Human Medicines (Amendment) Regulations 2026 Debate

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Department: Department of Health and Social Care
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.
Baroness Bennett of Manor Castle Portrait Baroness Bennett of Manor Castle (GP)
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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 question is about vaccination as we move increasingly into an ecology where some people are able to afford to protect themselves against a wide range of risks, for travelling but also even if they are not travelling. I randomly selected a provider and saw that there is a huge range in prices. Vaccination against dengue fever and Japanese encephalitis costs £125 for each, and for typhoid it costs £40. I wonder whether the Government are taking into consideration the availability of these crucial health measures. Some people are able to afford a broad range of protection but some may not be able to afford or have access to protections that could keep them healthy and, eventually, save the NHS a great deal of money.

Through this SI, we are making sure that we are able to react quickly in crisis situations, but it would be interesting and important to hear from the Minister about whether we are looking at the broader ecology of all this. What are we are doing for public health in the new, increasingly privatised medical arrangements that we are seeing?

Earl of Effingham Portrait The Earl of Effingham (Con)
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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.

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Baroness Bennett of Manor Castle Portrait Baroness Bennett of Manor Castle (GP)
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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 Portrait Baroness Merron (Lab)
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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.