PV Strategy Document, AESI spreadsheet, Pfizer case output files

Roedd y cais yn rhannol lwyddiannus.

Dear Medicines and Healthcare Products Regulatory Agency,

Please provide the following files:

- All versions of the document referred to as the "PV Strategy Document" or "Refined PV strategy document" in the December 2021 and June 2022 versions of "Monitoring and signal detection activities for ADR reports concerning the COVID-19 vaccine"

- The "AESI Line Listing.xlsx" file in this sub-folder: "https://mhra.sharepoint.com/.../Covid-19 vigilance/COVID-19 Vaccine".

- All files in the sub-folder: "https://mhra.sharepoint.com/.../Covid-19 vigilance/COVID-19 Vaccine/COVID-19 mRNA BioNTech Case Outputs"

Yours faithfully,

D Jackson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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________________________________________ From: D Jackson
<[FOI #888095 email]> Sent: Wednesday, August 17,
2022 7:56:47 PM To: MHRA Customer Services Subject: Freedom of Information
request - PV Strategy Document, AESI spreadsheet, Pfizer case output files
Dear Medicines and Healthcare Products Regulatory Agency, Please provide
the following files: - All versions of the document referred to as the "PV
Strategy Document" or "Refined PV strategy document" in the December 2021
and June 2022 versions of "Monitoring and signal detection activities for
ADR reports concerning the COVID-19 vaccine" - The "AESI Line
Listing.xlsx" file in this sub-folder:
"https://eur01.safelinks.protection.outlo...
vigilance/COVID-19 Vaccine". - All files in the sub-folder:
"https://eur01.safelinks.protection.outlo...
vigilance/COVID-19 Vaccine/COVID-19 mRNA BioNTech Case Outputs" Yours
faithfully, D Jackson
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dangos adrannau a ddyfynnir

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 22/912

Dear D Jackson,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 17 August 2022.

We confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...

Kind Regards,

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

dangos adrannau a ddyfynnir

Dear MHRA Customer Services,

Please provide an update on the progress of my request.

Yours sincerely,

D Jackson

Gadawodd D Jackson anodiad ()

IC-193020-D8Y0

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear D Jackson,

 

FOI 22/912

 

Thank you for your Freedom of Information (FOI) request dated 17^th August
2022, we apologise for the delay in response. You requested the following:

 

• All versions of the document referred to as the "PV Strategy Document"
or "Refined PV strategy document" in the December 2021 and June 2022
versions of "Monitoring and signal detection activities for ADR
reports concerning the COVID-19 vaccine"
• The "AESI Line Listing.xlsx" file (and then provided a link to a
sub-folder)
• All files in the sub-folder (COVID-19 mRNA BioNTech Case Outputs).

 

With regards to your request for all versions of the document referred to
as ‘PV strategy document’ or ‘Refined PV strategy document’ we are
refusing this aspect of your request under Section 14(1) of the FOI act.
We are unable to identify the value or purpose of this request, given that
the agreed position is publicly available via our website at the link
below:

 

[1]https://www.gov.uk/government/publicatio...

 

 

Your second two requests (for AESI line listings and for all files in a
particular sub folder): this information contains details of individual
Yellow Cards which have been submitted to us, and as such this information
could lead to patient identification. We are therefore exempting release
on account of Section 40 (Personal data) and Section 41 (Information
provided in confidence).

 

Members of the public and healthcare professionals voluntarily submit
reports of suspected side effects to us through the Yellow Card Scheme. As
outlined in our [2]Privacy Policy, we will not share the identity of
anyone submitting a Yellow Card report with any person outside the MHRA
without their explicit consent, unless we are required or permitted to do
so by law. The Policy also states that we may receive requests for Yellow
Card report data under the Freedom of Information Act. While we are
legally obliged to provide some of the requested information, we only
provide high-level summary information with all person-identifiable data
excluded.

We have been working proactively to encourage members of the public or
health professionals across the UK to immediately alert us to any concerns
they have without a formal diagnosis using the Yellow Card scheme. The
information and data provided to us by these third parties are shared in
confidence and, as above, are personal data. Sharing the information and
data received would not reflect the commitments we have made on our
confidentiality agreements. As this is personal data in relation to an
individuals’ health, this would be of detriment to them and may damage
their engagement with the scheme.

 

If you have a query about the information provided, please reply to this
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If you are dissatisfied with the handling of your request, you have the
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Yours sincerely,

 

 

 

MHRA Customer Experience Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000

 

 

dangos adrannau a ddyfynnir

Dear MHRA Customer Services,

Regarding my request for:

- All versions of the document referred to as the "PV Strategy Document" or "Refined PV strategy document" in the December 2021 and June 2022 versions of "Monitoring and signal detection activities for ADR reports concerning the COVID-19 vaccine"

This has been refused citing Section 14(1) of the FOI act explaining that the MHRA "are unable to identify the value or purpose of this request, given that the agreed position is publicly available via our website". Section 14(1) of the FOIA is for vexatious requests which is not an appropriate reason for refusal in this instance.

My request is for files referred to in these MHRA documents:

Monitoring Signal Detection Activities COVID 19 Vaccine Dec 2021.pdf
Monitoring Signal Detection Activities COVID 19 Vaccine Jun 2022.pdf

The information "publicly available via our [MHRA] website" is dated 5th February 2021 however both of these monitoring documents indicate more recent information might be available. The "PV strategy document" link in the Dec 2021 file references "19 Aug 2021 PV strategy refinement paper final - JM.docx". The Jun 2022 file refers to the "updated PV strategy document".

The response does not state that the information I have requested is already publicly available or give a reason why the content cannot be released. It therefore seems reasonable that the MHRA should provide these documents.

Regarding the other information I requested:

- The "AESI Line Listing.xlsx" file in this sub-folder: "https://mhra.sharepoint.com/.../Covid-19 vigilance/COVID-19 Vaccine".

- All files in the sub-folder: "https://mhra.sharepoint.com/.../Covid-19 vigilance/COVID-19 Vaccine/COVID-19 mRNA BioNTech Case Outputs"

This has been rejected citing Section 40 (Personal data) and Section 41 (Information provided in confidence). The response does not state whether redacting the sensitive data would be out-with the cost limit of processing the request. In the case of the AESI spreadsheet (based on the xlsx extension), it seems reasonable to assume the data would be structured in such a way that would make removing this data a less time-consuming process.

Please review how my request has been handled.

Yours sincerely,

D Jackson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 22/912

Dear D Jackson,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 22/912. We normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.  

Kind Regards  

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf,
London E14 4PU
Telephone 020 3080 6000

dangos adrannau a ddyfynnir

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

2 Atodiad

Internal Review of FOI 22/912

Dear D Jackson,

Thank you for your email.

Please find attached the response and attached document to your Internal Review request.

Kind Regards

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

dangos adrannau a ddyfynnir

Dear MHRA Customer Services,

Thank you for the response and providing the requested document.

Regarding the request for:

- The "AESI Line Listing.xlsx" file in this sub-folder: "https://mhra.sharepoint.com/.../Covid-19 vigilance/COVID-19 Vaccine".

It is unclear from the internal review why this file cannot be redacted and released. Please clarify why this file has not been provided.

Yours sincerely,

D Jackson