In Poland, the key provisions regulating the advertising of medicinal products are contained in the Pharmaceutical Law (Ustawa Prawo farmaceutyczne; the PhL). In this complex law regulating various topics and implementing the Polish Law Directive 2001/83, chapter 4 is entirely dedicated to the promotion and advertising of medicinal products (MPs). The provisions of the PhL are completed with the Regulation of the Minister of Health on the advertising of MPs (Rozporządzenie Ministra Zdrowia w sprawie reklamy produktów leczniczych; "the Regulation").  

Also of note is the Law on radio and television (ustawa o radiofonii i telewizji), which includes a number of provisions regarding advertising medicines on radio and television and the sponsoring of broadcasts by pharmaceutical companies. The Law on preventing unfair competition (Ustawa o zwalczaniu nieuczciwej konkurencji) regulates promotion and advertising in general and may be used by competitors. Another legal law, which in turn may be used by consumers, is the Law on preventing unfair market practices (Ustawa o przeciwdziałaniu nieuczciwym praktykom rynkowym). 

Promotion and advertising of medicines is also subject to ethical codes adopted by pharmaceutical industry associations. The key codes are: 

• the Employers’ Union of Innovative Pharmaceutical Companies (INFARMA) Code of Good Practice (Kodeks Dobrych Praktyk) ("the INFARMA Code"); and 
• the Medicines for Europe Code of Ethics (Kodeks etyki Medicines for Europe), adopted by the Polish Association of Pharmaceutical Industry Employers (PZPPF). 

INFARMA represents 25 pharmaceutical firms conducting research and development activities and manufacturing innovative medicines. 

The INFARMA Code has been drafted in accordance with the guidelines of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Its updated version is applicable as of 1 January 2021. 

The PZPPF is an association of 18 domestic manufacturers of pharmaceuticals (generics and biosimilars) and a member of the European association Medicines for Europe. Domestic members of Medicines for Europe, such as the PZPPF, are required to apply the Code from 1 January 2022. 

Given the international nature of this publication, we will focus our discussion on the provisions of the INFARMA Code. 

The provisions of the INFARMA Code are binding on pharmaceutical companies that are members of INFARMA. Other firms that are incorporated in Poland may voluntarily commit to observe its provisions by submitting an accession declaration to INFARMA. Other entities may apply the provisions of the Code as a set of standards, the voluntary respect of which ensures compliance of their operations with high ethical standards. The Code is not addressed to healthcare professionals (HCPs) or healthcare organisations (HCOs), but only to pharmaceutical companies. In terms of advertising, it covers the advertising of prescription-only medicines. 

The provisions of the Code cannot be considered binding law. However, they set certain standards in the industry and are often helpful in the practical implementation of legal regulations with a higher level of requirements. Breaching a provision of the Code alone, which at the same time cannot be considered a violation of the regulatory requirements, may result in disciplinary proceedings conducted according to the Code.  

The Medicines for Europe Code of Conduct is binding on members and affiliate members of PZPPF. Pharmaceutical companies that are not members of Medicines of Europe or its associated members (such as PZPPF) may voluntarily observe the provisions of the Code.  

The PhL provides a broad definition of the advertising of MPs. It is any activity consisting of providing information or encouraging the use of an MP with the aim of increasing the number of prescriptions or the supply, sale or consumption of MPs. Therefore, there are two key elements that must be combined: (i) kind of activity (provision of information or inducement), and (ii) the purpose of the activity (increasing sales, consumption, etc).  

The PhL lists a number of examples of pharmaceutical advertising, such as the advertising of medicines addressed to the general public or to HCPs and persons engaged in supplying MPs (mainly pharmacists); visits by medical representatives to HCPs and persons engaged in the supply of MPs; the distribution of samples of MPs; and the sponsorship of promotional meetings for HCPs and persons engaged in supplying MPs.  

In the numerous decisions of the chief pharmaceutical inspector (Główny Inspektor Farmaceutyczny; the GIF), the regulatory authority responsible for supervising pharmaceutical advertising in Poland, advertising is considered very broadly. In particular, information only, including even an indirect inducement to use a specific product, is considered advertising. The attractive manner of presenting information, use of specific colours, fonts, the size, channel of dissemination of information will be all taken into account while assessing whether a communication has a promotional nature or not. The purpose of communication will be a qualifying factor permitting in establishing whether it is advertising or not. The purpose does not need to be explicit – the intentions of the author of the communication are assessed, or even, in some cases, its effects.  

Only communications allowing  a specific MP to be identified (even if indirectly) are considered advertising. Therefore, those using a proprietary name of a medicine and marked with a logo or trademark of a specific MP are likely to be regarded as advertising, especially if addressed to the general public. 

An analysis of the GIF’s decisions and administrative courts’ judgments on advertising of medicines suggests a very broad interpretation of the term advertising for MPs. A piece of information will be considered advertising if it is distributed with the aim (both direct or indirect, or even secondary or incidental) of inducing someone to use an identifiable MP mentioned in the communication. The GIF very often assumes that such aim has been proven, despite the pharmaceutical company claiming otherwise.  

Disease awareness campaigns and patient-facing information are also assessed using the same criteria, ie, whether an intention (both direct and indirect) to increase sales, consumption or use of a medicine can be established (usually, very little is sufficient). Use of the product’s trademark or name will almost always result in assuming the promotional nature of a communication. The target audience may be helpful in assessing the nature of the communication, however, the intentions of the pharmaceutical company, also measured based on the communication’s effects (such as an increase in sales or number of prescriptions), will be a key factor. It is irrelevant whether the target audience is the general public or HCPs only. 

