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Health claims - misleading advertising of Medical Devices

Health claims can be effective in advertising, especially of medical devices (MDs). Sometimes, however, they cross certain regulatory borders, which may not only attract economic damage (fines) but also result in the overall loss of hard-won customer loyalty and market confidence.

Jurisdictions in our bnt attorneys in CEE countries rarely provide explicit regulations on MD advertising in general or health claims arising therefrom in particular. However, it is widely accepted that advertising of MDs must not be misleading, i.e., such that in any way deceives consumers and for that reason is likely to affect their economic behaviour or injure a competitor.
Hungarian legislation lays down several restrictions and prohibitions on the content of advertisements for MDs, among them:

• MDs must be clearly identified and demonstrated;
• advertisements must contain information and warnings necessary for correct use and an express, legible invitation to carefully read the instructions or the user's manual for the product.

Lithuanian Law on the Prohibition of Unfair Business-to-Consumer Commercial Practices presumes that advertising a MD by falsely claiming that a product is able to cure illnesses, dysfunction or malformations is misleading. The Lithuanian Competition Council as well as the Lithuanian State Consumer Rights Protection Authority are very active in reviewing presentations of MDs and MD advertising. Over recent years many decisions have been adopted on misleading advertising of MDs due to health claims and fines have been imposed.

In Belarus health claims in advertising are generally not allowed. However, an exception is made specifically in regard to medical products, including MDs, where health claims are possible subject to certain conditions and limitations. Similarly, exploitation of healthcare professionals’ (HCPs) images (including “fake” doctors) is generally forbidden unless the material is addressed specifically to HCPs or distributed at professional health-related events.

Belarus commands quite an extensive regulation on MD advertising, including use of health claims. The rules can be divided into two groups (a) general requirements that apply to all advertisements and (b) special requirements that apply only to MDs. MD advertisements may be classified as direct-to-consumer advertising and advertising to HCPs which is distributed during health-related events or in professional printed media (contained in a special approved list).

The main requirements concerning health claims in direct-to-consumer advertising of MDs are the following:
• must be pre-approved by the Ministry of Healthcare (its subordinate organisation RCETH);
• must be fact-based and true;
• must not contain superlatives or suggest superiority, unless proven;
• comparison with other products is banned;
• only self-care devices may be advertised;
• must advise reading the manual and/or doctor’s consultation;
• may contain therapeutic claims, except for hard-to-cure or terminal illnesses;
• health claims must be in line with the MD manual;
• must not contain absolute therapeutic guarantees;
• must not indicate that the MD has undergone pre-clinical or clinical trials;
• must not describe particular cases of healing and testimonials from patients;
• must not suggest that the consumer is ill and needs the MD, or that even a healthy person may need the MD;
• must not state that the MD is safe, including due to it being “natural”, or side-effect-free and must indicate that the MD has contraindications and may cause side-effects;
• must not create an impression of high speed of action;
• must not cause anxiety and fear in consumers that they might develop a condition or suggest that the condition will become more severe or their health may be adversely affected unless treated with the MD featured;
• must not contain endorsements by state authorities or other organisations for amplifying advertising effect.

Advertisements to HCPs must also follow these rules, with the exception that they can use images of HCPs; any category of MDs may be advertised, and there is no need for pre-approval by the Ministry of Healthcare. At the same time they are limited to certain channels of distribution and, for instance, may not be placed on the Internet.

It is important to distinguish between advertising of MDs, methods of treatment and medical services, as special regulations exist in respect of each category.

Generally, we may conclude that first and foremost health claims in an advertisement must be true, in line with an MD’s documentation and supported by sufficient scientific, research or clinical data. Although specific regulation may be lacking, general rules on misleading advertising apply with specific interpretation in the context of MDs.