The government of Belgium enacted new legislation governing transparency reporting on December 27, 2016. The new legislation is known as The Sunshine Act.
The law now deems it necessary for pharma manufacturers, retailers, medical device manufacturers, and even importers and distributors to disclose information about their interactions with HCPs and HCOs. This information has to be reported irrespective of whether the interaction took place for human or veterinary purposes.
Although the scope of spend types disclosures remains the same as for EFPIA, the report will now be owned and received by Belgium’s AFMPS (Agence Fédérale des Médicaments et des Produits de Santé), a department of the Ministry of Health.
A central platform will be used for report submissions, and these will be available in French, Dutch, and German. Also, there is no need for Life Sciences companies to acquire consent from HCPs and HCOs.
Spend reports need to be submitted by the 31st of May, and the reports will then be made public by the AFMPS on June 30th of each year. Apart from that, it will be necessary for companies to maintain proofs and receipts for a period of ten years after the first disclosure.
For the record, information pertaining to the ways in which the law will be enforced has not been released as of yet. Also, several decrees associated with the legislation are expected in times to come.
