FAMHP: New Legislative Measures for Unavailable Medicines

This new regulation offers for extra measures to limit the unavailability of medicines. On 3 February 2020, the law of 20 December 2019 amending various legislations regarding medicines shortages was published. The main guidelines of the new law presents clarification of the supply responsibility of pharmaceutical companies, the possibility to avoid or restrict the export of unavailable drugs or medicines and the possibility for pharmacists to supply an choice medication under certain conditions.

Main guidelines of the new law: 

The law clarifies the responsibility of pharmaceutical organizations to provide wholesaler-distributors (as part of their own special obligations) and pharmacists within 3 working days. Partial or interrupted deliveries are automatically considered as unavailability (referred to in the law as temporary cessation of marketing) and need to be notified to the FAMHP. A notification must clearly describe the purpose and period of the unavailability.

The export of an unavailable medicinal drug may be temporarily banned or restricted under certain conditions. 

Pharmacists will be capable to change or “substitute” an unavailable remedy with an alternative medication under certain conditions.

The provisions on the obligation to deliver (Article 4) and the notification of unavailability (Article 2) came into force retroactively on 31 January 2020. Public service orders that cannot be delivered within 3 working days are considered to be unavailable and should be reported to the FAMHP via Pharma status. This also applies if only part of the order can be delivered or the delivery is interrupted. Sanctions will not be utilized retroactively but the economic operators must follow these provisions from the day of publication, 3 February 2020.

The different provisions will come into force on 13 February 2020. Most of the provisions of this Law, such as the viable export limit or substitution, will be further elaborated by means of implementing decrees. It will therefore be some time earlier than all this can be put into practice. In the meantime the FAMHP will monitor compliance with the revised obligation to record unavailability and the stricter obligation to deliver.