On 22 August 2017, the second Royal Decree implementing the December 2016 Belgian Sunshine Act was published in the Official Gazette. The decree designates the ethical health platform Mdeon as the organisation that will handle the practical aspects of disclosure under the Sunshine Act on behalf of the Federal Agency for Medicines and Health Products (FAMHP).
The Sunshine Act, which entered into force on 23 June 2017 requires a large category of life sciences companies to notify the FAMHP of all premiums and benefits granted to healthcare professionals, healthcare organisations and patient associations established in Belgium. This information will be disclosed annually via a publicly accessible transparency platform (www.betransparent.be) that will be managed by Mdeon. The royal decree specifies that the designation of Mdeon is valid for an indefinite period.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, August 2017 Issue (Thomson Reuters).