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Govt to legislate for Assisted Human Reproduction & Associated Research

Outline of Bill will be drafted & followed by extensive public consultation process

The Government has agreed to prepare new laws to regulate surrogacy and the broader area of assisted human reproduction and associated research, and bring to an end the legal uncertainty in which these services currently operate.

Cabinet authorised the Department of Health to prepare legislation on Assisted Human Reproduction and associated research. This will regulate a range of practices for the first time, including:

· surrogacy;
· embryo donation;
· the screening of embryos for serious genetic diseases;
· gamete (sperm or egg) donation;
· stem cell research.

“The priority throughout will be to safeguard the welfare, safety and best interests of children and to uphold the principles of consent and equality,” Minister Varadkar said.

The Department of Health will now draft the Heads of the Bill before inviting submissions from interested parties as part of an extensive public consultation process. The Joint Committee on Health and Children will also be invited to hold public hearings on the matter and subject the draft legislation to scrutiny.

“Infertility rates are rising and more and more people are seeking assisted reproduction services. The range and potential of services available is developing rapidly, and things we once thought impossible are now becoming a reality,” Minister Varadkar said.

“Yet Ireland is one of the few countries in Europe which provides assisted human reproduction services without a regulatory framework. This means that individuals are accessing complex and sometimes risky procedures in a legal vacuum. It’s high time to address this matter and impose regulation, limitations and protections to meet the challenges, keep abreast of developments and protect the welfare of any resulting children.”

The draft legislation will include proposals for:

· A Regulator to promote patient safety and good clinical practice in the area of assisted human reproduction;
· The Regulator will maintain a national register of donors, recipients and donor-conceived children and maintain records of all Assisted Human Reproduction (AHR) activities and services;
· Surrogacy in Ireland will be regulated for the first time;
A ban on commercial surrogacy, however reimbursement of reasonable expenses will be permitted;
A requirement for intending parents, donors and surrogates to have counselling and give their consent before any procedure.

The specific proposals in the draft Heads of the Bill will include:

· On the basis of equality and non-discrimination AHR services will be available to people irrespective of gender, marital status or sexual orientation subject to the welfare of any future children;
· Clinics will have to assess patients to ensure that the treatment does not pose a disproportionate risk to the health of the mother and the future child;
· Standard practice for suitable candidates should include the transfer of one embryo into a woman’s womb, with the aim of minimising the risks associated with multiple births;
· A limit will be placed on the number of families to which sperm or eggs from the same donor can be donated;
· Embryos can be donated to other individuals to enable them to have a child, or can be donated for research;
· Embryonic stem cell research should be permitted in certain cases but the creation of embryos for research and other experimental practices will be prohibited;
· Sex selection for gender balancing will be banned. However, in cases where there is a high risk of serious genetic disease or impairment, sex selection for medical reasons will be permitted subject to strict criteria;
· Use of stored sperm, eggs or embryos after a person’s death by their spouse or civil partner, will be permitted, if that person gave their consent for such a use prior to their death.


Note for Editors:

The ability to conceive a child naturally is a normal human expectation. The rates of infertility and subfertility are increasing due to a number of social and lifestyle factors, e.g. delayed parenthood in order to pursue a career and ensure financial security, as well as higher rates of obesity and sexually transmitted infections.

Advances in assisted human reproduction (AHR) technologies have increased the number of treatment options available to those affected by infertility and subfertility including:
in vitro fertilisation, gamete donation from third party donors and surrogacy where a woman, i.e. the surrogate, agrees to carry and deliver a child on behalf of another individual or couple
and the categories of people wishing to access such treatments such as 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 an important issue.

Currently there are a number of fertility clinics operating in Ireland offering a broad range of services including: in vitro fertilisation; pre-implantation genetic diagnosis; intra-uterine insemination; intra-cytoplasmic sperm injection; and gamete donation.

Ireland remains one of the only countries in Europe which has not introduced specific legislation on AHR. This has resulted in a regulatory vacuum, which has significant consequences not only for couples and individuals using AHR treatments, but also for the fertility clinics themselves and for the general public who have a legitimate expectation that all AHR practice and embryonic research is regulated and carefully monitored.

The need for a specific regulatory framework for AHR and associated research has been highlighted in a number of expert reports including the Commission on Assisted Human Reproduction [2005] and the Irish Council for Bioethics [2008], and by a number of high-profile Irish court cases. For example, the Supreme Court ruling in the Roche v Roche (2009) case was highly concerned by, and critical of, the lack of regulation for AHR in Ireland.

More recently, the Supreme Court, in allowing the State’s appeal in the MR & Anor v An tArd Chláraitheoir & Ors case, was critical of the continued lack of Irish legislation on AHR and surrogacy and highlighted that it was the role of the Oireachtas to develop legislation in this area. Following this ruling, the Minister for Health gave a commitment that he would bring a memorandum to Government seeking approval to draft legislation on AHR, which he has now done.

The broader AHR policy issues have been under consideration in the Department of Health over the last number of years and in October 2013 the Department undertook a review of existing policy proposals on AHR in light of scientific, legal and ethical developments and to ensure that the proposals remained fit for purpose. The Department has prepared a comprehensive set of policy proposals dealing with a wide range of aspects of AHR, which form the basis of the proposed legislation.