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.

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

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.

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 (First sitting)

Alex Norris Excerpts

Committee stage & Committee Debate: 1st sitting: House of Commons
Monday 8th June 2020 Public Bill Committees

[The Chair]

Copies of written evidence that the Committee receives will be made available in the Committee Room.

We now begin line-by-line consideration of the Bill. The selection list for today’s sitting, which shows how the selected amendments have been grouped together for debate, is available in the room. Amendments grouped together are generally on the same, or a similar, issue. Please note that decisions on amendments do not take place in the order they are debated, but in the order 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. We will begin with amendment 9 to clause 1.

Clause 1

Power to make regulations about human medicines

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

I beg to move amendment 9, in clause 1, page 1, line 5, at end insert

“for a period of two years following Royal Assent.”

This amendment provides a sunset provision for the Bill requiring the Government to return with primary legislation.

It is a pleasure to serve under your chairship, Mr Davies. As the shadow Secretary of State for Health and Social Care said on Second Reading, we understand the need for, and urgency of, the Bill. We will therefore be supportive during its passage, but we will seek to improve it. These improvements will take three forms: a focus on patient safety, a focus on promoting greater transparency about the development and use of medicines and medical devices, and seeking to contain the massive and extraordinary powers the Secretary of State is securing for himself.

I am conscious, certainly in this first sitting, that we have an awful lot on. I hope that colleagues will be understanding if it feels like I am moving at pace, because there is quite a lot of ground to cover. However, I wanted to say how grateful I am to the Clerks for having helped me put these amendments together, and to the Minister and her officials for their constructive support so far. The tone of discussions about the Bill has been really good, and I am sure we will continue in this way.

Finally, a lot has happened since the First Reading of the Bill, not least the fact that I have taken over from my hon. Friend, the unstoppable Member for Washington and Sunderland West (Mrs Hodgson), as the Opposition public health lead. As I have been telling stakeholders, they will probably find me similar in approach—committed, but in good humour—but perhaps lacking the same colourful jackets.

This is an enabling Bill. It is a necessary Bill, but we cannot give the Government a blank cheque. We are talking about the power to decide critical, life-and-death matters involving medicines, devices, humans and animals, and we should not just wave that off to secondary legislation without understanding what that might mean and whether there might be a better way to do it. As such, amendment 9 seeks to put a limit on that power.

The proposed arrangements allow the Secretary of State and his successors to make hundreds or more individual decisions to change our current regulatory regime into a markedly different one, one statutory instrument at a time, which I do not think is desirable. Instead, this amendment offers the Secretary of State two years of that considerable power, but asks him to return in two years’ time with a comprehensive set of regulations across medicines for both humans and animals; for medical devices; and, critically, for the proposed new regime surrounding the Medicines and Healthcare Products Regulatory Agency.

That would provide a chance for proper consultation across the sector, including with patient groups, industry bodies and interested companies, as well as more parliamentary scrutiny to set up the regime that we all want—a safe one, an effective one and a world-class one. It would also give us two years of life outside the European Union and would really help us to land in that place and find out how different we intend to be, certainly in this sector. It would provide time for piecemeal change, but it would at least then reset things, and then I would be at the point where I would be much more relaxed about the use of secondary legislation to diverge from that as circumstances require, because we would have reset things in the full knowledge of Britain’s new place in the world.

There is a case to be made that the arrangements being proposed in the Bill reflect current arrangements; after all, we do not have parliamentary scrutiny over the regulations that have come traditionally in previous decades from the EU. However, that is a political argument—a very effective one—and we know that, outside the white-hot light of public debate around the EU, the EU works differently from that. That was a theme developed by the Member for Central Ayrshire on Second Reading.

Page 4 of the Government’s impact assessment of the Bill describes how a higher-risk medical device enters circulation in the UK for use, saying that for a high-risk medical device to enter the market “a Notified Body”—for us, that is the Medicines and Healthcare Products Regulatory Agency—has to “certify” it. So far, so similar—that is essentially what the Bill would allow, as well. However, at the moment the device would be checked by two further notified bodies from within EU structures and the European Commission, as it says on page 5. That is quite a protection; that is a triple lock. It is not just our own MHRA saying whether or not a device is safe; there are two other equivalent bodies saying that, too.

