MEDICINAL PRODUCTS FOR HUMAN USE. THE COURT OF JUSTICE OF THE EU RULES ON THE ADVERTISING BY PRICE OF MEDICINAL PRODUCTS NOT SUBJECT TO MEDICAL PRESCRIPTION AND NOT REIMBURSED

On 22 December 2022, the Court of Justice of the European Union held its judgement in Case C‑530/20, SIA «EUROAPTIEKA», on the interpretation of Article 86(1), Article 87(3) and Article 90 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^[1]. The request has been made in proceedings brought by ‘EUROAPTIEKA’ SIA (“EUROAPTIEKA”), a company established in Latvia which is part of a group which owns a network of pharmacies and companies distributing medicinal products for retail, concerning the legality of a national provision prohibiting certain forms of advertising of medicinal products.

In March 2016, EUROAPTIEKA announced a promotion on its website and in its monthly magazine, offering a 15% reduction on the purchase price of any medicinal product where at least three products were purchased. On the basis of the Ministru kabineta noteikumi Nr. 378 ‘Zāļu reklamēšanas kārtība un kārtība, kādā zāļu ražotājs ir tiesīgs nodot ārstiem bezmaksas zāļu paraugus (Decree No 378 of the Council of Ministers on the detailed rules for the advertising of medicinal products and detailed rules pursuant to which a medicinal product manufacturer may give free samples of medicinal products to medical practitioners)^[2], however, the Veselības inspekcijas Zāļu kontroles nodaļa (Medicinal Product Control Section of the Health Inspectorate) banned EUROAPTIEKA from the dissemination of advertising relating to that promotion. The latter, therefore, brought an appeal before the Latvijas Republikas Satversmes tiesa(Constitutional Court of Latvia; the “referring court”) which, in light of the need to interpret the relevant European legislation, decided to stay the proceedings and to refer to the Court of Justice three questions for a preliminary ruling.

By its first question, the referring court asked whether Article 86(1)^[3] 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.

The Court preliminarily reminded that European law provisions must be interpreted taking into consideration not only their wording, but also the context in which they occur as well as the objectives pursued by the rules of which they are part^[4]. In this regard, advertising of medicinal products is liable to harm public health^[5], one of the objectives pursued by Directive 2001/83, in light of the serious consequences for health which may arise from improper use or overconsumption of medicinal products available only on prescription^[6], as well as the risks which may also arise from excessive or ill-considered use of medicinal products not subject to such prescription^[7]. Medicinal products, indeed, stand out from other goods because of their therapeutic effects^[8], which imply that, if consumed unnecessarily or incorrectly, they may cause serious harm to health without the patient being in a position to realise that when they are administered^[9].

The essential aim of safeguarding public health, therefore, would be greatly compromised if Article 86(1) of Directive 2001/83 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, as such, avoided the prohibitions, conditions and restrictions laid down by that directive on the subject of advertising. To the extent that advertising for non-specified medicinal products, such as that of an entire class of medicinal products intended to treat the same pathology, may relate equally to medicinal products subject to medical prescription and to those the cost of which may be reimbursed, indeed, to exclude such an advertising from the scope of the provisions of Directive 2001/83 on the subject of advertising would result in the prohibitions laid down in Article 88(1)(a) and Article 88(3)^[10] of that directive being deprived of their effectiveness to a large extent, by allowing any advertising that does not refer to a specific medicinal product within that class to escape those prohibitions.

In the specific case, the activities to which Decree No 378 applies do not relate merely to dissemination to the public solely of information about medicinal products, such as the objective information as to their price, but are activities which encourage the purchase of medicinal products by justifying it on the basis of the price, by announcing a special sale, or by offering a sale that is bundled together with the sale of other medicinal products, as the case may be at a reduced price, or with the sale of other products sold by the pharmacy concerned. Such activities, therefore, appear to have a promotional purpose and, consequently, fall within the concept of “advertising of medicinal products” according to Article 86(1) of Directive 2001/83.

By the second and third questions, instead, the referring court asked, on the one hand, whether Article 87(3)^[11] and Article 90^[12] of Directive 2001/83 must be interpreted as precluding a national provision that imposes restrictions not provided for in that Article 90, by prohibiting the inclusion, in advertising to the public of medicinal products, 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 offering a sale of those medicinal products bundled together with other medicinal products, including at a reduced price, or with other products and, on the other hand, whether such a national provision may be regarded as promoting the rational use of medicinal products, within the meaning of Article 87(3) of that directive.

The Court preliminarily reminded that since Directive 2001/83 brought about complete harmonisation in the field of advertising of medicinal products, where the option of laying down different rules is not given to Member States expressly, the only conditions they need to abide by are those laid down by that directive^[13]. As regards the relationship between the requirement that advertising promotes the rational use of medicinal products and the restrictions referred to in Article 90 of Directive 2001/83 in the form of a list of banned advertising methods, the fact that the directive does not contain any specific rules concerning certain advertising material does not preclude that, with the aim of preventing any excessive and ill-considered advertising of medicinal products which could affect public health, Member States may prohibit that material to the extent that it encourages the irrational use of medicinal products^[14]. It is for Member States, therefore, to prohibit the inclusion of material other than that referred to in Article 90 of Directive 2001/83 in advertising to the general public of medicinal products that are neither subject to medical prescription nor reimbursed, where that material is of such a nature as to encourage the irrational use of those medicinal products.

As regards medicinal products which are neither subject to medical prescription nor reimbursed, it is frequently the case that the end consumer himself or herself evaluates, without the assistance of a doctor, the usefulness or need to purchase them. Since that consumer does not necessarily have the specific and objective knowledge enabling him or her to evaluate their therapeutic value, advertising may exercise a particularly strong influence on the evaluation and choice about the quality as well as the amount of the medicinal product to purchase. In that context, advertising methods such as those referred to in Decree No 378 are of such a nature as to encourage consumers to purchase medicinal products which are neither subject to medical prescription nor reimbursed according to an economic criterion connected with the price of those medicinal products, thereby being likely to lead them to purchase and consume those medicinal products, without an objective evaluation based on the therapeutic properties of those products and on specific medical needs.

An irrational and excessive use of medicinal products may also arise as a result of advertising material that, like Decree No 378’s one, by referring to promotional offers or bundled sales of medicinal products and other products treats the first ones in the same way as other consumer goods, which are in general the subject of discounts and price reductions where a certain level of expenditure is exceeded. Prohibitions such as Decree No 378’s ones do not cover the dissemination of merely informative statements, which lack any promotional intent, about those medicinal products, but rather the dissemination of content that seeks to encourage the purchase of those medicinal products, whether by reference to their price, to a special sale or a sale bundled with other medicinal products, including at a reduced price, or with the sale of other products. Despite the effective protection of health and life of humans demands that medicinal products be sold at reasonable prices and that, therefore, price competition could be capable of benefiting the patient^[15], therefore, Decree No 378 merely prohibits advertising of promotional offers or bundled sales and advertising on the basis of price, without prejudice to the possibility, recognised under Latvian law for undertakings that trade in medicinal products, to grant discounts and price reductions when selling medicinal products and other health products.

In light of the above, the Court therefore established 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”.

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