General policy statement
The Human Assisted Reproductive Technology Act 2004 (the Act) prohibits storage of a human in vitro gamete or a human in vitro embryo (being an embryo whose development has been suspended) for longer than the applicable period. The applicable period is 10 years or, if the ethics committee under the Act has, before the expiry of that 10-year period, approved a longer period in respect of the gamete or embryo, the longer period approved by the ethics committee.
This prohibition is in section 10 of the Act, which came into force on 22 November 2004. Contrary to the initial understanding of officials and fertility clinics, this prohibition applies to both—
Fertility clinics acting in good faith have therefore unknowingly acted in breach of the Act by storing gametes and embryos of that kind for longer than the applicable period. Fertility clinics will continue to act in breach of the Act unless it is amended or (which was not intended, and is not proposed) they destroy immediately gametes and embryos of that kind.
There has also been uncertainty as to whether—
the advisory committee under the Act may issue guidelines and advice to the ethics committee on the matters to be taken into account in considering whether to approve a longer period for the storage of a human in vitro gamete or a human in vitro embryo; and
a longer period for the storage of a human in vitro gamete or a human in vitro embryo may be approved only if the giving of an approval of that kind is covered in, and the ethics committee is satisfied that the proposed approval is consistent with, relevant guidelines and advice issued or given by the advisory committee.
This Bill therefore amends the Act both to maintain, and to make clear, its initial policy intent.
Clause by clause analysis
Clause 1 states the Bill's Title.
Clause 2 relates to commencement. The Bill is to come into force on the day after Royal assent. (However, the amendment made by clause 5(1) has effect from the commencement, on 22 November 2004, of the prohibition against storing a human in vitro gamete or a human in vitro embryo for longer than the applicable period.)
Part 1
Preliminary provisions
Clause 3 ensures that the Bill amends the Human Assisted Reproductive Technology Act 2004. (A reference in this analysis to a provision is, unless otherwise stated, a reference to a provision of that Act.)
Clause 4 states the Bill's purpose, which is to ensure that,—
(a) for the purpose of the prohibition against storing a human in vitro gamete or a human in vitro embryo for longer than the applicable period, no account may be taken of any period in which the gamete or embryo was stored before the commencement, on 22 November 2004, of that prohibition:
(c) a longer period for the storage of a human in vitro gamete or a human in vitro embryo may be approved only if the giving of an approval of that kind is covered in, and the ethics committee is satisfied that the proposed approval is consistent with, relevant guidelines and advice issued or given by the advisory committee.
Part 2
Amendments to principal Act
Clause 5(1) amends section 10 as from its commencement, on 22 November 2004. Section 10(1) prohibits storage of a human in vitro gamete or a human in vitro embryo (being an embryo whose development has been suspended) for longer than the applicable period (10 years or, if the ethics committee has, before the expiry of that 10-year period, approved a longer period in respect of the gamete or embryo, the longer period approved by the ethics committee). New section 10(1A)—
relates to any storage of a human in vitro gamete or a human in vitro embryo of that kind before the commencement, on 22 November 2004, of section 10; and
requires any storage of that kind to be disregarded in calculating, for the purposes of section 10(1), the period for which that gamete or embryo has been stored.
Clause 5(2) inserts a new section 10(1B). New section 10(1B) prevents the ethics committee from approving a longer period for the storage of a gamete or embryo for the purposes of section 10(1)(b) unless the giving of an approval for those purposes is covered in, and the ethics committee is satisfied that the proposed approval is consistent with, relevant guidelines or advice issued or given by the advisory committee.
Clause 6 relates to the advisory committee's functions under section 35(1)(a). Those functions are to issue or give guidelines and advice to the ethics committee on any matter relating to any kind of assisted reproductive procedure or human reproductive research and to keep such guidelines and advice under review. (The ethics committee is in performing its functions and exercising its powers required by section 29(a) to operate in accordance with any guidelines issued by the advisory committee.) New section 35(1A) ensures that the advisory committee's functions under section 35(1)(a) include the issuing or giving of guidelines and advice to the ethics committee on the matters that the ethics committee must take into account in considering whether to approve, for the purposes of section 10(1)(b), a longer period for the storage of a human in vitro gamete or a human in vitro embryo.