Pharmaceutical Advertising 2020

Last Updated March 02, 2020

Poland

Law and Practice

Authors



Tomasik Jaworski sp.p. specialises in advising entities from regulated industries (pharmaceutical, medical and food) and conducting litigation. The firm was founded by lawyers with long experience working for Poland’s biggest law firms, and advises Polish and international manufacturers of medicinal products and medical devices on all stages of product development, especially with regard to clinical trials, registration, reimbursement, advertising and compliance. It also provides advice to industry organisations including the Association of Pharmaceutical Employers PharmaNET, MedTech Polska, the Polish Association of Pharma Industry Employers and the Polish Federation of Food Industry, having participated as experts in the legislative processes concerning the most important legal changes in the life sciences sector in recent years. Tomasik Jaworski’s international activities include providing consulting services to the Ministry of Health of Ukraine on the reform of the drug registration system in Ukraine.

The advertising of medicines is primarily regulated by the Pharmaceutical Law Act of 2001 and the Regulation of the Minister of Health of 2008 on the advertising of medicinal products.

The additional requirements for marketing of reimbursed drugs are also laid down in the Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices of 2011.

The advertising of medicines is also subject to general consumer protection and fair competition acts, such as the Act on Combating Unfair Commercial Practices of 2007 and the Act on Combating Unfair Competition of 1993, the latter of which includes significant provisions on comparative advertising.

Binding law is supplemented by self-regulatory codes, which is implemented by industry organisations. The codes of the Employer’s Association of Innovative Pharmaceutical Companies (INFARMA), which is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Polish Association of Pharma Industry Employers (PZPPF), a member of Medicines for Europe, and the Polish Association of Self Medication Industry (PASMI), a member of the Association of the European Self-Medication Industry (AESGP) are the most important.

Self-regulatory codes adopted by the industry apply only to signatories (members of a particular industry association). However, they have a significant influence on everyday market practice, as most of the key players on the market are signatories of the local equivalents of EFPIA or Medicines for Europe codes.

The industry codes regulate certain activities in a more stringent way and cover some missing gaps and “grey areas” of the statutory law in respect to the interactions with healthcare professionals and institutions. As a result, the codes are often the point of reference in contentious matters. Furthermore, non-compliance with the provision of the self-regulatory code by its signatory can be also considered to be an unfair commercial practice prohibited by the statutory law.

Particular groups of healthcare professionals (HCPs) (physicians, pharmacists, nurses) have also adopted their own codes of ethics. The role of these codes is, however, of limited practical importance, as far as the relationships between HCPs and the industry are concerned.

The advertising of a medicinal product is broadly defined. It covers any activity that involves providing information about a medicine or encouraging to use it aimed at increasing the number of prescribed medicines, supply, sale or consumption of a drug.

Pharmaceutical Law indicates some examples of advertising such as: advertising directed at the general public (patients), advertising directed at persons entitled to prescribe and supply medicinal products, visiting HCPs, the supply of samples of medicines and sponsorship of promotional meetings, conferences and scientific congresses.

The key difference between information and advertising is the aim of the communication. Any information that is not aimed at increasing prescription, supply, sale or consumption of medicine shall not be considered to be an advertisement. The essential condition for classifying the communication as informative is, then, a real and verifiable reason for disseminating the information – other than aimed at increasing the use of medicine.

In practice, the circumstances of a particular case should be assessed in order to state whether the activities were undertaken for advertising purposes. When assessing it, the usefulness of the information for recipients as well as the neutral and objective presentation of the information are taken into account.

Pharmaceutical Law also indicates some activities that are not regarded as advertising of medicines (the catalogue is generally compliant with the exemptions set forth in the EU Directive 2001/83/EC):

  • information on the packaging and accompanying the packaging of medicines, in accordance with the marketing authorisation;
  • correspondence accompanied by informational, non-promotional materials necessary to answer questions about a particular medicinal product;
  • informative announcements not directed at the general public, in particular related to new packaging or warnings of adverse effects, provided that they do not contain information related to the properties of medicinal products;
  • trade catalogues or price lists containing only the commercial name, the non-proprietary name, the dose, form and price of a medicine and – in cases of reimbursed medicinal products – the official retail price, provided that there is no reference to the properties of medicinal products, including therapeutic indications; and
  • information about health and diseases in humans and animals, provided that it does not refer, even indirectly, to medicines.

Until recently, the Pharmaceutical Inspectorate (state administration body responsible for inspection and enforcement of Pharmaceutical Law) was of the view that unless otherwise expressed in the law, using the name of the drug was equivalent to advertising it, particularly if the communication could lead to increased use of the product. The result of such an approach was the blurring of the difference between acceptable information and illegal advertising.

