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Chandler, Eloise; Stuhmcke, Anita --- "Storage limits of gametes and embryos: Regulation in search of policy justification" [2014] UTSLRS 15; (2014) 22 Journal of Law and Medicine

Last Updated: 16 May 2017

Chandler, Eloise; Stuhmcke, Anita – “Storage limits of gametes and embryos: Regulation in search of policy justification[1]

This is a pre-publication draft which will appear in (2014) 22 Journal of Law and Medicine

ABSTRACT

In Australia regulatory limits with respect to the storage of gametes and embryos differ according to both the ‘type’ of reproductive material and the jurisdiction the material is stored within. This article examines the differences and similarities in storage limits across Australian states, evaluating the reasons for the introduction of storage limits and identifying historical policy change. The article argues that justifications for current storage limits are not clearly articulated and calls for further debate and discussion in this increasingly important area of law.

INTRODUCTION

Since the birth of Louise Brown, the first baby conceived through in vitro fertilisation (IVF) in 1978, there has been increasing use of assisted reproductive technology (ART) reflecting societal and medical acceptance of its role as treatment for subfertility.[2] For example, in 2010 there were 12,056 liveborn babies (3.6% of all Australian births that year) through ART.[3] It was estimated that same year that approximately 3.5 million children had been born worldwide following ART treatment[4]

Cryopreservation is an important component of the story of the medical and social success of ART, allowing gametes (semen and oocytes), gonadal tissue (ovarian and testicular) and embryos to be stored for future use. The freezing of reproductive material, especially of embryos, has ‘greatly reduced risk, cost and effort involved’ in the provision of ART.[6] However despite successfully serving scientific and social needs with respect to fertility treatment, cryopreservation, specifically the issue of storage limits, offers a case study in the haphazard development of Australian ART regulation as the regulation of storage limits fluctuates according to jurisdiction and type of reproductive material stored.

Part 1 of this article details the historical development of the regulation of storage limits examining this disparity between jurisdictions and type of reproductive material. A partial explanation for this haphazard regulatory response is due to the staggered nature of technological innovations in this area. In Australia ‘deep-frozen sperm banks were successfully developed in several Australian centres during the late 1970s’.[7] By 1981, the practise of using frozen semen for donor insemination in Australia had rapidly increased, with some fertility clinics treating around 170 patients a month resulting in the claim that by this point in time ‘frozen semen [was] more frequently used than fresh or non-frozen semen for AID in Australia’. [8] It was in 1983 when Trounson & Mohr reported the first Australian pregnancy (and the first achieved internationally) from a ‘preserved’ embryo[9] and it was in 1986 when Dr Chris Chen reported from the Flinders Medical Centre the world’s first successful pregnancy following the deep freezing of oocytes stating that ‘the human preovulatory oocyte can be successfully frozen and stored’.[10]

However, as Part 2 demonstrates the current divergence of differing storage limits is not readily explained through this staggered historical development of cryopreservation technology for semen, oocytes and embryos. Current Australian regulation reveals less emphasis upon the storage limits of gametes and an overwhelming preoccupation with a time limit of 10 years and under for embryos, confirming ongoing differences in the approach to embryo and gamete storage. This divergence in treatment between embryos and gametes is reflected in the definition of ART used by the Australian Institute of Health and Welfare (AIHW), the key organisation tasked with recording and publishing ART statistics as ‘treatments or procedures that involve the in vitro handling of human oocytes (eggs) and sperm or embryos for the purposes of establishing a pregnancy’, a definition which explicitly excludes the utilisation of sperm in clinically assisted insemination.[11]

The multi-jurisdictional fixation on 10 year limits for embryos and the lack of attention paid to gamete storage leads to an examination in Part 3 of the absence of policy justification for three particular issues raised by the historical and current analysis in Parts 1 and 2 of this article: (1) whether there should there be storage limits at all; and if so (2) how long such limits should last; and, (3) whether storage limits should continue to differ according to the type of reproductive material frozen. Here we draw on the experiences and perspectives of participants in a nation-wide study which explored the options IVF patients desired with respect to their stored embryos, a group whose views have often been sidelined in the formulation of ART regulation.[12] In conclusion this article suggests that considered and thoughtful interdisciplinary debate on the justification for storage limits for gametes and embryos is needed.

PART 1: HISTORICAL STORAGE LIMITS

The regulation of embryo freezing and storage in Australia trails the growth in the use of ART as a means of family formation.[13] The earliest national and international law reform inquiries into IVF raised the issue of freezing of reproductive material as a cause of concern. Given that Australia was a world leader in the use of IVF technologies in the late 1970s and early 1980s, it is not surprising that it was also the first to introduce an “official, Government-approved regulatory code for the practice of in-vitro fertilisation”, [14] through Supplementary Note 4 – In-vitro Fertilisation and Embryo Transfer, adopted by the National Health and Medical Research Council (NHMRC) at its 94th session in October 1982. Describing IVF as a “justifiable means of treating infertility”,[15] the Note warned of the possible “biological and social risks” of human embryo storage:

Storage for transfer should be restricted to early, undifferentiated embryos. Although it may be possible technically to store such embryos indefinitely, time limits for storage should be set in every case. In defining these time limits, account should be taken both of the wishes of the donors and of a set upper limit, which would be of the order of ten years, but which should not be beyond the time of conventional reproductive need or competence of the female donor.[16]

The ten-year time limit was also recommended by the United Kingdom Warnock Committee,[17] established in July 1982.[18] The Warnock Committee recommended that the use of frozen semen in artificial insemination be continued;[19] that the use of frozen eggs in therapeutic procedures not be undertaken until research has shown there are no unacceptable risks involved[20] and that there should be ‘a maximum of ten years for the storage of embryos after which time the right to use or disposal should pass to the storage authority’.[21]

Given that this recommended ten-year storage limit was adopted internationally and has remained unchanged by the NHMRC in Australia since 1982,[22] it is interesting to note that this limit has never been uniformly adopted by subsequent Australian state law reform inquiries or legislative processes. While early 1980s state government inquiries into the use of IVF identified the storage of embryos as a legal issue to be considered, there was considerable jurisdictional divergence on proposed storage limits. The first government inquiry, held in Victoria,[23] (referred to as the Waller Committee) was established to ‘consider whether the process of IVF should be conducted and if so, the procedures and guidelines that should be implemented in respect of such processes in legislative form or otherwise’.[24] Under its Terms of Reference, the Committee was empowered to consider ‘the methods of selection, treatment and protection of embryos prior to and after implantation and, if implantation does not proceed, the destruction or use of embryos for other purposes.’[25]

Delivering its Report in 1984, the Waller Committee found that the ‘...freezing and thawing of embryos must still be regarded as an experimental programme, even though there are established pregnancies and at least two successful live births.’[26] The very first pregnancy from the transfer of a frozen embryo was reported in Australia in 1983.[27] The first Australian live birth occurred in Victoria[28] on 28 March 1984.[29] The Committee recommended that ‘in general, storage shall be for very short periods. In a few instances it may need be for a comparatively long time, as where the woman whose ova have been used is undergoing prolonged chemotherapy...in that time the view of the couple and their circumstances may change. The Committee recommends that where a couple consents to long term storage the consent shall be reviewed after 5 years, and may then be renewed.’[30]

This shortened period of storage – reduced from the 10 year limit recommended by the NHMRC to a period of 5 years - was explained by specific reference to a case which had been the subject of widespread international media coverage at the time, that of Mr & Mrs Rio and their ‘orphaned embryos’.[31] Mr and Mrs Rio had stored two embryos, formed through Mrs Rio’s ova and donated sperm, in November 1981 in Victoria. In early 1984 Mr & Mrs Rio died in a plane crash in South America. They were United States citizens. [32] In direct reference, the Committee stated: [33]

The lengthy interval between the beginning of storage and the accident in which the couple died underlines very heavily the Committee’s view, already expressed, that storage shall be for as short a periods as possible in terms of the reason for the storage of that embryo or those embryos.


