Hot news: The Royal Decree (RD) that implements the Sunshine Act is published today, June 23rd 2017! We summarize the most important changes compared to the current practice on betransparent.be, which was solely based on the Deontological Codes of the industry associations as there was no legal basis yet.
As from now, besides Rx medicines and medical devices, also over-the-counter (OTC) medicinal products are in scope and will need to retro-actively comply with this RD for all transfers of value made since January 1st 2017. In addition, as the definition of a healthcare professional (HCP) in this RD has slightly changed, with the inclusion of veterinarians, the Sunshine Act is applicable to the business of veterinary medicines as well. However, animal health companies get an exemption from this obligation for one year and will only disclose as from 2018.
Furthermore, transfers of value made by a pharmaceutical company for the benefit of a HCP must be disclosed in name of the HCP, even if the HCP acts from a legal entity (NV/SA or bvba/sprl).
Indirect transfers of value (through a third party, congress organizer or a hospital) have to be disclosed in name of the final beneficiary HCP. This is no change, but in practice, this was hard to comply with for many pharmaceutical companies. This responsibility is now being shifted to the third party who will need to inform the pharmaceutical or medical device company of the identity of the final beneficiary and the exact amount he/she received. This information must be provided to the company at the latest on December 31st of the reference year.
As you know, transfers of value to patient organizations were to be made publicly available on the company’s website. According to this RD, however, these transfers of value need to be included in the transparency report.
Transfers of value must be disclosed in the year of the financial transaction, even if this year differs from the year that the services were provided.
And last but not least, an extra month was added to finalize the transparency report! Disclosure has to be made available at the latest on the 31st of May of the year following the financial transaction.
In conclusion, this RD clarifies several grey zones in transparency but also transforms a deontological commitment into a strict legal obligation!