Human Fertilisation and Embryology Act 1990

• Citation: 1990 c. 37
• Sections: 199

Section 1 Meaning of “embryo”, “gamete” and associated expressions.

(1) In this Act (except in section 4A or in the term “human admixed embryo”)—

(a) embryo means a live human embryo and does not include a human admixed embryo (as defined by section 4A(6)), and

(b) references to an embryo include an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo.

(2) This Act, so far as it governs bringing about the creation of an embryo, applies only to bringing about the creation of an embryo outside the human body; and in this Act—

(a) references to embryos the creation of which was brought about in vitro (in their application to those where fertilisation or any other process by which an embryo is created is complete) are to those where fertilisation or any other process by which the embryo was created began outside the human body whether or not it was completed there, and

(b) references to embryos taken from a woman do not include embryos whose creation was brought about in vitro .

(3) This Act, so far as it governs the keeping or use of an embryo, applies only to keeping or using an embryo outside the human body.

(4) In this Act (except in section 4A)—

(a) references to eggs are to live human eggs, including cells of the female germ line at any stage of maturity, but (except in subsection (1)(b)) not including eggs that are in the process of fertilisation or are undergoing any other process capable of resulting in an embryo,

(b) references to sperm are to live human sperm, including cells of the male germ line at any stage of maturity, and

(c) references to gametes are to be read accordingly.

(5) For the purposes of this Act, sperm is to be treated as partner-donated sperm if the donor of the sperm and the recipient of the sperm declare that they have an intimate physical relationship.

(6) If it appears to the Secretary of State necessary or desirable to do so in the light of developments in science or medicine, regulations may provide that in this Act (except in section 4A) “embryo”, “eggs”, “sperm” or “ gametes ” includes things specified in the regulations which would not otherwise fall within the definition.

(7) Regulations made by virtue of subsection (6) may not provide for anything containing any nuclear or mitochondrial DNA that is not human to be treated as an embryo or as eggs, sperm or gametes.

Section 1A Reference to Directives

In this Act—

“ the first Directive ” means Directive 2004/23/ EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells,

“ the second Directive ” means Commission Directive 2006/17/ EC of 8 February 2006 implementing Directive 2004/23/ EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, as amended by Commission Directive 2012/39/ EU , ...

“the third Directive” means—

in the application of this Act in relation to Great Britain, Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (“the 2006 Directive”), as it had effect immediately before 29 April 2015 (which is the date on which the amendments made by Commission Directive 2015/565/EU came into force), and

in the application of this Act in relation to Northern Ireland, the 2006 Directive as amended by Commission Directive 2015/565/EU ,

“the fourth Directive” means Commission Directive 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.

Section 2 Other terms.

(1) In this Act—

“ the Authority ” means the Human Fertilisation and Embryology Authority established under section 5 of this Act,

“ basic partner treatment services ” means treatment services that are provided for a woman and a man together without using—

the gametes of any other person, or

embryos created outside the woman's body,

“ competent authority ”, in relation to an EEA state ..., means an authority designated in accordance with the law of that state or territory as responsible for implementing the requirements of the first, second , third and fourth Directives,

“ directions ” means directions under section 23 of this Act,

“ distribution ”, in relation to gametes or embryos intended for human application, means transportation or delivery to any person in or outside the United Kingdom for human application , and related terms are to be interpreted accordingly,

“ human application ” means use in a human recipient,

“ licence ” means a licence under Schedule 2 to this Act and, in relation to a licence, “the person responsible” has the meaning given by section 17 of this Act, and

“ non-medical fertility services ” means any services that are provided, in the course of a business, for the purpose of assisting women to carry children, but are not medical, surgical or obstetric services,

“ nuclear DNA ”, in relation to an embryo, includes DNA in the pronucleus of the embryo,

“ processing ”, in relation to gametes or embryos intended for human application, means any operation involved in their preparation, manipulation or packaging, and related terms are to be interpreted accordingly,

“ procurement ”, in relation to gametes or embryos intended for human application, means any process by which they are made available, and related terms are to be interpreted accordingly,

“ serious adverse event ” means—

any untoward occurrence which may be associated with the procurement, testing, processing, storage or distribution of gametes or embryos intended for human application and which, in relation to a donor of gametes or a person who receives treatment services or non-medical fertility services—

might lead to the transmission of a communicable disease, to death, or life-threatening, disabling or incapacitating conditions, or

might result in, or prolong, hospitalisation or illness, or

any type of gametes or embryo misidentification or mix-up,

“ serious adverse reaction ” means an unintended response, including a communicable disease, in a donor of gametes intended for human application or a person who receives treatment services or non-medical fertility services, which may be associated with the procurement or human application of gametes or embryos and which is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or illness,

“ store ”, in relation to gametes , embryos or human admixed embryos , means preserve, whether by cryopreservation or in any other way, and “storage” and “stored” are to be interpreted accordingly,

“ tissue establishment ” means a tissue bank or a unit of a hospital or another body which procures, tests, processes, preserves, stores or distributes human gametes or embryos,

“ traceability ” means the ability—

to identify and locate gametes and embryos during any step from procurement to use for human application or disposal,

to identify the donor and recipient of particular gametes or embryos,

to identify any person who has carried out any activity in relation to particular gametes or embryos, and

to identify and locate all relevant data relating to products and materials coming into contact with particular gametes or embryos and which can affect their quality or safety,

“ treatment services ” means medical, surgical or obstetric services provided to the public or a section of the public for the purpose of assisting women to carry children.

(2) References in this Act to keeping, in relation to embryos , gametes or human admixed embryos , include keeping while preserved in storage .

(2A) For the purposes of this Act, a person who, from any premises, controls the provision of services for transporting gametes or embryos to any person in or outside the United Kingdom for human application is to be taken to distribute gametes or embryos on those premises.

(2B) Any reference in this Act to a requirement of a provision of the first, second, third or fourth Directive—

(a) in the application of this Act in relation to Great Britain, is to be read as a reference to a requirement which that provision would require to be imposed if the provision formed part of the law of England and Wales or Scotland, and

(b) in the application of this Act in relation to Northern Ireland, is to be read as a reference to a requirement which that provision requires to be imposed.

(3) For the purposes of this Act, a woman is not to be treated as carrying a child until the embryo has become implanted.

Section 2A Third party agreements

(1) For the purposes of this Act, a “third party agreement” is an agreement in writing between a person who holds a licence and another person which is made in accordance with any licence conditions imposed by the Authority for the purpose of securing compliance with the requirements of Article 24 of the first Directive (relations between tissue establishments and third parties) and under which the other person—

(a) procures, tests or processes gametes or embryos (or both), on behalf of the holder of the licence, or

(b) supplies to the holder of the licence any goods or services (including distribution services) which may affect the quality or safety of gametes or embryos.

(1A) For the purposes of subsection (1), as it applies in relation to Great Britain, Article 24 of the first Directive is to be read subject to the modifications set out in paragraph 11A(8) of Schedule 3A.

(2) In this Act—

“ relevant third party premises ”, in relation to a licence, means any premises (other than premises to which the licence relates)—

on which a third party procures, tests, processes or distributes gametes or embryos on behalf of any person in connection with activities carried out by that person under a licence, or

from which a third party provides any goods or services which may affect the quality or safety of gametes or embryos to any person in connection with activities carried out by that person under a licence;

“ third party ” means a person with whom a person who holds a licence has a third party agreement.

(3) References in this Act to the persons to whom a third party agreement applies are to—

(a) the third party,

(b) any person designated in the third party agreement as a person to whom the agreement applies, and

(c) any person acting under the direction of a third party or of any person so designated.

Section 2B Meaning of “importing licensee”, “third country premises” etc

(1) This section applies for the purposes of this Act.

(2) “Importing licensee” means a person—

(a) to whom a licence applies, and

(b) who is authorised by directions under section 24(4) to import qualifying gametes or embryos ... from a third country.

(3) “Qualifying gametes or embryos” means gametes or embryos intended for human application.

