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Time for public to have say on IVF Bill

Jail sentences and €70,000 fines for breaching IVF rules

Independent body will enforce the law

Malta’s first IVF law was launched for public consultation yesterday, regulating the therapy and explicitly banning embryo freezing in all but the most exceptional cases.

The law promises to make IVF free to would-be parents, provided they are heterosexual and either married or in a “steady relationship”.

Doctors performing the procedure will be allowed to fertilise a maximum of two eggs at a time, with any other eggs produced frozen through the process of oocyte vitrification, that is, freezing a woman’s eggs.

If a woman fails to conceive through either of the two fertilised eggs, she will be able to repeat the IVF process using excess eggs frozen from her first treatment, sparing her from having to repeat painful hyperstimulation therapy.

The two-egg limit, which Health Minister Joe Cassar said was now feasible due to “advances in medical technology”,

allows the government to sidestep the thorny issue of what to do when the fertilisation process results in multiple embryos being created.

An independent regulatory body, the Authority for Embryo Protection, will be charged with implementing and managing the law.

Among other things, the authority will issue licences to IVF-certified clinics and vet prospective parents to ensure they meet eligibility criteria, including deciding whether an unmarried couple is in a “stable relationship”.

The authority’s greatest discretionary power will be in establishing when an embryo should be frozen and subsequently matching such embryos for adoption.

Embryo freezing is prohibited except in what the draft law terms as “force majeure” cases, such as the prospective mother passing away after egg fertilisation but before the embryo is implanted, for example.

Deciding what constitutes such a “force majeure” case will be up to the five-person authority, which is likely to be made up of medical and bioethical experts.

Prospective parents will be vetted by the authority and must have exhausted all other conception methods before being allowed to undergo the procedure.

Medical practitioners who object to IVF on moral grounds will be allowed to exempt themselves from taking part in IVF-related procedures.

Years in the making, the draft law was presented just 24 hours after the Maltese bishops issued a pastoral letter decrying IVF as morally wrong and “a threat to human life”.

Justice Minister Chris Said explained the three key principles underpinning the draft Bill. The cardinal principle, he emphasised, was to safeguard human life from the moment of conception.

“The Bill makes it clear that fertilisation can only take place for the sake of pregnancy. Absolutely no other reason, be it research-related or otherwise, is permissible,” Dr Said stressed.

It would also give couples unable to conceive through natural means the possibility of having a baby as well as regulating a sector that had hitherto been operating in a regulatory vacuum, he added.

Those caught breaching the law faced hefty fines (of up €70,000) as well as prison sentences of up to seven years, Dr Said explained.

Dr Cassar said free IVF entitlement criteria would be established by the Health Department in collaboration with the yet-to-be-established regulatory authority, in line with internationally recognised guidelines.

Jargon explained

Assisted reproductive technology: The umbrella term for artificial methods used to achieve pregnancy. IVF is one, but not the only, form of ART.

In-vitro fertilisation: The process by which an egg is fertilised by a sperm outside the body. Once extracted, the egg is fertilised with a sperm. If successful, the result is a zygote – the earliest stage of an embryo.

Embryo: The first multi-cellular building block leading to birth. In humans, it is called an embryo for about eight weeks. After that, the embryo becomes a foetus.

Oocyte vitrification: The process of freezing a woman’s eggs. It supersedes previous freezing techniques by reducing the number of ice crystals that form on frozen eggs. Ice can destroy the egg’s cell structure. It is, however, relatively unproven, having only emerged as a viable medical technique over the past few years.

Ovarian hyperstimulation: The first step in the IVF process. An intensive course of fertility medications is used to stimulate egg production, resulting in more eggs than usual being produced.

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