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

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—

“the Act” means the Human Tissue Act 2004.

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—

(a) to enable the Authority to grant or refuse licences;

(b) to require that applications for licences are accompanied by such fee as the Authority shall determine in accordance with paragraph 13(2) of Schedule 3 to the Act;

(c) to enable the Authority to impose conditions on licences;

(d) to enable the Authority to vary, revoke or suspend licences;

(e) to enable the Authority to give directions under sections 23 and 24 of the Act and under paragraph 2(4) of Schedule 3 to the Act;

(f) to require the Authority to give notice of its decisions in accordance with paragraphs 10 and 11 of Schedule 3 to the Act;

(g) to enable a person to whom notice is given in accordance with paragraph 10 of Schedule 3 to the Act to require the Authority to give him an opportunity to make representations in accordance with that paragraph;

(h) to enable applicants to require the Authority to reconsider decisions to revoke or vary licences;

(i) to enable the Authority to reconsider decisions to revoke or vary licences;

(j) to enable persons aggrieved by a decision on reconsideration to appeal on a point of law to the High Court.

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:

(a) so far as not already in force, and

(b) so far as relevant to section 16 as brought into force by this Order or to provisions of the Act brought into force by previous Orders(1),

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:

(a) storage of relevant material for 48 hours or less,

(b) storage of relevant material for scheduled purposes other than transplantation,

(c) storage of relevant material for the purpose of organ transplantation.

(2) In this article—

“organ” means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy; and

“organ transplantation” means transplantation of:

(a)

a whole organ to function as such in the recipient, or

(b)

a part of an organ if it is to function for the same purpose as the whole organ in the recipient.

Transitional arrangements: deemed licences

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

(a) a licence is required for storage of relevant material,

(b) an application for such a licence is received by the Authority by 31st March 2006, and

(c) the application is accompanied by the appropriate fee as determined under paragraph 13(2) of Schedule 3 to the Act,

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:

(a) the premises specified in the licence shall mean the premises specified in the application form to which the licence relates;

(b) the individual designated in the licence shall mean the person specified in the application form to which the licence relates as the proposed designated individual.

Signed by authority of the Secretary of State for Health

Rosie Winterton

Minister of State,

Department of Health

19th February 2006