Medicines and Medical Devices Bill

Debate between Lord Lexden and Baroness Thornton

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Baroness Thornton (Lab)]

My Lords, we have reached the final amendment so I will be as brief as I can. The first thing I need to clarify, and I do not know if other noble Lords have spotted this, is that my amendment is actually to page 32 not page 34, otherwise it makes no sense at all. It is to amend line 10 on page 32—of the Bill that I have in front of me, anyway. But maybe I have an old copy of the Bill. Paragraph 13(7) of Schedule 1 says:

“The Secretary of State must have regard to the guidance or revised guidance published under this paragraph in exercising functions under this Schedule.”


That is the point of this tightening-up amendment, which would require the Secretary of State to “act in accordance with” the guidance.

Amendment 146 is about the planned civil sanctions regime for medical devices. Part 5 of Schedule 1 provides that the Secretary of State must “prepare and publish guidance” on

“the sanctions that may be imposed on”

someone who commits an offence,

“the action that the Secretary of State may take”,

and the circumstances in which they may take such action. This could be, for example, when a penalty may or may not be imposed, the amount of such a penalty, what the Secretary of State will take into account in determining that amount and so on. Before publishing the guidance the Secretary of State will, of course, consult devolved Administrations and anyone else they consider appropriate. Where necessary, should changes be needed, the Secretary of State must revise the guidance and publish the revised version.

Once published, this guidance is the information that will be in the public domain on the operation of this regime. Yet after all that preparation, as currently drafted, the Bill says the Secretary of State must only “have regard to the guidance” when “exercising functions under this Schedule”. The amendment would simply tighten this up, so that the Secretary of State must “act in accordance with” the guidance. I look forward to the Minister’s response, and I hope we can locate it in the right place—I obviously have an old version of the Bill in front of me.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

The amendment proposed is to page 34, possibly corrected by the noble Baroness, Lady Thornton, to page 32.

--- Later in debate ---

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

My Lords, I think that I have received no requests to speak after the Minister so, hoping that I have not overlooked the noble Lord, Lord Lansley, once again, I call the noble Baroness, Lady Thornton, to conclude this debate.

[Baroness Thornton (Lab)]

First, I need to say that I do have an old version of the Bill which I picked up from my desk on my way here, so I apologise to the Committee for that. I will read the Minister’s comments, but if the schedule already has, as I understand it, the ability to be flexible written into it—I think the Minister said that it was there in Clause 13—it seems to mean that one does not need to have regard to it. One would need to act in accordance with it, because the Bill already has built into it the flexibility needed under the circumstances that he was describing. However, I will read his comments and reflect on them. I beg leave to withdraw the amendment.

Medicines and Medical Devices Bill

Debate between Lord Lexden and Baroness Thornton

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

I have received a request to speak after the Minister from the noble Baroness, Lady Thornton. I now call the noble Baroness.

[Baroness Thornton (Lab)]

I thank the noble Baroness the Minister. This is such an important issue, with the potential for huge benefits and huge harms. I regard it slightly like the sort of issues we dealt with in relation to the Human Fertilisation and Embryology Authority and the Human Tissue Authority—this is very important and runs very deep into our humanity. So the question I need to ask the Minister is: when the consultation is over, will we be looking at primary legislation, because I am not sure that regulation will quite do?

--- Later in debate ---

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

I have received a request to speak after the Minister from the noble Baroness, Lady Thornton, on whom I now call.

[Baroness Thornton (Lab)]

Can the Minister run it by me again how this will protect patients? I heard a lot being said about physicians and their reporting. I am not sure that I understand how this will avoid the problems with valproate and all the other situations with mesh unless “must” is used rather than “may”.