Oral Answers to Questions

Alex Norris Excerpts

Tuesday 6th October 2020 Commons Chamber

[Matt Hancock]

My hon. Friend raises a very important point. As I mentioned in response to the first question, we now have referrals back up to over 80% of pre-pandemic levels, but we need to get that up further, because we all know that early diagnosis saves lives. I am also very glad to be able to report that in July, on the latest data, over 90% of patients saw a cancer specialist within two weeks of a referral from a GP, and 95% of patients receive treatment within 31 days of a decision to treat, so those referrals are leading to the action that is necessary. It is very important that the message goes out that the NHS is open, and anybody with a concern over cancer should come forward and they can get the treatment in a safe way that can help to save their lives.

[Alex Norris (Nottingham North) (Lab/Co-op)]

In June’s departmental questions, I pressed Ministers on the cancer backlog that has grown so greatly under covid, so it was alarming that despite those ministerial assurances, between August and September, with infection rates being much lower than they are today, the waiting list to see a specialist grew by 16%. Things will only get harder now that infection rates are rising and with the NHS facing winter pressures, so will the Secretary of State give us a categorical assurance that he has a cancer recovery plan, and that it will drive down the waiting lists each month for the rest of the year?

[Matt Hancock]

Yes, absolutely. I think we agree right across the House on the importance of this agenda. The first and most important part of it is to bear down on the long waits, because the longer that people wait, the more dangerous cancer can become. That is happening, and we also have to make sure we bring the referrals forward, because we do not want to have fewer people referred for the diagnostics. At the same time, we are expanding the diagnostics that are available, both in hospitals and increasingly in community hubs, which are safer from a covid point of view and, for the long term, will mean that diagnostic centres for things such as cancer can perhaps be on a high street or in the places where people live, so that they do not necessarily have to go to a big, acute hospital to get the diagnostics part of the pathway done.

Health Protection (Coronavirus, Restrictions) (Bolton) Regulations 2020

Alex Norris Excerpts

Tuesday 29th September 2020 General Committees

[Alex Norris (Nottingham North) (Lab/Co-op)]

The Minister and her colleague, the Minister for Health, the hon. Member for Charnwood (Edward Argar), together with my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders) and I are in a sort of Monday-Tuesday rotation for these statutory instruments. The SIs are broadly similar, but each one is exceptionally important to the local communities that they affect. There may therefore be some repetition in my speech, as I dare say there was in the Minister’s. Nevertheless, it is important that we discuss these matters fully, and that is what I will seek to do.

I always start these debates with a homily about the nature of opposition in coronavirus times; we are always a bit in the Goldilocks hot seat. I think it was last Wednesday night that I was on Talk Radio getting beaten up because we were too supportive of the Government and the lockdown regulations. On Sunday, I was then on Sky News being beaten up for playing party politics with our opposition to some elements of the restrictive measures. Such is life.

I say that to show that we genuinely treat these things on their merits. We want the Government to succeed; we want to get out of this coronavirus era, however long it lasts. We want to get back to the football—frankly, it is not a night out if it finishes at 10 pm. We do want the Government to succeed, but there are times when our good will and support are stretched, especially when it seems that the Government are losing control of the virus.

Over the weekend, there was another foreseeable but not particularly well-managed situation around universities in policy terms, but there was also chaotic communication, with successive Ministers unable to say the same thing in succession. Similarly, even this morning Ministers on national media were unable to stand up the messages given out yesterday in the Chamber. That makes things really hard, as do the regulations before us.

I will say a lot of the things that I have said before. Debating regulations 19 days after they came into force is a fool’s errand and a waste of all our time, other than the fact that it is really important that we do debate them. We cannot change anything; we will not divide over them. Of course we cannot—the horse is multiple fields down by now.

We appreciate the need for efficient action, particularly at the beginning of a crisis, but it is absurd that this far into the crisis we have still not managed to debate one of these statutory instruments prior to its coming into force. When we do reach an opportunity to debate them, it is not even days but weeks or months later— 19 days in this case. That is a regular pattern that has been raised many times by Members of all parties and many times in the other place.

The rubber will perhaps hit the road on this discussion tomorrow, because Parliament is not here to rubber-stamp Government decisions. Executive decisions are not meant to be rubber-stamped by the legislature many weeks later, but, as I say, we are here and there is not much choice. We have a responsibility to make sure that the Government do the best by the country and that our constituents have maximum confidence in what is done. We must be able to demonstrate that we properly scrutinise the decisions that are being taken, but we cannot say that at the moment.

When I raised the matter last week, the Minister asked whether I would be willing to work seven days a week in order to scrutinise legislation. That made me think of an American revolutionary, Nathan Hale, who, just before he was executed for spying, said,

“I only regret that I have but one life to lose for my country.”

I can probably bastardise that to say, “My only regret is that I have only seven days to give for my community.” Whatever the day, whatever the hour, if it is important enough for us to discuss and it means we can get upstream, I would be willing to meet—even on a Sunday. We are discussing regulations from 19 days ago and new ones were announced yesterday. If meeting on a Sunday is what it takes to discuss yesterday’s new regulations in a timely manner, I absolutely would be willing to do that.

Nevertheless, I recognise that last week we were talking about statutory instruments that were nine and a half weeks old, and the instrument we are discussing today is only two and a half weeks old. Perhaps the Minister can give us her thoughts on that, but I hope it demonstrates that we are catching up, in which case I recognise that and am grateful to the Minister and her team for it.

Similarly last week, the Minister mentioned that the statutory instruments were in accordance with the Coronavirus Act 2020. I do not dispute that that is the case with today’s instrument, but I gently say that that is not a particularly high bar. When the instruments are so badly out of date, the Act is weakened. Ahead of tomorrow’s discussions we will all have received emails. There is a lot of bad information out there about coronavirus. Some of the emails we get are perhaps less based in fact, but the emails we are getting at the moment about the Act are very well meant. They are evidence based, with serious discussions about civil liberties in the UK. Concern is growing because there is a sense that Parliament has not got a grip, which is very much the point that I am making this morning. Again, we will support the renewal of the Act tomorrow—what else could we do?—but we will seek to amend it to give a greater sense of transparency.

I know that there are other high profile suggestions centred on giving Parliament an automatic proactive say. I am attracted to that, but I have no confidence that it will be delivered, even if the Government are bounced into it. Yesterday the Secretary of State said,

“I strongly agree with the need for us in this House to have the appropriate level of scrutiny… The aim is to provide the House with the opportunity to scrutinise in advance through regular statements and debates, questioning the Government’s scientific advisers more regularly—that has already started—gaining access to local data”.—[Official Report, 28 September 2020; Vol. 681, c. 22.]

Even for the Secretary of State, that is a classic of the genre: suggesting agreement, but not actually agreeing; suggesting something new, but offering the status quo. I do not know if that will wash with Government Back Benchers—I would be amazed if it did—because that is what we have at the moment.

What we are talking about is significant restrictions on people’s liberties that are discussed in the past tense. I recognise that the Government have frequently made themselves available through statements, and Mr Speaker has facilitated urgent questions or general debates such as the one we had yesterday. However, it is not the chance to talk about coronavirus that has colleagues concerned, but the chance to discuss significant and important restrictions on people’s liberties, which we do not have at the moment.

[Matt Western (Warwick and Leamington) (Lab)]

It is a pleasure to serve under your chairmanship, Ms Nokes. As my hon. Friend said, we have debated the points in hindsight over many weeks now.

What is frustrating for the public and those of us representing the public is the fact that this legislation is being debated retrospectively. There is so much inconsistency and incoherence in so much of the Government policy, and that is the frustrating thing. That is why we need to get on the front foot and lay such legislation in advance.

[Alex Norris]

I agree with that. It is good for all of us—good for parliamentary democracy, but good for the Government too—to have the regulations and inconsistencies aired. We would hope that that is the way in which things will be improved. My hon. Friend’s point also reflects on the consistent and regular use of the negative procedure for these statutory instruments. Obviously, that is now very pertinent in the light of what we will discuss tomorrow—renewing the Act or not—but it is hard not to notice that the whole suite of Brexit-related legislation is wired in exactly the same way. The Government rely on these powers, and on secondary legislation approved via the negative procedure. Many of those who are opposing this method today and tomorrow have championed it for four years, so it is a little late to take it slowly. That is not Nathan Hale; it is Girls Aloud. We should have real concern that this is the nature of government in Britain for at least the next 12 to 18 months; decisions by the Executive are subsequently looked at by Parliament when it is a bit late. That should discomfort all of us.

Again, I would be interested in the Minister’s reflections on this situation. As I say, it would be hard to get in front of every single decision, but we should be trying to get in front of as many as possible. We would not want to bog down the process so that effective interventions happened in a less timely manner, but we could at least get away from introducing them 15 minutes before they are implemented. Again, that reflects a sense of chaos rather than order and organisation. I would be interested to hear the Minister’s views on that.

It goes without saying that the situation is now becoming more challenging. The regulations work, and our approach to tackling the virus works, for as long as people are willing to comply with them. In the beginning phases, people did incredible work and made personal sacrifices during lockdown. I fundamentally believe that that is a mark of the character of British people. That is the way in which people will continue to attack these challenging circumstances for as long as they have confidence in the measures that are being taken and they have a sense that other people—both their neighbours and at a national level—are complying too. Things like grouse shooting or Barnard Castle chip away at public opinion and make people think, “You know what? Forget about this. I’m just going to do it and see what happens.” That we cannot have, because our approach will fall apart.

Like the Government, the Opposition have said before that when infection rates rise, restrictions should increase. That is particularly pertinent in this case. We have all seen the significant and rapid rise in infection rates in Bolton, which is a concern for everybody, so of course these restrictions were necessary. There is an interesting nugget at regulation 3.1 that might be helpful for us: the closure of bars and restaurants at 10 o’clock. Of course, that is now our national reality. Again, we did not dispute this last week. We know that this is not something that has been built on SAGE advice or guidance; it is something that is not really based on evidence. I know the Government have relied on evidence from Antwerp in Belgium—that was certainly the line last Wednesday—which stretches credulity a bit, but Bolton might actually be a better example. I would be keen to know, because regulation 2.2 says that the reviews must be fortnightly and start on 24 September, which was last week. The Minister said that a review had already taken place, so it would be interesting to know what the impact of the closure at 10 o’clock was. Again, the picture that was painted by the Minister was one of younger people from diverse geographical parts of the borough, so it is probably fair to say that it is linked to the night-time economy. What has been the impact of the 10 o’clock closure? It might actually be the best evidence that we have for the national curfew.

Finally, I am really pleased hear that the local consultation was good in the case of Bolton, particularly given how rapidly things changed there. In relation to the new regulations announced for the north-east from the Dispatch Box last night—that is the right way to do it—given that we seem to have this conversation every time, it is hard not to be struck that the leader of Newcastle City Council,  Councillor Nick Forbes, said, “We have been having conversations, but this is the first we have heard of it.” I know him well and he is a very sensible, practical and not particularly dogmatic or partisan individual. I am glad to hear it is not the case in Bolton, but such a lack of consultation will not do for public confidence. Perhaps the Minister could reiterate that there is a genuine commitment to working in partnership and that local authorities will not find out about new regulations in the news rather than through conversations, even if the Government, of course, need the final say. Again, the Opposition do not intend to divide the Committee, but there are many elements that could be done better.

HEALTH PROTECTION (CORONAVIRUS, RESTRICTIONS) (NO. 2) (ENGLAND) (AMENDMENT) (NO. 3) REGULATIONS 2020 HEALTH PROTECTION (CORONAVIRUS) (RESTRICTIONS ON HOLDING OF GATHERINGS AND AMENDMENT) (ENGLAND) REGULATIONS 2020

Alex Norris Excerpts

Tuesday 22nd September 2020 General Committees

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is a pleasure to serve with you in the Chair for the first time, Dr Huq. I am grateful to the Minister for his introductory remarks and his service over the last seven-plus months. Whatever we think about coronavirus and whatever our views on where to go next, Ministers have clearly been working at very high frequency for a long time, which would tire anyone. We are grateful for that important public service.

It is risky business, Dr Huq, to be on your feet speaking at the same time as your party’s leader makes their speech to conference. In fact, it might the first time that I or any colleague would be so brave. I hope the Whip will get me out of any trouble, should it be seen that I am trying to elevate my standing prematurely. I apologise to the hon. Members for Erewash and for St Austell and Newquay, because they may have heard some of this speech 18 hours ago, but they will see just how many of my jokes really are ad hoc rather than just delivered with aplomb.

I will start, as I did yesterday, with a couple of things about opposition in the time of covid—like love in the time of cholera, or the other way around. We have set out our stall throughout the pandemic to be a supportive Opposition. The Leader of the Opposition spoke about that on Sunday and, as I said yesterday, some of the replies to his tweet are extraordinary, saying that perhaps we should not be as supportive of these sorts of restrictions and regulations. But we are, and we think that is right.

It would be easy to fall into the narcissism of small differences that one can in opposition, with the Government saying it should be a role of six and us saying it should be a rule of seven or five. Or the Government could say, as they do in SI No. 907, that the fixed penalty should be £10,000, and we could say it should be £9,500. We are not doing any of that—it takes up time and it does not help—but that shared and collective well of goodwill has to come from being able to scrutinise what the Government choose to do and to regulate in a proper and timely manner and in a way that is effective for our constituents. I would gently say, and I will talk about this shortly, that we are on the edge of that goodwill with these regulations. In fact, we are probably past the edge.

