Medicines and Medical Devices Bill

Baroness Jolly Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Baroness Thornton (Lab)]

I thank the noble Earl for that statement, which is extremely helpful. I am alarmed, or surprised, that we are at this stage looking at a grey area about whether or not it is necessary for these amendments to be moved and accepted. It is very important that that is clarified, and I would just like to make one or two other points.

Grand Committee is for probing; it is for consensus, and then it is up to the House to take the decisions on Report about that. These amendments, which we are being asked to nod through, really are not consistent with what the Companion says Grand Committee is there for, so the clarification that we will have to return to these at a later stage is, of course, absolutely necessary.

However, that also means that on Report we will have a Bill before us that is not the same Bill as we have now. It will have been significantly amended in some very significant areas of policy. So I am writing to the Constitution Committee and the Delegated Powers Committee today to ask them to look again at the Bill. When the amendments have been accepted, it will not be the same Bill as we have now.

We will not negative the amendments today, because I accept the noble Earl’s statement and, on the balance of risks, the Opposition would not wish to delay the Bill for three months, into next year. We can see the dangers that that would represent. However, I ask the Government to examine the proposal made by my noble friend Lord Hunt to the Minister and the Bill team in a meeting to discuss the issue. That was that they should look at paragraph 8.127 of the Companion and consider removing from the Bill all the government amendments concerned with this issue. We could then take those in a group at the end, on the Floor of the House. That would give us time to do the stuff we have not yet done and discuss the substance of the amendments.

If the Minister and the Bill team had come to us a month ago and said, “We’ve got this problem with the Northern Ireland consent process, and this is what it means,” we would not be having this discussion now, because we would have worked out how to resolve that problem. I regret that that is not what happened and I hope that we will now move forward in a more positive way. Finally, we will look carefully at what is added in Grand Committee as a result of these very particular circumstances and we may seek to delete or amend some of the government amendments at the next stage of the Bill.

[Baroness Jolly (LD) [V]]

With the Northern Ireland component, a time constraint was imposed on the Committee, and people have been looking at ways of solving the problem since our previous meeting. Since 8.30 am I have been in various meetings with various people looking for ways forward. The one described by the noble Earl, Lord Howe, is on the table and has been agreed by all party spokespersons. It was finally agreed at a meeting with the Minister and others at 1.30 pm. Like the noble Baroness, Lady Thornton, I am grateful to the noble Earl for his help in resolving this issue.

[Earl Howe (Con)]

I am grateful to both noble Baronesses for their responses. I think that this provides a basis on which to proceed with our Grand Committee debate today, pending further clarification on the matters that I referred to earlier between now and Wednesday, our next Grand Committee day. I can assure noble Lords that my colleagues and I will endeavour to achieve that clarity, which we will disseminate at the earliest opportunity.

Covid-19: South Yorkshire

Baroness Jolly Excerpts

Thursday 22nd October 2020 Lords Chamber

[Lord Bethell (Con)]

First, I am glad to say that we have struck a financial arrangement with the Mayor of Manchester, and one of the valuable points that I think the noble Lord is alluding to is that that agreement is fair to all the other regions where we have struck agreements. It is not possible to do more generous agreements with one region over another simply because of the hard bargaining of one mayor over another. I pay tribute to those in Sheffield and South Yorkshire for the way in which they have gone about their negotiations and the implementation of the new tiering system in South Yorkshire.

[Baroness Jolly (LD) [V]]

My Lords, as was shown in Manchester, the Government can impose tier 3 on an area where an agreement cannot be reached. Can the Minister inform the House if discussions with local leaders are now about not whether the area will be placed in tier 3 for the good of the population’s well- being but the financial package?

Health Protection (Coronavirus, Restrictions) (Self-Isolation) (England) Regulations 2020

Baroness Jolly Excerpts

Thursday 22nd October 2020 Lords Chamber

[Baroness Jolly (LD) [V]]

My Lords, when an individual self-isolates, the whole household is impacted too. What financial support might be available? Does enforced self-isolation mean that the individual is entitled to statutory sick pay? In Germany they would get full pay. If the rest of the family have to isolate too, are they entitled to any financial support to supplement their loss of income? Who gives guidance to the Covid-affected individual as to what they may and may not do, and where to find help and support? Are there arrangements for non-English speakers? What about caring responsibilities?

What other criteria might there be to extend the isolation if a family member shows signs, is tested and found positive? Does that then become a family lockdown? Are those family members expected to quarantine for two weeks?

Could the Minister clarify paragraph 6.7 of the Explanatory Memorandum? It states that adults who have been notified other than through the app that they are positive should self-isolate “for a specified period”. What is the contact: by phone, in person, by letter or by email? Of course, some parts of the countryside have no mobile coverage. I have no signal at home, but I am not aware that I have indicated my preferred method of communication.

Not everyone has the app. Could the Minister tell us what proportion of the adult population has downloaded it? A recent report suggests that many people may use a phone only to text and chat. What assumptions has the test and trace team made in this regard? What proportion of the general population are regular IT users who can handle this way of information dissemination?

Has the Department of Health and Social Care done any analysis of the effectiveness of test and trace? It certainly got off to a bumpy start, but could the Minister tell the House whether there are any plans to carry out a review so that it could be improved for a possible second or subsequent wave?

Covid-19

Baroness Jolly Excerpts

Tuesday 20th October 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, first, I declare my interests in the register.

I thank the Minister for taking both these Statements, because we are in fact updating ourselves on Thursday’s and Monday’s Statements. Without doubt, the virus continues to grow. The R rate is now between 1.3 and 1.5, unless it has increased in the past 24 hours. We on these Benches welcome the advances in saliva and LAMP testing, of course. Indeed, I join everyone in being in awe of the work being carried out in our universities.

I will briefly describe the real-life experience of Test and Trace that happened to a neighbour of mine and her family in the past few weeks. After the first member of the family tested positive, they were given one ID and told to isolate for 14 days as a contact of that family member. The remaining members of the family tested positive four days later. They were given a second ID as a positive contact and told to isolate for 10 days. They all then gave each other’s names to Test and Trace as contacts—of course they did; they live in the same house—and were given a third ID. They were then rung up and told to isolate for another 14 days. When they put their test results into the app, they were given a fourth length of time to isolate, which did not match up with what they had been told on the phone. The various Test and Trace staff did not seem able to collate the information that they were being given or to join it up—although some of them tried, it must be said.

