The Human Fertilisation and Embryology (Amendment) Regulations 2024

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend Schedule 3A to the Human Fertilisation and Embryology Act 1990 (c. 37) (“the 1990 Act”). Schedule 3A relates to the technical requirements for the donation, procurement and testing of human tissues and cells.

The amendments—

(a) enable female same sex couples donating eggs to one another to undergo less stringent selection and testing criteria set out in paragraph 6 of Schedule 3A to the 1990 Act, as opposed to more stringent screening under paragraph 7 of Schedule 3A to the 1990 Act; and

(b) enable people diagnosed with HIV to donate gametes and embryos to family, friends or persons who have been introduced to the donor by a third party for the purpose of conceiving, where donors can demonstrate that they have a sustained undetectable HIV viral load of no more than 200 copies per millilitre and have been undergoing antiretroviral therapy for at least 6 months prior to the date of donation.

Regulation 2 amends Schedule 3A to the 1990 Act to—

(a) modify the definition of partner donation in the Directive;

(b) require conditions of licences issued under the Act (“licence conditions”) to require partner-donated eggs to comply with the selection criteria for donors and the requirements for laboratory tests in section 2 of Annex III to Commission Directive 2006/17/EC of 8 February 2006 (“the Directive”);

(c) except partner-donated eggs from being required by licence conditions to comply with the selection criteria for donors and the requirements for laboratory tests in section 3 of Annex III to the Directive;

(d) prohibit licence conditions, in Section 3.2 of Annex III to the Directive requiring donors to be HIV negative, if the donation is within paragraph 7 and meets the conditions in sub-paragraphs 7A(2), (3), (4) and (6). The donor must demonstrate that they have a sustained undetectable HIV viral load of no more than 200 copies per millilitre (regulation 7A(2)) and be receiving antiretroviral therapy for at least 6 months up to and including the date of donation (regulation 7A(3)). The donation must be to family, friends, or to persons who have been introduced to the donor by a third party for the purpose of conceiving (regulation 7A(4)). The recipient of the donation must be aware of the HIV diagnosis, understand the health risks of being treated with the donation and consent to the donation (regulation 7A(6)).

Regulation 2(6) amends Schedule 3A to similarly except partner-donated eggs from requirements under the Directive in relation to donation and procurement procedures and reception of tissue and cells at the tissue establishment.

Regulation 2(7) inserts the following new definitions; “HIV”, “partner-donated eggs” and “RNA”.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.