On 17 October 2019, the Belgian Constitutional Court rendered a final judgment , annulling Article 3.2° of the new legislation applicable to shortages of medicines in Belgium. The Article had banned the parallel export of medicines by Belgian wholesale distributors, requiring them to only supply medicines for human use to other Belgian wholesale distributors, licensed pharmacies or hospitals, and the Court suspended the Article in July 2019 (See our previous blog post: Belgian Constitutional Court suspends sales restriction for wholesale distributors of medicines). The legislator initially imposed the restriction because it aimed to guarantee the delivery of medicines to both pharmacies and patients in Belgium.
In its judgment, the Court first emphasised the importance of the wholesale distributors’ role in the medicines distribution chain. The Court stressed that the restriction had far-reaching consequences for ordinary wholesalers, who could no longer replenish their supplies via wholesale distributors. Subsequently, the Court investigated whether the restriction constituted a measure having an equivalent effect to quantitative restrictions, which is prohibited under European law. The Court noted that even though the protection of health and human life could be invoked as an exception to the European rule, firstly, the exception only applied if the measure was suitable to accomplish the aim pursued, and secondly, if such measure did not go beyond what was necessary to reach the aim. With regard to the first requirement, the Court stated that it was not proven that the activities of ordinary wholesalers had an influence on the unavailability of medicines in Belgium. Regarding the second requirement, the Court stated that wholesale distributors were already committed to complying with their public service obligation (such as permanently guaranteeing the availability of medicines to satisfy the need in a geographical area). The Court also noted that it was demonstrated that only a very marginal percentage of unavailable medicines in Belgium was exported.
The Court found that the supply restriction was not suitable to reach the aim set out by the legislator. Hence, the exception to the European rule did not apply, causing the restriction of Article 3.2° to be a violation of European law. As a consequence, the Court annulled Article 3.2°.
Belgian wholesale distributors are therefore, not 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 outside of Belgium.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, November 2019 Issue (Thomson Reuters).