Debate contribution: Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024

Debate contribution by Mr Robin Swann on 19 March 2024.

MLA

Mr Robin Swann

Party at the time

Ulster Unionist Party

Date

19 March 2024

Type

Debate contribution (made as a minister)

Business

Executive Committee Business

Heading

Human Medicines (Amendments Relating to Coronavirus and Influenza) Regulations (Northern Ireland) 2024

Assembly identifier

Official Report component 4278932

Read the official Assembly record

Text

I beg to move

I seek the Assembly's approval for the making of this set of regulations, which contain important provisions relating to the continued support of the United Kingdom's COVID-19 and flu vaccination programmes in Northern Ireland. I am sure that Members will agree that the vaccination programmes in recent years have been an outstanding success and that they have helped us once again to live a more normal way of life. The Human Medicines Regulations 2012 (HMRs) are a set of UK-wide 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 those products; for their labelling and advertising; and for pharmacovigilance. The Human Medicines Regulations have a UK-wide territorial application and must be amended using powers set out in the Medicines and Medical Devices Act 2021. Subsequently, any statutory instruments that amend the Human Medicines Regulations on a UK-wide basis must also be made jointly and debated and approved via the draft affirmative procedure in the Houses of Parliament and in the Northern Ireland Assembly. As part of the UK's response to the pandemic, the Human Medicines Regulations were amended jointly in 2020 by the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 to provide regulatory flexibility to support the roll-out of the vaccination campaign and upscale the influenza vaccination programme in the UK while protecting public safety. Therefore, the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 were introduced to extend some of the flexibilities around the supply, distribution and administration of COVID-19 and influenza vaccines up until 1 April 2024. Those changes have helped to facilitate the vaccination campaigns against seasonal flu and COVID-19. The health service in Northern Ireland has made use of the full range of options available to it, as enabled by those amendments to the HMRs, in order to safely vaccinate our health staff and the wider population. That was done with the aim of protecting those most at risk and minimising disruption to normal health services. Given the experiences arising from the pandemic, we needed to retain some flexibility to deal with the unknowns. We now know that vaccines have more than proved their worth, and it is therefore important that we retain the flexibility and ability to deliver the vaccination programmes that some of those provisions have afforded to us.

