It is generally known that the advertising of prescription-only medicines to the general public in Sweden is prohibited. However, one sole exception to this rule is the advertising of vaccination campaigns on human infectious diseases. This type of advertising is subject to a comprehensive regulatory framework consisting of laws and self-regulatory codes that govern how the advertising of medicines should be designed. Nevertheless, the marketing practice criteria in the national laws and regulations make no theoretically significant distinction between over-the-counter (“OTC”) medicines and vaccination campaigns and, considering the historical lack of relevant national court cases, it has not been an easy task to confidently interpret and approach these criteria in such a way that would minimise the risk of being sanctioned by the Swedish Medical Products Agency (the “MPA”) (Sw. Läkemedelsverket).

Opportunely, on 10 October 2022, the Administrative Court of Appeal in Stockholm delivered its judgment in a case concerning the advertising of shingles vaccines (hereafter referred to as the “Vaccine Case”) 1 . The judgment in the Vaccine Case facilitates the possibility of better understanding and interpreting the marketing criteria specifically in relation to the advertising of vaccines and accordingly navigating the legal restrictions on such advertising adequately.

In this article, the regulatory framework for advertising OTC medicines and vaccination campaigns is considered in light of the Vaccine Case when assessing the legal restrictions on advertising vaccination campaigns to the general public in Sweden. It can be concluded that, given the lack of additional relevant case law and the delicate and serious nature and purpose of vaccination campaigns, the rules pertaining to pharmaceutical advertising, particularly the requirements that the advertising is objective, balanced and not misleading, could potentially be interpreted and applied more strictly in relation to vaccination campaigns compared to OTC medicines. Therefore, given that the legal definition of advertising medicinal products is broad, when reviewing different options for advertising vaccines, special considerations and caution should be taken and when in doubt, the stricter option may be the more suitable way to go. 

The Regulatory Framework for Advertising Vaccines to the General Public 

At the outset, the Swedish Marketing Practices Act (2008:486) (Sw. marknadsföringslagen) sets out general rules applicable to all products and services, including medicines. Under this Act, advertising must comply with good marketing practices, and all marketing claims must be accurate and thus not misleading. This Act also regulates matters relating to, for example, comparative advertisements and special offers. Moreover, the Swedish Radio and Television Act (2010:696) (Sw. radio- och tvlagen) prohibits the advertising of prescription-only medicines, including vaccines, in broadcast television, searchable television text and pay-per-view television.

For medicinal products, the framework mainly consists of: (i) the Swedish Medicinal Products Act; (ii) the MPA’s regulations (LVFS 2009:6) on the marketing of medicinal products for human use (“LVFS 2009:6”); and (iii) The Swedish Association of the Pharmaceutical Industry’s (“LIF”) Ethical Rules for the Pharmaceutical Industry (the “LER Rules”). 

The Medicinal Products Act 

The Medicinal Products Act establishes the general requirements for the advertising of medicines. Under this Act, advertising must be in accordance with good marketing practice, be up-to-date, objective, and balanced and not be misleading. This Act explicitly prohibits the advertising of prescription-only medicines towards the general public. However, as previously mentioned, vaccination campaigns on human infectious diseases are exempt from this prohibition. Moreover, this Act prohibits the advertising of medicinal products or indications that have not been authorised for sale in Sweden and the advertising of medicinal products targeting children. These prohibitions include vaccines. 

LVFS 2009:6 

LVFS 2009:6, which implements Directive 2001/83/EC on the Community code relating to medicinal products for human use, sets out further clarifications complementing the Medicinal Products Act. Relevant to vaccination campaigns, LVFS 2009:6 requires that the advertising includes the name of the medicinal product and the generic name if the medicinal product contains only one active ingredient. Further relevant for vaccination campaigns, LVFS 2009:6 prohibits the advertising from using: (i) claims and implications that the medicine’s effect is guaranteed, is without adverse reactions or is better than, or equivalent to, another treatment or product; (ii) suggestions that a person’s well-being can be generally improved by taking the medicine; (iii) referrals to recommendations by scientists, health professionals or other people, who because of their celebrity, could increase the use of the medicinal product; (iv) suggestions that the medicinal product is equal to any foodstuffs, cosmetics or other consumer goods; (v) exaggerating, worrying or misleading claims of a cure; or (vi) exaggerating, worrying or misleading visual representations of changes in the human body caused by disease or injury. 

