Non-publication of COVID-19 vaccine iDAPs - Decision-makers

Kenneth MacArthur

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.

In response to a number of freedom of information (FOI) requests over the last several months (including my own: https://www.whatdotheyknow.com/request/s... ; others are linked at the end of this message), you have stated that you plan to publish interactive drug analysis profiles (iDAPs) for the COVID-19 vaccines at some point in the future, without committing to a particular publication date (or even suggesting a likely publication date). You have cited section 22 FOIA 2000 as exempting the publication of the iDAPs data, on the basis that you intend to publish it in the future.

In a subsequent response to me, you say that you "recognise that there is strong interest in seeing this data and accept it should not be withheld."

Yet more than 6 weeks after writing that, you continue to withhold the data.

In your response to my request for internal review, you have additionally cited section 35 FOIA 2000 as exempting the publication of the data on the basis that the data is linked to the formulation or development of government policy.

You are not of course required by law to make use of any exemptions provided for in sections 22 and 35 FOIA 2000. You have made a decision to do so.

Please can you confirm:
1) Which individual or individuals have made the decision to not publish the above-mentioned iDAPs at the present time, whether this individual/these individuals is/are within the MHRA, the wider Department of Health and Social Care, or somewhere else in government, and on what grounds the decision was made
2) Which individual or individuals will make the eventual decision about when to go ahead and publish the above-mentioned iDAPs, and whether this individual/these individuals is/are within the MHRA, the wider Department of Health and Social Care, or somewhere else in government
3) Whether ministers were involved in the decision not to publish so far, and whether ministers will be involved in the decision to publish in the future, and in each case in what capacity (ie, ultimate decision-maker, consultee, or some other capacity)

NB: While the names of individuals are clearly personal data, you will be familiar with the ICO guidance on section 40 FOIA 2000 (https://ico.org.uk/media/for-organisatio...), which states:
"Disclosure of personal data will always involve some intrusion into privacy, but intrusion may be warranted. For example, disclosure may be acceptable if the information relates to the performance of public duties ... by senior officials."

Yours faithfully,

Kenneth MacArthur

-----

Other FOI requests mentioned above (in which the future publication of iDAPs for the COVID-19 vaccines has been promised):
https://www.whatdotheyknow.com/request/a...
https://www.whatdotheyknow.com/request/n...
https://www.whatdotheyknow.com/request/d...
https://www.whatdotheyknow.com/request/c...
https://www.whatdotheyknow.com/request/a...
https://www.whatdotheyknow.com/request/1...
https://www.whatdotheyknow.com/request/c...
https://www.whatdotheyknow.com/request/v...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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London 
E14 4PU
gov.uk/mhra
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The UK has left the EU, and the transition period ends on 31 December
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References

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/794

Dear Kenneth MacArthur,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 9 July 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

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/794

Dear Kenneth MacArthur,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 9 July 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

show quoted sections

Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency,

It is now over 20 working days since my request for information under section 1 of the Freedom of Information Act 2000 was submitted. Can you please now respond to it without further delay?

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Kenneth MacArthur,

Thank you for your email.

Please find attached our response to FOI 21/794.

Kind regards,

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency (MHRA),

Thank you for your response.

You have commented that the information I have requested is exempt as per section 35 of the Freedom of Information Act (FOIA) 2000. For clarification, can you confirm which paragraph of section 35(1) FOIA 2000 the information I have requested is exempt as a result of? (Information is not exempt simply as a result of section 35 in general.)

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Reference: CSC 64635

Dear Kenneth MacArthur,

Thank you for your email.

We have reviewed your enquiry and this has been passed on to our Vigilance Risk Management of Medicines experts.

Kind regards
 
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Dear Medicines and Healthcare products Regulatory Agency (MHRA),

Is it possible for someone to reply to my short clarifying question-containing e-mail of 26 August 2021?

Thank you in advance.

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Kenneth MacArthur,
 
Thank you for your email.
 
We have chased your enquiry with our Vigilance Risk Management of Medicines experts and we can only apologise that you have not yet received a response. We have notified the team concerned and they will respond to you as soon as they can.
 
We are sorry for the length of time you have to wait for a response.
 
In the meantime should you require any further advice or assistance on this matter please feel free to call us on 020 3080 6000 or reply to this email.
 
Our opening hours are Mon – Fri 9am to 5pm (excluding UK Public Holidays)
 
With regards,

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

Dear Mr MacArthur,

The exemption cited is 35(1)(a) and in deciding that this was relevant we took into account that releasing the information prematurely could impact adversely on the policy around the wider government vaccine campaign as the information may be misused once in the public domain by those who do not agree with vaccination in general.

