In this session, Dr Esther Velilla, CEO & Founder of Reproclinic, Barcelona, Spain has explained IVF treatments, and egg donation in Spain.
There is no common legislation on human-assisted reproduction in Europe. Each country has its own law, but there is an overall European directive that is specifically for handling traceability and transport of biological samples, including gametes and embryos. Spain was one of the first European countries that had legislation for assisted reproduction, and this law has been updated several times. In general, it is one of the countries that has one of the most permissive laws. But when it comes to a couple or a woman wanting to have a baby, there are no borders, and they just keep these things and move from one country to another to have the desired baby.
1996: The first law came out in 1996. In that law were stated the protocols for gamete donors and all the protocols for assisted reproduction users, but in a general way, not very specifically. Then, in 2006, we transformed the European directive that specialized in the quality and safety of the donation, procurement, storage, and distribution of human tissues and cells, because you have to consider that gametes are cells and embryos are tissues. So, it’s the same law that regulates organ donation, and we have a very roomy place there for cells and embryos. This law has been transposed and updated several times in Spain, until the law that we have now, with the last update in 2017.
The main flaw of the law that we had from the beginning was that we didn’t have a national registry for egg donation, and we neither had the obligation to present the data to a national system. The law stated that we had to present the data to a general regulation, but at that time, it was managed by the Spanish Fertility Society. This Spanish Fertility Society was not an independent body and was related to different scientists and people in the field who already had some other clinics as well. Few centres were reporting that data at that time.
2015: In 2015, the ministry took this registry through a completely independent body and made the registration mandatory for all clinics. So now, every single clinic must send the annual activity to this registry, and this can be updated randomly for all clinics.
The main aim of the Spanish law is to regulate, in general, just so you know how the law is structured. The main aims are:
The law is based on the principle that they don’t want to accumulate a huge number of embryos stored in the clinic.
We can treat:
The Assisted Reproduction law is very specific. It states that Assisted Reproduction Techniques can only be performed if:
About the clinic requirements:
Let me give you an example:
If a heterosexual couple where both partners signed a consent form for IVF have embryos, transfer one, and have remaining embryos; after some years, things don’t go well, and they divorce. The woman cannot use the embryos for herself unless she has a consent form from the husband, because the husband is the one who signed the consent form. This is very important to note.
Also, on the consent form, the male can indicate what he wants to do with his frozen sperm in the centre in case he passes away. If he has previously signed the consent form stating that he accepts that his sperm can be used for assisted reproduction techniques with his woman in case of his death, this sperm can be used within 12 months from the day of his death. The law doesn’t state that for the woman because, as I said, the law requires a living woman. Therefore, in the event of her passing away, there is no possibility of doing anything.
Additionally, it is not possible to transfer the embryos from one country to another because we need the consent form signed by both members. So, in the event of any loss, the embryos will remain in the centre.
Surrogacy is not contemplated by law. The law does not explicitly state that surrogacy is not allowed or that it is a serious offence. However, there are two important scenarios to consider:
1. The law states that the contract between the biological mother and the intended mother is not valid.
2. The woman who gives birth is considered the biological mother.
With these two scenarios, we can see that there is no legal framework for surrogacy in Spain.
The law aims to avoid having a large number of embryos remaining frozen in the clinic. It stipulates that we have to create enough embryos for the reproductive project of the couple. For example, if a couple only wants to have one embryo transfer and does not want to freeze any embryos, we cannot overly stimulate the woman and must fertilize a limited number of oocytes to prevent having remaining embryos.
The law also states that the only way to terminate an embryo is if it is cryopreserved. The law does not contemplate terminating the maintenance of the embryo without it being cryopreserved. This means that if we have good-quality embryos remaining from a reproductive project, we must freeze all these embryos. We cannot decide to terminate them because the patient does not want to freeze them. If we have remaining good-quality embryos, we need to freeze them, and then the patients will sign the destiny of the embryos as they wish.
In case we have embryos frozen at the clinic, we need to ask every two years by law, –in our clinic, we do it every year because we want to be sure that we know the destiny of the embryos-. We have to ask the destiny of the cryopreserved material. By law, we have four possible destinies:
Sometimes, patients don’t respond to these letters. The law also says that after five years and two consecutive letters without any response (considering there are two years between letters), we can consider the embryos abandoned. If the embryos are considered abandoned, the centre takes responsibility for those embryos and can use them for one of the four destinies: research, a donation to other couples, or termination of storage.