That system will go and instead we will have a Secretary of State, we will have a Department, and I am sure that NHS England will have a view, too, but fundamentally we will just have a Committee of the House—a statutory instrument Committee. That is quite a diminution. Surely we at least need to know that there will be adequate safeguards in place. If the Government do not accept the amendment, I would be very keen to know what can be done to protect that triple lock.

I will move on to tell a story about two page 10s. Paragraph 42 on page 10 of the impact assessment refers to the potential to move to “hub and spoke dispensing” for pharmacy. That is a very live debate in the field of pharmacy at the moment, I have to say. I have probably not checked this with the shadow Secretary of State, but I see some positive arguments for it, although I can also see significant risks. It is the sort of thing that I think parliamentarians from all parties will be very interested in. I think that we would form different views on it, and not on party lines, because we are basically saying that pharmacy changes—that it is less about dispensing and more clinical, and that bigger nationally based pharmacies, as it were, will instead provide an outsourced dispensing arm. I can see efficiencies in that system; we are doing an awful lot of that at the moment in the context of coronavirus. However, that would be a radical change for pharmacy. At the moment, paragraph 42 on page 10 of the impact assessment says it is a potential direction for where things will go for pharmacy.

If we look at the Bill, we do not see the words “hub and spoke” anywhere, which is very significant. I gently say to Back-Bench Members of the governing party: “You could be in a situation in a year’s time where you are in a statutory instrument Committee being asked, basically, to make the most significant change to pharmacy in decades, and one that you will get a lot of emails about from your local pharmacists, certainly in community pharmacy, and I really do not think that is the sort of power that the Bill is intended to give.”

I said that this was a story of two page 10s. Page 10 of the delegated powers memorandum refers to clause 1 of the Bill and justifies the use of delegated powers:

“The human medicines regulatory regime is ever-changing and requires technical changes in order to keep up to date. These are changes we cannot predict in advance and therefore would not be practical or appropriate for these amendments to be made through primary legislation each time an update is required.”

That is saying, “Something changes a little bit and we would not want a whole new law to keep pace.” Of course, I understand that. However, we are talking about something really significant here; I would argue that it is an entire model change for pharmacy. We know that this is of interest to the Government, because it is in their own impact assessment. They say that it is a possibility. We really need to square that.

I accept that the Secretary of State will need powers and will have to do things through secondary legislation to keep us up to pace with, or to diverge from, European regulations. However, I am not confident that this is a mandate to make really significant changes to something that is very important to us all. That is why I have moved amendment 9. It would say to the Secretary of State, “Go and have a look at this for a year-plus, and then develop legislation to reset that.” Let us have proper consultation with the sector and with citizens. Let us have proper parliamentary scrutiny. Then, if we come to the view that this is the best way to do it, by all means that is what we should do.

I hope that the Government are minded to accept the amendment, but I am sceptical of that chance, so I would be keen for the Minister to return to these two points. First, will this provision mean a diminution of protection, certainly when it comes to the triple lock on medical devices? Secondly, there needs to be at least an acceptance from Government that the liberty to make quite big and bold changes is not licence to make any changes that they want, bolstered by a Committee majority, because I do not think that that is in the spirit of the legislation or of this exercise, which is about getting us to a safe position following the end of the transition period.

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

It is a pleasure to serve under you, Mr Davies. I agree with the hon. Member for Nottingham North that we have worked on the Bill in a spirit of co-operation, and I would very much like that to continue, because sitting at its heart is the patient, and patient safety is what we are after here. I will come on to the two specific points, but I shall address now the sunset element and why, in our opinion, that is not the way to proceed, because of its time-limited nature.

As the hon. Gentleman said, the Bill is necessary because at the end of the transition period, we will lose the ability to update. I am grateful for his words saying that both he and the shadow Secretary of State for Health and Social Care understand what we are trying to do. We need to be able to amend the legislation that governs human medicines and medical devices and veterinary meds. This measure will enable us to update the regulations in the light of patient needs and in the light of changes and innovation. I am sure that the hon. Member for Nottingham North would agree that one challenge is the dynamic nature of how medical devices in particular, but also medicines, are changing—at the bedside, but also right across healthcare. Patients and their best interests are at the heart of the Bill, and that is where I want to start.

