The Czech Advertisement Act is currently undergoing some legislative changes. An amendment thereto has been included in a larger legislative package dealing with the regulation of medical devices.
This legislative initiative was launched by the Czech Ministry of Health to align national rules with the EU's Medical Device Regulation (MDR). To this end, a new act on medical devices is being proposed as well as amendments to the existing legislation.
As is the case in pharma regulations, the amendment proposes that the following activities in the medical-devices sector are classed as advertising: the advertised promotion of prescriptions for medical devices, the sale or use of medical devices; meetings between sale representatives and healthcare professionals; giving out samples of medical devices; making certain types of donations or organising consumer competitions; sponsoring promotional events; and sponsoring scientific events.
The draft amendment expressly prohibits advertising prescription-based medical devices or medical devices that can only be used by healthcare professionals to the general public.
The draft amendment also addresses advertising of medical devices for healthcare professionals and sets out rules similar to pharmaceutical-industry regulations. Hospitality during events demonstrating medical devices, for example, can be provided to healthcare professionals, but cannot be extended to their family members or any other third persons. Any hospitality must be commensurate with the purpose of the event.
The draft amendment identifies the State Institute for Drug Control as the authority overseeing and supervising medical-device advertising.
Although the draft amendment is still in the midst of the legislative process with a debate in the Chamber of Deputies scheduled for 15 September, we expect that the amendment's core proposals will be approved since they correspond with the currently applicable rules on the advertisement of pharmaceuticals.
For more information on this draft amendment and the medical-device and pharmaceutical industries, contact your regular CMS advisor or local CMS experts.