Official Report: Minutes of Evidence

The Chairperson (Mr McGuigan): I welcome Chris Garland, senior principal pharmaceutical officer; Eddie Murphy, acting head of medicines legislation unit; and Martin Coleman, head of vaccination and screening policy branch. You are all very welcome. I will hand over to you to make some brief remarks.

Mr Eddie Murphy (Department of Health): Thank you, Chair, for those introductions and for the opportunity to brief the Health Committee on our proposals to further amend the Human Medicines Regulations 2012 to support the ongoing supply and deployment of vaccinations across the UK. Chair, if you are happy that I do so, I will make a brief statement, and then you can ask us a few questions.

The Chairperson (Mr McGuigan): Yes.

Mr Murphy: As members will know, the UK Human Medicines Regulations 2012 — the "HMRs", as they are better known — govern the arrangements for the licensing, manufacture, wholesale dealing and sale or supply of medicines for human use. They are made under powers contained in the Medicines and Medical Devices Act 2021. The Department of Health in Northern Ireland is named as an "appropriate authority" in that Act, in recognition of the fact that the regulation of medicines is devolved to Northern Ireland. Amendments to the HMRs are normally made jointly by the Secretary of State for Health and Social Care in England and the Department of Health in Northern Ireland, and that is the case with these regulations. They are subject to the draft affirmative procedure. Section 47 of the Medicines and Medical Devices Act stipulates that they must be laid before and approved by resolution of the Northern Ireland Assembly. An Assembly debate will, therefore, be required on the regulations.

As detailed in the SL1, which was submitted to the Committee on 2 February, the policy intent of the planned amendments and the statutory rule itself were provided, along with the accompanying explanatory memorandum. That was done in line with the newly introduced four-week period for Committee's to scrutinise subordinate legislation. The SL1 sets out the policy intent of the UK-wide instrument in amending existing legislative provisions of the HMRs that were introduced, initially, to support the COVID-19 vaccination programme and to extend influenza vaccination programmes across the UK. The instrument amends those provisions that are set out in regulations 3A, 19, 247A, 233(8) and schedule 17 of the HMRs. The instrument amends the HMRs to introduce permanent legislative provisions, where time-limited provisions that were made during the COVID-19 pandemic are due to lapse on 1 April 2026. It expands the regulations on vaccine supply, distribution and administration in the HMRs to include any "vaccine against an infectious disease", instead of being limited to COVID-19 and influenza vaccines. The legislation aims to support the development of a vaccination system that is fit for purpose for the future, through supporting the safe supply, distribution and administration of a wider range of vaccines, now and into the future.

The proposed amendments will increase flexibility in the movement, preparation and labelling of vaccinations in defined circumstances and with appropriate safeguards, increasing flexibility in the vaccinator workforce and enabling community pharmacists to deliver a wider range of vaccinations off-site. The overarching policy objective is to safeguard public health and promote patient safety in accordance with section 2(2) of the Medicines and Medical Devices Act 2021.

The provisions in regulations 3A, 19 and 247 of the HMRs proved vital to the success of the COVID-19 and influenza vaccination programmes during the COVID-19 pandemic and enabled the continued safe and effective deployment of vaccines across the UK to help to safeguard public health. Those legislative provisions are, however, time-limited: they include sunset provisions that will cause them to lapse on 1 April 2026. Without the proposed amendments being made to the HMR regulations, COVID-19 and influenza vaccination services will not be able to continue in their current form, and certain Health and Social Care (HSC) vaccination activities will need to cease. Regulation 233(8) and regulation 3 of and schedule 17 to the HMRs do not have the same time limitations, but the legislative proposals suggest ways in which to further utilise those particular regulations to ensure that the vaccine system is as effective as it possibly can be.

It is proposed that regulations 3A, 19 and 233 of the HMRs be expanded in scope. A new permanent legal mechanism, known as a "vaccine group direction", has been drafted to replace regulation 247 of the HMRs and include vaccinations against any infectious diseases, where they are currently limited to COVID-19 and influenza. That will build on the lessons that were learned during the COVID-19 pandemic and the successful roll-out of the COVID-19 and influenza vaccination programmes. The occupational health vaccinator provisions in schedule 17 of the HMRs will be expanded in scope to cover any vaccination that is supplied in the course of an occupational health scheme. By amending the regulations, we seek to maintain important safety measures, while increasing the effectiveness of the system's supply chain and workforce, including health-visiting teams and community pharmacists, in order to improve vaccination uptake.
Between 5 September and 28 November 2025, the UK Government hosted a 12-week joint public consultation on amending regulations to support the supply and deployment of vaccines across the UK. The consultation response, which was published on 20 January 2026, detailed how the majority of responses received were supportive of the proposals outlined in the consultation. Many positive comments were received, detailing that the flexibilities provided by the regulations have had a positive impact and that they help to increase access to efficiency across the system, while using the workforce effectively to safely deliver COVID-19 and influenza vaccinations. Of the 217 responses received from across the UK, six were from Northern Ireland. Overall, broad support was expressed by organisations from Northern Ireland that participated in the consultation, but responses from individuals sharing their professional and personal views and experiences were mixed: comments that fell into the category of personal views and experiences were more negative and unsupportive of vaccines in general.

