Laws

The laws that regulate the advertisement and promotion of medicines are governed by both EU laws and national laws in Hungary. The main regulatory framework for pharmaceutical promotion and advertisement includes the following EU and Hungarian laws:

• Directive No 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use (the “Pharma Directive”);
• Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products (the “Drug Economy Act”); and
• Decree No 3/2009 (II. 25.) of the Minister of Health on the Detailed Rules of the Promotion of Medicinal Products and Therapeutic Medical Devices for Human Use, and the Registration of Medical Sales Representatives and Commercial Practices Targeted at Consumers (“Decree No 3/2009”). 

Self-Regulatory Codes

With the expansion of the globalised world economy, the role of self-regulation has increased in Hungary over recent decades. Recognising the importance of unified and coherent self-regulation, the main representative organisations of pharmaceutical companies, ie, the National Association of Hungarian Pharmaceutical Manufacturers, the Association of Innovative Pharmaceutical Manufacturers (AIPM), the Hungarian Association of Generic Pharmaceutical Manufacturers and Distributors, and the “VÉDETTSÉG” Association of Immunobiological Product Manufacturers and Distributors (jointly referred to as the “Associations”) prepared and ratified a joint Code of Ethics for Pharmaceutical Communication (the “Code of Ethics”). The Code of Ethics follows the Code of Practice of the European Federation of Pharmaceutical Industry Associations (EFPIA) and the Code of Conduct of the Medicines for Europe.

Within the framework of self-regulation, the Hungarian Code of Advertising Ethics adopted by the Hungarian Advertising Association sets out requirements for the advertisement of healthcare products, which also includes medicines. Corresponding to the Code of Ethics, compliance with the Hungarian Code of Advertising Ethics is an obligation of its signatories, which being an umbrella organisation represents professions in the field of advertising, marketing and manufacturing of certain foods, drinks and cosmetics. 

The Associations also have their own code of practice which is consistent with the Code of Ethics. The transparency obligations of the member companies are regulated in the Code of Practice of the concerned Associations. 

In practice, the Code of Ethics is considered to be general guidance prepared by the members of the relevant industries. The Code of Ethics is binding on the member companies of the Associations and on other companies which voluntarily accept the obligations as binding. Signatories of the Code of Ethics are pharmaceutical companies and their associations.

It is voluntary to join any professional association for the conducting of pharmaceutical marketing and manufacturing activities in Hungary. Therefore, the Code of Ethics is treated as self-regulatory guidance for the pharmaceutical industry. 

Though the Code of Ethics is considered guidance, the Associations comply with the provisions of the Code of Ethics as a soft law. The Associations have internal organisations, such as executive bodies and communication ethics committees, which are tasked to identify conducts which violate the provisions of the Code. They also publish their positions to assist in the implementation of the Code.

The definition of (pharmaceutical) advertising is primarily stipulated in the Drug Economy Act, which follows EU law but makes a clear distinction between the advertisement and the promotion of medicines. Advertisement is defined as commercial communication directed to consumers. Promotion is defined as commercial communication directed toward healthcare professionals (HCPs). In Hungary, only over-the-counter (OTC) medicinal products which do not receive any state subsidies, ie, are not included in the social reimbursement system, can be advertised. 

Pursuant to Point 11 of Section 3 of the Drug Economy Act, advertising includes any form of communication, information or the making of a representation in any form with the aim, or having the direct or indirect effect, of promoting the supply of medicinal products or, in connection with this purpose, the representation of the name, the trade mark or the activities of a producer of medicinal product, excluding the following:

• the labels and package leaflets of medicinal products;
• the factual, informative announcements and reference material relating, for example, to package changes, and adverse-reaction warnings as part of general drug precautions relating to medicinal products; and
• trade catalogues and price lists, provided, that they do not include any product claims concerning the efficacy of medicinal products.

Section 12 (1) of the Drug Economy Act sets forth the definition of promotion as: “The promotion of medicinal products shall mean commercial practices pertaining to medicinal products applied for or against healthcare professionals with proper entitlement for the prescription and distribution of medicinal products, including instructions as to their use and information provided in connection with the composition and efficacy of the medicinal products and for the application of the medicinal products.”

Generally, the content of the information material determines whether it is considered as disease awareness or advertising. Disease awareness campaigns and materials cannot include any product information or branded elements and must focus on disease information of a specific therapeutic area. The distinction between disease awareness campaigns and advertising is that patient education focuses on diseases rather than specific medicines and is often delivered in groups with the use of educational materials. The relevant materials and any activity related to disease awareness campaigns must be examined as a whole in order to determine if they qualify as awareness campaign materials or as advertising. 

Point 11 of Section 3 of the Drug Economy Act clearly stipulates that patient information leaflets are not considered advertising of medicinal products. Branded patient leaflets can only be shared with patients who are already receiving the designated therapy. 

In Hungary, no specific legal regulations provide the framework for activities aiming at disease awareness. Patient support programmes are considered as special disease awareness campaigns. In order to provide additional assistance for the legal interpretation of the respective regulations on pharmaceutical advertising, the National Centre for Public Health and Pharmacy (Hungarian abbreviation, NNGYK) issued its position on patient support programmes and patient educational activities. According to this position, patient education campaigns are aimed at increasing patients’ knowledge and health awareness. Its purpose is to help patients understand the nature of their diseases, which in turn can contribute to the success of their treatments and may have a positive impact on their quality of life. 

Press releases regarding medicinal products and, in particular, their indications, compositions and characteristics are allowed only if they meet the general conditions set forth for the advertisement and promotion of medicines as regulated in the Drug Economy Act and Decree No 3/2009. 

The Hungarian legislation establishes different provisions for introducing information on medicines depending on the target audience and the type of the medicinal product presented (OTC product or prescription-only product). 

