Europe moves towards complete statutory regulation of assisted reproduction

But large variations still exist in how the legislation is applied

Embargo: 00.01, 6 February 2020 CET

This press release relates to a study reported today in the journal Human Reproduction Open.

Although assisted reproduction is now controlled by legislation in almost all European countries, substantial variations exist within the detail of that legislation. The most complete survey ever of the legal and funding framework of 43 European countries has found that almost all of them (with the exceptions of Albania, Bosnia and Herzegovina, Ireland, Romania and Ukraine) now have specific legislation in place.(1) However, while there is some shift towards homogeneity in a growing number of jurisdictions (such as the removal of donor anonymity in sperm and egg donation, or the treatment of single and lesbian women), Europe remains a patchwork of local legislations in how its main fertility treatments are controlled and made available to the public.(2)

The greatest legal variants were found in access to treatment (according to age, relationship status), third-party donation, fertility preservation (either ahead of cancer treatment or for personal/social reasons), and public funding.

Access to treatment

In 11 of the 43 countries surveyed access is limited to heterosexual couples with a diagnosis of infertility, which precludes treatment of single and lesbian women (who often have no diagnosed cause of infertility). These countries include Czech Republic, France, Italy, Poland, Slovakia, Slovenia, Switzerland and Turkey. France is presently in the process of relaxing its legislation to include the treatment of single and lesbian women.

Thirty-four of the 43 countries have legal age limits for treatment. In 21 (including Czech Republic, Denmark, Greece, Portugal, Spain, Sweden, UK) males and females must be above 18 years. Maximum female age is also a legal limit in 18 countries, ranging from 45 years in Denmark and Belgium (in the latter this limit applies to egg retrievals while embryo replacement and insemination are allowed up to 47 years) to 51 in Bulgaria. There are no legal age limits in Finland, Germany, Norway, while current legislation in France sets a female upper limit at "normal reproductive age", Spain at the "age of the menopause", and the Netherlands at age 49.

Treatments

While donor sperm for IVF and intrauterine insemination is allowed in almost all European countries, egg donation is banned in Germany, Norway, Switzerland and Turkey. Embryo testing for chromosomal status (PGT-A, formerly known as PGS) is not permitted in Denmark, France, Germany, Hungary, Lithuania, Norway, Slovenia, Sweden and the Netherlands. Embryo sex selection (by PGT-A) is not allowed in any country (except in some countries to screen embryos for sex-linked diseases).

Age limits are set for sperm donors in most countries - most commonly a lower age of 18 years and upper age of 40 years. Limitations on the number of infants originating from the same donor are in place in 30 countries, in five as a recommendation and not a legal obligation. In seven of these 30 countries (Belgium, Denmark, Finland, Portugal, Slovenia, Sweden and UK) there is a maximum number of families/women who may have children resulting from the same donor (from two for Slovenia, to 10 for UK and 12 for Denmark). Most countries set a lower age limit of 18 for egg donors, and an upper limit ranging from 34 years in Serbia to 38 years in France, with the vast majority of countries setting the limit at 35 years.

The biggest recent change moving towards homogeneity in Europe is in the anonymity of egg and sperm donors. However, strict anonymity remains the law in 18 countries, including France, where regulatory developments are likely to change this requirement. In some countries anonymity applies to recipients but the born children can have access to donors’ identity when above a defined age (Austria, Croatia, Finland, Malta, Portugal, UK). In Germany and Switzerland, where anonymous donation is not allowed, recipients may bring their own donor to provide eggs just for that couple, a practice also allowed in all countries. Recent developments in direct-to-consumer DNA testing and the huge DNA databanks building up as a result means that anonymity can no longer be guaranteed anyway.

Similarly, legislation has not caught up with egg freezing, which was made possible with the widespread introduction of fast-freezing by vitrification. However, the freezing of eggs (and sperm) for the preservation of fertility ahead of cancer treatment (ie, for medical reasons) is allowed in all countries, despite an absence of specific legislation in 17 of them. Non-medical ("social") egg freezing is not permitted in Austria, France, Hungary, Lithuania, Malta, Norway, Serbia and Slovenia, but is allowed in Germany and Switzerland.

Public funding

Public funding systems are extremely variable. While four countries (including Ireland) provide no financial assistance to patients, limits to funding are defined in all the others - most commonly female maximum age, previous children, and a maximum number of treatments publicly supported. Generous public schemes are found in Denmark, France, Sweden, the Netherlands, Belgium, Czech Republic, and Slovenia; in the latter three countries funding is linked to a clinical policy, such as the number of embryos transferred (relative to female age) and the rank of the treatment attempt.

Public centres have far longer waiting lists than private ones, with a waiting time between 12 and 24 months in Italy, Spain, Ukraine and some areas of Portugal.

The authors report that "social, cultural or religious" factors in different countries explain some of the variations in regulation and application, especially in third-party donation treatments and surrogacy. "Our data show how differently European countries have dealt with these issues," said Professor Carlos Calhaz-Jorge, first author of the study and a former chairman of ESHRE's IVF Monitoring Consortium. He added that travel for treatment to other jurisdictions may overcome these restrictions - reflecting the strength of patient power in assisted reproduction. "Lower treatment costs, access to techniques not possible in the home country, donor eggs and sperm more readily available, and expectations of better quality treatments are key drivers for this cross-border phenomenon," he said. However, he warned that such movement may expose patients to "less controlled clinical environments".

Commenting on the findings, Calhaz-Jorge was doubtful of pan-European legal homogeneity in the coming years. "In each country there are subgroups with different views from the majority - or, at least, from the politicians in charge. That's why cross-border treatments developed. However, with third-party donation there is evidence of a general trend towards less restrictive regulation. But even here we've seen that that move depends mainly on the individual commitment of a couple of politicians with strong convictions."


1. The survey was performed by the European IVF Monitoring Consortium of the European Society of Human Reproduction and Embryology (ESHRE). The full report of the survey is published today in the ESHRE medical journal Human Reproduction Open: Calhaz-Jorge C, De Geyter C, Kupka MS, et al. Survey on ART and IUI: Legislation, regulation, funding and registries in European countries. Hum Reprod Open 2020; doi:10.1093/hropen/hoz044
Please see this report for more specific data on individual countries.

2. Details in the report were accurate on 31 December 2018. Since then, some countries are in the process of updating their regulations (such as France), or introducing new legislation (such as Ireland).

* When obtaining outside comment, journalists are requested to ensure that their contacts are aware of the embargo on this release.

For further information on the details of this press release, and access to the full paper, please contact:
Laura Rossignoli at ESHRE
Mobile: + 32 (0)499 92 32 49
Email: laura@eshre.eu