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STATUTORY INSTRUMENTS


2006 No. 404 (C. 12)

HUMAN TISSUE, ENGLAND AND WALES

HUMAN TISSUE, NORTHERN IRELAND

The Human Tissue Act 2004 (Commencement No. 4 and Transitional Provisions) Order 2006

  Made 19th February 2006 

The Secretary of State for Health makes the following Order in exercise of the powers conferred upon her by sections 58(3) and 60(2) of the Human Tissue Act 2004[1]. In accordance with sections 58(5) and (6) and 60(3) and (4) of that Act she has consulted the National Assembly for Wales and the relevant Northern Ireland Department before exercising these powers.

Citation and interpretation
     1. —(1) This Order may be cited as the Human Tissue Act 2004 (Commencement No. 4 and Transitional Provisions) Order 2006.

    (2) In this Order—

Appointed Day
    
2. —(1) This article is subject to article 4.

    (2) Section 16(1) and (2)(e)(ii) of the Act, so far as they apply for the purposes set out in paragraph (4), shall come into force on 1st March 2006 for those purposes.

    (3) The provisions of the Act listed in the Schedule to this Order, so far as they apply for the purposes set out in paragraph (4), shall come into force on 1st March 2006 for those purposes.

    (4) The purposes mentioned in paragraphs (2) and (3) are—

     3. —(1) This article is subject to article 4.

    (2) Section 16(1) and (2)(e)(ii) (licence requirement) shall come into force, so far as not already in force, on 7th April 2006.

    (3) The provisions listed in the Schedule:

shall come into force on 7th April 2006.

Partial commencement of section 16(1) and (2)(e)(ii)
     4. —(1) Articles 2 and 3 do not bring into force section 16(1) and (2)(e)(ii) to the extent that those provisions require the authority of a licence for:

    (2) In this article—

Transitional arrangements: deemed licences
    
5. —(1) Where under provisions brought into force by this Order:

a licence shall be deemed to have been granted in relation to that application.

    (2) A licence deemed to have been granted under paragraph (1) shall have effect from 7th April 2006 and shall continue to have effect until either a licence is granted on the application or the application is refused.

    
6. —(1) Subject to paragraphs (2) and (3) the provisions of the Act in force or brought into force by this Order apply to a licence deemed to have been granted under article 5(1) of this Order to the same extent as they would apply to a licence granted under the Act.

    (2) Paragraphs 2(2), 4 and 6 of Schedule 3 to the Act shall not apply in relation to a licence deemed to have been granted under article 5(1) of this Order.

    (3) For the purpose of licences deemed to have been granted under article 5(1) of this Order references in Schedule 3 to:



Signed by authority of the Secretary of State for Health


Rosie Winterton
Minister of State, Department of Health

19th February 2006



SCHEDULE
Articles 2(3) and 3(3)


Table 1
Provisions of the Act coming into force on 1st March 2006 for the purposes of article 2 of this Order and on 7th April 2006 for the purposes of article 3 of this Order
Provision of the Act Subject matter
Section 17 Persons to whom licence applies
Section 18 Duty of the designated individual
Section 19 Right to reconsideration of licensing decision
Section 20 Appeals committee
Section 21 Procedure on reconsideration
Section 22 Appeal on a point of law
Section 23 Conduct of licensed activities
Section 24 Changes of licence circumstances
Section 25 Breach of licence requirement
Section 37 Directions
Section 39 Criminal justice purposes
Section 41 Interpretation of Part 2
Section 44 Surplus tissue
Section 48 Powers of inspection, entry, search and seizure
Section 49 Offences by bodies corporate
Section 50 Prosecutions
Section 51 Offences: Northern Ireland
Section 52 Orders and regulations
Section 53 Relevant material
Section 54 General interpretation
Section 56 Consequential amendments
Section 58(1) and (2) Transition
Schedule 3 Licences for the purpose of section 16
Schedule 5 Powers of inspection, entry, search and seizure
Schedule 6, paragraph 5 Criminal Justice and Police Act 2001



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 1st March 2006 and 7th April 2006, by articles 2 and 3 of the Order respectively.



