Belgium - Medicine Shortages | Wholesaler-Distributors Curtailed
Today’s Belgian Official Journal contains the text of the “Law of 7 April 2019 modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (Wet tot wijziging van de wet van 25 maart 1964 op de geneesmiddelen voor wat de onbeschikbaarheden van geneesmiddelen betreft / Loi modifiant la loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments) (the “Law”).
The Law (i) allows the concept of “temporary cessation of supply of medicines” to be determined by Royal Decree;
(ii) allows the Minister to make recommendations of suitable therapeutical alternatives in case of temporary shortages of specific medicines;
(iii) allows wholesalers (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur) only to supply specific categories of clients, namely (a) other WS with a public-service WS status; (b) community pharmacists; and (c) hospitals recognised under applicable rules; and
(iv) imposes particular shortage-related obligations on parallel traders which previously only applied to the marketing authorisation holders.
The Federal Agency for Medicines and Health Products has already announced implementing rules that will define the unavailability of a medicine and the period within which the orders of a WS with a public-service WS status will have to be supplied ( NL / FR )
The statutory limitation of the authorised categories of clients of WS with a public-service WS status (which are all based in Belgium and service the Belgian market) is designed to ensure the steady supply of medicines to the Belgian market and, conversely, cut down on exports that threaten public health. Under specific conditions, that limitation will not apply to medicines earmarked for clinical trials. To be sure, unlike WS with a public-service WS status, marketing authorisation holders and regular wholesalers will still be able to sell abroad.
Lastly, the Law implements European rules that combat the trade in falsified medicines by creating criminal sanctions for specific violations of Regulation 2016/161 which lays down safety features for the packaging of medicines for human use.