Health (Assisted Human Reproduction) Act 2024

PART 1 Preliminary and General

1. Short title, collective citation and commencement

1. (1) This Act may be cited as the Health (Assisted Human Reproduction) Act 2024.

(2) Section 226 and the Irish Nationality and Citizenship Acts 1956 to 2004 may be cited together as the Irish Nationality and Citizenship Acts 1956 to 2024.

(3) Section 230 and the Civil Registration Acts 2004 to 2019 may be cited together as the Civil Registration Acts 2004 to 2024.

(4) This Act (other than sections 226, 227, 228, 229, 230 and 231) shall come into operation on such day or days as the Minister may appoint by order or orders either generally or with reference to any particular purpose or provision, and different days may be so appointed for different purposes and different provisions.

(5) Sections 226, 227, 228 and 231 shall come into operation on such day or days as the Minister for Justice may, after consultation with the Minister, appoint by order or orders either generally or with reference to any particular purpose or provision, and different days may be so appointed for different purposes and different provisions.

(6) Section 229 shall come into operation on such day or days as the Minister for Foreign Affairs may, after consultation with the Minister, appoint by order or orders either generally or with reference to any particular purpose or provision, and different days may be so appointed for different purposes and different provisions.

(7) Section 230 shall come into operation on such day or days as the Minister for Social Protection may, after consultation with the Minister, appoint by order or orders either generally or with reference to any particular purpose or provision, and different days may be so appointed for different purposes and different provisions.

2. Interpretation - general

2. (1) In this Act—

“Act of 2004” means the Civil Registration Act 2004;

“Act of 2007” means the Medical Practitioners Act 2007;

“Act of 2010” means the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010;

“Act of 2014” means the Companies Act 2014;

“Act of 2015” means the Children and Family Relationships Act 2015;

“adult (AHR)” means a person born as a result of AHR treatment who has attained the age of 16 years;

“AHR” means assisted human reproduction;

“AHR counselling”—

(a) in relation to AHR treatment, other than AHR treatment to be provided pursuant to a surrogacy agreement attached to a section 53 application, means a service provided by an AHR counsellor under which he or she counsels a person regarding the potential social and psychological implications that may arise in the case of the person where that person, or another person with whom the first mentioned person is connected, is provided such treatment, or

(b) in relation to AHR treatment to be provided pursuant to a surrogacy agreement attached to a section 53 application, means a service provided by an AHR counsellor under which he or she—

(i) if the application involves two intending parents, counsels such parents regarding the potential social and psychological implications that may arise in the case of such agreement being approved under section 53 and, if applicable, such parents, or one of them, as the case may be, being provided such treatment,

(ii) if the application involves a single intending parent, counsels such parent regarding the potential social and psychological implications that may arise in the case of such agreement being approved under section 53 and, if applicable, such parent being provided such treatment, or

(iii) counsels the potential surrogate mother regarding the potential social and psychological implications that may arise in the case of such agreement being approved under section 53 and such mother being provided such treatment;

“AHR counsellor”, in relation to an AHR treatment, means a person who has the requisite skills and judgment to provide AHR counselling as regards such treatment;

“AHRRA” shall be construed in accordance with section 122(1);

“AHR treatment” means assisted human reproduction treatment;

“AHR treatment facility”, in relation to an AHR treatment that the AHR treatment provider is authorised to provide by virtue of the licence held by the provider, means the premises specified in the licence at which the provider is authorised to provide such treatment;

“AHR treatment provider” means the holder of a licence authorising the holder to provide the AHR treatment the subject of the licence at the premises specified in the licence;

“animal” means an animal other than a human;

“applicant”, in relation to an application made under this Act, means the person who made the application;

“application”, in relation to an application made to the AHRRA, means an application in the specified form;

“assisted human reproduction treatment” means any treatment or procedure that involves the handling of gametes, embryos or tissues (including the storage thereof), or any combination thereof, for the purposes of establishing a pregnancy or enabling a pregnancy to be established, and includes—

(a) a DAHR procedure, and

(b) a further DAHR procedure;

“authorised officer” means a person appointed under section 171(1) to be an authorised officer;

“capacity” has the meaning assigned to it by the Assisted Decision-Making (Capacity) Act 2015;

“child” means a person who has not attained the age of 18 years;

“child (AHR)” means a person born as a result of AHR treatment who has not attained the age of 16 years;

“civil partner” shall be construed in accordance with section 3 of the Act of 2010;

“cohabitant” shall be construed in accordance with section 172(1) of the Act of 2010;

“company” means—

(a) a company formed and registered under the Act of 2014, or

(b) an existing company within the meaning of that Act;

“court” shall be construed in accordance with section 5 (except in the case of subsection (2));

“created”, in relation to an embryo, includes formed;

“DAHR procedure” has the meaning assigned to it by the Act of 2015;

“disposed of”, in relation to a gamete, embryo or tissue (howsoever described in this Act), means the gamete, embryo or tissue is destroyed (by whatever means);

“donor-conceived child” has the meaning assigned to it by the Act of 2015;

“embryo” means a human embryo formed by the fertilisation of a human egg by a human sperm;

“embryo transfer” means the final procedure of an in vitro fertilisation process that consists of the transfer of one or more than one embryo into the womb of a woman;

“embryonic stem cell” means a stem cell, derived from the inner cell mass of a five to seven day-old embryo, which is self-renewing and pluripotent;

“enactment” has the same meaning as it has in the Interpretation Act 2005;

“ESC” means embryos and stem cells;

“ESC research” means—

(a) research involving embryos, or

(b) research involving the derivation, collection, storage or use of—

(i) embryonic stem cells or stem cell lines, or

(ii) induced pluripotent stem cells or stem cell lines;

“ESC research facility”, in relation to ESC research that an ESC researcher is authorised to undertake by virtue of the licence held by the researcher, means the premises specified in the licence at which the researcher may undertake such research;

“ESC researcher” means the holder of a licence authorising the holder to undertake the ESC research the subject of the licence at the premises specified in the licence;

“establishment day” means the day appointed under section 121;

“fit and proper”, in relation to a person, shall be construed in accordance with Schedule 1;

“further DAHR procedure” has the meaning assigned to it by the Act of 2015;

“gamete” means—

(a) a human sperm, which is formed in the body of and provided by a male, or

(b) a human egg, which is formed in the body of and provided by a female;

“induced pluripotent stem cell” means a somatic cell with a specialised function, such as a skin cell, that has been reprogrammed to be a pluripotent stem cell;

“intending parent”, in relation to AHR treatment, means a person who intends to become the parent of any child born as a result of such treatment or, in the case of such treatment provided to any other person (including a child), to safeguard that person’s possibility of becoming a person first-mentioned in this definition;

“legal practitioner” has the meaning assigned to it by the Legal Services Regulation Act 2015;

“licence” means a licence granted under section 155(1);

“licence application” means an application under section 153(1);

“local authority” means a local authority within the meaning of the Local Government Act 2001;

“medical specialist” means a registered medical practitioner whose name is entered in the Specialist Division of the register of medical practitioners maintained by the Medical Council under section 43(2)(b) of the Act of 2007;

“Minister” means the Minister for Health;

“National Donor-Conceived Person Register” means the register known by that name established and maintained under section 33 of the Act of 2015;

“National Surrogacy Register” means the register known by that name established and maintained under section 68;

“PAHR” means posthumous assisted human reproduction;

“parental order” means (other than in Part 8 or 12) an order granted by the court under section 66(1)(a) for the transfer of the parentage of a child;

“person (D)”, in relation to a surviving partner, means the deceased person referred to in the definition of “surviving partner”;

“pluripotent stem cell” means a stem cell that can become all the cell types that are found in an implanted embryo, foetus or developed organism, but not the embryonic components of the trophoblast and placenta that are required to support development and birth;

“posthumous assisted human reproduction” means AHR treatment involving the use of the gametes of person (D), or of an embryo created by the use of such gametes, subsequent to the death of such person;

“premises” includes place;

“prescribed” means prescribed by regulations made by the Minister under this Act;

“public body” means—

(a) a Department of State,

(b) a local authority,

(c) any other entity established by or under any enactment (other than the Act of 2014 or a former enactment relating to companies within the meaning of section 5 of that Act), charter or any scheme administered by a Minister of the Government,

(d) a company a majority of the shares in which are held by or on behalf of a Minister of the Government,

(e) a subsidiary (within the meaning of the Act of 2014 or a former enactment relating to companies within the meaning of section 5 of that Act) of a company referred to in paragraph (d),

(f) an entity established or appointed by the Government or a Minister of the Government,

(g) any entity (other than one that falls within paragraph (e)) that is directly or indirectly controlled by an entity that falls within any of paragraphs (b) to (f),

