Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024
Lord Evans of Rainow
That the Grand Committee do consider the Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024.
Relevant document: 10th Report from the Secondary Legislation Scrutiny Committee
Lord Evans of Rainow (Con)
My Lords, these important regulations were laid before the House on 10 January 2024 and I am grateful to be leading the debate on them.
In autumn 2020, in response to the Covid-19 pandemic and following a public consultation, the Government introduced several temporary amendments to the Human Medicines Regulations 2012 to support the deployment of Covid-19 and flu vaccinations. The instrument we are debating today seeks to amend the temporary provisions in the Human Medicines Regulations—Regulations 3A, 19 and 247A—in order to maintain these provisions and support the ongoing delivery of Covid-19 and influenza vaccinations.
I will briefly set out what each of these regulations does. Regulation 3A enables trained healthcare professionals or staff under the supervision of healthcare professionals to conduct the final stage of assembly, preparation and labelling of Covid-19 vaccines, without requiring additional marketing authorisations or manufacturers’ licences, provided that vaccines are supplied under NHS arrangements or by suppliers of medical services to His Majesty’s Armed Forces. The measure also allows for the reformulation and reassembly of authorised Covid-19 vaccines without the need for additional marketing authorisations.
Regulation 19 has enabled Covid-19 and flu vaccines to be moved safely between premises by providers operating under NHS arrangements or suppliers of medical services to His Majesty’s Armed Forces without the need for a wholesale dealer’s licence. Regulation 247A provides a mechanism to expand the workforce who are legally and safely able to administer a Covid-19 or flu vaccine without the input of a prescriber, using an approved protocol. Regulations 3A and 19 have sunset provisions, which mean that they will cease to have effect on 1 April 2024 unless they are extended. Regulation 247A is permitted for use only during a pandemic.
These regulations play a vital role in both the Covid-19 and the flu vaccination programmes. The measures have helped enable Covid-19 and flu vaccines to be safely deployed at speed and scale. They have also ensured that there is sufficient workforce available to administer vaccines.
The Government are committed to protecting people who are most at risk of Covid-19. We are guided by the independent Joint Committee on Vaccination and Immunisation in our approach. While for most people Covid-19 is thankfully a much less serious risk than it was when these regulations were first enacted, vaccines remain the most effective line of defence for those at greatest risk from the Covid-19 virus. In the latest autumn vaccination campaign, more than 11.8 million Covid-19 vaccines were administered by NHS England in the period after national bookings opened on 11 September last year. In addition, over 18 million flu vaccinations were administered in England during the latest autumn campaign, with over 4.5 million people receiving their flu and Covid-19 vaccinations at the same appointment.
Given the continuing importance of these vaccination programmes in protecting public health, the Government have engaged widely to determine whether to retain the provisions in the Human Medicines Regulations beyond their current period. Following initial engagement with key stakeholders, including NHS England, the Government ran a public consultation, from 7 August to 18 September 2023, on proposals to temporarily extend these regulations until 1 April 2026 while a permanent solution is developed. For Regulation 247A, this also involves removing condition A from the regulation, which requires there to be a pandemic. This proposal was based on feedback, including from NHS England, that without these regulations the Covid-19 and flu vaccination services would be negatively impacted and could not continue to be delivered at the scale required. Overall, from the 220 respondents to the consultation, a high level of support was shown for these proposals across all nations.
For Regulation 3A, 89% of respondents agreed that the regulation should be extended. The flexibility provided by this provision continues to play an important role in the Covid-19 vaccination programme due to the supply chain arrangements and the way in which the vaccinations are packaged. Covid-19 vaccinations are not available as a pre-filled syringe and so each vaccine administered continues to require final-stage preparation before administration to patients. The consultation found that the flexibilities have allowed for the safe assembly and preparation at the pace and scale required within the programme. It also found that Regulation 3A improves the operational delivery of Covid-19 vaccines through a safe and effective framework, increases efficiency within the system and allows for delivery at scale, in turn helping to improve access and more effectively using the workforce.
There was also a high level of support in the consultation response for the proposal to extend Regulation 19, with 91% agreeing that this regulation should be extended. Many respondents had commented that, due to vaccines being more easily moved between sites, vaccine wastage had been reduced, helping to reduce the environmental impact of our vaccination programmes—something that we are obviously keen to encourage. At the same time, these regulations were found to have brought about a more efficient use of resources and improved patient access to vaccines, including through co-administration. As I mentioned, 4.5 million people had both their Covid-19 and flu vaccinations at the same time during the last autumn campaign.