I am sure the irony will not be lost on hon. Members of discussing legislation that reopens part of the economy as we wait to hear at half-past 11 details of it being closed down again. It will definitely affect venues that are covered in SI No. 863. I have seen it said by industry bodies, certainly about casinos, that they will hear about the retrospective rubber-stamping of their ability to reopen on the one hand and the 10 pm curfew on the other, if what has been briefed to the newspapers is accurate, and that is likely to be harmful for them.

That does not mean that it is the wrong thing to do, but when we are not discussing such matters in a timely manner, they start to look inconsistent and a bit chaotic. Part of that is inevitable because of the fast-moving pace of the pandemic, but part of it is a need for better organisation. I hope that the Minister will talk about where we might go in future on that.

We broadly support the measures and we will not divide the Committee on them, because halting the spread of the virus and keeping people safe is the No. 1 priority for us all. SI No. 863, however, came into effect nine and a half weeks ago, so we are scrutinising it long after the fact. SI No. 907 is much more recent and came into effect only three and a half weeks ago. That is pretty hard to justify. I had a similar conversation with the Minister for Public Health, the hon. Member for Bury St Edmunds (Jo Churchill), yesterday about measures that were eight weeks old. She discussed the backlog and the complications because of recess, but we had four or five sitting days after SI No. 863 came into effect on 15 July. We are running just to catch up and we are a long way behind.

We understand the need to be efficient. We never want to be in a situation where important regulations that would reduce infection rates are being held up merely because of our opportunity to talk about them, but I do not think that is the same. No one could make a solid case for the public interest of waiting nine and a half weeks to discuss these things. It is a pattern that has been raised many times.

[Craig Williams (Montgomeryshire) (Con)]

I welcome the constructive tone of the hon. Gentleman’s speech which, in Wales, we try to emulate, given that the Welsh Labour Government are in charge of similar regulations. May I gently push back, however, since he is gently pushing, and say that the level of scrutiny that we are operating for these regulations far exceeds what we have in Wales in terms of the scrutiny of the regulations there?

[Alex Norris]

I am certainly no expert in the operation of secondary legislation in the Senedd; my hon. Friend the Member for Newport East might be better at that than me. From what we have in front of us, however, I know that nine and a half weeks does not work, whether that is a good level of scrutiny or not. We are here on a fool’s errand, frankly. Our time is not being used in particularly constructive way. I do not know if that is revealing what is behind the curtain in a way that we are perhaps not allowed to do, but that is true. I cannot address the specific point about Wales, but I know that it will not do for us.

The issue has been raised by hon. Members on both sides of the House and, indeed, in the other place. We do not exist to rubber stamp and nobody would want us to. We are here to scrutinise, because these are exceptionally important regulations. They are important in their substance, because we are all significant stakeholders in their success, and our scrutiny of them is important because of public confidence. We need public confidence in the changes that are made because we need people to comply with them. People are smart. If they think that the process has been cooked, they will smell that a mile off.

Some 17 statutory instruments are being debated this week, all of which are in force. Recently, regulations have come into force only a quarter of an hour after they have been available to read, which does not work. Other regulations have come into force and been revoked before being discussed. That will not do; it is not proper parliamentary scrutiny. We absolutely need a solid commitment from the Government, hopefully today, or definitely soon, about how we will get upstream and catch up. I said this yesterday and I was not contradicted by my Whip so I will say it again: we would be minded to be efficient and fast-moving in our scrutiny of the backlog if it meant that we could get upstream to the consideration of the measures that are coming in.

Indeed, it seems that extra restrictions are coming in today, so when does the Minister foresee a Committee discussing them? What will be the timeline for that? The Under-Secretary of State for Health and Social Care, the hon. Member for Bury St Edmunds (Jo Churchill) asked yesterday what we would be willing to do workwise in order to be available at the right time, and my answer is whatever it takes. I hope the Whip does not contradict me; I am volunteering myself more than anything else. The Under-Secretary asked whether I would be willing to be here seven days a week. Well, yes, if that is what it takes. I have no doubt the Minister is working seven days a week. We are more than willing to match that energy.

To make a very quick point, I see lots of 2019 Members and I envy them to a great degree because they missed what we were doing this time last year on Brexit. Putting aside the massive substance of that issue, we have an awful lot of debates, increasingly on other Bills too, on statutory instruments and the negative and affirmative procedure. Sometimes I think it looks as if we are being deliberately obtuse and saying, “That is by the negative procedure; it should be by the affirmative procedure.” Of course, that is what an Opposition would want. We do not want really significant changes such as these discussed at such a distant time period so that the discussion is meaningless and the horse is already three or four fields down. That is why it matters to us. I raised the matter at length during debates on the Medicines and Medical Devices Bill, and I know that on Second Reading peers in the other place did, too. I hope the Government can come up with something more sensible because there are significant powers under the negative procedure. I think that is disproportionate and I have explained the reasons why.

Moving back to these statutory instruments, our operating them competently proves the value of the Coronavirus Act 2020. Colleagues will have had conspiracy theory emails about coronavirus, many of which carry little value, but they will also have had a smaller number of emails that sometimes get lost in it all about very legitimate concerns to do with the Coronavirus Act—I would say rightly; we all supported it—because it gives the Government a lot of power to act swiftly to make significant regulations regarding individual freedom. The catch in that, or the check and balance in that, is that we reassure constituents that these things are scrutinised properly, and that has to be true. We cannot be far from the Act being up for renewal. I have already had emails, as others have, saying, “You had better not support it now; it is a massive breach of personal liberty”, but I do not buy that analysis. We have to be able to say that, during the six months, it has done its job competently, and we are, as I say, stretching that as a credible argument at the moment.

SI No. 907 is significant. Again, I think it is proportionate. The Minister made the point that someone cannot stumble accidentally into a party of more than 30 people. There is no way that someone acting responsibly and in line with regulations could accidentally get caught up in that. That is why the fine is significant and probably about right. How many times has it been used? I know it has definitely been used once in Nottingham—not in my constituency, but in the Nottingham South constituency. It got a lot of interest locally, which is not a bad thing because it was a good reminder of what people can and cannot do. I am interested to know how many times it has been used.

The vast majority of people have done the right thing the vast majority of the time. The Minister was right to praise the British people because they have responded incredibly in really difficult times, but the shoe has to drop sometimes, and that is the right thing to do.

I want to make a final point on testing and tracing because I cannot miss an opportunity to raise it with Ministers. This afternoon we are almost certainly going to backslide. We are going to rubber-stamp opening up parts of our economy, and in about two hours’ time we are going to close it back down again. That is not a good sign. To a certain extent it is to be expected. As infection rates rise, restrictions will increase. We have known that from the start. However, it would be less likely to happen, if at all, or would happen in a much more modest way, if we had an effective testing and tracing operation in place, which we do not, as everybody knows. Part of the problem is that the Minister is very defensive when we raise that, but we do so it because we need it to work. A vaccine is something in the middle distance, but testing and tracing is a way to drive down infection rates today. It clearly is not operating at its full capacity—forget world-class and all the nonsense public relations elements of it. We need it to be an effective operation so that people can have confidence in it. Again, I would be very grateful for the Minister’s engagement and reflections on that.

I note that the Minister referred to sports pilots, but it seems that we are going to find out that they cannot take place. Perhaps I have a personal vested interest in that, but there will be a lot of disappointment. There will be an existential problem for a lot of clubs in our communities that are struggling. People who are desperate for one of those great pleasures in life will be very disappointed. We need that proper test and trace operation in place if we are to do everything we can to drive down infection rates. I will conclude on that point. I am grateful for the Minister’s remarks, and I hope he can address some of my points.

Health Protection (Coronavirus, Restrictions on Gatherings) (North of England) Regulations 2020 Health Protection (Coronavirus, Restrictions on Gatherings) (North of England) (Amendment) Regulations 2020 Health Protection (Coronavirus, Restrictions on Gatherings) (North of England) (Amendment) (No. 2) Regulations 2020 Health Protection (Coronavirus, Restrictions) (North of England) (Amendment) Regulations 2020 Health Protection (Coronavirus, Restrictions) (North of England) (Amendment) (No. 2) Regulations 2020

Alex Norris Excerpts

Monday 21st September 2020 General Committees

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is a pleasure to serve with you in the Chair, Mr Hollobone. I thank the Minister for her remarks and explanations of what the Government are seeking to do, as well as for her efforts over the past six months. It has been an awful lot of work for Ministers, and we are grateful; when we disagree, I hope that we disagree firmly but well.

It is a funny time to be in opposition. The clue is in the name: we oppose very many, if not most, of the things in the Government’s legislative agenda. We have significant concerns about some or all of them, so we seek to amend, we scrutinise, and in that way we hope to improve our parliamentary democracy. On any issue, it is very easy to engage in the narcissism of small differences, but in a pandemic that will not do. If the Government say, “There is a rule of six,” we could very easily say, “It should be a rule of five, or a rule of seven.” We could play that game all day—indeed, I was on the radio on Thursday, and people were saying just that. “You are too co-operative. The Opposition are too supportive of the restrictions being put on our freedoms.”

Similarly—obviously, this gained much more coverage—on Sunday morning, my right hon. and learned Friend the Leader of the Opposition reiterated that we support the Government on the restrictions being put in place. We think it is obvious that if the infection rate increases, restrictions have to increase as well, but there were some extraordinary comments on Twitter—this was just from our own side—about how easily we were rolling over. I should probably never look at the comments, but sometimes I cannot help it.

The point I am building up to, however, is that the well of good will is not unlimited, because there is a real problem. Hon. Members will have read their papers, and will know that what we are discussing now is long after the fact. I do not think we would be popping anybody’s bubble or revealing what is behind the curtain, if I can mix my metaphors, to say that today is a bit of a fool’s errand. We are meeting weeks and weeks after these regulations were not only put in place, but changed. The first one we are discussing has since been amended on essentially four different occasions. There has to be a sense of reality about what we are doing, but hopefully also a recognition that, fundamentally, as an operation, this will not do. Are these very significant changes to happen on a very regular basis, only to be scrutinised in Parliament seven weeks later? I do not think so. It is not good for us as an Opposition, and it is also not good for the Government or for Government Back Benchers.

Of course, these regulations came into effect on 5 August. At that point, people living in the 15 local authority areas specified, as well as Blackburn—which was already under alternative restrictions—could no longer meet in groups of two or more households in a private dwelling, or in groups of more than 30 people outdoors. A variety of other conditions and exceptions was also in place. I recall this well: I was up in Manchester myself when it was announced, visiting my sister and her newborn baby, and I needed to beat a hasty retreat lest I had to stay there. I do not think my constituents would have been too impressed by that.

Again, we broadly support these measures and the intention behind them, because we all want to halt the spread of the virus, and we know that keeping people safe must be the No. 1 priority. However, we as an Opposition have to put on the record our concerns that it has taken seven weeks for us to get here. I talked to the Minister before we started, and I am sure that her colleagues have had a series of different versions of these delegated legislation Committees over the past few weeks.

Normally, we would put up my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders), but we are giving him a bit of a rest. I think that is why they have sent me out to bat: some fresh legs with half an hour to go, to run around and put a few tackles in, which has never been something I have worried about doing.

This point needs to be reiterated. We are rightly talking about having control of this virus, but there is concern across the House and definitely among the population that we do not now have control of the virus, and are certainly losing it. A big part of that control has to be our understanding and scrutiny of the regulations, their quality, and their effectiveness.

Of course, we need to act efficiently. We would never support a situation where important and effective regulation that was needed could not be introduced in a timely manner, because we had not yet got to Committee Room 10 to deal with it. We know the pattern on which the regulations will be popping up—a statement from the Health Secretary has just finished and there will be one from the Prime Minister tomorrow—and I do not think it is beyond the realms of possibility that new regulations are coming. However, while we are talking about regulations from seven weeks ago, when will we reach the new ones? Will it take seven weeks? I do not think that that will be in our interest or anyone else’s. I hope that the Minister will address that point.

I know that the subject has been raised many times by Members on both sides of the House, and in the other place. We cannot be here just to rubber stamp what the Government propose. That stretches things too far. I believe that we are taking responsible paths, although I say that with the caveat that I state whenever I do any media work. When I open my emails, half of them say that I have been too hard on the Government and am not supporting the national effort; the other half say that the Opposition are too acquiescent. Who knows? Nevertheless, I do not think that anyone would think arriving late and rubber stamping a measure is in our interest or is what our constituents need from us.

Mr Speaker gets upset, as do we, that often we hear of important policy changes on a Friday or Sunday night, long before Parliament has the opportunity to hear them. Sometimes I talk about that to my friends who are non-political and they say, “Well, you know, you can’t be that person who’s worried about being told first.” I remember Gareth from “The Office”, who would always insist on having the news whispered in his ear just before the big team meeting so that he knew it first. That is not the point or what we are saying. We are saying that we have a parliamentary democracy for a reason. It is a very effective one and has been this way for a long time. We all treasure and love it. We must be among its greatest enthusiasts because we choose to come here every day. We cannot lose that, even in the most important circumstances. That is when it becomes all the more important.