(h) an entity on which any functions are conferred by or under any enactment (other than the Act of 2014 or a former enactment relating to companies within the meaning of section 5 of that Act) or charter, or

(i) a designated institution of higher education (within the meaning of the Higher Education Authority Act 2022) in receipt of public funding;

“pursuant to” includes for the purposes of;

“record” includes—

(a) a book or other written or printed material in any form (including in any electronic device or in machine readable form),

(b) a map, plan or drawing,

(c) a disc, tape or other mechanical or electronic device in which data other than visual images are embodied so as to be capable, with or without the aid of some other mechanical or electronic equipment, of being reproduced from the disc, tape or other device,

(d) a film, disc, tape or other mechanical or electronic device in which visual images are embodied so as to be capable, with or without the aid of some other mechanical or electronic equipment, of being reproduced from the film, disc, tape or other device, and

(e) a copy or part of any thing which falls within paragraph (a), (b), (c) or (d),

and a copy, in any form, of a record shall be deemed, for the purposes of this Act, to have been created at the same time as the record;

“registered medical practitioner” has the meaning assigned to it by the Act of 2007;

“Regulations of 2006” means the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 (S.I. No. 158 of 2006);

“relevant activity” means—

(a) the provision of AHR treatment, or

(b) the undertaking of ESC research;

“relevant donation (E)” means, as appropriate—

(a) a donation of supernumerary embryos made in accordance with—

(i) section 30(1), or

(ii) the law of a jurisdiction other than the State,

for use in the provision of AHR treatment in accordance with this Act, or

(b) the supernumerary embryos the subject of such donation;

“relevant donation (ER)” means, as appropriate—

(a) a donation of supernumerary embryos made in accordance with—

(i) section 31, or

(ii) the law of a jurisdiction other than the State,

for use in the undertaking of ESC research in accordance with this Act, or

(b) the supernumerary embryos the subject of such donation;

“relevant donation (G)” means, as appropriate—

(a) a donation of gametes made in accordance with—

(i) section 27(1) or (2), or

(ii) the law of a jurisdiction other than the State,

for use in the provision of AHR treatment in accordance with this Act, or

(b) the gametes the subject of such donation;

“relevant donor (E)”, in relation to a relevant donation (E), means—

(a) subject to paragraph (b), the person who has made or proposes to make the donation, or

(b) if section 30(1)(b) applies, the two persons who have made or propose to make the donation;

“relevant donor (ER)”, in relation to a relevant donation (ER), means—

(a) subject to paragraph (b), the person who has made or proposes to make the donation, or

(b) if section 31(b) applies, the two persons who have made or propose to make the donation;

“relevant donor (G)”, in relation to a relevant donation (G), means the person who has made or proposes to make the donation;

“relevant storage (E)” means, as appropriate—

(a) the storage of embryos by the holder of a licence pursuant to the provisions of the licence, or

(b) the embryos the subject of such storage;

“relevant storage (G)” means, as appropriate—

(a) the storage of gametes by the holder of a licence pursuant to the provisions of the licence, or

(b) the gametes the subject of such storage;

“relevant storage (T)” means, as appropriate—

(a) the storage of tissues by the holder of a licence pursuant to the provisions of the licence, or

(b) the tissues the subject of such storage;

“relevant storage period (E)”, in relation to a relevant storage (E), means—

(a) if applicable, the shorter storage period (E) specified for such storage, or

(b) in any other case, the period specified in section 41(1)(a)(ii)(I) or (II), as appropriate (including any such period as extended under section 41(3)(a));

“relevant storage period (G)”, in relation to a relevant storage (G), means—

(a) if applicable, the shorter storage period (G) specified for such storage, or

(b) in any other case, the period specified in section 40(1)(a)(ii)(I) or (II), as appropriate (including any such period as extended under section 40(3)(a));

“relevant storage period (T)”, in relation to a relevant storage (T), means—

(a) if applicable, the shorter storage period (T) specified for such storage, or

(b) in any other case, the period specified in section 42(1)(a)(ii)(I) or (II), as appropriate (including any such period as extended under section 42(3)(a));

“relevant storer (E)”, in relation to a relevant storage (E), means the holder of the licence undertaking such storage;

“relevant storer (G)”, in relation to a relevant storage (G), means the holder of the licence undertaking such storage;

“relevant storer (T)”, in relation to a relevant storage (T), means the holder of the licence undertaking such storage;

“satisfied” means satisfied on reasonable grounds;

“section 18 report” shall be construed in accordance with section 18;

“section 19 consent” shall, subject to subsection (4), be construed in accordance with section 19;

“section 53 application” shall be construed in accordance with section 53(2);

“shorter storage period (E)”, in relation to a relevant storage (E), means the shorter period (if any) specified for such storage in a section 19 consent pursuant to section 19(2)(d);

“shorter storage period (G)”, in relation to a relevant storage (G), means the shorter period (if any) specified for such storage in a section 19 consent pursuant to section 19(2)(d);

“shorter storage period (T)”, in relation to a relevant storage (T), means the shorter period (if any) specified for such storage in a section 19 consent pursuant to section 19(2)(d);

“specified”—

(a) in relation to a form, means specified under section 151, and

(b) in relation to a fee, means specified in regulations made under section 168;

“specified upper age limit”, in relation to a type of AHR treatment, means the upper age limit specified for that type of AHR treatment in regulations made under section 12;

“spouse” means a partner to a marriage recognised at a given time by the law of the State as valid;

“stem cell” means an unspecified cell capable of perpetuating itself through cell division and having the potential to give rise to differentiated cells with specialised functions;

“stem cell line” means embryonic stem cells that can be maintained and grown in vitro and that display an immortal or indefinite life span;

“supernumerary embryo” means an embryo that was created and stored for use as part of a person’s AHR treatment but remains unused following the completion of that treatment;

“supernumerary gamete” means a gamete that was stored for use as part of a person’s AHR treatment but remains unused following the completion of that treatment;

“surrogacy” means an agreement between a woman and the intending parents (or, in the case of a single intending parent, that intending parent) under which the woman agrees to attempt to become pregnant, by the use of an egg other than her own, and, if successful, to transfer the parentage of any child born as a result of the pregnancy to the intending parents (or, in the case of a single intending parent, that intending parent);

“surrogacy agreement” means an agreement referred to in the definition of “surrogacy”;

“surrogate mother” means, subject to sections 55(2) and 91(2), a woman referred to in the definition of “surrogacy”;

“surviving partner” means the surviving female spouse, female civil partner or female cohabitant of a deceased person at the time of the person’s death;

“tissue” means—

(a) human testicular tissue which has been retrieved from the body of a male, or

(b) human ovarian tissue which has been retrieved from the body of a female.

(2) Where a provision of this Act confers a discretion on the AHRRA or any court to revoke or suspend a licence and the holder of the licence holds two or more licences, that discretion may be exercised so as to revoke or suspend, as the case may be, some or all of those licences as the AHRRA or the court, as the case may be, thinks fit in all the circumstances of the case, and the other provisions of this Act shall, with all necessary modifications, be construed accordingly.

(3) A reference in this Act to a licence includes a reference to—

(a) the relevant activity the subject of the licence, and

(b) the conditions attached, or deemed to be attached, to the licence by virtue of section 156.

(4) A reference in this Act to a section 19 consent includes a reference to a replacement of that section 19 consent by another section 19 consent effected by a section 19 revocation and replacement as construed in accordance with section 19(4).

(5) (a) A reference in this Act to a gamete (other than in section 27(1)) includes a reference to a supernumerary gamete.

(b) A reference in this Act to an embryo (other than in section 29(1)) includes a reference to a supernumerary embryo.

(6) Nothing in this Act shall be construed to prejudice the generality of the Assisted Decision-Making (Capacity) Act 2015.

3. Regulations, etc.

3. (1) The Minister may by regulations provide for any matter referred to in this Act as prescribed or to be prescribed.

(2) Regulations made under this Act may contain such incidental, supplementary and consequential provisions as appear to the Minister to be necessary or expedient for the purposes of the regulations.

(3) Every order under section 81 or 162 or regulation made by the Minister under this Act shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the order or regulation is passed by either such House within the next 21 days on which that House has sat after the order or regulation is laid before it, the order or regulation shall be annulled accordingly, but without prejudice to the validity of anything previously done thereunder.

4. Expenses

4. Any expenses incurred by the Minister or the AHRRA in the administration of this Act shall, to such extent as may be sanctioned by the Minister for Public Expenditure, National Development Plan Delivery and Reform, be paid out of moneys provided by the Oireachtas.

5. Circuit Court’s jurisdiction under this Act

5. (1) Subject to subsection (2), a reference in this Act (other than in Part 12) to an application being made to the court shall be construed as a reference to an application being made to the Circuit Court and the Circuit Court shall have jurisdiction to hear and determine proceedings under this Act in relation to any such application.