It is not surprising, then, that a significant number of people are not complying with self-isolation advice. They may not even understand it. This family, all of whom were being contacted several times a day by phone and text, felt that they were caught in a Kafkaesque world where they were given different advice daily. One said that when the Test and Trace adviser rang her to say that she could go out on Saturday morning, she was afraid to leave the house until the day after because that was what the app told her.

Everyone in that household wanted to get this right; indeed, they tried very hard to do so. What is being done better to make sure that people are being given clearer advice and to ensure that the Test and Trace system is keeping up with people’s changing circumstances? What efforts are being made to match up what the app tells people and what they are being told to do over the phone?

While all these resources are being expended on one family, we know that others are finding it difficult to get tests at all. The Government promised millions of tests a day. Now, 300,000 are happening per day, with the Secretary of State telling us that there will be 500,000 tests a day by the end of the month. Despite the hard work of Test and Trace workers on the ground, we know that the system is in chaos. People are not getting test results within 24 hours, and many people are still having to drive miles to a drive-in centre to get a test. If they send away for a test, it can take up to a week between ordering the test and getting a result back, especially if the test is delivered at the weekend. People are also being urged to take a test only if they have symptoms, yet we already know that up to 80% of people who have the virus have no symptoms. Once people test positive, they are being given contradictory advice about isolation times.

This virus spreads with speed, so testing must be quick, yet results are not being turned around within 24 hours. Again, when will that happen? Contacts must be traced quickly and those who are traced must be given support to isolate. Yet, to be frank, we have a badly designed system that is failing to trace sufficient contacts, has cost £12 billion so far and is paying consultants £7,000 a day. The Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office, the right honourable Michael Gove, justified these failings on “The Andrew Marr Show” by saying that, when the virus is escalating,

“any test and trace system of whatever kind has less utility.”

I wonder what on earth that means. Perhaps the Minister can explain it to me.

Do the Government have confidence in the leadership of Test and Trace, now that we know that so much money is being spent on it? The Minister’s honourable friend Sir Bernard Jenkin MP said yesterday:

“May I also emphasise that one of the reasons why public confidence in the Government’s strategy is somewhat in decline is that we have yet to see the transformation of the leadership of test and trace, which I have discussed with the Secretary of State many times?”.—[Official Report, 19/10/20; col. 784.]


The Secretary of State did not seem to have any answer to his honourable friend’s question. Perhaps the noble Lord could have another go.

What is the estimate of the number of Covid-19 tests that will be delivered per day by the end of the year? As winter is coming, healthcare workers will also need constant testing. Can the Minister guarantee that all healthcare workers and care workers will be able to have quick Covid tests this winter? The Secretary of State has said that quick tests are now being bought. When will they be ready and rolled out?

I understand that a Statement is being made right now in the Commons about the situation in Manchester and the lack of support for low-paid workers and the self-employed if they move to tier 3. If a person works full time for a minimum wage, their take-home pay will be based on £8.20 an hour. If that is reduced to two-thirds, it is £5.47 an hour. Does the noble Lord think that that is a reasonable amount of money for a family with children? Why do he and his colleagues feel that it is acceptable to ask their fellow citizens to live on such a small amount? Why are we not continuing the furlough scheme?

If the mayor, Andy Burnham, and the leaders of all the boroughs in the Manchester area seem to be angry, it is because they know and understand the hardship which the noble Lord’s Government are visiting upon their communities—people who are already living on low wages—and the effect that this will have on them and their children.

[Baroness Jolly (LD) [V]]

Next week is half term. If one looks at the graphs, the south-west looks to be a good destination for the week. I live in Cornwall and tourism is vital to our economy, which was already blighted in the earlier holiday seasons this year. We need visitors and we are ready. What guidance would the Minister give those visitors about the need for social distancing and the wearing of masks? In the summer, there was a reluctance in some cases to comply; many just said that they were on holiday.

Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 5) Regulations 2020

Baroness Jolly Excerpts

Tuesday 20th October 2020 Lords Chamber

Moved by

[Baroness Jolly]

At end to insert “but that this House regrets that, given the significant impact on the hospitality industry, Her Majesty’s Government have not outlined the scientific evidence behind the 10.00pm curfew, and that they have not sufficiently consulted local authorities and law enforcement agencies to ensure that the provisions are effective and enforceable.”

[Baroness Jolly (LD) [V]]

My Lords, I am looking forward to this debate. A two-minute speaking limit really focuses the mind and the pearls of wisdom do not get lost among preambles and conclusions.

It seems a very long time since we had our first Covid SI debate. SAGE, the Prime Minister, the Secretary of State and the Minister have all wrestled with various aspects of handling this virus. We know more about it now, yet we have not yet managed to tame it. Despite optimism, it will probably take some time before we will be safe and feel safe wherever we go. I suspect that localised flare-ups will be with us for some time.

Questions have been asked as to why restaurants and pubs that serve food might be closed to control outbreaks of Covid-19 when many outbreaks are in private households and very few confirmed outbreaks have been linked to settings such as pubs and restaurants. However, a leading public health expert has said that while the question is understandable, it arises from a misinterpretation of the data. Professor Philip Nolan, who chairs the National Public Health Emergency Team’s Irish Epidemiological Modelling Advisory Group, has said the idea that very few cases are connected to such social settings

“is misreading and misinterpreting the data on outbreaks and clusters.”

Professor Nolan explained that contact tracing resources are concentrated on where the virus is likely to spread to, rather than on where it has come from. He gave the example of someone who contracted the virus in a restaurant, saying it will then have “multiplied silently” inside them for three days before they

“started shedding virus, and potentially infecting others”

for two days, at which point they may then become symptomatic, self-isolate and, he hoped, get a test. If they test positive, contact tracers will usually ask them only about the previous 48 hours, when they were potentially infectious, and not the day five days earlier when they contracted the virus in the pub or restaurant. The individual’s contacts will then be tested. If their family members test positive, it becomes a household outbreak. The original case is classed as a community transmission, even though the individual

“got it in a restaurant and brought it home.”

