• Eur. J. Intern. Med. · Jul 2019

    Review

    Compassionate use of unauthorized drugs: Legal regulations and ethical challenges.

    • Jan Borysowski and Andrzej Górski.
    • Centre for Studies on Research Integrity, Institute of Law Studies, Polish Academy of Sciences, Nowy Świat 72, 00-330 Warsaw, Poland; Department of Clinical Immunology, Medical University of Warsaw, Nowogrodzka Str. 59, 02-006 Warsaw, Poland. Electronic address: jborysowski@interia.pl.
    • Eur. J. Intern. Med. 2019 Jul 1; 65: 12-16.

    AbstractCompassionate use (also referred to as expanded access) is therapeutic use of unauthorized drugs outside of clinical trials. The objective of this review is to discuss practical aspects of the current legal regulations concerning compassionate use that have been introduced in the European Union, the USA (both the Food and Drug Administration regulations and Right-to-try laws), Canada and Australia. We also present main ethical challenges associated with use of unauthorized drugs such as possible difficulties with obtaining informed consent and fair patient selection. Moreover, we discuss guidelines, especially those contained in the Declaration of Helsinki, which may aid doctors in the ethical conduct of compassionate treatments.Copyright © 2019 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

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