February 2022: Penalties on Failure to Submit Results in Belgium – A TranspariMED Report

An article “Belgium: What does the new clinical trial transparency law say?” has been published on February 15, 2022, on TranspariMED.

With the European Union Clinical Trial Information System (EU CTIS) coming into force on 31 January 2022, sponsors can face penalties for failure to report results, irrespective of the outcome, within one year of study completion. As laid down in Article 94 of the Regulation (EU) No 536/2014, the Member States shall lay down rules on penalties applicable to infringements and shall take all measures necessary to ensure that they are implemented.

As per the Belgian regulation already published on May 22, 2017, sponsors can be fined between 500 and 250,000 Euros and a prison sentence between one month and two years. Repeat offenders can be imposed up to a maximum fine of 500,000 Euros and a three-year prison sentence. In addition, the judge may prohibit any person convicted under this Act from participating in a clinical trial as a sponsor, investigator, or in any other way, even under the direction of an investigator for a period he determines, which may not be less than three years or more than ten years.

In addition, this report also describes how fines will be imposed, how violations will be detected, and the strengths and weaknesses of Belgium’s law. For more information, please refer to the article “Belgium: What does the new clinical trial transparency law say?” published on February 15, 2022, on TranspariMED.