OPP Explainer: Guide to the Pharmaceutical Package

Soon, the European Commission is set to adopt the highly anticipated Pharmaceutical Package, which features revisions to the general pharmaceutical legislation and legislation regarding medicines for children (known as the ‘Paediatric’ Regulation) and rare diseases (the ‘Orphan’ Regulation). While initially scheduled for adoption in the Q4 of 2022, the Commission has constantly delayed its publication. Additionally, the Package will incorporate a Council Recommendation that focuses on combating antimicrobial resistance (AMR) from a one-health perspective. This OPP Explainer primarily focuses on the modifications made to the general pharmaceutical legislation, along with the regulations concerning paediatric and orphan drugs. Our document offers a concise summary of the challenges existing in the current legislative frameworks, plausible measures the Commission may adopt to tackle these issues, and the viewpoints of the European Parliament, Member States, and stakeholders.