Pharmaceutical advertising regulation and medical device advertising in Poland

• The main act providing the legal framework for advertising of medicinal products is the Pharmaceutical Law of 6 September 2001 together with the implementing Ordinance of the Minister of Health of 21 November 2008 on the Advertising of Medicinal Products;
• The most important act regulating the advertising of medical devices is the Act on Medical Devices of 07 April 2022 together with the implementing Ordinance of Minister of Health of 21 April 2023 on the Advertising of Medical Devices. 

Additional (stricter) principles applicable to advertising of both: medicines and medical devices being subject to reimbursement from public funds arise from the Act of 12 May 2011 on Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses, and Medical Devices. 

The most important self-regulatory codes adopted by associations of entities operating respectively in the pharmaceutical and medical devices sector include:

The Code of Good Practice for the Pharmaceutical Industry was established by the Employers’ Association of Innovative Pharmaceutical Companies INFARMA on the basis of the Code of the European Federation of the Association and Pharmaceutical Industry (EFPIA). The Code is open not only to innovative companies, but also to other pharmaceutical industry entities and their organisations;

The Code of Ethical Business Practice, adopted by the Polish Chamber of Commerce for Medical Devices POLMED as an implementation of the MedTech Europe Code of Ethical Business Practice tailored to the Polish regulatory realities. 

There are no specific licences, approvals or fees required to advertise medicines and/or medical devices in Poland. 

Yes. Under Polish law, it is generally prohibited to address advertising to the general public related to: (i) medicinal products dispensed exclusively on the basis of a prescription, or (ii) products whose name is identical to the name of such a medicinal product. The prohibition only does not apply to some specific protective vaccines

5.1 Medicines 

The general principles applicable to the advertising of medicines addressed to both the general public and healthcare professionals, are as follows: 

1. advertising may be conducted exclusively by the MAH (i.e. theMarketing Authorisation Holder) or upon the order of the MAH;
2. it is prohibited to advertise medicinal products which have not been authorised for marketing in Poland;
3. it is also prohibited to provide information inconsistent with the Summary of Product Characteristics;
4. advertising must not be misleading, should present the product objectively and should inform about its reasonable use;
5. advertising must not involve an offer or promise of any indirect benefits for purchasing the medicinal product or for the delivery of evidence that the medicinal product has been purchased; and
6. advertising may not be addressed to children or contain any elements addressed to children.

Additionally, the advertising addressed to the general public must not: 

1. involve celebrities, scientists, healthcare professionals or persons implied to be healthcare professionals presenting the medicinal product or
2. refer to recommendations made by such people.

Furthermore, the advertising of medicinal products addressed to the general public must not suggest that:  

• a medical consultation or surgical operation is unnecessary;
• even a healthy person taking the medicinal product can enhance his/her own health;
• failure to take the medicinal product may cause the health of the specific person to deteriorate (with the exception of specific vaccinations);
• the medicinal product is a foodstuff, cosmetic or represents other consumer goods; or
• the efficacy or safety of use of the medicinal product arises from its natural origin. 

The advertising of medicinal products addressed to the general public must also not:

• assure that taking the medicinal product guarantees the appropriate effect, is unaccompanied by adverse reactions or that the effect is better than or equivalent to that of another treatment or medicinal product;
• lead to erroneous self-diagnosis by presenting detailed descriptions of case histories and disease symptoms; and
• contain improper, alarming or misleading terms referring to graphically represented pathologies, human body injuries or actions of the medicinal product on the human body or its parts.

Regardless of the above, it is prohibited to address to the general public advertising related to medicinal products: 

• dispensed exclusively on the basis of a prescription;
• containing narcotic agents and psychotropic substances; and/or
• registered as reimbursed medicines or whose name is identical with such medicines. 

5.2 Medical devices 

Medical devices are currently regulated by the Act on Medical Devices of 7 April 2022. The Polish legislator has decided to regulate the advertising of medical devices more broadly than the regulations adopted by the EU.

