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Reduction of maximum wholesale price

According to an amendment to the Health Insurance Act entered into force in the beginning of 2016, the Pharmaceuticals Pricing Board shall review the maximum wholesale prices of original medicinal products (direct and parallel import) included in the reference price system.  According to the entry-into-force provision of the Act, the maximum wholesale prices of medicinal products included in the reference price system before 1 January 2016 shall be reviewed all at once. After that, the maximum wholesale prices of medicinal products included in new reference price groups shall be reviewed once every reference price period.

New reference price groups from 1 January 2016 onwards

The Pharmaceuticals Pricing Board will reduce the confirmed maximum wholesale prices of medicinal products included in a reference price group in the beginning of the fourth reference price period after the establishment of the reference price group. The decisions will be made by the initiative of the Pricing Board. The Pricing Board will hear the holders of the marketing authorisations before reducing the prices.

The reduction of maximum wholesale prices applies to medicinal products whose maximum wholesale price is higher than the highest confirmed maximum wholesale price for a generic product included in the reference price group. The maximum wholesale prices for those products will be confirmed to correspond to the highest confirmed maximum wholesale price of a generic product included in the reference price group.

Every reference price period, the Pharmaceuticals Pricing Board will publish a list of the reference price groups to be reviewed in the reduction procedure and of the medicinal products included in the groups.

Medicinal products included in the reference price system before 1 January 2016

The Pharmaceuticals Pricing Board will also reduce the maximum wholesale prices for medicinal products included in the reference price system before January 1, 2016, if their maximum wholesale prices are higher than the highest maximum wholesale price confirmed for a generic product. The decisions on the maximum wholesale prices for these products will enter into force on 1 July 2016. The Pricing Board shall hear the holders of the marketing authorisations before reducing the prices.