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

show quoted sections

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 'Non-publication of COVID-19 vaccine iDAPs - Decision-makers'.

In your response to question 1 in my request, you state that the MHRA are still considering the timing of the publication of the COVID-19 vaccine iDAPs and that "therefore" the information I have requested is exempt under section 35 of the Freedom of Information Act (FOIA) 2000 (which you later clarified to me to be section 35(1)(a) FOIA 2000 in particular).

There are several issues with this.

a) Firstly, you have responded to a different question than the one I asked. I asked you to confirm which individual or individuals have made the decision to not publish the iDAPs at the present time - ie, thus far. I understand that you may still be considering the timing of the iDAPs' publication, but someone, or some group of people, has made the decision to not publish up until this point. That is clear from the clarification e-mail you sent me on 9 September 2021, in which you said: "we took into account that releasing the information prematurely could impact adversely on the policy around the wider government vaccine campaign as the information may be misused once in the public domain by those who do not agree with vaccination in general". Ie, it is clear from that e-mail that an _active decision_ was taken to not publish yet. I would like to know who made that decision (along with the other pieces of information requested in question 1). Can you please now provide that information?

b) The MHRA's role in the UK's public administration architecture is, inter alia, to license and to provide post-licensing pharmacovigilance for medicinal products. It has a specific statutory role under, inter alia, The Human Medicines Regulations 2012. In exercising that statutory role and broader public administrative function, it is implementing existing government policy around medicines regulation. That point is prima facie clear. However, even if it were not, the ICO, on page 19 of their guidance document "Government policy (section 35)" (https://ico.org.uk/media/for-organisatio...), state: "In general, arm’s-length bodies are created to deliver specialist services which do not require the day to day engagement of ministers, or which need to be independent of government. As only ministers can approve government policy, it follows that the day to day business of these bodies will not involve government policymaking. By delegating an activity to a body at arm’s length from ministers, the government has in effect signalled that the activity is considered operational or otherwise independent of government." (The previous page of the document enumerates the different types of "arm's-length body", with executive agency - which the MHRA is - being one of these.) Can you please now accept that the MHRA's pharmacovigilance function, including the publication of datasets such as iDAPs, is the implementation of existing government policy around medicines regulation, and withdraw your assertion that section 35(1)(a) is relevant to the publication or otherwise of iDAPs for COVID-19 vaccines? Alternatively, if you are unwilling to do this, can you please provide a more robust defence of your reliance on section 35(1)(a) beyond simple assertions like "this information is exempted as per section 35 of the Freedom of Information Act"?

c) Further to point (b), could I also ask you to consider the example of iDAPs for HPV vaccines. Given that it is government policy for as many eligible individuals as possible to get an HPV vaccine, is your view that - while you recognise that there is strong interest in seeing iDAPs for HPV vaccines, and accept in principle that they should not be withheld - you could rely on section 35(1)(a) FOIA 2000 to withhold iDAPs for HPV vaccines for many, many years on the basis that their publication "could impact adversely on the policy around the wider government [HPV] vaccine campaign as the information may be misused once in the public domain by those who do not agree with vaccination in general"?

In your response to question 2 in my request, you state both that the information is covered by a section 35 FOIA 2000 exemption, and that you do not hold the information "as [it] is a future decision".

d) Can you please clarify which of the above two statements is true? Specifically, does the information around who will make the eventual decision about when to go ahead and publish the iDAPs (along with the other pieces of information requested in question 2) exist, or does it not exist?

With regards question 3 in my request, part of this question asks whether ministers were involved in the decision not to publish thus far - this part is not about the future.

e) In light of the various points made above with respect to question 1, can you now please confirm whether ministers were involved in the decision not to publish thus far, and, if so, in what capacity?

Can I kindly ask you to respond individually to each of points (a), (b), (c), (d) and (e).

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/n...

