PART 7PHARMACEUTICAL SERVICES

I1111Pharmaceutical needs assessments

1

After section 82 of the National Health Service (Wales) Act 2006 (c.42) (arrangements for additional pharmaceutical services: terms and conditions), insert—

82APharmaceutical needs assessments

1

A Local Health Board must prepare and publish an assessment of needs for pharmaceutical services in its area.

2

A Local Health Board must—

a

keep the assessment most recently published by it under subsection (1) under review, and

b

revise it as appropriate.

3

Regulations must—

a

specify a date by which a Local Health Board is to prepare and publish its first assessment under subsection (1);

b

make provision about circumstances in which a Local Health Board is to review and if appropriate revise its assessment (and may make such provision by reference to, among other things, a period within which or following which a Local Health Board is to review and if appropriate revise its assessment);

c

make provision about the way in which an assessment is to be published.

4

The regulations may make other provision about the preparation, publication, review and revision of an assessment under subsection (1), including (among other things) about—

a

the information to be contained in an assessment (which may include, among other things, information relating to persons with whom a Local Health Board has entered into a general medical services contract);

b

the extent to which an assessment is to take account of likely future needs and of other matters;

c

consultation to be carried out in connection with an assessment;

d

procedural requirements.

2

In section 203 of the National Health Service (Wales) Act 2006 (c.42) (orders, regulations and directions), after subsection (6) insert—

6A

A statutory instrument containing the first regulations under section 82A (pharmaceutical needs assessments) may not be made unless a draft of the instrument has been laid before, and approved by resolution of, the National Assembly for Wales.

I2112Pharmaceutical lists

1

Section 83 of the National Health Service (Wales) Act 2006 (c.42) (regulations as to pharmaceutical services) is amended as follows.

2

In subsection (2), in paragraph (c), for the words from “satisfied,” to the end of the paragraph, substitute “ satisfied as mentioned in subsection (2B), and ”.

3

After subsection (2) insert—

2A

The regulations may specify persons or descriptions of persons who are not to be included in a list prepared by virtue of subsection (2)(a).

2B

The Local Health Board is satisfied as mentioned in this subsection if, having regard to the assessment most recently published by it under section 82A and to any matters specified in the regulations, it is satisfied that granting the application would meet a need in its area for the services, or some of the services, specified in the application.

2C

In relation to cases where the Local Health Board is satisfied as mentioned in subsection (2B), the regulations may make provision as to—

a

the procedure for determining whether to grant the application;

b

matters to be taken into account for the purpose of determining whether to grant the application.

4

After subsection (3) insert—

3A

The regulations may prescribe circumstances in which two or more applications referred to in subsection (2)(c)(i) or (ii) may or must be considered together by the Local Health Board.

5

In subsection (4)—

a

for the words from “include” to “the case” substitute “ make provision for the Local Health Board to take into account prescribed matters ”;

b

omit paragraph (a);

c

in paragraph (b), for “they” substitute “ two or more applications referred to in subsection (2)(c)(i) or (ii) ”;

d

in paragraph (c), for “subsection (2)(c)” substitute “ subsection (2B) ”.

6

After subsection (4) insert—

4A

The regulations may in particular make the provision mentioned in subsection (5), with or without modifications.

7

In subsection (6)—

a

before paragraph (a) insert—

za

as to circumstances in which the Local Health Board may invite applications for inclusion in a pharmaceutical list,

b

after paragraph (f), insert—

fa

about the timescale for dealing with an application,

c

in paragraph (g), after the words “other grounds on which” insert “ or circumstances in which ”;

d

after paragraph (m) insert—

n

as to circumstances in which a Local Health Board may, or must, remove a person or an entry in respect of premises from the pharmaceutical list for breach of a term or condition of arrangements made with the Local Health Board for the provision of pharmaceutical services.

8

After subsection (6), insert—

6A

The regulations, if they make provision within subsection (6)(n), must specify that a person or entry is not to be removed by a Local Health Board unless—

a

the Local Health Board has given notice under section 106A (notice in relation to breach of arrangements) in respect of the breach, and

b

the person in respect of whom the notice was given has failed to comply with a requirement of that notice.

9

After subsection (10) insert—

10A

The regulations may make provision for a Local Health Board to give reasons for decisions made by virtue of this section.

10

In section 84 of the National Health Service (Wales) Act 2006 (c. 42), in subsection (2)—

a

after “application” insert “ on grounds corresponding to the conditions referred to in section 107(2), (3) or (4) as read with section 109 ”;

b

after “appeal” omit “(by way of redetermination)”.

11

In section 84 of the National Health Service (Wales) Act 2006 (c.42), after subsection (3), insert—

4

If regulations made under section 83 include provision for a Local Health Board to remove a person or an entry in respect of premises from a pharmaceutical list, the regulations must also make provision —

a

requiring the Local Health Board to give notice of its intention to remove the person or entry (including provision requiring the notice to give reasons for the intended removal);

b

about making representations.

12

In Schedule 6 to the Health Act 2009 (c.21) (repeals and revocations), in the table, omit the entry relating to section 83(6)(d) of the National Health Service (Wales) Act 2006 (c.42).