The impact of off-label, compassionate and unlicensed use on health care laws in preselected countries

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In situations of therapeutic impasse, health care professionals (HCPs) face pressure to engage in non-licensed drug use (NDU), which includes off-label and compassionate drug use. This practice raises liability, contractual, and penal risks, highlighting a knowledge gap regarding institutional and governmental approaches to address these issues. Various countries have developed strategies to manage NDU, which Vanessa Platé examines by comparing its effects on pharmaceutical legislation in several industrial nations. Her study includes Canada, the U.S., the U.K., Japan, France, Germany, Switzerland, Austria, and the E.U., utilizing semi-structured qualitative interviews, legal comparisons, and literature research. Key areas of focus include terminology, supply, necessity, pharmaceutical promotion, legal responsibility, and public policies related to NDU. Findings indicate a circumstantial need for NDU, alongside isolated instances of non-rational use. Legal comparisons reveal obligations for physicians to perform NDU and evidence of inappropriate marketing by market authorization holders (MAH). There is also a clear demand for information on NDU from HCPs. Results show cross-liability for HCPs and MAH and highlight varying regulatory efficiencies, with the E.U. having limited incentives for new indications. The absence of standardized terminology leads to inconsistent interpretations of NDU. Proposed solutions include amending