On December 27th 2016, the Sunshine Act was adopted in Belgium. It introduces a new transparency obligation applicable to the pharmaceutical and medical devices industries. The legislation requires pharmaceutical manufacturers, importers and distributors, as well as retailers and medical device manufacturers, to disclose all pecuniary advantages or benefits provided to healthcare professionals, healthcare organisations and patient associations registered in Belgium. According to this law, any transfer of value in money or in kind must be notified to the FAMHP.
For this law to be effective, two Royal Decrees on the disclosure obligation are in preparation. The first Decree concerns the types of transfers of value and the practical and technical arrangements. In the second Decree, an organization -anticipated to be Mdeon- will be assigned responsibility to perform the functions and tasks on behalf of the FAMHP. After publication of these Decrees, the Sunshine Act can enter into force. This is expected for April 2017.
The obligation to disclose will however apply to all transfers of value provided from January 1st 2017 to December 31st 2017. Related notification of these transfers of value is due likely by May 31st 2018 at the latest. A record of all transfers of value must be kept by companies for a period of 10 years from the date of publication.