Hidden advertising, influencer marketing and medicines in Bulgaria: where is the regulatory line?

In Bulgaria, growing public interest in health, wellbeing and therapies for chronic and lifestyle-related conditions has led to increased scrutiny on health-related content, particularly where promotional messages appear alongside educational materials, patient stories or social-media content.

For pharmaceutical companies, this creates a challenging environment. Disease-awareness initiatives, sponsored publications, advertorials and influencer campaigns may appear similar from a consumer’s perspective, while being subject to different legal and ethical standards.

The following article explores these standards.

Why are advertorials attracting regulatory attention?

The term “advertorial” is commonly used to describe commercial content presented in an editorial format. Such content may resemble an independent article, interview or journalistic report, but serves a marketing objective.

From a legal perspective, advertorials are not inherently problematic. Neither EU nor Bulgarian law prohibits sponsored editorial content. Regulatory concerns arise, however, where consumers cannot clearly identify the commercial nature of the communication or distinguish promotional content from independent editorial material.

Under EU and Bulgarian consumer-protection rules, paid editorial content used to promote a product must clearly disclose its commercial nature. Point 11 of Annex I to Directive 2005/29/EC classifies as an unfair commercial practice the use of paid editorial content to promote a product where this is not made clear in the content or by images or sounds clearly identifiable by the consumer. The corresponding Bulgarian rule is set out in point 11 of Article 68ж of the Consumer Protection Act. Consequently, hidden sponsorship arrangements and surreptitious advertising through advertorials may expose both advertisers and publishers to regulatory scrutiny.

Disclosure is only part of the analysis.

Why are medicines different?

Medicinal products are subject to a separate, significantly stricter regulatory regime than most other products.

Article 88(1)(a) of Directive 2001/83/EC and Article 247 of the Bulgarian Medicinal Products in Human Medicine Act (MPHMA) prohibit advertising prescription-only medicinal products to the general public. Disclosure of sponsorship, however, does not make content lawful if its overall effect is to promote a product to consumers. The only exception to this general prohibition is vaccination campaigns, which in Bulgaria must comply with the requirements applicable to the advertising of over-the-counter (OTC) medicinal products.

OTC medicinal products that can lawfully be advertised to the public are subject to a further procedural requirement. Under the MPHMA and Article 2 of Ordinance No. 1 of 25 January 2012 on the requirements for the advertising of medicinal products, this advertising may be disseminated after authorisation by the executive director of the Bulgarian Drug Agency.

Claims that a prescription-only medicine produces benefits outside its authorised indications may create additional risks, particularly where this use is not authorised, expected outcomes are overstated or inadequately substantiated, material limitations or risks are omitted, or the communication implies approval for that purpose. Depending on their content and overall presentation, such claims may constitute misleading advertising or an unfair commercial practice.

Furthermore, advertising of medicinal products must encourage their rational use by presenting their therapeutic indications objectively, without exaggerating their potential for treatment, prevention or diagnosis, and must not be misleading.

Genuinely non-promotional disease-awareness information or an individual medical response will not automatically constitute advertising, provided it does not directly or indirectly encourage the prescription or use of a particular product.

The decisive question is whether, viewed as a whole, the communication informs consumers about a health condition or encourages the use of a particular medicinal product, and not merely whether it discloses a commercial relationship.

When does content appear to be company-backed?

Regulatory concerns may arise even where a pharmaceutical company has not formally sponsored a publication.

Information creating the impression that content has been endorsed or supported by the company include references to collaboration with a pharmaceutical company, participation of health-care professionals associated with the company, use of corporate branding, links to particular providers or repeated references to specific treatment approaches.

This issue may be particularly relevant in publications discussing chronic, widespread or high-profile health conditions where consumers may be influenced by perceived corporate endorsement even in the absence of explicit product promotion.

For this reason, pharmaceutical companies should consider both their own communications and third-party content that they commission, fund, approve, control or materially influence. Such involvement can engage regulatory or ethical responsibility even where the content is published through an ostensibly independent editorial or influencer (i.e. creator) channel, particularly if the presentation obscures the company’s role or creates a misleading impression of independent endorsement.

When does health information become advertising?

Article 86(1) of Directive 2001/83/EC defines advertising of medicinal products broadly to include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products. Article 244(1) of the MPHMA follows the same approach. Whether health-related content constitutes advertising depends primarily on its promotional purpose, assessed via the content, context and overall presentation of the communication.

Regulators are likely to consider factors such as:

• references to specific products or brands;
• product images or packaging;
• efficacy or treatment-outcome claims;
• links directing consumers to suppliers or providers; and
• the overall commercial message conveyed by the content.

