I Know What This Drug Did Last Summer

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 prevention 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 injuries that already occurred, while pharmacovigilance intervenes ex-ante to prevent the occurrence of some of those damages.