On many occasions, the Chief Pharmaceutical Inspector has investigated whether brochures or leaflets directed to patients or disease awareness campaigns were not in fact medicine advertising. The case-law shows that the regulatory authority broadly interprets the “indirect reference to medicines” condition. Hitherto, a few awareness and/or educational campaigns were questioned due to inter alia:

  • the commercial name of the product in the website address of the campaign;
  • the link to the sponsor’s website posted on the campaign’s website;
  • reference to the website of the campaign, on which the address data and the logo of the sponsor were placed; or
  • information about the sponsor in the campaign materials.

The Pharmaceutical Inspectorate’s approach could be perceived as devoid of legal grounds due to it being overly restrictive. The approach is now more liberalised after a few court cases, where courts underlined that actions may be considered to constitute advertising of medicinal products only if they are deliberately aimed at achieving the assumed result.

As with awareness and/or educational campaigns, it depends on the aim of the communication as to whether patient support programmes qualify as advertisements for medicines. It is worth pointing out that if such programmes are run in pharmacies, there is a risk that they will be considered as illegal pharmacy advertising.

Press releases of a non-promotional nature regarding medicines are expressly allowed if they are directed at HCPs and do not contain information relating to the properties of medicinal products. They can relate, in particular, to packaging changes and adverse-reaction warnings and should be published in media directed exclusively to HCPs, such as the specialised trade press.

The case law of the Chief Pharmaceutical Inspector includes cases in which the authority questioned the press release addressed to patients published in the national press. However, it may be argued that press releases in mainstream media should also in certain cases be admissible if the release is of a purely informative character, not aimed at increasing the use of medicine.

The comparative advertising of medicines is generally allowed. However, there is a specific restriction for advertising addressed to patients. Such advertisements cannot include any contents that would ensure that the effect of taking the given medicine is better or the same as in the case of another method of treatment or treatment with the use of another medicine.

The word “effect” should be understood as the therapeutic effect of the product. A therapeutic effect implies a consequence of medical treatment and is usually formally juxtaposed with a placebo effect, as a non-therapeutic effect. Adoption of a narrow understanding of the word “effect” allows for comparative claims that do not in fact refer to any therapeutic effects from taking the medicine, but provide information about other properties of the product. The other characteristics may include, for instance, the speed of action of the medicine, the total cost of therapy for a patient, the absence of contraindications or frequency of taking the medicinal product and the convenience associated with it.

The market practice follows this interpretation. For instance, “top-parity claims” with comparisons on how fast over-the counter (OTC) medicine works are broadcasted. The superlative claims like “No. 1 on the market” or “most commonly bought product”, evidenced by supporting sales data, are also widely used.

In any case, for advertisements addressed to both the general public and to professionals, the comparative advertising must meet specific conditions set out in the Act on Combating Unfair Competition, namely:

  • it is not misleading;
  • it compares medicines meeting the same needs or intended for the same purposes in a fair and verifiable manner on the basis of objective criteria;
  • it compares objectively one or more important, specific, verifiable and representative features of products, which may include the price;
  • it does not cause confusion in the market between the advertiser and its competitor or between products, trade marks, company logos or other distinguishing markings;
  • it does not discredit goods, services, activities, brand names, trade marks or other distinguishing markings, as well as the circumstances regarding a competitor;
  • goods with a protected geographical indication or protected designation of origin are always compared with goods with the same markings;
  • it does not use in an unfair manner the reputation of a brand name, trade mark, company logo or another marking distinguishing a competitor; and
  • it does not present goods or services as an imitation of goods or services bearing a protected trade mark or other distinguishing marking.

Pharmaceutical Law expressly states that advertising unauthorised medicines or unauthorised indications is prohibited. The prohibition applies to all unauthorised medicines and indications, regardless of their proximity of approval.

However, this does not ban companies from informing people about research and development plans that the products company is currently working on (upon request or on the corporate website) – as far as such information is not aimed at increasing the use of medicine.

In addition, after the European Court of Justice judgment in the Ludwig case C-143/06, for specific types of medicines, authorised and available on a named-patient basis. Pharmaceutical Law directly allows correspondence that is accompanied by informative material of a non-promotional nature needed to answer a question about a particular medicinal product and trade catalogues or price lists that contain certain information (commercial name of the product, nonproprietary name, dose, form and price of a medicine), provided that there is no reference to medicine properties, including therapeutic indications.

Scientific conferences directed at HCPs are a natural circumstance for announcing and discussing new discoveries and inventions. Providing scientific information about unauthorised medicines or unauthorised indications is allowed at such events.

However, such lectures or debates should be purely scientific and of a non-promotional nature. In practice, it means that communication should not relate to any particular medicine, but rather to an active substance. Moreover, it should focus on the scientific and medical issues (evidence based) and should not refer to market or commercial matters.

Generally, sending information about unauthorised medicines to HCPs upon their request and answering their questions about the medicinal product is allowed. In any case, such information should not be of promotional nature, deliberately aimed at increasing the use of the product.

