[EXPLAINER] IVF round 3: Embryo genetic testing and the protocol

Malta’s in-vitro fertilisation law is set for another overhaul but this time government is shifting the onus of detail onto the Embryo Protection Authority’s protocol.

The proposed changes lay emphasis on EPA’s role to draft a protocol where important details such as how many eggs can be fertilised in one cycle and which genetic diseases can be tested for will be listed.

This marks a departure from existing legislation, which in many aspects defines clinical and scientific restrictions. This may all sound legalistic hogwash but it does respond to concerns raised over the years by IVF practitioners, who wanted a nimbler process that allows EPA to respond to scientific developments and patient needs.

What does this mean? Well, the law retains the obligation imposed on legislators to discuss and approve any protocol published by EPA within four weeks. The law also says such a discussion should take place in parliament’s health committee.

This is a more expedient way of approving changes to protocols proposed by EPA than having to change the law itself, which is a more cumbersome process.

Today, the IVF law itself limits the maximum number of eggs that can be fertilised to five. Government is now proposing that the law only makes reference to a maximum number “as defined in the protocol”.

Another example involves pre-implantation genetic testing for inheritable diseases. This is a new aspect being introduced by the proposed changes but rather than putting the clinical and medical details in the law, these will be defined by EPA’s protocol.

So, the law does not make a list of genetic diseases that can be tested or define the eligibility criteria for them. Again, it enables the process to take place but makes reference to the protocol for the details. This makes it easier in the future for EPA to increase the list of genetic disorders or change eligibility criteria through a simpler legislative process.

Health Minister Chris Fearne has promised that the protocol drawn up by EPA after consultation with experts in the field will be published when the Second Reading of the Bill in parliament kicks off. No reason was given as to why this was not published last Thursday alongside the Bill containing the legal amendments.

Discussing the protocol will be as important as the legal changes themselves, given the significant decision to shift the onus of detail onto EPA.

MaltaToday takes a look at some of the key changes announced by Fearne.

IVF The key changes explained

Pre-implantation genetic testing

Current law: The IVF law allows doctors to carry out “clinical interventions” on embryos, however these have to be “exclusively diagnostic or therapeutic”. The law also makes it a condition that any such interventions are “in the interests of the health and development of the embryo itself”. However, the law prohibits any further medical actions based on the diagnosis. In practice this has stopped doctors from carrying out any genetic tests since the law disallowed any further action and women are still constrained to use all frozen embryos before undergoing another cycle. The law also prohibits the discarding of embryos or giving them up for scientific research.

New law: A new proviso clarifies that it is not prohibited to have clinical interventions “allowed by the protocol”. This gives a wider margin of appreciation to allow for pre-implantation genetic testing (PGT) and required follow-up action. The new law also makes it clear that based on the clinical interventions, parents can choose to freeze the embryos if such a choice is permitted by the protocol. In practice this means that parents with an inherited disease listed in the protocol would be able to have embryos tested so that only healthy ones are implanted. Embryos that are genetically defective will have to be frozen, since the law will still prohibit the discarding of embryos or giving them up for scientific research.

Using frozen embryos before new cycle

Current law: A woman has to first use embryos frozen from prior treatments before fresh eggs derived from a new cycle can be fertilised. This proviso had been introduced to limit the number of embryos that remain frozen.

New law: Women will still have to use embryos frozen from previous cycles before fresh eggs can be fertilised but the law will now allow the authority to make an exception for “circumstances specified in the protocol”. The law itself does not define the specific circumstances, leaving it up to the authority to do so. This proviso is necessary because of the introduction of embryo genetic testing. It would be counterproductive to force a woman to make use of a frozen embryo that would have been diagnosed with a genetic disease. This change allows these women to have fresh eggs fertilised despite still having frozen embryos and thus giving them another chance to have a healthy child.

Eugenics and sex choice

Current law: Embryo selection for eugenic purposes is illegal. It is also illegal to select sperm for the sex chromosome they contain, although doctors can select particular sperm cells to prevent the child from falling ill with a sex-linked genetic illness.

New law: Embryo selection for eugenic purposes will remain illegal but the amendments include a proviso to clarify that embryo selection “in certain exceptional circumstances” is not eugenics. This is necessary because of pre-implantation genetic testing, which means doctors will be selecting which embryos are implanted and which are set aside to be frozen because they are diagnosed with a genetic disease. The other legal provisos concerning sperm selection for sex purposes remain unchanged.

Gamete donation

Current law: Gamete donations are allowed but people who are related by consanguinity (blood relations) and affinity (through marriage) are excluded.

New law: Gamete donations by people related through marriage will no longer be excluded. This removes an anomaly that currently hinders women in a same-sex relationship from donating eggs to each other if they are married. Donations from people related by consanguinity will remain excluded.

Protocol

Current law: Although the law defines protocol as the written document drawn up by the authority and stipulates this should be discussed by parliament’s health committee within four weeks of publication, it does not say much else about it.

New law: EPA’s obligation to have a written protocol that lists the regulatory principles to be followed in IVF processes is more clearly defined. It retains the obligation for the protocol to be discussed by parliament’s health committee within four weeks.

Egg fertilisation limit

Current law: 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. Doctors can fertilise “more than two eggs but up to a maximum of five” in particular circumstances after receiving the authority’s blessing. 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.

New law: The provisions related to egg fertilisation will largely remain the same apart from the upper limit of five, which is being removed from the law proper and being replaced by a reference to the “maximum amount established by the protocol”. The protocol may still stipulate that the upper limit should be five but removing the upper ceiling from the law proper allows the authority to be more flexible if it deems it necessary. Approving changes to the protocol is less cumbersome than changing the principle law.

Import and export

Current law: Prospective parents who had frozen embryos in foreign clinics are allowed to transfer two embryos to Malta per cycle. However, the law only allows this for those who underwent IVF abroad before 2018 when the Maltese law was updated. The law makes no provisions for the export of oocytes and sperm frozen in Malta for use in foreign clinics.

New law: The 2018 limit is being removed so that prospective parents with frozen embryos abroad will be able to transfer two embryos irrespective of when these were frozen. Additionally, the law will allow the export of frozen eggs and sperm but introduces a traceability register.