Action for annulment of the normative provisions regarding the determination of the maximum prices for an innovative medicine. The existence of a generic reference price

DREPTUL CONTENCIOSULUI ADMINISTRATIV ŞI FISCAL

Abstract

The provisions of Article 3 para. (1) letter o of the Order of the Minister of Health no. 386/2017 cannot be interpreted in the sense that, once the ACE-TAB product has never been marketed since its authorization, its price could not be used for comparison. The legal text does not mention the condition that, as at the report date, the medicine should be present on the market or should have ever been marketed, and this condition shall not even result, in the opinion of the court, from the corroboration of other legal provisions. The only requirement is that, at a given time, there should have been an application for approval of a first generic medicine from the respective common name, concentration and pharmaceutical form, in relation to which this generic reference price to be used from that moment on shall be approved once, no matter the subsequent fate of the medicine. The legal text applicable in this case shall be Article II para. (4) of the OMH no. 1246/2018, according to which in the event that, within 10 days from the issue of the decision for denial, DAPP/the representative communicates to the ministry the non-acceptance of the price established according to the decision for denial provided for under paragraph 3, DAPP/the representative is required to sell the medicines for a 12-month period from the communication of the decision for denial provided for under para. (3), without exceeding this period, at the lowest price between the previously approved price and the price proposed by DAPP/the representative. As an effect of the notification submission in due time, according to the same legal text, DAPP/the representative was required to sell the medicines for a 12-month period from the communication of the decision for denial provided for under para. (3), without exceeding this period, at the lowest price between the previously approved price and the price proposed by DAPP/the representative (market price), an issue which the defendant did not take note of unlawfully and which actually determined the establishment of the price challenged by the plaintiff.