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Clause 92: Functions under Medical Act 1983 and Opticians Act 1989

304.     Clause 92 brings into effect Schedule 7.

Schedule 7

305.     Schedule 7 is split into two parts. Part 1 makes amendments to the Medical Act 1983 and Part 2 makes amendments to the Opticians Act 1989. These have the effect of transferring the functions in relation to the adjudication of fitness to practise of the GMC and the GOC to the OHPA. They also have the effect of transferring the CRHP's rights to refer a case to the relevant court, where the findings are thought to be too lenient, to the GMC and the GOC. The relevant court for those whose registered address is in Scotland is the Court of Session and in Northern Ireland, the High Court of Justice in Northern Ireland. For all other persons, it is the High Court of Justice in England and Wales.

306.     Paragraph 4 inserts a new section 35ZA into the Medical Act 1983. The effect of this is to allow the GMC to publish guidance on the factors that they consider to indicate:

  • where a practitioner's fitness to practise is found impaired, what sanction would or would not be appropriate;

  • where a practitioner's fitness to practise is not found impaired, whether a warning should or should not be given regarding future conduct or performance;

  • and where a person has previously had his name erased from the register, whether their registration should be restored or not.

307.     The GMC may also publish guidance on:

  • the type of conditions to be imposed, where a practitioner's registration is to be made conditional

  • the period of time that a person's registration should be suspended or made conditional.

308.     Paragraph 29 inserts a new section 13AA into the Opticians Act 1989, allowing the GOC to publish similar guidance in relation to types of sanctions available, in cases involving those regulated by the Opticians Act 1989.

309.     Under subsection (3) of each of the new sections described above, the OHPA must take account of any guidance published by the GMC and the GOC under these powers when making decisions on what sanctions to impose in any particular case.

310.     Paragraph 11 inserts a new section 40A into the Medical Act 1983, allowing the GMC to refer a case to the High Court where it thinks that the OHPA has reached a finding relating to fitness to practise that is unduly lenient, and that it is necessary in the interests of public protection for it to take action. The new section sets out the decisions which can be referred and the timescales for such referrals.

311.     Paragraph 38 inserts a new section 23AA into the Opticians Act 1989, allowing the GOC similar rights of referral.

Clause 93: Fitness to practise panels

312.     Clause 93 sets out that the OHPA's function of adjudication of fitness to practise cases is to be carried out by panels. The members are to be drawn from lists held by the OHPA and must consist of at least 3 people - a chair, a lay member and a professionally qualified member. The chair may be either a lay member or professionally qualified. Other lay or professionally qualified members may be appointed to the panels provided they are on the OHPA's lists (see clause 94 below). Subsection (3) empowers the OHPA to make further provision about the selection of fitness to practise panels through its rules. For example, this may cover how those lay and professional members able to act as a chair of a panel are identified. Rules could also provide that professional panel members are selected from the professional list with due regard to the profession of the practitioner whose fitness to practise is being considered.

Clause 94: Lists of persons eligible for membership of fitness to practise panels

313.     Clause 94 requires the OHPA to hold two lists: one of persons eligible to sit as lay members of its panels, and the other of persons eligible to sit as professionally qualified members. Rules made by the OHPA under this clause may set out further details of how these lists will be kept and the information relating to each individual appointed which will appear on the lists. Rules may also set out the requirements for appointment to either list; no member of the OHPA may be appointed to a list.

Clause 95: Further provisions about listed persons

314.     Clause 95 provides that the OHPA may pay fees, allowances and expenses to people it has appointed to its lists. It must provide for their training and must establish and maintain a system for the declaration and registration of their interests and publish entries recorded in the register.

Clause 96: Legal assessors

315.     Under clause 96 the OHPA must appoint or arrange for the appointment of legal assessors to give advice on points of law to the OHPA's panels. To be eligible for appointment such assessors must meet the requirements set out in rules made by the OHPA. Rules made by the OHPA must set out the required qualifications, and may make further provision about their functions. The OHPA may pay such fees, allowances and expenses as it deems appropriate to these legal assessors. A legal assessor may be appointed either generally or for particular proceedings or a particular class of proceedings.