Regardless of the aforementioned requirement under LVFS 2009:6 that the advertising includes the name of the medicinal product and the generic name if the medicinal products contain only one active ingredient, it is not an uncommon practice that when advertising the action of getting vaccinated, many vaccine clinics and other relevant actors choose not to mention any specific vaccines, neither the brand name nor the generic name. Instead, the advertiser may promote the sole action of getting vaccinated against a specific infectious disease and then refer to visiting the vaccine clinic or the clinic’s website where more information is provided. 

The LER Rules 

The LER Rules state that the purpose of campaigns for vaccines against human infectious diseases shall be that the general public gets access to necessary information regarding protection against infectious diseases through vaccination. Therefore, the requirements for such advertising are that the medicinal product’s name, logotype or similar distinctive mark or feature, such as administration method, are not included in the information. However, although the LER Rules can be considered by Swedish courts when assessing good marketing practice, they are not legally binding and apply only to members of LIF, the Association for Generic Pharmaceuticals and Biosimilars in Sweden, the business organisation for CROs Active in Sweden (ASCRO) and the industry association for innovative smaller life-science companies (IML). Accordingly, LIF’s two regulatory bodies that supervise compliance with the LER Rules, i.e., the Information Examiner Committee (“IGN”) and the Information Practices Committee, can review matters relating to medicinal products from nonmembers. However, such non-members cannot be subject to any sanctions. 

The Vaccine Case 

In October 2021, the MPA decided to prohibit, on two counts (decision points), the vaccine clinic chain Svea Vaccin from using a certain image when advertising a vaccine against shingles. Svea Vaccin was also prohibited from using two Facebook posts implying that a person’s well-being can be generally improved by taking the vaccine. 

The image in question depicted a shirtless person with a shingles rash illustrated as a glowing crater with the caption “Shingles can break out at any time” (decision point 1). Moreover, Svea Vaccin made posts on Facebook advertising gift cards for the shingles vaccine with the captions “Give a gift for health” and “To someone whom you want to feel good” (decision point 2). The MPA stated that the posts implied that the vaccine has general health-improving effects.

The MPA’s decision was combined with a periodic penalty of SEK 250,000 per decision point. As a basis for its decision, the MPA stated that the marketing was unfair and unbalanced under the Medicinal Products Act and LVFS 2009:6.

Svea Vaccin appealed the decision to the Administrative Court in Uppsala and requested that the decision be set aside or that the periodic penalty fee be removed. Svea Vaccin’s main defence was that its advertising was objective and balanced as the consequences of shingles and the effects of the vaccine had been described adequately and factually. In relation to the MPA’s first decision point, Svea Vaccin also referred to one of IGN’s decisions where the committee in question approved the marketing of vaccines for shingles where the text “hellfire” in red was used. In the same decision, a picture of an eye with complications after shingles was also not considered unbalanced or disturbing marketing. As regards the MPA’s second decision point, Svea Vaccin argued that the captions did not suggest that the vaccine can improve one’s well-being. Svea Vaccin reasoned that the purpose of the captions was to inform about the vaccine’s preventive benefits. Moreover, Svea Vaccin argued that the periodic penalty fee was unreasonable with regard to Svea Vaccin’s financial conditions.

The MPA maintained its position in relation to the decision points and argued that Svea Vaccin’s marketing was unfair and unbalanced. In relation to the first decision point, the MPA elaborated that the image and caption gave a disturbing, exaggerated impression, and reasoned further that, although the smaller information text on the picture saying that “[s]hingles mainly manifests itself in the form of unpleasant blisters on the body. These blisters go away but can lead to chronic pain and other lasting problems.” somewhat nuanced the image, the image and the caption were still construed to promote the vaccines by instigating worry. 

Further, in relation to the second decision point, the MPA argued that the captions on the Facebook posts suggested that the vaccine can engender general well-being. The MPA elaborated that the marketing targeted the general public and that such a target group cannot be considered sufficiently knowledgeable about vaccines to understand solely through the captions “Give a gift for health” and “To someone whom you want to feel good” that the marketing refers to the vaccine’s preventive effect. The MPA concluded that such captions, considering the lack of further nuance or explanation, gave the impression that the vaccine can cause general improvements in one’s well-being. 

