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Conduct and performance of medical practitioners and other health care workers
Clause 110: Responsible officers and their duties relating to medical profession
351. This clause inserts a new Part 5A (responsible officers) into the Medical Act 1983 (which sets out the general provisions for the regulation of the medical profession). The new Part will contain six sections.
New section 45A of the Medical Act 1983 - requirement to nominate or appoint responsible officer
352. Subsection (1) allows the appropriate authority by regulations to designate certain organisations ("designated bodies"), which will be required to appoint or nominate persons who are to have specified responsibilities relating to the regulation of medical practitioners. These persons are to be known as "responsible officers". The appropriate authority in relation to England, Wales and Scotland is the Secretary of State and in relation to Northern Ireland is DHSSPSNI.
353. Subsections (3) and (4) set out the types of organisations which may be required to nominate or appoint a responsible officer. These are organisations which are directly or indirectly involved in providing healthcare, or which employ or contract with doctors (including in an administrative capacity). This wide definition of designated bodies is intended to ensure that all doctors in the United Kingdom, whether employees or self-employed, are linked to an appropriate responsible officer. The intention is that all NHS hospital trusts and PCTs in England and Wales, Health Boards in Scotland, larger private sector healthcare organisations such as independent hospitals, and larger locum agencies supplying the services of doctors, should nominate or appoint responsible officers.
354. Subsection (5) allows regulations to include criteria for appointment of responsible officers, and a requirement for designated bodies to provide them with resources. It would also allow regulations to permit two or more healthcare organisations to share the services of a single responsible officer - this could be helpful, for instance, for organisations only employing one or very few doctors. It also allows regulations to be made to authorise or require an organisation to have more than one responsible officer. Subsection (6) allows for regulations to require the GMC to be consulted before a responsible officer is nominated or appointed. Subsection (7) allows the regulations to specify cases where the Secretary of State is to nominate the responsible officer instead of the designated body itself.
New section 45B of the Medical Act 1983 - responsibilities of responsible officer
355. Subsection (1) allows regulations made under the new section 45A to specify the responsibilities of the responsible officer. Such responsibilities can include the evaluation of the fitness to practise of medical practitioners having a prescribed connection with the designated body; and, a duty to cooperate with the GMC in connection with its responsibilities either for medical revalidation (Part 3A of the Medical Act 1983) or fitness to practise proceedings (Part 5 of the Medical Act 1983). Subsection (3) sets out the power to prescribe a connection between a medical practitioner and the designated body. Subsection (4) enables the designated body to confer on the responsible officer any powers needed to undertake such responsibilities. Subsection (5) requires designated bodies to have regard to the responsible officer's functions under the regulations if it gives them other functions to perform.
New section 45C of the Medical Act 1983 - further provisions
356. Subsection (1) of this new section allows the appropriate authority to create, in regulations made under section 45A, offences for non-compliance or other procedures for enforcement. Subsection (2) allows for regulations to require healthcare organisations or their responsible officers to take account of guidance issued by or on behalf of the appropriate authority. Subsection (3) enables the regulations to require bodies employing medical practitioners (but which are not designated bodies), or medical practitioners themselves, to provide funds and resources to a responsible officer (or their employer) having prescribed responsibilities in relation to such medical practitioners. Subsection (4) allows for the regulations to require specified persons to supply information or produce documents to a responsible officer in connection with the performance of that officer's responsibilities.
New section 45D of the Medical Act 1983 - Crown application
357. This section extends this new Part 5A of the Medical Act 1983 to the Crown and to people in the service of the Crown. Subsection (2) provides that the Crown will not be criminally liable for contravention of any provision of that Part but any such contravention may be declared unlawful by the relevant court.
New section 45E of the Medical Act 1983 - regulations under section 45A: supplementary provisions
358. Section 45E requires regulations to be made by statutory instrument, or by statutory rule in relation to Northern Ireland, subject to the negative resolution procedure before Parliament or the Northern Ireland Assembly (as the case may be). Before making any regulations, the Secretary of State must consult Scottish and Welsh Ministers if the regulations are to extend to Scotland or apply to Wales respectively.