Clause 97: Clinical and other specialist advisers

316.     Clause 97 provides that the OHPA may appoint persons as clinical advisers who will advise its fitness to practise panels on issues relating to health. The OHPA may also appoint other specialist advisers who will advise the panels on issues falling within their specialty on which the OHPA considers that specialist knowledge is required. To be eligible for appointment such advisers must meet the requirements set out in rules made by the OHPA. The rules may also make provision about their functions. The OHPA may pay such fees, allowances and expenses as it deems appropriate to these advisers. Advisers may be appointed either generally or for particular proceedings or a particular class of proceedings.

Clause 98: Procedural rules

317.     Clause 98 requires the OHPA to make rules about the procedures to be followed in making referrals to it under the Medical Act 1983 or the Opticians Act 1989 and the procedures to be followed before its panels (including the rules of evidence). The rules will not instruct the regulatory bodies on the conduct of their investigations or the preparation of the case before it is referred to the OHPA.

318.     The rules must include:

  • provision for a practitioner to be notified that proceedings are being brought against them;

  • provision for notice of decisions of a fitness to practise panel to be given to the parties to the proceedings (i.e. the practitioner and the regulator) and the registrar of the relevant regulatory body;

  • the right of parties to the proceedings to put their case at a hearing;

  • the right of parties to the proceedings to be represented at any hearing by a person meeting criteria specified in the rules; and

  • provision for hearings to be held in public except in circumstances that the rules state otherwise. For example, the rules could make provision for a hearing in private in some circumstances.

Clause 99: Administration of oaths and issuing of witness summonses etc

319.     Clause 99 makes provision for panels to require persons giving evidence during a hearing to give the evidence under oath and for witnesses to be summoned. Similar provision is made in subsection (1) for hearings in England and Wales or in Northern Ireland to that made in subsection (4) for hearings in Scotland.

Clause 100: Duty to inform the public

320.     This clause requires that the OHPA publish certain information about itself and the way it carries out its functions, and the decisions of its panels. The OHPA may withhold from publication confidential information about a person's health, and other information specified in rules. It is not required, or authorised, to publish information if publication is prohibited by any enactment or would be a contempt of court.

Clause 101: Duty to consult

321.     This clause requires the OHPA to seek the views of the following about the way it discharges its functions:

  • members of the public;

  • bodies which appear to the OHPA to represent the interest of patients;

  • the GMC and the GOC;

  • any other bodies that appear to the OHPA to represent the professions regulated by the Medical Act 1983 and Opticians Act 1989.

Clause 102: OHPA rules: supplementary

322.     Clause 102 provides that before making rules, the OHPA must consult:

  • the Council for Healthcare Regulatory Excellence;

  • the GMC, if the rules affect the profession regulated by the Medical Act 1983;

  • the GOC, if the rules affect the professions regulated by the Opticians Act 1989;

  • other bodies which appear to the OHPA to represent the professions regulated by the GMC or, as the case may be, the GOC, if the rules affect these regulated professions;

  • bodies that appear to the OHPA to represent the interests of patients;

  • any other persons the OHPA considers appropriate.

323.     The rules come into force only if approved by the Privy Council by an Order of Council, subject to the negative resolution procedure. The Privy Council may modify the rules before approving them but must first give the OHPA the opportunity to make observations on the proposed changes.

Amendments of Part 3 of Health Act

Clause 103: Extension of powers under section 60 of Health Act 1999

324.     Section 60 of the Health Act 1999 allows Her Majesty, by Order in Council, to modify the regulation of the existing regulated healthcare professions and to bring other healthcare professions into statutory regulation. An Order made under section 60 may repeal or revoke any enactment or instrument, amend it, or replace it (subject to the restrictions in paragraphs 7 and 8 of Schedule 3 to the Health Act 1999). The Government must consult on draft Orders prior to them being laid before Parliament. The Orders are subject to the affirmative procedure. Orders which make provision for professions whose regulation is not a "reserved matter" for the purposes of the Scotland Act 1998 (in effect, those made subject to statutory regulation since 1 July 1999) are subject to affirmative procedure in the Scottish Parliament (as well as at Westminster).