(2) The Circuit Court for the purposes of subsection (1) shall be—

(a) subject to paragraph (b), the Circuit Court for that circuit in which the applicant concerned ordinarily resides or carries on any profession, business or occupation, or

(b) where the applicant concerned neither ordinarily resides nor carries on any profession, business or occupation in the State, the Circuit Court for the Dublin Circuit.

6. Review of operation of Act

6. (1) The Minister shall, not later than 3 years following the passing of this Act, carry out a review of the operation of this Act, subject to subsection (2).

(2) Where sections of this Act have yet to be commenced within the timeframe set out in subsection (1), these sections shall not be subject to the review under subsection (1) but shall be subject to a subsequent review not less than 5 years following the passing of this Act.

PART 2 General Provisions Relating to Relevant Activities

7. Definition - Part 2

7. In this Part, “AHR information document”, in relation to a type of AHR treatment, means the document published on the AHRRA’s website pursuant to section 13(1) and that relates to that type of AHR treatment.

8. Application

8. (1) For the purposes of this Act, there shall not be more than two intending parents of a child born as a result of AHR treatment and, in the case of two intending parents, they shall be spouses, civil partners or cohabitants of one another.

(2) Nothing in this Act shall be construed to prejudice the generality of any enactment or rule of law relating to consent to medical treatment.

(3) For the purposes of this Act—

(a) a gamete obtained by the provision of AHR treatment to a person where such person is an intending parent of any child that may be born as a result of the use of the gamete in any further AHR treatment is not a relevant donation (G) in the meanings assigned to the term in the definition of “relevant donation (G)”, and

(b) an embryo created, by the provision of AHR treatment, from the gametes of two persons where such persons are the intending parents of any child that may be born as a result of the use of the embryo in any further AHR treatment is not a relevant donation (E) in the meanings assigned to the term in the definition of “relevant donation (E)”.

(4) Subject to section 172(6), nothing in this Act shall be construed to prejudice the operation of the Act of 2007 or the Act of 2015.

(5) (a) Subject to paragraph (b), where section 19(1)(b) or (c), 27(3) or 30(2) applies, the provisions of the Act of 2015 shall, in addition to the provisions of this Act, apply to the use in AHR treatment of the gamete or embryo concerned.

(b) Where, but for this paragraph, there would be an irreconciliation between a provision of the Act of 2015 and a provision of this Act, that irreconciliation shall be decided in favour of the provision of the Act of 2015.

(6) A reference in this Act to a surrogacy, not being a reference to a surrogacy in section 2 or 55(2), Part 8 or 12 or the long title to this Act, does not include a reference to a surrogacy to which Part 8 or 12 applies.

(7) A reference in this Act to a surrogate mother, not being a reference to a surrogate mother in section 2 or 55(2) or Part 8 or =12, does not include a reference to a surrogate mother in so far as she is a surrogate mother under a surrogacy to which Part 8 or 12 applies.

9. Prohibition against person providing or undertaking relevant activity except pursuant to licence

9. A person shall not provide or undertake any type of relevant activity except pursuant to a licence held by the person authorising that person to provide or undertake that type of relevant activity.

10. Prohibition against holder of licence providing or undertaking relevant activity except in accordance with licence and this Act, etc.

10. (1) The holder of a licence shall not provide or undertake the relevant activity the subject of the licence except under and in accordance with the provisions of—

(a) the licence, and

(b) this Act.

(2) A licence shall not authorise the undertaking of ESC research specified in Schedule 2 and any licence that purports to do so shall be void to the extent that it purports to do so.

(3) Subject to subsections (4) and (5), the Minister may by regulations specify, for the purposes of paragraph 5 of Schedule 2, a type of ESC research where he or she is of the opinion that, for ethical reasons, such research should not be undertaken.

(4) A type of ESC research specified in regulations made under subsection (3) shall not apply to such research undertaken, but not completed, before such specification unless the regulations expressly state the contrary.

(5) On and after the establishment day, the Minister shall not make regulations under subsection (3) except after consultation with the AHRRA.

11. Prohibition against ESC researcher using relevant donation (ER) for any purpose other than in undertaking ESC research

11. An ESC researcher shall not use a relevant donation (ER) for any purpose other than in the undertaking of ESC research.

12. Upper age limits for AHR treatment

12. (1) Subject to subsections (2) and (3), the Minister may by regulations specify the upper age limit for an AHR treatment specified in the regulations (in this section referred to as the “relevant treatment”) in respect of which an AHR treatment provider shall not provide such treatment to a person who has attained that age.

(2) Where the Minister makes regulations under subsection (1), he or she shall, in addition to having regard to the other provisions of this Act, have regard to the following:

(a) the current state of medical evidence as to—

(i) the increase in the number, or the severity, or both, of risks (whether bodily or otherwise), and

(ii) the likelihood of a successful outcome,

associated with providing the relevant treatment to persons by reference to increases in age;

(b) the current state of medical evidence or otherwise as to the increase in the number, or the severity, or both, of adverse social and psychological implications that may arise associated with providing the relevant treatment to persons by reference to increases in age;

(c) in so far as is practicable after considering the nature and purpose of the relevant treatment, what is in the best interests of any child that may be born as a result of such treatment (whether by virtue of such treatment alone or in conjunction with any further AHR treatment);

(d) that the best interests of a child referred to in paragraph (c) include at least one of the intending parents (or, in the case of a single intending parent, that intending parent) having objectively, and in all the circumstances of the case, a reasonable expectation of living to parent the child until that child has attained the age of 18 years.

(3) On and after the establishment day, the Minister shall not make regulations under subsection (1) except after consultation with the AHRRA.

13. AHR information document

13. (1) (a) Subject to sections 14 and 15, the AHRRA shall, as soon as is practicable after the commencement of this section, prepare and publish on its website a document, for each type of AHR treatment, setting out the basic information that it is satisfied that a person seeking, or potentially seeking, such type of AHR treatment ought to know about such treatment.

(b) Without prejudice to the generality of the reference to “basic information” in paragraph (a), such information should include information about the potential effect of the operation of section 38.

(c) The AHRRA shall maintain, and update as required, each AHR information document published on its website.

(2) When an AHR treatment provider is approached, in his or her professional capacity as such provider, by a person seeking, or potentially seeking, an AHR treatment from the provider, the provider shall, as soon as is practicable after being so approached, give, or cause to be given, to the person the AHR information document.

14. Provisions supplementary to section 13 - relevant storage (G), relevant storage (E) or relevant storage (T)

14. (1) This section applies without prejudice to the generality of section 13.

(2) The AHR information document for a type of AHR treatment to be provided for the purposes of facilitating a relevant storage (G) of a gamete referred to in section 8(3)(a) shall inform the intending parent referred to in that section that, when the relevant storage period (G) expires, the gamete, if it remains unused at the time of such expiration, will be disposed of in accordance with section 40 unless, before such expiration, the AHRRA grants under section 40 an extension to the relevant storage period (G).

(3) The AHR information document for a type of AHR treatment to be provided for the purposes of facilitating a relevant storage (E) of an embryo referred to in section 8(3)(b) shall inform the intending parents referred to in that section that, when the relevant storage period (E) expires, the embryo, if it remains unused at the time of such expiration, will be disposed of unless, before such expiration, the AHRRA grants under section 41 an extension to the relevant storage period (E).

(4) The AHR information document for a type of AHR treatment to be provided for the purposes of facilitating a relevant storage (T) for a person shall inform the person that, when the relevant storage period (T) expires, the tissue, if it remains unused at the time of such expiration, will be disposed of unless, before such expiration, the AHRRA grants under section 42 an extension to the relevant storage period (T).

15. Provisions supplementary to section 13 - surrogacy

15. (1) This section applies without prejudice to the generality of section 13.

