Explanatory note

These Regulations are made under Sections 19(6) and 45(3) and (3A) of the Human Fertilisation and Embryology Act 1990 (as amended by the Human Fertilisation and Embryology Act 2008).

The Regulations set out set out the procedure to be followed when a person wishes to make representations against certain decisions made by the Human Fertilisation and Embryology Authority.

Part 1 deals with preliminary matters, including commencement and interpretation (regulations 1 and 2).

Part 2 sets out the procedure for consideration of representations.

Regulation 3 provides that representations are to be considered by a Licence Committee of the Human Fertilisation Authority. This regulations sets out details of the quorum and voting procedure to be followed by the Committee, and provides for the Committee to be assisted by advisers and a secretary. This regulation further specifies the roles of the advisers and of the secretary.

Regulation 4 specifies the information and documents to be provided to the Authority at the same time that the person wishing to make representations serves the notice of exercise of right that is required by the Act.

Regulation 5 sets out the actions that need to be taken by the respective parties after service of the notice of exercise of right, and the required time limits for such actions. Regulation 6 sets out the information that must be contained in a notice of hearing (including information relating to the right to be represented and the procedure to be followed at a hearing) that is to be served on the person wishing to make representations, where that person has requested that a hearing be held.

Regulation 7 makes provision for case management meetings to be held, in order to ensure that hearings proceed smoothly and that effective use of time is made at the hearing. Regulation 8 provides for multiple representations to be considered by the same committee, where the committee are satisfied that it is fair and appropriate to do so.

Regulation 9 sets out detailed requirements relating to the evidence that the committee can consider. Regulation 10 provides for a power to summons witnesses (other than the person making representations) and to require production of documents. Regulation 11 sets out the burden and standard of proof to be considered by the committee.

Regulation 12 and 13 set out the respective procedures to be followed by the committee when it is considering representations on the papers, and when it is considering representations at a hearing.

Regulation 14 makes provision for representation and the entitlement of the person making representations to be heard before the committee and regulation 15 makes provision for witness evidence. Regulations 16-19 deal with administrative matters such as adjournments, format of decision notices, transcripts of hearings, and a requirement for the committee to provide an annual report of its activities to the Human Fertilisation and Embryology Authority.