However, we have had regulations coming into force only a quarter of an hour after they are available to read. Including the five before the Committee, there are 17 measures being debated this week, all of which are already in force. Other regulations have come into force before being revoked and never seen. There seems to be no opportunity during this period of time to debate them, and that will not work. We are hoping for some clarity and commitment from the Minister, and an assurance that the Government are actively seeking to get upstream of this blizzard of regulations.

I would hate to take the job of Whip, held by my hon. Friend the Member for Warwick and Leamington—I really would not want it—but I am sure the Opposition would be constructive about shifting the backlog if it meant that we could deal with regulations in something closer to real time. That would be better for everyone. However, this is not just about Parliament; it is a question of the cue we send out to the public. If they feel that the process is rushed or bypassed, there is a danger of undermining Parliament’s credibility.

People in the north are reasonable and intelligent—I am one of them. They are not daft and they know when things are being cooked up on the fly. I have heard that from friends and family. If they feel that measures are arbitrary, and that they have been made on the hoof, that undermines their confidence in whether they should stick to them or whether to say, “Just pop round, and no one will ever really know.” We know that in fighting the virus that will not do.

It is hard, as I mentioned a couple of minutes ago, not to reflect that we have just had a statement from the Health Secretary and there will be one from the Prime Minister tomorrow, and there was a chief advisers’ press conference this morning. We would never say no to hearing more information and certainly not to having more opportunities to talk about it, but it is hard to explain to a lay person what process of swift, clear and effective decision-making those things reflect.

Compliance is key to our success in getting out from under the virus and making the measures work. That is why we need to scrutinise them and have our say on them. As I have said, we do not propose to divide the Committee, but that does not mean we do not want greater understanding of some of the Government’s ideas. Certainly, as we get into discussion of curfews or hospitality closing times, we want to understand precisely the science behind such things.

[Matt Western (Warwick and Leamington) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Hollobone. My colleague is making an important point. I hope Members will forgive me for repeating something that has come up at many similar Committee sittings. We represent communities to whom we are answerable, who want to know what is going on—why such measures are being passed, and why the policies are being imposed on communities. It is very difficult to explain what is happening when we have not had scrutiny or access to Ministers. Explanations should be upstream of any regulations being made, as my hon. Friend said. Back Benchers across the House are crying out for that. There should be a strategy that explains why the measures might be required in future. Strategic thinking needs to take place in advance, in anticipation of the circumstances. Does my hon. Friend agree?

[Alex Norris]

Yes, I do. Again, that is necessary for public confidence. We have supported the Government throughout. As infection rates decrease, we can open up more things and do more things. As infection rates rise, there will be greater restrictions. It would be better to understand what greater restrictions mean earlier in the process. Instead, it feels as though we are always running to catch up.

I am in danger of being much more negative than I usually am, but I have the chance to extol some virtues and talk about the benefits that we have today. We at least have hindsight at our disposal. We do not often get reviews of legislation this quickly after it has come into force, but today we have that. On 5 August, the seven-day case average in the north-west region, which is a good cipher for the area we are talking about, was just under 250. On 2 September, with the most recent of the four amendments, the seven-day case average was 486, and last week the rolling day average peaked at 1,200 on Wednesday.

It is therefore clear that although the regulations might have been effective, they are not entirely sufficient. That makes the case for greater restrictions. People need to understand that, even though it is frustrating. Certainly in the communities where freedoms have been curtailed, no doubt willingly, to beat the virus and protect each other, they need to understand the picture, what has happened subsequently and why we need to go further. We have a duty as an Opposition to point out that that was undermined by slowness in the early stages regarding personal protective equipment; lockdown itself; social care and more; the lack of scrutiny, as I mentioned; and particularly now, as we reflect on this here in Parliament, the shambles that is test and trace.

Short of a wonder vaccine, which will be gladly received when it comes, test and trace is our most critical weapon to get out from underneath this, but at the moment it is not happening. It is not working in a timely manner to properly find those who have coronavirus and to isolate them. That is why we are seeing the virus spread. Will the Minister update us on the progress towards getting a system that meets what the Prime Minister said in June about a 24-hour turnaround in response, because that is what it will take?

Can we hear a little more about what was briefed over the weekend? I am a man of the world—I understand that things get briefed to the Sunday newspapers. Since the beginning of the pandemic, we have been calling for a recognition that if those who are being asking to self-isolate are offered only statutory sick pay that pushes them into poverty, that will be an incentive not to comply with the regulations. That is not a good thing, but it is entirely human. The £500 figure was briefed over the weekend. Will the Minister tell us more about that?

I have three final points. We have not had much of a debate on the merits of these specific restrictions because the horse is three fields down by now, but it would be interesting to hear the Minister’s view on where we are currently and where she feels we will be next week, in a month’s time and in three months’ time. We want a sense of what the journey is, even if that journey means things are getting more challenging. Okay, that will mean greater restrictions, but what sorts of restrictions and when? It would be good for Parliament and for everybody to know that.

I am sure this is close to your heart, Mr Hollobone, as someone with a long history in local government, but will the Minister tell us a little more about local authority engagement? She said in her contribution that that has always been good. That is not always the picture that we get from local councils in respect of whether conversations have happened and whether the announcement reflects them. Can we hear what process is being used to engage with council leaders?

Finally, regulation 4 of the first set of regulations requires a review at least once every 14 days, so there must have been three since they came into effect. I wonder why the results of the reviews have not been made public, and whether they could be more routinely in future. That would give us something better to debate when evaluating their effectiveness.

I will draw to a conclusion there; I have made my point on timeliness and I hope the Minister can address it.

Oral Answers to Questions

Alex Norris Excerpts

Tuesday 1st September 2020 Commons Chamber

[Matt Hancock]

The flu vaccination programme this year will be the biggest in history. As I was going to say in my statement—I will say it now for my hon. Friend—we will be putting before the House proposals to expand the number of NHS qualified clinicians who can administer vaccinations, whether for the flu programme, which is coming, or for a covid vaccination programme, should a covid vaccine come out.

[Alex Norris (Nottingham North) (Lab/Co-op)]

The NHS Confederation, the British Medical Association, the British Dental Association, NHS Providers, the Royal Society for Public Health and many health charities have expressed real doubts about the Secretary of State’s plans for Public Health England. It is evident that, come what may, he will have his own organisation for tackling disease and that, come what may, he will pick which of his pals he wants to lead it, but he seems to have ignored the fact that Public Health England also leads crucial work on tackling drug and alcohol misuse, reducing smoking, promoting sexual health and much more. Six weeks ago, obesity was the Prime Minister’s priority, and now the Health Secretary wants to cut the organisation that leads our fight against it. Will he end the confusion today by committing to the remaining functions of Public Health England continuing to be led by a dedicated national organisation?

[Matt Hancock]

The hon. Gentleman obviously did not read the announcement, because part of the purpose of having a dedicated national institute for health protection is also to ensure that the ill health prevention agenda—the health improvement agenda—is embedded in the health system, including the NHS. This is a good day to discuss this, because just this morning the NHS set out the next steps in its diabetes prevention and remission programme. Embedding the anti-obesity drive right across the health system, including the NHS, is a critical part of its future, and we are consulting widely on making sure we have the right and best organisational structure to deliver that.

Independent Medicines and Medical Devices Safety Review

Alex Norris Excerpts

Thursday 9th July 2020 Commons Chamber

[Alex Norris (Nottingham North) (Lab/Co-op)]

I am grateful to the Minister for coming to make this statement today and for providing advance sight of it.

“Ignored”, “belittled”, “derided”, “gaslit”—those who have campaigned to highlight the harm caused by Primodos, sodium valproate and pelvic mesh have been called every name under the sun, but today they are one thing alone: proven right. I thank the noble Baroness Cumberlege for overseeing a piece of work that will make a huge difference to so many people, both today and in the future. It is hard to read, but it is vital that we do, and that we understand it and learn from it. It is really important to note that campaigners have universally said how well the review team treated them.

The review’s report thoroughly investigates what happened in respect of each of the three areas that I mentioned. Although, on the surface, they are separate, they have an awful lot in common, not least that they were all taken and used by women, and in two cases, pregnant women. This is clearly no coincidence and I was glad to see that the Minister referenced that the healthcare system must do better to protect women, because these cases reek of misogyny from top to bottom— and ageism and ableism as well. They also share the reaction of the healthcare system, which, according to the report, failed to monitor the use of these medicines and medical devices, then failed to identify and acknowledge that things had gone wrong, and then failed to work in a joined-up fashion to improve. The healthcare system failed to protect these people. As the review says, it has taken the act of having a review to shine a light on these systemic failings. I share with everybody else the love affair that we, as a nation, have with our health system, but we cannot be blind to its faults, and it is time that we act on them.

We would not be here without the campaigners. Without their tireless activism—for many decades in some cases—this would have been ignored. I want to take the opportunity to highlight a few of the groups that have done such tremendous work. That is a dangerous game, I know, and I can only apologise to those whom I do not have time to mention. Marie Lyon has led the way in bringing to attention the damage that hormone pregnancy tests, including Primodos tablets, can do. This report has finally proven her to have been right all along, stating that opportunities were missed to remove them from the market. She is right, too, that the Department for Work and Pensions has mugged campaigners over the condition insight report. I hope the Minister will commit to righting that wrong, too. Janet Williams and Emma Murphy, who founded the Independent Fetal Anti-Convulsant Trust—In-FACT—have fought so long to be believed and for action to be taken regarding sodium valproate, the risks associated with which far too many expectant mothers were unaware of. Kath Sansom, who founded Sling the Mesh, has provided so much support for so many people living in incredible pain because of pelvic mesh. This is a sombre day for those people, but I hope that they can take some satisfaction that their efforts have paid off in this way.

I would not often say this, but this is a day for parliamentarians, too. It was not clinicians or regulators who brought this to the surface. It was right hon. and hon. Members who listened to and believed campaigners and fought for them, too. Again, there are too many to name, but I will mention my hon. Friends the Members for Bolton South East (Yasmin Qureshi), for Kingston upon Hull West and Hessle (Emma Hardy), for Lancaster and Fleetwood (Cat Smith), the right hon. Member for Elmet and Rothwell (Alec Shelbrooke), my hon. Friend the Member for Blaydon (Liz Twist) and my predecessor as shadow Public Health Minister, my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson).

There is not time for me to cover all the recommendations, but I want to highlight a few. Recommendation 1 calls for a fulsome apology. It was right that the Minister did that, and it will be greatly appreciated. Recommendation 3 of the report calls for a new independent redress agency for those harmed by medicines and medical devices, to create a new way of delivering redress in the future.  It suggests that manufacturers and the state could share the costs. I would be interested in the Minister’s reflections on that. When does she think that could be implemented by?

Recommendation 4 suggests separate schemes for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to all those who have experienced avoidable harm. That is the ethical responsibility of the state and manufacturers. Will the Minister today commit to that recommendation —to providing some redress for those who have suffered avoidable psychological, physical and neurodevelopmental harm? Will she commit, critically, to work on that with these people? For too long, they have had things done to them and they are owed the opportunity to shape their futures.

On recommendation 6, regarding the Medicines and Healthcare Products Regulatory Agency, I said at every stage of the Medicines and Medical Devices Bill that the timing for that Bill was challenging, although that was inevitable as we had to get on with it, because the report would have profound implications for the MHRA—and, boy, does it. I would like the Minister to commit to amendments in the other place to make sure that the MHRA regulatory regime is as strong as possible.

Finally, and absolutely critically, recommendation 9 calls for the immediate creation of a taskforce to implement the recommendations. Will the Minister commit to that? It was right for her to say that she needed time for reflection, but I would be keen to have a definition of how long she feels the Government will need to reflect.

This is a sombre moment. It is incredibly hard to read the report, but it is vital that we do so. Campaigners and those affected have got justice today; now they need action. We will not let the report gather dust on a shelf. We will be fighting every day to get the recommendations implemented and to meet the needs and the expectations of those who have fought for so long.

[Ms Dorries]

That was a long list of asks. I am sure the hon. Gentleman appreciates that we received the report yesterday, and it is a detailed, in-depth and complex report. He is pushing on an open door, with almost everything he asks—patients absolutely have to be at the heart of this. The report is titled, “First Do No Harm”. Our response has to be to do good. We are listening; I am in listening mode. I have listened to what he has said. I will listen to what everybody here has to say today, and to what all the groups have to say, to the details of the report. We will take it away.

The hon. Gentleman asks how long; I am sure he appreciates that work needs to be done to formulate a response. The response will come as soon as possible, as soon as the work has been done. He is quite right about the role of women, which he referred to at the start of his comments. Whether it is Shipman or Paterson or maternity issues or the Cumberlege report, more often than not women are at the heart of these—for want of a better word—scandals. He is absolutely right and I feel very passionately about making sure we come back with a really positive and robust response to this report as soon as possible.

Medicines and Medical Devices Bill

Alex Norris Excerpts

Report stage & 3rd reading & 3rd reading: House of Commons & Report stage: House of Commons
Tuesday 23rd June 2020 Commons Chamber

I move now to amendments tabled by the hon. Members for Nottingham North (Alex Norris) and for St Helens South and Whiston (Ms Rimmer). I thank them for tabling them and hope that I can engage as much as possible with the points raised. Amendments 21, 22 and 23 are similar to those put down—

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is a thrill for a Government Minister to move my amendments, although that might be giving me false hope. But I just wanted to put on record for colleagues that the purpose of amendment 21 is to make patient safety the uppermost priority.

