Pharmaceutical Advertising Laws and Regulations Report 2024 Poland
1. General – Medicinal Products
1.1 What laws and codes of practice govern the advertising of medicinal products in your jurisdiction?
Advertising of medical products is regulated in both statutory law and soft law. It should be pointed out that the main role in the Polish legal order will be played by statutory law.
In relation to statutory law:
- The Pharmaceutical Law Act of 6 September 2001 (Dz.U. z 2024 r. poz. 686) (Pharmaceutical Law).
- The Regulation of the Minister of Health of 21 November 2008 on the advertising of medicinal products (t.j. Dz. U. z 2023 r. poz. 1648) (Regulation of the Minister of Health on the advertising of medicinal products).
In Poland, there are also organisations of medical product manufacturers that adopt acts that are binding on the organisation’s members, e.g. the Code of Good Practice adopted by INFARMA. Despite the fact that, formally, the above acts apply only to members of the organisation, they are widely acclaimed in the producer community.
1.2 How is “advertising” defined?
The statutory definition of “advertising” is defined broadly by the legislature. As defined in Article 52(1) of the Pharmaceutical Law, advertising a medicinal product is the activity of informing or encouraging the use of a medicinal product with the aim of increasing the number of prescriptions, supply, sales or consumption of medicinal products.
Moreover, the legislator in Article 52(2) lists what “advertising” specifically includes. It is, for example, advertising of a medicinal product to the public, advertising of a medicinal product directed to persons authorised to issue prescriptions or those who trade in medicinal products or sponsorship of conferences, conventions and scientific congresses for persons authorised to issue prescriptions or those who trade in medicinal products.
1.3 What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as “sign off” of promotional copy requirements?
The law imposes an obligation on the responsible entity to conduct advertising of a medicinal product or on its order. It is the responsibility of the medicinal entity to ensure that advertising complies with the law. In addition, the responsible entity must employ, as medical and sales representatives, persons who have sufficient scientific knowledge to provide the most complete and accurate information about the advertised medicinal product. Moreover, some soft laws, for instance the Code of Pharmaceutical Marketing Ethics, make it mandatory to hire qualified personnel responsible for approving promotional materials before distribution.
1.4 Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities or to employ personnel with a specific role? If so, what aspects should those SOPs cover and what are the requirements regarding specific personnel?
In addition to the aforementioned duties, the Polish pharmaceutical law system does not introduce any specific SOPs governing advertising activities or the employment of personnel with specific roles. The Code of Pharmaceutical Marketing Ethics requires that advertisements be approved prior to distribution by qualified personnel, which should include a physician or, if warranted, a pharmacist as well as another person with sufficient knowledge to determine whether the promotional material meets the conditions set forth in the Pharmaceutical Law and this Code. Such a person should certify that he/she has reviewed the final version of the promotional material and that, in his/her opinion, this version complies with the requirements of the Code and the relevant advertising laws, is consistent with the Summary of Product Characteristics (SmPC), and that it fairly and faithfully presents the facts about the drug.
1.5 Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?
Polish law does not require regulatory approval of promotional materials. Industry codes of ethics govern the need for approval and procedures for advertising materials.
1.6 If the authorities consider that an advertisement which has been issued is in breach of the law and/or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal?
According to Article 62 of the Pharmaceutical Law, the Chief Pharmaceutical Inspector is the authority supervising compliance with the Pharmaceutical Law’s advertising regulations. He may, by decision, order the:
- cessation of the appearance or conduct of advertising of medicinal products contrary to the regulations in force;
- publication of the issued decision in places where advertising contrary to the applicable regulations has appeared, and publication of a correction of the erroneous advertising; and
- removal of the violations found.
It is also worth noting that the decisions listed in items (1) and (3) are immediately enforceable.
The above decisions may be appealed against with a request for reconsideration or a complaint to the Provincial Administrative Court in Warsaw.
As for the disciplinary courts operating at associations, they are tasked with ensuring that association members comply with the advertising codes. If a member of an association is found to have flagrantly violated the provisions of the association’s statutes or resolutions of the association’s bodies, the disciplinary court of first instance may decide to strike off the association’s list of members and make this fact public through an announcement in the national press and the posting of relevant information on the association’s website.
1.7 What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? If there have not been such cases, please confirm. To what extent may competitors take direct action through the courts in relation to advertising infringements?
In addition to the above-mentioned decisions of the Chief Pharmaceutical Inspector, anyone who, without being authorised, conducts advertising of medicinal products is subject to a fine, and the same penalty is imposed on anyone who does not immediately carry out decisions ordering the:
- cessation of the appearance or conduct of advertising of medicinal products in violation of applicable regulations;
- publication of the issued decision in the places where the advertisement contrary to the applicable regulations appeared, and publication of a correction of the erroneous advertisement; and
- removal of the violations found.