(4) “Third country” means—

(a) in relation to the import of qualifying gametes or embryos into, or the export of qualifying gametes or embryos from, Great Britain, a country other than the United Kingdom,

(b) in relation to the import of qualifying gametes or embryos into Northern Ireland, a country other than Northern Ireland or an EEA state, and

(c) in relation to the export of qualifying gametes or embryos from Northern Ireland, a country other than the United Kingdom or an EEA state.

(5) Premises are “third country premises” if—

(a) in relation to Great Britain—

(i) they are in a country other than the United Kingdom, and

(ii) they are premises in or from which a third country supplier, or a person providing services to a third country supplier, procures, tests, processes, stores, distributes or exports qualifying gametes or embryos intended for import into Great Britain, and

(b) in relation to Northern Ireland—

(i) they are in a country other than Northern Ireland or an EEA state, and

(ii) they are premises in or from which a third country supplier, or a person providing services to a third country supplier, procures, tests, processes, stores, distributes or exports qualifying gametes or embryos intended for import into Northern Ireland.

(6) “Third country supplier” means—

(a) in relation to qualifying gametes or embryos intended for import into Great Britain, a person in a country other than the United Kingdom who has an agreement with an importing licensee for exporting such gametes or embryos into Great Britain, and

(b) in relation to qualifying gametes or embryos intended for import into Northern Ireland, a person in a country other than Northern Ireland or an EEA state who has an agreement with an importing licensee for exporting such gametes or embryos into Northern Ireland.

Section 3 Prohibitions in connection with embryos.

(1) No person shall bring about the creation of an embryo except in pursuance of a licence.

(1A) No person shall keep or use an embryo except—

(a) in pursuance of a licence, or

(b) in the case of—

(i) the keeping, without storage, of an embryo intended for human application, or

(ii) the processing, without storage, of such an embryo,

in pursuance of a third party agreement.

(1B) No person shall procure or distribute an embryo intended for human application except in pursuance of a licence or a third party agreement.

(2) No person shall place in a woman—

(a) an embryo other than a permitted embryo (as defined by section 3ZA), or

(b) any gametes other than permitted eggs or permitted sperm (as so defined).

(3) A licence cannot authorise—

(a) keeping or using an embryo after the appearance of the primitive streak,

(b) placing an embryo in any animal, or

(c) keeping or using an embryo in any circumstances in which regulations prohibit its keeping or use, ...

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) For the purposes of subsection (3)(a) above, the primitive streak is to be taken to have appeared in an embryo not later than the end of the period of 14 days beginning with the day on which the process of creating the embryo began , not counting any time during which the embryo is stored.

Section 3A Prohibition in connection with germ cells.

(1) No person shall, for the purpose of providing fertility services for any woman, use female germ cells taken or derived from an embryo or a foetus or use embryos created by using such cells.

(2) In this section—

“ female germ cells ” means cells of the female germ line and includes such cells at any stage of maturity and accordingly includes eggs; and

“ fertility services ” means medical, surgical or obstetric services provided for the purpose of assisting women to carry children.

Section 3ZA Permitted eggs, permitted sperm and permitted embryos

(1) This section has effect for the interpretation of section 3(2).

(2) A permitted egg is one—

(a) which has been produced by or extracted from the ovaries of a woman, and

(b) whose nuclear or mitochondrial DNA has not been altered.

(3) Permitted sperm are sperm—

(a) which have been produced by or extracted from the testes of a man, and

(b) whose nuclear or mitochondrial DNA has not been altered.

(4) An embryo is a permitted embryo if—

(a) it has been created by the fertilisation of a permitted egg by permitted sperm,

(b) no nuclear or mitochondrial DNA of any cell of the embryo has been altered, and

(c) no cell has been added to it other than by division of the embryo's own cells.

(5) Regulations may provide that—

(a) an egg can be a permitted egg, or

(b) an embryo can be a permitted embryo,

even though the egg or embryo has had applied to it in prescribed circumstances a prescribed process designed to prevent the transmission of serious mitochondrial disease.

(6) In this section—

(a) “woman” and “man” include respectively a girl and a boy (from birth), and

(b) “ prescribed ” means prescribed by regulations.

Section 4 Prohibitions in connection with gametes.

(1) No person shall—

(a) store any gametes, or

(b) in the course of providing treatment services for any woman, use—

(i) any sperm, other than partner-donated sperm which has been neither processed nor stored,

(ii) the woman's eggs after processing or storage, or

(iii) the eggs of any other woman, ...

(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

except in pursuance of a licence.

(1A) No person shall procure, test, process or distribute any gametes intended for human application except in pursuance of a licence or a third party agreement.

(2) A licence cannot authorise storing or using gametes in any circumstances in which regulations prohibit their storage or use.

(3) No person shall place sperm and eggs in a woman in any circumstances specified in regulations except in pursuance of a licence.

(4) Regulations made by virtue of subsection (3) above may provide that, in relation to licences only to place sperm and eggs in a woman in such circumstances, sections 12 to 22 of this Act shall have effect with such modifications as may be specified in the regulations.

(5) Activities regulated by this section or section 3 or 4A of this Act are referred to in this Act as “activities governed by this Act”.

Section 4A Prohibitions in connection with genetic material not of human origin

(1) No person shall place in a woman—

(a) a human admixed embryo,

(b) any other embryo that is not a human embryo, or

(c) any gametes other than human gametes.

(2) No person shall—

(a) mix human gametes with animal gametes,

(b) bring about the creation of a human admixed embryo, or

(c) keep or use a human admixed embryo,

except in pursuance of a licence.

(3) A licence cannot authorise keeping or using a human admixed embryo after the earliest of the following—

(a) the appearance of the primitive streak, or

(b) the end of the period of 14 days beginning with the day on which the process of creating the human admixed embryo began, but not counting any time during which the human admixed embryo is stored.

(4) A licence cannot authorise placing a human admixed embryo in an animal.

(5) A licence cannot authorise keeping or using a human admixed embryo in any circumstances in which regulations prohibit its keeping or use.

(6) For the purposes of this Act a human admixed embryo is—

(a) an embryo created by replacing the nucleus of an animal egg or of an animal cell, or two animal pronuclei, with—

(i) two human pronuclei,

(ii) one nucleus of a human gamete or of any other human cell, or

(iii) one human gamete or other human cell,

(b) any other embryo created by using—

(i) human gametes and animal gametes, or

(ii) one human pronucleus and one animal pronucleus,

(c) a human embryo that has been altered by the introduction of any sequence of nuclear or mitochondrial DNA of an animal into one or more cells of the embryo,

(d) a human embryo that has been altered by the introduction of one or more animal cells, or

(e) any embryo not falling within paragraphs (a) to (d) which contains both nuclear or mitochondrial DNA of a human and nuclear or mitochondrial DNA of an animal (“animal DNA ”) but in which the animal DNA is not predominant.

(7) In subsection (6)—

(a) references to animal cells are to cells of an animal or of an animal embryo, and

(b) references to human cells are to cells of a human or of a human embryo.

(8) For the purposes of this section an “animal” is an animal other than man.

(9) In this section “ embryo ” means a live embryo, including an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo.

(10) In this section—

(a) references to eggs are to live eggs, including cells of the female germ line at any stage of maturity, but (except in subsection (9)) not including eggs that are in the process of fertilisation or are undergoing any other process capable of resulting in an embryo, and

(b) references to gametes are to eggs (as so defined) or to live sperm, including cells of the male germ line at any stage of maturity.

(11) If it appears to the Secretary of State necessary or desirable to do so in the light of developments in science or medicine, regulations may—

(a) amend (but not repeal) paragraphs (a) to (e) of subsection (6);

(b) provide that in this section “embryo”, “eggs” or “ gametes ” includes things specified in the regulations which would not otherwise fall within the definition.

(12) Regulations made by virtue of subsection (11)(a) may make any amendment of subsection (7) that appears to the Secretary of State to be appropriate in consequence of any amendment of subsection (6).

Section 5 The Human Fertilisation and Embryology Authority.

(1) There shall be a body corporate called the Human Fertilisation and Embryology Authority.

(2) The Authority shall consist of—

(a) a chairman and deputy chairman, and

(b) such number of other members as the Secretary of State appoints.