[Jo Churchill]

I thank the hon. Gentleman for his intervention. We are in completely unusual times: I get to respond to his amendments before he has actually spoken to them himself, but we will crack on.

I recognise that the hon. Gentleman said at the time that he wished to return to these issues during the proceedings and I was expecting him to do so. We agree that patient outcomes and patient safety are matters that we would expect the House to consider very seriously.

Amendments 21, 22 and 23 all seek to establish a hierarchy of considerations applied by the Secretary of State or the appropriate authority when making regulations under the Bill, making safety the primary consideration. It is important to say at the outset that there is a consensus on both sides of the House on patient safety. It matters to us as individuals and as MPs representing our constituents, who rightly wish to know that their safety and their animals’ safety is of uppermost importance when we look to make regulatory change.

--- Later in debate ---

Although I am entirely sympathetic to the concerns of the hon. Member for St Helens South and Whiston, I reassure Members that the current legislation provides extensive safeguards to ensure the ethical and appropriate use of human tissues in medicines and medicinal products. Equally, although I am sympathetic to the hon. Member’s intentions, I do not believe that the amendment would have the intended effect. I look forward to hearing further contributions from hon. Members.

[Alex Norris]

It is a pleasure to resume proceedings on the Bill. The exchanges in Committee were of a high quality in both content and tone, and I look forward to more of the same afternoon. I was proud to take the lead for the Opposition in Committee, as I am during the remaining stages of the Bill, and I thank my predecessor in the early rounds, my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson).

Let me turn to new clause 1. I am so pleased to see the Government introduce what we spoke of in Committee as a device registry, which is now called the information centre. Bad medicines and devices cause exceptional harm. The noble Baroness Cumberlege is looking at the impact of three of these: Primados, sodium valproate and surgical mesh. I pay tribute to the campaigners and their allies in this place for all their work to ensure that those who are suffering, or who have suffered, are not forgotten. Clearly there have been devices that, knowing what we know now, we would not have used. There is a risk of similar things happening in the future, and it is a risk that we cannot fully mitigate, so an information centre will at least put us in the strongest possible position to react quickly and clearly.

I am personally grateful to the Minister for the level of engagement from her and the Government in general. I and my colleagues in the other place are committed to continuing to develop the idea. I know that the hon. Member for Central Ayrshire (Dr Whitford)—who will be watching proceedings, and whose expertise and creativity are missed—is ready to do the same. I can tell from my inbox that there is considerable interest in the sector in making this work, and I hope the Minister will commit to full consultation with it.

Oral Answers to Questions

Alex Norris Excerpts

Tuesday 23rd June 2020 Commons Chamber

[Jo Churchill]

I would say that, as soon as people notice any signs that might worry them, they should seek help. We have worked at pace to ensure that services have been resumed and are able to deliver for patients. Ensuring both early diagnosis and that patients can access the treatment that they need swiftly is our key ambition. We know that, following the guidance that has been delivered, we are achieving that throughout the system. Covid-19 has upended all our lives, and some decisions have been made to ensure the safety of patients, but we are now firmly back on track and will ensure that patients get the care they need.

[Alex Norris (Nottingham North) (Lab/Co-op)]

Yesterday, the One Cancer Voice network of 25 charities published plans for restoring vital cancer services. I wrote to the Minister on 17 April with my own suggestion. Ideas included advanced radiotherapy, new models of chemotherapy, better cancer pathways and renewed screening and communication plans. This is not just about rebuilding what we had, but about making services better. If the Government are slow to do that, we face a cancer bubble that risks thousands of lives. Will the Minister commit to working with those charities and with me and other interested parliamentarians to form a cancer recovery plan to head off this looming crisis?

[Jo Churchill]

I assure the hon. Gentleman that, just as we have seen from working closely on the Medicines and Medical Devices Bill that is going through Parliament, there are lessons to be learned. There have been improvements in certain areas of radiotherapy in which it has been determined that fewer treatments actually mean a quicker and—I would not use the word “gentler”—an easier path for the patient. I would be happy to continue working both with him and with the cancer charities to ensure that we can improve that pathway for patients.

Medicines and Medical Devices Bill (Third sitting)

Alex Norris Excerpts

Committee stage & Committee Debate: 3rd sitting: House of Commons
Wednesday 10th June 2020 Public Bill Committees

[The Chair]

Before we resume, I remind hon. Members of the preliminary points that I made on Monday. Members will understand the need to respect social distancing guidance. I remind them to switch electronic devices to silent mode and that tea and coffee are not allowed during sittings.

The selection list for today’s sitting is available in the room. That shows how the selected amendments have been grouped for debate. Grouped amendments are generally on the same or a similar issue. Please be reminded that decisions on amendments take place not in the order in which they are debated, but in the order in which they appear on the amendment paper. The selection and grouping list shows the order of debates. Decisions on each amendment are taken when we come to the clause that the amendment affects. Again, the Hansard Reporters will be most grateful if Members could email any electronic copies of their speaking notes to [e-mail].

Clause 17

Suspension notices

[Alex Norris (Nottingham North) (Lab/Co-op)]

I beg to move amendment 29, in clause 17, page 10, line 12, at end insert—

“(f) advertising it.”

This amendment allows the enforcement authority to prevent an individual who has been served a suspension note from advertising their product.

It is a pleasure to be back. Monday’s discussions were of a high quality and in a good spirit, which is what we need at this time, so I am glad to be here and back at it.

This is a short amendment: again, I want to talk about the issue rather than do anything else. Clause 17 sets the context and is mirrored in clause 18, to which I have tabled amendment 18. It sets out what the Secretary of State or the enforcement authority can do in relation to a faulty product, a medical device that is presumably dangerous or certainly not known to be safe. It includes a list of five things that can be prohibited under either a suspension notice or a safety notice. This prevents an individual from

“(a) supplying the medical device;

(b) offering to supply it;

(c) agreeing to supply it;

(d) exposing it for supply;

(e) possessing it for supply.”

I would add a sixth one—advertising it for supply. I flagged this up with the Minister the other day and will obviously be interested to hear her reply. I am conscious that she has the collective might of the legal brains of the whole Government. It could be that I have spotted a gap, or that I have not. That depends on whether advertising is covered by “offering to supply it” or “exposing it for supply”.

I want to talk about a particular phenomenon—the current way in which clickbait is used. For example, over the weekend, I saw an article that normally would be up my street. It said, “Jason Statham says he no longer needs to do the ‘Fast and Furious’ films”. I am a big fan of the “Fast and Furious” franchise, and that would grieve me enormously. I did not click on the article, because it was obviously nonsense, but I later saw an article about the very same thing. It mentioned Jason Statham and other people, and when you click on that type of thing, it takes you through to bitcoin. It basically said that he does not need to do films anymore, because he has made so much money on bitcoin and so can you. There is an argument to be had about cryptocurrencies, but the issue there is people being shown one thing that actually leads them to something else.

In the medical devices space, it is very easy to see equivalent things for people to click on. They will show someone with dramatic weight loss and then say, “You won’t believe how they did it.” In this case, there will be a picture of a medical device, and the idea is that someone says, “Wow! I’ve found a magical device. I can do the same. I can do it just like this celebrity.” Then they click through and it takes them to diet pills. I would argue that at no point there—there is no price; the article may not name or price the product, but just picture the product—have those responsible exposed it for supply, because it would be possible to argue that we literally cannot buy it, it is just a picture and certainly it has not been offered for supply.

Again, I am happy to take the lawyers’ guidance on this, and I hope that the Minister will help us with that. I just want to ascertain whether that gap—the thing that would legitimise a product, the demonstrating of it for another end—is one that we have to close.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

I would also like to say what a pleasure it is to resume under your chairmanship, Mr Davies.

Amendment 29 seeks to amend clause 17 with regard to the suspension notices. I understand totally why hon. Members are looking to double-check where we are. The clause provides an enforcement authority with the power to serve a suspension notice on a person, where doing so is considered necessary to restrict the availability of a medical device in order to protect health and safety. It lists a number of prohibitions that may be imposed, and seeks to add a specific prohibition on advertising a medical device.

The Government recognise that the intention behind the amendment is to equip the enforcement agency with the ability to prohibit a recipient of a suspension notice from advertising a medical device where there is a need to protect health and safety. I assure hon. Members that the enforcement authority has the ability to do what the hon. Member for Nottingham North is asking and prohibit the advertising of a product already catered for in the clause. That is already in the Bill as it is currently drafted.

Hon. Members will note that prohibitions that may be impose include, in clause 17(2)(b), “offering to supply”, which encompasses advertising or an advertisement. Although I am grateful for the probe, I respectfully ask the hon. Gentleman to withdraw the amendment.

[Alex Norris]

I am content with that. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 17 ordered to stand part of the Bill.

Clause 18

Safety notices

[Alex Norris]

I beg to move amendment 18, in clause 18, page 10, line 34, at end insert—

“(f) advertising it.”

This amendment allows the enforcement authority to prevent an individual who has been served a safety note from advertising their product.

[Alex Norris]

This is exactly the point that I just made, so I will not labour it.

[Jo Churchill]

My explanation covered both points. Clause 18 provides an enforcement authority with the power to serve a safety notice on a person where doing so is considered necessary to restrict the availability of a medical device in order to protect health and safety. It provides the enforcement authority with discretion about the prohibitions that may be imposed. The amendment seeks to add a specific prohibition on advertising a medical device. We recognise that the purpose behind it is to equip the enforcement agency. I would like to reassure hon. Members that that sits in the Bill. On that basis, I commend the clause to the Committee.

[Alex Norris]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 18 ordered to stand part of the Bill.

Clauses 19 to 23 ordered to stand part of the Bill.

Clause 24

Defence of due diligence

[Jo Churchill]

I beg to move amendment 2, in clause 24, page 13, line 26, leave out ‘case’ and insert

‘proceedings for such an offence’.

This amendment, and amendments 3, 4, 5, 6 and 7, amend certain provisions to ensure they operate effectively in relation to Scotland.

[Jo Churchill]

Amendments 2 to 7 relate to the clauses about defences available for offences under clause 23 and regulation 60A to be inserted into the Medical Devices Regulations 2002 by schedule 2.

Clause 23 will provide that it is an offence to fail to comply with a compliance, suspension, safety or information notice. Schedule 2 makes it an offence to fail to comply with certain provisions of the Medical Devices Regulations 2002. Further, the Bill provides that a defence of due diligence will be available with respect to each of those offences. That means that a person charged with an offence under either clause 23 or regulation 60A will be able to argue that they have not committed an offence because they took reasonable steps to avoid doing so.

The provisions that make those defences available are in clause 24 and schedule 2. It is those provisions that we seek to amend. Amendments 2 to 4 are to clause 24 and amendments 5 to 7 are to schedule 2.

[Alex Norris]

I do not have an awful lot to say. I am comfortable with the amendments, and I know that the hon. Member for Central Ayrshire is, too, as she put her name to them. I always find it reassuring when there are Government amendments during Committee, as it means they are still reading the Bill, which is a good thing. So, yes, we are content.

[Jo Churchill]

On that basis I commend the amendment to the Committee.

Amendment 2 agreed to.

Amendments made: 3, in clause 24, page 13, line 32, after ‘hearing’ insert ‘of the proceedings’.

See the explanatory statement for Amendment 2.

Amendment 4, in clause 24, page 14, line 2, at the end insert ‘, and

(b) the reference in subsection (3) to “the hearing of the proceedings” is to be read as a reference to “the trial diet”.’—(Jo Churchill.)

See the explanatory statement for Amendment 2.

Clause 24 , as amended, ordered to stand part of the Bill.

Clauses 25 and 26 ordered to stand part of the Bill.

Schedule 1

Medical devices: civil sanctions

[Alex Norris]

I beg to move amendment 20, in schedule 1, page 31, line 16, after ‘guidance’ insert

‘within three months of this Act receiving Royal Assent’.

This amendment requires the relevant guidance relating to enforcement to be published within 3 months rather than at an undetermined time.

The schedule compels the Secretary of State to provide guidance on sanctioning powers and how they are likely to be used. Those are the new civil powers—among the bigger changes in the Bill—and the guidance will cover when they are likely to be used, the likely level of fines, and the cost recovery, which we spoke about earlier. They are clearly an area of significant interest. Those civil powers are new and important, and we will cover them a bit when we debate the next amendment. At the moment, schedule 1 states that:

“The Secretary of State must prepare and publish guidance”.

That is it. The amendment seeks for that to be done within three months. Three months might not be the right period of time, but I am keen to test when we are likely to see the guidance and whether we should put a bit of structure around that.

[Jo Churchill]

I would like first to address the intention behind the amendment. I recognise that it is driven by the desire to ensure that the Government issue guidance on the new civil sanctions regime within three months of the Bill gaining Royal Assent. The new civil sanctions regime will complement the consolidation of the current enforcement regime, enabling the Medicines and Healthcare products Regulatory Agency to impose a monetary penalty, an enforcement cost and a recovery notice, or to accept an enforcement undertaking as an alternative to criminal prosecutions. That will enhance the MHRA’s ability to incentivise compliance with the Medical Devices Regulations 2002.