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Thursday, September 23,
2021 8:49:08 PM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Non-publication of COVID-19 vaccine iDAPs
- Decision-makers 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 'Non-publication of COVID-19 vaccine
iDAPs - Decision-makers'. In your response to question 1 in my request,
you state that the MHRA are still considering the timing of the
publication of the COVID-19 vaccine iDAPs and that "therefore" the
information I have requested is exempt under section 35 of the Freedom of
Information Act (FOIA) 2000 (which you later clarified to me to be section
35(1)(a) FOIA 2000 in particular). There are several issues with this. a)
Firstly, you have responded to a different question than the one I asked.
I asked you to confirm which individual or individuals have made the
decision to not publish the iDAPs at the present time - ie, thus far. I
understand that you may still be considering the timing of the iDAPs'
publication, but someone, or some group of people, has made the decision
to not publish up until this point. That is clear from the clarification
e-mail you sent me on 9 September 2021, in which you said: "we took into
account that releasing the information prematurely could impact adversely
on the policy around the wider government vaccine campaign as the
information may be misused once in the public domain by those who do not
agree with vaccination in general". Ie, it is clear from that e-mail that
an _active decision_ was taken to not publish yet. I would like to know
who made that decision (along with the other pieces of information
requested in question 1). Can you please now provide that information? b)
The MHRA's role in the UK's public administration architecture is, inter
alia, to license and to provide post-licensing pharmacovigilance for
medicinal products. It has a specific statutory role under, inter alia,
The Human Medicines Regulations 2012. In exercising that statutory role
and broader public administrative function, it is implementing existing
government policy around medicines regulation. That point is prima facie
clear. However, even if it were not, the ICO, on page 19 of their guidance
document "Government policy (section 35)"
(https://urldefense.proofpoint.com/v2/url...
), state: "In general, arm’s-length bodies are created to deliver
specialist services which do not require the day to day engagement of
ministers, or which need to be independent of government. As only
ministers can approve government policy, it follows that the day to day
business of these bodies will not involve government policymaking. By
delegating an activity to a body at arm’s length from ministers, the
government has in effect signalled that the activity is considered
operational or otherwise independent of government." (The previous page of
the document enumerates the different types of "arm's-length body", with
executive agency - which the MHRA is - being one of these.) Can you please
now accept that the MHRA's pharmacovigilance function, including the
publication of datasets such as iDAPs, is the implementation of existing
government policy around medicines regulation, and withdraw your assertion
that section 35(1)(a) is relevant to the publication or otherwise of iDAPs
for COVID-19 vaccines? Alternatively, if you are unwilling to do this, can
you please provide a more robust defence of your reliance on section
35(1)(a) beyond simple assertions like "this information is exempted as
per section 35 of the Freedom of Information Act"? c) Further to point
(b), could I also ask you to consider the example of iDAPs for HPV
vaccines. Given that it is government policy for as many eligible
individuals as possible to get an HPV vaccine, is your view that - while
you recognise that there is strong interest in seeing iDAPs for HPV
vaccines, and accept in principle that they should not be withheld - you
could rely on section 35(1)(a) FOIA 2000 to withhold iDAPs for HPV
vaccines for many, many years on the basis that their publication "could
impact adversely on the policy around the wider government [HPV] vaccine
campaign as the information may be misused once in the public domain by
those who do not agree with vaccination in general"? In your response to
question 2 in my request, you state both that the information is covered
by a section 35 FOIA 2000 exemption, and that you do not hold the
information "as [it] is a future decision". d) Can you please clarify
which of the above two statements is true? Specifically, does the
information around who will make the eventual decision about when to go
ahead and publish the iDAPs (along with the other pieces of information
requested in question 2) exist, or does it not exist? With regards
question 3 in my request, part of this question asks whether ministers
were involved in the decision not to publish thus far - this part is not
about the future. e) In light of the various points made above with
respect to question 1, can you now please confirm whether ministers were
involved in the decision not to publish thus far, and, if so, in what
capacity? Can I kindly ask you to respond individually to each of points
(a), (b), (c), (d) and (e). A full history of my FOI request and all
correspondence is available on the Internet at this address:
https://urldefense.proofpoint.com/v2/url...
Yours faithfully, Kenneth MacArthur
------------------------------------------------------------------- Please
use this email address for all replies to this request:
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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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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.

