Medicines and Medical
Devices Bill
Commons Amendments
15:00:00
Relevant documents: 19th and 33rd Reports from the Delegated
Powers Committee, 10th Report from the Constitution Committee
The Deputy Speaker ()
(Con)
My Lords, hybrid proceedings will now resume. There are no
counter-propositions, so the only speakers are those listed and
the Minister’s Motion may not be opposed. Short questions of
elucidation from listed speakers after the Minister’s response
are permitted but discouraged. A Member wishing to ask such a
question must email the clerk. We will now begin.
Motion A
Moved by
That this House do not insist on its Amendments 2, 3, 12, 13, 14,
23, 24, 25, 30, 40, 48, 49 and 50 and do agree with the Commons
in their Amendments 50A, 50B and 50C in lieu.
50A: Clause 42 page 24, line 36, leave out subsections (3) to (9)
and insert—
“(3) The procedure for making regulations under Part A1, 1, 2 or
3 is to be determined in accordance with this table and
subsection (4)—
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|If the regulations contain provision madein reliance on|the
regulations are subject to |
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|section 5(1)(a) |the negative procedure |
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|section 10(1)(a) |the negative procedure |
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|section 14(1)(a) |the negative procedure |
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|paragraph 9 of Schedule 1 |the negative procedure |
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|section 6 |(a) the made affirmative procedure, where the
regulations contain a declaration that the person making them
considers that they need to be made urgently to protect the
public from an imminent risk of serious harm to health|
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| |(b) the draft affirmative procedure in any other case |
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|section 15 |(a) the made affirmative procedure, where the
regulations contain a declaration that the person making them
considers that they need to be made urgently to protect the
public from an imminent risk of serious harm to health|
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| |(b) the draft affirmative procedure in any other case |
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|any other provision of Part A1, 1, 2 or 3 |the draft affirmative
procedure |
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(4) Provision that may be made by regulations subject to the
negative procedure may be made by regulations subject to the
draft affirmative procedure.
(5) Where regulations are subject to “the negative
procedure”—
(a) in the case of regulations made by the Secretary of State
acting alone, the statutory instrument containing the regulations
is subject to annulment in pursuance of a resolution of either
House of Parliament,
(b) in the case of regulations made by a Northern Ireland
department acting alone, they are subject to negative resolution
within the meaning given by section 41(6) of the Interpretation
Act (Northern Ireland) 1954, and
(c) in the case of regulations made by the Secretary of State and
a Northern Ireland department acting jointly, the statutory
instrument containing the regulations is subject to—
(i) annulment in pursuance of a resolution of either House of
Parliament, and
(ii) negative resolution within the meaning given by section
41(6) of the Interpretation Act (Northern Ireland) 1954.
(6) Where regulations are subject to the “draft affirmative
procedure”—
(a) in the case of regulations made by the Secretary of State
acting alone, the statutory instrument containing the regulations
may not be made unless a draft of the instrument has been laid
before and approved by a resolution of each House of
Parliament,
(b) in the case of regulations made by a Northern Ireland
department acting alone, they may not be made unless a draft of
the regulations has been laid before and approved by a resolution
of the Northern Ireland Assembly, and
(c) in the case of regulations made by the Secretary of State and
a Northern Ireland department acting jointly, the statutory
instrument containing the regulations may not be made unless a
draft of the instrument has been laid before and approved by a
resolution of—
(i) each House of Parliament, and
(ii) the Northern Ireland Assembly.