Under paragraph 13 of schedule 1, the Secretary of State has to publish guidance on the new civil sanctions regime. However, the timeframe for doing so is not specified on the face of the Bill. Before it is fully operational, the new civil sanctions regime provided for by the Bill will require further provision, to be set out in supplementary regulations made under paragraph 9 of schedule 1. The regulations will cover matters such as enforcement and monitoring of compliance with enforcement undertakings and appeals.

Clause 40 provides that any regulations made under paragraph 9 of schedule 1 must be consulted on. There needs to be enough time to do that, which is why a three-month period is perhaps too truncated. The Government wish to allow sufficient time for such a consultation on these matters before we make the regulations, in order to ensure that they best fit the situation that we are trying to enforce. As I have explained, the civil sanctions regime will not be fully effective before the regulations are made. Under paragraph 13 of schedule 1, the Secretary of State must also consult before issuing guidance on the new regime.

It is right that we consider the views of stakeholders. As we discussed at length on Monday, this is about getting it right for patients and all stakeholders before we bring the regulations into force. It is important that we allow sufficient time to engage effectively and to ensure that we act in the best interests of both patients and the healthcare sector. The effect of the amendment would be that the Government are required to consult on, and publish guidance on, the civil sanctions within a tight three-month period before the regulations have been made, and at a point when the consultation might still be ongoing, so that we arrive at the best place.

Paragraph 13 of schedule 1 already places a duty on the Secretary of State to publish the guidance in order to be transparent, and the new civil sanctions regime will require consultation and secondary legislation. It is therefore impractical to specify on the face of the Bill that we would have a timeframe for doing so. On that basis, I hope that the hon. Member understands that we wish to get this right, and that he will withdraw the amendment.

[Alex Norris]

I am happy with that, certainly for the purpose of greater consultation, because a theme in the written evidence is that the sector wants to continue to talk about such things and get them right. We will return to this issue when we debate the next amendment.

I hope the Government will not leave it too long. There is a very important bit of guidance that the Secretary of State is compelled to publish under the Modern Slavery Act 2015, but we have still not seen it. The regulations are likely to be less challenging than that. I do not like the open-ended space, so I hope the Government will move on precipitously. On the basis of the Minister’s answer, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Alex Norris]

I beg to move amendment 21, in schedule 1, page 32, line 18, leave out “from time to time” and insert “every 12 months”.

This amendment requires the Secretary of State to report back on their use of civil sanctions every year rather than at an undetermined frequency

Again, this helps us to delve into the new sanctions regime and to talk about the Medicines and Healthcare products Regulatory Agency. As we see from the written evidence, there is a lot of interest in that. The Bill seems to do two things, certainly regarding the Medicines and Healthcare Products Regulatory Agency: consolidate disparate bits of legislation that govern its activity, and provide it with new civil powers.

--- Later in debate ---

[Jo Churchill]

Once again, I recognise that the hon. Gentleman is probing, to ensure we make good legislation. For that, I am extremely grateful.

The Government have every intention of providing greater transparency about the safety and effectiveness of medical devices on the UK market, including on how our use of civil sanctions will achieve that aim. On that basis, I confirm that the Cumberlege report will definitely be with us on 8 July, which I do not think I stated during proceedings on Monday. I take on board the hon. Gentleman’s point that we may well be looking at things in the round.

Civil sanctions will provide an alternative to criminal prosecution where the latter is not suitable. If, for example, a breach is judged to have had the potential to cause harm but it does not, the civil sanction is a second tool in the toolbox. As the hon. Gentleman said, there have been very few prosecutions in the last decade. Criminal prosecutions can be used where the breach of regulations leads to a serious incident or death, or where a manufacturer has directly contravened the conditions set out in a safety or suspension notice. As I am sure he will agree, other incidents very often need a flag raising, and that is the point of bringing civil sanctions into the legislation.

Currently, as the hon. Gentleman said, the Secretary of State is committed, under paragraph 15 of schedule 1, to publishing reports on the use of civil sanctions from time to time. The requirement to publish reports on the use of civil sanctions is in line with existing obligations on other Government agencies that already operate a civil sanctions regime for their sector. The Environment Agency is one—in respect of environmental civil sanctions—while the Secretary of State for Business, Energy and Industrial Strategy, who is responsible for enforcing the Ecodesign for Energy-Related Products Regulations 2010, is another. Those regulations explicitly state that reports on the use of civil sanctions will be published “from time to time”.

The new civil sanction regime would require supplementary legislation, as per paragraph 9 of schedule 1. A consultation on the supplementary legislation would be necessary to ensure that the new regime is operational. I assure Members that the Government intend to publish reports on their use of those measures at regular and appropriate intervals, and the hon. Gentleman will bring me up on that. The Government may indeed decide that reporting annually is appropriate. However, as the new regime will require secondary legislation, which must be consulted on before it comes into force, it is not practical to specify at this point the frequency of Government reports on the use of civil sanctions.

On the hon. Gentleman’s specific point about burden of proof and how we arrived at that, I will write to him. On that basis, I invite him to withdraw the amendment.

[Alex Norris]

On the principle of civil sanctions, we are content. I am really grateful to the Minister for her offer to write to me about the burden of proof, and I will definitely take her up on that. It is important to reflect on why that is different in different cases.

I meant to refer to the potential to do harm, which is something worth reflecting on that, and we can talk about it in the remaining stages. At the risk of going into pub chat—if only—let us imagine that I throw a stone at someone. Whether I hit or miss, have I committed an offence? Does it matter that I have good or poor aim? When it comes to medical devices, if we find something with the potential to do significant harm, the fact that it has not yet done so would certainly not be a good enough reason to downgrade the way in which that was treated. Again, we can reflect on that another time, and it is also tied up with the burden of proof, but on the basis of the answers so far, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Schedule 1 agreed to.

Clauses 27 to 29 ordered to stand part of the Bill.

Clause 30

Recall of medical device by enforcement authority

[Alex Norris]

I beg to move amendment 28, in clause 30, page 16, line 23, at end insert—

“(4) The Secretary of State must, within 24 months of this Act receiving Royal Assent, lay a report before Parliament reviewing uses of this clause.”

This amendment requires the Government to review any use of the recall powers made in the first 2 years of the Act.

Again, this is a simple amendment. The clause governs the recall of a medical device by the MHRA. That is of significant public interest—recall, obviously, is important to people. It is also really challenging, and we have all seen that, whether with washing machines, cars or whatever. Once devices are out there, it is hard to recall them, so we want to know that these powers are working effectively.

The obligation that the amendment would put on the Secretary of State is to provide, within two years, a report on when recall has been used. That would do two things: first, it would allow us to evaluate how effectively recall was being used; and, secondly, it would act as a further publicity tool, so that people understood that the device has been recalled and, if they were still in possession of it, that they could do something about it.

At the moment, subsection (2) states: “The authority”—the MHRA—

“may take such steps as it considers necessary to organise the return of the device”,

but the clause does not quite say anywhere that the MHRA will then tell people what it has done. If that is implied, I am probably willing to accept that answer, but I am keen for the Minister to note that the Government’s clear intent is not only to organise the recall of unsafe devices, but to publicise that significantly, such that it will be reasonable to expect people to see such publicity and therefore to act on it.

[Jo Churchill]

The Government consider the new recall power to be crucial to ensuring that unsafe devices are removed from the market. It is important to note, however, that subsection (3) requires that the power is used only as a last resort.

The Bill introduces this statutory power for the MHRA, on behalf of the Secretary of State, to conduct recalls on the rare occasions when a manufacturer is either unwilling to carry out a recall imposed under clause 18 or is unable to do so because the manufacturer no longer exists as an entity. I am sure Members will agree with this power, as it is intended to ensure the safety of devices for patients and, without it, there would be a gap. In the case of companies unwilling to take action, devices that are not recalled might well present risks to patients. It is right that the regulator can take action if and when companies fail to recall devices.

The statutory power also addresses an anomaly in the existing enforcement regime, whereby the MHRA has the statutory power to conduct a recall under the General Product Safety Regulations 2005 where the medical device in question meets the definition of a consumer good—typically, a low-risk medical device—but the MHRA does not currently have the commensurate statutory power to conduct recalls for higher-risk medical devices that are not also consumer goods under the GPSR. That would appear to be an inconsistency that does not align with risk to patients. I am sure all hon. Members would agree that, where possible, that is what good legislation should do, and the Bill seeks to correct that anomaly.

The Bill already provides the Government with the power to make public the details of recalls they conduct, because clause 34(2) allows the Secretary of State to disclose information for the purpose of warning the public—this is what I think the hon. Gentleman was alluding to—about concerns relating to the safety of a medical device. The Government consider that such information could include information about whether a medical device has been recalled. Accordingly, I reassure hon. Members that the Government intend to act transparently when they conduct recalls, using the power provided in clause 30. On that basis, I ask the hon. Gentleman to withdraw the amendment.

[Alex Norris]

I will not labour the point, but the Government must act not just transparently, but transparently, publicly and proactively. That is something we would be really keen on.

[Matt Western (Warwick and Leamington) (Lab)]

On a point of clarification, at what point does the MHRA intervene? At what point is the threshold—that is perhaps a better way of putting it—at which a recall is demanded? Depending on the product, at what point is that necessary and who bears the cost? I am not sure whether that should be covered by the clause, or whether it is simply within the remit of the MHRA.

[Alex Norris]

That is interesting, and if the Minister wants to intervene to address that point, I will take an intervention. Otherwise, my best guess is that it would be covered by the regs and, presumably, subject to consultation. However, I hope the Government have a clear trigger point, so that we are all clear and transparent about what will happen.

[Jo Churchill]

The MHRA has a specific compliance department. It works on a case-by-case basis, and it would issue a notice—see clause 18—and it would move forward on that basis with an individual recall against a company. I hope that clarifies the situation.

[Alex Norris]

I am grateful for that clarification. On the basis of the answer I have received, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 30 ordered to stand part of the Bill.

Clauses 31 to 36 ordered to stand part of the Bill.

Schedule 2

Offence of breaching provisions in the Medical Devices Regulations 2002

Amendments made: 5, in schedule 2, page 34, line 8, leave out “case” and insert

“proceedings for such an offence”.

See the explanatory statement for Amendment 2.

Amendment 6, in schedule 2, page 34, line 14, after “hearing” insert “of the proceedings”.

See the explanatory statement for Amendment 2.

Amendment 7, in schedule 2, page 34, line 28, at the end insert “and

(b) the reference in paragraph (3) to ‘the hearing of the proceedings’ is to be read as a reference to ‘the trial diet’.”—(Jo Churchill.)

See the explanatory statement for Amendment 2.

Schedule 2, as amended, agreed to.

Clauses 37 to 42 ordered to stand part of the Bill.

Clause 43

Commencement

[Alex Norris]

I beg to move amendment 19, in clause 43, page 24, line 17, leave out

“on such day or days as the Secretary of State may by regulations made by statutory instrument appoint”

and insert

“six months after this Act receives Royal Assent.”

This amendment brings the enforcement regime into force at a defined period after Royal Assent rather than at a date of the Government’s choosing.

Having accepted the principle of the new enforcement regime and seeing its potential, I am keen to know when it will be in place and what the Government’s intentions are for getting on with it. Clause 43(3) says:

“Chapters 2 and 3 of Part 3”—

the bit that governs the enforcement and disclosure around medical devices—

“come into force on such day or days as the Secretary of State may by regulations made by statutory instrument appoint.”

Basically, that means at some point in the future.

The amendment, which is in my name and the name of the hon. Member for Central Ayrshire, suggests the regime should come into force within six months of Royal Assent. As was said in our earlier discussion, I imagine that the Government want to return to consultation on that point, so that might not be the right period. We are keen to know that the Government intend to get on with it, however, because there may be some push-back from those with vested interests who do not want the scheme to go ahead. I talked about there being three prosecutions in 12 years; we are likely to see much greater activity than that, and there will be those with vested interests who do not want that to happen.

I am keen for the Government not to leave this forever. If we accept in primary legislation that the regime is going to happen and is a good idea, that is what matters, and it should happen at a defined point. I am keen to know what the Government see as the timeline for introducing it. As Parliament has decided that we will do this, I would like a firm commitment on the record that we are actually going to do it.

[Jo Churchill]

I am grateful to the hon. Gentleman for raising, through amendment 19, the issue of the commencement of chapters 2 and 3 of part 3 of the Bill, which is concerned with medical devices. Chapter 2 introduces a new enforcement regime that includes the civil sanctions set out in schedule 1, which we discussed. Chapter 3 concerns data and disclosure provisions, and contains a number of consequential amendments, which facilitate the introduction of the new enforcement regime in chapter 2.

On chapter 2, as I have said, a key element of the new enforcement regime is the addition of civil sanctions, which will act as a flexible, proportionate enforcement mechanism to enhance the MHRA’s ability to incentivise compliance. Supplementary regulations must be made under paragraph 9 of schedule 1 before the new civil sanctions can be fully operational. Those regulations, which could relate to matters such as the enforcement of a monetary penalty regime, monitoring compliance with an enforcement undertaking, and the provision of appeals, are subject to a consultation requirement, as set out in clause 40. It is right that we consider the views of stakeholders before bringing the regulations into force, and it is important to allow for time to engage effectively, so that we can ensure that we act in the best interests of patients, and thereby in the best interests of the healthcare sector that serves them.

