Noninvestigational use of unapproved drugs--experience from the Scandinavian countries.

In the Scandinavian countries it is possible to use unapproved drugs for treatment purposes with special permission from the drug control authorities (individual licenses). The Scandinavian practice and the problems connected with it are described. The basic principle underlying the laws and regulations has been and is the same in each country: unapproved drugs should be used only in exceptional cases for special reasons. However, the practice has become different: many individual licenses have been granted, giving physicians much greater opportunity to prescribe drugs of their choice than the apparently tight Scandinavian licensing laws and practices would suggest. The great number of individual licenses has become an administrative problem and has also undermined the principle underlying the law.