New Appeals Board decision on the use of recommendations from the Danish Medicines Council

In a new decision, the Appeals Board of ENLI (the Danish Ethical Committee for the Pharmaceutical Industry) confirms ENLI's guidelines on the use of recommendations from the Danish Medicines Council.

In a recent case, the Appeals Board has decided on whether to characterize the recommendations from the Medicines Council as scientifically substantiated research. The issue is relevant as Section 7(5) of ENLI's Promotion Code stipulates that the substantiation of information on medicinal products must, in addition to the summary of product characteristics, only include scientifically substantiated research.

The Appeals Board reached the decision that the recommendations of the Medicines Council cannot be characterized as scientifically substantiated research and thus cannot be used to substantiate the properties of medicinal products. The Appeals Board also concluded that a recommendation from the Medicines Council cannot be used to make health claims regarding medicinal products either, including in a comparison with competing products. In this connection, the Appeals Board referred to ENLI's new Guide on informative material and documentation, which Guide establishes on page 9 that "(…) it is considered a health claim regarding the medicinal product to state that the Medicines Council recommends your product as the preferred choice (…)".

Based on these considerations, the Appeals Board concluded that in the case in question the company had used the Medicines Council's recommendation as a health claim for its medicinal product and that was contrary to ENLI's Promotion Code.

This decision comes only a few weeks after ENLI's publication of the new Guide on informative material and documentation in connection with an update of the existing Promotion Code.

Read the guidelines and guide here.

The Boards of Appeal has not made the decision public, but ENLI's newsletter of 29 May 2019 mentions it.

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