Thursday, 17 October 2019
Department of Health
Assisted Human Reproduction Legislation
Currently there is no specific legislation in Ireland governing assisted human reproduction (AHR). However, certain aspects of the operation of fertility clinics are regulated. SI No. 158 of 2006 (Quality and Safety of Human Tissues and Cells) Regulations 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. Under these Regulations the Health Products Regulatory Authority (HPRA) is empowered to authorise and monitor tissue establishments involved in the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications.
Of further relevance is the Children and Family Relationships (CFR) Act 2015, which reforms and updates family law to address the needs of children living in diverse family types. Parts 2 & 3 of the CFR Act make provision for children conceived through the assistance of a donor. This includes a requirement for gamete and embryo donations to be made on a non-anonymous basis and the establishment of a National Donor-Conceived Person Register to enable children to access information on their donor and genetically related siblings when they come of age, should they so wish. Parts 2 & 3 will commence on 5th May 2020.
In addition to these, the Medical Council provides specific guidance in the area of AHR in the ethical guidelines issued periodically to registered medical practitioners for application in the clinical situations in which they work. However, these Guidelines have no statutory remit and do not apply to anyone working in the area other than medical practitioners.
Given the lack of specific regulation in this area, the Government approved the drafting of a bill on assisted human reproduction (AHR) and associated areas of research, based on the published General Scheme of the Assisted Human Reproduction Bill. This comprehensive piece of legislation encompasses the regulation of a range of practices, including: gamete (sperm or egg) and embryo donation for AHR and research; surrogacy; pre-implantation genetic diagnosis (PGD) of embryos; posthumous assisted reproduction; and embryo and stem cell research. The General Scheme also provides for an independent regulatory authority for AHR.
The Joint Oireachtas Committee on Health published the report of its review of the General Scheme on 11 July 2019, as part of the pre-legislative scrutiny process, which began in January 2018. This report will be considered as part of the ongoing process of drafting the Assisted Human Reproduction Bill in conjunction with the Office of the Attorney General.