House of Commons - Explanatory Note
Health And Social Care Bill - continued          House of Commons

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Prescribing rights

Clause 60: Extension of prescribing rights

292. Clause 60 introduces new arrangements for the prescribing of medicines. Currently doctors, dentists and certain specified nurses, health visitors and midwives are authorised to prescribe prescription only medicines for human use. The Review of Prescribing, Supply and Administration of Medicines recommended the extension of prescribing rights to other health professionals.

293. Clause 60 amends section 58 of the Medicines Act 1968 which governs the sale, supply and administration of prescription only medicinal products both privately and within the NHS. New subsection (1)(e) enables new registered professional groups to be designated by order for the purpose of prescribing such medicines for human use. For example, physiotherapists may be given prescribing rights for certain drugs eg anti- inflammatories. One of the effects of this policy might be to remove the need for routine visits to the GP for continuing care.

294. Subsection (3) provides that the categories of persons who may be granted prescribing rights must be registered health professionals.

295. Subsection (4A) allows Ministers to provide by order that specified descriptions of appropriate practitioner designated under subsection (1)(e) (or nurses, midwives or health visitors designated under subsection (1)(d)) must comply with specified conditions relating to the circumstances of prescribing which may apply to appropriate practitioners.

296. Subsection (6) makes it an offence for a person to prescribe a medicinal product or to prescribe a medicinal product for which he is not an appropriate practitioner in contravention of a condition imposed under subsection (4A).

297. Subsection (7) enables the Secretary of State to establish an advisory body under section 4 of the 1968 Act to consider whether prescribing rights should be granted to any additional group of health professional and to advise on any conditions or limitations that should be applied to their prescribing, prior to the clause coming into force.

Clause 61: Regulations and orders

298. Clause 61 makes provision about orders and regulations , in particular where they are exercisable by statutory instrument; the parliamentary procedure governing statutory instruments; how the powers may be exercised.

Clause 62: Interpretation

299. This clause gives definitions of terms used in the Bill. In particular it provides that "regulations" means regulations made by the relevant authority. It also gives the definition of "relevant authority".

Clause 63: Minor and Consequential amendments and repeals

300. Clause 63 gives effect to amendments made in Schedule 5 and the repeals specified in Schedule 4.

Clause 64: Powers of National Assembly for Wales for Wales under amended Acts

301. Clause 64 provides that any reference to an Act mentioned in the National Assembly for Wales for Wales (transfer of functions) Order 1999 and amended by the Bill, shall be a reference to that Act as amended.

Clause 65: Financial provisions

302. Clause 65 provides for expenditure relating to the Act to be paid out of money provided by Parliament.

Clause 66: Short Title commencement and extent

303. Clause 66 gives the short title of the Bill and makes provisions for commencement and extent.

Financial and public service manpower effects of the bill

304.      The provisions for free nursing care introduce considerable additional public spending. Other proposals in the Bill will result in much smaller levels of additional expenditure, or transfer the costs around the public expenditure system as existing functions are exercised in new ways. The details of the financial and manpower consequences are set out below.

305. Significant increases in health and social services expenditure have been provided for in the Year 2000 Spending Review. NHS expenditure will grow in real terms by 5.8% in each of the next three years. Social services will see real terms increases of 3.4% on average, over the next three years. The additional expenditure associated with this Bill will be meet within these planned increases.

Part I The National Health Service

306. Clauses 2 and 3 provide new powers for the provision of a more flexible performance fund to reward performance. While these powers do not in themselves require any additional expenditure the NHS Plan proposes the provision of a performance fund to underpin the system of earned autonomy. £500m will be available to reward the performance of the NHS in 2003/04.

307. Clause 4 provides for the Secretary of State to invest in companies to establish public private partnerships to provide facilities and services to the NHS. The intention is to invest £50m between 2001/02 and 2003/04 in NHS LIFT, a public private partnership to invest in primary care facilities. This public investment is to underpin a much larger fund of up to £1bn to be raised by NHS LIFT for primary care improvements.

308. Clause 7 expands the remit of local authority Overview and Scrutiny Committees to cover health services. Local authorities will be expected to absorb the costs of this additional function. As the powers are essentially permissive the exact costs involved will depend on local decisions as to the level of NHS scrutiny each authority undertakes.

