31.—(1) This regulation applies where—
(a) immediately before the initial commencement date, a person who was before that date using gametes for the purpose of providing basic partner treatment services either—
(i) does not hold a licence under paragraph 1 of Schedule 2 to the 1990 Act, or
(ii) holds a licence under that paragraph which would not authorise the use of gametes for that purpose after the main commencement date, and
(b) before the main commencement date, that person applies for a licence under that paragraph authorising the use of gametes for that purpose, or a variation of a licence that will authorise the use of gametes for that purpose.
(2) In a case to which this regulation applies, section 9(7) (licence committees and other committees) of the 1990 Act (which requires a licence committee to arrange for an inspection of premises where a licensable activity is to be carried out before considering a licence application) shall be read as providing the Authority with power to inspect such premises before granting or varying a licence before the main commencement date, but not as placing a duty on it to do so.
(3) Where, in a case to which this regulation applies—
(a) either—
(i) a licence is granted under paragraph 1 of Schedule 2 to the 1990 Act, or
(ii) a licence granted under paragraph 1 of Schedule 2 to the 1990 Act is varied,
before the main commencement date, and
(b) any premises on which the activities governed by the 1990 Act are carried out were not inspected on behalf of a licence committee before the licence was so granted or varied,
a licence committee shall arrange for such premises to be inspected on its behalf before the end of the period of two years beginning with the day the licence or variation (as the case may be) is granted.
32.—(1) This regulation applies where a person who, before the initial commencement date, was not using gametes for the purpose of providing basic partner treatment services applies, before the main commencement date, for a licence under paragraph 1 of Schedule 2 to the 1990 Act authorising the use of gametes for that purpose.
(2) In a case to which this regulation applies, the Authority may provide for any of its functions relating to the granting of licences which are discharged by a licence committee in accordance with section 9(1) of the 1990 Act, to be discharged prior to the main commencement date by a member of the Authority.
(3) Where, in accordance with paragraph (2), the Authority has provided for any of its functions in relation to the grant of licences to be discharged by a member of the Authority, any such function which has been properly discharged by any such member shall be treated as having been properly discharged by the Authority for the purposes of the 1990 Act.
33.—(1) This regulation applies to any case where—
(a) immediately before the initial commencement date a person was carrying on activities pursuant to—
(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.
(2) That requirement does not prevent the person mentioned in paragraph (1)(a) from continuing to act as the responsible person in relation to—
(a) the activities authorised by the licence, and
(b) where before the initial commencement date persons to whom the licence applies were using gametes for the purpose of providing basic partner treatment services, the continued use of gametes for that purpose if that use is authorised by a variation of the licence taking effect on the main commencement date,
for a period of six months beginning with the main commencement date.
Signed by authority of the Secretary of State for Health
Caroline Flint
Minister of State
Department of Health
24th May 2007
(This note is not part of the Regulations)
These Regulations implement, in relation to gametes and embryos intended for use in a human recipient, 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(5), as well as Commission Directive 2006/17/EC(6) and Commission Directive 2006/86/EC(7) laying down technical requirements in relation to Directive 2004/23/EC (“the Directives”). They do so by amending the Human Fertilisation and Embryology Act 1990 (“the 1990 Act”).
Regulation 2 appoints the Human Fertilisation and Embryology Authority (“the Authority”) as the competent authority in relation to the Directives. Regulations 4 to 7 insert new definitions in sections 1 and 2 of the 1990 Act and inserts a new section 2A (which relates to interpretation).
Regulations 8 and 9 amend sections 3 and 4 (prohibitions in connection with embryos and gametes). The licence requirement in section 4(1)(b) is expanded to include treatment services provided to persons together where there is no third party donor. Sections 3 and 4 have been amended to expressly prohibit the procurement, processing or distribution of any embryo or gametes, and the testing of any gametes, intended for human application except pursuant to either a licence or an agreement with a licence holder which complies with certain requirements of the Directives.
Regulations 10 (which inserts a new section 8A (duty of Authority to communicate with competent authorities of other EEA states)), 18 (which inserts a new section 15A (duties of the Authority in relation to serious adverse events and serious adverse reactions)) and 20 (which amends section 17) impose additional duties on the Authority and the person responsible (in relation to a licence). Regulation 11 amends section 9 of the 1990 Act (licence committees and other committees) to make further provision in relation to the inspection of premises, including premises of third parties.
Regulation 12 amends section 11 of the 1990 Act (licences for treatment, storage and research) to provide for a new licence in relation to non-medical fertility services. Regulation 29 amends Schedule 2 to the 1990 Act (activities for which licences may be granted) by inserting a new paragraph 1A to make provision in relation to such licences.
Regulations 13 to 17 amend sections 12 to 14 of the 1990 Act and insert new sections 13A and 14A (which relate to licence conditions) to make further provision in relation to licence conditions. In particular, licences are to contain conditions required by a new Schedule 3A (supplementary licence conditions: human application) to the 1990 Act (inserted by regulation 30), to secure compliance with requirements of the Directives. Regulation 19 amends section 16 (grant of licence) to require persons responsible in relation to a licence to have minimum qualifications and experience.
Regulation 21 amends section 18 (revocation and variation of licence) of the 1990 Act to permit licence revocations or variations if premises of third parties providing services are not suitable. Regulation 22 amends section 24 (directions as to particular matters) to expand the Authority’s powers of direction. Regulations 23 to 25 amend sections 31 to 33 (which relate to information to be kept by the Authority and disclosure of such information), in particular by inserting new sections 31A and 31B to require the Authority to keep registers of licences and of serious occurrences affecting donors or recipients.
Regulation 26 amends section 39 (powers of members and employees of Authority) of the 1990 Act to extend the Authority’s enforcement powers to cover third party premises and serious occurrences. Regulation 27 amends section 41 (offences) to provide for maximum penalties for the new offences created by the amendments to sections 3 and 4 of the 1990 Act.
Regulations 31 to 33 make transitory provision in relation to licences under the 1990 Act.
A Regulatory Impact Assessment and a Transposition Note have been prepared for these Regulations and a copy of each has been placed in the library of each House of Parliament. Copies of the Regulatory Impact Assessment and the Transposition Note can be obtained from the Assisted Reproduction Team, Department of Health, Room 609, Wellington House, 133-155 Waterloo Road, London SE1 8UG.