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IVF legislation in Greece

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ivf-regulations-greece
Elias Tsakos MD, FRCOG
Medical Director , Embryoclinic
From this event you will find out:
  • What is the legal framework of IVF in Greece?
  • What number of embryos is possible to transfer?
  • Is surrogacy allowed in Greece? What are surrogacy laws, requirements?
  • What about cryopreservation?
  • Is preimplantation genetic testing allowed?
  • What are the future challenges of IVF laws in Greece?

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What laws are regulating IVF/egg donation treatment in the Greece?

In this session, Dr Elias Tsakos, FRCOG, Medical Director at EmbryoClinic, Thessaloniki, Greece, talked about IVF/egg donation regulations, such as age limit, surrogacy, cryopreservation in Greece.

Dr Elias Tsakos begins the session by introducing himself. He mentions that he has been on the field for about 30 years, has served patients from more than 40 countries all over the world and created families in those countries. He has primarily practiced in the UK, and Greece and has been a member of the College of gynaecologist of London and fellow colleges.
Dr Tsakos’s generation has tried to shape the clinical practice of IVF and has tried not only to serve their patients but also to lead the next generation into improving the practice and the service.

Greece – IVF Legal Framework

Dr Elias explains this is something that the country has regulated and at the moment, although there are a lot of differences throughout Europe, there are quite a lot of common facts and factors within the European Union.
In general, the Greek legal framework is considered comprehensive, liberal, patient-friendly and progressive, although it was instituted roughly about 15 years ago. Dr considers it is time for an update of this legal framework, and part of this update is the fact that they are now working towards increasing the female age limit from 50 to 52 years old.  He considers this would be a huge relief for many patients all over the world, especially the ones who’ve been stranded by the coronavirus issues.  However, for the time being, the general requirement in Greece to undergo fertility treatment is that the age of the woman has to be 50, but hopefully, 52 very soon, that they complete some bio blood tests to ensure their health and also that there’s not a transmission to the child or children. Concerning marital status, there is no inconvenience in Greece. Any female single, married or in a heterosexual relationship of any kind can legally undergo IVF. Human cloning is not allowed in Greece. And there are some particular techniques which are also not allowed, in particular sex selection for family balancing. Social reason is not permitted. Although sex selection and genetic testing for medical reasons are allowed.
Dr Tsakos mentions the patients they accept, which are married and unmarried heterosexual couples, couples in civil partnerships and partnerships in single women. At the moment, same-sex couples, gays or lesbians, are not legally allowed in Greece to undergo IVF.

Information and consent

Dr Tsakos points out the importance of consent because the consent requirements also include a lot of areas that the patients should be informed about, in particular concerning safety and success. If there is a single woman or an unmarried couple, then the consent is in the form of a legal notarized document and part of the consent also includes the future of the cryopreserved material. They must know beforehand what is the possible potential future of gametes stored in the facility.

Number of Embryos Transferred

Regarding the matter of the number of embryos transferred in each cycle of is up to the clinical judgment. However, there are some very strict rules. In women under the age of 35, the clinic is only permitted to transfer one or two embryos. In women between 35 and 40, using their eggs, the clinic can transfer up to two embryos in the first and second cycles, but three embryos are allowed in the third cycle. Then, for women over 40 using their eggs, they may be transferred up to four embryos. This is taking into account the fact that there’s a huge possibility of chromosomal anomaly in women over the age of 40. Triplet gestation is avoided since it’s associated with complications.
Moreover, in terms of egg donation, when either donor eggs or donor eggs and donor sperm are used, the clinic can only transfer up to two embryos. Dr judges this is fair considering that the majority of professionals are now aiming to transfer one healthy embryo at a time.

Methods and Techniques

The methods listed below are the only methods and techniques allowed in Greece now.  The doctor points out, at this moment of the session, that Greece is the only country within the European Union in which surrogacy is legal and regulated.

