Unintended consequences of regulatory interventions - A focus on Risk Minimisation Measures

The presentation explores the European Union's pharmacovigilance system, emphasizing the continuum from pre- to post-marketing safety monitoring. It outlines the types of RMMs—routine (rRMMs) and additional (aRMMs)—and their implementation, such as educational materials, controlled access programs, and direct healthcare professional communications (DHPCs). A key focus is on evaluating the effectiveness of RMMs and the unintended consequences that may arise. Studies show that while RMMs aim to reduce adverse drug reactions and improve safety, they can also lead to changes in prescribing behavior, substitute medication use, and even unintended health outcomes. Systematic reviews and meta-analyses reveal that many regulatory interventions lack robust impact assessments, and only a minority of studies evaluate unintended effects. The presentation highlights challenges in conducting effectiveness studies, including delays, inconclusive results, and methodological limitations—especially in survey-based and secondary data studies. It also discusses the complexity of implementing RMMs for Advanced Therapy Medicinal Products (ATMPs), which often require specialized handling and post-authorisation safety monitoring.