Yesterday, the Belgian Act of 20 December 2019 amending the existing framework regarding shortages of medicines (the “Act”) was published in the Official Belgian Gazette. The main impact of this new Act is that it further reinforces the supply obligation that already existed for wholesalers in the pharma sector and expands the notification rules in case of temporary or definite medicines unavailability by including the following provisions:
1. Article 4 introduces a three business days’ time limit for wholesalers to supply (i) wholesaler-distributors for orders in the context of a public service obligation and (ii) pharmacists. A Royal Decree still needs to be adopted regarding detailed rules concerning this supply obligation and its enforcement;
2. Article 2 further expands the notification obligation in case of medicines unavailability: If an order from a wholesaler-distributor in the context of its public service obligation or from pharmacist remains unfulfilled, such situation qualifies as a temporary unavailability of a medicine and is subject to a notification obligation on the newly established platform of the FAMHP, and
3. Article 3 introduces the possibility for the FAMHP to impose a temporary export ban or export limitation in case of a medicines shortage. Detailed rules on procedure and criteria will be adopted by Royal Decree.
Further measures such as the right for pharmacists to replace medicines that are affected by supply cessations by an alternative product with same active ingredient (or combination of active ingredients), the same dosage, the same route of administration and the same frequency of administration are embedded in the law.
The supply and notification obligations took immediate effect as of publication yesterday. The other provisions including the possibility for the regulator to impose an export ban will become applicable by 13 February 2020. However, without the above mentioned Royal Decree, uncertainty remains as to how these obligations will be applied and enforced. The Royal Decree is currently expected to be adopted by March or April 2020. However, if the Royal Decree must be notified to the EU Commission (which is determined by the Council of State), a mandatory standstill period of an additional three months will need to be taken into account.