Draft Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024

Maria Caulfield Excerpts

Tuesday 30th January 2024 General Committees

[The Chair]

I am sure the Chairman of Ways and Means would always want to acknowledge that sort of event, so happy birthday to the Government Whip. I call the Minister to move the motion.

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

I beg to move,

That the Committee has considered the draft Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024.

It is a pleasure to serve under your chairmanship, Dame Maria. I also want to pass on my best wishes to my hon. Friend the Member for Beaconsfield; it is always best to keep in with the Government Whip.

In autumn 2020, as part of the response to the covid pandemic, a number of temporary amendments were made to the Human Medicines Regulations 2012 to support the deployment of covid-19 and flu vaccinations following public consultation. This instrument looks to amend the temporary provisions in those regulations—regulations 3A, 19 and 247A—in order to maintain them and support the ongoing delivery of covid-19 and influenza vaccination.

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 manufacturer’s licences, provided that vaccines are supplied under NHS arrangements or by suppliers of medical services to His Majesty’s armed forces. Regulation 3A 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 at the end of the supply chain 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 has provided a mechanism to expand the workforce that is 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 and will cease to have effect on 1 April 2024 unless extended today. Regulation 247A is only permitted for use during a pandemic, so we want to amend it to be valid outside a pandemic for a temporary period.

The regulations continue to play a vital role in the covid-19 and flu vaccination programmes and have helped us to roll out both vaccines this autumn and winter. We are committed to protecting those who are most vulnerable, guided by the independent Joint Committee on Vaccination and Immunisation. Although for most people covid-19 is no longer a serious risk, for some it remains one and vaccines are still the first line of defence for those people. In our latest roll-out, more than 11.8 million covid vaccines have been administered by NHS England since national bookings opened on 11 September last year, and more than 17.9 million flu vaccinations were administered in England during the latest autumn campaign. That includes more than 4.5 million people who received their flu and covid-19 vaccines at the same appointment. The regulations we wish to extend today play a huge part in making that happen.

The Government have engaged a broad range of stakeholders to determine whether to retain the provisions in the 2012 regulations beyond their current period, which ends in April. That initial engagement led the Government to propose an extension, as key stakeholders, including NHS England, said that without these regulations the covid-19 and flu vaccination services would be negatively impacted. Following that engagement, the Government ran a public consultation from 7 August to 18 September 2023 on proposals to temporarily extend the regulations until 1 April 2026 while a permanent solution is developed.

In regulation 247A, condition A, which requires there to be a pandemic for it to be used, would be removed. We had 220 responses, and there was a high level of support for the change.

Eighty nine per cent of respondents agreed that regulation 3A should be extended. It is important to note that covid-19 vaccinations are not available as pre-filled syringes, so a lot of work is done when a covid vaccination clinic is running. The regulations will make that as efficient as possible. The consultation found that the flexibilities of the arrangements for safe assembly and preparation at the pace and scale required mean that our vaccination programmes are as efficient as they can be.

Again, there was a high level of support for regulation 19, with 91% agreeing that it should be extended. There was a similar level of support for the change to regulation 247A, with 82% agreeing with the proposal to remove condition A so that the regulation can be used outside a pandemic.

The regulations have played an important role in reducing workforce pressures, so we are looking at how that can be made permanent. Work is being done to see how we can use our learning from the regulations and the tools they offer to reduce workforce pressures in the future and increase our capacity to deliver hundreds of millions of covid-19 and flu vaccinations. The regulations have also released qualified healthcare professionals to deliver other care across the system.

There are a range of benefits to extending the regulations. The Government propose to temporarily extend the provisions to 1 April 2026 and, in the case of regulation 247A, to remove the requirement that there should be a pandemic or imminent pandemic when the medicine is supplied while a more permanent solution is developed. Extending the provisions will allow the Government to work with system partners to undertake a fuller consideration of longer-term mechanisms that could be deployed to better support the delivery and administration of covid-19 and flu vaccines.

