Evusheld RAPID C19 Oversight meetings 12 August to 6 September 2022

The request was successful.

Dear National Institute for Health and Care Excellence,

As NICE is the Secretariat for the RAPID C19 Oversight Group please provide details of all scheduled or ad hoc meetings (whether by email, phone, attendance or other
electronic means) that took place between 12 August and 6 September 2022 for this Group

For each meeting please provide:

- the details of the attendees;

- the agenda;

- any briefing/advice papers provided on Evusheld including
horizon-scanning outputs; and

- any actions and decisions from these meetings that refer to Evusheld,
including any assessment of the evidence and suggested next steps.

For the avoidance of doubt when I refer to Evusheld I mean the product with the brand name Evusheld which could be called a combination of tixagevimab and cilgavimab, AZD7442 or any other name that this Group uses either jointly or severally for theses compounds.

Yours faithfully,

Louise Bicknell

National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

Dear Louise

Reference No: EH-325504

FREEDOM OF INFORMATION ACT 2000

Thank you for your request, received by our office on 15 September 2022, in which you asked for the following information:

"As NICE is the Secretariat for the RAPID C19 Oversight Group please provide details of all scheduled or ad hoc meetings (whether by email, phone, attendance or other electronic means) that took place between 12 August and 6 September 2022 for this Group

For each meeting please provide:

- the details of the attendees;

- the agenda;

- any briefing/advice papers provided on Evusheld including horizon-scanning outputs; and

- any actions and decisions from these meetings that refer to Evusheld, including any assessment of the evidence and suggested next steps."

Your request will now be considered under the Freedom of Information Act 2000, which provides public access to information held by public authorities. You will receive a response within the statutory timescale of 20 working days as defined by the Act, subject to the information not being exempt or containing a reference to a third party. In some circumstances we may be unable to achieve this deadline. If this is likely you will be informed and given a revised timescale at the earliest opportunity.

There may be a fee payable for the retrieval, collation and provision of the information you request. If this is the case you will be informed and the 20 working day timescale will be suspended until we receive payment from you. If you chose not to make a payment then your request will remain unanswered.

Some requests may also require either full or partial transference to another public authority in order to answer your query in the fullest possible way. Again, you will be informed if this is the case.

I would like to take this opportunity to thank you for your interest in NICE.

Yours sincerely,

Victoria

Communications manager
National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United Kingdom
Tel: 0300 323 0141

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National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

1 Attachment

Dear Louise

Please see the email below that was sent to you on Friday in response to
your Freedom of Information request.

Unfortunately, the email has bounced back as the attachments were too big
to get through whatdotheyknow.com’s firewall. We received the error
message:

“Delivery has failed to these recipients or groups:

[1][FOI #899211 email]
([FOI #899211 email])
Your message is larger than the size limit for messages. Please make it
smaller and try sending it again.”

Do you have an alternative email address that we can send our full
response to please?

Many thanks,

Victoria

Communications manager

National Institute for Health and Care Excellence

Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

 

 

From: National Institute for Health and Care Excellence (NICE)
<[NICE request email]>
Sent: 14 October 2022 18:02
To: [FOI #899211 email]
Subject: Freedom of Information request - Evusheld RAPID C19 Oversight
meetings 12 August to 6 September 2022 (NICE ref. EH-325504)

 

Dear Louise

 

Reference No: EH-325504

 

FREEDOM OF INFORMATION (FOI) ACT 2000

 

Thank you for your request, received by our office on 15 September 2022,
in which you asked for the following, in relation to the RAPID C-19
oversight group:

 

“…details of all scheduled or ad hoc meetings (whether by email, phone,
attendance or other electronic means) that took place between 12 August 
and 6 September 2022 for this Group”.

 

For each meeting please provide:

 

- the details of the attendees;

 

- the agenda;

 

- any briefing/advice papers provided on Evusheld including
horizon-scanning outputs; and

 

- any actions and decisions from these meetings that refer to Evusheld,
including any assessment of the evidence and suggested next steps.”

