Upcoming Changes to Advertising Regulation: What Lies Ahead for the Medical Devices and IVD Market?

The rules governing the advertising of MDs and IVDs are set to undergo a significant overhaul. Although the originally proposed amendment to the Advertising Regulation Act was not debated during the previous legislative session, it is now returning to the Chamber of Deputies as Bill No. 153. This comprehensive bill was drafted by the Ministry of Health in collaboration with the State Institute for Drug Control (SÚKL), with the Ministry of Industry and Trade serving as the official submitting authority. In addition to MDs and IVDs, the proposal also addresses the necessary implementation of European legislation on infant formula. If the legislative process proceeds as usual, the new rules will take effect on January 1, 2027.

The main objective of the amendment is to eliminate the historical distinction between advertising aimed at professionals and that aimed at the general public, and to almost completely harmonize their conditions. Basic terminology is also changing. The legislative term “healthcare professional” will remain reserved for medicinal products; for MDs and IVDs, the broader term “device professionals” is being introduced. This will include, for example, speech therapists, hospital procurement officers, and service technicians. The term “general public” will be replaced by the terms “consumer” and “patient.” In addition, all addressees are required to include a call to familiarize with the risks under the MDR or IVDR in their advertising and to refrain from referring to well-known figures or clinical trials.

Updates regarding consumers and specialists

For consumers, the amendment brings some relief, as it lifts the ban on advertising prescription drugs linked to a safety voucher. “Patient information” is also being legalized, though it may be provided exclusively by a healthcare professional. Furthermore, this information must be based on scientific evidence and must not involve any compensation for the patient. It will still be possible to legally provide samples to consumers, but now only in quantities necessary for testing.

For device professionals, the amendment introduces even stricter rules. A number of strict prohibitions that previously applied only to laypeople will now also apply to professionals. On the other hand, the requirement to label product samples with the words "neprodejný vzorek" (meaning non-saleable sample) will be abolished. The law newly defines activities exempt from advertising regulations, such as insurance companies’ incentive programs or educational events for professionals. However, educational programs are subject to new strict rules and the obligation to report them to SÚKL 30 days in advance. From a law enforcement perspective, direct responsibility of advertisement distributors (e.g., the media) is also being introduced for highly harmful forms of promotion, where illegality can be recognized even without specialized knowledge.

Although, according to its sponsors, the amendment was intended to ease the burden on the market and reduce administrative burdens, in practice suppliers must prepare for a fundamental change in approach and, in some cases, a partial tightening of existing rules. Furthermore, given the absence of any transitional provisions in the currently debated proposal, it will be essential for suppliers to adapt their marketing processes well in advance, before the amendment takes effect.

Author: Markéta Hrubá