Off-label: horizons of freedom
https://doi.org/10.33667/2078-5631-2022-15-40-49
Abstract
This article gives a review of the regulation by the Russian law of the so-called ‘off-label’ use of medicinal drugs, that is the use of drugs outside their approved indication, information in data sheets and other known properties. The definition of the term ‘off-label’ is presented in details for which the understanding of the term in different countries is summarized. The discussion covers both off-label prescription and marketing practices. The article emphasizes the connection between the legal aspects of the off-label use and the model of national law regulation for providing legal services in general. The text culminates at an introduction of the new Russian legislative amendments granting more opportunities for off-label drug prescription.
About the Author
A. B. Generalov
Academy of Interventional Medicine; Association of Legal and Medical Assistance
Russian Federation
Russian Federation
Generalov Alexander B., life science lawyer, legal counsel; director
Moscow
References
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Review
For citations:
Generalov A.B. Off-label: horizons of freedom. Medical alphabet. 2022;(15):40-49. (In Russ.) https://doi.org/10.33667/2078-5631-2022-15-40-49
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