New section 45F of the Medical Act 1983 - Interpretation of Part 5A
359. Section 45F sets out the meaning of various terms used within this new Part 5A of the Medical Act 1983.
Clause 111: Additional responsibilities of responsible officers: England and Wales and Northern Ireland
360. This clause allows the Secretary of State in relation to England, the Welsh Ministers in relation to Wales, and the DHSSPSNI in relation to Ireland, by regulations to confer further responsibilities on responsible officers nominated or appointed under Part 5A of the Medical Act 1983. Subsection (1) sets out that these additional responsibilities may relate to the initial employment of doctors, the monitoring of the performance or conduct of doctors, and ensuring appropriate action is taken when concerns are raised in relation to such performance or conduct (in circumstances which would not call into question the doctor's fitness to practise under the Medical Act 1983). Subsection (5) applies sections 45A(5)(d), 45B(2) to (5) and 45C(1), (3) and (4) of the Medical Act 1983 (relating to the provision of resources, organisations having more than one responsible officer, the connection between a medical practitioner and a designated body, designated bodies conferring powers and additional functions on responsible officers, the creation of offences and procedures for enforcement and the provision of information) to regulations made under this clause in the same way as those sections apply to regulations made under section 45A of that Act. Subsection (6) enables regulations to require designated bodies or their responsible officers to take account of guidance issued by or on behalf of the appropriate authority.
Clause 112: Co-operation between prescribed bodies
361. Subsection (1) allows the appropriate Minister to make regulations requiring specified bodies:
- to share information relating to healthcare workers whose conduct or performance could be a threat to the safety of patients;
- to respond to appropriate requests for information from other specified bodies about the conduct or performance of any health care worker;
- to consider appropriate action and to take specified steps.
362. The bodies that may be specified for these purposes are those required to have responsible officers under the new Part 5A of the Medical Act 1983 (see the notes on clause 110 above) and any other organisations specified by the regulations (it is intended that all organisations employing or contracting with health care or social care workers, public bodies exercising regulatory functions in relation to the work of such persons, social services authorities, other health related organisations, and the police will be specified for these purposes).
363. Subsection (2) allows the regulations to require specified bodies to take active steps to disclose information in specified circumstances whether or not the information has been requested. Subsection (3) allows the appropriate Minister to create, in the regulations, offences for non-compliance, or other procedures for enforcement. Subsection (4) allows for the regulations to require specified bodies to take account of guidance given by or on behalf of the appropriate Minister. Subsection (5) defines a number of terms used in the clause. The "appropriate Minister" is defined as the Secretary of State except that, in relation to co-operation by a Welsh health body or a Welsh social services body, it means the Welsh Ministers.
Clause 113: Crown application
364. Clause 113 applies clauses 111 and 112 to the Crown and to people in the service of the Crown. Subsection (2) provides that the Crown will not be criminally liable for contravention of any provision of those sections or regulations made under them but any such contravention may be declared unlawful by the relevant court.
Regulation of social care workforce
Clause 114: Regulation of social care workers
365. Clause 114 enables the Secretary of State (in relation to England) and Welsh Ministers (in relation to Wales) to make regulations modifying the regulation of social care workers. Regulations may amend or repeal any enactment (subject to paragraphs 3 and 8 of Schedule 9). Subsection (3) defines "social care workers" by reference to the definition in section 55 of the Care Standards Act 2000. Subsection (4) clarifies certain matters that are within the scope of regulations under clause 114.
366. It is intended that regulations will be made to enable the legislative framework governing the social care workforce to be kept up to date; to take account of changing public expectations of the workforce; and to take account of the workforce's own views about the development of their regulation. New responsibilities can also be given to the Councils.
367. Schedule 9 supplements clause 114.
Schedule 9: Regulation of social care workers
368. Paragraph 2 of the Schedule gives examples of the matters which may be dealt with in regulations. Regulations may make changes to any aspect of the regulation of the social care workforce, subject to the limitations in paragraphs 3 and 8.
