PART III: MISCELLANEOUS AND SUPPLEMENTARY
CLAUSE 47: REGULATION OF HEALTH CARE PROFESSIONS
160. Clause 47 provides for Her Majesty
by Order in Council to make provision modifying the regulation
of the health care professions to which subclause (2) applies
or regulating the health care professions to which subclause (3)
applies. This includes repealing, amending or replacing any enactment
or prerogative instrument, or other instrument or document.
161. Paragraph 1 of Schedule 3 provides an illustration
of the matters about which an Order may make provision. These
include the establishment of regulatory bodies, the keeping of
a register, education and training of members of the profession,
procedures relating to discipline and fitness to practice.
162. The enactments that currently regulate the
health professions make detailed provisions which, with very few
exceptions, may only be changed by means of primary legislation.
It has hitherto not proved possible to make amendments as promptly
as would be desirable. In the Government's view therefore there
is a need for a mechanism to enable the legislation governing
the professions to be kept up to date. The Order-making power
would enable the Government to be more responsive to changing
public expectations of the professions and the professions' own
views about the development of their regulation. It will enable
new responsibilities to be given to existing bodies or new professional
regulatory bodies to be established to carry out new or existing
163. Many of the Acts strike a different balance
between primary and secondary legislation from that which might
be thought more appropriate today, having very detailed procedural
and administrative provisions on the face of the Act. There is
no common approach across all the professions on many matters.
For instance, Schedule 1 to the Dentist Act 1984 stipulates that
there shall be six members of the General Dental Council (GDC)
who are not registered dentists. The GDC wishes to increase lay
involvement, which will therefore require amendment to the primary
legislation. This is in contrast to the position under the Medical
Act 1983 which gives the General Medical Council powers to make
regulations about the constitution of its membership. In
the Government's view it is desirable to have the ability to make
changes to such provisions without the need for an Act of Parliament
whilst strengthening the arrangements for consultation of interested
parties and maintaining an appropriate level of Parliamentary
164. The independent review of the Professions
Supplementary to Medicine Act 1960, which reported in July 1996,
concluded that completely new legislation is needed to streamline
existing arrangements. The Government broadly accepted the key
recommendations of the review. It is intended that the Order making
power be used to replace the regulatory framework of the 1960
Act at the same time as it is repealed under clause 47(4).
165. The Government will soon be publishing the
results of the independent review into the Nurses Midwives and
Health Visitors Act 1997. It is intended that the Order making
power would be used to implement many of the report's recommendations.
However, if it is concluded that the Act should be repealed, this
would be put on the face of the Bill.
166. Ministers have been asked to make changes
that require amendments to the law. In addition to the implementation
of the review of the 1960 Act, the professional regulatory bodies
have proposed changes to allow greater lay representation, mandatory
continued postgraduate education, professional performance procedures,
amongst other matters. It is anticipated that the majority of
the changes made by these Orders will be at the request of the
167. Clause 47 also enables the Secretary of
State to make statutory provisions covering health professions
not currently regulated by statute. It will enable provision to
be made, for example, for the registration of individual practitioners,
disciplinary and health procedures, protection of common title
and the making of a link between remaining on the register and
demonstration of continued competence. A number of health professions
have expressed a wish for such statutory provisions.
168. Some of those professions will be content
to be included under a new health professions' council, which
would replace the Council for Professions Supplementary to Medicine.
Others may wish to have a separate regulatory framework, for instance
by the establishment of a free-standing regulatory scheme or the
conferral of statutory powers on an existing body which governs
169. In order to make the kind of changes proposed,
the Order-making power needs to be of sufficient scope. However,
Schedule 3 sets some important limits on the power:
paragraph 2(2)(a) provides that an Order setting
up a replacement for the 1960 Act should not make provision for
the professions covered by existing single professions' Councils
paragraph 6 places limits on the ability of the power
to create criminal offences to those where the maximum punishment
on summary conviction is a fine at level 5 on the standard scale.
This is commensurate with penalties in the existing professional
paragraph 7 provides that an Order cannot abolish
the regulatory body of the professions listed in clause 47(2).
(The Council of Professions Supplementary to Medicine is excepted
as it will be replaced by a new council when the 1960 Act is repealed
under the Bill.)
paragraph 8 provides that where the four core functions
associated with professional regulation, listed in paragraph 8(2),
are exercised in accordance with legislation by a professional
body, the Order may not provide for them to be exercised by anyone
other than a professional body.
