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 4278967

Text

I thank the Committee Chair and other Members who have made contributions on the regulations as part of what has been a wider debate. I will turn to some of the points that have been raised. I thank the Chair for the ongoing support and engagement of the Committee for Health. In regard to Mrs Dodds' enquiries about why we need to extend provisions for COVID-related medicines to 2026 and why we do not have a more conventional way of delivering the provisions, the provisions continue to be important for the COVID-19 vaccination programme in Northern Ireland owing to supply chain arrangements and the way in which vaccines are packaged. The current recommended COVID-19 vaccinations, as has been said, are still not available as prefilled syringes, so each vaccine continues to require final-stage preparation before administration to patients. They are also distributed through the supply chain in a frozen state and require defrosting prior to final distribution to the health service vaccine providers. I do not have the specific number of businesses involved in that, but I will put that in writing to the Member. Allowing the provisions to lapse would, as I said, significantly disrupt plans for the distribution and deployment of vaccines for the upcoming spring programme. The provisions have allowed movement of vaccine between providers under our health and social care arrangements without the need for the wholesale dealer's licence. Such movement is in order to meet patient need, improve access and reduce waste. The supply of vaccines from one healthcare organisation to another would normally be classed as wholesale distribution supply and therefore as subject to having a wholesale dealer's licence under regulation 18 of the HMRs.
If such a licence is not held by the organisation because it is not required for normal business, as is the case for many healthcare organisations, it could lead to problems and delays with moving the vaccines between service providers and run the risk of appropriate vaccination of at-risk groups not taking place and wastage of vaccine. While the deployment programme is now more mature and, in normal circumstances, the requirement for wholesale dealer licences is that important safeguard, there is a continuing need for the flexibilities to be retained for future campaigns to ensure accessibility and to reduce wastage while longer-term and permanent proposals are developed.
Looking to some of the other comments, as part of that UK-wide collaboration across the four nations, it is about how we look between now and 1 April 2026 to get a permanent solution in regard to how we manage vaccine supply and distribution, relabelling and the workforce challenges that we have had. Vaccine safety is not included in the SRs, but it has been mentioned today. Safety is at the forefront of the COVID-19 and influenza vaccination programmes. Important safeguards have been put in place to ensure that the flexibilities provided by the amendments and wider do so safely and effectively. Vaccines are still subject to the usual controlled storage requirements, which include the maintenance of the cold chain in the transfer of any medicine between vaccine providers. Under those arrangements, storage is properly controlled and appropriate records of correct storage and transfers are maintained. A key part of safety is ensuring that the vaccinator workforce is trained to the highest level and ensuring that the workforce has undergone comprehensive training before administering a vaccine. Staff operating under national protocol arrangements are supervised by a named healthcare professional. I will mention the safety of COVID-19 vaccines. Each COVID-19 vaccine candidate is assessed by teams of scientists and clinicians on a case-by-case basis and is authorised only once it has met the robust standards of effectiveness, safety and quality set out by the independent medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is a globally recognised organisation that is recognised for requiring high standards of safety. Importantly, the monitoring of vaccine safety does not stop once a vaccine has been approved. The MHRA continuously monitors the safety of the COVID-19 vaccines through a comprehensive COVID-19 vaccine surveillance strategy to ensure that the benefits outweigh any known risks. All the COVID-19 vaccines administered in Northern Ireland to date have been approved for use by the MHRA. In addition, the COVID-19 vaccine programme has followed the advice and recommendations of the Joint Committee on Vaccination and Immunisation (JCVI), which is the independent expert advisory group that advises the four UK Health Departments on all vaccination-related matters. The MHRA, in the report on coronavirus vaccines, which was updated in March 2023, states:
"All vaccines and medicines have some side effects ... These side effects need to be continuously balanced against the expected benefits in preventing illness. Following widespread use of these vaccines across the UK, the vast majority of suspected adverse reaction reports confirm the safety profile seen in clinical trials. Most reports relate to injection-site reactions ... and generalised symptoms such as a ‘flu-like’ illness, headache, chills, fatigue ... Generally, these reactions are not associated with more serious illness and likely reflect as expected".
It continues:
"The benefits of the vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects ... the safety of COVID-19 vaccines will be continuously monitored"
by the MHRA
"and benefits and possible risks remain under review, as with all vaccines and medicines".
Anyone receiving a COVID-19 vaccination in Northern Ireland should also receive a leaflet advising them of the possible side effects, as well as how to report a suspect adverse reaction via the yellow card reporting scheme. The yellow card scheme is run by the MHRA and is the UK system for collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices. It relies on the voluntary reporting of suspect adverse drug reactions by health professionals and patients. All COVID-19 and flu vaccinations administered to date in Northern Ireland have been entirely voluntary. COVID-19 and flu vaccines are made available to those considered at greatest risk on the basis of the recommendations of the JCVI. The general public continue to make up their own minds regarding the vaccines that they receive, and hundreds of thousands continue to take up the offer of vaccination when they are invited to do so. Mr Frew will know that the vaccine damage payment is a UK-wide system that is set at the Westminster level. To date, my Department has not reviewed stepping outside what is a UK-wide system, given that COVID-19 vaccinations are administered through that system and the purchase that is supplied and regulated is done on a UK-wide basis. I firmly believe that the provisions are vital and should be extended as proposed, that the COVID-19 and influenza vaccination programmes in Northern Ireland have made extensive use of those flexibilities and that their cessation would cause significant disruption to our programmes. I therefore commend the motion on the regulations to the Assembly.

1,158 words. Text as published by the Northern Ireland Assembly.

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