[co-author: Vicky Vlontzou]

On 11 June 2020, the Court of Justice of the European Union (CJEU) delivered a judgement in case C-786/18 GmbH v. Novartis Consumer Health GmbH. The judgment followed a request for a preliminary ruling by the German Federal Court of Justice regarding whether pharmaceutical companies may distribute free samples of medicinal products to pharmacists. The Court ruled that even though pharmaceutical companies are authorised to distribute free samples of these medicinal products to pharmacists under certain restrictive conditions, it is not permitted to distribute to pharmacists medicinal products that are available only on prescription.

On 11 June 2020, the Court of Justice of the European Union (CJEU) delivered a judgment in case C-786/18 GmbH v. Novartis Consumer Health GmbH. The judgment followed a request for a preliminary ruling by the German Federal Court of Justice regarding the interpretation of Article 96 of Directive 2001/83 on the Community code relating to medicinal products for human use (Community Code).

Article 96 of the Community Code provides that:

"free samples shall be provided on an exceptional basis only to persons qualified to prescribe them…"

The German Federal Court submitted a request to the CJEU for a preliminary ruling concerning whether pharmaceutical companies may distribute free samples of medicinal products to pharmacists, or, whether this distribution activity must be restricted to physicians.

In its judgement, the CJEU concluded that it is permissible for pharmaceutical companies to distribute free samples of medicinal products to pharmacists subject to the strict conditions laid down in Article 96 of the Community Code.

The CJEU's interpretation was based on Recital 51 of the Community Code, which provides that:

"it should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them…".

According to the CJEU, however, pharmaceutical companies may not distribute medicinal products that are available only on prescription to pharmacists.

To avoid potential risks of circumvention of the rules relating to the supply of medicinal products that are subject to medical prescription, the CJEU interpreted Article 96 of the Community Code as meaning that only persons authorized to prescribe these medicinal products may receive free samples of these products. Pharmacists are, therefore, excluded from that right.

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