Russian Federation: Overview Of Effective And Proposed Changes To Russian Laws In Pharmaceutical Sector And Medical Services

Last Updated: 14 July 2014
Article by Яна Дианова

I. Advertising of Medical Services

The Federal Law № 190-FZ dated 28 June 2014 "On Amending Article 24 of the Federal Law On Advertising" (hereinafter – the Law № 190-FZ) which excludes from the restrictions on advertisement placement the advertisements of medical services came into force from 30June 2014.

Advertising of medical services was allowed before only in the venues of medical or pharmaceutical exhibitions, seminars, conferences and similar events, as well as in specialized printed mass media for medical and pharmaceutical professionals. From the date of entry into force of the Law № 190-FZ this restriction applies only to the methods of preventive treatment, diagnostics, treatment and medical rehabilitation as well as with respect to advertising of prescription medicines and medical devises' application of which requires special training.

According to the clarifications issued by the Federal Antimonopoly Service of the Russian Federation (FAS) starting from 30 June 2014 advertisements of medical services may be placed in any form subject to compliance with Article 24 of the Federal Law On Advertising and the general requirements to advertising established by this law.

FAS also instructed its regional divisions that proceedings in connection with administrative offences due to a breach of part 8 of Article 24 of the Federal Law On Advertising may not be instituted at present and those which were instituted due to distribution of medical devices' advertisement in the venues prohibited before by part 8 of Article 24 of the Federal Law On Advertising should be terminated if a decision has not been taken yet and such proceeding is in the course.

It is worth mentioning that out of more 11 thousand claims in connection with undue or illegal advertisement that were considered by antimonopoly authorities in 2013 the majority of offences were connected with distribution of advertisements of medicines, medical devices and biologically active supplements: 21,38% of all the breaches.

II. Liability for Falsified Medicines, Medical Devices and Biologically Active Supplements

The State Duma has adopted in the first reading the bill "On amending certain laws of the Russian Federations for the purposes of countering falsified, counterfeited, poor-quality and unregistered medicines, medical devices and falsifiedbiologically active supplements". The bill provides for supplementing the Criminal Code of the Russian Federation with new articles establishing liability for:

a. manufacturing of medicines and medical devices without a special permit or license required under the law;

b. manufacturing, sale and import in Russia of falsified or unregistered medicines and medical devices or sale, illegal import in Russia of poor-qualitymedicines, medical devices as well manufacturing, sale and import in Russia of falsified biologically active supplements which contain prohibited components if any such deed is committed in significant amount (the price of the respective medicines, medical devices or falsified biologically active supplements exceeds RUB 100 thousand);

c. producing of fake documents for medicines and medical devices (registration certificates, certificates or declarations of compliance, application instructions for medicines and medical devices, user manuals for medical devices), fake primary package and/or secondary (consumer) package of a medicine.

Penalties for the respective crimes shall be inter alia imprisonment for a term from 5 to 8 years with a fine in the amount from RUB 500 thousand to 2 million.

It is contemplated as well under the bill to introduce administrative liability (an administrative fine in the amount of RUB 600 thousand on companies' officers and an administrative fine in the amount from RUR 1 to 5 million or administrative suspension of activity on legal entities) for:

  • actions in the sphere of turnover of falsified and counterfeited medicines and medical devices;
  • engaging in turnover of falsified biologically active supplements;
  • sale, illegal import in Russia of poor-quality medicines, medical devices; illegal manufacturing, sale and import in Russia of unregistered medicines and medical devices, committed by a legal entity or individual entrepreneur if such actions do not constitute a crime.

Furthermore, the bill provides for supplementing the Federal Law № 29-FZ dated 2 January 2000 "On quality and safety of food products" with the definition of falsified biologically active supplements and the Federal Law № 323-FZ dated 21 November 2012 - with the definition of falsified, counterfeited and poor –quality medical devices and to prohibit import and sales of such medical devices.

This overview is prepared on the basis of the information as of 3 July 2014.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Яна Дианова
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