[co-author: Vicky Vlontzou]
The General Administrator of the AFMPS issued a Decision on 1 April 2020 introducing urgent measures regarding specific medicinal products used in the context of the SARS-CoV-2 pandemic. The purpose of the decision is to prevent shortages in the event of a sudden increase in infected patients. The intended purpose of the decision is to address the uneven distribution of medicinal products that are indispensable for the COVID-19 epidemic by introducing measures of strategic stockpiling and controlled distribution.
The decision provides that, in the absence of a medicinal product suitable for treatment of COVID-19, all medicinal products that have the potential to be effective against the SARS-CoV-2 virus, such as those based on chloroquinephosphate and hydroxychloroquine, should be considered as therapeutically essential. Medicinal products such antibiotics and curariform medicines used to sedate intubated patients with COVID-1 are also considered therapeutically necessary despite the fact that they have no antiviral effect. The Decision includes three Annexes, which contain extensive lists of medicinal products used intensively during the epidemic. To ensure the continuity of their supply the Decision provides that:
- Wholesalers must limit the sales of quantities of medicinal products referred to in Article 1, paragraph 1, and 2 of the Decision to quantities corresponding to last year’s sales for the same period, increased by a maximum coefficient of 50%;
- The delivery of the medicinal products referred to Article 1, paragraph 1 and 2 of the Decision to persons other than wholesalers established in Belgium, or persons established in Belgium that are authorized to deliver medicines to the public, or hospitals established in Belgium, is forbidden;
- Hospitals and persons entitled to dispense medicines to the public, who have stocks of the medicinal products referred to in Article 1, paragraph 1 and 2 of the decision, exceeding the sales volume of one month must report the stock to the AFMPS so that they can potentially be redistributed.
The Decision allows, however, for certain derogations. These include:
- Deliveries of medicinal products in quantities larger than those provided in the Decision are permitted provided that the AMPFS is notified. Such deliveries must not impose a burden on other wholesalers, or other persons authorised to dispense the products, or hospitals;
- Delivery of a medicinal product to another EEA Member State shall be authorized if the medicinal product is intended to be administered in that State. In these circumstances, the supplier shall give prior notice to the AFMPS by indicating the name and quantity of the medicinal products as well as the EEA Member State to which the delivery will take place;
- Delivery of the medicinal products referred to Article 1 paragraph 1 and 2 of the Decision to the Federal Public Services, health, food chain safety and environment (FPS), is permitted for the establishment of strategic stocks.
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