Session 2019-21
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Other Bills before Parliament


 
 

1

 

House of Commons

 
 

Monday 8 June 2020

 

Public Bill Committee

 

New Amendments handed in are marked thus Parliamentary Star

 

Parliamentary Star - whiteAmendments which will comply with the required notice period at their next appearance

 

Amendments tabled since the last publication: NC6 to NC8

 

Medicines and Medical Devices Bill


 

Note

 

This document includes all amendments tabled to date and includes any

 

withdrawn amendments at the end. The amendments have been arranged in the

 

order in which they relate to the Bill.

 


 

Resolution of the Programming Sub-Committee

 

The Programming Sub-Committee appointed by the Speaker in respect of the Bill

 

agreed the following Resolution at its meeting on Thursday 4 June (Standing Order No.

 

83C):

 

That—

 

(1)  

the Committee shall (in addition to its first meeting at 11.30 am on Monday

 

8 June) meet—

 

(a)  

at 3.30 pm on Monday 8 June; 

 

(b)  

at 9.25 am and 2.00 pm on Wednesday 10 June;

 

(2)  

the proceedings shall be taken in the order shown in the first column of the

 

following Table;

 

(3)  

the proceedings shall (so far as not previously concluded) be brought to a

 

conclusion at the times specified in the second column of the Table.

 

TABLE

 

Proceedings

Time for conclusion of proceedings

 
 

Clauses 1 to 4

1 pm on Monday 8 June

 
 

Clauses 5 to 11

6 pm on Monday 8 June

 
 

Clauses 12 to 26; Schedule 1;

11.25 am on Wednesday 10 June

 
 

Clauses 27 to 33

  
 

Clauses 34 to 36; Schedule 2;

5 pm on Wednesday 10 June

 
 

Clauses 37 to 45; new

  
 

Clauses; new Schedules;

  
 

remaining proceedings on the

  
 

Bill

  

 
 

Public Bill Committee: 8 June 2020                     

2

 

Medicines and Medical Devices Bill , continued

 
 

Jo Churchill has given notice of her intention to move a motion in the terms of the

 

Resolution of the Programming Sub-Committee [Standing Order No. 83C].

 


 

Jo Churchill

 

That, subject to the discretion of the Chair, any written evidence received by the

 

Committee shall be reported to the House for publication.

 

 


 

Jo Churchill

 

That, at this and any subsequent meeting at which oral evidence is to be heard, the

 

Committee shall sit in private until the witnesses are admitted.

 


 

Alex Norris

 

9

 

Clause  1,  page  1,  line  5,  at end insert “for a period of two years following Royal

 

Assent.”

 

Member’s explanatory statement

 

This amendment provides a sunset provision for the Bill requiring the Government to return with

 

primary legislation.

 

Alex Norris

 

Dr Philippa Whitford

 

22

 

Clause  1,  page  1,  leave out lines 10 to 16

 

Member’s explanatory statement

 

This amendment removes the requirement to consider the attractiveness of the relevant part of the

 

UK when making regulations under subsection (1).


 
 

Public Bill Committee: 8 June 2020                     

3

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

Dr Philippa Whitford

 

23

 

Clause  1,  page  2,  line  3,  at end insert—

 

“(5)    

In making regulations under subsection (1), the appropriate authority must give

 

primary regard to the safety of human medicines.”

 

Member’s explanatory statement

 

This amendment requires the appropriate authority to consider patient safety first when making

 

regulations under subsection (1).

 


 

Ms Marie Rimmer

 

Dr Philippa Whitford

 

1

 

Clause  2,  page  2,  line  23,  at end, insert—

 

“(o)    

the origin and treatment of human organs used in the process of

 

developing or manufacturing medicines”

 

Member’s explanatory statement

 

This amendment empowers the appropriate authority to make provisions on the process of

 

developing or manufacturing medicines in relation to the origin and treatment of human organs.

 


 

Alex Norris

 

Dr Philippa Whitford

 

8

 

Clause  4,  page  3,  line  25,  at end insert—

 

“(f)    

to support the involvement of the UK in EU-wide clinical trials.”

 

Member’s explanatory statement

 

This amendment gives the Secretary of State powers to continue the UK’s collaboration with

 

clinical trials involving multiple EU countries.

 

Alex Norris

 

10

 

Clause  4,  page  3,  line  25,  at end insert—

 

“(1A)    

The Secretary of State must lay before Parliament a report outlining which

 

proposed clinical trials related to human medicines have been rejected in the

 

preceding 3 months.

 

(1B)    

The first report mentioned in subsection (1A) must be laid before Parliament

 

within three months of this Act coming into force, with subsequent reports laid

 

every three months thereafter.”

 

Member’s explanatory statement

 

This amendment would give the Secretary of State a duty to report rejected applications for

 

proposed clinical trials related to human medicines.

 



 
 

Public Bill Committee: 8 June 2020                     

4

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

11

 

Clause  5,  page  3,  line  39,  at end insert—

 

“(1A)    

The Secretary of State must publish a fees regime within three months of the date

 

on which this Act receives Royal Assent.”

 

Member’s explanatory statement

 

This amendment requires the Secretary of State to publish their proposed list of fees in respect of

 

human medicines.

 


 

Alex Norris

 

12

 

Clause  8,  page  5,  line  17,  at end insert “services.”

 

Member’s explanatory statement

 

This amendment broadens the range of issues that the Secretary of State must consider to include

 

access to the relevant services to dispense veterinary medicines.

