Updated | IVF bill hinges on success of egg freezing

Updated with statement by Alternattiva Demokratika at 3:50pm.

Malta's health and justice ministers today unveiled the country's first law that will regulate the industry of in vitro fertilisation, marking a policy shift towards the science of egg freezing and a ban on embryo freezing, except in exceptional medical cases.

The draft law, dubbed the Embryo Protection bill, will be open for public consultation up until the 14 September.

In regulating a service that has so far been practised freely for the past 22 years by private hospitals, the new law will for the first time offer IVF to both married and unmarried couples on the national health system, as well as set-up an authority that will regulate medical protocols and best practice on IVF.

The 'Authority for the Protection of the Embryo', as it has been dubbed, will be a five-man committee of medical and bioethical specialists, who will also have to certify prospective parents as to whether they are eligible for IVF.

The inevitable emphasis on protecting human embryos makes Malta's IVF law particular because it will not allow the freezing of embryos, but adopt the science of oocyte vitrification.

This means that women who are hyper-stimulated to produce an excess of eggs will have a maximum of two fertilised for implantation, while the rest of the eggs will be frozen.

As health minister Joe Cassar noted, an advantage of egg freezing means less hyperstimulation cycles for women.

Ethically, the government also skirts the issue of freezing excess embryos that can be normally created in IVF when these are not implanted. However, the new law provides exceptions under a blanket 'force majeure' proviso, to be decided by the new authority when embryo freezing can be allowed, and whether such embryos can be put for up for adoption - for example, in the case of the mother's death.

Asked why the government had opted for egg freezing, when a previous parliamentary committee chaired by Nationalist MP Jean-Pierre Farrugia had recommended the option of embryo freezing, Cassar said that the science of oocyte vitrification had advanced considerably since then.

"At the time of the Farrugia committee, the impression was that egg freezing could not guarantee certain success rates, but the science has advanced considerably since then. We are confident that the success rate is satisfactory," Cassar said.

The law prohibits the donation of gametes - eggs and sperm - surrogacy and the use of embryos for any other reason other than procreation, such as scientific research or cloning.

It will oblige doctors to offer full information to prospective parents and afford total equality to children born with IVF. Professionals will be allowed to conscientiously elect themselves not to participate in IVF procedures.  

Coming less than 24 hours after a pastoral letter by the Catholic bishops warning MPs against legislating IVF, the new law does not fail to make 'embyro protection', not least as represented in its name, its main concern.

"This law is underpinned by three principles," justice minister Chris Said said. "The safeguarding of life from conception, giving the opportunity to couples to have recourse to assisted reproduction treatment, and preventing any type of abuse in the medical process.

"The Authority regulating the practice will issue guidelines and codes of best practice, certify medical clinics and eligible couples to receive treatment, ensure the highest of standards, and monitor the industry."

The authority will also have to decide on ethical matters that could force the inevitable freezing of human embryos, as well as their adoption. "Although the law prohibits embryo freezing, exceptions of force majeure are considered, and this will have to be decided by the new authority," Said said.

"An example could be the death of the mother, wherein such case the embryos have been frozon and can then be adopted by eligible couples."

One of the questions the ministers faced on the composition of the new authority is whether Catholic churchmen and theologians - not an uncommon presence on such sensitive committees like the Bioethics Consultative Committee - will be allowed to take their place on an authority which effectively regulates a practice shunned by the Vatican.

"We're not excluding anybody," Cassar said. "We believe that the people who serve on this committee have to come from a variety of specialist backgrounds."

AD reaction

In a preliminary reaction, Alternattiva Demokratika chairperson Michael Briguglio said free IVF treatment by the NHS facilitate matters for prospective parents who are infertile.

But, he added, this should not create unnecessary hurdles for other infertile people. "There should not be discrimination on any grounds for access to this service, and applicants should be offered professional counseling. Government's fundamentalist proposal to grant access to only one type of family is definitely objectionable."

AD secretary-general Ralph Cassar said it remains to be seen whether the proposed law is too restrictive, making the procedure too difficult.

"Putting in rules to safeguard the health of the mother and avoid dangerous multiple pregnancies is important. Preventing the creation of unnecessary fertilised eggs is good, but making the procedure too restrictive and depicting the viable storage of the minimum number of fertilised cells for the procedure as 'immoral' or 'bad' is over-the-top.

"What is hardly ever mentioned is that the success rate of IVF closely follows that of conception by natural means - science is not replacing nature in this case, it is just helping it along."

IVF debate in Malta

A select parliamentary committee of Nationalist MPs led by Jean-Pierre Farrugia, a family doctor, proposed the creation of an embryology agency and also the freezing of additional healthy embryos that are created during IVF but cannot be implanted inside women.

Another parliamentary committee, the social affairs committee led by Nationalist MP Edwin Vassallo, delivered a more conservative viewpoint against the suggestions of the Farrugia report.

Oocyte vitrification enjoys the support of pro-life lobby Gift of Life, which had recently stepped up its campaign against embryo freezing. The pro-life organisation, which had unsuccessfully petitioned MPs to entrench the Criminal Code's provisions against abortion in the Constitution, said it objected to the freezing of embryos when female egg freezing technology is available.

Prime Minister Lawrence Gonzi and Health Minister Joe Cassar had already pronounced themselves in favour of egg freezing shortly after the conclusions of the Farrguia committee: partly because Mater Dei already has what was once a state-of-the-art IVF unit installed by Skanska back in 2004, equipped with two Planer freezers and nitrogen tanks that can freeze both eggs and human embryos.

The unit was never set up, something that earned the rebuke of Labour leader Joseph Muscat, who has pledged to make IVF legislation one of the first laws if elected to power.

The Catholic Church's Dignitas Personae maps out the position against IVF because it substitutes the personal act of procreation between husband and wife. The Church says there is "no morally licit solution regarding the human destiny of the thousands and thousands of 'frozen' embryos which are and remain the subjects of essential rights and should therefore be protected by law as human persons".

But it goes further: because even the freezing of oocytes, or eggs, so that it can be fertilised with the sperm and implanted as and when necessary, is "morally unacceptable" in Dignitas Personae.