Across the European Union, it is firmly established at the directive level that medicines dispensed only with a prescription may not be advertised to the public. The purpose of the ban is to protect patients' health and ensure that medicines are prescribed by doctors based solely on medical need, not chosen by patients because of aggressive marketing. So what is the problem?

The law and nonbinding guidelines

The law does not state this clearly, and the guidelines of the State Agency of Medicines, the supervisory authority, send mixed signals. No one understands what is allowed and what is not. Such a situation is bad for any state‑imposed ban.

People ask for and receive exceptions, but the rules should be the same for everyone. This distorts the market and gives one party an advantage over others. A publicly available, up‑to‑date, clearly written rule would reduce this inequality and lessen the agency's workload from repeated individual inquiries.

In the weight‑loss campaign example, consumers and media outlets asked whether it is permitted if the public can understand which manufacturer and which product is being referenced, even if the product is not named. At the same time, the State Agency of Medicines had already given the campaign a favorable preliminary assessment, and changing that afterward would be at least inconsistent, if not harmful to legal certainty.

Under the law, information about people's health or diseases is not considered drug advertising if it contains no direct or indirect reference to a medicine. On the other hand, the law considers it drug advertising if information is published or ordered with the aim of increasing sales and directs people to consult a doctor, with direct or indirect references to a medicine. No legal act defines what constitutes an indirect reference, leaving everyone to guess.

In practice, additional information can be found in the agency's guidelines or in answers to frequently asked questions on its website. For example, the agency has explained that when assessing drug advertising, it focuses on the content of the information — whether the aim is to increase sales or use of medicines, or whether the published information could increase sales, use or prescribing.

Contradictorily, the agency has also recommended using the name of the active substance to avoid the information being classified as drug advertising.

Relying on guidelines or FAQ answers poses another serious problem: neither source is legally binding. A person may follow the answers published on the agency's website and still be punished later.

Such cases exist in Estonian court practice involving other agencies' guidelines. A person may request a preliminary assessment from the State Agency of Medicines, but this assessment is also not binding. This leaves the campaign planner in a legally absurd situation where it is impossible to obtain a binding interpretation of an unclear rule.

The phrase "indirect reference" is especially problematic. For lawyers, it is one of the most ambiguous expressions, belonging to the same vague category as the word "reasonable." In a dispute, only a court can later decide what is direct or indirect, reasonable or unreasonable. Retroactive judgments on unclear rules are bad for everyone. Rules should be known in advance, not discovered afterward.

What is the solution?

The current rules should be clearly worded, not vague — and this must be done at the level of legislation, not only through nonbinding guidelines.

At minimum, the agency should quickly review whether its published guidelines and FAQ answers are still up to date or need clarification.

For example, the agency has answered on its website that links may be added to online drug advertising, but the information in those links becomes part of the advertisement and must comply with advertising requirements.

In the recent example, the campaign used a warning when redirecting to a healthcare provider's website: "Please note that advertising prescription medicines to the public is prohibited (Medicinal Products Act § 84 (1))." It is clear that even if the redirected page contained prescription drug advertising (which it did not), such a warning would not make it non‑advertising, because information accessible through a link is considered part of the advertisement.

The agency should provide a clear guideline defining the criteria used to assess "indirect references."

European Court practice guides rule clarification

Some clarity can be found in the case law of the European Court, although none of the cases resemble the recent weight‑loss campaign. The Court has consistently emphasized that the key is determining the campaign's purpose, and the rules apply even when the campaign concerns an unspecified group of medicines.

For example, in case C‑190/20 DocMorris, the Court examined a pharmacy's promotional game offering participants a chance to win everyday items other than medicines, with participation requiring submission of a prescription medicine order. The Court found the campaign permissible because its aim was not to influence the choice of a specific medicine but the choice of pharmacy.

In case C‑316/09 MSD Sharp & Dohme, the Court explained that given the directive's main goal — protecting public health from the potentially serious consequences of misuse or overuse — a broad interpretation of the prescription drug advertising ban is justified.

If the message aims to promote prescribing, supplying, selling or consuming medicines, it is advertising. If there is no sales‑promotion purpose, it is not advertising. Each case must be assessed to determine whether the intention is to promote prescribing, supplying, selling or consuming medicines.

The Court also found that it is not prohibited for a prescription drug manufacturer to make the package leaflet or summary of product characteristics available on its website unchanged. This is allowed if the information is not selectively or promotionally edited.

The information must be accessible through a pull‑service system, meaning the user must actively seek it. This differs from push‑services, where information is sent to the user through pop‑ups appearing without request. In such cases, the information may be considered advertising.

In case C‑530/20 Euroaptieka, the Court examined a promotion offering a 15 percent discount on each medicine when buying at least three products. The Court found that advertising an unspecified group of over‑the‑counter medicines — such as the entire selection sold in a pharmacy — may be excessive and careless, potentially harming health by encouraging overuse or misuse.

In case C‑517/23 Apothekerkammer Nordrhein, the Court examined a campaign offering a €2.50–€20 reward per prescription for sending a doctor's prescription and participating in a medicine check. The Court found that the campaign did not promote prescribing or consuming unspecified prescription medicines, because only a doctor can decide on prescribing.

EU pharmaceutical law reform will bring changes

The ongoing EU pharmaceutical law reform will also change drug advertising rules. The ban on advertising prescription medicines to the public will clearly remain.

Based on European Court practice, the reform will allow member states to ban medicine‑related advertising that does not refer to a specific medicine. This means current disease‑information pages and awareness campaigns may fall under new regulation. The directive changes are planned to take effect in 2026, with member states given until 2028 to align national laws.

Businesses planning their activities need greater clarity now. Hopefully Estonia's national rules and the guidelines explaining their practical application will become clearer at least during the directive's transposition.

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