Pharmaceutical Medicine

, Volume 27, Issue 3, pp 157–164

Pharmacovigilance and Public Health Ethics

Current Opinion

DOI: 10.1007/s40290-013-0016-4

Cite this article as:
Callréus, T. Pharm Med (2013) 27: 157. doi:10.1007/s40290-013-0016-4


Traditionally, bioethics has focused on the obligations of healthcare professionals and the rights of individual patients as well as participants in clinical research. However, in recent years, this center of attention has been questioned and a new “Public Health Ethics” has emerged. It argues that when dealing with ethical issues related to research or interventions, the health of groups and populations should be considered and not only that of individuals. This article reviews the background to the current debate on Public Health Ethics as well as some ethical theories and principles guiding its development. Following a discussion of issues in pharmacovigilance with an ethical dimension, the article explores the potential implications of the emergence of a Public Health Ethics perspective for regulatory pharmacovigilance as a public health activity. In summary it appears that this new perspective may offer a new take on ethical issues in pharmacovigilance and provide guidance as to when public health paternalism is justified or when the public good should take precedence over rights of individuals.

Copyright information

© Springer International Publishing Switzerland 2013

Authors and Affiliations

  1. 1.Danish Health and Medicines Authority, Pharmacovigilance and Medical DevicesCopenhagenDenmark

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