325.     Clause 103 brings into effect Schedule 8 which provides that section 60 of, and Schedule 3 to, the Health Act 1999, are to be amended, the effect of which is to extend the powers available under section 60.

Schedule 8: Extension of powers under s.60 of Health Act 1999

326.     Paragraph 1(2) brings the OHPA within the scope of section 60 of the Health Act 1999. This enables changes to be made to the constitution, functions, power and duties of the OHPA by an Order in Council so that they can be updated as approaches to regulation change and evolve and so that additional professions can be brought within the remit of the OHPA.

327.     Paragraph 1(3) removes the reference to the 'Pharmacy Act 1954' (which has been repealed by the Pharmacists and Pharmacy Technicians Order 2007) from section 60(2)(a). This is replaced by section 60(2)(aa) which refers to 'professions regulated by the Pharmacists and Pharmacy Technicians Order 2007 and the Pharmacy (Northern Ireland) Order 1976', the first now being the relevant legislation for the regulation of pharmacists and pharmacy technicians in Great Britain and the second being the relevant legislation in respect of the regulation of pharmacists in Northern Ireland.

328.     Paragraph 1(4) inserts a new subsection (2A) into section 60. This enables an Order in Council under this section to make provision relating to, or connected with, the specific statutory functions of the RPSGB and the PSNI. These are:

  • the functions under the Medicines Act 1968 in relation to the registration and regulation of pharmacy premises, and the other inspection and enforcement functions which the RPSGB and the PSNI have under that Act;

  • the functions under the Poisons Act 1972 and the Poisons (Northern Ireland) Order 1976 in so far as they relate to persons admitted to practice, such as pharmacists, and persons carrying on a retail pharmacy business;

  • the grant of authorisations under section 28 of the Regulation of Investigatory Powers Act 2000 concerning directed surveillance.

329.     The primary purpose of the inclusion of subsection (2A) is to ensure that these statutory functions, which are separate but connected to the regulation of individual practitioners, are brought within the scope of section 60, so that changes can be made across all of the RPSGB's and the PSNI's functions where necessary. For example, this will facilitate the transfer of all of the RPSGB's and the PSNI's (subject to a decision by Northern Ireland Ministers to proceed in this way) functions under these Acts to the proposed General Pharmaceutical Council which the Government intends to create in the future by a section 60 order. However, it is also envisaged that these powers will be used to modernise the requirements in relation to pharmacy premises in particular.

330.     Paragraphs 2, 6(3) and (4) and 7(a) of Schedule 8. An Order in Council under section 60 of the Health Act 1999 can amend or repeal (by virtue of paragraph 2(1) of Schedule 3 to that Act) any enactment. Paragraph 7(a) of Schedule 8 inserts a definition of "enactment" into Schedule 3. The definition includes not only Acts of the Westminster Parliament (and instruments made under them), but also Acts of the Scottish Parliament, Measures or Acts of the National Assembly for Wales and Northern Ireland legislation (and instruments made under them). Paragraph 2 amends section 62(10) of the Health Act 1999 to provide that where an Order in Council includes provision amending Scottish legislation on devolved matters but the provision is incidental to or consequential on provision about a reserved matter, the Order does not on that account require the approval of the Scottish Parliament. Paragraph 6(3) and (4) of Schedule 8 provides that in those circumstances, Scottish Ministers are not required to consult on a draft of the Order in Council. Rather, the Secretary of State alone will consult on the draft Order (although he will have to consult the Scottish Ministers).

331.     Paragraph 4(1) provides for amendments to paragraph 7 of Schedule 3, which specifies matters outside the scope of the Orders under section 60. Paragraph 4(2) replaces the existing sub-paragraph (1) of paragraph 7. New sub-paragraph (1) has the effect that those regulatory bodies to which section 60(2)(a) applies, the Health Professions Council, the NMC, and any other regulatory body established by an Order under section 60 (such as the proposed new General Pharmaceutical Council), cannot be abolished by an Order under section 60.

