Explanatory note

These Regulations amend the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (“the Principal Regulations”) in order to transpose Commission Implementing Directive 2012/25/EU laying down information procedures for the exchange, between Member States, of human organs intended for transplantation (“the Implementing Directive”).

Regulation 3 inserts a definition of the Implementing Directive into regulation 3 of the Principal Regulations. Regulation 4 amends regulation 6 of the Principal Regulations to enable the Human Tissue Authority (“HTA”) to issue directions made in relation to licences issued under the Principal Regulations to ensure compliance with the Implementing Directive. It also corrects minor drafting errors.

Regulation 5 amends regulation 12 of the Principal Regulations to enable the HTA to issue guidance in relation to the Implementing Directive.

Regulation 6 amends regulation 13 of the Principal Regulations so that the HTA’s duty to establish a framework under that provision includes specifying how their requirements for the quality and safety of organs for transplantation shall be met in compliance with the Implementing Directive. Regulation 7 amends regulation 16 of the Principal Regulations to correct a minor drafting error.

Regulation 8 amends regulation 18 of the Principal Regulations so that where organs are sent to or received from another country, the HTA must ensure compliance with the information procedures in specified Articles of the Implementing Directive.

Regulation 10 amends Schedule 2 to the Principal Regulations so that the HTA is required to issue directions for the purpose of ensuring compliance with specified Articles of the Implementing Directive.

Regulation 11 amends regulation 3 of the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006. This is to correct an error made by regulation 27(a) of the Principal Regulations to ensure that the definition of “organ” in that regulation is consistent with that specified in Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (“Directive 2010/53/EU”). Regulation 9 consequently omits regulation 27(a) of the Principal Regulations.

Regulation 12 amends the Human Tissue Act 2004. It substitutes section 32(3A) of that Act so that the HTA may not make a designation under section 32(3) if doing so could result in the United Kingdom’s breach of Article 12 of Directive 2004/23/EC of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, or Article 13 of Directive 2010/53/EU.

An impact assessment has not been produced for this instrument as no impact on the private or voluntary sectors is foreseen.