[ Legal aspects of advice provided by an institutional pharmacovigilance specialist to health-care professionals. Consequences in the field of teratology ].
An institutional pharmacovigilance specialist gives advice only when consulted by a prescribing physician about a pregnant woman. The situation may involve a pregnant woman for whom a prescription may be considered or a pregnant woman for whom a prescription has been given. The aim is to evaluate the risk for the fetus, both before and after the fact. In view of recent decisions by the Cour de Cassation (*) which imposed penalties for preventing a woman exposed to a teratogenic risk from resorting to an abortion by providing her with inapropriate information, we are suggesting here the hypothesis that an institutional pharmacovigilance specialist acting as a consultant could be implicated. However, this hypothesis is purely academic. If action were taken to render a pharmacovigilance specialist liable, it is in fact the State that would have to answer.
Département Pharmacologie Clinique, Hôpital Saint-Antoine, Paris, France.
J P
JP
Demarez
D000014:Abnormalities, Drug-Induced; D005260:Female; D006801:Humans; D016365:Liability, Legal; D010601:Pharmacology, Clinical / Q000331:legislation & jurisprudence*; D011247:Pregnancy; D018600:Teratology / Q000331:legislation & jurisprudence