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MHRA buyer requests software package and information systems

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This is a request for proposals.

Description of the procurement:

The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed.

…

For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool.

Strictly necessary — it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health.

Reasons of extreme urgency — the MHRA recognises that its planned procurement process for the SafetyConnect programme, including the AI tool, would not have concluded by vaccine launch. Leading to a inability to effectively monitor adverse reactions to a Covid-19 vaccine.

Events unforeseeable — the Covid-19 crisis is novel and developments in the search of a Covid-19 vaccine have not followed any predictable pattern so far.

— Ted-Tenders

In other words, MHRA wants to enhance or replace the Yellow Card system to help them keep up with the expected high volume of reports. They seem certain already that there will be adverse events.

How did the MHRA know at this point that there would be a high volume of reports? And if they knew, why were the jabs allowed to proceed?

To their credit, I suppose, the MHRA seems to have been genuinely caught off guard by the COVID situation.  The request came quite late.  Had they been part of the planning of the COVID-19 event, this would have been done long ago.

I agree with Janet Menage on The BMJ:

And would it not be more sensible to determine the safety profile of a Covid-19 vaccine while the stable door is shut, rather than monitor the galloping horse once it has bolted?

But I think perhaps that the agenda goes well beyond trying to control a disease. Otherwise, the jab rollouts would have been halted in February 2021, if not sooner, after results of the initial jabs came in.  Instead, with each bad report, we saw the health agencies doubling down on their urgency to get the jabs out as if there was some hidden imperative to do so no matter the consequences.  I am beginning to think that when “they” say that the benefits still outweigh the risks, they are not talking about health benefits, but rather “they” are considering the benefits of hidden purposes.  I am not sure I have fully identified “they” yet, and so I hesitate to point out any particular individuals.  It is possible that identities of “they” could be determined from some of the patents.

This is the regulation that was referred to in the Ted-Tenders request:

Regulation 32(2) sets out the following:

The negotiated procedure without prior publication may be used for public works contracts, public supply contracts and public service contracts in any of the following cases: …

(c) insofar as is strictly necessary where, for reasons of extreme urgency brought about by events unforeseeable by the contracting authority, the time limits for the open or restricted procedures or competitive procedures with negotiation cannot be complied with.

… the circumstances invoked to justify extreme urgency must not in any event be attributable to the contracting authority.

— Cabinet Office

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