Federal Antimonopoly Service (FAS of Russia) has issued Letter No. АЦ/49132/18 dated 29 June 2018 in which expressed its opinion regarding selling prices for drugs, included in the List of vital and essential drugs (the “Essential drug list”). FAS indicated that these prices, when set by wholesale and retail organizations, shall be dependent on the terms of their purchase.
The letter is posted on the official web-site of FAS of Russia1.
The key points, outlined by FAS of Russia in this respect, are as follows:
1. Should wholesale and (or) retail organizations, which sell drugs, purchase the drug, that is included in the Essential drug list in 2018 at first time, prior to the date such drug is included in such list, i.e. before the beginning of 2018, and should they purchase such drug at the price exceeding registered maximum selling price of the manufacturer, then the selling price of such drug shall be reevaluated.
In such case wholesale and (or) retail organizations shall execute Price negotiation memorandum in order to sell such drug in future.
The selling price in such case shall be calculated based on the price, specified in the column of the Price negotiation memorandum entitled “Actual selling price, set by the manufacturer, excluding VAT (Roubles)”.
This column shall be filled-in, based on the following directions: in the event such drug is purchased from the manufacturer, then the actual selling price of the manufacturer, that does not exceed the maximum selling price of the manufacturer, shall be specified in the column of the Price negotiation memorandum entitled “Actual selling price, set by the manufacturer, excluding VAT (Roubles)”, and the registered maximum selling price of the manufacturer for such drug shall be specified in the column of the Price negotiation memorandum entitled “Registered maximum selling price, set by the manufacturer (Roubles)”; in the event such drug is purchased from another wholesale organization, then such purchasing price, not exceeding registered maximum selling price of manufacturer, shall be specified in the column entitled “Actual selling price, set by the manufacturer, excluding VAT (Roubles)”.
2. The selling price (including wholesale and retail mark-up) shall be calculated by wholesale and (or) retail organizations (i.e. by all organizations in distribution chain), which sell drugs, based on the actual selling price of the manufacturer of the respective drug, not exceeding registered maximum selling price as of the date of sale of this drug by the manufacturer.
This relates to the event when such drug, included in the Essential drug list, was sold by the manufacturer before the manufacturer reduced the maximum selling prices, specified in the Price Register.
The actual selling price of the manufacturer, which is actual as of the date of sale of such drug by the manufacturer, shall be specified in the column of the Price negotiation memorandum entitled “Registered maximum selling price, set by the manufacturer (Roubles)”.
Price negotiation memorandum may contain information on the date of sale of such drug by the manufacturer.
3. Should the decision on state registration or reregistration of maximum selling price of the manufacturer of the respective drug be cancelled, then the sale of such drug shall not be permitted.
In such case upon new registration of selling price for the drug the wholesale and (or) retail organizations, which sell drugs and which purchased such drug prior to the cancellation of the decision on state registration or reregistration of maximum selling price, shall specify the price, not exceeding new registered maximum selling price, in the column of the Price negotiation memorandum entitled “Actual selling price, set by the manufacturer, excluding VAT (Roubles)”.