The Impact of Off-Label, Compassionate and Unlicensed Use on Health Care Laws in Preselected Countries

In times of situational therapeutic impasse, health care professionals (HCPs) are under pressure to conduct off-label, unlicensed and compassionate drug use--generally summarized under the term non-licensed drug use (NDU). Liability, contractual and penal risks pose a problem when treating a patient in a non-licensed way. There is a knowledge gap about institutional and governmental methods to resolve these problems. Different countries have developed strategies to manage NDU. Vanessa Platé gives a comprehensive overview of practices Canada, the U.S., the U.K., Japan, France, Germany, Switzerland, Austria, and the transnational E.U. A must-read for everyone interested in the discussion on how to administer the best treatment, especially regarding early access to yet unapproved treatments.

Vanessa Plate is a pharmacist specializing in drug information. She was part of the research group Drug Regulatory Affairs. In this function, Plate did extensive research on NDU on behalf of the German Federal Ministry of Health.