The Law of 20 December 2019 modifying various laws related to medicines shortages was published in the Belgian Official Journal on 3 February 2020.
The aim of this law is to tackle certain issues related to the problem of medicines shortages. The Law introduces a set of measures in order to address deliberately created medicines shortages. The main measures are the following:
- Stricter notification obligations on the wholesaler (distributor) in case of temporary discontinuation of medicines supply.
- The possibility to temporarily suspend or limit exports of medicines that are subject to a supply discontinuation. A Royal Decree will provide for the implementation of this requirement.
- An obligation on wholesalers (distributors) to supply all medicines within three days if such supply relates to their public service obligations. A Royal Decree will provide for the implementation of and compliance with this obligation.
- If the medicines shortage lasts, allow pharmacists to replace the medicinal product with an alternative if the medicines shortage lasts, but only within the conditions and framework set by the Federal Agency of Medicines and Health Products.
The Law entered into force on 13 February 2020. The accompanying Royal Decrees have not yet been published.
This article was co-authored by Nieke Vanavermaete.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, March 2020 Issue (Thomson Reuters).