show quoted sections

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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Saturday, November 13,
2021 2:21:40 PM To: MHRA Customer Services Subject: RE: Internal review of
Freedom of Information request - Non-publication of COVID-19 vaccine iDAPs
- Decision-makers 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. Ourguidance and information can be accessed here.
________________________________________ From: Kenneth MacArthur <[FOI
#772871 email]> Sent: Thursday, September 23, 2021 8:49:08 PM To: MHRA
Customer Services Subject: Internal review of Freedom of Information
request - Non-publication of COVID-19 vaccine iDAPs - Decision-makers 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 'Non-publication of COVID-19 vaccine iDAPs - Decision-makers'. In
your response to question 1 in my request, you state that the MHRA are
still considering the timing of the publication of the COVID-19 vaccine
iDAPs and that "therefore" the information I have requested is exempt
under section 35 of the Freedom of Information Act (FOIA) 2000 (which you
later clarified to me to be section 35(1)(a) FOIA 2000 in particular).
There are several issues with this. a) Firstly, you have responded to a
different question than the one I asked. I asked you to confirm which
individual or individuals have made the decision to not publish the iDAPs
at the present time - ie, thus far. I understand that you may still be
considering the timing of the iDAPs' publication, but someone, or some
group of people, has made the decision to not publish up until this point.
That is clear from the clarification e-mail you sent me on 9 September
2021, in which you said: "we took into account that releasing the
information prematurely could impact adversely on the policy around the
wider government vaccine campaign as the information may be misused once
in the public domain by those who do not agree with vaccination in
general". Ie, it is clear from that e-mail that an _active decision_ was
taken to not publish yet. I would like to know who made that decision
(along with the other pieces of information requested in question 1). Can
you please now provide that information? b) The MHRA's role in the UK's
public administration architecture is, inter alia, to license and to
provide post-licensing pharmacovigilance for medicinal products. It has a
specific statutory role under, inter alia, The Human Medicines Regulations
2012. In exercising that statutory role and broader public administrative
function, it is implementing existing government policy around medicines
regulation. That point is prima facie clear. However, even if it were not,
the ICO, on page 19 of their guidance document "Government policy (section
35)"
(https://eur01.safelinks.protection.outlo...
), state: "In general, arm’s-length bodies are created to deliver
specialist services which do not require the day to day engagement of
ministers, or which need to be independent of government. As only
ministers can approve government policy, it follows that the day to day
business of these bodies will not involve government policymaking. By
delegating an activity to a body at arm’s length from ministers, the
government has in effect signalled that the activity is considered
operational or otherwise independent of government." (The previous page of
the document enumerates the different types of "arm's-length body", with
executive agency - which the MHRA is - being one of these.) Can you please
now accept that the MHRA's pharmacovigilance function, including the
publication of datasets such as iDAPs, is the implementation of existing
government policy around medicines regulation, and withdraw your assertion
that section 35(1)(a) is relevant to the publication or otherwise of iDAPs
for COVID-19 vaccines? Alternatively, if you are unwilling to do this, can
you please provide a more robust defence of your reliance on section
35(1)(a) beyond simple assertions like "this information is exempted as
per section 35 of the Freedom of Information Act"? c) Further to point
(b), could I also ask you to consider the example of iDAPs for HPV
vaccines. Given that it is government policy for as many eligible
individuals as possible to get an HPV vaccine, is your view that - while
you recognise that there is strong interest in seeing iDAPs for HPV
vaccines, and accept in principle that they should not be withheld - you
could rely on section 35(1)(a) FOIA 2000 to withhold iDAPs for HPV
vaccines for many, many years on the basis that their publication "could
impact adversely on the policy around the wider government [HPV] vaccine
campaign as the information may be misused once in the public domain by
those who do not agree with vaccination in general"? In your response to
question 2 in my request, you state both that the information is covered
by a section 35 FOIA 2000 exemption, and that you do not hold the
information "as [it] is a future decision". d) Can you please clarify
which of the above two statements is true? Specifically, does the
information around who will make the eventual decision about when to go
ahead and publish the iDAPs (along with the other pieces of information
requested in question 2) exist, or does it not exist? With regards
question 3 in my request, part of this question asks whether ministers
were involved in the decision not to publish thus far - this part is not
about the future. e) In light of the various points made above with
respect to question 1, can you now please confirm whether ministers were
involved in the decision not to publish thus far, and, if so, in what
capacity? Can I kindly ask you to respond individually to each of points
(a), (b), (c), (d) and (e). 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 #772871
email] Disclaimer: This message and any reply that you make will be
published on the internet. Our privacy and copyright policies:
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For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #772871 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
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For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
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.

show quoted sections

Dear Medicines and Healthcare products Regulatory Agency,

It is now over 40 working days since the date of my internal review request.

If you have not responded to my request by 1 December 2021, I will raise a case with the ICO regarding this matter.

