Pricing Regulation of Reimbursable Pharmaceuticals in Spain and Germany | Max-Planck-Institut für Sozialrecht und Sozialpolitik - MPISOC


Doctoral Group: "The Triangular Benefit Delivery Relationship in Social Law"

Pricing Regulation of Reimbursable Pharmaceuticals in Spain and Germany

The supply of pharmaceuticals has for years been considered to be a strong cost driver in German statutory health insurance, with the structure of the drug portfolio and, related thereto, the prices demanded by the drug companies for new pharmaceutical products being one of the main reasons for the additional costs. Due to this development, which is not limited to Germany, national legislators have been attempting to cut costs through various price regulation measures with respect to pharmaceuticals.

The aim of this doctoral thesis is, first and foremost, to systematically describe the instruments for regulating or controlling the ex-factory prices in the German statutory health insurance and the Spanish health care system and to evaluate them from a legal point of view. Spanish law lends itself as a comparative legal system primarily because of its diverging approach in price regulation.

The legal comparison shows that the regulatory instruments in the pharmaceutical sector feature a number of distinctive characteristics in both countries. They represent a special form of product law whose focus of regulation under social law is on the financing of pharmaceutical services and cost control and not, for instance, on the quality of the services  provision. The dissertation concludes with a comparative analysis of the constitutional limits of price control, drawn by the instruments made available to the legislator and the administration, and the fundamental economic rights of the pharmaceutical manufacturers.


Michael Schlegelmilch