Cardiac suspected adverse reactions to COVID-19 vaccines
Dear Medicines and Healthcare products Regulatory Agency (MHRA),
I am writing to make a request for information under section 1 of the Freedom of Information Act (FOIA) 2000.
Please can you confirm whether the MHRA holds any information which relates to the following suspected adverse reactions to COVID-19 vaccines:
- Myocarditis
- Pericarditis
- Other cardiac disorders
If any such information exists, please can you provide it to me, in each case ensuring it is clear which COVID-19 vaccine or vaccines is/are involved (except where this is unknown).
For clarity, "information" refers to all recorded information held by the MHRA - including, but not limited to, e-mails and other correspondence, messages on internal chat systems (such as Slack, Google Chat/Hangouts and Microsoft Teams), and documents (such as reports, slide decks, transcripts, minutes and notes), including unfinished/unpublished versions of such. However, if it is necessary to ensure the cost of dealing with this request does not exceed the statutory appropriate limit (but only if it is necessary), it is acceptable to constrain your searches to the electronic records of those working on the licensing of, and/or pharmacovigilance for, COVID-19 vaccines.
For the avoidance of doubt, this request is a refined version of the following request:
https://www.whatdotheyknow.com/request/c...
Per the Information Commissioner's Office's guidance document "Requests where the cost of compliance exceeds the appropriate limit" (https://ico.org.uk/media/for-organisatio...), "original and refined/new requests should not be aggregated for the purposes of calculating the costs of dealing with the new request as to do so would frustrate the purposes behind sections 12 and 16 [FOIA 2000]".
Yours faithfully,
Kenneth MacArthur
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Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
Canary Wharf,
London
E14 4PU
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
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The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here.
References
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Our Ref: FOI 21/672
Dear Kenneth MacArthur,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 16th June 2021.
I 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 Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
Dear Mr MacArthur,
Thank you for your FOI request, dated 16^th June 2021.
We have determined that the requested information is exempt from release
under Section 12 of the Freedom of Information Act and we cannot process
your request any further.
Section 12 of the Act allows public authorities to refuse requests where
the cost of dealing with them would exceed the appropriate limit, which
for central government is set at £600. This represents the estimated cost
of one person spending 24 working hours in determining whether the
department holds the information, locating, retrieving and extracting the
information.
In order to process your request, we would need to identify all members of
staff who may have correspondence relating to your request and search
their entire email and messaging history, extract these emails and
messages and review them. We consider that this would take longer than 24
working hours to complete.
If you disagree with how we have interpreted the Freedom of Information
Act 2000 with regards to your request, you can ask for the decision to be
reviewed. The review would be carried out by a senior member of the Agency
who was not involved with the original decision.
If you have a query about the information provided, please reply to this
email.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear Medicines and Healthcare Products Regulatory Agency (MHRA),
Please pass this on to the person who conducts Freedom of Information reviews.
I am writing to request an internal review of the MHRA's handling of my FOI request 'Cardiac suspected adverse reactions to COVID-19 vaccines'.
I have a number of concerns, which I have set out below. I would appreciate if you could address each one individually and in turn - in particular, answering each of the labelled questions.
1) This request was a deliberately more focused version of an earlier request with the same title. In this new request, I said, "if it is necessary to ensure the cost of dealing with this request does not exceed the statutory appropriate limit (but only if it is necessary), it is acceptable to constrain your searches to the electronic records of those working on the licensing of, and/or pharmacovigilance for, COVID-19 vaccines."
You say in your response that you would "need to identify all members of staff who may have correspondence relating to your request", as if this was an onerous exercise in itself. But I already told you in my request that you can if necessary constrain your searches to the electronic records of those working on the licensing of, and/or pharmacovigilance for, COVID-19 vaccines.
Particularly at the current time when there is so much attention on the COVID-19 vaccination programme, I assume the list of members of staff who are "working on the licensing of, and/or pharmacovigilance for, COVID-19 vaccines" is already well known, or can be established very quickly, and I assume further that it is a relatively modest portion of the MHRA's approximately 1300 staff (Source: MHRA Annual Report and
Accounts 2019/20 - https://assets.publishing.service.gov.uk...).
a) Can you confirm if my assumptions in (1) above are correct, or, if they are not, can you explain what the reality is?
2) Having established the above-mentioned list of staff members, you say that you would then have to "search
their entire email and messaging history, extract these emails and messages and review them". Again, you make this sound like an extremely onerous activity. However, given that this is not your first FOI request, you presumably have tools and techniques in place for "searching email and messaging history", and can make use of a small number of judiciously chosen search terms to locate the information I have requested, focusing your attention, as per paragraph 6.8 of the guidance issued under section 45 of the Freedom of Information Act (FOIA) 2000 (https://assets.publishing.service.gov.uk...), "on the locations most likely to hold the relevant information".
a) Did you base your estimate of the cost of dealing with my request on the premises set out in (2) above? (That is, the use of existing tools and techniques for searching email and messaging history, the use of a small number of judiciously chosen search terms, and the focusing of your attention on the locations most likely to hold the relevant information.) If not, why not?
b) More broadly, per the case law (Randall v Information Commissioner and Medicines and Healthcare products Regulatory Agency (EA/2006/0004, 30 October 2007)) - which states that estimates should be "sensible, realistic and supported by cogent evidence" - will you provide me with cogent evidence of how your estimate was calculated, in particular addressing the five bullet points under the heading "Providing 'cogent evidence'" in the ICO guidance document "Requests where the cost of compliance exceeds the appropriate limit" (https://ico.org.uk/media/for-organisatio...) ?
