On 23 June 2017, the Royal Decree of 14 June 2017 on the implementation of the Sunshine Act was published in the Official Belgian Journal.
This Royal Decree implements the Belgian Sunshine Act that was adopted by the Law of 18 December 2016 containing various provisions on health (Articles 41 to 48). The Act contains obligations for pharmaceutical and medical devices companies to document and disclose information regarding benefits and premiums granted directly or indirectly to healthcare professionals and healthcare institutions (“transfers of value”). These transfers of value include contributions to the costs of scientific events (registration fees, and travel and accommodation expenses), fees and reimbursement for services and consultancy, and donations and grants to the healthcare sector, etc. The information that must be disclosed will then be published.
The main principles of the Sunshine Act are the following.
The pharmaceutical or medical devices company (itself or through its distributors) must notify the transfers of value to the Federal Agency for Medicines and Health Products (“FAMHP”).
The transfers of value that must be notified concern those granted, directly or indirectly, in cash or in kind, to (i) wholesalers or persons who may prescribe, deliver or administer medicinal products for human or veterinary use that have a practice in Belgium (healthcare professionals – “HCPs”); (ii) institutions where the prescribing, issuing or administering of medicinal products takes place that have a registered or operating office in Belgium (healthcare institutions – “HCIs”); (iii) organizations in the healthcare sector; and (iv) patient associations with a registered office or permanent place in Belgium.
There are, however, certain benefits and premiums granted to these beneficiaries that do not have to be notified. These exceptions are (i) premiums and benefits of limited value that concern the practice of medicine, dentistry, pharmacy or veterinary medicine; (ii) meals and drinks supplied during scientific events; (iii) premiums and benefits that are part of ordinary-course purchases and sales of medicinal products or medical devices by and between a pharmaceutical or medical devices company and the beneficiary; and (iv) samples of medicines.
The information notified to the FAMHP is disclosed on an individual registered basis. The disclosed data contains, inter alia, the amount of the premiums and benefits and the name of the beneficiary. However, premiums and benefits granted for experiments are disclosed on a non-individual, aggregate basis.
The disclosed data remains available to the public for three years from the date of publication.
The Sunshine Act has now entered into force, meaning that transfers of value made in 2017 must be disclosed by 31 May 2018 at the latest.
Before the implementation of the Sunshine Act, only industrial codes of conduct were adopted in order to enhance the transparency of transfers of value from pharmaceutical and medical devices companies to HCPs and HCIs. The transparency obligations were only mandatory for companies that were members of an association that had a code of conduct in place (for example, pharma.be and beMedTech).
The transparency obligations are now mandatory for all companies under the Sunshine Act. Considering the scope of the definition of “notifiers”, this practically covers all companies in the healthcare sector. The scope of the notification obligation is thus very broad.