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Belgium - Medicine Shortages - New Development

  • 19/08/2019
  • Articles

At the end of July 2019, Febelco and PharmaBelgium-Belmedis, two wholesalers (“WS”) with a public-service WS status (groothandelaar-verdeler/grossiste-répartiteur – “WSD”), and the National Association of Wholesaler-Distributors (NVGV/ANGR) filed with the Constitutional Court (“CC”) a petition for annulment of Article 3, 2° of the Law of 7 April 2019 “modifying the Law of 25 March 1964 on medicines as regards the unavailability of medicines” (Wet van 7 april 2019 tot wijziging van de Wet van 25 maart 1964 op de geneesmiddelen voor wat de onbeschikbaarheden van geneesmiddelen betreft/Loi du 7 avril 2019 modifiant la Loi du 25 mars 1964 sur les médicaments en ce qui concerne les indisponibilités de médicaments) (see attached excerpts from the list of pending CC cases). Pursuant to Article 3,2°, WSD are no longer allowed to supply medicines to customers of their choice and should limit their supplies to specific customer categories, namely (a) other WSD; (b) community pharmacists; and (c) hospitals recognised under applicable rules (see Van Bael & Bellis Life Sciences Newsflashes of 8 May 2019 and of 17 May 2019).
 
In a judgment of 18 July 2019, the CC had already suspended Article 3,2° at the request of a number of regular WS which claimed that the new rule had cut off a major source of supplies – the WSD – which they had not been able to replace (see Van Bael & Bellis Life Sciences Newsflash of 19 July 2019). This suspension took effect on 22 July 2019. The WS concerned had also sought the annulment of Article 3,2°. The CC must rule on the action for annulment within three months of the date of the suspension judgment, i.e., by 18 October 2019 at the latest. If not, the suspension will cease to have effect (see Article 25 of the Special Law on the CC of 6 January 1989).
 
The decision of the WSD to join the regular WS in their efforts to have Article 3,2° annulled further diminishes the chances of survival of this provision which were already remote following the CC’s suspension judgment. The action of the WSD therefore further increases the likelihood of the future federal government having to pursue similar and possibly better documented avenues to remedy some of the existing medicine shortfall problems.

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