Legal and scientific deficiencies of drug advertisements on German television

Poor compliance with the legally mandatory information in the package insert and advertising clip

There are ten mandatory disclosures for the package insert. The analysis showed that only four of these ten mandatory details were provided in full in each of the package inserts examined (Table 1). These included the name of the active ingredients, the dosage, the preparation form, and the directions for take and use. The information of the pharmaceutical company (one exception) and the indication (four exceptions) were almost complete. In contrast, there were large gaps in the information on the manufacturer, the effect, the adverse effects, and the interactions. It is noticeable that the latter is primarily information that could pose major risks to consumers if missing. The statement in some package inserts that no interactions were known should also be viewed critically, as this did not mean that these had been investigated.

Six mandatory disclosures for the advertising clips were examined as part of the study (Table 2). The information also includes a reference if a medicine is subject to prescription. However, prescription-only medicines may only be advertised to doctors, dentists, veterinarians, pharmacists, and persons who are authorized to trade in these medicines (HWG, §4). This therefore excludes advertising to the general public on television and also explains that there were no prescription-only medicines among the medicines examined. Consequently, this information was omitted from the advertising clips and the ban was complied with. Of the remaining five mandatory statements analyzed, only one, namely, the name of the drug, was fulfilled in every advertising clip. With regard to the pharmaceutical company, the indication, the active ingredients, and the adverse effects, most of the information was missing, incomplete, or too specific.

Keuper and Seifert (2023) investigated compliance with the legal requirements for pharmaceutical advertising in the German magazine Apotheken Umschau. Advertisements for 123 preparations were analyzed. The results of this study are comparable to the results for television advertising (Table 4) with regard to the mandatory information that applies to both print and television advertising. The mandatory information is also not fully complied with. Only the name of the medicinal product was stated in every advertisement in both Apotheken Umschau and television advertising. The indication is almost completely stated in the Apotheken Umschau. The pharmaceutical company and the composition were stated more frequently than on television, although adverse effects were only mentioned in one case in the Apotheken Umschau.

Table 4 Direct comparison between compliance with the mandatory information in the advertising clips (AC) and in the Apotheken Umschau (AU) (according to Keuper and Seifert, 2023). In red, cases with missing mandatory information. In yellow, cases with unclear information. In green, mandatory information included in every advertising

Two other studies also came to similar conclusions when examining compliance with the HWG. Kuschel and Seifert (2024) examined drug advertising in the Deutsche Apotheker Zeitung (German Pharmacy Journal), an independent journal addressed primarily to pharmacists. A total of 167 advertisements for non-prescription medicines were analyzed. Similarly, there were major information gaps, such as a lack of references to adverse effects. The study by Barlage and Seifert (2024), which was focused on compliance with legal requirements in the product catalogs of two different online pharmacies, showed the analogous results. In conclusion, the inadequate compliance with the law is not only a problem in television advertising, but in print advertising for the general public, advertising in specialist circles, and online pharmacies as well.

In view of the fact that all of the drugs examined are not prescription-only and therefore can be used without any control by a doctor, it is particularly clear from the predominant lack of information on interactions and instructions for taking and use that patient education and objective information is not the focus of drug advertising. This is also emphasized by the fact that the font size of the information displayed is often minimized to the point of illegibility or information such as the form of the preparation is neither mentioned nor displayed, but can at best be read from the packaging shown. Although every drug is accompanied by a package insert as a legally required information carrier, which is intended to serve as a generally understandable summary of the most important information for the consumer (Blasius 2014), a study by Bruchmann and Nägelein (2018) showed that the package insert is rarely consulted in reality. The study was conducted by Promio.net on behalf of Nebenwirkungen.de and investigated whether and how Germans deal with package inserts and the adverse effects of medicines. A total of 1535 men and women aged between 25 and 60 took part in the study across Germany. The study showed that only a quarter of respondents always read the package insert for prescribed medicines, and only one in five for over-the-counter medicines. Almost one in ten stated that they never read the package insert for over-the-counter medicines. The categories “adverse effects,” “dosage,” “instructions for use,” and “indications” were mentioned most frequently when the study participants were asked what they would read in the package insert for prescription medicines. Nevertheless, around half of all respondents stated that they did not feel sufficiently informed about adverse effects. The study suggested that many patients felt that the instructions for use were too long and too complicated. This becomes a cause for concern when the adverse effects of non-prescription drugs are underestimated.