The data and disclosure provisions in chapter 3 will provide greater transparency about the safety and effectiveness of medical devices on the UK market. I am sure we all agree that that is what we are after: knowing what is going where and helping whom, and, if there is an issue, being able to isolate and highlight it, and then provide a remedy. The Government are exploring how we can ensure that the new powers are as effective as possible and secure the needs of the healthcare community, patients and the wider public. It is therefore appropriate that due consideration be given to how the powers can most effectively be used before they are commenced. An amendment putting in place a deadline by which the powers must come into force could limit the MHRA’s ability to find the most effective route, and it could limit the time that MHRA has before commencement for the important process of engaging with stakeholders on the powers.

Finally, the consequential provisions in clause 36 are linked to the disapplication of the previous enforcement regime in part 2 of the Consumer Protection Act 1987. They too must be commenceable by regulations, so that they come into force at the same time as the new enforcement regime.

I reassure hon. Members that the Government are committed to bringing the enforcement, data and disclosure chapters of the Bill into force as soon as is appropriate, in order to enhance the safety of the medical devices regime, which I think we all see as important. I therefore ask the hon. Member for Nottingham North to withdraw the amendment.

[Alex Norris]

The final part of that answer answered my question. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 43 ordered to stand part of the Bill.

Clauses 44 to 45 ordered to stand part of the Bill.

New Clause 6

Registration of Medical Devices

‘(1) The Secretary of State shall by regulations establish a UK Registry of all devices implanted into patients on a long-term basis.

(2) The identifier details of any devices implanted into patients, on a long-term or permanent basis, must be registered.

(3) The information registered must include—

(a) The unique identifier of the patient into whom the device is implanted;

(b) The Clinician responsible for the procedure;

(c) The hospital or clinic in which the procedure is performed;

(d) A standardised description of the device;

(e) The unique identifier code of the device implanted.

(4) Efforts must be made for this unique identifier data to be gathered by barcode reader as in the trial of ‘Scan for Safety’.

(5) This Registry shall require linkage from all currently established speciality device registries, in current operation, to avoid duplication of registration.

(6) Devices without any form of specialist registry currently available shall be registered in this UK Registry.

(7) Governance structures regarding the management and access to registry data shall be established after consultation with stakeholders including but not limited to—

(a) the appropriate authorities as defined in Section 1 (4);

(b) all UK based Royal Colleges of Surgery or Radiology and any others representing clinicians involved in such procedures;

(c) Managers of current speciality device registries;

(d) the Medicines and Healthcare products Regulatory Agency;

(e) the Directors of each of the four UK based National Health Services;

(f) healthcare quality improvement bodies from each of the four UK based National Health Services;

(g) representatives of the Healthcare device manufacturing sector;

(h) academics with expertise in the design and maintenance of registries;

(i) additional stakeholders as identified during the development and maintenance of such a registry.

(8) Patient information from such a registry shall be provided to clinicians if there is concern regarding the management of or complications from any implanted device to allow closer monitoring or removal if so warranted.”

The aim of such a UK register is to ensure earlier recognition of complications from implantable devices and allow the easy identification and urgent recall of affected patients should such a concern be recognised.

Brought up, and read the First time.

[Alex Norris]

I beg to move, That the clause be read a Second time.

I am pleased to give this clause a run-out on behalf of the hon. Member for Central Ayrshire. We have missed her during these proceedings, and I hope that conversations are ongoing through the usual channels about how we can make Public Bill Committees work and perhaps give hon. Members who cannot be here—for very good reasons—a chance to contribute.

This is the final new clause, but it is by no means the least important. In fact, it has the most potential to be a clause with which we do something quite exciting. A great deal of pain has been caused in the past. I will not get ahead of the Cumberlege review, but when things go wrong in the space of medical devices, they go wrong catastrophically and in a life-altering fashion. None of us would want to see that; all of us would want to do anything we can to avoid or mitigate that harm.

The new clause would establish an exciting regime of registration of medical devices. It would provide information on a granular level—we have seen the level of detail that the hon. Member for Central Ayrshire has put into it—so that we know exactly what medical device has gone where and for what purpose. This is a complex area. We talked on Monday about the various different registries or registrations we could have, and all are complex and require reflection. This would be a good part of marking the Government’s card. Since Monday, we have had very good informal conversations about how we can take this forward.

--- Later in debate ---

[Jo Churchill]

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.

[Alex Norris]

We are in vicious agreement on this point. The new clause provides a possible destination, but through conversations and the expertise of colleagues, we may end up going in a similar but different direction. It is right that we start with the goal in mind and then work to where we get to. I think there is real potential in this area. As the Minister said, my hon. Friend the Member for Warwick and Leamington made a very important point, because the principles are very similar. There may be scope to include the areas that he mentioned also.

I thank the Clerks and you, Chair, for your support in this process. We have had some very good discussions, and laid the groundwork to do even more. I beg to ask leave to withdraw the motion.

Clause, by leave, withdrawn.

Question proposed, That the Chair do report the Bill, as amended, to the House.

[The Chair]

Before I put the final question, I thank all Members, particularly the Minister and the shadow Minister, for the way they have conducted themselves throughout the proceedings, which have been a pleasure to chair. I also thank the two Clerks and the Hansard reporters for their hard work.

Question put and agreed to.

Bill, as amended, accordingly to be reported.

Medicines and Medical Devices Bill (Second sitting)

Alex Norris Excerpts

Committee stage & Committee Debate: 2nd sitting: House of Commons
Monday 8th June 2020 Public Bill Committees

[The Chair]

As I mentioned this morning, I remind Members to respect social distancing guidance. I will intervene if necessary to remind people of that. I also remind Members that tea and coffee are not permitted in Committee sittings and to ensure that their mobile phones are switched off or switched to silent mode. Finally, the Hansard reporters would be very grateful if Members could email copies of their speaking notes to [e-mail].

Clause 5

Fees, offences, powers of inspectors

[Alex Norris (Nottingham North) (Lab/Co-op)]

I beg to move amendment 11, in clause 5, page 3, line 39, at end insert—

“(1A) The Secretary of State must publish a fees regime within three months of the date on which this Act receives Royal Assent.”

This amendment requires the Secretary of State to publish their proposed list of fees in respect of human medicines.

It is a pleasure to resume serving under your chairship, Mr Davies. We move to the rapid-fire round, which will almost inevitably lead to me at some point giving a speech to a previous or future amendment—I am sure colleagues will be gentle and generous with me when I do so. This short probing amendment relates to fees in the discharge of the human medicines sphere. The principle is that, in the exercising of clause 1(1) it is conceivable that the Secretary of State, the Department and the Government in general will incur costs, so clause 5(1)(a) allows for provision to be made to exercise a function to charge for that, which makes perfect sense.

The Medicines and Healthcare Products Regulatory Agency has previously worked on a cost recovery basis, which makes a lot of sense, but the amendment is designed to test whether it would not be better to have a comprehensive, clear and consistent fees regime. The MHRA and the Government in general have a tough job against a potential occasional big foe in the pharmaceutical industry—or big partner to work with, at least. I assume, but would like to hear from the Minister on the record, that the expectation is that there will be equal pay for an equal job, so a bigger firm that is better equipped to lobby would not end up paying smaller fees than a smaller firm, simply because that firm was better at arguing or making its case. Is cost recovery still in general the preferred option? If so, might it not strengthen the Secretary of State’s hand if that were put in the Bill?

[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

It is a pleasure to be back this afternoon. I am grateful to the hon. Member for raising the important issue of fees in his amendment, and I recognise the intent of that probe. I am sure we agree that it is important that all new fees for human medicines are set in an open, fair and transparent way. I want to reassure him that what the amendment seeks to achieve is already standard practice and is happening. I will rapidly set out the steps already in place to ensure the fairness, openness and transparency that underpin the fees regime for human medicines.

The current fees have been subject to consultation and are provided for in legislation. They are published online and publicly available at gov.uk. All of that is supported by a formal and standardised process for reviewing existing fees and for the introduction of new fees for human medicines. The standard approach for setting statutory fees is full cost recovery, as the hon. Member alluded to, which means that fees must be set at a cost that reflects the activity involved in carrying out such a specific regulatory function.

The full cost recovery approach is set out by Her Majesty’s Treasury in its “Managing public money” guidance, which ensures that the Government neither profit at the expense of consumers nor make a loss for taxpayers to subsidise. Therefore, fees cannot be set arbitrarily, and the fee must reflect the cost of the regulatory work carried out. I think that goes some way to addressing the hon. Member’s probe on size.

Existing fees for human medicines are kept under active review by the Medicines and Healthcare Products Regulatory Agency. The amendment is specifically concerned with new fees that might be introduced under the powers in the Bill. It is already a requirement that new fee proposals are subject to consultation, and that duty continues for fee proposals under the Bill. We will publish impact assessments with the new proposals, which will set out the effects of any changes to fees in the UK on Government, industry or the general public. Her Majesty’s Treasury will be engaged throughout the fee proposal process, and any proposals for new fees will be subject to approval from HMT. It is also standard practice for the MHRA to engage with industry and trade bodies through regular meetings to discuss any new fee proposals that might be coming up.

I trust my explanation has reassured the hon. Member for Nottingham North that the requirements are and will continue to be in place so that fees for human medicines are fair, open and transparent. I therefore ask him to withdraw his amendment.

[Alex Norris]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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

[Jo Churchill]

Clause 5 provides that changes can be made to the law relating to human medicines with respect to fees, criminal offences and the powers of inspectors. Regulations made under clause 1(1) allow us to change the UK’s regulatory framework for human medicines as science, technology and clinical needs evolve. When the regulatory regime is updated, it is important that the regulator—in this case, the MHRA—can continue to regulate effectively and maintain compliance with all elements of the regime. To ensure this, it may be necessary to make provision about charging fees, creating criminal offences, and updating inspectors’ powers when making changes to the regulatory regime. Regulations made under clause 1 and relying on clause 5 will enable us to do this. We will consult before making any of those changes.

Clause 5(1)(a) allows us to make provision about the charging of fees. The regulator is self-funding for the purposes of medicines regulation. This work includes assessment for marketing authorisations and clinical trials of human medicines and inspections. It is funded by fees payable by the pharmaceutical industry in relation to the services and regulatory work provided. The current fees are set out in the Medicines (Products for Human Use) (Fees) Regulations 2016 and vary according to the specific areas of work.

It is important that existing fees can be amended, or fees can be introduced in connection with the MHRA exercising functions conferred by human medicines provisions as they evolve. Any proposal to introduce new fees is subject to consultation. The impacts on industry, Government and the general public would be evaluated through the usual process of an impact assessment. As part of its regulation of human medicines, the MHRA is able to impose criminal sanctions for certain regulatory breaches. As the regulatory regime is updated in future, it is important that we have the ability to also update the corresponding list of offences against which the MHRA can take action.

Clause 5(1)(b) allows us to create criminal offences with a maximum of two years’ imprisonment to cover updated requirements to supplement the evolution of the regulatory regime. MHRA inspectors play a critical role in ensuring compliance so that medicines are safe and effective for patients, and so that manufacture, research and surveillance processes are carried out to recognised standards. Inspectors already have all the powers to enter premises at any reasonable time to determine whether there has been a contravention of medicines regulations. For example, they may take samples or copies of documents if it is suspected that an offence has been committed. We have published two illustrative statutory instruments to demonstrate how provision can be made in regulations, relying on clause 5(1)(b) in combination with subsections of clause 2, to create a criminal offence for failing to comply with the new requirement set out in the regulations.

Clause 5(1)(c) allows us to update the relevant powers of entry and other powers of inspectors to align with new elements of the regulatory regime as it evolves. I commend the clause to the Committee.

Question put and agreed to.

Clause 5 accordingly ordered to stand part of the Bill.

Clauses 6 and 7 ordered to stand part of the Bill.

Clause 8

Power to make regulations about veterinary medicines

[Alex Norris]

I beg to move amendment 12, in clause 8, page 5, line 17, at end insert “services.”

This amendment broadens the range of issues that the Secretary of State must consider to include access to the relevant services to dispense veterinary medicines.

I did not want us to miss out the veterinary medicines part of the Bill, because it is important. We are a nation of animal lovers and we are keen that the laws we make are sympathetic to all living beings. The issue was also raised on Second Reading, because it has an impact on the food chain, so we must be mindful of setting an effective regime, as I know the Government are keen to do.

The amendment is simple. Again, I hope that it is redundant, but I want to test that with the Minister. There is a clear read-across between parts 1 and 2 of the Bill, which is that the powers being reserved for human medicines are largely the same as those being reserved for veterinary medicines. The word that I would like to be added in clause 8(2)(b) after

“the availability of veterinary medicines”

is “services”, because one way in which veterinary medicine differs from human medicine is that we do not have a universal service, so that access point is an important consideration for the Secretary of State.

I have not drafted the amendment elegantly enough. When we get to amendment 13, we will discuss something called the cascade, which was new to me until a couple of weeks ago. The principle of the cascade is that, whereas in human medicine we have expectations that certain medicines will be used to treat certain conditions and doctors do not have a massive amount of latitude to go outside that, in veterinary medicine, if such a thing is not available, the veterinarian can fall down the chain and use a different painkiller—perhaps a human painkiller. That is obviously important.