In accordance with Section 17 of the Drug Economy Act, advertising prescription-only or reimbursed medicines to the lay public is prohibited in Hungary, where only the promotion of these products to HCPs is permitted. It also means that the promotion of these medicines and the provision of any information which can only be presented to HCPs is prohibited in the mainstream printed, audio and visual media. Anything else would create a clear violation of the Drug Economy Act with severe consequences and fines. In the case of press releases, the content of the press release and the target audience must be assessed. If the press release is addressed to representatives of the media working for professional platforms which are not available to the lay public, the press release can also cover prescription-only products. 

For further clarification on these requirements and differences, please see 4. Advertising Pharmaceuticals to the General Public and 5. Advertising to Healthcare Professionals. 

Under Act LVII of 1996 on the Prohibition of Unfair Trading Practices and Unfair Competition (the “Competition Act”), comparative advertising is permitted only upon the meeting of certain conditions.

Pursuant to Sections 6/A and 10 of the Competition Act, the comparative advertising of medicinal products is permitted if:

• it compares medicines meeting the same needs or intended for the same purpose, ie, medicines for the same disease or with the same active substance;
• it objectively compares one or more material, the relevant, verifiable and representative features of those goods, which may include the price if the price is also part of the comparison;
• it does not result in any unfair advantage derived from the reputation of the competitor or the name, merchandise, brand name and other marking of such competitor;
• it does not harm the reputation of the competitor or the name, merchandise, brand name and other marking of such competitor,
• it does not present the medicinal product as imitations or replicas of medicinal products bearing a protected trade mark or trade name; or
• it does not create confusion among market participants, between the advertising business entity and a competitor or between the advertising business entity’s trade name, medicinal products, trademarks or other distinguishing marks and those of a competitor.

The Code of Advertising Ethics also lists conditions for comparative advertising and stresses that comparative advertisements must not:

• be misleading;
• lead to confusion with the competitor or its product;
• tarnish the reputation of the competitor;
• disparage the competitor or its product; and
• unfairly harm the interests of the competitor.

According to Section 3.11 of the Code of Ethics, any price comparison included in the material is considered as a medicinal product advertising, therefore, the references must be indicated.

Under Section 11/A of the Drug Economy Act, regardless of the audience, carrying out any form of commercial practice relating to unauthorised medicinal products (ie, without a marketing authorisation (MA)) is prohibited. 

In 2019, NNGYK issued guidance on the applicable requirements of the promotional activities of pharmaceutical companies (“NNGYK Guidance”). The NNGYK Guidance described the specific rules on the promotion of medicinal products without MAs to HCPs. According to the NNGYK Guidance, the general prohibition set forth in the Drug Economy Act does not preclude the possibility to provide HCPs with scientific publications published about medicinal products without MAs. In the case of clinical trials, the scope of public data must be limited to the data set forth in the EU clinical trial register.

According to the consistent practice of NNGYK, the provision of information or dissemination of scientific publications published about a new, unauthorised indication of an already authorised medicinal product must be carried out at professional events and separated from the company’s promotional activity. 

In the case of advertisement to the lay public, in compliance with 2.3 Restrictions on Press Releases Regarding Medicines, the advertising of medicinal products without MA is strictly forbidden under Hungarian law. 

Having regard to 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications, the scientific nature of work excludes the commercial nature of the conduct of providing information on investigational and unauthorised medicines to HCPs. With respect to this interpretation, presenting information on medicinal products without a valid MA at scientific events can be directed only to HCPs.

It must be stressed that the above rules only apply to events falling under the scope of the Drug Economy Act, ie, professional events held in Hungary with the participation of Hungarian HCPs or events held by international companies carrying out promotional activities in the territory of Hungary. 

Providing HCPs with scientific publications or presenting them with scientific information in accordance with 3.2. Provision of Information to Healthcare Professionals may be carried out both in a proactive and a reactive manner upon meeting the aforementioned conditions. 

Pharmaceutical companies may share scientific information on unauthorised medicines or unauthorised indication with HCPs in a reactive manner, such as in response to HCPs’ request for information.

Under Hungarian law, no specific legal rules are set forth regarding the provision of information on unauthorised medicines or unauthorised indications to healthcare institutions. Under Hungarian law, this activity is regarded as interacting with HCPs, which is examined in 3.2 Provision of Information During a Scientific Conference and further sections below.

In Hungary, in accordance with Regulation (EC) No 726/2004, Act XCV of 2005 on Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products (the “Medicine Act”) specify the rules for compassionate use programmes. Pursuant to Section 25/C (4) of the Medicine Act, NNGYK publishes the notices of its decisions relating to the compassionate use of medicinal products on its official website. 

Publishing the approval of compassionate use of a medicine by the marketing authorisation holder would be considered unlawful since unauthorised medicinal products cannot be advertised to the lay public; and providing information on a medicinal product without an MA to HCPs may only occur in the context of scientific interaction, ie, by sending scientific publications to HCPs or making a presentation at a scientific event. In the latter case, the information must be limited to the data set forth in the EU clinical trial register.

Information on approved compassionate use of a medicine can only be obtained from the official website of NNGYK and communicated to HCPs.

The Drug Economy Act sets forth the applicable legal rules for advertising medicines to members of the lay public.

With respect to the advertisement of medicinal products, the following prohibitions apply:

• all forms of commercial practices relating to products without a valid MA are prohibited; 
• advertising prescription-only (Rx) medicines is prohibited to the lay public; and
• advertising reimbursed medicines (Rx and OTC) is prohibited to the lay public.

In other words, only OTC products and medicinal products without social security reimbursement can be advertised to consumers and the general public in Hungary. It must also be emphasised that, due to the public interest in receiving vaccinations, the prohibition on advertising Rx or reimbursed (OTC) medicinal products does not apply to vaccination campaigns, which are pre-approved by NNGYK, and to information on medicinal products connected to these campaigns.

