Validating COVID-19 tests in the private market; RPC Opinion (Green-rated)
Regulatory Policy Committee opinion on DHSC's validating COVID-19 tests in the private market IA
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The proposed regulation would make mandatory validation requirements for COVID-19 test devices for sale in the private market.
The Department first published an IA on 20 July 2021, on which the RPC issued and published an opinion which was rated as not fit for purpose based on the calculation of the equivalent annual net direct cost to business (EANDCB). The first stage (desktop validation) of the measure was introduced in legislation on 28 July 2021. The Department has now submitted the next iteration of the IA in anticipation of the passage of legislation to introduce the second stage (laboratory validation) of the measure.
The IA provides a clear rationale for intervention. It is well researched and draws upon a range of sources, such as consultations and commissioned research, to inform the assumptions used in the cost-benefit analysis. However, the IA may contextualise the analysis further by illustrating the acceptable levels for producing false results and how this compares to government-procured devices or other forms of available testing. The IA apportions the impacts to non-UK businesses and correctly excludes these from the calculation of the equivalent annual net cost to business and net present value. The IA could have provided more on any insights from the implementation of the first stage earlier in 2021