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Wednesday, November 24,
2021 9:12:00 PM To: MHRA Customer Services Subject: RE: Internal review of
Freedom of Information request - Non-publication of COVID-19 vaccine iDAPs
- Decision-makers Dear Medicines and Healthcare products Regulatory
Agency, It is now over 40 working days since the date of my internal
review request. If you have not responded to my request by 1 December
2021, I will raise a case with the ICO regarding this matter. Yours
faithfully, 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. Ourguidance and information can be
accessed here. ________________________________________ From: Kenneth
MacArthur <[FOI #772871 email]> Sent: Saturday, November 13, 2021 2:21:40
PM To: MHRA Customer Services Subject: RE: Internal review of Freedom of
Information request - Non-publication of COVID-19 vaccine iDAPs -
Decision-makers 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. Ourguidance and information can be accessed here.
________________________________________ From: Kenneth MacArthur <[FOI
#772871 email]> Sent: Thursday, September 23, 2021 8:49:08 PM To: MHRA
Customer Services Subject: Internal review of Freedom of Information
request - Non-publication of COVID-19 vaccine iDAPs - Decision-makers 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 'Non-publication of COVID-19 vaccine iDAPs - Decision-makers'. In
your response to question 1 in my request, you state that the MHRA are
still considering the timing of the publication of the COVID-19 vaccine
iDAPs and that "therefore" the information I have requested is exempt
under section 35 of the Freedom of Information Act (FOIA) 2000 (which you
later clarified to me to be section 35(1)(a) FOIA 2000 in particular).
There are several issues with this. a) Firstly, you have responded to a
different question than the one I asked. I asked you to confirm which
individual or individuals have made the decision to not publish the iDAPs
at the present time - ie, thus far. I understand that you may still be
considering the timing of the iDAPs' publication, but someone, or some
group of people, has made the decision to not publish up until this point.
That is clear from the clarification e-mail you sent me on 9 September
2021, in which you said: "we took into account that releasing the
information prematurely could impact adversely on the policy around the
wider government vaccine campaign as the information may be misused once
in the public domain by those who do not agree with vaccination in
general". Ie, it is clear from that e-mail that an _active decision_ was
taken to not publish yet. I would like to know who made that decision
(along with the other pieces of information requested in question 1). Can
you please now provide that information? b) The MHRA's role in the UK's
public administration architecture is, inter alia, to license and to
provide post-licensing pharmacovigilance for medicinal products. It has a
specific statutory role under, inter alia, The Human Medicines Regulations
2012. In exercising that statutory role and broader public administrative
function, it is implementing existing government policy around medicines
regulation. That point is prima facie clear. However, even if it were not,
the ICO, on page 19 of their guidance document "Government policy (section
35)"
(https://eur01.safelinks.protection.outlo...
), state: "In general, arm’s-length bodies are created to deliver
specialist services which do not require the day to day engagement of
ministers, or which need to be independent of government. As only
ministers can approve government policy, it follows that the day to day
business of these bodies will not involve government policymaking. By
delegating an activity to a body at arm’s length from ministers, the
government has in effect signalled that the activity is considered
operational or otherwise independent of government." (The previous page of
the document enumerates the different types of "arm's-length body", with
executive agency - which the MHRA is - being one of these.) Can you please
now accept that the MHRA's pharmacovigilance function, including the
publication of datasets such as iDAPs, is the implementation of existing
government policy around medicines regulation, and withdraw your assertion
that section 35(1)(a) is relevant to the publication or otherwise of iDAPs
for COVID-19 vaccines? Alternatively, if you are unwilling to do this, can
you please provide a more robust defence of your reliance on section
35(1)(a) beyond simple assertions like "this information is exempted as
per section 35 of the Freedom of Information Act"? c) Further to point
(b), could I also ask you to consider the example of iDAPs for HPV
vaccines. Given that it is government policy for as many eligible
individuals as possible to get an HPV vaccine, is your view that - while
you recognise that there is strong interest in seeing iDAPs for HPV
vaccines, and accept in principle that they should not be withheld - you
could rely on section 35(1)(a) FOIA 2000 to withhold iDAPs for HPV
vaccines for many, many years on the basis that their publication "could
impact adversely on the policy around the wider government [HPV] vaccine
campaign as the information may be misused once in the public domain by
those who do not agree with vaccination in general"? In your response to
question 2 in my request, you state both that the information is covered
by a section 35 FOIA 2000 exemption, and that you do not hold the
information "as [it] is a future decision". d) Can you please clarify
which of the above two statements is true? Specifically, does the
information around who will make the eventual decision about when to go
ahead and publish the iDAPs (along with the other pieces of information
requested in question 2) exist, or does it not exist? With regards
question 3 in my request, part of this question asks whether ministers
were involved in the decision not to publish thus far - this part is not
about the future. e) In light of the various points made above with
respect to question 1, can you now please confirm whether ministers were
involved in the decision not to publish thus far, and, if so, in what
capacity? Can I kindly ask you to respond individually to each of points
(a), (b), (c), (d) and (e). 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 #772871
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...
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #772871
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...
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #772871 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...
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.

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr MacArthur,

Thank you for your email.

We are sorry that their has been a delay in our providing a response.

We are working on providing you a response as soon as possible and we appreciate your patience at this time.

