Course BASIC_Graduate level learning material about the challenges of human reproductive medicine in a changing Europe

2021-1-HU01-KA220-HED-000027613 - COHRICE

Teacher´s Guide

7. Regulations of ART across Europe and their effect 

(Basic level)

Slides 1-5

Explain that ART is a widely used technique in reproductive medicine. Emphasize its development in the last 40 years. Outline the main questions which will be addressed in today's lecture. 

Most countries reported having specific ART laws, in which various ART techniques are precisely regulated, but these laws differ from country to country.  ART methods include , in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), preimplantation genetic diagnosis (PGD), preimplantation genetic screening (PGS) as well as egg donation, sperm donation, embryo donation, surrogacy.

A number of questions arise as a result of the aspects mentioned.

• Should there be a common policy in the EU for the use of ART?
• What forms of ART should be allowed?
• Who should get access to these technologies?
• Should  preimplantational genetic diagnostic (PGD) be unlimitedly allowed?
• What kind of information should be given to doctors, patients and allied professionals?
• What kind of psychological preparation is needed for people undergoing ART?

Exercise 1: 
Initiate a  discussion in small groups, where these controversial topics should be discussed (examples: Should single women have access to ART?, Should surrogacy be legal across Europe?  Should preimplantational genetic screening be  employed before embryo transfer?)

A common opinion should be noted in each groups with pros and cons, than it should be discussed openly in the seminar. This exercise allows open discussion and dive into the complexity of these questions as well as leave us with open questions and raises interest. 

Slides 5-9  Legal framework
Most countries reported having specific ART laws, in which various ART techniques are precisely regulated, but these laws differ from country to country.  ART methods include , in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), preimplantation genetic diagnosis (PGD), preimplantation genetic screening (PGS) as well as egg donation, sperm donation, embryo donation, surrogacy.

In other countries no regulating law exists, or they still have not passed legislation ( for example in Albania, Bosnia and Herzegovina (Federation), Ireland, and Ukraine.)

But these laws also make a strict distinction as to who has access to these ART techniques.

Access is restricted by law to heterosexual couples in 11 countries – Albania, Bosnia and Herzegovina, Czech Republic, France, Italy. Lithuania, Poland, Slovakia, Slovenia, Switzerland and Turkey. In Romania, the Netherlands and UK, as well as Belgium and Malta, ART and IUI techniques are also allowed for single women and same-sex couples. Most countries fall somewhere between these two extremes, with a total of 30 where treatments are available for single women and 18 countries where treatments are also available for female couples. A transgender person can have access to ART techniques in 21 countries.

Slides 7-8
Mirroring the above-mentioned variation of attitudes towards ART, a variety of ART regulation exists in Europe. There are several possibilities to categorize these differences (Calhaz-Jorge et al., 2020, Engeli & Rothmayr Allison 2016, Leibetseder & Griffin 2019, Griessler 2022). Engeli and Rothmayr-Allison, e.g., distinguish between permissive, intermediate, and restrictive ART policies.

• Permissive ART policies consist of “broad patients’ access, AND broad medical autonomy, AND full/quasi full reimbursement.”
• Intermediate ART policies are defined as “patients’ access under conditions, OR limited medical autonomy, OR low or no reimbursement”.
• Restrictive ART policies comprise of “patients’ access under conditions, AND limited medical autonomy, AND/OR no or low reimbursement” (Engeli & Rothmayr Allison, 2016, p. 90).

Restrictive and permissive ART regulations represent opposing ART policies; intermediate policies combine characteristics of both. Table 1 builds on data and the typology generated by Engeli and Rothmayr-Allison (2016) and was updated, adding countries to the initial comparison (Griessler 2022).

Slides 9-10
Experts, patient advocats and representatives of various legistlations attempted to characterised an ultimate framework of ART. This is however not possible if we concern the different cultural, religious and ethical aspects.  Fertility Europe suggested a “perfect country” in terms of regulated ART. This example of “perfect country” incorporated several aspects which needs to be considered when employing ART as a medical procedure. 

