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Prof Deirdre Madden first began looking at the area of assisted human reproduction (AHR) 30 years ago.
Based at the School of Law at UCC, Prof Madden examined the subject as a postgraduate student and completed her PhD on law relating to AHR.
Since this time there has been much debate around AHR and issues relating to it, such as IVF (in vitro fertilisation), surrogacy and stem cell research, not alone in Ireland, but internationally.
In 2000 then Minister for Health Micheál Martin established the Commission on Assisted Human Reproduction, of which Prof Madden was a member, and it went on to have 23 plenary meetings and to establish a number of working groups.
In 2005, amid much fanfare, the Commission produced a landmark report on the possible approaches to the regulation of all aspects of AHR and social, ethical and legal factors relating to AHR in Ireland. The comprehensive report made 40 recommendations.
However, despite promises of imminent AHR legislation by successive Governments, Ireland continues to operate in an unregulated vacuum as new AHR treatments and technology continue to come on stream.
A huge move towards the development of legislation finally occurred when the Department of Health published the General Scheme of the Assisted Human Reproduction Bill 2017 recently.
“I think it’s to be welcomed. We’ve been waiting a very long time for legislative proposals,” Prof Madden told the Medical Independent (MI).
“We’ve had successive Ministers for Health promising that they had instructed their Department officials to work on producing legislation in the area. I remember as far back as Mary Harney in the mid 2000s when we presented our report to her in 2005 she had said that they were going to start work on it.”
So why has AHR legislation taken so long to be published?
“It is a complex area with many controversies,” acknowledged Prof Madden. “For many years there was concern that Article 43.3 of the Constitution, the 8th Amendment, might have impacted on some of the practices associated with IVF, like embryonic stem cell research, destruction of embryos or failure to implant or transfer embryos,” she advised.
“There was a concern that maybe the State would have an obligation to protect the right to life of those embryos as unborn under Article 40.3.3, but that was dispelled by the Supreme Court a number of years ago, so that position has been finally clarified by the Courts. So there were certainly a couple of things that made it a little bit more complicated, but I still think it’s too long to wait for legislation.”
The General Scheme of the Bill has been submitted to the Joint Oireachtas Committee on Health for review.
It contains several elements, including outlining the conditions under which research into embryos, embryonic stem cells and induced pluripotent stem cells may be permitted.
It also provides for the establishment of an Assisted Human Reproduction Regulatory Authority, outlines the conditions relating to the donation of gametes and embryos and also details the rules around surrogacy arrangements.
Proposed regulations around posthumous assisted reproduction (PAR) are also included.
Now that a detailed breakdown of the proposed AHR legislation has been published, the challenging work begins in ensuring that it is in the best interests of parents and children.
But this, as has been experienced in other countries following the enactment of AHR legislation, can prove extremely difficult if legislation is created that gives rise to further problems for families.
“There is a huge diversity of legislative approaches to human assisted reproduction. Some countries have primary legislation, some countries have codes of practice, some countries have standards; there is a great deal of divergence,” Prof Madden noted.
“Some would leave it to professional organisations like the Medical Council to regulate, so there is a variety of approaches taken to it. But I think legislation is certainly the preferable option because it offers certainty and clarity and I think that’s the best way to go.”
Healthcare professionals who work in the area of AHR in Ireland are already bound by the Medical Council and the codes of practice of their professional discipline, but the legislation will introduce a number of new requirements for fertility clinics.
Under the proposed legislation all intending parents must receive counselling from a counsellor who is operating on behalf of the AHR treatment provider.
Work is ongoing in the Department of Health in relation to implementing provisions for the designation and regulation of counsellors under the Health and Social Care Professionals Act 2005, the General Scheme notes.
Prof Madden advised that when the regulatory system is up and running there would be increased adherence to standards and inspections of premises and treatments provided.
Irish AHR clinics are also eagerly awaiting the details of the Government’s planned funding scheme for AHR treatment for public patients.