With regards,

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Dear Medicines and Healthcare products Regulatory Agency,

It is now over 60 working days since I submitted my internal review request.

Please can you confirm whether you intend to provide a response to my internal review request, and, if so, by when.

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Tuesday, December 21,
2021 11:01:42 AM To: MHRA Customer Services Subject: Re: FOI 21/794
Internal review of Freedom of Information request - Non-publication of
COVID-19 vaccine iDAPs - Decision-makers Dear Medicines and Healthcare
products Regulatory Agency, It is now over 60 working days since I
submitted my internal review request. Please can you confirm whether you
intend to provide a response to my internal review request, and, if so, by
when. Yours faithfully, Kenneth MacArthur -----Original Message----- Dear
Mr MacArthur, Thank you for your email. We are sorry that their has been a
delay in our providing a response. We are working on providing you a
response as soon as possible and we appreciate your patience at this time.
With 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 #772871 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...
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.

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Kenneth MacArthur,

Thank you for your email.

We have chased your enquiry with our experts and we can only apologise that you have not yet received a response. We have notified the team concerned and they will respond to you as soon as they can.

We are sorry for the length of time you have to wait for a response.

In the meantime should you require any further advice or assistance on this matter please feel free to call us on 020 3080 6000 or reply to this email.

Our opening hours are Mon - Fri 9am to 5pm (excluding UK Public Holidays)

With regards,

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000

show quoted sections

Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency,

It is now almost 80 working days since I submitted my internal review request, far in excess of the maximum time permitted to respond to internal review requests.

Please can you ask the team responsible to provide a target date for their response, noting that this is required by ICO guidance (https://ico.org.uk/for-organisations/req...).

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Saturday, January 15,
2022 7:10:15 PM To: MHRA Customer Services Subject: Re: FOI 21/794
Internal review of Freedom of Information request - Non-publication of
COVID-19 vaccine iDAPs - Decision-makers Dear Medicines and Healthcare
products Regulatory Agency, It is now almost 80 working days since I
submitted my internal review request, far in excess of the maximum time
permitted to respond to internal review requests. Please can you ask the
team responsible to provide a target date for their response, noting that
this is required by ICO guidance
(https://eur01.safelinks.protection.outlo...).
Yours faithfully, Kenneth MacArthur -----Original Message----- Dear
Kenneth MacArthur, Thank you for your email. We have chased your enquiry
with our experts and we can only apologise that you have not yet received
a response. We have notified the team concerned and they will respond to
you as soon as they can. We are sorry for the length of time you have to
wait for a response. In the meantime should you require any further advice
or assistance on this matter please feel free to call us on 020 3080 6000
or reply to this email. Our opening hours are Mon - Fri 9am to 5pm
(excluding UK Public Holidays) With regards, MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade,
Canary Wharf, London E14 4PU Telephone 0203 080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #772871 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...
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.

show quoted sections

Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency,

It is now significantly more than 80 working days since I submitted my internal review request, far in excess of the maximum time permitted to respond to internal review requests.

Please can you advise within the next 5 working days whether you are intending to respond to this internal review request.

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Thursday, February 3,
2022 9:53:35 PM To: MHRA Customer Services Subject: RE: FOI 21/794
Internal review of Freedom of Information request - Non-publication of
COVID-19 vaccine iDAPs - Decision-makers Dear Medicines and Healthcare
products Regulatory Agency, It is now significantly more than 80 working
days since I submitted my internal review request, far in excess of the
maximum time permitted to respond to internal review requests. Please can
you advise within the next 5 working days whether you are intending to
respond to this internal review request. Yours faithfully, 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. Ourguidance and information can be accessed here.
________________________________________ From: Kenneth MacArthur <[FOI
#772871 email]> Sent: Saturday, January 15, 2022 7:10:15 PM To: MHRA
Customer Services Subject: Re: FOI 21/794 Internal review of Freedom of
Information request - Non-publication of COVID-19 vaccine iDAPs -
Decision-makers Dear Medicines and Healthcare products Regulatory Agency,
It is now almost 80 working days since I submitted my internal review
request, far in excess of the maximum time permitted to respond to
internal review requests. Please can you ask the team responsible to
provide a target date for their response, noting that this is required by
ICO guidance
(https://eur01.safelinks.protection.outlo...).
Yours faithfully, Kenneth MacArthur -----Original Message----- Dear
Kenneth MacArthur, Thank you for your email. We have chased your enquiry
with our experts and we can only apologise that you have not yet received
a response. We have notified the team concerned and they will respond to
you as soon as they can. We are sorry for the length of time you have to
wait for a response. In the meantime should you require any further advice
or assistance on this matter please feel free to call us on 020 3080 6000
or reply to this email. Our opening hours are Mon - Fri 9am to 5pm
(excluding UK Public Holidays) With regards, MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade,
Canary Wharf, London E14 4PU Telephone 0203 080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #772871
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...
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #772871 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...
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.

show quoted sections

Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency,

It is now over 120 working days since I submitted my internal review request, far in excess of the maximum time permitted to respond to internal review requests.

