In the previous issue of the newsletter, we announced the continuation of the topic of medical device advertising that was raised.
The reasons are at least two. First, the topic is important from the point of view of the medical device market and the advertising market. Secondly, a draft regulation implementing the Medical Devices Act of April 7, 2022 (hereinafter “the Act”) has been published.
What is the role of this regulation? In short – to specify the technical details of the advertising message.
As you can read in the document called “Regulatory Impact Assessment“ [1] :
The draft regulation specifies the necessary data that an advertisement should contain, other than the name or trade name of the device and the intended use of the device, as well as the manner in which the advertisement should be presented, taking into account the need for objective presentation of the device, the safety of its use, the state of knowledge of device users and the need to ensure the uninterrupted use of health and pharmaceutical services.
The draft regulation specifies:
1) the necessary data that the advertisement directed to the public contains - in order to ensure that the recipients receive adequate knowledge of the advertised product, and that will be in the instructions and label of the product;
2) the manner of presentation of advertising of medical devices - analogously to the forms of presentation of advertising of medicinal products, along with an appropriate warning broadcast or placed with the advertisement, and limiting the forms of advertising in pharmacies and medical entities in order to allow the proper provision of services in these places.
It is worth noting that the legislator in the construction of rules and normative guidelines
in the field of medical device advertising is increasingly turning to tried-and-true models that have been in place for a long time in the field of drug advertising.
I think this is a good direction. It makes it easier for advertisers, for whom the change in product advertising is significant anyway. Last but not least, it also facilitates the reception of advertising by consumers/patients who are already accustomed to this form of information presentation (changes are also being designed for medicines).
Thus, as we pointed out in a previous article, the law prohibits, among other things, the use in advertising directed to the public of the image of persons engaged in the medical profession or claiming to be such persons, or the depiction of persons presenting a product in a manner suggesting that they are engaged in such a profession.
This eliminates perhaps the most common form of advertising message to date, in which people dressed up as doctors, dentists or pharmacists in a more or less convincing acting manner were expected to reach the public with their supposedly professional image more effectively than the competition. The features of the product, its use or the actual benefits of using the product were relegated to the background in the advertising, as the space of the doctor’s office and the figure of the doctor, perceived by the sense of sight, were in the foreground. The prevalence of this form of advertising leads us to believe that it was an effective message, although perhaps not very ambitious and creative, and above all – in a sense – misleading the viewer / listener / reader.
In addition, the draft regulation, in a manner similar to drug advertising, indicates the necessary data and information that an advertisement for a product, depending on the form and manner of presentation, should contain.
Mandatory information concerns:
- contraindications to the use of the device, if they relate to the use of the device;
- information for the user or patient about the likely risks associated with
With the use of the product in accordance with its intended use; - Indication of the name of the manufacturer and authorized representative, if appointed,
and moreover:
Information that the presented product is a medical device, and a warning
with the following content:
1. for products for which no contraindications have been identified:
"This is a medical device. For safety, use it in accordance with instructions or label. If in doubt, consult with specialist.";
2. for products for which contraindications have been identified:
"This is a medical device. For safety, use it in accordance with instructions or label. If in doubt, consult with specialist, as this medical device may not be suitable for you.".
The legislator mandates that the data contained in the advertising of the product be presented in a conspicuous manner
and legible (audiovisual and visual advertising), in a clear way (audio advertising).
This is to ensure that the information contained in the advertisement is properly received and that it is understood by the recipient/patient.
The design and content requirements of the warning, is already a familiar model from advertisements for medicinal products. Depending on the form of advertising:
- In audiovisual advertising, the warning is to be placed in the lower part of the advertisement, on a plane constituting not less than 20% of its surface and in such a way that the text stands out from the background of the plane, is visible, legible, fixed, placed horizontally, with the distance of the letters from the lower and upper edges of the background of the advertising plane not exceeding ½ the height of the letters, and the distance between the lines of the inscription not exceeding the height of the letters. The warning is to be read clearly in Polish
and appear on the screen for no less than 8 seconds; - In audio advertising, the warning is to be read clearly in Polish, and the duration of the message must not be less than 8 seconds;
- In visual advertising, the warning is to be read placed at the bottom of the advertisement, on a plane representing not less than 10% of its surface and in such a way that the text stands out from the background of the plane, is visible, legible, stationary, placed horizontally, with the distance of the letters from the lower and upper edges of the background of the advertising plane not exceeding 1/2 the height of the letters, and the distance between the lines of the inscription is not greater than the height of the letters;
The drafting of the ordinance also did not forget about the new sphere of regulation of advertising in the forms listed in Art. 58 para. 1 points 1-3 of the Law (among others. Influencer reviews, presenting products at meetings, sponsoring events, providing samples
for promotion purposes).
As the OSR reads:
In order to ensure transparency in the advertising of products, an obligation was introduced to inform about all benefits received, both tangible
and intangibleand this information is to be placed in graphic or audio form.
The draft of this regulation raises quite a few objections; not as to the advisability, but as to the way it is regulated. The provision is laconic, vague and raises significant questions of interpretation (e.g., what the intangible benefits are to be indicated, on whom in specific situations the information obligation will fall, how the information should be structured and presented, etc.).
The last regulated issue in the draft regulation is advertising in pharmacies, medical facilities and doctors’ offices. Restrictions have been put in place to not disrupt the main activities carried out at these sites and facilities. In pharmacies, advertising must not restrict the dispensing area for people using the pharmacy’s services and must be arranged in an orderly manner in fixed, separate locations. For medical establishments and doctors’ offices, advertisements will only be allowed to be placed in patient waiting rooms. At the same time, in all the aforementioned places excluded the possibility of advertising in audio or audiovisual forms.
The draft regulation was published on 27.07.2022. and is currently in public consultation. The planned effective date is 01.01.2023.
It is expected that changes will still be made to the draft regulation discussed above. A reading of the content indicates that they are desirable, and from both a normative and semantic point of view (use of vague, undefined terms, syntactic constructions).
On the other hand, I assume that the scope of regulation contained in the regulation itself will not change significantly, which means that the above study will remain relevant.
However, I expect and hope that the drafter will take into account the legitimate comments to the project made by the “Polish Pharmacy” Chamber of Commerce, pointing out, among other things, the lack of regulation, on the model of advertising of medicinal products, of the so-called “advertising”. reminder advertising, which can significantly complicate and relatively increase the cost of advertising activities in the medical device market, as well as the lack of regulation on the transfer of samples to promote devices.
We will follow the progress of these works and changes and keep our readers informed.
[1] Source: Regulatory Impact Assessment (RIA) to the draft regulation of the Minister of Health on advertising of medical devices dated 27.07.2022(https://legislacja.gov.pl/projekt/12362406/katalog/12898282#12898282)
