Running a pharmacy means functioning in a reality of continuous regulatory oversight. The greatest regulatory risks associated with pharmacy operations are increasingly concentrated not around the product itself, but around the way it is communicated. In practice, this means that a pharmacy may simultaneously remain in the sphere of interest of several independent authorities, and basically all the time, especially Sanepid.
Dietary Supplement Marketing – An Area of Particular Interest for Sanepid
This stems from a fundamental principle of food law. A dietary supplement is a foodstuff, not a medicinal product. Therefore, it cannot be presented as a product serving to treat or prevent diseases, nor can it induce a belief in the consumer that it possesses properties characteristic of medicines (medicinal products).
In practice, it is not only the labels on product packaging that are inspected. The authorities’ interest also covers flyers, brochures, promotional leaflets, advertising stands, product displays, descriptions on websites, newsletters, communication conducted by personnel, and content published on social media.
Inspectors analyze, above all, whether the communications suggest medicinal properties of the product and whether they blur the line between a dietary supplement and a medicinal product.
In practice, particular risk is generated by messages suggesting that a supplement:
- treats a specific disease,
- prevents illness,
- constitutes an alternative to pharmacological therapy,
- is a substitute for a medicinal product,
- can replace a medical visit or treatment.
More subtle messages can also be problematic. For example, using graphics showing disease lesions and their “resolution” after applying the product, publishing stories of “cure,” or juxtaposing a supplement with a medicinal product in a way that suggests their equivalence can be evaluated as a violation of regulations.
Health Claims – A Risk Often Underestimated by Entrepreneurs
A significant portion of proceedings concerning dietary supplements centers around the incorrect use of health claims.
Entrepreneurs often assume that a slight modification of an allowed message is enough to create a more attractive marketing communication. In practice, even seemingly minor changes can lead to the entire message being questioned.
Authorities pay attention to, among other things:
- the use of claims not found in the EU register of authorized health claims,
- modifying the content of approved messages,
- attributing scientifically unproven effects to ingredients,
- the lack of required accompanying information,
- creating messages suggesting benefits that go beyond the scope of the approved claim.
In practice, it is precisely this area that is currently among the most difficult from the perspective of marketing compliance.
Materials from Sales Representatives – An Underappreciated Source of Liability
One of the most common mistakes observed during inspections is the unreflective use of marketing materials supplied by manufacturers, distributors, and sales representatives.
Entrepreneurs often assume that since the material was prepared by a professional entity operating in the pharmaceutical or food market, its compliance with regulations is unquestionable.
This is a risky assumption.
From the perspective of control authorities, what matters above all is the fact that a given material was used towards consumers. An inspector does not focus on who prepared the flyer, but on the fact that it was made available to the patient.
In practice, the following are often questioned:
- outdated flyers remaining in circulation,
- materials containing prohibited health claims,
- messages suggesting the equivalence of a supplement and a medicine,
- communications defining a supplement as a substitute for a medicinal product,
- materials referring to unverified research,
- the use of experts’ authority without an appropriate basis.
Particularly problematic are situations in which a sales representative passes on to the personnel an informal way of communicating the product to patients. During an inspection, it is precisely the employees’ answers to questions regarding the supplement’s effects that can become one of the key elements of evidentiary material.
Influencer Marketing Under the Authorities’ Magnifying Glass
Actions conducted using influencers are becoming a separate source of risk.
Such collaborations are often formed under the belief that responsibility for the content of the publication rests solely with the internet creator. In practice, authorities are increasingly examining the entire chain of entities participating in the campaign.
The following may be questioned, among other things:
- the lack of advertising disclosure,
- the lack of information about the nature of the product,
- attributing medicinal properties to supplements,
- publishing health stories suggesting therapeutic efficacy,
- using the influencer’s authority as proof of the product’s effectiveness.
From an authority’s perspective, social media no longer constitute an alternative communication channel. They are a fully-fledged marketing tool subject to the same requirements as traditional forms of advertising.
In Conclusion!
Running a pharmacy entails functioning in conditions of multidimensional and permanent regulatory oversight. Unlike many other sectors of the economy, the subject of interest of public administration bodies is not limited solely to verifying the legality of the business activity conducted. The scope of inspection also covers areas related to public health protection, the trade in medicinal products, foodstuffs and medical devices, consumer rights, the fulfillment of reimbursed services, personal data protection, as well as the compliance of advertising and marketing activities with legal regulations.
In practice, this means that regulatory risk does not only apply to the basic operational activity of the pharmacy, but also encompasses its communication activity, including that conducted on the internet and in social media. Supervisory bodies are increasingly analyzing content published on pharmacy profiles, promotional materials, marketing campaigns, influencer collaborations, educational posts, and the way products are presented on websites and in social media. Often, it is precisely a single internet publication or a report from a competitor or consumer that becomes the impulse for initiating verification activities or administrative proceedings.
The authorities’ attention is particularly drawn to messages concerning dietary supplements, foods for specific groups, medical devices, and products located on the borderline between different regulatory categories. One of the most frequently questioned areas remains communication suggesting medicinal properties of products that do not have the status of a medicinal product. Consequently, even a seemingly neutral flyer, a social media post, a pharmacy employee’s recommendation, or a graphic posted on Facebook or Instagram can be deemed a violation of regulations concerning advertising, product labeling, or consumer protection.
If you have questions related to inspections in the pharmacy market, please feel free to contact us: ajlaw.pl juchanska@ajlaw.pl office@ajlaw.pl