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.
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