Overview
- Negotiators set eight years of data protection plus one year of market protection for new medicines, capped at a combined eleven years.
- Companies may gain additional 12-month extensions for meeting criteria such as addressing unmet medical needs, introducing a qualifying new active substance, or adding indications with significant clinical benefit.
- The package clarifies the Bolar exemption so generics and biosimilars can complete studies, filings and tender bids before exclusivities expire.
- A transferable 12‑month exclusivity voucher will incentivize priority antimicrobials, with reported limits barring its use on products exceeding €490 million in average annual EU sales over four years.
- Measures to bolster supply include mandatory shortage‑prevention plans, EMA monitoring with a critical shortages list, default unlimited marketing authorisations, retention of Article 56a on adequate supply, and the option for regulatory sandboxes.