§ Baroness Robson of Kiddington
asked Her Majesty's Government:
When they intend to license the drug Tacrine, developed for the treatment of Alzheimer's disease, and, if so, whether it will be freely available on the NHS.
§ The Parliamentary Under-Secretary of State, Department of Health (Baroness Cumberlege)
The Committee on Safety of Medicines (CSM), an independent advisory body, has provisionally concluded that it is unable to advise Health Ministers that the drug 15WA should be licensed at this stage. Under the United Kingdom licensing procedures, applicants for drug licences have extensive rights of appeal against the provisional conclusions of the CSM. The company promoting Tacrine are exercising these rights and the CSM will consider its appeal at a hearing.
The drug still remains available for use in the United Kingdom, because doctors who identify a need to treat patients with an unlicensed drug can do so on a "named patient" basis. A doctor prescribing an unlicensed medicine does so entirely on his or her own responsibility.