The same rules apply to sending information about unauthorised indications to HCPs.

However, controversies may arise if the communication is disseminated by the company actively, irrespective of the request of the professional, eg, providing professionals with reprints of publications regarding unauthorised indications. Such activity may be considered advertising and thus considered to be an infringement of Pharmaceutical Law, ie, prohibition of advertising inconsistent with the Summary of Product Characteristics (SmPC).

A similarly controversial practice is to provide a medical journal (as a legitimate gift) with an article about the new indication of an active substance followed by the advertisement of a medicine containing such substance.

It is possible to provide HCPs with a copy of the reimbursement decision if the medicine is reimbursed from public funds for certain off-label indications.

There are no specific provisions that refer to sending information about unauthorised medicines or unauthorised indications to healthcare institutions. 

Generally, the same rules should apply as when providing similar information to HCPs.

The compassionate use programmes are regulated at the level of EU law. In Regulation (EC) No. 726/2004, there are general frames for these programmes, which allow Member States to introduce relevant national regulations. In Poland, compassionate use programmes do not have their regulations (in 2016 a draft regulating these programmes was presented, but it did not enter into force). Hence, the general rules concerning advertising and information shall apply to the publication of information on compassionate use programmes availability.

In Poland, as in other EU jurisdictions, advertising to the general public of prescription-only medicines is prohibited (excluding certain preventive vaccinations). Similarly, it is prohibited to advertise reimbursed medicinal products, products containing psychotropic or narcotic substances and products with the same name as prescription only or reimbursed medicinal products.

The fundamental restriction is the prohibition of misleading advertising. Pharmaceutical Law also includes three other principles that are complementary to this ban and clarify it. They state that advertising of a medicine should present a product objectively, provide information on the rational use of the product and contain information that is compliant with the SmPC.

Infringements of the above principles usually occur simultaneously and constitute one of the most common bases for the Chief Pharmaceutical Inspector’s decisions to stop advertising.

Additionally, the advertisements of a medicinal product addressed to the general public cannot include any contents that would ensure that taking a given medicine guarantees an appropriate effect, is not accompanied by any undesirable effects or that the effect is better or the same as in the case of another method of treatment or treatment with the use of another medicinal product.

Advertising should not cause fear in patients. Pharmaceutical Law stipulates that advertising may not contain material that refers, in improper, alarming or misleading terms, to therapeutic indications or contains improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury or of the action of a medicine on the human body or parts thereof.

Moreover, OTC advertisements cannot be directed at children and/or contain any element directed at them.

In the case of general public advertising, HCPs, as well as individuals who only suggest that they hold a medical or pharmaceutical degree, cannot advertise medicines to patients in any way, including presentation or recommendation. The same prohibition applies to celebrities and scientists.

Furthermore, the above also implicates the prohibition of recommendations from medical and pharmaceutical scientific societies in advertisements.

The law also states where and how pharmaceutical companies may advertise medicines to the general public in healthcare organisations. In pharmacies, advertisements may only be placed on permanent and specially separated places, and those advertisements cannot limit the expeditionary space intended for patients. In healthcare institutions (such as hospitals or outpatient clinics), advertisements may only be placed in patients’ waiting rooms. Advertisements should not have an audio-visual or audio form either in pharmacies or in healthcare institutions. When advertising in healthcare organisations, it should be remembered that in Poland there is a ban of advertising of pharmacies and healthcare institutions.

Every advertisement to the general public must contain two types of information: a special warning about the obligation to read the leaflet or to consult the HCP before using a medicine and a summary of basic information about the medicine.

The warning should be located at the bottom of the advertisement (10% or 20% of the advertising space, depending on its form) and – in the case of audio or audio-visual form – be read in a clear and understandable way (in a minimum of eight seconds). The warning should be placed in such a way that the text is distinguishable from the background and visible. In the case of visual advertising on more than one page, the warning is placed on the first page.

Advertising must contain the name of the medicinal product, the common name of the active substance or the term “combined product” if there are more than three active substances, a dose or a concentration of an active substance (with the exception of a combined product), pharmaceutical form, therapeutic indications, contraindications and the name of the Marketing Authorisation Holder.

The data contained in advertising aimed at the general public must be provided in a form that complies with the SmPC and, in its absence, with the documentation approved in the process of obtaining marketing authorisation. The advertisement should not be misleading and should present a medicinal product objectively.

Furthermore, Pharmaceutical Law states the list of content and information that cannot be present in an advertisement to the general public. It is prohibited to include content which suggests that:

  • a medical consultation or surgical operation is unnecessary;
  • even a healthy person’s health can be enhanced by taking the medicine; 
  • a person’s health could be affected by not taking the medicine (this does not apply to certain preventive vaccinations); 
  • a medicine is a foodstuff, cosmetic or other consumer product; and
  • the safety or efficacy of the medicine is due to the fact that it is natural.

