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EnactedRoyal Assentc. 3

Medicines and Medical Devices Act 2021

This bill became lawView the statute on acthub →c. 3 · 11 Feb 2021

Bill texts 9

  • Bill 90 2019-21, as introducedBill · 13 Feb 2020download soon
  • Bill 90 2019-21 - large font accessible versionBill · 13 Feb 2020download soon
  • Bill 136 2019-21 (as amended in Committee)Bill · 10 Jun 2020download soon
  • Bill 136 2019-21 (as amended in Committee) - large font accessible versionBill · 10 Jun 2020download soon
  • HL Bill 116 (as introduced)Bill · 24 Jun 2020download soon
  • HL Bill 154 (as amended in Grand Committee)Bill · 19 Nov 2020download soon
  • HL Bill 163 (as amended on Report)Bill · 14 Jan 2021download soon
  • Bill 242 2019-21 (Lords Amendments)Bill · 21 Jan 2021download soon
  • HL Bill 167 Commons amendments, disagreements and amendments in lieuBill · 27 Jan 2021download soon

Amendments 48

Committee stage — Lords 20

NotMovedClause 1EditBillBody

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”

Moved: Lord SharkeySponsor: Baroness Jolly, Baroness Finlay of Llandaff#53851
NotMovedClause 1EditBillBody

at end insert— In subsection (2)(c), “attractiveness” means the quality of being—

Moved: Lord PatelSponsor: Lord Mackay of Clashfern#53861
NotMovedClause 1EditBillBody

at end insert— In subsection (2), “attractiveness” means—

Moved: Baroness ThorntonSponsor: Lord Hunt of Kings Heath, Baroness Watkins of Tavistock, Lord Patel#53898
WithdrawnClause 1EditBillBody

leave out “have regard to” and insert “act with a view to ensuring”

Moved: Baroness ThorntonSponsor: Lord Hunt of Kings Heath#53899
WithdrawnClause 1EditBillBody

at end insert— The power under subsection (1) may not be exercised to—

Moved: Baroness ThorntonSponsor: Lord Hunt of Kings Heath#53900
WithdrawnClause 1EditBillBody

at end insert— In making regulations under subsection (1), the appropriate authority must have regard to the desirability of—

Moved: Baroness ThorntonSponsor: Lord Hunt of Kings Heath, Baroness Finlay of Llandaff#53901
WithdrawnClause 1EditBillBody

at end insert “for a period of three years beginning with the day on which this Act is passed.”

Moved: Baroness ThorntonSponsor: Lord Hunt of Kings Heath#53902
NotMovedClause 1EditBillBody

at beginning insert “the priority of ensuring”

Moved: Lord SharkeySponsor: Baroness Jolly#53907
NotMovedClause 1EditBillBody

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,”

Moved: Lord SharkeySponsor: Baroness Jolly#53908
WithdrawnClause 1EditBillBody

at end insert— the effect of the regulations on the ability of the National Health Service to meet the needs of patients;

Moved: Lord LansleySponsor: Lord Woolf#54074
NotMovedClause 1EditBillBody

after “trials” insert “, promote medical innovation”

Moved: Lord LansleySponsor: Lord Woolf#54075
NotMovedClause 1EditBillBody

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.”

Moved: Lord LansleySponsor: Lord Woolf, Baroness Jolly#54077
WithdrawnClause 1EditBillBody

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.”

Moved: Lord SharkeySponsor: Lord Forsyth of Drumlean, Lord Judge, Baroness Andrews#54105
WithdrawnClause 1EditBillBody

at end insert— the environmental and social impact of such medicines, including their manufacturing.”

Moved: Baroness Bennett of Manor Castle#54269
AgreedClause 1EditBillBody

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.”

Moved: Lord Bethell#54290
AgreedClause 1EditBillBody

leave out “making regulations under subsection (1)” and insert “considering whether they would”

Moved: Lord Bethell#54291
AgreedClause 1EditBillBody

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.”

Moved: Lord Bethell#54292
NotMovedClause 1EditBillBody

at end insert “the safety of human medicines as the overriding consideration.”

Moved: Baroness CumberlegeSponsor: Baroness Burt of Solihull, Baroness Hollins, Lord Patel#54295
NotMovedClause 1EditBillBody

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—”

Moved: Baroness CumberlegeSponsor: Baroness Burt of Solihull, Baroness Hollins, Lord Patel#54296
WithdrawnClause 1EditBillBody

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;

Moved: Baroness SheehanSponsor: Baroness Jolly, Lord Sharkey, Lord Alton of Liverpool#54303

Report stage — Lords 20

AgreedClause 1EditBillBody

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.”

