The Danish Medicines Council publishes new principles regarding the use of unpublished data

The Danish Medicines Council has published a document on the principles for when and how the Council can use unpublished and potentially confidential data in its work. This comes as a result of the Danish Regions' decision in November 2019 to allow the Danish Medicines Council to include unpublished data in its assessments.

Initially, the document on the principles establishes that data on which the Danish Medicines Council bases its recommendations and guidelines should be peer-reviewed and publicly available wherever possible, but that there might be cases where it is both necessary and relevant for the companies to submit unpublished data. Next, the Danish Medicines Council lists six principles for the Medicines Council's processing of unpublished and potentially confidential data. It is also worth mentioning that the document establishes that the Medicines Council shall only include unpublished data when drafting treatment guidelines, if the company submitting the data accepts that any such data might be published subsequently.

Additionally, the Medicines Council states that 12 months after drafting recommendations or treatment guidelines, in which unpublished and confidential data were included, the Medicines Council will review the case files for the purpose of making any unpublished data public. The relevant companies will be consulted during this process in order to continually respect confidentiality (pursuant to the legislation governing this subject). The Medicines Council's document does not describe the further details of the Medicines Council's assessment of confidentiality. 

You can read the Danish Medicines Council's document on the principles here (in Danish).

See Plesner's previous newsletters on this here and here.

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