Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Lord Hunt of Kings Heath

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for moving Amendment 50 enabling regulations to be made to establish the medical devices advisory committee to advise the Secretary of State and to place the existing Devices Expert Advisory Committee on a statutory footing. We welcome this proposed new clause to the information system requirements as an important step towards bringing more transparency to the devices system and ensuring that the regulator seeks independent expert advice on the safety of devices.

As will be seen from Amendments 51, 52, and 53, however—I am moving Amendment 51 on behalf of my noble friend Lady Thornton—we want the requirement on the Secretary of State to establish the MDAC as a “must do” commitment, rather than the “may” in proposed new subsections (1), (2) and (3) of the amendment in relation to: the need for the regulations; providing advice; and making key provisions, such as how independent members should be from the Secretary of State. I know that numerous debates have been held during the course of legislation going through this House about the differences between “must” and “may”. However, “must” is surely the necessary language to require the Secretary of State to establish the committee and ensure its independence.

The Government’s briefings on the amendment—and the Minister today—as well as referring to the committee providing independent expert advice, emphasise that this will include “the views of patients”, complementing the work of the patient safety commissioner and giving patients a voice within the system of regulating medical devices. Through every stage of the Bill, noble Lords have underlined the importance of consultation with patients and end-users of medicines and medical devices. Can the Minister explain the thinking behind not including a subsection in the amendment which underlines the importance of the patient’s voice and perspective? I would also be grateful if he could tell the House what he considers will be the impact on the advisory role and scope of the change to a statutory footing for the committee.

We acknowledge the need for the two technical government Amendments 64 and 96. On Amendment 64, I note the explanation from the Minister today, and in his briefing letter to Peers of 5 January, of the need to reinstate provisions in the Medical Devices Regulations 2002 extending time limits for bringing proceedings in relation to medical devices offences. Amendment 96 is a necessary consequential amendment in relation to the added clause on the MDAC under Clause 18, bringing the whole clause into force two months after the Bill is passed.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I am glad to be able to take part in this debate, which allows the House to have a preliminary discussion about the future of medical devices regulation. I certainly welcome the establishment of an advisory committee, but I also welcome my noble friend’s amendment which makes sure that the rather tentative “may” is replaced by “must”. The Minister’s amendment is rather open-ended. It does not specify what matters it will advise the Secretary of State on, nor does it give any indication of the likely balance of membership. This is important because, as I have said, there has been some concern over quite a few years that the regulation of medical devices is not up to the mark, nor sufficiently protective of patient safety. The report by the noble Baroness, Lady Cumberlege, has identified some weaknesses. In that regard, I declare my interest as president of GS1 UK, the bar-coding association.

We received a very helpful briefing from Professor Muireann Quigley and colleagues at the University of Birmingham, pointing to the rather confused state that medical devices regulation is in. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 came into force at the end of the EU exit transition period. These amend the Medical Devices Regulations 2002 to mirror key elements contained in EU regulations 2017/745, on medical devices, and 2017/746 on in vitro diagnostic medical devices. The aim of that was to make sure that there was good regulatory alignment between the UK and EU, as well as between different parts of the UK’s own regulatory framework. This Bill, when enacted, will provide an opportunity to mandate a more streamlined legislative approach. That would benefit all stakeholders, including industry, businesses and patients.

At present, the MHRA has no involvement in the pre-market phase of medical device development and there is a question as to whether it ought to have. Birmingham University colleagues are certainly proposing a proactive regulatory role for devices that is more akin to that for medicines. This would be clinically focused and, as they say, at least as stringent as the new EU medical devices regulations. Under that proposal, manufacturers could be required to apply to the MHRA before marketing their device. The MHRA could also assess the application in a way that is proportionate to the risks. It is proposed to take account of relevant factors, such as evidence-based supply, approvals in other jurisdictions and post-marketing surveillance plans. I know that that view may not necessarily be shared by industry, which would, perhaps, be concerned about the cost and delay in achieving licensing. However, we can expect a pretty intense debate about medical device regulation in the future.

Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Lord Hunt of Kings Heath

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Baroness Wheeler (Lab)]

I am pleased to move Amendment 46 in the name of my noble friend Lady Thornton, which, alongside other amendments in this group, amends provisions in Clauses 6 and 15 and removes provisions for the disapplication of regulatory provisions in an emergency to be made subject to conditions set out in a protocol published by Ministers.

We understand why the Bill confers emergency powers on the Government to disapply existing health medicine regulations in circumstances which give rise to the need to protect the public from a serious risk to public health. However, we are concerned that the disapplication authorised in the regulations can be subject to conditions specified in the regulations, or conditions set out in a protocol published by the public authority. Furthermore, no formal requirements are set for the form, publication or dissemination of a protocol. It may simply be a document published on a website by the appropriate authority. This is completely inappropriate and unsatisfactory.

The Minister will be very aware that both the Delegated Powers and Regulatory Reform Committee and the Constitution Committee raised concerns about this provision. The Constitution Committee noted that:

“In other bills emergency powers are time-limited and there are often requirements for periodic reviews of their use”,


and yet

“No such constraints or safeguards exist in this Bill. These powers are subject only to the negative resolution procedure and can be adjusted by the amendment of a protocol which is not subject to parliamentary scrutiny”.


As the DPRRC commented at paragraphs 39 and 42:

“On a number of occasions, we have drawn the attention of the House to provision in Bills which enables Ministers to make what are, in effect, legally enforceable rules under the radar of the Parliamentary scrutiny that is afforded to primary and secondary legislation … Allowing regulations to make the disapplication of legislation subject to conditions set out in a ‘protocol’ is yet another example of ‘camouflaging legislation’ … we consider that, where those powers are to be used to provide for legislation to be disapplied in an emergency, any conditions to which disapplication is to be subject should be set out in the regulations themselves and not in a ‘protocol’ which is not subject to Parliamentary scrutiny.”


The Constitution Committee concurred and recommended that

“the use of these powers should be time bound, subject to periodic review and that any conditions on the disapplication of legal provisions should be set out in regulations.”

Although the Government have yet to publish their full response to those reports, as we know, the Minister has tabled, and indeed moved, a number of amendments in Grand Committee which are intended to address the concerns of the DPRRC and the Constitution Committee. This amendment provides an excellent opportunity for the Minister to explain to the Committee exactly why he has not therefore tabled an amendment ensuring that the disapplication of legal provisions is invariably set out in regulations, as recommended. I beg to move.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I am very glad to support my noble friend Lady Wheeler. I will not repeat what she said, because I thought she put across the points very powerfully. She quoted extensively from the Delegated Powers Committee, which complains that no justification whatever has been given for what the Government seek to do.

It is worth saying that the committee has drawn the attention of the House to this kind of mechanism being adopted in a number of Bills over the past few years. I was very struck by the assurance it sought from the Government that they would not continue the practice of what it called “camouflaging legislation” as guidance. In response to the committee’s report on both the Ivory Bill and the Mental Health Units (Use of Force) Bill, the Leader of the House, the noble Baroness, Lady Evans, wrote:

“As you will be aware, it is Government policy that guidance should not be used to circumvent the usual way of regulating a matter. If the policy is to create rules that must be followed, the Government accepts that this should be achieved using regulations subject to parliamentary scrutiny and not guidance”.