Prevention of congenital malformations by means of folic acid - Insurmountable problems due to the German penal code and German drug legislation whenpreparing a preconceptional model in Saxony-Anhalt

For the last 20 years the prophylactic effect of the vitamin folic acid aga inst the occurrence of neural tube defects has been known but in Germany th is fact has not been realized by the public. The recommendations by medical institutions fail, among other reasons, because a folic acid prescription by gynaecologists comes too late in the course of events, i.e., women go to the gynaecologist when pregnancy has already set in and it is too late for preventive measures. An effective folic acid prophylaxis must take place b efore the onset of pregnancy. Data from the regional surveillance of congen ital anomalies of the German Federal State of Saxony-Anhalt and interviews with women in maternity, as well as gynaecologists, indicate that there is a substantial knowledge deficit concerning folic acid prophylaxis. In 1998, therefore, a working group was set up in Saxony-Anhalt. It comprises repre sentatives from interested institutions and has the goal of rectifying the knowledge deficit of women of childbearing age by way of a broad-based camp aign while making use of the results of regional congenital anomalies monit oring. A pharmaceutical company was enlisted for cost-free distribution of its folic acid product. Legal problems with the prescription drug laws, the law against unfair competitive practices, the advertising of medicaments l aw and the SGB V (social code) made it impossible to procure multivitamins containing folic acid free of charge for women wanting a child. A highly di fferentiated legislation has hitherto prevented an elementary improvement i n prevention.