Kristina Šotter: Clear Boundaries Needed for Ban on Prescription Drug Advertising
An expert calls for clarifying the rules on advertising prescription drugs, as current legislation and non-binding guidelines create confusion about what is allowed.
Across the European Union (EU), a directive clearly bans the advertising of prescription-only medicines to the public, aiming to protect patient health and ensure medications are prescribed solely based on medical need. However, in Estonia, the law lacks clarity, and the Medicinal Products Department's recommendations send contradictory signals, leading to market distortions and legal uncertainty.
The department's guidelines are not legally binding, and even a preliminary assessment of a campaign does not guarantee it will not be penalized later. This creates an absurd situation where businesses cannot obtain a binding answer on how to apply vague rules.
A particularly problematic term is "indirect reference" to a medicinal product, which is not defined in any legal act. Everyone must interpret it themselves. Case law from the European Court of Justice (ECJ) provides some clarity. For instance, in case C-190/20 DocMorris, the ECJ ruled that advertising aimed at choosing a specific pharmacy, rather than a drug, is permissible. In case C-316/09 MSD Sharp & Dohme, the ECJ stated that the ban should be interpreted broadly to protect public health. If the purpose of a campaign is to promote prescribing, supply, sale, or consumption of medicines, it constitutes advertising.
Currently, the EU is reviewing pharmaceutical law reform, which will maintain the ban on prescription drug advertising but allow member states to also prohibit medicine-related advertising that does not reference a specific product. The directive amendments are set to take effect in 2026, with a transition period until 2028 for national implementation. However, businesses need legal certainty now, and Estonia should clarify both the rules and the department's recommendations in advance.