The PhL includes a list of determined categories of communication that will not be considered advertising. These include:  

• information placed on external packaging (labelling) and patient leaflets, provided they conform with the marketing authorisation;  
• correspondence accompanied by informative materials that are not of a promotional nature and are needed to answer specific questions about a particular MP;  
• informative non-public announcements  relating to packaging changes, adverse reaction warnings, provided they do not include references to MP properties; and  
• statements relating to human and animal health or diseases, provided there is no reference, even indirect, to MPs.  

Please note, however, that the content of a patient leaflet placed in an external communication, depending on circumstances (especially if accompanied by the product’s trademark), may qualify as advertising.  

With respect to disease awareness campaigns (eg, educational campaigns on vaccinations) and patient support programmes, whether or not they would be considered advertising would largely depend on their wording. As far as they include general statements on a disease and information on its treatment, adverse reactions, etc, and do not include specific product claims (usually mentioned using its proprietary name) information on its indications or an inducement to use the product, these may fall under one of the exceptions listed above. Disease awareness campaigns and other patient-facing information should not include any promotional content and should be free from any inducement to use an identifiable product.  

The GIF adopted a broad interpretation of whether a product referred to in an educational campaign may be identifiable (and so materials distributed as part of a campaign may be, but do not need to be, regarded as advertising). For example, a product may be identifiable if: 

• its name is included in the website address of the campaign; and
• there is a link to the product’s website or the products list of the campaign’s sponsor on the campaign website.  

According to the GIF, use of the word "educational” does not exclude a qualification of a material distributed as part of a campaign as pharmaceutical advertising, since its content and purpose will be the key factors rather than its name or form.  

Interestingly, the Polish administrative courts do not always share the very strict assessments made by the GIF. In one of its judgments, an administrative court held that despite use of the proprietary name in the materials distributed as part of an educational campaign, the materials should not be considered advertising, since the promotional intent of the sponsor of the campaign has not been proved. Even if an effect of the campaign was an increase in the sales of an MP mentioned in this campaign, this alone cannot be regarded as proof of the sponsor's promotional intentions (in that case, however, the sponsor was not a pharmaceutical company, but a non-profit organisation).  

Educational materials, not including any promotional content, addressed to patients who have already obtained a prescription for the medicine referred to in such material, which are to be handed to individual patients by the treating physician and which are fully compliant with the patient leaflets are likely to be accepted.  

Press releases will be assessed similarly to other types of communications issued by a pharmaceutical company regarding a specific MP. Therefore, they are governed by the general rules applicable to pharmaceutical advertising, such as, the prohibition to promote prescription-only medicines to the general public. To avoid allegations of incompliance, press releases concerning prescription-only medicines should only be distributed to authorised recipients such as HCPs and persons engaged in the supply of MPs (eg, pharmacists). It should be noted that in line with the decisions issued by the GIF, almost all announcements addressed to the general public and allowing the identification of an MP are considered medicinal advertising and, therefore, should meet all applicable requirements.  

However, an administrative court, after having assessed a complaint brought by a pharmaceutical company on a decision issued by the GIF, held that this company was allowed to address a press release to the general public regarding a prescription-only medicine, issued in reply to discrediting information on its medicine published by another company. It should be noted that the press release was a one-off publication and appeared in the same media as the discrediting material. The court held that the intention of the company was to protect the reputation of the medicine and not to promote it.  

Certain press releases will also be accepted as allowed in company advertising. A pharmaceutical company will be allowed to make objective updates and information available to the general public about, eg, outcomes of R&D activities, clinical trials, products in the pipeline and other significant developments, provided that no inducement to use an MP is included in the communications.  

There is only one regulatory restriction concerning comparative advertising of medicines and it is related to the advertising addressed to the general public only. It states that advertising of an MP should not contain any claim suggesting that the effects of taking it are better than, or equivalent to, those of another treatment or MP.

It should be noted that not only comparing effects of treatment with specific products mentioned by their names will be prohibited, but also comparing such effects with regard to medicines that are identifiable (not necessarily mentioned by their name). Claims on the same effects of compared medicines, or of a given pharmaceutical form of a medicine versus another form, are also prohibited. In contrast, such comparative advertising will not be restricted if addressed to HCPs or pharmacists.  

Irrespective of the above pharmaceutical sector-specific provision, the Law on preventing unfair competition allows for comparative advertising (defined as advertising allowing to identify, either directly or indirectly, competitor’s goods or services), but only under specific conditions. In particular: 

• it cannot be misleading, compares a number of goods or services meeting the same needs or designed for the same purpose in a way which is accurate and may be proven, based on objective criteria;  
• it compares, in an objective way, relevant, verifiable and typical features of compared goods, including their prices;  
• it does not discredit goods, activities, trademarks, names, distinguishing features or circumstances concerning a competitor; and  
• it does not take unfair advantage of the trademarks or name or other distinguishing features of a competitor.   

The PhL strictly prohibits promoting MPs which are unauthorised in Poland (that did not obtain marketing authorisations), and those which are authorised without the need to obtain a marketing authorisation (such as medicines brought from abroad to treat individual patients, authorised with special consents issued by the Minister of Health). The advertising of an MP cannot include information that does not comply with the Summary of the Product Characteristics (SmPC). This means a prohibition to promote medicines in their off-label indications, but also to include any other information that may be regarded as not complying with the SmPC. Claims in off-label indications, in which an MP is reimbursed in Poland, may also be considered illicit advertising due to incompliance with the SmPC, even if reimbursement (granted under a decision issued by the Minister of Health) is an official confirmation that the product may be used in such off-label indication. 

