Any visitors to the Bionews website may have come across a very different version of this commentary last week, published the day before the UK's Department of Health suddenly announced changes to the law last Wednesday. In a surprise last-minute u-turn, the government announced that it was taking urgent Parliamentary action to widen the scope of the new embryo storage laws due to come into force in less than three weeks' time.
The government's decision has addressed an important potential injustice in the new embryo storage rules by ensuring that embryos stored for surrogacy whose storage period expires before 1 October will be entitled to extended storage. This is a very welcome step forward and addresses a problem which the Minister rightly described as 'morally straightforward but legally complex'.
In response, it seems appropriate to unpack and explain the change in more detail in the context of the wider changes being made to the embryo storage rules from 1 October.
The current law
Under the current law, embryos can be stored for a basic statutory storage period of five years, and must be allowed to perish at the end of that period unless they qualify for extended storage. Extended storage is permitted (under regulations made in 1996) where, for medical reasons, couples are storing embryos which represent their last chance of having their own genetic child, including people facing treatment for cancer.
The detail of the 1996 regulations is complex. Storage up to ten years is permitted where a doctor certifies that either gamete provider has or is likely to develop 'significantly impaired fertility' or carries a genetic disorder causing serious disability. Alternatively, storage is permitted until the woman being treated is approximately age fifty-five if two doctors certify that either gamete provider is 'prematurely and completely infertile'. Both gamete providers must consent to extended storage, and the rules do not apply if surrogacy is envisaged at the time of first storage.
There are separate, but similar, rules for extended storage of gametes.
The effect of these rules in practice has been to allow extended storage only in quite limited circumstances. Most situations involving surrogacy or donation have been excluded.
The new rules
The complexity of the existing rules has caused much confusion, and the changes undoubtedly simplify and unify the law.
As from 1 October 2009, the basic statutory storage period for both embryos and gametes will be ten years, and the new rules apply to embryos already in storage as well as those stored on or after 1 October.
From 1 October, extended storage will also be more straightforward, available for embryos (and gametes) where the gamete providers consent in writing to storage beyond ten years, and where one doctor gives a written opinion that either of the gamete providers or the intended recipient is prematurely infertile. There will now simply be an overall maximum fifty-five year storage period from first storage for both gametes and embryos, renewable every ten years provided that a doctor re-certifies as to 'premature infertility' before the expiry of each ten year period.
The restrictions on donation and surrogacy have also been removed. In relation to donation, the new ability to qualify for extended storage because the intended recipient - rather than the gamete provider - is prematurely infertile means that couples storing embryos created with donor gametes and patients donating their gametes to an infertile recipient (for example, a daughter with Turner's Syndrome) can now enjoy extended storage.
The former restriction barring extended storage for surrogacy also does not feature in the new regulations, allowing couples to store embryos for an extended period (provided they meet the medical criteria) whether or not the woman is able to carry a future pregnancy. This welcome change means that the law will no longer create bizarre distinctions in practice; previously, a cervical cancer patient who had chemotherapy could store her embryos until she was fifty-five, but a cancer patient who had a hysterectomy could only store her embryos for five years.
The changes announced last week
Despite the advances of the new rules, a potential injustice remained in the law as originally drafted. The new Regulations, despite applying to most embryos already in storage, did not benefit the embryos of surrogacy patients whose five year storage period came to an end before 1 October 2009 and who, under the old rules, were not allowed to extend storage beyond five years.
As lawyers representing several couples caught in this difficult position, we have been acutely aware of the human implications of this technicality. We have clients with precious embryos in storage to preserve their last chance of having a child through surrogacy, who previously faced losing those embryos against their wishes because of a matter of timing, even though there was no policy, safety or human objection to their preservation.
These couples include Melanie and Robert Gladwin from Gloucester, a married couple who stored embryos in 2003 when Melanie was diagnosed with cervical cancer at age 22 and who were told their embryos would have to be destroyed because the old law did not allow storage for surrogacy beyond five years. It all came down to the arbitrariness of timing: had Robert and Melanie's embryos been stored on or after 1 October 2004, they could have been kept until 2059, but because they were stored in 2003 and their five year period came to an end before the new rules came into force, they would have to be allowed to perish.
Although the Department of Health had previously rejected any change allowing extended storage for such surrogacy embryos - on the basis that it was inappropriate to re-legalise storage retrospectively - after media coverage and a Downing Street petition (added to a long public campaign on this issue by patient Michelle Hickman), the Department of Health announced last week that emergency measures would be taken to ensure that embryos like Robert and Melanie's would now be covered by the new rules.
The Minister's announcement prompted a letter being sent by the HFEA (Human Fertilisation and Embryology Authority) last week to all licensed centres asking them to halt pending embryo destructions, and special guidance is now available on the HFEA website. A special Order in Parliament is being made this week to give ‘out of time' surrogacy embryos the right to ten year storage, and following further correspondence, the Department has confirmed that additional regulations will be made as soon as possible to ensure that these embryos are also entitled to full extended storage where the medical criteria are satisfied.
The Department's decision is to be applauded (although it has to be said that the issue has been known for some time and could have been dealt with as part of the original regulations) and has brought enormous relief to an 'ecstatic' Robert and Melanie and others in a similar position.
So where does this leave the law?
The decision makes the position on embryo storage simpler and clearer for clinicians across the UK. From 1 October, all embryos can be stored for ten years. Where either gamete provider or the intended recipient is prematurely infertile and the person/couple consents to longer storage, the ten year period can be extended by certification of premature infertility by a doctor every ten years, giving up to a maximum of fifty-five years storage.
Clinicians no longer need to worry about which extended storage period applies, what degree of premature infertility their patient suffers, whether embryos are being stored for surrogacy or own use, or when the embryos were first stored.
The clarity and fairness this will bring is undoubtedly to be welcomed.
Sources and References
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Woman cancer survivor told she cannot keep frozen embryos
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Embryo storage law leaves some parents out in the cold
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HFEA guidance for clinics following the government’s announcement on 9 September
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Government bows to pressure on embryo storage rules
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Embryo storage u-turn allows couples chance of parenthood
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Couple win battle to save frozen embryos from destruction
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Mother fights for embryos 'on death row'
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