Special permission for compassionate use
According to the Medicines Act, Fimea may give permission for a medicinal product without a marketing authorisation in Finland to be released for consumption in individual cases for special therapeutic reasons.
The Medicines Decree (693/1987, 1184/2002 and 868/2005) (www.finlex.fi) only allows compassionate use in exceptional cases where no other treatments are appropriate or yield the desired effect.
Products available for compassionate use may be prescribed by doctors and dentists. The use of electronic prescriptions is currently not possible.
In outpatient care, permission should be obtained for each individual patient. Health care institutions may apply for an institutional permission that applies to several users within the institution. The permission is valid for one year, starting from the date of issue.
Account of special therapeutic reasons
To complement an application for special permission for compassionate use, the physician/dentist prescribing the product should submit an account of the special therapeutic reasons for choosing the product in question. This should show that the case is exceptional and that no other treatments are appropriate or yield the desired effect.
It is also recommended to list the pharmacotherapies previously used by the patient without the desired effect.
The physician in charge of the patient's treatment is ultimately responsible for any treatments she/he prescribes.
When applying for special permission for compassionate use, it should be remembered that the product in question does not yet have a marketing authorisation or that its marketing authorisation has been withdrawn. This may be due to inadequate efficacy, safety or product quality or to a changed view of the medical value of the product, its necessity or its safety and efficacy. The person prescribing the product may be unaware of changes to the product.
It may also be that the product has been granted a marketing authorisation but has not been launched with the appropriate labelling, and a summary of product characteristics and a package leaflet may be unavailable. In such cases, the person prescribing the product may be unaware of any precautions relating to use.
Should a physician consider an individual treatment plan involving a product available for compassionate use, the physician should update his/her knowledge of the product as necessary.