The Greek Market
Overview
The Greek healthcare environment
Regulatory Bodies
EOF
National Organization for Medicines:
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 and is the competent Authority for the following products, marketed in Greece:
- Medicinal products for human and veterinary use.
- Biological products for human and veterinary use.
- Food Supplements and Food for Special Medical Purposes.
- Foods intended for particular nutritional uses (eg. for infants, young children) and Total Diet Replacements for weight control.
- 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 2022)
ECONOMIC ENVIRONMENT
Greece recorded GDP growth of 5.6% in 2022, following a strong recovery in 2021 of 8.4%, fully making up for the pandemic losses. The recovery of 2021- 2022 was based on the increase in investments, private consumption, the increase in tourism receipts and spending, but also exports, mainly in 2021.
The population health expenditure needs are affected by demographic trends and developments, such as the negative natural balance (births – deaths) where a decrease of 64.7 thousand people (2022) is observed and leads to a gradual decrease of the total population. While high life expectancy (80.2 years, close to the EU27 average of 80.1 years for 2021), combined with the increase of the oldest population (over 65 years) from 22.9% of the total population in 2022 to 33.5% in 2060, means that health and social insurance systems will be under greater pressure. For 2020, deaths from diseases of the circulatory system are responsible for 34.9%, while neoplasms are responsible for 23.5% of total deaths. In addition, the percentage of the population aged 16 and over with a chronic health problem is increasing from 2018 to 2022, reaching 24.9%. The percentage of the population over 65 with multiple chronic diseases in Greece reaches 40%, a percentage higher than the average of EU countries (36%).
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.
Total health expenditure in Greece decreased by -22.1% in the period 2010- 2022 (+10.9% in the Southern countries, +28.6% in the EU), and amounted to €16.7 bil. in 2021 (9.2% of GDP). Public health expenditure decreased by -29.2% (+6.4% in the Southern counties, +32.7% in the EU) over the same period, to €10.4 bil. in 2021 (5.7 % of GDP). The reduction in public health expenditure resulted in a shift to the private sector, with private health expenditure reaching 37.9% in 2021 (27.0% in the South, 18.9% in the EU). Additionally, pharmaceutical expenditure (outpatient and hospital) amounted to €5.6 bil. in 2021, compared to €5.2 billion in 2020, while it is estimated at €6.2 bil. in 2022 public expenditure reached €2.6 bil. in 2021, at the same level as in 2020 and is estimated to have increased marginally in 2022 to €2.7 bil., while the share of industry in pharmaceutical expenditure increased in 2021 to €2.4 bil., compared to €2.0 billion in 2020. The estimation for 2022 is that the industry’s contribution is higher around €500 mil., surpassing for the first time public pharmaceutical expenditure. Finally, patient contribution increased in 2021 to €662 mil., with an increase from 2020.
The continuous reduction in public pharmaceutical expenditure resulted in a remarkable increase in the returns and discounts of the pharmaceutical industry reaching 46% of total public pharmaceutical expenditure in 2021, from 6% in 2012. Total public outpatient pharmaceutical expenditure (including estimated patients and pharmaceutical industry contribution) reached €4.2 bil. in 2021. Public expenditure stood at €2.0 bil. in 2021, stable from 2020. Industry contribution (clawback, rebates, and closed sub-budget discounts) amounted to €1.5 bil. in 2021, compared to €1.4 bil, in 2020 and €272 mil. in 2012. The reduction in public outpatient expenditure over the period 2012-2021 by approximately 31% resulted in a significant increase in industry contributions over the same period by 458% and patient contribution by 59%.
For the period 2018-2021, of the 168 innovative medicines that received central authorization from the EMA, 90 medicines are available to the Greek patient, i.e. 54% of approved innovative medicines compared to 47% EU average In particular, 58% of the new medicines available in Greece, against the European average of 37%, are under a limited availability or reimbursement, mainly reflecting the medicines that are available through IFET and the Electronic Pre-Authorization System. Finally, regarding the time required from the date of approval of the drugs by the EMA to the date of their reimbursement by the health systems, Greece significantly lags behind the reimbursement time of a new treatment compared to the European average, as this is calculated equal to 674 days (against 517 days in the EU countries). The pharmaceutical industry remains a pillar for investment in Greece with Research and Development (R&D) expenditure close to 8% of total R&D expenditure in Greece (2020) and 3,830 clinical studies independent of phase and stage conducted during the period 2002-2022 (2,250 completed). Production of pharmaceutical products in Greece was estimated at €1.7 bil., with Gross Value Added (ex-factory) at €1.4 bil. (6.9% of total manufacturing). Employment in the manufacturing of pharmaceutical products in Greece was estimated at 25.1 thousand people in 2021, with 49.5% of them with university education, compared to 37.5% of the total economy and 23.3% of the total manufacturing. In 2020, sales of pharmaceutical products in pharmacies & wholesalers (in value) amounted to €4.6 bil., increased by 3.7% compared to 2019, while sales to hospitals and EOPYY pharmacies amounted to €2.4 bil. Increased by 5.0% Lastly, imports and exports of pharmaceutical products amounted to €4.4 bil. and €2.6 bil., respectively in 2022 indicating a decline compared to 2020. Εxports of pharmaceutical products accounted for 7.3% of total Greek exports in 2021.
The pharmaceutical industry sector is a driver of investment with R&D expenditure accounting for 8% of total R&D spending in Greece (2020), while in the period 2002-2022 3,830 clinical studies (all phases or stages) were conducted with 2,250 being completed. Additionally, for 2022 the domestic production of pharmaceutical products in value (ex-factory) amounted to €1.9 bil., with the added value reaching €1.5 bil. (6.4 % share in the manufacturing sector). The total employment in the pharmaceutical industry was 28.9 thousand people in 2022 with a clear upward trend in recent years. Finally, imports and exports of pharmaceutical products amounted in 2022 to €4.4 bil. and €2.6 bil., respectively, with a decrease compared to 2021. Exports of pharmaceutical products correspond to 4.7% of the total of Greek exports of all goods for 2022 with the main export destinations being Germany, France and the UK. Accordingly, imports make up about 4.7% of the country’s total imports in 2022 compared to 6.9% in 2021.
FUNDING ON HEALTH EXPENDITURE
PHARMACEUTICAL EXPENDITURE
PHARMACEUTICAL EXPENDITURE (EOPYY)
The Supply Chain of Pharmaceuticals
Pharmaceutical companies: 56 Multinational & 50 Greek Pharma companies
Pharmacies: 10.400 pharmacies, 35 EOPYY pharmacies
Wholesalers & pharmacist co-operations: 145