It has been a little over a year now since similar legislation on advertising for medical devices to that for pharmaceuticals began to apply. And how can the new system of advertising regulation be assessed after one year?
As is well known, devices are divided into several risk classes. This corresponds to the general regulatory requirements, which are less strict for the lower classes than for the higher ones. But this is no longer the case for advertising rules, which does not address risk classes. Risk class I devices are often similar in nature to other products (e.g. hygiene products) but the rules for advertising are clear: it is a medical device and the risk class is irrelevant. Thus, advertising of, for example, a simple plaster is regulated in the same way as advertising of an insulin pump.
The definition of a professional is also problematic. While a professional is considered exclusively a doctor or pharmacist, others in the medical or similar profession are considered as the general public, the same way as an electrician or a lawyer. For example, in IVDs, it do not take into account the fact that, with the exception of self-tests, they are handled primarily by laboratory specialists and other professions not fulfilling the definition of a professional. Another paradox is the position of non-medical health professionals, who do not meet the definition and cannot be targeted by this type of advertising, but in some cases cannot be targeted by advertising to the public either, because if the device is intended by the manufacturer to be used only by a health professional, public advertising is prohibited. A similar situation arises for social service workers, such as nurses.
Manufacturers and distributors also hesitate over every word when creating a website. They would like to have a presentation of the marketed products on it, listing their features, but a detailed list is considered advertising. Even seemingly purely technical articles can be problematic. In fact, the law and SÚKL claim that even an indirect reference to a specific product makes an article on human health an advertisement, which must meet all the requirements or is even prohibited.
It is clear from the above that the current system of regulating advertising of medical devices has not been chosen happily, given its incompatibility with the area for which it was originally intended. In the future, we hope to see an amendment from the Ministry of Health taking into account the specifics of the medical device sector, which, given its size, deserves its own unique regulation of advertising activities.
Author: Aneta Dostálová