The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

PART 2 Permitted eggs and permitted embryos

Permitted egg

3.  An egg (“egg P”) is a permitted egg for the purposes of section 3(2)(b)(1) of the Act if—

(a) egg P results from the application of the process specified in regulation 4 to two eggs, each of which—

(i) is a permitted egg as defined in section 3ZA(2)(2) of the Act (not an egg which is a permitted egg by virtue of these regulations), and

(ii) was extracted from the ovaries of a different woman;

(b) that process has been applied to those eggs in the circumstances specified in regulation 5; and

(c) there have been no alterations in the nuclear or mitochondrial DNA of egg P since egg P was created by means of the application of that process.

Permitted egg: process

4.—(1) The process referred to in regulation 3(a) consists of the following two steps.

(2) In step 1—

(a) either—

(i) all the nuclear DNA of an egg (“egg A”) is removed, or

(ii) all the nuclear DNA of egg A other than polar body nuclear DNA is removed; and

(b) either—

(i) all the nuclear DNA of another egg (“egg B”) is removed, or

(ii) all the nuclear DNA of egg B other than polar body nuclear DNA is removed.

(3) In step 2 all the nuclear DNA of egg B which is not polar body nuclear DNA is inserted into egg A.

Permitted egg: circumstances

5.  The circumstances referred to in regulation 3(b) are that—

(a) the Authority has issued a determination that—

(i) there is a particular risk that any egg extracted from the ovaries of a woman named in the determination may have mitochondrial abnormalities caused by mitochondrial DNA; and

(ii) there is a significant risk that a person with those abnormalities will have or develop serious mitochondrial disease; and

(b) egg B was extracted from the ovaries of the woman so named.

Permitted embryo

6.  An embryo (“embryo P”) is a permitted embryo for the purposes of section 3(2)(a) of the Act if—

(a) embryo P results from the application of the process specified in regulation 7 to two embryos, each of which—

(i) is a permitted embryo as defined in section 3ZA(4) of the Act (not an embryo which is a permitted embryo by virtue of these regulations), and

(ii) was created by the fertilisation of a permitted egg as defined in section 3ZA(2) of the Act (not an egg which was a permitted egg by virtue of these regulations) extracted from the ovaries of a different woman;

(b) that process has been applied to those embryos in the circumstances specified in regulation 8; and

(c) since embryo P was created by means of the application of that process—

(i) there have been no alterations in the nuclear or mitochondrial DNA of any cell of embryo P, and

(ii) no cell has been added to embryo P other than by the division of embryo P’s own cells.

Permitted embryo: process

7.—(1) The process referred to in regulation 6(a) consists of the following two steps.

(2) In step 1—

(a) either—

(i) all the nuclear DNA of an embryo (“embryo A”) is removed, or

(ii) all the nuclear DNA of embryo A other than polar body nuclear DNA is removed; and

(b) either—

(i) all the nuclear DNA of another embryo (“embryo B”) is removed, or

(ii) all the nuclear DNA of embryo B other than polar body nuclear DNA is removed.

(3) In step 2 all the nuclear DNA of embryo B which is not polar body nuclear DNA is inserted into embryo A.

Permitted embryo: circumstances

8.  The circumstances referred to in regulation 6(b) are that—

(a) the Authority has issued a determination that—

(i) there is a particular risk that any embryo which is created by the fertilisation of an egg extracted from the ovaries of a woman named in the determination may have mitochondrial abnormalities caused by mitochondrial DNA; and

(ii) there is a significant risk that a person with those abnormalities will have or develop serious mitochondrial disease; and

(b) embryo B was created by the fertilisation of an egg extracted from the ovaries of the woman so named.

Supplemental provision – licences

9.—(1) Any reference to a permitted egg in a licence whenever issued does not include an egg which is a permitted egg for the purposes of section 3(2) of the Act by virtue of regulation 3 unless express provision is made in the licence to that effect.

(2) Any reference to a permitted embryo in a licence whenever issued does not include an embryo which is a permitted embryo for the purposes of section 3(2) of the Act by virtue of regulation 6 unless express provision is made in the licence to that effect.

(1)

Section 3(2) was substituted by section 3(2) of the 2008 Act.

(2)

Section 3ZA was inserted by section 3(5) of the 2008 Act.