While not particular to storage it is nonetheless interesting to note that Victoria was also the first jurisdiction to openly distinguish between the use of embryos, eggs and sperm in infertility treatment. This was done in 1983 when, due to the ‘unknown outcome of donor egg pregnancies, a moratorium on the donor egg program was placed by the Victorian Government’.[34] This occurred despite a Morgan Gallup poll at the time showing no difference in acceptance of the use of eggs and sperm.[35] The decision led to a large protest by patients affected by the moratorium, which then forced a hearing at the Equal Opportunities Board on the grounds of discrimination – as donor sperm treatment was still allowed. The moratorium was lifted that same year. The first donor egg pregnancy and birth was achieved in Australia by Monash IVF in December 1983.[36]

Similarly to the Victorian Waller Committee, in 1984 the Queensland Government established an Inquiry (subsequently referred to as the Demack Report) to consider the ‘status of the embryos, and the control of fetal experimentation, storage and destruction’. [37] The Demack Report noted that the ‘freezing’ of embryos was then ‘in the experimental stage’ and that it ‘may provide an alternative to a discarding of “surplus” embryos.[38] In terms of storage limits the Demack Report specifically states with reference to the 1982 NHMRC recommendation of 10 year storage that:[39]

In the opinion of the Committee, the suggested period of ten years is unduly long. It understands that a British Medical Associations Working Group has recommended that cryostorage should not exceed twelve months and should be done on behalf of a particular patient/couple. Freezing should be restricted to a period which is not so prolonged as to put at risk a subsequent transfer to the mother. A period of two years would seem ample, except in exceptional circumstances.

This was the recommended time limit put forward in the report.[40] Much of the perceived danger of prolonged storage was discussed in terms of the impact it may have upon the embryo. Indeed at the time the Queensland Report was written ‘no pregnancies had occurred from embryos that been frozen for over two years.’[41]

While Queensland and Victoria moved towards shortened periods of storage, other jurisdictions favoured the ten-year storage limitation period determined by the NHRMC. The NSW Law Reform Commission in its Artificial Conception Report: In Vitro Fertilization recommended an initial limit of 10 years.[42] South Australia, in its Working Party of 1984[43] recommended that ‘storage of fertilized gametes should be maintained... at the expiration of an agreed period of time but in any event no longer that ten years from the date of commencing storage.’[44] As the following section explains this inconsistency in storage limits remains the case in Australia today.

PART 2: CURRENT AUSTRALIAN POSITION
Under the Research Involving Human Embryos Act 2002 (Cth), embryos can only be used or developed in the course of a woman’s reproductive treatment by RTAC[45] accredited ART units. What this means in practice is that all Australian clinics which in the course of their practice create, develop or store embryos, must adhere to the Fertility Society of Australia’s (FSA) Reproductive Technology Accreditation Committee Code of Practice for Assisted Reproductive Technology Units (the RTAC Code).[46] It is through this Commonwealth Act that the RTAC Code is given quasi legislative effect and has become a means of regulating the provision of ART across Australian states and territories (including those which have legislated in this area). Only four Australian states have legislated on the provision of ART in their jurisdictions: New South Wales, Victoria, South Australia and Western Australia. Of these, just New South Wales, Victoria and Western Australia now impose statutory storage limits on reproductive tissues[47]. In the remaining states and territories, access to, and the provision of, ART (including how long embryos or gametes may be stored) is regulated by the RTAC accreditation scheme, which mandates adherence to the NHMRC Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (NHMRC Guidelines).

The table below sets out the divergent rules governing the storage of embryos and gametes across Australian states and territories.


NHMRC Ethical Guidelines
ACT
NSW
NT
Qld
Vic
SA
Tas
WA
Storage limitation period for gametes
Subject to gamete provider’s consent and individual clinic policies
Subject to NHMRC Ethical Guidelines
Donated gametes: 10 years

Own Gametes: subject to gamete provider’s consent and individual clinic policies
Subject to NHMRC Ethical Guidelines
Subject to NHMRC Ethical Guidelines
10 years
Subject to NHMRC Ethical Guidelines
Subject to NHMRC Ethical Guidelines
15 years
Storage limitation period for
embryos
5 years with the option to consent for a further 5 year period
Subject to NHMRC Ethical Guidelines
Donated embryos & embryos formed with donated gametes: 10 years

Patients’ own gametes used to form embryo:
Subject to gamete provider’s consent and individual clinic policies
Subject to NHMRC Ethical Guidelines
Subject to NHMRC Ethical Guidelines
5 years with the option to consent for a further 5 year period
Subject to NHMRC Ethical Guidelines
Subject to NHMRC Ethical Guidelines
10 years

National ART Unit Accreditation Scheme and the NHMRC Ethical Guidelines

Under the RTAC Code, clinics must provide evidence of compliance with the NHMRC Ethical Guidelines (unless alternate policies have been directed by a registered and affiliated Human Research Ethics Committee).[48] It is these guidelines (as opposed to the Code itself) which now restrict the time period under which embryos and gametes may be stored. Previous versions of the Code imposed set time limits on the period of storage of gametes and embryos, however since 2005 this has been left to the NHMRC Ethical Guidelines and respective state legislation. The 2010 Code does however require that clinics provide evidence of procedures and policies which limit the length of time gametes and embryos can be stored as a measure of good practice in the safe management of cryopreserved gametes, embryos and tissues.[49]

As the table above demonstrates, the NHMRC Ethical Guidelines stipulate different storage requirements for embryos and gametes. While they permit embryos to be stored for a maximum of five years, with the option to extend storage for a further five-year period,[50] they do not set a maximum storage period for gametes. Rather they leave the time period for gamete storage to the discretion of clinics and those people on whose behalf the gametes are stored, under the proviso that clinics set clear policies limiting the duration of their storage.[51] In both cases however, the guidelines state that “the storage of gametes [and] embryos is associated with a range of ethical, social and legal considerations for all participants”[52] and that “it is not desirable” to leave gametes or embryos in storage indefinitely.[53] Following this, patients’ written authorisations to store their embryos and gametes should include the maximum period of storage.[54] For embryos, consent forms for storage should include a “clearly expressed and witnessed directive” of what should happen if the persons on whose behalf the embryos are stored die, are rendered incapacitated or otherwise fail to give further instructions at the expiry of the maximum period of storage.[55]

