Overview
- Baseline protection is set at eight years of data plus one year of market exclusivity, with targeted extensions capped at eleven years, including for certain orphan medicines.
- To fight antimicrobial resistance, negotiators backed a transferable 12-month data exclusivity voucher for priority antibiotics, which cannot be used on products averaging over €490 million in annual EU sales.
- The deal clarifies the Bolar exemption so generic and biosimilar makers can complete studies, filings, pricing and reimbursement steps, and tender bids during protection periods.
- EMA procedures would be streamlined, cutting assessment timelines, consolidating committees, moving to electronic submissions and electronic product information, and making most authorisations valid without time limits.
- Companies must maintain shortage-prevention plans and notify disruptions, with EU-level monitoring and an EMA list of critical shortages, while countries retain powers to require adequate supplies as industry reaction remains mixed.