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.

According to the law, publication of information about any medicines, regardless of their inclusion in the list of medicines prohibited for advertising, unregistered medicinal products, or the products that are in the process of development or putting into production, shall be allowed in specialised publications intended for healthcare and pharmaceutical professionals, as well as in the materials distributed at specialised seminars dedicated to medical issues.

Such information may include only the name, characteristics, therapeutic properties and possible side effects of a medicine. The fact that such information is not qualified as advertising of medicinal products indicates that in this part the legislation of Ukraine approximates to the EU practice (in particular, Directive 2001/83).

The law does not specify an exact scope of information to be provided in each of these categories concerning the name, characteristics, therapeutic properties and possible side effects of a medicine, which allows providing a broader scope of information about the medicine. In the course of development of layouts of informational materials, the following approaches are recommended:

  • including a statement that information provided is intended for healthcare professionals or for a specific event (if disseminated during specialised conferences, symposia, etc);
  • structuring information in accordance with the components of information established by law (namely, name, characteristics, therapeutic properties, possible side-effects);
  • in cases where the information material concerns an unregistered medicine, the respective note should be made stating that the data are not final or are incomplete and may be updated;
  • ensure that information has no advertising effect; and
  • complies with the requirements of anti-competitive legislation.

Information regarding unauthorised medicines and/or unauthorised indications provided during a scientific conference and directed at healthcare professionals restricted by providing exclusively the name, characteristics, therapeutic properties and possible side effects of a medicine.

Please see 2.2 Difference Between Information and Advertising and 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications for detailed information.

Dissemination of information on medicines on unauthorised medicines or unauthorised indications is limited to:

  • publications intended for healthcare and pharmaceutical professionals; and
  • materials disseminated at specialised seminars, conferences and symposia dedicated to medical issues.

The scope of issues that can be covered by information on medicines is clearly defined: name, characteristic, therapeutic properties, possible side effect.

The law does not provide for sending  information on medicines to healthcare institutions, but it is allowed to provide such information to healthcare professionals. As regards healthcare institutions, the law stipulates that legislative restrictions provided for in Article 21 of the Law of Ukraine "On advertising" are not applied to advertising of medicines placed in specialised publications intended for healthcare institutions.

Namely, there are no restrictions with regard to the advertising of prescription medicines and the ones included in the list of medicines whose advertising is prohibited, doping substances and/or methods of their use in sports. Also, it is not required to include a notice on the need to consult a doctor prior to the use of the medicine; recommendations on obligatory familiarisation with the instructions for the use of medicinal product; and the text of the notice stating as follows: "Self-treatment can be harmful to your health" occupying not less than 15% of the space (duration) of the whole advertisement.

Please see 3.3 Provision of Information to Healthcare Professionals for further details.

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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