作者

Dr. Daniel Tietjen

合伙人

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Katharina Hölle

律师

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作者

Dr. Daniel Tietjen

合伙人

Read More

Katharina Hölle

律师

Read More

2023年12月18日

CJEU on the interpretation of the term "advertising of medicinal products"

  • Quick read

Co-author: My Anh Cao

On 22 December 2022, the Court of Justice of the European Union (CJEU) issued a ruling (case reference C-530/20) on three questions of interpretation of Directive 2001/83/EC submitted by the Latvian Constitutional Court. It concerns the questions how the term "advertising of medicinal products" is to be interpreted within the meaning of this directive and whether the term also includes advertising for unspecified medicinal products.

Furthermore, the Latvian Constitutional Court wanted to know whether the prohibition of price-related advertising and advertising of special offers or combined sales of medicinal products together with other goods provided for in the national provision was compatible with that directive.

A pharmaceutical group of companies operates a pharmacy chain and companies for the retail sale of medicinal products in Latvia. In 2016, the Latvian health inspectorate banned a discount promotion in which the company offered a discount on any medicine with the purchase of at least three items. The pharmaceutical company lodged a constitutional complaint with the Latvian Constitutional Court in 2020, arguing that the national provision referred to medicinal products in general and not to a specific medicinal product, whereas the EC Directive only provides for provisions on the advertising of a specific medicinal product. Due to the full harmonization of the Directive, the Member States are not permitted to lay down additional rules restricting such advertising, which is why there is an infringement of Art. 288 para. 3 TFEU.

The CJEU answered the question on the interpretation of the term "advertising of medicinal products" in Art. 86 para. 1 of Directive 2001/83/EC to the effect that the advertising of medicinal products refers to specific and unspecified medicinal products, i.e. medicinal products in general or to an entirety of unidentified medicinal products. In the absence of reference to national legal systems, the autonomous term is to be interpreted uniformly throughout EU law. The wording is to be understood in the plural and very broadly, so that an exclusion of undefined medicinal products is not recognizable. Excluding unspecified medicinal products from the scope of the provision would jeopardize the objective of ensuring the protection of public health and would render the prohibitions in Art. 88 para. 1 lit. a and para. 3 of Directive 2001/83/EC ineffective.

On the question of whether Art. 87 para. 3 and Art. 90 of Directive 2001/83/EC preclude the national provision prohibiting price-related advertising and advertising of special offers and combined sales of medicinal products together with other goods, the CJEU clarifies that it is compatible with Directive 2001/83/EC. The advertising exerts an influence on the consumer's assessment and decision regarding the quality and quantity to be purchased. The advertising elements are likely to induce the consumer to purchase medicinal products on the basis of the economic criterion of price, without the consumer carrying out an objective examination of the therapeutic properties of the medicinal product or medical need. Inappropriate and excessive use of medicinal products exists if the advertising distracts the consumer from the objective examination of the necessity of taking the product.

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