The Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010

Suspension of authorisation

16.—(1) The Authority may suspend an authorisation if—

(a)the research establishment has failed to comply with the conditions imposed on it by the Authority or the Data Protection Act; or

(b)the information given pursuant to regulation 4(4) or (6) or 9(2) was inaccurate or misleading.

(2) Subject to paragraph (3), before suspending an authorisation of a research establishment, the Authority shall serve a notice on the research establishment—

(a)stating the Authority’s intention to suspend its authorisation on the date specified in the notice;

(b)stating on what grounds it proposes to suspend the authorisation; and

(c)giving the research establishment the opportunity to make written representations by a specified day, provided that at least 24 hours notice of that day is given.

(3) Where the Authority considers that it is necessary to do so in the public interest, it shall suspend an authorisation without prior notice under paragraph (2).

(4) Where the Authority decides to suspend an authorisation under paragraph (1) or (3), it shall give notice to the research establishment informing the research establishment—

(a)that the authorisation has been suspended and the period of suspension; and

(b)of the reasons for its decision.

(5) Any suspension pursuant to paragraph (1) or (3) shall be for such period but not exceeding 6 months as the Authority shall consider necessary having regard to the reasons for the suspension.

(6) The Authority may review a suspension at any time and shall review a suspension after a period of three months beginning with the date of the decision to suspend the authorisation if so requested by the relevant research establishment.

(7) Where the Authority reviews a suspension, it may—

(a)revoke the suspension, in which case the suspension shall cease to have effect; or

(b)suspend the authorisation for a further period not exceeding 6 months beginning with the date of the expiry of the current period of suspension.

(8) Where the Authority reviews a suspension it shall give notice to the research establishment informing the research establishment—

(a)of its decision including where applicable the period of suspension; and

(b)of the reasons for its decision.

(9) Where the Authority suspends an authorisation, any processing of the disclosable protected information by the research establishment shall not be in accordance with these Regulations (and accordingly the provision in paragraph (2) of regulation 15 shall not apply).