The CJEU clarifies the term ‘promotion’ of medicinal products – reason to panic?

The CJEU has handed down its judgment in the EUROAPTIEKA case. Interpretation of the judgment begs the question where to draw the line between indirect promotional activities and non-promotional information.

The Court held that (i) ‘advertising of medicinal products’ applies to both specific identifiable medicinal products and to advertising of unspecified medicinal products in general as well as a set of non-identified medicinal products and (ii) the list of banned advertising methods in the medicines directive does not preclude Member States from prohibiting material which is not included in the list to the extent that such material encourages the irrational use of medicinal products.

Background

EUROAPTIEKA is part of a group which owns a pharmacy chain and pharmaceutical retail companies in Latvia. In March 2016, EUROAPTIEKA launched an advertising campaign offering discounts on medicines when purchasing three or more medicinal products. The advertising campaign did not refer to specific medicinal products.

The national supervisory authority (Veselības inspekcijas Zāļu kontroles nodaļa) prohibited the advertising activity, citing a national Latvian provision banning advertising to the general public of a medicinal product which encourages the purchase of the medicinal product by justifying the need for purchase by the price of the medicinal product, by advertising a special discount or by stating that the medicinal product is sold together with other medicinal products (including at a reduced price) or other products.

EUROAPTIEKA brought a constitutional appeal before the Constitutional Court of Latvia (the referring court) and submitted, in particular, that the abovementioned provision applies not only to advertising relating to a specific medicinal product, but also to advertising for medicinal products in general. However, the provisions of the Directive, which the national provision implements, does not apply to any advertising relating to the pharmaceutical sector or to medicinal products in general, only to advertising relating to specific medicinal products. EUROAPTIEKA further submitted that the Directive brought about complete harmonisation in the field of advertising of medicinal products and that it therefore precludes Member States from laying down additional rules in their legislation which will restrict such advertising. By laying down the national provision, the list of advertising methods stated in Article 90 of the Directive was extended and the third paragraph of Article 288 TFEU was infringed, according to EUROAPTIEKA.

CJEU judgment

On the basis of the above, the Constitutional Court of Latvia asked, in essence, the CJEU for a preliminary ruling on whether Article 86(1) of Directive 2001/83 must be interpreted as meaning that the dissemination of information which encourages the purchase of medicinal products by justifying the need for such a purchase on the basis of the price of those medicinal products, by announcing a special sale or by indicating that those medicinal products are sold together with other medicinal products, including at a reduced price or with other products, falls within the concept of ‘advertising of medicinal products’, within the meaning of that provision, even where that information does not refer to a specific medicinal product, but to unspecified medicinal products.

By its second and third questions, which were examined together, the referring court asked whether Article 90 of the Directive precludes legislation of a Member State which extends the list of prohibited methods of advertising and imposes stricter restrictions than those expressly provided for in that provision, and further whether the legislation at issue in the main proceedings should be considered to restrict advertising of medicinal products in order to encourage the rational use of such products, within the meaning of Article 87(3) of the Directive. 

In regard to the concept of ‘advertising of medicinal products’, see Article 86(1) of the Directive, the CJEU argued, i.a., that it cannot be deduced from the wording or the context of Article 86(1) that the advertising of unspecified medicinal products does not fall within the concept of ‘advertising of medicinal products’ within the meaning of that provision.

The Court also underlined that the essential aim of safeguarding public health would be greatly compromised if Article 86(1) were to be interpreted as meaning that an activity of door-to-door information, canvassing or inducement seeking to promote the prescription, supply, sale or consumption of medicinal products without making reference to a specific medicinal product did not fall within the concept of ‘advertising of medicinal products’, within the meaning of that provision, and, therefore, avoided the prohibitions, conditions and restrictions laid down by that directive on the subject of advertising.

In conclusion, the Grand Chamber of the CJEU ruled that:

1. Article 86(1) of the Directive must be interpreted as meaning that the dissemination of information that encourages the purchase of medicinal products by justifying the need for that purchase on the basis of the price of those medicinal products, by announcing a special sale or by indicating that those medicinal products are sold together with other medicinal products, including at a reduced price or with other products, falls within the concept of ‘advertising of medicinal products’, within the meaning of that provision, even where that information does not refer to a specific medicinal product, but to unspecified medicinal products.
2. Article 87(3) and Article 90 of the Directive must be interpreted as not precluding a national provision that prohibits the inclusion – in advertising to the general public of medicinal products that are neither subject to medical prescription nor reimbursed – of information which encourages the purchase of medicinal products by justifying the need for that purchase on the basis of the price of those medicinal products, by announcing a special sale or by indicating that those medicinal products are sold together with other medicinal products, including at a reduced price or with other types of products.

Click here to read the full CJEU judgment.

Our comments

The judgment provides welcome clarification for how to interpret the concept of advertising of medicinal products and the scope of the rules at product level.

It may appear as a clear and logical conclusion made by the CJEU; nevertheless, this judgment will contribute to reducing the regulatory questions which exist in practice in the area of pharmaceutical advertising across Member States.

However, interpretation of the judgment begs the question of where to draw the line between indirect promotional activities and non-promotional information. Although the judgment concerns OTC products, some commentators suggest that this erodes the general space for disease awareness campaigns. They seem to argue that since most campaigns at least indirectly refer to underlying treatments with one or more medicinal products, such campaigns will, in the future, be considered to constitute advertising for medicinal products. In that case, the campaign must comply with applicable advertising rules. The prohibition on Rx advertising to the general public would mean the end to disease awareness campaigns involving Rx. 

We do not share that view. In our opinion, the judgment does not address any of the exclusions expressly provided for in the directive, e.g., information about health and disease (disease awareness). On the contrary, the judgment confirms that advertising involving unidentified and/or unspecific medicinal products falls within the scope of the directive and can be subject to restrictions. The judgment, however, serves as a reminder that any communication to the public or healthcare professionals that could relate to medicinal products must always be considered carefully.