New South Wales

In New South Wales, the Assisted Reproductive Technology Act only imposes a storage limitation period for donated gametes and embryos (those created through the use of donated gametes and those subsequently donated by others). This Act is currently under review.[56] Under the current legislation the maximum storage period for donated gametes and embryos is 10 years, with the Director General empowered under the Act to extend storage periods in particular circumstances providing there are reasonable grounds to do so.[57] Notably, this ten year storage limitation period when applied to embryos formed from donated sperm is triggered from the point at which the donated gamete is “obtained” from the donor, not the point at which the embryo is stored.[58]

The Act does not impose a maximum storage period for those gametes or embryos stored on behalf of the gamete providers. Instead, gamete providers when consenting to the storage of their embryos or gametes must specify a time period of storage within their written consent. Without doing so their consent to storage will be invalid.[59] Gametes or embryos stored with the intention of later use by gamete providers can then only be removed: in accordance with the gamete provider’s consent;[60] at the expiration of the storage period set by the ART provider (either before or after the gamete was obtained); [61] or in the case of stored embryos only, where one gamete provider has stipulated a shorter period of storage than the other gamete provider, at the time when this shorter period has expired.[62] This allows for one gamete provider to withdraw consent subsequent to their initial agreement and is in line with the general policy position within the Act that any positive use of the embryo (including its prolonged storage) must be mutually consented to by both gamete providers.

This Act’s refrain from setting the above limit, is in keeping with the position reached by the 1988 NSW Law Reform Commission (NSWLRC) report on gamete storage,[63] however discords with the Commission’s recommendation to set a maximum time frame of 10 years for the storage of embryos, whether stored on behalf of the gamete providers or not.[64] The 1988 policy position was based at the time on the final positions reached by the UK Warnock Report, the Ontario report and the NHMRC, in its 1982 ethical guidelines.[65] The 1988 Commission also felt that the 10-year period would go some way to address community concerns of possible ‘adverse effects’ of long-term storage, and the legal and ethical implications raised by the possibility of gamete provider’s deaths or relationship breakdowns.[66] Following the NSWLRC’s 1988 Report, nearly a decade passed before the issue of legislating on ART was addressed again in the NSW Health Review of the Human Tissue Act[67]. While the Review itself did not publish a concrete policy stance, it did ask the question of whether it was necessary for any potential state legislation to restate the NHMRC 10 year rule on embryo storage – a question which may point to an intention at the time that the storage of all embryos (regardless of whether they were donated or not) should be so limited[68]. In the NSW Government’s belated response to the 1997 review in 2003, the ART Bill Consultation Draft, this question was not addressed. Instead, the Consultation draft proposed the position we see in today’s legislation (the 10 year storage period for donated reproductive material, and the prohibition of gamete/embryo storage in situations where gamete providers do not specify a maximum storage period within their consent), without setting out the policy justification for this. The topic of storage was also contemplated in terms of consent requirements (or rather a reticence to impose specific consent requirements on diverse clinic practices); the ability for gamete providers to withdraw consent to the positive use of any longer term stored embryos in the case of divorce or death, and finally in terms of imposing a maximum storage period and trigger for disposal of embryos and gametes which had been donated[69].

The current NSW Act’s silence on a storage limitation period for embryos stored for later use by gamete providers may suggest an intention on behalf of legislators to leave the question of how long embryos can be stored by gamete providers (as opposed to recipients of gamete/embryo donation) to the discretion of the gamete providers and their particular clinics. The outlined historical policy development in this area, the current requirement that consents to storage include specific time limits coupled and the legislated right of clinics to terminate storage periods (over-riding gamete providers’ consents), do however also suggest a policy stance against indefinite storage. Should clinics enable patients to consent to further storage at the expiration of the ten-year period, the legal position is unclear.

The experience of one participant in our recent study[70], Clarice, does indicate however that at least some NSW clinics are interpreting the legislative silence liberally as permitting storage beyond a ten year period. Clarice and her husband underwent IVF 14 years ago. They have one 13 year-old daughter as a result of this treatment, and another who was conceived naturally two years later. At the time of interview, Clarice and her husband still had three embryos in storage, frozen from the time of their treatment. At the 10 year mark, Clarice contacted her clinic: “...I put to them that I was aware of the NHMRC guidelines about 10 years. First of all they couldn’t answer me and then they got back to me by phone. They said words along the lines of “it’s just a guideline and there is no evidence that they can’t be stored safely for longer than that. It’s entirely legal and within our rights to store them for longer than that as are you”... I don’t think we talked about does that end then at some other point in the future if it’s not going to be 10 years”. It is important to note here that at the time Clarice contacted her clinic, the NSW Assisted Reproductive Technology Act had not yet been passed, so the clinic’s interpretation of the law at this stage was purely based on the NHMRC guidelines and the RTAC Code. That being acknowledged, following the NSW ART Act’s commencement, Clarice continued to renew her consent to storage at the end of each storage billing cycle. She expressed that she will probably continue to do so until the point (if any) when this option is removed, and argued in favour of the patient’s right to store indefinitely and her clinic’s interpretation of NSW law: “... a comment I would like to make is that if [the clinic] is legally entitled to interpret the storage of embryos in favour of storing them for a longer period of time, then while there is no evidence that that’s unsafe, then to do so is probably – you know, the right thing by their patients. If there’s a lack of clarity in the law, then I think they’re right to interpret it aggressively in favour of keeping them for a longer period of time”.

Victoria

Victoria sets a maximum storage period of 10 years for gametes,[71] and five years, with the option of extending for another five, for embryos (mirroring the NHMRC guidelines).[72] This is regardless of whether the gametes or embryos are stored on behalf of the gamete providers or not, although in the latter case, donors (as gamete providers) must provide written consent to the requested storage period. Specifically relating to stored embryos, as with the NSW Act, where one of the persons whose gametes were used to form an embryo has specified a storage period of less than five years or revokes their consent, then that embryo must be removed in accordance with their specifications, regardless of the other gamete provider’s instructions.[73] The Patient Review Panel, a statutory authority established by the Act, is empowered to approve longer storage periods for both gametes and embryos if it considers there are reasonable grounds to do so.[74] Notably recent amendments to the Victorian Assisted Reproductive Treatment Act 2008 enable the Patient Review Panel to approve storage extensions for gametes and embryos in situations where gamete providers’ consent to do so can not be obtained providing there are exceptional circumstances for doing so.[75] In the Explanatory Memorandum to the amendments, explicit reference is made to such circumstances being triggered in instances where donors whose gametes were used to form embryos are unable to be contacted or located to seek their written approval before the expiry of the statutory storage period.[76] The Amendments also allow for gametes retrieved from children and/or people certified by a doctor as at reasonable risk of becoming prematurely infertile (due to a medical procedure or condition), to be stored for a maximum period of 20 years.[77] Again, longer storage periods may be approved by the Patient Review Panel in these instances if it considers there are reasonable grounds.[78] In making its decision to approve storage extensions the Patient Review Panel must have regard to the guiding principles set out in the Assisted Reproductive Treatment Act 2008 (Vic)[79], which include amongst others, that the welfare and interests of persons born or to be born as a result of treatment must be paramount; and that treatment procedures should not be used for the purpose of exploiting in trade or otherwise, the reproductive capabilities of men and women or the children born as a result of treatment procedures.[80] In 2010, a total of 123 applications for extending storage of gametes and 152 applications for the extended storage of embryos were received by the Patient Review Panel. These figures dropped in 2012, with only 66 applications for extended storage of gametes and 59 for extended storage of embryos.[81] (While the Victorian authorities do not provide information on how many of these applications are successful, it is interesting to note that their Western Australian equivalent granted all 16 requests for extension of embryo and 20 requests for sperm storage in 2012.[82])

The original Victorian ART legislation, the Infertility Treatment Act of 1995, limited the duration of embryo storage to 5 years, and gamete storage to 10 years, with the Infertility Treatment Authority empowered to approve a longer period of storage if it found there were reasonable grounds to do so.[83] This statutory limitation was justified on the basis of concerns raised in the Waller report.[84] The move to a maximum storage period of 10 years for embryos came with the Assisted Reproductive Treatment Bill 2008 – largely justified on the basis of bringing the Victorian legislation into line with contemporary NHMRC Ethical Guidelines.[85] The more recent Amendments discussed above only came into effect in 2013.

