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b. EveryDoctor, Suites 1-3, The Hop Exchange, 24 Southwark Street, London, SE1 1TY.

c. Ecotricity New Ventures Ltd, Lion House, Rowcroft, Stroud, United Kingdom, GL5 3BY

d. Mr Dale Vince. Contrary to the Pre-Action Protocol for Judicial Review, Mr Vince’s address has not

been provided in either LBA or LBA2.

The details of the matter being challenged

4. At LBA §1.1, your clients identify the impugned decision/s as “the decision(s) of the Prime Minister and the

Secretary of State for Health and Social Care and/or other Government Ministers ... in relation to “Project

Moonshot”. We understand that Project Moonshot is a Central Government initiative involving the intention

to spend c. £100 billion of public money on a new, mass population COVID-19 testing programme

providing 6-10 million tests a day.”

5. In that context, the details of the matter being challenged are set out at LBA §1.5 as follows:

“...the Claimants have serious concerns, that they consider may appropriately be addressed by way of

judicial review, in respect of:

(a) the lawfulness of the decision-making process leading to the decision to approve and

commit £100 billion of public money to Project Moonshot; and

(b) the lawfulness of the decision-making process(es) leading to the award or intended award

of the Contracts.”

6. At LBA2 §§5-6, your clients have expressed “serious concerns in respect of the lawfulness of the

Defendants’ decision making process”, including in respect of:

a. the Proposed Defendants’ vires “having regard, amongst other things, to the fundamental

requirement in s. 1(4) of the National Health Service Act 2006 that “services provided as part of the

health service in England must be free of charge except in so far as the making and recovery of

charges is expressly provided for by or under any enactment...”; and

b. “the steps that were taken to ensure compliance with s. 149 of the Equality Act 2010, as well as

relevant human rights obligations under Article 8 and Article 14, when making the decision to

approve the Project.”

7. Our clients address those two additional matters below. So far as the “concerns” listed at LBA2 §§5-6 are

not exhaustively set out, our clients reserve all rights.

8. It is noted at the outset that your clients’ proposed claims, whether by way of judicial review or under the

Public Contracts Regulations 2015 (“PCR 2015”), are speculative, vague, lacking in proper particulars, and

lacking in any proper evidential foundation. In particular, that there has been no “decision to approve and

commit £100 billion of public money to Project Moonshot”. Indeed, as made clear in our letter of 28

September 2020, no financial commitment has been entered into approaching anything like that sum. It

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appears to our clients that your clients’ concern is based on having had sight of a leaked document, namely

the Project Moonshot Briefing Pack (as to which see further below). The Project Moonshot Briefing Pack

was a document designed to provoke discussion: it did not and does not reflect an adopted policy.

Relevant Factual background

9. At present, the best known test for detecting COVID-19 infection is reverse transcription polymerase chain

reaction (“RT-PCR”), extracting viral RNA from a swab. PCR is very sensitive and highly specific. It has the

ability to detect very low levels of viral RNA, and as such will detect individuals who are infectious, as well

as those who have recovered and are not infectious but still shed virus. The tests require laboratory

processing and therefore take time to process.

10. New technologies are available that are less sensitive (i.e. produce more false negatives) or less specific

(i.e. produce more false positives) than RT-PCR, but are faster and simpler and may be suitable for use

outside labs. These include direct detection of antigen by various methods, rapid RT-PCR in portable

instruments, and an approach called reverse transcription loop-mediated amplification (“RT-LAMP”). LAMP

is a similar approach to conventional PCR, but can be carried out at a fixed temperature rather than the

cycling temperatures needed for PCR. It can allow the test to be done much faster, and with simpler

equipment. New techniques allow both PCR and LAMP to be carried out without extracting RNA from the

sample; these techniques are known as direct amplification. Direct amplification is faster, due to the

elimination of extraction steps, but can also introduce variability in results or affect sensitivity. Direct

antigen detection methods (hand-held assays, similar to a pregnancy test) have also been developed.

11. In late July 2020, it was recognised that the RT-LAMP approach could allow very rapid testing (less than 30

minutes) and could be scaled to allow very widespread and frequent testing. Accordingly, attention turned

to selecting which RT-LAMP test(s) have the best performance in clinical samples and gaining a good view

of their operational sensitivity and specificity. New approaches to testing were being and continue to be

developed at a considerable rate, with a highly competitive global market in the development, piloting and

purchase of such technologies.

12. For the avoidance of doubt, the delivery of such mass testing was without prejudice to the then already

existing plans to increase diagnostic testing to 800,000 tests per day by the end of 2020.

13. On the 12 August the Chancellor agreed to allocate £0.5 billion of preliminary funding, including to proceed

with investments in new testing technologies. Spending within this envelope is subject to the usual

Managing Public Money controls.

