GREECE Law and Practice Contributed by: Angela Livgieri, Danai Panopoulou and Iliana Andronou, ALG Manousakis Law Firm
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds Pharmaceuticals According to Article 1 (paragraph 2) of Law 3457/2006 (Government Gazette Α 93/8.5.2006), the medicinal products that are classified as OTC are not reimbursed by social security funds. The reimbursement rules regarding pre- scription-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 reim- bursed products (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 Products for Human Use (Evaluation Committee – Article 247 of Law 4512/2018), which opinion is issued fol- lowing an application from the MAH. The Evaluation Committee, in order to evaluate the cost-effectiveness ratio and the impact on the state budget, refers for an opinion to the Drug Price Negotiation Committee (Negotiation Committee) and is responsible for negotiating the prices or discounts of medicinal products which are going to be reimbursed (and often concludes separate agreements including fur- ther discounts). The Negotiation Committee initiates and con- cludes the negotiation process for the medicinal product by issuing a justified opinion. The Evalu- ation Committee takes into account the justified opinion of the Negotiation Committee for its final opinion.
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 prices. EOPYY (National Organization for Health Care Services) sets maximum reimbursement limits for certain categories of devices. Prices are primarily controlled through hospital tenders and reimbursement policies rather than direct price caps. 8.2 Price Levels of Pharmaceuticals or Original medicinal products are priced in accord- ance with a median of the two lowest prices of the two Member States of the Eurozone. The same applies to off-patent medicinal prod- ucts (original products following the expiration of their market exclusivity). Medical Devices Pharmaceuticals Generic products are priced at 65% of the origi- nal 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 a median of the three lowest prices of the three EU Member States. This price is not obligatory for the retail channel (pharmacies) but is mandatory when sales are made to public hospitals. Medical Devices For medical devices, Greek legislation does not explicitly tie, their price to other countries under general pricing rules but relies on EOPYY reim- bursement rules considering costs across the EU.
139 CHAMBERS.COM
Powered by FlippingBook