- Considered in Grand Committee
- 4:41 pm
- Moved by
- That the Grand Committee do consider the Human Medicines (Amendment) Regulations 2026.Relevant document: 51st Report from the Secondary Legislation Scrutiny Committee
- My Lords, I am glad to introduce these regulations, which will take effect from 31 March 2026. This statutory instrument is technical, relating to the preparation and administration of vaccines.In autumn 2020, in response to the Covid-19 pandemic, multiple temporary amendments were made to the Human Medicines Regulations 2012 to support the rollout of the Covid-19 and influenza vaccination programmes. Three of these amendments were extended in 2022 and 2024 following public consultation, and are due to lapse on 1 April 2026.These regulations look to retain several provisions within those amendments—which have been utilised in the Covid-19 and influenza programmes for five years—as permanent legislation and expand them to other vaccines. They are designed to build on the benefits that the amendments have provided to date, as well as on the wider lessons learned during the pandemic and in recent polio and MMR vaccine catch-up programmes. I will briefly set out what each of these regulations does, and what amendments this instrument will make to them.Regulation 3A(1) and (2) of the 2012 regulations enable trained healthcare professionals, or staff under the supervision of trained healthcare professionals, to conduct the final stage of assembly and preparation of Covid-19 vaccines without additional marketing authorisations or a manufacturer’s licence being required. This enabled bulk assembly of Covid-19 vaccines during the pandemic. Given that we are no longer in a pandemic and have taken a more targeted approach to recent Covid-19 vaccination campaigns, this instrument allows these provisions to lapse from 1 April 2026.Regulation 3A(3) and (4) permit holders of a wholesale dealer’s licence who do not hold a manufacturer’s licence to relabel Covid-19 vaccines to reflect changes in shelf life resulting from product thawing. This instrument retains these provisions as permanent legislation and expands them to include any vaccine against an infectious disease, which will helpfully support flexibilities in the supply chain now and in the future.Regulation 19 allows Covid-19 and influenza vaccines to be moved between different NHS service providers at the end of the supply chain, without the need for a wholesale dealer’s licence. This instrument retains these provisions as permanent legislation and expands them to include any vaccine against an infectious disease, with relevant safeguards in place to regulate its use.
- 4:45 pm
- Regulation 247A enables the use of an extended workforce that is legally and safely able to administer Covid-19 or influenza vaccines without the input of a prescriber, using an approved protocol. This instrument allows Regulation 247A to lapse from April 2026 and introduces a new permanent provision, new Regulation 235A. This will enable the use of an extended workforce to administer any vaccine against an infectious disease as directed by a national body under a vaccine group direction.
- Regulation 233 enables persons conducting a retail pharmacy business to deliver Covid-19 and influenza vaccination services off the registered premises. This instrument expands this provision to include any vaccine against an infectious disease.
- Schedule 17 to the 2012 regulations introduced a category of “occupational health vaccinators” who are permitted to administer Covid-19 and influenza vaccines as part of an NHS or local authority occupational health scheme. This instrument amends the list of professionals who are able to deliver occupational health scheme vaccinations to align with the professionals who are able to supply medicines under a patient group direction, including private providers. It also expands the scope of Schedule 17 to cover any vaccination or immunisation offered as part of an occupational health scheme.
- In developing the instrument that is before the Committee, the Government ran a public consultation from 5 September to 28 November 2025 on the proposals to amend the regulations. This consultation was hosted by my department in relation to England, Wales and Scotland, acting jointly with the Department of Health in Northern Ireland. We had 218 responses from organisations and individuals, who shared professional or personal views.
- Overall, the majority of responses were supportive. There were many positive comments on how the regulations have already helped increase access and efficiency across the system while effectively utilising the workforce to deliver Covid-19 and influenza vaccinations safely. Further details and analysis of the consultation responses can be found in the published government response.
- Noble Lords will be aware that these regulations were debated and approved by the Second Delegated Legislation Committee. During that debate, a few questions were asked about the clinical oversight of vaccine group directions, which I will address in order to assist noble Lords.