On amendment 9, what the hon. Gentleman says is important, but the explanatory statement, while giving clarity, still leaves us with the challenge of an overarching sunset clause for the Bill, such that two years after Royal Assent, the primary legislative framework would fall away and Parliament would have to re-legislate for the provisions in the Bill once again. I understand that the hon. Gentleman’s intention is to ensure that Parliament reconsiders, and those checks and balances are important —it is important that we think about the legislation that we are passing. One would hope that at that time, Parliament will be sitting under normal circumstances, but, to be frank, we are not sure. That said, I would like to set out specifically why this proposal would be unhelpful and cause a potential risk to patient safety.

The Bill, in the main, does not deliver any immediate change to the regulation of medicines and medical devices. It provides a framework of powers to ensure that regulatory change can be made as and when necessary. It does, as I hope all hon. Members will recognise when we reach the relevant clauses, increase the level of parliamentary scrutiny, and it is that that enables us to look before something goes forward. There is going to be more scrutiny, under the affirmative procedure, for us to look and understand what it is we are legislating for than we have had thus far. Use of the affirmative resolution is made near universal, other than in the event of an emergency and for very minor changes.

--- Later in debate ---

On the hon. Gentleman’s concerns about pharmacy, which I will come to later, essentially it is about ensuring that community pharmacies are enabled. I am cognisant that we wish to empower small pharmacies to be able to use a hub and spoke model to secure their place on the high street and to ensure that, with appropriate training for technicians, the clinician can be freed to move forward, as per the pharmacy contract, to give advice to patients as part of the primary care team. That is what, in essence, lies behind the desire for pharmacy to be enabled, in order to deliver more for patients and for pharmacists, who are highly skilled and to whom I pay tribute. They have been a stalwart part of the entire system through the past 12 weeks. They have met patients in the high street and their doors have remained open. This legislation will enable them to be the fine clinicians that we know they are, and to use their high level of skill to benefit others.

[Alex Norris]

I take the point about not wanting to rely on primary legislation all the time. I would be much more comfortable—in this Bill in its entirety, but certainly in any future legislation—with provisions for technical updates. Nobody would think that we would need to return to primary legislation, especially not in an emergency, but I do not think that anything in the clause says that would have to be the case. I would probably accept that two years is too short a period, given the amount of work that has to be done prior to something coming into law. However, that might be an argument for a greater sunset clause rather than none at all.

I did not quite agree that nearly everything would be covered under the affirmative procedure. I am very happy to be wrong on this, but the delegated powers memorandum states, on clause 1 alone, that the scrutiny will be by the affirmative procedure

“with the exception of…the labelling and packaging of human medicines…advertising human medicines…prohibitions in the supply provisions for human medicines…the charging of fees in relation to human medicines”

and emergency powers.

If we discount the emergency powers because of the need to move quickly, we are still talking about the labelling, advertising, prohibiting and charging of fees for human medicines. Those are quite significant areas that will not be covered under the affirmative procedure. That may be a distinction without a difference, given that fundamentally there are devices that the Opposition could use if we wanted those to get an airing. However, it is important that hon. Members know that not everything will be covered by the affirmative procedure except for some very small elements.

Finally, I really appreciate the clarity on the hub and spoke model, for which the Minister made a very strong case. The argument is going on sector-wide. I do not think that there has been much of a political conversation on it. I cannot remember it in the Conservative manifesto, but I might be wrong. It feels a little bit as though we have reached the conclusion without having done all the work behind it—the Minister may well have done; I mean more generally.

[Jo Churchill]

This will be done in consultation with pharmacists, in a discursive way. As the hon. Gentleman has articulated, we have found ourselves in unusual times. Ensuring that we seize the advantage, in a way that is clear, transparent and consultative, is the aim of what we are trying to set out.

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[Alex Norris]

I am grateful for that clarity, which gives me much reassurance. All I will add is a request that the Government include Opposition parties in that. For something this sensitive, forming a political consensus would be good for everybody. I do not intend to press the amendment to a Division, although we are likely to return to it at future stages. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Alex Norris]

I beg to move amendment 22, in clause 1, page 1, leave out lines 10 to 16.

This amendment removes the requirement to consider the attractiveness of the relevant part of the UK when making regulations under subsection (1).

[The Chair]

With this it will be convenient to discuss the following:

Amendment 23, in clause 1, page 2, line 3, at end insert—

“(5) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of human medicines.”

This amendment requires the appropriate authority to consider patient safety first when making regulations under subsection (1).

Clause stand part.

Amendment 24, in clause 8, page 5, leave out lines 18 to 24.