369. Paragraph 3 prevents the amendment by regulations of section 55 of the Care Standards Act 2000 which contains the definition of "social care worker" and is used for the purposes of clause 114 and the Schedule. But it permits the amendment or repeal of any other provision of the Act or any other enactment, instrument or document.
370. Paragraph 4 enables regulations to make provision for the delegation of functions, including the power to make, confirm or approve subordinate legislation. This paragraph enables regulations to confer the power on the Councils to make rules, and to make provision for any such rules to be confirmed or approved. Currently, the Care Standards Act 2000 enables the Councils to make rules about issues detailed in Part 4 of that Act. Any such rules are subject to the approval of the appropriate Minister.
371. Paragraph 5(a) provides for regulations to make provision about the charging of fees. It is intended that where fees are charged, the level of those fees will not exceed the costs incurred in exercising the function to which the fees relate.
372. Paragraph 6 enables regulations made by the Secretary of State to confer functions on Ministers of the Crown. It also enables regulations made by the Welsh Ministers to confer functions on the Welsh Ministers. For example, regulations might enable a Minister to pay grants to a body. Any conferment of functions would be subject to paragraph 8.
373. Paragraph 7 limits the new criminal offence that can be created using this power to one which, on summary conviction, leads to a fine not exceeding level 5 on the standard scale.
374. Paragraph 8 provides that regulations cannot abolish either the GSCC or the CCW. Paragraphs 8(2) and (3) state that regulations may not transfer to any other person certain functions conferred on the Councils (or any of their committees or officers) by the Care Standards Act 2000. These functions are: the keeping of the register of social care workers; determining standards of education and training required as a condition of registration; giving advice about standards of conduct and performance; and administering procedures relating to misconduct, removal from registration and similar matters.
375. Paragraph 9 obliges the Secretary of State (in relation to England) to consult persons appearing to him to represent social care workers affected by the regulations, those provided with services by the social care workers, and other persons that the Secretary of State considers it appropriate to consult prior to laying the draft regulations before Parliament. The consultation will be on the basis of the draft regulations. The Secretary of State must publish these in draft three months before they are laid before Parliament. Following consultation, the draft regulations will be laid before Parliament (as originally drafted or with appropriate amendments) accompanied by a report about the consultation. Draft regulations will be subject to Parliamentary scrutiny under the affirmative procedure.
376. Paragraph 10 imposes requirements, similar to those contained in paragraph 9, upon Welsh Ministers in relation to the procedure for making regulations in relation to Wales.
Clause 115: Standard of proof in proceedings relating to registration of social care worker
377. Clause 115 makes provision for the civil standard of proof to be used in any proceedings which relate to a social care worker's suitability to be or remain registered. The civil standard is to be used in all such proceedings whether before the GSCC or the CCW, or before one of their committees or any of their officers. It ensures that the civil standard of proof is applied consistently by all of the health and social care professions regulatory bodies.
378. Subsection (4) prevents regulations made under clause 114 from amending this section or making any provision that is inconsistent with the requirement to adopt the civil standard of proof. This means that any change to the requirement to use the civil standard can only be made through another Act of Parliament.
Approved mental health professionals
Clause 116: Education and training of approved mental health professionals
379. The Mental Health Act (as amended by the Mental Health Act 2007) provides for the approval of persons to act as AMHPs and confers functions on the Councils in relation to the education and training of people who are or wish to become AMHPs. When the relevant provisions come into force, AMHPs will take on the functions previously exercised by approved social workers, including making applications for a patient's admission and detention in hospital under Part 2 of the Mental Health Act. In addition to social workers, a wider group of professionals (for example nurses, occupational therapists and psychologists) will potentially be eligible for approval as AMHPs as long as they have the right skills, experience and training.
380. Clause 116 allows the Secretary of State in relation to the GSCC and the Welsh Ministers in relation to the CCW to make regulations modifying the functions of the Councils that relate to the education and training of AMHPs. This might cover, for example, their functions that relate to the approval of courses for social workers when acting as AMHPs.