 

I can confirm that meetings of the RAPID C-19 oversight group were held on
the following dates during the period you have asked about:

 

• 17 August 2022
• 24 August 2022.

 

We do hold information that falls within the scope of your request; our
answers to each of the points in your request are included below.

 

 1. Details of the attendees

 

We do not hold the details of the people who attended the meetings on 17
and 24 August 2022. The names of the people who were invited to the
meetings (but did not necessarily attend) are included in the agendas
(please see section 2 below).

 

 2. The agendas

 

Attached are the agendas for the meetings on 17 and 24 August 2022 (marked
‘doc A’ and ‘doc B’).

 

Some of the information within these documents has been redacted, as we
believe that section 40 of the FOI Act applies. This information consists
of the names and initials of some members and attendees of the RAPID C-19
oversight group whose details are not already in the public domain in this
context. Please see below for further details on section 40.

 

 3. Any briefing/advice papers provided on Evusheld including
horizon-scanning outputs

 

The information we hold for this part of your request is attached in the
documents named ‘Doc C’ and ‘Doc D’.

 

Some of the information within these documents (some names and people’s
initials) has been redacted, as we believe that section 40 of the FOI Act
applies. Please see below for further details.

 

In addition, some further information has been redacted as we believe that
sections 41 and 43(2) of the FOI Act apply. This information consists of
data that was provided to RAPID C-19 in confidence by the UK Health
Security Agency (UKHSA) or the manufacturer of tixagevimab–cilgavimab
(Evusheld). Further details about sections 41 and 43(2) are included
below.  

 

 4. Any actions and decisions from these meetings that refer to Evusheld,
including any assessment of the evidence and suggested next steps

 

The information we hold for this part of your request is attached in the
documents named ‘Doc E’ and ‘Doc F’.

 

Some of the information within document E has been redacted, as either it
falls outside the scope of your request (for example, it does not refer to
Evusheld), or we believe that section 40 of the FOI Act applies. This
information consists of the names and initials of some members and
attendees of the RAPID C-19 oversight group whose details are not already
in the public domain in this context.

 

Please see below for further details on section 40.

 

Section 40 of the FOI Act

 

Section 40(2) of the FOI Act exempts third party personal data (i.e.
personal data of anyone other than the applicant) from disclosure if
disclosure would breach any one of the data protection principles (section
40(3A)). The data protection principles are provided in Article 5 of the
General Data Protection Regulation (GDPR). Principle 1(a) states that
personal data must be ‘processed lawfully, fairly and in a transparent
manner in relation to the data subject’.

 

Releasing personal information in response to an FOI request is classed as
‘processing’ and can only be done if there is a lawful basis to do so. The
lawful bases are outlined in Article 6 of the GDPR. Only (a) consent and
(f) legitimate interests are relevant to disclosure under FOIA and are
considered below.

 

On basis a, we do not have explicit consent for the disclosure of the
third party’s personal data.

 

While section 40(2) and (3A) is an absolute exemption, and thus not
subject to the public interest test, a balancing exercise is required to
weigh up the rights and interests of the data subject against the
legitimate interests of disclosure, basis f. We do not believe that the
legitimate interests in disclosure outweigh the interests or fundamental
rights and freedoms of the data subjects. Disclosure would therefore
breach data protection principle (a), which requires personal data to be
processed lawfully, fairly and in a transparent manner in relation to the
data subjects. As such, section 40(2) and (3A) of the FOIA is engaged and
it is unlawful for NICE to disclose the information requested.

 

We have therefore redacted some information from the attached documents
(as detailed above in our response to sections 2, 3 and 4 of your
request).

 

Section 41 of the FOI Act

 

We consider that the redacted information in the attachments named ‘Doc C’
and Doc D’ is exempt from disclosure under section 41 of the Freedom of
Information Act 2000. Section 41(1) states:

 

Information is exempt information if –

 

 a. It was obtained by the public authority from any other person
(including another public authority), and,
 b. The disclosure of the information to the public (otherwise than under
this Act) by the public authority holding it would constitute a breach
of confidence actionable by that or any other person.

