[WATCH] Preimplantation genetic diagnosis for embryos to be allowed in IVF changes

Malta’s in-vitro fertilisation law will be amended to allow pre-implantation genetic testing of embryos in cases that have a family history of serious genetic disorders.

But the law will not allow defective embryos to be discarded or given up for scientific research and instead will remain frozen for posterity.

Health Minister Chris Fearne unveiled the changes government is proposing to the IVF law to make the treatment more widely accessible.

A key development is the introduction of genetic testing, which until today was not possible.

Asked by MaltaToday what will happen to defective embryos identified by the genetic test, Fearne said these will remain frozen with the possibility of adoption.

“In medicine, we cannot exclude that sometime in the future a cure will be found for some of these diseases,” he said, suggesting that the frozen embryos could become viable at some stage.

In most cases abroad, genetically defective embryos are discarded or given up for scientific research, something which would conflict with Malta’s outright ban on abortion that is not being changed.

Fearne skirted the question when asked whether the possibility for prospective parents utilising IVF to genetically test their embryos and not utilise them would be discriminatory against women who conceive naturally and have no option to terminate their pregnancy if genetic tests reveal that their foetus has inherited a severe genetic condition.

Pre-implantation genetic testing will take place for monogenic disorders - caused by variation in a single gene – and only in cases where the parents have a family history of hereditary disease. Examples of such disorders include Huntington disease and Finnish Nephrotic Syndrome.

A protocol drawn up by the Embryo Protection Authority will list the testable conditions and will be published alongside the proposed legal changes for discussion.

Other changes include the increase in the age limit to 45 from 42 for women to be able to undergo IVF treatment and the possibility for women to access free IVF for a second child.

Fearne said that the changes will allow doctors to use scientific advances for the benefit of their patients facing fertility problems.

He said that the success rate of IVF at Mater Dei Hospital was better than the European average, refuting claims that the success rate was very low.

Fearne also refuted assertions found in the annual report of the Embryo Protection Authority that said in 50% of cases, all embryos in a cycle had to be frozen because of the risk of ovarian hyperstimulation. He insisted that there were no incidences of ovarian hyperstimulation. “Since 2018 we did not have ovarian hyperstimulation. The rate is zero,” he insisted, refuting a MaltaToday report based on the EPA findings.

Reforms parliamentary secretary Rebecca Buttigieg also addressed the press conference, saying that the Labour government remained “a government of reforms, rights and equality”.

The proposed IVF changes do not tackle surrogacy, which Fearne said will be dealt in a separate law altogether.

Proposed changes

• Gamete donations from persons related by affinity (through marriage) in the direct line will no longer be excluded. Removes an anomaly that hindered lesbian couples from donating their eggs to each other.
• Donations by an ascendant to a descendant and vice versa, or from siblings will remain illegal.
• Changes in the Embryo Protection Authority (EPA) to allow for third party identity release donors. This shall allow collaboration with foreign oocyte/sperm banks.
• Donor must have not attained 36 years on date of donation.
• Embryo adoptions will be regulated by the Adoption Act in terms of assessing the adequacy of prospective parents.
• Entitlement criteria for free IVF will apply up to having two children. Today a woman who has a child, irrespective of how it was conceived, cannot apply for free IVF.
• Each cycle shall include either one episode of ovarian stimulation and retrieval of oocytes or use of cryopreserved oocytes. Retrievals of frozen eggs or embryos will not be considered a new cycle thus giving women the possibility to access more cycles.
• Couples/single women who have already utilised three cycles as defined today, will be allowed to apply for an additional cycle.
• A maximum three cycles of IVF will be offered to women under 46 years. This increases age of entitlement to 45 from 42. The transfer of frozen embryos will continue being done up to the age of 48, as is the case today.
• Women who have frozen embryos abroad will be able to transfer two embryos per cycle to Malta.
• Pre-implantation genetic testing for monogenic disorders (PGT-M) will be allowed. A draft protocol for PGT-M has been drafted by EPA after consultation with professionals, which establishes which specific diseases are to be applied for the local scenario.
• Protocol will be published as a draft so that it can be discussed alongside the legal amendments.
• EPA protocol needs to be discussed within four weeks in parliamentary committee for health.