Human Fertilisation and Embryology (Mitochondrial Donation) Bill

A

BILL

TO

Allow mitochondrial transfer IVF procedures.

BE IT ENACTED by the Queen’s Most Excellent Majesty, by and with the advice and consent of the Lords, and Commons, in this present Parliament assembled, and by the authority of the same, as follows –

1. Principal Act

In this Act the “Principal Act” means the Human Fertilisation and Embryology Act 1990.

2. Section 31ZA Amended

(1) Section 31ZA of the Principal Act is amended as follows.

(2) For the heading substitute “Request for information as to genetic parentage or mitochondrial donors etc”.

(3) In subsection (1) at the end insert “or (2A)”;

(4) After subsection (2) insert—

“(2A) The applicant may request the Authority to give the applicant notice stating whether or not the information contained in the register shows that a person is the applicant’s mitochondrial donor, and if it does show that, giving the applicant the following information contained in the register—

(a) the screening tests carried out on the mitochondrial donor and information on that donor’s personal and family medical history,

(b) matters contained in any description of the mitochondrial donor as a person which that donor has provided, and

(c) 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,

but not giving any information which may identify the mitochondrial donor or any person who was or may have been born in consequence of treatment services using genetic material from the applicant’s mitochondrial donor, by itself or in combination with any other information which is in, or is likely to come into, the possession of the applicant.”;

3. Section 31ZB Amended (Mitochondrial Donor-Conceived Persons Able To Request Information)

After subsection (6) of Section 31ZB of the Principal Act insert—

“(6A) For the purposes of this section, in a case where the information contained in the register shows that the applicant is a mitochondrial donor-conceived person, the applicant is not a person who, but for the relevant statutory provisions, would or might be related to—

(a) the applicant’s mitochondrial donor, or

(b) any person who was or may have been born in consequence of treatment services using genetic material from the applicant’s mitochondrial donor.”.

4. Section 31ZC Amended (Duty To Notify Mitochondrial Donors About Information Requests)

(1) Section 31ZA of the Principal Act is amended as follows.

(2) For the heading substitute “Requests for information under section 31ZA: informing donors”;

(3) After subsection (1) insert—

“(1A) Where—

(a) the Authority has received from a person (“the section 31ZA(2A) applicant”) a notice containing a request under section 31ZA(2A), and

(b) compliance by the Authority with its duty under that section has involved or will involve giving the section 31ZA(2A) applicant information relating to that applicant’s mitochondrial donor,

the Authority must not notify the section 31ZA(2A) applicant’s mitochondrial donor that the request has been made.”

5. Section 31ZD Amended

After subsection (3)(b) of Section 31ZD of the Principal Act insert—

“(ab) the number of persons in respect of whom the donor is a mitochondrial donor,”.

6. Section 31ZE Amended (Mitochondrial Donors not to be parents)

After subsection (1) of Section 31ZE of the Principal Act insert—

“(1A) Subsection (1B) applies in respect of a mitochondrial donor-conceived person (“P”) and P’s mitochondrial donor (“D”).

(1B) For the purposes of this section, D is not a person who would or might, but for the relevant statutory provisions, be the parent of P.”.

7. Schedule 3 Amended (Meaning Of Terms In Licenses & Qualification Of “Persons Who Created An Embryo” With Respect Mitrochinidal Donors)

(1) In paragraph 4 schedule 3 of the Principal Act is amended as follows.

(2) After sub-paragraph (1) insert—

“(1A) Sub-paragraph (1B) applies to a case where an egg is used in the process set out in paragraph 3 to the schedule of the Human Fertilisation and Embryology (Mitochondrial Donation) Act 2020 (and “egg A” and “egg B” have the same meanings in this paragraph as in that acts schedule).

(1B) The terms of the consent to that use of egg A or egg B cannot be varied, and such consent cannot be withdrawn, once all the nuclear DNA of egg B which is not polar body nuclear DNA is inserted into egg A.”,

(3) in sub-paragraph (2), for “sub-paragraph (3)” there were substituted “sub-paragraphs (3) to (3B)”, and

(4) after sub-paragraph (3) there were inserted—

“(3A) Sub-paragraph (3B) applies to a case where an embryo is used in the process set out in paragraph 5 to the schedule of the Human Fertilisation and Embryology (Mitochondrial Donation) Act 2020 (and “embryo A” and “embryo B” have the same meanings as in that schedule).

(3B) The terms of the consent to that use of embryo A or embryo B cannot be varied, and such consent cannot be withdrawn, once all the nuclear DNA of embryo B which is not polar body nuclear DNA is inserted into embryo A.”

(5) In paragraph 22 schedule 3 of the Principal Act before (1) insert—

“(A1) For the purposes of this Schedule, neither of the following is to be treated as a person whose gametes were used to create an embryo (“embryo E”)—

(a) where embryo E is a permitted embryo by virtue of regulations under section 3ZA(5), the person whose mitochondrial DNA (not nuclear DNA) was used to bring about the creation of embryo E;

(b) where embryo E has been created by the fertilisation of an egg which was a permitted egg by virtue of regulations under section 3ZA(5), the person whose mitochondrial DNA (not nuclear DNA) was used to bring about the creation of that permitted egg.

