Explanatory note

These Regulations amend the Human Fertilisation and Embryology Act 1990 (“the 1990 Act”) to implement Directive 2015/565 (“the coding Directive”) of the European Commission, laying down technical requirements for the coding of tissues and cells and Directive 2015/566 (“the fourth Directive”) of the European Commission, setting out procedures for verifying standards of quality and safety of imported tissues and cells. These Regulations apply in relation to gametes and embryos intended for use in human application.

Regulation 2 appoints the Human Fertilisation and Embryology Authority (“the Authority”) as the competent authority in relation to the fourth Directive.

Regulations 3 to 5 amend the 1990 Act. Regulation 3 amends definitions. Regulation 3(2) amends section 1A to ensure that all references in the 1990 Act to the “third Directive” include amendments made to that Directive by the coding Directive. It also amends that section to incorporate the definition of the fourth Directive. Regulation 3(3) clarifies the meaning of “distribution”. Regulation 3(4) inserts new section 2B to define “importing licensee”, “qualifying gametes or embryos”, “third country”, “third country premises” and “third country supplier” for the purposes of that Act.

Regulation 4(1) inserts new section 8ZB which requires the Authority to take steps to ensure compliance with requirements imposed by the coding Directive relating to the application of a Single European Code (“SEC”) to gametes and embryos intended for human application. Regulation 4(2) amends section 24(12) to require the Authority to issue directions to licence holders requiring the application of the SEC to gametes and embryos intended for human application and regulation 4(3) inserts new subsection (12A) requiring the Authority to issue directions relating to information licence holders must provide relating to the SEC. Regulation 4(5) amends paragraph 1 of Schedule 3A to remove the requirement for conditions relating to coding since the requirements relating to application of the new SEC will be conveyed in directions to licence holders issued by the Authority. Regulation 4(6) omits paragraph 2 of Schedule 3A which is no longer required.

Regulation 5 makes amendments relating to the import of gametes and embryos. Regulation 5(2) inserts new section 15B to allow the Authority to carry out inspections of third country premises or documents held by a third country supplier, or to take control measures in relation to importing licensees, where appropriate, following a request from another competent authority in whose country the gametes or embryos have been distributed. Provision is made for the Authority to agree how it will participate in any inspection or to give reasons for refusing to allow such participation.

Regulation 5(2) also inserts new section 15C to make provision requiring the Authority to provide where it is appropriate, a report or information on any inspection of third country premises or documents held by a third country supplier or information on any appropriate control measures carried out following a request from the European Commission or another competent authority.

Regulation 5(3) amends section 18 to add to the list of grounds upon which the Authority may revoke a licence otherwise than on application, to include where the Authority is not satisfied that third country premises are suitable for carrying out activities in a manner which will meet standards of safety and quality laid out in the Act.

Regulation 5(4) amends section 24. This section relates to directions to import and inserts new subsections (4AA) to (4AD), the detail of which is set out in new Schedule 3AA which reflects the requirements of the fourth Directive. Subsection (4AA) and paragraph 1 of Schedule 3AA require the Authority to ensure that certain conditions in the fourth Directive are met before issuing any directions enabling a licence holder to import gametes or embryos for human application from a third country. Subsection (4AB) together with paragraph 2 of Schedule 3AA set out the requirements which must be satisfied before directions can be given authorising a one-off import of such gametes or embryos from a third country. Subsection (4AC) together with paragraph 3 of Schedule 3AA sets out further requirements which must be specified in directions authorising the import of gametes or embryos from a third country. Subsection (4AD) provides that when authorising a licence holder to import gametes or embryos from a third country, the Authority must provide that licence holder with the certificate set out in Annex II to the fourth Directive.

Regulation 5(5) amends section 47 to update the index. Regulation 5(6) inserts Schedule 3AA.

Regulation 5(8) and (9) amend Schedule 3B to allow the Authority to carry out where appropriate an inspection of relevant documents held by an importing licensee and premises where any activity governed by this Act is carried out in relation to gametes or embryos imported from a third country and intended for human application. Regulation 5(12) makes provision requiring the Authority to provide a report or information as appropriate on inspections of documents or premises which the Authority has carried out under Schedule 3B.

Regulation 6 makes transitional provision. Regulation 6(1) makes provision to the effect that existing licences to which section 14A of the 1990 Act applies will be deemed from the commencement date to be subject to the revised conditions in Schedule 3A.

Regulation 6(2) and (3) provide that, where gametes or embryos are in storage on 29th October 2016 and are transported or delivered to any person in or outside the United Kingdom within 5 years of that date, the licence holder will be exempted from applying the requirements of the Single European Code. Regulation 6(4) and (5) provide that where gametes or embryos were in storage on 29th October 2016 and are transported or delivered to any person on or after 30th October 2021, the procedures in the coding Directive which relating to gametes or embryos with small labels will apply. Similarly, these procedure apply to gametes or embryos which were placed in storage after 29th October 2016 but which are in storage on the commencement date, irrespective of when they are transported or delivered.

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 Health Ethics Team (Assisted Reproduction and Embryology), Department of Health, 6^th Floor, 39 Victoria Street, London SW1H 0EU.