Heterologous Artificial Fertilization (IUI/IVF) – Egg/Sperm Donation

Dr Tsakos explains that the egg donors, by law in Greece, have to be under the age of 35.  However, some units including his only use egg donors under the age of 30. Understandably, a donor in their 20s is highly fertile and potentially highly successful.
Sperm donors by law have to be under the age of 40. And overall, the donation has to be anonymous. The identity of the donor may only be disclosed on medical grounds and cannot be disclosed on any other grounds. Only non-identifying information can be given to the recipient.  Particularly in Greece, photographs, baby photos or any other sort of marketing material, that may be used in other countries of the world, are not used.
In terms of matching the donor, there are very strict criteria depending on the clinic. It is a clinical decision based on physical, genetic and psychological characteristics and none of those details are disclosed. Only non-identifying information is shared with the couple. Conversely, the donors have no access to the offspring and the offspring have no access to the donor.
Donor anonymity is largely standard practice in continental Europe at this time. In the doctor’s opinion, this is one of the reasons why egg donation is popular, and it’s available. Donors come forward because they’re covered by their anonymity, so they can be altruistic and anonymous at the same time.
Sperm donation follows the same rules and discussed before. Fresh sperm donation is not allowed from the third donor. Only preserved sperm is possible, legal and available at the moment. With regard to compensation, there is a compensation, which it’s not a payment, it’s a compensation given to the donor for the physical exhaustion during the donation process and that is   legal and covered by the legal framework.

Dr Tsakos also explains post-mortem fertilization is possible under the following rules and circumstances.

Surrogate Maternity/Surrogacy

Surrogacy has been legal in Greece for many years since 2005. However, international surrogacy has been made possible only in the last seven or eight years. This has attracted many couples and many single women from all over the world to come to Greece for surrogacy. The doctor explains it is legal and regulated and it has some advantages over other countries. According to Dr Tsakos’ opinion, the most important advantage is the fact that the court order and the parental order are issued before the IVF process. This takes away all the stress of the parents regarding the parental order, which is issued beforehand, and it’s a security measure for the surrogate carrier herself that the parents, the commissioning parents, would be the parents of the child.

Dr Tsakos explains there are a lot of issues associated with surrogacy, mentioning a special event to cover all surrogacy issues should be held. He says it is very complex and complicated sometimes since it is a process that involves many people, commissioning parents, surrogates, and sometimes egg donors or sperm donors, among others. It is one of the most complex fertility treatment clinics offer. However, for many couples, this is the only way to childhood, and they need to understand that this is legally regulated and available.

With regards to the carrier, she has to be between 25 and 35 years old.  She has to have at least one child of her own and she’s not allowed by law to use her own genetic material.

Cryopreservation

In Greece, cryopreservation is legal.  It is a common place within the European Union. All the genetic material has to be kept in a licensed cryobank. All IVF units have their cryobanks and there’s a special license in Greece for a cryobank on top of the IVF unit license, to ensure quality and safety.

Preimplantation Genetic Testing (PGT-A)

Dr Tsakos mentions this is a very important advancement of technology and science which has made possible the elimination of some diseases before implantation. Furthermore, over the last 10 or 15 years it has also been used for screening for standard common genetic anomalies that  may be associated with age, for instance down syndrome; and it has also been used to exclude  anomalies that are inheritable.

However, PGT-A in Greece is legal and regulated, it’s been recently implemented that, although all units are licensed, units require a special license to perform PGT-A and to follow certain criteria for that.

Comparison with other nations’ Legislative Systems

Moving on, Dr Elias compares Greece’s and other countries’ systems. Firstly, in Italy, there’s limited availability of egg donation. Although it is legal, it is not available, which is an oxymoron according to the doctor. It was illegal until  2014, but not available at the moment. That is the reason why Italian patients at the moment either have the option of using frozen eggs shipped to Italy by other European countries or they would still need to travel physically to  Greece or other countries, like Spain, Praga and Belgium, maybe to receive egg and sperm donation.

In Germany and Turkey, egg donation is illegal. In France, there’s limited availability of egg donors and that’s why French people travel to Greece.

