Belgian Constitutional Court suspends sales restriction for wholesale distributors of medicines

On 18 July 2019, the Belgian Constitutional Court suspended Article 3.2 of the legislation applicable to shortages of medicines in Belgium, after receiving multiple applications for both suspension and annulment of the Article. The Article obliged Belgian wholesale distributors to only supply their medicines for human use to other Belgian wholesale distributors, licensed pharmacies or hospitals. Hence, wholesale distributors were prohibited from supplying their products to ordinary wholesalers and exporting medicines. The only exception to this was the supply in the framework of clinical trials, on the condition that there was not a risk to the supply of the medicine in the wholesale distributor's territory. The parliamentary works explained that the restriction had been imposed to guarantee the delivery of medicines to Belgian pharmacies and Belgian patients.

In its judgment, the court investigated whether the restriction violates European law, as it constitutes a measure having an equivalent effect to quantitative restrictions, which is prohibited. Limited exceptions to this prohibition exist, such as with regard to the protection of the life and health of humans, which could be considered to coincide with the aim stated by the legislator. However, first, the court noted that it was not proven that the activities of ordinary wholesalers had an influence on the unavailability of medicines in Belgium. The court referred to a communication of the Federal Agency for Medicines and Health Products (FAMHP). Second, it pointed out that it was demonstrated that only a very marginal percentage of unavailable medicines in Belgium were effectively exported. Therefore, the court decided that the supply restriction did not suitably fulfil the aims set out by the legislator, and no exception applied. The court thus found the restriction to be a violation of European law and suspended the new Article 3.2.

Belgian wholesale distributors are consequently no longer limited to distribute their products only to other Belgian wholesale distributors, pharmacies or hospitals, and they are at all times allowed to export part of their supplies, as permitted by the former legislation. The FAMHP has announced in a press release that it is assessing the judgment, and its possible options. The court will render a final judgment on the annulment of Article 3.2 by 18 October 2019.

This article was co-authored by Tine Carmeliet.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, August 2019 Issue (Thomson Reuters).