Advertising medical devices (MD) is in general far less regulated compared to advertising medicinal products.
Several CEE countries have no specific regulation at all on promoting MDs. For example, this is true for Bulgaria, Hungary, the Czech Republic, Slovakia, Latvia and Estonia. However, Lithuanian law contains some special regulation for advertising MDs, while Polish law has some brief, general rules on the subject. In many jurisdictions, general restrictions and principles for advertising also apply to promotion of MDs. The new Medical Devices Regulation (MDR) prohibits promotional activities or materials which result in the user or patient being misled with regard to a device’s intended purpose, safety and performance.
At the same time, advertising health services may be banned altogether. For instance, under the Estonian code of medical ethics it is generally not appropriate for a doctor to take part in commercial advertising in the media that promotes treatments or products where a doctor’s credibility and authority are used to influence consumers. For example, a doctor or dentist advertising MDs to the public in connection with their own services could fall under advertising of health services, which may be prohibited. Strict bans generally also apply to offering “advantages” or gifts when marketing to healthcare professionals.
But is the medical device sector legally rather free to promote MDs with marketing authorization to all types of consumers in any media format as long as the advertisement is in correct language, accurate, substantiated and not misleading?
Interesting questions arise about different measures and means of advertising:
- Can a beauty clinic promote dermal fillers to patients along with consultation by a dermatologist?
- Can commercial posters for certain products be displayed on the premises of a doctor’s practice?
- Can images of patients or treatments be used? And does it matter what those images show?
- Can specific statements by patients be referred to?
- What are the differences between healthcare sectors, e.g. dentists, doctors, hospitals, medical suppliers?
- How would the picture change if a promotion includes introducing health apps or other healthcare-related software?
- What would be the limitations if a promotion targets teenagers via social media using teen celebrities that encourage the use of MDs or referring to testimonials of satisfied (teenage) patients?
Different Central and Eastern European jurisdictions possess different rules in terms of the details.
In Estonia, advertising where the target group is primarily children (i.e. under 18) must take into account their unique physical and mental state resulting from their age. Advertising cannot take advantage of the credulity of a target group arising from age. For example, advertising a target group consisting primarily of children must not create the impression that acquiring certain goods or using certain services will give one child an advantage over other children or that not having them will have the opposite effect.
If you come across of any of these questions, you are welcome to contact a member of our bnt attorneys in CEE Life Sciences & Pharma Practice Group. We will be glad to provide more detailed information.
Undoubtedly, before starting to promote their products distributors of MDs need to consider a wide spectrum of legal issues in addition to MDR, such as rules on data protection, consumer protection, product liability, safety and performance requirements, as well as regulation of advertising and commercial practices in general. When advertising MDs, special focus is also needed on restrictions related to the age of the target group and issues concerning the involvement of health professionals.