Denmark - Danish Medicines Agency Vows to Step up Enforcement to Ensure Publication of Clinical Trial Results

• 07/10/2020
• Articles

The Danish Medicines Agency (DMA) announced on 6 October 2020 that it is stepping up enforcement against clinical trial sponsors who fail to report the results of clinical trials in accordance with applicable rules (see, attached press release). The DMA intends to avail itself in the future of the possibility offered by Danish law to request the public prosecutor to prosecute sponsors who fail to publish clinical trial results in a timely fashion. Such sponsors risk a fine or imprisonment of up to four months.
 
While the DMA would mainly seem to be targeting non-commercial sponsors, who allegedly fall short of their reporting obligations more often than commercial sponsors, the second category of sponsors should expect increased enforcement activity as well.
 
The DMA’s announcement illustrates and reflects a broader European trend towards increased transparency of clinical trial results. Further transparency with regard to clinical trials will be introduced through the EU Clinical Trials Information System (EU portal and EU database, together CTIS), which will centralise and contain detailed information on the authorisation, conducting and results of each clinical trial carried out in the EU. Subject to limited exceptions, this information will be publicly available. The go-live date of the CTIS has been postponed repeatedly due to IT difficulties. The European Medicines Agency has indicated that the audit of the CTIS, which is a necessary prerequisite for the system to go live, will commence in November 2020.
 
At present, the EU Clinical Trials Register already publishes summary results of interventional clinical trials conducted in the EU or in the European Economic Area (see, https://www.clinicaltrialsregister.eu/ctr-search/search).