The assessments to which AIFA is called are the expression of a power in which there are profiles of both technical and administrative discretion, reserved to the Agency in the context of the rules governing the case in point, and can be challenged in court only in the presence of profiles of incongruity and illogicality of evidence such as to bring out the unreliability of the same. Since the legislation on the matter provides that reimbursement is also allowed for drugs "not involving (...) therapeutic advantage", but "only if the price of the same drug is lower than or equal to the lowest price of the drugs for the related homogeneous therapeutic category", the judgment of the Technical-Scientific Commission regarding the inclusion of a drug in group C under the "RR" regime (medicine subject to medical prescription) is certainly incongruous and clearly illogical, because the dosages of the products already on the market cover all therapeutic schemes; this limiting criterion is not only not foreseen by any law, the reasoning of the law being otherwise, but there is also an innumerable number of drugs existing in range A for all the most widespread therapeutic categories. In other words, although the automatic nature of the reimbursement following the issue of the Marketing Authorization must be excluded, the essentiality of satisfying the therapeutic need does not constitute a prerequisite for the reimbursement itself.
[Adv. Ennio Grassini – www.dirittosanitario.net]
