Human Fertilisation and Embryology: Storage of Gametes and Embryos
Fertility preservation is increasingly possible through the freezing of gametes (eggs and sperm) and embryos. This allows fertility patients to keep their gametes or embryos in storage until they are ready to undergo treatment at a later date. The Human Fertilisation and Embryology Act 1990 (the "1990 Act"), as amended by the Human Fertilisation and Embryology Act 2008 (the "2008 Act"), sets the maximum storage limit for frozen gametes and embryos, which prior to the changes made by this Act was set at 10 years. In exceptional circumstances, those who are deemed to be "prematurely infertile", could store their gametes and embryos for longer – up to a maximum of 55 years. This was permitted through the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009 (the "2009 Regulations"). The provisions governing storage are set out in section 14 of the 1990 Act, and the requirements in relation to consent to storage are set out in Schedule 3 to that Act.
	In February 2020 the Government launched a public consultation to test whether there was a case for changing the above storage limits, as fertility patients, the fertility sector, and fertility charities argued the current limit no longer functions to serve modern society. Such groups argued the maximum storage limit should be increased from the current 10 year limit to maximise reproductive choice for all, including for those who wish to freeze their gametes or embryos for social (non-medical) reasons, for example because they wish to start a family later in life.
	The consultation ran from the 11 February 2020 until the 5 May 2020. In September 2021, following careful analysis of all submissions, the Government published its response to the consultation. The Government announced that the maximum storage limit for gametes and embryos would be increased from the current 10-year limit, to 10-year renewable periods up to a maximum of 55 years for all, regardless of medical need. The policy announcement by the Government on the 6 September 2021 was welcomed by key stakeholders, including fertility patients, charities, professional organisations, and the Human Fertilisation and Embryology Authority, the sector regulator.
	These sections amend the 1990 Act to implement the above policy and increase the maximum storage period to 55 years for all. Patients will be required to renew their consent to storage every ten years. These changes will allow everyone, irrespective of medical need, to store their gametes or embryos for longer and therefore to make unpressurised decisions about when to start a family.
	Embryos that are to be stored for the purposes of research and training will be limited to a maximum of 10 years, as is the case currently. This is because a 10-year storage period was judged to be sufficient for researchers to get approval for their proposals, to secure their research licences from the regulator, and for the projects using human embryos to be completed. The 1990 Act limits the length of time that human embryos can be used in research to a maximum of 14 days beginning the day on which the process of creating the embryo began or until appearance of the primitive streak, whichever comes first.
	The sections also amend the 1990 Act to specify a scheme for the storage of donated gametes, embryos created from donated gamete(s), and donated embryos. In all these instances the donor(s) will be able stipulate the length of time that their donated materials can be stored and used for, up to the maximum of 55 years. Donors will not need to be contacted every 10-years to renew their consent in instances where they specify a storage limit longer than 10-years, however they will be able to contact the facility storing their material(s) and can withdraw their consent at any time, until the point of treatment. This is to enable donors to consider and set out how long their gametes or embryos are stored and used for; if they wish to avoid large age gaps between themselves and any donor-conceived children, they can do so.
	The sections will also amend the 1990 Act to extend the provisions in relation to posthumous storage of gametes and embryos, where a person wishes to enable their partner to use their gametes or embryos made with their gametes after the person’s death. Under the 1990 Act, posthumous storage is already possible where a gamete provider gives consent to this. The consent requirement will remain. In addition, where a person who has given consent to posthumous use of their gametes or embryos dies, their storage period will automatically be renewed for a further 10 years from the date of their death. The living partner will need to provide a death certificate to the clinic to validate the extension; however, the death certificate does not need to be provided immediately and the extension can be applied retrospectively from the date of death by facilities. This change aims to provide the living partner with sufficient time to grieve, undertake counselling, and make unpressurised decisions about whether to undergo fertility treatment or not.
	The sections in Part 2 also set out the transitional arrangements. The new provisions came into force on the 1 July 2022. The fertility sector, the regulator, and patients will have 2 years, until the 1 July 2024, to comply with the new requirements and to settle the status of any doubtful storage cases.