 

Section 41(1) is an absolute exemption which means that there is no need
to consider the public interest test under the Act. However, the common
law duty of confidence contains an inherent public interest test which we
have considered in order to decide if the information that you requested
is exempt. As the information was provided to RAPID C-19 by an external
organisation, the UK Health Security Agency or AstraZeneca, and disclosure
of the information could give rise to an actionable breach of confidence,
we are satisfied that both of the above components apply.

 

The public interest test when considering a duty of confidence assumes
that information should be withheld unless the public interest in
disclosure outweighs the public interest in maintaining the confidence. In
favour of releasing the information that you have requested, we
acknowledge that it is in the interests of the public generally that all
relevant information about technologies being monitored by RAPID C-19, be
put into the public domain to promote openness and transparency.

 

However, the interest in favour of disclosure has to be balanced against
the potential damage caused by disclosure of information provided in
confidence. Companies would be discouraged from submitting data and
information to RAPID C-19 and, more broadly, NICE if they did not have a
degree of certainty that such confidences would be respected.

 

Furthermore, there is a public interest in preserving a free flow of
information to a public authority where this is necessary for the public
authority to perform its statutory functions. If we were to release
information provided in confidence we would not only risk action being
taken against us by the providers of the information, but we would also
risk losing the confidence of other companies and organisations that we
are working with currently, and will need to work with again in the
future.

 

Section 43(2) of the FOI Act   

 

Section 43 of the FOI act states that if providing information to comply
with the request “would, or would be likely to, prejudice the commercial
interests of any person (including the public authority holding it)”, the
information is exempt from release. For the purposes of the Act,
‘prejudice’ means causing harm in some way.

 

In this case we consider that disclosure of the redacted information in
the reports (which was marked as ‘commercial in confidence’) would be
likely to prejudice the commercial interests of AstraZeneca if it were
released in response to an FOI request, as it could be commercially
exploited by others, including the company’s commercial competitors.

 

We also believe that by disclosing the information, it would likely affect
the willingness of AstraZeneca to engage with RAPID C-19 and NICE in
future arrangements and so reduce the pool of drug manufacturers available
to work with us to provide treatment for NHS patients.

 

Exemptions under section 43(2) of the FOI Act are subject to a public
interest test, meaning that even though we have concluded that an
exemption applies, we must also consider whether the information should be
disclosed on the basis that it is in the public interest to do so. 

 

When considering factors in favour of disclosure, we have taken into
account the public interest in transparency, accountability and promoting
public confidence in our guidance and our decision-making.

 

However, the information has commercial value to the company
(AstraZeneca), it is intrinsically sensitive to the business of the
company concerned, and is unique and not in the public domain. This
commercial interest will be prejudiced by disclosure since releasing it
into the public domain would devalue the company’s intellectual property
and undermine them commercially. The information would be beneficial to
AstraZeneca’s commercial competitors, and therefore carries significant
commercial value.

 

Releasing the requested information into the public domain would be likely
to cause considerable commercial prejudice to the company.

 

Disclosure may also harm NICE’s commercial interests in ensuring our
ability to support the industry to bring new technologies to the NHS in a
cost-effective manner, ultimately having an adverse impact on the NHS and
people in need of treatment. Therefore, on balance, we have concluded that
the information requested should not be disclosed in response to your
request.

 

We have therefore redacted some information from the documents provided in
response to section 3 of your request, under sections 41 and 43(2) of the
FOI Act.

 

I hope this information is useful. If you have any questions on this
response you are welcome to contact the enquiry handling team at
[2][NICE request email].

If you are unhappy with this response and want an internal review of how
we handled your request, you must write to us within 40 working days of
our response. Send your request to: Associate Director, Corporate Office,
National Institute for Health and Care Excellence, 2nd Floor, 2 Redman
Place, London, E20 1JQ or email: [3][email address]. When we
receive your request, we will send you an acknowledgement within 5 working
days.

