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Belgium - Constitutional Court Rejects Request for Suspension of Key Provisions of Latest Medicine Shortages Law

  • 20/07/2020
  • Articles

On 16 July 2020, the Constitutional Court rejected several requests for suspension of Articles 2, 3 and 4 of the Law of 20 December 2019 modifying various laws to tackle medicine shortages (Wet van 20 december 2019 tot wijziging van diverse wetgevingen wat de tekorten aan geneesmiddelen betreft/Loi du 20 décembre 2020 modifiant diverses législations, en ce qui concerne les pénuries de medicaments – the Law – see attachments). The requests had been introduced by the Belgian Association of Parallel Importers and Exporters, various other parties active in the parallel trade in medicines and pharmacists in the Democratic Republic of the Congo and Rwanda (the Applicants).
 
The challenged provisions, broadly, created the following rules: 

  • They tightened the notification requirement of temporary medicine supply cessations.
  • They equated a partial or interrupted supply of medicines to wholesaler-suppliers and pharmacists with a temporary cessation of supplies that gives rise to notification.
  • Medicines affected by notifiable supply cessations may be made subject to a temporary export limitation or prohibition. A Royal Decree is supposed to determine detailed rules, but has not yet been adopted.
  • Wholesalers with a public service obligation and pharmacists started to benefit from a supply obligation of three working days in their favour (see, Van Bael & Bellis Life Sciences News Alerts of 20 December 2019 and 3 February 2020).

The Applicants objected to what they regarded as an illegal export prohibition of medicines and maintained that this prohibition essentially replicated a similar export ban which the Constitutional Court had found to be illegal as an unjustifiable restriction of trade between Member States (see, Van Bael & Bellis Life Sciences News Alerts of 19 July 2019 and 17 October 2019). By contrast, the Belgian government was confident that a focused export restrictions procedure that may result in narrow export limitations would pass muster under European law.

The Constitutional Court sided with the Belgian government and reached the conclusion that the new export prohibition is not similar to the blanket export prohibition which it annulled. However, it did not proceed with an assessment of the merits of the new export ban and its attendant provisions and declined to suspend the challenged provisions because the applicants failed to show that the application of these provisions would cause them serious harm which is difficult to repair.

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