The Supreme Court has dismissed the contentious-administrative appeal filed by the General Council of Official Colleges of Pharmacists (Cgcof) against articles 84 to 86 and additional provision 6 of Royal Decree 717/2019 relating to Nodofarma, the verification management system of Cgcof medicines.
Thus, the State Attorney, reproducing a passage from his claim, maintains that “the integration of the SNSFarma Node in the Spanish repository must be done through an agreement to be entered into between the Ministry of Health and the Spanish Medicines Verification System SL, managing entity of the Spanish repository.In addition, it affirms that the model of the SNSFarma Node does not interfere in the operation of the repository, therefore the budget on which the Court of Justice of the European Union is based. trial, proceed to dismiss the contentious-administrative appeal”, as stated in the ruling.
Last January, the Court of Justice of the European Union (CJEU) ruled that the drug verification system promoted by the Ministry of Health and the autonomous communities, Node SNSFarma, “is compatible” with the rules of the European Union on the need to have a mechanism for verification and authentication of drugs from end to end of the supply chain.
“In view of the foregoing, it is indisputable that the Court of Justice of the European Union understands that the imposition by regulation of the creation of a publicly owned node to access the national repository, the use of which is mandatory for the dispensation of medicines financed by the National Health System, is not contrary to Delegated Regulation (EU) 2016/6. It is, thus, a lawful regulatory possibility for Member States. This conclusion is clear from a simple reading of the sentence and, Of course, none of the parties questions it in their pleadings,” says the court’s brief in this regard.
The conflict arose in 2019, when the Ministry of Health created SNSFarma Node, a system that came to replace Nodofarma, the previous database that dated back to 2016, and whose verification management corresponded to Cgcof itself. The royal decree that gave entry to Node SNSFarma in 2019 attributed these responsibilities to the Ministry of Health, something that the Council of Pharmacists considered to exceed the powers that the European delegated regulation confers on the national administration.