Moreover, under Article 24(2) of the Law on Competition and Consumer Protection, the President of the Office of Competition and Consumer Protection (OCCP) may impose a penalty of up to 10% of a given entrepreneur’s turnover in the previous year for violating the collective interests of consumers, for example, by violating the obligation to provide consumers with fair and complete information and unfair trade practices.
Competitors can take action in court under the Unfair Competition Law.
1.8 What is the relationship between any self-regulatory process and the supervisory and enforcement function of the competent authorities? Can and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self-regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body?
The Chief Pharmaceutical Inspector is a body appointed by the Prime Minister, from among persons selected through open and competitive recruitment, on the proposal of the Minister responsible for health. It is independent of self-regulatory bodies. The Chief Pharmaceutical Inspector may be informed and act on the decisions of self-regulatory bodies, but they are not binding on him.
1.9 In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action?
As a rule, the main body supervising the advertising activities of pharmaceutical companies is the Chief Pharmaceutical Inspector. However, if there is a violation of the interests of competition, the court may also take appropriate action.
In addition, it is possible to file a complaint with the President of the OCCP.
If an act of unfair competition is committed, the entrepreneur whose interest has been threatened or violated may demand:
- abandonment of the prohibited acts;
- removal of the consequences of the prohibited actions;
- one or more statements of appropriate content and form;
- reparation of the damage caused, on general principles;
- surrender of unjustly obtained benefits, on general principles; and
- award of an appropriate sum of money for a specific social purpose related to the promotion of Polish culture or protection of national heritage – if the act of unfair competition was culpable.
The basis for the above claims is the Act on Combating Unfair Competition.
An act of unfair competition is defined as an act contrary to the law or morality, if it threatens or infringes the interest of another entrepreneur or customer.
The above claims shall be adjudicated in court proceedings.
2. Providing Information Prior to Authorisation of Medicinal Product
2.1 To what extent is it possible to make information available to healthcare professionals about a medicine before that product is authorised? For example, may information on such medicines be discussed, or made available, at scientific meetings? Does it make a difference if the meeting is sponsored by the company responsible for the product? Is the position the same with regard to the provision of off-label information (i.e. information relating to indications and/or other product variants not authorised)?
At the outset, it should be noted that, in accordance with Article 129 of the Pharmaceutical Law, anyone who conducts advertising of medicinal products not authorised for marketing on the territory of the Republic of Poland is subject to a fine.
Polish law does not prohibit conducting and organising meetings concerning medicinal products not authorised for marketing on the territory of the Republic of Poland, as long as they do not fulfil the prerequisites to consider such a meeting as advertising.
Meetings to discuss advances related to unregistered drugs may be held as long as they do not constitute advertising. Sponsorship of such meetings by product-responsible companies is considered advertising and is therefore prohibited.
On the other hand, as for the sponsorship of conferences, conventions and scientific congresses for persons authorised to issue prescriptions or for persons marketing medicinal products, which will concern medicinal products not authorised for marketing in the Republic of Poland, they will be considered advertising in accordance with Article 52(2)(6) of the Pharmaceutical Law.
2.2 May information on unauthorised medicines and/or off-label information be published? If so, in what circumstances?
Polish law does not prohibit the publication of information on drugs not approved for marketing in the Republic of Poland. However, the information must not fulfil the prerequisites to qualify as advertising within the meaning of the Pharmaceutical Law. Such information can be published at least in the form of correspondence, accompanied by non-promotional information materials necessary to answer questions about a specific medicinal product.
If the publication is accompanied by scientific data, analysis or research results taken from literature or scientific journals in order to facilitate the verification and assimilation of the information presented in the advertisement of a medicinal product, they should be provided in the content consistent with the original, along with their source and the date of publication or last update.
2.3 Is it possible for companies to issue press releases about unauthorised medicines and/or off-label information? If so, what limitations apply? If differences apply depending on the target audience (e.g. specialised medical or scientific media vs. mainstream public media), please specify.
Public press releases regarding unauthorised medicines and/or off-label information will be prohibited, in this regard, as they should be considered advertising under the Pharmaceutical Law. If, on the other hand, such information does not meet the prerequisites for it to qualify as an advertisement, then it is legal.
2.4 May such information be sent to healthcare professionals by the company? If so, must the healthcare professional request the information?
If such information does not have the character of advertising under the Pharmaceutical Law, it is not prohibited to spread it, even without a request from a healthcare professional.
2.5 How has the ECJ judgment in the Ludwigs case, Case C-143/06, permitting manufacturers of non-approved medicinal products (i.e. products without a marketing authorisation) to make available to pharmacists price lists for such products (for named-patient/compassionate use purposes pursuant to Article 5 of the Directive), without this being treated as illegal advertising, been reflected in the legislation or practical guidance in your jurisdiction?
Currently, according to Article 52(3)(4) of the Pharmaceutical Law, such action does not constitute advertising.
2.6 May information on unauthorised medicines or indications be sent to institutions to enable them to plan ahead in their budgets for products to be authorised in the future?
This action will constitute advertising under the Pharmaceutical Law and is therefore prohibited.