Following the consultation and formal review and scrutiny by the Joint Committee on Statutory Instruments, the Department of Health and Social Care in England laid the draft proposed instrument in the UK Parliament on 29 January 2026. The intention is to debate the statutory instrument in both the House of Commons and the House of Lords, before bringing it into force prior to the sunset provisions that I mentioned causing the current provisions to lapse on 1 April 2026. That is a challenging timescale for both Governments, but we are working closely with Department of Health and Social Care colleagues with the aim of laying the draft regulations in the Northern Ireland Assembly within as short a time frame as possible, pending, of course, the Health Committee's approval of the instrument and its policy intent. An Assembly debate has been provisionally scheduled for 24 March 2026. The regulations are being progressed at pace, given that it is necessary to have the provisions in place by 1 April 2026 to support the COVID-19 and flu vaccination programmes in Northern Ireland.

The Department of Health has accepted the latest advice of the Joint Committee on Vaccination and Immunisation (JCVI) to offer COVID-19 vaccinations to the following cohorts in spring 2026: those aged 75 and over; those living in care homes for older adults; and immunosuppressed individuals aged six months and over. Failure to meet the deadline may result in eligible individuals being unable to take up their COVID-19 vaccinations and will have implications for the planned spring COVID-19 vaccination campaign in Northern Ireland, which is scheduled to take place from 20 April 2026 until the end of June 2026, around the same time as the spring COVID-19 vaccination programme in the rest of the UK.

The regulations were successful in expanding the number of locations where vaccinations can be given, thus ensuring greater access for those who are eligible. While we acknowledge that the timescale of getting the amending regulations debated and made prior to 1 April is challenging, we would be extremely grateful for the Committee's support in progressing the amendments to the Floor of the Assembly. Thank you. I am happy to take any questions.

The Chairperson (Mr McGuigan): Thanks. There was a lot to take in there. You said that this is about protecting public health. What will the risks be to public health if the amendments are not implemented?

Mr Chris Garland (Department of Health): As Eddie indicated, there are certain HSC vaccination activities that would need to cease if the amendments were not enacted by 1 April. Primarily, regulation 247A allows for what is known as a vaccination protocol, which is to be authorised by Ministers. That allows for parts of the vaccination process to be delivered by non-registered healthcare staff under the supervision of a healthcare professional. If the regulations are not progressed, that legal mechanism will fall from 1 April, which will have an impact on the workforce that is available to deliver vaccination programmes.

The other key aspect where there will be an impact relates to regulation 3A, which provides for the activities of thawing and relabelling a vaccine. Some vaccine products are supplied at ultra-low temperatures in the supply chain. They are thawed and relabelled with a revised expiry date prior to distribution to the final vaccine provider. Currently, those activities can take place without a manufacturing licence. If the provisions are not enacted by 1 April, those provisions will also fall, and that distribution will be impacted on, which will impact on the ability to distribute vaccines to vaccine providers.

The Chairperson (Mr McGuigan): Thanks. What steps is the Department taking to promote and maintain public confidence in vaccines?

Mr Martin Coleman (Department of Health): The Public Health Agency (PHA) mainly leads on monitoring what is said on the internet and other things out there. It feeds that in. It does a lot of social media posts to try to counteract any negative headlines or stories about vaccinations. Various work is going on behind the scenes to try to promote vaccines in general. A lot of vaccines — not these vaccines, but childhood vaccines — are based on the child health system. That system is quite old and complicated, so the PHA is working with GP practices to make sure that they get the best out of the child health system when they schedule appointments. Eventually, the child health system will move onto Encompass, which should make the process more streamlined and make the recording and scheduling of appointments more accurate. That should make it easier for the practices involved.

Various work is going on behind the scenes on the behavioural science around flu and COVID vaccines to try to work out what puts people off getting the vaccine. That work is seeking to get things right by encouraging people that getting the vaccine is personal protection for them and to try to encourage them to come forward and take up the offer. I appreciate that the COVID-19 vaccine in particular is quite regular: those who are eligible are offered it twice a year, whereas the flu vaccine is offered only once a year, and many other vaccines are just one-offs. It is a hard sell to ask people to come back constantly to be revaccinated, but that is the advice from the JCVI, and we have to make sure that we abide by that advice and that the offer is there for those who want to come forward to be vaccinated.

Mr Donnelly: The legislation is clearly very important. We all encourage people to take up a vaccine whenever they are offered one, but the ability to deliver that vaccine has to be in place if people are to be able to take up that offer. The roll-out of the COVID vaccination saved many lives here, and we want to encourage that to be able to continue.

Recently, we have heard some concerning things about the possibility of the medicine supply being interrupted in Northern Ireland. Will this legislation affect that at all? Would that be impacted?

Mr Garland: The vaccines for the COVID and flu vaccination programmes, and, indeed, for other vaccination programmes, are procured centrally. The Department, along with the Public Health Agency, procures the flu vaccine on behalf of the whole HSC vaccination programme. Similarly, the Department participates in UK-wide procurement activities for the COVID vaccine and other vaccination programmes. No, we do not foresee any supply issues.

The Chairperson (Mr McGuigan): Thank you very much.

Members, we received no responses to the call for views on the proposed rule. Do members have any comments? No. Are members content that the Department make the statutory rule?