The Associate Director, Corporate Office, will review your complaint and
send you a full reply usually within 20 working days. If you are
dissatisfied with the outcome of this review, you can apply directly to
the Information Commissioner for a decision at: The Information
Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9
5AF.

Kind regards,

Victoria

 

Communications manager

National Institute for Health and Care Excellence

Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

 

 

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Dear National Institute for Health and Care Excellence (NICE),
Your reference EH-325505

Hi Victoria

If you have difficulty providing all the documents as one file, please can you send through this website as 6 individuals files A, B, C, D, E & F.

If that does not work, please provide a direct email address or direct telephone number and I will revert with another method to provide these

I look forward to reviewing the paperwork

Yours sincerely,

Louise Bicknell

Louise Bicknell left an annotation ()

NICE advise that they cannot send the documents to this site as they are too large. I have asked that they send the six different sets separately to this site as responses

National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

2 Attachments

Dear Louise

Thank you for your email.

Document A and B attached,

Best wishes,

Victoria

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National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

1 Attachment

Dear Louise

Thank you for your email.

Document C attached.

Best wishes,

Victoria

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National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

2 Attachments

  • Attachment

    Doc E Rapid C 19 Oversight Group Meeting Action Log updated 25.08.2022 Redacted.pdf

    103K Download View as HTML

  • Attachment

    Doc F Rapid C 19 Oversight Group Meeting Decision Log updated 25.08.2022 Redacted.pdf

    150K Download View as HTML

Dear Louise

Thank you for your email.

Document E and F attached,

Best wishes,

Victoria

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National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

1 Attachment

Dear Louise

Thank you for your email.

Document D attached,

Best wishes,

Victoria

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Dear National Institute for Health and Care Excellence,

NICE ref. EH-325504

Thank you for your response.

Please can clarify a point for me

In respect of document E “The RAPID C-19 Oversight Group Action Log” you state “the information within document E has been redacted, as either it falls outside the scope of your request (for example it does not refer to Evusheld), or we believe that section 40 of the FOI applies. This information consists of the names and initials of some members and attendees of the RAPID C-19 oversight group whose details are not already in the public domain in this context”

In respect of the redaction to the middle line of the action log, please be clear which exemption you are applying - outside scope or section 40 (third party personal data)?

I do not believe that the deletion of the entire line is appropriate. You can provide the numbers, the item details and the date added and deadline as none of these fall within the section 40 exemption.

As shown in action log item 1, you can delete the persons name/initials and leave the rest of the text in.

Please therefore review this and provide this detail from the action log

Yours faithfully,

Louise Bicknell

National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

Dear Louise

Reference No: EH-325504

FREEDOM OF INFORMATION (FOI) ACT 2000

Thank you for your follow-up email, received by our office on 21 October 2022, in which you asked us to clarify the following:

“In respect of document E “The RAPID C-19 Oversight Group Action Log” you state “the information within document E has been redacted, as either it falls outside the scope of your request (for example it does not refer to Evusheld), or we believe that section 40 of the FOI applies. This information consists of the names and initials of some members and attendees of the RAPID C-19 oversight group whose details are not already in the public domain in this context”

In respect of the redaction to the middle line of the action log, please be clear which exemption you are applying - outside scope or section 40 (third party personal data)?”

I would like to confirm that the middle line of document E was redacted as it does not refer to tixagevimab–cilgavimab (Evusheld), and therefore did not fall within the scope of your FOI request.

I hope this clarification is useful. If you are unhappy with this response and would like an internal review of how we handled your request, you must write to us within 40 working days of our response. Send your request to: Associate Director, Corporate Office, National Institute for Health and Care Excellence, 2nd Floor, 2 Redman Place, London, E20 1JQ or email: [email address]. When we receive your request, we will send you an acknowledgement within 5 working days.

The Associate Director, Corporate Office, will review your complaint and send you a full reply usually within 20 working days. If you are dissatisfied with the outcome of this review, you can apply directly to the Information Commissioner for a decision at: The Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF.
Kind regards,
Victoria

Communications manager
National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United Kingdom

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