The lack of external information is becoming a problem, especially in light of the fact that more and more Germans are purchasing their medication from online pharmacies. According to a study conducted by the market research institute Appinio in November 2020 (Appinio 2020), in which a total of 1000 people from Germany aged between 16 and 65 were surveyed, 69% of respondents stated that they at least occasionally order over-the-counter medicines online. Twenty-nine percent of respondents even use online pharmacies for over-the-counter medicines more frequently than local pharmacies, and 7% stated that they would only use online pharmacies. According to the study, 17% of online pharmacy users did so for the first time during the coronavirus pandemic, primarily among 18- to 34-year-olds. The main advantages of online pharmacies are their convenience but also the fact that the product range can be viewed very easily and prices can be compared. The disadvantages, on the other hand, are the lack of advice and external control over whether customers are aware of adverse effects and interactions.

A 2014 report by the Regensburger Verbund für Werbeforschung (Regensburg Association for Advertising Research) (Mitteilungen des Regensburger Verbunds für Werbeforschung 2014), based on empirical studies on the advertising of prescription drugs, described how advertising can lead to increased health worries among potential consumers and ultimately to an increase in the unnecessary use of medication. In addition to the direct functions of informing and motivating, advertising also fulfills the function of socialization. For example, the use of certain products should be made “socially acceptable” and implemented as normal behavior. In this way, a lack of information about the adverse effects of medication also harbors the risk of trivialization. Without information, advertising also encourages self-treatment through the listing of symptoms and the presentation of the drug as a solution to these complaints in the course of self-diagnosis. This involves the risks of overmedication and overdosing. Furthermore, adverse effects and interactions can easily be underestimated by people without the appropriate specialist knowledge. One of the package inserts examined included the information that the medication should only be used under medical supervision. In view of the fact that the drugs analyzed are only over-the-counter medicines, it would certainly make sense for the consumer to receive this information prior to purchase, whether from a pharmacist or a warning displayed in the advertising clip. It can be concluded that only a small proportion of the mandatory information in the advertising clips examined is complied with and that the information in the accompanying package inserts is also incomplete in some cases, which poses a risk to the consumer in several respects.

Structural design of the advertising clips

The examination of the structural composition of the advertising clips made clear that the frame story plays a dominant role in pharmaceutical advertising (Fig. 7). The frame story has no pharmacological-medical added value in terms of information, so the relations between this content and the overall length of the advertising clips were analyzed. Not every advertising clip contained an explicit frame story, but there were also many advertising clips in which the frame story took more than half or even three-quarters of the advertising time (Fig. 8). It is noticeable, however, that both the shorter and the longer advertising clips tend to have less frame story. The largest proportion of frame story is found in the commercials with a medium duration.

Against the background of the average duration of an advertising clip of 17 s, the average duration of the frame story of 6 s seems quite long. If the advertising clips without a frame story are excluded from the analysis, the average duration of the frame story increases to 8 s, which corresponds to almost 50% of the advertising time. This result reinforces the assumption that the function of advertising as a source of information tends to be neglected. This can also be seen in the analysis of the explanation of the effect in the advertising clips (Figs. 5 and 6). The average duration of the explanation of the effect is only 1.2 s. The analysis of the quality of the existing explanation of the effect also makes clear that the focus is not on informing viewers and potential consumers, even though this is not a mandatory requirement for the advertising clips but only for the package inserts. Where an explanation was included, in most cases, only the impact target was mentioned, but no further reference was made to the operating principle (Figure S20). Of 52 advertising clips, the effect of the advertised medication was only explained in detail and comprehensibly in five cases. Of these, only one advertising clip stood out both in terms of its auditory explanation of the effect and its visual presentation.