Variation in the regulation of ART is not a deviation from an ideal normal. Variation is to be expected because ART addresses many sensitive, intersecting and value-loaden issues.

Slide 11
Refresh the European Atlas for Fertility Treatment Policies and discuss the differences.  Use up to date legislative sources for your country of interest or just point out the differences according to the lists provided.

Slides 13-21 are blended, use them if you wish, or just use them to get more information for your country of interest. BAsed on theses slides you can construct slides concerning your country of interest (Slide 21-23)

To begin with there are differences in the definition fo ART in the national laws. IUI counts as an ART technique under the national laws of 35 countries.

The use of donated sperm in ART and IUI is legal in most countries except Bosnia and Herzegovina and Turkey. However, Croatia and Montenegro indicated that local donors are not available in their countries, which is why sperm can only be imported to Croatia from abroad. Simultaneous donation of sperm and egg is not permitted.

Egg donation is not allowed in Bosnia and Herzegovina, Germany, Norway, Switzerland and Turkey. Although accepted in Croatia, Ireland, Italy and Montenegro, no local donations are made.

Simultaneous sperm and egg donation is not allowed in countries where egg donation is banned, such as Armenia, Croatia, France, Montenegro, Slovenia and Sweden.  14 countries do not allow embryo donation, including Austria, Armenia, Belarus, Bosnia and Herzegovina, Bulgaria, Denmark, Iceland, Italy, Kazakhstan, Norway, Slovenia, Sweden, Switzerland and Turkey.

In some countries there is also a difference in relation to certain techniques. This is the case for preimplantation genetic testing (PGT) for monogenic diseases/chromosomal structural changes (PGT-M/SR; formerly PGD), which is allowed in all countries except Bosnia and Herzegovina and Malta.

PGT for aneuploidy (PGT-A; formerly Preimplantation Genetic Screening) is not allowed in Bosnia and Herzegovina and Malta, as well as in Denmark, France, Germany, Hungary, Lithuania, Norway, Slovenia, Sweden and the Netherlands. 

Surrogacy is legal in Albania, Armenia, Belarus, Belgium, Cyprus, Czech Republic, Georgia, Greece, Kazakhstan, Macedonia, Romania, Russia, Netherlands, United Kingdom and Ukraine.

Embryo sex selection (with the exception of PGT-M for sex-linked diseases) is not allowed in any of the 43 countries.

Situation worldwide:

• In some countries the law states that sex selection is not allowed but there is no specific regulation. For example Ukraine or Russia.
• In other countries legislation is backed by guidance provided by a regulatory body which means that PGT-A test results should not contain any information about embryo sex. For example in countries like Spain and Portugal.
• And there are also countries, where there is no specific legislation which covers the information which can be listed on PGT-A results, but clinics are recommended not to allow patients to select the sex of the embryo by the national regulatory body which oversees the work of those involved in assisted reproduction. Like in North Cyprus.
  

Legal limits for ART access

As previously mentioned, marital status and sexual orientation are often considered limitations on ART. However, 34 of the 43 countries also have legal age limits for candidates for ART. In 21 countries, men and women must be over 18 years of age. Belgium, Kazakhstan and Malta define a minimum age for women but have no such restriction for men. The 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 retrieval, while embryo replacement and insemination are allowed up to 47 years) to 51 in Bulgaria. In Austria, "natural cycle available" is an undefined criterion for a maximum age until women reach menopause. The maximum age for men is 60 years in Portugal, while in Finland 60 years and in Sweden 56 years are recommended age limits for men. According to Swiss regulations, "the potential father should be able to live until the child is 18 years old". A particular case is France, where there is no definition of numerical age limits and it is the responsibility of the centers to define the legal notion of “normal reproductive age” in practice.

It is also interesting to mention that in Lithuania, for example, ART is not allowed if patients have medical contraindications listed in the specific ART law. According to the regulations in Germany, ART is not reimbursed after sterilizations such as vasectomy and tubal ligation.

