Contributed By Pakharenko & Partners (Kyiv)
In accordance with the Law on Advertising, compliance with the legislation on the protection of consumer rights, particularly the rights of advertising consumers, shall be controlled by the State Service of Ukraine for Food Safety and Consumer Protection and its territorial bodies.
Furthermore, according to the Law on Advertising, the AMCU shall control compliance with the legislation on the protection of economic competition in the field of advertising. Decisions of the Anti-monopoly Committee may be appealed before the commercial court by an individual/entity on which a fine has been imposed for violation of the legislation in the field of advertising.
According to Article 26 of the Law on Advertising, the National Council of Ukraine on Television and Radio Broadcasting shall control within its powers the broadcasting organisations of all forms of ownership.
With regard to criminal (including corruption) offences (eg violation of rules for medicinal preparation advertising by an official of the public/municipal healthcare institution), liability for which is set forth in the Code on Administrative Offences of Ukraine, the National Agency on Corruption Prevention (NACP) and police are entitled to produce protocols (reports) on the administrative offence (containing information on the circumstances of the offence, evidence confirming its commission, etc), but a decision on liability and the penalty to be imposed shall be issued by court.
Also, there are self-regulatory authorities that may be responsible for enforcing the rules on advertising and the rules on inducement, eg, IFPMA and AIPM. In particular, the AIPM sets out some rules on advertising and methods of promotion to the general public. These requirements are prescribed by the AIPM Code of Practice, which is a self-regulatory code, and applicable only to the pharmaceutical companies that are members of AIPM.
First, proceedings may be initiated pursuant to the Law of Ukraine on Consumer Rights Protection of May 12, 1991 No 1023-XII (“Law on Consumer Rights Protection”) based on a request of a consumer (individual) who considers that his or her rights are violated as a result of unfair advertising of medicinal products. Such a request shall be submitted by a consumer to the State Service of Ukraine for Food Safety and Consumer Protection or its territorial bodies.
Second, any individual or legal entity may apply to the AMCU in the event of violation of their rights in result of acts or inactions identified as violations of the legislation on economic competition protection (constituting an act of unfair competition). Thus, according to the Law of Ukraine on Protection against Unfair Competition of 7 June 1996 No 236/96-VR (the “Law on Protection against Unfair Competition”), an act of unfair competition is constituted by a comparative advertisement containing comparison with goods, works, services or activities of another entity. Comparisons in advertising shall not be recognised as unlawful if the provided information on the goods, works and services is confirmed by actual data, reliable, objective and useful for informing consumers. Dissemination of misleading information in advertising also constitutes an act of unfair competition. Misleading information includes inter alia information containing incomplete, inaccurate or false information about a product origin, manufacturer, seller, method of manufacture, source and manner of purchase, sale, quantity, consumer properties, quality, completeness, suitability for application, standards, characteristics, peculiarities of sales of goods, works, services, prices and discounts on them and the essential terms of the contract. Furthermore, this includes incomplete, inaccurate or false information about the financial condition or economic activity of the entity; attributing powers and rights that they do not have or relationships that do not exist; containing references to the volumes of production, purchase, sale or supply of goods, execution of works, provision of services, which did not actually exist on the day of the information dissemination.
Based on the results of consideration of consumer requests, the State Service of Ukraine for Food Safety and Consumer Protection or its territorial bodies have the right to:
Furthermore, according to the Law on Consumer Rights Protection, damages caused to consumers by unfair advertising are subject to reimbursement by the guilty party in full.
In accordance with the provisions of the Law of Ukraine on Protection against Unfair Competition, commission by economic entities of actions determined by this Law as unfair competition, entails imposition of a fine by the AMCU of an amount of up to 5% of the income (proceeds) from the sale of the products (goods, works, services) of the economic entity for the last reporting year preceding the year in which the fine is imposed.
The Fundamentals of the Ukrainian Legislation on Health Care also provide for the responsibility of medical and pharmaceutical workers for violating the procedure of medicinal products advertising during their professional activities (please see 8 Inducement/Anti-bribery). For example, according to Article 44-2 of the Code of Ukraine on Administrative Offences, violation of the restrictions imposed on medical and pharmaceutical workers in the course of their professional activities entails a fine of UAH5,100–20,400 (approximately EUR160–640).
Officials of public or municipal medical institutions may be held liable for violation of the procedure for advertising of medicinal products containing signs of criminal offences, including corruption (please see 8 Inducement/Anti-bribery). For the time being, such cases are examined by general courts in criminal proceedings. In particular, such cases refer to criminal offences stipulated by Articles 364, 364-1, 368, 368-3, 369, namely: abuse of power or office; abuse of authority by an official of a legal entity of private law, irrespective of legal business structure; acceptance of a proposal, promise or obtaining an unlawful benefit by an official; bribery of an official of a legal entity of private law irrespective of business legal structure; and proposal, promise or providing an unlawful benefit to an official. The above-mentioned actions are punishable by a fine of UAH144,000–1,441,500 (approximately EUR4,500–45,000), as well as removal of the right to occupy certain positions or engage in certain activities for a certain period of time, arrest, custodial restraint or imprisonment.
Also, the High Anti-Corruption Court of Ukraine is to be established by March 2019. Cases concerning corruption in Ukraine will be brought directly to this court. The jurisdiction of the court covers crimes that caused damage in the amount exceeding USD31,000.
The two processes of procedures before or measures taken by the self-regulatory authority and the procedures before or measures taken by courts are parallel and separate. There is no relationship between them unless there is a court decision which enforces certain decision made by the self-regulatory authority.
In light of active harmonising the Ukrainian legislation in force with the legislation of EU, public discussion is currently ongoing with regard to a new Ministry of Health bill on advertising, in particular, to regulate the issue of medicinal products advertising among medical workers. The draft provides for a clear definition of professional medical editions, where advertising of drugs unprovided by law is permitted, as well as the development and approval by the Government of separate rules on advertising of medicinal products aimed at healthcare professionals. In addition, it is proposed to strengthen the monitoring and control of the content of advertising by the Ministry of Health of Ukraine and to establish clear penalties for violation of the Law on Advertising. It should be noted that for the time being, the Ministry of Health is as for now not among the authorities controlling the advertising of medicines/medicinal products in Ukraine.
Two recent cases that also illustrate trends in relation to pharmaceutical advertising in Ukraine are the following: