Plan To Share Clinical Data Could Stifle EU Drug Innovation

Law360, New York (December 19, 2012, 12:00 AM EST) -- The European Medicines Agency’s announcement that it plans to proactively release drug sponsors’ clinical trial data in 2014 has pharmaceutical companies on edge, with experts saying drug companies could avoid seeking approval for their products in European markets, stifling innovation and potentially depriving patients of access to drugs.

The EMA has declared that clinical trial data is not commercial confidential information, and held a public meeting in November on its proposal to release clinical trial data after drugs go through the agency's marketing authorization process. The...
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