Consent to Change: What do New Gamete and Embryo Storage Regulations Mean for You?

The Progress Educational Trust (PET)'s event 'Consent to Change: What do New Gamete and Embryo Storage Regulations Mean for You?' explored the changes in relation to storage of sperm, eggs and embryos made by the Health and Care Act 2022, amending the Human Fertilisation and Embryology Act 1990.

The event was chaired by PET's director Sarah Norcross, who explained that the law had changed following PET's #ExtendTheLimit campaign to allow women who stored their eggs for non-medical or (so-called) 'social' reasons to be able to store them for more than ten years. In July 2022, changes came into force allowing all patients (and donors) to store sperm, eggs or embryos for up to 55 years, and many are complex. This event explained these recent changes and challenges for clinics, the regulator, and – most importantly of all – patients.

Joanne Anton, Head of Policy at the Human Fertilisation and Embryology Authority (HFEA), spoke first on 'Understanding the Impact of the new gamete and embryo storage rules'. Before 1 July, patients could store gametes and embryos for a maximum of ten years. In 2009 the law was amended to allow 55 years' storage where the patient is, or is likely to become 'prematurely infertile', which had to be medically certified. The complexity and the seemingly arbitrary time limits led to pressure for reform: campaigners argued the rules were too restrictive of reproductive choice as well as administratively complicated and difficult to implement. Anton said that the updated law 'reflects advances in science, changes in modern society and individuals' reproductive choice' and gives patients 'more time to make important decisions about their future'. Currently, we are in a 'transitional period' (by the end of which all material already in storage must be brought under the new regime), lasting until 30 June 2024.

Clinics must contact patients who stored gametes or embryos before 1 July where there is no effective consent or where consent would expire before 30 June 2024, to obtain or renew consent as appropriate. Gametes in storage without effective consent in place by then will be removed. It will, however, remain lawful to store an embryo without renewed consent until 31 December 2024, though use of that embryo would be unlawful and no further consent for storage can be given (and none of the speakers, in the Q&A, could explain why this was the case). Importantly, the changes supersede all previous storage regulations – meaning there is no longer a need for patients to show 'medical need' to store for longer than ten years, and no ten-year maximum period in any case.

Anton explained that it is more important than ever that patients keep contact details up to date, as the new rules require renewal of consent every ten years. A big change comes for patients who have already stored their gametes or embryos for medical reasons, such as before cancer treatment, as they must also renew consent every ten years. This has sparked concerns from some clinics regarding patients who have entered into long-term storage and may not know that the rules have changed. Anton explained various awareness-raising campaigns the HFEA is undertaking with patient groups and stakeholders to try to solve this.

There are also new regulations regarding posthumous use. Where patients storing gametes or embryos for treatment have also given consent for posthumous use and consent to storage for a period of ten years after their death, clinics may store for up to ten years from the date of death of the gamete provider. However, where such consent was given for less than ten years from the date of death, storage can only last for the period for which effective consent was given. Similar rules apply to patients who lose mental capacity. The advice is that people whose partners have died or lost capacity and have gametes or embryos in storage should contact their clinic to discuss.

What is the impact of the changes on donors and donor-conceived people? The new law states that donated gametes and embryos may be stored for up to 55 years, but consent does not need to be updated every ten years. Clinics should offer counselling to potential donors, to ensure awareness of the potential timeframes and implications of this and provide information to patients choosing to use long-term stored donated material about the implications to any child born. There is an acknowledged potential impact on the ability of donor-conceived people to meet their donor while they are still alive, if gametes are stored long-term. However, Anton pointed out, most donor gametes are used within the first ten years of storage. Gametes intended for use in training/research may be stored for 55 years from the date of storage (whether or not before 1 July). Still, for embryos, the maximum period is ten years, which runs from the date of consent to use in research (which may not be the date the embryos were first stored).

The second speaker was Joanne Leitch, lead scientist at Fertility Scotland and scientific lead and lead clinical embryologist at Glasgow Royal Infirmary's Assisted Conception Service. Giving the clinical perspective, she explained that the new regulations brought lots of new consent forms, and more time dedicated to collecting patient information and ensuring they understand what they are consenting to.

While this has created challenges for clinics, however, Leitch said that the extension of storage limits was a 'positive change', in that it enhanced patients' reproductive autonomy and gave them time to make decisions. However, despite that, there were significant challenges for clinics in implementing the changes: 13 HFEA consent forms were updated, four more were created for renewal of consent, and three more for withdrawal of consent! Updated consent forms were also longer than previously and contained more questions. This inevitably means that clinics need to take more time to provide information to patients, the consent process itself is longer and the time to review completed forms extended.

She also described the new defined renewal period and statutory notices that clinics must use to obtain renewed consent. Again, these have led to increased workload and increased storage and other costs. The transitional period, where clinics must contact appropriate patients to request renewal of consent is also labour intensive, including the provision of additional counselling. Despite the additional work caused (and the time pressure involved, as well as ongoing impacts of COVID-19 and Brexit), Leitch said that it was important to have effective implementation strategies – including resources and infrastructure – to maintain staff morale, well-being and trust in management, as well as protecting patients. Additionally, she concluded, centres must continue to work on the sustainability of the new regulations and ongoing resource costs they bring.

Sharon Martin, business development manager at Fertility Network UK was the third speaker, bringing the patient perspective. She said that Fertility Network UK overwhelmingly supports that change to the laws on storage and said that they have been largely welcomed by patients who sought to freeze eggs for so-called 'social' reasons. She also spoke about conversations she has had with people who faced the difficulty of embryo storage time limit running out before they were ready, adding that the ten-year limit had 'caused a lot of angst for a lot of patients', who felt it was 'too soon' to decide whether they wanted to destroy or donate.

One perspective not previously considered was concern expressed by patients who might need donated eggs, who worried that the changes could negatively impact on the number of women choosing to donate, potentially leading to increased numbers of treatments being sought abroad.

The final speaker, James Lawford Davies, partner at Hill Dickinson LLP, London, spoke on potential legal issues that might arise due to the complexity of the changes and their implementation. He discussed new legal terminology about 'consent periods' and 'renewal periods' that derives from the regulations, and the new statutory notices that clinics must use to ask for consent renewal and/or to notify patients that stored material will be removed and disposed of should consent not be given in the correct period.

He also pointed out that, importantly, the changes to storage rules do not diminish other, already existing, legal obligations and principles (and in some cases – eg in relation to counselling – they extend them), such as welfare of the child considerations. He explained that the changes do not affect patients' ability to vary or withdraw consent to use at any time (which may have implications for storage), and that patients do not have to wait until the end of a ten-year period to do so.

Summarising what he considered the major potential problems, he said that particular care must be taken in relation to existing patients with extended storage (under old regulations) when calculating the renewal date; patients who consented for 55 years under the old regulations and who will now have to renew consent may not respond in time to renew under the new regulations. Donors' ability to store for 55 years without interim renewals may increase the risk that clinics and storage banks may lose contact with them. Legally speaking, he also foresees potential consequences arising from the obligation of clinics to dispose of gametes at the end of the renewal period (if no response is received) but having different measures in place for embryos, especially as patients may not understand all implications at the outset.

Overall, all the speakers agreed that although some of the complexities of the old storage regime have been removed, new ones have been introduced, bringing with them further cost and time implications, as well as an increased need to keep patients well-informed about the importance of the detail and of staying in touch, and well-supported by clinics and counsellors. Given the number and nature of the questions directed to the speakers in the Q&A, it's safe to say that other participants realised this too.

PET is grateful to the Scottish Government for supporting this event.