Pharmaceutical advertising regulation and medical device advertising in Hungary

• 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 (“ Medicines Thrift Act”)
  • applicable to medicines and medical devices qualifying as medical aids;
• Decree no. 3/2009 (II. 25.) of the Minister of Health on the detailed rules concerning the promotion of medicinal products for human use and medical aids, the registration of persons carrying out promotional activities and the commercial practices towards consumers in respect of medicinal products and medical aids (“ Promotional Decree”)     
  • applicable to medicines and medical devices qualifying as medical aids;
• Act XLVIII of 2008 on the Basic Requirements and Certain Restrictions of Commercial Advertising Activities (“Advertisement Act”);
• Act XLVII of 2008 on the Prohibition of Unfair Business-to-Consumer Commercial Practices (“Unfair Commercial Practices Act”);
• Act CLV of 1997 on Consumer Protection (“Consumer Protection Act”);
• Act LVII of 1996 on the Prohibition of Unfair Trading Practices and Unfair Competition (“Competition Act”). 

Yes. The main codes of conducts are the following (note: the list is not exhaustive):

• Medicines: Code of Ethics for Pharmaceutical Communication of the Association of the Innovative Pharmaceutical Manufacturers and other associations (“Code of Ethics for Pharmaceutical Communication”); (note: updated wording entered into force on 1 June 2022);
• Code of Conduct for the Association of Innovative Pharmaceutical Manufacturers;
• Summary and position of the National Institute of Pharmacy and Nutrition on promotional activities related to the subject matters covered by the Public Consultation on Promotion Supervision held on September 12, 2019 (note: this is a non-binding document, including the interpretation of the authority on the laws);
• Summary of the National Institute of Pharmacy and Nutrition on the amendments to the Medicines Thrift Act, effective from 29 June 2021, concerning the rules on the promotion of medicinal products, infant formulae and medical aids (note: this is a non-binding document, including the interpretation of the authority on the laws);
• Medical Devices: Code of Conduct of the Association of Health Technology Suppliers and Medical Device Manufacturers (“ETOSZ Code of Conduct”);
• As of 30 June 2023, the New Hungarian Code of Advertising Ethics of the Hungarian Advertising Self-Regulatory Board and other associations (“Code of Advertising Ethics”);
• The MedTech Europe Code of Ethical Business Practice. 

3.1 The general public

There are no specific rules for the licensing of the advertisement of medicines and medical devices to the general public.

Under the general legal rules, in connection with advertising relating to products which are subject to prior quality control or conformity assessment, the advertiser shall supply a statement to the advertising service provider that the product has been inspected or certified and found suitable for marketing. In the absence of such statement, no advertising may be published. 

3.2 Healthcare professionals ("HcPs") 

Medicines/medical devices qualifying as medical aids

If a promoter of medicinal products or medical aids (e.g. the MAH or authorised distributor; “Promoter(s)”) wishes to engage in promotional activities (e.g. in advertising prescription-only-medicine [“POM”] or over- the-counter medicinal products [“ OTC”] in a more professional context to HCPs), it shall notify the National Centre for Public Health and Pharmacy  (“NNGYK”) thereon and pay an administrative service fee of HUF 101,500 (app. EUR 262).

On behalf of the Promoters the medical sales representatives carry out the promotional activity. The sales representatives must be registered with NNGYK which issues a certificate on the registration. The administrative service fee (i) for the registration is HUF 100,000 (app. EUR 258) / sales rep, and (ii) for the certificate is HUF 12,900 (app. EUR 33).

Promoters are required to pay HUF 832,000 (app. EUR 2,150)/month for medical sales representatives, and HUF 83,000 (app. EUR 214)/month for sales reps promoting medical aids. (For certain SMEs, a diminished amount is applicable). 

Medical devices not qualifying as medical aids:

N/A 

Yes. POMs cannot be advertised to the general public. 

5.1 Medicines/medical devices qualifying as medical aids 

Under the relevant legal rules, all the information included in the commercial communication shall be in conformity with the SmPC and the package leaflet of the medicinal product, or with the instructions for use of the medical aid.

Under the specific legal rules, it is prohibited to:

• Conduct any commercial practices relating to a product with no valid MA;
• Promote any medicinal products or medical aids subsidised by the social security system to the general public;
• Advertise medicinal products and medical aids to children, including advertising in programmes or publications aimed at children.

It is also prohibited to publish an advertisement if it relates to:

• A medicinal product/medical aid that is not authorised to be marketed or used in Hungary;
• A medicinal product that contains narcotics or psychotropic materials;
• An investigational medicinal product;
• An OTC product holding the same name as a POM;
• A medical aid that bears the same name as (and differs only in designation or number from) a medical aid subsidised by the social security system.