South Australia

Until very recently South Australia rigorously regulated the provision of ART in its jurisdiction through its Code.[86] While gametes were not subject to a maximum storage period, under the now repealed Reproductive Technology (Clinical Practices) Act 1988 clinics were prohibited from storing embryos for more than 10 years after the point of fertilisation[87]. Patients on whose behalves embryos were being stored had the right to review their consent to storage at 12-month intervals during this time and clinics were bound to notify their patients of this right at least 90 days before each 12-month anniversary of storage. Following the 2009 Amendment, South Australian ART legislation no longer stipulates a maximum storage period for gametes or embryos. Instead, clinics must adhere to the NHMRC Ethical Guidelines.

Western Australia

Under the Western Australian Human Reproductive Technology Act 1991 (HRTA), embryos cannot be stored for any longer than 10 years unless the Reproductive Technology Council (RTC) approves storage for a further period.[88] RTC approval can only be sought before the expiration of this statutory storage period (or before the expiration of a previously approved extended storage period)[89] and only then given if the RTC considers there are special reasons for doing so in a particular case.[90] The RTC is unable under the Act to consider extensions once the storage period has expired. Storage (at any time) is only permitted when it relates to the probable future implantation of the embryo or its probable future use under an NHMRC license (for research).[91] Where the extension for storage relates to the former, the IVF eligibility requirements laid out in the Act will be taken into consideration by the Council, which include that the reason for seeking IVF must be something other than the age of the applicants.[92] In their Policy on Embryo storage, the Council advises potential applicants that if their age is such that it may trigger suspicions on this point, medical confirmation of their fertility will be required.[93]

The Western Australian legislation is now unique in that it statutorily prescribes that clinics take reasonable steps to notify each person for whom the embryo is being stored three months before the end of their storage period.[94] Further, the HRTA Directions explicitly state that where clinics fail to take reasonable steps to notify their patients of the impending storage expiration, they may be found liable to the persons on whose behalf they were storing the embryo(s).[95] While clinics are prohibited from applying for extensions of embryo storage themselves, they are obliged to assist patients with completing the requisite application forms.[96] They must also ensure their patients have been given information about the possibility of applying for an extension of storage and further informed that should they intend to apply they must submit their application at least one month before the RTC meeting that precedes the expiry of their storage period.[97]

While the HRTA itself does not impose a maximum storage period for gametes, according to the HRTA Directions, gametes can only be stored for a maximum of 15 years unless the RTC approves a longer period.[98] Consent to storage must also be renewed at the end of every 5-year period.[99] As with embryos, requests for extensions can only be approved in situations in which the gametes are to be used in the treatment of the gamete provider or for research.[100] Curiously, a note in the Directions states that in situations of gamete storage, patients should be informed that any future use of their gametes will be subject to the approval of the RTC.[101] Put another way, a patient’s ability to direct the future use of their gametes within the storage period may be tapered by the requirement that they must seek Council approval to do so on an individual basis. In deciding to grant this approval, the Council must consider the safety and effectiveness of the proposed procedures and outcomes for both the woman and any potential offspring. The Directions note, “such approval cannot be assumed”.[102]

Like the other jurisdictions we have addressed, the storage period in Western Australia has not been constant. While the current HRTA permits the storage of embryos for a period of up to ten years, this was increased from an initial period of three years in 2004. The justification for this change was to bring Western Australian legislation into line with the NHMRC guidelines. Ten years was seen as allowing a reasonable time for treatment to be completed while “reflect[ing] the position that leaving an embryo ‘in limbo’ indefinitely is not ethically acceptable”[103]. Today’s Western Australian policy on storage repeats this sentiment, stating that “[i]ndefinite storage of embryos is arguably not ethical, and does not assist participants, many of whom are repeat applicants, to resolve their issues concerning their stored embryos.”[104] The reference to indefinite storage being ‘arguably not ethical’ is not explained in the Western Australian literature.

PART 3: RETHINKING CURRENT STORAGE LIMITS

Regardless of any legislative prohibition, recent scientific research has indicated that human reproductive material may be stored indefinitely.[105] A study examining whether frozen embryo survival and quality diminished over time, found that the length of storage does not significantly influence thaw survival or pregnancy outcomes.[106] Despite this, regulators have continued to cast the need for storage limits as being self-evident. In 1982, the NHMRC in the first Australian official regulatory code for IVF stated that ‘...time limits for storage should be set in every case’. In the Explanatory Memorandum to the Western Australian Human Reproductive Technology Amendment Bill 2003, the 10 year storage limitation period was justified by reference to the NHMRC Ethical Guidelines and by ‘allow[ing] a reasonable time for treatment to be completed’ while ‘reflect[ing] the position that leaving an embryo “in limbo” indefinitely is not ethically acceptable.’[107] Historically, similar views have been expressed with respect to the storage of eggs and semen, for example, when the Warnock report stated that it would be “unreasonable and impractical to expect those responsible for storage to maintain all eggs and semen stored indefinitely”.[108]

The policy reasons for setting storage limits, when given, have centred on avoiding the accumulation of large numbers of embryos,[109] the burden unclaimed embryos place upon clinics,[110] or as outlined at the beginning of this article, assumptions about reproductive choices based upon the reproductive age of women. Historically the wishes and desires of the individuals responsible for the reproductive material have not factored as policy considerations for the setting of storage limits. Our study, the most recent Australian study of its type, confirmed that of 290 survey respondents with embryos in storage only a minority would choose a storage time of less than 10 years.[111] Most preferred no time limit at all or one based on a patient’s need or ability to use.[112] These findings are in step with other studies, which have found that when the option is available individuals will extend the storage time of their embryos[113] and many would prefer to maintain them in storage indefinitely.[114]

Not only has individual preference been hitherto ignored by policy makers, the justifications given are at best awkward and at worst highly dubious if not wrong. For example, the Western Australian policy justification for storage limits on the basis that ‘leaving an embryo “in limbo” indefinitely is not ethically acceptable’ belies the outcome of storage limits where history shows that their imposition and enforcement can have extremely adverse effects. For example in the United Kingdom on August 1 1996, nearly 3000 embryos were destroyed. This was done in accord with the five-year storage limit in the Human Fertilisation and Embryology Act 1990 being enforced. Whether this outcome is ethical is highly doubtful. As Rosenwaks and Davis observe in a rather understated fashion, ‘In matters relating to the ultimate disposition of embryos, it would be far better if a greater degree of flexibility had been displayed.’[115]

