(This note is not part of the Regulations)
M1M2M3These 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 , as well as Commission Directive 2006/17/EC and Commission Directive 2006/86/EC 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.