The advertisement cannot:

• claim or give the impression that a medical consultation or surgical operation is unnecessary or redundant;
• suggest that the medicinal product guarantees recovery, or does not have any side effects;
• suggest that the medicinal product is a foodstuff or cosmetic product;
• suggest that the safety or efficacy of the medicinal product is due to its natural origin;
• lead to erroneous self-diagnosis by a description or detailed representation of a case history;
• present changes or conditions resulting from disease or injury, or present effect of a medicinal product or a medical aid on human body or parts thereof in an unrealistic way or in a way that creates a sense of fear; 
• refer to a recommendation by scientists, health professionals or celebrities;
• suggest that human health could be damaged by not taking the medicinal product or by not using the medical aid.

The advertisement shall not contain references or expressions which may mislead the consumer with respect to the characteristics and effects of the product.

It is prohibited to provide or offer any gifts, product samples or gift certificates (coupons), prizes to patients and customers directly, or by way of healthcare providers, that is intended to promote the use of medicinal product/the products of a specific MAH/a specific medical aid subsidised by the social security system.

The Code of Ethics for Pharmaceutical Communication prescribes that (i) commercial practices shall appear as neutral information, (ii) it shall clearly appear that it advertises medicinal products, (iii) the materials must not resemble to and should be distinguished from independent professional, scientific publication. Claims for a special merit, property, or capability of a medicinal product/active ingredient can only be used if such are well founded and scientifically proven.

5.2 Medical devices not qualifying as medical aids: 

In addition to the general prohibitions listed in Article 7 of the MDR, aggressive, misleading and unlawful comparative advertising is prohibited.

Aside from the above, general advertisement rules also apply, e.g. no advertisement may be published if it, amongst others, (i) incites a behaviour endangering personal safety, (ii) may harm the physical, intellectual or moral development of children. In the medical field, inter alia, the advertising of any devices for carrying out abortions is strictly prohibited. 

6.1 Medicines/medical devices qualifying as medical aids 

All the information included in a commercial communication relating to a medicinal product/medical aid shall be in conformity with the SmPC and the package leaflet of the medicinal product, or with the instructions for use of the medical aid. 

It is prohibited to conduct any commercial practices relating to a medicinal product with no valid MA.

In the course of promotional activity towards HCPs, a medicinal product/medical aid shall be presented or communicated in such detail to enable the HCP to form an opinion on the use thereof. 

6.2 Medical devices not qualifying as medical aids 

Same rules apply as in the case of advertisements to the general public.  

7.1  Medicines/medical devices qualifying as medical aids 

In case the medicinal product/medical aid subsidised by the social security system, the promotional material shall include the price, amount and reimbursement price of the medicinal product and/or the medical aid.All the information must be accurate, verifiable and up-to-date. The date on which the document was finalised or last updated must also be indicated.

Quotations, tables and other illustrative material from medical journals or other scientific sources shall be presented in a faithful manner to the original and include the exact source and date of the publication.

In case of medicines under additional monitoring, the black triangle needs to be included with the following note: “This medicine is under additional monitoring, which enables the swift identification of new medicine safety information. HCPs are requested to report any suspected side effects.”

The Code of Ethics for Pharmaceutical Communication prescribes further requirements re the content of the promotional materials presented/provided to HCPs in relation to a medicinal product. 

7.2 Medical devices not qualifying as medical aids

Under the ETOSZ Code of Conduct, the promoted device must be described in such detail that HCPs can offer a well-based opinion about the device. All the information and documentation provided during the promotion must be detailed, verifiable and up-to-date.

8.1 Medicines/medical devices qualifying as medical aids 

The advertisement of OTC medicinal products/medical aids not subsidised by social security may be published if:

• The product is clearly identified as a medicinal product or as a medical aid;
• The advertisement includes the name of the medicinal product (also the internationally used common name if it contains only one active substance), or the name of the medical aid;
• The advertisement encourages the correct use of the medicinal product or medical aid;
• The advertisement demonstrates the medicinal product and the medical aid based on the SmPC or the user’s manual;
• The advertisement contains the warning text (in HU) for medicinal products: “Regarding risks and side effects, please read the package leaflet or consult your physician or pharmacist.” or for medical aids: “Regarding risks, please read the instructions for use or consult your physician.”
• In case of medicines under additional monitoring, the black triangle needs to be included with the following note: “This medicine is under additional monitoring, which enables the swift identification of new medicine safety information. You can also contribute to this by reporting any side effects you become aware of.” 

8.2 Medical devices not qualifying as medical aids 

No specific wording is required, general advertising rules apply, e.g. under the Code of Advertising Ethics, claims referring to characteristics of the product shall be true and, where necessary, clearly demonstrable by impartial and professional investigation. The factual basis must not go beyond the evidence and the evidence must be timely, relevant and scientifically sound. The evidence must comply with the sectoral rules, and the advertiser may use his own research only in accordance with the sectoral rules.

9.1 Medicines/medical devices not qualifying as medical aids 

See the answer under 7.1.

