On 9 July 2020, the Progress Educational Trust (PET) – the charity that publishes BioNews – held its first ever online event, 'More Trouble in Store? The Two-Year Extension to Embryo and Gamete Storage Limits'. The event explained and discussed the recent change to UK law in regard to the storage of embryos and gametes.
In March 2020, the UK went into lockdown due to the coronavirus pandemic. This led to the suspension of a number of medical treatments and services across the country including the fertility sector, causing patients stress and concern given the time-sensitive nature of these treatments.
The statutory storage period for embryos and gametes in the United Kingdom is ten years, and patients whose embryos and gametes were reaching the end of the permitted storage time faced the risk of them being destroyed before they could be used. The pandemic was also impacting researchers working with donated material who were unable to access their laboratories during lockdown. To address this pressing issue, the UK Government introduced a new regulation granting a temporary two-year extension to the ten-year legal limit.
Norcross introduced James Lawford Davies, a solicitor and partner at Hempsons, a firm of health and social care lawyers. As an expert in the field, he has spoken at previous PET events regarding storage regulations of reproductive material.
Lawford Davies began by explaining the overarching regulation of the Human Fertilisation and Embryology Act 1990 which prohibits the storage of gametes and embryos except under a licence. Conditions of the licence include that there must be effective consent and that embryos or gametes can only be kept for ten years. However, a series of statutory instruments to extend this storage period for medical reasons was introduced in 2009. Patients are able to extend storage to up to 55 years by meeting requirements including a written opinion from a medical practitioner every ten years.
The new Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) (Coronavirus) Regulations 2020 extend the statutory storage period from ten years to 12 under certain circumstances to address the impact of coronavirus.
Lawford Davies described coronavirus-related problems affecting patients who are unable to access fertility treatment, as well as examining the effects on patients coming to the end of their storage period. He then went through examples of different situations of how the new statutory storage periods would apply, demonstrating the ways in which it would help those affected by infertility and by the pandemic.
The Q&A of this session was particularly important as there were a number of concerned patients and representatives of fertility clinics attending the event. This gave attendees the chance to ask pressing questions about the change in the statutory storage regulations and their treatments.
There were concerns about whether a clinic could be found at fault for not extending the storage period for patients, or for not contacting patients to warn them of an approaching deadline. However, Lawford Davies doubted whether a clinic could be criticised unless patients were facing pressing medical conditions. He hoped that patients who are or have been unwell would be prioritised and that clinics will be prompt in reaching out and assisting patients. Nonetheless, the extension of storage cannot be dealt with immediately for all patients as it was pointed out that these changes would cause a large administrative burden that clinics may not be ready for. Attendees were worried about how patients would be prioritised and how clinics would triage patients.
The Human Fertilisation and Embryology Authority (HFEA) was able to give an official answer about the challenges of clinics contacting patients: 'It is a local decision as to when clinics decide to contact their patients to tell them about the possibility of extension. They may choose to do this now or when their patients are nearing the end of their initial storage period.'
Importantly, it also noted that patients who may have been affected by the closure of clinics due to COVID-19 should be prioritised.
Questions were asked about the further problems that may arise from local lockdowns, such as the one in Leicester. One attendee asked whether there would be further extensions or chances for appeals for people affected by local lockdowns, or whether more changes to the permitted storage period would be required with possible national lockdowns in the future. Lawford Davies said that these additional disruptions would certainly cause patients to be affected differently across the country, but additional regulations would need to be put in place to help such groups.
The final question asked whether the cost of storage should be reduced for patients given that the cost keeping material for a longer period could be problematic for patients. Lawford Davies pointed out that the legislation does not regulate the cost or the charges of storage and treatments. Clinics have separate contracts in place for the consent to storage and costs of storage, therefore clinics will be able to make independent choices about the costs going forward.
Register now for PET's next free-to-attend online event 'An All-Consuming Problem? How to Protect Patients in the Fertility Market', taking place on Thursday 14 January 2021.