Moved: Lord SharkeySponsor: Lord Judge, Baroness Andrews, Lord Forsyth of Drumlean#72467
WithdrawnClause 6AddClauseOrSchedule

Insert the following new Clause— “Entitlement of a doctor to prescribe medicinal cannabis products

Moved: Lord Field of BirkenheadSponsor: Baroness Meacher, Baroness Walmsley, Lord Norton of Louth#72499
AgreedClause 7EditBillBody

at end insert— Nothing in this section authorises a disclosure of patient information without the consent of the individual to whom that information relates.”

Moved: Lord Bethell#72595
AgreedClause 7EditBillBody

after “a” insert “relevant”

Moved: Lord Bethell#72596
AgreedClause 1EditBillBody

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.”

Moved: Lord Bethell#72597
AgreedClause 1EditBillBody

leave out “conduct clinical trials or supply human medicines” and insert “— carry out research relating to human medicines,

Moved: Lord Bethell#72598
AgreedClause 1EditBillBody

leave out “an attractive or” and insert “a”

Moved: Lord Bethell#72599
AgreedClause 1EditBillBody

leave out “they would” and insert “regulations under subsection (1) would contribute to this objective”

Moved: Lord Bethell#72600
AgreedClause 1EditBillBody

leave out subsection (2) and insert— In making regulations under subsection (1), the appropriate authority’s overarching objective must be safeguarding public health.”

Moved: Lord Bethell#72601
AgreedClause 1AddClauseOrSchedule

Insert the following new Clause— “PART A1

Moved: Lord Bethell#72602
AgreedClause 2EditBillBody

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.”

Moved: Lord Hunt of Kings HeathSponsor: Baroness Finlay of Llandaff, Baroness Northover, Lord Bethell, Lord Ribeiro#72603
WithdrawnClause 1EditBillBody

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;

Moved: Baroness SheehanSponsor: Baroness Bennett of Manor Castle, Lord Alton of Liverpool, Lord Crisp#72604
NotMovedClause 1EditBillBody

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.

Moved: Baroness Thornton#72690
WithdrawnClause 1EditBillBody

Leave out “public health” and insert “the health and safety of the public”

Moved: Baroness ThorntonSponsor: Baroness Jolly#72691
AgreedClause 1EditBillBody

at end insert “for a period of three years beginning with the day on which this Act is passed.”

Moved: Baroness ThorntonSponsor: Lord Patel, Baroness Jolly#72692
DisagreedClause 1EditBillBody

at end insert— the protection of the environment;”

Moved: Baroness Bennett of Manor CastleSponsor: Baroness Jolly#72696
NotMovedClause 7EditBillBody

After the first “the” insert “informed”

Moved: Lord Clement-Jones#72738
WithdrawnClause 3EditBillBody

leave out “for any purpose to do with human medicines” and insert “for the purpose of ensuring patient safety”

Moved: Lord Clement-JonesSponsor: Baroness Thornton#72739
AgreedClause 7EditBillBody

at end insert— Where information is disclosed in accordance with subsection (2) such disclosure will only be permitted where—

Moved: Baroness ThorntonSponsor: Lord Patel, Lord Clement-Jones, Lord Freyberg#72741
WithdrawnClause 6AddClauseOrSchedule

Insert the following new Clause— “Strategy for tackling vaccination disinformation

Moved: Baroness Thornton#72743

3rd reading — Lords 8

AgreedClause 52EditBillBody

leave out “order in its initial form, or a revised draft order” and insert “regulations in their original form, or revised draft regulations”

Moved: Lord Sharkey#72856
AgreedClause 52EditBillBody

leave out “order”

Moved: Lord SharkeySponsor: Baroness Jolly#72857
AgreedClause 52EditBillBody

leave out “order”

Moved: Lord SharkeySponsor: Baroness Jolly#72858
AgreedClause 52EditBillBody

leave out “ an order” and insert “regulations”

Moved: Lord SharkeySponsor: Baroness Jolly#72859
AgreedClause 52EditBillBody

leave out “order” and insert “regulations”

Moved: Lord SharkeySponsor: Baroness Jolly#72860
AgreedClause 52EditBillBody

leave out “section 11(1), section 17(1) and section 21(1)” and insert “and section 11(1)”

Moved: Lord SharkeySponsor: Baroness Jolly#72861
AgreedClause 21EditBillBody

leave out from “subject” to end of line 25 and insert “to the super-affirmative procedure set out in section 51”

Moved: Lord SharkeySponsor: Baroness Jolly#72862
AgreedClause 17EditBillBody

leave out from “subject” to end of line 8 and insert “to the super-affirmative procedure set out in section 51”

Moved: Lord SharkeySponsor: Baroness Jolly#72863