This country-specific Q&A provides an overview of Pharmaceutical Advertising laws and regulations applicable in Poland.
What laws are used to regulate advertising on medicines in your jurisdiction?
Advertising on medicinal products in Poland is regulated by the provisions of the Act of 6 September 2001 – the Pharmaceutical Law and of the Minister of Health’s Regulation of 21 November 2008 on advertising of medicinal products.
However, advertising of drugs is also regulated by the laws applicable to advertising or promotion of different categories of goods, not only medicinal products; for example by:
the Act of 16 April 1993 on combating unfair competition, which regulates unfair advertising of goods, including unfair comparative advertising;
the Act of 29 December 1992 on radio broadcasting and television, which sets rules for advertising of goods in radio and television.
Are there any self-regulatory or other codes of practice which apply to the advertising of medicines? a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)? b) What is the legal status of the self-regulatory codes?
a) If there are any such codes, to whom do they apply (companies, or healthcare professionals, for example)?
There are self-regulatory acts adopted by organizations of entrepreneurs / pharmaceutical producers, which regulate certain aspects of advertising of medicinal products. The most comprehensive one is the Code of Good Practices adopted by the Employers’ Union of Innovative Pharmaceutical Companies INFARMA, the association of innovative pharmaceutical companies in Poland (member of EFPIA). The Code contains several provisions on promotion of medicinal products, as well as on relations with healthcare professionals, healthcare organisations or patient organisations.
Some rules on promotion of medicinal products can also be found in the Code of Conduct on Interactions with the Healthcare Community of the European Generic Medicines Association, which has been adopted in Poland by the Polish Association of Pharmaceutical Industry Employers.
b) What is the legal status of the self-regulatory codes?
The self-regulatory codes are treated as soft law in Poland, i.e. they are not binding law, although they should be followed by their signatories. There is a disciplinary court established within the Employers’ Union of Innovative Pharmaceutical Companies INFARMA and a member company, which is in breach of INFARMA’s Code of Good Practices, can be subject to the disciplinary proceedings.
Is there a statutory or generally accepted definition of “advertising”? a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example? b) Does the definition apply equally to all target audiences?
The article 52 of the Polish Pharmaceutical Law provides for a general definition of advertising of drugs. Further to that definition, advertising of a medicinal product is an activity consisting in informing or inducing to use a medicinal product, aimed at increasing: number of prescriptions, deliveries, sale or consumption of medicinal products.
a) What does the definition cover? – does it include patient information leaflets, for example, catalogues, disease awareness campaigns or correspondence, for example?
The key aspect of advertising of medicinal products, which distinguishes it from other activities, is a promotional purpose of advertising. Only such activity can be found to constitute advertising of drugs, which is aimed at achieving certain promotional effect (i.e. increasing: number of prescriptions, deliveries, sale or consumption of medicinal products).
Certain types of materials are expressly mentioned in the Pharmaceutical Law as excluded from the scope of the definition of pharmaceutical advertising. The following shall not be considered advertising of medicinal products:
information placed on packaging or enclosed to packaging of medicinal products, in line with a marketing authorisation;
correspondence with enclosed informational, non-promotional materials which are necessary in order to respond to questions concerning a particular medicinal product;
informational advertisements, not addressed to the general public, concerning, in particular, a change of packaging, adverse effects warnings, provided that they do not contain any content referring to medicinal products’ properties;
trade catalogues or price lists, which contain only trade name, international name, dose, pharmaceutical form and price of a medicinal product (and in case of reimbursed drugs – also an official retail price), provided that they do not contain any content referring to medicinal products’ properties;
information about human or animal diseases, provided that they do not refer, even indirectly, to medicinal products.
b) Does the definition apply equally to all target audiences?
Two major forms of advertising of medicinal products, which are provided for under the Polish law, are: advertising of drugs to healthcare professionals (i.e. to persons entitled to prescribe drugs or to persons entitled to sell drugs) and advertising to the general public (e.g. to patients). The law also mentions, as permissible forms of advertising of drugs, visiting healthcare professionals, delivering samples of drugs, sponsoring promotional meetings for healthcare professionals, sponsoring scientific conferences or congresses for healthcare professionals.