2.7 Is it possible for companies to involve healthcare professionals in market research exercises concerning possible launch materials for medicinal products or indications as yet unauthorised? If so, what limitations apply? Has any guideline been issued on market research of medicinal products?
Polish law does not regulate this. Industry codes of good practice permit such practices. Arrangements for the provision of such services should be in writing or documented whether there should be a legitimate need for such services.
3. Advertisements to Healthcare Professionals
3.1 What information must appear in advertisements directed to healthcare professionals?
Advertising directed to healthcare professionals first of all must comply with the Pharmaceutical Law.
In addition, according to §12 of the Regulation of the Minister of Health on the advertising of medicinal products, advertising of a medicinal product directed to healthcare professionals must contain the following data:
- the name of the medicinal product and the name commonly used;
- qualitative and quantitative composition with respect to active substances and those excipients that are important for the proper use of the medicinal product;
- pharmaceutical form;
- indication or therapeutic indications for use;
- dosage and method of administration;
- contraindications;
- special warnings and precautions for use;
- adverse reactions;
- indication of the responsible party;
- the number of the marketing authorisation and the name of the authority that issued it; and
- information on the granted category of availability.
Special requirements as to the form of advertising directed to healthcare professionals are also set by a reference to the Pharmaceutical Law, which stipulates that in the case of medicinal products included in the lists of reimbursed drugs – also information on the official retail price and the maximum amount of the surcharge borne by the patient.
3.2 Are there any restrictions on the information that may appear in an advertisement? May an advertisement refer to: (a) studies not mentioned in the SmPC; or (b) studies which have not been published either in peer-reviewed journals or at all (“data on file”)?
First of all, based on Article 56(2), a contrario of the Pharmaceutical Law, it should be pointed out that advertising of medicinal products must contain information in accordance with the Characteristics of Medicinal Products.
Pursuant to §5 of the Regulation of the Minister of Health on the advertising of medicinal products, scientific data or analyses and studies must be provided in content consistent with the original, along with their source and date of publication or last update. Accordingly, the use of such studies will be legal as long as they comply with the SmPC.
Moreover, under Article 55(2) of the Pharmaceutical Law, advertising directed to the public may not contain content that:
- suggest that:
- it is possible to avoid medical advice or surgery, especially by making a diagnosis or recommending treatment by correspondence;
- even a healthy person taking the medicinal product will improve his/her health;
- not taking a medicinal product may worsen a person’s health condition (this proviso does not apply to vaccinations);
- the medicinal product is a foodstuff, cosmetic product or other article of consumption; or
- the efficacy or safety of the medicinal product is due to its natural origin;
- ensure that taking the medicinal product guarantees the right effect, is not accompanied by any side effects or that the effect is better or the same as with another treatment or treatment with another medicinal product;
- may lead to misdiagnosis by citing detailed case descriptions and disease symptoms;
- refer in an inappropriate, alarming or misleading form to therapeutic indications; or
- contain inappropriate, alarming or misleading terms for graphically depicted lesions, injuries to the human body or effects of the medicinal product on the human body or its parts.
3.3 Are there any restrictions to the inclusion of endorsements by healthcare professionals in promotional materials?
Pursuant to Article 55(1)(1) of the Pharmaceutical Law, advertising of a medicinal product to the public may not consist of the presentation of a medicinal product by persons known to the public, scientists, persons with medical or pharmaceutical training or persons suggesting that they have such training.
3.4 Is it a requirement that there be data from any, or a particular number of, “head to head” clinical trials before comparative claims may be made?
There is no such requirement in Polish law. The only requirements that are placed on this by industry codes of good practice include the requirement that the comparison of selected features of medicinal products should not be misleading as to the properties of the compared products and their features not covered by the comparison, and should not cause confusion in distinguishing between medicinal products, trademarks, business signs or other distinctive signs.
3.5 What rules govern comparative advertisements? Is it possible to use another company’s brand name as part of that comparison? Would it be possible to refer to a competitor’s product or indication which had not yet been authorised in your jurisdiction?
Comparative advertising has not been regulated in Poland in the context of the use of medicines.
The general principles of comparative advertising are regulated by the Act on Combating Unfair Competition, which stipulates that comparative advertising is understood as advertising that directly or indirectly identifies a competitor or goods or services offered by a competitor. Such advertising is permitted if it is not contrary to good practice and, among other things, is not misleading, compares goods or services meeting the same needs or intended for the same purpose in a fair and verifiable manner based on objective criteria and does not disparage the goods, services, activities, trademarks, business signs or other distinctive signs or circumstances of the competitor.
3.6 What rules apply to environmental “green” claims made in relation to specific products in promotional material?
Polish law or industry codes do not regulate this issue.
3.7 What rules govern the distribution of scientific papers and/or proceedings of congresses to healthcare professionals?
There are no specific rules governing the distribution of scientific papers and/or proceedings of congresses to healthcare professionals. If these materials were to be used in advertising medical products, they must comply with the SmPC.
