Human Reproductive Technology (Licensing) Regulation
(Enacting provision omitted—E.R. 1 of 2022)
[1 August 2007] L.N. 165 of 2007
(Format changes—E.R. 1 of 2022)
(Omitted as spent—E.R. 1 of 2022)
In this Regulation, unless the context otherwise requires—
AIH licence (夫精人工授精牌照) means an artificial insemination by husband licence as described in section 10(1)(a); Children Register (孩子登記冊), in relation to licensed premises, means a register that contains information, if available, on every child born in consequence of a reproductive technology procedure provided in those premises at any time on or after the commencement* of Part 3; Donors Register (捐贈人登記冊), in relation to licensed premises, means a register that contains information on every donor of gametes or embryos stored in those premises at any time on or after the commencement of Part 3; Inspection Committee (視察委員會) means the committee established under section 6(b) of Schedule 1 to the Ordinance; Investigation Committee (調查委員會) means the committee established under section 6(c) of Schedule 1 to the Ordinance; licensed premises (持牌處所) means the premises specified in a licence as the premises in which the relevant activity authorized by the licence may be carried on; live birth event (活產個案) means an event of the birth in Hong Kong of one or more than one live child from one single pregnancy; Patients Register (病人登記冊), in relation to licensed premises, means a register that contains— (a)information on every person who undergoes a reproductive technology procedure in those premises at any time on or after the commencement of Part 3; (b)where the person is a woman, information on the person who was her husband when gametes were, or an embryo was, placed in her body pursuant to that procedure; and (c)where the person is a man, information on the person who was his wife when gametes were obtained from him; research licence (研究牌照) means a research licence as described in section 10(1)(c); storage licence (儲存牌照) means a storage licence as described in section 10(1)(d); treatment licence (治療牌照) means a treatment licence as described in section 10(1)(b).In this Regulation—
a reference to a person to whom a licence applies (however expressed) is to be construed as any one of the persons prescribed in section 24(3) of the Ordinance;
except for the purposes of section 8, a reference to an application for a licence (however expressed) includes an application for the renewal of a licence; and
a reference to the grant of a licence (however expressed) includes the renewal of a licence.
An application for a licence made under section 21 of the Ordinance must be—
in a form specified for that purpose under section 42 of the Ordinance; and
accompanied by a prescribed fee.
An application for variation or revocation of a licence made under section 27(4) of the Ordinance must be accompanied by a prescribed fee.
The Council may do any of the following matters upon receipt of a prescribed fee—
grant a licence under section 23(1)(a) of the Ordinance;
issue an exact copy of a licence for the purposes of section 30 of the Ordinance;
issue a licence in like terms as those contained in a lost, defaced or destroyed licence under section 31 of the Ordinance.
Any premises specified in an application for a licence pursuant to section 21 of the Ordinance must belong to one of the following classes—
a clinic registered under the Medical Clinics Ordinance (Cap. 343);
a private healthcare facility within the meaning of the Private Healthcare Facilities Ordinance (Cap. 633) for which a licence under that Ordinance is in force; (34 of 2018 s. 190 and E.R. 5 of 2018)
a public hospital as defined in section 2(1) of the Hospital Authority Ordinance (Cap. 113);
a private consulting room that is—
used by a registered medical practitioner in the course of his practice; and
not located in premises used for residential purposes;
a medical or research laboratory that is not located in premises used for residential purposes.
For the purposes of section 23(2)(c) of the Ordinance, an individual designated in an application for a licence has the prescribed qualifications if—
he is a registered medical practitioner;
he is a registered nurse within the meaning of the Nurses Registration Ordinance (Cap. 164);
he is a medical laboratory technologist registered under the Medical Laboratory Technologists (Registration and Disciplinary Procedure) Regulations (Cap. 359 sub. leg. A);
he holds a bachelor degree or above in a field of science that is considered by the Council as relevant to human reproductive technology; or
he holds other qualification in the medical, nursing, scientific or management field that is considered by the Council as acceptable for the purposes of supervising the relevant activity specified in the application.
For the purposes of performing its functions under section 6(b) of Schedule 1 to the Ordinance, the Inspection Committee may require an applicant for a licence to—
make arrangements for any authorized person to inspect the premises specified in the application pursuant to section 21 of the Ordinance; and
provide such information, documents, assistance and facilities as are reasonably necessary to enable the Committee to make recommendations to the Council in respect of—
the grant of the licence; or
any condition to which the licence may be subject.
Any requirement contained in, or made pursuant to, section 3, 4 or 6 is a requirement in relation to the granting of the licence for the purposes of section 23(2)(e) of the Ordinance.
