Dr. Tony Holohan:

I thank the Chairman and members of the committee for the opportunity to address them on this draft legislation. As the Chairman said, I am joined from the Department of Health by Ms Geraldine Luddy, head of the bioethics unit, and Mr. Paul Ivory, assistant principal at the bioethics unit, as well as some colleagues from the HSE: to my left is Mr. Liam Woods, national director for acute operations; Dr. Colm Henry, consultant geriatrician at the Mercy University Hospital, Cork, and national clinical adviser and group lead on acute hospitals; Dr. Jerome Coffey, consultant radiation oncologist at the St. Luke's Radiation Oncology Network and national director of the national cancer control programme; and Dr. Peter McKenna, former master of the Rotunda Hospital and clinical director of the national women and infants health programme. I hope to provide the Chairman and these hearings with some background to the Government decision to approve the general scheme of the assisted human reproduction Bill 2017 and to outline briefly the main provisions of the scheme.

It is estimated, as I am sure the committee knows, that one in six couples worldwide experiences infertility at some point in their lives. The rate of infertility and subfertility is increasing due to a range of both social and lifestyle factors - for example, due to delayed decisions surrounding parenthood to support the pursuit of careers and to ensure financial security - as well as higher rates of obesity and sexually transmitted infections, particularly chlamydia, which can impact a person's reproductive health and fertility. From the Irish point of view, based on information we have from the Health Products Regulatory Authority, the number of cycles for assisted human reproduction, AHR, procedures conducted in fertility clinics in Ireland is increasing. For example, the provision of treatment has risen from 7,589 cycles in 2009 to almost 9,000 in 2016.

We understand the impact that the issues of infertility and subfertility can have at an individual level. The ability to conceive a child naturally is a normal human expectation, and a diagnosis of infertility can be a source of severe emotional and psychological distress, discomfort and financial hardship. These decisions and the impact they can have at a personal level have been brought to the fore in our engagements with various stakeholders on behalf of people with infertility and in the context of developing the general scheme as well as through a number of representations made to us in the Department, in particular to the Minister on behalf of citizens affected by infertility.

As the committee will be aware, work is ongoing in the Department on proposals for a potential public funding model for AHR treatments, which I will discuss in more detail shortly. The development of the general scheme and the work relating to a possible public funding model for assisted human reproduction, AHR, has generated debate. While we endeavour to progress these important policy and regulatory issues we are conscious of the direct impact this work will have on individuals. For example, people listening to these discussions who are currently undergoing AHR treatment, or who may be considering such treatment, may adjust or defer their plans in anticipation of impending policy changes arising from this work. As such, we understand that we have a responsibility to provide a realistic and reasonable appraisal of what the Department is endeavouring to do in this space and the timelines involved.

The development of reproductive technologies means that children can be created outside of what may be seen as the normal male-female sexual relationship. Sperm and eggs can now be manipulated and embryos created in laboratories. While reproductive medicine is one of the most innovative and rapidly developing areas of medicine it also raises challenges from ethical and legal perspectives. Advances in AHR technologies have increased the number of treatment options available to those affected by infertility and subfertility, for example in vitrofertilisation; the donation of gametes, either sperm or eggs, from third party donors; and surrogacy to name just a few. The categories of people wishing to access such treatments have also expanded to include heterosexual couples, same-sex couples, single people and people wishing to avoid serious hereditary diseases. Therefore, from a medical and social perspective, infertility and subfertility represent important issues that require a considered health service response and regulation.

As we know, we currently have no specific legislation in Ireland governing AHR. There is limited existing regulation relating to the use of gametes and embryos. In 2006 the Health Products Regulatory Authority, HPRA, was designated as the competent authority for SI 158 of 2006, the quality and safety of human tissues and cells regulations, which govern the quality and safety standards in the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, including gametes and embryos. These regulations empower the HPRA to authorise and monitor tissue establishments, which include some of the existing fertility clinics.

