GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
Medical Devices The reimbursement of medical devices is regu- lated under Article 108 of Law 4461/2017 (Gov- ernment Gazette Α’ 38/28.03.2017). In particu- lar, for the reimbursement of medical devices for special medical purposes (FSMPs), the importer/ manufacturer/representative of these products must submit to EOPYY a declaration stating that: • the items are registered in the registers of EOF and in the registers of reimbursable products of EOPYY if the product is regis- tered in the latter; and • that the product is marketed in at least three countries of the European Union. The reimbursement price of the product is deter- mined by a maximum of the average of the three lowest prices in the countries of the European Union. 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices In Greece, Health Technology Assessment (HTA) plays a significant role in reimbursing pharma- ceuticals and medical devices. Currently, the country has established the Com- mittee for Assessment and Reimbursement of Medicines for Human Use, effectively function- ing as an HTA body, which evaluates new prod- ucts as follows (Article 245 of Law 4512/2018): • clinical benefit – assessing the therapeutic value and efficacy of the medicine; • comparison with existing therapies – evaluat- ing how the new medicine compares to treat- ments already available and reimbursed; • data reliability – ensuring the robustness and credibility of the submitted clinical and eco- nomic data;
• cost-effectiveness – analysing the economic value of the medicine in relation to its thera- peutic benefits; and • budget impact – estimating the financial implications of including the medicine in the reimbursement list. The assessment process begins with the MAH submitting a dossier. For products receiving a positive initial assessment, the Pricing Nego- tiation Committee (as per Article 254 of Law 4512/2018) evaluates their budget impact and negotiates pricing and discounts with the MAH. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies Prescription and Dispensing by Physicians According to Law 3892/2010, physicians are required to issue prescriptions through the Electronic Prescription System, a centralised platform managed by IDIKA SA (e-Government Center for Social Security Services). IDIKA S.A. maintains a database of all insured individuals in all social insurance funds based on the unified Social Security Registry Number (AMKA Regis- try). This system monitors prescribing practices and ensures compliance with national guide- lines. According to the provisions of Laws 4052/2012 and 4093/2012, doctors must prescribe exclu- sively based on the active substance’s Interna- tional Nonproprietary Name (INN). Doctors are required to select the appropriate medication in compliance with the therapeutic protocols of EOF. Also, physicians are legally obligated not to exceed prescription limits for patients. Pharmacy Sales Pharmacies, according to law 4316/2014, are required to dispense the pharmaceutical product with the lowest retail price for each active sub-
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