The general principles applicable to the advertising of medical devices addressed to the general public are as follows: 

1. advertising may be conducted exclusively by a business entity (a manufacturer, an authorised representative, an importer, a distributor) or upon the written approval of a business entity
2. advertising of a product to the public must be worded in a way that can be understood by a layman,
3. the advertising must not involve healthcare professionals or persons implying to be healthcare professionals presenting the medical device, or present persons displaying the device in such manner as to suggest that they are healthcare professionals,
4. the advertising may not include a direct appeal aimed at children to purchase advertised products, or to persuade parents or other adults to buy the advertised product for a child,
5. the advertising cannot concern products intended for use by professionals. 

Additionally, advertising of medical devices must not mislead about e.g. the terms and conditions of maintenance, software updates, adjustments or calibrations. 

Promotional materials, instructions, presentations and product information concerning medical devices must not be misleading by: 

1. assigning properties, functions and/or activities to the device that the device does not have;
2. giving the false impression regarding treatment or diagnosis, functions or properties which the device does not have;
3. failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose,
4. suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

A business entity that conducts advertising of a medical device directed to the public is obliged to keep samples of advertisements and information about the places where the advertisements are distributed for a period of 2 years after the end of the calendar year in which the advertisements were distributed. 

6.1 Medicines

For general rules applicable to medicinal products advertising regardless of its addressees, please see Q5 above. 

Additionally, for persons qualified to prescribe medicinal products and persons trading in medicinal products, it is prohibited to advertise medicinal products by providing, offering or promising pecuniary advantages, gifts and various types of facilitation, prizes, trips, and organising and financing medicinal product promotional meetings at which the hospitality towards participants is not limited to the main purpose of the meeting. At the same time, it is prohibited to accept the advantages and benefits referred to above. These prohibitions do not apply only to giving or accepting objects of a value not exceeding PLN

100.00 (about EUR 23.00), which are related to the medical or pharmaceutical practice and bear a mark advertising a specific company or medicinal product. 

Advertising of medicinal products which involves the free-of-charge delivery of product samples may be addressed exclusively to persons qualified to prescribe medicinal products. Additionally, such advertising is admissible only provided that specific conditions listed in the Pharmaceutical Law have been met (e.g. the person qualified to prescribe medicinal products submitted a written request for the supply of a sample, each sample must be marked as “free sample – not for sale”, etc.). In any case, however, it is not possible to provide samples of medicinal products free of charge that contain narcotic agents or psychotropic substances, as well as precursors of category 1. Furthermore, providing samples to pharmacists is only allowed if the samples are samples of OTC medicines. 

Advertising for medicinal products addressed to persons qualified to prescribe medicinal products or to persons trading in medicinal products should contain information consistent with the Summary of Product Characteristics and information on the dispensing category, and in the case of medicinal products entered in the lists of reimbursed medicinal products, also the official retail price and the maximum amount of supplementary payment made by the patient. 

6.2 Medical devices 

As per the Act on Medical Devices of 7 April 2022, visiting medical practitioners who are a health care provider or employed by a health care provider at a health care provider's place of service for the purpose of advertising medical devices shall be performed, by prior appointment, outside the working hours of such persons, and shall require the approval of the head of the health care provider in question and, in the case of a professional practice, the approval of the medical practitioner of the practice. 

For other general rules applicable to medical devices advertised to healthcare professionals, please see the answer to Q5.2 above.

7.1  Medicines 

The advertising of a medicinal products addressed to persons authorised to issue prescriptions or persons trading in medicinal products must contain the following data:

1. the name of the medicinal product and commonly used name;
2. qualitative and quantitative composition in terms of active substances and those excipients that are essential for the proper use of the medicinal product;
3. pharmaceutical form;
4. therapeutic indication or indications for use;
5. dosage and method of administration;
6. contraindications;
7. special warnings and precautions for use;
8. side effects;
9. indication of the MAH;
10. marketing authorisation number and name of the issuing authority;
11. information on the dispensing category; and in the case of medicinal products entered in the lists of reimbursed drugs, also
12. the official retail price and the maximum amount of supplementary payment made by the patient. 

