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Embryo Freezing And Gamete Donation: Malta’s Laws On Assisted Reproduction Have Just Changed, And Here’s What That Means

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You may have blinked and missed it, but yesterday heralded a not-unsubstantial change in the way all things fertility-related are to be regulated in Malta. The amended law on assisted reproduction was approved and passed and started being implemented as of 1st October.

What I will attempt to do is give you a little summary of what can and can’t be done in Malta from this point on, and what has actually changed. Once again, I’ll refrain from rhetoric and judgement. You’re all grown-ups and capable of forming your own opinions, however, the unfortunate (or fortunate) thing is, the die has been cast and this is the law that Maltese residents must abide by for the foreseeable future.

1. More people are eligible for assisted reproduction

The law passed in 2012 allowed two people of opposite sex to undergo any form of assisted reproduction. In the case of in-vitro fertilisation (IVF), these people had to be married or in a stable relationship for at least two years.

The woman had to be over 25 years of age, but under 43. With the new amendments, this rule has been flushed down the toilet of non-inclusiveness. Now, any person over the age of 18 can apply for assisted reproduction, including IVF, regardless of gender or sexual orientation. Women can have IVF up until the age of 48. The whole couple thing is gone too. Single people can apply for assistance, which brings us to the second point.

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2. Gamete donation is legal

Gametes (sperm and eggs) were illegal to donate up until last Monday.

Any couple in which one of the people could not produce gametes were forced to either lump it or seek treatment abroad. Now, the legislation allows for donation of both sperm and eggs, by people over the age of 18, but under the age of 36. Sounds great! But…

3. Gamete donation is highly restricted

Each donor can make one donation of gametes. In simple terms, that means one collection of sperm from a man, or one collection of eggs from a woman. This one donation can only be used by one recipient. And once that one recipient has made use of gametes from that donation, whether they are successful in bringing a child into the world or not, they are limited to the use of gametes from that one donation. What does this mean, in real-life terms? Say Suzy and Jessie are a lesbian couple who wish to have a child. They decide that Suzy will bear the child and that they will use donor sperm. They choose an anonymous donor, who has given a semen sample a few months ago, which lies frozen, awaiting to be thawed and used. Suzy undergoes insemination (injection of semen into the vagina or uterus) with some of the donor’s semen. She does not get pregnant. She tries again the following month. Once again, she is unsuccessful. The next month she tries again, with what remains of the donor’s semen. She is unluckily unsuccessful and her donor’s semen sample has finished. Suzy cannot use any other donated gametes in Malta. Ever again. One donor, one donation, one recipient. Regardless of outcome. Anyone in Malta who tries to assist her with gametes from another person, or even with gametes from the same donor given at a different donation, will be breaking the law.

The rationale of this part of the law is to eliminate consanguinity: basically if Mario is allowed to donate sperm every other day of the week and to give it to as many women as necessary, the chances are that there will be many little Marios and Marionettes running around in a few years’ time. Two of these, not knowing who provided the sperm which formed half of their genetic code, might meet and decide to make babies together. This would mean that two half-siblings could potentially produce offspring. For various genetic, ethical and cultural reasons, this is not a good idea. However, this does not explain why, if a donation is unsuccessful (meaning no child is born), a recipient cannot turn to anther donor for help.

If you’re willing to take this risk, and are hoping to get a donation of gametes pretty soon, you need to hold your horses. Malta does not yet have donor gamete banks, nor is a donor system set up as yet at Mater Dei Hospital. Although these are presumably things that will happen in the (hopefully) near future, at the moment gamete donation is legal but not practically available on the public or private sector.

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4. Assisted reproduction is more tightly regulated

Whereas before, should a woman wish to have intra-uterine insemination (IUI), all they needed was to present a semen sample from their partner to their nearest friendly gynaecologist, and he or she would gladly inject it into their uterus, now all IUI procedures need to be reported to the Embryo Protection Authority (EPA). Also, IUI can only be performed by centres licenced to perform it.

(IUI can be used in situations where there is a problem getting pregnant which does not necessarily warrant IVF yet. It is cheaper, safer and, until now, easier to perform than IVF, although it is less likely to succeed.)

5. Embryo freezing is legal

Except that it was legal before… under exceptional circumstances. So, let’s recap what we were able to do from 2012 until 30th September 2018.

We could attempt to fertilise two eggs per woman. In certain circumstances, we could apply to fertilise three eggs (depending on the judgement of the EPA). Any eggs which were fertilised (producing embryos) had to be transferred into the woman’s uterus. The only exception was if the woman’s health suddenly made it inadvisable to transfer the embryos; a situation which actually occurred twice. From now on, this has been changed.

First of all, the transfer of any more than two embryos is now illegal

This is a good thing in that it decreases the risk of triplet and higher order pregnancies (triplet pregnancies are considered much higher risk than singleton or even twin pregnancies).

Now, depending on the woman’s medical situation, doctors can apply to fertilise up to five eggs. The EPA takes the final decision on each request. So, potentially, a woman might end up with five embryos. In reality, this is quite unlikely, since attempting to fertilise five eggs will not often result in five embryos. Also, since Nature is wasteful in itself, not all embryos are equal. Many embryos are not destined to become children. A high proportion of embryos, both naturally and in IVF, will fail to develop past a certain stage. So increasing the number of eggs in which fertilisation can be attempted will probably increase the chance of ending up with at least one good embryo which can be transferred. However, this depends on some obstacles along the way. Doctors might decide there is no reason to apply for fertilisation of more than two eggs and the EPA might decide that there is no reason to allow fertilisation of more than two eggs. The potential parents themselves might decide not to opt for this option. Unfortunately, quite a bit of uncertainty for an already stressed patient.

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So, what happens if there actually are embryos which are created and do not get transferred?

These embryos will be frozen.

The government will then allow for the eventual transfer of any frozen embryos a potential parent may have, up to a maximum of two at a time, until the woman uses up all her frozen embryos. This is regardless of whether these embryos result in a live birth or not. Women can only fertilise more eggs after any existing frozen embryos are transferred. But wait; IVF is only legal until the age of 48. So what happens in the (very unlikely) situation that a woman gets to 48 and still has frozen embryos? What happens if she has frozen embryos that she does not wish to transfer? Many reasons for this exist. She might be successful at her first try and not want more children. She might have health problems that don’t allow her to be pregnant again. She might even pass away. What then?

Maltese law does not allow for the disposal of embryos under any circumstances

All surviving embryos created must be transferred. So, any embryos left over will have to be given up for adoption. This is a pre-condition that potential parents must consent to before any fertilisation attempts are made.

So patients are faced with a choice: not consent and decrease your chances of success, or consent and potentially (although in practice, rarely) have to give up embryos for adoption? Not an easy or fun choice to make.

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Some things are completely absent from the law. Surrogacy is one of them. With this law, a female same-sex couple can get assistance, but a male couple is stuck in that they don’t have a uterus to gestate a pregnancy in. Similarly, women who are born without a uterus or have had it removed are still unable to get help in having children.

So there it is. This is obviously a highly simplified version of a very long amendment to a very long law. But the general gist is that. Is the amendment good news or not? I’m sure you have an opinion about that, but truth is, only time will tell.

Max Dingli is an obstetrician and gynaecologist working at the Assisted Reproduction Technologies Clinic at Mater Dei Hospital.

What do you make of the recent amendments? Let us know in the comments below

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