- In England, the UK Health Security Agency will author the vaccine group directions, which will be drafted by clinical and public health experts, and will outline the conditions for which the VGD can be used. Once the VGD has been authored, the organisation commissioning the vaccination service must authorise its use and ensure that only fully trained professionals use it. When administering vaccines under the VGD, the assessment and consent must be undertaken by a specified registered healthcare professional, who must also supervise any further delegated tasks.
- Given the broad level of support expressed in the consultation, the Government wish to proceed with the proposed amendments. They will help facilitate the shift from sickness to prevention, as described in the 10-year health plan for England, and will support the delivery of commitments in vaccination frameworks in Scotland and Wales. An instrument is being laid in parallel in the Northern Ireland Assembly to deliver UK-wide changes.
- To conclude, this instrument makes amendments to support permanently the safe supply, distribution and administration of a wider range of vaccines. Most importantly, it will ensure that we have a vaccination system that is fit for the future. I beg to move.
- My Lords, I thank the Minister for her clear and comprehensive introduction to this statutory instrument, and I express Green Party support for it. I echo the comments of the Minister in the House of Commons, who said that,“after clean water, vaccination is the most effective public health intervention for saving lives and promoting good health”.—[Official Report, Commons, Second Delegated Legislation Committee, 3/3/26; col. 8.]We need to say that and keep saying it, particularly in the current era. I am glad that, through this SI, the Government are making sure that we prepare ourselves for the next pandemic, because we know there will be one. I shall speak briefly about the vaccination situation and some of the changes relating to vaccination that occurred in our health system during the Covid pandemic. I have a question for the Minister; if she cannot answer it now, I will entirely understand and appreciate a reply in writing.In her introduction, the Minister said that we are no longer in a Covid pandemic, but we are still seeing the extensive spread of the Covid disease. I declare an interest as someone who has the financial wherewithal and ability to have had—and will continue to have—regular vaccinations against Covid, although I am not in one of the Government’s target groups. I want to address this because we saw the development of a great deal more private medicine during the pandemic. Private clinics were set up, running Covid tests and offering vaccinations. We have seen a profound change in the ecology of the vaccination system.In the context of this SI, I have looked at NHS travel vaccines. Typically, the NHS offers vaccination against hepatitis A, typhoid fever, diphtheria, tetanus and polio, if not previously received, and cholera. These are available for certain destinations, but a number of travel vaccines are not covered by the NHS, including for yellow fever, hepatitis B, Japanese encephalitis, rabies and meningitis ACWY. Many noble Lords will have seen the recent tragic case of travel-acquired rabies—the most hideous disease—acquired from the lick of a puppy on a beach, I believe.
- My Lords, I thank the Minister for introducing these regulations. Vaccination remains one of the most effective public health interventions available to us all. The flexibilities introduced during the pandemic enabled the rapid deployment of both Covid-19 and influenza vaccines at scale. It is understandable that the Government now seek to make certain arrangements permanent and extend them to other infectious diseases.His Majesty’s loyal Opposition support a vaccination system that is resilient, agile and capable of responding to future public health requirements. Expanding the role of community pharmacies and broadening the vaccinator workforce may well assist in that aim, provided that safeguards are robust. However, it would be wrong to wave this past without scrutiny, as temporary powers become permanent.The introduction of a permanent vaccine group direction mechanism is a significant change. Flexibility must be matched by clarity. If a patient experiences a serious adverse reaction following vaccination under a vaccine group direction, where does the ultimate legal and clinical responsibility lie? Is it with the authorising body, the supervising clinician, the employer or the individual vaccinator? It would be helpful to have that clearly set out by the Government.On workforce scope, the regulations expand the occupational health vaccinator provisions and align them with professions able to operate under a patient group direction. Can the Minister clarify the criteria used to determine inclusion? Were decisions based on professional registration, competence in administrating injectable medicines, workforce capacity or other considerations? I am sure all noble Lords agree that consistency and safety are paramount.On public confidence and uptake, greater flexibility does not automatically mean higher vaccination rates, so how will the Government ensure that these changes actually translate into improved uptake among eligible and vulnerable groups? What benchmark will the Government use to evaluate the success of the measures?