In brief

As every year since the creation of the reference price system back in 2014, the Spanish Ministry of Health published the new Reference Price Order Order SND/1308/2021 (“Order“) on 29 November 2021. The reference price system consists of the annual revision of the maximum price at which medicinal products included in the National Health System portfolio are financed. Our team already analyzed the draft Order published on 14 July 2021, and the final text barely differs from the draft.

A closer look

By Order, the Minister of Health annually creates new reference groups of publicly financed medicinal products with their corresponding reference prices, revises the reference prices if applicable and removes those groups that no longer meet the requirements for their formation. This year was no exception and the content of the Order remains virtually unchanged from what was outlined in our alert last summer.

The main change this year has to do with the criteria used to form the reference groups, the most contentious issue ever since the inception of the reference price system. The 2020 order meant a brief interlude during which the Ministry of Health formed the reference groups with medicinal groups sharing an identical active ingredient. However, the draft Order and now the final Order attest that the Ministry of Health has come back to ATC5 classification to form the groups, based on a recent legislative change that we echoed last summer.

Those laboratories in disagreement with the reference prices set for their medicinal products are entitled to file an appeal before the Administrative Chamber of the Spanish National High Court (Audiencia Nacional) within two months (i.e., by 29 January 2022) or, alternatively, to appeal before the Minister of Health within one month (i.e., by 29 December 2021) and then appeal before the Spanish National High Court if the Minister of Health does not reconsider its position.