Human Medicines (Amendment) Regulations 2026
(Limited Text - Ministerial Extracts only)
Read Full debate
Baroness Merron
That the Grand Committee do consider the Human Medicines (Amendment) Regulations 2026.
Relevant document: 51st Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
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.
The Earl of Effingham (Con)
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?
A full impact assessment has not been produced. Although the stated impact may be minimal, these are system-wide changes. Reporting under the Medicines and Medical Devices Act occurs on a two-year cycle. Does the Minister consider that sufficient, or will interim data on safety, workforce, deployment and uptake be made available?
These are important questions to answer, and His Majesty’s loyal Opposition do indeed support a framework that is safe, proportionate and future-proofed, but one which has been properly stress-tested.
Baroness Merron (Lab)
My Lords, I am most grateful to noble Lords for participating in this debate. I appreciate the welcome for these measures and the acknowledgement of their importance from the Opposition Front Bench and the noble Baroness, Lady Bennett. I will turn to some of the questions. I will, of course, be very pleased to write to noble Lords on anything I am unable to answer.
The noble Baroness, Lady Bennett, raised the issue of provision of Covid-19 vaccinations and remarked that Covid is still very much with us; I am not quoting her directly but that is what I took from what she said. In answer to that, this is a big change, but it is now a relatively mild disease—I stress relatively—for, I stress again, most people. It can still be unpleasant, but I am glad to say that the rates of hospitalisation and death have reduced significantly since the pandemic. These proposals, as I mentioned in my opening remarks, are very much about building on the successes that we saw in the Covid-19 and the flu vaccination programmes. As I mentioned, they are about taking that best practice and ensuring that we have a vaccination system in the future.
The noble Baroness also asked about private vaccination services. It is still the case, of course, that the NHS offer of vaccination is there for all those who are at higher risk of serious outcomes; there are a number of such people and we want to ensure they are properly looked after. Private provision is also available, as the noble Baroness said, as with some other vaccines. The availability and price of any vaccines provided through the private market is a matter for the private sector and not something that we seek to regulate.
On travel vaccines, as I am sure the noble Baroness is aware, a number of such vaccines are available free on the NHS through GP surgeries. These are against polio, typhoid, hepatitis A and cholera. These vaccines are free because they protect the public against those diseases that are thought to carry the greatest risk if they were to be brought into this country.
Baroness Bennett of Manor Castle (GP)
One of the vaccines on the list of those that are only available privately is against typhoid. There was a publication last week, I believe, looking at the spread of antimicrobial resistance to typhoid and the fact that antibiotics that we have been using against typhoid for decades are now increasingly not working. Can the noble Baroness assure me—again, I will understand if she wants to write—that the Government keep this constantly under review? Drug-resistant typhoid would be very serious; 10 or 20 years ago we might have thought that we could just treat people, but that may no longer be the case.
Baroness Merron (Lab)
I can certainly assure the noble Baroness that effectiveness is kept under review. I know that she was not questioning this, but I also re-emphasise that typhoid vaccinations are available free on the NHS from GP surgeries. It is important to give that reassurance.
The noble Earl, Lord Effingham, asked where ultimate legal and clinical responsibility lies. An appropriate person has to be responsible for ensuring that only fully competent qualified and trained health professionals are individually authorised to use the most recently approved version of the VGD. That authoriser is usually a clinical manager or service lead. Authorised health professionals working under VGDs must understand their legal and professional responsibilities before they use VGDs. This follows the same principles set out in the NICE guidance. In that respect, I say to the noble Earl that this is not a new situation, but I accept it is quite right to ask about that.
The noble Earl also asked how we will ensure that changes translate into improved uptake. He will know our commitment to stabilising and improving uptake across the vaccination system, including, importantly, among those in underserved communities and groups that have historically lower vaccination rates. We have set out actions to improve uptake in our 10-year plan, as well as in our strategy Giving Every Child the Best Start in Life. We are also taking a multipronged approach, if I can put it that way, to improving vaccination uptake. That includes exploring whether there are other settings, such as community pharmacies and health visitors, who can assist in this. We also seek to continue to deliver clear messaging on the risks of disease and the benefits of vaccination. Importantly, we are investing in better digital services and data so that we know where we can target our efforts.
With regard to the question about community pharmacies having the necessary training and equipment if there are, unfortunately, adverse reactions, all providers and trainers have to ensure that those who are involved in vaccination have the right, high-quality training that enables them to deal with such reactions. I should say—I hope that this is a reassurance—that the amendment does not change the training expectations of those staff. Also, they are consistent: it does not matter where the service is being delivered.
A full impact assessment covering these amendments was carried out in 2023. It considered that making the relevant parts of the regulations permanent and expanding them is unlikely to create any significant additional impact. The amendments delivered by this SI are not controversial and do not reach the cost to business threshold; as such, a de minimis assessment was carried out and published on GOV.UK.
I hope that noble Lords will accept that, in amending these regulations, the Government are seeking to maintain important safety measures while increasing the effectiveness of the system’s supply chain and workforce. With that, I thank noble Lords for their contributions and questions.