The Court of Justice of the European Union (CJEU) has recently issued a judgment clarifying that wholesale distributors may not obtain medicines directly from pharmacies that do not hold a wholesale distribution licence (WDA). This represents a useful confirmation of the current law, a rule that is set to remain under the new EU Pharmaceutical Package.
With its judgment dated September 21, 2023 (Case C-47/22), the CJEU ruled on the interpretation of Article 80, first subparagraph, point (b), of Directive 2001/83/EC regarding wholesale distributors. The CJEU confirmed that wholesale distributors must obtain their supplies of medicinal products only from persons who are themselves in possession of a WDA or who are exempt from obtaining such a license.
The dispute in the main proceedings
The request for a preliminary ruling was made in the context of a dispute between the Austrian Federal Office for Safety in Healthcare and an Austrian pharmacy holding a WDA. The Austrian pharmacy filed an appeal before the local Federal Administrative Court against a local prohibition to purchase medicinal products from other pharmacies not holding a WDA, as they claimed it does not specifically jeopardise the safety of the medicinal products.
The CJEU’s interpretation of the applicable regulatory framework
The Austrian Court asked the CJEU to issue a preliminary ruling on whether Article 80 of the Directive allows the holder of a WDA to obtain medicinal products from other persons who, although authorised to supply medicinal products to the public, such as pharmacies, do not hold a WDA nor are exempt from that requirement.
The CJEU ruled that Article 80 must be interpreted as meaning that the holder of a WDA can only obtain medicinal products from persons who are themselves holders of a WDA or are exempt from obtaining such a license and that Article 80 does not provide for any exception for pharmacies. Moreover, the fact that the purchase may relate to a small quantity of medicines, which may be intended to be resold to persons authorised to supply drugs to the public or holding a WDA would be irrelevant according to the Court.
Similar restrictions foreseen in the EU Pharmaceutical Package
It is interesting to note that similar restrictions to those foreseen by the CJEU are also envisaged in the EU Pharmaceutical Package . Indeed, Article 166(1)(c) of the Commission’s Proposal for a Directive requires holders of a WDA to obtain their supplies of medicinal products only from persons who are themselves in possession of a WDA or a manufacturing license in the Union.