Legal limits in third-party donations

Sperm donation is restricted to men over the age of 18 in 16 of the 41 countries where donation is legal. In other countries where the procedure is allowed, no minimum age is defined. 21 countries have maximum male ages for donors, ranging from 35 in Hungary, Kazakhstan, Russia and Slovakia to 55 in Slovenia. The most common maximum age is 40 years. In 30 countries there are some restrictions on the number of infants from the same donor, although in five countries this restriction is only a recommendation and not a legal obligation. This number ranges from 1 Cyprus to 25 in the Netherlands. In 7 of the 30 countries (Belgium, Denmark, Finland, Portugal, Slovenia, Sweden and United Kingdom) there is a maximum number of families/women who can have children from the same donor (from two for Slovenia to 12 for Denmark).

Egg donors must be over 18 in 15 of the 36 countries where donation takes place. 25 countries set a maximum age for donors, ranging from 34 in Serbia to 38 in France, with the vast majority of countries setting the limit at 35. Bulgaria and Denmark have less restrictions on the maximum age of the donor if the donors/relatives are known to each other. In Belarus, Bulgaria, Hungary and Ukraine, egg donors must have at least one child. This condition is considered desirable but not mandatory when selecting egg donors in Romania and Sweden. The maximum number of donations is set in 10 countries - from one (two in rare exceptions) in Slovenia to 20 in Belarus. The most common numbers are between 4 and 6. 25 countries have defined a maximum number of infants from the same donor, although in 3 of them it is only a recommendation and not a legal requirement. This value ranges from 2 in Montenegro to 10 in France, Greece, Kazakhstan and Italy. In 6 of the 25 countries (Belgium, Finland, Serbia, Slovenia, Sweden and the UK) there is a maximum number of families/women that can have children from the same egg donation (from 1 for Serbia to 10 for the UK). Armenia, Bosnia and Herzegovina, Germany, Iceland, Ireland, Moldova, Poland,  Republic of Serbia, Russia and Turkey don’t have legal  age limits for ART. In other countries, such as Switzerland, the age restrictions are not clearly declared.

There is no embryo donation in Austria, Armenia, Belarus, Bulgaria, Denmark, Iceland, Italy, Kazakhstan, Slovenia, Sweden and Switzerland.

The issue of anonymity

There are different approaches to anonymity of the donors across Europe.

Regarding gamete donation, four different scenarios were identified. Strict anonymity is the rule in 18 countries, although 5 of these countries allow disclosure of the donor's identity in the event of serious health problems of the child. A special situation is Lithuania, where the identity of a donor may be known after a court decision for other (unspecified) important reasons. In some countries (Estonia, Poland and Russia) general information about the donors (nationality, age, weight, height, education) is available for recipients and children. In a second group of countries, the recipients are anonymous, but the children born can have access to the donor's identity if they are over a certain age (Austria, Croatia, Finland, Malta, Portugal, United Kingdom). A third scenario is gamete donation in a mixed system (anonymous and non-anonymous) as described in 13 countries. In Bulgaria, non-anonymity is an exception and affects donors who are relatives, while recipients in Germany and Switzerland can bring their own donor who will only donate to that couple. In Belgium, non-anonymous donation is only allowed if there is a formal agreement between the donor and the recipient. Georgia, Romania and the Netherlands are countries with non-anonymous embryo donation, while in Georgia and the Netherlands this also applies to gamete donation. In Hungary, egg donors must be a relative of the recipient, but a sperm donor must be anonymous. While local donations in Romania do not have to be anonymous, imported gamete donations can also come from anonymous donors. Whereas in Georgia and the Netherlands, non-anonymity is the rule for gamete donations. 

Embryo donation is allowed in 29 countries under one of three perspectives: strict anonymity, anonymity except for born children, and non-anonymity. No country has a mixed system of embryo donation. Five of the 13 countries with a mixed situation for gamete donation allow embryo donation under strict anonymity (Belgium, Germany, Hungary, Ireland and Ukraine). In Romania embryo donation is possible only with non-anonymous donors, while in the seven remaining countries Embryo donation is not performed.

