Session 2016-17
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Other Bills before Parliament


 
 

 

LORDS AMENDMENTS TO THE

health service medical supplies (costs) BILL

[The page and line references are to HL Bill 81, the bill as first printed for the Lords]

Before Clause 1

1

Insert the following new Clause—

 

“Controlling costs of health service medicines

 

Remuneration for persons providing special medicinal products: England

 

In section 164 of the National Health Service Act 2006 (remuneration for

 

persons providing pharmaceutical services), after subsection (8) insert—

 

“(8A)    

Regulations may impose requirements in relation to remuneration

 

in respect of special medicinal products.

 

(8B)    

Such regulations may, for example, require determining authorities

 

to ensure—

 

(a)    

that remuneration is to be calculated by reference to the

 

outcome of prescribed procedures, or

 

(b)    

that determinations do not provide for or permit

 

remuneration to be paid in prescribed circumstances.

 

(8C)    

Procedures prescribed by virtue of subsection (8B)(a) may include

 

the person to whom remuneration is payable, a health service body

 

or a determining authority—

 

(a)    

carrying out inquiries to ensure that remuneration is

 

reasonable, or

 

(b)    

estimating an amount of remuneration that is reasonable

 

(whether or not the estimated amount corresponds exactly

 

to expenses in respect of which remuneration is to be paid).

 
 

 

 
 

2

 
 

(8D)    

Circumstances prescribed by virtue of subsection (8B)(b) may

 

include circumstances in which special medicinal products are

 

made available to persons who provide pharmaceutical services

 

under this Part—

 

(a)    

by a health service body, or

 

(b)    

under an arrangement for the supply of special medicinal

 

products to which a health service body is a party.

 

(8E)    

In subsections (8A) to (8D)—

 

“health service body” has the meaning given by section 9(4);

 

“special medicinal product” means a product which is a

 

special medicinal product for the purposes of regulation 167

 

of the Human Medicines Regulations 2012 (S.I. 2012/

 

1916).””

 

2

Insert the following new Clause—

 

“Remuneration for persons providing special medicinal products: Wales

 

In section 88 of the National Health Service (Wales) Act 2006 (remuneration

 

for persons providing pharmaceutical services), after subsection (8)

 

insert—

 

“(8A)    

Regulations may impose requirements in relation to remuneration

 

in respect of special medicinal products.

 

(8B)    

Such regulations may, for example, require determining authorities

 

to ensure—

 

(a)    

that remuneration is to be calculated by reference to the

 

outcome of prescribed procedures, or

 

(b)    

that determinations do not provide for or permit

 

remuneration to be paid in prescribed circumstances.

 

(8C)    

Procedures prescribed by virtue of subsection (8B)(a) may include

 

the person to whom remuneration is payable, a health service body

 

or a determining authority—

 

(a)    

carrying out inquiries to ensure that remuneration is

 

reasonable, or

 

(b)    

estimating an amount of remuneration that is reasonable

 

(whether or not the estimated amount corresponds exactly

 

to expenses in respect of which remuneration is to be paid).

 

(8D)    

Circumstances prescribed by virtue of subsection (8B)(b) may

 

include circumstances in which special medicinal products are

 

made available to persons who provide pharmaceutical services

 

under this Part—

 

(a)    

by a health service body, or

 

(b)    

under an arrangement for the supply of special medicinal

 

products to which a health service body is a party.

 

(8E)    

In subsections (8A) to (8D)—

 

“health service body” has the meaning given by section 7(4);

 
 

 


 
 

3

 
 

“special medicinal product” means a product which is a

 

special medicinal product for the purposes of regulation 167

 

of the Human Medicines Regulations 2012 (S.I. 2012/

 

1916).””

 

3

Insert the following new Clause—

 

“Duty to have regard to the life sciences sector and access to new medicines and

 

treatments

 

In discharging, through the provisions established or amended by this Act,

 

its responsibility to secure best value for the National Health Service in

 

purchasing medicines and medical supplies, the Government must have

 

full regard to the need to—

 

(a)    

promote and support a growing life sciences sector within the

 

United Kingdom economy; and

 

(b)    

ensure that patients have rapid clinical access to new clinically

 

effective and cost-effective medicines and treatments approved by

 

the National Institute for Health and Care Excellence through their

 

technology appraisal process.”

Clause 5

4

Page 3, line 25, at end insert—

 

“( )    

Section 260 (control of maximum price of medical supplies, other than

 

health service medicines) is amended in accordance with subsections (2)

 

and (2A).”