The last thing to explain is that the destiny of the cryopreserved embryos, once signed, can be revoked at any time.
PGT can be done without previous concerns to governing bodies in most cases, first to detect any alterations of the embryos that can compromise their viability. This means that, for example, PGT for aneuploidy screening or PGT for chromosome rearrangements are completely accepted, and we can proceed right away without previous concerns to competent bodies.
For genetic diseases or monogenic inherited diseases that are serious and have no treatment, the interpretation can be challenging. Phrases like “serious genetic inherited illness” and “earlier stages” are difficult to interpret in some neurogenic diseases. What constitutes a “serious” genetic inherited illness, and what does “earlier stages” mean? Does it refer to childhood, or does it include individuals in their 40s, considering the average lifespan of 85 years? For me, 40 years old may be considered an early stage, but it may not be the same for everyone.
Sometimes, when facing monogenic and rare diseases, it’s not easy to decide to proceed with PGT for that specific disease without previous consensus. I may need to present or request permission on a case-by-case basis, which involves paperwork and takes time. Most diseases are accepted, but it’s true that, for example, HLA cases and certain diseases like cancer predisposition must be approved by the competent body.
In terms of research, we can use gametes for research, but we cannot use embryos for this purpose. Additionally, we must not use embryos for commercial purposes. We can only use embryos for research if we have an officially approved research program, and if the embryo has not been cultured for longer than 14 days. Two experimental procedures have recently emerged and have been approved by law and they need special permits from CNRHA: cytoplasm transfer cycles and ovarian rejuvenation.
The maximum number of babies born in Spain per donor is six. We cannot accept any donor who has contributed to the birth of more than six babies in Spain. This regulation is enforced through the national registry, SIRHA, where we must update all donor and recipient information. This system checks if a donor has made previous donations at other centres and how many babies have been born from those donations. If the number exceeds six, the donor is not allowed to proceed, and we cannot perform the treatment.
Clinical data must be preserved for 30 years to maintain the tracking of the donor in case of any adverse effects in the future. Additionally, gamete donation publicity must be approved by the competent bodies. We cannot advertise compensation for donors; the only permissible publicity is that which offers hope and explains the risks and limitations of gamete donation.
A contract between the donor and the clinic is required before the donation. All data from donors and recipients participating in the donor program must be registered in the national registry, SIRHA.
You may be interested in reading: IVF in Spain – costs, availbility and legal aspects
The requirements to be a donor when a donor comes into the clinic include:
General Data
To be eligible for the donor program, candidates must undergo several evaluations:
This comprehensive approach ensures that donors meet the necessary health and genetic criteria to participate in the assisted reproduction program, safeguarding the health of both the donor and potential offspring.
The aim of the national register is:
In terms of revocation of the donation, the donation can only be revoked when the donor needs the cells or gametes for himself; if not, it cannot be revoked.
In terms of safety, we are routinely informing a competent body of adverse effects. We have our (SOP) Standard Operation Protocols for the control and release of biological samples. Additionally, we have the national registry (SIRHA) where all the trustability is registered for all the gametes and recipients from the beginning to the end.
What is the most relevant infraction regulated by law? In general, the most important offences or relevant infractions by Spanish law are:
In general, it’s important to point out that Spanish law:
We have embryos available. These embryos are considered abandoned. Normally, these are good embryos because patients already have one embryo transfer, that has given pregnancy. To transfer there is no issue with this, unless there is some specific phenotype, that is not common in Spain. In such cases, we could have problems or may not be able to find a matching embryo.
No, there is no waiting time in general for gamete donation or sperm donation. We work with a lot of donors, and for example, in our clinic, we work with a sperm bank. There is no waiting list in general unless there’s a very specific phenotype that we don’t have many donors, but it must be a very specific case.
No, because the only egg donation allowed from a family member will be in case of ROPA (Reception of Oocytes from partner) or sub-donation in the case of lesbian couples. When a couple is married, confidentiality no longer exists between both partners by the constitution. This means that we can break the anonymity of the donors, so one woman can give the eggs, and the other woman can receive the embryos.