309. Clauses 9 -14 establish new Patients Forums as part of a new system to engage and involve patients in decisions about their local health services. Non-statutory Patient Advocacy and Liaison Services (PALS) and Independent Local Advisory Forums (ILAFs) will complete the new arrangements and CHCs will be abolished with effect from 31 March 2002. The new arrangements will require additional investment over that provided for CHCs. A further £10m is to be made available annually over the next three years on top of the £23m currently committed to funding CHCs. Health Authorities, NHS trusts and Primary Care Trusts will also be expected to contribute to the running of the PALS service from their main allocations.

310. Clause 17 abolishes the Medical Practice Committee resulting in a potential saving to the Government. Medical Practice Committee staff will be absorbed elsewhere in the NHS. Health Authorities will take on the Medical Practice Committee's major function of declaring GP vacancies in a particular area. This is not expected to lead to additional costs as Health Authorities are already required to do much of this work in order to apply to the Medical Practice Committee for a vacancy to be declared.

311. Clause 19 abolishes the NHS Tribunal. Clauses 21 -28 set out the replacement arrangements. Health Authorities will take on responsibility for maintaining lists of all Family Health Service practitioners entitled to practice in the NHS, and for removing and suspending practitioners from those list. There will be additional costs associated with establishing new lists; these are to be met within existing provision. The ongoing cost implications of these changes will depend on the numbers of suspension and removals made by each Health Authority. The current funding for the NHS Tribunal will be made available to cover the additional costs of the FHSAA in hearing appeals against Health authority decisions to remove practitioner from their lists.

Part II Pharmaceutical Services

312. Clauses 29 - 41 provide for the establishment of Local Pharmaceutical Services, where the Health Authority agrees the provision of local pharmaceutical services on the basis of a local contract. LPS schemes are intended as a way by which Health Authorities may make better use of resources, through making more cost effective arrangements for pharmaceutical and related health services in place of, or in addition to existing provision. There will be some additional costs for Health Authorities associated with setting up schemes, the exact amount will depend on the number of such schemes and the extent of any financial assistance that HAs provide for preparatory work.

313. Clause 43 provides for an extension to the range of professionals able to prescribe prescription only medicines on the NHS. While these provisions could lead to an increase in prescribing we expect their prescribing activity to largely substitute for the prescribing by other professionals, and should reduce the need for patients to attend multiple consultation.

Part III Care Trusts

314. Care Trusts are intended to build on partnership arrangements between health and social services to deliver more effective, integrated services. It is not anticipated that they will lead to additional expenditure overall although there may be some initial start up costs.

Part IV Social Care

315. Clause 48 ensures the NHS takes responsibility for nursing care, and local authorities no longer purchase nursing care. As local authority services are currently means tested and NHS services free, transferring nursing care to the NHS will lead to increased public expenditure. It is anticipated that the additional full year costs of providing free nursing care will be £165m. Initial costs will be higher as existing recipients of local authority commissioned nursing care will need to be assessed. These costs are additional to existing public expenditure on nursing care by local authorities and the Department of Social Security for people with preserved rights.

316. Clause 49 transfers responsibility for the provision of services for people with preserved rights to higher levels of income support to local authorities. To support this change of responsibility the £528m the Government would expect to spend on social security benefits for this group will be made available to local authorities in 2002/03. A further £86m will also be made available to local authorities to cover the shortfall between preserved rights benefits levels and the actual costs of care, together with the costs of assessment and case management.

317. Clause 53 enables local authorities to enter into a deferred payment arrangement with a person entering care, so that the local authority picks up the costs of the placement to be reimbursed through a charge on the residents home on its eventual sale. There will be a substantial initial cost to this policy which will reduce over time as charges start to balance the costs of new residents' care. To help local authorities meet these costs a special grant of £15m / £30m / £40m is to be provided in each of the next three years.

Part V Miscellaneous and Supplementary

318. Clause 60 allows for the extension of prescribing rights to professional groups beyond Doctors and Nurses and for an advisory committee to recommend the granting of applications for prescribing rights. Initial costs for training and the advisory committee are estimated at £5.5m spread over three years.

Summary of the regulatory appraisal

319. Many of the provisions of the Health and Social Care Bill relate to the provision of the National Health Service and the legal framework within which that service is provided. A limited number of measures will have an indirect effect on businesses.

320. The first three proposals (accreditation by Health Authorities of all organisations providing out-of-hours GP services; local pharmaceutical services and cross boundary dispensing) are not primarily regulatory in purpose or effect. They neither impose, remove, nor reform any regulatory burdens. Instead they are concerned with the relationship between the NHS and those people who provide medical services on its behalf, and the legal framework within that relationship operates.

