§ Mr. Godsiff
To ask the Secretary of State for Health when Sativex will be licensed; and what restrictions will be placed on its prescription. 1708W
§ Miss Melanie Johnson
The Medicines and Healthcare products Regulatory Agency (MHRA) will grant a licence for Sativex only when satisfactory data have been provided to demonstrate that the product is efficacious, safe and of adequate quality for its intended use.
In accordance with the Government's undertaking given in 1998 to the House of Lords Science and Technology Committee, the Misuse of Drugs Regulations 2001 would be amended to permit Sativex to be prescribed by doctors, if it is successful in gaining a marketing authorisation from the MHRA.
The Advisory Council on the Misuse of Drugs has recommended that if Sativex is authorised, it should be placed in Schedule 4 Part I of these regulations. It would also attract prescription-only-medicine status, but the scheduling would impose no additional restriction upon prescribing. If authorised, manufacturers and wholesalers would be required to be licensed to produce and supply the product, and would have to comply with the regulatory requirements on record keeping and destruction.