This lack of thoughtful policy justification around storage limits is most obvious in the recent innovations made in successful cryopreservation of oocytes. Hope has been expressed by some commentators that oocyte storage will render embryo creation and storage less relevant. As Gook & Edgar observe, this would ‘allow the circumvention of moral, ethical and legal problems which arise as an inevitable consequence of embryo freezing’.[116] Despite this interest in egg freezing and the fact that in 2012, the process of cryopreservation of oocytes was no longer regarded as experimental in the United States,[117] little has been said about how long eggs may be stored for, despite the flagging of several controversial policy issues.[118] Perhaps unsurprisingly given the pattern of regulatory formation analysed in Part 1 and 2 of this article, informed and sustained policy debate surrounding storage limits is again absent and instead the void is filled by observations which are largely outdated and perhaps unnecessary such as whether ‘marketing this technology for the purpose of delaying childbearing may give women false hope and encourage women to delay childbearing’[119] or alternatively as Bankowski observes that ‘women might desire or even feel pressured to initiate prophylactic storage of their oocytes, even before establishing and long-term personal relationships...’[120]

Drilling down further this absence of careful consideration as to why and how storage limits should be imposed is clearly seen in the divergent storage limits applied to different reproductive material. While this may be due to assumptions made about embryos, and beliefs that the entity of an embryo and its prolonged status through freezing is ethically more challenging than that of gametes this point is neither evidenced nor clearly made in policy justifications. Indeed it has been a decade since Bennett wrote that ‘Even with regulation, the nature of the interest that individuals and couples have in their frozen embryos remains unclear.’ [121] What is clear from the study we have undertaken is that the experience of the IVF journey is individual and complex. As one of the study participants, Jacqui, observes:

It would be really hard to legislate because I think everyone's fertility or infertility journey is so different and so personal. It's an out of body experience in that you just don't really want to be going through it, but you are and you've taken a deep breath and you have to just go through that journey, and the journey needs an end which you have to be aware of. So [the question is] whether legislation would help some people create an end to it. (Interview 16, Jacqui)

Given these observations as to the enormity of IVF and embryo storage it is perhaps not surprising that debate has come to centre more around the disposition options for stored embryos such as donation for reproductive use of others; donation for research, allowing them to succumb, rather than exploring the issue of storage limits, which more often than not trigger consideration of these disposition options to begin with.
The Australian tendency to conform to the historical preoccupation with relatively short storage limits for embryos as well as basing storage limits on reproductive tissue type seems increasingly anachronistic in light of international developments. More recently the United Kingdom has given legislative recognition both to more lengthy storage periods, the policy justification for longer limits being to bring storage time for embryos ‘... in line with that of gametes (sperm and eggs).’ [122] Thus the clear policy reason is to treat gametes and embryos similarly. This has come with the passing of the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009. These regulations make it possible to extend the storage of gametes and embryos for a maximum of 55 years – although only for a specified group of what is described as ‘out of time;’ embryos’.[123]

Conclusion

Cryopreservation has added an extra temporal and scientific dimension to reproductive choice. However while cryopreservation has facilitated the social and medical success of ART, storage limits have been applied without sufficient policy justification. The result is that policy choices made with respect to storage limits have resulted in the prioritisation of both the embryo over gametes and the role of external actors such as clinics over the needs and desires of individuals responsible for the stored material. The historical development of storage limits evidences prioritisation of different human reproductive material - storage limits were not created for cryopreservation of sperm however were created to apply to frozen embryos. Further, there is a stricter approach applied to embryo storage than to the storage of gametes with limits of 10 years and under being applied to embryos across all Australian jurisdictions. In prioritising and distinguishing the embryo through storage limits, the social and medical significance of gametes is in turn squeezed out of consideration. Take for example the view expressed with respect to egg freezing, that ‘this is of little moral or ethical concern because an egg alone is not yet a human being’[124]
Whether or not it is appropriate to have storage limits, or indeed differing limits based on the kind of reproductive material stored, is a debate that must be had. Of course it may well be appropriate that differing time frames for embryos and gametes continue to be implemented. The nature of the embryo and the rights that should attach to it remain the subject of ongoing international and interdisciplinary legal and ethical debate.[125] Indeed while our study focused on embryo storage rather than gamete cryopreservation, unsolicited comments were made by some participants comparing and contrasting embryos and gametes. For example some participants saw the difference between gametes and embryos arising through the harsh and emotionally tumultuous IVF journey: ‘It’s a really hard process to get to have embryos’ (Scarlet); ‘...in my view embryos are precious. They’re hard to make...’(Mariana).

In discussion of policy formation around storage limits for ART the desires of gamete providers and recipients of donor gametes must be incorporated[126] as must research into change of disposition preferences for embryos.[127] This is necessary as in Australia, policy justifications for regulatory limits have either been assumed or framed in extreme terms. Dr John Cornwall’s rhetoric in the 1984 South Australian debate provides an illustrative example of this: ‘How do we resolve the conflict between common sense and idealism which demands that every single fertilized ovum must be implanted or preserved indefinitely?’.[128] Of course the Australian political canvass is not alone in serving such blanket statements. More recently in the United Kingdom, Tory former Education Secretary, Lord Patten, protested in parliamentary debate: 'I dislike intensely the thought of scrambling the generations'.[129] Given the increasing use of ART and the linked usage of cryopreservation it is time to have a considered and thoughtful interdisciplinary debate over the need for and justification of storage limits and human reproductive material.


