(4 years, 2 months ago)
General CommitteesI place on the record my thanks for the hon. Gentleman’s tone; I am grateful for the support. As we know from this morning’s announcement by Professor Whitty and Patrick Vallance, this is a difficult, fluid situation that is changing. It is important, as I answer some of the questions that the hon. Gentleman put to me, that we keep that level of dynamism in mind, because that is the problem: we cannot see into the future. One of the challenges is that if we pre-empt where we are going, we are much more likely to be over-restrictive than under-restrictive.
The one thing we have not heard in the offer of support is how that support would work within the parliamentary framework. Do we sit for seven days, because these things are arguably coming at us hourly? Do we do it on a smaller basis? Do we go through usual channels? This is considerably more complex. I understand the point the hon. Gentleman makes, because often members of the public are not sure how this place works, and there is a challenge in helping them to understand why we do things in certain ways.
The Minister makes a valid point. As a constructive suggestion, we have Westminster Hall and we have spare capacity in this place. How about using Westminster Hall solely for the purpose of having these debates about everything related to the covid-19 pandemic and how we work our way through it, and we could do stuff in advance?
I thank the hon. Gentleman for his suggestion; I am sure my Whip will take that away and feed it up through the usual channels. The hon. Gentleman makes the point that there are other places on the estate but, as he will know, there are also restrictions on movement around the estate and what parts of if we can move to.
The restrictions we have debated today are necessary and important for three reasons. First, and most importantly, they are necessary to protect the people in the north of England and surrounding areas from this terrible virus. The restrictions imposed have been difficult, but I think the people of the north of England recognise that the measures have been paramount to try to stop the spread of the virus.
Secondly, the restrictions protect those of us outside the north of England. Containing was very much the strategy laid out on 10 May. These restrictions greatly reduce the risk of transmission within the protected area, which in turn reduces the risk of infection rates increasing elsewhere. We recognise and appreciate that in abiding by these restrictions, those in the north of England benefit the whole country, and I place on the record my thanks to them.
Thirdly, the restrictions show the absolute determination to respond to the outbreaks of the virus in a focused and effective way. We are learning from what happened in the north of England as we work with local authorities and others to respond to future localised outbreaks, such as those that one of my colleagues will be debating in the House in due course. Indeed, we were able to work down to a granular, ward-by-ward level, but we have found that it is probably not the best strategy to open up on that basis.
The next review of the regulations will take place on or before 25 September. I am grateful to hon. Members for their contributions to the date today. I would like to address the point that the hon. Member for Nottingham North made first about timeliness and speed. The Government are confident that the regulations were made lawfully under the emergency procedure of the Public Health (Control of Disease) Act 1984. They are receiving parliamentary scrutiny in accordance with the emergency procedure, and are being debated within 28 days.
The challenge with these regulations is that we caught the tail end of recess, which obviously pushed them out a little further. The procedure allows us to respond quickly to the serious and imminent threat to public health posed by coronavirus, first by imposing restrictions to break the transmission chain and to protect people, and secondly by removing those restrictions when it is safe to do so. The regulations we are debating show how fluidly and quickly we can make those adjustments and changes.
The Secretary of State considers that the requirements imposed by the regulations are a proportionate public health response to the threat of incidence and spread in England of severe acute respiratory syndrome coronavirus 2— SARS-CoV-2—or covid-19. The regulations set out that a review of those requirements must take place every 14 days to ensure that they continue to be necessary to
“prevent, protect against, control or provide a public health response to the incidence or spread of infection”.
It is also important that timely reviews are made so that restrictions are not overly imposed on any part of the population.
We have subsequently amended the regulations to ensure that we continue to take necessary steps to protect public health as national restrictions were lifted over the summer—amendments were accordingly made on 8, 15 and 26 August. The hon. Member for Nottingham North asked how decisions are made locally and what the system is. Public Health England, the Joint Biosecurity Centre and NHS Test and Trace are constantly monitoring the levels of infection across the country, and work with local authorities to implement additional control measures as appropriate. Those decisions will be taken on a case-by-case basis, which is why that local knowledge is so important, and advice may differ according to the specific circumstances of any given outbreak. Indeed, tomorrow we will be talking about an outbreak in and around a place of work, which is obviously quite different.
