The EU Council approved a comprehensive pharmaceutical package to improve patient access, prevent shortages, and ensure affordable medicines across the union, complemented by a major reform of EU rules to balance patient access with incentives for drug research and antibiotic development.

Innovative products may qualify for extended protection, with typical protection up to 11 years and possible extension to 12 years.

The Bolar exemption is broadened to let generics begin preparatory work before patent expiry, enabling quicker market entry after protection ends.

New rules provide eight years of regulatory data protection for new medicines, followed by one year of market protection, with potential for up to 12 years under conditions including transferable exclusivity vouchers.

Additionally, eight years of data protection grant exclusive rights to data from preclinical and clinical trials for new medicines.

An incentive mechanism specifically targets antibiotics to spur vaccine development and prioritize antimicrobial agents.

A transferable exclusivity voucher may be awarded for developing priority antibiotics, giving another product up to one extra year of protection, subject to a sales cap to protect health budgets.

Member states gain authority to require pharmaceutical companies to supply medicines protected by regulatory exclusivity in sufficient quantities to meet patient needs, with safeguards against unintended disruptions like parallel exports.

Expanded supply obligations are paired with safeguards to prevent adverse effects on trade or access.

Rare-disease medicines receive a distinct regime, with standard orphan products enjoying nine years of market exclusivity and breakthrough orphan medicines potentially up to 11 years.

The European Parliament must formally adopt the regulation and directive, with the package taking effect after publication in the Official Journal.

The reforms are part of a broader EU push on medicine shortages and manufacturing resilience, including a separate Critical Medicines Act focused on security of supply.