(1) This section applies in relation to information which the Secretary of State holds in connection with medical devices.
(2) The Secretary of State may disclose information for the purpose of warning members of the public about concerns that the Secretary of State has in relation to the safety of a medical device.
(3) The Secretary of State may disclose information to a person who provides services or exercises functions relating to medical devices for the purposes of—
(a) enabling or facilitating the exercise by the Secretary of State of a function relating to medical devices;
(b) enabling or facilitating the exercise by another person of a function relating to medical devices;
(c) enabling or facilitating the provision of a service relating to medical devices by another person.
(4) The Secretary of State may disclose information for the purposes of—
(a) civil proceedings;
(b) criminal investigations or proceedings.
(5) The Secretary of State may disclose information to a relevant person outside the United Kingdom where—
(a) the disclosure is required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of medical devices, and
(b) the Secretary of State considers that the disclosure is in the public interest.
(6) But subsection (5) does not authorise a disclosure of patient information without the consent of the individual to whom that information relates.
(7) The Secretary of State may not disclose commercially sensitive information in reliance on subsection (2), (3), (4) or (5) unless the Secretary of State—
(a) considers that it is necessary to do so for one or more of the purposes mentioned in subsection (2), (3), (4) or (5), and
(b) is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.
(8) Where information to which this section applies is disclosed to a person in reliance on subsection (3) or (4), the person may not use or further disclose the information except—
(a) with the agreement of the Secretary of State and for a purpose mentioned in subsection (3) or (4), or
(b) in accordance with an enactment or order of a court or tribunal.
(9) Except as provided by subsection (10), the disclosure of information in accordance with this section does not breach—
(a) an obligation of confidence owed by the person making the disclosure, or
(b) any other restriction on the disclosure of the information (however imposed).
(10) Nothing in this section authorises a disclosure of information which—
(a) contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), ...
(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016 , or
(c) contravenes any obligation or restriction created or arising by or under the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement, whether or not an obligation or restriction to which section 7A(2) of the European Union (Withdrawal) Act 2018 applies.
(11) This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.
(12) In this section—
“commercially sensitive information” means commercial information whose disclosure the Secretary of State thinks might significantly harm the legitimate business interests of the undertaking to which it relates;
“patient information” means information (however recorded) which—
relates to—
the physical or mental health or condition of an individual,
the diagnosis of an individual's condition, or
an individual's care or treatment,
or is (to any extent) derived directly or indirectly from information relating to any of those matters, and
identifies the individual or enables the individual to be identified (whether by itself or in combination with other information);
“relevant person” means—
the government of a country or territory outside the United Kingdom;
a person who exercises functions on behalf of such a government;
any other person who exercises functions or provides services relating to medical devices in a country or territory outside the United Kingdom;
an international organisation that exercises functions or provides services relating to medical devices.
(1) A person to whom information is disclosed under section 39 commits an offence if the person uses or discloses that information in contravention of subsection (8) of that section.
(2) A person to whom information is disclosed under regulations under section 19 (information systems) commits an offence if the person uses or discloses that information in contravention of those regulations.
(3) A person guilty of an offence under subsection (1) or (2) is liable—
(a) on summary conviction in England and Wales, to imprisonment for a term not exceeding 51 weeks, to a fine or to both;
(b) on summary conviction in Scotland or Northern Ireland, to imprisonment for a term not exceeding 6 months, to a fine not exceeding level 5 on the standard scale or to both.
(4) In relation to an offence committed before the coming into force of section 281(5) of the Criminal Justice Act 2003, the reference in subsection (3)(a) to 51 weeks is to be read as a reference to 6 months.
(1) In the Consumer Protection Act 1987—
(a) in section 11 (safety regulations), in subsection (7), at the end insert—
(e) medical devices.
;
(b) in section 19 (interpretation of Part 2), in subsection (1), at the appropriate place insert—
“medical device” has the same meaning as in Part 4 of the Medicines and Medical Devices Act 2021;
.
(2) In the Consumer Rights Act 2015, in Schedule 5 (investigatory powers etc)—
(a) in paragraph 10 (enforcer's legislation: duties and powers mentioned in paragraph 9(1)(a)), at the appropriate place insert “ regulation 61 of the Medical Devices Regulations 2002 (S.I. 2002/618) ”;
(b) in the table in paragraph 11 (enforcer's legislation), at the end insert—
The Secretary of State, a local weights and measures authority in Great Britain or a district council in Northern Ireland | Regulations made under section 15(1) of the Medicines and Medical Devices Act 2021
The Secretary of State, a local weights and measures authority in Great Britain or a district council in Northern Ireland | Chapter 3 of Part 4 of the Medicines and Medical Devices Act 2021
;
(c) in paragraph 19 (exercise of powers in Part 4), after sub-paragraph (7) insert—
(7A) A domestic enforcer may exercise the power in paragraph 30A (power to decommission or switch off fixed medical devices)—
(a) if an officer of the enforcer reasonably suspects a breach of the Medical Devices Regulations 2002 (S.I. 2002/618) or of regulations made under section 15(1) of the Medicines and Medical Devices Act 2021, and
(b) for the purpose of ascertaining (by means of testing or otherwise) whether there has been such a breach.