A pharmaceutical company which obtained a reimbursement decision for its product in an off-label indication or with a dosage scheme or other terms of treatment deviating from the SmPC may notify HCPs only through simple and objective notifications on reimbursement (eg, with a link to the reimbursement list or content of the drug programme), without any other promotional content or inducement to use the medicine in such newly reimbursed indication (or dosage form or other).  

Conveying scientific information on unauthorised medicines or unauthorised indications is accepted only as part of an exchange of information at scientific events. Sometimes, pharmaceutical companies sponsor presentations given by HCPs who address such topics. However, in such cases the HCPs are required to provide the full information on the current registration status of the medicine (making it clear that discussed claims relate to unauthorised indications or dosage forms, for example). 

Sending information on unauthorised medicines or unauthorised indications to HCPs should always be assessed taking into account the risk of it being considered advertising. In this respect, our comments included in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications and 5.2 Reference to Data Not Included in the Summary of Product Characteristics fully apply, irrespective of whether the provision of information to HCPs is done proactively or reactively.  

It should be noted that the sending of information reactively in response to a specific query may fall under one of the exceptions referred to in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information, provided that no promotional content or material accompanies it. 

The provision of information on unauthorised medicines or unauthorised indications is allowed only if explicitly addressed to HCPs. The provision of such information to administrative personnel of HCOs would not be allowed, regardless of the purpose.  

Compassionate use programmes are not yet officially allowed in Poland, however, a new draft law on clinical trials, published in January 2022, finally implement them into the Polish law. Their application will require a prior consent to be granted by the regulatory agency in Poland.  

Even after this law becomes binding, publishing information on the availability of treatment with a medicine which is not yet authorised, or one including an unauthorised indication (like in a compassionate use programme) will be illicit, since it would be considered forbidden advertising of a non-authorised medicine. Therefore, only HCPs treating patients will be allowed to inform patients about the availability of these programmes and the specific medicines used in them. 

However, if information on a compassionate use programme does not include any references to identifiable medicines, it may not be regarded as advertising at all (see our comments in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information). Similar comments would apply to early access programmes. 

The PhL provides for a number of general requirements with respect to the advertising of MPs, relating to both advertising to the general public and to HCPs, and the detailed restrictions that apply to advertising to the general public.  

General Requirements Applicable to Pharmaceutical Advertising 

Advertising of an MP cannot be misleading, should present the product objectively and encourage its rational use. It cannot be addressed to children or include any element addressed to them. It is also prohibited to conduct pharmaceutical advertising consisting of offering or promising any benefits (see also 8.1 General Anti-bribery Rules Applicable to Interactions between Pharmaceutical Companies and Healthcare Professionals and 8.2 Legislative or Self-Regulatory Provisions). Misleading advertising is one of the most common allegations and has been the grounds of numerous GIF decisions.   

The PhL allows for a so-called reminder, which is an additional advertising material that may follow a full advertisement. While the ordinary advertising should meet all the applicable requirements, a reminder should include only the name of the medicine, its international nonproprietary name and the trademark. It cannot include any claims, references to indications, pharmaceutical form, dosages or other promotional elements. 

Prohibition of Adverting of Certain Categories of Medicines to the General Public 

The prohibition to advertise to the general public covers:  

• prescription-only medicines (except for determined listed vaccinations);  
• MPs reimbursed from public funds; and 
• medicines containing psychotropic or narcotic substances.  

OTC MPs may be advertised to the general public, subject to a number of restrictions.  

Prohibited References and Prohibited Reliance on Authorities’ (Experts’) Opinions 

Advertising of a medicine to the general public cannot consist of: 

1. the presentation of the product by publicly known persons, scientists, persons with medical or pharmaceutical education or persons suggesting that they have such an education; or  

2. references to recommendations of persons listed in point 1.  

Advertising to the general public should contain, at least: 

• the name of the MP; 
• the name of the active substance, and in case of a product containing more than three active substances, the term: "composite product"; 
• the qualitative and quantitative composition of active substances(safe for a combination product); 
• the pharmaceutical form; 
• therapeutic indications; 
• contra-indications; and
• the name of the marketing authorisation holder (MAH). 

The above data must comply with the SmPC, or with the documentation approved in the process of granting the market approval (if there is no SmPC). 

The prices may be mentioned, but it is not required and the market practice in this respect varies.  

All advertising to the general public should be accompanied by special warnings that have a determined wording, varying slightly depending on the form of the dissemination (audio, audio-visual or visual). The essential wording in English would be: “Read the package leaflet or consult a doctor or pharmacist before use, as any medicine used improperly may threaten your life or health”.  

The Regulation provides for very detailed requirements concerning where these warnings should be placed, their minimum size and duration, etc (these depend on the form of dissemination).  

The advertising of an MP addressed to the general public cannot contain any material that suggests that: 

• a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;  
• the health of even a healthy subject can be improved by taking the medicine; 
• the health of the subject could be affected by not taking the medicine (this prohibition does not apply to vaccination campaigns);
• the MP is a foodstuff, cosmetic or other consumer product; and 
• the safety or efficacy of the MP is due to the fact that it is natural. 

