Author:

• Patricia Fernandes da Silva Nobre - Nobre, P.F.S. - Rio de Janeiro, RJ - Instituto Nacional de Controle de Qualidade em Saúde - <patricia.silva@incqs.fiocruz.br>

Thematic Area:

Políticas em Saúde

Abstract:

Objectives: Review the legal features of off-label prescription in Brasil comparing with the North-American regulatory environment, in order to verify whether or not it derives from the structure of the administrative rule-making process as it currently is.
Methods: bibliographic research in English and Portuguese in public databases about legislation, articles, books and dissertations using the key words off-label, health Law, health regulation, with respective translations into Portuguese.
Results: Both in Brasil and in the USA Health Surveillance institutions have no jurisdiction on the medical practice itself and can´t restrict off-label prescriptions beyong educational measures. Indications of use are na endpoint against which it is determined minimum safety and efficacy for product commercialization, but it is not a restrictive factor in practise, what does not excempt practioners from punitive damages in tort litigation. Public measures to restrict off-label prescriptions are more freqüent in the control of the incentives and dissemination of information to the medical community about such uses.
Conclusion: Off-label prescription is a risk-benefit evaluation done by the clinician which has several for and againsts described on the literature. Pivotal to the debate is the State and its role as regulator and health care provider. The Brazilian laws and regulations and their posture towards the subject still need more observation and further development.

Keywords:

Health Surveillance Off-label prescription Health Law Health Regulation

Content:

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