Belgium Introduces New Sunshine Act

By Benoit Racault

On December 27, 2016, the Belgian government enacted new legislation governing transparency reporting called The Sunshine Act.

The law requires pharmaceutical manufacturers, importers and distributors, as well as retailers and medical device manufacturers, to disclose interactions with HCPs and HCOs, whether for human or veterinary purposes.

The scope of spend types disclosure is the same as for EFPIA but the owner and receiver of the report is now Belgium’s AFMPS (Agence Fédérale des Médicaments et des Produits de Santé), a department of the Ministry of Health.

Reports will be submitted through a central platform that will be available in French, Dutch and German (but not English). R&D spending reports may aggregate all R&D-related transfers of value, however all other types of transfers of value must be reported for each individual HCP/O. Additionally, Life Sciences companies are not required to obtain consent from HCPs and HCOs.

Companies must submit reports by May 31st of each calendar year, and the AFMPS will make the reports public on June 30th of each year. Furthermore, companies will be required to keep proofs and receipts for a period of ten years after the first disclosure.

Details of how the law will be enforced have not been released and several decrees associated with the legislation are expected in the coming days.