2. Are there specific criteria for access to MAP?
Medical reasons:
a. Infertility:
For a heterosexual couple? Yes; For women not living in a heterosexual couple? Yes
b. Risk of transmission of a disease
For a heterosexual couple? Yes; For women not living in a heterosexual couple? Yes
On the basis of Section 3a(2) of the Embryo Protection Act a pre-implantation genetic diagnosis is exceptionally permitted where the genetic predisposition of the woman from whom the egg cell was collected, or that of the man producing the sperm cell, or both, suggest that their offspring will be highly likely to have a serious genetic illness or to identify an abnormality that would be highly likely to lead to still-birth or miscarriage. With regard to the further requirements for a pre-implantation genetic diagnosis, reference is made to Section 3a(2) and (3) of the Embryo Protection Act. The execution of the MAP, in these cases, depends on the result of the pre-implantation genetic diagnosis.
c. Other
Pursuant to Section 6(2) of the Tissues and Cells Regulation of the Transplantation Act, the use of sperm cells for heterologous fertilisation, as a medically assisted procreation technique requires that the sperm donor is medically assessed as suitable for sperm donation, regarding his age, state of health and medical history and that the use of the donated sperm will not pose any health risks to others. Sperm donors are selected according to the criteria and laboratory tests laid down in Annex 4 Numbers 2 und 3 of the Tissues and Cells Regulation of the Transplantation Act. Annex 4 has implemented the selection criteria and laboratory tests for donors of reproductive cells laid down in Annex III of the Directive 2006/17/EC of 8 February 2006 as regards certain technical requirements for the donation, procurement and testing of human tissues and cells in national law. For this purpose, in particular, the donors’ serum or plasma samples must be tested and found negative for HIV 1 and 2, HCV, HBV and syphilis. Furthermore, urine samples of sperm donors must be tested and found negative for chlamydia by the nucleic acid amplification technique (NAT).
Additional aspects are set out in the Guidelines of the German Medical Association, paragraph 2.7.