EC Report Recommends Policy Actions on Off-Label Use
Regulations on off-label use are not harmonized across the European Union — only 10 out of 21 surveyed member states have specific policies, according to a European Commission report.
Off-label use is prevalent to some extent across most of Europe, in both out- and in-patient settings, and is especially high for pediatric populations. A review of studies found that off-label use was more frequent in oncology and hematology, as well as psychiatry and rheumatology. EU laws do not regulate off-label drug use in medical practice in individual countries.
Currently, there are limited incentives for the pharmaceutical industry to get off-label uses approved. EU legislation allows a one-year extension to market protection if a new indication is added within eight years of product approval. Off-label sales would still continue, the report said, and off-patent medicines that already face generic competition could be a harder sell for more research investment.