La primacía del derecho de la Unión Europea y su aplicación al ámbito del medicamento

On 2 December 2021, the Spanish Audiencia Nacional issued a ruling where it partially accepted an appeal filed by Farmaindustria against the Order SBC/953/2019 of 13 September, which updated, for 2019, the reference price system that applies in the Spanish National Health System.
The judgement annuls the inclusion, in reference price group H35, of the medicinal product named Onivyde®, approved for a treating metastatic adenocarcinoma of the pancreas and designated as an “orphan medicine”.

The annulment relies on the idea than making orphan medicines subject to the common rules which aim to limit prices of medicines impedes the achievement of the objective foreseen in Regulation (EC) nº 141/2000 of the European Parliament and the Council which according to the wording of the judgement is “to establish incentives to promote the research, development and commercialization” of these products.

Moreover, the Court relies heavily, in a precise and clear manner, on the principle of primacy of European Union law, which we analyse in this commentary considering its impact in the area of medicinal products.