Human Fertilisation and Embryology Act 1990

Principal terms used

Meaning of “embryo”, “gamete” and associated expressions

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• (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 aboutin 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.

The person responsible.

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• (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, orembryos 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, ormight result in, or prolong, hospitalisation or illness, orany 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, andto 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.

Activities governed by the Act

Prohibitions in connection with embryos

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• (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.

Prohibitions in connection with gametes

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• (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”.

The Human Fertilisation and Embryology Authority, its functions and procedure

The Human Fertilisation and Embryology Authority

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• (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.

Accounts and audit

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• (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.

Reports to Secretary of State

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• (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.

General functions of the Authority

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• (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).

Disclosure in interests of justice.

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• (1) The Authority shall maintain one or more committees to discharge the Authority’s functions relating to the grant, variation, suspension and revocation of licences, and a committee discharging those functions is referred to in this Act as a “licence committee”.

• (2) The Authority may provide for the discharge of any of its other functions by committees or by members or employees of the Authority.

• (3) A committee (other than a licence committee) may appoint sub-committees.

• (4) Persons, committees or sub-committees discharging functions of the Authority shall do so in accordance with any general directions of the Authority.

• (5) A licence committee shall consist of such number of persons as may be specified in or determined in accordance with regulations, all being members of the Authority, and shall include at least one person who is not authorised to carry on or participate in any activity under the authority of a licence and would not be so authorised if outstanding applications were granted.

• (6) A committee (other than a licence committee) or a sub-committee may include a minority of persons who are not members of the Authority.

• (7) Subject to subsection (10) below, a licence committee, before considering an application for authority—

• (a) for a person to carry on an activity governed by this Act which he is not then authorised to carry on, or

• (b) for a person to carry on any such activity on premises where he is not then authorised to carry it on,

shall arrange for the premises where the activity is to be carried on to be inspected on its behalf, and for a report on the inspection to be made to it.

• (7A) Before considering such an application, the licence committee may also arrange for—

• (a) any premises that will be relevant third party premises for the purposes of the application to be inspected on its behalf, and

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

• (8) A licence committee shall arrange for any premises to which a licence relates to be inspected on its behalf at intervals not exceeding two years, and for a report on the inspection to be made to it.

• (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (10) A licence committee need not comply with subsection (7) above where the premises in question have been inspected in pursuance of that subsection or subsection (8) above at some time during the period of two years ending with the date of the application, and the licence committee considers that a further inspection is not necessary.

• (10A) A licence committee may arrange for any relevant third party premises to be inspected on its behalf and for a report on the inspection to be made to it.

• (11) An inspection in pursuance of subsection (7), (7A), (8) or (10A) above may be carried out by a person who is not a member of a licence committee.

Licensing procedure

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Scope of licences

Licences for treatment, storage and research

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• (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,