We know that public health officials would like to go back and find out where people are getting the virus but we know they do not have the time or resources to pursue this exercise. International evidence shows that social settings, including bars and restaurants, drive community transmission. Unless we stop mixing in these settings, we know the disease could spiral out of control. All this is despite the hard work of those working in cafés, pubs and restaurants to minimise the risks, knowing that their livelihoods are at stake.

Indoor venues, including bars and restaurants, have long been considered particularly vulnerable to the spreading of the virus. Dr Julian Tang, a professor in respiratory sciences at the University of Leicester, says:

“Wherever you get people crowded together, for example concert halls, cruise ships, house parties, bars and pubs, you risk spreading a virus”.


UK coronavirus cases were up by 17,540 on Thursday. Dr Tang says:

“If people are sitting near each other talking without face masks or coverings, it can maximise the amount of spit droplets that are transferred between people”.


His research also highlights the potential risk if the virus is projected into the air while breathing and talking, where it stays suspended and may then be inhaled by others.

I have started to look at how other parts of world have been handling this epidemic. The case of Taiwan is particularly interesting. One of the main reasons for Taiwan’s success in containing the virus is speed. I suspect that another reason is lessons learned from the 2003 SARS outbreak, when Taiwan was hit very hard and started building up its capacity to deal with major pandemics. Late in 2019, when it heard there were some secret pneumonia cases in China where patients were treated in isolation, it knew it was something similar. The island’s leaders were quick to act as rumours spread online of an unidentified virus in Wuhan and unconfirmed reports of patients having to isolate. Taiwan began screening passengers arriving from Wuhan and early travel restrictions were put in place.

As much of the world waited for more information, Taiwan activated its Central Epidemic Command Center to co-ordinate different ministries in the emergency, and the military was brought in to boost mask and PPE production. The other major decision was to wear masks and promote handwashing from the outset, and to go into lockdown from 23 January. Those initial early responses to the outbreak in China were critical in preventing the spread of the virus in Taiwan, potentially saving thousands of lives.

Mask wearing is now normal in Taiwan, the washing of hands is second nature, and since April only seven Covid deaths have been recorded. Taiwan has no curfews and its residents eat in crowded restaurants. It seems that, from the outset, the population paid attention to public health advice and have reaped the dividend.

Taiwan looked at the evidence and asked its citizens to comply, and they did. Taiwan worked at messaging, as I am sure we have done, but it might be worth reviewing the messaging for the next time. I also commend Learning Disability England for the Covid materials that it has produced for people who find it difficult to read.

I look forward to the debate and I hope that the Minister will get some suggestions from noble Lords. Our major cities have been in the spotlight over the past few weeks: Leicester, Newcastle and now Manchester. I wonder how well the Prime Minister knows that city and, when he was the Mayor of London, what he would have felt if David Cameron had kept telling him what needed to be done.

My amendment states:

“this House regrets that, given the significant impact on the hospitality industry, Her Majesty’s Government have not outlined the scientific evidence behind the 10.00 pm curfew, and that they have not sufficiently consulted local authorities and law enforcement agencies to ensure that the provisions are effective and enforceable.”

As far as the data is concerned, I have found papers which suggest that close conversation is enough to transfer the virus, but the Government have chosen not to use it or quote it. Close quarters in a pub are part of the ambience, and for regulars it must seem galling to distance. However, I have also outlined what is possible if masks are worn, as in Taiwan. I beg to move.

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[Baroness Jolly (LD) [V]]

My Lords, as I expected, this has been an excellent debate with informed contributions from right across the House. I am happy to withdraw my amendment.

Amendment to the Motion withdrawn.

Medicines and Medical Devices Bill

Baroness Jolly Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

The Government’s amendments, referred to in a letter dated 13 October from the Minister, do not in my view address the substance of the concerns. It is all very well to alter the safeguards that apply to the making of delegated legislation, moving away from the negative resolution procedure, defining the purpose of regulations, requiring consultations and imposing a reporting requirement, as the Minister set out in his letter, but none of this addresses a fundamental concern, which is that Ministers should not have the discretion to decide on primary policy choices. That should be a matter for full parliamentary debate. Regulations that might be debated for 90 minutes, where there is no power to amend, are a totally inadequate substitute. The powers granted in this Bill will be a gross act of legislative and executive overreach, hence the need for a time limit on certain parts of the Bill through a sunset clause.

[Baroness Jolly (LD) [V]]

My Lords, given that we are in Committee, I will not be making lengthy speeches, but I will raise what I think are the key issues in each of the groups. The amendments to the Bill relate to some of the constitutional issues. As a general rule, noble Lords do not much care for delegated powers because it is not considered good practice or procedure to give a Secretary of State carte blanche in any area. There are some areas in this Bill where the Secretary of State is being given powers that we would rather that he or she did not have.

As the Bill is skeletal and consists mostly of delegated powers, it is important and a good idea to ensure that appropriate steps are taken to set an end date on these, so sunset powers are being proposed. The noble Lords, Lord Lansley and Lord Kakkar, and the noble Baroness, Lady Thornton, have requested the Secretary of State to publish draft legislation to consolidate the legislation relating to human and veterinary medicine within three years of the Bill being enacted.

My noble friend Lord Sharkey and I have put our names to several amendments in this group. My noble friend calls for the super-affirmative procedure so that all powers given in the Bill will elapse after three years. I confess that this is the first time that I have seen that being used. The super-affirmative procedure involves an additional stage of scrutiny where Parliament considers a proposal for a statutory instrument before it is formally laid. This procedure is used for those instruments that are considered to need a particularly high level of scrutiny, which I think is certainly the case with this Bill.

