Opinion of the National Ethics Council “Genetic diagnosis before and during pregnancy”. - In the opinion of the National Ethics Council presented on 23 January 2003 a majority of 15 members voted in favour of a “limited authorisation of PGD”. A minority of 7 members suggested both to “uphold the ban on PGD as laid down in the current version of the Embryo Protection Act and to render the regulations governing PGD more precisely”. Two members basically agreed with the minority vote, pointing out, however, that “in the case of an existential conflict the individual decision of conscience must be free and must not be forced by the power of penal law.” All members agreed with the recommendation “to regulate all questions relevant to reproduction medicine in a separate Reproduction Medicine Act”.
According to the majority vote, preimplantation genetic diagnosis (PGD) should be authorised in exceptional cases:
- for couples who run a high risk that their child will develop a severe genetic disorder or disability for which there are no effective therapies and who would be thrown into an existential conflict should the child be born;
- for couples who run a high risk of passing on a chromosome disorder which may prevent the embryo from reaching the stage of extra-uterine life [..];
- for infertile couples, if there is scientific evidence that by testing for chromosome disorders the success rate of sterility therapies for certain patient groups (e.g. higher age or after several unsuccessful treatment cycles without known chromosomal disorders) could be raised significantly and that the reduced number of embryo transfers would also reduce the risk of multiple pregnancies. Moreover “adequate counselling has to be provided covering medical, ethical as well as psychosocial aspects”. The diagnosis process itself should be restricted to “a small number of centres under revocable license”. It should be regulated by procedural rules which guarantee the “existence of an indication”, the “quality of implementation”, “scientific appraisal and analysis” as well as “adequate transparency ensuring professional secrecy and data protection”. Apart from this “central documentation and monitoring” must be implemented .
Study Commission “Law and Ethics in Modern Medicine” of the German Bundestag on preimplantation genetic diagnosis (25 February 2002). - On 25 February 2002 the Study Commission on “Law and Ethics in Modern Medicine” of the German Bundestag concluded its deliberations concerning preimplantation genetic diagnosis. The recommendations are laid down in the Commission’s Final Report (Section on PGD) which was handed over to the President of the Bundestag on 14 May 2002.
According to the Report a majority of 16 Commission members voted in favour of a ban on PGD in Germany. The Report recommends to amend the German Embryo Protection Act to include PGD explicitly in the existing ban on in vitro fertilisation for diagnostic purposes. Three members of the Commission expressed their opinion that PGD should under certain and in exceptional cases be open to couples with a high genetic risk factor only.
Three members of the Study Commission voted in favour of lifting the ban on PDG in exceptional cases for couples with a high genetic risk factor only. A precondition for this would, however, be the establishment of a legal framework designed to preclude a repeat of developments which occurred in prenatal diagnostics, where a weakening of the original regulations led to a proliferation of its use and an increase in the number of terminations.
Fundamental to such a framework would be a legal requirement to seek counselling which would explore alternatives to PGD. Moreover, access to PGD would be on the condition that the conflict situation of the couple concerned is similar to that of a pregnant woman who is considering an abortion and cannot be forced by law to bear her child. In order to determine such a conflict the dissenting opinion in the Report considers two options:
- first, a catalogue of severe health impairments which could be diagnosed by PGD combined with a precise assessment of the couple’s personal conflict. Such a catalogue, could, however, give rise to the misunderstanding that the law implicitly approved of PGD as an agent in eugenic selection. Moreover, the dissenting opinion in the Report stated that the use of this catalogue could also result in the stigmatisation of people suffering from the impairments listed in it;
- as a second option it therefore suggests to avoid such a catalogue and to formulate general stipulations for a counselling and monitoring procedure in a way that excludes any widening of the PGD practice similar to the use of prenatal diagnosis. Thereby PGD should only be performed at centres specially licensed for this purpose. The Federal Minister of Health should establish an appropriate authority for the licensing and monitoring of PGD which would also collect reports from the PGD centres and their ethics commissions .