;
(d) after paragraph 30 insert—
30A (1) The power in sub-paragraph (2) is available to an officer of a domestic enforcer acting pursuant to the duty in regulation 61(1A) or (1B) of the Medical Devices Regulations 2002 (S.I. 2002/618) or to a duty in regulations made under section 15(1) of the Medicines and Medical Devices Act 2021.
(2) The officer may decommission or switch off any medical device to which the Medical Devices Regulations 2002 apply which is installed at a given location.
;
(e) in paragraph 31 (power to break open container etc)—
(i) in sub-paragraph (1), for “30” substitute “ 30A ”;
(ii) in sub-paragraph (2), for “30” substitute “ 30A ”.
(3) The Medical Devices Regulations 2002 (S.I. 2002/618) are amended in accordance with subsections (4) to (7).
(4) In regulation 2 (interpretation), in paragraph (1) omit the definition of “the 1987 Act”.
(5) Omit regulation 3B (confidentiality).
(6) In regulation 61 (enforcement and the Consumer Protection Act 1987 etc), for paragraphs (1) to (8) substitute—
(1A) It is the duty of the Secretary of State to enforce these regulations in relation to relevant devices and devices for performance evaluation.
(1B) It is the duty of each weights and measures authority in Great Britain and each district council in Northern Ireland to enforce these regulations within its area (concurrently with the Secretary of State) in relation to relevant devices that are ordinarily intended for private use or consumption.
(1C) Nothing in this regulation authorises a weights and measures authority to bring proceedings in Scotland for an offence.
(7) Omit—
(a) regulation 62 (compliance notices),
(b) regulation 63 (restriction notices), and
(c) regulation 64 (notification of decisions etc).
(8) As a result of the amendments made by subsections (1), (4), (6) and (7), the Medical Devices Regulations 2002 are not to be recognised as safety regulations for the purposes of the Consumer Protection Act 1987, but those amendments do not otherwise affect the continued operation of those regulations.
(9) Schedule 3 makes it an offence to breach various provisions in the Medical Devices Regulations 2002.
(1) In this Part, apart from in sections 32, 33 and 34 (provisions relating to forfeiture or seizure of medical devices), references to a medical device include references to a type of medical device.
(2) In this Part—
the “appropriate appeals court” means—
in England and Wales, the Crown Court;
in Scotland, the Sheriff Appeal Court;
in Northern Ireland, a county court;
the “appropriate lower court” means—
in England and Wales, a magistrates' court;
in Scotland, the sheriff;
in Northern Ireland, a court of summary jurisdiction;
“compliance notice” has the meaning given by section 21(2);
“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;
the “enforcement authority” means—
in relation to medical devices which are ordinarily intended for private use or consumption—
a local weights and measures authority in Great Britain or a district council in Northern Ireland, or
the Secretary of State, or
in relation to other medical devices, the Secretary of State;
“EU Medical Devices Regulations” means—
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, and
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;
“forfeiture order” has the meaning given by section 32(1);
“information notice” has the meaning given by section 24(2);
“manufacture” includes assembly;
“manufacturer” means any person who is a manufacturer for the purposes of any provision in—
the Medical Devices Regulations 2002 (S.I. 2002/618), or
the EU Medical Devices Regulations;
“medical device” includes—
medical devices to which the Medical Devices Regulations 2002 apply, and
devices to which the EU Medical Devices Regulations apply;
“medical devices provision”—
in Chapter 1, has the meaning given by section 17(2), and
in Chapter 3, has the meaning given by section 21(1A);
“relevant requirements” has the meaning given by section 16(1)(a);
“safety notice” has the meaning given by section 23(1);
“suspension notice” has the meaning given by section 22(2).
(1) Subsection (2) applies to regulations under a power in Part 1, 2, 3 or 4, apart from regulations under paragraph 9 of Schedule 2.
(2) The regulations may—
(a) make consequential, supplementary, incidental, transitional, transitory or saving provision;
(b) make different provision for different purposes;
(c) make different provision for different areas;
(d) make provision for all cases to which the power applies or for those cases subject to specified exceptions or for any specified cases or descriptions of case.