In an issue of Media Perspektiven (4/2004), the ARD Research Service presented a number of studies on the subject of advertising design and its effect on radio and TV commercials. In one of these studies, which dealt with attention-grabbing design elements in TV commercials, Doormann (2003) summarizes that an advertising clip must contain three different factors to generate attention. These included activation, involvement, and likeability. Viewers need to be psychologically activated (for example, through intense auditory and visual stimuli or emotional stimuli that act as “eye-catchers”) and involved internally so that the advertising clip is ultimately viewed with favor. A comprehensible plot, suspense, aesthetics, emotionality, and entertainment value are important for this. Another empirical study (Trommsdorff and Becker 2003) examined the significance of creativity for the effectiveness of advertising clips. The more creativity criteria (for example, originality, clarity, and inventiveness) were fulfilled in the advertising clip, the higher its effectiveness, particularly with regard to achieving psychological goals (for example, product awareness, product image, and awareness).

The results of these two studies therefore underline the importance of the dominance of the frame story in the structure of the advertising clips. Furthermore, it is clear that various design elements are used to make advertising appear authentic and enable personal identification (Fig. 9). This was evident, for example, in the frequency of personal experiences (Figure S21) shared by the protagonists of the advertising clips. This design element was used in more than a quarter of all advertising clips. In addition, a quarter of all commercials also included a personal recommendation from satisfied users or emphasized the market leadership of the drug in German pharmacies (Figure S22).

Fig. 9figure 9

Composition of the individual segments at a glance

It also became apparent that drug advertising is designed with a focus on appealing to the viewer. The frame story, product presentation, and promise of effectiveness stand in the foreground; the function of informing and educating is rather neglected. This also becomes clear once again in Table 5. The most important key features with regard to pharmacological content are summarized here. There may also be a correlation with the average age of viewers. A study published by the Statista Research Department (2011) showed that the average age of viewers on ZDF and ARD was 60 in 2011. By contrast, the average age of the private television channels surveyed in 2011 was between 35 and 51. A study conducted by AGF Videoforschung in collaboration with GfK showed that the average age in 2022 was already 64 for ARD and 65 for ZDF (Mantel 2022). The average age of viewers of private television channels has also risen to 44 to 54 years, but there is still a clear age difference between private and public television channels. The selection of medicines advertised, which mainly refer to pain, gastrointestinal complaints, and sleep problems and therefore primarily correspond to the health restrictions of the older generation, also speaks for the interpretation of drug advertising for an older audience.

Table 5 Overview of the key features of the advertising clipsLimitations of the study

The analysis was limited to 52 current advertising clips, and we could not go back to history since previous clips were not accessible to us. A high-quality version of advertising clips on YouTube was not available for all items analyzed. It could not be guaranteed that the broadcast version on television and the version analyzed were identical. Due to the use of Austrian and Swiss advertising clips and correspondingly different legal requirements, the mandatory warning in Germany “In case of risks and adverse effects, read the package insert and ask your doctor or pharmacist.” could not be included in the analysis. In individual cases, there were incorrect information in the package insert or discrepancies between the package insert and the advertising clip. When asked, not all pharmaceutical companies or manufacturers responded, meaning that these discrepancies could not be corrected for the analysis. However, as the analysis performed here only examined whether a statement was made and not which one, this has no effect on the results. The package inserts used as the basis for the analysis were found online. In some cases, no online versions were available but were sent by the pharmaceutical company or manufacturer on request. For those package inserts that were available online, it was not possible to check whether they were the most up-to-date version. Some of the rating scales developed in this study are not completely objective but have a subjective character.

Lastly, the authors have a medical and pharmacological background and no formal legal education but did their best to assign the advertisement content to proper legal categories. An argument for the validity of this paper comes from the fact that so far five independent primary investigators (and accordingly, first authors; including this study) analyzed various aspects of drug advertisements and came to similar conclusions (Keuper and Seifert 2023; Leemhuis and Seifert 2024; Barlage and Seifert 2024; Kuschel and Seifert 2024).

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