Belgium - Constitutional Court Rejects Challenge to Statutory Medicine Shortage Rules, Including Export Restrictions
- 11/06/2021
- Articles
The Constitutional Court dismissed on 10 June 2021 the action which the Belgian Association of Parallel Importers and Exporters, several other parties active in the parallel trade in medicines, and pharmacists in the Democratic Republic of the Congo and Rwanda (the Applicants) had brought to obtain the annulment 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 médicaments – the Law). The Constitutional Court had already rejected a request for suspension of the same provisions (see, Van Bael & Bellis News and Insights of 20 July 2020).
Yesterday’s judgment (see, attachments) focused on the powers given by statute to the government to establish a procedure for the creation of a temporary limitation or prohibition of the exportation of medicines that are unavailable on the Belgian market. The Applicants relied on the European free movement of goods principles but also on several provisions of Belgian law to challenge these restrictions. However, the Constitutional Court considered the contested rules justified in that they permit the government to counter situations in which medicine supplies to Belgian patients are no longer guaranteed. The Constitutional Court distinguished the new rules, which will be applied on a case-by-case basis following an assessment of the causes and nature of the particular shortage afflicting a specific medicine, from the blanket export prohibition imposed on wholesaler-distributors which it struck down in 2019 (see, Van Bael & Bellis Life Sciences News and Insights of 19 July 2019 and 17 October 2019).
As the Constitutional Court has allowed the challenged statutory medicine shortage rules to stand, the question arises when the government will come up with the requisite implementing rules. Pressed on the subject in Parliament, the Minister of Social Affairs and Public Health indicated back in February 2021 that these proposed rules are under review, but he did not give a timetable for their adoption. Four months later, it is still not clear when they will become law.
