Session 2019-21
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Other Bills before Parliament


 
 

1

 

House of Commons

 
 

Notices of Amendments

 

given up to and including

 

Tuesday 2 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

 

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withdrawn amendments at the end.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: 2 June 2020                     

2

 

Medicines and Medical Devices Bill , continued

 
 

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”

 


 

Jo Churchill

 

2

 

Parliamentary Star - white    

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

 

3

 

Parliamentary Star - white    

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

 

Parliamentary Star - white    

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.

 


 

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.

 

(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;


 
 

Notices of Amendments: 2 June 2020                     

3

 

Medicines and Medical Devices Bill , continued

 
 

(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.

 

(7)    

The Secretary of State shall create such posts or bodies as needed to ensure the

 

creation and maintenance of the registry, and to ensure it delivers on its

 

objectives.

 

(8)    

The Secretary of State shall establish by regulations a mechanism ensuring that

 

the registry is accountable and delivers on its objectives, and to enable

 

transparency and access to the data in the registry by health care providers and

 

Clinical Commissioning Groups and such other national and international bodies

 

as the Secretary of State shall authorise.

 

Member’s explanatory statement

 

This new clause requires the Government to create a national registry of implanted and inserted


 
 

Notices of Amendments: 2 June 2020                     

4

 

Medicines and Medical Devices Bill , continued

 
 

medical devices which tracks their history and the patient experience to improve patient safety,

 

enable efficient recall if needed and to evaluate device performance.

 

 


 

Jo Churchill

 

5

 

Parliamentary Star - white    

Schedule  2,  page  34,  line  8,  leave out “case” and insert “ proceedings for such an

 

offence”

 

Member’s explanatory statement

 

See the explanatory statement for Amendment 2.

 

Jo Churchill

 

6

 

Parliamentary Star - white    

Schedule  2,  page  34,  line  14,  after “hearing” insert “of the proceedings”

 

Member’s explanatory statement

 

See the explanatory statement for Amendment 2.

 

Jo Churchill

 

7

 

Parliamentary Star - white    

Schedule  2,  page  34,  line  28,  at the end insert “and

 

(b)    

the reference in paragraph (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.

 

 

Order of the House [2 March 2020, as amended 22 april 2020]

 

That the following provisions shall apply to the Medicines and Medical Devices Bill:

 

Committal

 

1.    

The Bill shall be committed to a Public Bill Committee.

 

Proceedings in Public Bill Committee

 

2.    

Proceedings in the Public Bill Committee shall (so far as not previously

 

concluded) be brought to a conclusion on Thursday 11 June 2020.

 

3.    

The Public Bill Committee shall have leave to sit twice on the first day on

 

which it meets.

 

4.    

Proceedings on Consideration and any proceedings in legislative grand

 

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

 

conclusion one hour before the moment of interruption on the day on which

 

proceedings on Consideration are commenced.

 

5.    

Proceedings on Third Reading shall (so far as not previously concluded) be

 

brought to a conclusion at the moment of interruption on that day.

 

6.    

Standing Order No. 83B (Programming committees) shall not apply to

 

proceedings on Consideration and up to and including Third Reading.


 
 

Notices of Amendments: 2 June 2020                     

5

 

Medicines and Medical Devices Bill , continued

 
 

Other proceedings

 

7.    

Any other proceedings on the Bill may be programmed.

 


 

 

Revised 03 June 2020