The Administrative Court in Uppsala found that the image and its caption did not meet the requirements for an objective and balanced presentation under the Medicinal Products Act. The court emphasised how the image was designed and that there was a lack of additional information that nuanced the image. On the subject of IGN’s decision that Svea Vaccin referred to, the court did not consider the decision and held that IGN’s decisions are not binding for the application of the law. As regards the Facebook posts that, according to the MPA, suggested that the vaccine can cause a general improvement in one’s well-being, the court found the posts to be in breach of the provisions in LVFS 2009:6. Altogether, the court found that the MPA’s decision was justified on both counts, including the periodic penalty fee. Therefore, the court dismissed the appeal.

Following the Administrative Court’s judgment, Svea Vaccin appealed to the Administrative Court of Appeal in Stockholm, which shared the Administrative Court’s reasoning and thus upheld its judgment.

Concluding remarks 

As the research, development, and importance of vaccines for human infectious diseases are becoming more prevalent in society, it can be expected that the interest in advertising vaccines will grow over time. Considering the applicable regulatory framework and the MPA’s as well as the administrative courts’ reasoning and application of the law, it is apparent that the purpose of the legal possibility to advertise vaccines is to provide the general public with correct and balanced information and thereby protect and promote public health. However, as private actors are central in developing and providing vaccines, the promotional nature of advertising vaccines to the general public cannot be ignored. Although the law in this area is very strict, there is still some room for promotional manoeuvre. The Vaccine Case, although being a lower instance decision, does bring at least some clarity and provides a couple of good pointers about how to navigate and interpret the regulatory legal framework in relation to advertising vaccines to the general public.

Dampening the visual representation parts of the advertising 

As observed in the Vaccine Case, the legal requirements that advertising is up-to-date, objective and does not include claims with exaggerating, worrying or misleading visual representations of changes in the human body caused by disease or injury are applied and interpreted strictly when assessing vaccine advertising, not least in relation to the illustrative aspects of the advertising. In the Vaccine Case, it is noticeable that the threshold for what is considered exaggerating, worrying, or misleading is low, especially if it is not nuanced and explained. Although visual representations of changes in the human body caused by disease or injury are not explicitly prohibited, with regard to the delicate and serious nature and purpose of vaccine campaigns, such visual representations should be kept at a minimum, and any dramatising effects, such as troubling and ominous captions, should be avoided. 

The importance of nuance and explanations 

In the Vaccine Case, both the MPA and the administrative court emphasised the “lack of nuance and explanations” in Svea Vaccin’s advertising that could have potentially clarified Svea Vaccin’s claims and suggestions. Against this background, a practical pointer to take from the Vaccine Case is a rule of thumb that all claims and suggestions, whether positive or negative, should always be nuanced and explained as much as reasonably possible so that the general public can effortlessly understand the advertising’s message.

Avoiding the use of OTC medicine advertising as a reference 

As mentioned above, the nature and purpose of vaccine campaigns are delicate and serious, which can affect the interpretation and application of the advertising and applicable legal framework. Considering that vaccines for human infectious diseases are the only prescription-only medicines that can be advertised to the general public, it would be misguided to compare them to OTC medicine advertising for reference, even though both are subject to the same legal framework. OTC medicine advertisements often include short and general claims about the effects of the advertised medicine and sometimes even subtly suggest, mostly through visual representations, that the advertised medicine could generally improve one’s well-being. However, when it comes to widely known OTC medicines, such as ibuprofen and antihistamines, the general public should arguably be considered sufficiently knowledgeable about such medicines to understand the message of the advertisement and not be at such an elevated risk of being misled as when it comes to vaccines. Therefore, one could argue that the threshold for what is considered to be, e.g., exaggerating, worrying, or misleading, is higher when it comes to OTC medicines. In light of the above, OTC medicine advertising should not be used as a reference when planning and assessing advertising for a vaccine. Instead, a stricter standard should be applied, and special considerations and caution should be taken.