4. After regulation 2 insert—
2A.—(1) For the purposes of these Regulations, “relevant independent hospital” means an independent hospital which the Department has determined satisfies the conditions set out in paragraph (2).
(2) The conditions are—
(a)the independent hospital is directly or indirectly concerned with the provision of health care; and
(b)management or use of controlled drugs forms part of the activities of the independent hospital; and
(c)requiring that independent hospital to appoint or nominate an accountable officer would not give rise to difficulties that would be disproportionate to the benefits to be derived from such an appointment or nomination, having regard to—
(i)the usual number of relevant individuals who work at the independent hospital;
(ii)the usual level of relevant activities at or provided from the independent hospital; and
(iii)any difficulties there may be in identifying a suitable individual to act as an accountable officer for that independent hospital, taking into account the size of the business being carried on at or from the independent hospital and any possibility of a joint appointment or nomination by that independent hospital together with other independent hospitals.
(3) A determination under paragraph (1) is to be notified to the independent hospital and is for such duration as the Department specifies, but the determination may thereafter be—
(a)renewed for such further period as the Department specifies; or
(b)rescinded, after the Department has given the independent hospital to which the determination relates reasonable notice of the rescission.
(4) A refusal of a determination under paragraph (1), renewal or refusal to renew under paragraph (3)(a) or rescission under paragraph (3)(b) must be notified to the independent hospital.
(5) Where, in respect of an independent hospital, the Department—
(a)makes a determination, or decides to refuse a determination, under paragraph (1);
(b)renews or refuses to renew a determination under paragraph (3)(a); or
(c)rescinds a determination under paragraph (3)(b),
that independent hospital may request a review of that determination, refusal, renewal or rescission as the case may be.
(6) A request under paragraph (5) must be made in writing within a period of 28 days beginning with the date of the determination, refusal, renewal or rescission as the case may be.
(7) Where an independent hospital has requested such a review under paragraph (5), the Department may ask that independent hospital to furnish such additional information as it thinks fit.
(8) The accountable officer of a relevant independent hospital shall inform the Department of any change in its circumstances which is likely to affect the conditions set out in paragraph (2).”.