381. Subsection (2) provides that the regulation-making power may be used to amend, repeal or applying (with or without modifications) any provision of any enactment, instrument or document.
382. Subsection (3) provides that certain paragraphs of Schedule 9 also apply (with modifications) to regulations made under this clause. For example, the regulations may provide for fees to be charged and payments to be made by the Councils (paragraph 5 of Schedule 9). The same procedure for making regulations under clause 114 applies to regulations made under this clause (paragraphs 9 and 10 of Schedule 9).
PART 3 - PUBLIC HEALTH PROTECTION
Public Health Protection
Clause 119: Public Health Protection
383. Clause 119 inserts a new Part 2A into the Public Health Act 1984. This new Part 2A replaces the existing Part 2 of the Act.
384. New section 45A defines certain terms used in the new Part. It provides that reference to infection or contamination is to that which presents or could present significant harm to human health. It also provides that reference to disinfection or decontamination includes the removal of any vector, agent, or source of infection or contamination.
385. New section 45B enables the appropriate Minister (defined in new section 45S(6) as the Secretary of State for England, or the Welsh Ministers for Wales) to make regulations for preventing danger to public health from conveyances (or the persons, or articles on those conveyances) arriving at for preventing the spread of infection or contamination by conveyances leaving any place. It also provides a power for regulations to give effect to international agreements or arrangements, for example World Health Organisation recommendations. It gives examples of particular measures the regulations might include. The powers are needed to enable similar provision to be made to that contained in the Public Health (Aircraft) Regulations 1979 (S.I. 1979/1434), the Public Health (Ships) Regulations 1979 (S.I. 1979/1435) (the "port health regulations"), or the Public Health (International Trains) Regulations 1994 (S.I. 1994/311), all of which are made under section 13 of the Public Health Act 1984.
386. New section 45C provides a power for the appropriate Minister to make regulations to prevent, protect against, control or provide a public health response to the incidence or spread of infection or contamination in England and Wales. The threat can come from outside England and Wales.
387. Section 45C(3) and (4) give examples of particular provision which might be made. For example new section 45C(3)(a) would enable the Secretary of State or Welsh Ministers to set out standing national requirements for notification of cases of specified diseases by registered medical practitioners to the local authority. Section 45C(3)(c) allows the Secretary of State or Welsh Ministers to impose restrictions or requirements directly on persons, or in relation to things or premises, or to enable another body, such as the local authority, to do so. Section 45C(4)(a) to (d) provide examples of measures that might be imposed, including special restrictions or requirements.
388. Section 45C(6)(a) defines special restrictions or requirements by reference to the measures that a justice of the peace can include in a court order by virtue of new section 45G(2), 45H(2), or 45I(2). The following measures are not regarded as special restrictions or requirements: a requirement to keep a child away from school, a restriction on the holding of an event or a requirement relating to the disposal of dead bodies.
389. New section 45D contains restrictions on the exercise of the power under section 45C. Section 45D(1) prohibits the appropriate Minister from making regulations containing restrictions or requirements under section 45C(3)(c) unless the Minister considers that the measures are proportionate to what is being sought to be achieved. Similarly regulations under section 45D(2) which enable imposition of a restriction or requirement under section 45C(3)(c) must provide that the person who decides to impose such a measure must consider when taking the decision that the restriction or requirement is proportionate to what is sought to be achieved by imposing it.
390. Section 45D(3) prohibits regulations from imposing a special restriction or requirement restricting or requiring medical examination, removal to or detention in hospital or another suitable establishment, or isolation or quarantine. Section 45D(4) prohibits regulations enabling a decision-maker to impose special restrictions or requirements unless there is a serious and imminent threat to public health when the regulations are made, or the power to impose the restrictions or requirements is expressed in the regulations to be contingent on there being such a threat at the time the power to impose them is exercised.
391. New section 45E excludes compulsory medical treatment, including vaccination, from the ambit of regulation-making powers in sections 45B and 45C.
