Publication: Regulation of pharmaceuticals in EU and liability arising out of medicinal products
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Publication date
2021-12
Defense date
2022-05-20
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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
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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.
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Keywords
Pharmaceutical products, Regulation, Pharmaceutical industry, Pharmaceutical law, European Union