Preservation of fertility potential

Fertility protection, gamete cryopreservation for fertility-limiting diseases is allowed in all countries, although 17 of them have no specific legislation. The same applies to the cryopreservation of gonad tissue (with the exception of Bosnia and Herzegovina, where the technique is not performed). The cryopreservation of embryos for medical reasons is not permitted in Italy and Portugal, but is only possible in Germany in the two-nuclear stage and is carried out in all other countries. Non-medical egg freezing is not allowed in Austria, France, Hungary, Lithuania, Malta, Norway, Serbia and Slovenia, nor is it performed in Bosnia and Herzegovina and Moldova, although there are no laws prohibiting this technique. 

Public Funding

The importance of public and private ART centers varies greatly from country to country.

In 29 of the 39 countries with public financial support for ART, access to public funding is subject to some limiting criteria, such as the age of the woman or man, the indication, the number of previous attempts, or the presence of previous children.

In order to contract with the public support system, centers in Austria, Bulgaria, Finland, Romania and the United Kingdom must have a minimum success rate. A special case is Hungary, where no minimum success rate is required, but public centers receive a special amount of money for each live birth resulting from ART.

The total number of cycles reimbursed also varies by country, with information on some countries requiring additional detail. In Austria, for example, the funded number of cycles per clinical pregnancy applies without a defined limit on the number of pregnancies.

In 19 countries, not all ART performed are eligible for public financial support. PGT is not promoted in Bulgaria, Greece and Italy. Russia and Spain (Spain is not supported only for repeated implantation failures). Expenditure related to donor cycles is not financially supported in Estonia, Montenegro and Russia. Cryopreservation of gametes and embryos is not publicly funded in the Czech Republic, Lithuania, Montenegro and Russia. In the case of premature ovarian failure, egg donation is not publicly supported in Spain for women over 36 years of age. Iceland and Ukraine indicated that only standard IVF/ICSI receive public funding, and the Czech Republic and Slovakia maintain that there is no public financial support for ICSI. Austria, Latvia and Turkey, "add-on" techniques are not included in the public funding. The Federation of Bosnia and Herzegovina, Macedonia and the United Kingdom indicated that not all techniques will be funded, but no details were given.

In Belarus, the Federation of Bosnia and Herzegovina, Estonia, Denmark, Germany, Italy, Kazakhstan, Norway, Russia, Spain and the UK, ART was considered to be unequally publicly funded across the country.

Slides 24-27  Discuss the evolution of the Austrian Law of Reproductive Medicine.

In the  Austrian Law of Reproductive Medicine (Fortpflanzungsmedizingesetzt from 1992) expressed and reinforced conservative attitudes, gave limited access to assisted reproductive technology to traditionally structured families. It rejected the creation of new family forms and discriminated against same-sex couples. Procedures, such as egg donation, surrogacy           were banned to protect women from exploitation. 

Assisted reproductive technology was allowed only within strict limits: 

(i) as medical Ultimo Ratio only, i.e. if pregnancy by sexual intercourse is impossible because the woman and/or her partner have a medical condition; 

(ii) access to assisted reproductive technology was limited to married or co-habiting heterosexual couples;

(iii) sperm donation was in general prohibited except for heterologous insemination, i.e. insemination with donor sperm if the husband or established partner is infertile; 

(iv) egg donation, donation of embryos and surrogacy were not allowed;

(v) preimplantation genetic diagnosis (PGD) was not explicitly regulated, but the FMedG only allowed genetic analysis if it was necessary to accomplish pregnancy. Therefore, analysis of the fertilized egg (blastocyst) was illegal but polar body diagnostics, which is, in a strict sense, not based on analysis of the fertilized egg and provides similar information, was not covered by the law.

The limitation of certain ART procedures created inequality between patient groups with different medical conditions and assisted reproductive technology needs.

Unclear regulation made it possible to trick the system: for example by using the polar body analysis instead of blastomere analysis.

The law created an inequality between people to whom access to assisted reproductive technology was granted and those who were excluded. As such it discriminated against same-sex couples as well as single people, unmarried people or people who were not in long-term partnerships. 

