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.

In Ukraine, advertising activity is regulated by the general Law of Ukraine on Advertising of 3 July 1996 No 270/96-VR (“Law on Advertising”), which also contains special provisions regulating the rules for the advertising of medicines, medical equipment, methods of preventive care, diagnosis, treatment and rehabilitation. In addition, the provisions on advertising and certain requirements for the promotion of medicines are enshrined in special legislation, such as the Fundamentals of the Legislation of Ukraine on Health Care of 19 November 1992, 2801-XII, and the Law of Ukraine on Medicines of 4 April 1996 No 123/96-VR.

Self-regulatory organisations of pharmaceutical companies (manufacturers and/or distributors) also develop and approve the relevant documents regulating the ethics of promotion and interaction with patient organisations and healthcare institutions for their members. In particular, the Association of Pharmaceutical Research and Development (APRAD), which represents the interests of the pharmaceutical research industry in Ukraine, being a non-governmental and non-profit organisation, a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), has introduced the ethics code (Code of Pharmaceutical Marketing Practices), by which APRAD acknowledges the role of relevant codes of ethics developed by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), EFPIA, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Association of International Pharma Manufacturers (AIPM). Furthermore, AIPM Ukraine has introduced the Code of Good Conduct and the Ethical Promotion of Pharmaceutical Products, which applies to the conduct of IFPMA Ukraine Members and their agents, and helps ensure that their interactions with stakeholders are appropriate.

Ukrainian pharmaceutical companies, which are members of IFPMA, are engaged in medical and biopharmaceutical research in order to benefit patients and to support high-quality patient care, to promote, sell and distribute their products in an ethical manner and in accordance with all the rules and regulations for medicines and healthcare. The Guiding Principles set out the basic standards applicable to IFPMA Membership Companies and their agents.

Self-regulatory codes apply to and cover issues of interaction with healthcare professionals, healthcare institutions and patient organisations as part of the promotion of pharmaceutical products. This applies to any activity undertaken, organised or sponsored by a member company that is directed at healthcare professionals to promote the prescription, recommendation, supply, administration or consumption of its pharmaceutical product(s) through all acceptable methods of communications.

Provisions of self-regulatory codes of a particular association are the responsibility of the individual company (please also see 11.4 Relationship Between Regulatory Authorities and Courts concerning legal value). In any case, the companies are obliged to adhere to all appropriate laws and other national regulations. Before placing the promo materials or conducting any other promotional activities or interactions with healthcare professionals in Ukraine, they need to check its compliance to the requirements of the national legislation.

The companies must implement and maintain relevant procedures ensuring complete observance of the provisions of the Code and the current legislation as well as the control and monitoring of all activities and materials related thereto.

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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