(3) Provision made by regulations under section 7A or 19 by virtue of subsection (2)(a) may include provision—
(a) changing the territorial extent of provisions of Chapter 2 of Part 9 of the Health and Social Care Act 2012 (NHS England: health and social care information etc.), or
(b) otherwise amending that Chapter.
44 Scope of powers of Northern Ireland departments
No provision may be made by a Northern Ireland department acting alone in regulations under section 2(1) , 7A(1) or 10(1) unless the provision, if it were contained in an Act of the Northern Ireland Assembly—
(a) would be within the legislative competence of the Assembly, and
(b) would not require the consent of the Secretary of State.
(1) Before making regulations under a provision of Part 1, 2, 3 or 4, the relevant authority must carry out a public consultation.
(1A) In relation to proposed regulations under section 7A(1), the Secretary of State must—
(a) where the regulations relate to Wales, specifically consult the Welsh Ministers, and
(b) where the regulations relate to Scotland, specifically consult the Scottish Ministers.
(2) In relation to proposed regulations under section 19(1), the Secretary of State must specifically consult—
(a) the Welsh Ministers,
(b) the Scottish Ministers, and
(c) the Department of Health in Northern Ireland.
(3) In relation to proposed regulations under section 2(1), 10(1) or 15(1), the consultation document must include a summary of the relevant authority's assessment of the matters mentioned in section 2, 10 or 15 (as the case may be).
(4) The duty to consult imposed by subsection (1) does not apply in relation to regulations that contain only provision made in reliance on—
(a) section 7 (disapplication of provisions relating to human medicines where there is a risk of serious harm to health), or
(b) section 18 (disapplication of provisions relating to medical devices where there is a risk of serious harm to health),
where the regulations contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health.
(5) The duty to consult imposed by subsection (1) may be satisfied by consultation carried out before this Act was passed.
(6) In this section, “the relevant authority” means—
(a) in relation to regulations made under section 2(1) or 7A(1), the appropriate authority within the meaning given by section 2(6),
(aa) in relation to regulations made under section 10(1), the appropriate authority within the meaning given by section 10(6), and
(b) in relation to any other regulations, the Secretary of State.
(1) As soon as reasonably practicable after the end of each reporting period, the relevant authority must lay before the appropriate legislature a report on the operation of any regulations made by the relevant authority under sections 2(1), 7A(1), 10(1), 15(1) and 19(1) that were in force at any time during the reporting period.
(2) In preparing a report, the relevant authority must consult such persons as the relevant authority considers appropriate.
(3) A report must include a summary of—
(a) any concerns raised, or proposals for change made, by a person consulted in accordance with subsection (2), and
(b) the relevant authority's response to those concerns or proposals, including any plan the relevant authority may have to make further regulations under section 2(1), 7A(1), 10(1), 15(1) or 19(1).
(4) The reporting periods are—
(a) the period of 24 months beginning with the day on which the first set of regulations under section 2(1), 7A(1), 10(1), 15(1) or 19(1) comes into force, and
(b) each successive period of 24 months.
(5) In this section—
“appropriate legislature” means—
in relation to a report of the Secretary of State, Parliament;
in relation to a report of a Northern Ireland department, the Northern Ireland Assembly;
“relevant authority” means—
in relation to regulations made under section 2(1) , 7A(1) or 10(1) by the Secretary of State (whether acting alone or jointly with a Northern Ireland department), the Secretary of State;
in relation to regulations made under section 2(1) , 7A(1) or 10(1) by a Northern Ireland department (whether acting alone or jointly with the Secretary of State), the Northern Ireland department;
in relation to regulations made under section 15(1) or 19(1), the Secretary of State.
(1) Any power to make regulations under a provision of Part 1, 2, 3 or 4 so far as exercisable by the Secretary of State, or by the Secretary of State acting jointly with a Northern Ireland department, is exercisable by statutory instrument.
(2) Any power to make regulations under section 2(1) , 7A(1) or 10(1) so far as exercisable by a Northern Ireland department (other than when acting jointly with the Secretary of State) is exercisable by statutory rule for the purposes of the Statutory Rules (Northern Ireland) Order 1979 (S.I. 1979/1573 (N.I. 12)) (and not by statutory instrument).