I wonder—and this is what I am testing with the amendment—whether that creates a possible inequity. If there is better access to veterinary medicines or supplies in certain communities, perhaps rural versus urban, that could create not a two-tier service, but a slightly different service from the one we want. It would therefore be useful for the Secretary of State to have regard to the services, as well as the physical ability to get pills, potions or whatever. That is all the amendment seeks to test and I am interested to hear what the Minister says.

[Jo Churchill]

I am grateful to the hon. Gentleman for raising the important issue of the availability of veterinary medicines. The intention is clear: to ensure continued access to veterinary medicine equitably for all the nations’ animals.

The Bill provides the power to amend or supplement the Veterinary Medicines Regulations 2013, which cover the full supply chain of veterinary medicines from development to supply. The requirement for the appropriate authority to have regard to the availability of veterinary medicines, as set out in clause 8, therefore ensures that when making regulations under the clause, the availability of veterinary medicines throughout the supply chain is considered.

Although the intended effect of amendment 12 is to expand on those factors, the actual effect would be to inadvertently narrow their scope to focus only on the availability of veterinary medicines services, such as the dispensing of veterinary medicines, rather than the availability of veterinary medicines more widely and more equitably. Veterinary medicines services alone are not the determining factor in the availability of veterinary medicines.

Clause 8, as drafted, ensures that the appropriate authority must have regard to the availability of veterinary medicines throughout the supply chain, so that the rural versus urban comparison the hon. Gentleman used would not be a comparator and medicines would be equally available. I therefore ask him to withdraw the amendment.

--- Later in debate ---

[Alex Norris]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

--- Later in debate ---

[Jo Churchill]

Clause 8 provides the power to amend or supplement the Veterinary Medicines Regulations 2013. Subsection (1) gives the appropriate authority a power, by regulation, to make amending or supplementing provision within the scope of the matters set out in clauses 9 and 10. The appropriate authority may use this power only to build on—in other words, amend and supplement —the current regulatory framework for veterinary medicines. Clauses 9 and 10 set out an exhaustive list of matters about which regulations could be made on veterinary medicines. An in-depth explanation of those clauses will be shared with the Committee throughout the course of these sittings.

Subsection (2) sets out three matters to which the appropriate authority must have regard when making regulations under clause 8: the safety of veterinary medicines in relation to animals, humans—including consumers of produce from treated animals—and the environment; the availability of veterinary medicines; and the attractiveness of the relevant part of the UK to industry for developing or supplying veterinary medicines. Subsection (3) explains that

“the relevant part of the UK”

depends on where the UK regulations will apply. The environmental safety aspects could include considering the potential impact of veterinary medicines on terrestrial and aquatic eco-systems and their flora and fauna—for example, the environment can also be affected by slurry application and excretion by grazing animals.

Subsection (4) sets out the appropriate authority for the purposes of regulations made under clause 8(1). The appropriate authority able to exercise this delegated power for England, Scotland and Wales is the Secretary of State. For Northern Ireland, the appropriate authority is either the Department of Agriculture, Environment and Rural Affairs in Northern Ireland acting alone, or the Secretary of State and the Northern Ireland Office acting jointly. This means that the powers can be exercised on their own, as well as jointly on a UK-wide basis.

[Alex Norris]

I will speak briefly to new clause 5. I was happy to withdraw amendment 12, but the principle was about trying to ensure that there is equitable access to services, because that is how veterinary medicine differs from human medicine. New clause 5 follows that principle through to its logical conclusion. This may have been done; I have been looking but have been unable to find it. I am sure the Secretary of State for Health and Social Care has seen hundreds and hundreds of health equity audits: how are things in Nottingham different from in Shipley, and how does that impact on health outcomes? For all the reasons I mentioned at the beginning, I wonder whether it is the same in the veterinary industry and whether there are regional, rural-urban and north-south disparities that mean access is different. The potential fall-outs from that are worth considering.

The new clause is intended to probe and to see whether the Government have that sort of information. If so, maybe they could let us see it—either shortly or during the rest of the proceedings on the Bill.

[Jo Churchill]

I am grateful to the hon. Member for raising the matter of capacity within the veterinary industry as it stands, in order to provide equity throughout. I recognise that he has given us examples of north-south disparities and so on, and I recognise the good intentions behind the new clause and his desire to ensure that the veterinary industry is working to full capacity and in unanimity across the piece. We agree that vets are an essential part of our animals’ lives and a key component of the UK system of protecting food safety, providing international assurance and upholding standards in welfare.

The Government are already working with various veterinary sector stakeholders, including the Royal College of Veterinary Surgeons and the British Veterinary Association, to understand the UK’s veterinary resourcing needs and ensure that there are adequate numbers of vets in the short and long term. We are working with a variety of initiatives to build a sustainable, diverse and modernised UK veterinary infrastructure to ensure that we maintain access to the right people, with the right skills and knowledge, supporting food safety and animal health and welfare, as well as trade. DEFRA has successfully secured a place for the veterinary profession on the Home Office shortage occupation list, and we are grateful to the Royal College of Veterinary Surgeons and British Veterinary Association for their work on the issue. It makes it easier for veterinary employers to gain visas.

To turn to specifics, as Members will know, the Bill introduces a statutory duty to consult before making changes to the Veterinary Medicines Regulations 2013. That consultation duty, in clause 40, requires that the appropriate authority must, before making regulations, consult those it considers appropriate. That is the most suitable route for ensuring that all those in the veterinary industry who need to be consulted are included. We are working across Government and with the veterinary profession to help to develop a flexible, skilled workforce that meets UK needs and irons out disparity of service. I want to assure the hon. Member for Nottingham North that it is a key priority to enable an innovative, productive and competitive veterinary medicine sector that invests in its people and skills. To help to achieve that, we shall ensure that there is access to sufficient appropriately skilled labour to drive continued industry growth and productivity, while ensuring that the environment for humans and animals is safe.

[Alex Norris]

I appreciate that answer, and the detail in it. I guess the only way in which I would supplement my questions is to ask that, once the fruits of the work with the relevant stakeholder bodies are available, they should be shared. That would be of great interest to Members on both sides of the House.

Question put and agreed to.

Clause 8 accordingly ordered to stand part of the Bill.

Clause 9

Manufacture, marketing, supply and field trials

[Alex Norris]

I beg to move amendment 13, in clause 9, page 6, line 11, at end insert—

‘(1A) The Secretary of State must by regulations make provision about the use of the Cascade.”

This amendment gives the Secretary of State the responsibility to make provisions regarding the Cascade, a process where veterinarians can dispense different medicines to animals, such as human medicines, should appropriate conventional animal medicines not be available.

I have buried the lede, obviously, by talking about the cascade already; but I am interested to hear a little more detail about the Minister’s vision for the cascade. It is obviously an entrenched principle across the European Union, and an industry standard. It has a significant impact on the lives of animals and, by proxy, humans as well. It seems to me an important principle, but it is not on the face of the Bill. The Government would, on Royal Assent, have the immediate ability to diverge away from the cascade quite quickly, but I wonder about the safety of that and whether that is in the Government’s plans. It was not in the impact assessment, so I am keen to scope out whether we expect the cascade to continue to be a principle in this country, and, if so, whether we expect our cascade to reflect closely the one used by our EU counterparts.

[Jo Churchill]

A clause or so back, the hon. Gentleman gave us a snapshot of what a cascade is, and I do not think I could put it better. My notes say that veterinary surgeons can prescribe gabapentin, a human medicine, to treat chronic pain in animals, particularly if it is of a neuropathic origin, as there is no equivalent in veterinary medicine. As the hon. Gentleman said, the cascade is about making sure that there is something in the veterinarian’s bag to enable appropriate care to be given to animals.

I am grateful to the hon. Member for Nottingham North and to the hon. Member for Central Ayrshire, who I think also signed the amendment, for raising the important issue of the prescribing cascade. However, not only is the amendment not necessary, but I argue that it could be unhelpful in certain instances. I recognise the desire to ensure that the use of prescribing cascades is regulated. The cascade enables veterinary surgeons to have access to a wider range of medicines to treat animals under their care and, in particular, to prevent the unacceptable suffering that might occur if they could not prescribe those alternatives.

The provisions with regard to the cascade are set out in schedule 4 to the Veterinary Medicines Regulations 2013 and the Bill already confers discretionary powers that would allow the appropriate authority to decide, following consultation, whether and how cascade requirements in the existing regulations might be amended in the future. That is provided for in clause 9(1), for the professionals to decide, arguably.

The amendment as drafted would appear to obligate the Secretary of State to update the regulations with regard to the cascade, as opposed to making those changes when it is appropriate to do so, and evaluate the cascade above other important aspects of the veterinary medicines regulatory framework. Although the cascade is important, it is our position that the regulations should be updated when it is clear and necessary to do so, rather than operating under a compulsion to do so for any one element, as putting it in the Bill might lead to. In that light, I ask the hon. Gentleman to withdraw it.

[Alex Norris]

I am happy to withdraw the amendment on that basis. The point of putting it in was to shoehorn the subject into the conversation, which was obviously effective. I did not hear from the Minister whether she felt that we are likely to continue to reflect the EU arrangements on that. Given that it is novel and specific to this area of medicine, and given that it is not risky, but diverges from what we consider basic medical practice in humans, it is of interest to people.

Perhaps now is not the moment to hear about the Government’s plans to reflect, or not, the judgments made by EU colleagues in future, but I hope that, over time, we can continue to have that conversation because I think there is public interest in that. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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

[Jo Churchill]

On amendment 13, I will write to DEFRA to seek clarification for the hon. Gentleman if that would be helpful. As we move through the Bill in the spirit of co-operation, I am more than happy to continue the conversation.

Clause 9(1) provides that amendments may be made to the Veterinary Medicines Regulations 2013 about the manufacture, marketing, supply and field trials of veterinary medicines. The Committee will note that in large part, clause 9(1) makes very similar provision to clause 2(1). I will take each subsection of clause 9(1) in turn.

Subsection (1)(a) sets out that the regulations made under the power in clause 8(1) may make provision about authorisations to manufacture veterinary medicines. The subsection means that it will be possible to update the rules around manufacturing authorisations—for example, to reflect the latest scientific advances in manufacturing and to address the manufacture of novel and innovative veterinary medicines. The subsection is therefore needed to future-proof the regulatory regime.

Subsection (1)(b) allows provision to be made about authorisations to import veterinary medicines, which is needed to continue to secure supply chains for those medicines entering the UK. By updating our existing regulatory framework, we can maximise the availability of veterinary medicines, while taking care that our approach does not place an additional burden on those who import medicines. Such a change can benefit animal owners, as it can lead to quicker access to veterinary medicines, a point that my hon. Friend the Member for Penrith and The Border brought up on Second Reading. We could use the subsection to allow additional professions, for example veterinary nurses, to import certain types of veterinary medicines with appropriate controls.

Subsection (1)(c) allows for provision to be made about authorisations to distribute veterinary medicines by way of wholesale dealing, which would ensure that we can provide further assurance on the quality and security of the full distribution chain for veterinary medicines. We could, for example, amend the application process for a wholesale dealer’s authorisation, supplement the requirements that must be met by the holder of such an authorisation, or amend the exceptions to the requirements for an authorisation.

The subsection could also be used to change the requirements for a wholesale dealer’s authorisation to cover new and novel products that may have new or additional storage and distribution requirements. That would maintain the quality and security of the distribution chain for such veterinary medicines and ensure that they are stored appropriately and safely throughout.

Subsection (1)(d) allows for provision to be made about marketing authorisations for veterinary medicines. This would help to ensure that the UK remains an attractive place for the pharmaceutical industry to bring to market both new and established medicines, and that UK animal owners do not have to wait for new, innovative or generic veterinary medicines. As an example, regulations could offer statutory rewards or incentives for certain types of applications for marketing authorisation.

--- Later in debate ---

Fees, offences, powers of inspectors, costs

[Alex Norris]

I beg to move amendment 14, in clause 10, page 6, line 35, at end insert—

‘(1A) The Secretary of State must publish a fees regime within three months of the date on which this Act receives Royal Assent.”

This amendment requires the Secretary of State to publish their proposed list of fees in respect of veterinary medicines.

This amendment is substantially the same as amendment 11, but it relates to veterinary medicines rather than to human medicines. So, assuming that the answer will be pretty much the same as for amendment 11, I do not really want to labour the point.

[Jo Churchill]

The short answer is probably yes, but I will just give the hon. Gentleman half a page of explanation.

I recognise that, as before with amendment 10, amendment 11 would ensure transparency, in essence, on fees that stakeholders may have to pay with regard to veterinary medicines, such as fees for marketing, manufacturing and distribution. The fees relating to veterinary medicines are set out in schedule 7 to the Veterinary Medicines Regulations 2013, and the power in the Bill is to amend the fees where necessary, rather than to create anything new. Indeed, it is unlikely that any new or amended fees would be introduced within three months following Royal Assent. The fees are already published online and are publicly available on the gov.uk website, as I mentioned earlier.

Therefore, the amendment would create an obligation for the Secretary of State simply to republish the existing fee regime, which is already publicly available; hence the continuity element. Any proposal to amend fees or to introduce new fees would be subject to consultation. In addition, potential impacts on businesses or organisations based in the UK would be evaluated through an impact assessment, which would also be made publicly available during the consultation process.

In light of that explanation, I cordially ask the hon. Gentleman to withdraw his amendment.