Some of the amendments call for consolidation within three years, but in general what we are saying to the Minister is that there are not enough checks and balances. Please use the time between now and Report stage to look again, speak to Members of the Committee and bring forward government amendments—otherwise, I suspect that we may be voting on Report.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I have added my name to Amendments 1 and 140 tabled in the name of my noble friend Lady Thornton. As we are at the start of the Committee stage, perhaps I may remind the House of my membership of the board of the General Medical Council and my role as president of GS1 and the Health Care Supply Association.

I agree with my noble friend Lady Thornton about the clash between the first day of the Committee stage of this Bill and the Second Reading of the United Kingdom Internal Market Bill in the main Chamber. Today we are dealing with some of the most important debates in the whole Bill and when we come back on Report there will be a need to give more time to allow those people who could not be present today to make a full contribution to these debates. I hope that the usual channels will take that away. I am not quite sure about the procedure in these unusual circumstances, but in normal times I would have asked that the Committee stage procedure be used for these introductory debates on Report in order to allow for interventions. However, since interventions are now limited, that may not run well, although I think that noble Lords will understand what I am getting at.

This is an important Bill on patient safety and the health of our life sciences sector. It is striking in its brevity and in the extensive powers to be given to Ministers. The noble Lord, Lord Patel, has spelled out the wide range of delegated powers contained in the Bill, while a pungent analysis by my local university, the University of Birmingham, points out that, while delegated powers may be needed to ensure responsiveness in the EU exit transition period and to meet the challenges of technological change, they should not be used indefinitely or relied on to implement matters of policy. I am not going to repeat what the Delegated Powers Committee or the House of Lords Select Committee on the Constitution have said, but it is rare for two Select Committees to comment at the same time and in such a critical way about the skeletal nature of a Bill. It is to be hoped that the Government will listen carefully to what is being said.

At Second Reading, the Minister suggested that the sunset clause as proposed by my noble friend would emasculate legislation

“meant to give regulators the powers to be effective and to future-proof medical regulation in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.”—[Official Report, 2/9/20; col. 433.]

I have to say to the Minister that most of the regulatory uncertainty has been caused by the Government’s failure to be clear about what regulatory regime they want for medicines and medical devices. They have now had four years to think about this and we are still nowhere near knowing what regulatory system they want to put in place. Are they going to go for alignment with the European Medicines Agency or do they want to strike out on their own? Do they want to ally with the US FDA? What on earth are the Government’s aims? The industry is at risk because of this huge uncertainty. The idea that we should allow the Government willy-nilly to get this Bill through and make whatever changes they want without the House treating it as primary legislation simply will not wash. I am absolutely convinced that the long-term regulatory system must be subject to detailed primary legislation. As far as I can see, the amendment to bring in a sunset clause is probably the most appropriate vehicle to ensure that that happens.

--- Later in debate ---

[Lord Sharkey (LD) [V]]

My Lords, I have only just learned that if we do not pass the government amendments in this group, we put at risk the required legislative consent order for Northern Ireland. I had intended to oppose Amendments 2, 7 and 14; I did not understand why Amendment 2 was necessary or had any real force or meaning—in any case, I much preferred Amendment 5 —and Amendment 7 seemed downright confusing, since its net effect is to impose an obligation on the Minister to have regard to certain things when considering making regulations but no obligation to consider the specified things when actually making these regulations.

I have spoken to the Minister and will now not oppose the government amendments. However, I feel that we have been bounced. I first realised the Government’s intention to move when I read today’s Chair’s guidance and I understood that there was a Northern Ireland problem when I was given, about 40 minutes ago, a copy of the note from the noble Lord, Lord Bethell, to the noble Lord, Lord Lansley, from yesterday. We were not copied in on that note. I strongly feel that this is all very unsatisfactory.

The Minister has not really answered the question that I asked him in our impromptu interval of why we need to rush. Could he explain why delaying the start of the legislative consent order process until Report would be a problem? It is still not clear to me. I trust the Minister’s assessment but I do not understand how he arrived at it. In his note to the noble Lord, Lord Lansley, he says, for example, that the delay would mean that we could not meet some unspecified timing objective but he prays in aid the notion that the minimum interval between Committee and Report is a contributing factor. We can change that interval; we could choose. Could the Minister explain again why it is necessary to do this today?

[Baroness Jolly (LD) [V]]

My Lords, this has been a useful debate on health and safety when making regs. The Government have tried to strengthen this with their amendments in this group. My noble friend Lord Sharkey just spoke about that; I too will look at them in the light of Committee and determine what to come back with on Report.

On government Amendments 2, 7 and 68, we should have these regulations only if we are absolutely satisfied that they would promote health and safety. Government amendments 51, 54 and 56 are all about the promotion of one or more of health and welfare of animals, health and safety of the public, and the environment. There is a clear connection with animals and the environment; has the Minister spoken to Defra and BEIS about these amendments?

I also wonder that we are not discussing those medical devices that are joint veterinary and medical devices. As I said at Second Reading, veterinary medicine is becoming much more sophisticated and slightly less agricultural—that is not the right way to describe it, but it is now very high-tech in certain areas. Could the Minister outline the legal situation here, as, when we are discussing medical devices, veterinary devices are not included? Clearly this should fall within the scope of the Bill but, as I see it, there are no amendments covering that.

Moving to the amendments from the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, I supported Amendment 5. We have left the EU, but I see no reason why we cannot use its regulation if we think it cannot be improved on. I was happy to put my name to this amendment and agree that subjective measures are nowhere near as effective as objective ones. This is an area where objectivity is much more important than subjectivity.

The amendment elegantly reflects the objective of safeguarding the public health element in EU regulations. A Secretary of State has a duty to maximise the public health of our English population. I am sure it is not written down anywhere, but that is absolutely what he or she is responsible for doing. As such, I firmly believe that this amendment belongs in the Bill. My noble friend Lady Walmsley spoke powerfully about Amendment 5; we should really consider her arguments when we determine what we will do on Report.

My final point is on the objective of Amendment 70 to

“safeguard public health through the supply of medical devices.”

This amendment elegantly reflects the objective of safeguarding public health in EU regulations. There is much to look at in this group. I am sure that we will determine what comes back on Report later in the day.