(7) Where regulations are subject to the “made affirmative
procedure”—
(a) in the case of regulations made by the Secretary of State
acting alone, the statutory instrument containing the
regulations—
(i) must be laid before Parliament after being made, and
(ii) ceases to have effect at the end of the period of 40 days
beginning with the day on which the instrument is made unless,
during that period, the instrument is approved by a resolution of
each House of Parliament,
(b) in the case of regulations made by a Northern Ireland
department acting alone, they—
(i) must be laid before the Northern Ireland Assembly after being
made, and
(ii) cease to have effect at the end of the period of 40 days
beginning with the day on which they are made unless, during that
period, the regulations are approved by a resolution of the
Assembly, and
(c) in the case of regulations made by the Secretary of State and
a Northern Ireland department acting jointly, the statutory
instrument containing the regulations—
(i) must be laid before Parliament and the Northern Ireland
Assembly after being made, and
(ii) ceases to have effect at the end of the period of 40 days
beginning with the day on which the instrument is made unless,
during that period, the instrument is approved by a resolution of
each House of Parliament and by a resolution of the Assembly.
(8) In calculating the period of 40 days for the purposes of
subsection (7)(a)(ii) or (c)(ii) in relation to Parliament, no
account is to be taken of any time during which—
(a) Parliament is dissolved or prorogued, or
(b) either House of Parliament is adjourned for more than 4
days.
(9) In calculating the period of 40 days for the purposes of
subsection (7)(b)(ii) or (c)(ii) in relation to the Northern
Ireland Assembly, no account is to be taken of any time during
which the Assembly is—
(a) dissolved,
(b) in recess for more than 4 days, or (c) adjourned for more
than 6 days.
(10) If regulations cease to have effect as a result of
subsection (7) that—
(a) does not affect the validity of anything previously done
under the regulations, and
(b) does not prevent the making of new regulations.”
50B: After Clause 42, insert the following new Clause—
“Part 4A
Report on Operation of Medicines and Medical Devices
Legislation
Report on operation of medicines and medical devices
legislation
(1) The Secretary of State must, before the end of the relevant
period, publish a report on the operation of medicines and
medical devices legislation.
(2) The report must, in particular, include an assessment of
whether—
(a) some or all medicines and medical devices legislation should
be consolidated or otherwise restructured,
(b) provisions of medicines and medical devices legislation
should be included in regulations or Acts of Parliament, and
(c) powers to make regulations should be modified or
repealed.
(3) In preparing the report, the Secretary of State must take
into account any report relating to the operation of medicines
and medical devices legislation made by a Parliamentary
Committee.
(4) The Secretary of State must lay a copy of the report before
Parliament.
(5) In this section—
“medicines and medical devices legislation” means—
(a) the law relating to human medicines within the meaning of
section 7 (interpretation);
(b) the Veterinary Medicines Regulations 2013 (S.I.
2013/2033);
(c) the Medical Devices Regulations 2002 (S.I. 2002/618);
(d) Parts 1 to 4 of this Act; (e) regulations made under those
Parts;
“Parliamentary Committee” means a committee of the House of
Commons or of the House of Lords or a joint committee of both
Houses;
“relevant period” means the period of 5 years beginning with the
day on which this Act is passed.”
50C: Clause 44, page 26, line 8, at end insert—
“(ha) Part 4A.”
Motion B
Moved by
That this House do agree with the Commons in their Amendments
11A, 11B, 11C and 11D.
11A: After Clause 6, line 6, after “where” insert “—
(a) the disclosure is”
11B: Line 8, at end insert “, and
(b) the relevant authority considers that the disclosure is in
the public interest.”
11C: Line 9, leave out subsection (3)
11D: Line 20, leave out “subsection (7)” and insert “subsections
(6) and (7)”
Motion C
Moved by
That this House do agree with the Commons in their Amendments
22A, 22B and 22C.
22A: After Clause 10, line 6, after “where” insert “—
(a) the disclosure is”
22B: Line 8, at end insert “, and
(b) the relevant authority considers that the disclosure is in
the public interest.”
22C: Line 9, leave out subsection (3)
Motion D
Moved by
That this House do agree with the Commons in their Amendments
32A, 32B and 32C.
32A: Clause 35, line 3, after “where” insert “—
(a) the disclosure is”
32B: Clause 35, line 5, at end insert “, and
(b) the relevant authority considers that the disclosure is in
the public interest.”
