The Council of State has delivered two important rulings on the clawback mechanism applicable to medical devices, medical consumables and special nutritional supplements. While the Court found the 2017 clawback unlawful and annulled the relevant assessment acts, it upheld the mechanism's constitutionality for 2018. The key points of the decisions are outlined below.
At a glance
On 29 May 2026, summaries of Decisions No. 662/2026 and 663/2026 of the seven-member chamber of the Sixth Section of the Council of State were published on the Court's website. These decisions address the application of clawback mechanism to medical devices, medical consumables, and special nutritional supplements, pursuant to Article 100 of Law 4172/2013, as amended by Article 34 of Law 4447/2016 and as in force during the years at issue in the above decisions (2017 and 2018). The measure, as it stood at the material time, imposed the relevant burden on manufacturers in the case of domestic products and on importers, suppliers, and distributors in the case of products originating from other countries.
Decision No. 662/2026 — Year 2017
By Decision No. 662/2026, the Court held that the clawback mechanism could not lawfully be applied for the year 2017. According to the ground examined by the Court of its own motion, the EKAPY–EOPYY Registry—a necessary precondition for the inclusion of the products at issue in the EOPYY reimbursement system—had not been adequately regulated for that year. The Council of State further emphasised that, during 2017, importers who were not contracted with EOPYY and who bore the burden of the mechanism had no bargaining power and could not contribute, even indirectly, to the determination of maximum reimbursement prices. As a consequence, the reimbursement prices forming the basis for the calculation of the clawback coincided, for that year, with retail prices and diverged significantly from import or wholesale prices. On the strength of those findings, the Court upheld the application before it and annulled the contested acts imposing the clawback for the year 2017.
Decision No. 663/2026 — Year 2018
By Decision No. 663/2026, which concerns the year 2018, the application of the clawback mechanism to the above products was held, by majority, to be constitutional. The ruling was based, by express reference, on the reasoning of Decisions No. 904–905/2024 of the Plenary Session of the Court, which had likewise upheld, by majority, the constitutionality of the mechanism for the containment of pharmaceutical expenditure. A crucial point of convergence between these decisions is the finding that the measure is consistent with the Constitution insofar as it aims at reducing EOPYY expenditure and safeguarding the public health system. Moreover, in both cases the majority's reasoning is identical on the following essential point: the voluntary entry of private parties into the reimbursement system—whether through the reimbursement list for medicines (CoS Plenary 904–905/2024) or the EKAPY–EOPYY Registry (CoS seven-member 663/2026)—entails their acceptance of the clawback as a condition of the "transaction" with EOPYY, a consideration that contributes substantially to the assessment of the measure as constitutional.
The minority opinion
The minority opinion is also noteworthy, as it bears marked similarities to the dissent expressed in Decisions No. 904–905/2024 of the Plenary Session regarding the application of the mechanism to pharmaceutical expenditure. It merits particular attention that the now-retired Vice-President of the Council of State, Mr I. Gravaris, and Councillor Ms V. Raftopoulou dissented both in Decisions 904–905/2024—maintaining that the extension of an initially temporary measure over a decade had not been sufficiently justified by the legislature and was, to that extent, contrary to the Constitution—and in Decision 663/2026, holding that the relevant provisions fail to satisfy the fundamental requirements of foreseeability and clarity, which derive from provisions of supra-legislative force. This consistent minority position underscores the acute concern within the Court regarding the lawfulness of the clawback mechanism, particularly in light of the principles of the rule of law and legal certainty.
Preliminary observations and outlook
The foregoing constitutes an initial commentary on the published summaries of Decisions No. 662/2026 and 663/2026 of the seven-member chamber of the Council of State, the text of which is reproduced below. Further analysis may follow upon publication of the full text of these decisions.
In light of the above rulings—and in particular the finding that the imposition of clawback amounts for the year 2017 is unlawful (Decision No. 662/2026)—it remains to be seen whether the legislature will take any initiative for the refund or set-off of the amounts unlawfully collected for that year. It should be noted that those who paid the relevant amounts for 2017 without having exercised a legal remedy against the imposing deeds may bring an action before the administrative courts; however, it is very likely that the relevant claims have already become time-barred.
For the full text of the summary of Decision No. 662/2026 as posted on the Council of State's website, please click here.
For the full text of the summary of Decision No. 663/2026 as posted on the Council of State's website, please click here.