March 2020: Denmark to Introduce Sanctions for Non-reporting of Clinical Trial Results

As explained by Lene Grejs Petersen of the Danish Medicines Agency (DKMA), sponsors that fail to report clinical trial results will soon face fines or even prison sentences.

Under the current legal framework in Denmark, sponsors that fail to report results on time can be fined or given a prison sentence of up to four months. However, DKMA cannot issue fines by itself. Instead, the regulator has to go through the public prosecutor. Going forward, DKMA has decided to make use of this legal basis.

To clarify responsibilities, DKMA has made clear that it is sponsors’ responsibility to upload their trial results. Sponsors can do this directly. There is no requirement to additionally submit results to the medicines agency, which avoid needless duplication of effort. The sole exception to this rule are Phase I trials; because their results are not made public, they still need to be submitted to DKMA.

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