Medicines and Medical Devices Bill
Tuesday 2nd February 2021
(3 years, 10 months ago)
Lords ChamberMedicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 167-I Marshalled list for Consideration of Commons amendments, disagreements and amendments in lieu - (29 Jan 2021)
The Deputy Speaker (Lord Duncan of Springbank) (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
Lord Bethell
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.
“(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)—
If the regulations contain provision madein reliance on | the regulations are subject to |
section 5(1)(a) | the negative procedure |
section 10(1)(a) | the negative procedure |
section 14(1)(a) | the negative procedure |
paragraph 9 of Schedule 1 | the negative procedure |
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 |
(b) the draft affirmative procedure in any other case | |
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 |
(b) the draft affirmative procedure in any other case | |
any other provision of Part A1, 1, 2 or 3 | 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.”
“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.”
“(ha) Part 4A.”
Lord Bethell
That this House do agree with the Commons in their Amendments 11A, 11B, 11C and 11D.
(a) the disclosure is”
(b) the relevant authority considers that the disclosure is in the public interest.”
Lord Bethell
That this House do agree with the Commons in their Amendments 22A, 22B and 22C.
(a) the disclosure is”
(b) the relevant authority considers that the disclosure is in the public interest.”
Lord Bethell
That this House do agree with the Commons in their Amendments 32A, 32B and 32C.
(a) the disclosure is”
(b) the relevant authority considers that the disclosure is in the public interest.”
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (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, Lord Sharkey, put in the super-affirmative procedure. Lords Amendments 12, 23 and 40, in the name of the noble Lord, Lord Patel, 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.
Lord Patel (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, Lord Bethell, 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.
Baroness Jolly (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.
Baroness Thornton (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, Lord Lansley, 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.
Lord Bethell (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 (Lord Duncan of Springbank) (Con)
Noble Lords will be pleased to know that no one has requested to speak after the Minister.