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• W2154687063 abstract "In order to detect potential adverse drug reactions, pharmaceutical companies con-duct clinical trials before they introduce a new drug on the market. However, it is often difficult to get the complete picture of a drug's safety profile prior to its marketing. Consequently, pharmaceutical companies have an obligation to report adverse events as part of their pharmacovigilance duties. Alongside their pharmacovigilance commitments, listed pharmaceutical companies have an obligation to disclose all price-sensitive information.This thesis places adverse event reports in the context of Swedish securities law. The central question concerns the extent to which the specific features of adverse event reports affect the companies’ disclosure obligations. Two factors are high-lighted as particularly relevant to the subsequent exposition. Firstly, adverse event reports are inherently unreliable, which means that their existence rarely shows that the ill effect was caused by use of the drug. Secondly, the question arises how the existence of a separate system of pharmacovigilance affects the pharmaceutical companies’ disclosure obligations under the securities law. The thesis deals with these issues from both an economic and a comparative perspective.The economic theory behind the disclosure obligations found in the securities laws can be divided into two different threads: the efficient market hypothesis and behavioral finance. According to the efficient market hypothesis, efficient markets reflect all available information. Some argue that the mechanism of market efficiency implies a relationship between the stock’s market value and company’s fundamental value. Behavioral finance attacks the link between stock prices and fundamental values. Because investors are irrational and arbitrage is limited, stock prices run the risk of being distorted by noise.The comparative part of the thesis applies an American perspective to issue of adverse event reports. Unlike their Swedish counterparts, listed companies in the U.S. do not have a duty to disclose price-sensitive information. However, whenever a company communicates with the market it has implicitly assumed an obligation to do so truthfully. The comparative perspective primarily details issues concerning the materiality of adverse event reports in the absence of statistical significance and the truth-on-the-market-doctrine. In light of the economic and comparative perspectives, there is good reason to believe that the disclosure requirements of pharmaceutical companies subject to the securities laws include adverse event reports despite the reports’ inherent unreliability. However, it is conceivable that the system of pharmacovigilance will limit the companies’ duty to disclose. This is particularly the case when a third party’s pharmacovigilance duties lead it to disclose adverse event reports." @default.
• W2154687063 created "2016-06-24" @default.
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• W2154687063 date "2014-01-01" @default.
• W2154687063 modified "2023-09-27" @default.
• W2154687063 title "Rapporter om medicinska biverkningar i en aktiemarknadsrättslig kontext" @default.
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