This amendment removes the requirement to consider the attractiveness of the relevant part of the UK when making regulations under subsection (1).

Amendment 25, in clause 8, page 5, line 32, at end insert—

“(5) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of veterinary medicines in relation to animals, humans and the environment.”

This amendment requires the appropriate authority to consider animal, human and environmental safety first when making regulations under subsection (1).

Amendment 26, in clause 12, page 7, leave out lines 26 and 27.

This amendment removes the requirement to consider the attractiveness of the relevant part of the UK when making regulations under subsection (1).

Amendment 27, in clause 12, page 7, line 27, at end insert—

“(3) In making regulations under subsection (1), the appropriate authority must give primary regard to the safety of medical devices.”

This amendment requires the appropriate authority to consider safety first when making regulations under subsection (1).

New clause 3—Report on availability of medicines—

“The Secretary of State must report to Parliament when a medicine which is clinically beneficial has not been made available on the NHS.”

This new clause requires the Secretary of State to report to Parliament when a medicine which is effective has not been made available on the NHS.

[Alex Norris]

Turning to clause 1, page 1, subsection 2, as we might have said at school—I think this is verbal reasoning, if my memory is good enough—one of these is not like the other. As the Minister said, and as I think every person in the room and indeed across the House would say, the most important thing is patient safety. The human medicines regime must be safe. There is no doubt about that, and I know that is a personal priority for the Minister and something that she works very hard on.

Similarly, availability is crucial. We all want everybody in this country to have access to the vital medicines and medical devices that can enable them to live full, happy lives. We know that is challenging. Since I am here, I might cover new clause 3, which is essentially the Orkambi clause. Hon. Members who were here in the previous Parliament will know what a difficult and perhaps even unedifying process it was to get a much-needed medicine on to the market to give relief to thousands of people in the UK, and how frustrating and ineffective it was— for whatever reasons people would think that was frustrating—over a number of years to get from the place of this thing existing and being available to some people in other parts of the world but not in the UK. What could be more frustrating?

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[Rushanara Ali (Bethnal Green and Bow) (Lab)]

It is absolutely right that there should be some way of setting out a hierarchy, with public safety at the top. Like my hon. Friend, I have a major project in my constituency to promote the life sciences, through The Royal London Hospital, Queen Mary University of London and others. It would be great for investment and we want to see that happen. However, in the light of what has recently happened and the public loss of confidence in the focus on public safety, particularly with reference to chlorinated chicken and the rest of it, the public feel great concern about safety. It is important that the Minister is able at least to provide the reassurance that public safety would be at the top of the agenda, with some sort of hierarchy.

[Alex Norris]

I completely agree. I think that if we stood in the street for a bit and just straw-polled people, everybody would say that safety is uppermost and they would see the value in its being set on a higher tier, which is what I am suggesting. We are at this possibly significant moment—I believe it is 8 July—when the noble Baroness Cumberlege will come back with her review into what has happened. Obviously, it is a sign of the times and where we are, but at Second Reading people talked about it coming out in March. The world has passed us by, but I understand that publication of the review is imminent and I am keen for that date of 8 July to be confirmed.

If the review says that there are issues around patient safety, we would expect there to be recommendations and changes, which I think is reasonable. I will return to this theme later in the day. What might this say about the MHRA? Is it possible that the regime that we seek to put in place through the Bill might be overrun by events? If recommendations come out of that, is there a possibility of revisiting that in future stages to be clear about it? That is an argument against the sort of piecemeal regime that the Bill proposes, instead of coming back in, if not two years, then three or four, to set a full codified bringing together of the different Acts into one Bill.

I will finish on amendment 23 by referring to one of my favourite contributions from Second Reading:

“Patient safety is not a partisan issue; it is paramount.”—[Official Report, 2 March 2020; Vol. 672, c.689.]

The Minister may recognise her words. I completely agree with her.

Amendments 24 to 27 essentially make the same provisions across veterinary medicines and medical devices, and I do not intend to rehearse the arguments. On medical devices, surgical matters was a good example. There is the potential for life-changing and wonderful things, but also the real potential to do harm. We want to know that with every hip, breast, knee—whatever it is that is done—safety is paramount. Amendments 22 and 23 seek to create a special place for patient safety. I hope that the Minister will accept them.

