Debate contribution: Human Medicines (Amendment) Regulations 2026

Debate contribution by Mr Mike Nesbitt on 24 March 2026.

MLA

Mr Mike Nesbitt

Party at the time

Ulster Unionist Party

Date

24 March 2026

Type

Debate contribution (made as a minister)

Business

Executive Committee Business

Heading

Human Medicines (Amendment) Regulations 2026

Assembly identifier

Official Report component 5463626

Read the official Assembly record

Text

I beg to move

Principal Deputy Speaker, I seek the Assembly's approval for the making of the set of draft regulations. They contain important further provisions relating to the Human Medicines Regulations 2012 (HMRs) to support the ongoing supply and deployment of vaccinations across the United Kingdom. In response to the COVID-19 pandemic, multiple temporary amendments were made to the HMRs in autumn 2020 to enable the roll-out of the COVID-19 and influenza vaccination programmes. The amendments were extended in 2022 and 2024 following public consultation, and they are due to lapse on 1 April 2026. The instrument looks to retain several provisions in the regulations as permanent legislation and expand them to other vaccines. The aim is to build on the benefits that the amendments have provided to date, as well as wider lessons learned during the pandemic. The COVID-19 and flu vaccination programmes are based on recommendations from the Joint Committee on Vaccination and Immunisation (JCVI), which is an independent expert committee advising on all vaccination-related matters. The programmes are a critical element in helping to protect the health of our population and reduce pressures on our health and care services. Vaccinations remain our best form of direct protection against flu and COVID-19. I will now set out and explain the proposed amendments contained in the draft regulations that are before the Assembly, and explain why the provisions are still needed. The HMRs are a set of UK laws that regulate the use of medicinal products for human use. They set out a comprehensive regime for the authorisation of products for the manufacture, import, distribution, sale and supply of the products, for their labelling, advertising and pharma co-vigilance. The HMRs have a UK-wide territorial application, and they must be amended using powers set out in the Medicines and Medical Devices Act 2021. Subsequently, any statutory instruments (SIs) amending the HMRs on a UK-wide basis must also be made jointly and debated and approved via the draft affirmative procedure in both Houses of Parliament and here in the Northern Ireland Assembly. The current proposal relates to provisions that were introduced to support COVID-19 and extend flu vaccination programmes, namely regulations 3A, 19(4A-4D), 247A and 233(8) and schedule 17(S17). The purpose of the SI is to further amend the HMRs to continue to safeguard public health and ensure that lessons learned can be used to support the safe supply, distribution and administration of a wider group of vaccinations. That will help the ongoing development of a vaccination system that is fit for the future. The proposed amendments will increase flexibility in the movement, preparation and labelling of vaccinations in defined circumstances, with appropriate safeguards. They will increase flexibility in the vaccinative workforce and enable community pharmacies to deliver a wider range of vaccinations off-site. The overarching policy objective is to help safeguard public health in accordance with section 2(2) of the Medicines and Medical Devices Act 2021. It is designed to protect public health and to promote the safety of patients. The provisions in regulations 3A, 19 and 247A of the HMRs proved vital to the success of the COVID-19 and flu vaccination programmes during the pandemic and enabled the continued safe and effective deployment of vaccines across the UK, helping to safeguard public safety. The legislative provisions are, however, time-limited and have sunset provisions that will cause them to lapse on 1 April 2026.

Without the proposed amendments to the HMRs, COVID-19 and flu vaccination services will not be able to continue in their current form, while certain Health and Social Care (HSC) vaccination activities will need to cease. That will inevitably delay or even prevent those considered most at risk from those diseases from receiving their vaccinations, as is recommended by the JCVI.

