The law of 18 December 2016 published in the Belgian State Gazette of the 27th of December concerns the upcoming implementation of a “Sunshine Act” in Belgian legislation.
EFPIA/Pharma.be and BeMedTech have already adopted a Disclosure Code on the direct and indirect transfers of value by pharmaceutical companies to Health Care Professionals (HCPs), Health Care Organisations (HCOs) or Patient Organisations (POs). The same rules will now become a legal obligation in Belgium.
In practice, Marketing Authorisation Holderss will have to notify every year to the Belgian Halth Authority FAMHP, and this before the 31st of May, all premiums and benefits (direct or indirect) offered to HCPs, HCOs or POs.
Must not be notified:
- Premiums and benefits of limited value, related to the profession of the HCP
- The invitation and sponsoring of the participation of a HCP at a scientific meeting, including the hospitality
How this will be done in practice is not yet known but will be described in a Royal Decree still to be published. In the meantime, all marketing authorisation holders should prepare to submit the required information.
The Archemin Medical Information team is ready assist: medical.information [at] archemin.eu .