392. New section 45F makes further provision about regulations under section 45B or 45C. This includes at new section 45F(3) details of when the regulations may be used to amend primary or secondary legislation. Section 45F(5) outlines the penalties for the offences that can be created using the regulations. These are a fine not exceeding £20,000 and a daily penalty not exceeding an amount equal to 2% of level 5 on the standard scale (£100) for continuing to commit an offence after initial conviction. Under subsection (2)(f) regulations may permit or prohibit the levy of charges. It is intended that where charges are levied, the level of those charges would not exceed the costs incurred in exercising the function to which the charges relate.
393. New section 45F(6) and (7) provide that, where a decision is taken under regulations made under section 45C by virtue of which a special restriction or requirement is imposed on or in relation to a person, thing or premises, the regulations must include provision allowing an individual (or business) to appeal to a magistrates' court against the decision. The regulations should also include a right of periodic review if the restriction or requirement continues.
394. New sections 45G to 45J make new provision for court orders. The powers conferred on justices of the peace are wider than currently provided for under the Public Health Act 1984. For example, court orders cannot currently be made under the Act in relation to things or premises. In some cases, requirements which could previously be imposed by a local authority under the Public Health Act 1984 will now be subject to a court order.
395. New section 45G(1) sets out the criteria that must be met for a justice of the peace to make an order under the legislation in relation to a person. The justice of the peace must be satisfied that:
- the person is or may be infected or contaminated;
- the infection or contamination presents or could present significant harm to human health;
- there is a risk that the person might infect or contaminate others; and
- it is necessary to make the order to remove or reduce that risk.
396. The measures that an order can provide for are described at section 45G(2). They are that a person be required to submit to medical examination, removal to or detention in hospital or other suitable establishment, be kept in quarantine or isolation, disinfected or decontaminated, wear protective clothing, provide information, have their health monitored, attend training or advice sessions, or be restricted as to where they go or with whom they have contact or from working or trading.
397. Section 45G(3) and (4) enable the justice of the peace to make an order requiring an individual who is, or may be, infected or contaminated to provide information about the identity of another individual where that other individual may also be infected or contaminated and there is a risk that that person might infect or contaminate others. This is known as contact tracing.
398. New section 45G(7) requires the appropriate Minister to make regulations setting out what evidence must be available to the justice of the peace before the justice can be satisfied that there are grounds for making an order. Section 45H(7) and 45I(7) enable the appropriate Minister to make similar regulations in relation to evidence for orders regarding things and premises, and in relation to evidence for orders regarding contact tracing in relation to things and premises.
399. New sections 45H(1) and 45I(1) require similar criteria to be fulfilled as new section 45G for a justice of the peace to make an order, but in relation to things and premises respectively. An order in relation to a thing might require, under section 45H(2), that the thing be seized, retained, kept in isolation or quarantine, disinfected or decontaminated, or destroyed. Similar measures are available under section 45I(2) in relation to premises (which include conveyances) except that instead of quarantine or isolation an order could require premises to be closed. New sections 45H(3) and (4) and 45I(3) and (4) also enable contact tracing in relation to things and premises respectively.
400. New section 45J makes provision in relation to groups of people, things or premises with regard to the powers in new sections 45G, 45H, and 45I. This will assist the justice of the peace to make the same provision in one order where, for example, more than one person has been contaminated by the same contaminant.
401. New section 45K makes supplementary provision about what can be included in an order of a justice of the peace, known as a "Part 2A order". It includes at new section 45K(3) provision that a measure in an Part 2A order may be conditional. For example, an order might state that if an individual refuses to be decontaminated, he must stay in isolation until the risk of contaminating others has passed.
402. Section 45K(5) allows the justice of the peace to include in a Part 2A order directions as to any action that might be appropriate to give effect to the order. This might, for example, include putting in place support provisions for a person undergoing a measure such as quarantine.