The advertising of an MP addressed to the general public cannot contain any material that ensures that:  

• it implies that the effects of taking the medicine are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or MP; 
• it could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis; 
• it refers, in improper, alarming or misleading terms, to claims of recovery; and
• it uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of an MP on the human body or its parts. 

Apart from the prohibition to advertise prescription-only medicines to the general public, the binding laws in Poland do not include any provisions on interactions between the pharmaceutical industry and the patients.  

Instead, such interactions are the subject of provisions contained in the industry's ethical codes. The INFARMA Code broadly addresses the interactions of pharmaceutical companies with patients or patient organisations (PO). The aim of respective provisions is to ensure the independence (in terms of their judgement and activities) of the PO and transparency of such interactions (with regard to the objectives and scope of any collaboration). Such interactions should be based on mutual respect, with the views and decisions of each partner having equal value. They cannot concern promotion of MPs. Any financial and non-financial support provided must always be clearly acknowledged. The provision of financial or non-financial support to a PO, whether directly or indirectly (eg, through an advertising agency), requires the execution of a contract.  

Signatories of the INFARMA Code must not influence the text of PO material they sponsor in a manner favourable to their own commercial interests. This does not preclude them from correcting substantive errors in PO material. In addition, at the request of POs, they may co-operate in the preparation of material, always subject to the reservation that such co-operation must be fair and balanced from a scientific perspective.  

With respect to events organised or sponsored by or on behalf of a signatory of the INFARMA Code for POs (among others), see our comments in 9.3 Sponsorship of Scientific Meetings.  

The INFARMA Code also prohibits the donation of gifts to PO personnel and provides for terms and conditions of grants and donations to POs and sponsorship of PO personnel attending events (see our comments in 9.1 Gifts to Healthcare Professionals and 9.3 Sponsorship of Scientific Meetings that would also apply to interactions with POs).  

All advertising, including that addressed to HCPs, must meet the requirements referred to in 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public.  

The following persons would be entitled to review the advertising dedicated to HCPs:

• physicians;
• certain nurses (meeting determined criteria) who are authorised to issue prescriptions for determined medicines; and
• persons dealing with the supply of MPs (in particular, pharmacists). 

One of the key requirements for advertising to HCPs is that it includes information compliant with the SmPC. It should also contain information on the supply classification of the product and, in the case of reimbursed products, its official retail price and the maximum amount of patient co-payment (in practice, for pharmacies’ medicine, this amount will be the fixed amount rather than the maximum). Therefore, the retail price must only be provided in the case of reimbursed medicines.  

Any documentation delivered to HCPs (relating to the advertising of an MP) should include data which are accurate, up-to-date, verifiable and complete enough to permit its addressee to assess the therapeutical features of the medicine on by themselves. It should also state the date on which the documentation was drawn up or last revised. Quotations, tables and drawings originating from scientific journals or other scientific works should be faithfully reproduced and include respective references.  

Any promotional material addressed to HCPs should include: 

• the name of the MP and its common name; 
• the qualitative and quantitative composition of the excipients and the additives which are essential for the proper administration of the product; 
• the pharmaceutical form; 
• therapeutic indications or indications for use; 
• dosages and method of administration; 
• contra-indications; 
• special warnings and precautions for use; 
• adverse reactions; 
• the MAH; and 
• the marketing authorisation number  and the name of the authority granting it. 

It should also be noted that ethical codes (such as the INFARMA Code) include numerous and detailed provisions concerning advertising to HCPs.  

It is quite common in the advertising of MPs to include references to various clinical studies. However, this is only allowed under a condition that data, information or sources to be referred to must be verifiable for the recipient of the advertising. Referenced clinical studies do not have to be included in the SmPC. In addition, any claims, including any outcomes or findings from referenced clinical trials, must be compliant with the SmPC. This does not mean that any information or claims must reproduce the wording of the SmPC, however, such information or claims should confirm or provide more details in relation to the information included in the SmPC; they must be consistent with and not distort the information.  

If the outcomes of the clinical trials are not consistent with the content of the SmPC of the advertised medicines, these cannot be quoted, referred to or even discussed in the advertising. Any claims relying on such outcomes may only be the subject of scientific papers or materials addressed to HCPs. It is prohibited to include these in any advertising materials and the Polish supervisory authority is very strict in this respect.  

Considering that all data referenced in the advertising addressed to HCPs should be verifiable and accessible, enabling the recipient to form its own judgement, references to data on file, even if consistent with the SmPC, are prohibited.  

The advertising of combination products relying on claims not included in the SmPC may be considered as advertising incompliant with SmPC and, therefore, prohibited. In this respect, our comments in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications and 5.2 Reference to Data Not Included in the Summary of Product Characteristics fully apply.

With respect to a companion diagnostics, it should be clear to the recipient that such a diagnostics is not a part of the MP (the advertising should not be misleading), in particular, it should not mislead the user or the patient with regard to the device's intended purpose, safety and performance. In the case of any claims on a diagnostic device, the applicable requirements for advertising medical devices should be met. 

Pharmaceutical companies may provide reprints of journal articles to HCPs. However, should these include any claims on an MP that could be considered as inconsistent with its SmPC, these reprints cannot be accompanied by any promotional materials or content concerning this product.  

In contrast, should the claims on an MP included in such reprints confirm or clarify in more detail the data and information included in the SmPC, without distorting, challenging or arguing with these, these reprints may be accompanied by promotional materials concerning the medicinal product. Such accompanying materials should meet all requirements applicable to advertising to HCPs.  

