Uncertainty Remains Over The Future Of Regulatory Data Protection In The EU

As talks continue on the EU pharmaceutical legislative reform proposals, drug firms may have to wait some time before they find out what the future periods of regulatory data protection and orphan market exclusivity will be.

Many flags in front of the EU Commission building in Brussels — • Source: JLBvdWOLF / Alamy Stock Photo (JLBvdWOLF / Alamy Stock Photo/Alamy Stock Photo)

The EU regulatory data protection regime is facing one of the biggest shake-ups in 20 years, with proposals by the European Commission to reduce the baseline period of RDP and introduce a system under which a set of top-up protection periods could be granted under certain conditions.

While the move to cut RDP is controversial in itself, companies that will be affected by this change – R&D-based...