Pharmaceutical advertising regulation and medical device advertising in Ukraine

Article 21 of the Law on Advertising No. 270/96-ВР dated 3 July 1996 (as amended) (the “Law on Advertising”) provides for rules applicable to advertising of medicines and medical devices, while Article 26 of the Law on Medicines No. 123/96-ВР dated 4 April 1996 (as amended) (the “ Medicines Law”) provides for specific regulation of advertising and promotion of Rx medicines, as well as OTC medicines, allowed and prohibited for advertising. 

The Ministry of Health of Ukraine (the “MoH”) in its Order No. 422 dated 6 June 2012 sets the criteria for OTC medicines to be assigned to the List of OTC medicines prohibited for advertising. At the end of 2021, the MoH updated the criteria by adding some additional ones. Consequently, advertising medicine is prohibited if the trade name of the medicine and/or the INN, as well as the dosage form of the finished medicinal product, are the same as for the prescription-only medicine. In accordance with the new criteria, a List of OTC medicines prohibited for advertising (the “Prohibition List”) was approved by MoH order No. 1295 dated 18 July 2023. However, currently, the mentioned order has been suspended and it will come into force on 1 March 2024. The suspension occurred because the Prohibition List was underdeveloped and inconsistent with the information in the state register of medicines, where it is also indicated whether the registered medicine can be advertised.  

In addition, the following laws contain general provisions applicable to advertising of medicines and medical devices: 

• The Fundamentals of the Health Care Legislation of Ukraine No. 2801-XII dated 4 November 1992;
• The Consumer’s Rights Protection Law No. 1023-XII dated 12 May 1991; and
• The Law on Protection Against Unfair Competition No. 236/96-BP dated 7 June 1996.

Furthermore, the advertising of medicines will be regulated differently upon entry into force of the new version of the Medicines Law, which is scheduled to occur within 2.5 years following the end of martial law in Ukraine. This Law has been adopted in order to align Ukrainian legislation with the respective EU regulations. In particular the new law:

• clearly differentiates between advertising of medicines, targeting an indefinite audience, and promotion of medicines, targeting a particular audience and only permitted when targeting healthcare and pharmaceutical professionals. Promotion of medicines covers “medical representatives visits, distribution of promo materials, sampling of medicines, organisation of events, compensation of expenses of the healthcare professionals associated with participation in events)
• significantly align the Law on advertising on part of advertising medicines, medical devices and health other technologies with the Directive 2001/83/EC 

As for now there is no single market-wide self-regulatory code of conduct in Ukraine that would govern the advertising of medicines and medical devices. In the meantime, certain self-regulatory organisations (associations) provide the professional ethics rules in this area, which are mandatory for their members. The notable example is the Code of Pharmaceutical Marketing Practices of the Association of Pharmaceutical Research and Development (APRAD). 1

However, in 2023, the government approved changes to the Law on Advertising. Among other amendments, an article on joint regulation and self-regulation in the field of advertising was added. The article promotes the development of self-regulation in advertising by adopting codes (rules) for the creation and distribution of advertising, particularly in areas such as advertising, sponsorship, and product placement of medicinal products, medical devices, and methods of prevention, diagnosis, treatment, and rehabilitation permitted for advertising. In this regard, we can expect the establishment of a self-regulatory code of conduct that would encompass the advertising of medicines and medical devices in Ukraine.

Under Article 21(1) of the Law on Advertising, both medicines and medical devices may be advertised to the general public only if they are permitted (approved) for use in Ukraine by the MoH (for OTC medicines) and if they passed Ukrainian national conformity assessment procedure in accordance with the Technical Regulation on medical devices, approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 of 2 October 2013 (for medical devices). 

Article 26(3) of the Medicines Law allows to communicate promotional materials to healthcare professionals regarding both medicines, approved for use, and unapproved medicines on the development stage.

No additional permit or approval is currently required for advertising of medicines or medical devices. 

Moreover, a business entity can request from the Antimonopoly Committee of Ukraine (the “AMCU”) an analysis of the advertising prior to its launching in order to ensure that it does not violate the requirements for fair business practices (Art. 15-1 “Dissemination of the misleading information” of the Law of Ukraine “On protection against unfair competition”). The administrative fee for violation of such requirements amounts to UAH 5,440 (ca EUR 150). 

Ukrainian legislation differentiates the advertising medicines to the general public and to healthcare professionals, as well as Rx and OTC medicines. 

If advertising targets the general public, under Article 21(1) of the Law on Advertising, only OTC medicines not included in the Prohibition List may be advertised. Advertising of Rx medicines and OTC medicines listed in the Prohibition List to the general public is prohibited. 

Both OTC and Rx medicines may be advertised to healthcare professionals. But, there are certain limitations, based on Article 26(3) of the Medicines Law, applicable to the Rx medicines' advertising.

