Belgium - Royal Decree Creates Increased Transparency of Medicines Supply Chain

• 20/12/2021
• Articles

Following the extended parliamentary trajectory that eventually resulted in new rules governing medicine shortages (see, Van Bael & Bellis Life Sciences News and Insights of 20 December 2019), it took successive federal governments almost two years to come up with the first of what is intended to be a series of implementing measures. Today, the Royal Decree of 29 November 2021 “implementing Article 6, paragraph 1sexies of the Law of 25 March 1964 governing medicines with regard to the transparency of the stock of medicines dedicated for public service obligations” (the RD) is the first such measure to enter into force (see, attachment).
 
The RD establishes a stock monitoring system for wholesaler-distributors (WDs) as part of the public service obligations of that group of stakeholders in the medicine supply chain. Its goal is to give the Federal Agency for Medicines and Health Products (FAMHP) a picture of the medicine stocks held by WD. This should allow FAMHP to have a better view of patient needs, to step in to avert or reduce the unavailability of any given medicine at any particular time, and to develop a policy regarding unavailable medicines and guarantee a steady stream of medicine supplies to meet patient needs.
 
To this end, WDs will be under a duty to provide the following data to FAMHP about sales, purchases and stock positions:
 
• Historical data for 2019, 2020, and January-November 2021;
• Monthly overviews (the first data set will cover December 2021).
 
The RD also details a procedure for notifications of unavailable medicines which is based in part on the current usage of the Pharmastatus website. The RD specifically addresses the reporting of unavailable medicines by WDs and pharmacists. Any such notification will have to be assessed by the marketing authorisation holder (MAH) and, based on such assessment, may give rise to a notification of unavailability by the MAH.
 
This complements the existing and autonomous obligation of MAHs to notify unavailable medicines. The RD now specifies in greater detail the information which MAHs are under a duty to supply.