Is the regulation of genetic parentage information (when mitochondrial replacement is used) an ethical approach?

Does the current law allow for future ethical embryo implantation?

A treatment rarely mentioned in discourse surrounding the ethics of UK embryo implantation is mitochondrial replacement, also known as mitochondrial donation. Mitochondrial replacement (MRT) is a specialised IVF technique involving the removal of the intended mother’s nuclear DNA from her oocyte or zygote. [1] These contain mutated mitochondrial DNA which is transferred into a donor's oocyte or zygote, which contains nonpathogenic mitochondrial DNA and from which the nuclear DNA has been removed. [2] This replaces the mother’s defective mitochondrial DNA with mitochondria from a healthy donor.  This allows for the prevention of mitochondrial disease being passed from the mother to the embryo. [3] It is a fairly new technology and is currently only available in Newcastle University Hospital. [4]

Mitochondrial replacement is currently lawful in the UK with the acquisition of a license from the Human Fertilisation and Embryology Authority. However it is not regulated by the Human Fertilisation and Embryology Act 1990. The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 came into force in 2015 to regulate the practise of MRT and the rights afforded to the resulting children. The regulations currently permit two forms of MRT: maternal spindle transfer (MST) and pro-nuclear transfer (PNT).

When MRT is utilised together with embryo implantation it essentially becomes a special case of embryo implantation and resulting children are not afforded the same scope of access to donor information as children born as a result of other other assisted conception under the Human Fertilisation and Embryology Act 1990.

31ZA, 31ZB, and 31ZE of the HFEA 1990 allows children born through assisted conception techniques, without MRT, the right to request information as to genetic parentage or donor-conceived genetic siblings; provided that the information does not ‘identify the donor’ under 31ZA(5). The HFEA reserves the right under 31ZC(1) to inform the donor that a request has been made, however the notification does not appear to give statutory power to the donor to prevent information being disclosed to children born through assisted contraception techniques licensed by the HFEA. This creates ethical transparency for children born with HFEA licences. When children conceived through embryo implantation using a HFEA license have an identifiable donor, upon turning 18, they will be told: the donors full name; date of birth; town or district of birth; and last known postal address. [5]

However, in contrast, the 2015 regulations that regulate embryo implantation when MRT is utilised modify sections 31ZA, 31ZB and 31ZE to give children limited, non-identifying information about their donor. Regulation 11(2A) [6] holds that the only information children born from MRT will be able to receive are the following:

1. the screening tests carried out on the mitochondrial donor and information on that donor’s personal and family medical history,

2. matters contained in any description of the mitochondrial donor as a person which that donor has provided, and

3. any additional matter which the mitochondrial donor has provided with the intention that it be made available to a person who requests information under this section, [6]

This contrast within the statutory provisions opens the floodgates for ethical debate surrounding the rights of donor-conceived children to obtain information about their donor.  However, the contrast the law has created for when a child is born as a result of MRT is ultimately down to numbers. The mitochondria donated for MRT makes up less than 1% of the resulting child’s DNA. Therefore the full access to identifying information afforded to children under the HFEA who gained 50% of their DNA from their donor cannot be argued to be appropriate in cases of MRT.

Further, arguably the most important provision for protecting ethics and morality is afforded to children born from all assisted conception technologies including MRT. This is 31ZB of the HFEA 1990 which allows a child to receive information as to whether or not they are genetically related to someone they intend to marry, enter a civil partnership or intimate physical relationship with (or are already having); providing that person consents to the request.

Therefore it can be argued that while the The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 have a far narrower scope for information request right than the HFEA 2018, they do not extend to a point of rendering the regulations to be unethical.

References:

[1] Committee on the Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases, ’Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations’ (1st edn, National Academies Press (US), 2016)

[2] Committee on the Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases, ’Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations’ (1st edn, National Academies Press (US), 2016)

[3] Emily Jackson, ’Medical Law’ (6th edn, Oxford Academic Press, 2022) 882

[4] Newcastle University, 'World first mitochondrial donation - from science to families’ (Newcastle University, 2015) <https://from.ncl.ac.uk/world-first-mitochondrial-donation#:~:text=The%20donation%20technique,DNA%20from%20the%20donor%20egg.?>

[5] Emily Jackson, ’Medical Law’ (6th edn, Oxford Academic Press, 2022) 853

[6] The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015