NHS SCOTLAND
Providing advice about the status of all newly licensed medicines
1. To obtain marketing authorisation for a new medicine, the sponsor has to provide the licensing authority with evidence of safety, quality and efficacy. Comparative safety can be taken into account, but not comparative efficacy. The relevant regulatory authorities are the Medicines & Healthcare products Regulatory Agency (MHRA) for a UK license and the European Medicines Agency (EMEA) for a European one. Over the last 20 years some Health Boards have added an additional hurdle by requesting advice on cost-effectiveness from their Area Drug and Therapeutics Committee.
2. SMC was created to avoid duplication of effort, improve the standards and efficiency of the system, and give uniform advice on new medicines across Scotland. An important additional factor is the participation of the pharmaceutical industry. Industry has the opportunity to ensure that all relevant information is considered by SMC at the time of its recommendation.
3. SMC evaluates only licensed medicines and advises only on licensed uses of these medicines. Data are accepted for review where new products are compared with licensed products within or outwith the terms of their UK and/or European license. However SMC advice is targeted solely on the UK licensed indication. Studies involving unlicensed medicines will normally be disregarded.
4. Where a body of clinicians or group of experts elects to advise the use of an unlicensed medicine in the treatment of a condition or of a sub-group of patients, this fact may be made known to SMC by its specialist advisors. However, SMC will not take these data into account when coming to its final conclusion.
D H Lawson, Chairman
October 2004