A new law provides for additional measures to limit the unavailability of medicines. The main guidelines of the new law are a clarification of the supply obligation of pharmaceutical companies, the possibility to prohibit or restrict the export of unavailable medicines and the possibility for pharmacists to supply an alternative medicine under certain conditions.
On 3 February 2020, the law of 20 December 2019 amending various legislations regarding medicines shortages, was published. This law lays down a number of measures to limit the unavailability of medicines
Main guidelines of the new law
The law clarifies the obligation of pharmaceutical companies to supply wholesaler-distributors (as part of their own special obligations) and pharmacists within three working days. Partial or interrupted deliveries are automatically considered as unavailability (referred to in the law as temporary cessation of marketing) and must be notified to the FAMHP. A notification must clearly describe the cause and duration of the unavailability.
The export of an unavailable medicine may be temporarily banned or restricted under certain conditions.
Pharmacists will be able to replace or "substitute" an unavailable medicine with an alternative medicine 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 three working days are considered to be unavailable and must be reported to the FAMHP via PharmaStatus. This also applies if only part of the order can be delivered or the delivery is interrupted.
Sanctions will not be applied retroactively but the various economic operators must apply these provisions from the day of publication, 3 February 2020.
The other provisions will come into force on 13 February 2020. Most of the provisions of this Law, such as the possible export restriction or substitution, will be further elaborated by means of implementing decrees. It will therefore be some time before all this can be put into practice. In the meantime the FAMHP will monitor compliance with the revised obligation to report unavailability and the stricter obligation to deliver.
The circular 605 will be reworked to be in line with this new legislation and will no longer apply for the time being.
Other measures relating to unavailability
The FAMHP uses a decision tree that prescribes different actions depending on the critical nature of the unavailability. In the most critical situations it is possible to import the same medicine or alternative medicines from abroad.
The FAMHP launched the online application PharmaStatus at the end of 2019. PharmaStatus collects information on the availability of medicines in Belgium. Up-to-date information helps patients, doctors, pharmacists and the pharmaceutical industry to limit the impact of unavailable medicines.