32C: Clause 35, line 8, leave out subsection (4C)
The Parliamentary Under-Secretary of State, Department of Health
and Social Care () (Con)
My Lords, with the leave of the House, I beg to move that the
House do agree with the Commons in their Amendments 11A to 11D,
22A to 22C, 32A to 32C, and 50A to 50C en bloc. I pay tribute to
noble Lords on all sides of the House in reaching consensus on
the issues dealt with in these amendments. They were put down in
the other place after cross-party discussions and I believe they
reflect the aims and agreement of the House.
Amendments 11A to 11D, 22A to 22C and 32A to 32C all make minor
amendments to Lords Amendments 11, 22 and 32. These amendments,
in the name of the noble Baroness, Lady Thornton, made further
changes to the clauses allowing the MHRA and the VMD to share
information with relevant persons, such as regulators, outside
the UK. Lords Amendments 11, 22 and 32 create a new safeguard
that information could be shared only when in the public interest
or for pharmacovigilance. I thank the noble Baroness very much
for her remarks on Report. She made it very clear that the
reference to pharmacovigilance was illustrative.
Pharmacovigilance is very important, but it is also very much in
the public interest and so does not need to be included outside
the reference to the public interest. It is already captured. The
Commons amendments therefore remove the reference to
pharmacovigilance and the purpose of the amendments remains.
The majority of the Commons amendments deal with the variety of
ways that noble Lords sought to create means to bring the Bill,
and the principles of the Bill, back before Parliament in the
future. Three methods were put forward and, in fact, noble Lords
eloquently pressed the point on all of them. Lords Amendments 2,
13 and 24, which were tabled by the noble Baroness, Lady
Thornton, put forward a sunset on delegated powers. Lords
Amendments 3, 14, 25, 30, 48 and 49, which were tabled by the
noble Lord, , put in the
super-affirmative procedure. Lords Amendments 12, 23 and 40, in
the name of the noble Lord, , put forward the
idea of bringing forward consolidated draft legislation within
three years. I do not intend to repeat my arguments against all
three; I have said throughout this Bill that we have been
listening carefully to all noble Lords who have put forward very
clearly their continued concerns.
Commons Amendments 50A, 50B and 50C are an alternative, which I
believe we can agree avoids the issue of introducing a “cliff
edge” for legislation—and potentially patient safety—but
importantly provides the reassurances that noble Lords quite
reasonably sought. They collectively create an obligation for the
Secretary of State to prepare a report on the operation of the
legislation within five years of Royal Assent, and the amendments
specify the considerations that must be addressed in that report:
first, whether the legislation should be consolidated or
restructured; secondly, whether legislation ought to be in
regulations or in Acts of Parliament; and, thirdly, whether any
of the powers to make regulations should be modified or repealed.
This would mean actively considering all the questions raised by
noble Lords. It would give the time needed for making changes to
the current legislation governing medicines and medical devices
using the Bill’s powers, and allow for those changes to bed down
and for those complex areas of law to reach a steady state,
before considering these important issues.
The Secretary of State must also take into account any report of
a parliamentary committee in preparing that report. This would
mean that if any committee—whether your Lordships’ Delegated
Powers and Regulatory Reform Committee or the Health Select
Committee in the other place—decided to take a view on the
operation of the legislation in the intervening time, its
conclusions and considerations would have to be taken into
account. If any committee should choose to do so, perhaps on the
basis of the post-legislative memorandum that must be prepared
within three to five years of the Bill being enacted, Parliament
will have expressed a view before being presented with the
Secretary of State’s report.
I think this is a satisfactory compromise. It meets the principle
of parliamentary review without the practical impact on patient
safety of powers lapsing. It ensures that Parliament has the
ability to express a view and for that view to be heard, without
asking for review before it is practicable. Amendment 50A makes
the necessary changes to reinstitute the parliamentary procedure
changes made at Lords Committee stage, in place of the
super-affirmative.