Are press releases regarding medicines allowed in your jurisdictions, and if so what are the restrictions on these (bearing in mind the target audience)?
Any press release, which can be found to have promotional purpose (and thus, which qualifies as advertising of a medicinal product), must meet specific legal requirements for advertising of drugs, which may differ, depending on the target audience of the release. For example, advertising addressed to the general public cannot promote prescription-only drugs. On the other hand, advertising addressed to healthcare professionals must contain detailed data on the properties of a medicinal product, compliant with the Summary of the Product’s Characteristics.
Are there any processes prescribed (whether by law or Codes of Practice) relating to the approval of advertising of medicines within companies?
There are no rules on the approval process of advertising adopted in Poland, either in the law or in the industry self – regulatory acts (codes of practice). Each company has its own process adopted, which may involve assessment of advertising by a compliance officer, legal or medical team.
Do companies have to have material approved by regulatory bodies prior to release?
There is no preapproval of pharmaceutical advertising mechanism regulated in Poland. However, once advertising is disseminated, the local authority, the Chief Pharmaceutical Inspector, may instigate the proceedings aimed at establishing, whether the advertising is in line with the law. So there is a compliance control ex post, not before the launch of advertising.
Is comparative advertising for medicines allowed and if so, what restrictions apply?
As mentioned, comparative advertising is provided for under the Act on combating unfair competition. Also INFARMA’s Code of Good Practices refers to the Act’s provisions on comparative advertising, as binding for advertising of medicines as well.
Further to the Act on combating unfair competition, comparative advertising – advertising which directly or indirectly allows for recognizing a competitor or competitor’s goods or services – is an act of unfair competition if it is contrary to good practices. Comparative advertising is in line with good practices only if it meets all of the following requirements:
it is not misleading,
it objectively and reliably compares goods or services which meet the same needs or which are intended for the same purpose,
it objectively compares one or few important, characteristic, verifiable and typical features of those goods or services (e.g. their price),
it does not cause mistakes as to identity of an advertiser and their competitor, or of their goods or services, trademarks, etc.,
it does not discredit goods, services, activities, trademarks or other features of a competitor,
in case of advertising of goods, which have a protected geographical indication/protected name of origin – it always refers to goods with the same indication,
it does not unfairly use competing products‘ trademark, indication of producer or other features,
it does not present a good or service as imitation of a good or service with protected trademark, geographical indication, name of origin or another distinguishing designation.
Is it possible to provide information on unauthorised medicines or unauthorised indications? Is it possible to provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals, or to send information to healthcare professionals?
It is prohibited to advertise unauthorised medicines or medicines in unauthorised indications. What is more, advertising of unauthorised medicines or pharmaceutical advertising, which is not in line with the Summary of Product’s Characteristics (e.g. advertising of unauthorised indications), is a criminal offense, further to the Pharmaceutical Law.
Information on unauthorised medicines or unauthorised indications can be provided to healthcare professionals, but not within advertising materials or within any promotional activities. Such information should be presented during purely scientific events, such as scientific conferences or congresses, and it should be properly redacted, so that it does not bear any promotional features.
Please provide an overview of the rules that apply to advertising to the general public for prescription only medicines and over the counter medicines, an indication of the information that must or must not be included.
It is prohibited to advertise prescription only (OTC) medicines to the general public.
Advertising of OTC products to the general public cannot consist in presenting drugs by celebrities, scientists, physicians or pharmacists (or by persons suggesting that they have medical or pharmaceutical background). The Pharmaceutical Law provides for the list of prohibited messages in the pharmaceutical advertising to the general public; such advertising cannot contain, for example:
suggestion that efficacy or safety of a product results from its natural origin,
suggestion that not using the product can deteriorate a person’s health (except for vaccines),
information assuring that using a medicine guarantees proper effect, does not have any adverse effect,
information which refers to therapeutic indications in inappropriate, threatening or misleading way.