In principle, Medical Science Liaisons (MSLs) (usually called Medical Directors, or Directors for Medical Affairs) would be allowed to engage in the exchange of scientific information with HCPs. However, information provided by MSLs, should it include any claims on unauthorised medicines or unauthorised medications, cannot contain any promotional content and should be clearly separated from the promotional and supply activities of the company, otherwise there is a risk that it might be considered prohibited off-label advertising. 

In Poland, there is no obligation to seek prior authorisation from a regulator or to make any notification of an anticipated advertising. Ensuring that advertising is compliant with the applicable requirements is the exclusive responsibility of the MAH.  

The PhL provides for a general obligation on the MAH to ensure that any advertising conducted by it is compliant with the regulatory requirements. More specific provisions require that the MAH employs, for positions of medical and marketing representatives, only persons possessing sufficient scientific knowledge enabling them to convey complete and accurate information about promoted MPs (no other specific qualifications are required). The MAH is also required to employ someone to be responsible for providing information about the MPs placed on the market by the MAH (again, no specific qualifications are required).  

The MAH should store mock-ups (samples) of any advertising for two years following the end of the calendar year in which the advertising was distributed (published) and ensure that any decisions of the supervisory authority are enforced without delay. Only the MAH, or an entity acting on behalf of the MAH, may engage in pharmaceutical advertising.  

Polish law does not require MAHs to adopt any specific policies or procedures regarding the approval of advertising. In practice, most firms voluntarily (or following the requirements of applicable ethical codes) adopt standard operating procedures regulating the internal process of approving all promotional materials and dedicate personnel to review the promotional materials. Detailed responsibilities of such personnel and the approval process are usually clearly defined in SOPs or other internal policies.  

The INFARMA Code includes numerous provisions regarding the obligations of MAHs aimed at ensuring compliance with the regulatory requirements, such as: 

• the MAH’s personnel should be trained and familiar with the requirements in accordance with the Code and with the applicable laws; and 
• the MAH must establish a service (eg, medical department) with appropriate scientific knowledge to be in charge of information about its MPs and the approval of promotional materials.  

The MAHs are free to decide how best to establish such service(s) (ie, whether there is one service in charge of both duties or separate services with clearly delineated duties), taking into account their own resources and internal organisation. The scientific service must include a medical doctor or, where appropriate, a pharmacist. 

In line with the INFARMA Code, all promotional materials must be approved for compliance with the Code, applicable laws and the SmPC; such approval should also ensure fair and truthful presentation of the facts about the MP. The Code also includes detailed requirements regarding medical representatives employed by the MAHs. 

There are no specific regulatory requirements applicable to the adverting of medicines on the internet. Therefore, it should meet respective regulatory requirements applicable to advertising.  

In the case of advertising addressed to HCPs (eg, advertising of prescription-only medicines), MAHs are required to ensure that their online advertisement is accessible only to HCPs, however, the regulatory provisions do not include any specifics with regard to how to restrict the access.  

In many cases the GIF held that restrictions adopted by MAHs were insufficient. In particular, if access to restricted content required that the viewer simply answered “yes” to a question of whether they are an authorised HCP, this was considered incompliant. Promotion on the internet, access to which was only restricted that way, was considered to be addressed to the general public, so if it concerned a prescription-only medicine, this resulted in the issuing of a decision ordering such advertising be immediately removed.  

In practice, a very commonly used restriction is an obligation not only to confirm that the recipient is a HCP, but also to enter the physician’s licence number. However, since this number is available in a public register, the risk that this will also be held insufficient cannot be fully excluded.  

Polish law does not include any provisions on medicinal advertising on social media. Therefore, all the regulatory requirements, without any exception, would also apply to such advertising.  

Considering the general prohibition to promote prescription-only MPs to the general public, any promotional content concerning such MPs on social media will, in principle, be illicit (unless sufficient measures permitting restricted access to specific groups would be implemented).  

Advertising of OTC medicines on social media should meet applicable requirements, including those on the required content of the advertising medicine and warnings (see 4.2 Information Contained in Pharmaceutical Advertising to the General Public). Pharmaceutical companies, if using social media, do not place any content relating to specific products, but rather general information on diseases or health, or their other activities (eg, corporate social responsibility). A company’s corporate advertising on social media is permitted. 

The INFARMA Code includes detailed guidelines for its signatories, split into various digital channels (social media, blogs, podcasts, webinars, direct channels and discussion forums). One guideline is to ensure transparency; in particular, if the pharmaceutical company has sponsored a communication or materials concerning MPs this should be clearly indicated. The signatory of the Code should be able to differentiate what content is appropriate for the different digital channels and the respective audiences. All laws and regulations in this regard must be complied with in the same way as for other media.  

Information made available via a digital channel should be regularly updated and should clearly display, for each page or item, as applicable, the  date on which such information was most recently updated. Whenever a company provides information on a digital channel, its involvement should be clearly stated. With respect to social media described in the Code as websites or applications on which people can interact on social networks (eg, Facebook, Twitter, Snapchat, LinkedIn, YouTube, Instagram), they are considered to be aimed at the public and therefore used to reach or interact with the public. A social media platform can also be a closed channel for a targeted audience where the verification of the audience is required before providing access. 

Pharmaceutical companies are required to ensure the restriction of access on websites containing advertising or other information intended for HCPs. There is no specific provisions in Polish law besides the general requirement that advertising intended for HCPs should be disclosed in a manner not permitting access of persons to whom it is not addressed.  

