Office of Public Sector Information

PART 6 AMENDMENTS TO THE 2004 ACT

Remit of the Authority

30.—(1) Section 14 (remit) of the 2004 Act is amended as follows.

(2) At the end of subsection (1) insert—

“(h) the procurement, processing, preservation, testing, storage, distribution, import or export of tissue or cells, in so far as those activities are activities to which regulation 7(1) or (2) of the 2007 Regulations applies and are not within the remit of the Authority by virtue of paragraphs (a) to (g).”.

(3) After subsection (2) insert—

“(2A) Expressions used in paragraph (h) of subsection (1) and in the 2007 Regulations have the same meaning in that paragraph as in those Regulations; and the reference to activities to which regulation 7(1) or (2) of those Regulations applies is to be read subject to regulation 2(3) of those Regulations.”.

Exclusion from licensing requirement of section 16

31.—(1) Section 16 of the 2004 Act is amended as follows.

(2) After subsection (2), insert—

“(2A) This section does not apply to the procurement, testing, processing, preservation, storage, distribution, import or export of tissue and cells intended for human application in so far as those activities are activities to which regulation 7(1) or (2) of the 2007 Regulations applies.

(2B) Expressions used in subsection (2A) and in the 2007 Regulations have the same meaning in that subsection as in those Regulations; and the reference to activities to which regulation 7(1) or (2) of those Regulations applies is to be read subject to regulation 2(3) of those Regulations.”.

Interpretation of Part 2 of the 2004 Act

32.  In section 41 (interpretation of Part 2) of the 2004 Act, before the definition of “anatomical specimen” insert—

““the 2007 Regulations” means the Human Tissue (Quality and Safety for Human Application) Regulations 2007;”.

Applications under Schedule 3 to the 2004 Act

33.  In paragraph 13(1) of Schedule 3 to the 2004 Act, after “Schedule”, insert “and Schedule 1 to the 2007 Regulations”.

PART 7 GENERAL

Offences by bodies corporate

34.—(1) Where an offence under these Regulations is committed by a body corporate and is proved to have been committed with the consent or connivance of or to be attributable to any neglect on the part of—

(a) any director, manager, secretary or other similar officer of the body corporate, or

(b) any person who was purporting to act in any such capacity,

he (as well as the body corporate) commits the offence and shall be liable to be proceeded against and punished accordingly.

(2) Where the affairs of a body corporate are managed by its members, paragraph (1) applies in relation to the acts and defaults of a member in connection with his functions of management as if he were a director of the body corporate.

(3) Where an offence under these Regulations is committed by a Scottish partnership and is proved to have been committed with the consent or connivance of a partner, or to be attributable to any neglect on the part of a partner, he (as well as the partnership) commits the offence and shall be liable to be proceeded against and punished accordingly.

(4) In paragraph (3), “partner” includes a person purporting to act as a partner.

Transitional arrangements: storage licences

35.—(1) This regulation applies where, immediately before the commencement date, a licence granted under Schedule 3 to the 2004 Act authorises the carrying-on of the activity described in section 16(2)(e)(ii) of the 2004 Act for use for transplantation.

(2) A licence referred to in paragraph (1) shall, from the commencement date, also be treated as a licence granted pursuant to Schedule 1 to these Regulations in respect of the storage of tissue or cells for human application and shall authorise the carrying-on of the activities to which regulation 7(2) applies.

(3) Where any premises to which a licence referred to in paragraph (1) relates have not been inspected on behalf of the Authority since the licence was granted, the Authority shall arrange for such premises to be inspected on its behalf before the end of the period of two years beginning with the commencement date.

Regulation 7

SCHEDULE 1 Licences for the purposes of regulation 7

Power to grant licence

1.  The Authority may on application grant a licence for the purposes of regulation 7.

Characteristics of licences

2.  A licence under this Schedule may authorise the carrying-on of any of the activities to which regulation 7(1) or (2) applies.

3.  A licence—

(a) shall designate an individual as the designated individual, and

(b) shall not authorise the licensed activities to be carried on under the supervision of more than one such individual.

4.  A licence —

(a) shall specify the premises (other than relevant third party premises) where the licensed activity is authorised to be carried on, and

(b) shall not authorise the licensed activity to be carried on on premises (other than relevant third party premises in the case of activities to which regulation 7(2) applies) at different places.

5.  It shall be a condition of a licence under this Schedule—

(a) that the licensed activities shall be carried on only under the supervision of the designated individual;

(b) that the licensed activity shall be carried on only on the premises specified in the licence or, in the case of activities to which regulation 7(2) applies, on relevant third party premises.

Fees

6.  In determining the amounts of any fees to be charged under paragraph 13 of Schedule 3 to the 2004 Act, as applied by regulation 8, the Authority shall have regard to its costs in connection with the consideration of applications for licences under this Schedule.