The Order of the Russian Ministry for Healthcare and Social Development dd. 15.06.2012 # 7н “On adopting the Regulation for importing medical goods into the territory of Russia for state registration” stipulates that importation of medical goods into the territory of Russia for state registration purposes shall be performed by the manufacturer or its authorized representative, under the permission of Roszdravnadzor.
The validity term of the permission shall be 6 months from the issuance date. The Order also stipulated the template application for the permission and the set of accompanying documents.
The issue of restricting the advertising of biologically active supplements was numerously raised by the state authorities (please refer to KPMG Pharma Bulletin, issue #23). The respective draft law addressing the requirements to the printed and TV advertisement is now drafted by the FAS of Russia and published at its official web-site. It is supposed to oblige the advertisers to publish a warning that biologically active supplements are not considered as medications.
In case of breaking the requirements to advertising, the company’s management could be penalized for kRUB 10 – 20 and the company itself could be penalized for kRUB 200 – 500.
In particular, the amendments include provision on regulating bio-technological and orphan pharmaceuticals circulation, substitutability of pharmaceuticals and changes to the procedure for state registration of drugs.
In addition, according to the Head of the Ministry for Healthcare and Social Development Veronika Skvortsova, it is being considered to establish a unified federal body responsible for state purchases. The Minister also noted that, in terms of international non-proprietary name, generics of the Russian origin would be the priority. The Ministry plans to re-consider and extend the “7 Nosologies” list as well.
According to the Head of the Ministry for Healthcare and Social Development Veronika Skvortsova, by 1 December 2012 the Ministry will announce the strategy for pharmaceutical coverage for the period till 2020 and will launch its active discussion. The Minister did not provide more details, outlining only the general approach: the state is supposed to provide 50% cost reimbursement. Previously it was announced that pharmaceutical insurance would not be introduced earlier than 2016.
FAS plans to computerize the process of gathering information on the local market of pharmaceutical trading, by implementing the special information system for these purposes. Currently, FAS representatives are collecting data on Russian pharmacies, pharmacy chains and pharmaceutical trading companies manually.
FAS is hoping that launch of the new information system would raise the efficiency of identifying dominating market players and unfair competition cases.
The Ministry for Industry and Trade published at its web-site the draft Resolution of the Government of Russia “On introducing amendments into the Federal purposed program “Development of the pharmaceutical and medical industry in the Russian Federation for the period till 2020 and further perspective”, adopted by the Resolution of the Government of Russia dd. 17 February 2011 # 91.
According to the amendments, the total amount of investments into the Program will be reduced by RUB 314 MM (from RUB 188,067 MM to RUB 187,753 MM), including RUB 122,188 MM related to the federal budget sources.