Monday, December 9, 2013
EMA's draft policy on data transparency may have the
unintended consequence of jeopardizing data exclusivity in non-European
jurisdictions, according to two lawyers on the industry side of the issue.
EMA has proposed to proactively
publish a large amount of clinical trial data following a decision on marketing
authorization, and to make raw patient-level data available through a
controlled access system (see BioCentury, July 22).