Pharmaceutical advertising regulation and medical device advertising in Poland

  1. 1. Which laws are applicable regarding advertising of medicines and medical devices?
  2. 2. Are there any other legal regimes such as self-regulatory codes of conduct that govern the advertising of medicines and medical devices?
  3. 3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?
  4. 4. Does the law in Poland regulate the advertising of prescription-only and over-the-counter medicines differently?
  5. 5. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?
  6. 6. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?
  7. 7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?
  8. 8. What information must appear in advertisements directed to the general public for medicines and medical devices?
  9. 9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?
  10. 10. Are there specific rules for comparative advertisement of medicines and medical devices?
  11. 11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?
  12. 12. Please describe the enforcement mechanism. Which bodies monitor compliance with the advertisement provisions and what are the legal consequences (e.g. penalties) for non-compliance?
  13. 13. Any future developments in Poland?

1. Which laws are applicable regarding advertising of medicines and medical devices?

  • 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.

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.

3. What kind of licenses/approvals/fees (if any) are required for medicines and medical devices to be advertised to the general public and healthcare professionals?

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

4. Does the law in Poland regulate the advertising of prescription-only and over-the-counter medicines differently?

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. What are the main restrictions applicable to the advertising of medicines and medical devices to the general public?

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. the Marketing 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:

  1. a medical consultation or surgical operation is unnecessary;
  2. even a healthy person taking the medicinal product can enhance his/her own health;
  3. failure to take the medicinal product may cause the health of the specific person to deteriorate (with the exception of specific vaccinations);
  4. the medicinal product is a foodstuff, cosmetic or represents other consumer goods; or
  5. 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:

  1. 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;
  2. lead to erroneous self-diagnosis by presenting detailed descriptions of case histories and disease symptoms; and
  3. 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:

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

5.2 Medical devices

Medical devices are currently regulated by a new law - 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. Rules relating specifically to the advertising of medical devices presented below are already enacted but they come into effect on January 1, 2023.

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 celebrities, scientists, healthcare professionals or persons implying to be healthcare professionals presenting the medicinal product,
  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. What are the main restrictions applicable to the advertising of medicines and medical devices to healthcare professionals?

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.

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

Previously, the advertising of medicinal devices has not been separately regulated and would be included in the content of the answer to Q6 above. 

As per the new Act on Medical Devices of 7 April 2022Please see the answer to Q6 above with regard to medical devices., 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 p. b) above. 

Rules on advertising of medical devices presented above come into effect on January 1, 2023.

7. What information must appear in advertisements directed only to healthcare professionals for medicines and medical devices?

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. other information consistent with the Summary of Product Characteristics;
  12. information on the dispensing category; and in the case of medicinal products entered in the lists of reimbursed drugs, also
  13. the official retail price and the maximum amount of supplementary payment made by the patient.

7.2 Medical devices

Currently, there are no specific requirements with regard to advertisements of medical devices addressed to healthcare professionals. However, the Act on Medical Devices of 7 April 2022 envisions the adoption of a precise regulation of technical issues concerning the contents of advertisements of medical devices. 

For information about the Draft Regulation see answer to Q8 below. The Draft Regulation currently only addresses the advertising of medicinal devices to the general public.

8. What information must appear in advertisements directed to the general public for medicines and medical devices?

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) contraindications; (vii) indication of the MAH.

Additionally, such an advertisement must contain a warning of strictly defined content.

8.2 Medical devices

Currently, there are no specific requirements with regard to advertisements of medical devices addressed to the general public. However, the Act on Medical Devices of 7 April 2022 envisions the adoption of a precise regulation of technical issues concerning the contents of advertisements of medical devices. Such regulation is now under way - the Draft Regulation provides for, inter alia: the mandatory elements to be contained in advertising directed to the public (i.e. information on the probable risks associated with the use of the device in accordance with its application), the content of the mandatory warning, the way the warnings are presented and the manner of presenting data in an ad for a medical device. The Draft Regulation is to come to effect on 1 January 2023.

9. Please summarise the requirements for scientific data indicated in advertisements. Are there any restrictions on the data on which the promotional claims are based (data on file, retrospective analyses, such as subgroup analyses or meta-analyses etc.)?

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 medical devices, pursuant to new regulations, medical and scientific wording, as well as to the citation in the advertisement of scientific studies, opinions, literature or scientific papers and other materials directed in an advertisement must be worded in a way that can be understood by a layperson.

10. Are there specific rules for comparative advertisement of medicines and medical devices?

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.

11. Are there specific provisions for advertisement of medicines and medical devices on the internet/in social media postings?

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:

  1. that advertising in violation of the provisions of the Pharmaceutical Law cease;
  2. 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;
  3. 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:

  1. the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
  2. the minister responsible for health matters (with regard to entities performing medical activities) and
  3. the MPI.

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

  1. the removal of the violation found,
  2. that advertising in violation of the provisions of the Act on Medical Devices cease,
  3. that the issued decision be published in places where advertising in violation of the provisions of the Act od 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

13. Any future developments in Poland?

Regulations concerning the advertising of medical devices (articles 54-61) of the Act on Medical Devices of 7 April 2022 come into effect on 1 January 2023. 

As the Act on Medical Devices provides for the adoption of a separate regulation on the advertising of medical devices, a Draft Regulation concerning the necessary data to be included in the advertisement of medical devices and the manner of presentation of the advertisement is currently subject to public consultation. The scheduled date of entry into force of the Daft Regulations is 1 January 2023. 

Additionally, the Ordinance of the Minister of Health of 7 July 2022 on advertising of medicinal products amending the Ordinance on advertising of medicinal products of 21 November 2008, mainly regarding changes in the content of obligatory warnings contained in advertisements, comes into effect on 26 January 2023.

Portrait ofAgnieszka Starzyńska
Agnieszka Starzyńska
Counsel
Warsaw
Katarzyna Łoś