Amendment to the Act on Reimbursement of Medicines – European reference price definition

On 16 October 2019, the Slovak Parliament has adopted Act No. 343/2019 amending Act No. 363/2011 on the Scope of and Conditions for the Reimbursement for Medicinal Products, Medical Devices and Dietetic Food on the Basis of Public Health Insurance. The main purpose of the amendment is the change of definition of European reference price, and the conditions of elimination of patient co-payment.

European reference price

According to the current legal regulation, maximum price of a medicinal product in Slovakia is determined based on the prices of the same product in other EU Member States. For this purpose, prices in other Member States are regularly referenced, and the European reference price is calculated, defined as the average of three lowest prices from among officially determined prices of the medicinal product in other Member States, while if the medicinal product has an officially determined price:

1. only in one other Member State, then the officially determined price of the medicinal product in this state,
2. in two of other Member States, the average of the prices in these Member States.

According to the current legal regulation, only the prices of identical packages are mutually referenced, therefore, e.g. the price of a 20 pcs package is not referenced with the price of a 10 pcs package. If the package size of a medicinal product authorised in Slovakia is different from package sizes authorised in other Member States, prices of these different packages are currently not referenced against each other. The amendment is introducing a rule that, if there is an identical package size in another EU Member State, the price of this package is taken into account in price referencing, however, if not, the price of the most advantageous package recalculated to the Slovak size shall be taken into account.

Effective from 1 January 2020, the European reference price shall be defined as the arithmetic average of three lowest prices from among officially determined prices of the medicinal product in other Member States, while if:

1. the medicinal product has an officially determined price only in one other Member State, the arithmetic average of the sum of the officially determined price of the medicinal product in this state, and two lowest unit prices of this medicinal product in other Member States with the lowest unit price recalculated to the package size for which the European reference price is being determined,
2. the medicinal product has an officially determined price only in two of other Member States, the arithmetic average of the sum of the officially determined prices of the medicinal product in these states, and the lowest unit price of this medicinal product in another Member State with the lowest unit price recalculated to the package size for which the European reference price is being determined,
3. the medicinal product does not have an officially determined price in any other Member States, the arithmetic average of three lowest unit prices of this medicinal product in other Member States with the lowest unit price recalculated to the package size for which the European reference price is being determined.

The Government expects this measure to bring savings of public funds of at least EUR 3 million.

Elimination of co-payment

The conditions under which the principle of retaining of the ratio of the amount of reimbursement of a medicinal product by a health insurance company, and the patient co-payment, in case of change of price in a retail pharmacy, shall be changed as follows:

1. The possibility to eliminate the co-payment for a medicinal product, patient co-payment of which is higher than 5% of the average monthly wage of an employee in the economy of the Slovak Republic determined by the Statistical Office of the Slovak Republic for the calendar year preceding by two years the calendar year in which the reimbursement is being determined, shall be restricted, and shall be available only on condition that the same reference group does not include another medicinal product with the patient co-payment lower that 5% of the average monthly wage;
2. the possibility to eliminate the co-payment for medicinal products listed in the list of reimbursed medicinal products in the reference group that includes a medicinal product with the patient co-payment higher than 5% of the average monthly wage is being removed.

This change shall entire into force on 1 July 2020.

***

This legal update has been prepared by in November 2019 solely for the purpose of general information and is not a legal advice. The information above is not comprehensive and the legal update only briefly outlines the respective legislative changes. In case you are interested in further information on the above legislative change, do not hesitate to approach your contact person in Čechová & Partners.