[1] This article was supported by research carried out throughout 2009-2012 funded by the Discovery Project Grant DP 0986213 from the Australian Research Council and additional funding from UTS: Law. Ethics approval to conduct this research was obtained through the University of Technology, Sydney Human Research Ethics Committee (UTS HREC Reference Number: 2009-262A). Details of the project can be found at www.allabouttheembryo.net. For a full description of the methodology see the final Report on the Project updates page.
[2] CM Farquhar, YA Wang & EA Sullivan, ‘A comparative analysis of assisted reproductive technology cycles in Australian and New Zealand 2004-2007 (2010) 25(9) Human Reproduction 2281
[3] Macaldowie A, Wang YA, Chambers GM & Sullivan EA 2012. Assisted reproductive technology in Australia and New Zealand 2010. Assisted reproduction technology series. Cat. no. PER 55. Canberra: AIHW, 1.
[4] MP Connolly, S Hoorens, GM Chambers ‘the costs and consequences of assisted reproductive technology: an economic perspective’ (2010) 16(6) Human Reproduction Update 603, 604 citing ESHRE. The first recorded birth in Australia of a baby conceived through IVF, Candice Reed, was in 1980. Just over a decade later in 1991 there were 1,064 live births in Australia resulting from ART,5 in 2002 there were 5,953 liveborn ART babies see: Bryant J, Sullivan EA & Dean JH 2004. Assisted reproductive technology in Australia and New Zealand 2002. Cat. no. PER 26. Canberra: AIHW.
[6] G.T. Kovacs, S.A. Breheny & M.J. Dear, ‘Embryo donation at an Australian university in-vitro fertilisation clinic: issues and outcomes’ (2003) 178 Medical Journal of Australia 127. Embryo storage may also be required due to the relatively recent addition of clinical factors such as a strict limitation on the numbers of embryos to be transferred in the fresh cycle which also ‘usually increases the number of embryos available for cryopreservation’ see Wang XJ, Ledger W, Payne D, Jeffrey R & Matthews CD, ‘The contribution of embryo cryopreservation to in-vitro fertilization/gamete intra-Fellopian transfer: 8 years experience’ (1994) 9(1) Human Reproduction 103 – note these authors have a clinic policy to actively manage the numbers of stored embryos by encouraging couples to discard or have them used for research, at 108.
[7] John Leeton, ‘The early history of IVF in Australia and its contribution to the world (1970-1990)’ (2004 ) 44 Australian and New Zealand Journal of Obstetrics and Gynaecology 495, 497. The first reported artificial insemination using fresh semen occurred in 1790 see: Fader, Sonia (1993) ‘Sperm Banking: A Reproductive Resource’, California Cryobank. http://www.cryobank.com/sbanking.cfm?page=2&sub=126
[8] AO Trounson, CD Matthews, GT Kovacs, A Spiers, SJ Steigrad, DM Saunders, WR Jones & S Fuller, ‘Artificial Insemination by frozen donor semen: results of multicentre Australian experience’ (1981) 4 International Journal of Andrology 227 at 228
[9] A. Trounson & L. Mohr, ‘Human pregnancy following cryopreservation, thawing and transfer of an eight-cell embryo’ (1983) 305 Nature 707.
[10] Chen C Pregnancy after human oocyte preservation’ lancet 1986 1, 884
[11] Macaldowie A, Wang YA, Chambers GM & Sullivan EA 2012. Assisted reproductive technology in Australia and New Zealand 2010. Assisted reproduction technology series. Cat. no. PER 55. Canberra: AIHW, 1. This exclusion of artificial insemination is supported by international definitions such as that used by ICMART has recently defined assisted reproductive technology as ‘all treatments or procedures that include the in vitro handling of both human oocytes and sperm or of embryos for the purpose of establishing a pregnancy’ – including ‘gamete and embryo cryopreservation’ but has nevertheless excluded assisted insemination from that definition, stating that ‘ART does not include assisted insemination (artificial insemination) using sperm from either a woman’s partner or a sperm donor.’Zegers-Hochschild F, Adamson GD, de Mouzon J, Ishihara O, Mansour R, Nygren K, Sullivan E, Vanderpoel S; International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) revised glossary of ART terminology, 2009. Fertil Steril. 2009 Nov;92(5):1520-4
[12] For an expansive coverage of the views of individuals with embryos in storage see note 1 and: Jenni Millbank, Eloise Chandler, Isabel Karpin, Anita Stuhmcke, ‘Embryo donation for reproductive use in Australia’ 20(4) Journal of Law and Medicine 773-789; Eloise Chandler, Anita Stuhmcke, Jenni Millbank and Isabel Karpin, ‘Rethinking Consent, Information Giving and Counselling Concerning Stored Embryos in IVF Treatment’20(4) Journal of Law and Medicine 759-773; Anita Stuhmcke, Isabel Karpin, Eloise Chandler and Jenni Millbank, ‘Use of Stored Embryos in IVF Following Separation or Death of a Partner’20(4) Journal of Law and Medicine 773-789; Isabel Karpin, Jenni Millbank, Anita Stuhmcke, Eloise Chandler ‘Analysing IVF Participant Understanding of, Involvement in, and Control over Embryo Storage and Destruction in Australia’ 20(4) Journal of Law and Medicine 789-811
[13] Indeed in South Australia in 1984 Working Party the then Minister of Health Dr John Cornwall states that Cabinet allowed the freezing of embryos – as ‘we were confronted with a situation in which the I.V.F. programmes were up and running and we had to make decisions on the basis of what was actually happening and not on what might happen.’ In Vitro Fertilization and Artificial Insemination by Donor in In Vitro Fertilisation and Artificial Insemination by Donor, 28 July 1984, proceedings of the Seminar and Public Lecture held by the South Australian Health Commission, at 3.
[14] Scott R. (1984) Experimenting with Life: Must Law-Makers Experiment Too? 5th International Conference on Forensic Science, Sydney Australia at 3 cited in Research Ethics in Australia A-1 Donald Chalmers University of Tasmania ‘Ethical and Policy Issues in Research Involving Human Participants, Vol II, Commissioned papers and staff analysis, Bethesda, Maryland, 2001, at A-10 http://bioethics.georgetown.edu/nbac/human/overvol2.html
[15] National Health and Medical Research Council, Supplementary Note 4 – In-vitro Fertilisation and Embryo Transfer, at 9 see: http://www.spinalresearch.com.au/GrantApps/docs/nhmrc_statement_human_experimentation.pdf
[16] National Health and Medical Research Council, Supplementary Note 4 – In-vitro Fertilisation and Embryo Transfer, at 10 http://www.spinalresearch.com.au/GrantApps/docs/nhmrc_statement_human_experimentation.pdf
[17] United Kingdom, Department of Health and Social Security, Report of the Committee of Inquiry into Human Fertilisation and Embryology (1984) (Warnock Committee Report).
[18] Of course this is not uniform – for example in Denmark the initial storage period allowed in 1992 was for 12 months – in 1997 this was prolonged to 24 months : Bansball S, Pinborg A, Yding Andersen C, Nyboe Andersen A, ‘patients’ attitudes towards donation of surplus cryopreserved embryos for treatment or research’ (2004) 19(10) Human Reproduction 2415
[19] Ibid, para 10.1 at 53
[20] Ibid, para 10.2 at 53
[21] Ibid, Recommendation 32, 83
[22] This is discussed more fully below.
[23] Victorian Committee to Consider the Social, Ethical and Legal Issues Arising From In Vitro Fertilization, Report on Donor Gametes in IVF (1983), Report on the Disposition of Embryos Produced by In Vitro Fertilisation, 1984, para 4.17, Victoria, Australia. Victorian Committee to Consider the Social, Ethical and Legal Issues Arising From In Vitro Fertilization. Known as the Waller Report this Committee was established by the Victorian Government on 24 May 1982. The reports of the Committee were published in two parts – part one on donor gametes published in 1983 and the second report which refers to surrogacy is published in August 1984.
[24] Committee to Consider the Social, Ethical and Legal Issues Arising From In Vitro Fertilization’ Interim Report September 1982, at 1.1.
[25] Committee to Consider the Social, Ethical and Legal Issues Arising From In Vitro Fertilization Interim Report September 1982, at 1.1.
[26] Committee to Consider the Social, Ethical and Legal Issues Arising From In Vitro Fertilization Report on the Disposition of Embryos Produced by In Vitro Fertilisation, 1984 2.1
[27] Trounson A, Mohr L ‘Human pregnancy following cryopreservation, thawing and transfer of an eight cell embryo’ (1983) 305 Nature 707
[28] Note that according to Boulton the first live birth from a frozen embryo took place in the Netherlands in 1983, see Boulton A, ‘Britain poised to extend storage of frozen embryos’ (1996) 312 BMJ 10
[29] Victorian Committee to Consider the Social, Ethical and Legal Issues Arising From In Vitro Fertilization, Report on the Disposition of Embryos Produced by In Vitro Fertilisation, 1984, para 1.23, Victoria, Australia.
[30] Committee to Consider the Social, Ethical and Legal Issues Arising From In Vitro Fertilization Report on the Disposition of Embryos Produced by In Vitro Fertilisation, 1984 2.13.
[31]. See ‘Panel in Australia Urges that Orphaned Frozen Embryos be Destroyed’, New York Times, September 4, 1984.
[32] Victorian Committee to Consider the Social, Ethical and Legal Issues Arising From In Vitro Fertilization, Report on the Disposition of Embryos Produced by In Vitro Fertilisation, 1984, para 1.25, Victoria, Australia.
[33] Committee to Consider the Social, Ethical and Legal Issues Arising From In Vitro Fertilization Report on the Disposition of Embryos Produced by In Vitro Fertilisation, 1984 2.14.
[34] John Leeton, ‘The early history of IVF in Australia and its contribution to the world (1970-1990)’ (2004 ) 44 Australian and New Zealand Journal of Obstetrics and Gynaecology 495, 497
[35] Citing at footnote 35 Roy Morgan Opinion Poll, Use of donor sperm and eggs in IVF in Melbourne, Melbourne 1983.
[36] John Leeton, ‘The early history of IVF in Australia and its contribution to the world (1970-1990)’ (2004 ) 44 Australian and New Zealand Journal of Obstetrics and Gynaecology 495, 497
[37] Demack J, Report of the Special Committee Appointed by the Queensland Government to Enquire into the Laws Relating to Artificial Insemination, In Vitro Fertilisation and Other Related Matters, (Qld Parliament, Brisbane, Volumes I and II 1984) (Demack report) at 13. Known as the Demack Report the Committee was established by the Queensland Cabinet on 8 February 1983 and the report was published on the 1st March 1984.
[38] Ibid, at 75
[39] Ibid at 76-77
[40] Together with the statement that ‘Legislative control of the process of freezing of embryos is not required at present, but the position will need to be kept under review.’ (At 141)