(2) The AHR information document for a type of AHR treatment to be provided pursuant to a surrogacy agreement shall inform the surrogate mother and the intending parents (or, in the case of a single intending parent, that intending parent) involved of the following:

(a) that the surrogate mother will be the mother of any child born as a result of AHR treatment provided pursuant to the agreement;

(b) that the surrogate mother’s husband (if any) under a subsisting marriage will not be presumed to be the father of any child born as a result of AHR treatment provided pursuant to the agreement;

(c) that the intending parents (or, in the case of a single intending parent, that intending parent) will not, without a parental order, be the parents (or, in the case of a single intending parent, the parent) of any child born as a result of AHR treatment provided pursuant to the agreement other than in the case of an intending parent who provided the sperm used in such treatment;

(d) where a relevant donation (G) will be used to create the embryo to be transferred to the surrogate mother pursuant to the agreement, the relevant donor (G) will not be a parent of the child;

(e) that the information specified in section 62(1) will be recorded in the National Surrogacy Register in respect of—

(i) the surrogate mother,

(ii) the intending parents (or, in the case of a single intending parent, that intending parent),

(iii) any child born as a result of AHR treatment provided pursuant to the agreement, and

(iv) where a relevant donation (G) was used to create the embryo that was transferred pursuant to the agreement, the relevant donor (G);

(f) that any person born as a result of AHR treatment provided pursuant to the agreement may, in accordance with the provisions of Part 7—

(i) access the information pertaining to each party to the agreement recorded on the National Surrogacy Register, and

(ii) seek to contact any party to the agreement;

(g) that, where a relevant donation (G) will be used to create the embryo to be transferred to the surrogate mother pursuant to the agreement, the relevant donor (G) is entitled to obtain from the National Surrogacy Register the information specified in section 70(2);

(h) that the surrogate mother has an obligation under section 62(2) to give the information specified in that section to the AHR treatment provider;

(i) having regard to the child’s right to know his or her origins, that it is desirable that—

(i) the surrogate mother and the intending parents (or, in the case of a single intending parent, that intending parent) keep updated, in accordance with section 74, the information in relation to him or her that is recorded on the National Surrogacy Register, and

(ii) the intending parents (or, in the case of a single intending parent, that intending parent) inform the child, at an appropriate age, that he or she was born as a result of AHR treatment provided pursuant to the agreement;

(j) the right of the surrogate mother and the intending parents (or, in the case of a single intending parent, that intending parent) to revoke, or revoke and replace, his or her section 19 consent.

16. Provision of AHR treatment

16. An AHR treatment provider shall not provide AHR treatment to a person unless—

(a) subject to sections 9(1)(a) and 11(1)(a) of the Act of 2015 and sections 39, 55(1)(b) and 56(2), the person has attained the age of 18 years but has not attained the specified upper age limit (if any), and

(b) the provider is satisfied that, in all the circumstances of the case—

(i) such treatment is necessary to—

(I) enable pregnancy or birth or both,

(II) enable fertility preservation, or

(III) avoid, in accordance with the provisions of Part 6, serious disability or illness in a child,

(ii) such treatment does not pose a disproportionate risk to the health of a child that may be born as a result of such treatment, and

(iii) where the person is a woman, pregnancy or birth, following such treatment, does not pose a disproportionate risk to her health.

17. Safety of children - AHR treatment provider

17. (1) This section shall not apply where section 54 applies to the relevant person in relation to the surrogacy agreement concerned.

(2) An AHR treatment provider shall not provide AHR treatment to a relevant person unless the provider is satisfied, based on the information available to the provider, that the relevant person, and each other relevant person, does not present a potential significant risk of harm or neglect to—

(a) any child that may be born as a result of such treatment, or

(b) any other child.

(3) (a) Subject to paragraph (b), the AHR treatment provider shall, for the purposes of subsection (2), make a request in writing to each relevant person to complete and submit to the provider within the period specified in the request (being a period reasonable in all the circumstances of the case), a return in the specified form (in this section referred to as a “section 17 return”) attached to the request.

(b) Subject to paragraph (c) and subsection (7), the Minister—

(i) shall, as soon as is practicable after the commencement of this subsection, by regulations specify the information, or information falling within a class of information specified in the regulations, that a section 17 return may require a relevant person, or a relevant person falling within a class of relevant persons specified in the regulations, to provide, and

(ii) may by regulations specify the circumstances (if any) in which such information may be further disclosed by an AHR treatment provider in addition to further disclosures required by law.

(c) Where the Minister makes regulations under paragraph (b), he or she shall, in addition to having regard to the other provisions of this Act, have regard to the following:

(i) that, in determining the information to be specified, the paramount consideration is the safety of any child referred to in subsection (2);

(ii) that the information sought needs to be appropriate and proportionate to satisfying the AHR treatment provider as referred to in subsection (2);

(iii) that any information sought which may reasonably be regarded as sensitive information is protected from any unnecessary further disclosure by the AHR treatment provider concerned except where such further disclosure is required by law.

(d) The AHRRA shall, in specifying different forms of section 17 returns, ensure that the forms are consistent with the regulations made under paragraph (b).

(4) Subject to subsection (5), where the AHR treatment provider is not satisfied after having assessed the section 17 returns concerned, as referred to in subsection (2), the provider shall, as soon as is practicable after the expiration of the period concerned referred to in subsection (3)(a), by notice in the specified form (in this section referred to as a “section 17 notice”) given to each relevant person, state the reasons why the provider is not so satisfied.

(5) For the purposes of subsection (4), the AHR treatment provider may also assess information obtained otherwise than from a relevant person.

(6) An AHR treatment provider shall retain the original or a copy of—

(a) a section 17 return,

(b) a section 17 notice,

(c) information referred to in subsection (5) which is in writing, and

(d) any note made in writing, by the provider, of information referred to in subsection (5) which is not in writing,

for not less than 30 years after receiving the return, issuing the notice, obtaining the information or making the note, as the case may be.

(7) On and after the establishment day, the Minister shall not make regulations under subsection (3) except after consultation with the AHRRA.

(8) In this section, “relevant person”, in relation to any child that may be born as a result of AHR treatment, means—

(a) in the case of two intending parents, each of the parents,

(b) in the case of a single intending parent, that parent and the parent’s spouse, civil partner or cohabitant (if any), and

(c) in the case of a surrogate mother, that mother and her spouse, civil partner or cohabitant (if any).

18. AHR counselling

18. (1) (a) An AHR treatment provider shall not provide relevant AHR treatment to a person seeking such treatment unless the provider is satisfied that the person and the relevant person have received AHR counselling in relation to such treatment.

(b) In paragraph (a), “relevant AHR treatment” means AHR treatment—

(i) involving the making or the use of—

(I) a relevant donation (E), or

(II) a relevant donation (G),

(ii) involving the provision of PAHR, or

(iii) involving surrogacy.

(2) (a) An AHR treatment provider shall inform any person seeking AHR treatment (not being relevant AHR treatment within the meaning of subsection (1)) that the person may, if he or she so wishes, receive AHR counselling as regards such treatment.

(b) The information referred to in paragraph (a) shall be in the specified form.

(3) Where an AHR counsellor is providing AHR counselling to two intending parents, he or she shall offer the counselling to the parents individually, together as a couple, or both.

(4) The AHR counsellor shall, as soon as is practicable after he or she has completed the AHR counselling of a person who is seeking to be a surrogate mother, make a report in the specified form (in this Act referred to as a “section 18 report”) as regards such counselling and give a copy of the report to the AHR treatment provider.

(5) (a) The AHR counsellor shall keep the original of the section 18 report for not less than 30 years.

(b) The AHR treatment provider shall keep the copy of the section 18 report for not less than 30 years.

(6) (a) Subject to paragraph (b), an AHR treatment provider shall not be, or hold out to be, an AHR counsellor.

(b) Paragraph (a) shall not be construed to prevent the AHR treatment provider from having an AHR counsellor as a member of the provider’s staff.

(7) In this section, “relevant person”, in relation to a person seeking AHR treatment, means, if such person is an intending parent, the other intending parent (if any).

19. Consent

19. (1) Subject to subsections (2) to (8) and section 25, an AHR treatment provider shall not provide AHR treatment to a person unless—

(a) consent in the specified form (in this Act referred to as a “section 19 consent”) to the provision of such treatment (including every stage of such treatment) has been given by—

(i) the person, and

(ii) each relevant person,

(b) in the case of such treatment involving the use of a gamete in a DAHR procedure provided on or after the establishment day, consent to such use has been given under section 6 or 26(1)(b)(ii), as appropriate, of the Act of 2015, and

(c) in the case of such treatment involving the use of an embryo in a DAHR procedure or further DAHR procedure provided on or after the establishment day, consent to such use has been given under section 14, 16 or 26(2)(b)(ii), as appropriate, of the Act of 2015.

