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The effects of limited approval in Germany
Recommendations on preimplantation genetic diagnosis: Ad-hoc statement by the Leopoldina favours allowing this diagnostic procedure subject to strict conditions.
On 18 January 2011 the Leopoldina publically issued and published an ad-hoc statement on preimplantation genetic diagnosis (PGD). This was done in conjunction with acatech – the German Academy of Science and Engineering, the Berlin-Brandenburg Academy of Science and Humanities (BBAW) and by the majority of the academies belonging to the Union of German Academies of Science. The underlying message of the statement: PGD is to be placed on an equal footing with prenatal diagnosis (PD) by lawmakers and access should be given in Germany under certain conditions to those women affected. This prevents having to terminate pregnancies where the embryo is severely affected by hereditary disease.
The statement entitled „Präimplantationsdiagnostik – Auswirkungen einer begrenzten Zulassung in Deutschland“ (an English version will be published this spring) covers not only medical and legal aspects, but also the ethical aspects of PGD as well. This comes in light of the current need for regulation, resulting from the decision made by the federal supreme court on 6 July 2010 that a ban on PGD cannot be derived from the embryo protection laws.
The 30-page report was presented on 18 January by the members of the PGD workgroup at a federal press conference and information event in the German parliament in Berlin. Since then it has received a great deal of public response as part of the current debate. Parliamentarians want to finalize a law on regulating PGD before summer recess. Further statements, for instance from the German Ethics Council are expected shortly. PGD is a diagnostic procedure. It allows people carrying a diseased gene to become parents of a child not suffering from this severe hereditary disease.
To enable this, embryos conceived through in-vitro fertilization are tested for this disease before being implanted in the uterus. An example of a similar test in the field of prenatal diagnoses, i.e. examination of the embryo in the womb, is amniocentesis. As a result the pregnancy may be terminated due to medical indication. The statement by the Academies formulates in summary the following main recommendations. The text:
“Due to a similar conflict situation for the woman, PGD should be legally allowed under limited and defined conditions and the consequences associated with this for the embryo are to be placed by lawmakers on an equal footing with PD (prenatal diagnosis, GenDG) and pregnancy termination (Article 218 of the German Penal Code). This equal footing is to be restricted by only allowing in vitro PGD for non-totipotent cells of the embryo, whereby it is recommended that conditions be considerably restricted. Testing can only be done for couples whose children, from a medically objective point of view, are at high risk of an onset of a wellknown, severe monogenic disease or a genetic chromosomal disorder, or if there is a risk of a stillbirth or a miscarriage. There should be no age limit for the onset of the disease. PGD may not be used for nationally or socially defined objectives that do not concern the well-being of the couple affected. A ban on selecting the genetic traits of children according to the wishes of their parents, determining the sex of the child with no relevance to genetic disease, using embryos for research purposes and investigating new, in other words, non-hereditary chromosomal disorders (aneuploidy screening) should continue to exist. Furthermore a competent authority should be set up to pass regulatory statutes or guidelines on how PGD is to be conducted. PGD should only be allowed to be carried out at a handful of facilities that are designated for this purpose and regularly checked by the competent authority. PGD should only be allowed if authorized by the designated competent authority following a substantiated request. On top of a law governing PGD and a possible modification to the genetic diagnosis law, the passing of a reproduction medicine law should be considered.“
The statement was produced by an Academy group consisting of 13 renowned scientists of various fields:
Prof. Dr. Claus R. Bartram ML (human geneticist, Heidelberg), Prof. Dr. Henning M. Beier ML, who is also a member of acatech, (embryology and reproduction biology, Aachen), Prof. Dr. Klaus Diedrich ML (gynecology and reproductive medicine physician, Lübeck), Prof. Dr. Philipp U. Heitz ML (Physician, member of the Leopoldina Steering Committee, Zurich), Prof. Dr. Hermann Hepp ML (gynecology and reproductive medicine physician, Munich), Prof. Dr. Otfried Höffe ML (legal and moral philosopher, Tübingen), Prof. Dr. Christiane Nüsslein-Volhard ML, and member of the BBAW, (developmental biologist, Tübingen), Prof. Dr. Peter Propping ML (human geneticist, Bonn), Prof. Dr. Bettina Schöne-Seifert ML (medical ethicist, Münster), Prof. Dr. Jochen Taupitz ML (medical law specialist, Mannheim), Prof. Dr. Anna M. Wobus ML, also member of the BBAW, (cell biologist, Gatersleben), Prof. Dr. Rüdiger Wolfrum ML (legal scholar, Heidelberg) (physician, member of the Leopoldina Presidium, Tübingen) as leading moderator.