I will now set out and explain the proposed amendments that are in the draft regulations and explain why those provisions are still needed. Regulation 3 enables trained healthcare professionals or staff under the supervision of healthcare professionals to conduct the final stage of assembly, preparation and labelling of COVID-19 vaccines without additional marketing authorisations or manufacturers' licences being required. The flexibility that that provision provides continues to play an important role in our COVID-19 vaccination programme due to the supply chain arrangements and the way in which vaccinations are packaged. COVID-19 vaccinations are still not available as a prefilled syringe, so each vaccine that is administered continues to require final-stage preparation before administration to patients. The provision also allows the labelling of vaccines with a new shelf life at distributor level after thawing without the need for a manufacturer's licence or marketing authorisation. The current provisions expire on 1 April 2024, and, if they are not extended, that has the potential to significantly disrupt preparations for the upcoming spring booster programme, which will rely on the ability of vaccine distributors to thaw and relabel COVID-19 vaccines prior to final distribution to Health and Social Care (HSC) vaccine providers. Regulation 19 allows COVID-19 and influenza vaccines to be moved between vaccine providers that operate under Health and Social Care arrangements without the need for a wholesale dealer's licence. The supply of vaccines from one healthcare organisation to another is normally classed as a wholesale distribution supply and is therefore subject to having a wholesale dealer's licence under regulation 18 of the HMRs. If the organisation does not hold such a licence because it is not required for normal business, that can lead to problems and delays in moving the vaccines between service providers and can run the risk of appropriate vaccination of at-risk groups not taking take place and the vaccines that could be used to facilitate access being wasted. The flexibility provided by the amendment to regulation 19 has enabled COVID-19 and seasonal influenza vaccines to be moved swiftly and safely in our healthcare system between HSC providers in order to meet patient need, improve access and avoid wastage. While the deployment programme is now more mature and, in normal circumstances, the requirement for wholesale dealer licences is an important safeguard, there is a continuing need for those flexibilities to be retained for future campaigns to ensure accessibility and reduce wastage. Regulation 247A enables the use of an extended workforce that is legally and safely able to administer a COVID-19 or influenza vaccine without the input of a prescriber. That is done using an approved protocol. The national protocol model has become a key tool in supporting both vaccination programmes by enabling the use of an expanded workforce to administer vaccines, with safeguards in place to ensure public safety, such as requirements for supervision by a prescriber or specified registered healthcare professional. That reduces pressure on our Health and Social Care workforce in other areas. Nearly 500,000 influenza vaccines are administered as part of our annual flu programme, and almost 350,000 COVID-19 vaccines are now administered as part of the autumn programme. That puts additional strain on an already stretched system, so, given that almost 80% of flu and COVID-19 vaccines are co-administered, it is essential that we make the best use of the available workforce to ensure that those considered most at risk receive their vaccines on time. Although COVID-19-related deaths and hospitalisations have declined, largely due to the continued effectiveness of vaccines and improved treatments, it continues to be recognised globally as a pandemic, which, in turn, enables the continued use of regulation 247A to develop those national protocols for the administration of our vaccine. There is a continuing requirement to deliver vaccines at pace and at scale, now and in the future, while maintaining public safety. Vaccines have proven to be the best line of defence against COVID-19 and for the prevention of severe illnesses arising from seasonal influenza, and that helps to reduce unplanned hospital admissions, which is a key factor in Health and Social Care resilience. However, I acknowledge that some of the measures may not be the most appropriate means of supporting vaccine deployment outside a pandemic response and that a more permanent solution needs to be put in place. During the period in which the amended regulations will operate, my officials will work collaboratively with their counterparts in England, Scotland and Wales to undertake consideration of longer-term and permanent proposals that will be consulted on at a later date. In the short term, however, at a time when COVID-19 continues to be prevalent, there is an ongoing need to support the continued safe and effective supply, distribution and administration of vaccines by maintaining the provisions until April 2026. There was a UK-wide public consultation in 2023 on the proposed amendments to the three regulations, and my Department circulated the consultation to all relevant stakeholders in Northern Ireland. There were 220 responses from across the UK. Due to the consultation's technical nature, less than 3% came from Northern Ireland. However, over 80% of those who responded expressed their support for each of the proposed amendments. The Human Medicines Regulations have a UK-wide territorial application and are normally made jointly by my Department and the Secretary of State for Health and Social Care, using the draft affirmative procedure, and debated and approved via the draft affirmative procedure in both Houses of Parliament and in the Assembly. However, with Northern Ireland not having a sitting Assembly until recently and given the significance and time-limited nature of the amendments, the UK Government recently made the decision to proceed with the laying of draft amending statutory instruments that applied only to Great Britain. The statutory instrument was made for Great Britain on 6 March, following debate in the House of Commons and the House of Lords, and will come into operation on 31 March 2024, extending the legislative provision that I have outlined today to 1 April 2026. The draft regulations before the Assembly replicate the provisions made for Great Britain. If the draft regulations are approved by the Assembly today, the respective provisions will be extended and will continue to apply to Northern Ireland after 31 March 2024 and until 1 April 2026 in the same way as they will apply to the rest of the United Kingdom. My officials attended the Health Committee meeting on 29 February to outline the policy intent of the draft statutory rule and to respond to any questions the Committee had with regard to the regulations possibly being debated in the Assembly. I am pleased to confirm that the Committee raised no issues on the content of the draft regulations. It is with the Committee's support that I now bring the statutory rule (SR) before the wider Assembly and its Members. I therefore commend the motion to the Assembly.

1,551 words. Text as published by the Northern Ireland Assembly.

Assessment

Not qualifying

Jev’s structured answers

Assessed 21 October 2026 at 09:45 UTC by jev-1.13.0 (requested as typesafe/jev) under rubric 2026.10-r9, methodology 1.9.

Disagree with this assessment?

Classifications can be challenged. A person reviews every challenge, and any change is recorded publicly above with its reason.

Challenge this classification