In practice, usually only the content of patient leaflets and SmPCs is disclosed on pharmaceutical companies' websites, without any promotional content. Such promotional content appears in magazines and medical journals in their online editions, at virtual stands or online events, etc. It is a market standard to require the user, before granting access to online content potentially containing medicinal advertising or information concerning prescription-only medicines, to confirm their professional status as a HCP and to enter the physician's licence number. Please also see 7.1 Regulation of Advertising of Medicinal Products on the Internet for more detailed comments in this respect.  

Pharmaceutical companies are allowed to provide disease awareness information or materials to patients online, however, the risk of regarding the material as pharmaceutical advertising should always be considered. In particular, it is important to observe the strict prohibition to address all advertising of prescription-only medicines, products containing psychotropic and narcotic substances, and reimbursed products to the general public.  

With regard to OTC products, if material or information made available online allows a specific MP to be identified and it may be considered promotional, all requirements applicable to pharmaceutical advertising should be observed. In this respect, our comments included in 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public and 4.2 Information Contained in Pharmaceutical Advertising to the General Public will fully apply.  

Online scientific meetings are not regulated in Poland. Therefore, general rules on the exchange of scientific information (see 3.2 Provision of Information during a Scientific Conference), promotion of MPs to HCPs (see 5. Advertising to Healthcare Professionals), and sponsorship of scientific events attended by HCPs, would apply here (see 9.3 Sponsorship of Scientific Meetings). Such online meetings are commonly held, especially during the COVID-19 pandemic, and pharmaceutical companies do sponsor such events or HCPs’ attendance.

General anti-bribery rules included in Polish law apply to interactions between pharmaceutical companies and HCPs or HCOs. First, both the provision and promise of a bribe (a material or a personal benefit) to a public official (an individual) in relation to their official position is a crime penalised in the Polish Criminal Code. In certain cases, HCPs may be considered as public officials. The Criminal Code does not include specific provisions on bribing HCPs. 

The Reimbursement Act is more specific in this respect, but only penalises activities related to reimbursed products (including MPs). It includes several provisions severely penalising the provision, promise or acceptance of a material or personal benefit in relation to the procurement or supply of reimbursed MPs or in exchange for activities affecting the supply of such MPs, or in exchange for issuing prescriptions.  

In line with the PhL, the advertising of MPs cannot consist of offering or promising to offer any benefits, either directly or indirectly, in exchange for an acquisition of an MP, or delivery of proofs confirming such acquisition. Another provision states that it is strictly forbidden to address any advertising consisting of providing, offering or promising any material benefits, gifts (for exceptions, see our comments in 9.1 Gifts to Healthcare Professionals) or any other bonuses, awards, trips, or to organise or sponsor any kind of promotional meetings where hospitality exceeds the main purpose of such meeting to any persons authorised to issue prescriptions (HCPs) or persons dealing with the supply of MPs. It is also illicit to accept such benefits.  

These provisions are aimed at prohibiting the provision of any inducement to prescribe or supply MPs, and mainly concern inducements to individual recipients; however, the GIF’s practice suggests that this prohibition may also be applied to inducements addressed to entities supplying MPs.   

The INFARMA Code also contains a number of provisions on prohibited inducements in relation to HCPs. The following activities cannot constitute an inducement to recommend or prescribe, purchase, supply, sell or administer specific MPs:  

• grants and donations;  
• contracts executed with HCPs, HCOs and POs or POs’ representatives, and related to the retaining of the given person to provide the relevant service; and  
• provision of informational or educational materials and items of medical utility (defined in the Code). 

Medical representatives are prohibited from using any inducement to gain a meeting.  

Permitted hospitality at sales meetings and scientific events is described in 9.3 Sponsorship of Scientific Meetings. The PhL allows for the provision of items whose material value (including VAT) does not exceed PLN100 (approximately EUR22), provided that they are relevant to the practice of medicine or pharmacy and are branded with the company’s or product's logo. In line with the GIF’s decisions, the market value of such items is taken into account and not the actual paid price. 

The INFARMA Code explicitly prohibits the provision of gifts. Gifts of a personal nature (eg, tickets for sports events or entertainment, presents marking milestones or occasions) may not be given, whether directly or indirectly, to HCPs, HCO personnel or PO personnel. Giving or offering of cash, cash equivalents, and of personal benefits is also prohibited.  

The Code’s provisions are more stringent with regard to small items of insignificant value than the regulatory requirements. A gift of a promotional character is an object given for promotional purposes (other than the educational materials specified in the Code). In the context of the promotion of MPs, presenting or offering such objects to HCPs, HCO staff, or PO representatives, is entirely prohibited. The Code makes the only exception for ballpoint pens, notebooks, tote bags or folders of insignificant value inscribed with company logos. Only these items may be provided for note-taking in the course of meetings organised exclusively by a signatory of the Code. 

The PhL allows for the distribution of free samples of MPs to HCPs, under certain conditions. First, it is forbidden to distribute samples of medicines containing psychotropic or drug substances. Both prescription-only and OTC medicines may be sampled. Secondly, free samples can only be provided in response to a written request from a physician, addressed to a medical or sales representative. Those supplying samples are required to keep records of dispensed samples.  