The watchlist is already publicly available in Public Health England’s weekly surveillance report, and the decision to place restrictions on local authorities in the north of England was based on a number of factors, including not just the positivity rate, but the incidence rate of the virus, the extent of high-risk behaviours and the rise in the increased risk of transmission between the population. The next review will take place on Friday 25th—this Friday—and we are debating the regulations before that review. My right hon. Friend the Secretary of State will consider all those factors when making his decision.
As I have just mentioned, we have increased the capacity of the test and trace system by more than 10% in the last few weeks, with the aim of reaching 500,000 tests per day by the end of October. I pay tribute to all those involved in the test and trace system because, initially, we could process some 2,000 per day. We are now well over 240,000 per day, and some capacity, including antibody tests, is well over 370,000 tests per day. We are on track to hit 500,000 tests per day by the end of October. There are four new Lighthouse labs coming on stream, including Newport, Newcastle, Charnwood and Brants Bridge. There are hundreds of additional staff and capacity is being bought up abroad. Test and trace has led to more than 420,000 people isolating who may otherwise have spread the virus. As we heard this morning, breaking that transmission chain is so important.
I thank the Minister for giving way—she is being very generous. I have an observation: I visited our testing centre at the Ricoh Arena in north Coventry, which serves the whole region of Warwickshire and Coventry. In the hour I spent there yesterday, only 16 cars went in. There was clearly a lot of capacity—a big facility has been established there—and very professional people on site, but there must be a disconnect between the capacity she describes, which I saw, and what is being fed through to those centres. The numbers that she describes are huge, but I am not seeing that on the ground.
I think what we are all seeing on the ground is that demand has become exponential in the past few weeks. It is therefore a question of the system catching up, but it is important that the Government assess the risk factors and continue to protect healthcare workers and members of the social care workforce first to ensure that we are protecting the most vulnerable in society with the capacity that we have, and then begin to move through to other key workers. We need to have a risk stratification approach as the numbers increase.
This country’s population is in the region of 67 million. Even with a testing rate at 500,000 per day, it would take some weeks to get through that. There has to be a marrying of the testing capacity within the testing facilities and the ability of the labs to have the throughput that backs up behind it. We are doing an enormous number of tests, and it has been noted that we actually have a larger throughput than Germany, Italy, Spain and France.
(4 years, 4 months ago)
General CommitteesI thank the hon. Member for Ellesmere Port and Neston for once again asking for proper scrutiny. However, as he articulated the challenges, he also very readily showed how dynamic the situation is and why the challenge of using parliamentary procedure and the normal channels, which are scheduled through House authorities in conjunction with the Whips, leads to a disconnect.
The hon. Gentleman will also be very much aware that Parliament expressly gave the Government the power in section 45R of the Public Health (Control of Disease) Act 1984: it is under that provision that we are now having this debate. It gave the Government the power to respond quickly in an emergency, such as the one we now face, before they have to come to Parliament for the right and proper parliamentary scrutiny.
Given that just along the corridor in another Committee room Members are debating the lockdown regulations for Leicester, I gently push back against earlier comments: we are making great progress, and the assertion that this crisis is still not the complete focus of the Government is wrong. That is why we are coming forward in this way. The Government will keep the restrictions under review; as the hon. Gentleman said, the Secretary of State has a duty to keep them under review in a timely fashion and a duty laid upon him to make sure that he releases these restrictions as rapidly as possible. That is what we are involved in.
I do, however, hear the point that this is, once again, a timing issue for the Opposition in respect of being allowed to scrutinise measures in an effective way. I hope that my comments have set out, in part, where we are.
The point is that all the Opposition and Members from across the Committee are trying to do is help come up with the best legislation. It is a surprise that a lot of this is not being done in anticipation of what is likely to happen, so that we can help collectively to ensure that any inconsistencies are avoided. To use an example from my constituency, someone who provides beauty treatments asked me a very simple question: “Why is it that a barber can work on a man’s face, but I cannot work on a woman’s face?”
