Communications with MHRA/CHM regarding Valneva COVID-19 vaccine
Dear Department of Health and Social Care,
Please could you provide a copy of all communications to date between, on the one hand, ministers and selected civil servants in the Department of Health and Social Care (or their offices), and, on the other hand, the Medicines and Healthcare products Regulatory Agency (MHRA) and/or the Commission on Human Medicines (CHM) regarding the Valneva COVID-19 vaccine candidate.
The selected civil servants mentioned above are as follows: (i) Director - Medicines & Pharmacy, (ii) Deputy Director - Medicines Regulation & Prescribing, (iii) Deputy Director - EU Exit & Medicines Supply, (iv) Deputy Director - Medicines & Pharmacy Analysis, (v) Deputy Director - Medicines Pricing & Supply, and (vi) Senior Policy Manager, MHRA Sponsorship.
Yours faithfully,
Kenneth MacArthur
This is an acknowledgement - please do not reply to this email.
Thank you for contacting the Department of Health and Social Care.
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focusing our resources on the Coronavirus (COVID-19) response.
If your enquiry is in relation to the pandemic, the Government has
launched a COVID-19 ‘hub’, which can be found
at [1]www.gov.uk/coronavirus and is regularly updated.
The answers to many other questions can be found on [2]GOV.UK,
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GP, clinical commissioning group or call 119. [5]This webpage gives
information on vaccination. If you have symptoms of COVID-19 you must get
tested as soon as possible. The swab test takes less than a minute and is
pain-free. Results from test sites are generally received within 24 hours
of the test being administered. Further information, including what
symptoms to look out for, can be found [6]here.
If your business is interested in helping the Government increase
COVID-19 testing capacity, please visit [7]this webpage. Please note that
the service that was set up for businesses to offer other COVID-19 support
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A list of the current exemptions on medical and compassionate grounds can
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found [12]here.
If you are, or have been, in quarantine and have a complaint about the
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If you are writing in connection with an NHS or social care service please
note that the department does not manage health and social services
directly, nor does it process complaints. It also cannot give clinical
advice or intervene in matters concerning patient care or social services.
If you wish to make a complaint about a healthcare professional, an NHS
organisation or a social care provider, please visit [14]this link.
If you would like to raise your concerns about a COVID-19 testing
provider, or have any other NHS Test and Trace enquiries, you can
contact [15]NHS Test and Trace enquiries, feedback and complaints.
Our [16]Personal information charter and [17]privacy notice explain how we
treat your personal information.
This e-mail and any attachments is intended only for the attention of the
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permitted. If you are not the intended recipient, please destroy all
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References
Visible links
1. https://www.gov.uk/coronavirus
2. https://www.gov.uk/
3. https://www.gov.uk/government/organisati...
4. https://www.nhs.uk/
5. https://digital.nhs.uk/coronavirus/vacci...
6. https://www.gov.uk/getting-tested-for-co...
7. https://www.gov.uk/guidance/help-the-gov...
8. https://www.supplychain.nhs.uk/
9. mailto:[email address]
10. mailto:[email address]
11. https://www.gov.uk/guidance/exemptions-f...
12. https://www.gov.uk/government/publicatio...
13. https://dhexchange.kahootz.com/MQS.lands...
14. https://www.nhs.uk/using-the-nhs/about-t...
15. https://enquiries.test-and-trace.nhs.uk/...
16. https://www.gov.uk/government/organisati...
17. https://www.gov.uk/government/publicatio...
Dear Mr MacArthur,
Please find attached the Department of Health and Social Care's response
to your recent FOI request (our ref:FOI-1393824).
Yours sincerely,
Freedom of Information Team
Department of Health and Social Care
Dear Department of Health and Social Care,
Thank you for your response to my request.
In your response, you say:
"None of the civil servants specified in the request have had any communications with the MHRA in relation to Valneva."
However, in my request I specified four groups of people:
1) Ministers
2) Ministers' offices
3) Selected civil servants
4) Selected civil servants' offices
Can you confirm that no-one in any of these four groups of people has had any communications with the MHRA in relation to Valneva?
I would be content if you could confirm this to me in a quick response. Alternatively, I would also be content for you to consider this a request for an internal review, if you prefer.
Yours faithfully,
Kenneth MacArthur
This is an acknowledgement - please do not reply to this email.
Thank you for contacting the Department of Health and Social Care.
We are currently experiencing very high volumes of enquiries and we are
focusing our resources on the Coronavirus (COVID-19) response.
If your enquiry is in relation to the pandemic, the Government has
launched a COVID-19 ‘hub’, which can be found
at [1]www.gov.uk/coronavirus and is regularly updated.
