29.05.2025

Some particularities of pharmaceutical advertising

Advertising for medicinal products is defined by Law No 95/2006 as any form of information through direct contact, as well as any form of promotion intended to stimulate the prescription, distribution, sale or consumption of medicinal products. Depending on the addressee, the advertising of medicinal products is either addressed to the general public or to persons qualified to prescribe or distribute medicinal products.

In addition to these classical meanings of the term 'advertising', the law also includes other activities in the same category, such as, among others, visits by medical representatives or the provision of samples. Sponsorship activities (which in turn constitute a form of advertising) must be declared and the information declared becomes public and must be published on the website of the Romanian National Agency for Medicines and Medical Devices ("ANMDMR"), of the entities granting the payments, sponsorships or other benefits, as well as of their beneficiaries.

The law bans advertising to the general public for prescription-only medicines. A notable exception are vaccination campaigns, approved by the Ministry of Health. In other words, only over-the-counter (OTC) medicines can be advertised to the general public. Even in the case of these medicines, the law imposes an additional condition that the medicine must be intended to be used without the intervention of a doctor, and that pharmacists' advice is sufficient if necessary.

There is a prior control of advertising materials intended for the general public, as they are subject to prior approval by the ANMDMR.

However, the situation of pharmacies and the publicitythey advertise their activities is a special case. In other words, the question arises as to whether these actions fall within the concept of 'advertising for medicinal products' or whether, on the contrary, they are merely intended to influence the choice of pharmacy from which a customer buys a prescription medicine.

Thus, the meaning of the expression "advertising of medicinal products" has in the past been the subject of several judgments of the Court of Justice of the European Union ("CJEU/Court"), whereby the Court has consistently favoured the broadest possible definition, taking into account the public health implications of communications relating to health advertising in general and to medicinal products in particular. The Court has also emphasised the importance of assessing actual intention - whether or not it is designed to encourage the prescription, sale or use of medicines.

In a recent judgement in Case C-517/23, the CJEU has analysed five advertising campaigns carried out by a pharmacy chain. Three of the campaigns involved offering customers either a cash reward per prescription or an immediate price reduction for prescription-only medicines. The CJEU reasoned that these campaigns only sought to influence the choice of pharmacy and did not promote the prescription or consumption of medicines. Therefore, the Court categorised these campaigns as advertising which does not seek to influence the customer's choice of a particular medicine, but the downstream choice of the pharmacy from which the customer buys that medicine. The Court held that when the patient receives a prescription, the only choice left for him to make as regards the prescription medicine is the choice of the pharmacy from which he will purchase that medicine. As such, since prescribing decisions are the sole prerogative of doctors, these campaigns were not considered "advertising of medicines".

The other two campaigns offered customers vouchers for over-the-counter medicines or non-medical products, such as health and care products, in exchange for a prescription. For example, a consumer could choose between purchasing over-the-counter medicines and purchasing other consumer products such as health and care products. Such advertising equates non-prescription medicines with other consumer products offered by a pharmacy. However, such assimilation may lead to irrational and excessive use of non-prescription medicinal products, since it disguises the very special character of medicinal products, the therapeutic effects of which distinguish them substantially from other goods. That assimilation diverts the consumer from an objective assessment of the need to use those medicinal products. The CJEU considered that these campaigns encouraged the purchase of non-prescription medicines because consumers, attracted by the economic advantage, could use the vouchers to obtain non-prescription medicines at a reduced price. Therefore, the Court held that these campaigns do indeed fall within the definition of 'advertising of medicinal products'.

Thus, the Court has reiterated that 'advertising of medicinal products' can cover both communication about specific medicinal products and communication about non-specified medicinal products. However, the purpose of the communication is essential to determine whether it qualifies as advertising for medicinal products. If a communication is intended to influence consumer purchasing behaviour, it will qualify as advertising. In contrast, an advertising campaign which merely seeks to influence the choice of pharmacy does not fall within the definition of "advertising of medicinal products".

In Case C-530/20, the Court was confronted with the announcement by a pharmacy chain of a promotional campaign on its website and in its monthly printed catalogue, offering a discount of 15% off the purchase price of any medicine for the purchase of at least three products. Again, there was no explicit naming of any medicine in the promotion.

The Court held that the dissemination of information which encourages the purchase of medicinal products by justifying the need to purchase them by their price, by announcing a special sale or by indicating that they are sold together with other medicinal products, including at a reduced price, or together with other products, falls within the concept of 'advertising of medicinal products', even where that information does not relate to a specific medicinal product. The Court held that the activities at issue in the case did not concern the mere dissemination to the public of purely informative indications concerning medicinal products, such as objective information on their price, but were those which encourage the purchase of medicinal products by justifying the need for such purchase by price, by announcing a special sale or by referring to a sale combined with that of other medicinal products, possibly at a reduced price, or with that of other products sold by the pharmacy in question. The measure at issue would thus infringe the rule that the advertising of a medicinal product must encourage the rational use of the medicinal product. Such irrational and excessive use of medicinal products may result from advertising relating to promotional offers or combined sales of medicinal products and other products, assimilating medicinal products to other consumer products, which are generally subject to rebates and price reductions linked to exceeding a certain level of expenditure.

The advertising of medicinal products has been and is a subject that is constantly evolving in the light of European regulations, and new channels of advertising make the legal nuances increasingly complex. One of the well-established distinctions is between the advertising of medicinal products to the general public and the provision of general, non-product specific information about medicines and treatments. This distinction allows for institutional or awareness-raising publicity campaigns on various conditions. Such campaigns often encourage patients to seek medical diagnosis or treatment in general rather than specific treatments.

However, pharmaceutical companies should bear in mind that a non-specific and general message about medicines is not a guarantee that they are outside the scope of the rules on medicines advertising. Regulators have often ruled against some forms of indirect drug advertising, where although the name of a particular drug was not mentioned, an underlying intention to promote the unnamed drug could be inferred.

From current CJEU case law, however, a number of criteria can be deduced which should be used in the case of unspecified messages to determine whether they constitute a form of advertising for medicinal products: (i) whether the context and underlying intention were promotional; and (ii) whether the communication was likely to encourage irresponsible or excessive use of medicinal products. If the answer is in the affirmative, such communications are likely to be considered as advertising even if a particular product is not being promoted.

Certainly, there will continue to be practical challenges when it comes to making a delineation between indirect advertising of medicines and non-promotional information activities.

An article signed by Mihai Stănescu, Managing Associate - mstanescu@stoica-asociatii.ro -  STOICA & ASSOCIAȚII