07 September 2015
The Buchmann Faculty of Law, Tel Aviv University, Israel; School of Public Health, University of Montreal, Canada.Appeared in BioNews 818
Switzerland upholds stricter legislation on assisted reproduction and prenatal genetic testing than most European countries (1). However, recent regulatory changes demonstrate a possible shift towards a more liberal approach.
In a referendum held on 14 June 2015, a majority of the Swiss population accepted an amendment of article 119 of the Constitution governing medically assisted procreation (reported in BioNews 809). Previously, the Constitution allowed for the creation in vitro of the number of embryos 'that can be immediately implanted', which in practice is three. As a consequence, PGD was banned under Swiss law. The new amendment allows the creation of as many embryos 'as necessary for medically assisted reproduction', which has significant consequences.
Implementing this constitutional reform, the Swiss parliament has modified the law on medically assisted reproduction. It now permits the creation of a maximum of twelve embryos per treatment cycle and embryo freezing through cryopreservation, opening the possibility for single-embryo transfers. The law also allows the screening of all embryos created in vitro for incurable diseases and genetic anomalies, making Switzerland one of the last European countries to authorise PGD.
This law – currently adopted by parliament but not yet in force – might be challenged by a popular vote next year, if Swiss voters successfully collect 100,000 signatures. Religious groups and disability organisations have already announced their intention to attack the law via referendum.
In this context of a nascent more liberal approach to assisted reproduction, it is interesting to point to a more permissive approach to non-invasive prenatal testing (NIPT) by Swiss social health insurance, which is mandatory for all citizens. Although NIPT has been privately available in Switzerland since 2012, a regulatory update entered into force on 15 July 2015 included NIPT for the first time in the list of covered services and tests (2). However, the regulation subjects NIPT to strict conditions when administered within the framework of social health insurance.
NIPT can only be performed to detect trisomy 21, 18 or 13 in a single pregnancy, after the twelfth week for pregnant women whose first trimester test indicates a risk of 1:1000 or higher. It also requires a pre-test counselling session where the test is explained in detail, followed by written consent. Furthermore, the regulation indicates that 'if the sex of the fetus is determined for technical reasons, that information cannot be communicated before the end of the twelfth week of gestation'.
The Government's decision to include NIPT as a covered service for the entire Swiss population is certainly a welcome move. Limiting coverage for NIPT to high-risk pregnancies is in line with current recommendations of leading professional associations word-wide and is thus a justified limitation (3, 4).
However, the prohibition of communicating fetal sex before the end of the twelfth week raises questions regarding a possible infringement of a parent's right to know, as an expression of a right to self-determination. It could be argued that it also stands in contradiction to a woman's right to an abortion within the first twelve weeks of pregnancy without indication of specific reasons, as protected by article 119 of the Swiss Criminal Code. Furthermore, it is rather unusual for a social health insurance regulation to include guidelines as to a physician's conduct, entering the usually protected sphere of physician-patient relationship.
This 'small-print' limitation on disclosure of fetal sex prior to the end of the twelfth week of pregnancy must be understood within the context of the wider legislative picture. Today, Swiss law prohibits genetic testing for the purpose of sex-selection, but does not impose obligations on physicians with regards to communicating fetal sex when this information is obtained as a result of testing for other purposes. However, the Swiss Government is currently preparing a draft for a new law regulating human genetic testing in general. This draft includes a prohibition for physicians to communicate fetal sex prior to the twelfth week.
This legislative process is at an early stage and this provision may thus still change. It is interesting to note, though, that in the case of NIPT, the recent regulation on health insurance coverage precedes substantive legislation regarding genetic testing, by prohibiting in 'small print' what a draft law is proposing to prohibit more generally. This reverses the usual regulatory path for new technologies, where substantive regulation precedes insurance coverage, and may be perceived as introducing an important feature through the backdoor of administrative regulation, without proper democratic debate.
In sum, whereas recent regulatory changes in Switzerland indicate a trend towards a more liberal approach to assisted reproduction and prenatal testing, as well as more generous insurance coverage for pregnancy related services and tests, these changes may also introduce a subtle shift in balance regarding how parents' right to know and abortion rights are perceived within the Swiss legal framework.