Ordinance no. 280/2021, dated 3 December (entering into force on December 4, 2021) creates an exceptional criterion to be used in the annual price review for 2022, with the purpose of establishing a pricing brake mechanism.

The framework establishes:

(a) The application of existing rules on the annual revision of the prices of branded medicines is suspended for all medicinal products whose maximum retail price in force is less than or equal to EUR 15.00;

(b) For all medicinal products with a maximum retail price of more than EUR 15.00 and up to EUR 30.00, the application of existing rules may not result in a reduction of more than 5% in relation to the maximum retail price in force;

c) For all medicinal products with a maximum retail price of more than EUR 30.00, the application of the annual price revision scheme may not result in a reduction of more than 10% in relation to the maximum retail price in force.

The recently published Ordinance further amends the framework on the annual revision of the maximum prices for the purchase of medicines by National Health Service’s establishments and services, establishing that:

• All Rx medicines used or dispensed therein are subject to annual revision of their maximum purchase prices;
• The annual revision is also applicable to medicines that are included in an exceptional co-payment regime.
  
  

Additionally, in what concerns the approval of prices of new medicines and annual revision of the maximum retail price of medicinal products, the Government has decided to keep for the year 2022 Spain, France, Italy, and Slovenia as reference countries.