In the short term, however, given the high level of support expressed in the consultation and at a time when covid-19 and flu continue to be prevalent, 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 provisions to April 2026. I commend the regulations to the Committee.

--- Later in debate ---

[Maria Caulfield]

I am pleased that we have cross-party support for the regulations. They are important in ensuring that we can deliver an efficient vaccination roll-out, particularly with a potential spring roll-out coming early this year.

In answer to the questions from the hon. Member for Bury South, yes, we are working to look at a more long-term solution. We are engaging with key stakeholders such as NHS England, and proposals will be made. There will need to be a consultation, and we will set out the date of that so that everyone can engage with it. It is one thing to put temporary measures in place, but it is another thing to put in long-term, sustainable measures, so it is important that all stakeholders are consulted, particularly those in primary care.

The regulations today extend only to Great Britain. Northern Ireland is not included because health is a devolved matter and there is not a sitting Assembly, but work is going on with Northern Ireland officials and there was positive news today of the potential of the Assembly restarting. We want to make sure that Northern Ireland will be covered by the provisions once there is an Assembly.

[Christian Wakeford]

On that point, it was helpful to have the news today about the Northern Ireland Executive. If, for any reason, they take a long period for this—they have two years to catch up on—will there be a further SI to implement these provisions in Northern Ireland?

[Maria Caulfield]

Ideally, we would not want to do that, because it is for Northern Ireland to determine its own health decisions. However, I can say that Department officials have been sharing draft materials with Northern Ireland officials so, once the Assembly is up and running, that could potentially happen fairly quickly.

On the point that the hon. Member for Bury South made about vaccine hesitancy, it is absolutely true that we are seeing vaccine and immunisation hesitancy across the country. It is very unhelpful that some of these misleading claims are being made, but, when we engage with community leaders, faith leaders and primary care teams that know their communities, we are able to engage.

We had a very successful covid-19 vaccine roll-out, getting to communities that are usually under-represented in vaccination programmes. During covid, that was thanks to the work of the Equality Hub and teams such as the Office for Health Improvement and Disparities. We are now using them again, particularly in London and the west midlands, for the measles immunisation programme, and we should be able to update colleagues about progress on that fairly swiftly.

Although it is not an issue with covid-19 and flu vaccines, there is concern among the Muslim and Jewish communities, and among Seventh-day Adventists and Rastafarians, about the use of pork in some of the measles vaccines. I would just reiterate that there are non-pork-based measles vaccines available, so that should reassure communities on the alternatives. However, there is work to be done in providing reliable information, getting the confidence of communities and making that vaccine as accessible as possible. That is why we are also working with our school teams to ensure that when young children need immunisation, it is as accessible as possible.

The hon. Member touched on the availability of vaccines. We follow JCVI advice and we expect to publish the JCVI advice for the spring roll-out fairly shortly. For those not covered by NHS vaccine programmes—we did not do the over-50s this year—we are looking at the options of a private market for covid-19, as is currently the case for flu. We are having discussions with both suppliers and pharmacies to see what is possible. Again, we will support any moves towards that as much as we can.

The hon. Member’s final point, I think, was about ensuring that we can cover as many people as possible with the vaccines. It is down to the JCVI advice. We almost always follow its advice, and it looks at a range of risk factors. That will also change over time; we may move to an annual covid vaccine at some point, compared with the spring and autumn roll-outs, but that will all be guided by the JCVI advice. Obviously, if a variant of concern emerges, that will change things.

The flexibility that these regulations provide really makes a difference, and we have had a positive reception from NHS England—from primary care—about the difference that it has made to the skills mix and career progression of many who administered the vaccines, as the hon. Member pointed out. It has also been a real opportunity to develop the workforce. I hope that that answers hon. Members’ questions. I thank them for their cross-party support.

Question put and agreed to.