The CJEU rules on the legality of a national law prohibiting medicinal product advertising to the general public that uses price to induce consumers to purchase

Background

EUROAPTIEKA, a group that owns a network of pharmacies and distribution companies engaged in retail sales of medicines, brought a case before the Latvian Constitutional Court against a national rule under which the public health inspectorate banned an advertising initiative addressing the public and offering a 15% discount on the price of any medicine when purchasing at least three products. The company complained that in prohibiting such initiatives, even if they related to medicinal products in general and not to a specific medicinal product, the Latvian law was contrary to Directive 2001/83, which prevents Member States from introducing rules limiting medicinal product advertising targeting unspecified products.

The Latvian Constitutional Court decided to suspend national proceedings and refer the matter to the CJEU.

Definition of medicinal product advertising and advertising of indeterminate products

First, the constitutional court asked whether medicinal product advertising as defined in the directive includes promotional information that does not concern a specific medicine but indeterminate products, which would lead to application of the relevant rules.

Specifically, Article 86(1) of the Medicinal Products Directive defines advertising as “any act of information, canvassing, or inducement intended to promote the prescription, supply, sale, or consumption of medicinal products” (a definition slavishly reproduced in Italy by Legislative Decree 219/2006).

The CJEU noted in this regard that (i) the definition as worded does not in any way appear to limit its scope to the advertising of clearly identified medicinal products and (ii) the principle of the protection of public health, including with reference to risks that may arise from excessive consumption of even medicinal products not subject to medical prescription that are not reimbursable (Recital 45 of the Directive), would be stymied if the restrictions provided by the directive on advertising did not apply to the promotion of unspecified medicinal products. Thus, the distinction for the purposes of classifying information on medicinal products as advertising under the meaning of Directive 2001/83 lies not in the reference to a specific medicinal product, but in the characteristics and purpose of the message.

Therefore, the court held that the initiative undertaken by the Latvian company clearly is of a promotional nature.

Legality of a Member State introducing prohibited advertising forms/modalities beyond those provided in Directive 2001/83

Second, the CJEU asked (i) whether the national legislation may extend the list of prohibited forms of advertising by imposing restrictions different from and in addition to those set forth in Article 90 of Directive 2001/83 and (ii) whether the additional prohibition set forth in the Latvian legislation is in line with the principles protected by the directive and is therefore aimed at promoting the rational use of medicinal products under the meaning of Article 87(3) of Directive 2001/83.

The CJEU noted that, generally speaking, Directive 2001/83 fully harmonized the field of medicinal product advertising. As a result, Member States may introduce different rules only if the directive itself expressly grants them that power.

With specific reference to the restrictions set forth in Article 90 of the directive on prohibited advertising content, the introduction—via a national rule—of a prohibition in addition to those listed therein does not constitute a different rule and does not contravene the process of harmonization if the national rule prohibits conduct that, by encouraging the irrational use of medicinal products, is in direct conflict with another provision of the directive, namely Article 87(3).

Member States not only may prohibit advertising of medicinal products but must do so if the advertising promotes their irrational use, regardless of whether the elements of the message are directly covered by Article 90 on prohibited advertising content.

Ultimately, the court held that the prohibition in the Latvian legislation on advertising that promotes the purchase of medicinal products by means of their price, by announcing a special sale, or by indicating that medicinal products be sold together with other products, medicinal or otherwise, including at a discount (prohibitions not specifically provided in Article 90 of the directive), fulfills the objective of promoting the rational use of medicinal products and must therefore be regarded as lawful under the meaning of Directive 2001/83/EC.

In support of that decision, the court pointed out that (i) consumers often make their own judgements as to whether to purchase non-prescription and non-reimbursable medicinal products in the absence of specific knowledge as to the therapeutic value of the products, so advertising can greatly influence that choice; (ii) using price for commercial leverage may induce consumers to purchase and consume medicinal products for reasons unrelated to the therapeutic properties of the products and actual medical needs; (iii) advertising that misleads the consumer this way may encourage irrational consumption of medicinal products and therefore prohibitions such as those set forth by the Latvian rule in question meet the essential objective of ensuring protection of public health.

Text of the court’s decision

Based on the above grounds, the CJEU ruled that:

– Article 86(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EU of the European Parliament and of the Council of 31 March 2004, 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.

– Article 87(3) and Article 90 of Directive 2001/83, as amended by Directive 2004/27, 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.