NOTE AS TO EARLIER COMMENCEMENT ORDERS

(This note is not part of the Order)




Provision Date of Commencement S.I. No.
Section 1(9) (partially) 20 October 2005 2005/2792
Section 1(11) (partially) 20 October 2005 2005/2792
Section 4(10) (partially) 20 October 2005 2005/2792
Section 4(10) (partially) 20 October 2005 2005/2792
Section 6 (partially) 20 October 2005 2005/2792
Section 7(4) 20 October 2005 2005/2792
Section 10(9) 20 October 2005 2005/2792
Section 13 1 April 2005 2005/919
Section 14 1 April 2005 2005/919
Section 15 1 April 2005 2005/919
Section 16(3) and (5) 20 October 2005 2005/2792
Section 16(6) (partially) 20 October 2005 2005/2792
Section 21(5) 20 October 2005 2005/2792
Section 26 1 April 2005 2005/919
Section 27 1 April 2005 2005/919
Section 28 1 April 2005 2005/919
Section 29 1 April 2005 2005/919
Section 32 20 October 2005 2005/2792
Section 33(3) and (4) 20 October 2005 2005/2792
Section 34(1) 20 October 2005 2005/2792
Section 35 1 April 2005 2005/919
Section 36 1 April 2005 2005/919
Section 38 1 April 2005 2005/919
Section 39 (partially) 1 April 2005 2005/919
Section 40 (partially) 1 April 2005 2005/919
Section 41 (partially) 1 April 2005 2005/919
Section 42 1 April 2005 2005/919
Section 45 (partially) 20 October 2005 2005/2792
Section 46 20 October 2005 2005/2792
Section 47 3 October 2005 2005/2632
Section 48 (partially) 20 October 2005 2005/2792
Section 51 (partially) 20 October 2005 2005/2792
Section 52 (partially) 20 October 2005 2005/2792
Section 53 (partially) 1 April 2005 2005/919
Section 54 (partially) 1 April 2005 2005/919
Section 54(10) 20 October 2005 2005/2792
Section 54 (partially) 20 October 2005 2005/2792
Section 55 1 April 2005 2005/919
Section 57 (partially) 20 October 2005 2005/2792
Schedule 1 to the Act 1 April 2005 2005/919
Schedule 2 to the Act 1 April 2005 2005/919
Schedule 3 to the Act, paragraph 10(5) 20 October 2005 2005/2792
Schedule 3 to the Act, paragraph 13(1) 20 October 2005 2005/2792
Schedule 4 to the Act, paragraph 6(2) 20 October 2005 2005/2792
Schedule 4 to the Act, paragraph 10(b) 20 October 2005 2005/2792
Schedule 4 to the Act, paragraph 12(2) 20 October 2005 2005/2792
Schedule 4 to the Act, paragraph 13 20 October 2005 2005/2792
Schedule 5 to the Act, paragraph 4(5) 20 October 2005 2005/2792
Schedule 6 to the Act, paragraph 6 1 April 2005 2005/919
Schedule 7 to the Act, paragraph 1 (partially) 20 October 2005 2005/2792


Notes:

[1] 2004 c.30back

[2] SI 2005/919 Human Tissue Act 2004 (Commencement No.1) 2005 (c.40), SI 2005/2632 Human Tissue Act 2004 (Commencement No. 2) Order 2005 (c.108), SI 2005/2792 Human Tissue Act 2004 (Commencement No. 3 and Transitional Provisions) Order 2005 (c.115)back



ISBN 0 11 074090 4


 © Crown copyright 2006

Prepared 27 February 2006


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URL: http://www.bailii.org/uk/legis/num_reg/2006/20060404.html