FAMHP: New Legislative Measures for Unavailable Medicines

Belgium has introduced new legislative measures to help reduce the unavailability of medicines. On 3 February 2020, the Law of 20 December 2019—amending several provisions relating to medicine shortages—was officially published. The law outlines strengthened supply obligations for pharmaceutical companies, provisions to limit or restrict the export of unavailable medicines, and conditions under which pharmacists may supply an alternative treatment.

Key Provisions of the New Law

• The law clarifies that pharmaceutical companies are responsible for supplying wholesaler-distributors (as part of their specific obligations) and pharmacists within three working days. 
• Partial or interrupted deliveries are automatically classified as “unavailability” (referred to as a temporary cessation of marketing) and must be reported to the FAMHP. Notifications must clearly specify the reason and expected duration of the unavailability. 
• The export of a medicinal product identified as unavailable may be temporarily restricted or prohibited under defined conditions. 
• Pharmacists may substitute an unavailable medicine with an alternative medication when certain legal requirements are met.

Implementation Details

The provisions on supply obligations (Article 4) and mandatory reporting of unavailability (Article 2) came into retroactive force on 31 January 2020. Public service orders that cannot be fulfilled within three working days must be reported to the FAMHP through PharmaStatus. This requirement also applies in cases of partial delivery or delivery interruption. Although sanctions are not applied retroactively, all economic operators must comply with these requirements as of the publication date—3 February 2020.

Other provisions, including potential export restrictions and substitution rules, will take effect on 13 February 2020. These will be further developed through implementing decrees, meaning full practical application will take additional time. Meanwhile, the FAMHP will monitor compliance with strengthened reporting obligations and the stricter supply requirements.