Objectives: The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use.
Methods: Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure.
Results: The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures—such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting—have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market.
Conclusions: Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.