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Baby steps forward, baby steps back: towards a more liberal Swiss regulation of reproduction

07 September 2015

By Dr Melanie Levy and Professor Vardit Ravitsky

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.

SOURCES & REFERENCES
1) De Geyter, C., 'Assisted reproductive medicine in Switzerland'
Swiss Medical Weekly. 2012:142:w13569. | 
 
2) Manegold-Brauer, G. et al., 'A new era in prenatal care: non-invasive prenatal testing in Switzerland'
Swiss Medical Weekly. 2014:144:w13915. | 
 
3) International Society for Prenatal Diagnosis, 'Position statement from the Aneuploidy Screening Committee on behalf of the Board of the International Society for Prenatal Diagnosis'
Prenatal Diagnosis. 2013:33(7):622–9 | 
 
4) American College of Obstetricians and Gynecologists Committee on Genetics, 'Committee Opinion No. 545: Noninvasive prenatal testing for fetal aneuploidy'
Obstetrics & Gynecology. 2012;120(6):1532–4. | 
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

24 April 2017 - by Dr Jane Currie 
Australia has maintained a ban on sex selection for non-medical reasons, in revised guidelines on assisted reproductive technologies (ART) published this month...
25 January 2016 - by Vardit Ravitsky, Jessica Mozersky, Marsha Michie, Rayna Rapp, Megan Allyse, and Subhashini Chandrasekharan 
Since its introduction in 2011, the availability of non-invasive prenatal testing has been expanding globally and rapidly. The clinical introduction of NIPT has clear benefits for pregnant women, such as reducing the need for invasive testing. But, depending on local circumstances, it also raises varying challenges and opportunities...

06 July 2015 - by Kirsty Oswald 
In a national referendum, a majority of Swiss voters have supported allowing preimplantation genetic diagnosis to screen for genetic diseases...
08 June 2015 - by Michael Wells-Greco 
On 21 May 2015 the Swiss Federal Court refused to register a male couple - who are in a civil partnership and living in Saint-Gallen, Switzerland - as the legal fathers of a child born following an inter-country surrogacy arrangement...
01 September 2014 - by Antony Blackburn-Starza 
Judges in two European countries with restrictive laws governing IVF and surrogacy have taken steps towards recognising non-biological parents in same-sex relationships as the legal parents of children born through assisted conception....

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