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Predictive Genetic Diagnosis

--- Overview Germany ----

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(Author: Staff from Inter-University Chair in Law and the Human Genome, Spain & DRZE staff, Germany)


In Germany, different regulations on predictive genetic diagnosis need to be distinguished.

First of all Preimplantation Genetic Diagnosis (PGD). The legal regulations governing the application of these diagnoses are part of the respective national legislation on embryo protection. In this respect, the interpretation of some provisions of the German Embryo Protection Act (Embryonenschutzgesetz) is subject to controversy. It is agreed that PGD using totipotent cells is prohibited, because these cells meet the legal definition of an embryo. Some legal experts assume that the fact that PGD may lead to a selection of embryos runs counter to the overall intention of the Embryo Protection Act and even conflicts with core provisions of the constitutional law. However, the Draft guidelines of the German Medical Association (Bundesärztekammer) are based on the assumption that the removal of non-totipotent cells from blastocysts for diagnostic purposes with the ultimate intention of establishing a pregnancy does not contravene the Act. The guidelines envisage a restrictive application of PGD, limiting it to couples “whose offspring are at high risk of developing a known, serious genetic disorder”. Late-onset disorders are to be excluded from the diagnosis.


On 25 February 2002 the Study-Commission (Enquete-Kommission) 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 conditions and in exceptional cases be open to couples with a high genetic risk factor only.


In the Opinion of the National Ethics Council (Nationaler Ethikrat) 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 (Embryonenschutzgesetz) 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 in the recommendation "to regulate all questions relevant to reproduction medicine in a separate Reproduction Medicine Act."

According to the majority vote PGD (preimplantation genetic diagnosis) should be authorised in exceptional cases:

  1. 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.

  2. 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 [..];

  3. 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 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" has to be taken care of.


Voluntary undertaking by the member companies of the Confederation of the German Insurance Industry (Gesamtverband der Deutschen Versicherungswirtschaft e.V.) (GDV) (7 November 2001)
In their voluntary undertaking of 7 November 2001 the member companies of GDV (Gesamtverband der Deutschen Versicherungswirtschaft) undertake not to make the conducting of genetic tests the precondition for an insurance contract nor to require their clients to submit voluntarily conducted predictive genetic tests to an insurance company prior to the conclusion of a contract. One exception is to apply in the case of life insurance involving very high sums insured (more than EUR 250,000 or annual pensions of more than EUR 30,000 in disability pensions, incapacity to work pensions and care pensions). It applies initially up to 31 December 2006.

Coalition Agreement of SPD and Bündnis 90/DIE GRÜNEN(16 October 2002)
According to the Coalition Agreement of SPD and Bündnis 90/DIE GRÜNEN (16 October 2002) the handling of genetic tests is to be regulated in a Genetic Test Act in order to protect the personal rights of the citizens. In this context, the right to ignorance is to be guaranteed in order to protect those concerned from genetic discrimination and to establish clear boundaries to the passing on of genetic data to third parties (e.g. employers and insurance companies).


(Collected by: Staff from Inter-University Chair in Law and the Human Genome, Spain & DRZE staff, Germany)

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