Belgium - Medicine Shortages - New Developments
On 14 May 2019 the head of the Federal Agency for Medicines and Health Products (“FAMHP”), Xavier De Cuyper, sent a letter to all stakeholders in the pharmaceutical supply chain explaining his organisation’s view on the effects of the Law of 7 April 2019 “modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (the “Letter” - see attached). The Letter has since been published on the FAMHP website.
The Law of 7 April 2019 introduces a range of measures to reduce medicine shortages in Belgium (see, Van Bael & Bellis Life Sciences Newsflash of 8 May 2019). The Letter focuses on the practical consequences of the specific rule that limits the categories of customers to which a wholesaler (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur) is allowed to supply. These groups of potential customers are (a) other WS with a public-service WS status; (b) community pharmacists; and (c) hospitals recognised under applicable rules. As a result, WS with a public service WS status will no longer be able to sell medicines abroad.
The Letter highlights what FAMHP considers to be the following practical effects:
- Suppliers will no longer be able to refuse supplies to WS with a public-service WS status who will have to meet their public-service obligations in Belgium at all times and for that purpose require reliable and uninterrupted sources of medicines. The Letter stresses that FAMHP will monitor and enforce the supply obligation.
- WS with a public-service WS status can no longer sell abroad. To the extent their owners want to continue pursuing export activities, these will have to act through a distinct legal entity that will require a separate WS licence.
- FAMHP will also monitor the obligation imposed on WS with a public-service WS status only to supply the limited categories of customers defined by law.
- The status of community pharmacists and hospital pharmacists does not change.
Holders of marketing authorisations are required to report the unavailability of specific medicines. Additionally, WS with a public-service WS status and pharmacies are urged to report medicines that as a practical matter are not available even though they do not feature on the dedicated website of medicines reported as unavailable by the marketing authorisation holders.
The Letter addresses the status of ordinary WS only in passing (for example, by indicating – as noted – that ordinary WS will still be able to engage in export activities). In reality, the role and status of ordinary WS does not change under the Law of 7 April 2019.
Finally, the Letter repeats an earlier indication by FAMHP that a Royal Decree implementing the Law of 7 April 2019 will be adopted shortly.