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As a number of noble Lords have mentioned, a number of international organisations are key to ensuring harmonisation and regulatory alignment. It is important that we seek full membership of these organisations post Brexit. Have the Government considered that point? The ABPI has recommended that we seek full membership of, for example, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization, although the latter is outside the scope of the Bill. I hope to hear from the Minister in some detail.

[Baroness Jolly (LD) [V]]

It was almost inevitable, looking at the amendments that were coming up and knowing the people who would be discussing them in Committee, that this was going to be one of the most interesting debates. It has been fascinating and well informed. The amendments relate to our future relationship with the EMA and other international organisations after Brexit. My Amendment 125 in this group is on future regulatory alignment; I am grateful to my noble friend Lady Sheehan for her contribution.

The Government have not been forthcoming on whether they will pursue regulatory alignment and, more importantly, what the implications of not doing so would be. I would be grateful if the Minister clarified that second point. Our clinical trials are hugely important and widely respected. The clinical trials information system is critically important; the noble Lord, Lord Lansley, made that vital point. What aspect of the role of the EMA are we trying to replace? It has four parts: to facilitate development and access to medicines; to evaluate applications for marketing authorisations; to monitor the safety of medicines across their life cycle; and to provide information to healthcare professionals and patients. We need urgent clarification on how the future information system will work, who will host it, how it will be staffed and how we will share our research.

As the noble Lord, Lord Patel, said, we do not have a large enough population for significant research without partners. Are we clear that we could work with the FDA in the US—or, indeed, with the TGA in Australia? Would that give us a sufficient body of people from which to take on our research? Perhaps. Are there any moves to seek full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use? I am sure that the Minister will have the answers but the regulations must have regard to the desirability of alignment, somehow or other, with the rest of the world. We cannot work as a small unit—perfectly formed, maybe, but we are small compared with the US, Europe and other groupings.

How is this going to be measured and monitored? The noble Lord, Lord Hunt, spoke about the fast-track licensing of medicines and devices. The point he made so clearly is that public safety has to be paramount so we cannot rush this sort of thing. We have to get it right; if people have to wait, so be it. It has been interesting to hear the reflections of the noble Lord, Lord O’Shaughnessy, because he was sitting in the hot seat of the department. I wonder whether he is glad that he is not there now.

The other interesting amendment concerns the definition of attractiveness, which included collaboration with the EMA. The noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff, attempted a definition. I am sure that if we were all given a piece of paper and asked to write down our definition of attractiveness, there would probably be as many answers as there are people in the debate today. I would like a definition from the Minister: how is this to be measured and by which body?

Without a doubt, under the provisions of Amendment 34, regulations must be made, while under Amendments 35 and 36, they should correspond with the EU clinical trials regulations. Amendment 38 provides that we must continue our collaboration with the EU in whatever form we can manage between us. We also need to look hard at clinical trials portals, not only with the EU but with our other partners in future.

[Lord Bethell (Con)]

My Lords, as the Minister for Innovation, I am very keen on the UK’s continued leadership in this area; I have made it something of a personal cause. I am very proud of the fact that the MHRA approves around 950 medicinal trials a year, over half of which are multinational.

We know that once an early phase trial is established in this country, the industry is more likely to keep its later phase multi-country trials here. I would say to the noble Lord, Lord Hunt, and others who have questioned this point, that I can confirm that the purpose of the measures in this Bill are absolutely to build on our established strengths so that the UK has the opportunity to anchor international drug development in this country and grow that capability. I am committed to international standards, international partnerships and multi-country clinical trials. It is of course important that we work with our international partners both within the EU and globally to the benefit of patients. I assure noble Lords emphatically that we are committed to international co-operation.

However, I do not agree that our future relationships will be furthered by mandating the consideration of alignment with EU regulations and the European Medicines Agency. The UK has a long track record of jointly tackling global challenges with strong international links already in place between research and innovation communities. The UK works closely with many other regulators; those relationships are underpinned by many shared international standards. The EU bases its regulations on exactly those standards, as do we, and we will continue to do this going forward.

As a number of noble Lords have noted, we have the opportunity to create a better regulatory framework. The feedback from the industry is that an agile, proportionate UK system with familiar data submission requirements would increase the UK’s attractiveness as a place to conduct multinational studies, even if we are operating outside the EU’s network. My noble friend Lord O’Shaughnessy’s quote from the ABPI made this point. The powers in the Bill as it stands will allow us to develop exactly that kind of system.

Progress is already happening. The MHRA and the Health Research Authority are already taking steps to streamline the approvals process for UK clinical trials and are currently piloting a new process that has been shown to reduce overall approval times by more than 30%. I say to the noble Lord, Lord Sharkey, that this change does not rule out co-operation. Data generated in a UK clinical trial will continue to be admissible to support regulatory activity in the EU—and, indeed, globally. We can also look at how we can go further in making clinical trials and their results transparent and visible to the public. Co-operation does not require alignment.

Amendment 3 in the name of the noble Baroness, Lady Thornton, also suggests considering alignment with EU licensing processes. In the short term, the MHRA has already taken steps to recognise for two years future EMA decisions for medicine licences approved through the centralised authorisation procedure from January 2021. In the long term, there are opportunities to establish new UK routes to market, such as a new expedited pathway for innovative products, and to establish shorter assessment timeframes.

We have the ability to make corresponding or similar provisions to the EU CTR, but Amendment 38 would oblige us to align. Amendment 35, in the name of my noble friend Lord Lansley, does something similar. My noble friend makes the point that we have the opportunity to do better than the EU CTR, and that is very much our intention. That regulation replaces current separate regulatory authority and ethics approvals with a single national decision for a trial. The UK could adopt a similar methodology and associated data requirements for approvals, but in a much quicker timeframe. We have already introduced the combined ways for a working pilot to streamline approvals by the MHRA and ethics committees, and industry has told us that our scheme is one of the most appealing among the various pilot schemes in the EU, leading to a reported 30% reduction in timelines. The UK may wish to go further and develop our existing national system to further adapt requirements according to risk so as to reduce unnecessary burdens, such as academic trials involving a marketed product already in common usage.

