To the relief of many patients and those working in the IVF sector, the Department of Health and Social Care (DHSC) announced on 6 September 2021 that the storage limit for embryo and gametes would be extended from ten years to a maximum of 55 years with a renewal every ten-years (see BioNews 1111). This storage limit applies regardless of whether sperm, eggs or embryos are being stored due to 'medical' or 'social' reasons by the patient. This followed the #Extendthelimit campaign spearheaded by the Progress Education Trust and a subsequent public consultation in 2020.
Following the Government's announcement, the Human Fertilisation and Embryology Authority (HFEA) released a statement confirming that they welcomed the planned changes. HFEA chair, Julia Chain said: 'It is important that the new rules are clear and that fertility clinics are given adequate time to update their procedures to ensure they can both implement the changes effectively and give patients sufficient information so that they are fully informed about their options.'
While many in the sector will welcome this sentiment, it is not yet clear how the change in law will affect material already in storage and how any retrospective issues will be resolved. This article considers some of these issues.
The current regime
The Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009, which currently govern the extension of storage beyond ten years, are complex both in their content and in their application. They require written consent from the gamete provider(s) to an extended storage period, as well as a written statement from a registered medical practitioner known as a Medical Practitioner Statement (MPS) that either the person who provided the gametes, or the person to be treated with them is, or is likely to become, 'prematurely infertile'. The concept of premature infertility applies to people who have, for example, undergone cancer treatment that has affected their fertility. It is considered a 'medical', not a 'social' reason for gamete or embryo storage.
Medical Practitioner Statement
The most significant issue which has arisen under the current regime relates to the need for an MPS. This must be written in the 'relevant period' which is considered to be within ten years from either the initial date of storage or from the most recent statement, if later. However, confusingly, the rules change if the material in question was already in storage when the 2009 Regulations came into force.
Due to these strict rules, the HFEA has previously taken the view (confirmed at their 2019 Annual Conference) that there can be no flexibility on the timeframe in which an MPS can be written and that it cannot be 'backdated'.
Consequently, a failure to comply with this requirement has led, in some instances, to material being unlawfully stored at clinics either after the initial ten-year storage period has expired or to the material of patients' who meet the requirement of premature infertility and therefore qualify for a longer storage period, being discarded. This places clinics at a difficult juncture between patients who wish to continue storing their embryos and gametes and the HFEA's regulatory powers.
That said, more recently there has been some flexibility in relation to this requirement. In 2020, in response to the COVID-19 pandemic which interrupted hundreds of patients' IVF treatment, regulations came into force allowing for the extension of the statutory storage period for embryos and gametes from ten years to twelve years where certain conditions were met. The twelve-year period is calculated from the date of initial storage. At that time, the HFEA's 'FAQ Coronavirus Regulations' document stated that '[t]he Regulations do not stipulate that the gametes or embryos must be lawfully in storage in order to be eligible for the extension'. Furthermore, no MPS was required to extend storage to twelve years and a statement could be written within those additional two years to extend storage beyond twelve years, where a patient was considered to be prematurely infertile.
While the Government has confirmed that an extension to storage beyond ten years will no longer require a 'medical need' such as premature infertility, it is not yet clear when the new regulations will come into effect. Clarification is needed on whether embryos and gametes technically being unlawfully stored now because no MPS was written within the relevant period, can remain in storage pending the introduction of the new regime. Many will hope, given the approach taken in 2020, that such material will be able to remain in storage under the new regime, allowing patients to use it when they're ready to do so.
Gaps in consent
A further issue that has arisen since the 2009 Regulations is so-called 'gaps' in consent. This occurs where there is a gap between the expiry of a patient's initial written consent to storage and their subsequently written consent to an extended storage period being obtained. The HFEA have previously taken the view that where a patient has subsequently provided their written consent to storage (i.e. after any 'gap'), it is clear that their wish was and is to continue storage and that the clinic has, therefore, acted in accordance with their wishes. As such, assuming there are no other problems, the material may remain in storage.
The DHSC has confirmed that the new regime will give all patients the option to keep or dispose of their material at ten-year intervals, up to a period of 55 years. To avoid the issue of a 'gap' in consent occurring, it might be sensible to allow patients to consent from the off-set to a storage period of up to 55 years, with clinics 'checking in' with patients at least every ten years on whether they wish to continue storage pursuant to their consent. This would help avoid any gap in consent from occurring and allow for an extended period of posthumous storage, where a patient has explicitly consented to this.
That said, there are certain difficulties that could arise. For instance, clinics will need to be careful about informing patients that storage is dependent upon the patient fulfilling contractual obligations, including payment of storage fees for embryos and gametes and keeping the clinic informed of their up-to-date contact details.
The DHSC's announcement is great news for many, but the draft legislation should aim to simplify the current regime and iron out the issues outlined above, with the help of guidance from the HFEA. Those drafting the legislation should be mindful of the DHSC's statement that: 'This update not only ensures greater reproductive choice and less pressured decision-making for parents thinking about when to start a family, it will ensure greater equality as the same rules will apply to everyone and storage limits will not be dictated by medical need.'
It is not yet clear whether this objective will be achieved for both new patients and those with material already in storage.