The European Commission (“Commission”) intends to change the rules on regulatory data protection (“RDP”) of medicinal products. The Commission stated in its Impact Assessment for the revised pharmaceutical legislation that it wants to strike a balance between “providing attractive incentives for innovation and supporting timely patient access to medicinal products across the EU.” To achieve this, it has proposed replacing the old 8 + 2 (+1) RDP system with a new system that will offer innovators variable durations of RDP. However, this new system may raise a number of concerns for innovator companies. We summarize the new rules on RDP and then discuss the possible implications below.
