In relation to the adaptation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (MDR) the Czech government has proposed various amendments to the regulation of medical devices in order to ensure compliance with EU law. Within these amendments, the Czech government also envisages explicitly regulating the advertising of medical devices and enacting stricter and more detailed regulation of advertising of medical devices than is required by the MDR.
Current regulation of advertising of medical devices
Currently, advertising of medical devices is not specifically regulated in the Czech Republic. If it is carried out, it must comply in particular with the general requirements of Act No 40/1995 Coll., on Advertising Regulation. The supervision of compliance with the general requirements of the act in advertising, including advertising of medical devices, is performed by regional trade licensing authorities.
Under the general requirements — in particular advertising in violation of legal regulations, including competition law — deceptive advertising and advertising contrary to good morals or promoting behavior prejudicial to the health or safety of persons or property is forbidden. Comparative advertising is allowed only under specific conditions.
The governmental proposal envisages introducing regulation of advertising of medical devices (both general medical devices and in vitro diagnostic medical devices), which is in various respects inspired by the regulation of advertising of medicinal products. Only a medical device that can be placed on the market according to the applicable legal regulations will be allowed to be the subject of an advertisement (an exception is envisaged for advertising at congresses if the device is labelled accordingly). Special rules will apply depending on whether the advertising is directed at professionals or at the general public.
Advertising directed at professionals will only be disseminated through communication channels intended mainly for professionals and will fulfil specific content requirements, such as information that will allow experts to form their own opinion and basic information contained in the instructions for use of the medical device. It will be forbidden to provide gifts to professionals in connection with advertising and any hospitality or accommodation provided to professionals at professional meetings or congresses will be adequate.
Advertising directed at the general public must fulfil specific content requirements, such as the name of the device and an invitation to carefully read the instructions for use, and it must not promote medical devices that, in accordance with the manufacturer’s instructions, are intended for use by a healthcare professional only or that may be issued only on a voucher or request issued by a doctor. Various other partial bans will be introduced in this area, along the lines of the regulation of the advertising of medicinal products, such as the prohibition of references to the recommendations of scientists, health professionals or celebrities.
Supervision of advertising of medical devices is to be entrusted to the State Institute for Drug Control.
Current status of the proposal
The government submitted its proposal to the Chamber of Deputies, the Lower House, in January 2020. However, due to the COVID-19 crisis, the hearings regarding the proposal were interrupted and the proposal was subject to further discussions. If the proposal is approved by the Chamber of Deputies as well as the Senate, the Upper House, and signed by the president, it will become effective on the first day of the calendar month following its publication in the Collection of Laws.
This proposal is not the first governmental attempt to reintroduce specific regulation of advertising of medicinal products, which was regulated until January 2006, into the Czech legal system. In 2013, the legislative attempt to incorporate regulation of advertising of medical devices was unsuccessful. In October 2020, a member of the Chamber of Deputies proposed the removal of the regulation of advertising of medical devices from the proposal as a whole. It therefore remains to be seen whether this proposed regulation of advertising of medical devices will be approved by the Czech Parliament.