In relation to scientific data the Code of Ethics for Pharmaceutical Communication further establishes that:

• the source must be clearly specified;
• the original information must be faithfully reproduced; the artwork cannot be misleading;
• the data published in the referenced publications may be displayed graphically under the specific conditions prescribed by the Code.

9.2 Medical devices not qualifying as medical aids 

Under the ETOSZ Code of Conduct, quotes, charts and other visual materials from medical journals or scientific sources must be introduced in a form near the original and the exact source must be indicated.

Under the Code of Advertising Ethics, an advertisement should not misuse research results or quotations from technical and scientific publications. Misleading use of scientific and research results and terms is prohibited. In particular, the use of scientific terms and words in advertising shall not be used to falsely imply that the advertising is scientifically based. Where the use of scientific terminology is justified, it must be clear and unambiguous. The use of pseudo-scientific or confusing terms is prohibited. Advertising may only refer to market research results based on scientific methods. The professional parameters (methodology) and information supporting the substantiation of the results must be available at the time of publication of the advertisement in such a way that the party involved in the advertising ethics procedure can present them without delay. 

There are no rules in the sector specific laws for comparative advertisement. (However, the Competition Act prescribes general requirements for these advertisements that must be taken into consideration.) 

According to the Code of Ethics for Pharmaceutical Communication all claims in comparative advertisements serving as the basis for comparison shall be objective. The comparison should be relevant and it should compare one or more essential, dominant, characteristic and verifiable properties of the medicinal products in an objective way. Only comparable aspects are permitted to be compared. Superlatives shall only be used to describe specific and sufficiently substantiated facts. Further, no differentiation shall be made between originator and follow-on medicinal products unless the difference is scientifically demonstrated. 

Pursuant to the Code of Advertising Ethics, nourishment or health related comparisons must be placed on proved foundations/supported objectively and are clearly understandable. 

There are no rules in the sector specific laws for advertisement of medicines and medical devices on the internet/in social media postings. The Competition Authority, however, has issued a guidance on social media and influencer advertisement 1
https://gvh.hu/pfile/file?path=/szakmai_felhasznaloknak/tajekoztatok/Tajekoztato_az_influenszer_marketingrol.pdf1&inline=true , which could apply.

The Code of Ethics for Pharmaceutical Communication states, amongst others, that the name or international non-proprietary name of a POM or a medicinal product subsidised by the social security system as a domain name or part of a domain name shall only be used if the website operator ensures that the information is only available to HCPs. Furthermore, it sets out that companies should have appropriate social media policies in place for their employees to ensure that individual employee interactions (such as forwarding, retweeting, commenting and liking) with the company's social media profile do not result in sharing content with inappropriate audiences (e.g. content intended for HCPs with laypersons). 

The following bodies are competent for assessing infringing advertisements addressed to the general public:

• The Hungarian Competition Authority (“HCA”), where the alleged practice potentially affects the competition;
• The Hungarian consumer protection authorities (“CPAs”) in any other cases;
• With the proviso that NNGYK is entitled to monitor the compliance with the rules of the Medicinal Thrift Act and the Promotion Decree.

In case of infringement, both HCA and CPAs are entitled to prescribe certain conducts (e.g. terminating the practice, publishing corrective statement, etc.) and impose fines.

The HCA may impose fines up to the 13 % of the net income generated in the previous business year by the whole group of undertakings being liable. The CPAs may impose fines up to the 5 % of the net income generated in the previous business year by the company being liable, but max. HUF 2 billion (app. EUR 5.172 million; other lower thresholds may be applied under special circumstances). 

12.1 Medicines/medical devices qualifying as medical aids 

In addition, NNGYK is the competent authority in case of infringement of the provisions on the promotion of medicinal products/medical aids towards HCPs. NNGYK may, amongst others, impose a fine in the amount of:

• Between HUF 500,000 (app. EUR 1,292) and HUF 25,000,000 (app. EUR 64,600) in the case of authorised distributors;
• Between HUF 500,000 (app. EUR 1,292) and HUF 500,000,000 (app. EUR 1,291,990) in the case of Promoters, MAHs and manufacturers;
• Between HUF 500,000 (app. EUR 1,292) and HUF 5,000,000 (app. EUR 12,920) in the case of medical sales representatives.

The fines may be imposed cumulatively. In case of repeated or serious infringements, NNGYK may even ban the Promoter from engaging in promotional activities for a period of between 6 months and 3 years.

Violation of the Code of Ethics for Pharmaceutical Communication result in the ethical procedure of the Communication Ethics Committee.

12.2 Medical devices not qualifying as medical aids

Aside from the general advertisement rules mentioned above, violation of the ETOSZ Code of Conduct may result in the ethical procedure of the ETOSZ Ethics Committee. Violation of the Medtech Code may result in the ethical procedure as well. 

With respect to the advertisement of medicinal products, there are no future developments envisaged.