[Alex Norris]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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

[Jo Churchill]

Clause 10 provides that regulations made under clause 8(1) may make provision about charging fees, criminal offences and powers of inspectors. It enables the recovery of costs incurred in the administration of improvement or seizure notices under the Veterinary Medicines Regulations 2013.

We need to ensure that the regulator—the Veterinary Medicines Directorate, which I will now call VMD for ease—can continue to effectively regulate and confirm compliance with new or updated elements of the 2013 regulations. Therefore, it may be necessary to make appropriate changes to fees, offences and inspectors’ powers before making any such change; as I have constantly said, consultation will take place if that is the case.

The VMD is required to recover the costs of the regulatory services that it provides from fees and charges. It is important that existing fees can be amended or that fees can be introduced to meet the cost of functions exercised by the VMD. An essential part of protecting animal, human and environmental safety is ensuring compliance with the Veterinary Medicines Regulations 2013. The existing regime imposes criminal sanctions for breaches of the regulatory framework. This clause would allow for making the breach of requirements or prohibitions introduced under clause 8(1) a criminal offence, punishable by imprisonment of up to two years.

VMD inspectors play a critical role in ensuring compliance with the 2013 regulations, helping to ensure that medicines are safe and effective for animals by monitoring their manufacture and supply. Inspectors already have powers to enter premises at a reasonable time to ensure compliance with the 2013 regulations. Clause 10 would allow for the extension of existing powers of entry and inspection to new prohibitions and requirements introduced by regulations made under the Bill.

Subsection (2) provides that regulations made under clause 8(1) may not confer a power of entry to premises used wholly or mainly as a private dwelling, unless those premises or any part of them are approved, registered or authorised for the sale of veterinary medicines under the 2013 regulations.

I commend clause 10 to the Committee.

Question put and agreed to.

Clause 10 accordingly ordered to stand part of the Bill.

Clause 11 ordered to stand part of the Bill.

Clause 12

Power to make regulations about medical devices

[Alex Norris]

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.

[Matt Western (Warwick and Leamington) (Lab)]

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.

[Alex Norris]

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.

[Jo Churchill]

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.

[Alex Norris]

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.

[Jo Churchill]

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.

[Jo Churchill]

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

[Alex Norris]

I beg to move amendment 16, in clause 13, page 8, line 22, at end insert—

“(1A) In making regulations under section 12(1), the Secretary of State must evaluate the extent to which the market is meeting medical need.”

This amendment requires the Secretary of State to ensure that the market in devices is keeping pace with the UK’s medical needs.

This is the very nub of the Bill, and of the process of leaving the European Union and transitioning away from the relationship with it. That bears some important consideration, because presumably one does not leave unless one intends to do something differently; otherwise it would not be worth it. What is not clear is whether we intend to do something differently across all pieces, or whether that just happens inevitably over time because others choose to do something within this topic area and we, by default, do not and we start to diverge.

We could make this argument for medicines, but I have restricted it to medical devices because I think it only needs to be discussed once, and it is more easily conceivable and easier for me to explain my case when we talk about medical devices. I wrenched my wrist a few weeks ago, so I went to find some wrist support. I was thinking about it in this context, because I was starting my prep for the Bill, and it is striking how I started to see things on the box that perhaps I would not previously have seen or was not looking for, about all the different codes and regulations. The schedules to the Bill have a whole litany of them, and every medical device has some configuration of them on there.

In the future that will change, or at least the Secretary of State will be able to make that change. He can make it more complicated, much easier or more onerous, depending on our perspective; but it is almost inevitable, if only by the passage of time, that it will diverge from our friends on the continent. At that point, we create a market force. We know that companies developing medical devices will now have to make a choice about how they span the two markets. Of course, these issues have had hundreds of hours of parliamentary time, so I do not intend to rehash them much further, but I think there is a legitimate anxiety about the risk—and there must be a risk—that manufacturers prioritise the EU market over us and therefore we are behind in the queue and cannot get access to meet medical need.

The purpose of amendment 16 is to be clear about that, because that will give us a chance to do something about it as a Parliament, and for the Government it will act as a call to action. The amendment asks the Secretary of State to keep the matter under constant evaluation. I am perhaps willing to take the point that any responsible Secretary of State would do so anyway, but I would like to hear that it will be uppermost in the Government’s mind.

The changes we make are driven by the things we have talked about, which we see repeated for a third time under medical devices: safety, availability and attractiveness. We understand that, but because those changes could be very small, there could be a butterfly effect where we change something on a leaflet, or a badge that has to go on a box, and thus create a “Sliding Doors” moment where we start to diverge in different places. Then there will be a choice, and manufacturers will have to try to work out whether they prioritise bigger markets or smaller ones, or try to do something that pleases everybody.

I would be interested to know what conversations have happened with manufacturers and what lobbying of Government they have done about the sort of regime they want, because that is the substance of this Bill. The Bill remains a blank canvas for Ministers to paint on later; we are taking a leap of faith with Ministers here, and that is why we have sought to restrict that. It is worth understanding this, because it is one of the most profound implications of the Bill, and I am keen to know from the Minister how it has been mitigated and, importantly, how, and how actively, it is being considered.

[Jo Churchill]

Once again, I understand fully the intention of the amendment: to tease out the fact that small, incremental changes might lead to a divergence further down the line. However, I gently say that the purpose is to enable, so that, come January, we are in exactly the same place.

I will also say that innovation is a two-way street.An example is our ability to publish online to help people who might find it difficult to read the small print on paper in a packet of medicines, or who might be better able to understand from pictures how a device can be enabled or can help them. There is the chance, once we are in January 2021, to make those positive movements. That may lead to the Europeans looking and thinking, “Actually that would be useful.” There is no unique place for the good idea—I think that that is what I am gently trying to say. There is no place for a particular divergence, and we would not want there to be. As I said, there is consultation with stakeholders and the industry to be done on the exact points that have been alluded to.

--- Later in debate ---

As I have noted, clause 12(2) already seeks to ensure that the safety of medical devices, their availability and the attractiveness of the UK as a place to supply and develop them are at the forefront of medical device regulation in the UK. On that basis, I ask the hon. Member for Nottingham North to withdraw the amendment.

[Alex Norris]

I am happy to leave this matter for now; we might come back to it on Report or Third Reading.

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Alex Norris]

I beg to move amendment 17, in clause 13, page 8, line 22, at end insert—

“(k) enabling the Secretary of State to compile a register of representatives for non-UK manufacturers.”

Manufacturers of medical devices based outside the UK must designate a UK representative. This gives the Secretary of State the power to compile a list of them.

This is a brief and probing amendment based on something I picked up on the road, as it were, while talking to people in the sector about what they wanted to see from the Bill and the areas that we ought to go at. I have not been able to quite stand it up in the way that I would have liked, but I am sure the Minister will humour me, in the spirit of an open constructive dialogue.

At the moment, a medical device manufacturer that is not based in the UK has to have a UK representative—and it makes absolute sense that there should be someone who is accountable for the manufacturer’s actions and the impact of its products. However, the suggestion is that there may be inconsistencies as to who that person is, whether they are a genuine person of corporate interest in the company who is in a position to make or shape decisions or whether they were an appointee almost like a paper candidate. I picked that up in a couple of places, but it is anecdotal rather than something I could stand up, despite having done quite a bit of digging. I would be keen to know whether the Minister recognises that characterisation, or at least that risk.

I have not pushed the point too far in the amendment. All I am asking is that the Secretary of State would be able to make a register for the purposes of transparency. One of the suggestions was that an individual might be acting as a representative for multiple manufacturers, and that a register would help tease that out and give us a bit of transparency. I appreciate that there may be commercial sensitivities or personal identity issues, but I am sure that such issues could be managed in a sympathetic way. Indeed, I have not suggested any obligation that the register be public.

I am interested in the concept. Do we think it is a risk, and as we move into this brave new world, is this a chance to try to close that loop? Perhaps there is a better way to do it. I am interested in the Minister’s views on that.

[Jo Churchill]

I am grateful to the hon. Member for mentioning the importance of establishing a UK device register that records UK representatives for non-UK manufacturers. We have actually spoken more broadly, but we both appreciate—as does the hon. Member for Central Ayrshire—that it is something on which we will probably need to have broader discussions in order to go forward.

First, I will look at the spirit of the amendment. I recognise that there is a desire to strengthen the Secretary of State’s ability to conduct market surveillance by including in the Bill a power to compile a register of representatives for non-UK manufacturers. I wish to reassure hon. Members that the regulation-making powers in the Bill are sufficiently robust to enable the Secretary of State to conduct effective market surveillance. In particular, clause 13(1)(h) empowers the Secretary of State to make provision for the creation of a device register. Discussing how that is to be done is the next step. As hon. Members can see, the intention is already laid out.

The register would hold information about the medical devices that become available for sale on the UK market. That could include information on non-UK manufacturers, if they have devices that are sold within the UK on the UK market. Government policy is to record the responsible person for all devices available on the UK market after the transition period. Furthermore, current registration requirements allow the Secretary of State to record manufacturer information for the lowest-risk devices, custom-made devices and all in vitro diagnostic devices in the UK. Mandatory registration with the MHRA provides a level of additional scrutiny on such products that would otherwise be absent.

The Bill provides a power to expand current registration requirements to deliver a more comprehensive record of information about a wider range of medical devices entering the UK market, in order to support the role of the MHRA and its post-market vigilance activity. The will is there but, as the hon. Member for Nottingham North knows, I am very keen that we get such a register, registry or data collection, over which there is already quite a lot of confusion out there. We need to work hard with clinicians and others to ensure we get this right. On that basis, I ask the hon. Member for Nottingham North to withdraw the amendment.

[Alex Norris]

I really appreciate that answer, and I appreciate the Minister’s commitments outside the Chamber—her work with me and the hon. Member for Central Ayrshire, whom we are all missing and who would have contributed considerably to our proceedings but cannot, for a very good reason. There is room in the space of registration. That is obviously one narrow aspect of it, so I am happy to withdraw the amendment in order to pursue the greater prize. There are subsequent amendments in my name that also look at this issue. As the Minister says, it is very complicated and there are myriad different aspects. It is potentially a barrier. It needs to be done well; otherwise, it would be a barrier to trade, which would be bad. The opportunity to come together and to hear from clinicians—to do this once and do it right—is a big prize, and I will certainly be keen to provide support in any way I can. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

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

[Jo Churchill]

Clause 13(1), which is similar to clause 2(1) on human medicines, provides for amending supplementary provisions to be made to the medical devices regulatory framework. Clause 13 lists the matters relating to the manufacture, marketing and supply of medical devices that may be under clause 12(1). The list is exhaustive in order to provide clarity.

Paragraphs (a) to (d) of subsection (1) provide the changes that can be made to regulatory requirements, which must be met before a product can be placed on the UK market, and outlines who can make such an assessment. The provision includes requirements about the characteristics of devices, such as design, manufacture and packaging, and the requirements placed on people involved in the marketing and supply of devices. Those paragraphs also allow for changes to be made to the rules governing the appointment of a specified person or persons, UK-based or not, to assess and certify that medical devices meet all relevant requirements. Changes may be made to conformity assessments, which are assessments of whether requirements, which could include conforming to agreed standards, have all been met. Under subsection (1)(e) and (f) provision could be made about the information to be provided to demonstrate that a device has met regulatory requirements. That could include specifying declarations that manufacturers must make, or certificates that must be provided, to show that a device has been through the appropriate kind of conformity assessment.

Clause 13(1)(g) enables provision to be about labelling, packaging, and information requirements for devices. That might, for example, include specifying warnings or expiry dates that must be included on the label or packaging for a device, and what information to include in the instructions for the use of the device.

We have considered additional ways in which we can improve our regulatory system to improve patient safety and aid market surveillance activities undertaken by the Medicines and Healthcare Products Regulatory Agency. One is the provision made in clause 13(1)(h), which would empower the Secretary of State to make registration requirements for devices marketed in the UK about the registration of devices and their manufacturers and suppliers, including information—this is probably our starting point—to be entered in a register. That is where I do not want the landscape to get confused. It is important that the register sits as that important piece.

Regulations made under clause 12(1) and relying on clause 13(1)(h) will enable the MHRA to create a register of medical devices available on the UK market. That could be requirements to increase the scope of current registration rules. Currently the lowest risk class of device—where they have been self-assessed by the manufacturer rather than assessed by a notified body—is required to be registered with the MHRA. Specified information in such a register, which would not include commercially sensitive information or personal data, could be made publicly available under clause 13(1)(h)(iii), allowing clinicians and patients access to information on the device that they intend to use. Again, there would be transparency.

Under clause 13(1)(i) and (j) changes could be made to the rule around investigations and evaluations for safety, performance and clinical effectiveness, and monitoring of performance through market surveillance. Having the ability to update the rules is essential to maintaining patient safety standards.

The UK does not operate in isolation to the rest of the world, and we have provided at subsection (2) that, where regulations are made relating to matters in clause 13(1)(a)—requirements that must be met in relation to medical devices—those requirements can refer to international agreements or standards for marketing or supplying medical devices.

Question put and agreed to.

Clause 13 accordingly ordered to stand part of the Bill.

Clauses 14 to 16 ordered to stand part of the Bill.

Ordered, That further consideration be now adjourned.–(Maggie Throup.)