 

Alex Norris

 

Dr Philippa Whitford

 

24

 

Clause  8,  page  5,  leave out lines 18 to 24

 

Member’s explanatory statement

 

This amendment removes the requirement to consider the attractiveness of the relevant part of the

 

UK when making regulations under subsection (1).

 

Alex Norris

 

Dr Philippa Whitford

 

25

 

Clause  8,  page  5,  line  32,  at end insert—

 

“(5)    

In making regulations under subsection (1), the appropriate authority must give

 

primary regard to the safety of veterinary medicines in relation to animals,

 

humans and the environment.”

 

Member’s explanatory statement

 

This amendment requires the appropriate authority to consider animal, human and environmental

 

safety first when making regulations under subsection (1).

 



 
 

Public Bill Committee: 8 June 2020                     

5

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

Dr Philippa Whitford

 

13

 

Clause  9,  page  6,  line  11,  at end insert—

 

“(1A)    

The Secretary of State must by regulations make provision about the use of the

 

Cascade.”

 

Member’s explanatory statement

 

This amendment gives the Secretary of State the responsibility to make provisions regarding the

 

Cascade, a process where veterinarians can dispense different medicines to animals, such as

 

human medicines, should appropriate conventional animal medicines not be available.

 


 

Alex Norris

 

14

 

Clause  10,  page  6,  line  35,  at end insert—

 

“(1A)    

The Secretary of State must publish a fees regime within three months of the date

 

on which this Act receives Royal Assent.”

 

Member’s explanatory statement

 

This amendment requires the Secretary of State to publish their proposed list of fees in respect of

 

veterinary medicines.

 


 

Alex Norris

 

Dr Philippa Whitford

 

15

 

Clause  12,  page  7,  line  27,  at end insert—

 

“(d)    

the environmental sustainability of medical devices.”

 

Member’s explanatory statement

 

This amendment obliges the Secretary of State to pay regard to the environmental impact of

 

medical devices.

 

Alex Norris

 

Dr Philippa Whitford

 

26

 

Clause  12,  page  7,  leave out lines 26 and 27

 

Member’s explanatory statement

 

This amendment removes the requirement to consider the attractiveness of the relevant part of the

 

UK when making regulations under subsection (1).


 
 

Public Bill Committee: 8 June 2020                     

6

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

Dr Philippa Whitford

 

27

 

Clause  12,  page  7,  line  27,  at end insert—

 

“(3)    

In making regulations under subsection (1), the appropriate authority must give

 

primary regard to the safety of medical devices.”

 

Member’s explanatory statement

 

This amendment requires the appropriate authority to consider safety first when making

 

regulations under subsection (1).

 


 

Alex Norris

 

16

 

Clause  13,  page  8,  line  22,  at end insert—

 

“(1A)    

In making regulations under section 12(1), the Secretary of State must evaluate

 

the extent to which the market is meeting medical need.”

 

Member’s explanatory statement

 

This amendment requires the Secretary of State to ensure that the market in devices is keeping pace

 

with the UK’s medical needs.

 

Alex Norris

 

17

 

Clause  13,  page  8,  line  22,  at end insert—

 

“(k)    

enabling the Secretary of State to compile a register of representatives for

 

non-UK manufacturers.”

 

Member’s explanatory statement

 

Manufacturers of medical devices based outside the UK must designate a UK representative. This

 

gives the Secretary of State the power to compile a list of them.

 


 

Alex Norris

 

29

 

Clause  17,  page  10,  line  12,  at end insert—

 

“(f)    

advertising it.”

 

Member’s explanatory statement

 

This amendment allows the enforcement authority to prevent an individual who has been served a

 

suspension note from advertising their product.

 



 
 

Public Bill Committee: 8 June 2020                     

7

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

18

 

Clause  18,  page  10,  line  34,  at end insert—

 

“(f)    

advertising it.”

 

Member’s explanatory statement

 

This amendment allows the enforcement authority to prevent an individual who has been served a

 

suspension note from advertising their product.

 


 

Jo Churchill

 

Dr Philippa Whitford

 

2

 

Clause  24,  page  13,  line  26,  leave out “case” and insert “proceedings for such an

 

offence”

 

Member’s explanatory statement

 

This amendment, and amendments 3, 4, 5, 6 and 7, amend certain provisions to ensure they operate

 

effectively in relation to Scotland.

 

Jo Churchill

 

Dr Philippa Whitford

 

3

 

Clause  24,  page  13,  line  32,  after “hearing” insert “of the proceedings”

 

Member’s explanatory statement

 

See the explanatory statement for Amendment 2.

 

Jo Churchill

 

Dr Philippa Whitford

 

4

 

Clause  24,  page  14,  line  2,  at the end insert “, and

 

(b)    

the reference in subsection (3) to “the hearing of the proceedings” is to

 

be read as a reference to “the trial diet”.”

 

Member’s explanatory statement

 

See the explanatory statement for Amendment 2.

 


 

Alex Norris

 

Dr Philippa Whitford

 

28

 

Clause  30,  page  16,  line  23,  at end insert—

 

“(4)    

The Secretary of State must, within 24 months of this Act receiving Royal Assent,

 

lay a report before Parliament reviewing uses of this clause.”

 

Member’s explanatory statement

 

This amendment requires the Government to review any use of the recall powers made in the first

 

2 years of the Act.

 



 
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Revised 05 June 2020