11.— (1) Subject to subsections (3), (4) and (5), the Council—

(a) may make rules for the purposes of the better operation of any provision of this Act, or

(b) at the request in writing of the Minister and in accordance with the request, shall make rules for the purposes of the better operation of any provision of this Act.

(2) Without prejudice to the generality of subsection (1), the Council may make rules under this section in relation to—

(a) the establishment, membership, functions and procedures of committees,

(b) the form and manner in which the register and its divisions are to be maintained,

(c) the details relating to medical practitioners that, in addition to their names, are to be entered in the register or their certificates of registration or both,

F23[(ce) permits for the purposes of section 38B(3),]

(d) the manner in which appropriate fees are to be paid and the time limits for payment of appropriate fees for the retention of registration,

(e) the receiving and recording of evidence by section 20(2) committees,

(f) the receiving of submissions by section 20(2) committees,

(g) the establishment, membership, functions and procedures of subcommittees of committees including, in the case of the Fitness to Practise Committee, subcommittees inquiring, on behalf of that Committee, into different grounds founding a complaint,

(h) the setting of criteria for assessing applications for registration in the Specialist Division,

(i) the specification of examinations for the purposes of subparagraph (i) of section 46(b),

(j) the specification of grounds for the purposes of subparagraph (ii) of section 46(b),

(k) the grounds on which subparagraph (iv) of section 46(b) shall not apply to a medical practitioner due to the unfeasibility of a document referred to in that subparagraph being produced in respect of that practitioner,

(l) the grounds on which paragraph (c) of section 48(2) or (3) shall not apply to a medical practitioner due to the unfeasibility of a document referred to in that paragraph being produced in respect of that practitioner,

(m) the specification of examinations for the purpose of subparagraph (i) of section 48(3)(a),

(n) the specification of grounds for the purposes of subparagraph (ii) of section 48(3)(a),

(o) the specification of examinations for the purposes of subparagraph (i) of section 48(4)(a),

(p) the specification of grounds for the purposes of subparagraph (ii) of section 48(4)(a),

(q) the specification of requirements for the purposes of paragraph (c) of section 48(4),

(r) the specification of—

(i) a period or periods,

(ii) a hospital, health institution, clinic, general medical practice, or other health service setting,

for the purposes of subsection (3) of section 49,

F24[(ra) the setting of criteria for assessing applications for registration, in the Supervised Division, in respect of which different criteria shall be set in relation to different classes of posts,

(rb) the specification of examinations and assessments for the purposes of enabling a practitioner who has applied or intends to apply for registration in the Supervised Division to satisfy the Council that the criteria set in rules made under paragraph (ra) have been met, ]

(s) the setting of criteria that the Council shall consider under section 81 for the restoration of a medical practitioner’s registration,

(t) the setting of criteria for the purposes of section 88(2)(a),

(u) the setting of criteria for the purposes of section 88(3)(a) or (4)(a),

(v) the setting of criteria, in relation to each medical specialty recognised under section 89(1), for the purposes of section 89(3),

F25[(va) the evidence to be submitted to the Council by a medical practitioner to satisfy the Council that the minimum level of indemnity (if any) applicable to him or her is in place and the manner in which all or part of that evidence may be displayed for the purposes of section 43(7A),]

(w) the setting of criteria for the purposes of section 91(4),

(x) any professional competence scheme,

(y) any other matter relating to the Council’s functions.

(3) Without prejudice to the generality of subsection (2)(e) and (f), rules made under this section may specify—

(a) the form in which and the means by which evidence or submissions may be received by section 20(2) committees, and

(b) the conditions subject to which evidence or submissions may be received by section 20(2) committees by means of a live video link, a video recording, a sound recording or any other mode of transmission.

(4) Without prejudice to the generality of subsection (2)(x), rules made under this section may specify—

(a) categories of registered medical practitioners to which a professional competence scheme applies,

(b) definitions and descriptions of categories or ranges of activities which fall within a professional competence scheme,

(c) obligations to be placed on medical practitioners or categories of medical practitioners specified under paragraph (a) by virtue of a professional competence scheme,

(d) procedures to be followed by the Council and by registered medical practitioners for the purposes of a professional competence scheme (including, in the case of the Council, procedures to be followed for the purposes of the operation, administration and supervision of the professional competence scheme).

(5) The Council shall ensure that—

(a) a draft of any rule (including a rule revoking or amending any other rule) that it proposes to make under this section is published in the prescribed manner,

(b) with the draft is published an invitation to members of the public, any organisation and any other body to comment on the draft before a date specified by the Council in the invitation, being a date reasonable in the circumstances, and

(c) without prejudice to the generality of paragraph (b), a copy of the draft of the rule is given to—

(i) the Minister,

(ii) the Health Service Executive, and

(iii) if the draft relates to a competence scheme, the Minister for Finance,

not later than the date on which the Council complies with paragraph (a) in respect of that draft.

(6) Subject to subsection (7), the Council, after considering any comments on a draft of a rule published pursuant to subsection (5)(a) received before the date specified in the invitation referred to in subsection (5)(b) which relates to the draft, may—

(a) make the rule in the form of the draft as published or with such changes as the Council determines, or

(b) decide not to make the rule.

(7) The Council shall not make rules under this section relating to a professional competence scheme except with the consent of the Minister and the Minister for Finance.

(8) The Council shall ensure that, as soon as is practicable after a rule is made under this section, the rule—

(a) is published in the prescribed manner, and

(b) is submitted to the Minister for laying before each House of the Oireachtas.

(9) Every rule made under this section shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the rule is passed by either such House within the next 21 days on which the House has sat after that rule is laid before it, the rule shall be annulled accordingly, but without prejudice to the validity of anything previously done under it.