Any person may lodge a complaint with the Inspection Committee against an applicant for a licence.
On receiving such a complaint, the Inspection Committee may require the complainant to do all or any of the following—
set out the specific allegations in writing;
provide any further evidence or information about the complaint;
make one or more statutory declarations to support any allegation in the complaint.
The Inspection Committee shall give the applicant under complaint a notice inviting him to submit a written representation in respect of the complaint within 14 days after the date of the notice.
For the purposes of facilitating the determination of an application for a licence, the Inspection Committee shall present to the Council—
the Committee’s recommendations in respect of the application;
any representation submitted under section 8(3); and
any other information or documents that the Council or the Committee considers relevant to the application.
Subject to subsections (2), (3), (4), (5) and (6), the Council may only grant a licence that belongs to one of the following classes—
an artificial insemination by husband licence, which authorizes—
a procedure under which a man’s sperm are introduced into the vagina or uterus of his wife otherwise than by sexual intercourse; and
if necessary for and incidental to such procedure, the storage of sperm used or intended to be used in the procedure;
a treatment licence, which authorizes—
the carrying on of one or more than one type of reproductive technology procedure; and
the storage of gametes or embryos used or intended to be used in such procedure;
a research licence, which authorizes—
the conduct of one project of embryo research; and
the storage of gametes or embryos used or intended to be used in such research;
a storage licence, which authorizes the storage of gametes or embryos used or intended to be used in a reproductive technology procedure or embryo research.
The Council shall not grant a licence in contravention of section 19 of the Ordinance or any regulation made under section 45(1)(c) of the Ordinance.
Every AIH licence is granted subject to—
all general conditions specified in section 11;
all specific conditions specified in section 12; and
any other conditions specified in the licence.
Every treatment licence is granted subject to—
all general conditions specified in section 11;
all specific conditions specified in sections 13 and 15; and
any other conditions specified in the licence.
Every research licence is granted subject to—
all general conditions specified in section 11;
all specific conditions specified in section 14; and
any other conditions specified in the licence.
Every storage licence is granted subject to—
all general conditions specified in section 11;
all specific conditions specified in section 15; and
any other conditions specified in the licence.
For the purposes of section 10(3)(a), (4)(a), (5)(a) and (6)(a), the following are the general conditions specified in relation to every licence—
only the relevant activity specified in the licence may be carried on pursuant to the licence;
any such activity shall not be carried on in contravention of any provision of the Ordinance or any other enactment;
any such activity may be carried on only in the licensed premises and under the supervision of the person responsible;
without prejudice to other conditions applicable to the licence, the proper conduct of any such activity, and the proper discharge of the functions of any person to whom the licence applies, shall at all times be secured, taking account of any relevant provision of the code; (E.R. 1 of 2022)
any such activity may be carried on for a person only if a consent form has been signed in relation to that person in accordance with the code;
the registers and records in relation to any consent or information as required by the code to be obtained and kept shall be properly maintained in, or readily accessible from, the licensed premises;
the licensee shall provide to the Council the information required to be contained in Register A in such form as specified in the code; and
a notice of a change in any information provided in relation to the licence, or the application for the licence, shall be given to the Council within 28 days after the occurrence of the change.
For the purposes of section 10(3)(b), the following are the specific conditions specified in relation to every AIH licence—
any reproductive technology procedure specified in the licence may be provided only to persons who are the parties to a marriage, except where the procedure is continued to be provided to persons who were the parties to a marriage when sperm were placed in the body of the wife pursuant to the procedure;
proper practices and procedures shall be adopted to identify and record—
the identity of each individual who undergoes a reproductive technology procedure in the licensed premises; and
any sperm used at the time of insemination in each case; and
a Patients Register and a Children Register shall be properly kept and maintained in, or readily accessible from, the licensed premises.
