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Regulating reproduction is no easy feat. In the past three decades we have witnessed a reproductive revolution and great strides have been made to alleviate the effects of infertility. Reproductive advances such as in-vitro fertilisation (IVF), sex selection, reproductive cloning and embryo selection for the purpose of creating “saviour siblings” have all emerged as part of a rapid and ever-changing branch of medicine, each promising to upset the status quo and transform human reproduction.
Following much activity in this area, the lengthy process of updating the legislation is now complete. The Human Fertilisation and Embryology Act 2008 (HFE Act 2008) received Royal Assent on 13 November 2008. The majority of the HFE Act 2008’s amendments will come into force in October of this year, with the exception of the provisions pertaining to parenthood, which commenced in April 2009. Welcoming Royal Assent, Professor Lisa Jardine, Chair of the Human Fertilisation and Embryology Authority, stated:
“This is a momentous day for the HFEA and for those with fertility problems. The regulatory system that has served us so well has been renewed. Parliament has provided a clear framework for the future and a solid base on which to regulate 21st century practice within 21st century law.”1
However, as scientific endeavours into developments such as artificial gametes, womb transplantation and ectogenesis continue apace, it could be argued that Jardine was perhaps overly optimistic about the achievements of the new legislation. The HFE Act 2008 is an amending statute, and as Jackson2 notes “much of the regulatory architecture” in the 1990 legislation “remains intact”. In retaining the architecture of the 1990 legislation, and merely amending or adding certain provisions, has the government missed an ideal opportunity to consider how to equip the regulatory framework for the next phase/era of assisted reproduction?
The next …
Competing interests None.
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↵i The Offences Against the Person Act 1861 and the Abortion Act 1967 were drafted in the context of pregnancy in a woman and as such do not cover the fetus gestating in an ectogenic incubator.
↵ii Under the HFE Act (as amended), in vitro derived gametes are allowed for research but not treatment.
↵iii Assisting a man to become pregnant does not fall within the specified activities for which a licence can be granted when “bringing about the creation of embryos in vitro”. HFE Act 1990, Schedule 2 lists the activities for which licences may be granted and provides: s1 (1) A licence under this paragraph may authorise any of the following in the course of providing treatment services: (a) bringing about the creation of embryos in vitro; (b) keeping embryos; (c) using gametes; (d) practices designed to secure that embryos are in a suitable condition to be placed in a woman or to determine whether embryos are suitable for that purpose; (e) placing any embryo in a woman; (f) mixing sperm with the egg of a hamster, or other animal specified in directions, for the purpose of testing the fertility or normality of the sperm, but only when anything which forms is destroyed when the test is complete and, in any event, not later than the two cell stage; and (g) such other practices as may be specified in, or determined in accordance with, regulations. The HFE Act 2008, Schedule 2, para 2 amends paragraph 1 of Schedule 2 to the 1990 Act to enable treatment licences to be granted for the use of embryos for training persons in embryo biopsy, embryo storage and other embryological techniques, but only when the HFEA is satisfied that such use is necessary for that purpose.
↵iv The HFE Act 1990, s3(3) prohibits the use of embryos beyond the primitive streak. Section 3(4) states: “For the purposes of subsection (3)(a) above, the primitive streak is to be taken to have appeared in an embryo not later than the end of the period of 14 days beginning with the day when the gametes are mixed, not counting any time during which the embryo is stored.” The HFE Act 2008 retains this prohibition.