Draft Human Medicines (Amendment) Regulations 2026

Zubir Ahmed Excerpts

Tuesday 3rd March 2026 General Committees

[The Parliamentary Under-Secretary of State for Health and Social Care (Dr Zubir Ahmed)]

I beg to move,

That the Committee has considered the draft Human Medicines (Amendment) Regulations 2026.

It is a pleasure to serve under your chairmanship, Mrs Harris.

In response to the covid-19 pandemic, multiple temporary amendments were made to the Human Medicines Regulations 2012 in autumn 2020 to enable the roll-out of the covid-19 and influenza vaccination programmes. Those amendments were extended in 2022 and 2024 following public consultation, and are due to lapse on 1 April 2026.

This instrument will retain several provisions within those regulations as permanent legislation and expand them to other vaccines. It is designed to build on the benefits that the amendments have provided to date, as well as the wider lessons learned during the pandemic and in recent polio and measles, mumps and rubella vaccine catch-up programmes. It will support the safe supply, distribution and administration of a wider group of vaccines, helping the ongoing development of a vaccination system that is fit for the future.

I will briefly set out what each of the regulations does. Paragraphs (1) and (2) of regulation 3A 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. That enabled the bulk assembly of covid-19 vaccines during the pandemic. Given the more targeted approach of recent covid-19 vaccination campaigns, this instrument allows the provisions in paragraphs (1) and (2) of regulation 3A to lapse from 1 April this year.

Paragraphs (3) and (4) of regulation 3A permit holders of a wholesale dealer’s licence who do not hold a manufacturer’s licence to re-label covid-19 vaccines to reflect changes in shelf life resulting from product thawing. This instrument retains those provisions as permanent legislation, and expands them to include any vaccine against any infectious disease. That will enable a more efficient use of the capable vaccinator workforce, and will support further flexibilities in our supply chain.

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 those provisions as permanent legislation, and expands them to include any vaccine against any infectious disease, with relevant safeguards to regulate its use. That will ensure that vaccines can be rapidly deployed in exceptional circumstances in response to public health needs.

Regulation 247A enables the use of an extended workforce who are 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 1 April 2026, and introduces a new, permanent provision—regulation 235A —to continue the use of an extended vaccinator workforce through the introduction of a vaccine group direction. That will support the use of an extended workforce to administer any vaccine against any infectious disease where directed by a national body, and will ensure that the UK has the necessary agility and flexibility in its workforce to deliver those vaccinations.

Regulation 233 enables persons lawfully conducting a retail pharmacy business to deliver covid-19 and influenza vaccination services off their registered premises, under a patient group direction. This instrument expands that provision to include any vaccine against an infectious disease. Additionally, to enable those services to continue after paragraphs (1) and (2) of regulation 3 lapse from 1 April this year, this instrument amends regulation 3 to enable pharmacists to prepare or assemble medicines for a patient in the course of their treatment without a manufacturer’s licence. That will ensure that community pharmacies can deliver vaccination services off their registered premises, enabling them to deliver targeted outreach programmes.

Schedule 17 introduced a category of occupational health vaccinators, who are permitted under the written directions of a doctor 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 able to deliver OHS vaccinations, aligning it with the professionals able to supply medicines under a patient group direction. In addition, it expands the scope of schedule 17 to cover any vaccination or immunisation offered as part of an OHS. Those changes will improve access to vaccines for staff within and beyond the health and social care sector, protecting them in the vital roles that they do.

In developing this statutory instrument, from 5 September to 28 November 2025, the Government conducted a public consultation on our proposals, hosted by the Department of Health and Social Care for England, Wales and Scotland, and jointly with the Department of Health for Northern Ireland, as medicines regulation is a transferred matter in Northern Ireland, and a reserved matter in Scotland and Wales. The consultation received 218 responses, from organisations and individuals sharing professional and personal views, the majority of which were supportive of the proposals.

We received many positive comments about how the flexibilities within the regulations have helped to increase access and efficiency across the system, while effectively utilising the workforce that came into place to deliver covid-19 and influenza vaccinations following the covid-19 pandemic. The consultation posed 15 questions on the technical aspects of the regulations, and we saw broad agreement on each of those proposals. Given the technical nature of the questions and the limited time the Committee has to discuss this instrument, I will not provide an immediate analysis of each response here; however, the published Government response can be accessed on the gov.uk website.

