After more than a decade, the State Institute for Drug Control (SÚKL) has released an updated version of its guidelines UST-27 (full text available here: UST-27 version 4 - SÚKL). This new version, effective from 1 January 2025, clarifies the rules for advertising medicinal products, particularly specifying what does not constitute advertising.
Educational materials - when are they not considered advertising?
SÚKL explicitly stipulates that approved educational materials within the Risk Management Plan (RMP) published on SÚKL’s website are not considered advertising. This is not surprising, as these materials are inherently non-promotional.
However, SÚKL admits that other educational materials (outside the RMP) may also be non-promotional under certain conditions, even if they contain the name of a specific prescription medicinal product. These materials must be intended exclusively for patients who have been prescribed the specific therapy, must be objective, in compliance with the Summary of Product Characteristics (SPC), and must be provided to the patient by a doctor after verbal instruction during the prescription process. These conditions reflect SÚKL’s long-standing approach.
Patient organisation meetings - providing information about medicinal products
SÚKL clarifies the conditions under which patient organisations can provide patients with information about prescription medicinal products. An expert guarantor must be present at meetings to ensure the correct understanding of the communication. Only patients who have already been prescribed the treatment can participate, and all information must comply with the SPC. Meeting these conditions means the information will not be considered advertising.
Information about supplies
SÚKL confirms that information about the availability of medicinal products, interruptions or discontinuations of supplies, or batch recalls is not considered advertising, provided it does not contain promotional claims. This means pharmaceutical companies can continue to provide this information without needing to meet strict advertising requirements.
QR codes and web links instead of printed SPC
SÚKL is partially relaxing the requirement to provide the SPC in printed form.
Sales representatives are obliged to provide the full SPC of the promoted medicinal product during their visit to a healthcare professional. SÚKL now allows the SPC to be provided via a QR code or a web link, with a printed version available only upon request.
As for congress booths, SÚKL does not explicitly mention the use of QR codes for mandatory essentials of printed advertising materials. Therefore, it seems that the mandatory information (especially the abridged version of the SPC) will still need to be provided in printed form.
Online advertising - mandatory information can be provided via a click-through link
SÚKL explicitly permits that advertisements for medicinal products intended for healthcare professionals can include a click-through link to the mandatory information. In practice, SÚKL has already allowed this. This opens the door to more modern digital marketing, simplifying access to information and reducing administrative burden.
Assessment of changes: What will be the impact on the pharmaceutical sector?
The changes can be seen as positive, bringing greater legal certainty, and clarifying the rules. However, the changes are more evolutionary than revolutionary, confirming SÚKL’s existing interpretation and not addressing several controversial topics that also need clarification. Uncertainties remain, such as the use of QR codes at congresses. The future is uncertain – the guidelines are not fully compatible with the proposed amendment to the Advertising Regulation Act, which may necessitate further revision of the guidelines. Therefore, it is essential to monitor the progress of the amendment.
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