Of further relevance, the Children and Family Relationships Act 2015, the CFR Act, reforms and updates family law to address the needs of children living in diverse family types. Parts 2 and 3 of that Act are the responsibility of the Minister for Health. These parts of the CFR Act, when commenced, will regulate aspects of AHR involving donation of gametes and embryos and are specifically concerned with the parentage rules for children born through donor-assisted human reproduction procedures, obligations applying to facilities providing such procedures and the establishment of a national donor-conceived person register. We in the Department of Health are preparing draft regulations to facilitate the commencement of Parts 2 and 3 of the CFR Act 2015, and are working to resolve some final technical issues in order to ensure that the processes associated with these Parts of the Act can be commenced.

While the number of people accessing AHR treatments and services in Ireland is increasing, the provision of these services remains largely unregulated, as I have said. This means that individuals are availing of often complex and sometimes risky procedures in a legal vacuum. Legislation is therefore required in order to assist people to have children safely, to clarify the legal position of children born from these practices, and to ensure research and new reproductive technologies are carried out within a prescribed ethical framework.

While the vast majority of AHR treatments and services currently available in Ireland are provided through private AHR clinics, there is a limited specialist AHR service available through the HSE, which provides funding for fertility preservation for cancer patients whose treatment is likely to impact on their future fertility. The Department intends to work with representatives from the HSE to ensure that there is a coherent approach to the development of the AHR legislation, which is consistent with the existing publicly available cryopreservation service. In order to support the commencement of this legislation once it is enacted, the Department will work during the course of 2018 in parallel with the HSE to develop a model of care for infertility to ensure the provision of safe, effective and accessible services through the public health system as part of the full range of services available in obstetrics and gynaecology. To provide for that we intend to establish an implementation committee to ensure that the drafting of the legislation, the preparation of the above service arrangements and the development of any specific eligibility arrangements that we might approve can all proceed in line with each other to allow for the timely commencement of the legislation.

The scheme we are discussing this morning represents the first time a comprehensive package of measures has been drafted for AHR that includes aspects of research. The introduction of legislation in this area is a priority for the Minister and affirms the commitment contained in A Programme for a Partnership Government relating to the regulation of AHR and surrogacy.

Moving on to the detail of the scheme, we adopted three principles to guide our work in this area, namely, the welfare of any children born through assisted human reproduction technologies, which is the most important, safeguarding the health of women undergoing those procedures and the promotion of best clinical practice. Children born through AHR may be vulnerable as they obviously lack any control over the circumstances of their birth. For this reason, and in recognition of Article 42A of the Constitution, as well as the UN Convention on the Rights of the Child, the welfare and best interests of children born through AHR was a key consideration. Equally, the well-being of women involved in these procedures also requires special attention, as women are the main recipients of AHR interventions due to their biological role in pregnancy and childbirth. Finally, the promotion of best clinical practice should be standard in any recommendation put forward by the Government and, in the case of AHR, it has also been seen that adhering to this principle can positively impact the safety and well-being of women, for example, in the context of multiple pregnancies.

Officials in the Department are engaging with the Office of the Attorney General in respect of the process of drafting this legislation. Given the comprehensive scope of the legislation and the ethical, legal and social issues that arise with AHR practices, I anticipate that, as we go along, there will be areas of the scheme that will require further consideration and refinement, as is usual in the drafting of legislation.

The general scheme is comprised of nine parts. Part 1 deals with standard provisions relating to the legislation such as interpretation and commencement matters. Part 2 outlines the general principles that apply in the context of all AHR treatments and procedures, including requirements regarding informed consent and counselling, conditions regarding embryo transfer, and considerations involving the welfare of the child. Part 3 outlines the conditions and restrictions relating to the donation of gametes and embryos for use in AHR treatment by other people, for use in research or both. It also outlines specific requirements relating to people wishing to access AHR treatment involving donated material. This part includes specific requirements relating to informed consent and counselling, age restrictions for donors, the prohibition of the donation of embryos other than supernumerary embryos, limits on the use of donated material, the prohibition of commercial gamete and embryo donation and the permitted storage periods that should apply for any gametes and embryos in storage.

