The Sunshine Act was adopted on December 27th 2016 in Belgium. It will apply to pharma and medical devices companies that provide transfers of value to HCPs, HCOs and patient organizations established in Belgium. The first disclosure will concern transfers of value made from January 1st 2017 to December 31st 2017.
Notifications of these transfers of value must be made to the FAMHP (Federal Agency for Medicines and Health Products) by May 31st 2018. In all likelyhood, Mdeon’s BeTransparent.be website will be used as it is today to get an authorization prior to an event.
Non compliance with the disclosure obligation will be punished by fines ranging from 1200 € to 90 000 €.
The entities concerned are:
- Marketing authorization holders for medicinal products for human or veterinary use
- Importers, manufacturers and distributors of medicinal products for human or veterinary use
- Persons or entities trading or brokering medicinal products for human or veterinary use
- Distributors, retailers and manufacturers of medical devices
The elements concerned by this notification are any transfer of value in money or in kind.
The Sunshine Act gives a list of exceptions to the legal obligation of disclosure:
- Meals or drinks offered in the context of scientific events that are of an exclusively scientific nature
- Advantages and benefits of negligible value that relate to the exercise of the medical, dental or pharmaceutical profession or in relation with veterinar medicinal products
- The economic margins and price discounts in sales transactions between the company and the beneficiary
- Free samples
A Royal Decree will specify:
- The types of transfers of value that are concerned
- The technical specifications for notification and publication of transfers of value
- The date of entry into force of the Sunshine Act
Will the EFPIA transparency disclosure process that has applied to Belgium since 2015 be kept, or will Belgium, like France, be exempt?