It must be added that, under Section 17 (6) of the Drug Economy Act, an advertisement cannot be published if it:

• concerns a non-prescription (OTC) medicinal product that bears the same name as a prescription medicinal product which is otherwise available on the market; or
• concerns non-prescription (OTC) medicinal products, the price of which is reimbursed according to other specific legislation by the Central Budget Act or by the Healthcare Fund.

Requirements for the Content of Advertising

As stipulated in Section 17 of the Drug Economy Act, the advertisement must meet the following requirements:

• the advertising must encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating their properties;
• the information provided must conform to the information contained on the label and the package leaflet as approved in the MA;
• the product in the advertisement must be clearly identified as a medicinal product;
• the advertisement must include the name of the medicinal product;
• the advertisement must contain the information necessary for the proper use;
• the advertisement must demonstrate the medicinal product based on its summary of product characteristics;
• the advertisement must contain the patient information leaflet and disclaimer specified in Decree No 3/2009 (please see below); and
• the advertisement must contain an express, legible invitation to read carefully the instructions for the application of the medicinal product.

The disclaimer required and set forth by Section 4 of Decree No 3/2009 warns patients to read the package leaflet or ask their doctor or pharmacist for further information about the risks and side effects of the advertised medicinal product. The disclaimer must be written in the advertisement in a legible and visible manner, horizontally, prominently highlighted against the background in the Hungarian language. The disclaimer must cover 10% (in the case of two or more languages displayed, 20%) of the advertisement. If the advertising material comprises several pages, it shall appear on the last page of the material. For radio and generally audio advertisements, the disclaimer must be spoken at the end of the advertisement, clearly and comprehensibly in the Hungarian language, for at least five seconds and, in the case of traditional herbal medicines, at least ten seconds.

Restrictions on the Content of Advertising

In addition to the aforementioned, the following references and expressions are prohibited from being included in the advertisement:

• claiming or creating the impression that a medical consultation or surgical operation is unnecessary or redundant;
• suggesting that the effects of taking the medicinal product are guaranteed, or are unaccompanied by adverse reactions;
• suggesting that the medicinal product is a foodstuff or a cosmetic product;
• suggesting that the safety or efficacy of the medicinal product is because it is natural;
• suggesting, by a description or detailed representation of a case history, that it could lead to erroneous self-diagnosis; 
• using improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof;
• referring to the recommendation of scientists, healthcare professionals or celebrities; and
• suggesting that the health of the subject could be affected by not taking the medicinal product.

Further to 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public, no advertising can be published if:

• it concerns a medicinal product that contains narcotics or psychotropic materials;
• it concerns an investigational medicinal product; and
• it is directed at children, including advertising in children’s programmes and children’s publications.

Interactions with Patients

Section 12 (1) of the Medicine Act sets forth that medicinal products may be procured on behalf of and dispensed to patients by pharmacies; therefore, as a general rule, neither manufacturers, MA holders or distributors are allowed to directly interact with patients. As a main principle, only pharmacies and/or treating HCPs are entitled to dispense medicines to patients and provide pharmacist consultation to patients. This restriction does not pertain to dispensing medicinal products and providing consultations by HCPs at healthcare institutions.

Pharmaceutical companies may interact with patients through patient support programmes or disease awareness programmes. In this regard, the Drug Economy Act sets forth the following restriction with respect to data collected during these programmes: it is prohibited to collect and process data on illness or medication patterns in any manner that would allow the identification of the data subjects in the framework of patient support programmes or other programmes and encourage or reward the disclosure of any such restricted data.

Interactions with Patient Organisations

Detailed rules that must be taken into consideration for interactions with patient organisations are set forth in the Code of Ethics.

Concerning the interactions between member pharmaceutical companies and patient organisations, the Code of Ethics requires the following conditions to be met:

• independence of the patient organisations must be ensured regarding their political opinions, guidelines and activities;
• all co-operation must be based on mutual respect, where the views and decisions of each partner are considered of equal value;
• companies shall not request, and patient organisations shall not undertake, to promote a specific prescription (Rx) medicine; and
• every collaborative effort and co-operation must be transparent, and any monetary or non-monetary support provided by the pharmaceutical companies must be clearly documented and acknowledged.

In the course of interactions with patient organisations, companies must fully respect editorial freedom. Member companies shall not attempt in any way to influence the content of press and other materials, publications prepared by supported patient organisations or their participation, favouring their self-business interests. This prohibition does not preclude the company from requesting the opportunity to professionally review these materials for accuracy and, if necessary, correct any factual mistakes and inaccuracies.

The Code of Ethics includes detailed rules on events organised by patient organisations and donations provided by pharmaceutical companies to patient groups and organisations. 

The Drug Economy Act and Decree No 3/2009 set forth the legal requirements on the content of advertising materials directed to HCPs. Additional and more detailed requirements specified below apply to advertisers falling within the scope of the Code of Ethics.

Advertising must legally contain:

• accurate, verifiable and up-to-date information based on which HCPs can form their professional opinions;
• date of the last review or closing date;
• price information (price accepted as the basis of the social reimbursement, amount of reimbursement, amount of co-payment) for products with social reimbursement; and
• reference to the scientific material for quotations, tables and other illustrative material.

Additional requirements set forth by the Code of Ethics include:

• the authorised name, pharmaceutical form, strength and the active substance of the product;
• the approved indication(s), dosage and method of administration of the product; 
• the contra-indications; 
• the main adverse reactions; 
• the following warning: “For more information, read the summary of product characteristics”;
• the date of the last approved summary of product characteristics; 
• the name and contact details of the representative of the MA holder in Hungary; and
• the internal identification code of the material.

The following information is legally prohibited from advertising:

• information relating to not yet authorised products or indications (except in non-branded scientific publications);
• promotional or branded materials and information prepared by HCPs; and
• unreferenced scientific statements.

Advertising must be consistent with the information included in the MA, the approved package leaflet and the summary of product characteristics (the “Accompanying Documents”). This requirement does not mean that all statements must be literally included in the Accompanying Documents. The materials may contain claims that confirm or supplement the claims included in the Accompanying Documents. 