(3) Schedule 1 to this Act (which deals with the membership of the Authority, etc. ) shall have effect.

Section 6 Accounts and audit.

(1) The Authority shall keep proper accounts and proper records in relation to the accounts and shall prepare for each accounting year a statement of accounts.

(2) The annual statement of accounts shall comply with any direction given by the Secretary of State, with the approval of the Treasury, as to the information to be contained in the statement, the way in which the information is to be presented or the methods and principles according to which the statement is to be prepared.

(3) Not later than five months after the end of an accounting year, the Authority shall send a copy of the statement of accounts for that year to the Secretary of State and to the Comptroller and Auditor General.

(4) The Comptroller and Auditor General shall examine, certify and report on every statement of accounts received by him under subsection (3) above and shall lay a copy of the statement and of his report before each House of Parliament.

(5) The Secretary of State and the Comptroller and Auditor General may inspect any records relating to the accounts.

(6) In this section “ accounting year ” means the period beginning with the day when the Authority is established and ending with the following 31st March, or any later period of twelve months ending with the 31st March.

Section 7 Reports to Secretary of State.

(1) The Authority shall prepare—

(a) a report for the period beginning with the 1 August preceding the relevant commencement date (or if that date is a 1 August, beginning with that date) and ending with the next 31 March, and

(b) a report for each succeeding period of 12 months ending with 31 March.

(1A) In subsection (1)(a) “ the relevant commencement date ” means the day on which paragraph 3 of Schedule 7 to the Human Fertilisation and Embryology Act 2008 comes into force.

(1B) The Authority shall send each report to the Secretary of State as soon as practicable after the end of the period for which it is prepared.

(2) A report prepared under this section for any period shall deal with the activities of the Authority in the period and the activities the Authority proposes to undertake in the succeeding period of twelve months.

(3) The Secretary of State shall lay before each House of Parliament a copy of every report received by him under this section.

Section 8 General functions of the Authority.

(1) The Authority shall—

(a) keep under review information about embryos and any subsequent development of embryos and about the provision of treatment services and activities governed by this Act, and advise the Secretary of State, if he asks it to do so, about those matters,

(b) publicise the services provided to the public by the Authority or provided in pursuance of licences,

(c) provide, to such extent as it considers appropriate, advice and information for persons to whom licences apply or who are receiving treatment services or providing gametes or embryos for use for the purposes of activities governed by this Act, or may wish to do so, ...

(ca) maintain a statement of the general principles which it considers should be followed—

(i) in the carrying-on of activities governed by this Act, and

(ii) in the carrying-out of its functions in relation to such activities,

(cb) promote, in relation to activities governed by this Act, compliance with—

(i) requirements imposed by or under this Act, and

(ii) the code of practice under section 25 of this Act, and

(d) perform such other functions as may be specified in regulations.

(2) The Authority may, if it thinks fit, charge a fee for any advice provided under subsection (1)(c).

Section 8A Duty of Authority to communicate with competent authorities of EEA states: Northern Ireland

The Authority must, in relation to Northern Ireland, communicate to the competent authorities of EEA states , and to the European Commission, such information in relation to serious adverse events and serious adverse reactions as is necessary for the purpose of enabling appropriate action to be taken, including where necessary the withdrawal from use of gametes and embryos that are intended for human application but are known or suspected to be unsuitable for such application.

Section 8B Agency arrangements and provision of services

(1) Arrangements may be made between the Authority and a government department, a public authority or the holder of a public office (“ the other authority ”) for—

(a) any functions of the Authority to be exercised by, or by members of the staff of, the other authority, or

(b) the provision by the other authority of administrative, professional or technical services to the Authority.

(2) Arrangements under subsection (1)(a) do not affect responsibility for the carrying-out of the Authority's functions.

(3) Subsection (1)(a) does not apply to any function of making subordinate legislation (within the meaning of the Interpretation Act 1978).

Section 8C Contracting out functions of Authority

(1) This section applies to any function of the Authority other than—

(a) any function which, by virtue of any enactment, may be exercised only by members of the Authority,

(b) a function excluded from this section by subsection (2), or

(c) a function excluded from this section by the Secretary of State by order.

(2) A function is excluded from this section if—

(a) it relates to the grant, revocation or variation of any licence,

(b) it is a power or right of entry, search or seizure into or of any property, or

(c) it is a function of making subordinate legislation (within the meaning of the Interpretation Act 1978).

(3) The Authority may make arrangements with any person (“ the authorised person ”) for the exercise by that person, or by the employees of that person, of any function of the Authority to which this section applies.

(4) Any arrangements made by the Authority under this section—

(a) may be revoked at any time by the Authority, and

(b) do not prevent the Authority from exercising any function to which the arrangements relate.

(5) Subject to subsection (6), anything done or omitted to be done by or in relation to the authorised person (or an employee of the authorised person) in, or in connection with, the exercise or purported exercise of any function to which the arrangements relate is to be treated for all purposes as done or omitted to be done by or in relation to the Authority.

(6) Subsection (5) does not apply—

(a) for the purposes of so much of any contract between the authorised person and the Authority as relates to the exercise of the function, or

(b) for the purposes of any criminal proceedings brought in respect of anything done or omitted to be done by the authorised person (or any employee of the authorised person).

(7) Section 38A(2) of this Act (which relates to the keeping of embryos, human admixed embryos and gametes) applies in relation to the authorised person or any employee of the authorised person, when exercising functions of the Authority, as it applies in relation to any member or employee of the Authority exercising functions as member or employee.

Section 8D Disclosure of information where functions of Authority exercised by others

(1) This section applies to—

(a) the Authority,

(b) any public authority or other person exercising functions of the Authority by virtue of section 8B,

(c) any member of staff of any person falling within paragraph (b),

(d) any person exercising functions of the Authority by virtue of section 8C,

(e) an employee of any person falling within paragraph (d), or

(f) any person engaged by the Authority to provide services to the Authority.

(2) No obligation of confidence is to prevent the disclosure of information by a person to whom this section applies to another such person if the disclosure is necessary or expedient for the purposes of the exercise of any function of the Authority.

Section 8E Power to assist other public authorities

(1) The Authority may if it thinks it appropriate to do so provide assistance to any other public authority in the United Kingdom for the purpose of the exercise by that authority of its functions.

(2) Assistance provided by the Authority under this section may be provided on such terms, including terms as to payment, as it thinks fit.

Section 8ZA Duties in relation to carrying out its functions

(1) The Authority must carry out its functions effectively, efficiently and economically.

(2) In carrying out its functions, the Authority must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).

Section 8ZB Duties of the Authority in relation to the Single European Code: Northern Ireland

(1) The Authority in relation to Northern Ireland, must allocate to each holder of a relevant licence, one or more unique numbers as the tissue establishment number or numbers in relation to that licence holder in accordance with Annex VII and paragraph 2(a) of Article 10b of the third Directive.

(2) Any number allocated under subsection (1) must be in the format specified in Annex VII.

(3) In relation to Northern Ireland, the Authority must take steps to enable the information specified in Annex VIII to be recorded in the EU Tissue Establishment Compendium in relation to each holder of a relevant licence.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) The Authority must take the steps mentioned in subsection (3) to enable the information mentioned in that subsection to be recorded before the end of the period of 10 working days beginning with the day on which the person becomes the holder of a relevant licence.

(6) Subsection (7) applies if the Authority becomes aware that any information recorded under subsection (3) was incorrectly recorded or requires updating.

(7) The Authority must take steps to enable the information to be corrected or updated —

(a) in the case of a correction or update which the Authority considers to be a significant change to the information recorded under subsection (3), before the end of the period of 10 working days beginning with the day on which the Authority became aware that the information was incorrectly recorded or required updating;

(b) in any other case, as soon as is reasonably practicable.

(8) Subsection (9) applies if the Authority becomes aware that—

(a) any information recorded in the EU Tissue Establishment Compendium in respect of a tissue establishment in a relevant state was incorrectly recorded or requires updating, or

(b) a tissue establishment in a relevant state has not complied with the requirements of the laws or other measures adopted in that state for the purpose of implementing paragraph 1 of Article 10b of the third Directive and the non-compliance is significant.

