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Legal Frameworks

  • Burkhard SträterEmail author
Chapter
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Abstract

Understanding the legal obligations of pharmaceutical companies and regulatory authorities in relation to medicines information in any given jurisdiction is vital for appropriate preparation of medicinal product-related communication. Likewise, any evaluation of a communication intervention a posteriori needs to check if content and timing have been compliant with these obligations in place for consumer and patient protection. In particular, the right of patients to receive compensation in the case harm occurs due to the pharmaceutical company being non-compliant or negligent, i.e. the marketing authorisation holder’s liability, impacts on communication requirements. This chapter presents legal principles of global value, including the precautionary principle, with the historical but still fundamental case of the thalidomide disaster, and looks to challenging legal questions of the future.

Notes

Declarations

After graduating, the author was a judge in Berlin for 5 years and then head of the legal department of the German Federal Health Agency for 5 years. He then established the Sträter law firm and is partner of this law firm which advises pharmaceutical companies and medical device manufacturers, as well as physicians, pharmacies, hospitals and universities. He co-founded the Master’s Programme in Drug Regulatory Affairs (MDRA) at the University of Bonn 20 years ago and has headed its examination board for 10 years. Within the study programme, he leads one of the twelve modules, namely the “Pharma law” module, which addresses the balancing act between scientific evaluation and legal framework conditions for risk minimisation and other measures, i.e. also the legal framework described here for information to physicians, pharmacists and patients.

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Copyright information

© Springer Nature Singapore Pte Ltd. 2020

Authors and Affiliations

  1. 1.Rheinische Friedrich-Wilhelms-Universität Bonn, Master Study Course Regulatory Affairs – MDRABonnGermany

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