An idiot’s guide to how Maltese IVF law will change

MaltaToday gives a simple guide to the salient changes being proposed to the Embryo Protection Act and the ethical arguments that may follow

The Embryo Protection Act is in for a radical overhaul that will make in-vitro fertilisation accessible to more than just different-sex couples. The changes are also aimed at increasing the chances of infertile couples to conceive a child.

But the proposals put forward by the government also tread ethically contentious territory. This is a simple guide to the salient changes being proposed and the ethical arguments that may follow.

HOW THE LAW WILL CHANGE

Eligibility for IVF

IVF will be available to a wider range of people, including lesbians
IVF will be available to a wider range of people, including lesbians

Current law: IVF can only be provided to adult heterosexual couples who are either married or in a stable relationship. Lesbians are excluded despite the introduction of same-sex marriage last year and civil unions three years earlier. Single women are also excluded.

The new law: The definition of prospective parent will change to cover any adult person, irrespective of gender or sexual orientation. This will make IVF available to all women, including singles and lesbians. The inclusion of surrogacy may also open up the possibility for the whole spectrum of the LGBTI community to have a baby.

Egg fertilisation

Doctors will be able to fertilise up to five eggs if prospective parents agree that unclaimed embryos be given up for adoption
Doctors will be able to fertilise up to five eggs if prospective parents agree that unclaimed embryos be given up for adoption

Current law: The law prohibits the fertilisation of more than two eggs. It does allow an exception for three eggs to be fertilised, if this is medically necessary in some cases and doctors would first have to seek the authority’s consent. Statistics show that in 40% of cases doctors have asked for permission to fertilise three eggs. All embryos produced have to be transferred to the womb.

The new law: Doctors will be able to fertilise up to three eggs in the first cycle and five eggs in any subsequent cycle. However, if the prospective parents do not consent to embryo freezing and the subsequent adoption of any unclaimed embryos, doctors will only be able to fertilise up to two eggs in all cycles of the treatment. In all instances, the maximum number of fertilised eggs that can be transferred to the womb in any one cycle will be two. Any extra embryos will have to be frozen.

Embryo freezing

Embryo freezing will become an integral part of the IVF process
Embryo freezing will become an integral part of the IVF process

Current law: It is illegal to freeze embryos as part of the IVF treatment. The only exception is in cases - referred to in the law as force majeure - where implantation of embryos cannot take place because of something that happened to the woman. So far, there has only been one case where this has happened and two embryos had to be frozen because the mother fell ill before the implantation process.

The new law: Embryo freezing will be allowed subject to an agreement between the prospective parent or parents and the authority. The authority can issue a five-year permit to the prospective parents allowing them to freeze extra embryos if they agree to give up any unclaimed embryos for adoption. Given that the new law allows the fertilisation of a maximum of five eggs, of which only two can be implanted in the womb, embryo freezing becomes an integral part of the IVF process.

Adopted embryos

Prospective parents can choose to have a baby by adopting a frozen embryo
Prospective parents can choose to have a baby by adopting a frozen embryo

Current law: Although the authority can put up frozen embryos for adoption the law does not give a detailed outline of how this should be done. There is a one-year time frame from when the embryo is frozen by which the authority can proceed with adoption but makes it incumbent on the authority to consult with the prospective parents before proceeding with the process.

The new law: The authority can give up unclaimed frozen embryos for adoption, in a process that is better defined. The authority can proceed with adoption if the parents of the embryo decide not to renew the five-year certificate granted them to freeze embryos, or if the prospective mother reaches 43 years of age. The law makes it clear that the person adopting frozen embryos cannot have embryos originating from different couples, implanted into the womb at the same time. Once the adoption takes place, the original parents lose all rights on the embryo and are exempt from any obligation towards it.

Sperm and egg donations

Sperm and egg donation will become legal
Sperm and egg donation will become legal

Current law: Sperm and egg donations are illegal. Only gametes from the prospective parents can be used to produce embryos that will then be implanted in the same woman from which the eggs were harvested.

The new law: Sperm and egg donations will become legal. Prospective parents can identify the donors or donor, in which case, the identity of the person will be known to them. The donor or donors cannot be next of kin.

However, prospective parents can also benefit from gamete donations by using sperm and oocyte banks. In this case, the donor will remain anonymous.

The law will make it incumbent on the authority to hold a register with medical and other information on the anonymous donors. This information will be made available to the child born from the donated gametes upon reaching 16, or to the parents if required.

All donors, whether known or anonymous, have to be 18 and older, but women who donate eggs cannot be older than 36. Donors can only make one donation, and the gametes can only be used in one prospective parent.

Sperm and oocyte banks

New law will regulate sperm and oocyte banks
New law will regulate sperm and oocyte banks

Current law: The principle legislation makes no provisions for sperm and egg banks but regulations drawn up by the authority do allow the freezing of unfertilised eggs that are harvested from the woman who will make use of them. There have been IVF processes at Mater Dei that used frozen oocytes.

The new law: The law proper makes provisions for the creation of regulated sperm and egg banks, where gametes can be frozen for future use. Sperm can be preserved throughout the lifetime of the person from which it originates, while oocytes will have to come from women with a maximum age of 36. Eggs cannot continue to be preserved after the death of the woman from whom they originate. However, the law will allow the use of sperm and eggs of people who die but would have previously made a direct donation of their gametes.

Surrogacy

A discussion will start on altruistic surrogacy
A discussion will start on altruistic surrogacy

Current law: Surrogacy of all types is illegal and the doctor performing the IVF or embryo transfer can be punished by a fine ranging between €5,000 and €15,000 and a maximum three-year prison sentence. The surrogate mother’s punishment is decreased by one or two degrees.

