Paragraph 7A F1F2
In relation to a donation within paragraph 7 which meets the conditions in this paragraph, licence conditions must not include the requirement in section 3.2 of Annex III to the second Directive, that donors must be negative for HIV.
The first condition is the donor has a plasma HIV RNA load of no more than 200 copies per millilitre on—
a date no more than 6 months and no less than 21 days before the date of the donation; and
a date no more than 7 days before the date of the donation.
The second condition is the donor has been receiving antiretroviral treatment for a period of at least 6 months up to and including the date of the donation.
The third condition is the donor and the recipient declare that they have a qualifying relationship.
“Qualifying relationship” means a relationship between—
friends;
family; or
persons who have been introduced to each other by a third party for the purpose of conceiving.
The fourth condition is the recipient declares that they—
reasonably believe, on the facts known to them at the time, that the donor has tested positive for HIV;
understand the health risks involved in being treated with the donation; and
consent to being treated with the donation in light of the matters referred to in paragraphs (a) and (b).
Annotations
Textual amendments
- F1
Sch. 3A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs 1, 30
- F2
Sch. 3A para. 7A inserted (28.11.2024) by The Human Fertilisation and Embryology (Amendment) Regulations 2024 (S.I. 2024/1091), regs. 1(2), 2(5)