The Human Tissue (Quality and Safety for Human Application) Regulations 2007

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement in part 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”). These Regulations impose safety and quality requirements in relation to human tissue and cells intended for human application, including stem cells and cell lines grown outside the body. These Regulations do not apply to reproductive cells, embryos outside the human body, organs and blood.

These Regulations extend to the whole of the United Kingdom, except Part 6 which does not extend to Scotland.

Regulation 3 appoints the Human Tissue Authority (“the Authority”) as the competent authority for the purposes of the Directives.

Regulation 7 prohibits the storage of tissue or cells, which are intended to be applied in or on a human, otherwise than under a licence granted under Schedule 1 to these Regulations. It also prohibits the procurement, testing, processing, distribution, import or export of such tissue or cells otherwise than under a licence, or under an agreement with a licence holder which complies with certain requirements of the Directives. Regulation 11 makes it an offence to breach such prohibition and provides for maximum penalties. Schedule 1 provides for the grant of licences and regulation 8 applies a number of provisions of the Human Tissue Act 2004 (“the 2004 Act”) to such licences, including the procedures to be followed in respect of an application for a licence and powers to impose fees. These provisions, as well as other relevant provisions of the 2004 Act (regulation 9), are extended to Scotland in so far as they relate to the activities covered by these Regulations. Regulation 7(4) provides power for the Authority to authorise any person to distribute, import or export tissue or cells directly from where procurement takes place for immediate transplantation to humans.

Regulation 11 imposes preconditions to the grant of licences. Regulation 12 imposes a duty on the individual designated under a licence with responsibility for supervising the licensed activities to ensure that only suitable persons participate in carrying-on the activities, that suitable practices are used in doing so, and that the conditions of the licence and of agreements with third parties in relation to such activities are complied with.

Regulation 13 imposes restrictions on the disclosure of information obtained under the Regulations. Regulation 14 makes it an offence to breach such restrictions and imposes maximum penalties.

Regulations 15 and 16 make provision in relation to the giving of directions by the Authority in relation to the import or export of tissue or cells and in relation to the carrying-on of licensed activities. In particular, licence holders are required to comply with directions given by the Authority in accordance with Schedule 2 to the Regulations for the purpose of securing compliance with the requirements of the Directives.

Regulations 17 to 20 impose obligations on the Authority, including requirements to keep registers of licences and of serious occurrences affecting donors and recipients of tissue or cells, and to notify other EEA states of such occurrences.

Regulations 21 to 29 and Schedule 3 provide for enforcement and related matters, including powers of inspection. Regulations 30 to 33 make consequential amendments to the Human Tissue Act 2004.

Regulation 34 provides that an officer of a body corporate, or a partner in a Scottish partnership, commits an offence when it is proved that such body or partnership committed an offence under these Regulations with the consent or connivance of that officer or partner, or it was attributable to neglect on his part.

Regulation 35 makes transitional provision in relation to licences under the 2004 Act which authorised the storage of material (other than blood) which has come from a human body for use for transplantation. Such licences shall also be treated as licences under Schedule 1 to these Regulations on the commencement date (5 July 2007).

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 Organ and Tissue Transplantation Team, Department of Health, Room 611, 6th floor North, Wellington House, 133-155 Waterloo Road, London SE1 8UG.