(9) The Authority must inform the competent authority in the relevant state in question.

(10) If the Authority becomes aware that the information recorded in the EU Tissue and Cell Product Compendium requires updating, it must inform the European Commission and the competent authority in the relevant state.

(11) In this section—

“Annex VII ” means Annex VII to the third Directive,

“Annex VIII ” means Annex VIII to the third Directive,

“ EU Tissue and Cell Product Compendium” and “ EU Tissue Establishment Compendium” have the same meaning as in Article 2 of the third Directive,

“relevant licence” means a licence granted under any of the following provisions of Schedule 2—

paragraph 1,

paragraph 1A,

paragraph 2, so far as authorising the storage of gametes or embryos intended for human application,

paragraph 3, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application,

“relevant state” means an EEA State,

“working day” means any day other than—

a Saturday or Sunday,

Christmas Day or Good Friday, or

a day which is a bank holiday under the Banking and Financial Dealings Act 1971 in any part of the United Kingdom.

Section 9A Power to delegate and establish committees

(1) The Authority may delegate a function to a committee, to a member or to staff.

(2) The Authority may establish such committees or sub-committees as it thinks fit (whether to advise the Authority or to exercise a function delegated to it by the Authority).

(3) Subject to any provision made by regulations under section 20A (appeals committees), the members of the committees or sub-committees may include persons who are not members of the Authority.

(4) Subsection (1) has effect subject to any enactment requiring a decision to be taken by members of the Authority or by a committee consisting of members of the Authority.

Section 10 Licensing procedure.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 11 Licences for treatment, storage and research.

(1) The Authority may grant the following and no other licences—

(a) licences under paragraph 1 of Schedule 2 to this Act authorising activities in the course of providing treatment services,

(aa) licences under paragraph 1A of that Schedule authorising activities in the course of providing non-medical fertility services,

(b) licences under that Schedule authorising the storage of gametes , embryos or human admixed embryos , and

(c) licences under paragraph 3 of that Schedule authorising activities for the purposes of a project of research.

(2) Paragraph 4 of that Schedule has effect in the case of all licences.

Section 12 General conditions.

(1) The following shall be conditions of every licence granted under this Act—

(a) except to the extent that the activities authorised by the licence fall within paragraph (aa), that those activities shall be carried on only on the premises to which the licence relates and under the supervision of the person responsible,

(aa) that any activities to which section 3(1A)(b) or (1B) or 4(1A) applies shall be carried on only on the premises to which the licence relates or on relevant third party premises,

(b) that any member or employee of the Authority, on production, if so required, of a document identifying the person as such, shall at all reasonable times be permitted to enter those premises and inspect them (which includes inspecting any equipment or records and observing any activity),

(c) except in relation to the use of gametes in the course of providing basic partner treatment services ... , that the provisions of Schedule 3 to this Act shall be complied with,

(d) that proper records shall be maintained in such form as the Authority may specify in directions,

(e) that no money or other benefit shall be given or received in respect of any supply of gametes , embryos or human admixed embryos unless authorised by directions,

(f) that, where gametes , embryos or human admixed embryos are supplied to a person to whom another licence applies, that person shall also be provided with such information as the Authority may specify in directions, and

(g) that the Authority shall be provided, in such form and at such intervals as it may specify in directions, with such copies of or extracts from the records, or such other information, as the directions may specify.

(2) Subsection (3) applies to—

(a) every licence under paragraph 1 or 1A of Schedule 2, ...

(b) every licence under paragraph 2 of that Schedule, so far as authorising the storage of gametes or embryos intended for human application , and

(c) every licence under paragraph 3 of that Schedule, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application.

(3) It shall be a condition of every licence to which this subsection applies that—

(a) such information as is necessary to facilitate the traceability of gametes and embryos, and

(b) any information relating to the quality or safety of gametes or embryos,

shall be recorded and provided to the Authority upon request.

Section 13 Conditions of licences for treatment.

(1) The following shall be conditions of every licence under paragraph 1 of Schedule 2 to this Act.

(2) Such information shall be recorded as the Authority may specify in directions about the following—

(a) the persons for whom services are provided in pursuance of the licence,

(b) the services provided for them,

(c) the persons whose gametes are kept or used for the purposes of services provided in pursuance of the licence or whose gametes have been used in bringing about the creation of embryos so kept or used,

(d) any child appearing to the person responsible to have been born as a result of treatment in pursuance of the licence,

(e) any mixing of egg and sperm and any taking of an embryo from a woman or other acquisition of an embryo, and

(f) such other matters as the Authority may specify in directions.

(3) The records maintained in pursuance of the licence shall include any information recorded in pursuance of subsection (2) above and any consent of a person whose consent is required under Schedule 3 to this Act.

(4) No information shall be removed from any records maintained in pursuance of the licence before the expiry of such period as may be specified in directions for records of the class in question.

(5) A woman shall not be provided with treatment services ... unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting ), and of any other child who may be affected by the birth.

(6) A woman shall not be provided with treatment services of a kind specified in Part 1 of Schedule 3ZA unless she and any man or woman who is to be treated together with her have been given a suitable opportunity to receive proper counselling about the implications of her being provided with treatment services of that kind, and have been provided with such relevant information as is proper.

(6A) A woman shall not be provided with treatment services after the happening of any event falling within any paragraph of Part 2 of Schedule 3ZA unless (before or after the event) she and the intended second parent have been given a suitable opportunity to receive proper counselling about the implications of the woman being provided with treatment services after the happening of that event, and have been provided with such relevant information as is proper.

(6B) The reference in subsection (6A) to the intended second parent is a reference to—

(a) any man as respects whom the agreed fatherhood conditions in section 37 of the Human Fertilisation and Embryology Act 2008 (“ the 2008 Act ”) are for the time being satisfied in relation to treatment provided to the woman mentioned in subsection (6A), and

(b) any woman as respects whom the agreed female parenthood conditions in section 44 of the 2008 Act are for the time being satisfied in relation to treatment provided to the woman mentioned in subsection (6A).

(6C) In the case of treatment services falling within paragraph 1 of Schedule 3ZA (use of gametes of a person not receiving those services) or paragraph 3 of that Schedule (use of embryo taken from a woman not receiving those services), the information provided by virtue of subsection (6) or (6A) must include such information as is proper about—

(a) the importance of informing any resulting child at an early age that the child results from the gametes of a person who is not a parent of the child, and

(b) suitable methods of informing such a child of that fact.

(6D) Where the person responsible receives from a person (“X”) notice under section 37(1)(c) or 44(1)(c) of the 2008 Act of X's withdrawal of consent to X being treated as the parent of any child resulting from the provision of treatment services to a woman (“W”), the person responsible—

(a) must notify W in writing of the receipt of the notice from X, and

(b) no person to whom the licence applies may place an embryo or sperm and eggs in W, or artificially inseminate W, until W has been so notified.

(6E) Where the person responsible receives from a woman (“W”) who has previously given notice under section 37(1)(b) or 44(1)(b) of the 2008 Act that she consents to another person (“X”) being treated as a parent of any child resulting from the provision of treatment services to W—

(a) notice under section 37(1)(c) or 44(1)(c) of the 2008 Act of the withdrawal of W's consent, or

(b) a notice under section 37(1)(b) or 44(1)(b) of the 2008 Act in respect of a person other than X,

the person responsible must take reasonable steps to notify X in writing of the receipt of the notice mentioned in paragraph (a) or (b).

(7) Suitable procedures shall be maintained—

(a) for determining the persons providing gametes or from whom embryos are taken for use in pursuance of the licence, and

(b) for the purpose of securing that consideration is given to the use of practices not requiring the authority of a licence as well as those requiring such authority.

(8) Subsections (9) and (10) apply in determining any of the following—

(a) the persons who are to provide gametes for use in pursuance of the licence in a case where consent is required under paragraph 5 of Schedule 3 for the use in question;

(b) the woman from whom an embryo is to be taken for use in pursuance of the licence, in a case where her consent is required under paragraph 7 of Schedule 3 for the use of the embryo;

(c) which of two or more embryos to place in a woman.