In his Amendment 49, the noble Lord, Lord Sharkey, suggests that there would be benefits in adopting certain definitions in the EU CTR. These include the EU’s revised definition of a clinical trial and co-sponsorship set out in the EU clinical trials regulations. Under the EU CTR, this new definition of clinical trials is an attempt to avoid current variation in interpretations in different member states. Whether this will have the intended effect remains to be seen. EU legislation already includes a definition of a clinical trial, and the MHRA offers trial sponsors free advice on whether their study meets that definition, to ensure a consistent interpretation. If we wished to amend our definition of a clinical trial corresponding to that in the EU CTR, the Bill as drafted would enable that.

My noble friend Lord Lansley is right that the EU CTR introduces a single submission portal and co-assessment model, but I confirm that member states involved still have to individually authorise the trial, and therefore one or more member states could refuse authorisation. The portal is an IT system, the method of delivery. This does not mean centralised EU approval of a trial. Where a member state has national restrictions that require separate approvals outside the scope of the EU CTR, the sponsor would still have to seek the approval separately of the individual member state, in addition to the processes for seeking authorisation for the trial through the EU portal under the EU CTR. Industry has told us that if the UK has a rapid approval system, the lack of access to the EU portal is not a particular issue.

Amendment 52 introduced by the noble Lord, Lord Patel, suggests provision to develop a clinical trials portal that aligns with the European Medicines Agency for medicines for rare diseases. The EMA’s IT system does not address complex trial designs, such as umbrella, basket and platform trials that involve the use of master protocols. These are the very trial designs that have delivered the UK’s successes in Covid-19 research. On the EU portal, it is also extremely unlikely that the EU would agree to UK involvement, even if one were to request it, given that it is for EU member states and EEA countries. There are many other reasons why the UK is such an attractive place to run global rare disease trials: our world-class research infrastructure and centres for excellence, and so on and so forth.

--- Later in debate ---

Further, the amendment is not accompanied by amendments to Clause 6, which itself provides that regulations disapplying certain provisions of medicine and medical devices regulations can be subject to conditions to be set out in protocols. In my view, this circumvents parliamentary scrutiny. Overall, the amendment seems at least to address concerns relating to legislative procedure. However, none of the amendments includes a sunset clause, so they do not address the overarching concern that this skeleton Bill circumvents parliamentary scrutiny and adds to the complexity of existing regulations.

[Baroness Jolly (LD) [V]]

I speak in support of these amendments in the names of my noble friend Lord Sharkey and other eminent noble Lords. I confess that I had not heard of the super-affirmative procedure until my noble friend sat me down and talked me through it, and it struck me as being eminently sensible and doable, and this is exactly the right sort of Bill—or the regulations contained herein are exactly the right sort—for the super-affirmative procedure. I ask all noble Lords to support this amendment and those who support it.

[Baroness Thornton (Lab)]

My Lords, I thank the noble Lord, Lord Sharkey, for his comprehensive introduction to this group of amendments, particularly those that he is supporting.

We are minus at least four noble Lords from this debate because of the clash with the other Bill. I have certainly made my view known to the usual channels in the next booth that we cannot continue to discuss this Bill in those circumstances because we will be missing too many people who have a stake in the Bill and amendments down. I cannot imagine what the noble Lord, Lord Forsyth, is saying to his own Benches about this—actually, I probably can, and it will not be polite, I suspect. He put his name down to this amendment and, presumably, found out that he was not allowed to speak in both the Second Reading debate and in this Committee at the same time. I can see why that rule is there, but we are finding that this really does not work.

While the affirmative procedure offers nothing like the scrutiny given to a Bill, which typically goes through several substantive stages in each House and can be amended, we agree wholeheartedly with the DPRRC’s view that Clauses 1, 8 and 12 contain inappropriate delegations of power. We are where we are, and we therefore take the view that the affirmative procedure should apply. Amendment 134 provides for all regulations to be made subject to the draft affirmative procedure rather than the negative procedure and for urgent regulations to be subject to the made affirmative procedure rather than negative procedure.

Both the DPRR Committee and the Constitution Committee have expressed considerable concern at the inappropriate use of the negative procedure in this Bill. For example, Clause 2(1)(n) provides that regulations under Clause 1 may make provision about prohibitions relating to the supply of human medicines. Clause 42(9) provides for such regulations to be subject to the negative procedure. The explanation given for this in the memorandum, which I think I referred to in the very first debate in this Committee, is as follows:

“proposals to make changes to existing provisions, or to introduce new provisions enabling the supply, administration or prescribing of medicines are made to reflect shifts in best practice following extensive consideration and scrutiny by the relevant professional bodies.”

The DPRRC found this an unconvincing explanation. I probably do as well. It noted:

“It isn’t clear why consultation with relevant professional bodies lessens the requirement for scrutiny in Parliament. Indeed, if proposed changes are sufficiently important for there to be extensive consideration and scrutiny by professional bodies, this supports requiring the higher level of scrutiny in Parliament that the affirmative procedure affords. Furthermore, the prohibitions to which clause 2(1)(n) applies are sufficiently important that breach of them is a criminal offence (punishable, in the case of 4 of the 5 prohibitions, by imprisonment for up to two years). Even accepting the appropriateness of the delegation of powers in clause 1, we take the view that the affirmative procedure should apply. The consultation requirement imposed by clause 41 of the Bill is to be welcomed but we are concerned at consultation being presented as a substitute for Parliamentary scrutiny. On the contrary, if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”


The committee also highlighted and raised concerns about Clause 9(1)(f), which provides that regulations under Clause 8 may make provision about the categories of person who may apply for veterinary medicines. The EM states:

“any proposals to make changes to existing powers or to introduce new powers for veterinary professionals to supply, administer or prescribe medicines will be subject to extensive consideration and scrutiny by professional bodies”.