The Regulation on advertising of medicinal products provides for obligatory elements in the pharmaceutical advertising for the general public. Such advertising must contain data on:
name of a product,
international name of active substance,
dose of active substance,
marketing authorisation holder.
In addition, advertising of medicinal products to the general public must contain the following warning: Before using the product read a leaflet enclosed to the packaging or consult with a physician or pharmacist, since each medicine, when improperly used, endangers your life or health.
Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.
There are no restrictions on interactions between patients or patient organisations and pharmaceutical industry provided for under the binding law; companies must only bear in mind that any interactions with patients or patient organisation cannot infringe the rules on advertising medicines (e.g. by promoting Rx drugs to patients).
On the other hand, there are some rules on interactions with patient organisations specified in the INFARMA’s Code of Good Practices. For example, further to the Code, donations or grants for patient organisations are allowed only if:
they are offered in clearly identified purpose of supporting healthcare, research or education,
they are documented and the documentation is kept by the donor,
they do not constitute incentive for recommending, prescribing, purchasing, delivering, sale or using particular medicinal products.
In addition, signatories to the Code of Good Practices must observe the following rules in cooperation with patient organisations:
patient organisations must remain independent in expressing their views or undertaking actions,
cooperation with them should be based on mutual respect,
cooperation cannot cover advertising of medicinal products,
purpose and scope of cooperation must be transparent. Information about financial or other support from pharmaceutical companies should always be clearly revealed.
There are other rules on cooperation with patient organisations, set forth under INFARMA’s Code of Practice, including, for example, the following:
offering financial or non-financial support to patient organisations requires concluding a contract, which must contain certain obligatory elements,
pharmaceutical companies cannot influence the content of materials of patient organisations, supported by those companies,
each signatory must publish a list of supported patient organisations / organisations with which a given pharmaceutical company has concluded contracts.
Which information must advertising directed at healthcare professionals contain, and which information is prohibited? For example can information about clinical trials, or copies of journal be sent?
The Polish law requires that advertising of medicinal products is clearly distinguished from scientific or medical information. Certain important information about the products, such as about the clinical trials’ results or copies of journals, can be distributed to healthcare professionals as part of educational or scientific activities of pharmaceutical companies, but in the same time should not be included in advertising materials, as long as it can be found not in perfect compliance with the Summary of the Products’ Characteristics. Since the rule, further to which advertising of medicinal products directed at healthcare professionals must be in line with the SoPC, is one of the most important ones under the Pharmaceutical Law.
In addition, further to the Regulation on advertising of medicinal products, advertising directed at healthcare professionals must contain certain obligatory data, such as:
name / international name of the product,
dosage and administration route,
marketing authorisation holder,
marketing authorisation number / name of issuing body,
availability category (OTC, Rx, etc.),
if a product is listed on the reimbursement list – official retail price and maximum patient’s co-payment.
May pharmaceutical companies offer gifts to healthcare professionals and are there any monetary limits?
Further to the pharmaceutical law, it is prohibited to advertise a medicinal product to healthcare professionals in a form of offering healthcare professionals material benefits, except for items, the value of which does not exceed 100 PLN, which are related to performing medical or pharmaceutical profession and which are marked with the product’s or producer’s name.
In addition, INFARMA’s Code of Good Practices introduces more restrictions on offering gifts to healthcare professionals. Further to the Code, pharmaceutical companies may offer gifts to healthcare professionals only in specific situations, such as:
offering pens, notepads, bags or folders, used for taking notes during meetings organized by a pharmaceutical company,
offering informational or educational materials, if they contribute to ameliorating patient care,
offering items designed for performing medical profession, if they do not lower routine costs of healthcare professional’s practice.
Are pharmaceutical companies allowed to provide samples to healthcare professionals?
