IVF: what reform are Maltese specialists expecting?

The Labour Party has pledged to update the law regulating in vitro fertilisation within the first 100 days of government but has so far refrained from providing detail.

The PL manifesto speaks of “widening the scientific procedures” to give couples with multiple unsuccessful IVF treatments, or who have a medical history, or who have had multiple miscarriages, the chance to become parents.

When contacted by MaltaToday, a health ministry spokesperson said that an announcement on IVF amendments “will be made in due course.”

The most obvious inference from the manifesto pledge is the introduction of preimplantation genetic diagnosis (PGD) to ensure that only healthy embryos are transferred to the woman.

PGD is not currently offered as a treatment option since the existing law makes it illegal to discard embryos that are not deemed to be suitable for implantation due to heridetary conditions or diseases.

The IVF law was amended in 2018 to allow for embryo freezing, sperm and egg donation, the fertilisation of up to five eggs, and the possibility of single women and lesbians to access the treatment.

Government already covers the cost of IVF cycles, which cost between €15,000 and €20,000 each and has pledged to start covering the hormone treatment required in the run-up to the procedure.

But what would IVF specialists like to see in the fresh round of reforms being contemplated?

MaltaToday spoke to Dr Christine Schembri Deguara from Hope Fertility & IVF, who specialises in IVF and fertility issues, and senior embryologist Paul Sultana, a laboratory director at MLS Advanced Ltd, to gauge their views

MaltaToday spoke to Dr Christine Schembri Deguara from Hope Fertility & IVF, who specialises in IVF and fertility issues, and senior embryologist Paul Sultana, a laboratory director at MLS Advanced Ltd, to gauge their views.

Schembri Deguara said that she hoped the IVF reforms would include increasing the age limit of women eligible for IVF treatment and allow doctors to screen embryos before implantation. She also believes surrogacy should be made an option.

Sultana, a pioneer of IVF in Malta along with doctors Josie Muscat and Mark Brincat, said the IVF reforms should include the permission to use all the oocytes retrieved during an IVF cycle, effectively removing the limit of having only five fertilised eggs. He also believes the law should move away from a one-size-fits-all policy, giving specialists more leeway to adapt treatments to their patient’s needs.

Both Sultana and Schembri Deguara agreed that PGD should be introduced for specific circumstances when deemed appropriate by the specialist.

Does the current law restrict IVF?

Existing legislation allows for the creation of up to five embryos at one go.

Schembri Deguara said in a “perfect world”, they would be able to fertilise more eggs. However, she argued that there were ways to mitigate this by testing the eggs and sperm to ensure better quality embryos are created.

“In a perfect world it’s best to fertilise more eggs because this is going to give you more embryos and statistically, a higher chance to achieve good results. However, if you are able to choose those eggs that are good quality and fertilise them in batches, you can still get a good enough outcome and I don’t think you’re decreasing your chance of success substantially,” Schembri Deguara said.

Sultana said that Malta had come a long way in the IVF field but was still lagging behind other countries in many aspects due to several legal restrictions.

“Permission to use all the oocytes retrieved during an IVF cycle in order to identify and choose the best-quality embryos for transfer is one of the procedures which would give couples a better chance of conceiving through IVF, in the process increasing Malta’s IVF success rate,” he argued.

Should pre-implantation embryo genetic testing be introduced?

PGD is a controversial topic in Malta because of its ethical implications. PGD allows doctors to test embryos in couples who risk transmitting certain genetic disorders to their offspring. The tests are done before the embryos are implanted in the woman.

The genetic diagnosis is currently not carried out in Malta since the law does not allow doctors to discard defective embryos or give them up for scientific research, which is normally what happens in countries where PGD is allowed.

Schembri Deguara agreed that PGD testing should be introduced but cautioned that it is normally only used when there is a known hereditary disease in the family and which the parents would not want to be transferred to the embryo.   

“When you are biopsying an embryo even in good hands, there is a chance of damage to that embryo, so I wouldn’t go about randomly biopsying for women under 35, assuming they have not had recurrent miscarriages or I suspect a genetic condition,” she said.

Schembri Deguara said that even when PGD is available in the future, there are benefits to specific cases, but it’s not something that would apply across the board. “It’s always a matter of benefit over risk,” she said.

Likewise, Sultana said that introducing PGD testing into Malta’s IVF law must be “favourably considered.”

“One can still regulate its applicability depending on each individual,” he said. PGD testing should be used in cases involving women who have had two or more failed assisted reproductive cycles or have suffered two or more miscarriages due to unknown causes.

Sultana added that another example of when PGD testing should be used is where women have been through a pregnancy that involved chromosomal abnormalities, especially in assisted reproductive cycles, or when the man’s sperm reveals errors during meiosis or a low sperm count.

Sultana said that the benefits of using PGD testing include a lower risk of miscarriage and increased chances of having a healthy baby, and a lower probability of going through several IVF cycles.

What should the role of the Embryo Protection Authority be?

The law regulating IVF is actually called the Embryo Protection Act, which also includes the setting up of the Embryo Protection Authority. This authority is tasked with overseeing the sector, issuing guidelines and protocols and carrying out checks on IVF facilities.

Sultana said the authority in Malta has been a key player to ensure that in an area that is very sensitive, the highest levels of standards are adhered to. The EPA has done this job well, he added.

However, Sultana said the EPA should have the flexibility to adapt treatment options according to the different scenarios and varying needs and difficulties encountered by couples.

“Finding the right balance between ethical considerations, medical advancements, and the interests of the patients is never easy but identifying the best international IVF practices and adapting them to the local context is the least we can do to give couples in Malta the best chance of conceiving through IVF,” he said.

Schembri Deguara said the EPA’s role is to make sure that protocols are adhered to properly to ensure patient safety above all else. “At the end of the day, any controlling legislative body aims to ensure that treatments are done according to the law.”

She added that the EPA had ranked highly in the EU. “From our perspective, having opened a fertility clinic, the EPA has been helpful and meticulous.”