This is far longer than you are taking to respond to other FOI or internal review requests.

Please can you explain why you are taking so long to respond to this particular internal review request.

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Friday, March 25, 2022
5:00:16 PM To: MHRA Customer Services Subject: RE: FOI 21/794 Internal
review of Freedom of Information request - Non-publication of COVID-19
vaccine iDAPs - Decision-makers Dear Medicines and Healthcare products
Regulatory Agency, It is now over 120 working days since I submitted my
internal review request, far in excess of the maximum time permitted to
respond to internal review requests. This is far longer than you are
taking to respond to other FOI or internal review requests. Please can you
explain why you are taking so long to respond to this particular internal
review request. Yours faithfully, 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. Ourguidance
and information can be accessed here.
________________________________________ From: Kenneth MacArthur <[FOI
#772871 email]> Sent: Thursday, February 3, 2022 9:53:35 PM To: MHRA
Customer Services Subject: RE: FOI 21/794 Internal review of Freedom of
Information request - Non-publication of COVID-19 vaccine iDAPs -
Decision-makers Dear Medicines and Healthcare products Regulatory Agency,
It is now significantly more than 80 working days since I submitted my
internal review request, far in excess of the maximum time permitted to
respond to internal review requests. Please can you advise within the next
5 working days whether you are intending to respond to this internal
review request. Yours faithfully, 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. Ourguidance
and information can be accessed here.
________________________________________ From: Kenneth MacArthur <[FOI
#772871 email]> Sent: Saturday, January 15, 2022 7:10:15 PM To: MHRA
Customer Services Subject: Re: FOI 21/794 Internal review of Freedom of
Information request - Non-publication of COVID-19 vaccine iDAPs -
Decision-makers Dear Medicines and Healthcare products Regulatory Agency,
It is now almost 80 working days since I submitted my internal review
request, far in excess of the maximum time permitted to respond to
internal review requests. Please can you ask the team responsible to
provide a target date for their response, noting that this is required by
ICO guidance
(https://eur01.safelinks.protection.outlo...).
Yours faithfully, Kenneth MacArthur -----Original Message----- Dear
Kenneth MacArthur, Thank you for your email. We have chased your enquiry
with our experts and we can only apologise that you have not yet received
a response. We have notified the team concerned and they will respond to
you as soon as they can. We are sorry for the length of time you have to
wait for a response. In the meantime should you require any further advice
or assistance on this matter please feel free to call us on 020 3080 6000
or reply to this email. Our opening hours are Mon - Fri 9am to 5pm
(excluding UK Public Holidays) With regards, MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade,
Canary Wharf, London E14 4PU Telephone 0203 080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request: [FOI #772871
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For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
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Please note that in some cases publication of requests and responses will
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show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr Kenneth MacArthur,

Thank you for your email.

Please see below links to recent decision notices on the Information Commissioner's Office website relating to Interactive Data Analysis Profile and these documents are available in the public domain.

https://ico.org.uk/media/action-weve-tak...

https://ico.org.uk/media/action-weve-tak...

https://ico.org.uk/media/action-weve-tak...

Kind Regards

MHRA Customer Experience Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency,

Thank you for your message and for the links.

However, as I'm sure you would agree, a few links are not - in law or in any other way - a substitute for a response to my internal review request - nor to the question in my e-mail of 25 March 2022, namely:

Please can you explain why you are taking so long to respond to this particular internal review request.

I look forward to hearing from you.

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Monday, March 28, 2022
5:46:10 PM To: MHRA Customer Services Subject: RE: FOI 21/794 Internal
review of Freedom of Information request - Non-publication of COVID-19
vaccine iDAPs - Decision-makers Dear Medicines and Healthcare products
Regulatory Agency, Thank you for your message and for the links. However,
as I'm sure you would agree, a few links are not - in law or in any other
way - a substitute for a response to my internal review request - nor to
the question in my e-mail of 25 March 2022, namely: Please can you explain
why you are taking so long to respond to this particular internal review
request. I look forward to hearing from you. Yours faithfully, Kenneth
MacArthur -----Original Message----- Dear Mr Kenneth MacArthur, Thank you
for your email. Please see below links to recent decision notices on the
Information Commissioner's Office website relating to Interactive Data
Analysis Profile and these documents are available in the public domain.
https://eur01.safelinks.protection.outlo...
https://eur01.safelinks.protection.outlo...
https://eur01.safelinks.protection.outlo...
Kind Regards MHRA Customer Experience 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 #772871 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...
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.

show quoted sections

Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency,

Further to our exchange of messages last week, please can you confirm by the end of this week (ie, by 8 April 2022) whether you intend to respond to this internal review request.

