On November 25, 2013, the President of the Russian Federation has signed the Federal Law № 317 -FZ "On amendments to certain legislative acts of the Russian Federation and on the annulment of certain provisions of legislative acts of the Russian Federation on the health of citizens in the Russian Federation" ( "Law 317 - FZ "). The purpose of this statutory act is to harmonize various effective statutes in the area of healthcare, following the recently occurred amendments in connection with the adoption of the Federal Law of November 21, 2011 № 323- FZ "On the basis of health protection of citizens in the Russian Federation" ("Law 323 -FZ "), and amendments to the Federal Law of April 12, 2010 № 61 –FZ "On circulation of Medicines " ("Law 61-FZ ").
Particular attention should be paid to amendments made by the Law 317- FZ to the Russian Code of Administrative Offences ("Administrative Code ").
Thus, it is provided that the field of application of Article 3.11 of the Administrative Code ("disqualification") will be applicable to physicians and pharmacists.
Accordingly, for violations of the restrictions specified in Article 75 (and in the future - also Article 74) of Law 323 -FZ, physicians and pharmacists may be temporarily disqualified, i.e. deprived of their right to perform professional activities, as an administrative sanction imposed by the court.
Article 6.29 was introduced to the Administrative Code establishing liability for violation of the provisions of Article 75 of the Law 323-FZ, concerning the responsibilities of physicians, managers of healthcare organizations and individual entrepreneurs to inform of the situations of conflict of interest.
Initial violation is punishable by a relatively low fine (upper limit in the range of 5 to 10 thousand rubles). More severe sanction is provided for the repeated violation - up to 6 months disqualification.
At the same time, it should be noted that no specific sanctions for violation of the provisions of Article 74 of the Law 323- FZ (restrictions on receiving by medical staff gifts, money from representatives of pharmaceutical manufacturers and others) are proposed. Still, the repressive mechanism ensuring compliance with the provisions of Law 323 –FZ as before, remains targeted exclusively at healthcare professionals, and is not applicable to drug manufacturing companies or their representatives. The Bill establishing the relevant appropriate sanctions is still at the stage of the amendments in the State Duma.
Two new administrative violations are established in the field of circulation of medicines: violation of the order in wholesale and retail trade of medicines, as well as sale of poor-quality, falsed or counterfeit medicines. Per se, such violations are punishable by a fine of up to 100 thousand rubles.
However, an aggravating circumstance is established under which the maximum fine is the double of the specified figure, and also sanction is applied in the form of administrative suspension of operations: namely, incurring personal injury or threat of injury.
It appears that in practice finding such "threat" will depend in each case entirely on the discretion of the inspection, which is obviously creating a certain corruptive potential for the application of this statutory regulation.
The obligation of subjects of circulation of drugs to report to the authorized authority on detected cases of side effects not listed in the instructions for use of the drug (Article 64 of the Law 61-FZ) is supported by self consistent sanction.
At the legislative level (Article 23.81 of the Administrative Code), the Federal Service of Healthcare Surveillance (Roszdravnadzor) is now vested with competence to bring an action concerning mentioned administrative violations and to apply sanctions to violators.
Relevant provisions of the new Law 317-FZ will become effective after January 1, 2014.
At the same time, it should be expected to take additional specific regulatory act establishing administrative regulations for the Federal Service of Healthcare Surveillance (Roszdravnadzor) to carry out its new competences pursuant to Article 23.81 of the Administrative Code.