Abstract:

Evolution of the regulations governing price control and formation for medicinal specialties in Italy during the last 60 years and further outlook in the medium term. Detailed reconstruction of the statistic-mathematical price calculation method used during the period 1977-1984. Recent modifications of the method: increased incidence of research costs, incentivation parameter, fixed raw material costs, initial production cost, modifications in the formula for calculating the incidence of medico-scientific information. Considerations regarding the structure of the method (illustrated by means of numerical examples): rigidity of the mathematical structure, inadequacy of the pharmaceutical form and labour time parameters in the assessment of transformation costs, lack of market reference, and attribution of average unit costs far removed from industrial reality. Proposals for the medium and long term: simplification of the price calculation method or passage from government-controlled prices to a price-monitoring system.