Healthcare Advertising Under Scrutiny – Amendment to the Advertising Regulation Act

At the end of July, the Chamber of Deputies sent a proposed amendment to a second reading that significantly expands the scope of activities that will be considered advertising for medicinal products and medical devices. This means stricter regulations and penalties.

Going forward, any form of information, survey, or incentive will be considered advertising if it is intended to promote the prescribing, sale, dispensing, or use of medicinal products. The amendment will thus also affect activities that were previously viewed as “neutral.” The advertising regulations now also cover support for professional programs, including not only the sponsorship of educational meetings for experts but also activities that may indirectly promote prescribing or sales. The same applies to patient programs, including the provision of hospitality.

Until now, patient programs were considered non-advertising if they took place only after a medicinal product had been prescribed. However, once the amendment takes effect, this practice will no longer be permitted, and violations will be subject to penalties. The organization of patient programs will then be restricted solely to hospitals, patient organizations, or professional societies.

The amendment also significantly restricts communication with the public. Promoting hospital medical devices to the general public will no longer be permitted, as all forms of information, surveys, or incentives aimed at promoting their prescription, sale, dispensing, or use will now be considered advertising. At the same time, a ban is being introduced on legal entities accepting gifts in connection with advertising.

Among other things, it will no longer be permissible for experts hired to present a medical device at an event for a professional association to recommend the device or compare it with a competing product. Consequently, a hired expert will no longer be able to comment on a given medical device without violating the amended law.

Furthermore, advertising for medical devices must include information required by law, such as risk warnings; however, the exact scope of these requirements is not clearly defined. This creates room for subjective interpretation and potential uncertainty in practice.

The line between “information” and “advertising” is becoming significantly narrower. A number of activities that were previously standard practice may now fall under strict regulation. For entities operating in the medtech and healthcare services sectors, it will therefore be crucial—should the amendment be approved in its current form—to reassess their marketing strategies, partnership arrangements, and the operation of patient programs.