There are a few issues that cannot be guaranteed in medicine advertising. These apply to: An effect of taking a medicine, a lack of any adverse reactions connected with taking a medicine and the therapeutic efficacy in comparison with (“better than” or “equivalent to”) another treatment method or treatment with a medicine.

It is also forbidden to cite detailed descriptions of cases and symptoms of illness, which could lead to erroneous self-diagnosis.

Polish law regulates interactions between patients and industry partially. The key restriction is a prohibition of inducements for patients. Pharmaceutical Law states that an advertisement cannot involve offering or promising any benefits either directly or indirectly in exchange for purchasing a medicine or providing proof that a medicinal product was purchased.

Furthermore, there is special regulation regarding reimbursed products. It is prohibited to offer any material or personal benefits (including discounts, awards, trips, games of chance, betting, linked transactions and any types of coupons and vouchers) to patients in connection with reimbursed medicines.

The law does not regulate interaction between pharmaceutical companies and patient organisations. However, in practice, the restrictions described above apply by analogy.

Detailed rules about interactions with patient organisations are regulated in self-regulatory codes. The most important restrictions common for various industry associations are:

  • prohibition of the requirement to be the sole sponsor of an organisation or any of its major programmes;
  • the principle of separation (interactions should not affect materials prepared by an organisation); and
  • the principle of transparency and documentation (the aim and the scope of co-operation should be transparent and precisely defined in a written agreement and any payment or in-kind donation should be documented).

Necessary components of advertising aimed at professionals include providing information consistent with the SmPC and not in a misleading way.

Advertisements directed at HCPs must contain significant information about the medicine:

  • the name of the medicinal product and the international non-proprietary name;
  • qualitative and quantitative composition in terms of active substances and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product;
  • the pharmaceutical form;
  • therapeutic indications;
  • posology and method of administration;
  • contraindications;
  • special warnings and precautions for use;
  • adverse reactions;
  • the marketing authorisation holder;
  • the marketing authorisation number and the name of the marketing authority;
  • the accessibility category.

In the case of reimbursed medicines, advertising should also include information about the official retail price and maximum co-payment covered by the patient.

The documentation should include accurate, current, verifiable and sufficiently complete information, enabling the recipients to make their own assessment of the therapeutic value of the medicinal product, as well as information about the date of preparation or last update.

Quotations, tables and other illustrations from professional literature and other scientific publications should be faithfully reproduced and the source should be provided.

Information used in the advertising of a medicine in some cases may be based on scientific evidence not included in the SmPC (like scientific evidence presented at scientific events) – as far as they remain compliant with the SmPC. Such evidence has to be included in publicly available material, eg websites of a given scientific congress or summaries (abstracts) published in indexed scientific journals. Such data should be provided in accordance with the original materials, with its source and date of publishing.

Other sources such as information obtained from market research carried out by the marketing authorisation holder (MAH) or an external entity (if these data have not been published and does not contain explicit information about the principal of the market research) or data on file (unless it is part of the registration dossier, available on request) are questionable.

Polish Pharmaceutical Law does not contain provisions regulate referring to combination products or companion diagnostics.

Because of this, an advertisement for a medicine containing such references should comply with the SmPC.

It is worth underlining that Polish medical devices law includes regulations that indicate when a medical device associated with medicinal product is treated as part of the a medicinal product and when as a medical device.

Companies may provide a reprint of journal articles to HCPs. This activity (conducted with respect for copyrights) is perceived positively as contributing to the promotion of current medical knowledge.

However, controversies arise with the provision of articles regarding unauthorised indications, actively disseminated by a company. Such activity may be considered to be advertising and thus considered to be an infringement of Pharmaceutical Law (prohibition of advertising inconsistent with the SmPC).

A similarly controversial practice is to provide a medical journal (as a legitimate gift) in which an article on the new indication of an active substance is followed by an advertisement for a medicine containing such a substance.

There are no specific regulations for Medical Science Liaisons in Poland. In general MSLs are experienced HCPs employed by the pharmaceutical companies. Their main role is to support the company's scientific departments and to represent them in scientific relations with HCPs.

Polish law does not prohibit MSLs from proactively discussing scientific information about unauthorised medicines or indications with HCPs. However, MSLs should be compliant with general rules indicated in  3 Advertising of Unauthorised Medicines or Unauthorised Indications.

Moreover, in contacts with HCPs, MSLs should indicate their relations with the company.

Advertising of medicines is not subject to prior authorisation from or notification to the regulator. It is also not possible to obtain such authorisation in advance from the authority.

Advertisements may be subject to control after dissemination, ex officio or on request. The competent authority is the Chief Pharmaceutical Inspector.

Pharmaceutical Law imposes a number of duties on companies related to advertising of medicines.

To be compliant with the above rules, a company has to appoint a person whose duties include providing information about the medicinal products placed on the market by the MAH.

