Proposed amendment eases some of the new rules on advertising medical devices
In the May Newsletter, we introduced you to the government bill to amend the Act on the Regulation of Advertising, which is set to fundamentally rewrite the rules governing the promotion of medical devices and IVDs. Over the summer, a proposed amendment to that bill was drafted in response to some of the most problematic implications of the original text. For manufacturers, importers and distributors, it would primarily provide greater scope for professional communication, simpler educational activities and clearer rules for patient programmes. At the same time, it is intended to remove several new administrative obligations which, according to the explanatory memorandum, would bring more uncertainty than benefit to the market.
One of the practical changes concerns specialist and public awareness articles on health or diseases. These may be exempt from advertising regulations only if they do not refer, either directly or indirectly, to a specific medical device. However, the proposed amendment would clarify that, when assessing an indirect reference, the entire content and purpose of the communication must be evaluated. The mere inclusion of a logo or company name should therefore not automatically mean that educational material becomes advertising.
Training events for healthcare professionals, purchasers and service technicians are also to be simplified. The proposed amendment would remove from the bill the requirement for a person authorised to provide instruction in the use of medical devices to act as a guarantor for the event, as well as the planned requirement to notify the State Institute for Drug Control (SÚKL) of the event 30 days in advance. The instruction in the use of medical devices required by law is itself to be explicitly excluded from the definition of advertising. The proposed new obligation to state the ‘likely risks’ of a medical device in advertising would also be removed. The existing requirement to include in advertising a call to read the instructions for use and safety information is to remain; according to the authors, the obligation not to conceal risks is sufficiently covered by the MDR and IVDR.
Space for experts and patient programmes
The proposed amendment would also ease certain restrictions on advertising aimed at experts. It would now be possible to use expert opinions, clinical data or correctly described patient case studies. Provided the conditions for comparative advertising are met, it would also be possible to make claims to experts regarding the superior or equivalent efficacy of a device. However, the ban on claiming that clinical efficacy is guaranteed would still apply, as would the requirement for advertising to be truthful.
The proposed amendment would also affect gifts and sponsorship. The original proposal would have extended the ban on accepting benefits to legal entities, such as hospitals. The proposed amendment would delete this section so as not to hinder legitimate and transparent support for healthcare facilities; the ban on personally influencing healthcare professionals is to remain in place.
Information and programmes for patients are also to be regulated in greater detail. ‘Information for patients’ is to be intended for a specific patient to whom the device has been prescribed, dispensed or recommended; freely available online material is not to fall within this category. Act No. 375/2022 Coll. is also intended to explicitly regulate patient programmes as educational and support activities that do not constitute advertising and may also be organised by the manufacturer, importer or distributor of the medical device.
Author: Markéta Hrubá
