New Health Ministry Price Regulations for Medicinal Products
11. 02. 2019
On 1 January 2019 price regulation 1/2019/FAR1 of the Ministry of Health of the Czech Republic entered into effect. The regulation introduces in particular the following changes:
The maximum mark-up will be reduced in the 7th band and in the 8th band to 4% and to 2% respectively; the surcharge in these bands will be increased. After the change the maximum mark-up amount will be regulated as follows:
The price regulation now expressly deals with discounts and bonuses. If in connection with the supply of a reimbursed medicinal product a discount or bonus is granted and if it is possible to unambiguously determine their amounts and allocate them to a particular individual item in a tax document (invoice) already at the date of taxable supply – regardless of whether such a discount or bonus is provided or obtained at the date of taxable supply or at a later date –, then such a discount of bonus will be reflected in the unit price.
Changes are made to definitions of terms used in the price regulation. In particular, the new term “other person placing a regulated product on the market” is being introduced, the meaning of which is a distributor who places medicinal products on the Czech market but who is not a marketing authorization holder for these products and does not supply these products to the marketing authorization holder for these products. This new term will also be included, among others, in the definition of the manufacturer’s price.
In contrast to the original intention announced by Deputy Health Minister Filip Vrubel2 no cap on the distributors’ mark-up was introduced, i.e. the maximum mark-up was not divided into separate caps for distributors and pharmacies. The maximum mark-up thus remains shared between distributors and pharmacies. The Czech Chamber of Pharmacists expressed their disappointment in this connection3 .
Also, on 1 January 2019, the related price decision 1/19-FAR4 of the Ministry of Health entered into effect. This decision changes the list of ATC groups which are not subject to a maximum price regulation.
The State Institute for Drug Control issued a notice5 on the discussed price regulation and price decision which covers primarily the new list of “deregulated” ATC groups.
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