In connection with products that are in the research phase, scientific publications may be shared with HCPs if the information provided does not exceed the data available in the EU clinical trial register platform. In the case of not-yet-authorised indications of products with valid MA, data generated in clinical research can only be shared during scientific events organised for HCPs that are separate from promotional activities. For more information, see 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications.

Under Hungarian laws, general advertising rules and requirements apply to the advertising of combination products. In the case of product bundling (ie, the sale of two products together), competition law requirements must also be taken into account, especially in relation to a dominant market position.

If the advertising of a complementary product intends to promote the sale of a medicinal product or if the medicinal product is mentioned in the advertising of the complementary product, the general rules on advertising of medicinal products apply.

Advertising of companion diagnostic products shall comply with the requirements set forth for medical devices or in vitro medical devices, depending on the type of the product. General consumer protection and competition law requirements must be also taken into account in relation to the advertising of companion diagnostic products.

There is no specific regulation on the advertisement of companion diagnostic products which are not included in the summary of product characteristics as it is set forth in 5.3 Advertising of Combination Products.

Companies may provide reprints of scientific journal articles to HCPs if the following requirements are met.

Section 14 (1) of the Drug Economy Act sets forth the general rule on the prohibition of providing gifts or pecuniary advantages to HCPs. Gifts and other benefits may only be given to HCPs if these are of small value (does not exceed 5% of the then prevailing minimum wage) and are related to the healthcare activity in which the concerned HCP is engaged in. Pursuant to the Code of Ethics, gifts shall contribute to the improvement of patient care and cannot encourage the HCP to recommend, order or prescribe a particular medicinal product. For more detailed rules, please see 9.1 Gifts to Healthcare Professionals.

Permitted functions of MSL depend on whether they are registered as sales representatives with NNGYK or not. 

If MSLs are registered as sales representatives, MSLs may initiate proactive communication on scientific information with HCPs regarding authorised medicinal products. Proactive activities relating to authorised medicinal products are generally prohibited for non-registered MSLs in Hungary. According to the position and interpretation of NNGYK, non-registered MSLs may only share non-promotional scientific information with HCPs proactively at scientific congresses in line with the clinical trial registry. MSLs may share scientific information with HCPs in a reactive manner (ie, in response to a HCP’s specific request for information).

The proactive communication of MSLs relating to non-authorised products is strictly limited to clinical research-related scientific data that is publicly available on the EU clinical trial register platform or in scientific publications. Information on unauthorised indications of authorised products can only be shared during scientific congresses.

Pursuant to the Drug Economy Act, only campaign materials used during vaccination campaigns addressed to lay persons require the prior approval of NNGYK. Other advertising activities can be carried out without the authorisation or approval of the relevant authority but they must strictly comply with the limitations set forth in the Drug Economy Act.

The competent authority for the approval of vaccination campaign materials is NNGYK. According to the interpretation of NNGYK, the principles set forth in the Pharma Directive for the advertisement of medicinal products addressed to the lay public apply to vaccination campaigns. Related requests shall be submitted electronically to NNGYK together with the reference materials. NNGYK issues a formal decision on the approval or rejection of the submitted material.

Because the advertising of medicinal products, and specifically the advertising of Rx medicinal products, in Hungary is strictly regulated, companies generally adopt detailed standard operating procedures and create special positions and responsibilities (medical reviewer or compliance officer) within their organisations to closely monitor the laws, regulations, industry practices and NNGYK guidelines and ensure compliance with all applicable rules and regulations.

Hungarian laws regulate the following two areas relating to the advertisement of medicinal products where companies employ specific personnel.

Registered Sales Representatives 

The advertising of medicinal products to HCPs can only be carried out by registered sales representatives. Sales representatives registered with NNGYK must have a degree in medicine, dentistry, pharmacy, biology or chemistry or a bachelor’s degree in the area of medicine or health sciences, unless an exemption specified in Decree No 3/2009 applies to them. 

Scientific Internal Unit

In accordance with Decree No 3/2009, companies must ensure that the management of the commercial communication relating to medicinal products is organised within their organisation and a scientific unit is set up for this purpose. The role of the scientific unit is to manage the creation and distribution of information materials and brochures for HCPs, and ensure their content is scientifically verifiable and correct, and reviewed by professionals who are qualified and has appropriate experience in their field. Generally, these positions are held by people who have a medical or pharmacy degree and have relevant professional experience.

No specific rules and requirements are laid down in the Hungarian legislation regarding the advertising of medicinal products on the internet. The general advertising requirements set forth in 4. Advertising Pharmaceuticals to the General Public also apply to advertising on the internet.

The rules and requirements of advertising are not determined by the platform where the advertisement is published, but by the recipients of the advertisement (lay public or HCPs), the content of the advertisement (Rx or OTC), and whether it is branded or disease awareness information.

Special rules apply to the sale of medicinal products over the internet. Only OTC products can be ordered and dispersed online and only pharmacies that have registered their website addresses with the authority, at the latest when they start selling medicines online, are allowed to conduct internet sales activities.

Neither the Drug Economy Act nor any other Hungarian legislation provide specific rules on how to ensure that content addressed to HCPs is accessible only by them. 

In practice, the company publishing the information is expected to take sufficient measures to ensure that the content intended for HCPs only is not accessible to lay persons. The measures could include requiring registration on the website by providing the unique id of the medical professional or monitoring registrations. It is in the companies’ discretionary power to decide how they want to ensure that access to any such information is strictly limited.

Disease awareness information may be provided to the general public online, provided that the general advertising requirements are met. 

When providing educational content, it is important for companies to pay particular attention to educational content for children since Hungarian law prohibit the commercial marketing of medicinal products to children. When sharing disease awareness information, companies must declare if they have paid a service provider for the display of a particular piece of information. Disease awareness information that is available online cannot include promotional messages or branded communication regarding medicinal products.