3) The section 45 code of practice also states, in paragraph 6.9:
"Where a request is refused under section 12, public authorities should consider what advice and assistance can be provided to help the applicant reframe or refocus their request with a view to bringing it within the cost limit."
You have not done this.
a) Do you accept that you were incorrect not to do this?
b) Can you now do this, noting the ICO's guidance in the above-mentioned guidance document that "public authorities should try to be as helpful and flexible as possible", and paying particular attention to the fact that this was already a more focused version of an earlier request, crafted - thus far without any advice or assistance from you - to help you respond to the request within the cost limit?
(NB: Per the above-mentioned ICO guidance document, "original and refined/new requests should not be aggregated for the purposes of calculating the costs of dealing with the new request as to do so would frustrate the purposes behind sections 12 and 16 [FOIA 2000]".)
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/c...
Yours faithfully,
Kenneth MacArthur
Thank you for your email. This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible.
Please note that we may not respond if your query:
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only
Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
Canary Wharf,
London
E14 4PU
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC.
The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here.
References
Visible links
1. https://www.gov.uk/government/collection...
Dear Medicines and Healthcare products Regulatory Agency,
It is now well over 20 working days since my request for an internal review. Can you please now provide a substantive response to my request for an internal review without further delay?
Yours sincerely,
Kenneth MacArthur
Thank you for your email. This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible.
Please note that we may not respond if your query:
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only
Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
Canary Wharf,
London
E14 4PU
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC.
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.
________________________________________ From: Kenneth MacArthur
<[FOI #765872 email]> Sent: Friday, September 17,
2021 7:54:23 PM To: MHRA Customer Services Subject: Re: Freedom of
Information request - Cardiac suspected adverse reactions to COVID-19
vaccines Dear Medicines and Healthcare products Regulatory Agency, It is
now well over 20 working days since my request for an internal review. Can
you please now provide a substantive response to my request for an
internal review without further delay? Yours sincerely, Kenneth MacArthur
-----Original Message----- Thank you for your email. This auto-response is
to inform you that your email has been received and will be reviewed by
our Customer Service Team. We will respond to you as soon as possible.
Please note that we may not respond if your query: • contains offensive
language • has already been answered in a previous reply to you • is
illegible • is selling or promoting a product • is for information only
Medicines and Healthcare products Regulatory Agency 10 South Colonnade,
Canary Wharf, London E14 4PU gov.uk/mhra Stay connected For information on
how the Agency uses your personal data and your data protection rights,
please see our three centres’ Privacy Notices: MHRA, CPRD and NIBSC. The
UK has left the EU, and the transition period ends on 31 December 2020.
Our [1]guidance and information can be accessed here. References Visible
links 1.
https://urldefense.proofpoint.com/v2/url...
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #765872 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://urldefense.proofpoint.com/v2/url...
For more detailed guidance on safely disclosing information, read the
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Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.
Dear Kenneth MacArthur,
Thank you for your email.
We responded to you Internal Review requested with the attached on 9th August.
Kind regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear Medicines and Healthcare products Regulatory Agency,
Thank you for your reply.
As you can see from the request history at https://www.whatdotheyknow.com/request/c... I did not receive your internal review response prior to now.
Yours sincerely,
Kenneth MacArthur
Thank you for your email. This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible.
Please note that we may not respond if your query:
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only
Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
Canary Wharf,
London
E14 4PU
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC.
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.
________________________________________ From: Kenneth MacArthur
<[FOI #765872 email]> Sent: Tuesday, September 21,
2021 8:41:20 PM To: MHRA Customer Services Subject: RE: Freedom of
Information request - Cardiac suspected adverse reactions to COVID-19
vaccines Dear Medicines and Healthcare products Regulatory Agency, Thank
you for your reply. As you can see from the request history at
https://urldefense.proofpoint.com/v2/url...
I did not receive your internal review response prior to now. Yours
sincerely, Kenneth MacArthur -----Original Message----- Dear Kenneth
MacArthur, Thank you for your email. We responded to you Internal Review
requested with the attached on 9th August. Kind regards, MHRA Customer
Service Centre Medicines and Healthcare products Regulatory Agency 10
South Colonnade, Canary Wharf, London E14 4PU
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #765872 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://urldefense.proofpoint.com/v2/url...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://urldefense.proofpoint.com/v2/url...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.
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