(3) The procedure for making regulations under Part 1, 2, 3 or 4 is to be determined in accordance with this table and subsection (4)—
If the regulations contain provision made in reliance on | the regulations are subject to
section 6(1)(a) | the negative procedure
section 12(1)(a) | the negative procedure
section 17(1)(a) | the negative procedure
paragraph 9 of Schedule 2 | the negative procedure
section 7 | (a) the made affirmative procedure, where the regulations contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health (b) the draft affirmative procedure in any other case
section 18 | (a) the made affirmative procedure, where the regulations contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health (b) the draft affirmative procedure in any other case
any other provision of Part 1, 2, 3 or 4 | the draft affirmative procedure
(4) Provision that may be made by regulations subject to the negative procedure may be made by regulations subject to the draft affirmative procedure.
(5) Where regulations are subject to “the negative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations is subject to annulment in pursuance of a resolution of either House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they are subject to negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations is subject to—
(i) annulment in pursuance of a resolution of either House of Parliament, and
(ii) negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954.
(6) Where regulations are subject to the “draft affirmative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they may not be made unless a draft of the regulations has been laid before and approved by a resolution of the Northern Ireland Assembly, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations may not be made unless a draft of the instrument has been laid before and approved by a resolution of—
(i) each House of Parliament, and
(ii) the Northern Ireland Assembly.
(7) Where regulations are subject to the “made affirmative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations—
(i) must be laid before Parliament after being made, and
(ii) ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by a resolution of each House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they—
(i) must be laid before the Northern Ireland Assembly after being made, and
(ii) cease to have effect at the end of the period of 40 days beginning with the day on which they are made unless, during that period, the regulations are approved by a resolution of the Assembly, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations—
(i) must be laid before Parliament and the Northern Ireland Assembly after being made, and
(ii) ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by a resolution of each House of Parliament and by a resolution of the Assembly.
(8) In calculating the period of 40 days for the purposes of subsection (7)(a)(ii) or (c)(ii) in relation to Parliament, no account is to be taken of any time during which—
(a) Parliament is dissolved or prorogued, or
(b) either House of Parliament is adjourned for more than 4 days.
(9) In calculating the period of 40 days for the purposes of subsection (7)(b)(ii) or (c)(ii) in relation to the Northern Ireland Assembly, no account is to be taken of any time during which the Assembly is—
(a) dissolved,
(b) in recess for more than 4 days, or
(c) adjourned for more than 6 days.
(10) If regulations cease to have effect as a result of subsection (7) that—
(a) does not affect the validity of anything previously done under the regulations, and
(b) does not prevent the making of new regulations.
48 Report on operation of medicines and medical devices legislation
(1) The Secretary of State must, before the end of the relevant period, publish a report on the operation of medicines and medical devices legislation.
(2) The report must, in particular, include an assessment of whether—
(a) some or all medicines and medical devices legislation should be consolidated or otherwise restructured,
(b) provisions of medicines and medical devices legislation should be included in regulations or Acts of Parliament, and
(c) powers to make regulations should be modified or repealed.
(3) In preparing the report, the Secretary of State must take into account any report relating to the operation of medicines and medical devices legislation made by a Parliamentary Committee.
(4) The Secretary of State must lay a copy of the report before Parliament.
(5) In this section—
“medicines and medical devices legislation” means—
the law relating to human medicines within the meaning of section 9 (interpretation);
the Veterinary Medicines Regulations 2013 (S.I. 2013/2033);
the Medical Devices Regulations 2002 (S.I. 2002/618);
Parts 2 to 5 of this Act;
regulations made under those Parts;
“Parliamentary Committee” means a committee of the House of Commons or of the House of Lords or a joint committee of both Houses;
“relevant period” means the period of 5 years beginning with the day on which this Act is passed.
(1) The following come into force on the day on which this Act is passed—
(a) this Part,
(b) section 2,
(c) section 6(4),
(d) section 7,
(e) section 9,
(f) section 15,
(g) section 17(2),
(h) section 18,
(i) section 42,
(j) Part 5, and
(k) Part 6.
(2) The following come into force at the end of the period of two months beginning with the day on which this Act is passed—
(a) Part 1,
(b) the remaining provisions of Part 2,
(c) Part 3,
(d) the remaining provisions of Chapter 1 of Part 4, and
(e) Chapter 2 of Part 4.
(3) Chapters 3 and 4 of Part 4 (medical devices: enforcement and disclosure of information) come into force on such day or days as the Secretary of State may by regulations made by statutory instrument appoint.
(4) Regulations may not be made in reliance on section 7 or 18 that come into force before the end of the period of two months beginning with the day on which this Act is passed unless they contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health.
51 Transitional etc provision in connection with commencement
(1) The Secretary of State may by regulations made by statutory instrument make transitional, transitory or saving provision in connection with the coming into force of any provision of this Act (subject to subsection (4)).
(2) The relevant Northern Ireland department may by regulations make transitional, transitory or saving provision in connection with the coming into force of Part 2 or, as the case may be, Part 3 so far as relating to Northern Ireland.
