The genetic screening of embryos in the womb is already permitted, and is being carried out daily in Germany. However, the inspection of artificially fertilised eggs before insertion into the uterus, a process known as preimplantation genetic diagnosis (PGD), was previously something of a legal grey within the Embryo Protection Act. In January 2006, a Berlin doctor who had inspected embryos for gene defects on behalf of a number of child-seeking couples before implanting only perfect specimens, reported himself to authorities in an attempt to provide clarification on the law. The Fifth Senate of the Federal Court of Justice (BGH) has now acquitted him of charges, thereby permitting preimplantation genetic diagnosis to be carried out, although only for the detection of serious genetic diseases.Politicians and ethical bodies are now calling for clear legal regulation of reproductive medicine.

In 2005 and 2006, the Berlin-based gynaecologist genetically examined fertilized eggs from three couples for a predisposition to hereditary diseases. In one case, a man was found to have an unspecified genetic defect that increased the risk of his child being born with Down’s syndrome. In another, a mother exhibited so-called partial trisomy 22, aka Emanuel Syndrome. Here, as always, the chromosomes feature twice in each of the body’s cells, but one part of one chromosome is doubled-up, meaning that it is slightly longer than the other. Children born with the condition are at risk of organ damage and other disabilities. The third couple already had a severely disabled daughter. The doctor examined the artificially fertilised eggs outside of the body, and only implanted those that exhibited no genetic defects. One of the three women became pregnant as a result, and gave birth to a healthy baby.

In January 2006, the doctor handed himself over to the authorities. The central issue was whether PGD was counter to the Embryo Protection Act of 1990. At the time, the matter was yet to be given clear clarification. In 2001, the Enquete Commission on Law and Ethics of Modern Medicine from the German Parliament concluded that PGD was not compatible with the Embryo Protection Act. In a statement from 2003, the majority of the National Ethics Council argued for a strictly limited approval of PGD for detecting predisposition to serious genetic diseases.

Designer babies still prohibited
This opinion was shared by both the Berlin Regional Court, which dealt with the case in May 2009, as well as the Federal Court of Justice. Now, the 5th Senate of the Supreme Court in Leipzig concluded on 6 July that the doctor was not in breach of the Embryo Protection Act. The act foresees up to three years imprisonment if an “extra corporeal-produced” embryo is used for a purpose that “does not serve its preservation.” The Embryo Protection Act prohibits only the trade in embryos and their application in research, argued defence attorney Daniel Krause. Furthermore, investigations of embryos in pregnancy for chromosomal damage has long been permitted, and is routinely carried out. The Chief Judge at the Supreme Court, Basdorf Clemens, added that this does not concern the authorisation of embryo selection for planned children. The selection of eye- or hair colour and gender remains punishable by law. The narrowly defined conditions for PGD were also welcomed by Joerg-Dietrich Hoppe, President of the German Medical Association. “With this, the Federal Supreme Court has made it very clear that PGD is not permissible as a method for producing so-called designer babies.”

“The illogical discrepancy between the possibilities of prenatal diagnosis and preimplantation genetic diagnosis has finally been lifted by the ruling from the Supreme Court,” Hoppe continued. Indeed, genetic testing of embryos in the womb is permitted for the detection of hereditary diseases such as Down’s syndrome or Huntington's disease. These two methods are used above all in prenatal diagnosis to gain access to cells and genetic material from embryos. Foetal cells from amniotic fluid are examined during amniocentesis; chorion biopsies entail the extracting and testing of a sample of the chorionic villus (placental tissue). A method first developed in the United States of isolating and enriching foetal cells from the bloodstream of the mother remains in the early stages of development. Changes detected during genetic tests can, in extreme cases, result in the termination of the pregnancy. Abortions are permitted, for example, when from a medical point of view considerable damage to the health of the child can be expected, which would endanger the physical or mental health of the mother.

The verdict disposes of a legal grey area in Germany. A number of countries in Europe have already established statutory provisions (a subordinate instrument or provision of an act). Britain has one of the most liberal laws. In 2008, the Houses of Commons gave the green light to the use of embryos for research purposes, including chimeras of human and animal embryos. In December of last year, a baby was born in London that had been investigated prior to implantation for the breast cancer risk gene BRCA1 – a first of its kind. Six from eleven artificially produced embryos were chosen, and two healthy specimens implanted in the mother. The parents chose this procedure because both parents, grandparents and great-grandparents had been diagnosed with breast cancer.

More information:

• Federal Supreme Court allows preimplantation diagnosis