In the latest move to crack down on wayward clinical trial sponsors, Belgium may now fine companies, hospitals, and universities that fail to publicly disclose study results, a sign that more European regulators are growing concerned about a lack of transparency surrounding medical data.
As of this month, the Federal Agency for Medicines and Health Products can impose fines of $550 to $280,000 and threaten imprisonment of up to two years. The penalties, set forth in a 2017 law, did not go into effect for trial results until now because they were tied to European Union regulations that began in January. However, a new remedy adopted by the agency would permit violators to reach a settlement of at least $4,500 or otherwise face further proceedings, an FAMHP spokesperson explained.
By spelling out possible penalties, Belgium becomes the first country in the European Union to disclose such details, according to Till Bruckner, who heads TranspariMED, an advocacy group that tracks compliance with disclosure regulations. He noted other countries have integrated European Union requirements into their laws. But until now, only Denmark previously indicated plans to pursue sanctions and prison time. However, specifics were not offered.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
