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Pharma Flash
Legislative changes in the field of medical devices
3. 1. 2019
Authors: Václav Audes (Partner), František Neuwirth (Associate)
On 1 January 2019 price regulation 1/2019/FAR[1]of the Ministry of Health 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:
| Band | Base from (CZK) | Base up to (CZK) | Rate | Surcharge (CZK) |
| 1 | 0.00 | 150.00 | 37% | 0.00 |
| 2 | 150.01 | 300.00 | 33% | 6.00 |
| 3 | 300.01 | 500.00 | 24% | 33.00 |
| 4 | 500.01 | 1,000.00 | 20% | 53.00 |
| 5 | 1,000.01 | 2,500.00 | 17% | 83.00 |
| 6 | 2 500.01 | 5,000.00 | 14% | 158.00 |
| 7 | 5,000.01 | 10,000.00 | 4% | 658.00 |
| 8 | 10,000.01 | 9,999,999.00 | 2% | 858.00 |
- 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 Vrubel[2] 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 connection[3].
Also, on 1 January 2019, the related price decision 1/19-FAR[4] 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 notice[5]
on the discussed price regulation and price decision which covers primarily the
new list of “deregulated” ATC groups.
[1] Price regulation of the Ministry of Health 1/2019/FAR of 12 December 2018 on the regulation of prices of medicinal products and food for special medical purposes; available at: http://www.mzcr.cz/Odbornik/dokumenty/cenovy-predpis-1/2019/far_16489_1953_3.html.
[2] See https://www.mzcr.cz/dokumenty/namestek-filip-vrubelproti-emergentnimu-systemu-broji-tikdo-se-boji-o-zisky_15884_1.html
[3] See https://www.lekarnici.cz/Media/Tiskove-zpravy/Do-noveho-cenoveho-predpisu-ministerstva-zdravotni.aspx
[4] Price decision of the Ministry of Health 1/19-FAR of 12 December 2018 which sets out a list of ATC groups which are not subject to a maximum price regulation; available at: http://www.mzcr.cz/Odbornik/dokumenty/cenove-rozhodnuti-1/19/far_16490_1953_3.html
[5] See http://www.sukl.cz/leciva/cenovy-predpis-ministerstva-zdravotnictvi-1-2019-far-a
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