321. The accreditation by Health Authorities of all out-of-hours GP service providers was recommended by the recent independent review and subsequent Report Raising Standards for Patients, New Partnerships in Out-of-Hours Care. Organisations will be required to meet a set of nationally defined quality standards before being granted accreditation. The intention is to speed the quality and speed of service provision by all organisations in order to provide better protection for patients. The main effect of the proposal will be on GP practices and GP Co-operatives, and a limited number of commercial companies who provide out-of-hours GP services. The proposed quality standards are grounded firmly in current best practice. They are derived from observations made on visits to existing out-of-hours providers and from submissions to the Review from GPs and GP organisations, out-of-hours service providers and Health Authorities. Many of the organisations that provide out-of-hours services are already delivering these high standards of service within existing resources.

322. The first pharmacy proposal will provide the legislative framework within which Health Authorities will be able to negotiate individual agreements with pharmacies and others for the provision of NHS pharmaceutical services, initially on a pilot basis. The new agreement will be known as "local pharmaceutical services". Participation in LPS arrangements will be voluntary. The second proposal will permit cross boundary provision of pharmaceutical services. This will ultimately remove the obstacles to pharmacies wishing to dispense NHS prescriptions through "e-pharmacy". There could be indirect costs and benefits for retail activities associated with the provision of NHS pharmaceutical services, but at this stage it is not possible to make any assessment of its likely indirect impact.

323. The proposals for long term care will not impose direct costs to business providing health and social care. They will however have some effect on the market within which these businesses operate and their administrative arrangements.

324. In providing for free nursing care the Bill moves the responsibility for arranging these services to the NHS. In some cases this may mean that District Nursing services take on some of the care needs of people in residential care, or in other cases the NHS will simply contract with the Nursing Home for the nursing elements of the residents care. Transfer of preserved rights could prove of assistance to providers as preserved rights payments have not kept pace with the fees paid under local authority contracts in recent years. The moves to allow cross border placements are essentially deregulatory.

European convention on human rights

325. Section 19 of the Human Rights Act 1998 requires the Minister in charge of a Bill in either House of Parliament to make a statement, before second reading, about the compatibility of the provisions of the Bill with the Convention rights (as defined by section 1 of that Act). The Secretary of State for Health has made the following statement:

"In my view the provisions of the Bill are compatible with the Convention rights."

Extent

326. Clause 66 makes standard provision for commencement and extent. It provides that the Bill extends only to England and Wales, except sections 49 to 51 and 58 (preserved rights), section 60 (prescribing rights) and 61, 62 and 66 (supplementary provisions) which also extend to Scotland.

Commencement

327. Some technical provisions of the Act will come into force on Royal Assent. The substantive provisions of the Act will come into force on such a day, or days, as the relevant authority may determine.

ANNEX A

OUTLINE OF THE EXISTING LAW

328. The following paragraphs provide a brief description of the current legislative framework for the NHS and Social Services. The legislative framework for the NHS in England and Wales is mostly set out in the National Health Service Act 1977 ("the 1977 Act"). This has been amended quite substantially by various enactments, notably by the National Health Service and Community Care Act 1990 ("the 1990 Act"), the Health Authorities Act 1995 ("the 1995 Act"), the National Health Service (Primary Care) Act 1997 ("the Primary Care Act") and the Health Act 1999 ("the Health Act").

329. The legislative framework for Social Services in England and Wales is set out in the National Assistance Act 1948, the National Health Service Act 1977 ("the 1977 Act"), the National Health Service and Community Care Act 1990 ( "the 1990 Act") and the Community Care (Direct Payments) Act 1996 ( the "Direct Payments Act").

330. This section is divided into two : firstly existing legislation about the NHS and miscellaneous legislation and secondly existing legislation about social care.

Existing legislation about the NHS

National Health Service Act 1977

331. Under the 1977 Act, the NHS is essentially split into two different systems. The first is the system which consists primarily in the provision of health care in hospitals. It also covers those services described as "community health services", for example the services provided by district nurses, midwives or health visitors in clinics or individuals' homes, and the provision of medical services to pupils in state schools. This system is the subject of Part I of the 1977 Act. The responsibility for securing the provision of these services to patients rests with the Secretary of State, although under his powers in section 16C (formerly section 13) of the 1977 Act he has delegated most of his functions to Health Authorities. Health Authorities enter into arrangements with bodies known as NHS Trusts for the provision by the Trusts of hospital and community health services.