For Regulation 247A, a similarly high level of support was seen in the consultation responses: 82% agreed with the proposal to remove condition A from the regulation, which requires there to be a pandemic to be used, and 82% also agreed that this should be time- limited to April 2026. Many respondents cited that Regulation 247A provided a safe and effective mechanism to improve the delivery of Covid-19 and flu vaccines during the pandemic. The measures were also found to have played an important role in reducing workforce pressures, facilitating an increase in the capacity to deliver hundreds of millions of Covid-19 and flu vaccinations and releasing qualified healthcare professionals to deliver other care across the system.
The temporary amendments to the Human Medicines Regulations have been and continue to be vital to the successful delivery of the Covid-19 vaccination programme. To not extend these provisions would have a significant impact on the delivery of current vaccination programmes. Without these provisions, some NHS vaccination activities would need to cease, which would likely have a negative impact on the uptake of these vaccinations.
Therefore, the Government propose to temporarily extend the provisions provided by these regulations to 1 April 2026, while a more permanent solution is developed. In the case of Regulation 247A, the Government also propose to remove the requirement that there should be a pandemic or imminent pandemic when the medicine is supplied. I beg to move.
Lord Allan of Hallam (LD)
My Lords, the instrument seems entirely sensible and I suspect that many of us who have come here to debate it will join in a chorus of approval. I had anticipated that some people might have been here to talk about the evils of emergency regulation, which we are, in a sense, extending today, or even the evils of vaccination programmes—we would have had a lively debate around that. However, it seems that we are only going to be talking about the specific matters before us in the regulations, which is helpful.
It begs the question, which the Minister opened up in his introduction, of what the Government’s plans are for the longer term. The Government essentially face a choice: they can decide to have a single-tier system for the regulation of vaccination programmes, or a two-tier system, of which there are two variants.
The single tier would be that the additional flexibility that has been introduced should apply to all vaccines all the time. I can see that there might be a case for that. The Minister has explained why the Government feel confident that lifting some of the requirements on preparation and licensing for warehousing et cetera has been beneficial. That begs the question: if it is beneficial here, could that be safely changed for all vaccines all the time? Those are the first two parts of it—Regulations 3A and 19(4)(a) to (4)(c).
The second regulation the Minister referred to was Regulation 247A on who can deliver vaccines and making the most of the workforce. I can see that there may be a case for one of the following variants of the two-tier system. The first would be to have a set of criteria to decide when an epidemic is sufficiently serious that we are willing to introduce the extra flexibility. That would be a pandemic-targeted measure. If the Government are thinking in those terms, I hope that we can get on with it rather than waiting until we have a pandemic and going back to having emergency legislation.
If we have a choice between pre-planned legislation and emergency legislation, I think we in this House would always prefer pre-planned. We have a known unknown; we do not know what the new pandemic might look like, but we know that we are likely to get something that requires a mass vaccination programme. If there are criteria for when that programme would kick in in an emergency epidemic situation, it would be helpful if the Minister could give some indication of the Government’s thinking on that.
The second model would simply be that, when a vaccination programme is too big, we have an expanded workforce. The inclusion of influenza takes us into that territory. The influenza vaccine is not in response to a pandemic; influenza is an annual epidemic. Essentially I hear the Minister to be saying that we could not deliver all the flu vaccines we want to deliver without the relaxed model that the pandemic opened up for us in relation to the personnel who can deliver vaccines. If that is the case, it would make sense to get on with it and say that the criteria are that, once we need to deliver more than X million vaccines, we will move to the regime where a larger range of vaccinators can deliver them. It would make sense to do that in a planned way rather than as a reactive measure.
I want to raise another point with the Minister, which I hope he might be able to help us to think about. Do the Government have research under way into the different approaches? Whenever we are thinking of vaccination programmes—I am firmly in the pro-vax camp, if there is such a thing—overriding all this is that patient safety remains critical. If you support vaccination, you are very strongly motivated to make sure that the evidence is there to prove that it is safe.
Through the pandemic we were all part of a wonderful experiment. This is probably the single best-recorded health event in human history, which enables people to study all the different variations. I was jabbed by a soldier in uniform, by my GP, and by a pharmacist. We have had an incredible array of different models for delivering vaccination, not just in the UK but in lots of other countries. My assumption is that clever academics and epidemiologists are studying the cost benefits of all those different models and that that information can be used to inform which future models we want. I hope that the long-term successor regime we will have after 2026 will be informed by that. Does the Minister have any insights into that, and can he give us any pointers, or at least assure us that this kind of research is taking place, so that when we finally settle on a post-2026 regime it will be informed by the evidence?