Fertility Tourism

According to Dr Tsakos, fertility tourism is here to stay. It’s been happening for more than a decade now and it seems to be on the increase. Mainly because of various reasons, but legal barriers is one of those important reasons. There are legal barriers preventing patients from receiving treatment within their own country and therefore traveling to another destination in order to receive  a treatment.

You may be interested in reading: IVF in Greece – costs, availability and legal aspects

Fertility Clinics in Greece

Fertility clinics in Greece are all licensed by the Greek National Authority of Assisted Reproduction. There’s quite a good level of science and technology, regulation and quality assurance. He comments that up until a few months ago, there was no waiting list, but unfortunately due to the COVID situation, some waiting lists are being built up because with all this close and opening uh people are queuing for the opening times. Sometimes clinics cannot cope with the demand. The cost is still affordable. The doctor hopes it can be kept this way, despite the demand for more regulated standards, the demand for COVID compliance, and the demand for quality assurance in terms of ISO standards.

Greece is amongst the very few countries in the  world where fertility clinics are not only required to have high quality standards, but they also need to be ISO certified by regulators from both  quality and management but also on laboratory safety. ISO standards is  a procedure that  not only guarantees quality and success, but also it increases costs. There are excellent reviews about Greece. It is one of the emerging fertility destinations.

The authority that regulates the units is responsible for the accreditation, designation and licensing, and keeping the register of activities. They refer to the European Society of Human Reproduction and Embryology, where they publish results there. All professionals receive all the guidance and updates on science and technology.

Conclusions

The doctor mentions some of the future challenges in the legal framework of Greece. One of them is the age limit, which the doctor mentions the possibility that in the next few weeks, the announcement of the increase of the legal age limit for females to 52 may appear. That’s in light of the COVID pandemic that has prevented many women from going forward and having their IVF, especially those very near the 50-year-old mark. Moreover, about same-sex couples, there are a lot of talks at the moment between different authorities about whether that should be ethically or legally allowed.

Other future challenges mentioned by the doctor are treating single men, cryopreservation duration and the transportation of genetic material. The last one seems that because of the COVID jurisdictions, physical travelling seems to be becoming more and more complex. On the other hand, this has been proven to be safe, effective and regulated and therefore it is probably going to provide some extra options for patients all over the world who rightfully wish to become parents.

IVF legislation in Greece | FAQ

Why transfer more than 2 embryos? Since the studies prove that you don’t have any increasing in clinic pregnancies. We are going to SET to all treatments. 

This is an endless discussion. We’re all aiming for single pregnancies and single deliveries. However, as you know, as an embryologist, it’s not just a number, it’s the quality that can be variable. Sometimes, we cannot always guarantee a top-quality blastocyst for all our patients, and even if we do, for a 40-year-old or a 42-year-old, a top-called blastocyst doesn’t mean that this blastocyst is euploid is chromosomally normal.

So, double lambda transfer will always be an option, and also apart from the scientific, clinical and ethical point of view and apart from our agreement that we wish to go for single embryo transfers of a normal euploid embryo, there is the human factor as well. If our patients request for their own reasons that they wish for a double embryo transfer, I don’t think we can refuse or deny them that option. So, of course, whether that increases the chance of a single pregnancy, depends on the quality, of the patient’s characteristics. Again, I think it’s an endless discussion. All I mentioned in my talk was the legal regulation and I think it’s very important that in Greece, it is legally not allowed to transfer more than two embryos as a general rule, which is a very good step forward as we know that in many countries, even within Europe, they can transfer up to three or four embryos with disastrous outcomes.

How much does the surrogacy cost in Greece? 

To be honest, I don’t know. This is not up to me. I’m a medical director and clinical doctor. However, all I can say is that it’s expensive. It’s a very complex and expensive type of fertility treatment. It’s the end of the road for some couples. Thankfully not many couples,  but for some couples this is the only way to parenthood. The only way to achieve parenthood. It is an expensive, stressful and complex procedure that takes a long time to be accomplished. A minimum of maybe one and a half to two years. It’s very costly. However, if you’re particularly interested drop us an email at info@embryoclinic.eu, and I’m sure that my coordinators should be able to answer you specifically.

