GREECE Trends and Developments Contributed by: Ioannis Manousakis and Dimitra Panopoulou, ALG Manousakis Law Firm
in May 2010, broader reforms were foreseen to improve the management of the state budget and the efficiency of the entire healthcare sector. These measures sought to manage the previ- ously uncontrolled pharmaceutical expenditure. One of the initial steps was the introduction of a requirement for Healthcare Professionals (HCPs) to prescribe based on the active substance instead of the brand name of the drug, thereby annulling previous legislation providing for the latter (Decision 3802/14 of the Plenary Session of the ΣτΕ). More specifically, since 2012, doctors have been required to prescribe the correspond- ing international non-proprietary name (INN) of the active substance instead of the brand name. However, brand-name prescribing is allowed for up to 15% of the total annual prescription value in exceptional cases involving certain diseases. Despite the total consumption of generic drugs reaching 32.6% in 2022, with an annual increase rate of 8.5%, the fact that they were “imposed” as a memorandum-related economic measure lead citizens-patients to face them with suspi- cion – mainly, during the early years of the finan- cial crisis (2010-2014). However, the aforemen- tioned scepticism has been eliminated in recent years thanks to the continuous bioequivalence reports of generic drugs conducted by the Hel- lenic Medicines Organization (EOF). This ensures their equivalence to the original reference drugs and dispels any doubts regarding the quality and safety of generics. As a matter of fact, an additional significant fac- tor that contributed to the increase in the use of generics was the more rational legislative approach regarding their pricing and reimburse- ment. In Greece, the maximum price of generics is set at 65% of the price of the corresponding reference products when the market exclusivity period expires (10 years from the market authori-
sation issuance). Moreover, from 2014, as pro- vided in Ministerial Decision 38733/29.4.14, an increased patient co-payment is foreseen when the cost of the medicine exceeds the reimburse- ment price, which fosters the use of generics, since the reimbursed amount for generics equals the reimbursement price, while the price of the original product exceeds, most of the times, the reimbursement price. As a result, in Greece, the widespread use of generic medicines in recent years has brought a plethora of advantages: pharmaceutical expenditure is reduced, competition in drug pricing intensifies, and research for new drugs is encouraged, as generics limit the monopoly profits from brand-name drugs whose patent protection has expired, due to the decline in their sales. Significant investment by mostly Greek- owned generic drug producers in building manufacturing facilities in Greece Large manufacturing units have been built and begun operating in Tripoli and Attica during the past three years, a development not very com- mon during the past twenty years. In recent years, Greece has witnessed signifi- cant investments in pharmaceutical manufactur- ing, particularly in regions like Tripoli and Attica. This trend marks a departure from the past two decades, during which such developments were relatively uncommon. The industrial area of Tripoli, located in the cen- tral Peloponnese, is rapidly transforming into a centre for pharmaceutical research and produc- tion. Several factors contributed to this devel- opment, including investment incentives pro- vided through the “Just Transition Development Plan” following the phase-out of coal in nearby
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