The new law: Surrogacy against payment will remain illegal and punishable as it is today. But altruistic surrogacy may be allowed. However, the introduction of altruistic surrogacy is not automatic because it depends on the minister making rules on how it can be practised. Health Minister Chris Fearne has said this part of the law will be subject to a public consultation exercise. The introduction of altruistic surrogacy could mean that women unable to carry a child in their womb, will still be able to have a child but it also means that the whole spectrum of the LGBTI community could use surrogacy as an option to become parents. However, the manner by which surrogacy can be practised will depend on the type of regulations to be introduced, if at all.

Embryo research

Research on embryos will remain illegal
Research on embryos will remain illegal

Current law: Preimplantation genetic diagnosis (PGD) and research using embryos are both illegal.

The new law: PGD and research using embryos will remain illegal.

ETHICAL AND LEGAL IMPLICATIONS

Why is embryo freezing contentious?

Objections to embryo freezing stem from the core argument as to whether an embryo has a distinct right to life, over which there are opposing scientific, moral and religious views.

For those who believe the embryo is a human being vested with rights, any attempt at destroying or freezing it, is construed as a breach of the embryo’s right to life. However, there are those who argue that freezing is not equivalent to termination because life is being preserved.

Others contend that the embryo is only a group of cells, which cannot be vested with rights normally assigned to a person and so no ethical considerations should arise.

But the dilemma is not only whether to freeze embryos but what will happen to them if they remain unclaimed. Frozen embryos can be allowed to perish naturally or be given up for research apart from adoption. The new law retains the ban on embryo research and by obliging parents to give up unclaimed embryos for adoption, tries to minimise the number that will remain frozen.

Egg freezing is not ethically controversial
Egg freezing is not ethically controversial

Does egg freezing come with the same ethical dilemma?

No. Unfertilised eggs do not carry the same ethical and moral implications as embryos. But most experts contend that the success of an IVF programme depends on the judicious use of both egg and embryo freezing.

Can gamete donation and embryo adoption lead to people unwittingly marrying their sibling in the future?

Anonymous gamete donation may lead to such a circumstance but the new law has an inbuilt safeguard that limits the number of donations a person can make to one time. This zeroes the chances of having two people born in different families from the same sperm. However, the chances of siblings getting married because they do not know they were conceived from the same parents, are higher with embryo adoption. But according to the Health Minister, international studies have shown that this risk is less than what it is in ordinary circumstances.

What are the ethical implications of surrogacy?

The principle concern is the dignity of the woman that will carry someone else’s baby and the implications of what some believe is the commodification of the womb. Others believe surrogacy is a noble act of altruism that is no different from someone offering a kidney to someone in need. However, some argue that surrogacy will intentionally deny the baby from the maternal bond that would have developed throughout the pregnancy. Other ethical issues concern multiple parent babies, whereby the child is conceived by a surrogate mother from donor gametes. The new law only bars surrogacy against payment but the rules laying out what is permissible and not will have to be defined at a later stage by the minister.

The right of the child to know who her biological parents are is a legally contentious matter
The right of the child to know who her biological parents are is a legally contentious matter

Are there legal implications with donation and surrogacy?

The legal standing of the third party donating the gametes or offering her womb to carry the baby are one set of complications. The new law makes it clear that any child conceived by either of the two methods will be legally bound to the prospective parents. But a more significant stumbling block may be the child’s right to know who his biological parent or parents are in the case of gamete donation. Anonymous donations were stopped in the UK after a woman, conceived through donor gametes, won a court case that determined it was her right to know about her identity. The new law in Malta tries to mitigate the problem by ensuring the child will get access to important information on the donor but it stops at that. It will probably have to be tested in a court of law to determine whether this will be enough.

THE IVF PROCESS 

How does the IVF process start?

IVF starts with a course of hormone therapy for the woman, which is taken as pills and injections. This stimulates the development of eggs.

Is it painful?

It is uncomfortable and can pose the risk of hyper stimulation if the eggs grow too much. To avoid this, doctors normally ask the woman to have regular ultrasounds towards the end of the cycle to monitor egg growth. This adds to the anxiety.

What happens when the eggs are of the right size?

The woman undergoes a minor operation by which the eggs are harvested from her body and placed in a petri-dish. On the same day, sperm is collected from the partner or retrieved from a donor. In some instances, extra eggs can be frozen for future use, without the need to undergo the stimulation process.

Egg fertilisation in IVF happens in a petri dish
Egg fertilisation in IVF happens in a petri dish

What happens next?

At this stage doctors try to fertilise the eggs by putting the sperm in the same petri-dish in the hope that fertilisation occurs, normally within 24 hours. If fertilisation does occur, an embryo is formed. In some cases, a sperm is actually injected into the egg to aid the process. This is called ICSI. The embryos are left for three or four days in the petri-dish before being transferred to the woman. Under the new law doctors can try to fertilise more than two eggs and so the extra embryos can be frozen for future use.

How are frozen embryos used?

They first have to be thawed before being implanted in the womb. If they remain unclaimed the authority can give them up for adoption. If nobody adopts them they will remain frozen and likely to deteriorate naturally over time.

Does this mean that all embryos transferred to the woman will result in live births?

No. The take-home baby rate for IVF treatment in 2016 stood at 20%. This is why doctors prefer treatment options that allow embryo freezing, because this gives the prospective parent a greater chance to become pregnant without having to go through the trauma of stimulation at every cycle.

Why are doctors prevented from implanting more than two embryos?

Paediatricians have often raised concerns about the health risks associated with multiple pregnancies as a result of IVF processes. The transfer of two embryos, which at the most can lead to twins, seems to be a widely-accepted protocol. Transferring two embryos does not automatically translate into twins because either both or one of the embryos may be rejected by the body.

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