I agree that there are challenges to making guidance seem consistent, but we are led by advice from PHE and the risk assessments done in each individual business.
To answer my right hon. Friend the Member for Scarborough and Whitby, there is a duty on each and every business to ensure that it has done suitable and sufficient risk assessments to allow itself to restart. Yoga, for example, is an activity that can take place outdoors. However, there are restrictions on covered areas for indoor sports, so at the moment it cannot take place in an indoor sports venue.
We have made progress in the past few weeks. I hope that my right hon. Friend, who was previously a business Minister, welcomes the fact that we are reopening the economy for, among other things, people’s wellbeing—one of the biggest determinants of inequality is people’s ability to work, which has a long-term effect on their mental and physical health. It is important that we push forward and open businesses, with proper scrutiny from Public Health England, and ensure that they are safe places for work, for staff and for people visiting them.
My right hon. Friend spoke about having more oversight of the reviews and so on. We recognise that transparency is important in these times. SAGE has been publishing its statements, and the accompanying evidence as it is reviewed, to demonstrate how the scientific understanding of covid-19 has continued to evolve as new data emerges. SAGE’s advice has quickly adapted to new findings that reflect the changing situation.
My right hon. Friend mentioned the Imperial College study, which gratifyingly noted that the R number was lower than had been thought. That shows the benefits of the lockdown restrictions. I am sure all MPs agree that the vast majority of our constituents have behaved extremely responsibly. I trust them to continue to do so, notwithstanding the fact that over the past 17 weeks we have all had in our inboxes challenging stories of people who wanted to meet a grandchild or say their last goodbyes to someone.
This has been a national effort. The releasing of these regulations and guidance is the next step to ensuring that we get to where we want to be and start to resume life with our new normal, ensuring that social distancing still applies where possible—the advice is incredibly clear that social distancing is the primary measure for stopping the transmission. In places where that is not possible, we have the 1 metre-plus rule, with interventions such as Perspex screens in shops—or even in Parliament, as we now see in some of the Committee Rooms—to keep people safe, and the wearing of face masks.
I gently say that the face covering regulations come in on the 24th. We have been having conversations about enforcement with the National Police Chiefs Council and the College of Policing, and they have released guidance on each set of regulations. We are in daily contact with them to ensure that there is consistency around enforcement. People with inside businesses will not be expected to enforce.
The equalities impact has been considered throughout the restrictions across a range of protected characteristics, but the hon. Member for Ellesmere Port and Neston will have to raise the more specific instances for different protected groups with the relevant Department.
The hon. Gentleman asked two very specific questions on testing: on the Randox test and comments from yesterday. If he will forgive me, I will write with a more comprehensive answer on testing. He will be well aware that we now have the capacity in this country to test some 300,000 across the suite of tests per day. On the turnaround time, we get 91% of the tests done at either the satellite or mobile testing back within a shorter than 24-hour period, and 97.5% within the day.
(4 years, 5 months ago)
Public Bill CommitteesAs the hon. Gentleman knows, I am also enthused and excited about the register, because it offers us a space to do something good. I am very grateful to him and the hon. Member for Central Ayrshire, to whom I spoke at the weekend, as I said on Monday, and I noted that she would not be with us for Committee proceedings.
A registry of long-term implantable medical devices as suggested in new clause 6 is of significant interest to many Members. On Second Reading, many Members put forward good ideas on how we could make a register work for the benefit of patients. We should consider this in the context of the forthcoming report from the independent medicines and medical devices safety review and the matters it looked into, particularly the use of pelvic mesh, and how we oversee medical devices, including post-market surveillance. It is not only the point when the device is implanted that is vital, but also the potential impacts some years later. I know we all recognise the critical importance of ensuring that patients are heard and that concerns about medical devices are identified and dealt with quickly and effectively. That must be at the forefront of our minds. As the hon. Gentleman said, the impact on an individual’s life can be significant.
