United Kingdom Statutory Instruments

"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, and

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

(a) the gametes of any other person, or

(b) embryos created outside the woman's body,",

"competent authority", in relation to an EEA state other than the United Kingdom or in relation to Gibraltar, means an authority designated in accordance with the law of that state or territory as responsible for implementing the requirements of the first, second and third Directives,",

"distribution", in relation to gametes or embryos intended for human application, means transportation or delivery, and related terms are to be interpreted accordingly,",

"human application" means use in a human recipient,",

"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,",

"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—

(a) 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—


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

(ii) might result in, or prolong, hospitalisation or illness, or



(b) 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 or embryos, means preserve, whether by cryopreservation or in any other way, and "storage" and "stored" are to be interpreted accordingly,", and<

"traceability" means the ability—

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

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

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

(d) 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,".

(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.

    (2) In this Act—

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

(a) 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

(b) 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.".

(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.".

" (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, or".

(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.".

" (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,", and

(c) at the beginning of paragraph (c) insert "except in relation to the use of gametes in the course of providing basic partner treatment services or non-medical fertility services,".

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

(b) every licence under paragraph 2 of that Schedule, so far as authorising the storage of gametes or embryos 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.".

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

(b) every licence under paragraph 2 of that Schedule, so far as authorising storage of gametes or embryos 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 the United Kingdom from an EEA state other than the United Kingdom or from Gibraltar, 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.".

(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 receives a request from a competent authority in an EEA state other than the United Kingdom or in Gibraltar 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.".

" (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, 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 licence committee 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 or embryos not intended for human application or a licence under paragraph 3 of that Schedule, that the licence committee is satisfied that the qualifications and experience of that individual are such as are required for the supervision of the activities,

(cb) that the licence committee 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.".

" (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.".

" (ba) that any premises which are relevant third party premises in relation to the licence are not suitable for the activities entrusted to the third party by the person who holds the licence,".

(a) between premises to which licences relate,

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

(c) 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 other than the United Kingdom or of Gibraltar which implement the first, second and third Directives, or

(d) between premises referred to in paragraphs (a) and (b) and tissue establishments in a country which is not an EEA state, pursuant to directions given under subsection (4),

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

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

(b) have regard to ensuring traceability.".

(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) In this section, "tissue establishment" has the meaning given by Article 3(o) of the first Directive.".

" (a) the provision for any identifiable individual of treatment services other than basic partner treatment services,",

(b) after paragraph (a) insert—

" (aa) the procurement or distribution, in the course of providing non-medical fertility services for any identifiable individual, of any sperm (other than partner-donated sperm which has not been stored),",

(c) in paragraph (b), omit "or use",

(d) after paragraph (b) insert—

" (ba) the use, otherwise than for the purposes of basic partner treatment services, of gametes of an identifiable individual, or

(bb) the use of an embryo taken from any identifiable woman,", and

(e) for "was, or may have been, born in consequence of treatment services" substitute "is a relevant individual".

(a) treatment services other than basic partner treatment services, or

(b) the procurement or distribution, in the course of providing non-medical fertility services, of any sperm (other than partner-donated sperm which has not been stored).".

(a) every licence under paragraph 1 or 2 of Schedule 2 authorising activities in relation to gametes or embryos intended for use for human application, and

(b) every licence under paragraph 1A of Schedule 2.

    (2) The register shall specify, in relation to each such licence—

(a) the activities authorised,

(b) the address of the premises to which the licence relates,

(c) the name of the person responsible and, if applicable, the nominal licensee, and

(d) any variations made.

" (ba) to a person to whom a third party agreement applies for the purposes of his functions under the third party agreement,".

(i) omit the word "or" at the end of sub-paragraph (i), and

(ii) after sub-paragraph (i) insert—


" (ia) for the purpose of taking appropriate control measures in the event of a serious adverse event or serious adverse reaction, or".

" (ba) uses any gametes in contravention of section 4(1)(b),".

