Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024

Given the continuing importance of these vaccination programmes in protecting public health, the Government have engaged widely to determine whether to retain the provisions in the Human Medicines Regulations beyond their current period. Following initial engagement with key stakeholders, including NHS England, the Government ran a public consultation, from 7 August to 18 September 2023, on proposals to temporarily extend these regulations until 1 April 2026 while a permanent solution is developed. For Regulation 247A, this also involves removing condition A from the regulation, which requires there to be a pandemic. This proposal was based on feedback, including from NHS England, that without these regulations the Covid-19 and flu vaccination services would be negatively impacted and could not continue to be delivered at the scale required. Overall, from the 220 respondents to the consultation, a high level of support was shown for these proposals across all nations.

For Regulation 3A, 89% of respondents agreed that the regulation should be extended. The flexibility provided by this provision continues to play an important role in the Covid-19 vaccination programme due to the supply chain arrangements and the way in which the vaccinations are packaged. Covid-19 vaccinations are not available as a pre-filled syringe and so each vaccine administered continues to require final-stage preparation before administration to patients. The consultation found that the flexibilities have allowed for the safe assembly and preparation at the pace and scale required within the programme. It also found that Regulation 3A improves the operational delivery of Covid-19 vaccines through a safe and effective framework, increases efficiency within the system and allows for delivery at scale, in turn helping to improve access and more effectively using the workforce.

There was also a high level of support in the consultation response for the proposal to extend Regulation 19, with 91% agreeing that this regulation should be extended. Many respondents had commented that, due to vaccines being more easily moved between sites, vaccine wastage had been reduced, helping to reduce the environmental impact of our vaccination programmes—something that we are obviously keen to encourage. At the same time, these regulations were found to have brought about a more efficient use of resources and improved patient access to vaccines, including through co-administration. As I mentioned, 4.5 million people had both their Covid-19 and flu vaccinations at the same time during the last autumn campaign.

For Regulation 247A, a similarly high level of support was seen in the consultation responses: 82% agreed with the proposal to remove condition A from the regulation, which requires there to be a pandemic to be used, and 82% also agreed that this should be time- limited to April 2026. Many respondents cited that Regulation 247A provided a safe and effective mechanism to improve the delivery of Covid-19 and flu vaccines during the pandemic. The measures were also found to have played an important role in reducing workforce pressures, facilitating an increase in the capacity to deliver hundreds of millions of Covid-19 and flu vaccinations and releasing qualified healthcare professionals to deliver other care across the system.

The temporary amendments to the Human Medicines Regulations have been and continue to be vital to the successful delivery of the Covid-19 vaccination programme. To not extend these provisions would have a significant impact on the delivery of current vaccination programmes. Without these provisions, some NHS vaccination activities would need to cease, which would likely have a negative impact on the uptake of these vaccinations.

Therefore, the Government propose to temporarily extend the provisions provided by these regulations to 1 April 2026, while a more permanent solution is developed. In the case of Regulation 247A, the Government also propose to remove the requirement that there should be a pandemic or imminent pandemic when the medicine is supplied. I beg to move.