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EnactedMedicines and Medical Devices Act 2021

OverviewTimeline110Debates18Amendments48

Proposed amendments

48 amendments across 8 provisions

Clause 1 32

Amendment #53851#53851Not movedAmends text
Amendment text
leave out paragraph (c) and insert—
maintaining or improving the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply or manufacture human medicines”
Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Sharkey
Amendment #53861#53861Not movedAmends text
Amendment text
at end insert—
In subsection (2)(c), “attractiveness” means the quality of being—

The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.

Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Patel
Amendment #53898#53898Not movedAmends text
Amendment text
at end insert—
In subsection (2), “attractiveness” means—

The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.

Stage
Committee stage
Type
EditBillBody
Clause
1
Baroness Thornton
Amendment #53899#53899WithdrawnAmends text
Amendment text
leave out “have regard to” and insert “act with a view to ensuring”
Stage
Committee stage
Type
EditBillBody
Clause
1
Baroness Thornton
Amendment #53900#53900WithdrawnAmends text
Amendment text
at end insert—
The power under subsection (1) may not be exercised to—

The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.

Stage
Committee stage
Type
EditBillBody
Clause
1
Baroness Thornton
Amendment #53901#53901WithdrawnAmends text
Amendment text
at end insert—
In making regulations under subsection (1), the appropriate authority must have regard to the desirability of—

The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.

Stage
Committee stage
Type
EditBillBody
Clause
1
Baroness Thornton
Amendment #53902#53902WithdrawnAmends text
Amendment text
at end insert “for a period of three years beginning with the day on which this Act is passed.”
Stage
Committee stage
Type
EditBillBody
Clause
1
Baroness Thornton
Amendment #53907#53907Not movedAmends text
Amendment text
at beginning insert “the priority of ensuring”
Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Sharkey
Amendment #53908#53908Not movedAmends text
Amendment text
at end insert “, and, in the case of regulations not subject to section 42(6), (7) or (8), must publish with the draft regulations an assessment of their impact on,”
Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Sharkey
Amendment #54074#54074WithdrawnAmends text
Amendment text
at end insert—
the effect of the regulations on the ability of the National Health Service to meet the needs of patients;
Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Lansley
Amendment #54075#54075Not movedAmends text
Amendment text
after “trials” insert “, promote medical innovation”
Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Lansley
Amendment #54077#54077Not movedAmends text
Amendment text
at end insert—
In making regulations under subsection (1), the appropriate authority must have the objective of safeguarding public health by promoting the availability and supply of human medicines.”
Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Lansley
Amendment #54105#54105WithdrawnAmends text
Amendment text
at end insert—
Regulations made under subsection (1) are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Sharkey
Amendment #54269#54269WithdrawnAmends text
Amendment text
at end insert—
the environmental and social impact of such medicines, including their manufacturing.”
Stage
Committee stage
Type
EditBillBody
Clause
1
Baroness Bennett of Manor Castle
Amendment #54290#54290AgreedAmends text
Amendment text
leave out paragraph (c) and insert—
the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines.”
Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Bethell
Amendment #54291#54291AgreedAmends text
Amendment text
leave out “making regulations under subsection (1)” and insert “considering whether they would”
Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Bethell
Amendment #54292#54292AgreedAmends text
Amendment text
at end insert—
The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”
Stage
Committee stage
Type
EditBillBody
Clause
1
Lord Bethell
Amendment #54295#54295Not movedAmends text
Amendment text
at end insert “the safety of human medicines as the overriding consideration.”
Stage
Committee stage
Type
EditBillBody
Clause
1
Baroness Cumberlege
Amendment #54296#54296Not movedAmends text
Amendment text
leave out paragraph (a) and insert—
In making regulations under subsection (1), the appropriate authority must also have regard to the following as secondary considerations—”
Stage
Committee stage
Type
EditBillBody
Clause
1
Baroness Cumberlege
Amendment #54303#54303WithdrawnAmends text
Amendment text
at end insert—
citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966;
Stage
Committee stage
Type
EditBillBody
Clause
1
Baroness Sheehan
Amendment #72467#72467AgreedAmends text
Amendment text
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 procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”
Stage
Report stage
Type
EditBillBody
Clause
1
Lord Sharkey
Amendment #72597#72597AgreedAmends text
Amendment text
at end insert—
Where regulations under subsection (1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.”
Stage
Report stage
Type
EditBillBody
Clause
1
Lord Bethell
Amendment #72598#72598AgreedAmends text
Amendment text
leave out “conduct clinical trials or supply human medicines” and insert “—
carry out research relating to human medicines,
Stage
Report stage
Type
EditBillBody
Clause
1
Lord Bethell
Amendment #72599#72599AgreedAmends text
Amendment text
leave out “an attractive or” and insert “a”
Stage
Report stage
Type
EditBillBody
Clause
1
Lord Bethell
Amendment #72600#72600AgreedAmends text
Amendment text
leave out “they would” and insert “regulations under subsection (1) would contribute to this objective”
Stage
Report stage
Type
EditBillBody
Clause
1
Lord Bethell
Amendment #72601#72601AgreedAmends text
Amendment text
leave out subsection (2) and insert—
In making regulations under subsection (1), the appropriate authority’s overarching objective must be safeguarding public health.”
Stage
Report stage
Type
EditBillBody
Clause
1
Lord Bethell
Amendment #72602#72602AgreedNew clause / schedule
Amendment text
Insert the following new Clause—
“PART A1

Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.