I am thinking of the debate yesterday and looking across at the noble Baroness, Lady Merron. When I am talking about post 2026, perhaps I ought to direct some of my questions to the Labour Front Bench as well. This year, I might get into the habit of saying, “The Minister and the noble Baroness, Lady Merron”. If they have any thinking on the post-2026 vaccination regimes, it would be helpful to hear that.
Those are my points. Can the Minister give us any insights into the Government’s thinking about whether they are tending towards a single-tier regime with more flexibility for all vaccinations, or a two-tier regime based on the criteria of emergency or simply of scale, so that vaccination programmes larger than X are delivered in a different way from smaller vaccination programmes?
There is also that question about the research. I would like some assurance that we are trying to get some kind of silver lining from the cloud of Covid by taking all the wonderful data we have collected and ensuring that the future efforts we have to make are informed by our experience of the efforts of those incredible teams of vaccinators of all sorts who have been working busily on these programmes over the last three years or so.
Baroness Merron (Lab)
My Lords, our health and care staff, scientists and others in public services, and those who volunteered, did so much to keep the public safe and to vaccinate millions across the country as quickly as possible to save lives and drive down cases of Covid-19. They finally allowed us to end lockdowns and reclaim our lives, and I pay tribute to them all.
I thank the Minister for setting out today the provisions of these regulations, which are to update legislation pertaining to the movement and supply of Covid-19 and influenza vaccines. The changes, as he said, seek to extend the sunset clauses of Regulations 3A and 19 to 1 April 2026 and to alter Regulation 247A to extend its provision, also until 2026, instead of the current restriction on its use to being only during a pandemic. Extending these provisions, which will also allow the NHS to continue to use an expanded workforce, is important to continuing to allow the deployment of safe and effective Covid-19 and influenza vaccines at the pace and scale required to keep us all protected. The draft regulations aim to build on the work of the Covid-19 vaccine rollout across the country, and we certainly support them.
As the Minister said, the consultation last year confirmed that the provisions have found considerable favour with stakeholders in the health and care sector. Regulation 247A appears to have reduced workforce pressures while increasing flexibility in the workforce and providing opportunities for career progression. On all fronts, that has to be a good thing.
I note that the impact assessment highlights the positive expected value of these regulations and concludes that vaccinations are a powerful and beneficial tool in tackling viruses and diseases such as influenza and Covid-19. The impact assessment also refers to the work to move towards a permanent approach, which will likely alter these provisions again in the future. Can the Minister provide noble Lords with more detail about the progress the department has made in its planning for a more permanent approach?
The important matters of vaccine take-up, hesitancy and misinformation have of course come to the fore of late, given the recent measles outbreak across the country. All these matters have impacted in that too few have been protected against a potentially deadly virus. I recently asked the noble Lord, Lord Markham, as the Minister in the Chamber, about using pharmacists to vaccinate against measles through the delivery of the MMR vaccine, which he welcomed. I wonder whether the Minister today could undertake today to let me know what response the department gave to my suggestion. I appreciate that I had directed that question to the noble Lord, Lord Markham, but I am sure that the Minister will be able to assist, even if it is after this debate.
The Government have been called on to extend this winter’s Covid vaccination booster programme to 12 million people in the 50 to 64 age cohort. Can the Minister explain why the provision was not extended to that age cohort? What is the assessment of the impact of this on the health of both that group and those beyond it? Can the Minister share any details about whether and when Covid-19 vaccinations will be available privately?
Last winter, influenza admission rates were 2.6 times higher for those who live in the most deprived areas than for those who live in the least deprived areas, while Covid-19 admission rates were 2.1 times higher. The rate of emergency hospital admissions for influenza was 1.6 times higher for black British people and other minority ethnic groups than for white ethnic groups. What are the Government doing to address these inequalities?
Finally, can the Minister confirm what the Government are doing to tackle the vaccine misinformation that continues to be shared so widely across the country? As I said, we support this draft statutory instrument so that we can ensure the supply, and improve the take-up of, safe and effective Covid-19 and influenza vaccines at the pace and scale required.
Lord Evans of Rainow (Con)
My Lords, I am most grateful to noble Lords; in closing, I thank all noble Lords for participating in this debate. We always have healthy questions and, I hope, answers in this Room.
Extending these provisions will ensure that the important flexibilities established by these regulations are maintained, thereby supporting the continued safe and effective deployment of Covid-19 and flu vaccines to the pace and scale required. The Government will continue to work with system partners to consider fully a long-term mechanism to support the delivery and administration of Covid-19 and flu vaccines. This process is already under way; any new measures will of course be subject to public consultation. However, in the immediate term, given the high level of support expressed in the consultation, there is an ongoing need to support the continued safe and effective supply, distribution and administration of Covid-19 and flu vaccines by maintaining the existing provisions provided by these regulations to April 2026.