7.2 Medical devices

There are no specific requirements with regard to advertisements of medical devices addressed to healthcare professionals. However, the general rules will apply, which indicate that, as a minimum, any medical device advertisement should include:

• the name or trade name of the medical device; and
• the intended use of the device 

8.1 Medicines 

The advertising of a medicinal product to the general public must contain the following data: (i) the name of the medicinal product; (ii) the name of the commonly used active substance, and in the case of a medicinal product containing more than 3 active substances, the term “combined product”; (iii) the dose of the active substance or concentration of the active substance, excluding the combined product; (iv) the pharmaceutical form; (v) therapeutic indication or indications for use; (vi) indication of the MAH.

Additionally, such an advertisement must contain a warning of strictly defined content. The regulations provide for three different versions of the content of the warning. The advertising of a medicine must be conducted in such a way that each newly developed advertisement of the medicine should be emitted using a different content of the warning from that used in the advertisement developed and emitted previously. 

8.2 Medical devices 

The advertising of a medical device to the general public must contain the following data: (i) the name or trade name of the medical device, (ii) the intended use of the device, (iii) identification of the advertising entity and (iv) the name of the manufacturer and of the authorised representative, if appointed. 

In addition, every advertisement must contain a warning of strictly defined content. The regulations provide strict requirements as to the proportion and localisation of such a warning in relation to the rest of the advertising material, which vary for visual, audiovisual and audio advertising. 

9.1 Medicines 

The documentation concerning medicinal products supplied to persons qualified to prescribe medicinal products or to persons trading in medicinal products should be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned, and should include the date of its development or last revision. 

Quotations as well as tables and other illustrative matter taken from medical journals or other scientific works should be faithfully reproduced and the precise sources indicated. 

Moreover, scientific data, analyses, research results taken from professional literature or scientific journals in order to facilitate verification and assimilation of information presented in the advertisement of a medicinal product must be provided in line with the original and together with their source and date of publication or last update. 

9.2 Medical devices 

As for advertising of medical devices to general public, all information must be worded in a way that can be understood by a layperson. That also applies to medical and scientific wording as well as to the citation or references in the advertisement to scientific studies, opinions, literature or scientific papers and other materials directed at users other than laypersons. 

10.1 Medicines

Comparative advertising of medicines is regulated in pharmaceutical law to a very limited extent only. As mentioned above, the applicable legislation states that the advertising of medicinal products addressed to the general public must also not (among other things) claim that taking the medicinal product is better than or equivalent to, that of another treatment or medicinal product. 

10.2 Medical devices 

There are no specific rules regarding comparative advertising of medical devices.  

There are no specific rules on the advertising of medicines and/or medical devices on the Internet or in social media. 

The Main Pharmaceutical Inspector (“ MPI”) supervises the compliance of advertising with the provisions of the Pharmaceutical Law. The MPI may order, by way of a decision:

• that advertising in violation of the provisions of the Pharmaceutical Law cease;
• that the issued decision be published in places where advertising in violation of the provisions of the Pharmaceutical Law appeared as well as an erratum to the erroneous advertising;
• the remedying of the deficiencies found.

Regardless of the above, breaching some of the above-mentioned regulations on advertising of medicinal products may be deemed an offence punishable by a fine. 

Supervision over the advertisement of medical devices is the responsibility of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. 

The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products may order, by way of a decision: 

• the removal of the violation found,
• that advertising in violation of the provisions of the Act on Medical Devices cease,
• that the issued decision be published in places where advertising in violation of the provisions of the Act of Medical Devices appeared. 

Regardless of the above, breaching some of the above-mentioned regulations on advertising of medicinal products may be deemed an offence punishable by a fine. By way of an example, an entity which conducts advertising of medical devices in a manner contrary to the provisions of the Act shall be subject to a fine of up to PLN 2,000,000 

We are not aware of any plans or upcoming changes regarding the regulations on advertising of medicinal products  or medical devices.  However, as we have recently seen a large increase in the authorities' interest in regulating the advertising of these products and, in particular, advertising on the Internet, we do not rule out that further changes will be proposed in the near future.