(3B) For the purposes of this Schedule, in a case where an egg is permitted egg by virtue of regulations under section 3ZA(5) the egg is not to be treated as the egg of the person whose mitochondrial DNA (not nuclear DNA) was used to bring about the creation of that permitted egg.”.

8. Section 54 Human Fertilisation and Embryology Act 2008 Amended

In section 54 of the Human Fertilisation and Embryology Act 2008 after subsection (1) insert—

“(1A) For the purposes of this section, neither of the following is to be treated as a person whose gametes were used to create an embryo (“embryo E”)—

(a) where embryo E is a permitted embryo by virtue of regulations under section 3ZA(5) of the 1990 Act, the person whose mitochondrial DNA (not nuclear DNA) was used to bring about the creation of embryo E;

(b) where embryo E has been created by the fertilisation of an egg which was a permitted egg by virtue of regulations under section 3ZA(5) of the 1990 Act, the person whose mitochondrial DNA (not nuclear DNA) was used to bring about the creation of that permitted egg.”.

9. Schedule to have effect

The schedule has effect.

10. Ministerial Powers

(1) The Secretary Of State may by regulations revoke, amend the schedule, the 1990 Act or the 2008 Act in so far as they relate to the schedule.

(2) These regulations are subject to the affirmative resolution of—

(a) the House of Commons; and

(b) the House of Lords.

11. Extent, commencement, and short title

(1) This Act shall extend across the United Kingdom.

(2) This Act shall come into force after receiving Royal Assent.

(3) This Act may be cited as the Armed Forces Covenant Act.

Schedule

1. Interpretation

(1) In this schedule “the 1990 Act” means the Human Fertilisation and Embryology Act 1990.

(2) In this schedule “polar body nuclear DNA” means any nuclear DNA located in a polar body.

(3) In this schedule a reference to the removal of any nuclear DNA (including polar body nuclear DNA) includes a reference to the removal of any material which is necessarily removed along with that DNA, and such material may include any associated organelles.

(4) For the purposes of this schedule, the following are to be treated as removed from an egg—

(a) any polar body nuclear DNA which is destroyed while still located in the egg; and

(b) any material which is necessarily destroyed along with that DNA, and such material may include any associated organelles.

(5) In this schedule a reference to the insertion of nuclear DNA includes a reference to the insertion of any material which is necessarily inserted along with that DNA, and such material may include any associated organelles.

2 - Permitted Eggs

An egg (“egg P”) is a permitted egg for the purposes of section 3(2)(b)(2) of the 1990 Act if—

(a) egg P results from the application of the process specified in paragraph 3 to two eggs, each of which—

(i) is a permitted egg as defined in section 3ZA(2)(3) of the 1990 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) 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

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

(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.

3 - Permitted Process (Eggs)

(1) The process referred to in paragraph 2(a) of this schedule 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.

4 - Permitted Embryo

An embryo (“embryo P”) is a permitted embryo for the purposes of section 3(2)(a) of the 1990 Act if—

(1) embryo P results from the application of the process specified in 5 of this schedule to two embryos, each of which—

(a) is a permitted embryo as defined in section 3ZA(4) of the 1990 Act (not an embryo which is a permitted embryo by virtue of these regulations), and

(b) 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;

(2) the Authority has issued a determination that—

(a) 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

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

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

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

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

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

5 - Permitted Process (Embryos)

(1) The process referred to in 4(1) 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.

6 - Licenses

(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 1990 Act by virtue of paragraph 4 unless express provision is made in the licence to that effect.

This Bill was submitted by /u/LeChevalierMal-Fait on behalf of the Libertarian Party

Links to amended legislation:

Human Fertilisation and Embryology Act 1990

Human Fertilisation and Embryology Act 2008

M: Written using the 2015 regulations.

Advice on reading the bill

The key bit of the bill is the schedule it’s a bit jargon heavy but tldr it is saying;

Here are human genetic material that are permitted to have processes done to them;

The permitted process is X. (As for what that process is we will get on to latter).

The bill, consists of amendments to mostly the 1990 Human embryology act to allow people to request data, have their privacy respected, not be classed as parents, to prevent licenses currently in use to perform this procedure without a new license.

As a bit of a wtf does any of this actually mean;

Very simply Human cells contain small structures called mitochondria, which have their own DNA and are inherited exclusively from the mother, in most people this is perfectly fine, however Mitochondrial disease passed on matrilineally can be devastating.

This bill would allow ivf interventions to be made where two parents provide human genetic material but the mothers egg is modified to include mitochondrial DNA from a third person allowing the embryo to be free of disease.

Screening embryos for disease already happens, what is significant about this is that this can be passed down to future generations making this a much more permanent change.

As for how it would be regulated the bill provides for individual licenses to be granted to clinics to do this, and does so in a way that existing clinics couldn’t do this with existing licenses.

Finally the bill makes some provisions to prevent a mitochondrial donor being a parent, to protect their privacy and to absolve them of parental responsibilities that exist in say current arrangements between a couple who conceive via ivf.

Here is the impact assessment of the 2015 regulations

And lastly here is a rather balanced guardian explainer on the topic.

Vote Content/Present/Not Content. The division will end on the eleventh at 10pm BST.