gms | German Medical Science

Analogue drugs are a hot issue in the public health debate in Germany. They are usually characterized as pseudo innovations, presenting no advantages over existing medicines ('me-too drugs'). Released onto the market in large quantities, these patented and thus expensive drugs are seen to constitute a considerable burden for public health insurance. To date a solid scientific basis for a rational discussion of these habitual criticisms has been lacking. Our study aimed at examining, firstly, the significance of analogue drugs in medical terms, and secondly, the effects they have on health insurance expenditures.

The empirical examination of the German pharmaceutics market was based on a complete set of figures down to single pack level on prices and quantities sold. Every drug brought to market since January 1 1980 was re-classified and - for the first time in Germany - sorted into drug groups on the basis of internationally recognized ATC classification. In addition to the quantitative analysis of sales volume and price developments there was a further detailed clinical pharmacological description of three representative drug classes.

453 new drugs came onto the market in Germany in the period from January 1 1980 to December 31 2000. 70 of them established a new drug class. In 16 of these 70 classes did a new generic drug emerge within the study period. In only 11 of the 16 groups did at least one me-too drug enter the market. Since 1989, when stricter state regulation of the pharmaceutics market for public health insurance came into force, there were only two drug groups - the proton pump inhibitors (PPI) and the benzodiazepine receptor agonists (BRA) - which fulfilled the criterion of having produced a me-too as well as a generic drug. Only in such groups financial disadvantages for the health insurance system can arise. As a result of the stimulation of competition by me-too drugs there have been health insurance savings of appr. 400 million DM for the PPI group. In the case of the BRA group the me-too drugs caused appr. 60 million DM in extra expenditure over the same period. The clinical pharmacological observation of ACE-inhibitors, SSRI, and nonsedating H1 antagonists showed that the development of me-too drugs can lead to advances with regard to therapeutic efficacy and to the range of undesirable side effects, interactions with other drugs or pharmacokinetic aspects.

Within the study period, the contemporary availability of me-too's and generic drugs was limited to only a few drug groups. The development of analogue drugs can produce important therapeutic alternatives, but there are also many me-too's that represent no improvement on the original. Under current regulations the availability of me-too drugs on the market does not necessarily increase health insurance expenses. In the period under observation savings far exceed any extra expenditure.