Pharmaceutical regulation in Greece at the crossroad of change: economic, political and constitutional considerations for a new regulatory paradigm.

This paper examines the economic, political and legal characteristics of the Greek pharmaceutical market, which is largely affected by the paradox of state intervention: while pharmaceutical regulation is mainly directed towards a rationalisation of total pharmaceutical expenditure, all measures taken to date aim at exhaustive pricing controls, i.e. interventions on the supply side alone, disregarding the "balloon" effect of shrinking prices on the expanding volume of consumption. As a result, pharmaceutical expenditure has been steadily rising, adding a disproportional burden on both social insurance and private income. The "unconstitutionality" of current pricing regulations exerted further pressure for a comprehensive reform. The paper proposes an alternative regulatory paradigm, which is loosely founded on European experience with regulating pharmaceutical markets. The conclusions of the economic, political and constitutional analysis help formulate a proposal for a comprehensive pharmaceutical policy that could assure the financial viability of the system as well as adhere to the principle of "legality", as the latter is constitutionally defined.