Moreover, the MAH has to keep samples of every advertisement for two years from the end of the calendar year in which an advertisement was disseminated.

The law also regulates obligations relating to sales and medical representatives. In essence, they concern the assurance that representatives will be adequately educated (with sufficient scientific knowledge to provide precise and as complete as possible information about the medicines) and properly trained (by their company). In this context, running regular workshops for employees and preparing starter packs for new employees should be a standard practice.

In addition, a company must ensure that its medical representatives:

  • gather and send full information about medicinal products to the company, especially about any adverse reactions reported by the persons visited; and
  • have the SmPC and information on the official retail price and the maximum payment to be made by the patient (in the case of reimbursed medicines) to send or share it to an HCP.

Apart from well-educated and trained representatives, the key role is played by the medical department and compliance/legal staff. The effective, internal evaluation of the contemplated communication or marketing actions considerably reduces the risk of being questioned by regulatory authorities or competitors.

The law does not require specific standard operating procedure (SOP) to be adopted in the area of advertising. It is rather an element of the compliance policy of each company. However, having appropriate procedures seems essential, not only for the reasons of the division of responsibilities and consistent performance of duties by persons engaged in the marketing. Pharmaceutical firms face many risks regarding illegal advertising. Apart from financial penalties and losses, their reputation may be severely damaged; the management may even face prison time.

Having procedures that regulate the marketing and sales activities of the company that all of the employees are obliged to be accustomed with and to follow greatly reduces risks of violations of legal obligations, as well as the risk of the potential liability of the management of the company in the event of irregularities. The proper procedures may also be effective corporate defence in the event of infringements.

There are no specific rules for advertising of medicines on the Internet. General rules apply.

Advertising of medicines on social media is allowed. Such advertisements are subject to the same restrictions as other forms of advertising to the general public.

In particular, warnings referring to the safety of drug administration and obligatory information required for, respectively, audio-visual, audio or visual advertising addressed to patients should be used. In this context, some practical problems arise with the requirement to place the warning “at the bottom of advertisement” when advertising the product on social networks.

Advertising directed at HCPs must be secured against access by patients. However, the law does not specify the requirements of such security. Standards in this respect can be concluded from established case law of the Chief Pharmaceutical Inspector.

The authority does not accept methods based on two elements:

  • information that the website may contain advertising directed to HCPs and
  • a statement (confirmed by clicking the appropriate box) that the user is an HCP (it is underlined that such statement is unverifiable).

The Chief Pharmaceutical Inspector pointed out that websites solely for prescription-only medicines should have a system that indeed verifies that the potential user is qualified to prescribe medicines. Thus, more and more websites currently require a special account to be created for an HCP. Those persons are verified by their medical licence number.

According to Polish Pharmaceutical Law, information on human health and diseases is not treated as advertising of medicines as long as it does not apply, even indirectly, to medicines.

Companies are allowed to provide disease awareness information to patients. Polish law does not provide for special conditions for conducting such activities online.

In order to implement the informational nature of these activities, the principles set out in 2.2 Difference Between Information and Advertising shall apply.

Market practice indicates that disease awareness information provided online to patients is carried out using dedicated websites (of an informational, not marketing nature).

The Polish Criminal Code sets forth general anti-bribery rules, which also apply to interactions between pharmaceutical companies and HCPs or healthcare organisations.

Both offering and accepting a bribe is criminalised. These criminal provisions are applicable to a person who accepts the bribe who is considered to be a “person performing a public function” and committed the crime in relation to his/her function. In practice, a “person performing a public function” means any decisive person whose role is connected with the use of public funds (eg doctors prescribing reimbursed medicines or employees of a hospital taking part in public procurement proceedings).

The basic penalty for the person offering and the person accepting the bribe is imprisonment for between six months and eight years.

The Criminal Code also highlights commercial bribery. This applies to, among others, people performing a managerial function, who demand or accept the bribe in exchange for abusing granted authority or for failing to fulfil the incumbent duties in such a manner that it may inflict material damage upon such entity or constitute an act of unfair competition or an inadmissible preferential activity for the benefit of the buyer or recipient of merchandise, a service or performance.

Polish law provides for not only individual but also corporate criminal liability. The Liability of Collective Entities Act states that if an individual has been convicted by a final verdict and the corporation has or could have profited from his or her act and has contributed to its commission (insufficient oversight, flawed internal organisation), the corporation can be sentenced to a fine and suffer additional sanctions, such as a ban from advertising or public procurement proceedings for up to five years. Although, in its current state, the act is of limited efficiency, proceedings undertaken under this regulation have become more and more frequent in recent years.

Pharmaceutical Law states that it is prohibited to direct any advertising at HCPs involving the gift, offer and promise of material benefits, presents and other inducements, prizes, trips and the organisation and financing of meetings to promote medicinal products during which hospitality exceeds the main purpose of the meeting. The infringement of this prohibition may result in a criminal fine.

