New price controls for life-saving and essential medicines have
been introduced by the government.
Most of the key changes become effective from the 01 January
The key changes include:
a significant increase in overall controls over pricing
the introduction of new procedures and requirements
a requirement for manufacturers to register or re-register by 1
March 2010 their maximum sale price for each of the life-saving and
essential medicines on the official list under a new procedure
a requirement for maximum retail and wholesale margins to be
imposed by the Russian Regions under a new procedure
compliance with these requirements will form part of the
necessary conditions for obtaining and renewing manufacturing and
Manufacturers' maximum prices
Manufacturers must follow a new registration process, with
sanction for non-compliance or submitting false information. Prices
must be registered in Russian roubles from 1 January 2011. A
commission to resolve price registration disputes is being set up
from 1 October 2009, with a right of appeal to the commission
The price-setting methodology is to be developed and approved
within 4 months by the Ministry for Public Health and Social
Development (MoH) in cooperation with other related ministries.
Further details will be released by the ministry in due course.
Wholesale and retail margins
A new procedure is being developed for adopting maximum retail
and wholesale margins, which the Russian Regions must follow within
30 days of its approval. Both retail and wholesale margins must be
calculated on the basis of the manufacturer's price and must
take into account location, transport accessibility and other
There is also a detailed procedure for wholesalers and retailers
to apply the maximum margins, and a requirement for them to hold a
'price protocol' document in the prescribed form.
In two months' time, the MoH will start monitoring actual
prices and volumes for all drugs on the list of life-saving and
Prices are subject to monthly monitoring, for Russian
manufacturers by the bodies in charge of state statistics and for
foreign manufacturers by the Federal Customs Service. An electronic
database will also be created to facilitate monitoring by the
Federal Service of Supervision in Public Health and Social
Importers seeking import licences customs clearance for drugs on
the list must also provide information on the actual foreign
manufacturer's price, as well as documents confirming that it
has been registered.
The MoH has also produced draft legislation (draft Law On
Medicines Turnover) containing significant strengthening of pricing
controls which, after any Government amendments have been made, is
expected to be introduced to the State Duma in autumn 2009.
This is broadly in line with the measures introduced by the
Resolution but also proposes the introduction of a complete ban on
the sale of the drugs on the list whose manufacturer's prices
has not been registered. It also proposes the cancellation of any
manufacturer's price registrations and maximum margin approvals
if they are not in line with the approved methodologies.
Law: Resolution No 654 of the RF Government dated 08
August 2009 "On development of the government control over the
prices on life-saving and essential medicine"
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