The legislation ‘The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021’ came into effect on 1 September 2021 with the deadline for submissions by suppliers being the 31 August 2021. Tests would have needed to be approved by 31 October 2021 or withdrawn from the market.
On the 20 October, suppliers were written to and informed that due to issues with evidence required to approve tests under this legislation; in order to protect public health by ensuring availability of tests, the Secretary of State published a protocol listing certain tests that have both passed a public sector validation, and have a pending application awaiting validation, to remain on the market up to 28 February 2022 or until their validation application is determined.
This process has been ineffective and disjointed. BIVDA co-signed a letter with ABHI to which a response was provided which did not address any of the points made, but separate to this, BIVDA issued our own letter in early November which was more specific and outlined more relevant points to IVD manufacturers. We did not send to a large distribution list.
It highlighted our significant concerns with the manner in which the legislation has been implemented, and certain issues to which we require a response. This was followed up earlier this week and the letter is in review by Jennie Harries’ office.
Extracts are below;
• Timeframe allowed for the review of the products on the market has proved to be wholly insufficient.
• DHSC’s approach is having a significant distortive effect on the market.
• The implementation of the policy did not properly assess the availability of products on the market and how the legislated timescales could impact on this.
• Insufficient assessment was made of the processes needed to meet the requirements.
• The implementation has obviously been challenging for the CTDA team and the impact on competition not considered fully.
• The requirement that inclusion on the annex to the protocol only applies to tests that have undergone validation for public sector procurement or supply for Test and Trace contracts is having the effect of significantly curtailing access for many suppliers of tests.
• The triage process for suppliers was closed (CONDOR/NTAG) last year as the Test and Trace provision reached its capacity and there was no further requirement for applications. The government guidance made this clear to suppliers at the time.
• With regards to public sector procurement, the vast majority of suppliers have been supplying the NHS through NHS Supply Chain Framework and the PHE Microbiology Framework, neither of which required a validation to be undertaken by TVG (which is the list of products from which the temporary protocol was derived).
• No requirement was set out for this in the contract documentation and correspondence was sent to suppliers on 15 September 2020 confirming this to be the case.
• The guidance on the Government website stated that a test or developer did not need to submit through the triage process for TVG and could sell to the laboratories provided they had the relevant regulatory approvals (at the time) . This is unnecessary and disproportionate.
• The length of time the helpdesk is able to respond to suppliers is unsatisfactory, and it does not appear that time is of the essence when considering suppliers’ queries.
• The CTDA team did not have a set format for data prior to the deadline for application and stated that this would not affect supplier’s applications. This is clearly not the case and was misleading.
• In many cases, CTDA is in possession of the necessary information either directly from suppliers or from their own validation processes and has not evaluated it, and this has artificially distorted the market and competition within it.
• An extension of the time allowed for suppliers to continue to place products on the market whilst waiting for CTDA to work through the backlog would not only address patient safety and NHS workforce issues, but also minimise the risk to the UK government from any legal issues that the current implementation of the process has caused and would mitigate the risk of legal proceedings or judicial review being sought.
We are continually liaising with the CTDA team, and where members have asked questions, or sought our support we will be getting back to you as soon as answers are provided.
Please contact Helen for any further information.
