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Off Licence Use of Medications

Off-Label – Off Law?

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Legal and Forensic Medicine

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Abstract

Off-label prescription is a widely accepted practice for physicians. The label is a summary with all the information about that drug: approved uses, dosages, group of expected patients, or side effects. Although prescribing off-label is common, the truth is, mostly in Europe, there is not a consensus definition about what constitutes an off-label use. Off-label prescribing consists of recommending or proposing a use for the drug that is not yet tested and approved by the authorities of the country, so this use is off-license.

Should that be considered as experimental research or as a clinical trial? Can a physician carry out such a prescription? Is off-label lawful or unlawful? Can we find a place for that situation in the Convention on Human Rights and Biomedicine?

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Authors and Affiliations

  1. Centre for Biomedical Law, University of Coimbra, Faculdade de Direito, 3004-545, Coimbra, Portugal

    Mafalda Francisco Matos Graduated in Law-University of Coimbra, Master degree on Criminal Law-University of Coimbra, Post-Graduated in Minor’s Protection-Centre for Family Law-University of Coimbra, Post-Graduated in Pharmacy and Medicine Law-Centre for Biomedical Law-University of Coimbra, Participant on Specialization Course in Medical Law-Centre for Biomedical Law-University of Coimbra (Trainee Lawyer)

Authors
  1. Mafalda Francisco Matos Graduated in Law-University of Coimbra, Master degree on Criminal Law-University of Coimbra, Post-Graduated in Minor’s Protection-Centre for Family Law-University of Coimbra, Post-Graduated in Pharmacy and Medicine Law-Centre for Biomedical Law-University of Coimbra, Participant on Specialization Course in Medical Law-Centre for Biomedical Law-University of Coimbra
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Corresponding author

Correspondence to Mafalda Francisco Matos Graduated in Law-University of Coimbra, Master degree on Criminal Law-University of Coimbra, Post-Graduated in Minor’s Protection-Centre for Family Law-University of Coimbra, Post-Graduated in Pharmacy and Medicine Law-Centre for Biomedical Law-University of Coimbra, Participant on Specialization Course in Medical Law-Centre for Biomedical Law-University of Coimbra .

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Editors and Affiliations

  1. Chatswood, New South Wales, Australia

    Roy G. Beran

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© 2013 Springer-Verlag Berlin Heidelberg

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Francisco Matos, M. (2013). Off Licence Use of Medications. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_116

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