[Jo Churchill]

First, patient safety is paramount. That is where I began my journey into Parliament. In my case, it was access to cancer drugs—something close to my heart. With regard to Orkambi, I understand and share the frustration felt by everyone. My heart goes out to those affected, who are very often parents. The cystic fibrosis campaign has, I think, a 98% sign up of all parents who have had children with cystic fibrosis. On their fight for Orkambi, I am sure everybody feels sympathy for them, because it took so long to provide access.

Drug companies have a responsibility here. This refers slightly to the comments the hon. Member for Nottingham North made about life science sectors or pharmaceutical companies all being large. The drug companies have a responsibility to price their drugs responsibly in a way that reflects the benefits that they bring to patients. I feel that the arrangements that we have in place in the National Institute for Health and Care Excellence and the cancer drugs fund have helped people to get access to medicines rapidly. There is still work to do, but they need to be marketised at a fair price. We made a commitment in our manifesto to establish an innovative medicines fund to address slightly some of the points that he made.

Amendments 22 to 27 relate to the three considerations the appropriate authority must have regard to when making regulations in relation to medicines for human and veterinary use and medical devices. The effect of the amendment would be to remove the requirement to have due regard to the attractiveness of the UK as a place to market and develop these products, and to assert the primacy of patient safety above all other considerations.

The safety of patients and the environment, people and animals—when moving into the area of veterinary medicine—absolutely underpins the regulatory decisions that are made. It is absolutely the case that we would never seek to make a regulatory change that puts somebody’s health at risk; that would be counter-intuitive. However, I do not think that patient safety or safety in general is in conflict with the other considerations that these amendments are intended to affect.

The purpose of the regulation is to ensure that we do what is in the best interests of UK patients, or the veterinary sector when it comes to animals, so that they receive the best possible treatment without undue impact on the environment. It is likely that having a dynamic and innovative market, where treatments or technologies are developed in the UK, contributes to the overall benefit of the patient, as those treatments will become available to them. These are not binary principles where regulation works only in the interests of one or the other.

The hon. Member for Nottingham North mentioned Nottingham—I also shout out to Cambridge, which is just down the road, and London, which the hon. Member for Bethnal Green and Bow mentioned. This country’s life sciences sector is envied. The Government have committed to supporting it through the life science industrial strategy, in which we have sought to address the challenges faced by the industry and provide an environment that encourages companies to start and grow. All large companies start somewhere, and the hon. Member for Nottingham North knows that in the incubators around Nottingham, Cambridge and even my constituency of Bury St Edmunds, lots of small firms are working on the most incredible things to help patients.

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The consideration that amendments 22, 24 and 26 would remove is intended to ensure that we take into account the full spectrum of impacts that regulation will have, and to ensure that patients get access to the most innovative treatment as the UK’s regulatory model encourages development of new therapies and medicines. That is in itself intended to improve patient outcomes. Doing what is in a patient’s best interest is at the heart of the Bill. Therefore there is no need for amendments 23, 25 and 27, as we see patient safety not as in conflict with innovation but as complementary to it. On that basis I ask the hon. Gentleman to withdraw the amendment.

[Alex Norris]

It feels to a certain extent as if we are having this conversation the wrong way round. I have not been in Parliament very long, but I have been on quite a few Bill Committees—I am sad like that. Normally the Opposition try to put words in a Bill and the Government say, “We agree with the principle; it just does not need to be on the face of the Bill.” It feels as if on the attractiveness point we are doing that the other way round. I completely accept that there is no nefarious aim, but I personally think that it is superfluous. We can perhaps pursue that at a later stage.

I agree, too, that those things are not necessarily in conflict but, as my hon. Friend the Member for Bethnal Green and Bow said, I can see circumstances in which they might be, in the sense of pressure to drop our standards in order to get certain investments. For the Opposition, that has been a fear throughout, and we can certainly see it in this place, which is why we would like to enshrine a provision in the Bill.

Finally, I accept the point that patient safety must come first, but I do not think that the Bill—although it was written with lots of lists in it—creates hierarchies in those lists. It does not specify what falls down, that A is better than B which is better than C which is better than D, so that does not quite cover the point. I will not press the amendments to a vote, but with permission, we might come back to them later. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 1 ordered to stand part of the Bill.

Clause 2

Manufacture, marketing and supply

[Ms Marie Rimmer (St Helens South and Whiston) (Lab)]

I beg to move amendment 1, in clause 2, page 2, line 23, at end, insert—

“(o) the origin and treatment of human organs used in the process of developing or manufacturing medicines”.

