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The Human Fertilisation and Embryology (Procedure for Revocation, Variation or Refusal of Licences) Regulations 2009

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Consideration of representations made under section 19(4) of the Act

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3.—(1) Representations received from the person concerned shall be considered by the committee.

(2) When considering representations received from the person concerned, the committee —

(a)shall—

(i)sit with either 3 or 5 members, including the chair or deputy chair,

(ii)sit with a majority of members who are not persons with a professional interest,

(iii)participate in the decision making equally (and no member shall abstain from voting on any issue where a vote is required),

(iv)take decisions by simple majority (and the chair shall not have a casting vote),

(v)sit with a legal adviser,

(vi)be assisted by a secretary (provided that the secretary is not a member of the Authority or person acting as secretary to the Appeal Committee); and

(b)may sit with a clinical, scientific or specialist adviser where the chair considers it desirable to do so.

(3) No member of the committee shall consider representations received from the person concerned, if that member has a conflict of interest in relation to that case.

(4) The legal, clinical, scientific or specialist advisers referred to in paragraph (2) above—

(a)shall advise the committee on any areas within the adviser’s expertise;

(b)may intervene to advise the committee on an issue where it appears that without an intervention there is the possibility of an error being made;

(c)at the request of the chair, may be present during the private deliberations of the committee but shall not participate in the decision making of the committee (and are not entitled to vote);

(d)subject to sub-paragraph (e), shall tender any advice at a hearing in the presence of each of the parties in attendance at that hearing;

(e)where at a hearing the committee has begun to deliberate on its decision and needs to obtain advice in the course of its deliberations, may tender advice to the committee notwithstanding the absence of the parties; and

(f)where advice has been tendered in accordance with sub-paragraph (e), shall repeat the advice before the parties in attendance at the hearing.

(5) Where any advice tendered by an adviser to the committee is not accepted by the committee—

(a)if the advice is tendered at a hearing before the committee, the chair shall announce the reasons for not accepting the advice tendered;

(b)the chair shall ensure that a written record is kept of the advice tendered, and the reasons why the committee refused to accept that advice; and

(c)a copy of the record of the advice tendered and the reasons why the committee refused to accept that advice shall be sent to the parties.

(6) The secretary shall—

(a)not participate in the decision making of the committee (and is not entitled to vote); and

(b)keep a record of —

(i)the committee’s decision and of the reasons for such decision,

(ii)any advice tendered by the legal, clinical, scientific or specialist advisers (or any interventions made by them when they are present during the private deliberations of the committee); and

(iii)any declarations of interest (or potential conflicts of interest) made by a member during the proceedings.

(7) Subject to the Act and these Regulations, the committee may regulate its own proceedings.

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