What genetic tests do you do to donors?

We do the standard genetic tests that most people do which include a karyotype and the full cystic fibrosis gene testing, not just the df508, which is the commonest cystic fibrosis gene. We do the entire range of gene testing, which covers 99.9% of possible mutations. On top of that, we test for fragile X. These are genetic tests. Also, we’ll do more testing apart from genetics, which includes all the viral testing. I would do a formal psychological assessment and so forth.

What is the approximate cost for donor egg donation?

I still don’t know exactly the figures, so please drop us an email at info@embryoclinic.eu, and we should be able to answer that. Egg donation is also a complex procedure, not as complex as surrogacy. However, it involves a lot of work, a lot of counselling, and screening of the donors. In my clinic, we only accept probably about one in five donors who come forward. As I mentioned, we only accept donors under the age of 30, so a good proportion of the potential donors are excluded by age alone. So, if they’re over 30, although legally it is allowed up to 35 years old, they’re rejected.

We run various tests, including the genetic tests I mentioned, plus all the viral testing. We do microbiology testing. Of course, the psychological assessment and so forth. So only one in five donors are accepted in our program. And as you realize the added cost of that is, apart from the screening costs, it’s the cost of donor drugs, the stimulation drugs, the monitoring procedure, and the compensation which is legal and acceptable both ethically and legally in Greece. That increases the overall prices; however, egg donation is reasonably priced. It is roughly about half the price compared to the UK. It’s maybe 30 % cheaper than in Spain, and it’s the same as in the Czech Republic, just to give you a rough idea of the exact figures.

How much does IVF cost in Greece?

IVF in Greece is between three and three and a half thousand euros. Depending on whether, for example, there’s freezing or whether there are some adults in the lab. So, a rough figure is three to three point five thousand euros now. Unfortunately, there is a possibility that prices may increase because of the covid. Most of the products have started to increase, most of the technological equipment is increasing for some reason that perhaps some of us don’t understand and so forth, but at the moment the prices have remained the same, and it’s more or less at that level.

Do you exclude donors when you find a recessive monogenic abnormality?

Yes, we do. As I said, in my clinic we have a very low threshold in rejecting donors and so any abnormality, either in the history or in psychological assessment, or in the genetic testing any minor abnormality would be a reason for rejection.

Just to clarify regarding genetic testing, how many of the actual carrier-testing diseases are tested, for example, here in the US there are 301 genetic diseases that are tested. Do you do all these 301?

We do the standard testing that I mentioned and as I said in my clinic on top of the standard we do some extra tests, for example, the XY microdeletion, and also, of course, we test for thalassemia because in Greece thalassemia is a genetic disease fairly common. On top of this, of course, if the couple wishes, we can test for 301 genetic diseases, we also have a package for 500 genetic diseases and all that.

In request, we can test for anything that any couple would wish to test. Of course, in the US, as you probably know egg donation is probably seven to ten times more expensive than it is in Greece and this is one of the reasons why we have a lot of US patients flying out to Greece for the donation. We have one from Detroit coming next week for the second baby, having delivered the first one successfully. So, there’s no end to genetic testing and on request, anything could be done. There are costs of course but on top of that the cost-effectiveness of treatment increases is very favourable and that’s why Greece is so popular.

Just to clarify regarding genetic testing, how many of the actual carrier-testing diseases are tested, for example, here in the US there are 301 genetic diseases that are tested. Do you do all these 301?

We do the standard testing that I mentioned and as I said in my clinic on top of the standard we do some extra tests, for example, the XY microdeletion, and also, of course, we test for thalassemia because in Greece thalassemia is a genetic disease fairly common. On top of this, of course, if the couple wishes, we can test for 301 genetic diseases, we also have a package for 500 genetic diseases and all that.