170. Paragraph 3 of the Schedule enables an Order
to make provision for the delegation of functions, including the
power to make, confirm or approve subordinate legislation. All
the Acts regulating the health professions confer powers on the
regulatory bodies to make subordinate legislation. For example,
section 2 of the Nurses, Midwives and Health Visitors Act 1997
("NM&HV Act") enables the UKCC to make rules concerning
the content and standard of training. This paragraph enables an
Order to confer such powers on new or existing regulatory bodies.
It also enables an Order to make provision for confirming or approving
such subordinate legislation. Where subordinate legislation made
by the relevant professions is required to be approved, it is
the Privy Council that does so for all the relevant professions
(except regarding nurses, midwives and health visitors whose rules
are approved by the Secretary of State). Section 35(1) of the
Chiropractors Act 1994, for example, provides for this. In addition,
the power could provide for a regulatory body to be able to delegate
such functions as monitoring standards of education and training.
The regulatory body could then enter into a contract with another
body to exercise that function.
171. Paragraph 5 enables functions to be conferred
on Ministers of the Crown, Scottish Ministers or the National
Assembly for Wales. This will enable an Order to make provision
for a Minister to pay grants to a body. An example of such a power
is section 17(3) of the NM&HV Act. It would also enable an
Order to set up bodies for different parts of the UK to deal with
matters in connection with professional regulation.
172. Prior to the making of an Order under clause
47, it is intended that there will be full consultation with the
profession concerned and other interested bodies. It is anticipated
that in most cases the professions will wish to consult their
members and other interested parties before any decision is taken
to draft an Order.
173. Once an Order has been drafted, paragraph
9 of Schedule 3 provides that the draft must be published at least
three months in advance of the draft Order being laid before Parliament.
Following publication the Secretary of State must consult representatives
of the profession on the draft Order. It is also intended that
other interested parties (e.g. patients' groups) would be consulted.
After the consultation period, the draft Order, with any modifications
the Secretary of State considers appropriate in the light of the
consultation, may be laid before Parliament. Clause 48(6) provides
that the draft Order must be subject to affirmative procedures.
Only then may the Secretary of State recommend to Her Majesty
that the Order be made.
174. In the case of an Order which includes matters
within the legislative competence of the Scottish Parliament (for
example, where the regulation of that profession is not a reserved
matter under the Scotland Act 1998), paragraph 7 provides that
the Order must be subject to affirmative procedures in the Scottish
Parliament as well as the UK Parliament.
175. Paragraph 2(2)(b) makes clear that Orders
are not, in general, to be used to amend the Medicines Act 1968.
However, paragraph 2(3) allows an Order to amend sections 80 to
83 of the Medicines Act, which deal with the disciplinary functions
of the Statutory Committee in respect of retail pharmacy businesses.
The Statutory Committee is established under the Pharmacy Act
1954 as a committee of the Royal Pharmaceutical Society of Great
Britain (RPSGB), and is also responsible for disciplinary matters
in respect of individual pharmacists. Its functions under the
Medicines Act include the power to disqualify bodies corporate
from running retail pharmacy businesses where (for example) a
Director of the company has been guilty of the kind of misconduct
which would result in a pharmacist's name being removed from the
professional register. The RPSGB has recently consulted on a package
of proposals for modernising its disciplinary procedures for both
individual pharmacists and retail pharmacy businesses, and the
Government wishes to be able to use the Order-making power to
implement, as appropriate, the whole package.
176. Paragraph 12(1) provides that an Order may
amend the regulation of the profession of pharmacy in Northern
Ireland only to the extent that it is currently governed by UK
wide legislation (sections 80 to 83 of the Medicines Act). The
functions of the Statutory Committee under these sections are
exercised by a separate Committee in Northern Ireland. Paragraph
12(2) ensures that an Order cannot change this.
CLAUSE 48: REGULATIONS AND ORDERS
177. Clause 48 concerns regulations and orders
made under the provisions of the Bill. Such regulations or orders
are to be statutory instruments and, subject to certain exceptions,
will be subject to the negative resolution procedure. The exceptions
are: orders under clause 49 (supplementary and consequential provision)
which contain only provisions for or in connection with the transfer
of any property, rights or liabilities; and commencement orders
under clause 52.
178. Clause 48(2) contains the usual provision
that subordinate legislation under the Bill may make supplementary,
incidental, consequential, transitory, transitional or saving
provision as is necessary or expedient. Subject to subsection
(3), this power does not include a power to amend or repeal any
enactment instrument or document.
179. Clause 48(3) provides that regulations under
clause 15 (functions of the Commission for Health Improvement)
and clause 24 (arrangements between NHS bodies and local authorities)
may include supplementary, incidental or consequential provision
amending or appealing any enactment, instrument or document. The
justifications for such power are set out in the paragraphs of
this Memorandum dealing with those clauses (86 and 102 respectively).