Again, the committee found this unconvincing for the same reason, and took the view that the affirmative procedure still applies. I must say, I wholeheartedly agree with its assessment. As it says,

“if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”

My amendment also addressed the egregious provisions of Clause 42 that provide that where any such regulation needs to be made urgently to protect the public from imminent risk of serious harm to health, the negative procedure applies instead. The Government’s justification for departing from the affirmative procedure was that:

“It is appropriate for regulations made in these circumstances to be subject to the negative resolution so that they can come into force immediately and provide an efficient means of addressing an imminent serious public health risk. We expect that such regulations would only need to be in place for a very short period of time, potentially shorter than it would take to schedule and hold debates”.


This is wholly inadequate.

The DPRRC stated:

“We are wholly dissatisfied by departments repeatedly arguing for powers otherwise subject to the affirmative procedure to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure … Even accepting the appropriateness of the delegation of powers in clauses 1 and 12, if the affirmative procedure provides the appropriate level of Parliamentary scrutiny for regulations made in reliance on clauses 6 or 15 in non-urgent cases then, in the absence of cogent reasons for the negative procedure to apply in urgent cases, we take the view that the made affirmative procedure should apply in urgent cases.”


The Constitution Committee concurred, recommending that

“the emergency powers in this Bill are subject to the made affirmative procedure, rather than the negative procedure, such that Parliament is required actively to approve them.”

The Minister will be well aware that regulations under the “made affirmative” procedure can be made and laid as expeditiously as can regulations subject to the negative procedure. They can also be laid during a parliamentary recess, unlike draft affirmative instruments. Quite frankly, it is insulting that the Government have the gall to argue for emergency powers to be subject to less scrutiny under the negative procedure, especially in the current climate when hundreds of emergency regulations have been introduced with considerable haste using the “made affirmative” procedure. Can the Minister say how this dereliction ever made it into the Bill, never mind through the Commons? I imagine that the Minister might be quite embarrassed to put her name to the Bill, which is perhaps why the Government have introduced Amendment 133 at the 11th hour.

I also speak in support of the super-affirmative amendments in the name of the Lord, Lord Sharkey. They are supported by Members across the House—including my noble friend Lady Andrews who is not here to give her support although she is extremely enthusiastic about this amendment.

Given that this is a skeleton Bill, the use of the super-affirmative procedure seems a sensible and proportionate mechanism. In this case, it would allow relevant parliamentary committees, in consultation with stakeholders, opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form. It has been used effectively by Governments of all colours, who recognise that it allows them flexibility when they need to bring forward regulations, while consultation and scrutiny happen before any amendments come to the House by affirmative resolution.

That is particularly important given that many areas in which we expect regulations to be laid, ranging from life sciences and clinical trials to hub and spoke pharmaceutical models, could make the contents of the SIs—and, in the absence of policy details in the Bill, even examples of draft regulation that have been published in respect of other Brexit legislation—controversial. I hope that the Minister recognises the merit of this proposal.

Health Protection (Coronavirus, Local COVID-19 Alert Level) (Medium) (England) Regulations 2020

Baroness Jolly Excerpts

Wednesday 14th October 2020 Lords Chamber

[Baroness Jolly (LD) [V]]

My Lords, this has been a good debate, with more questions for the Minister about various concerns of noble Lords. It must seem to him like a never-ending SI marathon—and of course we all know there will be more.

Our Government have abandoned their attempts to control the spread of SARS-CoV-2 by means of piecemeal local regulations and have introduced a three-tier approach across England, with legal restrictions varying according to government-defined tiers. Tier 1 areas are referred to as medium restriction areas, with tier 2 high and tier 3 very high.

This third SI covers the majority of England and is the basis of those SIs that we have already heard debated. It is the least restrictive, repeating the rule of six and its attendant exceptions and outlining business restrictions in hospitality and leisure venues, the closing times of hospitality businesses and closures of such leisure venues which are deemed to have a higher transmission risk. Those SIs that have already been debated have covered this and more. We understand that lockdowns are not popular, that our economy is stretched towards breaking, and in some cases it has broken, but what is really at issue here is science, evidence and expertise.

What seems a long time ago—over six months—we went into our first lockdown; it was originally for three weeks, but became four months. We adapted to home working, school children at home too, parts of local economies failing, and clapping for carers on Thursdays. We came out of lockdown and things became a new normal. However, there was much concern over a second peak and, in an open letter to the BMJ, a number of health leaders called on UK politicians to conduct

“a rapid and forward looking assessment”

to assess how prepared the nation was for a potential second round of infections. The letter read:

“The job now is not only to deal urgently with the wide-ranging impacts of the first phase of the pandemic, but to ensure that the country is adequately prepared to contain a second phase.”


It added:

“While the future shape of the pandemic in the UK is hard to predict, the available evidence indicates that local flare ups are increasingly likely and a second wave a real risk. Many elements of the infrastructure needed to contain the virus are beginning to be put in place, but substantial challenges remain.”


Will the Minister outline what measures were put in place as a result of that letter or, if he does not know that, what lessons were learned from the first wave, what preparations are now in place for the second wave, and whether the Government feel confident that lessons were learned?

One area of failure, which many Peers have mentioned in today’s debate, was the test, track and isolate system. The technology did not instantly deliver—from the mobile app to the appointment system for testing. We have heard many examples this afternoon. Media coverage of call centre staff failing to track and trace sent all the wrong messages. If this has not already been rectified, any lockdown we find ourselves in must be used for getting this fixed.

Many local authorities requested that they should be sent into their own neighbourhoods to carry out track and trace on their own patches. Could the Minister explain why that did not happen from the beginning? They had local expertise and knowledge and were used to doing it. What was the Government’s objection to using these local experts?

I am alarmed that, while we have a Cabinet with very few scientists, we have a group of experts whose job it is to advise the Prime Minister. SAGE, headed by the Chief Scientific Adviser, Patrick Vallance, and Chief Medical Officer, Chris Whitty, provides scientific and technical advice to support government decision-makers during emergencies. That is what it does, and the minutes of its meetings make fascinating reading. We all want to put Covid behind us as soon as possible, so why would the Prime Minister either ignore the advice given to him by these experts or not ask them in the first place? Why would he ask us to follow measures that his chief advisers felt were not good enough?

