The Human Tissue Act 2004 (Commencement No. 4 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 1st March 2006 of section 16(1) and (2)(e)(ii) and 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)(e)(ii) of the Act from 7th April 2006.

Article 3 provides for the coming into force on 7th April 2006 of section 16(1) and (2)(e)(ii). Under these provisions a licence is required for the storage of human tissue for the purposes specified in Schedule 1 to the Act.

Article 3 also provides for the coming into force on that date of the provisions listed in the Schedule, to the extent that they are relevant to section 16 as brought into force by this Order or to other provisions of the Act which are already in force. In particular, section 48 and paragraphs 3 to 9 of Schedule 5 to the Act (powers of inspection, entry, search and seizure), section 50 (prosecutions), section 51 (offences: Northern Ireland) and section 58(1) and (2) (transition) are relevant to section 32 (prohibition of commercial dealings in human material for transplantation) of the Act which was brought into force by Human Tissue Act 2004 (Commencement No. 3 and Transitional Provisions) Order 2005 SI 2005/2792.

Article 4 of the Order has the effect that storage for 48 hours or less, for purposes other than transplantation, or for the purpose of organ transplantation will not be subject to licensing from 7th April 2006. The definition of the term organ is taken from Directive 2002/98/EC Setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC.

Articles 5 and 6 make transitional arrangements.

Article 5 provides that where an application for a licence under section 16, as brought into force by this Order, is made by 31st March 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.

Article 6 provides that the provisions of the Act will apply to licences deemed to have been granted, under article 5, to the same extent as they apply to licences granted under the Act.

Schedule 1 lists the provisions which are brought into force on 1^st March 2006 and 7th April 2006, by articles 2 and 3 of the Order respectively.