The Council of State annuls a clawback imposition for first time: “The Orphans case”

By virtue of a recent pioneer decision (1785/2019), the Council of State annulled the imposition of the clawback mechanism on “orphan drugs” on the basis that the imposition of said measure on this particular category of pharmaceutical products and therefore, their equation with other pharmaceutical products, is against the constitutional principles of Equality and Proportionality. In particular, the Court, taking into account that both the number of patients in need of orphan drugs and the cost of their treatment are known in advance and specific, given that the drugs for said specific diseases as well as the calculation of their price are determined strictly by a Ministerial Decision and not according to the market trends, acknowledged that burdening the cost of orphan drugs with clawback inevitably results to unequal and discriminatory treatment to the detriment of pharmaceutical companies marketing “orphan drugs”.

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