In Pursuit of Exclusivity: Conditional Regulatory Data Protection under the EU Pharma Package

Sammanfattning

This thesis examines the 2023 “Pharma Package” revision of EU pharmaceutical legislation, focusing on the renewed framework for Regulatory Data Protection (RDP) of medicinal products as set out in the 2026 final compromise texts of the proposed Directive and Regulation. The reform restructures RDP from a standard, one-size-fits-all approach into a system of conditional extensions, awarding additional exclusivity in exchange for outcomes tied to EU public health objectives. The study analyses two of the extension mechanisms in depth: the extension for unmet medical need (UMN) and the transferable data exclusivity vouchers (TEVs) for priority antimicrobials. It sets out their definitions and conditions throughout the 2023 and 2026 versions of the Directive and Regulation, positioning them within the broader architecture of extensions, and evaluates them against legal certainty and incentive-design coherence. On that basis, the thesis assesses whether the renewed RDP framework delivers on its dual objective of incentivising targeted innovation while safeguarding timely generic market access. Through doctrinal analysis and policy considerations, the thesis offers original insights into the design and viability of the reformed RDP regime, contributing to EU life science law at a pivotal moment ahead of the adoption of the final texts of the Directive and Regulation.