Power to make regulations about medical devices

Medicines and Medical Devices Bill – in a Public Bill Committee am 4:00 pm ar 8 Mehefin 2020.

Danfonwch hysbysiad imi am ddadleuon fel hyn

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care) 4:00, 8 Mehefin 2020

I beg to move amendment 15, in clause 12, page 7, line 27, at end insert—

“(d) the environmental sustainability of medical devices.”

This amendment obliges the Secretary of State to pay regard to the environmental impact of medical devices.

This is the “climate in all policies” amendment. We are in the middle of a global pandemic—an extraordinary time that we will all remember for the rest of our lives —but we are also in the middle of a climate emergency. Obviously, that was uppermost in all our thoughts a few months ago, and it must not fall down the order of priorities, because a similar existential threat exists as existed six months ago and it behoves us to act on it.

Amendment 15 is the first one relating to medical devices. To the principle that applies throughout the Bill of safety, availability and attractiveness, I think it would be suitable to add environmental sustainability, given that the types of materials used to create these devices could be finite resources. There could be opportunities for things to be reusable where they might at the moment be single use. I thought it important to probe this to see what the Government are doing, and could be doing, to ensure a medical devices market that promotes sustainability where that is responsible.

After tabling the amendment, I had a couple of emails from people making very fair points about things that could not be reusable. Of course, that applies to very many things in medicine; it is a very basic principle. I am very mindful of that. It is why the explanatory statement says “pay regard”. However, I think that the two things are compatible. There will be contexts where things that are currently single use do not have to be single use. I think that we should be seeking to promote that. There will be contexts where the market and the industry should be under pressure not to use finite resources, but to use all the considerable innovation to find other solutions. I feel that if Governments do not drive that in shaping the market, nobody else will. There should be pressure for, or at least interest in, buying British, for a variety of reasons. As well as being good for jobs and our local economies, that would be very good for reducing travel miles and therefore for sustainability. We have to decarbonise every industry we possibly can, so that applies to this industry also.

This is a basic principle that I seek in every policy—even though it might be a bit boring to hear me go on about it. We have to say, “But what about the climate? What about climate change?”. I think that this is the point in the Bill at which to do that. I would be interested to hear the Minister’s views on it, but also to hear what the vision is for shaping this market so that it is as sustainable as it can be.

Photo of Matt Western Matt Western Opposition Whip (Commons)

My hon. Friend makes a very important point about sustainability, and of course linked to that is durability—the durability of the materials used in devices, particularly if a device is actually put into the human body. Of course, the durability is down to not just the effectiveness of the device or implant, but the cost to the health service of any subsequent revisions that may be needed, and so on. That is a significant cost, and therefore my hon. Friend is making an important point.

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care) 4:15, 8 Mehefin 2020

I thank my hon. Friend for that intervention. It is important to seek quality and build to last, and to be sure that the products that enter the market are the best possible products in the round—not just those that have the best price on the box. There are other considerations of which we have to be mindful, whether they be patient safety, the long-term experiences that my hon. Friend has referenced or environmental sustainability.

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care

I do not think anybody in the room is unmindful of the issues of environmental impact and durability, but the hon. Gentleman’s point is well made. He alluded to Baroness Cumberlege’s report, which will be out on 8 July. One of the challenges is that when something is implanted in the body, it is often there for a long period of time, and we would not want it to not be durable. That is always a consideration because, for example, we would not want something biodegradable sitting in a moist, wet environment—that product is not going to be doing its job in the long term.

I will address amendment 15, which relates to the requirement on the Secretary of State to have regard to certain factors when making regulations for medical devices. Clause 12(2) sets out those factors as

“(a) the safety of medical devices;

(b) the availability of medical devices;

(c) the attractiveness of the United Kingdom as a place in which to develop or supply medical devices.”

As I understand it, amendment 15 would oblige the Secretary of State to have regard to

“the environmental sustainability of medical devices” as part of the assurances contained in clause 12(2).