332. The other main part of the NHS structure is what might be described as "the NHS on the high street". This is dealt with under Part II of the 1977 Act which governs the arrangements made by Health Authorities for the provision of services by the following professionals: general medical practitioners (GPs)(i.e. family doctors), general dental practitioners (GDPs), ophthalmic opticians and ophthalmic medical practitioners (also known as optometrists), and pharmacists. They respectively provide what are termed general medical services (GMS)(section 29ff), general dental services (GDS)(section 35ff), general ophthalmic services (GOS)(sections 38-40) and pharmaceutical services (PhS)(sections 41-43) respectively. The remainder of Part II contains other provisions relevant to the provision of these "high street" services, which are often referred to as family health services.

333. The 1990 Act, the Primary Care Act and the Health Act introduced a number of changes to these systems of health care. Broadly speaking, these changes were as follows:

(a) the 1990 Act introduced what is known as the internal market; by creating a divide between the planning and purchase of Part I services, on the one hand, and the provision of those services, on the other:

(b) the Primary Care Act in effect enabled what were previously Part II services to be delivered, not under Part II, but under a more flexible system within Part I of the Act - these changes applied only to doctors and dentists, and not the other family health services practitioners; and

(c) the Health Act made a number of changes, but in particular provided for the abolition of GP fund-holding (introduced by the 1990 Act), the establishment of Primary Care Trusts (a new type of NHS body to both commission and provide NHS care) and new arrangements to improve the quality of NHS services and co-operation between NHS bodies and local authorities.

334. The two systems, Part I and Part II, are very different. It should be noted that despite the changes introduced by the Primary Care Act the provision of Part I services is distinct from the provision of services under Part II. The changes proposed in this Bill will not alter this divide. The following is a more detailed description of the two systems.

Part I system - hospital and community health services

335. The system provided for under Part I of the 1977 Act (and Part I of the 1990 Act - discussed below) is the system under which all of the NHS, apart from family health services, is provided, including its hospitals. The core duty to ensure the provision of a health service is laid upon the Secretary of State (1977 Act, section 1) in extremely broad terms, and is supplemented by the provisions of the sections 2 to 5.

336. Section 3 sets out those general services which it is the Secretary of State's duty to provide to such extent as he considers necessary to meet all reasonable requirements. Most of the services that may be described as hospital and community health services are included under this section.

337. Section 5(1) and (1A) impose duties on the Secretary of State to provide medical and dental services to state school pupils. This is the basis for what is described as the school nursing service.

338. Section 2 confers wide ranging powers for the Secretary of State to provide such services as are appropriate to discharge any duty imposed on him by the Act (including his general duty under section 1), and to do any other thing whatsoever which is calculated to facilitate, or is conducive to or incidental to, the discharge of any duty imposed on him by the Act. Further miscellaneous powers relating to specific matters are conferred by section 5(2) (for example, the conduct and assistance of research and development (section 5(2)(d)).

339. Sections 8 to 18 of the 1977 Act go on to provide for the administration of the NHS. These sections have been substantially amended since 1977, most recently by the Health Act. As amended, they provide for the setting up of Health Authorities (section 8), Special Health Authorities (section 11) and Primary Care Trusts (section 16A, as inserted by section 2 of the Health Act). Health Authorities, Special Health Authorities and Primary Care Trusts are independent statutory bodies, although their membership is determined in accordance with regulations (and in the case of Special Health Authorities, the establishment order) and some of the appointments to their membership are made by the Secretary of State. Health Authorities and Primary Care Trusts are established for territorial purposes. Each Health Authority is established for such area of England and Wales as set out in the establishment order made under section 8. The entire area of England and Wales is covered by Health Authorities. Each Primary Care Trust is established for the area specified in its establishment order under section 16A(3). Each Primary Care Trust area is wholly contained within the area of a Health Authority, but there is no requirement for total coverage. Some areas of England are covered by Primary Care Trusts, others are not. There are no Primary Care Trusts in Wales, as the relevant provisions of the Health Act have yet to be brought into force in Wales. Special Health Authorities are established for specific functional purposes - they are established for the purpose of performing any functions of the Secretary of State which he may then direct them to perform under section 16C.

