title: [Prevention of congenital malformations by means of folic acid - insurmountable problems due to the German penal code and German drug legislation when preparing a preconceptional model in Saxony-Anhalt].
abstract: For the last 20 years the prophylactic effect of the vitamin folic acid against the occurrence of neural tube defects has been known but in Germany this 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 before the onset of pregnancy. Data from the regional surveillance of congenital 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 representatives from interested institutions and has the goal of rectifying the knowledge deficit of women of childbearing age by way of a broad-based campaign while making use of the results of regional congenital anomalies monitoring. 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 law 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 differentiated legislation has hitherto prevented an elementary improvement in prevention.
authors.affiliation: Fehlbildungsmonitoring Sachsen-Anhalt an der Medizinischen Fakultät der Otto-von-Guericke Universität Magdeburg. Christine.roesch@medizin.uni-magdeburg.de
authors.forename: C
authors.initials: C
authors.lastname: Rösch
authors.forename: V
authors.initials: V
authors.lastname: Steinbicker
authors.forename: B P
authors.initials: BP
authors.lastname: Robra
authors.forename: M
authors.initials: M
authors.lastname: Kolbe
authors.forename: C
authors.initials: C
authors.lastname: Heinrich
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016527:Drug Costs / Q000331:legislation & jurisprudence*; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage* / Q000191:economics; D005858:Germany; D006801:Humans; D007231:Infant, Newborn; D009436:Neural Tube Defects / Q000209:etiology / Q000517:prevention & control*; D016742:Preconception Care / Q000331:legislation & jurisprudence*; D011247:Pregnancy
chemical_list: D005492:Folic Acid
vernacular_title: Die Fehlbildungsprävention durch Folsäure - unlösbare Probleme mit Paragraph 20 SGB V und der Arzneimittelgesetzgebung bei der Vorbereitung eines perikonzeptionellen Modells in Sachsen-Anhalt1.