(2) Without prejudice to the generality of section 151, an intending parent’s section 19 consent shall—

(a) specify that each intending parent (or, in the case of a single intending parent, that intending parent) has provided his or her consent to the AHR treatment specified in the section 19 consent,

(b) (i) not have been revoked when the AHR treatment is provided, and

(ii) where the section 19 consent has been revoked and replaced in accordance with this section (whether once or more than once), specify that the AHR treatment is provided in accordance with the last such replacement of such consent,

(c) specify the action to be taken in relation to a relevant storage (G), relevant storage (E) or relevant storage (T) if an intending parent dies or subsequently lacks capacity to make a decision in that regard where—

(i) the gametes concerned are their gametes,

(ii) the embryos concerned were created from their gametes or the gamete from one of them,

(iii) the embryos concerned were created for use in the provision of AHR treatment to one of the intending parents (or, in the case of a single intending parent, that intending parent), or

(iv) the tissues concerned are their tissues,

(d) specify that each intending parent (or, in the case of a single intending parent, that intending parent) may, in relation to a relevant storage (G), relevant storage (E) or relevant storage (T), specify in his or her section 19 consent a shorter storage period than the period referred to in paragraph (b) of the definition of “relevant storage period (G)”, paragraph (b) of the definition of “relevant storage period (E)” or paragraph (b) of the definition of “relevant storage period (T)”, as appropriate, where—

(i) the gametes concerned are their gametes,

(ii) the embryos concerned were created from their gametes or the gametes from one of them,

(iii) the embryos concerned were created for use in the provision of AHR treatment to one of the intending parents (or, in the case of a single intending parent, that intending parent), or

(iv) the tissues concerned are their tissues,

(e) in the case of two intending parents, specify what to do in the event of post factum differences of opinion or where changes of circumstances occur, and

(f) be sought again if two or more years have elapsed from the giving of the section 19 consent (including any section 19 consent which arises from the operation of this paragraph) without the provider having provided the AHR treatment the subject of the consent.

(3) A person’s section 19 consent shall not be considered valid unless—

(a) it was given voluntarily,

(b) the person had the capacity to give such consent at the time it was given, and

(c) section 18 has been complied with.

(4) (a) Subject to paragraph (b) and subsections (5) to (8), a person who has given a section 19 consent may, while he or she has the capacity to do so, revoke in the specified form (in this section referred to as a “section 19 revocation”), or revoke and replace in the specified form (in this section referred to as a “section 19 revocation and replacement”), his or her section 19 consent before the AHR treatment the subject of the consent has been provided.

(b) A section 19 revocation, or section 19 revocation and replacement, by a person of his or her section 19 consent does not take effect until the person gives the revocation, or revocation and replacement, as the case may be, to the AHR treatment provider concerned.

(c) Where section 27(3) applies in the case of a relevant donation (G), the section 19 revocation of the section 19 consent for the use of such donation in the provision of AHR treatment shall be accompanied by a revocation under section 8 of the Act of 2015 of the consent under section 6 of that Act on which such section 19 consent is founded by virtue of section 27(3)(c).

(d) Where section 30(2) applies in the case of a relevant donation (E), the section 19 revocation of the section 19 consent for the use of such donation in the provision of AHR treatment shall be accompanied by a revocation under section 18 of the Act of 2015 of the consent under section 14 or 16, as appropriate, of that Act on which such section 19 consent is founded by virtue of section 30(2)(c).

(5) (a) The surrogate mother or intending parent may, while he or she has the capacity to do so, effect a section 19 revocation, or section 19 revocation and replacement, at any stage prior to the transfer of the embryo pursuant to the surrogacy agreement.

(b) Where a relevant donation (G) is to be used to create the embryo to be transferred pursuant to the surrogacy agreement, the relevant donor (G) may, while he or she has the capacity to do so, effect a section 19 revocation, or section 19 revocation and replacement, at any stage before the formation of the embryo.

(6) Where a relevant donation (ER) is to be used in the undertaking of ESC research, the relevant donor (ER) may, while he or she has the capacity to do so, effect a section 19 revocation, or section 19 revocation and replacement, at any time before the relevant donation (ER) is so used.

(7) (a) Where section 30(1)(b) applies and only one of the two relevant donors (E) effects a section 19 revocation, the unused relevant donation (E) concerned shall not be used to provide AHR treatment to a person.

(b) Where section 31(b) applies and only one of the two relevant donors (ER) effects a section 19 revocation referred to in subsection (6), the unused relevant donation (ER) referred to in that subsection shall not be used for ESC research.

(c) Where section 30(1)(b) applies and only one of the two relevant donors (E) effects a section 19 revocation and replacement, section 21(4) shall, with all necessary modifications, apply to that section 19 revocation and replacement and the section 19 consent of the other relevant donor (E).

(d) Where section 31(b) applies and both relevant donors (E) effect a section 19 revocation and replacement but there is a disagreement between the provisions of the two section 19 revocation and replacements, section 21(4) shall, with all necessary modification, apply to the section 19 revocation and replacements.

(e) Where section 31(b) applies and only one of the two relevant donors (ER) effects a section 19 revocation and replacement referred to in subsection (6), section 21(5) shall, with all necessary modifications, apply to that section 19 revocation and replacement and the section 19 consent of the other relevant donor (ER).

(f) Where section 31(b) applies and both relevant donors (ER) effect a section 19 revocation and replacement referred to in subsection (6) but there is a disagreement between the provisions of the two section 19 revocation and replacements, section 21(5) shall, with all necessary modifications, apply to the section 19 revocation and replacements.

(8) Nothing in this section shall be construed to prevent a person (howsoever described) effecting a section 19 revocation from making, as regards any unused gametes or embryos (howsoever described) referred to in this section that the section 19 revocation relates to and in accordance with this Act, a relevant donation (G), a relevant donation (E) or relevant donation (ER), as appropriate, of such gametes or embryos.

(9) Without prejudice to the generality of sections 40(3), 41(3) and 42(3), it is hereby declared that subsection (2) as read with subsection (4)(a) shall not be construed to enable—

(a) any combination of shorter storage periods (G) applicable to the same relevant storage (G) to exceed, in total, the period specified in paragraph (b) of the definition of “relevant storage period (G)”,

(b) any combination of shorter storage periods (E) applicable to the same relevant storage (E) to exceed, in total, the period specified in paragraph (b) of the definition of “relevant storage period (E)”, or

(c) any combination of shorter storage periods (T) applicable to the same relevant storage period (T) to exceed, in total, the period specified in paragraph (b) of the definition of “relevant storage period (T)”.

(10) The AHR treatment provider shall—

(a) retain the original of each section 19 consent, section 19 revocation, and section 19 revocation and replacement, given to the provider under this section, and

(b) ensure that a copy of each section 19 consent, section 19 revocation, and section 19 revocation and replacement, is given to the person who effected the section 19 consent, section 19 revocation, or section 19 revocation and replacement, as the case may be.

(11) In this section, “relevant person”, in relation to a person seeking AHR treatment, means, if such person is an intending parent, the other intending parent (if any).

20. Provisions supplementary to section 19 - relevant donation (G)

20. (1) This section applies without prejudice to the generality of section 151.

(2) The specified form of a section 19 consent shall, in the case of a relevant donation (G), require the relevant donor (G) to—

(a) confirm that consent under section 6 of the Act of 2015 has been given by him or her as regards such donation,

(b) specify the AHR treatment for which the relevant donation (G) may be used,

(c) specify that he or she has been given the opportunity to reduce the number of families referred to in section 33(1) in the case of the relevant donation (G) and—

(i) has so reduced that number, or

(ii) has declined that opportunity,

and

(d) subject to subsection (3), state whether or not he or she consents to the relevant donation (G), or an embryo created from such donation, being used—

(i) by an AHR treatment provider, other than the AHR treatment provider to whom such donation is proposed to be made, in providing AHR treatment to a person, or

(ii) by a person who is the equivalent, in another jurisdiction, of an AHR treatment provider (and noting that the law in that other jurisdiction may not be the same as the law in the State on AHR treatment) in providing AHR treatment to a person.

(3) A statement referred to in subsection (2)(d) is only relevant to an embryo referred to in that subsection where the intending parents (or, in the case of a single intending parent, that intending parent) for whom the embryo was created wish (or wishes) to use the embryo to make a relevant donation (E).

21. Provisions supplementary to section 19 - relevant donation (E) and relevant donation (ER)

21. (1) This section applies without prejudice to the generality of section 151.

(2) Subject to subsection (4), the specified form of a section 19 consent shall, in the case of a relevant donation (E), require the relevant donor (E) to—

(a) confirm that consent under section 14 or 16, as appropriate, of the Act of 2015 has been given by him or her as regards such donation,

(b) specify the AHR treatment for which the relevant donation (E) may be used,

(c) specify that he or she has been given the opportunity to reduce the number of families referred to in section 33 in the case of the relevant donation (E) and—

(i) has so reduced that number, or

(ii) has declined that opportunity,

and

(d) state whether or not he or she consents to the relevant donation (E) being used—

(i) by an AHR treatment provider, other than the AHR treatment provider to whom the relevant donation (E) is proposed to be made, in providing AHR treatment to a person, or

(ii) by a person who is the equivalent, in another jurisdiction, of an AHR treatment provider (and noting that the law in that other jurisdiction relating to AHR treatment may not be the same as the law in the State on AHR treatment) in providing AHR treatment to a person.

