On 23 June 2017, the Belgian Official Journal contained the Royal Decree of 14 June 2017 implementing the Sunshine Act (“Koninklijk Besluit van 14 juni 2017 tot uitvoering van de Sunshine Act”/”Arrêté royal du 14 juin 2017 portant exécution du Sunshine Act”)(the “Royal Decree”). As its name indicates, the Royal Decree offers the practical details necessary to apply the Sunshine Act provisions contained in Articles 41 through 48 of the Law of 18 December 2016 introducing miscellaneous provisions regarding health.
The Royal Decree specifies the notification requirements imposed on a range of firms dealing with medicines and medical devices. The notification targets a number of transfers of value which these firms carry out for the benefit of particular healthcare professionals, healthcare organisations and patient associations. The Royal Decree also elaborates on the publication which will be made annually on the basis of these notifications under the aegis of the Federal Agency for Medicines and Health Products.
Significantly, the Royal Decree provides that the Sunshine Act enters into force on 23 June 2017, the day of its publication, and that the first reference year for notification and publication purposes is 2017. It is unclear whether this determination causes the Sunshine Act to have retroactive effect in that it would require firms to notify and publish the transfers of value that occurred during all of 2017.
The Royal Decree also foresees a limited temporary exemption for firms dealing in veterinary medicines which will not have to notify transfers of value pertaining to their veterinary activities which healthcare professionals benefit from in 2017.
Both the Sunshine Act and the Royal Decree are enclosed below.