Part 4 of the scheme deals with posthumous assisted reproduction, PAR, which involves the use of frozen gametes or embryos from a deceased person to achieve a pregnancy. These provisions enable a surviving female partner to continue a parental project after the death of her partner, provided specific conditions are fulfilled. For example, the relevant parties must have received counselling and given their informed consent and a period of time, in this case one year, for grieving has to have elapsed since the death of that relevant partner. The scheme states that the deceased person would be recognised as a parent of any child born following PAR provided that child is born within 36 months of that person's death.

Part 5 provides for pre-implantation genetic diagnosis, PGD; sex selection for medical purposes; and human leucocyte antigen, HLA, matching in the context of AHR treatment, provided certain eligibility or qualifying criteria are fulfilled. For example, both PGD and sex selection would only be permitted where there is a significant risk of a child being born with a serious genetic disease. The AHR regulatory authority established by this legislation will be responsible for maintaining a list of genetic diseases for which PGD and sex selection would be permitted. In respect of HLA matching, the regulatory authority will also maintain a further list of eligible diseases but specific approval from the regulatory authority will be required on a case-by-case basis and will be subject to the consideration of any particular criteria in respect of those cases.

Part 6 outlines the specific conditions under which surrogacy will be permitted in Ireland. The term surrogacy relates to a situation whereby one woman, that is, the surrogate, agrees to become pregnant, carry and deliver a child on behalf of another individual or couple, that is, the intending parent or parents. This includes a requirement for all surrogacy agreements to be pre-authorised by the regulatory authority. This pre-authorisation process will help to safeguard the welfare of the parties involved in the surrogacy agreement, in particular that of any child who may potentially be born as a result of that agreement, as well as that of the surrogate involved. The scheme sets out a court-based mechanism through which the parentage of a child born through surrogacy may be transferred from the surrogate - and her husband, if applicable - to the intending parent or parents.

Commercial surrogacy raises a number of concerns relating to the welfare and commodification of the children involved as well as potential risks of coercion and exploitation of financially vulnerable women to act as surrogates. In light of this, the general scheme explicitly prohibits commercial surrogacy being conducted in Ireland.

Part 7 stipulates the conditions under which research involving embryos, embryonic stem cells and induced pluripotent stem cells may be permitted, subject to obtaining a licence from the regulatory authority. This part prohibits the creation of embryos specifically for research purposes and also prohibits certain practices that may be associated with embryo and stem cell research, for example, reproductive cloning.

Part 8 provides for the establishment of the AHR regulatory authority and outlines its functions in terms of the oversight and regulation of compliance with the legislation. This includes the issuing of licences to AHR treatment providers and researchers. As previously mentioned, the AHR regulatory authority will be essential to the successful implementation of the legislation given the complexity of the issues involved in regulating this area and the rapidly evolving nature of AHR and research technologies. A key function of the regulatory authority will be the collection of statistical information from AHR providers, beyond that which is currently available, on all AHR activities and their outcomes, such as the number of children born from such procedures. The collection of this detailed information would enable the regulatory authority to monitor and assess the safety and effectiveness of AHR practices and would also help to inform future policy-making in this area.

Part 9 outlines the various offences that apply in respect of contravening specific heads within the scheme and stipulates the level of penalty that could apply in each instance.

I reiterate that the provisions outlined within the scheme and, in particular, the establishment of a dedicated AHR regulatory authority will ensure that AHR practices and research in related areas will be conducted in a more consistent and standardised way and with the necessary oversight. As I outlined earlier, the commencement of the legislation is one element of the development of a model of care for infertility, which will ultimately aim to embed the provision of safe, effective and accessible AHR treatments and services into the broader range of obstetric and gynaecological services available through the public health service.

I thank the committee for undertaking this review of the general scheme. We are available to answer any questions members may wish to pose.