Regulation 233(8) and regulation 3 of the HMRs and schedule 17 to the HMRs do not have the same time limitations attached. The legislative proposals, however, suggest ways in which to utilise the regulations further to ensure that the vaccine system is as effective as possible. It is proposed that regulations 3A, 19 and 233 of the HMRs be expanded in scope, and a new permanent legal mechanism, known as vaccine group directions, has been drafted. That will replace regulation 247A of the HMRs and include vaccinations against any infectious disease where vaccinations are currently limited to COVID-19 and flu. Allowing regulations 3A(1) and (2) to lapse reflects the fact that we are no longer operating in a pandemic scenario and have instead moved to the more targeted approach of offering COVID-19 vaccination to those at greatest risk. Where necessary, any exceptional preparation or assembly will be satisfactorily covered by the amended regulation 3 and the existing regulation 4 of the HMRs. 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. The statutory instrument retains those provisions as permanent legislation and expands them to include any vaccine against an infectious disease. That will enable a more efficient use of a capable vaccinator workforce and support flexibilities in the supply chain. Regulation 247A will be allowed to lapse on 1 April 2026, and the aforementioned new permanent legal mechanism, regulation 235A, which is being introduced by the SI, will ensure that the UK has the necessary agile and flexible workforce to deliver a wider range of nationally commissioned vaccination programmes, including in the event of a future potential public health emergency requiring rapid vaccine deployment. In amending the regulations, we are seeking to maintain important safety measures while also increasing the effectiveness of the system's supply chain and workforce, including health visiting teams and community pharmacists, all of which will improve vaccination uptake. The occupational health vaccinator provisions in schedule 17 will also be expanded in scope, covering any vaccination that is supplied in the course of an occupational health scheme. On 20 January 2026, following the completion of a UK-wide consultation, which my Department ensured was circulated to all relevant Northern Ireland stakeholders, the UK Government published a response to their joint consultation on the proposals to amend the HMRs to support the ongoing supply and deployment of vaccinations across the UK. There were 217 consultation responses received, six of which were from Northern Ireland. Overall, most of the responses received across the UK were supportive of the proposals outlined in the consultation, stating how the existing flexibilities in the regulations had been, and continue to be, useful in supporting access to vaccines and in ensuring that there is a sufficient vaccination workforce. An overall broad level of support was expressed in Northern Ireland from the organisations here that participated in the consultation, while the responses from individuals who shared their professional and personal views and experiences were rather mixed. The personal views and experiences shared were of a more negative nature and were unsupportive of vaccines in general. Following the consultation, the Department of Health and Social Care (DHSC) in London laid the draft SI in Parliament on 29 January 2026. That was followed by a formal review and scrutiny of it by Parliament's Joint Committee on Statutory Instruments. The draft SI was then debated in the House of Commons and the House of Lords earlier this month, before its coming into force date of 1 April 2026. The regulations are being progressed at pace, given that the provisions for continued support of the COVID-19 and flu vaccination programmes in Northern Ireland also need to be in place by 1 April 2026. We know that that is a challenging timescale, but we would be extremely grateful for the Assembly's support in trying to meet it.

My Department has again accepted the latest advice of the JCVI to offer COVID-19 vaccination in the spring of this year to the following cohorts: all those aged 75 or over; all those living in care homes for older adults; and immunosuppressed individuals aged six months and over. Failure to meet the deadline could result in eligible individuals being delayed in taking up or unable to take up their COVID-19 vaccination, which would have major implications for the planned COVID-19 spring campaign in Northern Ireland. The campaign is scheduled to begin on 20 April and run until the end of June this year, which is a similar time frame to that of spring COVID-19 programmes in the rest of the UK. We know that the vaccination programmes have more than proved their worth. It is therefore important that we continue to retain the flexibility and ability to deliver the programmes that the provisions have afforded us. Over 5,400,000 COVID-19 vaccine doses have been administered in Northern Ireland since the introduction of the vaccination programme in December 2020. During the 2025-26 autumn and winter COVID-19 programme, over 100,000 COVID-19 vaccinations were administered here, and at 11 March 2026, over 560,000 flu vaccinations had been administered in Northern Ireland as part of the 2025-26 winter campaign. Given that almost 80% of flu and COVID-19 vaccines are co-administered during the autumn and winter campaigns, it is essential that we make the best use of the available workforce to ensure that the people considered most at risk continue to receive their vaccines on time. Safety is at the forefront of the COVID-19 and flu programmes. Important safeguards have been put in place to ensure that the flexibilities provided by the amendments do so safely and effectively. All COVID-19 and flu vaccinations, as well as other vaccines that are available as part of a national programme, are entirely voluntary. No one is forced to receive a vaccine. My officials attended the Health Committee's meeting on 5 March this year to outline the policy intent of the draft SI and respond to any questions that the Committee raised. I am pleased to confirm that the Committee raised no issues on the content of the draft regulations, and it is with the Committee's support that I bring the SI before the wider Assembly today. I commend the motion to the Assembly.

1,678 words. Text as published by the Northern Ireland Assembly.

Assessment

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Assessed 21 October 2026 at 15:16 UTC by jev-1.13.0 (requested as typesafe/jev) under rubric 2026.10-r9, methodology 1.9.

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