180. Clause 48(6) and (7) deal with the procedure
for Orders in Council under clause 47 (regulation of the health
care and associated professions).
CLAUSE 49: SUPPLEMENTARY AND CONSEQUENTIAL PROVISION
181. Clause 49 confers on the Secretary
of State a power to make orders containing supplementary, incidental,
consequential, transitory, transitional or saving provision, as
he considers necessary or expedient for the purposes, in consequence
of or for giving full effect to any provision of the Bill. Subsection
(2) then provides that such an order may make provision amending
or repealing any enactment, instrument or document. With a Bill
of this length, dealing with a wide range of different subjects,
a substantial number of consequential amendments to existing legislation
and other supplementary, incidental or transitional provisions
will be required. To include all the necessary consequential and
supplementary provisions in the Bill would lengthen the Bill,
and take up Parliamentary time on consequential and supplementary
matters. In addition, the nature and extent of some consequential
or supplementary requirements, including the necessary legislative
amendments, may not become apparent until after the Bill is in
force. The Department therefore considers it appropriate that
the power in clause 49 should extend to amending or repealing
other enactments, instruments or documents.
182. Orders under clause 49 will be subject to
the negative resolution procedure. The Department considers that
this procedure is justified in the present case, even where such
an order will amend or repeal an enactment. The powers are merely
to enable modification of statutory provisions by way of consequential,
supplementary or transitional adaptation. To apply the affirmative
procedure would involve the needless consumption of Parliamentary
time on consequential or supplementary matters.
CLAUSE 50: AMENDMENTS OF ENACTMENTS
183. Clause 50 gives effect to Schedule 4. Unless
stated otherwise below, the provisions of this Schedule do not
create new powers to make delegated legislation or alter the procedure
for existing powers. Generally speaking, they extend existing
powers consequentially, for example to make provision for the
new Primary Care Trusts. For the purposes of this Memorandum,
the Department has identified below those provisions of the Schedule
which extend existing powers.
184. Paragraph 4(c) confers on the Secretary
of State the power to change the name of a Health Authority. This
power is an extension of the existing power of the Secretary of
State by order to make provision in relation to Health Authorities
- see section 8 of the 1977 Act (as substituted by section 1 of
the Health Authorities Act 1995). At present the Secretary of
State has no such power; he may only vary a Health Authority's
area, abolish a Health Authority or establish a new one and make
incidental and supplemental provision (see section 8(4)). The
purpose of the power is to allow the Secretary of State to change
the name of a Health Authority without having to change the boundaries
of the Health Authority or establish a new one. This will be appropriate
where, for example, an existing name no long reflects the name
of a new unitary local authority, which has replaced the old county
or district councils as part of recent local government re-organisations.
185. Paragraph 5 extends the existing power to
make regulations under section 16 of the 1977 Act providing for
the exercise of functions on behalf of a Health Authority, or
by a Health Authority jointly with another. This will enable the
regulations to provide that Health Authorities may arrange for
the exercise of their functions jointly with a Primary Care Trust,
or on behalf of the Health Authority by a joint committee of the
authority and one or more Primary Care Trusts.
186. Paragraph 7 extends the existing power of
the Secretary of State to give directions to Health Authorities
to make their staff available to local authorities or other public
bodies (section 27 of the 1977 Act), so as to cover Primary Care
Trusts and their staff. Such directions will continue to be given
in writing (see section 126(3A) of the 1977 Act).
187. Paragraph 11 extends the existing power
of the Secretary of State to provide in regulations that any functions
exercisable by a Health Authority or Special Health Authority
in relation to the provisions of facilities for university clinical
teaching and research may be exercised jointly with other health
service bodies (section 51(2) of the 1977 Act), so as to cover
the exercise of such functions by Primary Care Trusts.
188. Paragraph 16 extends the existing power
to make orders transferring property held on trust between health
service bodies to Primary Care Trusts (see section 92 of the 1977
189. Paragraph 23 extends the existing power
to make an order conferring the function of paying sums to Health
Authorities in respect of Part II remuneration under section 103
of the 1977 Act to Primary Care Trusts.
190. Paragraph 24 amends section 126 of the 1977
Act, which makes provision for the orders, regulations and directions
made under the 1977 and 1990 Acts. To increase the consistency
and simplicity of the provisions of the Acts relating to directions,
paragraph 24(5) inserts a new section 126(3C), providing that
any person or body to whom directions are given under the 1977
Act or Part I of the 1990 Act must comply with the directions.