(9) Persons or embryos that are known to have a gene, chromosome or mitochondrion abnormality involving a significant risk that a person with the abnormality will have or develop—

(a) a serious physical or mental disability,

(b) a serious illness, or

(c) any other serious medical condition,

must not be preferred to those that are not known to have such an abnormality.

(10) Embryos that are known to be of a particular sex and to carry a particular risk, compared with embryos of that sex in general, that any resulting child will have or develop—

(a) a gender-related serious physical or mental disability,

(b) a gender-related serious illness, or

(c) any other gender-related serious medical condition,

must not be preferred to those that are not known to carry such a risk.

(11) For the purposes of subsection (10), a physical or mental disability, illness or other medical condition is gender-related if—

(a) it affects only one sex, or

(b) it affects one sex significantly more than the other.

(12) No embryo appropriated for the purpose mentioned in paragraph 1(1)(ca) of Schedule 2 (training in embryological techniques) shall be kept or used for the provision of treatment services.

(13) The person responsible shall comply with any requirement imposed on that person by section 31ZD.

Section 13A Conditions of licences for non-medical fertility services

(1) The following shall be conditions of every licence under paragraph 1A of Schedule 2.

(2) The requirements of section 13(2) to (4) and (7) shall be complied with.

(3) A woman shall not be provided with any non-medical fertility services involving the use of sperm other than partner-donated sperm unless the woman being provided with the services has been given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, and has been provided with such relevant information as is proper.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 14 Conditions of storage licences.

(1) The following shall be conditions of every licence authorising the storage of gametes, embryos or human admixed embryos —

(a) that gametes of a person shall be placed in storage only if—

(i) received from that person,

(ii) acquired in circumstances in which by virtue of paragraph 9 or 10 of Schedule 3 that person's consent to the storage is not required, or

(iii) acquired from a person to whom a licence or third party agreement applies,

(aa) that an embryo taken from a woman shall be placed in storage only if—

(i) received from that woman, or

(ii) acquired from a person to whom a licence or third party agreement applies,

(ab) that an embryo the creation of which has been brought about in vitro otherwise than in pursuance of that licence shall be placed in storage only if acquired from a person to whom a licence or third party agreement applies,

(ac) that a human admixed embryo the creation of which has been brought about in vitro otherwise than in pursuance of that licence shall be placed in storage only if acquired from a person to whom a licence under paragraph 2 or 3 of Schedule 2 applies,

(b) that gametes or embryos which are or have been stored shall not be supplied to a person otherwise than in the course of providing treatment services unless that person is a person to whom a licence applies,

(ba) that human admixed embryos shall not be supplied to a person unless that person is a person to whom a licence applies,

(c) that the requirements of subsection (3) (maximum storage periods) are met,

(ca) that any gametes, embryos or human admixed embryos that have been kept in storage pursuant to the licence must, once they may no longer lawfully be so kept, be removed from storage and disposed of, and

(d) that such information as the Authority may specify in directions as to the persons whose consent is required under Schedule 3 to this Act, the terms of their consent and the circumstances of the storage and as to such other matters as the Authority may specify in directions shall be included in the records maintained in pursuance of the licence.

(2) No information shall be removed from any records maintained in pursuance of such a licence before the expiry of such period as may be specified in directions for records of the class in question.

(3) The requirements referred to in subsection (1)(c) are as follows—

(a) gametes must not be kept in storage for longer than such period not exceeding 55 years beginning with the day on which they are first placed in storage as the licence may specify;

(b) an embryo must not be kept in storage for treatment purposes for longer than such period not exceeding 55 years beginning with the day on which it is first so kept as the licence may specify;

(c) an embryo that is kept in storage for the research or training purpose but not for treatment purposes must not be so kept for longer than such period not exceeding 10 years beginning with the day on which consent was given under Schedule 3 to the storage of the embryo for that purpose as the licence may specify;

(d) a human admixed embryo must not be kept in storage for longer than such period not exceeding 10 years beginning with the day on which it is first placed in storage as the licence may specify.

(4) Where under Schedule 3 consent is given to the storage of an embryo for the training or research purpose by different persons on different days, the reference in subsection (3)(c) to the day on which consent was given is to be taken as a reference to the last of those days.

(5) For the purposes of this section—

(a) “treatment purposes” are purposes referred to in paragraph 2(1)(a) or (b) of Schedule 3;

(b) the “training purpose” is the purpose referred to in paragraph 2(1)(ba) of that Schedule;

(c) the “research purpose” is the purpose referred to in paragraph 2(1)(c) of that Schedule.

Section 14A Conditions of licences: human application

(1) This section applies to—

(a) every licence under paragraph 1 or 1A of Schedule 2, ...

(b) every licence under paragraph 2 of that Schedule, so far as authorising storage of gametes or embryos intended for human application , and

(c) every licence under paragraph 3 of that Schedule, so far as authorising activities in connection with the derivation from embryos of stem cells that are intended for human application.

(2) A licence to which this section applies may not authorise the storage, procurement, testing, processing or distribution of gametes or embryos unless it contains the conditions required by Schedule 3A.

(3) In relation to any gametes or embryos imported into Northern Ireland from an EEA State , compliance with the requirements of the laws or other measures adopted in the relevant state or territory for the purpose of implementing the first, second and third Directives shall be taken to be compliance with the conditions required by Schedule 3A.

(4) Subsection (3) shall not apply to any licence conditions imposed by the Authority which amount to more stringent protective measures for the purposes of Article 4(2) of the first Directive.

Section 15 Conditions of research licences.

(1) The following shall be conditions of every licence under paragraph 3 of Schedule 2 to this Act.

(2) The records maintained in pursuance of the licence shall include such information as the Authority may specify in directions about such matters as the Authority may so specify.

(3) No information shall be removed from any records maintained in pursuance of the licence before the expiry of such period as may be specified in directions for records of the class in question.

(4) No embryo appropriated for the purposes of any project of research shall be kept or used otherwise than for the purposes of such a project.

(5) If by virtue of paragraph 20 of Schedule 3 (existing cells or cell lines) qualifying cells, as defined by paragraph 20(2) of that Schedule, of a person (“P”) are used to bring about the creation in vitro of an embryo or human admixed embryo without P's consent, steps shall be taken to ensure that the embryo or human admixed embryo cannot subsequently be attributed to P.

Section 15A Duties of the Authority in relation to serious adverse events and serious adverse reactions

(1) The Authority shall investigate serious adverse events and serious adverse reactions and take appropriate control measures.

(2) In investigating any serious adverse event or serious adverse reaction, the Authority shall, where it is appropriate to do so, arrange for—

(a) any premises to which a licence relates and any relevant third party premises to be inspected on its behalf, and

(b) a report on the inspection to be made to it.

(3) If the Authority, in relation to Northern Ireland, receives a request from a competent authority in an EEA state to carry out an inspection in relation to a serious adverse event or serious adverse reaction, the Authority must arrange for such an inspection to be carried out, for a report to be made of the inspection and for appropriate control measures to be taken.

Section 15B Inspection of third country premises etc.: Northern Ireland

(1) This section applies where—

(a) qualifying gametes or embryos are imported into Northern Ireland from a third country by an importing licensee,

(b) the gametes or embryos are distributed in an EEA state ... , and

(c) the competent authority in that state ... requests the Authority to carry out any of the following activities—

(i) arranging for an inspection of any third country premises to be carried out on behalf of the Authority,

(ii) arranging for an inspection of any relevant documents held by a third country supplier to be carried out on behalf of the Authority,

(iii) exercising the Authority’s powers under section 18(2) to revoke a licence held by an importing licensee,

(iv) exercising the Authority’s powers under section 18A(3) to vary a licence held by an importing licensee,

(v) exercising the Authority’s powers under section 19C(1) to suspend a licence held by an importing licensee, and

(vi) other appropriate control measures.

(2) The Authority must carry out the activity in question in subsection (1)(c), unless it considers that it would be inappropriate to do so in the particular circumstances of the case.