I assure all hon. Members that the Government are fully cognisant of the need to ensure the ongoing sustainability of the environment, and have made major commitments not only on the broader issue of climate change, but to make sure that we are mindful of the reusability or sustainability of the things we use. All of this has to bring us back to the points that were made this morning about the need to be mindful of patient safety and so on. My understanding is that the intent of the amendment relates to the safe and environmentally friendly production of devices, which could include the transportation and sale of those devices, their import, and—where achievable—the reuse of devices after reprocessing. The hon. Member for Nottingham North has mentioned people getting in contact with him to say, “You’re not having my hip after I’ve used it,” but there are cases in which reuse would be appropriate, and we should be mindful of those.

The Bill is designed to support the safety of patients by maintaining a robust framework for the regulation of medicines and medical devices. The medical device regulations that clause 12 seeks to enable focus principally on the standards of pre-market and post-market assessment, as well as the vigilance required when placing devices on the UK market, so that UK patients feel safe about the products they can access. Amendment 15 would require consideration of facts beyond the regulator’s purview and introduce an added burden on the development of regulations, particularly when changes might be needed expediently to address issues of patient safety.

I totally understand the hon. Gentleman’s intention to put these issues at the forefront of our minds. However, I say gently that legislation to protect the environment, such as the Environmental Permitting (England and Wales) Regulations 2016, already exists and runs throughout the statute book, so checks and balances are in place. It is appropriate that manufacturers, suppliers and users of medical devices continue to have regard to the legislation specific to their circumstances, including the appropriate existing regulations that achieve the hon. Gentleman’s aim. I therefore ask him to withdraw the amendment. If the Opposition have points to press—with specific items, for example—they should write to me directly.

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care)

I feel that I have made my point. I also discussed veterinary medicine and, with a Whip in the room, it might be misinterpreted that I am making a bid to be a shadow DEFRA Minister—I would not want that to be the sense that the Committee got. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care

Clause 12 provides the power to make changes to the Medical Device Regulations 2002, which regulate medical devices in the UK. Those regulations provide for the assessment of requirements and standards that must be met to place medical devices on the UK market, including in relation to packaging, labelling and user instructions, and for the requirements on manufacturers to conduct post-market surveillance of devices.

The first subsection of the clause is a delegated power allowing the Secretary of State to make amending or supplementing provisions to the Medical Devices Regulations. The exercise of that power is limited to making provisions about matters specified in clauses 13 to 15. Those clauses provide an explicit and exhaustive list of topics and give more detail on how the regulation-making power may be exercised. The Committee will, I am sure, hear in-depth explanations of those clauses during our consideration of them.

Subsection (2) explains that the Secretary of State must have regard to three factors when making provisions under subsection (1): the safety of medical devices; the availability of medical devices; and the attractiveness of the UK as a place in which to develop or supply medical devices. Those three factors must be taken into account, and they have been included to provide reassurance that future provisions are made with the best intentions for the safety of people and patients in the UK, as well as the continued development of our life sciences sector.

Photo of Matt Western Matt Western Opposition Whip (Commons)

I thank the Minister for giving way; she is being very generous. I want to press her on that point. She talks about reassurance, safety and how important this sector is to our economy and our scientific status. When we talk about safety, we think about gauze and metal implants and so on, and the Minister mentioned how important it is for consumer protection and assurance. However, in the way that we have a building regs centre, or whatever it is called, at Watford—it came to light after the Grenfell disaster—where building materials are tested, is there such a body that does testing of these medical materials and products in the UK? If not, is one envisaged?

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care

I will not bluff but, off the top of my head, I think that the MHRA would look at medical devices, as it does medicines—I was looking to where my box of officials would normally be. I am fairly sure that the MHRA pays regard to devices, as with the centre at Watford to which the hon. Gentleman alluded. That centre used to do its practices at the Cardington air hangars many years ago, I think, on fire in buildings, for example. Yes, I believe that there is sufficient regulatory oversight to ensure the safety of medical devices.

Medical devices are a reserved matter in relation to Wales, Scotland and Northern Ireland. As a result, unlike the enabling powers at clauses 1(1) and 8(1), regulations made under clause 12(1) can only be made by the Secretary of State.

Question put and agreed to.

Clause 12 accordingly ordered to stand part of the Bill.