A new industry code applicable to medical devices with a pharmaceutical appearance will be adopted in The Netherlands. The Code was drafted by the Supervisory Board on Public Advertising Medicinal Products (Keuringsraad Openlijke Aanprijzing Geneesmiddelen, (KOAG)) in cooperation with the Dutch Health Inspectorate and the Food and Consumer Product Safety Authority (VWA). These authorities have strict enforcement competence on the basis of Dutch legislation, which includes medical devices.
Introduction of this product specific code follows the increasing trend of introducing medical devices with a pharmaceutical appearance onto the market and is designed to create a clear self regulatory frame work for this type of product. Products covered by this code typically include shampoos, lotions, sprays, capsules, creams, powders such as ear solutions, eye drops and nose sprays where the working mechanism is physical in nature. Food supplements fall outside of this definition.
All advertisements for OTC medicines, health products and medical devices are subject to preliminary review and will be accepted or dismissed by the Board. The scope of review covers all forms of public advertisements, e.g. point of sale material, direct mail, brochures, advertorials and websites.
Public advertisement for Medical Devices is only allowed for indications resulting from self-diagnosis. A reasonable interpretation is that the specific expertise and experience of a medical doctor is not needed for a correct diagnosis.
The Board will assess whether or not the indications for use as presented on the packaging and advertisements are consistent and coherent with each other and with the Declaration of Conformity as prepared by the manufacturer (or authorised representative) or the CE certificate and dossier, whichever is applicable.
When an advertisement or campaign is scrutinised, the Board will not verify whether or not the claimed effect is achieved. Pursuant to European legislation on medical devices the manufacturer applying the CE brand is responsible for the correctness of the claims. For CE brands accompanied by a number, the notified body has assessed the claimed effect on the basis of the CE file.
An important feature of this code is that a more relaxed system applies to the use of price driven incentives such as refund actions, vouchers or quantum discounts. Also, free samples will be allowed with the exception of medical devices that support weight loss. This exception is not surprising and is in line with legislation.
Product packaging and user leaflets typically fall outside the scope of this Code, however if packaging is depicted in an advertisement, pursuant to the Code, the packaging is subject to the Code as well. In this context, claims such as “clinical effect proven” will be interesting. These types of claims are not allowed in advertising. In the view of the Board, when product packaging is depicted in an advertisement, such claims on the packaging must be camouflaged in the actual advertisement.