Summary

Competencies in the pharmaceutical sector are shared between the Commission and Member States. Due to national budget responsibilities, two key issues, namely pricing and reimbursement levels, remain entirely with the Member States and can vary considerably. European Union-wide pharmaceutical legislation focuses on some aspects of marketing (e.g. packaging, labeling, and advertising), safety (e.g. pharmacovigilance inspections, Good Manufacturing Practices, and good clinical practices), transparency, and authorization procedures.

This report provides both an update on EU legislation of the sector and discusses an overview of issues affecting it, including the regulatory framework, EU enlargement, and competitiveness issues.