(3) Subject to subsection (5), the specified form of a section 19 consent shall, in the case of a relevant donation (ER), require the relevant donor (ER) to—

(a) confirm that he or she has received the AHR information document concerned,

(b) specify that he or she has been given the opportunity to select the types of ESC research that the relevant donation (ER) may be used for and—

(i) has so selected the types, or

(ii) has declined that opportunity,

and

(c) state whether or not he or she consents to the relevant donation (ER) being used—

(i) for research in an ESC research facility in the State other than the ESC research facility at which the donation is proposed to be made, or

(ii) for research in a research facility in another jurisdiction (and noting that the law in that jurisdiction relating to ESC research may not be the same as the law in the State relating to ESC research).

(4) (a) Subject to paragraphs (b) and (c), where section 30(1)(b) applies and there is any disagreement between the section 19 consents of the two relevant donors (E), the provisions of those consents the subject of that disagreement shall not, to the extent of that disagreement, be treated as part of those consents.

(b) Subject to paragraph (c), where the disagreement referred to in paragraph (a) relates to subsection (2)(c), the lower of the numbers concerned shall be treated as part of the section 19 consents and the higher of those numbers shall not be treated as part of those consents.

(c) An AHR treatment provider may reject a relevant donation (E) on the ground of there being one or more than one disagreement referred to in paragraph (a).

(5) (a) Subject to paragraph (b), where section 31(b) applies and there is any disagreement between the section 19 consents of the two relevant donors (ER), the provisions of those consents the subject of the disagreement shall not, to the extent of that disagreement, be treated as part of those consents.

(b) An ESC researcher may reject a relevant donation (ER) on the ground of there being one or more than one disagreement referred to in paragraph (a).

22. Provisions supplementary to section 19 - relevant storage (G), relevant storage (E) or relevant storage (T) in case of two intending parents

22. (1) This section applies without prejudice to the generality of section 151.

(2) The specified form of a section 19 consent shall, in the case of two intending parents who as a couple wish to effect a relevant storage (G) of their own gametes, a relevant storage (E) of their own embryos, or a relevant storage (T) of their own tissues, or any combination thereof, for use in their AHR treatment only, require each of the intending parents to separately—

(a) confirm that he or she has received the AHR information document concerned,

(b) subject to sections 40, 41 and 42, specify the maximum period for which the gametes, embryos or tissues, or any combination thereof, may be stored,

(c) specify what should be done with the unused gametes, embryos or tissues, or any combination thereof, if he or she subsequently—

(i) lacks the capacity to make a decision in that regard, or

(ii) dies,

and

(d) specify what should be done with the unused gametes, embryos or tissues, or any combination thereof, in the case of post factum differences of opinion or changes of circumstances.

23. Provisions supplementary to section 19 - PAHR

23. (1) This section applies without prejudice to the generality of section 151.

(2) The specified form of a section 19 consent shall, in the case of PAHR, require the person (D) to—

(a) confirm that he or she has received the AHR information document concerned,

(b) confirm that he or she has received the AHR counselling required under section 18,

(c) consent to his sperm, or an embryo created using his or her gamete, being used, after his or her death, in PAHR involving his or her surviving partner as identified in the consent,

(d) if applicable, consent to the creation, subsequent to his death, of an embryo, for use in the provision of PAHR, using the retrieval and use of his sperm after his death,

(e) specify that he or she understands that he or she shall be a parent of any child born as a result of PAHR, and

(f) specify that he or she has expressed his or her own will and preference in relation to what should be done with any supernumerary gametes or supernumerary embryos that are not used in the provision of PAHR.

(3) The specified form of a section 19 consent shall, in the case of PAHR, require the surviving partner to—

(a) confirm that she has received the AHR information document concerned,

(b) confirm that she has received the AHR counselling required under section 18,

(c) specify that she has consented to PAHR,

(d) specify that she understands that she and the deceased person shall be the parents of any child born as a result of PAHR, and

(e) specify that she has expressed her own will and preference in relation to what should be done with any supernumerary gametes or supernumerary embryos that are not used in the provision of PAHR.

24. Two intending parents and section 19 revocation

24. Where section 22 applies and only one of the intending parents effects a section 19 revocation of the section 19 consent as regards the relevant storage (G), relevant storage (E) or relevant storage (T) concerned—

(a) that revocation shall be treated as a section 19 revocation of the other intending parent’s section 19 consent to such storage, and

(b) the relevant storer (G), relevant storer (E) or relevant storer (T), as appropriate, shall give effect to what was stated in the two section 19 consents as regards the information required by section 22(2)(d).

25. Provisions supplementary to section 19 - surrogacy

25. (1) This section applies without prejudice to the generality of section 151.

(2) The specified form of a section 19 consent shall, in the case of a surrogacy agreement, require the intending parents (or, in the case of a single intending parent, that intending parent) and the surrogate mother to—

(a) confirm that he or she has received the AHR information document concerned,

(b) confirm that he or she has received the AHR counselling required under section 18,

(c) confirm that he or she has received the legal advice required by section 61,

(d) consent to the recording of information required under section 62, and

(e) confirm that he or she understands that a person born as a result of AHR treatment provided pursuant to the surrogacy agreement may, in accordance with the provisions of Part 7—

(i) access the information specified in section 62(1), or

(ii) seek to contact any or all parties to the surrogacy agreement.

(3) The specified form of a section 19 consent shall, in the case of a relevant donation (G) proposed to be used to create an embryo to be transferred pursuant to a surrogacy agreement, require the relevant donor (G) to—

(a) consent to the recording of information required under section 62(1), and

(b) confirm that he or she understands that, under the law of the State—

(i) he or she shall not be a parent of any child born as a result of such use of such donation,

(ii) the information specified in section 62(1) in relation to him or her shall be recorded on the National Surrogacy Register,

(iii) the child, when he or she becomes an adult (AHR), may access the information specified in section 72(2) and seek to contact the donor,

(iv) the information that the donor is entitled to obtain from the National Surrogacy Register is restricted to the information specified in section 70(2),

(v) having regard to the child’s right to know his or her origins, it is desirable that the donor keep updated, in accordance with section 74, the information in relation to him or her that is recorded on the National Surrogacy Register, and

(vi) he or she has the right, in accordance with section 19(4), to revoke, or revoke and replace, such consent.

26. Embryo transfer

26. (1) An AHR treatment provider providing AHR treatment to a woman which involves the transfer of an embryo to that woman, being a woman who has a favourable prognosis for the successful outcome of such transfer in a treatment cycle, shall offer the woman only a single embryo for such transfer during such cycle.

(2) An AHR treatment provider providing AHR treatment to a woman which involves the transfer of an embryo to that woman, being a woman who does not have a favourable prognosis for the successful outcome of such transfer in a treatment cycle, shall not offer the woman more than two embryos for such transfer during such cycle.

PART 3 Gamete and Embryo Donation for use in AHR Treatment and Embryo Donation for use in ESC Research

27. Gamete donation for use in AHR treatment

27. (1) A person may donate his or her gametes to an AHR treatment provider, for use in the provision of AHR treatment, if the person has not attained the specified upper age limit (if any) at the time of such donation.

(2) A person may, before the expiration of the relevant storage period (G), donate his or her supernumerary gametes to an AHR treatment provider, for use in the provision of AHR treatment, where—

(a) the section 19 consent to donate the gametes is given separately from, and subsequent to, the completion of the AHR treatment referred to in the definition of “supernumerary gamete”, and

(b) the person has not attained the specified upper age limit (if any) at the time the gamete concerned was obtained by the provision of AHR treatment to that person.

(3) Where a person has, before the establishment day, given consent under section 6 of the Act of 2015 to the use in a DAHR procedure of a gamete provided by him or her—

(a) the gamete shall, for all purposes, be treated as a donation of a gamete under subsection (1) or (2), as appropriate, and the other provisions of this Act shall, with all necessary modifications, be construed accordingly,

(b) the person shall, for all purposes, be treated as the donor under this section of the gamete, and the other provisions of this Act shall, with all necessary modifications, be construed accordingly, and

(c) that consent shall, for all purposes, be treated as the section 19 consent of the person as to the use of the gamete in the provision of AHR treatment, and the other provisions of this Act shall, with all necessary modifications, be construed accordingly.

28. Provisions supplementary to section 27

28. An AHR treatment provider shall not accept a donation of gametes for use in providing AHR treatment other than a relevant donation (G).

29. Prohibition against donating embryos, etc.

29. (1) A person shall not donate an embryo, other than a supernumerary embryo, to any other person.

(2) Subject to sections 30 and 31, a person shall not donate a supernumerary embryo to any other person.