For the purposes of section 10(4)(b), the following are the specific conditions specified in relation to every treatment licence—
any reproductive technology procedure specified in the licence may be provided only to persons who are the parties to a marriage, except where the procedure is—
provided to a surrogate mother pursuant to a surrogacy arrangement;
continued to be provided to persons who were the parties to a marriage when gametes were, or an embryo was, placed in the body of a woman pursuant to the procedure; or
for obtaining gametes;
a reproductive technology procedure shall not be provided to a person unless account has been taken of the welfare of any child who may be born in consequence of the procedure;
if any surrogacy arrangement is authorized by the licence—
a reproductive technology procedure may be provided pursuant to such arrangement only if—
the gametes used in the procedure are those of the parties to a marriage; and
the wife in that marriage is unable to carry a pregnancy to term and no other treatment option is practicable for her; and
the arrangement shall be reported to the Council within 3 months after the completion of the procedure for each treatment cycle;
if sex selection is authorized by the licence—
it may be conducted only for the purpose of avoiding a sex-linked genetic disease specified in Schedule 2 to the Ordinance which may prejudice the health of the embryo; and
each case of sex selection achieved through a reproductive technology procedure shall be reported to the Council within 3 months after the procedure has taken place;
prior approval of the Council shall be obtained for carrying on any reproductive technology procedure involving tissue typing in conjunction with preimplantation genetic diagnosis in the licensed premises;
close liaison with—
any donor of gametes or embryos stored in the licensed premises;
any recipient of the donated gametes or embryos and her husband;
if other gametes or embryos of the donor are stored in the licensed premises under another licence, a person to whom that licence applies; and
if other gametes or embryos of the donor are donated in any other premises, the person in charge of those premises,
shall be established for the purpose of ensuring that no more than 3 live birth events are brought about by the gametes or embryos donated by any single donor;
a system shall be established and maintained so as to ensure that proper practices and procedures are adopted and followed in the licensed premises;
proper practices and procedures shall be adopted to identify and record—
the identity of each individual who undergoes a reproductive technology procedure in the licensed premises;
any sperm and egg used in each reproductive technology procedure;
any embryo used in each case and the patient undergoing the reproductive technology procedure at the time of embryo transfer; and
any gamete or embryo involved at the time of cryopreservation and thawing; and
a Patients Register and a Children Register shall be properly kept and maintained in, or readily accessible from, the licensed premises.
For the purposes of section 10(5)(b), the following are the specific conditions specified in relation to every research licence—
a person shall not do any of the following in the licensed premises—
for the purposes of embryo research—
bring about the creation of an embryo; or
combine human and non-human gametes or embryos or any part of them such as to give rise to a 2 cell zygote;
keep or use an embryo after the appearance of the primitive streak;
place any non-human gamete or embryo or any part of it in any human;
place any human gamete or embryo or any part of it in any animal;
replace the nucleus of a cell of an embryo with a nucleus taken from any other cell; or
clone any embryo;
an embryo the creation of which was brought about in vitro may be stored in the licensed premises only if acquired from a person to whom another licence applies or imported in accordance with the code; and
a notice with a copy of the report of the outcome of the research project authorized by the licence attached to it shall be given to the Council within 3 months after the completion of the project.
For the purposes of section 10(4)(b) and (6)(b), the following are the specific conditions specified in relation to every treatment licence or storage licence—
embryos may be stored in the licensed premises only for and on behalf of the parties to a marriage;
in the case of a treatment licence, an embryo the creation of which was brought about in vitro otherwise than pursuant to the licence may be stored in the licensed premises only if acquired from a person to whom another licence applies or imported in accordance with the code;
in the case of a storage licence, an embryo the creation of which was brought about in vitro may be stored in the licensed premises only if acquired from a person to whom another licence applies or imported in accordance with the code;
a person must not be allowed to collect his or her own gametes or embryos from the licensed premises except in circumstances specified in the code; (L.N. 160 of 2025)
except as provided in subsection (3)—
a gamete or embryo donated under an anonymous donation or designated donation must not be stored in the licensed premises beyond the period as provided in subsection (2); and (L.N. 160 of 2025)
the gamete or embryo must, on the expiry of that period, be disposed of or donated in accordance with the terms of the consent form in respect of the gamete or embryo; and (L.N. 160 of 2025)
a Donors Register must be properly kept and maintained in, or readily accessible from, the licensed premises. (L.N. 160 of 2025)
For the purposes of subsection (1)(e), regardless of whether any gamete or embryo has been stored in any premises before or since the commencement* of this section, it must not be stored in the licensed premises beyond the following period starting from the day on which the gamete or embryo begins to be stored— (L.N. 160 of 2025)
in the case of an anonymous donation, the shorter of the following—
10 years; or
the period up to the time when the donated gametes or embryos have brought about 3 live birth events, or such other number of live birth events as specified by the donor, whichever is smaller;
(Repealed L.N. 160 of 2025)
in the case of a designated donation—2 years, except as otherwise provided by the code. (L.N. 160 of 2025)
(Repealed L.N. 160 of 2025)
Subject to subsections (4) and (5), subsection (1)(e) does not apply to any gamete or embryo if—
it has been stored in any premises before the commencement of this section; and
the Council is satisfied that the person responsible under the licence has used his best endeavours but failed to obtain the consent of the person entitled to the gamete or embryo to dispose of it.
