The Greek Market
Overview
The Greek healthcare environment
Regulatory Bodies
EOF
National Organization for Medicines is the competent Authorities for the:
The National Organization for Medicines (EOF) was established in 1983, with Act 1316, and is a public entity of the Ministry of Health & Social Solidarity. The Agency’s Mission Statement was established by Presidential Decree 142 in 1989. The Presidential Decree defines the Agency’s legal framework, its function as the National Competent Authority, and its formal organizational structure.
EOF’s objective is to ensure public health and safety with regard to the following products, marketed in Greece:
• Medicinal products for human and veterinary use.
• Biological products for human and veterinary use.
• Medicated feeding stuff and food additives.
• Foodstuffs and food supplements.
• Biocides.
• Medical devices.
• Cosmetics
The responsibility for pricing of pharmaceuticals lies with the National Drug Organization (EOF) who issues the official prices having the consent of the Minister of Health. The prices of pharmaceuticals are published in a Price Bulletin. A medicine cannot be marketed unless it has been granted a price.
MINISTRY OF HEALTH
• Pharmaceutical policies and regulations
• Reimbursement (HTA)
• Issuing of price bulletins
THE SOCIAL INSURANCE SYSTEM (EOPYY)
In the context of the challenging economic environment, one of the government’s measures to increase efficiency and contain health expenditure was the establishment of a Unified Healthcare Fund (EOPYY).
The National Organization for Healthcare Provision (EOPYY) constitutes the healthcare insurer and a main provider of PHC in Greece.
The organization started its operations on 1st January 2012. EOPYY’s primary mission is the provision of health services to active members, pensioners and their family dependents registered to the merging healthcare funds. EOPYY unified the majority of healthcare funds, amongst them being the Private Employees’ Fund (IKA), the Public Employees’ Fund (OPAD), the Farmers’ Fund (OGA) and the self-employed/Entrepreneurs’ Fund (OAEE).
As a result, EOPYY covers over the 98% of the insured population (close to 11 million).
Unified Social Security Fund (E.F.K.A.)
A new fund is established, the “Unified Social Security Fund” (E.F.K.A.). As of 1 January 2017, it has absorbed the existing main social security funds (i.e., I.K.A. – E.T.A.M., E.T.A.P. – M.M.E., E.T.A.A., O.A.E.E., etc.).
Following the provisions of article 1 of law 4670, the “Single Unified Social Security Fund (EFKA)” is renamed to “Electronic National Social Security Fund”, hereinafter referred to as “e –EFKA”. The renaming of EFKA marks the transition of the social security system to the digital age, transforming EFKA and upgrading its online services to citizens.
The integration of the social security database is promoted and the digitalization of all social security functions aims to ensuring more efficient and faster services to the citizens. The integration of the social security database will allow the digitalization of all the functions of social security and consequently its better management.
The organization and operation of e-EFKA is governed by the provisions of law 4387/2016 and Presidential Decree 8/2019 “Organization of the National Electronic Social Security Fund: e-EFKA” as in force.
Greek Health Environment
IOBE FACTS AND FIGURES
(data from 2019)
Net public pharmaceutical expenditure is the final amount Social Security Funds have to spend to cover population needs, after deduction of discounts, rebates and clawback. From 2009 and onwards, pharmaceutical expenditure followed a downward trend, resulting in an overall decrease of 59.4% until 2018, reaching the target of €1,945 billion. This decline was the result of the fiscal adjustment program which included changes in the pricing system, increases in returns – rebates – to social security funds, reduction of regulated margins in the wholesale and retail distribution of drugs, reduction in VAT on medicines and more.
The decline in public health expenditure has resulted in a shift in health spending to the private sector, with private health expenditure increasing from € 1,3 billion in 2009 to € 1,8 billion in 2018, with industry’s contribution at the same time, through flat mandatory returns and discounts (rebate and clawback).
Despite the significant impact of fiscal adjustment on public funding, the pharmaceutical industry remains a pillar for investment in Greece with Research and Development (R&D) expenditure close to 5% of total R&D expenditure in Greece (2017) and 2,811 clinical studies independent of phase and stage conducted until 2019 (1,604 completed). Production of pharmaceutical products in Greece was estimated at €996 mil., with Gross Value Added (ex-factory) at €559 mil. (3.0% of the manufacturing). Employment in the manufacturing of pharmaceutical products in Greece was estimated at 21.2 thousand people in 2019, with 60.6% of them with university education, compared to 36.6% of the total economy and 22.8% of the total manufacturing.
The Greek medical devices market was 1.27B in 2015, which increased by 2,9% to reach 1,43B in 2019. The market is expected to grow to 1,7B in 2025.
The Supply Chain Of Pharmaceuticals
Pharmaceutical companies: 56 Multinational & 50 Greek Pharma companies
Pharmacies: 10.220 pharmacies, 37 EOPYY pharmacies
Wholesalers & pharmacist co-operations: 137