Last Updated February 20, 2019

Law and Practice

Authors



Pakharenko & Partners (Kyiv) is one of the largest and most experienced intellectual property law firms in Ukraine, with offices in Kyiv (Ukraine) and London (UK). It also has many international partners all over the world. The firm provides the full scope of IP services required by pharmaceutical industry clients, including patent and trade-mark protection and enforcement, and has well-established expertise in domestic and international technology transactions, licensing, distribution agreements, confidentiality agreements, software licences and advertising. Clients include multinational, national and local corporations, major academic and research institutions, small entrepreneurial companies and engineering organisations, and individual inventors.

General requirements for advertising include prohibition on: The dissemination of information about a product that is prohibited (production, circulation or importation into Ukraine), discriminatory statements, provision of information that may cause harm to people’s health or life and/or to the environment and prompt security safeguards to be neglected; having an effect on the subconsciousness of the consumers of advertising; the use of an individual’s image or the use of his or her name without written consent.

Advertising must be clearly separated from other information so that it can be identified as advertising. Hidden and unfair advertising is prohibited.

Under the current Ukrainian legislation (par. 1 Article 21 of the Law of Ukraine on Advertising, par. 4 Article 26 of the Law of Ukraine on Medicines) advertising of the following products shall be allowed:

  • medicines, medical products and methods of preventive care, diagnosis, treatment and rehabilitation, which are allowed for use in Ukraine under the established procedure; and
  • medicines dispensed without a doctor's prescription and which are not included in the list of medicines prohibited for advertising.

At the same time, the advertising of the following products shall be prohibited by the law:

  • medicines, the use and dispensing of which are allowed only upon a doctor’s prescription, and the ones included in the list of medicines whose advertising is prohibited; and
  • doping substances and/or methods of their use in sports.

General definition of advertising, in accordance with Article 1 of the Law on Advertising is as follows: Information about a person or a product disseminated in any form and in any manner, directed at unspecified range of consumers of advertising and intended to form or maintain awareness of the consumers of the advertisement and their interest with regard to such person or product.

Under the general legislation, advertising is not considered to cover placement of information about the registered name of an entity, marks for goods and services owned by this entity, the type of its activity (if it does not follow from the registered name of the entity), as well as information about the manufacturer of the goods and/or goods in the places, where this product is sold or offered to the consumer, in particular on the elements of equipment and/or design of sales areas, as well as directly on a product itself and/or on its packaging.

Also, information about a product that is provided in compliance with the law (for example, the remote provision of information about the products to the buyer) and information directed at a particular person shall not be considered as advertising.

As regards the distinction between advertising and information on medicines, it should be noted that the concept of advertising of a medicine is provided in the Law on Advertising, and the definition of information about a medicine is provided in the Law on Medicines.

Comparison of advertising and information about a medicine:

Advertising of medicine v information about medicine

Scope of information

  • Advertising of a medicine is any information about a person or a product intended to form or maintain the awareness of consumers of advertising and their interest with regard to such persons or products
  • Information about a medicine includes only four categories of data: A name; characteristics; therapeutic properties; possible side effects

Registered v non-registered medicines

  • Advertising of a medicine is allowed only with respect to the registered medicine. There is a direct prohibition on advertising of medicines, which are under consideration according to the established procedure, and that have not been approved for use yet
  • “Information” is used for registered medicines, unregistered medicines, medicines that are at the stage development or entering production

Prescription-only medicines v over-the-counter medicines

  • Advertising is allowed for prescription-only medicines not included in the list of medicines whose advertising is prohibited
  • vision of information is also permitted for over-the-counter medicines and medicines whose advertising is prohibited

Scope of persons

  • Advertising of a medicinal product is intended for an unlimited scope of persons; however, doctors and pharmacists are prohibited from advertising medicines, in particular from prescribing medicines on forms containing advertising information, and indicating manufacturers of medicines (trade marks)
  • Information on medicines (including unregistered medicines or medicines that are at the stage of development or putting into production) is published in publications intended for medical and pharmaceutical workers as well as in materials , which are distributed in specialised seminars, conferences, symposia on medical topics

Target audience: healthcare professionals v healthcare institutions

  • Limitations specified in Article 21 of the Law on Advertising (ie, all limitations regarding advertising of medicines referred to above and intended for an unlimited scope of persons), do not apply to the advertisements of medicinal products published in specialised publications intended for medical institutions and doctors, which are disseminated at seminars, conferences and symposia dedicated to medical issues
  • Information on medicines (including products that are not registered (or which are at the stage of development or putting into production) includes the name, characteristics, therapeutic properties, possible side effects and is published in publications intended for healthcare and pharmaceutical professionals, as well as in the materials disseminated at specialised seminars, conferences and symposia dedicated to medical issues

Disease awareness campaigns may be recognised as advertising if information about a medicine is disseminated among the general public and in a manner aimed at formation and maintenance of consumer awareness and interest to such persons or products and will encourage purchasing and consuming the advertised goods (medicines). If such information is directed at a target audience (for example, healthcare professionals) in observance of other limitations towards advertising, such information may not fall under the definition of advertising and limitations applied thereto.

Press releases regarding medicines for mainstream media can be treated as advertising and thus need to strictly comply with restrictions provided for the medicines advertising; in particular, adhering to general principles of advertising and special restrictions and requirements in terms of medicines advertising.

In cases when information contained in press releases is intended for placement in specialised industry publications dedicated to medical issues, fewer restrictions will be applied, that is, it is allowed to provide information about medicines in compliance with the requirements thereto set forth in the Law on Medicines.

More detailed information regarding restrictions and distinctions applied depending on the target audience is provided in 2.2 Difference Between Information and Advertising.

Advertising of medicines, medicinal products and methods of preventive care, diagnosis, treatment and rehabilitation shall not include: comparison with other medicines, medicinal products, methods of preventive care, diagnosis, treatment and rehabilitation aimed at enhancing the advertising effect.

It is worth mentioning that relations arising from comparative advertising are regulated by the Ukrainian unfair competition laws. The advertiser shall be responsible for the unlawful comparison used in advertising. Decisions regarding declaring a comparison used in advertising as unlawful are taken by the Anti-monopoly Committee of Ukraine (AMCU).

Pakharenko & Partners

72 Velyka Vasylkivska Str.
Entrance 1, 7th Floor.
Business Centre “Olimpiysky”
Kiev 03150 Ukraine

+380 44 593 96 93

+380 44 451 40 48

pakharenko@pakharenko.com.ua pakharenko.ua/
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Authors



Pakharenko & Partners (Kyiv) is one of the largest and most experienced intellectual property law firms in Ukraine, with offices in Kyiv (Ukraine) and London (UK). It also has many international partners all over the world. The firm provides the full scope of IP services required by pharmaceutical industry clients, including patent and trade-mark protection and enforcement, and has well-established expertise in domestic and international technology transactions, licensing, distribution agreements, confidentiality agreements, software licences and advertising. Clients include multinational, national and local corporations, major academic and research institutions, small entrepreneurial companies and engineering organisations, and individual inventors.

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