(3) Before an inspection of any premises is carried out in pursuance of subsection (2), the Authority must—

(a) make arrangements with the competent authority which made the request under subsection (1) for it to participate in the inspection, or

(b) notify the competent authority which made the request under subsection (1) that the Authority has decided that it is not appropriate for it to participate in the inspection and give reasons for that decision.

(4) For the purposes of ascertaining whether qualifying gametes or embryos imported into Northern Ireland from a third country meet standards of quality and safety equivalent to those laid down in this Act, the Authority may arrange for either or both of the following to be to be carried out on its behalf—

(a) an inspection of any third country premises,

(b) an inspection of any relevant documents held by a third country supplier.

(5) The Authority may arrange for a report to be made on any inspection carried out in pursuance of subsection (2) or (4).

(6) Any inspection carried out on behalf of the Authority in pursuance of subsection (2) or (4) must be carried out by a person authorised by the Authority to act for the purposes of this section.

(7) References in this section to carrying out an inspection of any premises include, in particular—

(a) inspecting any equipment found on the premises,

(b) inspecting and taking copies of any relevant documents or records found on the premises, and

(c) observing the carrying on of any activity relevant to ascertaining whether qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act.

(8) In this section, “relevant document” means a document relevant for the purposes of ascertaining whether qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act.

Section 15C Third country premises and third country suppliers: report of inspections etc: Northern Ireland

(1) This section applies in relation to Northern Ireland where the European Commission or a competent authority in an EEA state requests the Authority to provide it with—

(a) a copy of a report or information on any inspection of third country premises or relevant documents carried out in pursuance of section 15B(2) or (5),

(b) information on any exercise of the Authority’s powers under section 18(2), 18A(3) or 19C(1) in relation to a licence held by an importing licensee (whether in pursuance of section 15B(2) or otherwise), or

(c) information on any appropriate control measures carried out by the Authority (whether in pursuance of section 15B(2) or otherwise).

(2) The Authority must provide the report or information in question to the person requesting it, unless the Authority considers that it would be inappropriate to do so in the particular circumstances of the case.

Section 16 Grant of licence.

(1) The Authority may on application grant a licence to any person if the requirements of subsection (2) below are met.

(2) The requirements mentioned in subsection (1) above are—

(a) that the application is for a licence designating an individual as the person under whose supervision the activities to be authorised by the licence are to be carried on,

(b) that either that individual is the applicant or—

(i) the application is made with the consent of that individual, and

(ii) the Authority is satisfied that the applicant is a suitable person to hold a licence,

(c) in relation to a licence under paragraph 1 or 1A of Schedule 2 or a licence under paragraph 2 of that Schedule authorising the storage of gametes or embryos intended for human application or a licence under paragraph 3 of that Schedule authorising activities in connection with the derivation from embryos of stem cells that are intended for human application , that the individual—

(i) possesses a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences, awarded on completion of a university course of study, or other course of study recognised in the United Kingdom as equivalent, or is otherwise considered by the Authority to be suitably qualified on the basis of academic qualifications in the field of nursing, and

(ii) has at least two years' practical experience which is directly relevant to the activity to be authorised by the licence,

(ca) in relation to a licence under paragraph 2 of Schedule 2 authorising storage of gametes , embryos or human admixed embryos not intended for human application or a licence under paragraph 3 of that Schedule authorising activities otherwise than in connection with the derivation from embryos of stem cells that are intended for human application , that the Authority is satisfied that the qualifications and experience of that individual are such as are required for the supervision of the activities,

(cb) that the Authority is satisfied that the character of that individual is such as is required for the supervision of the activities and that the individual will discharge the duty under section 17 of this Act.

(d) that the Authority is satisfied that the premises in respect of which the licence is to be granted and any premises which will be relevant third party premises are suitable for the activities, and

(e) that all the other requirements of this Act in relation to the granting of the licence are satisfied.

(3) The grant of a licence to any person may be by way of renewal of a licence granted to that person, whether on the same or different terms.

(4) Where the Authority is of the opinion that the information provided in the application is insufficient to enable it to determine the application, it need not consider the application until the applicant has provided it with such further information as it may require him to provide.

(5) The Authority shall not grant a licence unless a copy of the conditions to be imposed by the licence has been shown to, and acknowledged in writing by, the applicant and (where different) the person under whose supervision the activities are to be carried on.

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 17 The person responsible.

(1) It shall be the duty of the individual under whose supervision the activities authorised by a licence are carried on (referred to in this Act as the “ person responsible ”) to secure—

(a) that the other persons to whom the licence applies are of such character, and are so qualified by training and experience, as to be suitable persons to participate in the activities authorised by the licence,

(b) that proper equipment is used,

(c) that proper arrangements are made for the keeping of gametes , embryos and human admixed embryos and for the disposal of gametes , embryos or human admixed embryos that have been removed from storage ,

(d) that suitable practices are used in the course of the activities, ...

(e) that the conditions of the licence are complied with,

(f) that conditions of third party agreements relating to the procurement, testing, processing or distribution of gametes or embryos are complied with, and

(g) that the Authority is notified and provided with a report analysing the cause and the ensuing outcome of any serious adverse event or serious adverse reaction.

(2) References in this Act to the persons to whom a licence applies are to—

(a) the person responsible,

(b) any person designated in the licence, or in a notice given to the Authority by the person who holds the licence or the person responsible, as a person to whom the licence applies, and

(c) any person acting under the direction of the person responsible or of any person so designated.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 18 Revocation of licence

(1) The Authority may revoke a licence on application by—

(a) the person responsible, or

(b) the holder of the licence (if different).

(2) The Authority may revoke a licence otherwise than on application under subsection (1) if—

(a) it is satisfied that any information given for the purposes of the application for the licence was in any material respect false or misleading,

(b) it is satisfied that the person responsible has failed to discharge, or is unable because of incapacity to discharge, the duty under section 17,

(c) it is satisfied that the person responsible has failed to comply with directions given in connection with any licence,

(d) it ceases to be satisfied that the premises specified in the licence are suitable for the licensed activity,

(e) it ceases to be satisfied that any premises which are relevant third party premises in relation to a licence are suitable for the activities entrusted to the third party by the person who holds the licence,

(f) it ceases to be satisfied that the holder of the licence is a suitable person to hold the licence,

(g) it ceases to be satisfied that the person responsible is a suitable person to supervise the licensed activity,

(h) the person responsible dies or is convicted of an offence under this Act, ...

(i) it is satisfied that there has been any other material change of circumstances since the licence was granted or

(j) it is not satisfied that any third country premises are suitable for carrying out activities in a manner which secures that qualifying gametes or embryos imported from a third country by the holder of the licence meet standards of quality and safety laid down in this Act.

Section 18A Variation of licence

(1) The Authority may on application by the holder of the licence vary the licence so as to substitute another person for the person responsible if—

(a) the application is made with the consent of that other person, and

(b) the Authority is satisfied that the other person is a suitable person to supervise the licensed activity.

(2) The Authority may vary a licence on application by—

(a) the person responsible, or

(b) the holder of the licence (if different).

(3) The Authority may vary a licence without an application under subsection (2) if it has the power to revoke the licence under section 18(2).

(4) The powers under subsections (2) and (3) do not extend to making the kind of variation mentioned in subsection (1).

(5) The Authority may vary a licence without an application under subsection (2) by—

(a) removing or varying a condition of the licence, or

(b) adding a condition to the licence.

(6) The powers conferred by this section do not extend to the conditions required by sections 12 to 15 of this Act.

Section 19 Procedure in relation to licensing decisions

(1) Before making a decision—

(a) to refuse an application for the grant, revocation or variation of a licence, or

(b) to grant an application for a licence subject to a condition imposed under paragraph 1(2), 1A(2), 2(2) or 3(6) of Schedule 2,

the Authority shall give the applicant notice of the proposed decision and of the reasons for it.

(2) Before making a decision under section 18(2) or 18A(3) or (5) the Authority shall give notice of the proposed decision and of the reasons for it to—

(a) the person responsible, and

(b) the holder of the licence (if different).

(3) Where an application has been made under section 18A(2) to vary a licence, but the Authority considers it appropriate to vary the licence otherwise than in accordance with the application, before so varying the licence the Authority shall give notice of its proposed decision and of the reasons for it to—

(a) the person responsible, and

(b) the holder of the licence (if different).