In request, we can test for anything that any couple would wish to test. Of course, in the US, as you probably know egg donation is probably seven to ten times more expensive than it is in Greece and this is one of the reasons why we have a lot of US patients flying out to Greece for the donation. We have one from Detroit coming next week for the second baby, having delivered the first one successfully. So, there’s no end to genetic testing and on request, anything could be done. There are costs of course but on top of that the cost-effectiveness of treatment increases is very favourable and that’s why Greece is so popular.

Do you do PGT-M for embryos that have a specific disease above the usual PGT 24?

Yes, we can. I mean technically we can test for anything under the sun and of course that requires a medical indication. 

Do you know if surrogacy or donor eggs are legal in Ireland?

Surrogacy is not legal because to my knowledge Greece is the only country within the European Union at the moment, not even Spain which is the mecca of IVF as we all know is offering legal services. So, within the European Union, Greece is the only option at the moment.  Of course, in continental Europe, there are other options like Georgia, Ukraine, and Russia for surrogacy and I think that’s about it in Europe. Then it’s the United States. Regarding egg donation, I’m not exactly familiar what is the situation in Ireland, to be honest.

What is your opinion in the foreseeable future regarding anonymous donors, will you be able to see photos of donors maybe?

I don’t know, I’m sorry. Now it’s anonymous. I think it’s going to stay anonymous for quite a while because, as you probably know in continental Europe including Greece, it’s not very easy to change the laws and my feeling is that it’s going to stay anonymous for a long time. However in selecting donors, although it’s a wonderful marketing tool to show photographs, trust me I don’t look anything like what I used to when I was a child. So, I think it’s nice and happy for many people to see what the donors look like, but I don’t think it has so much to do with reality when it comes to the actual child.

As far as I’m concerned, as a clinician and a doctor with more than 30 years of experience now, the most important is not perhaps the looks or the baby’s looks or the young adult’s looks, what’s most important is the general characteristics, the genetic characteristics, the age of the donor of course and some other factors that perhaps are not very good for marketing, but they’re good for the substance of the whole of the egg donation process and in Greece, in Europe, in my clinic, it’s the medical team that guarantee them the matching, the selection of the perfect donor for every single woman and every couple that we treat. This is a huge responsibility but believe me, thankfully it is possible, and it is creating beautiful families all over the world.

Do you use Lupron Depot for patients with endometriosis before frozen embryo transfer? If yes, for how many months before the transfer?

Endometriosis is one of my passions, and it’s a disease that affects a lot of women. It’s a disease that is causing a lot of problems in the everyday life of those women. Not just infertility but also other problems and, of course, we have to address that it’s the silent epidemic in my opinion. So, whether I use Lupron or not depends on the endometriosis is the answer. It depends on the stage of the endometriosis, on the previous history of that woman and so forth. It’s not a very easy answer to give.

I try to individualize and, to be honest, I’m a great believer in the surgical management of endometriosis. I feel that endometriosis is best treated surgically on many occasions, especially when it’s creating symptoms. So, I prefer not to have endometriosis at all. I prefer to have successful surgery, either laparoscopic surgery or robotic surgery for endometriosis, before attempting fertility treatment. 

However, if there is endometriosis, they are either visible on a scan or an MRI or clinically palpable or clinically suspicious endometriotic lesions, then yes, I would consider using Lupron. I must admit that I am a big fan of Lupron overall for frozen embryo transfers anyway. And maybe one of the reasons is that always in the back of my mind that there may be a possibility of undiagnosed endometriosis. Although I don’t like to think or to see endometriosis when I want to do embryo transfers or just before the end of the transfer, however, yes, I’m usually tempted to use Lupron how many months depends on the answer maybe six to eight weeks. 

You have mentioned before that male fertility is often overlooked. Why is it so important to address this thoroughly?

Male fertility has been neglected. Sperm quality is not only a fertility marker but also an indicator of overall male health.

A man with low sperm count at 35 may not only be subfertile but may also have underlying health issues. Semen analysis should be viewed as a general health assessment.

In our practice, we diagnose approximately one case of testicular cancer per month during fertility investigations. Early detection can be lifesaving.

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