This instrument builds on the successes of the large-scale vaccination programmes during the covid-19 pandemic to support patient safety, improve access to and availability of vaccines, and ensure that the vaccine system continues to innovate. The changes will implement improvements that will help to facilitate the shift from “sickness to prevention”, as described in the Government’s 10-year health plan, helping to restore trust in vaccinations and ultimately increasing vaccine uptake.

Regulations 3 and 8 will enable community pharmacies to play a bigger role in prevention by expanding their role in vaccine delivery and enabling targeted outreach in areas where health inequalities remain pervasive, and where evidence indicates that doing so is clinically appropriate and value for money. The changes will support the delivery of commitments on vaccination and immunisation frameworks in Scotland and Wales, and an instrument will be laid in the Northern Ireland Assembly in parallel to these regulations, to deliver changes to the vaccination system across the United Kingdom.

To conclude, the instrument makes changes that will permanently support the safe supply, distribution and administration of a wider range of vaccines, and the proposals were supported by the majority of respondents to our consultation. I therefore commend the regulations to the Committee, and hope that hon. Members will support them.

--- Later in debate ---

[Dr Ahmed]

I am grateful to the shadow Minister for her support; she is a learned Member of this House, and I know she takes these matters extremely seriously both here and in her own clinical practice.

She raised a technical point on whether the sub-paragraph should include the word “pharmacist”, given the updating of the regulations—I am very happy to explore that further to ensure that the wording is optimal. I also want to reassure her on the point she made about the workforce; training and a governance framework will be set up by the UK Health Security Agency, which will oversee all of this. Whether it is an operating department practitioner or anyone else, there will be a basal level of training that can reassure all Members of this House, whether we are the clinician prescribing the vaccination or the citizen receiving it. This will be overseen very tightly by the UKHSA.

[Dr Johnson]

Before the Minister moves on, can I just ask him why ODPs appear to have been removed from the list?

[Dr Ahmed]

I am not clear on why they have been removed from the list. However, I certainly expect that anyone who is reasonably trained will be able to deliver vaccines in the settings that we have proposed, which include community hospitals and everywhere in between, when we need to think about hard-to-reach communities.

The shadow Minister also asked a question on vaccine group direction versus patient group direction. The primary difference is that the VGD allows for the separation of the decisions to treat and provide consent by a registered healthcare professional, which still need to exist, from the administration of the vaccine, which is then done by a separate individual. That is not possible under a PGD, so it is about separating the roles. However, I reassure her that the consent process in prescriptions is paramount, and she is right that it must continue to be if we want to invite people’s confidence in the vaccination process.

[Dr Johnson]

Can the Minister confirm that the vaccine group direction—unlike a patient group direction, which ultimately needs to be signed by a clinician—would not need to be signed by a clinician, and can instead be signed by a senior manager either within a company or department?

[Dr Ahmed]

I will clarify that for the shadow Minister, but we are both cognisant of the wider point that clinicians ultimately take responsibility for prescriptions and informed consent of the vaccination process, and that will still continue. Healthcare professionals will still be seeking consent for treatment; the VGD simply means that they can be separate to the person who is then administering the vaccine in practice. There is no suggestion that there will not be clinical oversight or governance of this process—it is quite the opposite. This provision is designed to tighten governance frameworks and make them more transparent.

As I set out at the start of the debate, the proposed amendments aim to support the ongoing development of a vaccination system that is fit for the future. They are designed to build upon the benefits that HMRs have provided to date, as well as wider lessons learned during the pandemic, including recent polio and MMR catch-up programmes. In amending these regulations, the Government are seeking to maintain important safety measures while also increasing the effectiveness of the system’s supply chains and workforce in vaccination programmes.

The science unequivocally tells us that, after clean water, vaccination is the most effective public health intervention for saving lives and promoting good health. It is therefore a solemn duty of this Government to do all we can in this space to support the health system’s ability to deliver vaccines for all those eligible and, in turn, help support vaccine uptake. Given the overall support of the proposals in the consultation, and the ongoing need to support the continued safe and effective supply, distribution and administration of vaccines both now and in future, it is our intention to make permanent the provisions discussed during the debate. I commend the draft regulations to the Committee.

Question put and agreed to.