Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022

Baroness Healy of Primrose Hill Excerpts

Monday 14th March 2022 Grand Committee

[Viscount Stansgate (Lab)]

Am I allowed to ask a question before the Minister replies? I notice that one of the SIs has an impact assessment attached to it and the other, related to early access to medicines, does not. When I looked at the explanation, it said that it does not reach the threshold required to undertake a full impact assessment. What is the threshold above which you are required to provide a full impact assessment?

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

My Lords, the noble Baroness, Lady Brinton, is taking part remotely. I invite her to speak.

[Baroness Brinton (LD) [V]]

My Lords, I will speak about some the issues raised by the noble Lord, Lord Lansley, in relation to the current levels of Covid, when we discuss later on the third of the SIs before us today. I welcome the two sets of regulations that we are discussing in this first section. The first, the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022, modifies and extends regulations with a large number of measures relating to vaccinations for both Covid and influenza. The previous regulations were due to expire on 1 April. I want to put on record our thanks to Ministers and officials for the fact that, this time, we are considering a Covid SI before it comes into force. I hope that this will become routine again from now on.

This SI makes permanent changes to what medicines a range of registered healthcare professionals can administer to NHS and local authority staff. It could be transformational for the NHS if carefully assessed and if the wider group of staff have training and support built into their professional training. It is important that this is extended. The ability to deliver vaccines for coronavirus, influenza and—heaven help us—any other pandemic without the need for a wholesale dealer’s licence to be in place, and for the final stages of coronavirus vaccine preparation to be completed without those extra licences, is important. It is part of a complex legislative framework. I am glad that we do not need to discuss that today but, arising out of it, perhaps I may ask the Minister some questions.

There has been discussion in public in the past few days about the expansion of the fourth booster for certain groups. Can the Minister explain when, if a person has already had their fourth booster, as the severely clinically extremely vulnerable have already had, they would next expect a booster, which would in fact be their fifth? What is the timescale for those who are expecting a fourth booster, having had their third one in the autumn or more recently?

What are the Government doing to keep reaching out to hard-to-reach groups who are not yet fully vaccinated? On the case numbers going up at the moment, I think we all know that those in hospital with coronavirus are predominantly those who have not had any vaccines or their full vaccinations.

What progress is being made towards the development of nasal spray vaccines for Covid, such as the Fluenz Tetra nasal vaccines for influenza for children? Obviously, delivering nasal vaccines needs considerably less training for staff than do injections, although I note that the current flu nasal spray vaccine is live and therefore not suitable for the immunocompromised or immunosuppressed.

What are the Government doing to encourage pregnant and breastfeeding women to get vaccinated, given the confusion that there was last year and the delay before the JVCI said that they should be vaccinated?

As we lift restrictions, it is very much the unvaccinated who are at risk of serious illness, so what socioeconomic and ethnic divisions are there between the vaccinated and the unvaccinated? What has been the most recent clinical assessment of vaccine uptake for the severely clinically extremely vulnerable or, if the Minister prefers to call them this week, the immunocompromised and the immunosuppressed? That is a slightly naughty question because I know the answer, as does the noble Lord, Lord Lansley. We know that some will never make any antibodies at all, while others will make some but they will wane extremely fast.

I was interested to hear the noble Lord, Lord Lansley, discussing post-exposure prophylaxis trials, which are important. I note that, back in June and July last year, the Minister’s predecessor was telling us that pre-exposure prophylaxis treatment would be available very shortly, but in the last two or three meetings that I have been at with scientists and experts, they have said that it is much further away. I hope that the noble Lord, Lord Lansley, is right and that it is not far off. Can the Minister say whether it is going to happen? There is still a problem for the immunocompromised and the immunosuppressed in making sure that they get access to these antivirals and monoclonal antibody treatments.

I turn now to the human medicines amendments relating to the early access to medicines scheme. The review into EAMS in 2016 highlighted that, often, a medicine will be available to a patient under EAMS but, when it makes the transition to being fully available and is going through the final stages of approval, there can be a lull when patients are not able to access it. This is a very particular problem for those who were on it in the trial and for whom it is making their lives a lot more bearable and their health condition much more under control. Suddenly there is a period when they cannot access that medication. Is it proposed that this arrangement changes so that, if you are on a trial, you can continue on it until it definitely will not be approved, rather than having to wait? How will this legislation make that transition smoother? How are the Government prioritising pharmaceutical innovation for the clinically extremely vulnerable?