Moved by

Lord Patel

39: After Clause 12, insert the following new Clause—

“Requirement for draft consolidated legislation: veterinary medicines

The Secretary of State must, within the period of three years beginning with the day on which this Act is passed, publish draft legislation consolidating the regulatory regime as it applies to veterinary medicines.”

Member’s...

Moved by

Lord Patel

39: After Clause 12, insert the following new Clause—

“Requirement for draft consolidated legislation: veterinary medicines

The Secretary of State must, within the period of three years beginning with the day on which this Act is passed, publish draft legislation consolidating the regulatory regime as it applies to veterinary medicines.”

Member’s...

Moved by

Baroness Thornton

40: Clause 14, page 9, line 32, at end insert “for a period of three years beginning with the day on which this Act is passed”

Member’s explanatory statement

This amendment provides a sunset provision for Part 3 of the Bill requiring the Government to return with primary legislation. It...

Moved by

Baroness Thornton

40: Clause 14, page 9, line 32, at end insert “for a period of three years beginning with the day on which this Act is passed”

Member’s explanatory statement

This amendment provides a sunset provision for Part 3 of the Bill requiring the Government to return with primary legislation. It...

Moved by

Baroness Jolly

41: Clause 14, page 9, line 32, at end insert—

“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative...

Moved by

Baroness Jolly

41: Clause 14, page 9, line 32, at end insert—

“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative...

Moved by

Lord Bethell

42: Clause 14, page 9, line 33, leave out subsection (2) and insert—

“(2) In making regulations under subsection (1), the Secretary of State’s overarching objective must be safeguarding public health.”

Member’s explanatory statement

This amendment provides that the Secretary of State’s overarching objective in making regulations under Clause 14 must...

Moved by

Lord Bethell

42: Clause 14, page 9, line 33, leave out subsection (2) and insert—

“(2) In making regulations under subsection (1), the Secretary of State’s overarching objective must be safeguarding public health.”

Member’s explanatory statement

This amendment provides that the Secretary of State’s overarching objective in making regulations under Clause 14 must...

Moved by

Lord Bethell

47: Clause 14, page 9, line 40, at end insert—

“(4) Where regulations under subsection (1) may have an impact on the safety of medical devices, the Secretary of State may make the regulations only if the Secretary of State considers that the benefits of doing so outweigh the...

Moved by

Lord Bethell

47: Clause 14, page 9, line 40, at end insert—

“(4) Where regulations under subsection (1) may have an impact on the safety of medical devices, the Secretary of State may make the regulations only if the Secretary of State considers that the benefits of doing so outweigh the...

Moved by

Baroness Jolly

49: Clause 18, page 11, line 40, at end insert—

“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative...

Moved by

Baroness Jolly

49: Clause 18, page 11, line 40, at end insert—

“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative...

Moved by

Lord Bethell

50: After Clause 18, insert the following new Clause—

“Advisory committee

(1) The Secretary of State may by regulations establish, and make other provision about, a committee to advise the Secretary of State on such matters relating to medical devices as the regulations may specify.

(2) The regulations may (among other...

Moved by

Lord Bethell

50: After Clause 18, insert the following new Clause—

“Advisory committee

(1) The Secretary of State may by regulations establish, and make other provision about, a committee to advise the Secretary of State on such matters relating to medical devices as the regulations may specify.

(2) The regulations may (among other...

My Lords, in moving Amendment 50, I shall speak also to Amendments 64 and 96. We have spoken extensively about the critical importance of patient safety and the need to improve medical device safety in bold new regulations going forwards. The need for medical device scrutiny to the highest standards...

My Lords, in moving Amendment 50, I shall speak also to Amendments 64 and 96. We have spoken extensively about the critical importance of patient safety and the need to improve medical device safety in bold new regulations going forwards. The need for medical device scrutiny to the highest standards...

Moved by

Baroness Wheeler

51: After Clause 18, in subsection (1), leave out “may” and insert “must”

Member’s explanatory statement

This would require the Secretary of State to make regulations to creating a statutory committee to provide advice in relation to medical devices.

Moved by

Baroness Wheeler

51: After Clause 18, in subsection (1), leave out “may” and insert “must”

Member’s explanatory statement

This would require the Secretary of State to make regulations to creating a statutory committee to provide advice in relation to medical devices.

My Lords, I thank the Minister for moving Amendment 50 enabling regulations to be made to establish the medical devices advisory committee to advise the Secretary of State and to place the existing Devices Expert Advisory Committee on a statutory footing. We welcome this proposed new clause to the information...

My Lords, I thank the Minister for moving Amendment 50 enabling regulations to be made to establish the medical devices advisory committee to advise the Secretary of State and to place the existing Devices Expert Advisory Committee on a statutory footing. We welcome this proposed new clause to the information...

My Lords, I am glad to be able to take part in this debate, which allows the House to have a preliminary discussion about the future of medical devices regulation. I certainly welcome the establishment of an advisory committee, but I also welcome my noble friend’s amendment which makes sure...