This amendment empowers the appropriate authority to make provisions on the process of developing or manufacturing medicines in relation to the origin and treatment of human organs.

It is a pleasure to serve in Committee under your chairmanship, Mr Davies.

The purpose of the amendment is to empower the Government to make regulations providing for the treatment of human organs in the development of the manufacturing of medicines. This is necessary due to the actions of the Chinese Government in Beijing.

The China tribunal launched the first independent legal analysis of all evidence related to organ harvesting in China. The tribunal is headed by Sir Geoffrey Nice, QC, who served as the lead prosecutor of Slobodan Milošević. It stated:

“Forced organ harvesting has been committed for years throughout China on a significant scale”.

I have forwarded copies of this document to all members of the Committee. I am trying to be as transparent as possible—this is not about trying to kid or trick on our commitment. I am sure that people in the country would agree. All members have copies, which I sent out over the weekend. I have given a short version of what the independent public tribunal said. Clearly, on the second page, it stated:

“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one—and probably the main—source of organ supply. The concerted persecution and medical testing of the Uyghurs is more recent, and it may be that evidence of forced organ harvesting of this group may emerge in due course.

The Tribunal has had no evidence that the significant infrastructure associated with China’s transplantation industry has been dismantled and absent a satisfactory explanation as to the source of readily available organs concludes that forced organ harvesting continues till today.”

There is therefore clear evidence that China is conducting medical testing on organs forcibly harvested from Uighurs, the Falun Gong, conscientious objectors and political prisoners. Indeed, a study by medical journal The BMJ raised ethical issues about more than 400 Chinese medical studies. The harvesting of organs from those people not only is an abhorrent act in and of itself, but often involves forced brain damage and vegetation of the person involved, of course leading to their eventual death.

Those papers that I sent to all Committee members refer to a debate in the House of Lords on 2 March, which raised the issue of the tribunal on forced organ harvesting in China. On that harvesting, Lord Alton commented that the

“organised butchery of living people compares to ‘the worst atrocities committed in conflicts of the 20th century’, including the gassing of Jews by the Nazis and the Khmer Rouge massacres in Cambodia”.

The UK Foreign and Commonwealth Office informed the UK House of Lords that the World Health Organisation, which previously advised that China’s transplant system is ethical, responded:

“The evidence that it uses is based on the self-assessment made by the country that is a signatory, and in this case that is China.”

That comes from the UK Foreign and Commonwealth Office. The British Medical Association calls on the Government to reconsider their position on this issue in the light of the findings of the tribunal, and to use their influence with the international community to ensure that a full, proper investigation takes place.

We therefore need to take the necessary steps to protect the United Kingdom’s healthcare system from being morally compromised through an injection of Chinese medicines developed in a way that breaches some of the most basic human rights. This amendment does not aim to shut down trade in medicines between the United Kingdom and China. Leaps in progress made for preserving human rights should be readily shared and traded across the globe. However, these leaps in progress should not come at the expense of innocent human lives, and we must do all that we can to ensure that this practice cannot be profited from.

By passing this amendment, the Government will be empowered to make regulations ensuring that medicines supplied in the United Kingdom meet basic human rights standards with regard to how organs have been obtained in their development and manufacture. Any medicines that meet these standards and any other standards set by the Government will, of course, be welcomed into the United Kingdom.

This amendment does not force the Government to implement these regulations now; it merely empowers the Government and the relevant authorities to take the necessary steps to regulate around this issue when they are prepared to do so. I can therefore see no moral or practical reason why members of the Committee would not wish to see this amendment added to this Bill, and urge the Committee to consider it.

[Alex Norris]

My hon. Friend has made a persuasive and powerful case, as she did on Second Reading. From the debate on Second Reading, I took away the phrase that this gives us a chance to “strike a blow” against this heinous industry. I certainly support her in that regard.

[Jo Churchill]

I thank the hon. Member for St Helens South and Whiston for raising this issue and the pack that she so diligently sent to us all over the weekend, which I read with great interest. I know she holds this issue dear to her heart and she is passionate about it. I fully understand the intention behind the amendment. It is absolutely right that medicines that enter the UK supply must not have been manufactured or developed to using organs or human tissues that do not come from authorised sources.