Promotional materials on Rx medicines may be communicated to healthcare professionals in the form of “information about medicines” in professional medical publications or directly during professional medical events like seminars, conferences, symposia, etc. Such information shall normally include the trade name, product characteristics, side effects, etc. Although “information on medicines” is formally not considered as "advertising”, de facto, there is no practical difference between advertising and providing information on Rx medicines to healthcare professionals. 

The new version of the Medicines Law, in particular, defines it as a “promotion” and sets additional requirements. These requirements will enter into force 2,5 years after the end of martial law in Ukraine. 

Under Article 21 of the Law on Advertising, any advertising of medicines and medical devices directed to the general public shall not contain:

• references to therapeutic effect in connection to incurable or difficult-to-cure diseases;            information that may give impression that if the medicine or medical device is used the consultation of a doctor is not required;
• information that the therapeutic effect of the medicine or medical device is guaranteed;          
• images of changes in the human body or its parts caused by illness or injuries;
• allegations that promote the raise or development of fear of becoming ill or worsen health conditions if advertised medicines or medical devices are not used;
• statements that promote self-diagnosis of diseases, pathological conditions and their self- treatment using advertised medical products;
• references to medicines, medical devices as the most effective, harmless and free of any side effects;
• references to the individual cases of successful use of medicines, medical devices;
• recommendations or links to the recommendations of healthcare professionals, scientists, medical institutions and organisations regarding the advertised medicines or medical devices;
• special testimonials, appreciations, letters, excerpts of them with recommendations, stories about the use and results of the advertised medicines or medical devices;
• images and mentions of names of celebrities, heroes of movies or cartoons, as well as authoritative organisations;
• misleading information as to the content, origin, effectiveness, patent protection of the advertised goods; and
• information that may give impression that the medicine is a foodstuff, cosmetic or other consumer product or that the safety or efficacy of this product is caused by its natural origin; participation of doctors, other healthcare professionals or individuals, whose appearance imitates the appearance of doctors, healthcare professionals.

The parliament has already revised the above requirements and restrictions. The new wording will enter into force 2.5 years following the end of martial law in Ukraine. 

Ukrainian legislation does not provide for specific restrictions, applicable to advertising of medicines and medical devices to healthcare professionals. The restrictions listed in Article 21 of the Law on Advertising, mentioned in response to question 5 (immediately above), are applicable neither to advertising of OTC medicines and medical devices, nor to promotional information about Rx medicines targeting healthcare professionals. 

The new version of the Medicines Law provides for a number of new restrictions applicable to promotion of medicines targeting healthcare professionals, including: 

• provision of forms that can contribute to further control of the frequency of prescribing certain
• medicines by a specific healthcare professional;
• providing material incentives to increase the frequency of prescription of promoted medicines to patients; 

Offering or providing bonuses, premiums, cash refunds, or the right to participate in any game, lottery, contest, or event, if the condition of providing or participating is the prescription of certain medicines by a healthcare professional. 

Ukrainian legislation does not contain any specific rules on information that must appear in advertisements for OTC medicines and medical devices, directed only to healthcare professionals. 

Regulations on promotional materials in the form of “information on medicines” on Rx medicines directed to healthcare professionals (as described in answer to question 4 above) also do not set any specific requirements to the content of such promotional materials, apart from general indication that “information on medicines” should contain “name, product characteristics and potential side effects” of the advertised medicines. 

In practice, when communicating promotional materials on Rx medicines in professional medical publications, during professional medical events or directly to healthcare professionals, a written reservation is often made that the information about the Rx medicine is provided exclusively for healthcare professionals and the material is not an advertising. 

The new version of the Medicines Law provides for a number of new requirements applicable to promotion of medicines targeting healthcare professionals, e.g. promotion of medicinal products shall:

1. refer only to medicinal products with a valid marketing authorization;
2. encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties;
3. not be misleading.

Also, according to the new version of the Medicines Law , any documentation relating to a medicinal product which is transmitted as part of promotion to persons qualified to prescribe or supply medicinal products shall contain accurate, up-to-date, verifiable and sufficiently complete information to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. Medical or sales representatives shall be given adequate training and shall have sufficient scientific knowledge to be able to provide information which is precise and as complete as possible about the medicines which they promote. 

In accordance with Article 21(4) of the Law on Advertising the advertisements of both medicines and medical devices directed to the general public must contain the following information: 

• objective information about the product;
• clear indication that the piece of information is an advertisement and the advertised product is a medicine or medical device;
• warning that customers need to consult a doctor before using the advertised medicine or medical device;
• recommendation for the customer to review the patient information leaflet for the advertised medicine;
• text notice “self-treatment may be harmful for your health” that must occupy no less than 15% of the space (duration) of an advertisement material. For audio media, the text must be audible at least once per clip, but not less than once per minute, and it should be played at the same volume level as the rest of the audio sequence in the clip. 