Please see detailed rules on disease awareness materials in 2.2 Information on Advertising: Disease Awareness Campaigns and Other Patient-Facing Information.

The same rules and regulations apply to virtual scientific meetings as to in-person scientific events. Pursuant to Hungarian legislation, pharmaceutical companies may sponsor virtual scientific meetings and the virtual attendance of HCPs if the general requirements ‒ such as the separation of promotional and scientific content, thresholds or authority registration of the events ‒ are adhered to. 

In the context of sponsoring virtual events, companies may choose one of the following two options:

• companies can either sponsor the virtual event subject to the limits set forth by the Drug Economy Act; or
• they can purchase services (eg, virtual booth, advertising platform, symposium time) at fair market value from event organisers.

When supporting the virtual attendance of HCPs, the general rules of the Drug Economy Act on in-kind sponsorships apply, except that in the case of a virtual event the reimbursement of hospitality, travel and accommodation costs can only be justified in specific cases. In case of virtual events, these costs are not directly linked to the attendance of the concerned HCP.

National and International Virtual Events 

Virtual events organised by an international company, ie, a company that is not subject to the Drug Economy Act, are considered international events. If the event is organised by a company carrying out promotional activity in the territory of Hungary (therefore subject to the Drug Economy Act) or the event is organised exclusively for a Hungarian audience by an international company, Hungarian rules and requirements shall apply. Hungarian legislation also applies if a company provides sponsorship for the attendance of a Hungarian HCP in connection with an international virtual event.

Authorisation of Events

For the sponsorship of national virtual events or providing sponsorship to Hungarian HCPs for their attendance at virtual events, the event must be registered with NNGYK at least 15 days prior to its start date by using NNGYK’s electronic event registration platform.

Materials Shared at the Events

If the event concerned qualifies as a national event based on the above detailed rules, only materials and information that comply with Hungarian laws may be shared with Hungarian HCPs. Please see details on the requirements of promotional materials in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals.

Sharing Materials Following the Event

Recordings and other materials related to the events may be made available after the conclusion of the event if it is ensured that only HCPs have access to those materials. 

Advertisement of Rx medicinal products to lay persons is generally prohibited in Hungary, including advertising on social media. Only advertisements of OTC medicinal products and authority-approved vaccination campaigns may be shared on social media platforms available to lay persons. Rx medicinal products may only be advertised on restricted social media platforms available to HCPs only.

General rules and requirements are applicable to the advertising of medicinal products on social media platforms. With respect to influencer marketing activities, the Hungarian Competition Authority (Hungarian abbreviation, GVH) issued guidance on the applicable requirements and authority interpretations. In accordance with the practice of GVH, influencers are celebrities and not medical professionals and, as such, they cannot participate in any medical product-related commercial activity. 

Pharmaceutical companies are responsible for all communications made on their behalf. General rules must be followed for social media platform appearances, including the transparent labelling of sponsored content. Based on the Code of Ethics, if a company discovers that someone is engaging in uncompliant content in connection with their products and fails to notify the person to comply with the effective rules, the company can also be held responsible for the unauthorised content.

Anti-bribery and anti-corruption rules are set forth in Act C of 2012 on the Criminal Code (the “Criminal Code”) and the Drug Economy Act. The Criminal Code defines the crimes of corruption, which include active and passive forms of corruption. Pursuant to the Criminal Code, any person who gives or promises unlawful advantage to a person working for or on behalf of an economic operator (including healthcare organisations), or to another person on account of such employee, to induce them to breach their duties is guilty of bribery, which is a felony.

The Drug Economy Act sets forth a general prohibition on providing gifts to HCPs in Hungary with strict exemption rules (please see 9.1 Gifts to Healthcare Professionals).

The above rules and requirements apply to benefits provided to medical professionals employed in state-financed hospitals, clinics and health institutions. Donations and sponsorships may be provided for charitable reasons to healthcare organisations under a specific set of Hungarian laws. 

Anti-bribery and anti-corruption laws apply both to the private and public health sector in Hungary.

In accordance with the Code of Ethics, no gift, benefit in cash or in kind, personal benefit or personal service may be given to an individual HCP during the promotional activities of a company.

In line with the Drug Economy Act, the Code of Ethics sets forth that during the promotion of Rx products, occasional gifts of a small value may be given if it:

• is in compliance with the laws (not exceeding a small value as per the Drug Economy Act);
• is directly related to the practice of the medicinal activity and supports the healthcare activity;
• contributes to the improvement of patient care;
• does not constitute a circumvention of the otherwise prohibited gift; and
• does not encourage the prescription, order, recommendation or taking of a particular medicinal product.

In the case of OTC medicinal products, a gift or other benefit may be provided to individual HCPs if it is in compliance with the legal requirements and is related to the HCP’s healthcare activities.

Based on the Code of Ethics, donations provided to healthcare organisations are allowed if: 

• they are intended to promote healthcare or research activities; 
• accurate documentation and records are maintained by the company; and
• they are unconditional, meaning that they do not encourage to recommend, order, purchase, supply, sell or distribute any particular medicinal product.

Gift and Gadgets Provided to HCPs

The Drug Economy Act and the NNGYK Guidance summarise the rules on what gadgets and promotional materials pharmaceutical companies can give to HCPs during live meetings and/or professional events. Neither the Drug Economy Act nor the NNGYK Guidance contain a specific list of those gifts and the pecuniary advantages that can be given to HCPs, rather they both list the main principles that the authority follows, and, in certain cases, investigate the gift giving practices of pharmaceutical companies. 

As a general rule, Section 14 (1) of the Drug Economy Act sets forth that gifts, pecuniary advantages or other material benefits may not be provided, offered or promised by the promoters in the framework of their promotional activity directly to HCPs, unless:

• the gifts are of small value; 
• they are related to the healthcare activity in which the HCP is engaged; and
• their aggregate total value does not exceed 60% of the prevailing monthly minimum wage on an annual basis. 

