PHARMACEUTICAL PRODUCTS- PRICE DETERMINATION

How is the price of a pharmaceutical product determined?

The selling prices of pharmaceutical products in the internal market are determined by the competent Office of the General Secretariat of Commerce, after conducting research in the countries - members of the European Union (EU) in which the pharmaceutical product is already marketed by taking into account the selling price to the wholesaler. The prices of pharmaceutical products are determined for the packages that are approved by the National Drugs Organization (EOF) and the European Medicines Agency (EMEA) and results from the average of the three (3) lowest corresponding prices of the pharmaceutical product in the EU members-states, in which there exist official data which are announced by the competent authorities of those countries (Ministerial Decision 66084/2011 and Market Decree 7/2009). The price of the pharmaceutical products for which their patent has expired cannot exceed 70% of the price that the same pharmaceutical product had while the patent was still valid. The EU countries, for which official data exist, are announced through the 1st Price Bulletin of each year. According to Article 36 of Law 4025/2011, for the inclusion of a pharmaceutical product in the positive list of prescription only medicines, the pharmaceutical companies or marketing authorization holders must pay (a) an one off entry fee in said list per pharmaceutical product and (b) the corresponding rebate amount per pharmaceutical product for each year. Failure to pay said amounts will result to the exclusion of the product from the positive list of prescription only medicines.