These inequalities in turn led to a lively ART tourism. Seeking reproductive treatment abroad is expensive, which leads to socio-economic disparities.

In 2015 the legislation of Austria passed a renewed law for ART (Fortpflanzungsmedizinrechts-Änderungsgesetz 2015) Since 2015  heterosexual and same sex female couples can use sperm and egg donation  as well as in restricted cases preimplantational genetic testing. 

Slide 28 Theories behind the changes in the regulations of ART

Comparison shows a value shift in recent decades in many countries from basic scepticism concerning ART towards increased acceptance. This shift manifests in ART regulation which in general become more and more permissive. Still, countries differ, as the following examples show, when, on what topic, and in what context this change happened.

In the 1980s and 1990s, government in Denmark was very reluctant about ART. A clear indication for change towards more acceptance was replacing the initial term “artificial” in the naming of the relevant law with “assisted reproduction” in 2011 (Smart 2009).

So there are lots of points to be debated should there be a homogeneous law in Europe?

who are the decision makers? political, religious and specialists point of views, lack of a social consensus or compromise psychological aspects: effect on the couple, effect on the child born after autologous ART and donations. 
ethical arguments: autonomy of the infertile couple, bene and non maleficience, motivation of the donations, exploitation of donor/ surrogate, 

-> Difference in regulations lead to „Fertility Tourism“ 

Fertility Tourism

Over 97% of infertile couples are actively considering the concept of a fertility journey.

Cost does not appear to be the primary reason for all travelers, with the possible exception of younger patients who do not have comparable access to financial resources as their older counterparts.

Surprisingly, providing anonymous donors isn't the main determinant of the fertility traveler either — although it is important for some. It is much more the possibility of different treatments and feedback from patients who have returned from treatment.

Recently, more fertility clinics have opened in different places and the fertility tourists are overloaded with the number of choices. Countries that have traditionally done well in treating international patients continue to do so - Spain, Greece and Cyprus remain popular, but new markets such as the Czech Republic and Ukraine are becoming increasingly popular. At the moment the war in Ukraine forced fertility centers to reduce or stop their current activites.  

Efficient and reliable regulatory frameworks are also important drivers for patients and this is a reason for patients to seek treatment in countries like the United States and the United Kingdom. Visitors to treatment providers in these countries are not necessarily driven by price but by the reassurance and perception that they are receiving quality, regulated treatment that is performed professionally.

Yet there is no such thing as a general fertility tourist. Everyone has a different portfolio of needs, demands, expectations, doubts and fears and must be treated as an individual.

Nevertheless, the worries that torment patient couples,- be it the language barrier, travel arrangements or the legal framework- should not be ignored.

Europe moves towards complete statutory regulation of assisted reproduction. But large variations still exist in how the legislation is applied. So what are the real questions behind the legal regulation and practice of assisted reproductive technology?

• Issues of moral politics which are socially highly controversial
• Discussion is about value conflicts, 
• New and traditional family forms
• Forms of sexuality
• The status of the embryo
• The attitude towards disability
• Negative and positive eugenics
• New forms of exploitation of females
• Growing global inequality because of the costs of assisted reproductive technology. 

All of the above described data might change in time as ART regulation is subject to frequent legislative changes. 

C. Calhaz-Jorge, Ch De Geyter, M.S. Kupka, C. Wyns, E. Mocanu, T. Motrenko, G. Scaravelli, J. Smeenk, S. Vidakovic, and V. Goossens. "Survey on ART and IUI: legislation, regulation, funding and registries in European countries ." Human Reproduction Open 2020: 1-15.

Fincham, Anita. fertility europe. 10 December 2021. 08 December 2022. <https://fertilityeurope.eu/european-atlas-of-fertility-treatment-policies/>;.

European IVF-monitoring Consortium. ESHRE. 31 December 2020.  08 December 2022. <https://cm.eshre.eu/cmCountryMap/home/index/2021>;.

Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the Foundation for the Development of the Education System. Neither the European Union nor entity providing the grant can be held responsible for them.