Session 2019-21
Internet Publications
Other Bills before Parliament


 
 

Public Bill Committee: 8 June 2020                     

8

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

Dr Philippa Whitford

 

19

 

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.

 

(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


 
 

Public Bill Committee: 8 June 2020                     

9

 

Medicines and Medical Devices Bill , continued

 
 

(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

 

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

 

enable efficient recall if needed and to evaluate device performance.

 



 
 

Public Bill Committee: 8 June 2020                     

10

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

NC2

 

To move the following Clause—

 

         

“Report on medicines under development

 

On the date on which this Act is passed, and once every twelve months thereafter,

 

the Secretary of State must lay before Parliament a report detailing what

 

medicines the UK Government are developing.”

 

Member’s explanatory statement

 

This new clause requires the Secretary of State to lay before Parliament a report covering

 

medicines that the UK Government are developing.

 


 

Alex Norris

 

NC3

 

To move the following Clause—

 

         

“Report on availability of medicines

 

The Secretary of State must report to Parliament when a medicine which is

 

clinically beneficial has not been made available on the NHS.”

 

Member’s explanatory statement

 

This new clause requires the Secretary of State to report to Parliament when a medicine which is

 

effective has not been made available on the NHS.

 


 

Alex Norris

 

Dr Philippa Whitford

 

NC4

 

To move the following Clause—

 

         

“Antimicrobial Resistance

 

(1)    

The Secretary of State must regard antimicrobial resistance a priority in the

 

development of new medicines.

 

(2)    

The Secretary of State must, within 12 months of this Act receiving Royal Assent,

 

lay an updated report before Parliament setting out a UK-wide strategy for

 

tackling antimicrobial resistance.”

 

Member’s explanatory statement

 

This new clause requires the Government to prioritise tackling antimicrobial resistance and

 

produce an updated report setting out how it shall do so.

 



 
 

Public Bill Committee: 8 June 2020                     

11

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

NC5

 

To move the following Clause—

 

         

“Capacity of the veterinary industry

 

(1)    

The Secretary of State must, within 12 months of making regulations under

 

section 8(1), lay a report before Parliament setting out an assessment of the

 

capacity of the veterinary industry, relative to the requirements of those

 

regulations.”

 

Member’s explanatory statement

 

This new clause requires the Government to make an assessment of the capacity of the veterinary

 

industry.

 


 

Dr Philippa Whitford

 

Alex Norris

 

NC6

 

Parliamentary Star    

To move the following Clause—

 

         

“Registration of Medical Devices

 

(1)    

The Secretary of State shall by regulations establish a UK Registry of all devices

 

implanted into patients on a long-term basis.

 

(2)    

The identifier details of any devices implanted into patients, on a long-term or

 

permanent basis, must be registered.

 

(3)    

The information registered must include—

 

(a)    

The unique identifier of the patient into whom the device is implanted;

 

(b)    

The Clinician responsible for the procedure;

 

(c)    

The hospital or clinic in which the procedure is performed;

 

(d)    

A standardised description of the device;

 

(e)    

The unique identifier code of the device implanted.

 

(4)    

Efforts must be made for this unique identifier data to be gathered by barcode

 

reader as in the trial of ‘Scan for Safety’.

 

(5)    

This Registry shall require linkage from all currently established speciality device

 

registries, in current operation, to avoid duplication of registration.

 

(6)    

Devices without any form of specialist registry currently available shall be

 

registered in this UK Registry.

 

(7)    

Governance structures regarding the management and access to registry data shall

 

be established after consultation with stakeholders including but not limited to—

 

(a)    

the appropriate authorities as defined in Section 1 (4);

 

(b)    

all UK based Royal Colleges of Surgery or Radiology and any others

 

representing clinicians involved in such procedures;

 

(c)    

Managers of current speciality device registries;

 

(d)    

the Medicines and Healthcare products Regulatory Agency;

 

(e)    

the Directors of each of the four UK based National Health Services;

 

(f)    

healthcare quality improvement bodies from each of the four UK based

 

National Health Services;

 

(g)    

representatives of the Healthcare device manufacturing sector;

 

(h)    

academics with expertise in the design and maintenance of registries;


 
 

Public Bill Committee: 8 June 2020                     

12

 

Medicines and Medical Devices Bill , continued

 
 

(i)    

additional stakeholders as identified during the development and

 

maintenance of such a registry.

 

(8)    

Patient information from such a registry shall be provided to clinicians if there is

 

concern regarding the management of or complications from any implanted

 

device to allow closer monitoring or removal if so warranted.”

 

Member’s explanatory statement

 

The aim of such a UK register is to ensure earlier recognition of complications from implantable

 

devices and allow the easy identification and urgent recall of affected patients should such a

 

concern be recognised.

 


 

Dr Philippa Whitford

 

Alex Norris

 

NC7

 

Parliamentary Star    

To move the following Clause—

 

         

“Requirement for consolidated legislation

 

The Secretary of State is required to introduce to Parliament new primary

 

legislation consolidating the existing regulatory regime as it applies to Medical

 

Devices by the date 2 years following Royal Assent.”

 

Member’s explanatory statement

 

This new clause would commit the Secretary of State to introducing new, consolidated legislation

 

within two years.

 


 

Dr Philippa Whitford

 

Alex Norris

 

NC8

 

Parliamentary Star    

To move the following Clause—

 

         

“Time limits on delegated powers

 

Sections 1, 8 and 12 of this Act, and the powers they confer therein, shall be

 

revoked on the date that is 2 years after their implementation.”

 

Member’s explanatory statement

 

This new clause would ensure that the delegated powers are time limited to 2 years following Royal

 

Assent for all delegated powers conferred by the Bill.

 

 


 

Alex Norris

 

Dr Philippa Whitford

 

20

 

Schedule   1,  page  31,  line  16,  after “guidance” insert “within three months of this

 

Act receiving Royal Assent”

 

Member’s explanatory statement

 

This amendment requires the relevant guidance relating to enforcement to be published within 3

 

months rather than at an undetermined time.


 
 

Public Bill Committee: 8 June 2020                     

13

 

Medicines and Medical Devices Bill , continued

 
 

Alex Norris

 

Dr Philippa Whitford

 

21

 

Schedule   1,  page  32,  line  18,  leave out “from time to time” and insert “every 12

 

months”

 

Member’s explanatory statement

 

This amendment requires the Secretary of State to report back on their use of civil sanctions every

 

year rather than at an undetermined frequency

 


 

Jo Churchill

 

Dr Philippa Whitford

 

5

 

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

 

Dr Philippa Whitford

 

6

 

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

 

Dr Philippa Whitford

 

7

 

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.


 
 

Public Bill Committee: 8 June 2020                     

14

 

Medicines and Medical Devices Bill , continued

 
 

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.

 

Other proceedings

 

7.    

Any other proceedings on the Bill may be programmed.

 


 
PreviousBack to Start
 

Revised 05 June 2020