GREECE Trends and Developments Contributed by: Ioannis Manousakis and Dimitra Panopoulou, ALG Manousakis Law Firm
ALG Manousakis Law Firm 16 Laodikias Str Athens 11528 Greece Tel: +30 2107 232761
Email: info@alg.gr Web: www.alg.gr
Pharma-Related Trends in Greece Greek Government’s incentivisation of pharmaceutical companies’ investments in clinical research A recent legal initiative provides that pharmaceu- tical companies may offset the amounts owed as claw-back to the state (amounts paid for exceeding the budget of the Ministry of Health) against their expenditure on research activities. This measure is now financed by the Recovery and Resilience Fund (RRF), which is part of the NextGeneration EU program, a European finan- cial instrument aimed at economic recovery and strengthening the resilience of EU member states following COVID-19. The inclusion of this measure in the RRF aims to promote invest- ments and create a favourable environment for innovation in Greece’s pharmaceutical sector. The “claw-back” system is a mechanism that was established in Greek legislation, according to Annex 5 of the Memorandum for certain eco- nomic policy conditions of 2012. Article 11 of Law 4052/2012 states that “the monthly expenditure for pharmaceutical products by social security funds (SSFs) cannot exceed 1/12 of the amount recorded in the annual social budget allocated to pharmaceutical care” . Based on the limits of the monthly/yearly expenditure, an automatic recovery system is linked to the establishment of “closed budget” for pharmaceutical products.
The amounts that each Marketing Authorization Holder (MAH) is required to pay in the case of claw-back are determined based on: • the percentage contribution of each drug to pharmaceutical expenditure; • the market share of each drug within its therapeutic category on the reimbursement list; and • the comparative consumption of each drug relative to the market share it held during the corresponding period of the previous year. Initially, the aforementioned obligation was imposed due to the financial crisis, with the decision 668/2012 of the Plenary Session of the Conseil d’ Etat (ΣτΕ/Supreme Administra- tive Court), exclusively on a budget of the drugs sold through pharmacies and reimbursed by the Greek national payor of pharmaceutical products (EOPYY) for a limited period of time (eg, 2012-2015). It was essentially a corrective mechanism used to balance public spending. Subsequently, due to the continuing economic strain, the Greek government decided to extend the claw-back provisions for another three years (ie, 2015-2018) and to the in-hospital expendi- ture for pharmaceutical products. It becomes clear that the budget limitation will not be a temporary one but a permanent one, as Law 4837/2021 extended the claw-back until 2025.
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