New clause 6 is similar to new clause 1, which was tabled in the name of my hon. Friend the Member for Newton Abbot (Anne Marie Morris). I know that she and many other Members in the House and the other place are interested in what more we could do to improve the tracking of implantable medical devices. The issue has also been a subject of interest to the Health Quality Improvement Partnership and the Royal College of Surgeons. It is very topical.
Clause 13(1)(h) provides for the creation of a register of medical devices to capture which devices are available on the UK market and to ensure that the MHRA can identify which device has been produced by which manufacturer. There has been some confusion in some of the written evidence as to whether that is intended to constitute a registry. A registry as in new clause 6 suggests bringing together patient and clinical information with device information. We have device registries, such as the national joint registry in the UK, which is seen as a global exemplar, so it is important to make sure that we do what we need to in order to enhance what is already in the system.
I understand the intent behind the new clause and, as ever, I am keen to understand what more we can do to protect patients in a fast-moving and constantly innovating environment, but I am not sure that new clause 6 is practical. The hon. Member for Central Ayrshire and I discussed the fact that it was heading in the right direction, but we need to work on it.
Patient safety absolutely underpins everything in our approach to regulation of medical devices in the Bill. It is the key consideration for all of us, as set out in clause 12(2)—the Government have put it there as the key priority. That is why we have introduced the ability for the Secretary of State to disclose information in the event of a safety concern, as we discussed.
I am not sure that the new clause achieves what the hon. Members for Central Ayrshire and for Nottingham North want it to. The intent is to establish a UK registry linking together all existing device registries, so that duplication of the entry of information is reduced, and to require the information entered to include the specifics of a device, such as the clinician who implanted it—information that, in the event of something going wrong, would give a clear picture of what happened. Although that is a commendable aim, the existing registries have been established over time and have expanded into different regions, evolving as they go. We have not had conversations on linkages to the registers in various parts of the country and in devolved Administrations. It is right and proper that we pull back and ensure that we have taken in the views of all stakeholders, and done the proper engagement to ensure that we collect the information from registers appropriately. That needs some work, partly due to the differing operating approaches in each registry. I gently suggest that the proposal in subsection (6) that all implanted devices without a specialist registry be logged on a national registry is a little broad at this stage. We perhaps need to talk about that with stakeholders and others.
The new clause also seeks to establish a governance structure, after consultation with a range of stakeholders, on the management of and access to the proposed registry. I suggest that the consultation requirement is out of step with the consultation duty in clause 40, which provides that consultation with those considered appropriate must take place before we make the regulations. It is a little cart before the horse but, that notwithstanding, this is very much the direction of travel. I remain of the view—no doubt we will come to this point—that we must ensure that we do not inadvertently rule out consulting those who ought to be consulted.
The hon. Member for Nottingham North and I have had discussions in this space, and we are united in wanting this idea to get to the right place. I appreciate the careful consideration that was given to the new clause, and I am grateful for it. I would welcome further discussions in the near future.
I am keen to clarify, not having been party to previous debate, what happens with non-medical cosmetic devices implanted by a medical procedure. Should registry for them be part of this consideration? There is a subsequent impact on our NHS when things go wrong.
I thank the hon. Member for his intervention. We are not talking about cosmetic devices here, but I very much take his point. If it involves implantation, it is worth talking about, in the round, during consultation; however, many of the cosmetic issues he refers to may be temporary—if, for example, a device is inserted and then taken away. The legislation is about implanted devices. Again, it is something that we would talk about and ensure that we had consulted on, but for the purposes of the Bill, we are specifically looking at medical devices, and the definition of them.
As I said, I welcome discussion with those interested in these matters, particularly as we look forward to Baroness Cumberlege’s review, which is coming very shortly. On that basis, I ask the hon. Members for Central Ayrshire and for Nottingham North to withdraw the motion, but I will commit to following up with arrangements to have those discussions in a timely fashion.
(4 years, 5 months ago)
Public Bill CommitteesClause 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.
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?
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.
Clause 13
Manufacture, marketing and supply