OBSERVAȚII CRITICE REFERITOARE LA TRANSPUNEREA ÎN LEGISLAȚIA ROMÂNĂ PRIVITOARE LA MEDICAMENTELE COMPENSATE A DIRECTIVEI 89/105/CEE DIN 21 DECEMBRIE 1988

The field „Public Health”, regulated by Article 168 of the Treaty on the Functioning of the European Union, is part of the category of fields of competence shared between the Member States and the Union. The decision to subsidize the price of medicines is the result of several factors: technical, financial and political. For this reason, the Union leaves the decision in this field to the discretion of the Member States but, pursuant to the principle of subsidiarity and proportionality, it tries to standardize certain procedural aspects, meant to ensure the free movement of goods and services. In this respect, it has been adopted Directive 89/105/EEC of the Council of 21 December 1988. In order to ensure a better transposition of this directive, in 2014, Romania has fundamentally changed the normative framework regulating the criteria and the procedures by which new medicines are assessed in order to be introduced on the List including the international common names for medicines for insured persons, with or without personal contribution, based on medical prescription, within the health social insurance system (list of subsidized medicines). For the first time it has been introduced the system of inclusion in the list of subsidized medicines conditioned by the conclusion of cost-volume/cost-volume-outcome type contracts. However, as we will further show, the current Romanian legislation in the field of subsidized medicines does not ensure an effective and integral transposition of the European directive, particularly with regard to the compliance with the imperative time limit for adopting the inclusion/non-inclusion decisions provided in Article 6 (1) of the Directive 89/105/EEC of the Council of 21 December 1988. This study deals with the limits of the current normative framework from a theoretical perspective confirmed by the relevant majority case law in the field.