Let me answer to the specific questions that I was asked by the noble Lord, Lord Allan of Hallam and the noble Baroness, Lady Merron. They asked what the longer-term plans are for these regulations. It is important that we retain current flexibilities to continue to protect those at greatest risk, but we agree on the importance of long-term solutions, working with the system partners to undertake a fuller consideration of long-term plans. We do not want to pre-empt that process but can confirm that we will be informed by a full consultation, including in the House. We will certainly have opportunities to discuss this issue at length.
The noble Lord, Lord Allan, talked about his experience during Covid, as I presume most of us in this place experienced. He mentioned that he had injections from a solider, a nurse and another person, indicating that he had three injections. I remember, from my experience before I came to this place, how successful it was. It was a very British experience: it was in a community hall, with which we are all familiar, and a car park. We all queued in the rain, very British-like, ready to go in. We were met and greeted by volunteers; that was the first thing I noticed. The local CCG banners were around; it was very orderly and very dignified—very British. From what I remember, there was no soldier; they were NHS personnel, clearly identified, and we were all sifted through. The lessons that I took from it were that it is local but also national, and it is about volunteering as well. We have to work together on this, with government, local NHS provision and good vaccine provision working together, but you are reliant on volunteers to do it. In my experience, it worked very well.
As for who can deliver the vaccines and the flexibilities, as I indicated, in my experience and that of the noble Lord, it is healthcare professionals who deliver them. We discussed this yesterday in the Chamber, and the noble Baroness mentioned pharmacists. It is clear that other qualified and well-trained individuals, under supervision from healthcare professionals, can and should be able to do this. The lesson learned is that you can extend the number of individuals under supervision —who are very well trained—to make sure that there are no bottlenecks and you can open it up. That is the big lesson we can take from Covid.
This was introduced after the initial planning and preparation for a flu pandemic in 2016 so, on the noble Lord’s point about preferring to have pre-planned systems—the known unknowns, as he said—we have to be mindful of the unknown unknowns. We planned for influenza, not Covid-19. We in this House and elsewhere try our best to plan for the future but it is difficult. However, we can certainly learn from that and, as the noble Lord said, this has been well documented for the Government and the nation. So we have to learn the lessons from the planning for influenza from 2016 to 2019—only three years. God forbid that we have another pandemic, but we hope we will know about that. It is about making provision so that we can extend the workforce to deliver those vaccines.
On the specific question that the noble Baroness asked my noble friend Lord Markham, I will endeavour to get a specific answer if she has not already received one. She talked specifically about MMR, which we discussed previously. Some communities are perhaps vaccine-reluctant, for whatever reason. We mentioned that, in the black and ethnic minority communities, social deprivation has a lot to do with it in certain areas of the country—inner cities—as does misinformation.
Both the noble Lord, Lord Allan of Hallam, and the noble Baroness, Lady Merron, mentioned disinformation, which we have talked about before. Social media has a positive effect on our lives but, unfortunately, it is very easy to develop conspiracy theories from it. The Government are committed to tackling Covid-19 vaccine misinformation. At a national level, the Government, NHS England and UKHSA work together to create a range of personalised and accessible communications from trusted sources to maximise awareness, understanding and confidence in vaccines. At a local level, the NHS works with community leaders to design bespoke materials and services suited to their local populations, which may include outreach initiatives aimed at improving confidence and trust in the vaccines.
The conspiracy theories come from all sorts of places. The vaccines are perfectly safe. There may be occasions when individuals have allergic reactions to them, but this does not mean that people should not be vaccinated or that your children should not be vaccinated for MMR. I am afraid that one of the battles of the 21st century is trying to make sure that that disinformation does not have a detrimental effect on our children.
On what the Government have been doing, over 149 million Covid-19 vaccination doses were administered in England between December 2020 and 2023. This has saved tens of thousands of lives, significantly reducing the pressure on the NHS and allowing the economy and society to reopen. Since 11 September, when the latest autumn booster programme commenced, more than 11.8 million Covid-19 jabs have been delivered, providing vital protection to those at greater risk of severe illness.
To summarise, I believe that the long-term plan is to give that flexibility proactively. We cannot predict the future, but we can certainly learn from Covid-19, from 2020 to 2022, that the ability to expand a vaccine and its administration is critical, getting it in the right place at the right time. On the question asked by the noble Baroness, Lady Merron, about hard-to-reach communities, it is about communication and going through community leaders, but it is also about having the wherewithal so that people are not suspicious of going to a local community hall, where they will be welcomed by volunteers perhaps and injected by the appropriate people. We hope that can wear down this reluctance to take up life-saving vaccines.