If the gametes or embryos donated by any single donor fall within the description in subsection (3) and no proper record is kept of any live birth event brought about by them, those gametes or embryos must not be used in any reproductive technology procedure— (L.N. 160 of 2025)
after they have brought about 3 live birth events since the commencement of this section; or
after the expiry of 2 years from the commencement of this section,
whichever is earlier.
If the gametes or embryos donated by any single donor fall within the description in subsection (3) and proper record is kept of any live birth event brought about by them, but there is no proper record of the day from which they have been stored, those gametes or embryos must not be used in any reproductive technology procedure— (L.N. 160 of 2025)
after they have brought about 3 live birth events, or such other number of live birth events as specified by the donor, whichever is smaller; or
after the expiry of 2 years from the commencement of this section,
whichever is earlier.
In this section—
consent form (同意書), in relation to a gamete or embryo, means the consent form that—is required by the code to be signed by the donor or recipient, or both, (as the case requires) of the gamete or embryo; and
is so signed;
In this Part—
Committee Chairperson (委員會主席) means the Chairperson of the Investigation Committee; complaint (申訴) means a complaint lodged under section 17(1); complaint subject (申訴對象) means a person against whom a complaint is lodged.If the Council renews a licence while a complaint relating to the licence is being dealt with under this Part, the renewal does not—
affect the operation of this Part; or
prevent the renewed licence from being revoked, varied or suspended as a result of the complaint.
Any person may lodge a complaint with the Council against the person responsible under a licence or the licensee.
The Secretary to the Council shall refer a complaint to the Investigation Committee for further processing.
The Committee Chairperson may require the complainant to do all or any of the following—
set out the specific allegations in writing;
provide any further evidence or information about the complaint;
make one or more statutory declarations to support any allegation in the complaint.
Without prejudice to the generality of sections 37 and 38 of the Ordinance, the Committee Chairperson may direct an authorized person to—
enter and inspect any licensed premises under the licence related to the complaint for the purposes of investigating the complaint; and
make a report on the findings for consideration by the Investigation Committee.
If the Investigation Committee, having regard to any recommendation made by the Committee Chairperson and any report made under section 17(4), determines that a complaint is frivolous or groundless and should not proceed further, it shall—
dismiss the complaint; and
give the complainant a notice of the decision with reasons.
Any matter for determination under subsection (1) may be—
considered by the Investigation Committee by the circulation of papers; and
decided by a resolution approved in writing by a majority of the members of the Committee who are for the time being present in Hong Kong.
Unless the Investigation Committee dismisses a complaint under section 18(1), the Committee Chairperson shall fix the date, time and place of a meeting for the Committee to consider the complaint.
The Committee Chairperson shall ensure that the complaint subject is given notice of the following at least 28 days before the date of the meeting—
the receipt of the complaint;
any matter or allegation that may form the basis for the exercise of the Council’s power under section 27(1), (2) or (3) of the Ordinance; and
the date, time and place of the meeting.
The notice must be accompanied by—
a copy of the complaint if it is lodged in writing;
a copy of any statutory declaration made by the complainant;
an invitation to the complaint subject to submit in writing any explanation for any matter or allegation mentioned in subsection (2)(b) or any representations within 14 days after the date of the notice; and
an invitation to the complaint subject to attend the meeting to make oral representations.
If the Committee Chairperson considers that in the circumstances of a particular case, it is desirable not to disclose to the complaint subject the identity of any person contained in any document mentioned in subsection (3)(a) or (b), the Chairperson may arrange for such necessary obliteration or other editorial modification of the document so that the identity of such person will not be disclosed.
The Investigation Committee shall hold any meeting for considering a complaint in private subject to the direction of the Committee Chairperson to permit any person to be present as the Chairperson considers appropriate.
If the Investigation Committee considers that any matter or allegation mentioned in subsection (2)(b) should be amended, it may direct the Secretary to the Investigation Committee to—
make the amendment;
advise the complaint subject of the amendment; and
invite the complaint subject to submit any further explanation or representations.
The Investigation Committee may arrange any such investigation into the complaint to be made and obtain such additional advice or assistance as the Committee considers necessary.
After considering the complaint, the Investigation Committee shall submit a written report on the complaint to the Council setting out—
any matter or allegation that may form the basis for the exercise of the Council’s power under section 27(1), (2) or (3) of the Ordinance;
the representations made by the complaint subject in relation to those allegations;
the findings of the Committee; and
recommendations made by the Committee as to whether the Council should exercise its power under section 27(1), (2) or (3) of the Ordinance and the reasons for making the recommendations.
