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As mentioned in last week’s update, UKHSA has answered the questions raised at the webinar jointly held with UKHSA, ABHI and BIVDA on Monday 21st March.

There has been progress on applications and various updates since the webinar was held and some of the questions asked clearly reflect a moment in time.

The original Q&A document was sent to UKHSA without being edited so they received the comments and questions in the format provided to us, albeit not attributable to any given company or individual.

The reason for this was to ensure that the feeling across industry was understood. BIVDA followed up with a private letter to the directors of CTDA to indicate that the level of concern from our members had been underrepresented due to the controlled webinar structure. We sent in a significant amount of additional commentary to supplement the ones from the webinar. We feel that the majority of the progress that has been made is related to our separate correspondence and regular meetings with them rather than the impact of the show case event on the 21st March.

We are due to hold another industry webinar with UKHSA shortly which is likely to be of the same structure due to the stipulations and conditions from UKHSA. Whilst frustrating that its not completely free and open, it is at least understandable and fair due to the levels of commercial sensitivity and individuals involved in some quite difficult decisions and conversations.

Many of you will have seen the formal response through our issuance of the document and impact assessment on Monday this week through our Infectious Disease working party mailing, and perhaps also through the event registration from ABHI. However, for those who have not yet seen this, the document can be found HERE and the link to the referenced impact assessment is here.

The key points that have come out of this have mainly been answered before through our regular updates from the bi-weekly calls, specifically timelines for responses, quality of responses and their continued regulatory role. There is a review of the policy later in the year, and Doris-Ann and Ashleigh are involved in these discussions.

It is concerning, although not surprising that overall they feel that this process has been successful and widely supported, and BIVDA will continue to argue to the contrary with regard to future regulation and will work alongside ABHI to get this message across in an aligned manner. It is fair that the process has developed and improved significantly over the 12 months it has been in place and the achievements by key individuals at UKHSA to turn it around should be recognised as a positive. This does not change the fact it is costly and burdensome, and we will continue to represent members views robustly.

New applications are being reviewed and appear to be completing within the timescales stated in the regulations, and UKHSA are piloting ways to clear the backlog from the introduction of the legislation.

There are some outstanding questions that were not answered within this document and Ashleigh has followed up and will issue those answers to BIVDA members as soon as possible.

If anyone would like to discuss the CTDA process in more detail, or has a specific concern that we can support, please email either me, Doris-Ann or Ashleigh.

Natalie Creaney

About Natalie Creaney