 

5

Page 3, line 26, leave out from “In” to second “for” in line 27 and insert “subsection

 

(1)”

 

6

Page 3, line 28, at end insert—

 

“(2A)    

After subsection (1) insert—

 

“(1A)    

Before making an order under subsection (1) the Secretary of State

 

must consult any body which appears to the Secretary of State

 

appropriate to represent persons who manufacture, distribute or

 

supply medical supplies falling within subsection (1).””

 

7

Page 3, line 34, at end insert—

 

“( )    

In section 272(6) (orders, regulations, rules and directions subject to

 

affirmative procedure), after paragraph (a) insert—

 

“(aa)    

the first order under section 260,”.”

Clause 6

 

 


 
 

4

8

Page 5, line 24, at end insert “(including, in relation to profits, the costs incurred by

 

the producer in connection with the manufacturing, distribution or supply of the

 

products)”

 

9

Page 5, leave out lines 33 to 35 and insert—

 

“(5)    

Regulations under this section must require the Secretary of State to

 

give a UK producer an information notice if information is required

 

in respect of the costs incurred by the producer in connection with

 

the manufacturing, distribution or supply of a particular UK health

 

service product (other than costs which relate to any transaction

 

between the producer and a UK producer for that product).

 

(5A)    

An information notice is a notice stating—

 

(a)    

the period in relation to or for which, or intervals at which,

 

information is required to be provided,

 

(b)    

the form and manner in which information is required to be

 

provided,

 

(c)    

the time at which or period within which information is

 

required to be provided, and

 

(d)    

that a right of appeal is conferred by virtue of section

 

265(5A).

 

(5B)    

Regulations under this section may require information which does

 

not fall within subsection (5) to be provided—

 

(a)    

in relation to or for a prescribed period or at prescribed

 

intervals,

 

(b)    

in a prescribed form and manner, and

 

(c)    

at a prescribed time or within a prescribed period.”

 

10

Page 7, leave out line 9 and insert—

 

“(l)    

such of the following as may be prescribed—

 

(i)    

an NHS foundation trust;

 

(ii)    

any health service body within the meaning of

 

section 9(4) (not falling within any of paragraphs (a)

 

to (k) above).”

Clause 7

11

Page 9, line 18, at end insert—

 

“(5A)    

The penalty may be—

 

(a)    

a single penalty not exceeding £10,000, or

 

(b)    

a daily penalty not exceeding £100 for every day on which

 

the contravention occurs or continues.”

 

12

Page 9, line 27, at end insert—

 

“(7A)    

The Welsh Ministers may by regulations increase (or further

 

increase) either of the sums mentioned in subsection (5A).”

 
 

 


 
 

5

 
 

13

Page 9, line 46, leave out from “any” to end of line 47 and insert “of the following

 

persons—

 

(a)    

a Local Health Board or other person appointed under

 

section 88(3)(b) to exercise the functions of a determining

 

authority under Part 7;

 

(b)    

an NHS trust established under section 18;

 

(c)    

any person who provides services to the Welsh Ministers or

 

to any person falling within paragraph (a) or (b);

 

(d)    

any body which appears to the Welsh Ministers appropriate

 

to represent Part 4 providers or Part 7 providers (as defined

 

by section 201A(8)).”

 

14

Page 10, line 7, leave out “or 201B”

Clause 8

15

Page 11, line 4, after second “section” insert “(other than enforcement decisions

 

falling within subsection (5A))”

 

16

Page 11, line 4, at end insert—

 

“( )    

After subsection (5) insert—

 

“(5A)    

Provision must be made by regulations for conferring on UK

 

producers a right of appeal against enforcement decisions taken in

 

respect of them in pursuance of section 264A and this section if the

 

enforcement decisions relate to information notices given by virtue

 

of section 264A(5).””

 

17

Page 11, line 20, at end insert—

 

“(18)    

In section 203(6) of the National Health Service (Wales) Act 2006 (statutory

 

instruments which are subject to affirmative procedure) after “section

 

25B(3)(c) or” insert “201A(7A) or”.”

Clause 9

18

Page 11, line 24, after “Section” insert “(Remuneration for persons providing special

 

medicinal products: England) and”

 

19

Page 11, line 24, after “Section” insert “(Remuneration for persons providing special

 

medicinal products: Wales) and”

 

20

Page 11, line 24, after “7” insert “and 8(18)”

 
 

 


 
 

6

 

Clause 10

21

Page 11, line 29, leave out “Section 7 comes” and insert “Sections (Remuneration for

 

persons providing special medicinal products: Wales) and 7 and 8(18) come”

 

22

Page 11, line 33, leave out “make”

 

23

Page 11, line 34, leave out paragraph (a) and insert—

 

“( )    

appoint different days, or make different provision, for different

 

purposes or areas, and”

 

24

Page 11, line 35, at beginning insert “make”

 
 

 


 

 

Revised 24 February 2017