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 2000.
Please can you provide a dataset summarising all suspected adverse reactions to COVID-19 vaccines reported to the MHRA since December 2020. This summary dataset should be in the form of a count by (i) vaccine type, (ii) patient sex, (iii) patient 15-year age band (ie, 0-14, 15-29, etc), (iv) suspected adverse reaction (described using the MedDRA 'preferred term'), and (v) reaction seriousness (ie, fatal, serious excluding fatal, and non-serious).
Please note that no so-called 'special category data' is being requested, and, further, what is being requested is data which is in more summarised form than that published by the MHRA in interactive Drug Analysis Profiles (iDAPs) for other drugs. The request is therefore consistent with the MHRA's Yellow Card Privacy Policy, which states that only "high-level summary information with all person-identifiable data excluded" will be provided in response to requests under the Freedom of Information Act.
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,
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 #867029 email]> Sent: Thursday, June 2, 2022
8:59:15 AM To: MHRA Customer Services Subject: Freedom of Information
request - 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
2000. Please can you provide a dataset summarising all suspected adverse
reactions to COVID-19 vaccines reported to the MHRA since December 2020.
This summary dataset should be in the form of a count by (i) vaccine type,
(ii) patient sex, (iii) patient 15-year age band (ie, 0-14, 15-29, etc),
(iv) suspected adverse reaction (described using the MedDRA 'preferred
term'), and (v) reaction seriousness (ie, fatal, serious excluding fatal,
and non-serious). Please note that no so-called 'special category data' is
being requested, and, further, what is being requested is data which is in
more summarised form than that published by the MHRA in interactive Drug
Analysis Profiles (iDAPs) for other drugs. The request is therefore
consistent with the MHRA's Yellow Card Privacy Policy, which states that
only "high-level summary information with all person-identifiable data
excluded" will be provided in response to requests under the Freedom of
Information Act. Yours faithfully, Kenneth MacArthur
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Our Ref: FOI 22/735
Dear Kenneth MacArthur,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 6 June 2022.
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 Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
Dear Medicines and Healthcare products Regulatory Agency (MHRA),
It is now 20 working days since I made my request. By law, you should have responded to it by now.
Can you indicate whether you need more time to respond, and, if so, indicate a date by which you intend to respond? I am happy to be reasonable if you are too.
I look forward to hearing from you.
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. Ourguidance and information can be accessed here.
________________________________________ From: Kenneth MacArthur
<[FOI #867029 email]> Sent: Saturday, July 2, 2022
10:12:18 AM To: MHRA Customer Services Subject: Re: FOI 22/735 - RE:
Freedom of Information request - Suspected adverse reactions to COVID-19
vaccines Dear Medicines and Healthcare products Regulatory Agency (MHRA),
It is now 20 working days since I made my request. By law, you should have
responded to it by now. Can you indicate whether you need more time to
respond, and, if so, indicate a date by which you intend to respond? I am
happy to be reasonable if you are too. I look forward to hearing from you.
Yours faithfully, Kenneth MacArthur -----Original Message----- Our Ref:
FOI 22/735 Dear Kenneth MacArthur, RE: REQUEST UNDER THE FREEDOM OF
INFORMATION ACT 2000 Thank you for your enquiry which we received on 6
June 2022. 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://eur01.safelinks.protection.outlo...
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
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #867029 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
https://eur01.safelinks.protection.outlo...
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 Mr MacArthur,
Please find attached the response to your FOI request.
Kind regards,
FOI Team
Safety & Surveillance Group
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 'Suspected adverse reactions to COVID-19 vaccines'.
I have a number of specific questions, which I would appreciate separate, numbered responses to:
1) In your response, you note that your Yellow Card Privacy Policy states that you "may receive requests for Yellow Card report data under the Freedom of Information Act", and, further, that, "while [you] are legally obliged to provide some of the requested information, [you] only provide high-level summary information with all person-identifiable data excluded."
You then go on to say that "providing [me] with the 15- year age band data could lead to patient identification due to 5-year groupings once the 10-year age band data is published". However, you have not explained why a 5-year age grouping could lead to patient identification, but a 10-year age grouping - as you intend to publish - would not. Can you please elucidate your rationale here?
2) Do you agree that not only is the sharing of "high-level summary information with all person-identifiable data excluded" permitted by your Yellow Card Privacy Policy, but that "high-level summary information with all person-identifiable data excluded" does not meet the definition of "personal data", and thus that section 40 of the Freedom of Information Act (FOIA) 2000 cannot be engaged as the basis for refusing to provide "high-level summary information with all person-identifiable data excluded"?
3a) Do you agree that section 41 FOIA 2000 does not apply to _all_ information provided in confidence, but rather only to information provided in confidence where the disclosure of that information would constitute a breach of confidence actionable by the person who provided the information?
3b) Further, do you agree that, per your Yellow Card Privacy Policy, the provision of "high-level summary [Yellow Card] information with all person-identifiable data excluded" would be permissible, and thus would not constitute an actionable breach of confidence?
