Advertising of medical devices is a signiﬁcant market activity in the regulated pharma industry. Companies are always in search of new tactics and business strategies to remain competitive in the market and to attract new customers, in conditions of fierce market competition.
Medical devices carry certain risks, including health risks, hence everything connected to them, including their advertising, is heavily monitored by Croatia’s Ministry of Health and the national regulatory authority, HALMED.
Croatia has a brief, general set of national rules on the matter. In the absence of more extensive guidance, advertisers are thus challenged with a question: what rules to observe in order to stay compliant? As there is no obvious answer, advertisers often choose a conservative approach and advertise medical devices under the rules applicable to medicinal products. But is this absolutely necessary?
The answer is no: Medicinal products (medicines) are subject to a heavy set of rigid rules on advertising, and advertisers of medical devices need not strictly follow them. Their relative freedom is limited, of course. EU-wide rules require that medical devices can be advertised only if marked as Conformite Europeenne. Even if a device is CE-marked, any promotion must be limited to the specific purpose for which the mark has been granted. Promotion of off-label uses of medical devices is prohibited.
There is also a strict prohibition against misleading advertising and advertising that is mainly or exclusively addressed to children. Advertisers should carefully examine their advertising claims as these are always under the scrutiny of the regulatory authority. Advertising claims must be based on scientific evidence and avoid un-objective, discretionary statements. Advertising must not use inappropriate, disturbing, or misleading statements about recovery options or inappropriate pictorial representations. Advertisers must not give the impression that a medical device guarantees success in treatment of a disease and that the health of a patient can be improved solely by the use of a device.
These basic restrictions are EU-wide, and by now familiar to advertisers. Country-specific rules, though, may give a headache. In Croatia, all information related to a medical device must be in Croatian. Croatia provides a limited derogation from the national language requirement for medical devices that are intended for professional use only. Other marks (that serve promotion purposes) may be affixed, but these must not reduce the visibility and legibility of the CE marking.
In addition, two considerations deserve special attention: direct-to-consumer advertising and promotional actions, including interactions with key decision-makers and health-care officers (HCOs), such as hospital managers, acquisition managers, heads of departments, etc.
Croatia has not made direct-to-consumer advertising subject to a specific regulatory regime. Medical devices, unless professional-use only, can be advertised towards the general public under the rules applicable to health care professionals (HCPs). Professional-use only medical devices can be advertised only towards HCPs.
Interactions with decision-makers are increasingly used as a form of promotion, but many forget that these interactions are heavily restricted, especially if the HCOs are hospital officials and if the interaction occurs during a running public tender. Interactions having promotional goals must be kept separate from any other interaction. If there is a mixture of promotional interactions and other interactions, or if interactions are promotional only, then the interaction with a HCP or a HCO must not exceed 15 minutes / once a month. Interactions must not involve the giving of a gift or an item of value in excess of HRK 70 (approximately EUR 8).
Discussions about a tender must be kept separate from promotional activities. You are permitted to ask information about availability of funds, as long as such information is not requested specifically for a certain product. Asking to see or seeing/checking a necessity report or tender documentation before it is officially published is prohibited. Any involvement in preparing the necessity report or the tender documentation or placing the order to a wholesaler must be made only through official channels using a procedure of consultations with market participants.
Use of social media, and information technology in general, triggers additional concerns. As much as social media easily unfold vast promotional opportunities, it is a challenge to navigate through the legal rules on on-line advertising. It is a field where the rules on consumer protection, product liability, data protection, anticorruption, health and safety, etc., interact with the specific pharma rules on medical devices in a complex and often confusing manner.
Advertising of medicinal products, although barely explicitly regulated, should be carefully thought-through.
By Marija Musec, Partner, CMS Zagreb