The Quality and Safety of Organs Intended for Transplantation Regulations 2012

PART 5 General

Arrangements by the Authority for assistance with functions

21.—(1) Subject to paragraph (5), the Authority may make arrangements with a body in the United Kingdom for that body to assist the Authority in relation to any of its functions under these Regulations.

(2) Assistance under such arrangements may take the form of the carrying out by the body of the Authority’s functions.

(3) Before making arrangements under paragraph (1) the Authority must be satisfied that the body it is proposing to make arrangements with is a suitable body, as defined in paragraph (4).

(4) A suitable body is a body that the Authority determines will carry out functions effectively, efficiently and economically.

(5) Arrangements under paragraph (1) shall not affect the Authority’s responsibility for the carrying out of its functions.

(6) The Authority may not make arrangements under paragraph (1) in respect of the giving of—

(a) directions under section 23(1) (conduct of licensed activities) or 24(1) (changes of licence circumstance) of, or paragraph 2(4)(c) to (f) (characteristics of licence) of Schedule 3 to, the 2004 Act; or

(b) regulations under section 21(5) (procedure on reconsideration) of, or paragraphs 10(5) (procedure in relation to licensing decisions) or 13(1) (applications under Schedule 3 to the 2004 Act) of Schedule 3 to, the 2004 Act,

as applied by regulation 6.

Offences by bodies corporate

22.—(1) Where an offence under regulation 8 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,

that person (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 that member’s functions of management as if that member were a director of the body corporate.

(3) Where an offence under this Act 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, that partner (as well as the partnership) commits the offence and shall be liable to be proceeded against and punished accordingly.

(4) In subsection (3), partner includes a person purporting to act as a partner.

Licences: transitional arrangements

23.—(1) The requirement to be licensed by the Authority does not apply to a procurement activity or a transplantation activity carried out in respect of an organ that is retrieved from a donor before 27th August 2012.

(2) Where the surgical act of retrieving an organ from the donor commences before 27th August 2012 but is not completed by 27th August 2012, the requirement to be licensed does not apply to any procurement activity or transplantation activity carried out in respect of that organ.

(3) Regulation 9 shall not apply where—

(a) the Authority receives an application for a licence under Schedule 1 before 27th August 2012; and

(b) the Authority is of the opinion that the requirements for that licence are or will be met.

(4) Except where paragraph (5) applies, the duration of a licence granted by the Authority by virtue of paragraph (3) shall be such period not exceeding 4 months as is specified in the licence.

(5) If the Authority is satisfied that—

(a) an applicant for a licence granted by virtue of paragraph (3) meets the requirements specified in regulation 9(2); and

(b) the requirements of regulation 9(3) are met,

it may remove the restriction as to duration imposed under paragraph (4).

Review

24.—(1) The Secretary of State must from time to time—

(a) carry out a review of these Regulations;

(b) set out the conclusions of the review in a report; and

(c) publish the report.

(2) In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how the Directive is implemented in other Member States.

(3) The report must in particular—

(a) set out the objectives intended to be achieved by the regulatory system established by these Regulations;

(b) assess the extent to which those objectives are achieved; and

(c) assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(4) The first report under this regulation must be published before the end of the period of five years beginning on 27th August 2012.

(5) Reports under this regulation are afterwards to be published at intervals not exceeding five years.