No single factor is necessarily decisive. The central question is whether the communication primarily informs consumers about a health condition or encourages the use of a particular medicinal product.

Disease-awareness campaigns may remain outside the advertising regime where they genuinely focus on a medical condition and avoid direct or indirect product promotion. The distinction is highly fact-sensitive and depends on the cumulative effect of the factors identified above.

Influencers, patient stories and medical advice

Influencer marketing creates compliance challenges because promotional messages are often embedded within personal experiences, treatment stories and lifestyle content.

Recent public statements by the Bulgarian Ministry of Health have highlighted the risks of presenting promotional health-related content as medical advice, particularly in social-media environments. Consumers should be able to distinguish clearly between independent health information and content serving a promotional purpose.

Consumers frequently place significant trust in personal stories, particularly those describing dramatic treatment outcomes or positive treatment experiences. This increases the risk of promotional content being perceived as impartial health information or medical advice.

Additional concerns arise where influencers fail to disclose commercial relationships, make unsubstantiated or unbalanced claims regarding treatment outcomes, omit material qualifications or discuss prescription-only medicines in a manner that encourages consumer demand. Personal testimonials should reflect genuine, supportable experience and should not be presented as establishing outcomes that consumers can generally expect. The involvement of health-care professionals or individuals presented as experts may further increase regulatory and ethical scrutiny where their qualifications, relationship with the advertiser or statements could create a misleading impression of independent professional endorsement.

For pharmaceutical companies, influencer activity may create several layers of risk simultaneously, including hidden advertising, misleading health-related claims, unauthorised endorsements and the promotion of prescription-only medicines to the public.

Bulgarian enforcement and ethics

While publicly available Bulgarian enforcement practice specifically addressing pharmaceutical advertorials remains limited, consumer-protection rules prohibit commercial practices that mislead consumers on the nature or commercial purpose of a communication. The assessment is based on the communication’s overall impression on the average consumer, rather than solely on whether it contains a formal sponsorship disclosure.

From an ethical perspective, commercial communications should be readily recognisable as such, regardless of the form or medium used. Material claims must not mislead by statement, implication, omission, ambiguity or exaggeration, and advertisers should hold adequate evidence for objective claims that can be substantiated. In the context of medicines and related health content, these principles are particularly relevant to efficacy claims, expected outcomes, safety presentations, before-and-after narratives and statements attributed to health-care professionals, patients or influencers.

Even where a communication does not clearly qualify as unlawful advertising, it may still raise concerns under the applicable ethical standards. In the health-care sector, the commercial nature of a communication should be transparent, treatment-related information should be presented in a balanced manner, and claims should not create exaggerated expectations of treatment outcomes.

Practical considerations for pharmaceutical companies

Before publishing advertorial or sponsored content, companies should consider the following questions:

• Is advertising permitted to the general public?
• Is the commercial relationship clearly disclosed?
• Could readers perceive the content as independent editorial material?
• Does the content directly or indirectly promote a prescription-only medicinal product?
• Does it create the impression that a pharmaceutical company endorses a particular treatment approach?
• Are treatment-related benefits presented in a balanced and non-misleading manner?
• Could consumers interpret the content as personalised medical advice?
• Does the overall context remain educational rather than promotional?

If the answer to any of these questions is unclear, a more detailed legal and compliance review is likely to be warranted.

Looking ahead

In practice, the boundary between journalism, disease-awareness initiatives, influencer activity and pharmaceutical promotion is becoming increasingly difficult to identify. As a result, content endorsing medicinal products or treatments is increasingly becoming a focus of Bulgaria’s regulatory authorities.

The challenge for pharmaceutical companies is no longer confined to traditional advertising campaigns. Advertorials, sponsored publications, patient stories and influencer collaborations may attract regulatory and ethical scrutiny if they are not sufficiently transparent about their commercial purpose, if their claims are misleading or inadequately substantiated, or if they effectively promote prescription-only medicines to the public. 

Therefore, companies should do the following: 

• establish pre-publication review procedures that cover the applicable legislation and ethical codes;
• require clear disclosure and compliance obligations from publishers and influencers; 
• retain evidence that supports objective claims and endorsements; 
• document the assessment of promotional purpose and overall consumer impression; and 
• monitor published content to ensure that approved materials are not subsequently altered by media or influencers (creators) or presented out of context.

For more information, contact your CMS client partner. The CMS experts who contributed to this article are: Anna Tanova, Partner, Maxim Hristov, Senior Associate, and Sofia Brunzelova, Student.