Legal frameworks

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.