Draft Human Medicines (Amendment) Regulations 2026

Caroline Johnson Excerpts

Tuesday 3rd March 2026 General Committees

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

It is a pleasure to serve under your chairmanship, Mrs Harris. The Opposition do not intend to divide the Committee on these regulations, as anything that improves trust in medicines and vaccines is important. We need to increase the uptake of vaccines; it has fallen gradually and continues to fall, and we need to reverse that.

I have a couple of technical questions. As the Minister said, the principle behind the amendment to regulation 3 of the 2012 regulations is to make prescribing pharmacists equivalent to doctors and dentists. However, regulation 3(8) currently refers to,

“another doctor or dentist…of the same…practice.”

Given that pharmacists will now also be included, should that be amended to “another doctor, dentist or pharmacist”, or “a doctor or dentist”?

Regulation 5 redefines an “occupational health vaccinator” and refers to a list in part 4 of schedule 16 to the 2012 regulations. That significantly broadens the list to include individuals such as speech and language therapists who are not accustomed to dealing with injectable medications, but appears to exclude operating department practitioners, who, as the Minister will be aware of from his practice, are used to dealing with injectable medications. Could the Minister explain the reason for removing those practitioners from the list?

Regulations 8 and 9 talk about the vaccine group direction. The patient group direction is essentially a group prescription, where a clinician signs off the circumstances in which medication—say, paracetamol —may be given by a non-prescriber. We had such a direction for the covid-19 vaccine during the pandemic. This vaccine group direction would be different, so why does the Minister feel that we need a different process to the patient group direction that is already available for vaccines, which are prescription medicines? Instead, those directions can be signed by someone who is not a clinician—such as a manager in the Department of Health or, in fact, a private company—and they do not need to have any clinical skills or qualifications at all. A clinician, or one of the people listed, must decide whether the conditions have been met, and they can then give the patient the medicine without having prescribed it.

I want to ask a couple of questions on this issue. How does that improve trust, when we have a vaccine-sceptic population and lots of material on social media, some of which is not entirely accurate? How does allowing a prescription to be written by someone with no clinical experience help with trust and those rates? Is there a plan to contract out vaccine provision to the private sector, because that is what this provision allows for? Who is ultimately responsible? Is it the non-clinician who signs the vaccine group direction? Who is the clinician ultimately responsible for the decision to give the vaccine in the event that someone has an allergic reaction or an adverse reaction of some other type?

[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.

--- Later in debate ---

[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.