The various references throughout the legislation to the effect
that directions must be complied with may therefore now be removed
- the necessary amendments are made by paragraphs 12, 14, 20,
22, 26(3), 54(b). Similarly, the words do not now appear in the
new sections 16C to 17B of the 1977 Act, inserted by clause 7
(directions as to functions of Health Authorities and Primary
191. The two consequential amendments in paragraph 29
allow the Secretary of State to direct that Primary Care NHS Trusts
which have had Part II functions delegated to them from Health
Boards must consult local consultative committees in the same
way and in the same circumstances as Health Boards do at present.
This is a safeguard to ensure that when Part II functions
are delegated, the consultation arrangements are not disrupted.
A direction making power is desirable to allow for flexibility
in the range of matters relating to consultation which may require
to be addressed from time to time.
192. The minor provision paragraph 42(3) relates
to the powers of NHS Trust to invest money. Sub-paragraph (3)
allows a NHS Trust to invest only in an investment specified in
directions by the Secretary of State. This is to ensure that NHS
Trusts hold only limited amounts in financial institutions other
than paymaster accounts to ensure best value for money. The circumstances
will change from time to time and may vary from Trust to Trust;
and so a direction making power is appropriate.
193. Paragraph 49 makes changes to the provisions
concerning hospital complaints procedures (section 1 of the Hospital
Complaints Procedure Act 1985). Section 1(1) and (1A) impose a
duty on the Secretary of State to give directions to Health Authorities
and NHS trusts to make arrangements for dealing with hospital
complaints. Paragraph 49(c) of the Schedule inserts a new section
1(1C) that imposes a new duty on the Secretary of State to give
similar directions to Primary Care Trusts which manage hospitals.
194. Paragraph 55 amends the existing power to
make orders transferring staff from a Health Authority to an NHS
trust (section 6 of the 1990 Act), so as to enable the Secretary
of State to transfer staff from a Primary Care Trust to an NHS
trust, where a hospital or other establishment or facility managed
by a Primary Care Trust is to transfer to the NHS trust.
195. Paragraph 57 extends the existing power
to transfer property, rights and liabilities to an NHS trust (section
8 of the 1990 Act) so as to enable the Secretary of State to make
such transfers from a Primary Care Trust.
196. Paragraphs 61(3) and (4) make provisions
regarding NHS trusts' powers to invest money. Paragraph 61(3)
provides that NHS trusts may invest money in any investments specified
in directions under section 17 of the 1977 Act (as inserted by
clause 7). The aim is to ensure that NHS trusts hold only limited
sums in investments other than paymaster accounts, to reduce costs
to the Exchequer. The aim is to avoid placing a great deal of
administrative detail on the face of the Bill and enable the provisions
to be changed as necessary from time to time to reflect changing
financial circumstances. Paragraph 61(4) provides that certain
directions may only be given with the consent
of the Treasury.
CLAUSE 51: DEVOLUTION 1998
197. Clause 51(1) has the effect that where the
provisions of the Bill extend to Scotland (in particular clauses
36 to 46) the functions under those provisions, including powers
to make delegated legislation, will automatically transfer to
Scottish Ministers, when the Scottish Parliament inherits its
198. Clause 51(2) to (5) concern Wales and the
National Assembly for Wales. On the coming into force of a Transfer
of Functions Order under section 22 of the Government of Wales
Act 1998 many of the Secretary of State's functions in relation
to the health service will be transferred to the Assembly. Clause
51(2) provides that the functions of the Secretary of State under
the Bill, so far as exercisable in relation to Wales, will be
exercisable by the Assembly instead of the Secretary of State.
The powers to make delegated legislation conferred by the provisions
listed in subsection (2) will therefore be exercisable by the
Assembly. Delegated legislation made by the Assembly will be subject
to the procedures relating to subordinate legislation provided
for by the standing orders made under section 64 of the Government
of Wales Act 1998 (see also the provisions of 65 to 68 of the
Act relating to such procedures). The appropriate procedure for
each delegated instrument will therefore be a matter for the Assembly.
In accordance with the principles of devolution to Wales and the
provisions of the Government of Wales Act, such delegated legislation
will not be subject to procedures at Westminster.
199. The Committee will note that the order-making
power in clause 47 in relation to the regulations of the health
care and associated professions will not be exercisable by the
Assembly, and will be subject only to procedures at Westminster
and in the Scottish Parliament.
CLAUSE 52: COMMENCEMENT
200. Clause 52 provides for the Secretary
of State to commence provisions of the Bill by order. It would
not be practical for all the provisions to be introduced on Royal
Assent. Time is required to prepare for implementation of the
various provisions of the Bill, in particular the drafting of
delegated legislation. To allow flexibility in the time available
for preparation, commencement orders rather than fixed dates are
proposed. As is usual, such orders will not be subject to Parliamentary