The number of samples of each medicinal product is limited to five packs per year. Each sample should be no bigger than the smallest presentation authorised in Poland (which means that only the smallest authorised presentation can be a free sample). This requirement poses practical problems, especially if the smallest authorised presentation is not available on the market for any reason (Directive 2001/83/EC requires that each sample is identical to the smallest presentation on the market, which allows the use of the smallest available presentations, even if a smaller one has also been authorised). It is illicit to sample blister foils alone or divide presentations for sampling purposes. The sample should be marked “free sample – not for sale” and shall be accompanied by a copy of the SmPC.  

The provisions of the INFARMA Code include a number of more stringent provisions regulating sampling.  

Pharmaceutical companies are allowed to sponsor scientific meetings or congresses. Similarly, sponsoring HCPs’ attendance at these events is permitted. Certain conditions apply to both categories of sponsorship, however, while the legal provisions are very general, the ethical guidelines and market practices are much stricter.  

The PhL’s provisions are rather limited and general. They state only that it is not permitted to organise or sponsor promotional meetings providing hospitality exceeding the purpose of such meetings. They do not mention scientific events, however, in practice these principles also apply to such events.  

Excessive hospitality is, therefore, prohibited. The market practice and ethical codes allowed for the elaboration of detailed rules on how permitted hospitality should be understood. It is broadly admitted that such events should be held in locations and venues which are not extravagant, luxurious, or tourist attractions. Pharmaceutical companies should only cover limited expenses connected with attending such events, ie, participation fees, accommodation, meals and travel expenses. They should not sponsor any additional extraordinary attractions or entertainment that may accompany such events, and they should not cover any costs of HCPs’ family members or companions attending the event.  

The INFARMA Code includes numerous provisions regarding sponsorship of events and permitted hospitality. In line with these, any events organised or sponsored by or on behalf of a signatory of the Code for HCPs, HCOs, and POs must be held in locations and venues conducive to the main purpose of the event, avoiding those that are generally seen as “renowned” for their entertainment facilities or as “extravagant”. A signatory of the Code may not organise or sponsor an event to be held outside Poland unless organisation of the event abroad is justified by organisational or substantive considerations such as: most of the invitees are from outside Poland, or availability of resources or specialised expertise in the given location. Hospitality may not be excessive – the INFARMA auxiliary criteria concerning classification of hospitality at venues define the INFARMA procedures for events certification.  

Hospitality offered to events’ participants should be reduced to covering the cost of travel, meals, accommodation and registration fees associated with participation in the substantive part of the event. Signatories of the Code may not provide or offer to HCPs, HCO personnel or PO representatives any meals (food and beverage) the value of which, per person and per meal, exceeds the limits defined in accordance with the host country principle (PLN200, VAT included – for meals offered in Poland).  

Hospitality may only be extended to entitled event participants, and not to persons accompanying them or to their family members. Travel, meals, accommodation and registration fees entailed in the participation in the event of an accompanying person may only be covered on the same terms in exceptional cases associated with health reasons (eg, disability or injury).

Considering the restrictions regarding permitted hospitality at scientific events attended by HCPs, pharmaceutical companies are not allowed to organise or sponsor cultural, sports or other non-scientific events in relation to scientific conferences, even if the regulatory provisions do not include details of permitted hospitality. 

According to the INFARMA Code, hospitality may not include sponsoring or organisation of entertainment (eg, sports events or recreation).  

The regulatory provisions do not address grants or donations to HCPs or HCOs. In principle, grants and donations to an individual HCP will not be permitted, considering that they will be considered an inducement to prescribe MPs, or a prohibited benefit. In contrast, grants and donations to HCOs will be considered permitted, but certain conditions should be met to avoid an allegation of illicit inducements.  

Once again the provisions of the INFARMA Code include useful guidelines that may be used by a pharmaceutical company wishing to provide a grant or donation. First, the Code clearly prohibits any grant or donation from being provided to individuals. Grants and donations are only allowed if they:

• are made for a clearly defined purpose of supporting healthcare, research or education;
• are documented and kept on record by the donor or grantor; and
• do not constitute an inducement to recommend or prescribe, purchase, supply, sell or administer specific MPs.  

The PhL's provisions regulating pharmaceutical advertising do not include any restrictions on the right to give rebates or discounts to HCPs or HCOs, especially in the context of the prohibition to provide any benefits or inducement (there is no provision reflecting the one included in Directive 2001/83 stating that existing measures or trade practices relating to prices, margins and discounts should not be affected by provisions prohibiting benefits or inducements). However, it is widely accepted that giving rebates or discounts is an ordinary market practice and does not constitute the provision of prohibited benefits or inducement. Notwithstanding, HCPs may only purchase a limited portfolio of MPs (the supply in MPs is channelled through pharmaceutical wholesalers and pharmacies).  

In principle, the Reimbursement Act prohibits the provision of rebates and discounts with regard to products that are the subject of reimbursement, regardless of the beneficiary of such rebates or discounts.  

Pharmaceutical companies are allowed to pay for the services provided by HCPs, in exchange for the services provided.  

The regulatory provisions do not include any details of possible co-operation between pharmaceutical companies and HCPs. However, it should be taken into account that any payment made to a HCP should be in exchange for a real service that this company requires, and it should reflect the market value of this service, otherwise there is a risk to hold that such payment has been made as an inducement to increase sales of an MP, or other similar activities, which could be qualified not only as a violation of the PhL, but even, in certain circumstances, as a bribe (see 8.1 General Anti-bribery Rules Applicable to Interactions between Pharmaceutical Companies and Healthcare Professionals and 8.2 Legislative or Self-Regulatory Provisions).  