One of admissible forms of advertising of medicines directed at physicians is providing samples of medicinal products. Samples may be provided, subject to the following conditions:
a physician has requested a sample from a medical representative in writing,
a company runs inventory of samples provided,
a sample is not bigger than one smallest presentation of a product, authorised for marketing in Poland,
each sample is marked with an inscription ‘free sample – not for sale’,
each sample is provided with the Summary of the Product’s Characteristics,
one person can receive up to 5 packs of the same medicinal product per year.
Additional restrictions on distribution of samples are provided for under INFARMA’s Code of Good Practices. Further to the Code, samples can be delivered only in exceptional cases, in order to allow recipients to familiarise themselves with the product. One recipient cannot obtain more than 4 samples of the same product per year and cannot obtain any more samples after two years from the first request for a sample. In addition, the Code does not allow for distribution of samples after 5 years from authorising the product for marketing in Poland – samples of new products only can be distributed.
Is sponsorship of scientific meetings or congresses and/or attendance by healthcare professionals to these events? If so, which restrictions apply? Do additional restrictions apply to events taking place abroad?
Sponsorship of conferences or congresses for healthcare professionals is one of permissible forms of advertising of medicinal products. Companies may also sponsor attendance of healthcare professionals to these events, however, not in relation with advertising of a medicinal product – the only allowable form of offering any benefits to healthcare professionals, in connection with advertising of medicinal products, is offering them promotional items of small value, related to performance of a medical or pharmaceutical profession.
More detailed rules on sponsoring scientific or educational events, binding upon signatories, are regulated under INFARMA’s Code of Good Practices. In addition, there is a procedure of certifying such events binding upon INFARMA’s member companies. Further to the procedure, a company can only sponsor an event, which has been certified by INFARMA as meeting requirements concerning its compliance with the law and the ethical standards.
Among the rules on sponsoring scientific events, regulated under the INFARMA’s Code of Good Practices, there is also a rule, further to which a company cannot organise or sponsor an event abroad, unless it is justified by the event’s logistics or merits (e.g. when majority of speakers are from abroad). The Code also provides for the rules on sponsoring attendance by healthcare professionals to scientific events, including the principle that the criteria for selection and support of healthcare professionals should be objective and based on the merits.
What are the restrictions on the organisation of cultural, sports or other non-scientific events in relation to scientific conferences by pharmaceutical companies?
Further to the Pharmaceutical Law, it is prohibited to organise or sponsor meetings aimed at promoting medicinal products, during which manifestation of hospitality exceeds the major purpose of the meeting.
This rule is further elaborated on under the INFARMA’s Code of Good Practice. And thus, manifestation of hospitality during the events cannot be excessive and should not exceed the conditions, which a participant would be willing to cover himself / herself. In particular, it is not allowed to sponsor nor organise entertainment, such as sports or recreational events.
Is it possible to pay for services provided by healthcare professionals and if so, which restrictions apply?
Remunerating of healthcare professionals for their services is outside the scope of the legal provisions on advertising of medicinal products in Poland – of course provided that the cooperation in question is not aimed at promoting medicinal products to a healthcare professional in question.
Again, INFARMA’s Code of Good Practices contains more detailed provisions with this respect. Further to the Code, a company may enter into a contract for services with a healthcare professional only if the services are provided in the aim of supporting healthcare, research or education and are not aimed at inducing to prescribe, recommend, purchase, deliver, sell or use particular medicinal products.
In addition, the Code requires that such cooperation with a healthcare professional meets the following criteria:
a contract is signed before the HCP starts to provide services,
there is a justified need for services, which is documented before the contract is concluded,
criteria for selecting a services provider are directly connected with the indicated need for services,
a number of services providers and a scope of services does not exceed the real needs,
remuneration paid is adequate to and reflects the market value of services.
Are pharmaceutical companies permitted to provide grants or donations to healthcare professionals or healthcare institutions? Does it matter if the grant or donation is monetary or in kind?
As mentioned in above, grants or donations to healthcare professionals are prohibited, if they would be aimed at promoting particular medicinal products (except for small promotional items, the value of which does not exceed 100 PLN). On the other hand, donations or grants, which are not aimed at advertising medicinal products, are not provided for under the law – thus, they are not prohibited by the law (but of course, they need to be properly documented, e.g. for the tax purposes).
