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From next year, the actor will not be able to play the role of a doctor, pharmacist or other medical professional in an advertising spot or billboard and recommend medical devices. This is the result of the act passed by the Sejm on April 7, 2022, which regulates these issues for the first time. Direct advertising of such products to children or their parents will also be prohibited.
- From next year, we will no longer see a person in a white doctor’s coat advertising medical devices. Until now, the law allowed this and was a gateway to bypass the more restrictive regulations on advertising drugs
- Medical devices is a very broad concept. This includes orthopedic collars, condoms, contact lenses, examination gloves, protective masks, wheelchairs, hydrogel dressings, disposable catheters, blood containers or heart valves
- Commercial catalogs or price lists containing only the trade name, product price or technical specification are not an advertisement
- There are about 3,4 thousand companies on the Polish market. entities producing medical devices, about 280 authorized representatives of such products and over 3 importers and distributors
- More information can be found on the Onet homepage
New regulations on medical devices
The change in regulations results from the adaptation of Polish law to EU regulations, i.e. to two regulations of the European Parliament and of the Council (EU) of 2017. However, they left the freedom to adjust the rules on advertising of medical devices to Member States. Although the draft regulation was submitted to the Sejm in 2021, the parliament worked on it mainly from February 2022. The President signed it on April 20, 2022.
The intention of the act is to regulate and improve the internal market of medical devices, including in vitro diagnostic devices (e.g. pipettes, lenses). What is new in the provisions is that they regulate the advertising of these products for the first time.
«The new regulations regulate the issue of advertising directed to the public. Among them were introduced, among others ban on the use of the image of people working in medical professions and ban on advertising of products intended for use by professional users »- sums up Arkadiusz Grądkowski, president of the Polish Chamber of Commerce for Medical Products POLMED in an interview with Medonet.
As he explains further, the project developers were guided by the concern for the well-being of patients, so that the content of advertisements reaching them was reliable and related to the products they could use.
“The new regulations are intended to eliminate the currently encountered unfavorable phenomena, such as the use of a doctor’s image in order to support advertising with social authority” – adds the president of the Chamber.
The new regulations relate to the issue of advertising of medical devices to the public. As the president of POLMED reminds us, the advertising ban does not apply to producers, authorized representatives, importers, distributors or other entities after the advertising has been approved in writing by a given company.
Medical devices – what is it?
What are medical devices? It is a very broad concept. These are products supporting diagnosis, treatment, health monitoring, but also helping to alleviate the course of the disease or the effects of an injury, as well as replacing or changing the anatomical structure (e.g. endoprostheses, implants) or the physiological process (e.g. insulin pumps).
However, as emphasized by attorney Joanna Wajdzik, senior associate at Wolf Theiss, apart from products that we intuitively perceive as medical devices, this designation is more and more often used, for example, in relation to tablets, capsules and cough syrups. They are categorized as a medical device. It is a trick, thanks to which they can be advertised all the time in a less restrictive way than drugs. However, this state of affairs will only apply until January 1, 2023. After this date – in accordance with the new regulations – no actor will be able to play the role of a medic, pharmacist or other person in an advertising spot or billboard. performs a medical profession and encourage the use of a medical device. As is happening now with drug advertising.
«This does not apply to non-advertising activities. For example, educational campaigns are not covered by such regulations »- emphasizes the president of POLMED.
There is a penalty of up to PLN 2 million for violating the regulations. The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products may also order the removal of such advertising. Responsible for it is always – as President Grądkowski notes – the economic entity (including the manufacturer, authorized representative, importer, distributor) that advertises the product.
At the same time, in the light of the new regulations, it will be forbidden to use positive opinions of users about products or to present them during meetings with consumers. The idea here is to curb the influence of influencers in the world of social media (influencers) who encourage – based on their own experience – to use specific products.
“This is a completely new, comprehensive regulation that will significantly affect the activities of influencers,” emphasizes President Grądkowski.
The act also includes a transitional provision that allows the dissemination of advertising messages that will appear before January 1, 2023, for six months to continue under the old rules.
Simple advertising message
Advertising of medical devices will have to be understandable to a person who is not dealing with the product on a daily basis, i.e. an ordinary user. This also applies to materials, leaflets that end up in the hands of the user. All scientific and medical concepts must be presented in a clear and accessible way. Such advertising must not be misleading.
More changes are coming
This is not the end of tightening the regulations on advertising medicinal products. In addition to the issues arising from the new act, in April, the Ministry of Health presented a draft amendment to the regulation on this matter. The ministry proposes to change the content of the warnings regarding the safe use of the medical device. One of the proposed three warnings attached to each ad, when used interchangeably, should read: “This is a medicine. For safety, use it according to the package insert. Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist. ‘ The remaining warnings advise you to use the product only when necessary and pay attention to contraindications.
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