Legal requirements for physicians in Germany

Obligation to inform the patient and medical qualifications in accordance with the German GenDG

Doctors in Germany must observe the following legal requirements in the care of their patients:

 

Physicians are required to explain NIPT to their pregnant patients

Under the guidelines for prenatal diagnostic testing for diseases and disease dispositions (Deutsches Ärzteblatt 100, issue 9, pg. A583), treating physicians in Germany are required to explain NIPT to each pregnant patient in addition to invasive diagnostic options and to completely exhaust all low-risk diagnostic options based on the potential risk to the fetus of invasive prenatal diagnostic procedures.The guidelines on human genetic diagnostics and genetic counseling of the German Society of Human Genetics (GfH) and the Association of German Human Geneticists (BVDH) include the following obligations of the physician under section 10.12: “All available information and findings collected for medical purposes, which enable patients to arrive at their own decisions, must be made available to them.” Section 2.1. expressly states that the indication may include a subjective concern of the patient.

 

Medical qualification

In accordance with §10 German Genetic Diagnostic Act (GenDG), patients must receive unbiased genetic counseling before and after the PrenaTest®. As a result, the PrenaTest® may be provided primarily by physicians who meet the requirements set forth in §7 (1) (3) GenDG. These include human genetics specialists and other physicians who have acquired a corresponding additional qualification to perform genetic testing within the scope of their specialty. Due to the fact that the guidelines of the German Medical Association (BÄK) require that pregnant patients must be informed of all prenatal diagnostic options, especially low-risk diagnostic options, treating physicians must also include the non-invasive method associated with the PrenaTest® in their counseling of patients. If a pregnant patient is interested in the PrenaTest®, then the following options are available to the treating physician, depending on his or her qualifications:

  • Referral of the pregnant patient to a specialized prenatal diagnostic facility.
  • Referral of the pregant patient for genetic counceling to an external specialist in human genetics an application of the PrenaTest® at is or her own gynecological practice.
  • Genetic counceling of the pregnant patient and application of the PrenaTest® at his or her own gynecological practice.
Statutory requirements concerning fetal gender disclosure

In accordance with § 15 (1) German Genetic Diagnostics Act [GenDG], the fetal gender may only be disclosed to the expectant mother in Germany with her consent after the twelfth week of pregnancy has elapsed. Please comply with the corresponding national regulations in other countries.

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