Lithuania

[LT] New Provisions on Advertising of Pharmaceuticals

IRIS 2006-8:1/25

Jurgita Iešmantaitė

Radio and Television Commission of Lithuania

On 22 June 2006 the Seimas , the Parliament of the Republic of Lithuania, adopted a new Law on Pharmacy, the aim of which was to regularise the pharmaceutical practice in Lithuania. The said law will also change the rules on advertising and on the provision of information on drug substances and healthcare products. Until now advertising of pharmaceuticals was regulated by the former Law on Pharmaceutical Activity together with the Rules on Advertising of Pharmaceuticals, approved by the resolution of the Minister for Healthcare in May 2000.

The Law on Pharmacy provides new regulations concerning: information on pharmaceuticals, information on drug substances, advertising of drug substances and advertisers of pharmaceuticals. In accordance with this law, the information on drug substances is public and can be provided either as information on pharmaceuticals or as advertising of drug substances. Information on pharmaceuticals means any information, which is published and disseminated in any form and by any means on the pharmaceutical, clinical and pharmacological characteristics of a drug substance as well as the price of drug substances in the trade directories and price-lists.

The Law on Pharmacy broadens the definition of advertising of drug substances considerably. According to it the following will be considered as a form of advertising of drug substances:

- visits of an advertiser for pharmaceuticals with the aim of providing information on drug substances to healthcare specialists having the right to prescribe drug substances;

- dissemination of samples of drug substances, which are not meant for sale;

- encouragement of the usage of drug substances by means of presents, personal benefits or monetary bonuses in return;

- sponsorship of advertising events and scientific conferences at which healthcare and pharmacy specialists participate;

- sponsorship of radio and television programmes, where information on drug substances is broadcast.

Chapter X of the Law on Pharmacy lays down the requirements on advertising of drug substances and the rules for the provision of information on such substances. Art. 48 of this chapter lays down the content requirements for the information on pharmaceuticals. According to it, only the use of the generic name of drug substances shall be allowed while providing information about prescription medicines over radio or TV. According to the provisions of Art. 48 only registered drug substances may be advertised in the Republic of Lithuania. The advertising of drug substances shall be objective and not misleading. The law determines that it shall be made clear to the public in advertising for drug substances, that the advertised product is a drug substance. Para. 6 of the said article provides that pharmaceuticals which are only available on prescription shall not be advertised in any publications, over radio, television or any other means of electronic communications. The law also defines the category of persons who shall not be allowed to participate in advertising for drug substances, e.g. employees of state and municipal institutions, and specialists in the healthcare and pharmacy sector.

Due to the provisions of the law it shall also be forbidden to state in advertisements targeted at the public that a certain drug substance is recommended by scientists or famous people, to use misleading definitions and misleading graphic material or to provide information mostly or exclusively targeted at children. Apart from that, it shall also be forbidden to directly offer drug substances for advertising purposes.

The Law on Pharmacy sets down that all other requirements relating to the advertising of drug substances directed at the public, healthcare and pharmacy specialists shall be determined by the Minister of Healthcare.

In consideration of the above, a working group has been established to prepare Draft Rules on Advertising of Drug Substances and Healthcare Products.