In addition to the above requirements, the restrictions mentioned in answer to question 5 above must also be respected. 

The Law on Advertising does not contain any specific requirements or restrictions neither regarding scientific data that may not be indicated in advertisements of medicines or medical devices, nor regarding the data based on which the promotional claims are made. 

At the same time, some general restrictions from Article 21(6) of the Law on Advertising, listed in response to question 5 above, are applicable to the use of scientific data and promotional claims, and can be interpreted as prohibiting the use of the following scientific claims in advertising of medicines and medical devices targeting the general public: 

• retrospective analysis of the successful usage of medicines or medical devices (to the extent that such analysis describes individual cases of usage of the medical product or its guaranteed therapeutic effect);
• references to studies, conclusions or opinions, including opinions, that “recommend” the advertised medicine or medical device.

There are no requirements for scientific data indicated in advertisements targeting healthcare professionals. 

There are no specific requirements or rules applicable to comparative advertising of medicines and medical devices – therefore, general rules, described in the Law on Advertising and the Law on Unfair Competition, are relevant. 

In particular, it must be objective, based on true information, comparison of similar products that satisfy the same needs or have the same purposes and does not discredit the products of other manufacturers or sellers. 

Neither the Law on Advertising nor any other piece of Ukrainian legislation prescribe any specific rules for advertisement of medicines and medical devices on the internet/in social media postings. 

At the same time, any advertisements of medicines and medical devices, including those posted on the internet and on social media platforms must comply with the general requirements for advertising of medicines and medical devices, described in responses to questions 5 and 8 above. The rules set by the Law on Protection against Unfair Competition shall be adhered, respectively. 

Further general rules applicable to all advertisement vie means of electronic communications are also applicable. Distribution of advertising in the form of spam, including mass calls using any communication technology without the prior written consent of the consumer, including in electronic form, is prohibited. Distribution of advertising using telephone numbers or other network identifiers of the consumer may be carried out only with the prior written consent of such consumer, including in electronic form, and if the consumer is given the opportunity to refuse the use of his/her data, including the receipt of advertising using telephone numbers or other network identifiers of the consumer, free of charge at any time in a simple and understandable form. Additional general requirements also apply when advertising via on video sharing platforms and information sharing platforms. 

The Law on Advertising contains following enforcement mechanisms:

• requirement to the advertiser, advertisement producer/distributor to cease violation of advertisement legislation;
• suspension of the dissemination of the advertisement that violates the requirements of the advertisement legislation;
• imposition of fines on advertisers, advertisement producers/distributors.

Compliance with advertisement provisions is monitored by the State Service of Ukraine on Food Safety and Consumer Protection (“ Consumer Protection Service”) (with regards to the protection of consumers’ rights) and the AMCU (with regards to protection from unfair competition practices). 

The AMCU is empowered to investigate the facts of:

• dissemination of misleading information;
• violations regarding trade dress protection (i.e., illegal usage of trademarks, which leads to the confusion of the products, or copying of the visual appearance of the product);
• unfair comparative advertising.

The AMCU constantly focuses on the pharmaceutical market, including the cases of unfair competition. In its recommendations for pharmaceutical companies, the following claims are treated as a sign of unfair competition on the market:

• “good quality” of the medicine, as it is presumed that all medicines, authorised for use in Ukraine, are of a good quality;
• affordability of the medicines;
• leadership market positions without relevant evidence;
• fast action of the medicines, which is not confirmed by the instruction for medical use. 

Failure to comply with the rules governing advertising of medicines and medical devices may result in penalties, which vary depending on the particular type of violation. 

If the violation is related with the protection of consumer’s rights, Consumer Protection Service may impose fines on advertisers in the amount of the five times the value of the distribution of the advertising materials).If advertising violates competition rules, the AMCU may impose a fine on the breaching entity for the amount of up to 5 percent of the legal entity’s revenue from sales of products for the previous calendar year. 

In 2022 the parliament has adopted the new Medicines Law. We addressed above most of its specifically relevant provisions on advertising and promotion. Generally, the law is aimed at aligning Ukrainian legislation in the sphere of medicines with Directive 2001/83/EC. It comes into force 2,5 years after the end of martial law (unless the parliament adopt the new and more expedited schedule of entering the Law into force, which the MoH has recently proposed). 

Additionally, the Draft Law on Medical devices is currently being considered by the parliament. The currently available draft does not provide for amendments regarding advertising of medical devices, but one may expect them to appear in the final version of the law (if adopted).

Footnote : http://aprad.org.ua/en/innovatsiyna-farma/etichniy-kodeks/