(a) an offence under subsection (2)(ba) or (d) or (3) committed in the course of providing basic partner treatment services or non-medical fertility services, or

(b) an offence under subsection (2A).

    (4B) A person guilty of an offence to which this subsection applies is liable—

(a) on conviction on indictment, to imprisonment for a term not exceeding two years or a fine or both, and

(b) on summary conviction, to imprisonment for a term not exceeding three months or a fine not exceeding the statutory maximum or both.".

(i) for sub-paragraphs (b) and (c) substitute—

" (b) procuring, keeping, testing, processing or distributing embryos,

(c) procuring, testing, processing, distributing or using gametes", and

(ii) at the beginning of sub-paragraph (d) insert "other",

(b) after paragraph 1 insert—

(a) procuring sperm, and

(b) distributing sperm.

    (2) Subject to the provisions of this Act, a licence under this paragraph may be granted subject to such conditions as may be specified in the licence and may authorise the performance of any of the activities referred to in sub-paragraph (1) above in such manner as may be so specified.

    (3) A licence under this paragraph shall be granted for such period not exceeding five years as may be specified in the licence.",

(a) on premises specified in the licence or, in the case of activities to which section 3(1A)(b) or (1B) or 4(1A) applies, on relevant third party premises, and

(b) under the supervision of an individual designated in the licence.

    (1A) A licence which authorises activities falling within paragraph 1 or 1A above may not also authorise activities falling within paragraph 3 above.",

" (d) apply to premises of the person who holds the licence in different places.".

(a) in relation to traceability, compliance with the requirements of Article 8 (traceability) of the first Directive and Article 9 (traceability) of the third Directive, and

(b) in relation to the coding of information, compliance with the requirements of Article 25 (coding of information) of the first Directive and Article 10 (European coding system) of the third Directive.

(a) systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and

(b) accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction,

to be in place as are necessary to secure compliance with the requirements of Article 11 (notification of serious adverse events and reactions) of the first Directive and Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.

(a) donation and procurement procedures, and

(b) the reception of gametes and embryos at the premises to which a licence relates or at relevant third party premises,

licence conditions shall require compliance with the requirements of Article 15(3) (selection, evaluation and procurement) and Article 19(4) to (6) (tissue and cell reception) of the first Directive and with the requirements laid down in the provisions of the second Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.

	Relevant provisions of the second Directive
1. Donation and procurement procedures
Consent and donor identification (record of consent, method of identification, donor interview)	Annex IV, point 1.1
Donor evaluation: other than partner-donated sperm and partner-created embryos and autologous donors (assessment of donor's medical and behavioural information)	Annex IV, point 1.2
Procurement procedures for gametes and embryos (requirements relating to procurement procedures and instruments)	Annex IV, point 1.3
Donor documentation (record of donor and the procurement)	Annex IV, point 1.4
Packaging (requirements as to packaging and shipping containers)	Annex IV, point 1.5
Labelling of the procured gametes and embryos (minimum labelling requirements)	Annex IV, point 1.6
Labelling of the shipping container (minimum labelling requirements)	Annex IV, point 1.7
2. Reception of tissues and cells at the tissue establishment
Verification upon arrival (procedures for verification and requirement for quarantine until verification)	Annex IV, points 2.1 to 2.3
Registration of data (other than in respect of partner-donated sperm and partner-created embryos)	Annex IV, point 2.4
Registration of data (partner-donated sperm and partner-created embryos)	Annex IV, point 2.5

(a) the requirements of Article 20(2) and (3) (tissue and cell processing) and Article 21(2) to (4) of the first Directive, and

(b) the requirements laid down in the provisions of the third Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.

(i) a licence under paragraph 1 of Schedule 2 to the 1990 Act, or

(ii) a licence under paragraph 2 of that Schedule authorising the storage of gametes or embryos intended for human application, and

(b) the person responsible in respect of such licence does not meet the requirement specified in section 16(2)(c)(i) of the 1990 Act, as inserted by regulation 19.