Today we spent four and a half hours debating a suite of measures across England that are designed to set us right for Christmas. The case for a short circuit break is clear. The Government’s test, trace and isolate system is utterly failing to help them to get a grip on this second wave, leaving us with few other options. The country has made enormous sacrifices to try to contain the pandemic, and people will be rightly appalled to read that the Government have once again ignored the best scientific advice and wasted the sacrifices that everyone has made. The Prime Minister has made little effort to explain how his Government will get a grip on the rising cases, so that we have a chance of coming out of these restrictions. Until the Prime Minister fixes the test and trace system, people will continue to face lockdown as a result of this incompetence. Of course, we all understand that the economy is important, but lives are important too. I hope that in the near and mid future, No. 10 keeps that in mind.

Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 2) Regulations 2020

Baroness Jolly Excerpts

Friday 18th September 2020 Lords Chamber

[Baroness Jolly (LD)]

My Lords, as I expected, this has been a fascinating debate. I have drawn the short straw and will wind up; unfortunately, my noble friend Lady Brinton is still not well enough to join us, but I sincerely hope she will be back in her place soon. I am also sorry that the Minister is not in his place. I hope he is not unwell. It is not always helpful to have a Minister with dodgy connections—

[Noble Lords]

Oh!

[Baroness Jolly (LD)]

I shall just carry on.

When I was trying to put together what to say today, I started with the regulations and the Explanatory Notes. They are pretty dense, so I went to Wikipedia—the noble Baroness laughs, but it laid out extremely well and clearly how these three instruments work and fit together. So, there is a tip, because I think we will be doing this a few more times.

These three SIs are all derivatives of SI 684; we debated that on 24 July, but it was actually laid on 3 July—some 10 and a half weeks ago. Everything is so much after the event. I looked back at our debate in Hansard; the Minister outlined the key points because we had only a minute each. He was not given the challenge and scrutiny the public deserved. It is the same today. If we have to do this—I understand that we do—we need more time to do it justice.

In that debate, I asked the Minister about the Bournemouth beach crowd. It was topical at the time and, as my home is a notorious area, I really wanted to know the answer. The Minister was not able to give me one, but neither did I get a letter from his office picking up on questions not responded to. I appreciate that many questions are asked in the sort of debate we are having now. The Minister is pushed for time, but his competent and helpful staff should be able to put together a letter to all Peers covering issues raised and not responded to. This could be emailed to participants—possibly not put in the Library at the moment, but maybe both.

To give a bit of the detail, SI 788 allows swimming pools, indoor water parks, indoor fitness and dance studios, indoor gyms and sports courts to reopen. SI 863 allows indoor casinos, skating rinks, play areas, bowling alleys, conference centres and exhibition halls to reopen—perhaps we could have had our party conferences after all. Nightclubs, dance halls, discos, sex venues and hostess bars remain closed. My next point is quite serious—what about bingo halls? For an awful lot of people, bingo is really quite important. They get together and get away; it is a cheap way of having a bit of fun with your friends. I am sure they could be socially distanced, but these regs are silent on bingo.

SI 907 imposes a fixed penalty of £10,000 for gatherings or raves of more than 30 people. I wondered whether you can have a rave with fewer than 30 people —I am sorry the Minister is not here as I know he is the expert on raves. There are geographic restrictions as well, but some expired even before we had the debate. I apologise to the House if I sound grumpy, but debating these regs so long after they are laid is a silly way of doing business.

I have asked the Minister before about how effective a deterrent the fixed penalties are. My noble friend Lady Walmsley asked about fines as well. I would be grateful for an answer to that question. The noble Lord, Lord Hunt of Kings Heath, who is not in his place today, put the whole thing really well at the last airing of SIs. He got grumpy too, and I think we should.

What is bothering the population at large is the testing situation. If we are going to get through this pandemic efficiently, we will need to step up population testing in schools, workplaces, care homes and local drive-in centres. We should also, following on from the noble Baroness, Lady Donaghy, look again at airport testing. Data will help us beat this virus. Ignorance will not.

We are again debating these measures retrospectively. We are in strange times, but we live in a parliamentary democracy. That should not mean we have to accept a loss of parliamentary oversight. The noble Lord, Lord Bourne of Aberystwyth, put it very well: we really need proper parliamentary scrutiny, but this is not it.

Covid-19: NHS Long-term Plan

Baroness Jolly Excerpts

Tuesday 15th September 2020 Lords Chamber

[Lord Bethell (Con)]

We do not just stand and praise. We are recruiting a huge number of new staff—50,000 more nurses and more GPs—and we invest in them through our people plan.

[Baroness Jolly (LD)]

My Lords, the long-term plan cannot be delivered without effective community nursing support. Community nurses get people out of hospital and prevent others from being admitted. Currently, the service is short of several thousand nurses. What changes does the Minister expect to be made to get these nurses recruited, trained and operational?

[Lord Bethell (Con)]

I am grateful to the noble Baroness for raising the importance of community nursing, and all community-based healthcare, including community diagnostic hubs. The interest in nurse recruitment has risen dramatically—by 138% in recent months—partly because of our massive advertising campaign and the renewed focus of NHS trusts in community nursing, which will be matched by opportunities to provide training for those who step forward for jobs.

Covid-19: Rise of Positive Tests

Baroness Jolly Excerpts

Wednesday 9th September 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, the quarantine arrangements we have put in place are essential for containing the spread of the disease. We completely sympathise with parents who have found themselves caught overseas. However, we implore them to abide by the quarantine arrangements and return their children to school once the 14-day quarantine has passed.

[Baroness Jolly (LD) [V]]

My Lords, when Covid-19 first struck, care homes were almost forgotten. Will the Minister explain to the House what is the recommended Covid-19 testing regime for residents, visitors and staff in care homes, and what organisation monitors the tests in those local care settings?

[Lord Bethell (Con)]

Testing arrangements for care homes have, as the noble Baroness, Lady Jolly, alluded to, risen dramatically. Testing is done in a large variety of ways. For large care homes, mobile testing facilities are put in place; for care staff, facilities at local NHS hospitals are in place; and we invite visitors to have tests in advance of visiting their loved ones. This is all overseen by the NHS Test and Trace programme, and the CQC remains the auditor of the care sector.