GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
The Evaluation Committee, in order to evaluate the cost-effectiveness ratio and the impact on the state budget, refers for an opinion to the Drug Price Nego- tiation Committee (Negotiation Committee) and is responsible for negotiating the prices or discounts of medicinal products which are going to be reimbursed (and often concludes separate agreements including further discounts). The Negotiation Committee initiates and concludes the negotiation process for the medicinal product by issuing a justified opinion. The Evaluation Committee takes into account the justified opinion of the Negotia- tion Committee for its final opinion. Medical Devices The reimbursement of medical devices is regulated under Article 108 of Law 4461/2017 (Government Gazette Α’ 38/28.03.2017). In particular, for the reim- bursement of medical devices for special medical purposes (FSMPs), the importer/manufacturer/repre- sentative 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 registered in the latter; and • that the product is marketed in at least three coun- tries of the European Union. The product’s reimbursement price is determined by the maximum of the average of the three lowest EU market prices. 8.4 Cost-Benefit Analyses In Greece, Health Technology Assessment (HTA) plays a significant role in the reimbursement of pharmaceu- ticals and medical devices. Currently, the country has established the Committee for Assessment and Reimbursement of Medicines for Human Use, effectively functioning as an HTA body, which evaluates new products as follows (Article 245 of Law 4512/2018): • clinical benefit – assessing the therapeutic value and efficacy of the medicine;
• comparison with existing therapies – evaluating how the new medicine compares to treatments already available and reimbursed; • data reliability – ensuring the robustness and cred- ibility of the submitted clinical and economic data; • cost-effectiveness – analysing the economic value of the medicine in relation to its therapeutic ben- efits; and • budget impact – estimating the financial implica- tions of including the medicine in the reimburse- ment list. The assessment process begins with the MAH sub- mitting a dossier. For products that receive a positive initial assessment, the Pricing Negotiation Commit- tee (as per Article 254 of Law 4512/2018) evaluates their budgetary 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 Prescrip- tion System, a centralised platform managed by IDIKA SA (e-Government Centre for Social Security Servic- es). IDIKA S.A. maintains a database of all insured individuals in all social insurance funds based on the unified Social Security Registry Number (AMKA Reg- istry). This system monitors prescribing practices and ensures compliance with national guidelines. According to the provisions of Laws 4052/2012 and 4093/2012, doctors must prescribe exclusively based on the active substance’s International Non-proprie- tary Name (INN). Doctors are required to select the appropriate medication in compliance with the thera- peutic 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 low- est retail price for each active substance from the drugs listed in the positive list unless the consumer insists on a brand-name drug and pays the price dif- ference in addition to a co-payment, which is typically 0%-25% of the drug cost.
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