Session 2019-21
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Other Bills before Parliament


 
 

1

 

House of Commons

 
 

Notices of Amendments

 

given up to and including

 

Wednesday 3 June 2020

 

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: 8 to 28, NC2 to NC5

 

Public Bill Committee


 

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withdrawn amendments at the end.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.

 


 

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.

 



 
 

Notices of Amendments: 3 June 2020                     

2

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

9

 

Parliamentary Star    

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

 

22

 

Parliamentary Star    

Clause  1,  page  1,  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

 

23

 

Parliamentary Star    

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

 

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

 

8

 

Parliamentary Star    

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

 

Parliamentary Star    

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.


 
 

Notices of Amendments: 3 June 2020                     

3

 

Medicines and Medical Devices Bill , continued

 
 

(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.

 


 

Alex Norris

 

11

 

Parliamentary Star    

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

 

Parliamentary Star    

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

 

24

 

Parliamentary Star    

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).


 
 

Notices of Amendments: 3 June 2020                     

4

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

25

 

Parliamentary Star    

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).

 


 

Alex Norris

 

13

 

Parliamentary Star    

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

 

Parliamentary Star    

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

 

15

 

Parliamentary Star    

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

 

26

 

Parliamentary Star    

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).


 
 

Notices of Amendments: 3 June 2020                     

5

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

27

 

Parliamentary Star    

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

 

Parliamentary Star    

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

 

Parliamentary Star    

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

 

“(l)    

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

 

18

 

Parliamentary Star    

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

 

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.


 
 

Notices of Amendments: 3 June 2020                     

6

 

Medicines and Medical Devices Bill , continued

 
 

Jo Churchill

 

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

 

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

 

28

 

Parliamentary Star    

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.

 


 

Alex Norris

 

19

 

Parliamentary Star    

Clause  43,  page  24,  line  17,  leave out “on such day or days as the Secretary of State

 

may by regulations made by statutory instrument appoint” and insert “six months after

 

this Act receives Royal Assent.”

 

Member’s explanatory statement

 

This amendment brings the enforcement regime into force at a defined period after Royal Assent

 

rather than at a date of the Government’s choosing.

 


 

Anne Marie Morris

 

NC1

 

To move the following Clause—

 

         

“National Medical Devices Registry and governance

 

(1)    

The Secretary of State must by regulations establish a national registry of medical

 

devices the purpose of which shall be—

 

(a)    

to record—

 

(i)    

every medical device implanted in, or

 

(ii)    

inserted into

 

    

a patient.


 
 

Notices of Amendments: 3 June 2020                     

7

 

Medicines and Medical Devices Bill , continued

 
 

(b)    

to consolidate existing English registries and require their owners to

 

migrate their data to such a registry, ensuring all GDPR consents have

 

been obtained or deemed obtained and to organise such data in a common

 

and consistent way.

 

(2)    

In designing such a registry, the Secretary of State must take account of existing

 

international—

 

(a)    

frameworks;

 

(b)    

terminology;

 

(c)    

protocols; and

 

(d)    

quality standards

 

to enable better international learning, collaboration, health outcomes, research

 

and product improvement globally.

 

(3)    

For the purposes of subsection (1), every device shall be required to have its own

 

unique identifier. Manufacturers of such devices or components of such devices

 

shall be required to provide the identification data of every device or device

 

component to the registry on manufacture, and on its sale or change of ownership.

 

(4)    

Clinical Commissioning Groups in England shall require all health service

 

providers using medical devices covered by this section to put in place a system

 

to require NHS trusts to record the clinical use of any such device or component

 

of such devices on the registry when used in their population. The records must

 

include—

 

(a)    

the date of use,

 

(b)    

the nature of the procedure,

 

(c)    

the clinicians performing the procedure

 

(d)    

clinical information about the condition of the patient at the point of use

 

and thereafter on any future reviews of the performance of the device,

 

and

 

(e)    

health outcomes, and information on how such records will be collected

 

in future.

 

(5)    

Every health service provider whose clinicians are implanting or inserting

 

medical devices shall establish its own procedure and protocols to record the data

 

as prescribed in this Act and by the Secretary of State in regulations made under

 

this Act, which shall be consistent, efficient and integrated into the health care

 

pathway for the medical procedure in question.

 

(6)    

The Secretary of State shall by regulation establish a stakeholder consultation

 

group with which to consult on the governance of any registry established under

 

subsection (1). The stakeholder group which must include—

 

(a)    

patients and patient groups,

 

(b)    

current national and international medical device registries,

 

(c)    

the Royal College of Surgeons, the Royal College of Physicians,

 

(d)    

the Nursing and Midwifery Council,

 

(e)    

the Medicines and Healthcare Products Regulatory Agency,

 

(f)    

the National Institute for Health and Care Excellence,

 

(g)    

NHS England and NHS Improvement,

 

(h)    

such other regulatory bodies as shall have a regulatory role,

 

(i)    

manufacturers, suppliers, commissioners, and health care providers and

 

their representative bodies,

 

(j)    

academic experts in designing and analysing register data, and

 

(k)    

NHSX and NHS Digital.


 
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Revised 04 June 2020