The Reimbursement Act also prohibits a business entity engaged in manufacturing or marketing of reimbursed products from making conditional sales, discounts, rebates, bonuses, bundling and loyalty programmes, donations, prizes, trips, gambling, betting, all forms of lending for use, package deals, all kinds of coupons and vouchers, as well as providing other material or personal benefits to HCPs entitled to prescribe medicines.

There are also specific criminal offences concerning reimbursed medicines. The person who granted or promised to provide undue financial or personal benefits to HCPs, healthcare providers or representatives of a healthcare provider in connection with reimbursed medicines is subject to imprisonment for between six months and eight years. The same penalty applies to the person receiving or accepting the benefit.

It is legally possible to provide in-kind or financial donations to healthcare institutions (although there are some restrictions in this respect in self-regulatory codes). The aim of such contributions should be supporting scientific research, medical education, patient education, patient access to healthcare and the overall development of healthcare systems.

Such activity should be well-documented (including a written agreement). Moreover, grants and donations shall be provided by an unsolicited and independent request from the healthcare institution, not at the initiative of the company. Due to the anti-bribery rules, these contributions should not induce anyone to supply, promote, prescribe, recommend, purchase (especially in public procurements) or dispense a particular product and should not influence the medical or scientific decisions of HCPs employed at the recipient.

Pharmaceutical Law explicitly prohibits advertisements involving, inter alia, the gift, offer and promise of material benefits, presents and other inducements, prizes and trips.

However, pharmaceutical companies may offer, and HCPs may accept, promotional items that bear a mark promoting a given company or a medicine, are relevant to the medical or pharmaceutical practice and are have a value below PLN100. According to established practice, the above value should include all taxes.

Such gifts usually include: Professional literature (such as medical journals), minor medical equipment, educational materials, office accessories and not significant computer accessories.

The self-regulatory codes provide for additional requirements for the promotional items.

In the case of promotional meetings as part of allowed reasonable hospitality, the market practice includes: providing a refreshment and, in specific situations, financing travel and accommodation costs (on a basis analogous to sponsorship of scientific meetings – see 9.3 Sponsorship of Scientific Meetings).

Samples may only be provided to persons qualified to prescribe medicines (and not to other HCPs). Requirements for such an activity are set out in the Pharmaceutical Law.

The activity must be initiated by an authorised person who submits a written application for samples. That person may receive a maximum of five samples of each medicine per year. The authorised person must confirm the receipt of samples in writing.

Companies must maintain appropriate records of provided samples.

Moreover, each sample cannot be greater than the smallest packaging of the medicine registered in Poland, should bear the claim “free sample – not for sale” and should have the SmPC.

Providing samples does not apply to medicines containing psychotropic or narcotic substances.

Again, some of the self-regulatory codes provide for additional requirements (eg in the case of the INFARMA code, the maximum limit is four samples per year, and samples may be provided only with respect to new medicinal products).

Pharmaceutical companies are allowed to sponsor either scientific events (meetings, congresses, conferences, etc) or attendance by HCPs at these events.

Pharmaceutical Law prohibits the organisation and financing of promotional meetings during which hospitality exceeds the main purpose of the meeting. This principle also extends to scientific events.

More detailed principles are included in self-regulatory codes, regarding:

  • location, such as prohibiting the use of locations that are primarily known for their touristic or recreational character;
  • venue, such as prohibiting the use of hotels or other venues known for their entertainment or recreational value;
  • hospitality, such as limitation to the financing of only travel, accommodation, meals and registration fees and prohibiting the financing of the participation of guests (such as families of HCPs); and
  • scientific programme, such as an obligation to be of an undoubted scientific nature.

Pharmaceutical Law prohibits the sponsorship of scientific conferences during which hospitality exceeds the main purpose of the meeting.

Although it is not expressly forbidden by law, it is becoming a common rule that companies only organise and sponsor the main scientific event and do not engage in side, recreational or entertainment events (cultural, sports or other) in relation to the main event.

The above does not exclude organising or sponsoring commercial or promotional events that are organised by pharmaceutical companies during the main event (such as a sponsored lecture or promotional satellite session with not unlavish hospitality). 

In general, pharmaceutical companies cannot provide any grants or donations to HCPs. The prohibition does not include the advertising indicated in Pharmaceutical Law – providing gifts of a value less than 100PLN (circa EUR25), as long as they are related to medical or pharmaceutical practice.

More liberal arrangements apply to providing grants or donations to healthcare institutions. In practice, companies may provide in-kind or financial donations (with certain limitations coming from self-regulatory codes, in particular related to support to for-profit healthcare institutions like private medical clinics). The aim of such contributions should be to support scientific research, medical education, patient education, patient access to healthcare and the overall development of healthcare systems.