Stage
Report stage
Type
AddClauseOrSchedule
Clause
1
Lord Bethell
Amendment #72604#72604WithdrawnAmends text
Amendment text
at end insert—
the importance of prioritising the protection of human rights including citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966;
Stage
Report stage
Type
EditBillBody
Clause
1
Baroness Sheehan
Amendment #72690#72690Not movedAmends text
Amendment text
at end insert—
Before making regulations under subsection (1) that may have an impact on the safety of human medicines, the Secretary of State must publish the criteria the appropriate authority will use to determine whether the benefits of laying regulations outweigh the risks.
Stage
Report stage
Type
EditBillBody
Clause
1
Baroness Thornton
Amendment #72691#72691WithdrawnAmends text
Amendment text
Leave out “public health” and insert “the health and safety of the public”
Stage
Report stage
Type
EditBillBody
Clause
1
Baroness Thornton
Amendment #72692#72692AgreedAmends text
Amendment text
at end insert “for a period of three years beginning with the day on which this Act is passed.”
Stage
Report stage
Type
EditBillBody
Clause
1
Baroness Thornton
Amendment #72696#72696DisagreedAmends text
Amendment text
at end insert—
the protection of the environment;”
Stage
Report stage
Type
EditBillBody
Clause
1
Baroness Bennett of Manor Castle

Clause 2 1

Amendment #72603#72603AgreedAmends text
Amendment text
at end insert “, or
the use of tissues or cells (within the meanings given by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523)) in relation to human medicines.”
Stage
Report stage
Type
EditBillBody
Clause
2
Lord Hunt of Kings Heath

Clause 3 1

Amendment #72739#72739WithdrawnAmends text
Amendment text
leave out “for any purpose to do with human medicines” and insert “for the purpose of ensuring patient safety”
Stage
Report stage
Type
EditBillBody
Clause
3
Lord Clement-Jones

Clause 6 2

Amendment #72499#72499WithdrawnNew clause / schedule
Amendment text
Insert the following new Clause—
“Entitlement of a doctor to prescribe medicinal cannabis products

Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.

Stage
Report stage
Type
AddClauseOrSchedule
Clause
6
Lord Field of Birkenhead
Amendment #72743#72743WithdrawnNew clause / schedule
Amendment text
Insert the following new Clause—
“Strategy for tackling vaccination disinformation

Only the heading is published via the Bills API — the full text of this new clause/schedule is set out in the marshalled Amendment Paper.

Stage
Report stage
Type
AddClauseOrSchedule
Clause
6
Baroness Thornton

Clause 7 4

Amendment #72595#72595AgreedAmends text
Amendment text
at end insert—
Nothing in this section authorises a disclosure of patient information without the consent of the individual to whom that information relates.”
Stage
Report stage
Type
EditBillBody
Clause
7
Lord Bethell
Amendment #72596#72596AgreedAmends text
Amendment text
after “a” insert “relevant”
Stage
Report stage
Type
EditBillBody
Clause
7
Lord Bethell
Amendment #72738#72738Not movedAmends text
Amendment text
After the first “the” insert “informed”
Stage
Report stage
Type
EditBillBody
Clause
7
Lord Clement-Jones
Amendment #72741#72741AgreedAmends text
Amendment text
at end insert—
Where information is disclosed in accordance with subsection (2) such disclosure will only be permitted where—

The Bills API publishes only the tabling instruction here, not the inserted text itself — the full wording is set out in the marshalled Amendment Paper.

Stage
Report stage
Type
EditBillBody
Clause
7
Baroness Thornton

Clause 17 1

Amendment #72863#72863AgreedAmends text
Amendment text
leave out from “subject” to end of line 8 and insert “to the super-affirmative procedure set out in section 51”
Stage
3rd reading
Type
EditBillBody
Clause
17
Lord Sharkey

Clause 21 1

Amendment #72862#72862AgreedAmends text
Amendment text
leave out from “subject” to end of line 25 and insert “to the super-affirmative procedure set out in section 51”
Stage
3rd reading
Type
EditBillBody
Clause
21
Lord Sharkey

Clause 52 6

Amendment #72856#72856AgreedAmends text
Amendment text
leave out “order in its initial form, or a revised draft order” and insert “regulations in their original form, or revised draft regulations”
Stage
3rd reading
Type
EditBillBody
Clause
52
Lord Sharkey
Amendment #72857#72857AgreedAmends text
Amendment text
leave out “order”
Stage
3rd reading
Type
EditBillBody
Clause
52
Lord Sharkey
Amendment #72858#72858AgreedAmends text
Amendment text
leave out “order”
Stage
3rd reading
Type
EditBillBody
Clause
52
Lord Sharkey
Amendment #72859#72859AgreedAmends text
Amendment text
leave out “ an order” and insert “regulations”
Stage
3rd reading
Type
EditBillBody
Clause
52
Lord Sharkey
Amendment #72860#72860AgreedAmends text
Amendment text
leave out “order” and insert “regulations”
Stage
3rd reading
Type
EditBillBody
Clause
52
Lord Sharkey
Amendment #72861#72861AgreedAmends text
Amendment text
leave out “section 11(1), section 17(1) and section 21(1)” and insert “and section 11(1)”
Stage
3rd reading
Type
EditBillBody
Clause
52
Lord Sharkey