332.     New sub-paragraph (1A) of paragraph 7 of Schedule 3 qualifies new sub-paragraph (1) by providing that an Order in Council may establish a new regulatory body for the professions regulated by the Pharmacists and Pharmacy Technicians Order 2007 and the Pharmacy (Northern Ireland) Order 1976 and transfer to that new body functions currently exercised by the RPSGB and the PSNI.

333.     Under the current provisions in section 60 of, and Schedule 3 to, the Health Act 1999, an Order in Council cannot require a majority of the members of a regulatory body to be lay members. Paragraph 4(3) removes this restriction through the removal of paragraph 7(2) of Schedule 3 to the Health Act 1999.

334.     Paragraph 4(4) removes a restriction that has prevented Orders under section 60 from being used to make provisions allowing functions conferred on the Privy Council in relation to some of the regulated professions to be exercised by another person. The professions affected are pharmacists, doctors, optometrists, dispensing opticians, osteopaths, chiropractors, dentists and the other professions regulated, or to be regulated, under the Dentists Act 1984. In practice, it is anticipated that this extended power will generally be used to transfer functions from the Privy Council to the regulatory bodies for the affected professions rather than to third parties.

335.     Paragraph 5 makes amendments to paragraph 8 of Schedule 3 to the Health Act 1999, which specifies other matters that are outside the scope of an Order under section 60. Paragraph 5(2) and (3) allow the fitness to practise functions of the regulatory bodies to be transferred to the OHPA by a section 60 Order. It also ensures that the functions currently exercised by the RPSGB and the PSNI (or any of their committees or officers) can be transferred to a new regulatory body (the proposed General Pharmaceutical Council), using an Order under section 60, which would otherwise be prohibited as regards certain protected functions.

336.     Paragraph 6 makes amendments to paragraph 9 of Schedule 3 to the Health Act 1999, which specifies the preliminary procedures for making an Order under section 60. Paragraph 6(2) makes changes to clarify that where an Order under section 60 deals with more than one profession (for example, pharmacists and pharmacy technicians, or doctors and dentists), representations on the published draft order should be invited from people considered appropriate to represent any profession covered by the Order. Representations should also be invited from people considered appropriate to represent the users of the services provided by any profession covered by the Order.

337.     Paragraph 6(3) and (4): see the explanation in relation to paragraph 2 above.

338.     Paragraph 7(a): see the explanation in relation to paragraph 2 above.

339.     Paragraph 8 amends paragraph 11 of Schedule 3 to the Health Act 1999, by replacing references to the National Health Service Act 1977 with references to the NHS Act 2006 and the NHS (Wales) Act 2006 (which consolidate NHS legislation in England and Wales respectively).

340.     Paragraph 9 repeals paragraph 12 of Schedule 3 to the Health Act 1999, which contains limitations on the extent to which changes can be made under section 60 in relation to the regulation of the pharmacy profession in Northern Ireland. This will allow for changes to the PSNI through an Order under section 60, specifically for the regulatory function of the PSNI to be transferred to a new General Pharmaceutical Council (subject to a decision by Northern Ireland Ministers to proceed in this way).

Clause 104: Standard of proof in fitness to practise proceedings

341.     Currently, the application of the standard of proof in fitness to practise proceedings by regulatory bodies is not consistent. At present, eight of the health regulatory bodies use the civil standard of proof and three health regulatory bodies use the criminal standard of proof in fitness to practise proceedings. These are the GMC, the GOC, and the NMC.

342.     Clause 104 inserts a new section 60A into the Health Act 1999. This new section imposes a requirement for all regulatory bodies and the new OHPA to use the civil standard of proof in fitness to practise proceedings. A restriction is included in subsection (4), the effect of which is that an Order under section 60 of the Health Act 1999 may not amend this new section or make any provision which is inconsistent with the imposition of the civil standard of proof.