I hope that noble Lords will be content to accept the amendments
from the House of Commons. I beg to move.
(CB) [V]
My Lords, I am extremely grateful for the amendments that the
Government have brought from the Commons. I am grateful to the
Minister and his team for working so diligently with the rest of
us, and to all noble Lords who supported my amendments. It is not
unusual—but it is infrequent—for the votes that the Government
did not get through in the Lords to be reconsidered in the
Commons and brought back as government amendments. I am very
content that the amendments that the Government have brought are
very satisfactory and I congratulate them. I thank the noble
Lord, , the noble
Baroness, Lady Penn, the noble Earl, Lord Howe, and the legal
team for working with us throughout the Bill. That is all I am
going to say.
(LD) [V]
My Lords, I too shall be brief and I too am grateful to the
Minister and his team for giving Peers an opportunity to see the
Commons amendments to the Bill before they were tabled, so that
we might give some feedback. One of the things that has made this
Bill a pleasure to work on is the open way in which political
parties and Cross-Benchers have worked together, as well as the
way that the Minister and his team have worked with us. We
particularly welcome the clauses that have come to us from the
Commons; they make the Bill a more explicit and effective piece
of legislation than when it was debated either in Committee or on
Report in this House.
(Lab)
My Lords, I am very grateful to the Minister and his team for the
manner in which they have engaged and worked with us throughout
the passage of this Bill, particularly at this final stage. The
amendment in lieu is a good compromise that reflects the need for
scrutiny to be at the heart of the Bill. It provides a mechanism
to examine the powers of the Act in five years’ time and will
open the door for the restructuring and consolidation of the
post-Brexit medicines and medical devices regulatory regime. We
believe that this will prove both desirable and necessary, and
look forward to working with the Minister on such issues when the
time comes.
We welcome the requirement that the Secretary of State must
specifically consider whether this should be in the form of
primary or secondary legislation and hope that this will lead to
policy being put into a future Bill rather than scrolled away in
regulations. The Secretary of State will also have to take
account of all parliamentary committee reports. This would
include post-legislative scrutiny undertaken by a Select
Committee, as well as the DPRRC and Constitution Committee, whose
oversight played a crucial role in reshaping a skeleton Bill into
a framework Bill; I thank the noble Lord, , for explaining that to us all. I hope the Minister
can assure me that stakeholders will also be consulted. I am sure
that that will be the case. It is very important, given that they
are the end users of the legislation, and for the report to have
value and credibility it must reflect the experience of
regulators, industry, patients and medical professionals.
Finally, the tidying-up amendment that retains the requirement to
share information in the public interest is an important
provision because it will allow for substantive and ethical
issues relating to the sharing of public data to be considered.
This is of the utmost importance, given the role that the NHS and
patient data may have in future trade deals.
(Con)
My Lords, I do not intend to repeat much of what I said at Third
Reading. Many thanks to the noble Lords who have contributed to
the changing shape of the Bill. From Committee to ping-pong, we
have listened, heard proposals for change and brought workable,
practicable compromises forward.
I wish to repeat the remarks made by the noble Baroness, Lady
Thornton. She congratulated all of us on the effective
communication that has made it possible to make considered
progress on this Bill, despite all the challenges that Covid-19
has presented us with. This a very fair assessment; I agree with
it completely. From the report of my noble friend Lady Cumberlege
to the demonstrated expertise of our medicines regulator, the
MHRA, we have seen the importance of patient safety, clinical
trials, our life sciences sector and effective regulation bear
out in our hospitals, clinical trials and patient community.
I look forward to the debates ahead of us on the regulations that
will be made under the Bill. They will be important, as we set
forward on our course for the best possible regulatory regime for
the UK, with the patient at its heart.
The Deputy Speaker ()
(Con)
Noble Lords will be pleased to know that no one has requested to
speak after the Minister.
Motions agreed.