30. Embryo donation for use in AHR treatment

30. (1) A former intending parent may, before the expiration of the relevant storage period (E), donate his or her supernumerary embryo to an AHR treatment provider, for use in the provision of AHR treatment, where—

(a) the section 19 consent of such parent to donate the supernumerary embryo is obtained separately from, and subsequent to, the completion of the AHR treatment referred to in the definition of “supernumerary embryo”,

(b) such parent is part of a couple of former intending parents, the other former intending parent also gives his or her section 19 consent to the donation separately from, and subsequent to, the completion of the AHR treatment referred to in the definition of “supernumerary embryo”, and

(c) the gametes used to create the embryo were provided by persons who had not attained the specified upper age limit (if any) at the time the gametes concerned were obtained by the provision of AHR treatment to those persons.

(2) Where a person has, before the establishment day, given consent under section 14 or 16 of the Act of 2015 to the use of the embryo concerned in a DAHR procedure or further DAHR procedure—

(a) the embryo shall, for all purposes, be treated as a donation of an embryo under subsection (1), and the other provisions of this Act shall, with all necessary modifications, be construed accordingly,

(b) the person shall, for all purposes, be treated as the donor of the embryo, and the other provisions of this Act shall, with all necessary modifications, be construed accordingly, and

(c) that consent shall, for all purposes, be treated as the section 19 consent of the person as to the use of the embryo in the provision of AHR treatment, and the other provisions of this Act shall, with all necessary modifications, be construed accordingly.

31. Embryo donation for use in ESC research

31. A former intending parent may, before the expiration of the relevant storage period (E), donate his or her supernumerary embryo to an ESC researcher, for use in the undertaking of ESC research, where—

(a) such parent’s section 19 consent to the donation is given separately from, and subsequent to, the completion of the AHR treatment referred to in the definition of “supernumerary embryo”, and

(b) such parent is part of a couple of former intending parents, the other former intending parent also gives his or her section 19 consent to the donation separately from, and subsequent to, the completion of the AHR treatment referred to in the definition of “supernumerary embryo”.

32. Provisions supplementary to sections 30 and 31

32. (1) An AHR treatment provider shall not accept a donation of an embryo for use in the provision of AHR treatment other than a relevant donation (E).

(2) An ESC researcher shall not accept a donation of an embryo for use in the undertaking of ESC research other than a relevant donation (ER).

33. Limits on use of relevant donation (G) and relevant donation (E)

33. (1) (a) Subject to sections 20(2)(c) and 21(2)(c), paragraph (b) and subsection (2), an AHR treatment provider shall not use—

(i) one or more than one relevant donation (G) (including an embryo created from the donation) from the same relevant donor (G) in providing AHR treatment if to do so may result in children being born to more than four families from such donation, or

(ii) one or more than one relevant donation (E) from the same relevant donor (E) in providing AHR treatment if to do so may result in children being born to more than four families from such donation.

(b) Subject to sections 20(2)(c) and 21(2)(c) and subsection (2), where AHR treatment by an AHR treatment provider involves the use of—

(i) one or more than one relevant donation (G) from the same relevant donor (G) who is a man, and

(ii) one or more than one relevant donation (G) from the same relevant donor (G) who is a woman,

the provider shall not use that combination of donations (including an embryo created from such combination) in providing AHR treatment if to do so may result in children being born to more than four families from such combination.

(2) Subsection (1) shall not be construed to prevent an AHR treatment provider from providing AHR treatment to a person for the purpose of producing one or more than one sibling to a child of a family which is one of the four families referred to in subsection (1)(a) or (b).

(3) An AHR treatment provider shall not provide AHR treatment to a person which, as part of the same procedure, involves—

(a) the use of sperm from more than one male,

(b) the use of eggs from more than one female, or

(c) the use of two or more embryos (whether the embryos are created from relevant donations (G) or are relevant donations (E)) where the gametes creating the embryos were not provided by the same persons.

(4) (a) Subject to Part 5, where a relevant donor (G) has died and an AHR treatment provider receives notice in writing of such death, the provider shall not, on and after the receipt of such notice, use the relevant donation (G) (including any embryo created from such donation) in providing AHR treatment.

(b) Subject to Part 5, where a relevant donor (E) has died and an AHR treatment provider receives notice in writing of such death, the provider shall not, on and after the receipt of such notice, use the relevant donation (E) in providing AHR treatment.

34. Prohibited AHR treatment based on genetic grounds

34. (1) An AHR treatment provider shall not use a relevant donation (G) to create an embryo from—

(a) that donation, and

(b) the gamete of a genetic family member of the relevant donor (G) of such donation.

(2) In this section, “genetic family member”, in relation to the family of the relevant donor (G), means a parent, son, daughter, sibling (including half-brother or half sister), grandparent, grandchild, aunt, uncle, nephew or niece of such donor, being a member of such family from his or her birth.

35. Prohibition of commercial relevant donation

35. (1) Subject to subsection (2), a person shall not—

(a) receive or agree to receive any payment or other reward in consideration of the making of a relevant donation,

(b) offer, make or give or agree to offer, make or give any payment or other reward in consideration of the making of a relevant donation, or

(c) receive, make or give or agree to receive, make or give any payment or other reward in consideration of facilitating the making of a relevant donation.

(2) Any reference to payment or other reward in subsection (1) shall not include the reasonable expenses of a relevant donor as construed in accordance with section 36.

(3) In this section—

“relevant donation” means—

(a) a relevant donation (G),

(b) a relevant donation (E), or

(c) a relevant donation (ER);

“relevant donor”, in relation to a relevant donation, means whomsoever of the following who made the donation:

(a) the relevant donor (G);

(b) the relevant donor (E);

(c) the relevant donor (ER).

36. Reasonable expenses of relevant donor

36. (1) A payment or other reward may be made to a relevant donor in order to reimburse the relevant donor for the reasonable expenses incurred by him or her in the making of the relevant donation.

(2) An expense is reasonable under subsection (1) only if—

(a) the expense is actually incurred, and

(b) the amount of the expense can be verified by receipts or other documentation.

(3) In this section—

“reasonable expenses”, in relation to a relevant donor and the relevant donation, means the travel, medical, AHR counselling and legal expenses, and any net loss of income, incurred by the relevant donor in the making of the relevant donation;

“relevant donation” means—

(a) a relevant donation (G),

(b) a relevant donation (E), or

(c) a relevant donation (ER);

“relevant donor”, in relation to a relevant donation, means whomsoever of the following who made the donation:

(a) the relevant donor (G);

(b) the relevant donor (E);

(c) the relevant donor (ER).

37. Screening and evaluation of potential relevant donor (G) or relevant donor (E)

37. (1) The AHR treatment provider shall ensure that the potential relevant donor (G) or relevant donor (E) has undergone the testing required under the Regulations of 2006 before the relevant donation (G) or relevant donation (E), as the case may be, is made.

(2) Where the results of the testing referred to in subsection (1) undergone by the potential relevant donor (G) or relevant donor (E) are that the potential donation (G) or relevant donation (E), as the case may be, does not meet the standards of quality and safety set out by the Regulations of 2006, the AHR treatment provider shall, as soon as is practicable after obtaining those results, give such donor a notice in the specified form refusing to accept such donation.

38. Disclosing medical information about certain persons

38. (1) A registered medical practitioner may make a request in the specified form (in this section referred to as a “section 38 request”) of an AHR treatment provider for the provider to give to the practitioner medical information about a relevant person where, in the opinion of the practitioner, such information is necessary—

(a) to avoid an imminent and serious risk to the health of the relevant person or another person, or

(b) to enable the practitioner to provide medical advice to the relevant person or another person regarding the existence of a genetic or hereditary condition that may be harmful to the relevant person or another person or the children (including future children) of the relevant person or other person.

(2) The AHR treatment provider shall, as soon as is practicable after the provider receives a section 38 request, comply with the request by giving, without identifying the relevant person concerned, such medical information sought by the request as is within the provider’s power, possession or procurement to the registered medical practitioner who made the request.

(3) The consent of the relevant person, or other person referred to in subsection (1)(a) or (b), the subject of a section 38 request is not required for—

(a) the making of the request, or

(b) compliance with the request.

(4) In this section—

“registered medical practitioner” includes a medical practitioner who is the equivalent, in another jurisdiction, of a registered medical practitioner;

“relevant person” means—

(a) a relevant donor (G),

(b) a relevant donor (E),

(c) a child (AHR), or

(d) an adult (AHR).