The INFARMA Code includes detailed rules of contracting services from HCPs, HCOs, POs and/or PO representatives. Contracting would only be allowed if the services are provided for the purpose of supporting healthcare, research or education, and do not constitute an inducement to recommend or prescribe, purchase, supply, sell or administer specific MPs. The services may concern the provision of services of experts, advisors or consultants, services such as speaking at, or chairing meetings, involvement in medical or scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research. 

The INFARMA Code includes a number of requirements concerning the content of the contracts for such services (they should be concluded in writing, before the services are delivered, their scope and respective fee should be provided).  

The criteria for selecting service providers should be directly related to the identified need; persons responsible for selecting them should have the expertise necessary to evaluate whether a particular individual meets those criteria. Documentation concerning the contract should be kept. The retention of the given person to provide the relevant service may not be an inducement to recommend or prescribe, purchase, supply, sell or administer a particular medicinal product; remuneration should reflect the fair market value of the services. Pretended contracts executed for the sole purpose of contriving a basis for payments to HCPs or PO representatives are prohibited. 

Signing a contract with a HCP does not require employer consent or regulatory authority approval.  

Instead, the INFARMA Code requires that its signatories, whenever they employ HCPs on a part-time basis who are still practising their profession, obligate such persons to declare their employment arrangements with the signatory of the Code whenever they write or speak in public about a matter that is the object of their retention, or any other matter relating to that signatory of the Code and to notify this fact to their employers and to other entities if such person represents the interests of their employer.

There are no regulatory provisions requiring pharmaceutical companies to disclose details of transfers of value to HCPs or HCOs.  

This obligation has been provided for in the INFARMA Code. Its signatories must provide, on an individual basis for each clearly identifiable recipient (including HCP and HCO), information about the amounts attributable to determined transfers of value to the recipient for each calendar year. The transfer of value, with regard to HCPs, covers the contribution to costs related to events (such as sponsorship of HCPs' attendance to such events), and fees paid to HCPs for their services and consultancy.   

In cases where information about a transfer of value cannot be disclosed individually, they should be disclosed on a collective basis. Information on transfers of value related to research and development is provided on an aggregate basis.  

Transparency requirements are only applicable to signatories of the INFARMA Code, they are not regulatory requirements. The Code only applies to signatory pharmaceutical companies whose registered seats are in Poland. Whether a medicinal product has already been placed on the Polish market is not relevant in this regard.  

The responsibility for enforcing the rules on advertising in Poland is on the GIF as the head of pharmaceutical inspection. Its detailed and numerous tasks, including supervision of pharmaceutical advertising, are determined in the PhL.  

The GIF issues administrative decisions in which it may order: 

• that the dissemination of pharmaceutical advertising held incompliant with the regulatory requirements is stopped; 
• that the decision ordering that incompliant advertising is stopped is disseminated where the incompliant advertising was initially disseminated;  
• a rectification of the advertising which included errors; and  
• all infringements in the advertising are removed.  

All the above decisions are immediately effective. In practice, the vast majority of all decisions issued by the GIF order that the dissemination of a pharmaceutical advertising held incompliant with regulatory requirements is immediately stopped.  

Proceedings before the GIF in cases regarding medicinal advertising are initiated by the authority ex officio. In fact, they are often initiated following a letter from a competitor. The letter is not a formal complaint, and the competitor will not be a party to such proceedings or be notified of the final decision.  

It is common to bring lawsuits against competitors under the Law on preventing unfair competition. First, an interim injunction is sought and, finally, a court judgment ordering the adverting infringing a competitor’s interests be stopped. The possibility of obtaining an interim injunction is attractive since it can be obtained relatively quickly.

The PhL provides for a number of criminal sanctions for breaching determined provisions on advertising.  

A fine (up to PLN1, 080 000) may be imposed on those who: 

• as part of pharmaceutical advertising, deliver or promise to deliver material benefits to HCPs (persons authorised to issue prescriptions) or persons dealing with the supply of MPs;  
• promote MPs while not being an entity authorised to conduct pharmaceutical advertising;  
• promote medicines which are not authorised on the territory of Poland;  
• conduct advertising incompliant with the SmPC; 
• do not keep the mock-ups (samples) of the advertising materials which were distributed or published; 
• do not keep records of the distributed samples;  
• do not comply with the decision of the supervisory authority concerning incompliant advertising;  
• distribute samples to unauthorised persons; and 
• address advertising of prescription-only medicines, reimbursed medicines, or medicines containing psychotropic or narcotic substances to the general public.  

Proceedings before the GIF are administrative proceedings. A party that is not happy with the decision it received may apply for a reassessment of the matter (no appeal is available).  

A company that does not agree with a decision issued by the GIF (the initial one or the one issued following the application for the matter to be reassessed) may file a complaint to an administrative court. Administrative courts do not issue material judgments (they cannot modify an administrative decision), they may just waive the decision which was held breaching a material or a procedural provision, so the matter is reassessed by the authority who issued it. A party has a right to appeal against a judgment of the administrative court to the Supreme Administrative Court.  

The vast majority of decisions issued by the GIF concern the following allegations:

• misleading advertising;
• advertising to the general public of prescription-only medicines (following insufficient restriction of access to such advertising); or
• provision of information incompliant with the SmPC or exceeding or modifying the SmPC.

There has been no change in this trend.  

For many years, decisions of the GIF were published and disclosed on the authority's website. Since April 2020, decisions concerning pharmaceutical advertising are no longer published.