3.8 Are “teaser” advertisements (i.e. advertisements that alert a reader to the fact that information on something new will follow, without specifying the nature of what will follow) permitted?
“Teaser” advertisements are banned under Polish law, as they do not contain information that is contained in §6(1) of the Regulation of the Minister of Health on the advertising of medicinal products.
3.9 Where Product A is authorised for a particular indication to be used in combination with another Product B, which is separately authorised to a different company, and whose SmPC does not refer expressly to use with Product A, so that in terms of the SmPC for Product B, use of Product B for Product A’s indication would be off-label, can the holder of the MA for Product A nevertheless rely upon the approved use of Product B with Product A in Product A’s SmPC, to promote the combination use? Can the holder of the MA for Product B also promote such combination use based on the approved SmPC for Product A or must the holder of the MA for Product B first vary the SmPC for Product B?
This is not possible, as it is forbidden to advertise medical products that are not approved for marketing in Poland and to advertise information that is not included in the SmPC.
4. Gifts and Financial Incentives
4.1 Is it possible to provide healthcare professionals with samples of medicinal products? If so, what restrictions apply?
Under Article 54 of the Pharmaceutical Law, such advertising is permitted, subject to the conditions regulated by the law. First and foremost, such advertising must contain information in accordance with the SmPC and information on the granted category of availability, and in the case of medicinal products included in the lists of reimbursed drugs – also information on the official retail price and the maximum amount of the surcharge borne by the patient.
Moreover, such advertising will be allowed if:
- the person authorised to issue prescriptions has requested in writing to the sales or medical representative to provide a sample of the medicinal product;
- the person supplying the sample keeps records of the samples supplied;
- each sample supplied is no larger than one smallest package of a medicinal product authorised for marketing in the territory of the Republic of Poland;
- each delivered sample bears the inscription “free sample – not for sale”;
- each delivered sample is accompanied by a Characteristic of Medicinal Product or Characteristic of Veterinary Medicinal Product; and
- the number of samples of the same medicinal product supplied to the same person does not exceed five packages per year.
4.2 Are there any restrictions on the value of payments or benefits that may be provided to healthcare professionals or healthcare organisations for consultancy services? Is it necessary to obtain advance approval from the authorities for the arrangements?
Payments or benefits for consultancy services are not prohibited by law. Nor is any prior approval required.
Benefits, however, cannot be related to the advertising of a medicinal product; as according to Article 58 of the Pharmaceutical Law, it is prohibited to offer material benefits to healthcare professionals above PLN 100. This prohibition does not apply to items that are related to the practice of medicine or pharmacy, which bear a sign advertising a particular company or medicinal product.
4.3 Is it possible to give gifts or donations of money to healthcare professionals? If so, what restrictions apply? If monetary limits apply, please specify.
As a general rule, giving gifts or donations money to healthcare professionals is prohibited; however, there are some exceptions. According to Article 58 of the Pharmaceutical Law, it is forbidden to direct to healthcare professionals the advertising of a medicinal product by giving, offering and promising material benefits, gifts and various facilities, prizes, excursions, as well as organising and financing promotional meetings of medicinal products during which the manifestation of hospitality goes beyond the main purpose of the meeting. However, this prohibition does not apply to giving or accepting items of material value not exceeding the amount of PLN 100, related to the practice of medicine or pharmacy, bearing a sign advertising a particular company or medicinal product.
4.4 Is it possible to give gifts or donations of money to healthcare organisations such as hospitals? Is it possible to donate equipment, or to fund the cost of medical or technical services (such as the cost of a nurse, or the cost of laboratory analyses)? If so, what restrictions would apply? If monetary limits apply, please specify.
Donations to hospitals are not prohibited by law. They can be both monetary and in-kind donations. Monetary donations are most often accepted in the form of a transfer to a current bank account or a cash deposit at a cash register. In-kind donations are most often medicines, dressing materials, consumer electronics, household appliances, IT equipment or books. And when it comes to accepting donated medical apparatus and equipment, hospitals most often implement internal requirements for such donations. These include, for example, freedom from third-party rights, a positive technical and economic opinion or a valid certificate of admissibility for use in medical entities.
However, the donation must be made in accordance with the provisions of the Civil Code (Articles 888–902).
4.5 Is it possible to provide medical or educational goods and services to healthcare professionals that could lead to changes in prescribing patterns? For example, would there be any objection to the provision of such goods or services if they could lead either to the expansion of the market for, or an increased market share for, the products of the provider of the goods or services?
Such activity is not explicitly prohibited by law. Industry codes of good practice, however, indicate that pharmaceutical companies must respect the independence of healthcare professionals and must not interfere with the relationship and trust that exists between patients and their healthcare professionals.
4.6 Do the rules on advertising and inducements permit the offer of a volume-related discount to institutions purchasing medicinal products? If so, what types of arrangements are permitted?
Such action will be illegal, due to the prohibition on targeting advertising to persons authorised to issue prescriptions or offer material benefits.
