A patchwork of policies: assisted conception and embryo research in Europe

This session of the Progress Educational Trust (PET)'s 2018 Annual Conference 'Make Do or Amend: Should We Update UK Fertility and Embryo Law?' gave an overview of the regulatory framework of assisted conception and embryo research in Europe.

Chaired by Tim Child, director of the IVF clinic Oxford Fertility, the session kicked off with the reproductive law of Poland and its problems. Professor Robert Spanczyński, Poland's chief national consultant for gynaecological endocrinology and reproductive medicine, began his talk with a historical perspective.

The first IVF baby in Poland was born in 1987. For 28 years following the birth, there was no law relating to medical assisted conception, just professional guidelines. This changed in 2015, with the Polish Infertility Treatment Act. The act is very restrictive; it contains certain medical indications for the actual assisted fertility procedures and defines eligibility for them.

Medical assisted conception is just for married couples, according the Polish law, with single women and same-sex couples excluded. There is no age limit for reproductive procedures, but the law restricts the number of oocytes that can be fertilised at six, unless there is a well-documented condition that affects success, or a couple has had two or more unsuccessful attempts.

The Infertility Treatment Act does not allow embryo destruction to take place, and surplus embryos cannot be used in research. All unused embryos should be used in treatment – if not for the original couple, then via anonymous donation. Embryos can be donated to other couples voluntarily, or can be cryopreserved for up to 20 years. If the legal maximum of 20 years in cryopreservation is reached, then the embryos will be donated to another couple mandatorily. Destruction of an embryo is an offence punishable with imprisonment, for a period ranging from six months to five years.

Some amendments to the Act have been proposed but the tendency has been to try and make it more restrictive, when – according to Professor Spanczyński – the Act already fails to serve best medical practice. Couples who receive treatment are under a lot of stress, which can affect outcomes. Safety can be compromised, especially if a couple has to choose a multiple pregnancy in order to avoid freezing an embryo. Overall, the partial availability and accessibility to certain treatments (for example, due to unmarried status or sexual orientation) and the lack of state funding contribute to a framework of inequality.

The second speaker to take the stand was Satu Rautakallio-Hokkanen, Chair of Fertility Europe. In collaboration with the European Society of Human Reproduction and Embryology (ESHRE, the sponsor of this session) Fertility Europe started a policy audit in 2015. They collected and compared information and policies representing the national fertility spectrum or nine pre-selected European countries – the Czech Republic, France, Germany, Italy, Poland, Romania, Spain, Sweden and UK – in order to identify current needs from a meaningful social and geographical sample.

Their main aim was to create an effective and simple tool for advocacy, awareness and education about fertility preservation. Therefore, they looked at key facts and figures, infertility policies, screening methods and diagnosis, treatment and state funding, awareness raising activities and future outlook. The findings showed that Czech Republic and the UK offered the largest number of treatment options. Among the countries examined, there were a variety of biological factors for determining eligibility of treatment, with age being the common factor. Eligibility criteria based on age, sexual orientation and marital status differed significantly.

Of the nine countries audited, surrogacy was only permitted in the UK and the Czech Republic. Double gamete donation is not allowed in France, Germany or Sweden, embryo donation is not allowed in Germany or Sweden, and egg donation is not allowed in Germany. IVF remains the first line of treatment in many cases, with state funding provision at various levels. The Czech Republic and France fully fund up to four IVF cycles and six intrauterine inseminations (IUI), while Sweden funds three IVF cycles and six IUI. Germany reimburses 50 percent of the first three to four attempts, depending on the federal state, but this applies only to married couples. In Italy, Spain and the UK the funding varies with region, from full coverage in Scotland to no coverage in some parts of England.

The project found that patients across Europe want to see changes in availability of medical procedures, eligibility for treatment and funding. They want justification for treatment limitations, such as when a procedure is not safe or efficient, and to stop discrimination due to sexual orientation, life choices and ideology.

The last speaker was Professor Christian de Geyter, Chair of ESHRE's European IVF Monitoring Steering Committee and head of reproductive medicine and gynaecological endocrinology at the University Hospital of Basel in Switzerland. Professor de Geyter explained that in order for the law of assisted conception techniques in Switzerland to be uniform across the country, it had to be assigned to the Swiss Federal Constitution, which sought agreement from all 26 Swiss cantons.

IVF had a turbulent history in Switzerland. From 1990-1994 it was actually banned in the cantons of Basel City and St Gallen, but a referendum in 2000 resulted in an overwhelming majority for the use of assisted conception. The law regulating IVF came in soon after, on 1 January 2001, which – although it was very restrictive – helped in putting an end to the controversy around assisted conception.

This legislation prohibited preimplantation genetic diagnosis (PGD), embryo selection and cryopreservation. Since then, however, a combination of advocacy by fertility professionals and changing public opinion have helped to make the law less restrictive.

A revised law came into effect in September 2017, and this now allows patients to have up to 12 embryos frozen. These can remain in storage for up to ten years, whereupon they are destroyed. PGD and preimplantation genetic screening (PGS) are now permitted in limited circumstances. Elective single embryo transfer is the preferred choice, helping avoid multiple pregnancies are avoided. Egg donation, however, remains prohibited. Closing his speech, Professor de Geyter said that there is still room for improvement in the Swiss law.

At this point the chair turned to the audience for their questions and comments, and the issue of donor anonymity in European countries was raised. Rautakallio-Hokkanen said that there was great variation in the extent to which donor information is disclosed, but that generally there is a shift away from completely anonymous gamete donation. Professor de Geyter agreed, but said that there should be protection for both the donor and the resulting child. He said that in Switzerland anonymity was regulated by a central agency, which so far had not received a single request for the release of donors' details.

Another question was about the mandatory donation of embryos in Poland, after the 20-year limit on cryopreservation is reached. Professor Spanczyński replied that this aspect of the legislation has not yet been put to the test, as the law came into effect only recently.

Rautakallio-Hokkanen added that Fertility Europe is aware of single women in Poland who froze their eggs in the past, but who are not allowed to use them under the current legislation. Professor Spanczyński said that this issue has created a 'legal vacuum'.

Sarah Norcross, director of PET, asked which places have become popular destinations for fertility tourism and whether this is a problem. We were told that Polish patients tend to go to Georgia, as it has very limited regulations and treatment is cheaper. India is a common destination for surrogacy, and the Czech Republic and the Ukraine are also popular.

Rutakallio-Hokkanen said that regulations are good in her own country of Finland and in other Nordic countries. However, there are some fertility patients in Sweden and Norway who use Finland as a destination. For surrogacy, Finn also go to Ukraine, Russia or even the USA. Rutakallio-Hokkanen added that a lot of British patients go to the Czech Republic, which is a problem as donors there can be exploited.

Overall, it was a very stimulating and informative session. To me, it is evident that with the rapid advancement of assisted conception technologies and the reshaping of the modern family, lawmakers and politicians throughout Europe must keep up the pace. Their priorities should be to address patients' needs and attempt fairness for all.

PET would like to thank the sponsor of this session, the European Society of Human Reproduction and Embryology, and the other sponsors of its conference - the Anne McLaren Memorial Trust Fund, the Edwards and Steptoe Research Trust Fund, JMW Solicitors, Ferring Pharmaceuticals, the European Sperm Bank, the London Women's Clinic, Vitrolife and the Institute of Medical Ethics.