On 23 June 2017, the Royal Decree implementing the December 2016 Belgian Sunshine Act was published in the Official Gazette. The Royal Decree marks this date as the official entry into force of the Sunshine Act, which requires a large category of life sciences companies to notify the Federal Agency for Medicines and Health Products (FAMHP) of all premiums and benefits granted to a number of defined healthcare beneficiaries established in Belgium (see previous blog post: The Belgian Sunshine Act: what’s in a name?).
The Royal Decree confirms that the first reporting period will run from 1 January to 31 December 2017, requiring premiums and benefits granted during that period to be published by 30 June 2018, and defines the categories of premiums and benefits that must be disclosed under the new provisions. Life sciences companies will have to disclose the total annual amount of direct and indirect premiums and benefits granted on an individual basis (per beneficiary):
- Healthcare professionals: (i) costs for participation in scientific events, such as registration fees and travel expenses; and (ii) fees, payments and reimbursements of costs for services, including consultancy services.
- Healthcare organisations: (i) costs for participation in scientific events, such as registration fees and travel expenses, and sponsoring contracts with healthcare organisations or third parties appointed by these organisations to organise scientific events; (ii) fees, payments and reimbursements of costs for services, including consultancy services; and (iii) donations and grants that support healthcare.
- Patient associations: (i) fees, payments and reimbursements of costs for services, including consultancy services; and (ii) financial or other contributions.
In addition, the total annual amount of premiums and benefits made that concern research must be disclosed on an aggregate basis.
A second Royal Decree is expected to designate the ethical health platform Mdeon as the organisation that will handle the practical aspects of this disclosure on behalf of the FAMHP.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, June 2017 Issue (Thomson Reuters).