Such activity should be well-documented (including a written agreement). Moreover, grants and donations shall be provided by an unsolicited and independent request from the healthcare institution, not at the initiative of the company. Due to the anti-bribery rules, these contributions should not induce anyone to supply, promote, prescribe, recommend, purchase (especially in public procurements) or dispense a particular product and should not influence the medical or scientific decisions of HCPs employed at the recipient.

In Poland, pharmaceutical companies may give rebates or discounts to healthcare institutions. They should be compliant with the general rules of rebates based on competition law.

Due to fixed prices and margins for reimbursed products in open distribution, such activities are prohibited in respect of reimbursed products (for example giving a discount to the pharmacies). However, applying rebates or discounts is allowed in the case of public procurements organised by professionals or institutions that provide healthcare services financed from public funds.

In Poland, pharmaceutical companies may engage and pay HCPs and healthcare organisations for services provided by them. Such cooperation may include speaking engagements, participating in research, focus groups or market research, serving as experts on advisory boards, educating about a product or any other service with a legitimate business need.

Polish law does not provide comprehensive rules in this matter. There are only a few regulations. For example, the Public Procurement Law states that an HCP who was a service provider for a pharmaceutical company cannot participate in public procurement proceedings on behalf of the ordering party in which this company is one of participants.

Detailed restrictions in this area results from general principles of civil law, business practice and self-regulatory codes.

The cooperation should meet certain additional requirements adopted by industry organisations. First, as mentioned above, services provided by HCPs or organisations must reflect a legitimate business need of a company. Second, the remuneration must be commensurate with and represent a fair market value. Third, payment shall only be made for the service performed. Fourth, engagement must be confirmed in a written agreement (with a clear description of the services and the remuneration). Fifth, it is prohibited to offer or enter into an agreement with the intention to induce the HCPs to supply, promote, prescribe, recommend, purchase or dispense a particular product (which is particularly important in the context of reimbursed medicines). Six, HCPs must be selected and engaged as service providers based on their qualifications, expertise and abilities to provide the service.

As any service rendered to an HCP must not influence the purchasing or prescribing decisions of the HCP, special caution measures are particularly advised when conducting activities directed at HCPs in the area of reimbursed medicines.

Pharmaceutical Law requires prior authorisations only in cases of promotional visits. Medical or sales representatives have to obtain permission from the employer or immediate superior of the person qualified to prescribe medicines. Furthermore, this visit should be scheduled in advance (outside of working hours).

It is worth noting that prior acceptance instruments were introduced by some industry organisations. Currently, pharmaceutical companies associated in INFARMA have to verify whether the scientific event has an appropriate certificate. Events are evaluated on the basis of criteria stated in the Pharmaceutical Law and the self-regulatory act of INFARMA.

Moreover, under the INFARMA code of conduct it is recommended that contracts concluded between the companies and HCPs shall contain a commitment from the HCP to obtaining the consent of his or her employer, or the entity to whom he or she provides services on a permanent basis, to undertake the cooperation specified in the contract, taking into account, in particular, the need to avoid conflicts of interest.

Polish legal acts do not provide an obligation on pharmaceutical companies to disclose details of transfers of value to HCPs and healthcare institutions. However, this obligation is imposed by industry organisations in their codes of ethics, specially drafted disclosure codes of industry organisations.

Currently disclosure reports are published by pharmaceutical companies associated in INFARMA and PZPPF. Detailed disclosure rules have been set out in the codes of these organisations.

It should be noted that the law provides for certain provisions regarding disclosure obligations. National and voivodeship (regional) healthcare consultants (who advise public authorities such as the Minister of Health) have to disclose any benefits from pharmaceutical companies exceeding PLN380 (circa EUR95). These benefits include, among others, domestic and foreign trips not related to the consultant function, the cost of which was not covered by the institution employing the consultant.

Due to the fact that disclosure obligation is imposed by self-regulatory codes, it applies only to member companies of a particular industry organisation.

The advertising of medicines is supervised by the Chief Pharmaceutical Inspector. It is responsible for enforcing the rules on advertising and the rules on inducement. To a certain extent (inducement for reimbursed medicines) the competent authorities are also Voivodeship (regional) Pharmaceutical Inspectors.

Except for regulatory authorities, certain other authorities and courts may be involved in supervision over medical advertising.

Disputes between competitors or between pharmaceutical company and customer (patient) are resolved by civil courts.

In the field of competition law and consumer protection, the key role belongs to the President of the Office of Competition and Consumer Protection. In practice, the President rarely engages in matters regarding medicine advertising and usually leaves them to be resolved by regulatory authorities or courts.

In the case of illegal incentives or bribes, proceedings are conducted before criminal courts (with the participation of the prosecutor).

Disputes regarding infringements of self-regulatory codes are resolved by disciplinary courts or other special authorities of a particular industry organisation.

