GREECE Law and Practice Contributed by: Angela Livgieri and Danai Panopoulou, ALG Manousakis Law Firm
8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and According to Legislative Decree 96/1973 and Min- isterial Decisions D3 (a)/6295/2024 and D3 (a) 59308/2024, the maximum prices for prescription- only medicinal products – specifically the retail price, wholesale price, hospital sale price, and ex-factory price – are determined through Price Bulletins issued by the Minister of Health. This process follows a pro- posal by the EOF, as stated in Article 17 of Legislative Decree 96/1973, and requires an application from the MAH. OTC medicinal products are excluded from this pricing structure. Medical Devices Pharmaceuticals Original medicinal products are priced in accordance with the median of the two lowest prices of the two Member States of the Eurozone. The same applies to off-patent medicinal products (original products following the expiration of their market exclusivity). Generic products are priced at 65% of the original product’s price, while biosimilars are priced using the same method as their originals (the two lowest prices in the Eurozone). Non-prescribed pharmaceutical products (OTC) are priced according to the median of the three lowest prices across three EU Member States and this price is indicative for pharmacies but mandatory for sales to hospitals. The final price for all the above product categories is the ex-factory price, to which the wholesale and retail margins are added when the product is sold through a pharmacy. When the products are sold to a hospital, the ex-factory price is reduced by 8.74%. Medical Devices There is no legislation in Greece controlling their pric- es. EOPYY (National Organisation for Health Care Services) sets maximum reimbursement limits for cer- tain device categories. Prices are primarily controlled through hospital tenders and reimbursement policies rather than direct price caps.
8.2 Price Levels of Pharmaceuticals or Medical Devices Pharmaceuticals Original medicinal products are priced in accordance with the median of the two lowest prices of the two Member States of the Eurozone. The same applies to off-patent medicinal products (original products following the expiration of their market exclusivity). Generic products are priced at 65% of the corre- sponding original product’s price, while biosimilars are priced with the same method as their originals (the two lowest prices in the Eurozone). OTCs are priced in accordance with the median of the three lowest prices of the three EU Member States. This price is not obligatory for the retail channel (phar- macies) but is mandatory when sales are made to For medical devices, Greek legislation does not explicitly tie their price to other countries under gen- eral pricing rules but relies on EOPYY reimbursement rules, considering costs across the EU. 8.3 Reimbursement From Public Funds Pharmaceuticals According to Article 1 (2) of Law 3457/2006 (Govern- ment Gazette Α 93/8.5.2006), the medicinal prod- ucts that are classified as OTC are not reimbursed by social security funds. The reimbursement rules regarding prescription-only products are contained in Article 12 of Law 3816/2010 (Government Gazette Α’ 6/26.01.2010), as well as in Article 247 et seq of Law 4512/2018 (Government Gazette Α’ 5/17.01.2018). For the latter products to be reimbursed, they need to be approved on the positive list of reimbursed prod- ucts (Article 12 of Law 3816/2010). The inclusion of a medicinal product requires a Decision of the Minister of Health, following the opinion of the Committee for the Evaluation and Reimbursement of Medicinal Prod- ucts for Human Use (Evaluation Committee – Article 247 of Law 4512/2018), which opinion is issued fol- lowing an application from the MAH. public hospitals. Medical Devices
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