I can assure the hon. Lady that safeguards are in place to provide surety on these issues. The requirements around the donation, procurement, testing, processing, storage and distribution of organs, tissues and cells intended for human application are set out in the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004, which are separate from measures on medicines manufacture.

Medicines legislation already ensures that human tissues and cells used in the manufacture of medicinal products must meet those requirements. Safeguards are in place in those Acts to ensure that the appropriate quality, safety and origin of human tissue is known—for example, consent and traceability requirements apply to any human tissue or cell component imported into the United Kingdom and used as a material in the manufacture of a medicinal product. Importantly, a researcher is not able to conduct research on human tissue in the UK if they cannot provide evidence that it has been obtained ethically and in accordance with legal requirements. The Government will ensure that, under the new deemed consent arrangements for organ donations, donations of cells for advanced therapy and medicinal products cannot happen without expressed consent.

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Subsection (1)(n) deals with amendments made to the provisions that govern who can supply or prescribe human medicines. The provisions referred to are set out in subsection (2). The power gives the Government the ability to amend the rules around who can supply, administer and prescribe medicine in line with healthcare needs, where it is safe and appropriate to do so. The most recent change to prescribing responsibilities was in 2018, when legislation was amended to allow trained paramedics to act as independent prescribers. We have published an illustrative SI showing how the provision can be made to permit dental hygienists to supply and administer certain medicinal products in the course of their professional practice.

[Alex Norris]

I am conscious that our carriage will turn into a pumpkin shortly, so I will move with some tempo.

New clause 2 is the Porton Down clause, and the world has changed greatly in the last few months. We now know, in a way we could never have grasped before, how an air-borne virus can lock us up in our homes for months on end, and even longer for many. We also know that what happens on the other side of the world can be with us quickly, and that at times, as with the current coronavirus, there is not much we can do about that.

We ought to reflect on what we are doing at home. We have reached a point where we could have a greater public understanding and scrutiny of the sorts of things being developed in our name by our Government. Porton Down is a world class facility full of incredibly talented people serving our national interest, but we do not know what they do. We get snippets. We know that in the past decade they have experimented on 52,00 animals, which is six times the rate of any other UK lab. I have absolutely no idea whether that is too high, too low, or just right, because we do not know. I am trying to probe the ways in which we can get greater transparency about what potentially life-saving or possibly life-ending products are being developed on our doorstep. If the Minister thinks there are better ways to do that, I am happy to consider those. The drafting does not refer to everything developed in the UK, but things developed by the Government. It is behind closed doors, very secretive, and potentially quite dangerous, so I am keen to know how we might get greater scrutiny.

New clause 4 on antimicrobial resistance is a passion of my predecessor, my hon. Friend the Member for Washington and Sunderland West. It is topical now as we wrestle with a horrendous virus, and I express my solidarity with the Minister and her colleagues on their efforts in doing so. Clearly, microbial organisms can adapt and have an incredible impact, as we are seeing. They can also disrupt much more conventional matters such as the antibiotics that are crucial for transplants and chemotherapy. It is laudable that the Government have a 20-year vision for this, although I hate long strategies. What is done in year one is much more important than what is done in year 20. I know there is a five-year plan sitting behind that, but even that feels too long a time. The new clause gives the opportunity instead for an annual report, which would be an improvement. If that is not the right vehicle, how might we be able to play our role in the conversation around antimicrobial resistance, and how do we get an appropriate period in which to hold the Government to account to ensure that we make progress?

[Jo Churchill]

I am grateful to the hon. Gentleman for raising the development of new medicines in new clause 2, which are important in new clause 3 as well. Antimicrobial resistance, as he has mentioned, is an absolutely critical issue of today. I will first set out what we are doing in that area. The development of medicines is an integral part of the UK life sciences sector, and we are committed to making sure that we can develop such medicines. The Bill gives us powers to maintain an effective system for regulating, including with respect to clinical trials. New clause 4 allows us to adapt the regulatory framework around them in a way that best suits the industry. The development of medicines is the role of the pharmaceutical industries and researchers, and we want to support them fully. The Government are committed to supporting a thriving sector, investing more than £1 billion a year in health research through the National Institute for Health Research, which is committed to openness and transparency about where the funds go. It ensures that all trials publicly register before any patient intervention, and key trial outcomes are made publicly available. However, the arrangements for Government support and funding through trials is not within the Bill.