(4) A person to whom notice is given under subsection (1), (2) or (3) has the right to require the Authority to give him an opportunity to make representations of one of the following kinds about the proposed decision, namely—

(a) oral representations by him, or a person acting on his behalf;

(b) written representations by him.

(5) The right under subsection (4) is exercisable by giving the Authority notice of the exercise of the right before the end of the period of 28 days beginning with the day on which the notice under subsection (1), (2) or (3) was given.

(6) The Authority may by regulations make such additional provision about procedure in relation to the carrying out of functions under sections 18 and 18A and this section as it thinks fit.

Section 19A Notification of licensing decisions

(1) In the case of a decision to grant a licence, the Authority shall give notice of the decision to—

(a) the applicant, and

(b) the person who is to be the person responsible.

(2) In the case of a decision to revoke a licence, the Authority shall give notice of the decision to—

(a) the person responsible, and

(b) the holder of the licence (if different).

(3) In the case of a decision to vary a licence on application under section 18A(1), the Authority shall give notice of the decision to—

(a) the holder of the licence, and

(b) (if different) the person who is to be the person responsible.

(4) In the case of any other decision to vary a licence, the Authority shall give notice of the decision to—

(a) the person responsible, and

(b) the holder of the licence (if different).

(5) In the case of a decision to refuse an application for the grant, revocation or variation of a licence, the Authority shall give notice of the decision to the applicant.

(6) Subject to subsection (7), a notice under subsection (2), (4) or (5) shall include a statement of the reasons for the decision.

(7) In the case of a notice under subsection (2) or (4), the notice is not required to include a statement of the reasons for the decision if the decision is made on an application under section 18(1) or 18A(2).

Section 19B Applications under this Act

(1) Directions may make provision about—

(a) the form and content of applications under this Act, and

(b) the information to be supplied with such an application.

(2) The Secretary of State may by regulations make other provision about applications under this Act.

(3) Such regulations may, in particular, make provision about procedure in relation to the determination of applications under this Act and may, in particular, include—

(a) provision for requiring persons to give evidence or to produce documents;

(b) provision about the admissibility of evidence.

Section 19C Power to suspend licence

(1) Where the Authority—

(a) has reasonable grounds to suspect that there are grounds for revoking a licence, and

(b) is of the opinion that the licence should immediately be suspended,

it may by notice suspend the licence for such period not exceeding three months as may be specified in the notice.

(2) The Authority may continue suspension under subsection (1) by giving a further notice under that subsection.

(3) Notice under subsection (1) shall be given to the person responsible or where the person responsible has died or appears to be unable because of incapacity to discharge the duty under section 17—

(a) to the holder of the licence, or

(b) to some other person to whom the licence applies.

(4) Subject to subsection (5), a licence shall be of no effect while a notice under subsection (1) is in force.

(5) An application may be made under section 18(1) or section 18A(1) or (2) even though a notice under subsection (1) is in force.

Section 20 Right to reconsideration of licensing decisions

(1) If an application for the grant, revocation or variation of a licence is refused, the applicant may require the Authority to reconsider the decision.

(2) Where the Authority decides to vary or revoke a licence, any person to whom notice of the decision was required to be given (other than a person who applied for the variation or revocation) may require the Authority to reconsider the decision.

(3) The right under subsections (1) and (2) is exercisable by giving the Authority notice of exercise of the right before the end of the period of 28 days beginning with the day on which notice of the decision concerned was given under section 19A.

(4) If the Authority decides —

(a) to suspend a licence under section 19C(1), or

(b) to continue the suspension of a licence under section 19C(2),

any person to whom notice of the decision was required to be given may require the Authority to reconsider the decision.

(5) The right under subsection (4) is exercisable by giving the Authority notice of exercise of the right before the end of the period of 14 days beginning with the day on which notice of the decision concerned was given under section 19C.

(6) The giving of any notice to the Authority in accordance with subsection (5) shall not affect the continuation in force of the suspension of the licence in respect of which that notice was given.

(7) Subsections (1), (2) and (4) do not apply to a decision on reconsideration.

Section 20A Appeals committee

(1) The Authority shall maintain one or more committees to carry out its functions in pursuance of notices under section 20.

(2) A committee under subsection (1) is referred to in this Act as an appeals committee.

(3) Regulations shall make provision about the membership and proceedings of appeals committees.

(4) Regulations under subsection (3) may, in particular, provide—

(a) for the membership of an appeals committee to be made up wholly or partly of persons who are not members of the Authority, and

(b) for the appointment of any person to advise an appeals committee on prescribed matters.

(5) For the purposes of subsection (4) “ prescribed ” means prescribed by regulations under subsection (3).

Section 20B Procedure on reconsideration

(1) Reconsideration shall be by way of a fresh decision.

(2) Regulations shall make provision about the procedure in relation to reconsideration.

(3) Regulations under subsection (2) may, in particular, make provision—

(a) entitling a person by whom reconsideration is required, (“ the appellant ”) to require that the appellant or the appellant's representative be given an opportunity to appear before and be heard by the appeals committee dealing with the matter,

(b) entitling the person who made the decision which is the subject of reconsideration to appear at any meeting at which such an opportunity is given, and to be heard in person or by a representative,

(c) requiring the appeals committee dealing with the matter to consider any written representations received from the appellant or the person who made the decision which is the subject of reconsideration,

(d) preventing any person who made the decision which is the subject of reconsideration from sitting as a member of the appeals committee dealing with the matter,

(e) requiring persons to give evidence or to produce documents,

(f) concerning the admissibility of evidence, and

(g) requiring the appellant and any prescribed person to be given notice of the decision on reconsideration and a statement of reasons for the appeals committee's decision.

(4) Regulations under subsection (2) may, in particular, make different provision about the procedure on reconsideration depending upon whether the reconsideration is in pursuance of a notice under section 20(3) or a notice under section 20(5).

(5) Such regulations may, in particular, make provision—

(a) in relation to cases where a person requires reconsideration of a decision to suspend a licence and reconsideration of a decision to continue the suspension of that licence, and

(b) in relation to cases where reconsideration of a decision is required under section 20(2) by only one of two persons by whom it could have been required.

(6) In this section—

(a) “ prescribed ” means prescribed by regulations under subsection (2), and

(b) “ reconsideration ” means reconsideration in pursuance of a notice under section 20.

Section 21 Appeal on a point of law

A person aggrieved by a decision on reconsideration in pursuance of a notice under section 20 may appeal to the High Court or, in Scotland, the Court of Session on a point of law.

Section 22 Temporary suspension of licence.

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Section 23 Directions: general.

(1) The Authority may from time to time give directions for any purpose for which directions may be given under this Act or directions varying or revoking such directions.

(2) A person to whom any requirement contained in directions is applicable shall comply with the requirement.

(3) Anything done by a person in pursuance of directions is to be treated for the purposes of this Act as done in pursuance of a licence.

(4) Where directions are to be given to a particular person, they shall be given by serving notice of the directions on the person.

(5) In any other case, directions may be given—

(a) in respect of any licence (including a licence which has ceased to have effect), by serving notice of the directions on the person—

(i) who is the person responsible or the holder of the licence, if different, or

(ii) who was the person responsible or the holder of the licence, if different,

(b) if the directions appear to the Authority to be general directions or it appears to the Authority that it is not practicable to give notice in pursuance of paragraph (a) above, by publishing the directions in such way as, in the opinion of the Authority, is likely to bring the directions to the attention of the persons to whom they are applicable.

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 24 Directions as to particular matters.

(1) If, in the case of any information about persons for whom treatment services , other than basic partner treatment services, were provided, the person responsible does not know that any child was born following the treatment, the period specified in directions by virtue of section 13(4) of this Act shall not expire less than 50 years after the information was first recorded.

(2) In the case of every licence under paragraph 1 or 1A of Schedule 2 to this Act, directions shall require information to be recorded and given to the Authority about each of the matters referred to in section 13(2)(a) to (e) of this Act.

