Tests for specified pathogens
47.—(1)  Subject to paragraph (2), a licensee must ensure that, before collecting or receiving any reproductive cell from a patient, patient’s husband or donor (called in this regulation the relevant person) or storing any reproductive cell collected from a relevant person, the relevant person has been tested for each specified pathogen within 6 months before the collection of the reproductive cell.
(2)  A licensee must ensure that a donor of a reproductive cell is tested for the Human Immunodeficiency Virus —
(a)immediately before the licensee collects the reproductive cell from the donor; and
(b)after a period of at least 3 months after the collection of the reproductive cell.
(3)  Where a relevant person tests positive for a specified pathogen, the licensee must do the following:
(a)inform the following persons of the positive test:
(i)the proposed recipient of a reproductive cell collected from the relevant person and the proposed recipient’s husband;
(ii)the proposed recipient of an embryo that is created from a reproductive cell collected from the relevant person and the proposed recipient’s husband;
(b)explain to the persons mentioned in sub‑paragraph (a)(i) or (ii) (as the case may be) the risk of either of the persons or the child contracting an infectious disease caused by the specified pathogen or developing any related condition;
(c)obtain from each of the persons mentioned in sub‑paragraph (a)(i) or (ii), as the case may be —
(i)a signed written declaration that the licensee has explained, and the person is aware of, the risk mentioned in sub‑paragraph (b); and
(ii)a signed written consent for the transfer of the reproductive cell or embryo.
(4)  Where a relevant person tests positive for a specified pathogen, a licensee must ensure that any reproductive cell collected from the relevant person or embryo created from a reproductive cell collected from the relevant person is stored in a manner that minimises the risk of cross‑contamination with reproductive cells or embryos from persons who have tested negative for the specified pathogen.
(5)  Where a patient intends to use a reproductive cell collected from a donor at any time before the donor is tested for the Human Immunodeficiency Virus under paragraph (2)(b), then the donor is deemed to have tested positive for the Human Immunodeficiency Virus for the purposes of paragraphs (3) and (4).
(6)  In this regulation, “specified pathogen” means any of the following viruses or bacteria:
(a)Human Immunodeficiency Virus;
(b)hepatitis B virus;
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(c)hepatitis C virus;
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(d)Treponema pallidum bacterium.
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