From 1 January 2023, the rules for advertising medicines, medical products and services will change dramatically in Poland. Among other things, medicines and medical products will not be allowed to be advertised by actors in white coats who are not actually medical professionals. Entrepreneurs may be fined up to approx. €1 million for failing to comply with the act.
The current provisions on advertising law are rather general in nature, so the general principles of advertising and promotion of medicines, products or medical services are also regulated by additional provisions (also of a general nature). A drastic change will take place on 1 January 2023, when part of the provisions of the Medical Devices Act concerning the advertising of medical devices and related liability will come into force. This amendment aims to introduce the standards already existing in Regulation 2017/745 and Regulation 2017/746, among others.
Advertising under new rules
Advertising of a medical device to the public will have to be worded in a way that can be understood by a lay person. This requirement also applies to medical and scientific wording and to references in advertising to scientific research, opinions, literature or studies and other material directed at users other than lay persons. Such advertising may not, for example, use the image of persons practising or claiming to practise a medical profession or depict persons presenting a product in a manner suggesting that they are so practising, and include a direct appeal to children to purchase the advertised products or to persuade parents or other adults to buy them the advertised products. In addition, advertising will not be allowed for products intended for use by users other than lay persons. In addition, the use of texts, names, trade marks, pictures and symbols or other signs which are likely to mislead the user or the patient as to the intended use, safety and performance of the device by:
- attributing to the device functions and characteristics which the device does not possess;
- giving a false impression about a treatment or diagnosis, function or characteristic that the device does not have;
- failing to inform the user or the patient of the likely risks associated with the use of the device in accordance with its intended use;
- suggesting uses of a device other than those stated to be part of the intended use for which conformity has been assessed.
Definitions
What is a „medical device” within the meaning of the Act? The phrase means an instrument, apparatus, device, software, implant, reagent, material or other article intended by the manufacturer for use, either singly or in combination, in human beings for one or more of the following specific medical uses:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosing, monitoring, treating, alleviating or compensating for an injury or disability,
- investigating, replacing or modifying an anatomical structure or a physiological or pathological process or condition,
- providing information through in vitro testing of samples taken from the human body, including those taken from organ, blood and tissue donors,
- and which does not achieve its principal intended action by pharmacological, immunological or metabolic means in or on the human body, but which may be assisted in its action by such means.
Entities covered by the new regime
In the context of the scope of entities, indicate what the legislator means by the term „economic entity”. It is the manufacturer, the authorised representative, the importer, the distributor or entities and persons carrying out therapeutic activities and other entities that use devices in their business or professional activities.
The above provisions will apply, inter alia, to advertisements for business or professional activities in which a product is used to provide services - insofar as it concerns services provided using the product in question (e.g. medical services, aesthetic medicine). The regime will also apply to advertisements containing the opinions of users of these devices, if they receive a benefit from them. The advertising of a device will have to include at least the name or trade name of the device and the intended use of the device. The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products will supervise the advertising.
Exemptions
The Act also provides for certain exemptions. Indeed, the above-mentioned restrictions will not apply to trade catalogues or price lists, which contain only the trade name, the price of the product or the technical specification, and to information on packaging and accompanying the packaging of products, as required by the Act and Regulation 2017/745 or Regulation 2017/746.
Additional obligations and administrative penalties
Operators carrying out advertising of a product to the public will also be obliged to keep specimens of the advertising and information on the places where it is disseminated for a period of 2 years from the end of the calendar year in which that advertising was disseminated and to make these materials available to the President of the Office upon request .
