The EU Council formally adopted the pharma package, a comprehensive reform designed to improve access to affordable medicines, reduce regulatory burdens, and strengthen supply security, while preserving incentives for innovators and introducing tools like transferable exclusivity vouchers for antibiotics.

The package balances patient access with incentives for drug research and antibiotic development, updating EU pharmaceutical rules to promote safe, effective, and affordable medicines and boost industry competitiveness.

A key feature is data and market exclusivity protections for innovators, with eight years of data protection, plus one year of market protection, potentially extending to 11 years, and orphan medicines receiving nine to eleven years depending on breakthrough status.

The Bolar exemption is broadened to cover a wider range of preparatory activities, enabling generics and biosimilars to begin regulatory steps before IP expiry to facilitate market entry after protection ends.

Member states gain the power to require pharmaceutical companies to supply medicines protected by regulatory exclusivity in sufficient quantities, with safeguards to prevent unintended parallel exports.

There is a strengthened focus on supply security, including mandatory shortage notifications and commitments to ensure continued supply of critical medicines.

The reforms include new tools to safeguard patient access, such as supply commitments, while maintaining safeguards against market distortions.

The package sets a framework of eight years of data protection plus one year of market protection (up to 11 years), with orphan medicines enjoying nine to eleven years of exclusivity, and the possibility of extending periods under certain conditions.

Regulatory and manufacturing shifts accompany the reform, including capacity expansion by a major CDMO to support rising injectable demand and developments in tariff policy for specialty pharmaceuticals.

The package incorporates incentives for antimicrobial innovation, including a dedicated mechanism to encourage antibiotic development and vaccine efforts against antimicrobial resistance.

A new mechanism introduces transferable exclusivity vouchers, allowing one additional year of protection to be transferred to another product, with sales thresholds to limit impact on healthcare budgets.