Medical advertising in Ukraine will soon face additional restrictions. On 10 January 2012, the President of Ukraine signed into law certain changes to the Law on Medicines and the Law on Advertisement (the "Amendments") that affect advertising of medicines.

These Amendments mean that, in addition to the already existing prohibition on advertising prescription medicines, some OTC medicines could be included in the List of Medicines Advertising of Which is Prohibited. The criteria for including them in the List will be determined by the Ministry of Health. The decision to put an OTC medicine on the List will be made by the Ministry of Health when the medicine is registered for use in Ukraine (or when the registration is renewed). The State Registry of Medicines Registered for Use in Ukraine will indicate whether or not a medicine is on the List.

The Amendments introduce a new term, "information about medicine". This includes the name, the description, the cure properties (medical effect), and possible side effects. This relates to medicines that are registered, unregistered, and being developed, or the production of which is being launched. According to the Amendments, information about a medicine is to be published in the media for medical or pharmaceutical professionals, as well as in the materials distributed at specialized seminars, conferences and symposia on medicine. This clause potentially creates conflict with the Law on Advertisement (which currently does not restrict the media in which advertisement of medicines could be placed) because any advertisement may potentially fall under the definition of "information about medicines".

Furthermore, until the State Register of Medicines is updated to indicate which medicines are "unadvertisable", it will not be possible to advertise any medicines registered for use in Ukraine before the Amendments come into effect. Because it is still unclear how soon the Ministry of Health will update the State Register of Medicines Registered for Use in Ukraine, based on the literal interpretation of the Amendments, it is quite possible that advertisement of the OTC medicines will not be possible until the date when the registration in Ukraine of the particular medicine is renewed. As a result, advertisement of the OTC medicines that are currently registered in Ukraine will not be possible from 12 July 2012 at least until the date when their registrations are renewed (which may be the next 4 years, if the medicine was registered in 2011, for example).

Actions to consider

Due to the potentially severe restrictions on advertisement of OTC medicines in Ukraine, companies affected by the Amendments should think about what advertisement and registration strategies they may want to pursue in the Ukrainian market.

Additional notes

This LEGAL ALERT is issued to inform Baker & McKenzie clients and other interested parties of legal developments that may affect or otherwise be of interest to them. The comments above do not constitute legal or other advice and should not be regarded as a substitute for specific advice in individual cases.

For More Information:

Mariana Marchuk, Counsel

+380 44 590 0101

mariana.marchuk@bakermckenzie.com

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