4.7 Is it possible to offer to provide, or to pay for, additional medical or technical services or equipment where this is contingent on the purchase of medicinal products? If so, what conditions would need to be observed? Are commercial arrangements whereby the purchase of a particular medicine is linked to provision of certain associated benefits (such as apparatus for administration or the provision of training on its use) as part of the purchase price (“package deals”) acceptable? If so, what rules apply?
Such activity is incompatible with Article 58 of the Pharmaceutical Law, which prohibits the acceptance of material benefits for persons authorised to issue prescriptions and those who trade in medicinal products. Therefore, such activity is illegal.
4.8 Is it possible to offer a refund scheme if the product does not work? If so, what conditions would need to be observed? Does it make a difference whether the product is a prescription-only medicine, or an over-the-counter medicine?
At the moment when, during the course of inspections and examinations, there are reasonable suspicions that a medicinal product does not meet the requirements established for it, the authorities of the State Pharmaceutical Inspectorate will issue a decision to suspend the marketing of certain batches of a medicinal product in the territory of the competent authority or the entire country. A medicinal product withdrawn by the above decision cannot be marketed. Consequently, it is not possible for such a product to be offered in the reimbursement system.
4.9 Are more complex patient access schemes or managed access agreements, whereby pharmaceutical companies offer special financial terms for supply of medicinal products (e.g. rebates, dose or cost caps, risk share arrangements, outcomes-based schemes), permitted in your country? If so, what rules apply?
More complex patient access schemes or managed access agreements are prohibited by law because of the prohibition on targeting advertising to persons authorised to issue prescriptions or offer material benefits.
4.10 Is it acceptable for one or more pharmaceutical companies to work together with the National Health System in your country, pooling skills, experience and/or resources for the joint development and implementation of specific projects? If so, what rules apply?
There is no prohibition on cooperation between pharmaceutical companies and the National Health System. However, this cooperation must comply with the provisions of the applicable law, especially those concerning corruption.
4.11 May pharmaceutical companies sponsor continuing medical education? If so, what rules apply?
It is not prohibited by law for pharmaceutical companies to sponsor continuing medical education. However, this issue is partly regulated by industry codes. According to the INFARMA Code of Good Practice, pharmaceutical companies may engage in various types of medical education activities, but such activities must not be advertising. Moreover, it is possible to provide educational materials to persons authorised to issue prescriptions or who trade in medicinal products with informational and educational materials, if they meet the following prerequisites:
- Their value does not exceed PLN 100.
- They are directly related to the practice of medicine or pharmacy.
- They have a direct benefit in terms of patient care.
4.12 What general anti-bribery rules apply to the interactions between pharmaceutical companies and healthcare professionals or healthcare organisations? Please summarise. What is the relationship between the competent authorities for pharmaceutical advertising and the anti-bribery/anti-corruption supervisory and enforcement functions? Can and, in practice, do the anti-bribery competent authorities investigate matters that may constitute both a breach of the advertising rules and the anti-bribery legislation, in circumstances where these are already being assessed by the pharmaceutical competent authorities or the self-regulatory bodies?
In Poland, the body that is established to apply anti-bribery rules is the Central Anti-Corruption Bureau. It is a special service established to combat corruption in public and economic life, particularly in state and local government institutions, as well as to combat activities detrimental to the economic interests of the state. In addition, the police and the Public Prosecutor’s Office are the competent authorities for criminal proceedings related to cases of corruption.
Compliance of advertising with the law is controlled by an independent body from the Central Anti-Corruption Bureau, the Police and the Prosecutor’s Office.
If there is a reasonable suspicion that a crime has been committed, then the Police and the Public Prosecutor’s Office may initiate proceedings in the case.
Proceedings conducted by pharmaceutical competent authorities or the self-regulatory bodies do not prevent the initiation of criminal proceedings by the authorised authorities.
5. Hospitality and Related Payments
5.1 What rules govern the offering of hospitality to healthcare professionals? Does it make a difference if the hospitality offered to those healthcare professionals will take place in another country and, in those circumstances, should the arrangements be approved by the company affiliate in the country where the healthcare professionals reside or the affiliate where the hospitality takes place? Is there a threshold applicable to the costs of hospitality or meals provided to a healthcare professional?
According to Article 58 of the Pharmaceutical Law, persons authorised to issue prescriptions and persons trading in medicinal products are prohibited from taking part in promotional meetings for medicinal products, during which expressions of hospitality go beyond the main purpose of the meeting. However, such persons may receive material objects of material value not exceeding the amount of PLN 100, related to the practice of medicine or pharmacy, bearing a sign advertising a particular company or medicinal product.
It does not matter whether the manifestation of hospitality takes place in Poland or abroad.
Moreover, the law does not require any approval by the company affiliate in the country where the healthcare professionals reside or the affiliate where the hospitality takes place.
The law also does not place limits on the cost of hospitality or meals.
