Regulation of pharmaceuticals in eu and liability arising out of medicinal products

Abstract

The very nature of pharmaceutical products implies the need for their diligent regulation under the law, regardless of the jurisdiction in question, in order to alleviate the possibility of product liability. Yet, the pharmaceutical industry is continuously exposed to the threat of product liability litigation, since it is in itself innovative and dynamic, and is in direct connection with the health of human beings, carrying an inherent risk. That having said it is more than likely that a certain pharmaceutical product manufactured in an EU country can have an effect in other EU and non-EU countries alike. In this research the basic regulatory tools of the EU will be presented in the context of pharmaceutical law. The main aim of the research will be to examine if the current state of the laws in Europe satisfies the objective of providing safe and effective medicines for patients, promoting their overall health, whilst minimizing risks of consumption. An inevitable component of this will nevertheless be regulation of the safety of medicines through the European pharmacovigilance system and reporting adverse drug reactions (ADR’s). Thus, in this thesis I have made a comparative study of the reporting system in various EU states to analyze the level of harmonization of their laws and regulations in this area. Furthermore, the medical product liability schemes will be analyzed in different EU Member states and a comparison will be made from the latter. Finally, the notion of development risk defense that pharmaceutical companies usually evoke will be considered. The results will be based on a previous discussion on the retrospective and comparative analysis of case studies from the domain of EU law, and similar national laws of countries in Europe with regards to product liability litigation for pharmaceutical products. The results would be that with the recent evolvement and amendments in the law of pharmaceuticals in Europe grater power has been given to consumers both from the aspect of receiving adequate information, protection and access to safe medicines. Despite the fact that big pharmaceutical companies are already bound by soft law rules of regulatory agencies, and have per se product liability limitations imposed by informing consumers, the research will suggest that with recent progress in this domain of the law an even greater precaution has been imposed on pharmaceutical companies in manufacturing their products, by 6 strengthening the legal framework for protecting consumers within the various countries in Europe. In that respect the work of the EMA, the Spanish Agency of Medicines and Medical Devices (AEMPS), the French Agency of Medicines (ANSM) and similar regulatory agencies will be put forward, as well as the theoretical question of pros and cons of too much regulation in the pharmaceutical sector, in terms of promoting public health.