RT Dissertation/Thesis
T1 Regulation of pharmaceuticals in EU and liability arising out of medicinal products
A1 Kedeva Manevska, Karolina
AB The very nature of pharmaceutical products implies the need for their diligentregulation under the law, regardless of the jurisdiction in question, in order toalleviate the possibility of product liability. Yet, the pharmaceutical industry iscontinuously exposed to the threat of product liability litigation, since it is in itselfinnovative 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 certainpharmaceutical product manufactured in an EU country can have an effect in otherEU and non-EU countries alike. In this research the basic regulatory tools of the EUwill be presented in the context of pharmaceutical law. The main aim of the researchwill be to examine if the current state of the laws in Europe satisfies the objective ofproviding safe and effective medicines for patients, promoting their overall health,whilst minimizing risks of consumption. An inevitable component of this willnevertheless be regulation of the safety of medicines through the Europeanpharmacovigilance system and reporting adverse drug reactions (ADR’s). Thus, inthis thesis I have made a comparative study of the reporting system in various EUstates 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 EUMember states and a comparison will be made from the latter. Finally, the notion ofdevelopment risk defense that pharmaceutical companies usually evoke will beconsidered. The results will be based on a previous discussion on the retrospectiveand comparative analysis of case studies from the domain of EU law, and similarnational laws of countries in Europe with regards to product liability litigation forpharmaceutical products. The results would be that with the recent evolvement andamendments in the law of pharmaceuticals in Europe grater power has been given toconsumers both from the aspect of receiving adequate information, protection andaccess to safe medicines. Despite the fact that big pharmaceutical companies arealready bound by soft law rules of regulatory agencies, and have per se productliability limitations imposed by informing consumers, the research will suggest thatwith recent progress in this domain of the law an even greater precaution has beenimposed on pharmaceutical companies in manufacturing their products, by6strengthening the legal framework for protecting consumers within the variouscountries in Europe. In that respect the work of the EMA, the Spanish Agency ofMedicines and Medical Devices (AEMPS), the French Agency of Medicines (ANSM)and similar regulatory agencies will be put forward, as well as the theoreticalquestion of pros and cons of too much regulation in the pharmaceutical sector, interms of promoting public health.
YR 2021
FD 2021-12
LK https://hdl.handle.net/10016/34992
UL https://hdl.handle.net/10016/34992
LA eng
DS e-Archivo
RD 16 jun. 2024