Signatories to the INFARMA’s Code of Good Practices must observe the Code’s provisions on grants and donations to healthcare professionals or healthcare organisations. Further to the Code, donations or grants for natural persons (e.g. for healthcare professionals) are prohibited, except for small gifts allowed for under the Pharmaceutical Law or the Code; and except for the possibility of sponsoring HCPs’ attendance to scientific events.
Donations and grants (monetary and in kind) for healthcare organisations or patients organisations are permissible only when:
they are offered in clearly identified purpose of supporting healthcare, research or education,
they are documented and the documentation is kept by the donor,
they do not constitute incentive for recommending, prescribing, purchasing, delivery, sale or use of particular medicinal products.
Are pharmaceutical companies required to disclose details of transfers of value to healthcare professionals or healthcare institutions? If so, please indicate whether this is a legal requirement or not, and describe briefly what the companies must report and how. Do these transparency requirements apply to foreign companies and/or companies that do not yet have products on the market?
Pharmaceutical companies operating on the Polish market are subject to the rules on reporting transfers of value to healthcare professionals (HCPs) or healthcare organisations (HCOs), but only further to the self-regulatory codes signed by them, not under the law.
Further to the INFARMA’s Code of Good Practices, companies must publish once a year, on their websites, on a template form provided by INFARMA. The report should indicate the value of transfers for individual beneficiary or, if it is not possible (e.g. when a HCP does not agree on publishing her or his personal data) in the aggregated form.
The obligation to publish reports on transfers of value in Poland is binding upon companies, which run their activities in Poland. In case run abroad, local ethical codes adopted on the basis of EFPIA code should be applied with this respect.
The following categories of transfers of value for HCPs and HCOs should be reported:
donations and grants (only in case of HCOs; donations and grants for HCPs are prohibited),
covering costs of events (e.g. scientific events),
remuneration for services or consultancy.
Also the Polish Association of Pharmaceutical Industry Employers has adopted the rules on revealing transfers of value, which also require publication of reports on transfers of value to healthcare professionals, healthcare organisations and even patient organisations.
When if at all with a competent authority have to get involved in authorising advertising? Is advertising on the internet (including social media) for medicinal products regulated, and if so, how? Should companies include access restrictions on websites containing advertising or other information intended for healthcare professionals?
The Polish law does not provide for any procedure on authorising advertising before it is launched to the market. The Polish authority – the Chief Pharmaceutical Inspector can only react to the advertising, which is not in line with the law, after it is published / broadcasted.
There are no specific rules adopted on advertising on the internet (.e.g. in social media). Such advertising is subject to the same rules or restrictions as pharmaceutical advertising in any other media. Therefore, for example, websites containing advertising or any other information directed to healthcare professionals (e.g. advertising of prescription-only drugs) must be secured against unauthorised access of any other person than a healthcare professional. In the light of the case law of the Chief Pharmaceutical Inspector, the restriction of access must be designed in such a way as to truly protect the content of websites from being revealed to unauthorised persons. Thus, a simple declaration of a user, when accessing a website, that he or she is a healthcare professional, would not be sufficient.
Are there any anti-bribery rules apply to communications between pharmaceutical companies and healthcare professionals or healthcare organizations?
Any interactions between pharmaceutical companies and healthcare professionals or healthcare organisations are subject to the general provisions of the Polish law relating to bribery or other prohibited corrupted practices (e.g. the provisions of the Polish Criminal Code). In addition, several provisions of the local self – regulations (such as the INFARMA’s Code of Good Practices) state that any interactions with healthcare professionals or healthcare organisations should not be aimed at inducing undue behaviour of HCPs / HCOs (e.g. should not be aimed at inducing prescription, purchase, use, etc. of medicinal products).
What are the rules (whether statutory or self-regulatory) which govern the offering of benefits or inducements to healthcare professionals?
Please see information in above, e.g. in answers to questions no. 12, 14 and 17.