340. The Secretary of State may direct a Health Authority or Special Health Authority to exercise his functions (section 16C, formerly 13, of the 1977 Act). A Health Authority may direct a Primary Care Trust established in their area to exercise those of its functions which it is permitted to delegate (section 17A, inserted by section 12 to the Health Act). The Secretary of State may direct Health Authorities that delegable Health Authority functions are or are not to be exercisable by Primary Care Trusts, or are to be exercisable by Primary Care Trusts to any specified extent (section 17A(4)). The Secretary of State may also give directions to a Health Authority, Special Health Authority or Primary Care Trust about the exercise of any of their functions (section 17). A Health Authority may also give directions to a Primary Care Trust about the exercise of any functions which the Health Authority has directed the Primary Care Trust to exercise (section 17B). These Directions may be given by regulations or by instrument in writing (section 18). There is very little further prescription in primary legislation as to what the Secretary of State must do or how he must do it in relation to the provision of that part of the NHS which is not concerned with family health services. It will be seen that this way of providing services is a great deal more flexible than the regulatory system envisaged under Part II. There are probably historical reasons for this, but those reasons are no longer relevant.

341. Health Authorities may, in accordance with regulations and any relevant directions, delegate their functions (whether Part I or Part II) to each other, or to committees or others (section 16 of the 1977 Act (as substituted by paragraph 9 of Schedule 4 to the Health Act)). Similar provision is made for Primary Care Trusts (section 16B of the 1977 Act (as inserted by section 2(1) of the Health Act)). Regulations have been made under both provisions.

342. Health Authorities and Special Health Authorities are funded under the provisions of section 97, as substituted by paragraph 47 of Schedule 1 to the 1995 Act and amended by section 36 of the Primary Care Act and by sections 4 and 8 of the Health Act. Health Authorities are paid money in each year under section 97(1) and section 97(3). Section 97(1) concerns the remuneration of persons providing Part II services and is not cash-limited (in other words the Secretary of State must pay whatever it has cost the Health Authority, and he cannot impose a ceiling on the expenditure). Under section 97(3) a Health Authority is paid money not exceeding the amount allotted to them by the Secretary of State. This amount is allotted towards meeting their "main expenditure" which includes all expenditure attributable to the performance of their Part I functions, and all their administrative costs. The money paid in respect of Part I services is therefore ultimately cash-limited. To enforce the cash-limits set by the Secretary of State, Health Authorities have various financial duties imposed upon them by section 97A of the 1977 Act (as substituted by paragraph 48 of the 1995 Act and amended by paragraph 23 of Schedule 2 to the Primary Care Act).

343. Primary Care Trusts are funded by Health Authorities under section 97C of the 1977 Act, as inserted by section 3 of the Health Act. There is a similar distinction between cash-limited and non-cash-limited funding. PCTs are also subject to a set of financial duties similar to those for HAs.

344. The cash-based system provided by sections 97, 97A, 97C and 97D has now been supplemented by a "resource-based" system provided for in sections 97AA and 97E, as inserted by sections 12 and 13 of the Government Resources and Accounts Act 2000 (c.20). These provide for the Secretary of State to set an annual limit on the use of resources by each Health Authority and for Health Authorities to set annual limits on the resources used by each of their Primary Care Trusts.

Funding the NHS

345. Health Authorities are funded under the provisions of section 97 of the 1977 Act, as substituted by paragraph 47 of Schedule 1 to the 1995 Act and amended by section 36 of the Primary Care Act and sections 4 and 8 of, and paragraph 31 of Schedule 4 to, the Health Act. Health Authorities are paid money in each year under section 97(1) and section 97(3). Section 97(1) concerns the remuneration of persons providing Part II services and is covered in the next section. Section 97(3) concerns Part I expenditure and administrative costs. Under section 97(3) a Health Authority is paid money not exceeding the amount allotted to it by the Secretary of State. This amount is allotted toward meeting its "main expenditure", which includes all expenditure attributable to the performance of its Part I functions, all its administrative costs, and certain other expenditure. The money paid in respect of Part I services is therefore cash limited. To enforce the cash-limits set by the Secretary of State, Health Authorities have various duties imposed upon them by section 97A of the 1977 Act (as substituted by paragraph 48 of the 1995 Act and amended by paragraph 23 of the Schedule 2 to the Primary Care Act and paragraph 32 of Schedule 4 to the Health Act). It is possible for the Secretary of State to make one off direct payments to NHS Trusts by way of public dividend capital, loans or payments under NHS contracts. Direct payments to Primary Care Trusts can only be made by NHS contracts.

 
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Prepared: 21 December 2000