My Lords, I am glad to be able to take part in this debate, which allows the House to have a preliminary discussion about the future of medical devices regulation. I certainly welcome the establishment of an advisory committee, but I also welcome my noble friend’s amendment which makes sure...

My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who asked some relevant and useful questions about this while welcoming the new clause and the advisory committee on medical devices as a statutory body. I join him in that and think it is a...

My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who asked some relevant and useful questions about this while welcoming the new clause and the advisory committee on medical devices as a statutory body. I join him in that and think it is a...

My Lords, I am pleased to follow the noble Lord, Lord Lansley. I support Amendments 51 to 53 because it is important that the new clause will read “must” instead of “may”, so that the advice on medical devices will be clear and should be followed. “May” means it can...

My Lords, I am pleased to follow the noble Lord, Lord Lansley. I support Amendments 51 to 53 because it is important that the new clause will read “must” instead of “may”, so that the advice on medical devices will be clear and should be followed. “May” means it can...

My Lords, I am delighted to follow the noble Baroness, Lady Masham, and earlier speakers in welcoming this group of amendments. I support government Amendments 50, 64 and 96 and welcome the placing of the advisory committee on a statutory footing, and particularly that the affirmative procedure will be used.

My...

My Lords, I am delighted to follow the noble Baroness, Lady Masham, and earlier speakers in welcoming this group of amendments. I support government Amendments 50, 64 and 96 and welcome the placing of the advisory committee on a statutory footing, and particularly that the affirmative procedure will be used.

My...

My Lords, we support these amendments from the Government and from the noble Baroness, Lady Thornton, which relate to the creation of a statutory committee to provide advice to the Secretary of State. Government Amendment 50 would allow the creation of such a committee in relation to medical devices, and...

My Lords, we support these amendments from the Government and from the noble Baroness, Lady Thornton, which relate to the creation of a statutory committee to provide advice to the Secretary of State. Government Amendment 50 would allow the creation of such a committee in relation to medical devices, and...

My Lords, I am enormously thankful for that constructive debate. This change to the Devices Expert Advisory Committee should be welcomed. It provides for if not equivalence then equality between the medicines and medical devices regimes. It provides for transparency, which we value enormously, and it indicates our direction of...

My Lords, I am enormously thankful for that constructive debate. This change to the Devices Expert Advisory Committee should be welcomed. It provides for if not equivalence then equality between the medicines and medical devices regimes. It provides for transparency, which we value enormously, and it indicates our direction of...

I thank the Minister for his response and all noble Lords and noble Baronesses who have taken part in this useful debate. The points made by my noble friend Lord Hunt and the noble Lord, Lord Lansley, about the future role of regulation were particularly pertinent, and we look forward...

I thank the Minister for his response and all noble Lords and noble Baronesses who have taken part in this useful debate. The points made by my noble friend Lord Hunt and the noble Lord, Lord Lansley, about the future role of regulation were particularly pertinent, and we look forward...

Moved by

Lord Bethell

54: Before Schedule 1, insert the following new Schedule—

“SCHEDULE A1

FURTHER PROVISION ABOUT THE COMMISSIONER FOR PATIENT SAFETY

Principles relating to core duties

1_(1) The Commissioner must prepare and publish a set of principles to govern the way in which the Commissioner will carry out the Commissioner’s core duties.

(2) The Commissioner—

(a)...

Moved by

Lord Bethell

54: Before Schedule 1, insert the following new Schedule—

“SCHEDULE A1

FURTHER PROVISION ABOUT THE COMMISSIONER FOR PATIENT SAFETY

Principles relating to core duties

1_(1) The Commissioner must prepare and publish a set of principles to govern the way in which the Commissioner will carry out the Commissioner’s core duties.

(2) The Commissioner—

(a)...

Moved by

Lord Bethell

55: Clause 37, page 22, line 1, after “a” insert “relevant”

Member’s explanatory statement

This amendment and the amendment to clause 37 in the Minister’s name adding a definition of “relevant person” restrict the persons to whom information may be disclosed in reliance on Clause 37(5).

56: Clause 37, page 22,...

Moved by

Lord Bethell

55: Clause 37, page 22, line 1, after “a” insert “relevant”

Member’s explanatory statement

This amendment and the amendment to clause 37 in the Minister’s name adding a definition of “relevant person” restrict the persons to whom information may be disclosed in reliance on Clause 37(5).

56: Clause 37, page 22,...

Moved by

Baroness Wheeler

57: Clause 37, page 22, line 3, at end insert—

“( ) Where information is disclosed in accordance with subsection (5) such disclosure will only be permitted where—

(a) it is required as part of international cooperation in monitoring the performance and safety of medical devices; or

(b) it is in...

Moved by

Baroness Wheeler

57: Clause 37, page 22, line 3, at end insert—

“( ) Where information is disclosed in accordance with subsection (5) such disclosure will only be permitted where—

(a) it is required as part of international cooperation in monitoring the performance and safety of medical devices; or

(b) it is in...