PHARMACEUTICAL PRODUCTS- PRICE DETERMINATION
How is the price of a pharmaceutical product determined?
According to Law 4052/2012 and the latest Ministerial Decision Nr. 57408/14.6.2013, several methods of price calculation are employed, depending on whether a pharmaceutical product is (a) on patent, (b) off patent, (c) generic and (d) manufactured in Greece. Hence:
(a) Pricing of reference (original) medicinal products (on patent):
Before pricing a reference medicinal product, the competent Service of EOF shall undertake a survey in EU Member States in which data exists and are announced by the competent authorities, at the agencies of these countries or at official and reliable European institutions. Price research shall encompass any available price (ex-factory, wholesale, retail, hospital, insurance, etc.). Retail or wholesale prices shall be converted to ex-factory prices using a methodology and rates as announced from time to time by the competent service of EOF, as well as any other relevant information and data used in the pricing. For the price determination, the product must have been priced and be marketed in at least three EU Member States.
Thus, the prices of medicinal products under protection of the first patent of the active substance result from the average of the three lowest prices of the respective products in EU Member States.
(b) Pricing of reference (original) medicinal products after the expiry of the first Patent protecting the Active Substance (off patent):
Pharmaceutical companies must indicate to EOF through the relevant Price Verification Sheet, various data on the medicinal product concerned, and more specifically the full EOF-assigned code, the start and expiry date of the first National or European patent protecting the active substance of the medicine, as well as the requested price.
Prices of reference medicinal products whose patent protection expired but no generic products are marketed will result from the average of the three lowest respective prices of the said medicinal product in the EU Member-States, in which official data exists and are announced.
Prices of reference medicinal products whose patent protection expired but generic products are marketed, shall be reduced by at least fifty per cent (50%).
(c) Generic medicinal products:
The price of medicinal products with the same active substance and pharmacotechnical form that enter the market after the expiry of the first National or European Patent of the active substance of the reference medicinal product, is determined at a reduced level, at least by sixty per cent (60%) of the retail price of the respective reference medicinal product which existed exactly prior to the expiry of the validity of the first National or European Patent of the active substance. Generic products may not obtain a price exceeding 80% of the price obtained by the reference medicinal products after the end of their patent protection.
(d) Medicinal products manufactured in Greece
For medicinal products authorized and priced in the domestic pharmaceutical market and not marketed in any other EU country, their prices shall be determined on the basis of a cost assessment that shall include the cost of production and packaging for each form and pack size, the cost of Administration-Marketing-Distribution as determined by relevant tables updated every two years and reflecting the respective average costs in the industry.
In case of Greek-patented medicinal products involving research on active substance or pharmaceutical form, for which there are clinical pharmacokinetics trials and a marketing authorization by EOF, the cost assessment shall additionally take into account the value of new investment, the cost of research and development of the active substance or pharmaceutical form and a valuation of know-how. Similar pharmaceutical forms shall be exempted from this provision.
The maximum net profit margin shall be 8.5% of the total cost excluding depreciation, interest and third-party profits (contract manufacturing).