According to NNGYK’s practice, it is the everyday function of the gift which is relevant when examining if the gift/gadget is related to the HCP’s healthcare activity. Pursuant to the authority’s established and consistently enforced practice, (soft) toys, flowers, coffee, chocolates, wine and/or gift vouchers are never considered as related to the HCP’s healthcare activity. 

Cost Limit for the Business Hospitality Applicable to Pharmaceutical Company’s Events

Section 14 (2) of the Drug Economy Act sets forth the rules with respect to the acceptable amount of business hospitality provided by the promoter company during the pharmaceutical companies organised own events. According to Section 14 (2) of the Drug Economy Act, the costs of hospitality functions provided by pharmaceutical companies per day and per person must not exceed 5% of the then current minimum wage. The hospitality limits of pharmaceutical companies organised own events in 2024 is HUF13,340 (approximately EUR35) per day and per person.

NNGYK interprets the term "cost of the event" narrowly, therefore, in addition to the cost of meals and beverages, only the cost of those services which are closely related to the catering services and are typically provided by the catering service provider (room rental, audio, projector, etc), fall under the meal threshold.

According to Decree No 3/2009, medical sales representatives registered with NNGYK may provide samples of medicinal products with copies of the medicinal product’s SPC:

• in the case of a healthcare provider providing in-patient care, through the institute’s chief pharmacist;
• in the case of other healthcare providers, directly to the HCPs during personal meetings.

Maximum of two packets per year of the smallest commercial unit can be provided free of charge as a sample from the date the medicinal product has been marketed in Hungary, free samples, clearly marked on their boxes with the printed text of “free samples” cannot be provided after the end of the year following the start of marketing of the medicinal product in Hungary in case of medicinal products subject to social security reimbursement. 

The wholesaler or the person who made the delivery of the product sample shall keep minutes of the giving of the sample, which in all cases must include the names of the person handing over and the person receiving the sample. The following shall be marked, in a non-removable manner on the free product sample’s packaging: “Free product sample, not to be used for commercial purposes!”

Sponsorship of the Attendance of HCPs on Third-Party Events

As stipulated in 9.1 Gifts to Healthcare Professionals, Section 14 (2) of the Drug Economy Act sets forth a meal limit that applies to the costs of events organized by promoters of medicinal products. In contrast there is no cost limit set forth in the Drug Economy Act for the reimbursement of HCP expenses in case of third party organized events. Section 14 (4) of the Drug Economy Act states with respect to third-party organized events that in-kind support may be provided to HCPs to cover only their expenses (in particular, meals, travel expenses, accommodations, entry fees) arising directly out of or in connection with their attendance of the event. Any support provided - whether directly or indirectly - for events and programs for purely professional and scientific purposes shall always be reasonable in scope and must remain subordinate to the main scientific objective of the meeting.

Sponsorship of Third-Party Events 

According to Section 14 (3) of the Drug Economy Act the concept of sponsorship of the events should mean contributions of a primarily material nature the ultimate purpose of which is the realization of an event. In accordance with NNGYK’s consistent practice, the following is considered as sponsorship: the purchase of a sponsorship/sponsorship title for the sponsored event, irrespective of the fact that there may be various services included in the package. The fee paid in return for the purchase of a service (for example the rental of a stand), if it is not sold as part of a sponsorship package, is not considered as a support/sponsorship but as a service fee. 

Additional Restrictions for Events Organised Abroad 

Pursuant to the NNGYK Guidance pharmaceutical companies operating in Hungary cannot organise their own event abroad unless it is professionally or logistically justified, such as the majority of the participants are foreign nationals and the necessary resources related to the purpose of the event are not available in Hungary. This rule also applies to the sponsorship of third-party events held outside of the territory of Hungary.

Otherwise, there are no restrictions to the sponsorship of HCPs’ attendance at international congresses and meetings.

Under Hungarian laws third-party events organised for HCPs can be sponsored by pharmaceutical companies if they have scientific or educational purposes. Therefore, pharmaceutical companies cannot lawfully sponsor non-scientific events for HCPs.

The NNGYK Guidance clearly states that the pharmaceutical company’s own events must take place at a venue that is in line with the main objectives of the event, and when choosing a venue, companies must avoid venues that would question the professionalism of the event, which for example would include hotels built for or located in an area with a specific entertainment element such as gambling, with wine cellars in a famous wine region or built in a harbour for boat trips.

Rules on Product Donations

Pursuant to Section 9 of Decree No 3/2009 medicinal products may be donated free of charge for charitable purposes only and to a healthcare or social institutions or charitable organisations where the professional conditions for the use of the medicinal product and the control of the use are guaranteed. In other words, under Hungarian laws medicinal product donation cannot be given for commercial purposes and the donation cannot encourage the prescription, procurement, sale or supply of the medicinal product.

In case the donation is given to health care providers providing in-patient treatment, the medicinal products must be donated to the healthcare institutions through the institutional chief pharmacist. The pharmaceutical company or the wholesaler making the delivery must keep minutes of the delivery with the content set forth in the Promotional Decree. The packaging of each unit must contain the following text: “Product donation, this medicinal product cannot be marketed!”.

Exclusively medicinal product samples may be provided to HCPs as it is set forth in 9.2 The Provision of Samples of Medicinal Products to Healthcare Professionals.

Rules on Grants 

There are no rules set forth in Hungarian legislation relating to grants and charitable contributions provided by pharmaceutical companies. It shall be emphasised that grants and charitable contributions cannot be provided to HCPs as this practice would violate the prohibition on gift giving set forth in the Drug Economy Act, as detailed in 9.1 Gifts to Healthcare Professionals. Grants can be provided freely to healthcare institutions or foundations. 

Listed below are some key principles that shall be considered by pharmaceutical companies when offering grants or other charitable contributions.