Which bodies are responsible for enforcing the rules on advertising and the rules on inducement? Please include regulatory authorities, self-regulatory authorities and courts.
The competent body in cases related to pharmaceutical advertising is the Chief Pharmaceutical Inspector (GIF). GIF can instigate proceedings in case of suspicion that advertising of a medicinal product is not in line with the Pharmaceutical Law. If the suspicion is confirmed in the course of the proceedings, GIF may request the company in question to stop advertising infringing the law, to publish GIF’s decision in the media, in which advertising has been conducted, or to eliminate the effects of violation of the law.
If a party does not agree with GIF’s decision on advertising of a drug, they can move for reassessment of the case and, after the second decision from GIF, go to the administrative court. The case is then handled by the courts in two instances: by the Administrative Court in Warsaw and, in the second instance, by the Supreme Administrative Court.
Violation of the rules of ethical codes (i.e. of self-regulatory acts, adopted by particular industry organisations) is subject to the liability before a given organisation’s disciplinary court. Such disciplinary courts are established, for example, within INFARMA or within PASMI (Polish Associations of OTC drugs’ producers).
On what basis and before which bodies or courts can companies initiate proceedings against competitors for advertising infringements?
A company, which finds a competitor’s advertising of a drug being in breach of the Pharmaceutical Law, can notify the Chief Pharmaceutical Inspector, who may then start the formal proceedings. In case if the unfair (or not compliant) advertising may somehow infringe another company’s interests, that company may file a lawsuit to a civil court against an advertising company, based on the allegation that the latter company has committed an act of unfair competition. In such a lawsuit, a company may request the competition to stop unfair advertising, eliminate the effects of that advertising or even to pay compensation.
Companies, which are members of local industry organisations, may submit their case on advertising infringement against a competitor to a disciplinary body or court appointed within the organisation.
What are the penalties, sanctions or measures that regulators or courts can impose for violating medicines advertising rules and rules on inducements to prescribe in your jurisdiction?
The Chief Pharmaceutical Inspector (GIF) may order a company to:
stop publishing or distributing advertising which is in breach of the binding law,
publish GIF’s decision in the same places / media where the infringing advertising was published; or to publish rectification of the advertising found to be in breach of the law,
eliminate the irregularities discovered.
It should be noted that non-compliance with GIF’s decision on advertising infringement is, in the light of the Pharmaceutical Law, a criminal offense, subject to the penalty of a fine.
If, in case of unfair pharmaceutical advertising, a competing company brings the case to the civil court, based on the provisions of the Act on combating unfair competition, they may request the court to adjudge that the infringing company:
stops unfair advertising,
eliminates the effects of unfair advertising,
publishes one or several statements of a given content and in an appropriate form,
repairs the loss suffered by the competitor (e.g. pays damages),
gives back undue profits,
pays appropriate amount for the charity purpose related to the protection of Polish culture (if the act was caused by fault).
What is the relationship between procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts/government competent authorities?
Proceedings, which may be taken before the self-regulatory authorities (such as disciplinary courts), are independent from the potential proceedings or measures, which are available to a party based on the Polish law. In other words, a company, which finds its competitor to be in breach of the rules on pharmaceutical advertising regulated in the Pharmaceutical Law (or in breach with any other binding law provisions) does not have to pursue its claims in front of any self-regulatory body first (unless a specific code of conduct states otherwise), before starting its legal action.
Are there any recent enforcement trends in relation to pharmaceutical advertising in your jurisdiction? Please report any significant (publicly known) enforcement actions in the past two years.
The local authority responsible for supervising pharmaceutical advertising – the Chief Pharmaceutical Inspector – has not been very active in this field recently. Only few decisions on advertising infringement have been issued since 1 January 2020. This may the caused by increased compliance of companies with the law or less strict supervision. In addition, based on the case law of the Chief Pharmaceutical Inspector, a case must be discontinued when, after it is instigated, a company in question immediately stops advertising. This also may be a reason why there are very few new decisions of pharmaceutical advertising.
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