14. The initial Project Moonshot Briefing Pack was created in August 2020. “Project Moonshot” then referred to

the ambition to undertake integrated mass asymptomatic testing of the general population for COVID-19,

with a view to, amongst other things, saving lives by limiting the R-rate, building societal confidence, and

mitigating the significant economic prejudice arising as a consequence of the COVID-19 pandemic. Such

testing would also function to reduce the need for further lockdowns. New testing technology permitted

mass asymptomatic testing of a magnitude far greater than the iterative scaling up of RT-PCR testing.

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15. Even then, the Project Moonshot Briefing Pack did not reflect adopted governmental policy. As noted at

paragraph 8 above, the Project Moonshot Briefing Pack was for the purpose of provoking discussion. In

light of the content of the LBA, it bears repeating that no decision was taken then or at any subsequent

stage to approve and commit £100 billion of public funds to “Project Moonshot”.

16. The context in which the Project Moonshot Briefing Pack was created was one of, amongst other things:

a. The increasing numbers of deaths and serious illnesses arising from COVID-19;

b. COVID-19 having wrought increasingly significant economic damage;

c. A developing expert consensus that testing for COVID-19 need not be confined to diagnostic

testing;

d. The continued development of new and/or improved SARS-CoV-2 detection techniques; and

e. The extraordinarily fast-paced and competitive international market for the purchase of supplies of

testing technologies from a market characterised by a limited number of economic operators, albeit

with frequent new market entrants.

17. The proposal referred to in the Project Moonshot Briefing Pack was developed alongside the existing NHS

Test and Trace Programme (“NHSTT”) of the Department for Health and Social Care (“DHSC”). NHSTT’s

approved “core” budget was approximately £12.1 billion. NHSTT has an open supplier portal, where

suppliers can register solutions that they can supply. Certain suppliers have sought to do so in relation to

Project Moonshot.

18. The substance of the proposal referred to in the Project Moonshot Briefing Pack has since been subsumed

within NHSTT, reflecting the fast-moving and constantly evolving policy requirements in the field of testing

(both diagnostic and asymptomatic). It has come to be referred to as part of NHSTT’s “Mass Testing”

programme. In that context, it is noted that iterative developments of policy proposals per se do not

constitute a juristically relevant decisions capable of challenge in judicial review proceedings or pursuant to

the PCR.

19. On 27 August 2020, there was a “call to arms” roundtable meeting with invited representatives of the

manufacturing industry. The invitees were selected in view of their extraordinary capacity and expertise to

develop and scale up domestic supply chains and manufacturing in respect of testing.

20. Further:

a. A list of providers of relevant testing technologies created and updated by the Rockefeller

Foundation was consulted to identify those economic operators capable of providing relevant

testing supply chains and manufacturing, who were thereafter approached.

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b. The NHSTT website hosted at all material times a form for completion by anyone interested in

supplying relevant technologies.

21. On 28 August 2020 the Cabinet Office and the Treasury agreed to amend delegations to be in line with

wider DHSC thresholds and align the spending and commercial delegations to streamline the process for

commercial and financial approvals for NHSTT, together with the implementation of various financial

controls. When approving those enhanced delegations, the Chief Secretary of the Treasury stated:

“Central spending controls are a vital tool to protect taxpayers from misuse of public funds and drive

value for money in Government spending. It is therefore imperative that when raising delegations

DHSC’s internal processes provide adequate defence against poor value for money or misuse of public

funds, to ensure spending remains proper and in line with Parliamentary expectations. The ambition

should be to provide similar levels of scrutiny and challenge that would be achieved via HMT and CO

controls processes.”

22. The timescales required for securing supplies to test volumes were not sufficient to run an accelerated

procurement procedure. Without prejudice to the specific analyses of urgency in each relevant case in

which Regulation 32(2)(c) PCR 2015 was relied upon, our clients note the following features of extreme

urgency relevant to the contracts entered into and letters of intent issued to date:

a. The WHO Director General characterised COVID-19 as a pandemic on 11 March 2020. By that

stage Europe was the centre of the pandemic. The Commission itself confirmed: “The current

coronavirus crisis presents an extreme and unforeseeable urgency – precisely for such a situation

our European rules enable public buyers to buy within a matter of days, even hours, if necessary.”

(Commissioner Breton, Internal Market on 1 April 2020).

b. The upcoming autumn and winter will most likely see a further rise of COVID-19 alongside the

yearly flu season, as is already being seen. Further and in any event, the COVID-19 pandemic is

regaining traction. Local lockdowns are required to contain the virus and, it is anticipated, will

continue to be required throughout the autumn and winter.

c. It is essential that the initiation phase for testing technologies is commenced as soon as possible to

enable the testing infrastructure and capacity to be in place for the upcoming flu season when a

large number of patients with symptoms common to COVID-19 and the flu will require a clear test

result in case COVID-19 is not the underlying cause.

d. In situations in which Regulation 32(2)(c) PCR 2015 has been relied upon, the DHSC has lawfully

formed the view that an accelerated procurement exercise would delay the development and

implementation of testing technologies such that they will not be available for the period when they

will most likely save lives.