[41] Steinbock B, Life Before Birth: The Moral and Legal Status of Embryos and Fetuses (Oxford University Press, 2011), 212.

[42] See NSW Law Reform Commission, Artificial Conception: In Vitro Fertilization (1988), Recommendation 22 [5.46].
[43] In Vitro Fertilization and Artificial Insemination by Donor in In Vitro Fertilisation and Artificial Insemination by Donor, 28 July 1984, proceedings of the Seminar and Public Lecture held by the South Australian Health Commission, 94. In 1987 a Select Committee reported (it was appointed in October 1984 by the Legislative Council of South Australia) on artificial insemination by donor, in vitro fertilization and embryo transfer procedures and related matters.
[44] In Vitro Fertilization and Artificial Insemination by Donor in In Vitro Fertilisation and Artificial Insemination by Donor, 28 July 1984 at 94.
[45] The Fertility Society of Australia was established in 1982 and in 1987 RTAC was established.
[46] Interestingly units that do not engage in IVF treatment still may fall within this mandatory scheme: see the NSW Human Tissue Act.
[47] See Assisted Reproductive Technology Act 2007 (NSW), s25; Assisted Reproductive Treatment Act 2008 (Vic), ss31-34A; Human Reproductive Technology Act 1991 (WA), s24.
[48] See Fertility Society of Australia Reproductive Technology Accreditation Committee, Code of Practice for Assisted Reproductive Technology Units, Critical Criteria 1, 8.
[49] See Fertility Society of Australia Reproductive Technology Accreditation Committee, above n47, Good Practice Criteria 4, 18.
[50] See NHMRC, Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2007), 8.8.1.
[51] See NHMRC, Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2007), 8.3.
[52] NHMRC, Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2007), 9.7
[53] NHMRC, Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2007), 8.3 & 8.8.
[54] NHMRC, Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2007), 9.7.1.
[55] Ibid.
[56] See http://www.health.nsw.gov.au/art/pages/default.aspx.
[57] There is scope to extend this period of storage in circumstances where the Director General gives authorisation to do so on reasonable grounds: Assisted Reproductive Technology Act 2007 (NSW), s 26(1)&(2). In circumstances where gametes were donated prior to 1/1/2010 (the commencement of the Act), ART providers are prohibited from storing them, or any embryos created using them, for any longer than 10 years after the date the gamete was obtained from the donor: (ART Regs 2009, s18(1)). Again there is scope to extend the period of storage in this case, providing the Director General gives written authorisation to do so on reasonable grounds (ART Regs 2009, 18(2)).
[58] See Assisted Reproductive Technology Act 2007 (NSW), 25(3)(c).
[59] Assisted Reproductive Technology Act 2007 (NSW), s 25(2).
[60] Assisted Reproductive Technology Act 2007 (NSW), s 25(3)(b).
[61] Assisted Reproductive Technology Act 2007 (NSW), s 25(3)(a).
[62] Assisted Reproductive Technology Act 2007 (NSW), s 25(3)(c).
[63] See NSW Law Reform Commission, Artificial Conception: Human Artificial Insemination
[64] See NSW Law Reform Commission, above n41, [
[65] Ibid, [5.46]
[66] Ibid.
[67] NSW Health, Review of the Human Tissue Act 1983 Discussion Paper: Assisted Reproductive Technologies (1997).
[68] Ibid, at 39-40.
[69] NSW Department of Health, Assisted Reproductive Technology Bill 2003 Consultation Draft – Information Guide (2003) at [4.5] – [4.7].
[70] See above n 1.
[71] Assisted Reproductive Treatment Act 2008 (Vic), s31(1)(b)(i). This remains the case after the 2012 amendments.
[72] Assisted Reproductive Treatment Act 2008 (Vic), s33(2)(b)(i) & s33(2)(b)(ii).
[73] See Assisted Reproductive Treatment Act 2008 (Vic), s33(2)(a). Note however that gamete providers who disagree on continued storage can appeal to the Patient Review Panel. Embryos will then only be removed from storage upon the Patient Review Panel’s direction: see Assisted Reproductive Treatment Act 2008 (Vic), ss 33A, 34(1)(c), 85.
[74] For gametes see Assisted Reproductive Treatment Act 2008 (Vic) s31(2); for embryos, ss 33(2)(b)(iii) & s33A.
[75] For gametes see Assisted Reproductive Treatment Act 2008 (Vic) s31A(2); for embryos see s33A(2).
[76] See Explanatory Memorandum, Assisted Reproductive Treatment Amendment Bill 2012 (Vic), 5.
[77] See Assisted Reproductive Treatment Act 2008 (Vic), s 31(1)(b)(ii), 31(1)(b)(iii), 31(2).
[78] Assisted Reproductive Treatment Act 2008 (Vic)
[79] Assisted Reproductive Treatment Act 2008 (Vic), s91(2)
[80] See the Assisted Reproductive Treatment Act 2008 (Vic), ss5(a) & (b)
[81] http://www.health.vic.gov.au/prp/applications-prp.htm
[82] See Western Australian Reproductive Technology Council, Annual Report 2012, http://www.rtc.org.au/reports/docs/AR2012.pdf at 12
[83] Infertility Treatment Act 1995, ss51 & 52.
[84] See eg Victoria, Parliamentary Debates, Legislative Assembly, 4 May 1995, 1246 (Marie Tehan, Minister for Health).
[85] See eg Victoria, Parliamentary Debates, Legislative Assembly, 10 September 2008, 3452 (Rob Hulls, Attorney General).
[86] See the Reproductive Technology (Clinical Practices) (Miscellaneous) Amendment Act (2009).
[87] Reproductive Technology (Code of Ethical Clinical Practice) Regulations 1995 (SA), Schedule – Reproductive Technology Code of Clinical Practice, cl 4.
[88] Human Reproductive Technology Act 1991 (WA), s24 (1).
[89] Human Reproductive Technology Act 1991 (WA), s24 (1c).
[90] Human Reproductive Technology Act 1991 (WA), s24 (1a).
[91] Human Reproductive Technology Act 1991 (WA), s14 (1)(a).
[92] Human Reproductive Technology Act 1991 (WA), s23.
