EU Parliament and Council Reach Agreement on Pharmaceutical Legislation Reform

The European Parliament and Council have agreed on a significant reform of EU pharmaceutical legislation, marking the most substantial changes in two decades. This overhaul will restructure the regulatory data exclusivity and market protection framework for new human medicines. Key adjustments include a modulated system of market exclusivity, reducing the automatic baseline period for new active substances from two years to one, with extensions contingent on specific clinical studies. This aims to balance innovation incentives with timely access to medicines.