On 26 May 2021, an amendment to the Advertisements Regulation Act will come into force, introducing specific and detailed rules for advertisements for medical devices in the Czech Republic.
Aside from pharmaceuticals, medical devices and in-vitro diagnostics (IVD) are a commodity with direct impact on the health of individuals and the public at large.
Even so, the Czech Republic currently has no specific laws regulating the advertising for medical devices, so that they may be advertised under the same rules which apply to regular products. The supervisory authority over such advertising is thus put into the hands of the regional government offices, which lack the specific expertise for this segment, as opposed to the State Institute for Drug Control (SÚKL) which oversees the market for medical devices.
Change is afoot. Following the example of regulations in the field of advertising for pharmaceuticals, detailed and specific rules for advertisements will be added also for medical devices, both for advertising aimed at the broad general public and for advertising aimed at experts (i.e., those who may prescribe or issue medical devices, e.g. medical doctors). The new rules cover a broad range of activities, from advertising in the narrow sense (i.e., the wording and contents of ads) to the handout of samples, visits by trade representatives at experts’ offices, or the sponsoring for scientific congresses and similar gatherings.
The new rules apply irrespective of the risk class in which a given medical device has been categorized.
The supervisory authority will newly be the SÚKL, and the Radio and Television Broadcasting Council for advertisements for medical devices broadcast on the radio or television.
The amendment to the Act also introduces rules for advertising for what is known as consumer health products – i.e., products which are neither pharmaceuticals nor medical devices, but present themselves as such, a category in which one may find wearables such as smart watches which are able to monitor body functions, sporttesters, or various kinds of dietary supplements or cosmetics.
The amendment to the Advertisements Regulation Act will thus reverberate not only in the pharmaceutical sector, but also among businesses outside this particular market. All potential stakeholders are well-advised to familiarize themselves with the new rules and to review their advertising campaigns, business practices, and promotional activities before 26 May 2021, and in any case no later than on the day which marks the end of the 6-month transitional period after the effective date of the amendment.
In case of need, our law firm will gladly assist you with the analysis of your advertising campaigns.
Source:
Act No. 90/2021, explanatory memorandum related to the bill for the Act