[93] Reproductive Technology Council, Policy on Embryo Storage and Applications to Extend Storage Beyond Ten Years (2010)
[94] Human Reproductive Technology Act 1991 (WA), s24(3).
[95] Human Reproductive Technology Act 1991- Directions 2004 (WA), 6.10.
[96] Human Reproductive Technology Act 1991- Directions 2004 (WA), 6.12(b).
[97] Human Reproductive Technology Act 1991- Directions 2004 (WA), 6.12(a).
[98] Human Reproductive Technology Act 1991- Directions 2004 (WA), 6.8.
[99] Human Reproductive Technology Act 1991- Directions 2004 (WA), 3.1
[100] Human Reproductive Technology Act 1991- Directions 2004 (WA), 6.9.
[101] See note in Human Reproductive Technology Act 1991- Directions 2004 (WA), 6.8.
[102] Ibid.
[103] Western Australian Legislative Council, Human Reproductive Technology Amendment Bill 2003 – Explanatory Memorandum, p14
[104] Reproductive Technology Council, Policy on Embryo Storage and Applications to Extend Storage Beyond 10 Years, February 2010, 2.
[105] Animal studies and theoretical modelling speculate that a frozen mammalian embryo ‘should not be influenced by storage for several thousand years, see R Riggs, J Mayer, D Dowling-Lacey, MS Ting-Fing, Chi, E Jones & S Oehninger, ‘ Does storage time influence postthaw survival and pregnancy outcome? An analysis of 11,768 cryopreserved human embryos’ (2010) 93(1) Fertility and Sterility 109 citing Mazur P, Freezing of living cells: mechanisms and implications’ Am J Physiol 1984; 247 C125-42. As to births from long term storage see: J Feldschuh, J Brassel, N Durso & A Levine, ‘Succesful sperm storage for 28 years’ (2005) 84(4) Fertility and Sterility 1017
[106] R Riggs, J Mayer, D Dowling-Lacey, MS Ting-Fing, Chi, E Jones & S Oehninger, ‘ Does storage time influence postthaw survival and pregnancy outcome? An analysis of 11,768 cryopreserved human embryos’ (2010) 93(1) Fertility and Sterility 113
[107] Explanatory Memorandum to the Western Australian Human Reproductive Technology Amendment Bill 2003 at 14
[108] [10.7] At 55.
[109] Wang XJ, Ledger W, Payne D, Jeffrey R & Matthews CD, ‘The contribution of embryo cryopreservation to in-vitro fertilization/gamete intra-Fellopian transfer: 8 years experience’ (1994) 9(1) Human reproduction 108
[110] Lucinda L Veek, ‘Frozen preimplantation embryos: parental responsibility versus laboratory liability’(1997) 12(6) Human Reproduction 1121
[111] N 1, above, 99.
[112] Ibid
[113] See S. de Lacey , ‘Patients’ attitudes to their embryos and their destiny: social conditioning?’ (2007) 21(1) Best Practice & Research Clinical Obsterics and Gynaecology 101 citing international studies at note 74.
[114] Ibid.
[115] Zev Rosenwaks & OK Davis, ‘On the disposition of cryopreserved human embryos: An opinion’ (1997) 12(6) Human Reproduction 1121
[116] Debra A Gook & DH Edgar ‘Cryopreservation of the human female gamete: current and future issues’ (1999) 14(12) Human Reproduction 2938
[117] ‘Mature oocyte cryopreservation: a guideline’ The practice committees of the American Society for Reproductive Medicine and the Society for Assisted reproductive technology (2013) 99(1) Fertility and Sterility 37
[118] See for example Cutas D, ‘Postmenopausal Motherhood: Immoral, Illegal? A case Study’ (2007) 21(8) Bioethics 458
[119] ‘Mature oocyte cryopreservation: a guideline’ The practice committees of the American Society for Reproductive Medicine and the Society for Assisted reproductive technology (2013) 99(1) Fertility and Sterility 41
[120] BJ Bankowski, A D Lyerly, RR Faden, EE Wallach, ‘The social implications of embryo cryopreservation’ (2005) 84 (4) Fertility and Sterility 823, 830
[121] B. Bennett, “The human embryo as property? Cryopreservation and the challenges for law”, (2000) 7 Journal of Law & Medicine 434 at 437.
[122] Explanatory Memorandum to the Human Fertilisation and Embryology (statutory Storage period for Embryos and Gametes) (Amendment Regulations) 2009 No. 2581 http://www.legislation.gov.uk/uksi/2009/2581/pdfs/uksiem_20092581_en.pdf at [7.2]
[123] At [7.4] to [7.6]. The regulations state that when one of the recipient parents of the embryo or gamete (egg or sperm) is prematurely infertile, the ten year time limit for storage of frozen embryos or gametes can be extended to up to 55 years. Previously, storage could only continue until the provider of the embryo or gamete was 55 years old. This means that under the revised regulations, a child diagnosed as infertile will have the option of receiving her mother's eggs decades after they were frozen - at which time she will be at a normal childbearing age, regardless of whether or not her mother is over 55 years of age by this time.
[124] Kuo L, ‘Lessons learned from Great Britain’s Human Fertilization and Embryology Act: Should the United States regulate the Fate of Unused Frozen Embryos?’ (1996-1997) 19 Loy LA Int’l Comp. L J, At 1050
[125] See for example Lynne M Thomas ‘Abandoned Frozen Embryos and Texas law of Abandoned Personal Property: Should there be a connection?’ (1997-1998) 29 St Mary’s Law Journal 255
[126] Jenni Millbank, ‘Numerical Limits in Donor Conception Regimes: Genetic Links and “Extended Family’’ in the Era of Identity Disclosure ’ under submission
[127] For example Nachtigall RD, Becker G, Friese C, Butler A, MacDougall K, ‘Parents’ conceptualization of their frozen embryos complicates the disposition decision’ (2005) 84(2) Fertility & Sterility 431
[128] In Vitro Fertilization and Artificial Insemination by Donor in In Vitro Fertilisation and Artificial Insemination by Donor, 28 July 1984, at 9.
[129] http://www.parliament.the-stationery-office.co.uk/pa/ld200809/ldhansrd/text/91021-0010.htm


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