§ Mr. GalbraithTo 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-HamiltonCurrently 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 1001W 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.