5.2 Is it possible to pay for a healthcare professional in connection with attending a scientific meeting? If so, what may be paid for? Is it possible to pay for his expenses (travel, accommodation, enrolment fees)? Is it possible to pay him for his time?
It is possible to pay for a healthcare professional in connection with attending a scientific meeting, while being aware at all times of the laws prohibiting corruption.
The INFARMA Code of Good Practice sets limits on what can be spent for healthcare professionals:
- PLN 200 for meals offered in Poland.
- An amount set by the relevant local European Federation of Pharmaceutical Industries and Associations (EFPIA) member organisation, in the case of meals offered outside Poland.
- The equivalent of EUR 100 for meals offered outside Poland, when there is no monetary threshold set by the relevant local EFPIA member organisation.
What’s more, expressions of hospitality offered to event participants should be limited to covering the following costs:
- Travel.
- Food.
- Accommodation.
- Registration fees related to participation in the substantive part of the event.
When it comes to paying for a professional’s time for attending a meeting, corruption laws must be kept in mind, as this may be considered such an action.
5.3 To what extent will a pharmaceutical company be held responsible by the regulatory authorities for the contents of, and the hospitality arrangements for, scientific meetings, either meetings directly sponsored or organised by the company or independent meetings in respect of which a pharmaceutical company may provide sponsorship to individual healthcare professionals to attend?
The pharmaceutical company may be liable in such a situation, including for its representatives.
Depending on what kind of violation we will be dealing with, various regulations may apply, from pharmaceutical law, competition law, as well as criminal law. Each violation should be analysed ad casum.
5.4 Is it possible to pay healthcare professionals to provide expert services (e.g. participating in advisory boards)? If so, what restrictions apply?
Polish law does not prohibit this type of activity. In particular, the acts that do not prohibit this type of activity are the Law on the Profession of Doctor and Dentist and the Code of Medical Ethics. In addition, industry codes of ethics allow medical professionals to provide services as experts. However, they stipulate criteria such as, for example, the form of the contract, the legitimate need for the services or that the remuneration be adequate and reflect the market value of the services.
5.5 Is it possible to pay healthcare professionals to take part in post-marketing surveillance studies? What rules govern such studies?
Such activities are not prohibited outright by law. Moreover, industry codes allow medical professionals to provide services involving market research for remuneration. However, they stipulate criteria such as, for example, the form of the contract, the legitimate need for the services or that the remuneration be adequate and reflect the market value of the services.
5.6 Is it possible to pay healthcare professionals to take part in market research involving promotional materials?
Such action would be advertising under the Pharmaceutical Law and, as such, the law prohibits medicinal products from being advertised by people with medical training.
6. Advertising to the General Public
6.1 Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply?
Yes, it is possible to advertise non-prescription medicines to the general public.
Advertising of a medicinal product to the public must contain the following necessary data:
- the name of the medicinal product;
- the name of the commonly used active substance and, in the case of a medicinal product containing more than three active substances, the term “combination product”;
- the dose of the active substance or the concentration of the active substance, excluding the combination product;
- pharmaceutical form;
- indication or therapeutic indications for use; and
- indication of the responsible party.
All data must be in accordance with the SmPC.
Advertising of a medicinal product to the public may not consist of:
- presentation of a medicinal product by persons known to the public, scientists, persons with medical or pharmaceutical training or those suggesting that they have such training; and
- reference to the recommendations of persons known to the public, scientists, persons with medical or pharmaceutical education or those suggesting the possession of such education.
In addition, advertising of a medicinal product to the public may not contain content that:
- suggests that:
- it is possible to avoid medical advice or surgery, especially by making a diagnosis or recommending treatment by correspondence;
- even a healthy person taking the medicinal product will improve his health;
- failure to take a medicinal product may worsen a person’s health condition (this proviso does not apply to vaccinations referred to in Article 57(2));
- the medicinal product is a foodstuff, cosmetic product or other consumer article; or
- the efficacy or safety of the medicinal product is due to its natural origin;
- assures that taking the medicinal product guarantees the right effect, is not accompanied by any adverse effects or that the effect is better or the same as that of another treatment or treatment with another medicinal product;
- may lead to misdiagnosis by citing detailed descriptions of cases and symptoms of disease;
- refers in an inappropriate, alarming or misleading form to therapeutic indications; or
- contains inappropriate, alarming or misleading terms for graphically depicted lesions, injuries to the human body or the effects of the medicinal product on the human body or its parts.
6.2 Is it possible to advertise prescription-only medicines to the general public? If so, what restrictions apply?
Advertising prescription-only medicines to the general public is prohibited by the Pharmaceutical Law.
6.3 If it is not possible to advertise prescription-only medicines to the general public, are disease awareness campaigns permitted encouraging those with a particular medical condition to consult their doctor, but mentioning no medicines? What restrictions apply?
Disease awareness campaigns encouraging those with a particular medical condition to consult their doctor are not prohibited. However, they must not mention medical products directly or indirectly, as this would then be considered advertising.
