The Human Tissue Act 2004 (Commencement No. 5 and Transitional Provisions) Order 2006

Explanatory Note

(This note is not part of the Order)

This Order provides for the coming into force of provisions of the Human Tissue Act 2004 (c. 30) (“the Act”).

Article 2 provides for the coming into force on 31^st July 2006 of the provisions listed in the Schedule to the extent necessary to enable the Human Tissue Authority (“the Authority”) to deal with applications for licences which will be required under section 16(1) and (2) of the Act from 1^st September 2006.

Article 3 provides, subject to Articles 4 and 7, for the coming into force on 1^st September 2006 of the rest of the provisions of the Act so far as they have not already been brought into force by this Order and previous orders and for the coming into force of sections 5 and 8 of the Act (offences relating to carrying out section 1 activities without consent etc. and the restriction of activities in relation to donated material).

The two main themes of the provisions being brought into force are that after 1^st September 2006 it will be necessary, with some exceptions, to:

(a) obtain consent from a person before it is lawful to remove relevant material or to store or use their body, or relevant material from their body, for the purposes listed in the Schedule 1 to the Act, and

(b) obtain a licence in order to use or store relevant material for the purposes specified in Schedule 1 to the Act.

Other provisions being brought into force also make it an offence not to comply with these requirements and make it an offence in certain circumstances to possess anatomical specimens and former anatomical specimens away from licensed premises (section 30 and 31), to remove transplantable material from a live person or to use such material in certain circumstances (section 33) or to possess bodily material with the intention of performing DNA analysis on it or using the results of such analysis.

Articles 4 to 7 make transitional arrangements.

Article 4 provides that where an application for a licence under section 16 is made on or before 31^st August 2006 then a licence will be deemed to have been granted on that application until the Authority grants or refuses a licence on the application. This does not apply in relation to the types of licence which have been required since 7 April 2006, under provisions of the Act which were brought into force by the previous commencement order.

Article 5 provides that existing requests made under the Anatomy Act 1984 or the corresponding Northern Ireland provisions before 1^st September 2006 are to be treated as appropriate consent for the purpose of the Human Tissue Act.

Article 6 provides that authority given under the Anatomy (Northern Ireland) Order 1992 before 1^st September 2006 in relation to a person who died in the three years before the Act comes into force shall be treated as appropriate consent for the purpose of the Human Tissue Act in certain circumstances.

Article 7 provides that where a registered medical practitioner has referred a matter to the Unrelated Live Transplants Regulatory Authority (“ULTRA”) in accordance with the Human Organ Transplants (Unrelated Persons) Regulations 1989, or the corresponding Northern Ireland legislation, and ULTRA has received it before 1^st September 2006, then certain provisions of the Human Organ Transplant Act and legislation made under that Act, or the corresponding Northern Ireland legislation, will apply to that case and section 33(1) and (2) will not apply.