4) Per your duty under section 16 FOIA 2000, can you please advise on what "high-level summary [Yellow Card] information with all person-identifiable data excluded" you could provide for COVID-19 vaccines? I am aware of your intention to publish some such information by the end of this year, but I would like some information sooner (as I am entitled to). For example, would you provide the information I have requested but with 20-year age bands? I assume it will be more efficient for both of us for us to agree on an acceptable format for the high-level summary information now, than for me to submit further FOI requests probing the edges of what you feel able to refuse. I note your remark about potentially treating further requests in this area as vexatious, but I also note the 2015 judgement of the Court of Appeal on the subject of vexatiousness - namely, "that the starting point is that vexatiousness primarily involves making a request which has no reasonable foundation, that is, no reasonable foundation for thinking that the information sought would be of value to the requester or to the public or any section of the public", which is manifestly not the case here.
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/s...
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. Ourguidance and information can be accessed here.
________________________________________ From: Kenneth MacArthur
<[FOI #867029 email]> Sent: Friday, July 8, 2022
9:44:03 PM To: MHRA Customer Services Subject: Internal review of Freedom
of Information request - Suspected adverse reactions to COVID-19 vaccines
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 'Suspected adverse reactions to COVID-19 vaccines'. I have a
number of specific questions, which I would appreciate separate, numbered
responses to: 1) In your response, you note that your Yellow Card Privacy
Policy states that you "may receive requests for Yellow Card report data
under the Freedom of Information Act", and, further, that, "while [you]
are legally obliged to provide some of the requested information, [you]
only provide high-level summary information with all person-identifiable
data excluded." You then go on to say that "providing [me] with the 15-
year age band data could lead to patient identification due to 5-year
groupings once the 10-year age band data is published". However, you have
not explained why a 5-year age grouping could lead to patient
identification, but a 10-year age grouping - as you intend to publish -
would not. Can you please elucidate your rationale here? 2) Do you agree
that not only is the sharing of "high-level summary information with all
person-identifiable data excluded" permitted by your Yellow Card Privacy
Policy, but that "high-level summary information with all
person-identifiable data excluded" does not meet the definition of
"personal data", and thus that section 40 of the Freedom of Information
Act (FOIA) 2000 cannot be engaged as the basis for refusing to provide
"high-level summary information with all person-identifiable data
excluded"? 3a) Do you agree that section 41 FOIA 2000 does not apply to
_all_ information provided in confidence, but rather only to information
provided in confidence where the disclosure of that information would
constitute a breach of confidence actionable by the person who provided
the information? 3b) Further, do you agree that, per your Yellow Card
Privacy Policy, the provision of "high-level summary [Yellow Card]
information with all person-identifiable data excluded" would be
permissible, and thus would not constitute an actionable breach of
confidence? 4) Per your duty under section 16 FOIA 2000, can you please
advise on what "high-level summary [Yellow Card] information with all
person-identifiable data excluded" you could provide for COVID-19
vaccines? I am aware of your intention to publish some such information by
the end of this year, but I would like some information sooner (as I am
entitled to). For example, would you provide the information I have
requested but with 20-year age bands? I assume it will be more efficient
for both of us for us to agree on an acceptable format for the high-level
summary information now, than for me to submit further FOI requests
probing the edges of what you feel able to refuse. I note your remark
about potentially treating further requests in this area as vexatious, but
I also note the 2015 judgement of the Court of Appeal on the subject of
vexatiousness - namely, "that the starting point is that vexatiousness
primarily involves making a request which has no reasonable foundation,
that is, no reasonable foundation for thinking that the information sought
would be of value to the requester or to the public or any section of the
public", which is manifestly not the case here. A full history of my FOI
request and all correspondence is available on the Internet at this
address:
https://eur01.safelinks.protection.outlo...
Yours faithfully, Kenneth MacArthur
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #867029 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
https://eur01.safelinks.protection.outlo...
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.
Internal Review of FOI 22/735
Dear Mr MacArthur,
Thank you for your email.
We confirm that an internal review will be carried out on FOI 22/735. 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
Internal Review of FOI 22/735
Dear Kenneth MacArthur,
We thank you for your request for an internal review of the MHRA's
handling of your FOI request 'Suspected adverse reactions to COVID-19
vaccines'.
Following considered of the initial FOI response, we have upheld our
position and the use of the stated exemptions. It is noted that the that
internal review does not afford an opportunity to ask additional
questions, if further information is requested, please submit new FOI
requests. Published information, which you are aware of, is available via
the following link:
[1]https://www.gov.uk/government/publicatio...
We would also like to draw your attention to the following:
Please be aware if you continue to submit similar data requests this may
be considered as an inappropriate use of the Freedom of Information Act.
The Freedom of Information Act places a general duty on public authorities
to provide access to official information. However, the Act also provides
an exemption to that duty for requests that are determined to be
vexatious. Such requests can then be refused under Section 14 (1) of the
Freedom of Information Act. Please note that under Section 17(6) of the
Freedom of Information Act, should this criteria be met, we may not
respond to any further requests on the same or very similar topics.
If you remain dissatisfied, you may ask the Information Commissioner (ICO)
to make a decision on whether or not we have interpreted the FOIA
correctly in dealing with the request and subsequent internal review. The
ICO’s address is:
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000
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