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LEGISLATION GERMANY

Germany: embryo protection laws need overhaul, says national academy

Published 06 December 2019

Germany's National Academy of Science, Leopoldina, has issued a new proposal to update ART legislation in line with social changes and technical developments. Included in the proposals are egg donation and embryo selection. Meanwhile, legislation in France is about to change.

Leopoldina, the German National Academy of Science, continues to press for changes to the law governing ART, describing the current legal framework as outdated and incompatible with the new diagnostic and therapeutic measures for fertiliity, or with the new 'social concepts of marriage and family'. Leopoldina's arguments in favour of change have now been set out in English in a move to gather international support.(1)

ART legislation in Germany has since 1990 been based on its embryo protection laws, which have never been updated except, following legal challenge, to accept certain indications for PGT in 2011. It's because of this statutory anomaly and the evidence-based progress of fertility treatments that, according to Leopoldina, 'the legal regulation of reproductive medicine is currently incomplete, creates legal uncertainty, contains contradictory values and is partly considered unjust or even harmful to the well-being of children'.

Among the most contentious restrictions of the 1990 Embryo Protection Act are bans on embryo selection and on egg donation. Germany is only one of very few countries in Europe (with Norway and Switzerland, for example) where egg donation is not allowed. Many of the original concerns about the procedure - child development, donor exploitation - have been shown, says the report, to be groundless, and egg donation 'should now be permitted'. Leopoldina adds that safeguards over legal parenthood, as evident in other jurisdictions, should be stated such that the 'intended parents' are the legal parents and that the donor has no parental rights or liabilities.

Similarly, in the interests of 'minimising risks' and of embryo protection, the report calls for restrictions on embryo selection to be removed: 'It should be permissible, in accordance with international scientific standards, to select and transfer from a larger number of embryos the embryo with the best chances of development (eSET).'

The report addresses other matters of topical clinical interest:
the right to know one's biological origins; time limits on gamete/embryo cryopreservation; surrogacy; and PGT. The latter has been allowed in Germany since 2011, but only in identified cases of serious hereditary disease or to prevent stillbirth or miscarriage. Such decisions are currently left to regional ethics committees, which, says the report, 'does not do justice to the situation of the affected persons'. In future it is proposed that decisions on PGT (PGT-M, PGT-SR) should be taken within the doctor-patient relationship and should not require special approval of an ethics committee.

Leopoldina makes these proposals against an ever-present background of the welfare of the child, described as 'paramount'. Thus, 'treatments that entail serious, empirically substantiated risks for the health and/or well-being of the child during pregnancy or after birth should not be permissible. This includes, for example, the avoidable acceptance of higher-order multiple pregnancies,' which thereby opens the door to embryo selection and freezing.

Also in the background of the report is insurance funding, which in some (but not all) German states is available - though restricted to married couples and only half the full treatment costs covered. The report thus calls for full cost coverage through Germany's health insurance system, 'if medically justified and with a reasonable chance of success'. Further, the costs incurred in the context of PGT-M should also be borne by the state, 'as is already the case with the costs of prenatal diagnostics'.

Thomas Strowitzki from the University Women's Hospital in Heidelberg, one of the Leopoldina report authors and a member of ESHRE's Executive Committee, says there is ongoing debate on legislation in Germany, though it's not a high priority for government. 'That's why respected academies like the Leopoldina try to bring the discussion to public attention,' says Strowitzki. 'In Germany the Leopoldina proposals have been intensively and positively discussed by newspapers, politicians, patient groups and doctors, but so far there have been no indications that the law will change.'

While no-one in Germany is holding their breath for legislative change, France is now in the latest stages of implementing changes to its bioethics laws on ART. France too is shifting from a background which simply recognises the pathology of infertility and its treatment to one which respects the new family models and an individual's wish to become a parent. So in the forthcoming changes, which have already been approved by the French parliament, France will now allow lesbian and single women to have free access to fertility treatments within its national health insurance system. With legislation dating back to 1994, 'France is behind many other countries and is still bound by taboos regarding the family,' one MP for the ruling La République en Marche party told the Financial Times during the parliamentary debate in September, echoing much of the same argument now being heard in Germany.

1. See https://www.leopoldina.org/en/publications/detailview/publication/fortpflanzungsmedizin-in-deutschland-fuer-eine-zeitgemaesse-gesetzgebung-2019/