6.4 Is it possible to issue press releases concerning prescription-only medicines to non-scientific journals? If so, what conditions apply? Is it possible for the press release to refer to developments in relation to as yet unauthorised medicines or unauthorised indications?
Advertising of prescription-only medicines directed to the public is prohibited by the Pharmaceutical Law. Advertising in press releases and non-scientific journals would certainly be considered advertising directed to the public.
6.5 What restrictions apply to describing products and research initiatives as background information in corporate brochures/Annual Reports?
There are no restrictions applicable to describing products and research initiatives as background information in corporate brochures/Annual Reports. However, activities carried out in this way cannot have the character of advertising a medicinal product.
They are also obliged to use objective and substantive criteria for selecting and supporting the participation of Patient Organisation Representatives in events. It is forbidden to offer payments to a Patient Organisation Representative solely as compensation for time spent participating in an event.
6.6 What, if any, rules apply to meetings with, and the funding of, patient organisations?
This area is not regulated by law. In this case, industry codes of good practice will play a major role. They stipulate that funding of patient organisations is allowed when:
- donated for the clearly defined purpose of supporting health care, research or education;
- documented and records are kept by the donor; and
- not an inducement to recommend, prescribe, purchase, procure, sell or use specific medicinal products.
6.7 May companies provide items to or for the benefit of patients? If so, are there any restrictions in relation to the type of items or the circumstances in which they may be supplied?
Advertising a medicinal product by providing samples of it free of charge may only be directed to persons authorised to issue prescriptions.
Moreover, advertising of a medicinal product may not consist of offering or promising any benefit directly or indirectly in exchange for acquiring the medicinal product or providing evidence that an acquisition has taken place.
6.8 What are the rules governing company funding of patient support programmes?
This area is not defined by Polish law. Industry codes stipulate that a signatory to the code cannot claim exclusivity for supporting patient organisations. They are also obliged to use objective and substantive criteria for selecting and supporting the participation of Patient Organisation Representatives in events. It is forbidden to offer payments to a Patient Organisation Representative solely as compensation for time spent participating in an event.
Donations to patient organisations are permitted only if they:
- are made for a clearly defined purpose of supporting healthcare, research or education;
- are documented and documentation is kept by the donor; and
- do not constitute an inducement to recommend, prescribe, purchase, supply, sell or use specific medicinal products.
7. Transparency and Disclosure
7.1 Is there an obligation for companies to disclose details of ongoing and/or completed clinical trials? If so, is this obligation set out in the legislation or in a self-regulatory code of practice? What information should be disclosed, and when and how?
National law does not regulate this issue. In this aspect, a portal (Clinical Trial Information System (CTIS)) has been established at the EU level by the European Medicines Agency, which is a single point through which clinical trial data and information are submitted.
The system is used for the submission and evaluation of clinical trial data. It includes a searchable public database for health system professionals, patients and the general public.
As of January 31, 2023, all clinical trial applications in the EU must be submitted through CTIS, and from January 31, 2025, all ongoing clinical trials must be registered in CTIS.
Data from the database are publicly available unless, for all or some of the data and information contained therein, they are related to personal and/or commercial information.
The data that must be included in CITS are:
- title of the clinical trial;
- trial number;
- overall trial status;
- countries where the trial is taking place;
- overall start and end date of the trial (in the EU);
- decision date;
- conditions;
- name of sponsor/co-sponsors;
- sponsor type;
- trial phase;
- name of product in the clinical trial;
- age group;
- gender; and
- results.
7.2 Is there a requirement in the legislation for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations? If so, what companies are affected (i.e. do these requirements apply to companies that have not yet been granted a marketing authorisation and/or to foreign companies), what information should be disclosed, from what date and how?
There is no requirement in the legislation for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations.
7.3 Is there a requirement in your self-regulatory code for companies to make publicly available information about transfers of value provided by them to healthcare professionals, healthcare organisations or patient organisations? If so, what companies are affected (i.e. do these requirements apply to companies that have not yet been granted a marketing authorisation and/or to foreign companies), what information should be disclosed, from what date and how? Are companies obliged to disclose via a central platform?
Industry codes regulate this issue. Signatories to the INFARMA Code of Good Practice are obligated to the above information within six months after the end of the relevant Reporting Period, and the information must be available to the public for at least three years after it is first made available. Moreover, each Signatory of the Code is obliged to document and make public information about the benefits provided – directly or indirectly – to or for the Beneficiaries. The disclosures are made on an annual basis, with each Reporting Period covering a full calendar year. Moreover, each Code Signatory is obliged to make public the list of patient organisations to which it provides monetary or non-monetary assistance (direct or indirect), and with which it has entered into relevant agreements.
7.4 What should a company do if an individual healthcare professional who has received transfers of value from that company, refuses to agree to the disclosure of one or more of such transfers?