(3) No provision may be made by the relevant Northern Ireland department in regulations under subsection (2) unless the provision, if it were contained in an Act of the Northern Ireland Assembly—
(a) would be within the legislative competence of the Assembly, and
(b) would not require the consent of the Secretary of State.
(4) Regulations of the Secretary of State under this section may not contain provision that could be made by regulations of the relevant Northern Ireland department under this section.
(5) The power to make regulations under subsection (2) is exercisable by statutory rule for the purposes of the Statutory Rules (Northern Ireland) Order 1979 (S.I. 1979/1573 (N.I. 12)).
(6) In this section, the “relevant Northern Ireland department” means—
(a) in relation to Part 2, the Department of Health in Northern Ireland, and
(b) in relation to Part 3, the Department of Agriculture, Environment and Rural Affairs in Northern Ireland.
SCHEDULE 1 Further provision about the Commissioner for Patient Safety
Section 1
Principles relating to core duties
1 (1) The Commissioner must prepare and publish a set of principles to govern the way in which the Commissioner will carry out the Commissioner's core duties.
(2) The Commissioner—
(a) may revise the principles, and
(b) must publish any revised version.
(3) The Commissioner must carry out a public consultation in preparing or revising the principles.
Involvement of patients
2 (1) The Commissioner must take reasonable steps to involve patients in the discharge of the Commissioner's core duties.
(2) The Commissioner must in particular take reasonable steps to—
(a) ensure that patients are aware of the Commissioner's core duties and of how they may communicate with the Commissioner, and
(b) consult patients, or persons who appear to the Commissioner to represent the interests of patients, on matters which the Commissioner proposes to consider in the discharge of the core duties.
Supplementary functions and information
3 (1) For the purposes of carrying out the core duties, the Commissioner may—
(a) make a report or recommendation to a relevant person;
(b) consult or receive information from patients or any other person the Commissioner thinks appropriate;
(c) request information from a relevant person;
(d) share information with a relevant person.
(2) A relevant person to whom a report or recommendation is made under sub-paragraph (1)(a) must provide a response to that report or recommendation within such period as the Commissioner may reasonably require.
(3) A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner to provide information within such period as the Commissioner may reasonably require.
(4) Nothing in this Schedule authorises a disclosure of information which contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this Schedule).
(5) In this paragraph—
“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;
“health care” means all forms of health care provided for individuals, whether relating to physical or mental health, and including ancillary care;
“relevant person” means—
a person who exercises functions of a public nature, relating to medicines or medical devices, so far as those functions are exercisable in relation to England;
any other person who, in the course of providing health care, provides services relating to medicines or medical devices in relation to England.
Individual cases
4 (1) The Commissioner may not exercise functions in relation to an individual case.
(2) But sub-paragraph (1) does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue.
Amendments to primary legislation
5 (1) In Part 1 of the Table at the end of paragraph 3 of Schedule 1 to the Public Records Act 1958 (definition of public records), at the appropriate place insert— “ Commissioner for Patient Safety. ”
(2) In Part 3 of Schedule 1 to the House of Commons Disqualification Act 1975 (offices disqualifying for membership), at the appropriate place insert— “ Commissioner for Patient Safety. ”
(3) In Part 6 of Schedule 1 to the Freedom of Information Act 2000 (other public bodies and offices: general), at the appropriate place insert— “ The Commissioner for Patient Safety. ”
(4) In section 71 of the National Health Service Act 2006 (schemes for meeting losses and liabilities etc of certain health service bodies), in subsection (2), before paragraph (h) insert—
(ga) the Commissioner for Patient Safety,
.
(5) In Part 1 of Schedule 19 to the Equality Act 2010 (authorities subject to the public sector equality duty), in the group of entries under the heading “Health, social care and social security”, at the appropriate place insert— “ The Commissioner for Patient Safety. ”
Regulations about appointment and operation
6 (1) The Secretary of State may by regulations make such provision as the Secretary of State considers appropriate with regard to the appointment and operation of the Commissioner.
(2) Regulations under sub-paragraph (1) may (among other things) contain provision for and about—
(a) the Commissioner's terms of office;
(b) remuneration or other benefits;
(c) the provision of financial or other assistance, including staff, accommodation, equipment or other facilities, for the Commissioner;
(d) requirements to prepare business plans;
(e) requirements to prepare reports;
(f) requirements to lay documents before Parliament;
(g) requirements to provide documents to the Secretary of State or other persons specified in the regulations;
(h) the conferring of functions on other persons in relation to the Commissioner;
(i) the appointment of a board to provide advice to the Commissioner.