The Ministry for Healthcare and Social Development submitted to the State Duma a suggestion to delegate the functions for purchasing drugs under the "7 Nosologies" program to the regional level of authority. The Ministry explains this initiative by the difficulty of administering the program.
The initiative is formulated as a proposed amendment to the Law “On Healthcare” and is planned for implementation starting from January 2012.
The Ministry for Healthcare and Social Development of Russia posted at its website the Draft Federal law "On amending the Federal law "On circulation of pharmaceuticals”. The Draft introduces a new Article 58.1 "Itemized and quantitative accounting of pharmaceuticals for medical use”.
The itemized and quantitative accounting means that all operations with pharmaceuticals which result in change of the pharmaceuticals’ quantity and condition should be recorded in a special ledger.
The new requirement is mandatory for:
Violation of the new rules entails sanctions to the companies’ executives.
The law is supposed to be enforced after 180 days from its publication.
The Association of Russian Pharmaceutical Manufacturers submitted to the Minister for Healthcare and Social Development of Russia Tatiana Golikova the proposal for changes to the Federal law # 61-FZ "On circulation of pharmaceuticals".
The amendments relate to the system of definitions, pre-clinical trials, pharmaceuticals registration, including changes to the list of documents required for the registration dossier.
The Resolution of the Russian Government dated 3 June 2011 # 441 stipulates that the permission issued by the Ministry for Healthcare and Social Development enables importation of the following goods into Russia:
The above batches of goods may be imported without a license issued by the Ministry for Industry and Trade.
The Ministry for Healthcare and Social Development presented the draft resolution of the Russian Government stipulating the order for determining the initial prices for medical equipment purchases under state tenders.
In particular, the document provides for a closed list of information sources on the prices for medical equipment, according to which the permissible sources of information include: the register of state and municipal contracts, the data from the lists of equipment published at the state authorities’ websites and the data obtained from manufacturers.
Consequently, for identifying the list of producers, the customer will have to use the database maintained by the Ministry and to send to producers the inquiries for prices. The minimum of the prices offered by the manufacturers will be fixed as the initial contract price.
Should some of the addressed manufacturers not reply to the request, the customer would need to use either the register of contracts or the official databases. The selected initial price will have to be justified.
The Ministry for Healthcare and Social Development presented a draft resolution of the Russian Government stipulating additional requirements for placement of orders for supplies of medical equipment under state tenders.
In particular, the suppliers are required to submit (as a part of the application for participation in the state tender) a special document issued by the manufacturer of medical equipment. This document should validate the supplier’s authorization for the equipment supply, for warranty servicing and installation, etc.
According to the draft document, the new requirement should allow ensuring that professional market players take part in the tenders, reducing the number of intermediaries in the supply chain and, consequently, decreasing the costs associated with orders placement.
According to Mr. Sergey Tsyb, the Director of the Chemistry & Technical Complex & Bioengineering Technology Department with the Russian Ministry for Industry and Trade, the investments under the federal program "Pharma – 2020" are supposed to exceed 188 billion ruble during the next 10 years. More than 120 billion ruble are expected to come from the state budget and about 65 billion ruble – from non-budget sources (the companies’ own investments, loans, etc.)
According to the Department’s forecasts, the Russian pharmaceutical market should grow up to 50 – 60 billion US dollar by 2020, thus becoming an attractive platform for the investors realizing pharmaceutical projects.