HASHTAG HEALTH: HOW INFLUENCERS SHARING MEDICAL INFORMATION ARE REGULATED IN THE EUROPEAN UNION

I INTRODUCTION

Ozempic is a drug which helps people with type 2 diabetes manage their blood glucose levels and prevent dangerous complications of the condition. However, people with diabetes are struggling to access Ozempic after TikTok influencers shared their weight loss stories using the drug, despite experts warning against taking the drug for weight loss reasons.1 It is widely acknowledged that influencers can cause harm to the mental health of social media users, however influencers can also have a significant impact on health more broadly when they promote products and practices which they have little understanding of. This essay will examine how the publication of health-related information by influencers on social media is regulated in the European Union (EU) and whether the existing regulatory framework adequately protects against harmful content. First, it will outline the breadth of existing research on the topic in a brief literature review. Then, it will summarise the risks and benefits of allowing influencers to post health related information. Finally, it will describe and assess the role of EU legislation in regulating medical content posted by influencers.

II LITERATURE REVIEW

While there is no legislation focusing on influencer marketing at the EU level, there is a growing body of academic research on the role of more general EU instruments in the regulation of influencers. Such instruments include the Unfair Commercial Practices Directive (UCPD), the Consumer Rights Directive, and the Digital Services Act. Academics have explored how EU Directives providing consumer protection can be applied to influencers who are active as advertisers. 2 In analysing these legal instruments, limitations in their application have been identified. For example, the UCPD only applies to business-to-consumer practices,and the identification of an influencer as a trader is not clear in all cases.3 Research has also been devoted to developing a general definition of an influencer which would encompass key characteristics relevant to the consumer protection context. In a study commissioned by the European Parliament, the following definition was proposed; “a content creator with a commercial intent, who builds trust and authenticity-based relationships with their audience (mainly on social media platforms) and engages online with commercial actors through different business models for monetisation purposes”.4 Research has also been carried out on the operation of EU legislation which specifically regulates the advertising of medical products and the general publication of health claims.5 This legislation includes the Nutrition and Health Claims Regulation (NHCR) and the Directive on the Community Code relating to Medicinal Products for Human Use (Medicinal Products Directive). However, existing analysis is largely focused on more traditional forms of advertising as these legislative instruments were not drafted with influencer marketing in mind. As a result, issues remain as to the how these health specific legislative instruments should be applied in combination with consumer protection legislation to regulate influencers.

III THE IMPACT OF INFLUENCERS IN THE HEALTH CONTEXT

The practice of medicine has undergone radical changes in the past 50 years. During this period, there has been a transition from a paternalistic model in which the patient was a mere object of the application of medical science, to a model of informed consent where the patient makes the final decision on their treatment based on provided medical information.6 Traditionally, this information was obtained from the doctor, however the advent of the internet has provided a vast alternative source of information. This has created new types of mistrust in doctor-patient relationships and prompted anxieties in patients who often resort to demanding treatments which have no scientific validity. Agreeing to provide such treatments not only causes unnecessary risks to the patient but can also create medicine shortages as evidenced by the Ozempic example. Refusing to provide such treatments is similarly problematic as patients sometimes choose to end their relationship with their doctor, and instead rely solely on the internet for medical advice. Many influencers enthusiastically promote alternative medicines such as naturopathy and homeopathy, which can discourage their followers from seeking medical care for serious health problems. Inaccurate information about vaccines has also resulted in the re-emergence of preventable diseases and undermined global efforts to curb the COVID-19 pandemic. However, it should also be noted that influencers can play a crucial role in raising awareness about medical conditions and health issues.7 By posting trustworthy medical content, they can fight complacency and increase trust in immunisation.8 In Portugal, the Directorate-General of Health recruited and trained 5000 micro-influencers to provide trustworthy sources of information to communities during the pandemic. This approach helped the country achieve some of the highest vaccination rates in the world.9

IV THE REGULATORY FRAMEWORK IN THE EU

A. Nutrition and Health Claims Regulation (NHCR)

The NHCR aims to protect consumers against false nutrition and health claims by requesting scientific substantiation.10 Article 12(c) of the NHCR prohibits health claims that make reference to the recommendations of individual doctors or health professionals. This prohibition was implemented due to concerns that the added weight of perceived professional expertise might unduly influence consumers.11 However, non-professionals such as influencers do not fall within the scope of this prohibition, despite the substantial influence of such individuals. The increasing use of influencers for the promotion of health products and dietary supplements undermines the main principle of the NHCR, which is to protect consumers by distinguishing evidenced-based claims from those with no scientific validity. While claims made by influencers must still comply with the other provisions of the NHCR, the exclusion of influencers from the scope of Article 12(c) creates a non-level playing field where qualified professionals are not permitted to communicate authorised health claims to consumers in commercial communications, while unqualified influencers can.12