403. Section 61 of the Public Health Act 1984 as amended by paragraph 16 of Schedule 11 to the Bill provides for a right of entry or warrant authorising entry to enable a relevant health protection authority to enter premises other than a private dwelling, or a warrant authorising entry to premises including a private dwelling. Section 45K(6) provides that a Part 2A order can include authority to enter premises including a private dwelling instead of having to apply separately for a warrant under section 61. If an order includes such authority, subsections (1) and (1A) (as inserted by paragraph 17 of Schedule 11 to the Bill) of section 62 of the Public Health Act 1984 apply as if a warrant had been issued under section 61. This means, for example, that there can be tests of the premises or of anything found on them and that samples of the premises or anything found on them can be taken and retained.
404. New section 45L makes provision with regard to the length of time for which any restriction or requirement imposed by or under a Part 2A order may be in force. Section 45L(1) requires any restriction or requirement in an order to have a specified time limit. Section 45L(3) provides a time limit of 28 days where the order imposes detention in hospital or other suitable establishment, or quarantine or isolation of a person, Section 45L(2) enables further orders to be made extending the period. Section 45L(4) enables the appropriate Minister to specify in regulations the maximum period of any such extension under subsection (2). Subsection (4) also enables the appropriate Minister to specify in regulations the maximum period for which any restriction or requirement other than one for detention in hospital etc., quarantine or isolation may be imposed and the maximum period of any extension of that period.
405. New section 45M sets out the procedures for making, changing or revoking a Part 2A order. Only a local authority may apply for a Part 2A order (subsection (1) of section 45M), but an affected person, in addition to the local authority or any other authority with the function of executing or enforcing the order in question, can apply for the order to be varied or revoked (subsection (4)). Section 45M(5) sets out who is an affected person in the case of an order under section 45G(2), and enables regulations by the appropriate Minister to prescribe any other person as an affected person. Sections 45M(6)(c), (7)(c) and (8) provide similar regulation making powers in relation to the definitions of affected person for applications in respect of orders under sections 45H(2) and 45I(2). Section 45M(9) provides that varying or revoking a part 2A order does not invalidate any action already taken under the order. Part 2A orders can be made without the affected person being present or notified (subsection (3) of section 45M).
406. New section 45N enables the Secretary of State or Welsh Ministers to make regulations dealing with matters relating to the taking of measures pursuant to Part 2A orders including the provisions described at section 45N(2).
407. New section 45O provides that it is an offence to fail to comply, without reasonable excuse, with a restriction or requirement imposed by or under an order of a justice of the peace or to wilfully obstruct anyone executing the order. The offence is punishable with a fine of up to £20,000. Subsections (4) and (5) of section 45O provide that a constable may take into custody and return a person who leaves a place contrary to an order detaining or isolating or quarantining the person in that place.
408. New section 45P provides that regulations under Part 2A of the Public Health Act 1984 may make different provision for different cases or different areas.
409. New section 45Q sets out the three different Parliamentary procedures for making regulations under the powers at new sections 45B and 45C and those covering Part 2A orders. In general regulations including those under section 45B are made under the negative resolution procedure. Regulations made under section 45C are subject to the affirmative resolution procedure unless they contain a declaration under section 45Q(3) that the person making them is of the opinion that the regulations do not contain any provision made by virtue of section 45C(3)(c) imposing special restrictions or requirements, or restrictions or requirements that would have a significant effect on a person's rights. Regulations which amend primary legislation for the purpose of giving effect to an international agreement are also subject to the affirmative resolution procedure. The first set of regulations to be made under section 45G(7) will also be subject to the affirmative resolution procedure.
410. Regulations may be made and brought into effect immediately under section 45R(2) if they contain a declaration from the Minister who makes the regulations that the person making them is of the opinion that it is necessary by reason of urgency for them to be made without a draft being approved under the affirmative resolution procedure. If either House of Parliament (for English regulations) or the National Assembly for Wales (for Welsh regulations) decides to reject the regulations, then they will cease to have effect at the end of the day on which they are rejected (section 45R(5)). They will also cease to have effect after 28 days if a resolution approving them has not been passed by each House of Parliament (for English regulations) or the National Assembly for Wales (for Welsh regulations) (section 45R(4)).
411. Section 45S defines a number of terms used in new Part 2A of the Public Health Act 1984.
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