Council for Healthcare Regulatory Excellence

Clause 105 and Schedule 10: Council for Healthcare Regulatory Excellence

343.     Clause 105 changes the name of the CRHP to the Council for Healthcare Regulatory Excellence. As a consequence of the name change, a number of consequential amendments are required to the National Health Service Reform and Health Care Professions Act 2002 and other enactments, which are set out in Schedule 10.

344.     The general functions of the Council for Healthcare Regulatory Excellence are set out in section 25 of the Health Care Professions Act 2002. Clause 105 inserts a new subsection (2A) into section 25 of the Health Care Professions Act 2002, setting out that the main objective of the Council for Healthcare Regulatory Excellence, in exercising its functions, is to promote the health, safety and well-being of patients and other members of the public.

Clause 106: Constitution etc of the Council

345.     Clause 106 makes provision regarding the constitution of the Council for Healthcare Regulatory Excellence. The present Council of nineteen members is reduced to nine members. It will consist of a chair appointed by the Privy Council, six non-executives appointed by the Secretary of State and the devolved administrations, and two executives appointed by the Council itself. The Privy Council and the Secretary of State may, if they wish, delegate the selection process to the Appointments Commission.

346.     In addition, in subsection (3), amendments are made to the enabling powers to make regulations (contained in paragraph 6 of Schedule 7 to the Health Care Professions Act 2002) relating to conditions of appointments, tenure of office etc. of the chair, Council members and deputy chair as a consequence of the change in the constitution. Subsection (6) inserts a new sub-paragraph into paragraph 16 of Schedule 7 to require the Council for Healthcare Regulatory Excellence in its annual report to include a statement on how it and each health professions regulatory body has, in the Council's opinion, promoted the health, safety and well-being of patients and other members of the public.

Clause 107: Powers of Secretary of State and devolved administrations

347.     Clause 107 inserts a new section 26A in the Health Care Professions Act 2002 and amends section 26 of that Act. It enables the Secretary of State, the Welsh Ministers and the Scottish Ministers and the DHSSPSNI to require the Council for Healthcare Regulatory Excellence to provide advice, investigate and report on matters relating to the regulation of the health care professions. It also enables the Secretary of State, after consulting with the Welsh Ministers, the Scottish Ministers and the relevant Northern Ireland department and the Council for Healthcare Regulatory Excellence, to make directions as to the manner in which the Council carries out its functions.

Clause 108: Duty to inform and consult the public

348.     Clause 108 inserts a new section 26B into the Health Care Professions Act 2002, which imposes a duty on the Council for Healthcare Regulatory Excellence to publish, or provide in a suitable manner, information about itself and the carrying out of its functions. It also imposes a duty on the Council for Healthcare Regulatory Excellence to seek the views of members of the public, and bodies which appear to it to represent the interests of patients, on issues relating to the Council's functions.

Clause 109: Reference of cases by Council to court

349.     Clause 109 amends section 29 of the Health Care Professions Act 2002. Section 29 is extended to enable the Council for Healthcare Regulatory Excellence to refer to the High Court or, in Scotland, the Court of Session, cases relating to impairment of fitness to practise on grounds of ill health, in addition to cases relating to misconduct and professional competence.

350.     This clause makes some minor amendments which update references to the committees to which section 29 applies. It also makes amendments to remove the ability of the Council for Healthcare Regulatory Excellence to refer cases of the GMC and the GOC to the High Court or, in Scotland, the Court of Session, as those cases will fall within the remit of the new OHPA. The GMC and GOC are given powers to refer these cases in Schedule 7. Subsection (3) clarifies which court has jurisdiction to deal with the referral by the Council for Healthcare Regulatory Excellence by reference to the address to which notification of the relevant decision was sent. Subsection (4) amends section 29(6) (which provides a time limit of four weeks within which the Council may refer the case to the High Court or, in Scotland, the Court of Session). Section 29(6) is amended to provide that the Council may not refer a case to the High Court or, in Scotland, the Court of Session, after a period of forty days. The forty days begin on the last day on which an appeal against the decision could be made.

 
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Prepared: 16 November 2007