B. Directive on the Community Code relating to Medicinal Products for Human Use

The Medicinal Products Directive (Directive 2001/83/EC) regulates the advertising of medicinal products.13 The definition of medicinal products is broad, encompassing any substance presented as having properties for treating or preventing disease in humans, or which can be used to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action or make a medical diagnosis.14 Under the Directive, the advertisement of prescription-only medicines is prohibited and advertisement of products available over the counter is subject to precise conditions.15 For example, the advertising of a medicinal product shall not contain material which refers to a recommendation by a scientist, health professional, or other person, ‘who, because of their celebrity, could encourage the consumption of medicinal products’. In the UK, the Advertising Standards Authority took action against Sanofi because an Instagram influencer, ThisMamaLife, endorsed their product Phenergan, an over-the-counter medication used to treat insomnia.16 Sanofi argued that ThisMamaLife had a small following of only 32,000, and was unlikely to influence the medical decisions of consumers. However, ThisMamaLife was still considered a celebrity and Sanofi were warned to not use celebrities, including social media influencers, to endorse medicines in the future. It should be noted that this decision was taken in relation to the UK CAP Code which reflects the EU law, and not in reference to the EU Directive 2001/83/EC itself. It is unclear what threshold the Court of Justice of the European Union (CJEU) would apply to determine if an influencer has celebrity status. This is because while some influencers are clearly celebrities owing to fame outside of social media, others begin as fully anonymous individuals who develop market power and influence over time by attracting attention on social media.17

C. Unfair Commercial Practices Directive (UCPD)

Influencer marketing can also fall under the scope of the UCPD which regulates unfair commercial practices in business-to-consumer transactions. Where the provisions of other EU instruments overlap with provisions of the UCPD, the provisions of the lex specialis will prevail. 18 In the case of conflict between the provisions of the NHCR and the UCPD, the former takes precedence in relation to health claims.19 However, the UCPD can also apply to the marketing of products that fall under the Medicinal Products Directive. In Abcur, the CJEU noted that even where medicinal products for human use fall within the scope of the Medicinal Products Directive, advertising practices relating to those products can also fall within the scope of the UCPD.20 The UCPD aims to promote transparency, honesty and truthfulness and prohibit unfair commercial practices. Under the UCPD, there are two types of unfair commercial practices; these are misleading and aggressive commercial practices.21 Misleading practices include misleading advertising which deceives consumers and prevents them from making informed and efficient choices. Aggressive practices include those which influence consumers’ transactional decisions by harassment, coercion, or undue influence. Given that influencers build relationships with their followers based on trust and a personal connection, their behaviour can in some cases amount to an aggressive commercial practice through the use of undue influence. For example, an influencer used Instagram to promote the products of a company where she was the CEO, the main shareholder and the sole board member. One post promoting fish oil indirectly claimed that it could strengthen immune function and therefore protect against COVID-19. As there was no evidence for these claims, the post was found to be both misleading and aggressive.22 To be considered misleading or aggressive under the UCPD, a practice must be likely to cause the average consumer to take a transactional decision they would not have taken otherwise. The average consumer has been defined in case law as a person ‘reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors’.23 However, despite there being a significant body of case law discussing the concept, there is no clear pattern on how the CJEU interprets the average consumer.24 As a juridical concept, Schebesta and Purnhagen have observed that the CJEU seems to be struggling with providing meaning to the measurement and content of the average consumer test and is still striving to give it ‘sharper contours’.25 However, issues regarding the interpretation of the ‘average consumer’ are not relevant where a practice falls under the blacklist of unfair commercial practices in Annex 1 of the UCPD. Included in the blacklist is the practice of ‘falsely claiming that a product is able to cure illness, dysfunction or malformations’ (No. 17).26 By categorically prohibiting this practice, the UCPD can regulate a large proportion of harmful health content posted by influencers. In the European Commission Guidance on the Directive, it was noted that claims that a massage armchair had healing effects on human health (including curing spine and blood circulation diseases) fell under the ban imposed in No. 17.27 No. 17 also applies to goods and services including aesthetic treatments and wellness products in cases where they are commercialised with false claims that they are able to cure illness, dysfunction and malformations. To avoid falling within No. 17, a trader must be able to substantiate claims with scientific evidence.28 Thus, the UCPD can be clearly applied where influencer content falls within the strict prohibition of No. 17.