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Monday, April 4, 2022
12:12:21 PM To: MHRA Customer Services Subject: RE: FOI 21/794 Internal
review of Freedom of Information request - Non-publication of COVID-19
vaccine iDAPs - Decision-makers Dear Medicines and Healthcare products
Regulatory Agency, Further to our exchange of messages last week, please
can you confirm by the end of this week (ie, by 8 April 2022) whether you
intend to respond to this internal review request. Yours faithfully,
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. Ourguidance and information can be accessed here.
________________________________________ From: Kenneth MacArthur <[FOI
#772871 email]> Sent: Monday, March 28, 2022 5:46:10 PM To: MHRA Customer
Services Subject: RE: FOI 21/794 Internal review of Freedom of Information
request - Non-publication of COVID-19 vaccine iDAPs - Decision-makers Dear
Medicines and Healthcare products Regulatory Agency, Thank you for your
message and for the links. However, as I'm sure you would agree, a few
links are not - in law or in any other way - a substitute for a response
to my internal review request - nor to the question in my e-mail of 25
March 2022, namely: Please can you explain why you are taking so long to
respond to this particular internal review request. I look forward to
hearing from you. Yours faithfully, Kenneth MacArthur -----Original
Message----- Dear Mr Kenneth MacArthur, Thank you for your email. Please
see below links to recent decision notices on the Information
Commissioner's Office website relating to Interactive Data Analysis
Profile and these documents are available in the public domain.
https://eur01.safelinks.protection.outlo...
https://eur01.safelinks.protection.outlo...
https://eur01.safelinks.protection.outlo...
Kind Regards MHRA Customer Experience 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
#772871 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...
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.
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #772871 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...
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.

show quoted sections

Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency,

Can you please let me know whether you intend to respond to my internal review request of 23 September 2021.

If you do not intend to so respond, can you please let me know why.

Thanking you in advance.

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Tuesday, April 19, 2022
8:58:57 PM To: MHRA Customer Services Subject: RE: FOI 21/794 Internal
review of Freedom of Information request - Non-publication of COVID-19
vaccine iDAPs - Decision-makers Dear Medicines and Healthcare products
Regulatory Agency, Can you please let me know whether you intend to
respond to my internal review request of 23 September 2021. If you do not
intend to so respond, can you please let me know why. Thanking you in
advance. Yours faithfully, Kenneth MacArthur

show quoted sections

Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency,

I recently spoke on the phone to one of your colleagues, who promised to come back to me by e-mail on this request (FOI 21/794), in particular addressing the matter of by when you expect to be able to respond to the request for internal review.

Is it possible to provide me with that update?

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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 #772871 email]> Sent: Thursday, May 26, 2022
3:47:26 PM To: MHRA Customer Services Subject: RE: FOI 21/794 Internal
review of Freedom of Information request - Non-publication of COVID-19
vaccine iDAPs - Decision-makers Dear Medicines and Healthcare products
Regulatory Agency, I recently spoke on the phone to one of your
colleagues, who promised to come back to me by e-mail on this request (FOI
21/794), in particular addressing the matter of by when you expect to be
able to respond to the request for internal review. Is it possible to
provide me with that update? Yours faithfully, 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.
Ourguidance and information can be accessed here.
________________________________________ From: Kenneth MacArthur <[FOI
#772871 email]> Sent: Tuesday, April 19, 2022 8:58:57 PM To: MHRA Customer
Services Subject: RE: FOI 21/794 Internal review of Freedom of Information
request - Non-publication of COVID-19 vaccine iDAPs - Decision-makers Dear
Medicines and Healthcare products Regulatory Agency, Can you please let me
know whether you intend to respond to my internal review request of 23
September 2021. If you do not intend to so respond, can you please let me
know why. Thanking you in advance. Yours faithfully, Kenneth MacArthur
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #772871 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.

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Mr MacArthur

Please find a response to your request for an internal review of FOI 21/794 attached.

Kind regards,

Chris
MHRA Customer Experience Centre
Communications and engagement team
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.

Read our guidance on coronavirus (COVID-19)

show quoted sections