Pharmaceutical advertising: Latest trends of Ukrainian legislation
Alexander Bondar, Lawyer with Legal Alliance Company

On 20 December 2011, the Parliament of Ukraine adopted the Law No. 4196-VI "On Amendments to some Laws of Ukraine in Health care Area regarding Strengthening Control over Turnover of Medicinal Products, Food Products for Special Dietary Consumption, Functional Food Products and Dietary Additives" (hereinafter - the "Law").

The Law came into force on January 13, 2012 except for some certain provisions with regard to advertising pharmaceutical products.

The Law introduces changes to the Laws of Ukraine “On Medicines”, “On Licensing Certain Types of Business Activity”, “On Advertising” and “The Foundations of the Healthcare Legislation of Ukraine”, and significantly influences the possibilities for advertising pharmaceutical products.

In accordance with the changes introduced by the Law¹ to part 4 article 26 of the Law of Ukraine “On Medicines”, it is allowed to advertise only those OTC products, which have not been included into the list of the pharmaceutical products that are prohibited from being advertised. The list of pharmaceutical products prohibited from being advertised shall be approved by the Ministry of Health of Ukraine. The criteria used for determining the pharmaceutical products, which are prohibited from being advertised, shall be also approved by the Ministry of Health of Ukraine. The decision regarding inclusion of a pharmaceutical product into the list of the pharmaceutical products prohibited from being advertised shall be made while performing the State registration (re-registration) of such pharmaceutical product and introducing the respective information to the State register of pharmaceutical products of Ukraine.

This also corresponds to the changes introduced to by the Law to part 4 article 26 of the Law of Ukraine “On Medicines”, namely, the advertisement of the pharmaceutical products, which may be used and sold only under the prescription of a doctor, as well as those, which have been included into the list of the pharmaceutical products prohibited from being advertised, is banned. Thus, the Law imposes a total ban on advertising RX products (including for healthcare specialists).

At the same time, the Law provides that it is allowed to deliver the following information about a pharmaceutical product:

1. Name of a pharmaceutical product;
2. Characteristics of a pharmaceutical product;
3. Treating (therapeutic)qualities;
4. Possible adverse effects.

Such information shall be used in publications for medical and pharmaceutical professionals as well as in the materials, which may be distributed at specialized seminars, conferences, symposiums on a medical theme.

The changes specified above with regard to advertising pharmaceutical products shall come into effect on July 14, 2012.

₁ The Law of Ukraine "On Amendments to some Laws of Ukraine in Health care Area regarding Strengthening Control over Turnover of Medicinal Products, Food Products for Special Dietary Consumption, Functional Food Products and Dietary Additives", part 2, paragraph 6, article 2.