This issue is not regulated by law. In accordance with the INFARMA Code of Good Practice, in the case of Beneficiaries who are natural persons, the Code Signatory is obliged to ensure that the release of information is without prejudice to the Beneficiary’s rights as to the protection of his/her personal data. In particular, in situations required by law, the Code Signatory is obliged to make the necessary efforts to obtain the relevant consent of the Beneficiary.
Moreover, the Code Signatory is obliged to ensure the exercise of the Beneficiary’s rights under the personal data protection regulations, which may include, among others, the right to object or withdraw consent to data processing.
8. Digital Advertising and Social Media
8.1 How is Internet advertising regulated? What rules apply? How successfully has this been controlled?
Internet advertising is not regulated separately. The rules that we apply to all advertisements for medical products should be applied to Internet advertising, with particular attention paid to who the advertisement is directed to – those authorised to issue prescriptions or those trading in medicinal products or the public.
8.2 What, if any, level of security is required to ensure that members of the general public do not have access to websites or digital platforms intended for healthcare professionals?
Polish law does not regulate the required level of security to ensure that members of the general public do not have access to websites or digital platforms intended for healthcare professionals. Pharmaceutical companies should ensure that advertising aimed at healthcare professionals is properly targeted. Currently, companies use various types of security features, such as verification with a professional licence number or a declaration that one is a healthcare professional.
8.3 What rules apply to the content of independent websites or digital platforms that may be accessed by a link from a company-sponsored site? What rules apply to the reverse linking of independent sites to a company’s website or platform? Will the company be held responsible for the content of the independent site in either case?
The company will not be held responsible for the content on the resources of independent websites or digital platforms. According to the EU’s “Digital Services Act” regulation, the hosting provider (Article 6) may be liable for unlawful content that is stored on its resources. If the provider learns that its resources contain such content, if it promptly removes it or prevents access to it, it will not be liable.
8.4 What information may a pharmaceutical company place on its website that may be accessed by members of the public?
Members of the public may have access to information that is advertising directed to the public. Accordingly, advertising of medicinal products that are not authorised for marketing in the territory of the Republic of Poland and that contain information that does not comply with the SmPC of Medicinal Products or the SmPC of Veterinary Medicinal Products is prohibited.
8.5 Are there specific rules, laws or guidance, controlling the use of social media by companies?
Polish law does not regulate separately such issues. Industry codes of good practice, for example, state that social media (i.e. sites or applications that allow interaction in groups of users, e.g. Facebook, Twitter, Snapchat, LinkedIn, YouTube and Instagram) are considered digital channels aimed at the general public and are used precisely to reach the general public. However, a social media platform can be addressed only to a strictly defined group of users, who are subject to verification before gaining access.
In addition to the above, the advertising provisions of the Pharmaceutical Law will apply.
8.6 Are there any restrictions on social media activity by company employees using their personal accounts, including interactions with third parties through “likes”, “applauds”, etc.?
Polish law does not regulate separately such issues. Industry codes of good practice, for example, state that Code Signatories are responsible for information disseminated by their personnel using private social media profiles/pages in circumstances where:
- a person can reasonably be considered to be acting on behalf of a Code Signatory; or
- the individual publishes content on his/her private profile/page at the direction of the Code Signatory, with the Code Signatory’s consent or with the Code Signatory’s assistance. Code Signatories should implement internal guidelines governing the use of social media by their personnel, including for private profiles/pages.
8.7 Are there specific rules governing advertising and promotional activity conducted virtually, including online interactions with healthcare professionals, virtual meetings and participation in virtual congresses and symposia?
No, there are no specific rules governing advertising and promotional activity conducted virtually, including online interactions with healthcare professionals, virtual meetings and participation in virtual congresses and symposia. In accordance with the INFARMA Code of Good Practice, Code Signatories may organise webinars on their own or use the services of a third party, with the Code Signatory remaining responsible for the webinar, its content and for defining the target audience. The same rules apply to webinars organised by third parties on behalf of Code Signatories.
9. Developments in Pharmaceutical Advertising
9.1 What have been the significant developments in relation to the rules relating to pharmaceutical advertising in the last year?
The last year has not brought significant changes in terms of developments in relation to the rules relating to advertising. The last significant change took place in early 2023, where the warning about the safety of medicinal products was changed.
9.2 Are any significant developments in the field of pharmaceutical advertising expected in the next year?
As for national law, no work is being carried out to reform pharmaceutical advertising. At the EU level, work is currently underway on the Directive on the Union code relating to medicinal products for human use.
9.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?
At present, the regulations on advertising medical products are generally being complied with, due to the small number of decisions by the Chief Pharmaceutical Inspector halting advertisements.
Production Editor’s Note
This chapter has been written by a member of ICLG’s international panel of experts,
who has been exclusively appointed for this task as a leading professional in their field by Global Legal Group, ICLG’s publisher.
ICLG’s in-house editorial team carefully reviews and edits each chapter, updated annually, and audits each one for originality, relevance and style,
including anti-plagiarism and AI-detection tools.
This chapter was copy-edited by Oliver Chang, our in-house editor.
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