Regulatory data and market protection to support innovation

Parliament and Council negotiators agreed to a regulatory data protection period (during which other companies cannot access product data) of eight years, with one additional year of market protection (during which generic or biosimilar products cannot be sold), following a marketing authorisation.

Pharmaceutical companies would be eligible for additional periods of market protection:

• if the particular product addresses an unmet medical need (12 months);
• if it contains a new active substance, fulfilling a combination of conditions on comparative clinical trials, clinical trials carried out in several member states, and the obligation to apply for market authorisation within 90 days after the submission of the application for the first marketing authorisation outside the Union (12 months);
• if the company obtains an authorisation for one or more new therapeutic indications that bring a significant clinical benefit in…