Advertising and promotion activities violating fair competition rules can be questioned directly by competitors, as well as by consumers, in civil court proceedings. According to the act on Combating Unfair Competition, the entrepreneur whose interest has been threatened may demand inter alia cessation of the infringement and payment of damages. Similar rights are vested in consumers (patients) under the Act on Combating Unfair Market Practices.

Proceedings before the Chief Pharmaceutical Inspector and the President of the Office of Competition and Consumer Protection are instigated ex officio, based on these authorities’ own decisions. However, a competitor can inform relevant authorities about suspected infringement and inspire the instigation of proceedings.

If there is a breach of legal provisions on advertising, the Chief Pharmaceutical Inspector can order:

  • discontinuation of the advertisement;
  • removal of the identified infringement; and
  • publication of the order in places where the infringing advertisement was shown, with a correction of the said advertisement.

The selected infringements or non-performance of the order may also result in a criminal fine. 

Non-compliance with the prohibition of giving benefits in connection with reimbursed products is subject to fines of up to 5% of the value of net sales of the reimbursed products in the previous year, or – if the penalised entity has not sold any products for which a reimbursement decision was issued – of one hundred times the value of the benefit (ordered by the Voivodeship Pharmaceutical Inspector). It may also constitute a criminal offence with a basic sanction of imprisonment between six months and eight years.

Where an act of unfair competition is committed, the company whose interest is threatened or infringed may request:

  • cessation of the prohibited practices;
  • removal of the effects of the prohibited practices;
  • the making of one or a repeated statement of appropriate content and form;
  • repair of the damage;
  • the handing over of unjustified benefits; and
  • adjudication of an adequate amount of money to the determined social goal connected with support for Polish culture or related to the protection of national heritage.

Before or in conjunction with the commencement of the court proceedings, the company may also file a motion for interim injunction.

The same scope of claims (except for handing over unjustified benefits) also apply to the patient/consumer.

If the advertisement is considered to be an unfair commercial practice or act of unfair competition, the President of the Office of Competition and Consumer Protection imposes an obligation on a company to cease the infringement. In the decision, the President may also:

  • identify measures to remove the ongoing effects of the infringement;
  • order the publication of a decision;
  • impose a financial penalty on the company of an amount not exceeding 10% of the turnover achieved in the financial year preceding the year the penalty was imposed; and
  • impose a financial penalty up to PLN2,000,000 on the managing person (if such person intentionally contributed to the infringement).

Procedures before disciplinary courts or other authorities of industry organisations are independent from administrative or court procedures, and may be taken simultaneously.

The subject of self-regulatory procedures is only the potential violation of the code. However, such a procedure may result in the initiation of an administrative procedure by the Chief Pharmaceutical Inspector (for example one of the sanctions included in the INFARMA code of conduct is a notification of the Inspector about the final decision).

Currently, there are no official drafts that may directly change or affect regulation regarding medicines advertising.

An analysis of the practice of the Chief Pharmaceutical Inspector in recent years shows that due to the fact that the advertisements in question were withdrawn, the Inspector issued decisions to discontinue proceedings. Moreover, the activity of the Pharmaceutical Inspectorate seems to focus more on advertising of pharmacies, not on advertising of medicines (as indicated by statistics on the number of issued decisions demanding that advertising is stopped).

It is worth underlining that some solutions, so far, specific to medicinal products are implemented in medical devices and the IVD sector. The currently pending draft Act on medical devices provides for the introduction of analogous advertising rules for medical devices and IVD as for medicines. Moreover, on the self-regulatory level, solutions for interaction with HCPs and healthcare institutions are introduced, like the conference vetting system and the disclosure platform.

Also, in the case of advertising of other health-related products, ie, dietary supplements, from 1 January 2020, a code of good practice signed by several important industry organisations and key TV stations applies. The main purpose of this self-regulation is to eliminate television commercials which suggest that dietary supplements have a therapeutic nature.

Tomasik Jaworski sp.p.

Aleje Ujazdowskie 39/4
00-540 Warszawa
Poland

+48 22 625 10 81

+48 22 584 46 68

kancelaria@tjsp.pl www.tjsp.pl
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Law and Practice

Authors



Tomasik Jaworski sp.p. specialises in advising entities from regulated industries (pharmaceutical, medical and food) and conducting litigation. The firm was founded by lawyers with long experience working for Poland’s biggest law firms, and advises Polish and international manufacturers of medicinal products and medical devices on all stages of product development, especially with regard to clinical trials, registration, reimbursement, advertising and compliance. It also provides advice to industry organisations including the Association of Pharmaceutical Employers PharmaNET, MedTech Polska, the Polish Association of Pharma Industry Employers and the Polish Federation of Food Industry, having participated as experts in the legislative processes concerning the most important legal changes in the life sciences sector in recent years. Tomasik Jaworski’s international activities include providing consulting services to the Ministry of Health of Ukraine on the reform of the drug registration system in Ukraine.

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