At
the beginning of April, a draft amendment to the Act on the Regulation of
Advertising and the Act on Medical Devices and In Vitro Diagnostic Medical
Devices was circulated to Members of Parliament. Among other things, it focuses
on advertising of selected sensitive commodities, including human medicinal
products and medical devices.
The
scope of the Act is not limited to B2C relationships, i.e. advertising
directed at the general public, but also extends to B2B relationships,
including advertising targeted at healthcare professionals and employees of
healthcare providers.
The
expected effective date of the amendment is 1 January 2027.
In the following article, we present selected areas of the proposal in relation to specific product categories.
Medicinal Products
The draft expands the definition of advertising, under which all forms of information, market research or incentives intended to promote prescribing, sale, dispensing or consumption will newly be considered advertising.
The amendment also sets out strict conditions under which patient programmes may be conducted so that they are not regarded as impermissible advertising.
Changes will also affect advertising targeted at healthcare professionals. Commercial representatives will newly be allowed to provide Summaries of Product Characteristics (SPC) and reimbursement information also in the form of a link to a source enabling remote access.
Conversely, stricter rules will apply to the provision of free samples, including limits related to the duration of treatment.
The amendment also introduces exemptions from regulation, particularly for incentive programmes run by health insurance funds and for educational programmes aimed at non-physician healthcare professionals.
Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD)
For medical devices and in vitro diagnostic medical devices, the definition of advertising is both expanded and clarified. Advertising will explicitly include, for example, lotteries, similar games, or consumer experience-based testing.
A more precise definition is also introduced for the recipients of comparative advertising, replacing the previously used general term “professionals”.
As with medicinal products, certain exemptions from regulation are defined.
A separate section is dedicated to patient programmes, which aim to improve awareness of diseases, diagnosis and treatment, as well as to support patient cooperation in healthcare provision and to provide training and guidance on the proper use of prescribed medical devices.
Fines
The amendment introduces new obligations and therefore significantly expands the list of actions (administrative offences) subject to penalties.
A fine of up to CZK 500,000 may newly be imposed, for example, for conducting patient programmes in breach of the law—whether due to violation of their intended purpose, content, or the provision of prohibited benefits to patients. The same fine applies to failure to meet notification obligations towards SÚKL, breaches of hospitality rules in online professional meetings, and similar cases.
Fines of up to CZK 2,000,000 are newly expressly applicable to organising prohibited competitions, lotteries and user tests for medicinal products and medical devices, for missing or outdated information in advertising directed at professionals, or for exceeding limits on the number of samples.
Fines of up to CZK 5,000,000 may be imposed for suggesting that the safety of a medicinal product is guaranteed by its natural origin, for using inappropriate depictions of bodily changes, or for providing gifts and benefits to healthcare professionals that are unrelated to their professional activities, among other violations.
Healthcare professionals themselves may newly face fines of up to CZK 100,000 if they actively request prohibited benefits or excessive hospitality, rather than merely accepting them.
Would you like to stay informed about changes in legislation? Feel free to contact us. At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you need expert guidance.
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The text was translated using ChatGPT 5.2.