The Council may refer a complaint back to the Investigation Committee for further investigation if the Council considers necessary.
If the Council decides not to vary or revoke a licence related to a complaint, it shall—
give the complaint subject a notice of the decision; and
give the complainant a notice of the decision with reasons.
If the Council proposes or determines to vary or revoke a licence related to a complaint, it shall act in accordance with section 28 of the Ordinance.
The Council may propose to vary or revoke a licence related to a complaint by a resolution approved in writing by a majority of its members who are for the time being present in Hong Kong.
The Council may make a determination to vary or revoke a licence related to a complaint only at a meeting of the Council by a majority of votes of its members present and voting.
The Secretary to the Council shall publish a notice in the Gazette announcing the Council’s decision to vary or revoke a licence related to a complaint and any condition to which the decision is subject after the decision has taken effect according to section 23(4).
When considering a record of conviction of the person responsible under a licence or the licensee for the purposes of this Part—
the Council shall not be required to inquire into the question as to whether the person responsible or the licensee was properly convicted; and
the Council may consider any record of the case in which such conviction was recorded and any other evidence that may be available and is relevant as showing the nature and gravity of the offence.
The Investigation Committee shall, for the purposes of performing any function delegated to it by the Council pursuant to section 10(1) of the Ordinance in relation to the suspension of a licence related to a complaint, act in accordance with section 29(1) and (2) of the Ordinance, this section and section 22.
Except as provided in subsection (3), any matter for determination by the Investigation Committee under section 29(1) of the Ordinance may be—
considered by the Committee by the circulation of papers; and
decided by a resolution approved in writing by a majority of the members of the Committee who are for the time being present in Hong Kong.
If any member of the Investigation Committee requests a meeting to be held for the purpose of considering any matter for determination under section 29(1) of the Ordinance, the matter may be decided only at a meeting of the Committee by a majority of votes of its members present and voting.
If the Investigation Committee decides that a licence related to a complaint shall be suspended under section 29(1) of the Ordinance, it shall give the person responsible under the licence and the licensee a notice of the following—
the decision of the suspension of the licence with reasons;
the period of the suspension of the licence; and
any conditions that the Committee considers appropriate to impose in relation to the suspension of the licence.
The person responsible under a licence or the licensee who has received a notice under subsection (4) may at any time make a written representation to the Council for the purposes of—
raising his objection to the suspension of the licence; and
setting out any ground on which he seeks a revocation of that notice.
On receipt of any representation made under subsection (5), the Chairperson of the Council shall direct the Secretary to the Council to—
fix the date, time and place for the purpose of determining whether the notice of suspension should be revoked under section 29(4) of the Ordinance; and
invite the person responsible or the licensee concerned to make oral representations at the hearing, whether by himself or by a person acting on his behalf.
If the Investigation Committee decides to renew a notice given under section 21(4) for a further period, it shall give the person responsible under the licence and the licensee a notice of the following—
the decision of the renewal with reasons;
the period of the further suspension of the licence; and
any change to the conditions that the Committee considers appropriate to impose in relation to the suspension of the licence.
Section 21(5) and (6) applies in relation to a notice given under subsection (1) of this section as if it were a notice given under section 21(4).
This section applies to an appeal made against a decision of the Council mentioned in section 41 of the Ordinance to the Administrative Appeals Board (the Board).
If the Board reverses such a decision, the Council shall take the necessary action to give effect to that reversal.
If an appeal is made against a decision of the Council to—
refuse to grant a licence;
grant a licence in respect of part only of the premises or relevant activity specified in the application concerned;
grant a licence subject to conditions;
refuse to vary a licence so as to designate another individual in place of the person responsible;
refuse to vary or revoke a licence on an application by the person responsible or the licensee; or
suspend a licence for a certain period of time,
the appeal does not affect the operation of the decision pending appeal, unless the Council decides otherwise and the notice of the decision contains a statement to that effect.
If the Council makes a decision to vary or revoke a licence otherwise than on an application by the person responsible or the licensee, the decision takes effect—
upon the expiry of the time within which a notice of appeal may be lodged under section 9 of the Administrative Appeals Board Ordinance (Cap. 442); or
in the case of a notice of appeal having in fact been lodged under section 9 of that Ordinance, upon the disposal of the appeal,
unless the Council decides otherwise and the notice of the decision contains a statement to that effect.