Inteligência regulatória de tecnologias de saúde na Grécia

Abstract

Greece has a public universal health system, the National Health System (ESY) – with mandatory insurance coverage (IKA) for all working people (either employees or self-employed). On top of that, people can voluntarily have private insurance. EOPYY (National Organisation for Healthcare Provision) is the only responsible party for purchasing health services funded by public resources based on the National Social Security Fund (EFKA) contributions and state budget. There is only a limited number of drugs being exclusively provided by the public health care system, for free (EOPYY pharmacies) like the high-cost medications. Other than these, patients can buy any drug they want. National Organization for Medicines (EOF) is the regulatory authority and also responsible for pharmacovigilance of medicines, medical products, of beauty and veterinary drugs. In 2011, the pricing and reimbursement processes were separated, with pricing taking place after marketing authorization; subsequently, analysis for reimbursement by the social health insurance is allowed with inclusion in a positive list. New pharmaceutical products follow an external reference pricing system, in which the maximum ex-factory price for medicines under patent is defined by the mean of the three lowest prices for the same drug in European Union (EU) countries, this same rule being applied to biological and biosimilar medicines. Generic drugs are priced either by the mean of the three lowest prices charged in the EU or by a 50% price reduction in relation to the period in which the medication was under patent; thus, the maximum prices of the generic drugs are set at 65% of the price of the respective reference product. In 2018, the Health Technology Assessment (HTA) was introduced in the country to evaluate medications and to issue recommendations to the Ministry of Health on the inclusion or removal of products from the Positive List. As the HTA process is still being reformed in Greece, it is believed that, in the coming years, the country will have the opportunity to improve the implementation, having the linking of the HTA results with the clinical guidelines as one of the major challenges.