Nový cenový předpis Ministerstva zdravotnictví

New price regulation of the Ministry of Health

On 30 November 2022, the Ministry of Health issued Price Regulation No. 2/2023/OLZP, on the Regulation of the Prices of Medicinal Products and Foodstuffs for Special Medical Purposes (the "Price Regulation"). The Price Regulation will come into force on 1 January 2023 and will repeal the current Price Regulation of the Ministry of Health No. 1/2020/CAU of 10 December 2019, on the Regulation of the Prices of Medicinal Products and Foodstuffs for Special Medical Purposes.

The purpose of the Price Regulation is generally to establish binding rules for the pricing of medicinal products and foodstuffs for special medical purposes. Medicinal products and foodstuffs for special medical purposes that are covered by public health insurance are subject to price regulation on the basis of the Price Regulation, regardless of whether they are actually covered by public health insurance or are fully paid for by the patient in the particular case.

In addition to the purely technical changes contained in each newly issued Price Regulation (such as an increase in the lab fee for individual procedures), the Price Regulation also introduces several other changes that may have an impact on the setting of business models of manufacturers and distributors of medicinal products in the Czech Republic.

The most interesting change in this sense is the modification of the definition of another person supplying a medicinal product to the market. It is either a person authorised to carry out distribution activities who supplies mass-produced medicinal products to the market in the Czech Republic and forms a concern with the originator or has been authorised in writing by the originator to supply such products to the market in the Czech Republic, or a person authorised to import a mass-produced medicinal product in parallel. According to the currently effective price regulation, another person placing a registered medicinal product on the market is defined as a person authorised to carry out distribution activities who places registered mass-produced medicinal products on the market in the Czech Republic, while not being in the position of the holder of the decision on their marketing authorisation or supplying them to the holder of the marketing authorisation.

Therefore, the Price Regulation newly establishes, in relation to another person supplying a medicinal product to the market, a new requirement that this person forms a concern with the originator or is authorised by the originator to supply. At the same time, the definition is extended to include persons authorised to carry out parallel imports.

The definition of other persons supplying a medicinal product to the market is important from the point of view of price regulation, because other persons supplying a medicinal product to the market are, besides the originator of the medicinal product, the first link in the distribution chain to which price regulation under the Price Regulation applies - these persons may sell the medicinal product to local distributors or persons authorised to dispense medicinal products at a maximum price corresponding to the price ceiling set by the State Institute for Drug Control (the so-called originator price). The maximum amount of the trade mark-up is subsequently based on the originator price.

This change raises a number of questions:

• What impact does this change have on the business models of innovative pharmaceutical companies - will it enable them to buy from their suppliers at prices that allow them to realize a margin?
• Does this change affect the manufacturer's price, which is the basis for the European maximum pricing system?

We will keep you informed of any further developments in this area. If you would like more detailed information, please contact the authors of this article or other members of the EY team with whom you work.

Authors:

Ladislava Zamazalová

Ivan Zhurkin