferon in the treatment of multiple sclerosis. Details of the clinical trials and the licensing of beta-interferon are restricted by law in accordance with section 118 of the Medicines Act 1968.

In addition to the use of beta-interferon in controlled clinical trials, doctors who identify the need to treat a patient using this unlicensed medicine are able to do so on a "named-patient" basis in accordance with section 9(1) of the Medicines Act 1968 without the patient taking part in a clinical trial and without the doctor notifying the licensing authority. However, a doctor prescribing an unlicensed product does so entirely on his own responsibility. To stop such a use of beta-interferon would be a restriction on clinical freedom and prevent a doctor from offering his patient what in his clinical judgment is the most appropriate treatment for that patient.

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