• Grants shall not be offered or provided to induce or be in exchange for past or anticipated prescription of the company’s products, or to provide any other sales related benefit to the company.
• The objective should not be promotional in nature or be perceived as having promotional bearing.
• No tangible benefit or return of business is expected or received except incidental recognition.

The regulations regarding interactions between pharmaceutical companies and HCPs or institutions are stringent. The direct offering of rebates or discounts by pharmaceutical companies to HCPs is generally prohibited. Hungarian regulations emphasize transparency and ethical conduct in interactions between pharmaceutical companies and HCPs. While discounts or rebates directly to HCPs and healthcare institutions are restricted, there might be certain permissible activities such as:

• Discounts provided through regulated channels: Discounts might be offered through public procurement proceedings and social security reimbursement proceedings (inclusion and re-inclusion of products).
• Donations and grants: Companies may offer support or donations for educational or research purposes, but these must be transparent and not influence prescribing practices.

It shall be noted that general competition law rules apply to the offering of rebates and discounts. 

General Rules 

Pharmaceutical companies may conclude service agreements with HCPs for their professional services (advice, lectures, research, etc) if:

• the payment does not encourage the recommendation, prescription or promotion of a particular medicinal product of the company (ie, service fees provided to HCPs shall be determined based on their fair market value); and
• the subject of the agreement is related to the healthcare professional’s healthcare activities. 

No specific requirements are set forth in Hungarian laws for the determination of FMV rates applied by pharmaceutical companies. As for the generally accepted and regularly applied practices of NNGYK service fees should be determined by pharmaceutical companies in such way that the compensation of HCPs does not constitute an inducement to recommend and/or prescribe or purchase a medicinal product. 

We must add that since Act C of 2020 on the Status of Healthcare Professionals (the “Status Act”) entered into force HCPs must follow the conflict-of-interest rules set forth in the Status Act. As a result of the conflict-of-interest rules, pharmaceutical companies may only engage HCPs for strictly scientific activities or for activities falling under IP law protection (ie, copyrighted publications) and cannot involve them in the creation, review or sharing of their advertising materials and promotional activities.

Additional Expectations of NNGYK Regarding Speaker Agreements

The most typical service agreement concluded between companies and HCPs are the speaker agreements. 

As a general rule, the use of corporate presentation backgrounds should be avoided. The presentation should not include the name of the pharmaceutical company, its brand name, logo or image. 

The delivered presentation can only be the intellectual product of the engaged HCP and cannot be a slide deck previously provided by the company. The HCPs must prepare their presentations, which must be their intellectual work product and the pharmaceutical company cannot influence their free opinion formation. This should not prevent HCPs to contact the company in the medical field for necessary literature or other data and presentations required for the preparation of their own presentations. 

Events 

Third-party sponsored events, pharmaceutical companies organised own events, and the sponsorship of HCPs must be notified to NNGYK at least 15 calendar days before the start of the event. The scope of the data regarding the events are set forth in Decree No 3/2009 NNGYK may require copies of any contracts concluded in connection with the event. After the event, the sponsor has seven days to upload all required data and documentation to the NNGYK electronic platform.

Minutes of Donations and Free Samples

In accordance with Section 10 (3) of Decree No 3/2009 pharmaceutical companies shall send copies of the minutes on product donations and free samples quarterly to NNGYK if these included medicinal products subject to social security reimbursements.

It is not required under Hungarian law that pharmaceutical companies disclose details on transfers of value they make to HCPs or healthcare institutions. Donations provided to state-run healthcare institutions must be disclosed by the recipient institutions. 

Pursuant to the rules of the AIPM Code of Practice and the Transparency Code of the Associations, and the Hungarian Association of Generic Pharmaceutical Manufacturers and Distributors, disclosures of transfers of value must be made by each member company within six months after the end of the relevant reporting period, and the information disclosed must be made available for the public for a minimum of three years after the time such information was first disclosed. 

The scope of the AIPM Code of Practice only covers the member companies of AIPM. Under the definitive regulations of the AIPM Code of Practice, member companies of AIPM are research-based companies, developing and manufacturing medicinal products for human use in Hungary. Rules of the AIPM Code of Practice, including the transparency requirements, do not apply to foreign companies. 

Transparency requirements set forth in the AIPM Code of Practice apply with the same conditions detailed in 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value to member companies of AIPM that do not yet have products on the market but are members of the AIPM as they can conduct activities that fall within the transparency requirements.

The regulation and enforcement of rules on pharmaceutical advertising and inducement involve several entities, including regulatory authorities, self-regulatory bodies and courts. Enforcement and oversight require a collaborative effort from the below entities to ensure compliance with all the laws and regulations that govern pharmaceutical advertising and inducement. 

Regulatory Authorities

• NNGYK oversees pharmaceutical regulations, including the promotion of medicinal products. It ensures compliance with laws, approves medications, and monitors pharmaceutical activities.
• GVH, while primarily concerned with competition law, oversees unfair commercial practices, price gauging, false and misleading advertising and, as such, it may intervene in cases of anti-competitive behaviour and/or deceptive advertising.

Self-Regulatory Bodies

• Hungarian Association of Self-Regulating Bodies in Advertising (Hungarian abbreviation, ORT) oversees advertising content across various industries, including pharmaceuticals. It establishes and maintains advertising standards and handles complaints related to advertising ethics.
• The Communication Ethics Committee (Hungarian abbreviation, KEB) is allowed to investigate and rule conducts that may breach the provisions of the Code of Ethics. Within this power, KEB is permitted, among others, to order the member company to immediately cease the violating act, withdraw promotional materials, and/or send out a corrective letter. In the case of a particularly serious breach, it may initiate the temporary suspension or exclusion of the company violating the rules of ethics. 

Courts

The courts in Hungary can also play a role in enforcing regulations related to pharmaceutical advertising and inducements. Legal action can be taken against companies or individuals found in violation of the relevant laws or regulations. Pharmaceutical companies may initiate judicial review proceedings of the decisions of self-regulatory bodies before the courts. 

