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Mandatory Information in the Advertising of Medicinal Products

In addition to the prohibition of advertising gifts according to Section 7 of the Law on Advertising in the Health Care System (HWG) (see the blog post of August 3, 2021), the catalogue of mandatory information according to Section 4 HWG, among others, must also be observed in the advertising of medicinal products.

In addition to the information listed in Section 4 (1) HWG, such as the name or company and registered office of the pharmaceutical entrepreneur, the name of the medicinal product, its composition, as well as the indication, contraindications and side effects, the generally known additional text: “For risks and side effects, read the package leaflet and ask your doctor and pharmacist” (according to Section 4 (3) HWG) is also obligatory when advertising outside specialist circles, i.e. to consumers, with a few exceptions (so-called minimum information core).

In order to ensure that the above information is also seen by the consumer, it is the legislator’s intention that it must be “clearly distinct, delimited and clearly legible” in contrast to the other advertising statements (cf. Section 4 (3) sentence 1 et seq. and Section 4 (4) HWG).

However, when deciding on the specific design of an advertisement (on the internet or in print form), the question sometimes arises as to how these requirements should be implemented in detail, which is usually not easy to answer. Therefore, corresponding advertisements frequently find access to assessment by a competent court following an objection from a competitor or consumer association.

For example, last year, the Higher Regional Court of Cologne stated with regard to the placement of the necessary mandatory information that an overall view was required in the case of a double page spread for a pharmacy-only medicinal productInthis context, it is decisive whether the consumer perceives the two pages as a single advertisement or as two separate advertisements. In the specific case, the Higher Regional Court confirmed the Regional Court’s assessment, according to which there was no homogenous advertising on the double page spread due to the graphic design, and thereby dismissed the appeal directed against this decision (judgment of 26 June 2020, file ref. 6 U 17/20; previous instance: judgment of 7 January 2020, file ref. 81 U 90/19). However, under certain circumstances, corresponding assessments with regard to a print media advertisement may differ from an assessment of an internet advertisement.

For example, the Federal Supreme Court (BGH) ruled for a keyword-type advertisement on the internet that it is sufficient if the mandatory particulars are not directly accessible in an advertisement on an internet page, but rather via a clearly recognisable link, if they areeasily readable there without any further intermediate steps (judgement of 6 June 2013, file ref. I ZT 2/12). In another decision, the Cologne Higher Regional Court stated that it is not sufficient if, in the context of extensive advertising on the internet forseveral medicinal products, the mandatory information is only provided after the imprint, the terms of use and the data protection statement at the end of the page, so that the user first has to scroll through to this point (judgment of 13 March 2020, file ref. 6 U 201/19). However, the answer to the fundamental question of whether the relevant mandatory information for several medicinal products may be combined was left open.

The cited examples of case law clearly show that a schematic approach is also prohibited with regard to the assessment of the admissibility of advertisements for medicinal products under the HWG. Instead, an examination of the individual case is required, taking into account the case law of the competent higher courts.

Our blog contributions shall provide an overview with regard to legal topics, legislation and case law and are supposed to provide some general information rather than constituting any specific advice. Please do not hesitate to contact Maiwald and in particular the authors of the particular contributions if have any questions on the addressed topics or on other legal issues.

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Dr. Christian Meyer



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