Most countries that are looking at legislating for AHR look to the UK for inspiration and it would appear that this is the case with Ireland, she noted.
“It seems to be quite similar to what they do over there and that’s no surprise that we would avail of that example given the proximity in terms of culture and geography and language; it’s easy to model ourselves on that. But that’s not necessarily a good thing. I think there are good bits and bad bits to the model which I think those drafting the legislation should be aware of.”
For example, in relation to surrogacy, Prof Madden does not believe Ireland should model itself on UK legislation.
This is because a number of judges and commentators involved in surrogacy in the UK have said the legislation is not fit for purpose. The concerns relate to the timeline around when a parental order for a baby born of surrogacy must be made, surrogacies abroad and reasonable expenses for surrogate mothers.
According to Prof Madden, in the UK a child must not be more than six months old before a parental order is applied for.
“The problem with all of these provisions is, what happens if they are breached?” she argued.
“Let’s say the child is two-years-old when the application is made to court, what happens then? The English judges have been taking the view that if this is a case where there is a happy outcome for all involved, in the sense that the surrogate is happy to give up the child, the intended parents are genetically related to the child and are happy to take on parental responsibilities, the child is living with them and everybody is happy, the judges take the view that it’s in the best interests of the child to make that order, irrespective of the fact that they haven’t complied with the law.”
Similarly, in the case of a surrogate mother being paid what are considered in excess of reasonable expenses under law, judges are faced with a situation where there is a child in the care and custody of parents who are genetically related to it and are looking after the child very well.
“They have to make this order in the best interests of the child irrespective of the fact the law has been broken,” Prof Madden said.
“So what’s the point in putting provisions into the legislation that you know aren’t going to work?”
It would appear from the General Scheme published on the Department website that Ireland is following a similar legislative path to the UK in relation to surrogacy.
It states that applications for a parental order must be made when the child is aged between six weeks and six months. But the Scheme states that the court can extend this period in exceptional circumstances and if it is in the best interests of the child.
Under the proposed legislation, commercial surrogacy is not permitted and the Regulatory Authority must approve surrogacy agreements in advance.
It adds that medical professionals can treat a surrogate who is already pregnant regardless of the legality of the surrogacy agreement.
All surrogacy arrangements must be domestic, which means the embryo transfer must be carried out in Ireland. The General Scheme makes no reference to surrogacy arrangements that are made abroad.
Prof Madden has serious concerns that cases in which Irish people go abroad for surrogacy will not be regulated.
“I think that’s going to be very problematic because if it’s going to be the case that you can only do surrogacy in Ireland altruistically, and that you can’t pay people to become surrogate mothers, then a lot of people won’t be able to avail of that because they won’t have a sister or a friend who is prepared to carry a pregnancy for them. So the only way they’re going to be able to have a child is through going abroad to pay for surrogacy,” she outlined.
“We know that’s going to happen because it happens in every other jurisdiction. The problem is if the Bill isn’t going to regulate that, does that mean that when those people bring their child back to Ireland they are not going to be able to establish a legal relationship with the child? Are they going to experience difficulties getting passports and birth certificates? The Government says that the welfare of children is its first priority, but how can you say the welfare of children is your first priority if you’re not dealing with international surrogacy arrangements? How is that best for children born in these arrangements if you’re leaving them in a legal limbo?”
In February this year, MI revealed that some 106 emergency travel certificates had been issued since 2011 to children born abroad as a result of surrogacy arrangements to enable them travel to Ireland.
In 2016 alone, 25 emergency travel certificates were issued, 13 to children born in India and 12 to children born in the Ukraine, according to the Department of Foreign Affairs and Trade.
The Government has said the area is legally complex and that it cannot regulate what happens in another country, it is understood.
“But that to me is not a good enough reason; that’s what we elect them to do, to deal with legally complex situations,” Prof Madden stated.
“They can make it simple and straightforward for people when they come back to Ireland to avail of court procedures through which they can establish a legal connection with their child, and I think that’s what they need to do.”