I Know What This Drug Did Last Summer: Pharmacovigilance as a Mechanism For Consumer Protection

Authors

DOI:

https://doi.org/10.11606/issn.2316-9044.rdisan.2023.192083

Keywords:

Consumer Protection, Drugs, Pharmacovigilance, Prevention

Abstract

Drugs are, by their own nature, especially risky products, in particular those that just reached the market and were developed in a short time, such as the COVID-19 vaccines. The potential hazards they can involve for patients/consumers require additional measures of consumer protection, in addition to the general legal framework of manufacturer’s liability. This paper focused on one of these additional measures: pharmacovigilance, i.e., the post-commercialization monitoring of pharmaceutical products, from the perspective of European law. The aim of this paper was to demonstrate the role of pharmacovigilance in the prevent ion of harm caused by defective drugs and consequent consumer protection, highlighting its benefits and flaws. Pharmacovigilance is not a miraculous solution and has its flaws. However, it can be a useful tool for the management of benefit-risk to ensure appropriate drug use after marketing. Liability for defective products only addresses compensation for injur ies that already occurred, while pharmacovigilance intervenes ex-ante to prevent the occurrence of some of those damages.

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Author Biography

  • Vera Lúcia Raposo, NOVA University of Lisbon. NOVA School of Law. Lisbon, Portugal.

    PhD and master's degree in Political and Legal Sciences and degree in Law from the Faculty of Law of the University of Coimbra. Assistant professor of Law and Technology at Nova School of Law/Faculty of Law, NOVA University Lisbon. Vice-Director of Value Creation and Internationalization at Nova School of Law/Faculty of Law, NOVA University Lisbon.

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12/26/2023

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How to Cite

Raposo, V. L. (2023). I Know What This Drug Did Last Summer: Pharmacovigilance as a Mechanism For Consumer Protection. Journal of Health Law, 23, e0016. https://doi.org/10.11606/issn.2316-9044.rdisan.2023.192083

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