PART 4 Storage of Gametes, Embryos and Tissues

39. AHR treatment provided to certain children

39. (1) An AHR treatment provider may provide AHR treatment to a child for the purposes of obtaining the child’s gametes for a relevant storage (G) or the child’s tissues for a relevant storage (T) where—

(a) an appropriate medical specialist has stated in the specified form that such child is due to undergo medical treatment which, in the opinion of the specialist—

(i) is likely to cause a significant and irreversible impairment to the child’s fertility, and

(ii) such storage is in the child’s best interests, including, without prejudice to the generality of the foregoing, in respect of having objectively, and in all the circumstances of the case, a reasonable expectation of the child being in a position to use the relevant storage (G) or the relevant storage (T), as the case may be, after the child attains the age of 18 years,

and

(b) the relevant person gives the section 19 consent that would otherwise be required to be given by such child for such storage if the child had attained the age of 18 years at the time of such treatment.

(2) Where a relevant child the subject of a relevant storage (G) or a relevant storage (T) referred to in subsection (1) attains the age of 18 years, the relevant section 19 consent shall, on and after that attainment, be deemed to be the section 19 consent of that child and not the section 19 consent of the relevant person concerned, and the other provisions of this Act shall, with all necessary modifications, be construed accordingly.

(3) Subject to Part 5, where a relevant child the subject of a relevant storage (G) or a relevant storage (T) referred to in subsection (1) dies, the relevant storer (G) or relevant storer (T), as the case may be, shall, as soon as is practicable after the provider receives notice in writing of such death, dispose of such storage.

(4) In this section—

“relevant child” means a child referred to in subsection (1);

“relevant person”, in relation to a relevant child, means the parent or parents, or the guardian or guardians, or any combination thereof, who consented to the medical treatment referred to in subsection (1) that the child will undergo;

“relevant section 19 consent” means the section 19 consent referred to in subsection (1).

40. Disposal of relevant storage (G)

40. (1) (a) Subject to subsections (2) and (3), the relevant storer (G) of a relevant storage (G) shall dispose of such storage as soon as is practicable after—

(i) if applicable, the shorter storage period (G) has elapsed, or

(ii) in any other case—

(I) the period specified for the purposes of this clause in regulations made under paragraph (b) has elapsed, or

(II) where no such period stands so specified, the period of 10 years has elapsed from the date on which such storage was commenced.

(b) Subject to paragraphs (c) and (d), the Minister may make regulations to specify a period for the purposes of clause (I) of subparagraph (ii) of paragraph (a).

(c) Where the Minister makes regulations under paragraph (b), he or she shall, in addition to having regard to the other provisions of this Act, have regard to the following:

(i) the current state of medical evidence as to the viability of the use of gametes in AHR treatment by reference to the length of the period for which the gametes were stored;

(ii) where relevant, the age of the person for whom the gametes were stored for future use in the provision of the AHR treatment to that person;

(iii) where relevant, the ages of the intending parents (or, in the case of a single intending parent, the age of that parent) of any child that may be born as a result of the future use in the provision of AHR treatment of gametes that were stored for such use.

(d) On and after the establishment day, the Minister shall not make regulations under paragraph (b) except after consultation with the AHRRA.

(2) Subject to subsection (8), an eligible person may make an application in the specified form (in this section referred to as a “section 40 application”), before the expiration of the relevant storage period (G) for the relevant storage (G) the subject of the application where such period falls within paragraph (b) of the definition of “relevant storage period (G)”, to the AHRRA for the AHRRA to grant an extension to such period.

(3) Subject to subsection (6), the AHRRA shall determine a section 40 application—

(a) where it is satisfied that, in all the circumstances of the case, there are reasonable grounds for granting the extension sought by the application (or part only of such extension), by notice in writing given to the applicant and the relevant storer (G), granting such extension (or, as the case may be, part only of such extension), or

(b) in any other case, by notice in writing given to the applicant, refusing such extension.

(4) Where the AHRRA under subsection (3)—

(a) grants part only of the extension sought to the relevant storage period (G) for a relevant storage (G), or

(b) refuses to grant any such extension,

it shall, in the notice concerned referred to in that subsection, state its reasons for such partial grant or refusal, as the case may be.

(5) The relevant storer (G) shall, not less than six months before the expiration of the relevant storage period (G) for a relevant storage (G), make reasonable efforts to give a notice in the specified form to an eligible person—

(a) advising such person (and without prejudice to the generality of section 151) of the date on which such period ends, and

(b) to which is attached a statement as to the effect of this section.

(6) (a) Paragraph (b) applies where the AHRRA is minded to determine a section 40 application by—

(i) granting part only of the extension sought to the relevant storage period (G) for the relevant storage (G) the subject of the application, or

(ii) refusing to grant any such extension.

(b) The AHRRA shall give a notice in writing to the applicant stating—

(i) how the AHRRA is minded to determine the application as specified in paragraph (a) and setting out the AHRRA’s reasons why it is so minded, and

(ii) that the applicant may, if the applicant wishes to do so, within the period specified in the notice (being a period reasonable in all the circumstances of the case) provide, in view of those reasons only, supplementary material in the specified form to the AHRRA for the AHRRA’s further consideration before making a determination under subsection (3) following the expiration of that period.

(7) For the avoidance of doubt, it is hereby declared that subsection (6) only applies once to the same section 40 application.

(8) Where a combination of shorter storage periods (G) referred to in section 19(9)(a) applicable to the same relevant storage (G) results in the last shorter storage period (G) of that combination taking the combined periods up to the period specified in paragraph (b) of the definition of “relevant storage period (G)”, subsections (2) to (7) shall, with all necessary modifications, apply to the period the subject of that last shorter storage period (G) as they apply to a period which falls within paragraph (b) of the definition of “relevant storage period (G)”.

(9) (a) Where there has been a failure to make one or more than one payment to the relevant storer (G) of a relevant storage (G) for such storage, the storer may, by notice in writing (and to which is attached a copy of this subsection) given to the person who, under the terms and conditions on which the storage was made, is required to make such payment—

(i) request the person to make the payment, and

(ii) advise the person to read the copy of this subsection attached to the notice as to the consequences of continuing to fail to make the payment.

(b) Subject to paragraph (c), the relevant storer (G) may dispose of the relevant storage concerned where 12 months have elapsed from the date of issue of the notice concerned under paragraph (a) without the payment the subject of the notice having been made.

(c) Where section 39 applies, the relevant storer (G) may not exercise the power under paragraph (b) except with the consent of the AHRRA.

(10) In this section—

“eligible person”, in relation to a relevant storage (G), means—

(a) subject to paragraph (b), the person for whom the gametes the subject of such storage are being stored, or

(b) where section 39 applies and the child whose gametes are the subject of such storage has not attained the age of 18 years, the relevant person (within the meaning of section 39(4)) who gave the section 19 consent concerned referred to in section 39(1);

“extension” includes further extension.

41. Disposal of relevant storage (E)

41. (1) (a) Subject to subsections (2) and (3), the relevant storer (E) of a relevant storage (E) shall dispose of such storage as soon as is practicable after—

(i) if applicable, the shorter storage period (E) has elapsed, or

(ii) in any other case—

(I) the period specified for the purposes of this clause in regulations made under paragraph (b) has elapsed, or

(II) where no such period stands so specified, the period of 10 years has elapsed from the date on which such storage was commenced.

(b) Subject to paragraphs (c) and (d), the Minister may make regulations to specify a period for the purposes of clause (I) of subparagraph (ii) of paragraph (a).

(c) Where the Minister makes regulations under paragraph (b), he or she shall, in addition to having regard to the other provisions of this Act, have regard to the following:

(i) the current state of medical evidence as to the viability of the use of embryos in AHR treatment by reference to the length of the period for which the embryos were stored;

(ii) where relevant, the age of the woman for whom the embryo was stored for future use in the provision of AHR treatment to that woman;

(iii) where relevant, the ages of the intending parents (or, in the case of a single intending parent, the age of that parent) of any child that may be born as a result of the future use in the provision of AHR treatment of embryos that were stored for such use.

(d) On and after the establishment day, the Minister shall not make regulations under paragraph (b) except after consultation with the AHRRA.

(2) Subject to subsection (8), an eligible person may make an application in the specified form (in this section referred to as a “section 41 application”), before the expiration of the relevant storage period (E) for the relevant storage (E) the subject of the application where such period falls within paragraph (b) of the definition of “relevant storage period (E)”, to the AHRRA for the AHRRA to grant an extension to such period.

(3) Subject to subsection (6), the AHRRA shall determine a section 41 application by—

(a) where it is satisfied that, in all the circumstances of the case, there are reasonable grounds for granting the extension sought by the application (or part only of such extension), by notice in writing given to the applicant and the relevant storer (E), granting such extension (or, as the case may be, part only of such extension), or

(b) in any other case, by notice in writing given to the applicant, refusing to grant such extension.

(4) Where the AHRRA under subsection (3)—

(a) grants part only of the extension sought to the relevant storage period (E) for a relevant storage (E), or

(b) refuses to grant any such extension,

it shall, in the notice concerned referred to in that subsection, state its reasons for such partial grant or refusal, as the case may be.