Bulgaria

[BG] Changes to Advertising of Medical Goods

IRIS 2008-9:1/4

Rayna Nikolova

New Bulgarian University

In 2007 a new Act on Medical Products in Human Medicine was passed by the Bulgarian Parliament (published in State Gazette, issue No 31 dated 13 April 2007).

Chapter 11 of the Act is dedicated to advertising of medical goods. A definition of the term “Advertising of medical goods” is contained in Article 244 of the Act: “any form of information, presentation, promotion or suggestion, which is intended to stimulate the prescription, sale or use of any medical good and contains advertising aimed at the general public.”

There are a number of special requirements in the Act regarding the content of advertisements of medical goods. In case of violation of those requirements the Act provides for administrative sanctions, fines varying between BGN 10,000 and BGN 20,000, directed at the advertisers. The same sanctions apply to those who have permitted the broadcasting, publication or transmission of the advertisement.

In August 2008 the Act was amended and supplemented (State Gazette, issue No 71 dated 12 August 2008). The following two rules have been introduced:

1. A fine between BGN 10,000 and BGN 20,000 may be imposed on a person advertising a product which may contain characteristics related to prevention, diagnosis or treatment of human diseases.

2. A fine between BGN 1,000 and BGN 5,000 may be imposed on a medical specialist or a person presenting himself/herself as a medical specialist, who performs direct or indirect advertising of a medical product in the print or electronic media, including the Internet. In case of repeated violation of this prohibition the person may be obliged to pay a fine amounting to between BGN 3,000 and BGN 10,000.

Unlike the Health Act (State Gazette, issue No 70 dated 10 August 2004) regulating the direct and indirect advertising of alcoholic beverages, the Act does not contain different rules for direct and indirect advertising of medical goods.