V CONCLUSION

Inaccurate medical information can have far-reaching effects when disseminated online by influencers who have cultivated relationships of trust with their followers. The publication of of health-related content by influencers must be carefully regulated to ensure that the public are not deceived into seeking products and treatments with no scientific basis. The NHCR protects consumers by requiring health claims to be scientifically substantiated, however health professionals are subject to greater limitations than influencers, creating a non-level playing field which does not effectively promote factual information. The Medicinal Products Directive imposes strict regulations on the advertising of medicinal products, although the scope of the prohibition on celebrity endorsements is not entirely clear. The UCPD categorically prohibits false claims that a product can cure illness, dysfunction or malformation, however commercial practices that do not fall within this prohibition must meet the average consumer test in order to be considered unfair. Applying this test has proven to be problematic as the CJEU has struggled to interpret the concept consistently. Consequently, more research is required to understand how the legal framework can be updated to regulate influencers posting in the health and medical space in a more clear and consistent manner.

Sources

1 Nicole Glennon, ‘Ozempic: Is TikTok’s Newest Obsession Really a Weight-Loss Wonder Drug?’ (Irish Examiner, 11 November 2022) <https://www.irishexaminer.com/lifestyle/healthandwellbeing/arid- 41004467.html> accessed 12 December 2022.
2 Christine Riefa and Laura Clausen, ‘Towards Fairness in Digital Influencers’ Marketing Practices’ (2019) 8 Journal of European Consumer and Market Law <https://papers.ssrn.com/abstract=3364251>.

3 ‘The Impact of Influencers on Advertising and Consumer Protection in the Single Market’ (Policy Department for Economic, Scientific and Quality of Life Policies 2022) Study PE 703.350.
4 ibid.
5 Alie De Boer and others, ‘Enforcement of the Nutrition and Health Claim Regulation’ (2015) 10 European Food and Feed Law Review 334; Iñigo de Miguel Beriain, Ana Borovečki and Aleksandra Głos, ‘Legal Aspects of Knowledge Landscapes in Healthcare’ in Anna Lydia Svalastog, Srećko Gajović and Andrew Webster (eds), Navigating Digital Health Landscapes: A Multidisciplinary Analysis (Springer 2021) <https://doi.org/10.1007/978-981-15-8206-6_3>.

6 de Miguel Beriain, Borovečki and Głos (n 5).

7 Roger Collier, ‘Containing Health Myths in the Age of Viral Misinformation’ (2018) 190 CMAJ E578. 8 de Miguel Beriain, Borovečki and Głos (n 5).
9 ‘5000 Micro-Influencers in Portugal Build Confidence in COVID-19 Vaccination’ <https://www.who.int/europe/news-room/photo-stories/item/5000-micro-influencers-in-portugal-build- confidence-in-covid-19-vaccination> accessed 13 December 2022.

10 Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims made on Foods 2006.
11 Sara Stanner, Margaret Ashwell and Christine M Williams, ‘Why Do Health Professionals Need to Know about the Nutrition and Health Claims Regulation? Summary of an Academy of Nutrition Sciences Position Paper’ Nutrition Bulletin <https://onlinelibrary.wiley.com/doi/abs/10.1111/nbu.12598>.

12 ibid.
13 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 2001 (OJ L 311) 67.
14 ibid.
15 ibid.
16 Advertising Standards Authority Committee of Advertising Practice, ‘Sanofi UK’ <https://www.asa.org.uk/rulings/sanofi-uk-A19-557609.html> accessed 14 December 2022.

17 Catalina Goanta and Sofia Ranchordás, ‘The Regulation of Social Media Influencers: An Introduction’ in Catalina Goanta and Sofia Ranchordás, The Regulation of Social Media Influencers (Edward Elgar Publishing 2020) <https://www.elgaronline.com/view/edcoll/9781788978279/9781788978279.00008.xml>.
18 Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council 2005 (OJ L 149) 22. Art 3(4).

19 ‘Commission Notice – Guidance on the Interpretation and Application of Directive 2005/29/EC of the European Parliament and of the Council Concerning Unfair Business-to-Consumer Commercial Practices in the Internal Market’ (2021) C 526/1 (Guidance on the Interpretation of Directive 2005/29/EC).
20 Joined Cases C 544/13 and C-545/13, Abcur.
21 Unfair Commercial Practices Directive.

22 Guidance on the Interpretation and Application of Directive 2005/29/EC (n 21).
23 Hanna Schebesta and Kai Purnhagen, ‘Island or Ocean: Empirical Evidence on the Average Consumer Concept in the UCPD’ (2020) 28 European Review of Private Law 293.
24 ibid.
25 ibid.
26 Unfair Commercial Practices Directive. Annex I, No 17.
27 Guidance on the Interpretation and Application of Directive 2005/29/EC (n 21).
28 ibid.