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The paper discusses the problems of orphan drugs from the standpoint of the attitude of state authorities in the USA, Japan, and particularly Europe (the European Union) to their definition and the formation of appropriate legislation--financial provision for the development, production, provision of exclusive sale rights--which warranties the availability of the drug to every patient suffering from a rare disease.

The mortality dependence on age after the birth was observed for dominant causes of death in the USA, Japan and former Czechoslovakia for the period 1979-1991. The logarithm of mortality of following causes decrease linearly with logarithm of age at the interval 0-10 years: all, all without accidents, congenital anomalies of heart and circulatory system, spina bifida and hydrocephalus, diseases of the nervous system, other diseases of the respiratory system. The linear area is up to the age of 45 years for Spina bifida and hydrocephalus in the USA. This linear dependence in log-log scale corresponds to the Weibull distribution in case the slope is more than -1. However, the logarithm of mortality of Congenital anomalies decreases in the logarithm of age with the slope of -1. The number of death of congenital anomalies decreases in the logarithm of age with the slope -1, too. The number of death in one year corresponds to the failure density function. The mortality of congenital anomalies is described using another distribution function which is not Weibull function. This new distribution is defined at this paper. The number of death of congenital anomalies in one year is inversely proportional to the age of dead. This phenomenon can be interpreted that the lifetime is determine by the level of malformation at the moment of the birth. The number of people in particular level of congenital anomalies is inversely proportional to the lifetime.