(3) In relation to gametes or embryos that are not intended for human application, directions may authorise, in such circumstances and subject to such conditions as may be specified in the directions, the keeping, by or on behalf of a person to whom a licence applies, of gametes or embryos in the course of their carriage to or from any premises.

(3A) In relation to gametes and embryos that are intended for human application, directions may authorise the keeping of gametes or embryos by or on behalf of a person to whom a licence applies, in the course of their carriage—

(a) between premises to which licences relate,

(b) between such premises and relevant third party premises,

(c) in relation to Northern Ireland, between premises referred to in paragraphs (a) and (b) and tissue establishments accredited, designated, authorised or licensed under the laws, or other measures, of an EEA state which implement the first, second and third Directives, or

(d) between premises referred to in paragraphs (a) and (b) and tissue establishments in a third country , pursuant to directions given under subsection (4),

in such circumstances and subject to such conditions as may be specified in the directions.

(3B) Directions may authorise, in such circumstances and subject to such conditions as may be specified in the directions, the keeping, by or on behalf of a person to whom a licence applies, of human admixed embryos in the course of their carriage to or from any premises.

(4) Directions may authorise any person to whom a licence applies to—

(a) receive gametes, embryos or human admixed embryos—

(i) from outside the United Kingdom, and

(ii) in respect of Northern Ireland, from Great Britain, or

(b) send gametes, embryos or human admixed embryos outside the United Kingdom,

in such circumstances and subject to such conditions as may be specified in the directions.

(4ZA) Directions made by virtue of subsection (4) may provide for sections 12 to 14 of this Act to have effect with such modifications as may be specified in the directions.

(4A) In giving any directions under subsection (4) authorising any person to whom a licence applies to export from the United Kingdom to a third country , gametes or embryos intended for human application, the Authority shall—

(a) include directions specifying the measures that persons to whom a licence applies shall take to ensure that all such ... exports meet standards of quality and safety equivalent to those laid down in this Act, and

(b) have regard to ensuring traceability.

(4AA) Directions must, in accordance with paragraph 1 of Schedule 3AA, specify requirements with which any person to whom a licence applies who proposes to make qualifying imports (other than a one-off import) must comply before the Authority gives any directions under subsection (4) authorising the person to make qualifying imports.

(4AB) Directions must, in accordance with paragraph 2 of Schedule 3AA, specify requirements with which any person to whom a licence applies who proposes to make a qualifying import which is a one-off import must comply before the Authority gives any directions under subsection (4) authorising the person to make the import.

(4AC) In giving any directions under subsection (4) authorising any person to whom a licence applies to make any qualifying imports, the Authority must include the directions specified in paragraph 3 of Schedule 3AA.

(4AD) Where the Authority gives any directions under subsection (4) authorising any person to whom a licence applies to make any qualifying imports, it must—

(a) in relation to Great Britain, provide that person with a certificate of authority in such form as the Authority considers appropriate; and

(b) in relation to Northern Ireland, provide that person with a certificate in the form set out in Annex II to the fourth Directive.

(4AE) In subsections (4AA) and (4AB) a reference to a one-off import, in relation to gametes or embryos, is to gametes or embryos imported for the purposes of providing services to a particular person or persons on one occasion only.

(4AF) In subsections (4AA) to (4AD) and Schedule 3AA “qualifying import” means the import ... from a third country of gametes or embryos intended for human application.

(4B) Regulations may make provision requiring or authorising the giving of directions in relation to particular matters which are specified in the regulations and relate to activities falling within section 4A(2) (activities involving genetic material of animal origin).

(5A) Directions may make provision for the purpose of dealing with a situation arising in consequence of—

(a) the variation of a licence, or

(b) a licence ceasing to have effect.

(5B) Directions under subsection (5A)(a) may impose requirements—

(a) on the holder of the licence,

(b) on the person who is the person responsible immediately before or immediately after the variation, or

(c) on any other person, if that person consents.

(5C) Directions under subsection (5A)(b) may impose requirements—

(a) on the person who holds the licence immediately before the licence ceases to have effect,

(b) on the person who is the person responsible at that time, or

(c) on any other person, if that person consents.

(5D) Directions under subsection (5A) may, in particular, require anything kept, or information held, in pursuance of the licence to be transferred in accordance with the directions.

(5E) Where a licence has ceased to have effect by reason of the death or dissolution of its holder, anything subsequently done by a person before directions are given under subsection (5A) shall, if the licence would have been authority for doing it, be treated as authorised by a licence.

(11) Where the Authority proposes to give directions specifying any animal for the purposes of paragraph 1(1)(f) or 3(2) of Schedule 2 to this Act, it shall report the proposal to the Secretary of State; and the directions shall not be given until the Secretary of State has laid a copy of the report before each House of Parliament.

(11A) In relation to Great Britain, directions must specify the systems to be adopted for the identification of gametes and embryos intended for human application which the Authority considers appropriate to facilitate traceability.

(12) In relation to Northern Ireland, directions must specify the systems to be adopted for the identification of gametes and embryos intended for human application which the Authority considers appropriate to secure compliance with the requirements of —

(a) paragraph 1 of Article 25 of the first Directive (coding of information),

(b) paragraph 1 of Article 10 of the third Directive (European coding system), subject to any exemption specified in the directions in accordance with paragraph 3 of that Article,

(c) Article 10a of the third Directive (format of the Single European Code), and

(d) paragraph 1(a) to (f) and (h) of Article 10b of the third Directive (requirements related to the application of the Single European Code).

(12A) In relation to Northern Ireland, directions must require information to be provided to the Authority which the Authority considers appropriate to secure compliance with the requirements of paragraph 1(g) of Article 10b of the third Directive (European coding system).

(13) The Authority may give directions as to the information to be provided to it and any measures to be taken by the person responsible in the event of—

(a) any occurrence which may adversely influence the quality or safety of gametes or embryos intended for human application,

(b) any adverse incident which may be linked to the quality or safety of gametes or embryos intended for human application, or

(c) any misidentification or mix-up of gametes or embryos intended for human application.

(14) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 25 Code of practice.

(1) The Authority shall maintain a code of practice giving guidance about the proper conduct of activities carried on in pursuance of a licence under this Act and the proper discharge of the functions of the person responsible and other persons to whom the licence applies.

(2) The guidance given by the code shall include guidance for those providing treatment services about the account to be taken of the welfare of children who may be born as a result of treatment services (including a child’s need for supportive parenting ), and of other children who may be affected by such births.

(2A) The code shall also give guidance about—

(a) the giving of a suitable opportunity to receive proper counselling, and

(b) the provision of such relevant information as is proper,

in accordance with any condition that is by virtue of section 13(6) or (6A) a condition of a licence under paragraph 1 of Schedule 2.

(3) The code may also give guidance about the use of any technique involving the placing of sperm and eggs in a woman.

(4) The Authority may from time to time revise the whole or any part of the code.

(5) The Authority shall publish the code as for the time being in force.

(6) A failure on the part of any person to observe any provision of the code shall not of itself render the person liable to any proceedings, but—

(a) the Authority shall, in considering whether there has been any failure to comply with any conditions of a licence and, in particular, conditions requiring anything to be “proper” or “suitable”, take account of any relevant provision of the code, and

(b) the Authority may, in considering, where it has power to do so, whether or not to vary or revoke a licence, take into account any observance of or failure to observe the provisions of the code.

Section 26 Procedure for approval of code.

(1) The Authority shall send a draft of the proposed first code of practice under section 25 of this Act to the Secretary of State within twelve months of the commencement of section 5 of this Act.

(2) If the Authority proposes to revise the code or, if the Secretary of State does not approve a draft of the proposed first code, to submit a further draft, the Authority shall send a draft of the revised code or, as the case may be, a further draft of the proposed first code to the Secretary of State.

(3) Before preparing any draft, the Authority shall consult such persons as the Secretary of State may require it to consult and such other persons (if any) as it considers appropriate.

(4) If the Secretary of State approves a draft, he shall lay it before Parliament and, if he does not approve it, he shall give reasons to the Authority.

(5) A draft approved by the Secretary of State shall come into force in accordance with directions.