However, in other cases, for example, if I have a sister that can give the eggs for me or a relative, that’s not allowed because it breaks the confidentiality, and it’s not allowed.
No, we don’t do it at the clinic. PRP is considered experimental research, so we don’t do them. You must get special permission for that, and it’s not yet a standard practice. It’s still considered experimental.
No. It has been for a while during the lockdown in 2020, that we had to stop the clinic’s activities, but things have since returned to normal. There are plenty of donors available, and there’s no problem with that now. We do PCR screenings for all the recipients and donors beforehand, so everything is under control.
Regarding pricing, I prefer not to discuss it here, but I can give you an estimate. It’s approximately half the price of a full IVF cycle, around $3000 or so. However, if anyone is interested in more specific details and non-pricing information, they can contact us for a consultation. During the consultation, we can provide personalized information tailored to their situation because every case is unique.
I’m sorry, but it’s not possible. We receive a lot of questions like yours daily, but unfortunately, it’s not feasible due to legal restrictions. The competent body is very strict on this matter, and they don’t allow certain actions.
For instance, if we need to ship embryos from here to another country outside the European Union, we must ask for permission from the competent body. They do not allow the exportation of human embryos for purposes like surrogacy. I understand this is a concern for many people, but we cannot change that.
It is not that we have a cut-off for that because there are plenty of things to figure out, but in general, we recommend a BMI of less than 30-32. Over that, it could be problematic.
I don’t want to enter into that because I’m not an expert on surrogacy. I think surrogacy is probably not regulated by law. One thing to note is that you have two different situations here: countries where surrogacy is allowed by law and countries where it is not regulated by law.
So, if you are choosing a country for surrogacy, be sure that it has specific laws regulating it to avoid problems. There are some countries you can choose in Europe, such as Russia, Greece, and probably Ukraine. We’ve had some webinars, and we know that Greece and Ukraine definitely allow surrogacy.
I’m not a medical doctor, so I’m probably not the right person to answer that, but we do transfers within an endometrial thickness of 6 to 7 millimetres, which is within the acceptable range.
In general, egg donation is expected to be completely anonymous. However, there is one scenario that is non-anonymous, and it is explicitly contemplated by law. This scenario occurs when two women are legally married because, during marriage, it is considered that there is no confidentiality between both partners. Therefore, in these cases, one of the women can donate the eggs, and the other can receive the embryos. This is the only exception; all other scenarios are completely anonymous.
In general, I could say that no. Based on current legislation, the child is not going to know their genetic parents. However, what can happen is that there are these DNA data banks where, for example, you can take a sample of your DNA, put it in an envelope, and send it to the United States to check who your ancestor is. They take the genetic data, put it on the cloud, and they have all your genetic data.
Imagine, for example, that one donor does that to know whatever they want to know, not necessarily for their donation—they might want to know their ancestors or some other information that isn’t relevant to their donation. If you do the same, all these data could match in the system.
The system is protected to prevent the genetic identity of the parents from being known in egg donation. However, apart from our system, there are many companies and countries with different regulations in terms of data protection. For instance, you could do whatever you want by simply putting your sample in an envelope and sending it to a country with different regulations.
We cannot control what happens outside Spain.
I would prefer if the doctor could answer these questions for this specific case because I specialize in a different area, so I prefer not to say something incorrectly. I recommend you have a consultation with the doctor. As I said, it is for your commitment and initial charge, and you can discuss that with her depending on the doctor you choose.
Southeast Asian donors are very specific and, in general, are not easy to find because culturally, they are not prone to donate. However, we do have some Southeast Asian donors, though not many. If you have specific requests, you might encounter waiting lists for them.
It’s the same pattern. You have to consider that Barcelona, where we are located, is a very cosmopolitan city. We have plenty of students or people who come to Barcelona for work or to study for one or two years. We have a mix of ethnicities here in Barcelona, so we have plenty of diverse donors. However, as I said, some ethnicities are easier to find, and others are more difficult, which might result in waiting lists for some specific ethnicities. But in general, we have a variety of donors available.
Regarding donors, it is challenging to find Southeast Asian and Middle Eastern donors as they are less common culturally. However, Barcelona is a cosmopolitan city with a mix of ethnicities, so we do have some donors from these backgrounds, but they may have waiting lists.
