Draft legislation being developed at the Department of Health will explicitly permit the use of stored sperm, eggs or embryos after a person’s death by their spouse or civil partner, if that person gives their consent for such use prior to their death, the <strong><em>Medical Independent</em></strong> (<strong><em>MI</em></strong>) has been informed.
A Department spokesperson said no further details were available at this time. Drafting of the General Scheme of the legislation is ongoing and issues concerning various aspects of AHR, including posthumous assisted reproduction, are “still being considered”.
This legislation will regulate a range of practices for the first time, including gamete and embryo donation for AHR and research; surrogacy; pre-implantation genetic diagnosis (PGD) of embryos; and stem cell research. It will also provide for an “independent regulatory authority” for AHR. It is envisaged that the General Scheme will be completed by the end of June 2017.
Once the General Scheme has been completed, and approved by Government for publication, it will be uploaded on the Department’s website and submitted to the Joint Oireachtas Committee on Health for pre-legislative scrutiny, outlined the spokesperson.
<h3 class=”subheadMIstyles”>‘Unregulated’</h3>
The Department has acknowledged that the provision of AHR services remains “largely unregulated”. Its spokesperson told <strong><em>MI</em></strong>: “SI No 158 of 2006 (Quality and Safety of Human Tissues and Cells) Regulations governs the quality and safety standards in the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, including gametes and embryos. Under these regulations, the Health Products Regulatory Authority (HPRA) is tasked with authorising and monitoring tissue/cells establishments, including fertility clinics and their laboratories. The HPRA may grant licences to fertility clinics for practices encompassed under the 2006 regulations, however, they have no mandate to assess the ethical or medical desirability of such practices.”
Relatively little is known about posthumous AHR in Ireland. The <em>Report of the Commission on Assisted Human Reproduction</em>, published by the Department in 2005, reported on a survey of AHR clinics in Ireland on the subject of cryopreservation. Out of the eight respondent clinics, six stated that they had a policy on posthumous AHR and three of these indicated the policy was not to use cryopreserved material posthumously. However, this survey took place in late 2004/early 2005.
Statistics on the practice in the UK are not held by the Human Fertilisation and Embryology Authority (HFEA), its spokesperson told <strong><em>MI</em></strong>.
A briefing note prepared in 2015 by the Department’s Chief Bioethics Officer Dr Siobhan O’Sullivan, obtained by <strong><em>MI</em></strong> through a Freedom of Information request, referred to the Department having “anecdotal evidence that the practise is happening, largely in the context of men having previously stored sperm samples (prior to cancer treatment or as part of a reproductive project) and that has been used to assist conception after their death”.
In this briefing note for international colleagues, Dr O’Sullivan added that “most clinics will now cover that in their consent form but our intention is that a person’s gametes or any embryo created with those gametes should not be [redacted], stored or used for reproductive purposes without the person’s explicit consent”.
The next several lines were redacted. “In the meantime,” continued the briefing note, “there is nothing to stop someone going to the High Court to seek an order to authorise the use of gametes but given the case law around consent, my guess would be that without an explicit consent from the man stating that he intended for his gametes to be used after his death, the Courts would be slow to grant such an order.”
Another briefing note from 2015, prepared by Dr O’Sullivan for then Minister of State at the Department Kathleen Lynch, provided an insight into the types of issues the Department has been examining.
Dr O’Sullivan wrote that, in the vast majority of cases, posthumous AHR took place within “an existing parental project”, ie, where one of the couple undergoing AHR dies and use is sought of their existing cryopreserved sperm, eggs or embryo(s) by the surviving partner.
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‘The restrictive part of that would be if female age was advancing and we’d have to be cognisant of that’
</div> </blockquote> <h3 class=”subheadMIstyles”>Consent</h3>
She advised that, globally, there were few laws on posthumous AHR, while national and international policies varied. Some countries had legislation that prohibited the practice; others allowed for it where consent had been given by the gamete donor prior to death.
“The European Society of Human Reproduction and Embryology (ESHRE) guidelines only allow for PAR [posthumous assisted human reproduction] where consent has been given by the deceased person for use of his/her gametes or embryos after his/her death.”
Dr O’Sullivan noted the importance that guidelines placed on counselling, where posthumous AHR was being considered. The ESHRE guidelines also adopted a number of restrictions around the practice, including “a minimum waiting period of one year after the death before treatment can be started”.
The Chief Bioethics Officer noted that the Department had formulated policy proposals on posthumous AHR that would form the basis of the relevant AHR legislation.
The movement towards regulation of this delicate area has been welcomed by professionals in the fertility field. Mr Declan Keane, Director of ReproMed, told <strong><em>MI</em></strong> the area of posthumous AHR is “very much one of those major gaps in the guidance for those of us operating in the field of reproductive medicine, ie, we have no guidance, no regulation whatsoever on whether we should or should not be offering posthumous insemination”.
ReproMed has not yet been asked for cells to be released from a partner for posthumous use, he outlined.
Mr Keane is supportive of ESHRE guidance on a minimum waiting period of one year after the death, before treatment can be started.
He said people going through the grieving process would need to take time for themselves, engage with specialised counsellors, and also be fully aware of the fact that as with all assisted reproductive procedures, the desired outcome may not come to pass.
“I would welcome it. It makes sense to me,” he said of the one-year stipulation. Mr Keane said that when couples preserve cells for potential posthumous use, the surviving partner often does not return to use these cells.
He added that, in time, some people may also find themselves in a new relationship where they may consider reproduction with that partner.
“The restrictive part of that [one-year stipulation] would be if female age was advancing and we’d have to be cognisant of that. And perhaps you could leave some leeway with the use of the intervention, say, of a psychiatrist or psychologist, the clinic offering the procedure, and the patient looking to use the gametes posthumously within the year… possibly, you could look to have some sort of a caveat.
“But [with] everything we do, there are going to be unique scenarios where you are always going to be looking for the caveat… If we [in the fertility field] don’t have rules and regulations, so we start to change them to suit the individual, perhaps as reproductive medicine is evolving so rapidly we just keep opening up a newer Pandora’s box… I personally would call for legislation putting a regulatory body in place rather than strict guidelines and legislation because a regulatory body can grow and evolve as the reproductive technologies grow and evolve, and therefore we can constantly update the guidelines and regulations. Legislation is very hard to change, so that would be important for the Government to be cognisant of.”
On a much broader note, Mr Keane believes that public funding for fertility-related cryopreservation should be more accessible, such as to include people undergoing non-cancer-related gonadotoxic treatments.
Currently, the funding structure operated by the HSE is applicable to oncology patients only.
“So, if you are taking a chemotherapeutic agent like methotrexate — and some of the rheumatology patients would — you are lucky enough not to have cancer, but you are unlucky to have rheumatology disease, because that is not covered in the public funding stream,” noted Mr Keane.
In December, the HSE published a pre-tender market sounding for provision of oncofertility services for oncology and other defined patient groups. The Executive had not responded by press time on the definition of “other defined patient groups” and on questions regarding funding provision.
The Health Research Board was engaged by the Department to conduct a comprehensive review of international public funding models in relation to AHR. “This HRB evidence review is due to be finalised in the near future,” said a Department spokesperson. “The HRB evidence review will then be analysed by officials in the Department of Health in the context of considering policy options for a potential public funding model for AHR treatment.”