I will address some of the work that the hon. Member for Nottingham North alluded to at Public Health England’s Porton Down campus, sometimes referred to in the context of medicine developments. The current PHE facilities at Porton Down do not develop medicines for Government, but engage in a range of scientific work for commercial and public sector customers. This includes the safety and efficacy of testing vaccines and therapeutics, and discovery work relating to novel and dangerous pathogens. Porton Down is also the site for work by Porton Biopharma Ltd, which is a public non-financial corporation and is outside central Government. Although PBL develops and manufactures biopharma products, this falls outside the Government and we are therefore not in a position to publish reports on the development of its work.

The hon. Gentleman also raised the important issue of AMR in new clause 4. I want to reassure the Committee that tackling AMR is a high priority for the Government and that its impact remains on the national risk register. The UK continues to lead the way on global action to tackle AMR, working alongside international partners, the most famous of whom is probably the most recent chief medical officer before Professor Sir Chris Whitty, Professor Dame Sally Davies, who has taken up her position as the special envoy for AMR. Her role will continue to underline the UK’s position as a world leader in developing and delivering international action in that space.

In January 2019, the UK Government published their vision to contain and control AMR by 2040. Achieving that is supported by the delivery of a five-year national action plan from 2019 to 2024. The delivery of the cross-Government commitments in the action plan is being overseen by a joint DHSC and Department for Environment, Food and Rural Affairs-chaired programme board, established in October 2019. The commitments in the national action plan cover all sectors, including human health, animal health, food and the environment.

The UK has already made good progress in reducing its use of antibiotics in humans and animals, and we now have the fifth-lowest level of antibiotic consumption in food-producing animals out of 31 European countries. We have also seen unprecedented levels of investment in collaboration in research on AMR nationally and globally. The UK invests significantly in AMR through the Fleming Fund and the global AMR innovation fund.

The hon. Member for Nottingham North is correct that the Government should prioritise the development of new medicines to address antimicrobial resistance, including antibiotics. Indeed, we already do. Having a pipeline full of antimicrobial drugs is critical to our efforts to contain, control and mitigate AMR, as outlined in the strategy towards 2040.

In July 2019, the UK formally launched a project for developing and testing the world’s first subscription-style payment model for antibiotics. If successful, it would mean that pharmaceutical companies received payment up front for access to their antibiotic products, based on the products’ value to the NHS, as opposed to the volume used. We are the first country in the world to test such a model and more information will be published on it in due course.

Although we know how important new medicines are in tackling antimicrobial resistance, a strengthened focus on prevention and the control of infection will help to contain the emergence and spread of resistance to antibiotics. By limiting and reducing the need to use antibiotics in the first place, we are taking a zero-tolerance approach to avoiding infection in human healthcare settings, as set out in the action plan. Our plan will result in at least 15,000 fewer UK patients being affected by infections each year by 2024, and 5,000 fewer drug-resistant infections.

In parallel, we are focusing on reducing animal exposures and susceptibility to pathogens that could result in the need for treatment with antimicrobials. By working closely with the veterinary profession to implement those preventive measures, we will reduce the need for new antimicrobial medicines as we reduce them in the food chain.

I hope that hon. Members will agree that the UK Government are working hard to ensure that AMR is controlled and contained through the vision for 2040 and the five-year action plan. New clause 4 is not necessary for the Bill. If the hon. Member for Nottingham North has further specific questions in relation to either medicines by the Government or AMR, I would be happy for him to write to me and I will endeavour to answer those points in a closed format. On that basis, I ask him to withdraw the new clause.

[Alex Norris]

I do not intend to press new clauses 2 and 4 to a Division. The Porton Down answer was helpful. In the terms of the amendment, it is not necessary, but I will have to work out how to get from accepting the principle about not developing medicines to accepting the next sentence about testing vaccines. That is a distinction without a difference, but I accept that it would not quite work in the Bill. The answer about the limited company does not hold either. As a wholly owned subsidiary of the UK Government, I think we could take an interest in that.

I was grateful for the detailed answer about AMR. I will take up the offer of engaging directly as and when. To be clear, we are keen to engage on that, because it is a significant issue and we want the Government to succeed at it. I hope that can be part of an ongoing conversation about it. On that basis, I will not press the new clause.

Question put and agreed to.

Clause 2 accordingly ordered to stand part of the Bill.