Pharmaceutical companies operating in Hungary can initiate court proceedings against competitors for advertising infringements and can file a complaint with the competent authorities. 

Hungarian regulations on pharmaceutical promotion are primarily overseen by NNGYK and GVH. NNGYK monitors and regulates pharmaceutical promotion to ensure compliance with the laws and adherence to ethical standards. GVH oversees unfair commercial practices and may intervene in cases of anti-competitive behaviour and/or deceptive advertising.

If a pharmaceutical company believes that a competitor has engaged in practices that violate these regulations, they can file a complaint with NNGYK or GVH. The authorities can decide to investigate the complaint and take appropriate actions if it finds the promotional activity to be in breach of regulations. This could involve the issuance of warnings, fines and other penalties depending on the severity of the infringement.

Companies may also resort to civil litigation through the courts if they believe that the advertising practices of their competitors have caused them harm or violated specific laws. This could involve seeking injunctive relief and pecuniary damages through legal proceedings.

When pharmaceutical companies violate laws, several sanctions can be imposed by the regulators and the courts. The severity of sanctions imposed typically depends on various factors, including the gravity of the violation, the impact on public health, the recurrence of the offenses, and the intentions behind the violation. It is important to note that these sanctions aim not only to penalise non-compliance but also to ensure adherence to regulations that safeguard the integrity of pharmaceutical advertising and prescribing practices.

• Warnings and reprimands: authorities can issue warnings or reprimands to companies found in violation of advertising rules or rules related to inducements to prescribe. These serve as initial measures and are intended to alert companies about their non-compliant behaviour.
• Fines and financial penalties: monetary fines may be imposed by NNGYK or other regulatory bodies for violations. Fines can vary in amount depending on the severity of the violation and can be a substantial penalty for companies found to be in breach of regulations.
• Forced modification or withdrawal of advertisements: NNGYK and GVH can demand the modification or withdrawal of advertisements and promotional materials that are deemed to be in violation of advertising rules.
• Administrative measures: apart from fines, administrative measures can be imposed, such as the temporary suspension of certain activities related to the pharmaceutical company’s operations. If there are recurring infringements the authority may suspend the social security reimbursement of their product(s). 
• Legal actions and court penalties: courts in Hungary can impose additional sanctions or penalties on pharmaceutical companies violating advertising rules or rules on inducements to prescribe. These penalties might include additional fines, injunctions or compensation for damages caused by the violations. In the most serious cases that qualify as a crime, criminal courts can apply sanctions contained in the Criminal Code. 

Authorities, such as NNGYK or GVH, oversee pharmaceutical advertising and promotional practices. When a complaint is filed for the infringement of the rules on pharmaceutical advertising the authority investigates and may take action, which may include issuing warnings or fines, or requesting the modification or withdrawal of the advertisement. 

Courts handle disputes related to pharmaceutical advertising and regulatory compliance. Parties can bring cases before the courts seeking remedies such as injunctions, compensation for damages, or challenging the decisions made by authorities if they believe that there has been an error in the interpretation or the application of the law. 

The information discovered by the authorities might be considered as evidence in court proceedings, but courts independently assess cases based on the law, the submitted evidence and the presented legal arguments. The decision (judgment) of the courts can affirm, overturn or modify the actions taken by the authority.

In Hungary, it is common for regulatory bodies like NNGYK or GVH to periodically update guidelines, publish decisions and tighten regulations to ensure compliance with pharmaceutical advertising rules. There are some other potential trends or areas of focus in pharmaceutical advertising enforcement that might continue or gain prominence, as set out below.

• Focus on compliance training and education: regulatory bodies might focus on educating pharmaceutical companies, healthcare professionals and advertising agencies about compliance requirements to prevent inadvertent violations, which is why authorities frequently organise congresses and workshops. 
• Monitoring and enforcement collaboration: collaborative efforts between regulatory bodies, industry associations and self-regulatory entities might be strengthened to ensure more effective monitoring and enforcement of advertising rules.
• Increased scrutiny on digital marketing: given the prominence of online platforms and social media, there is an increased focus on regulating digital marketing practices in the pharmaceutical sector and ensuring compliance with advertising rules in this realm.

Applicable Legal Regime

Although there are many similarities for the advertisement of veterinary products, a separate regulatory framework has been established. These legal rules are mainly introduced in the following pieces of legislation.

• Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC sets out the directly applicable rules regarding veterinary products (the “Veterinary Medicinal Products Regulation”).
• Decree No 128/2009 (X. 6.) of the Minister of Agriculture and Rural Development on veterinary medicinal products (“Decree No 128/2009”) establishes the applicable rules for authorising, manufacturing, distributing and using veterinary products in Hungary.

Regarding the advertising of veterinary products, there are also self-regulatory codes in this field, such as the guidelines issued by AnimalHealth Europe and Access VetMed. 

Similarities and Differences

For medicinal products for human use:

• only those veterinary products can be advertised in Hungary that are authorised for distribution and sale in the country;
• the advertising must comply with the product characteristics as approved in the marketing authorisation; and
• the advertising must encourage the responsible use of the veterinary medicinal product.

For the advertising of prescription-only veterinary products, Section 98 of Decree No 128/2009 sets out certain rules that differ from the legislation on medicines for human use. Advertising prescription-only veterinary medicinal products is prohibited in TV and radio, and can only be advertised:

• on internet sites accessible only to veterinarians, pharmacists or agricultural engineers; and
• in the printed veterinary and pharmaceutical press and in the printed agricultural press with the additional wording “Ask your veterinarian or pharmacist for further information”.

Enforcement

Pursuant to Section 98 (7) of Decree No 128/2009, compliance with the rules to be applied for advertising veterinary medicinal products is supervised by the competent district office and the Hungarian Food Safety Office (Hungarian abbreviation, NEBIH). In the case of a breach, the district office is obliged to notify NEBIH of the violation.