Pharmaceutical companies in Greece are unable to set the prices for their medicinal products themselves, as these are set directly by the State, which issues a medicinal product pricing bulletin. As a matter a fact, not only is the price of the medicinal product set, but also the profit margin for each level during its distribution, i.e. the profit of wholesalers and pharmacies.
The medicinal product pricing provisions have changed many times in the last years and have been challenged in administrative courts as in contravention to the Constitution. The Council of State accepted that for any established medicinal product costing and verification criteria – which set the maximum sale price – to be constitutionally tolerable, they must lead to the calculation of the medicinal product manufacturing and marketing costs over which the profit margin set by the pricing control is calculated.
According to the Ministerial Decision in force, the pricing takes into account whether the medicinal product being priced is under a data protection regime or whether this has expired, and whether it is original or generic, hybrid, biological, biosimilar, orphan, medicinal product for well-established medicinal use or a steady combination of medicinal products.
The Ministerial Decision in force on medicinal product pricing sets the maximum ex-factory price (which is the price medicinal products are sold at to the wholesalers by the Marketing Authorisation Holders), based on the maximum wholesale price, decreased by i. 4.67% for reimbursable medicinal products priced up to €200.00 and 1.48% for reimbursable medicinal products priced equal to or over €200.01, and ii. 5.12% for non-reimbursable medicinal products.
The maximum wholesale price is the price medicinal products are sold at to pharmacies. This price includes the gross profit percentage of the wholesale authorisation holder, which is calculated as a percentage of the maximum net ex-factory price.
The maximum retail price is the price the medicinal products are sold at to citizens by pharmacies and is set by the maximum wholesale price plus the pharmacy’s legal profit, as specified in the provisions of Article 5 of the aforementioned Ministerial Decision, and the value added tax (VAT).
The Ministerial Decision also sets the maximum hospital price, i.e. the price the medicinal products are sold at by the companies to the public sector, public hospitals, social care units, EOPYY pharmacies, public-law legal entities under Article 37(1) of Law 3918/2011 (31/A) and private hospitals, based on the maximum ex-factory price, decreased by 8.74%.
The prices of all medicinal products are reviewed once a year and the Reviewed Medicinal Product Pricing Bulletin is issued in April each year.
A prerequisite for a medicinal product in Greece to receive a price is for the medicinal product to have received a price in at least 3 eurozone member state (for orphan drugs, only 2 eurozone member states are sufficient) for the specific pharmaceutical form, concentration and packaging. The prices in the eurozone member states are retrieved by the National Organization for Medicines (EOF) Pricing Department using the EURIPID database, as well as from official data posted by the competent agencies within each eurozone member state.
A key rule for setting the reference medicinal product price is that the maximum ex-factory price is set based on the average of 2 different lower prices for the same medicinal product in the eurozone member states, as to its active ingredient, pharmaceutical form, concentration and packaging. For generic medicinal products, their price is set at 65% of the price of the corresponding reference medicinal product.
Stefanos Economou & Associates Law Firm has over 20 years of experience and expertise in handling cases involving pharmaceutical and medical equipment companies, and can assist you in submitting your observations and objections regarding the pricing of your products to EOF and the Greek Ministry of Health. We have handled several related cases and have appeared before the Pricing Commission to safeguard the interests of our clients, as well as before the Council of State to annul Pricing Bulletins that involved illegal pricing of pharmaceutical products.
With its vast experience in pharmaceutical law, commercial law and compliance, the Stefanos Economou & Associates Law Firm is able to meet all the needs of pharmaceutical companies, pharmaceutical warehouses and medical equipment companies for legal services, either as an advisor or before the courts and authorities.