The answers to many other questions can be found on [2]GOV.UK,
the [3]Department of Health and Social Care website or by visiting
the [4]NHS website. We may not respond to you if the answer to your
enquiry can be found on either of these websites. Where a reply is
appropriate, we aim to send a response within 20 working days.
Please note that the department cannot arrange vaccinations. [5]This
webpage gives information on vaccination. You can also contact your GP,
clinical commissioning group or call 119.
If you have symptoms of COVID-19 you must get tested as soon as possible.
The swab test takes less than a minute and is pain-free. Results from test
sites are generally received within 24 hours of the test being
administered. Further information, including what symptoms to look out
for, can be found [6]here.
If your business is interested in helping the Government increase
COVID-19 testing capacity, please visit [7]this webpage. Please note that
the service that was set up for businesses to offer other COVID-19 support
has closed. If you have a product to sell to the NHS, please visit
[8]https://www.supplychain.nhs.uk/.
Since 15 February 2021, anyone travelling to the UK from a red-list
country has been required to quarantine in a managed quarantine facility
for a period of ten days. There will be periods where no countries are
listed, but the red list remains ready to be stood up should the global
epidemiological situation change. In these circumstances, there is
guidance available on a range of queries.
To find out how to apply for a medical or compassionate exemption, please
visit
[9]www.gov.uk/guidance/exemptions-from-managed-quarantine-for-compassionate-reasons.
If you have been in quarantine and have a complaint about the hotel,
please raise your concerns with the hotel itself in the first instance. If
your complaint is unresolved, please email the complaints team at
[10][email address].
If you are writing in connection with an NHS or social care service please
note that the department does not manage health and social services
directly, nor does it process complaints. It also cannot give clinical
advice or intervene in matters concerning patient care or social services.
If you wish to make a complaint about a healthcare professional, an NHS
organisation or a social care provider, please visit [11]this link.
If you would like to raise your concerns about a COVID-19 testing
provider, or have any other NHS Test and Trace enquiries, you can
contact [12]NHS Test and Trace enquiries, feedback and complaints.
Our [13]Personal information charter and [14]privacy notice explain how we
treat your personal information.
This e-mail and any attachments is intended only for the attention of the
addressee(s). Its unauthorised use, disclosure, storage or copying is not
permitted. If you are not the intended recipient, please destroy all
copies and inform the sender by return e-mail. Any views expressed in this
message are not necessarily those of the Department of Health and Social
Care. Please note: Incoming and outgoing email messages are routinely
monitored for compliance with our policy on the use of electronic
communications.
References
Visible links
1. https://www.gov.uk/coronavirus
2. https://www.gov.uk/
3. https://www.gov.uk/government/organisati...
4. https://www.nhs.uk/
5. https://eur03.safelinks.protection.outlo...
6. https://www.gov.uk/getting-tested-for-co...
7. https://www.gov.uk/guidance/help-the-gov...
8. https://www.supplychain.nhs.uk/
9. https://eur03.safelinks.protection.outlo...
10. mailto:[email address]
11. https://www.nhs.uk/using-the-nhs/about-t...
12. https://enquiries.test-and-trace.nhs.uk/...
13. https://www.gov.uk/government/organisati...
14. https://www.gov.uk/government/publicatio...
Dear Department of Health and Social Care,
Could you confirm whether you are considering my e-mail of 4 March 2022 to be a quick clarifying request, or whether you are considering it to be a request for an internal review?
Yours faithfully,
Kenneth MacArthur
Dear Mr MacArthur
Thank you for your message. I can confirm that we're handling your query as an FOI request (ref number: FOI-1397171) rather than as an Internal Review of our response to your previous request (FOI 1393824).
Yours sincerely
FOI team
Dear Department of Health and Social Care,
Thank you for your response.
In my original request of 14 February 2022, I referred to "ministers and selected civil servants in the Department of Health and Social Care (or their offices)".
In my e-mail of 4 March 2022, for your convenience, I wrote out explicitly the four groups of people referred to by the above - namely:
1) Ministers
2) Ministers' offices
3) Selected civil servants
4) Selected civil servants' offices
There is, however, no difference between the set of people referred to in my communication of 14 February 2022 and the set of people referred to in my communication of 4 March 2022.
Can you confirm therefore why you are treating this as a new FOI request?
To be candid, it seems you made a mistake in your original response on 4 March 2022. That is OK - we are all human and we all make mistakes from time to time. However, rather than simply admitting your mistake and correcting it forthwith, you seem to be implying that I have made a new request, when that is not the case.
Please can you clarify your understanding of the situation.
Yours faithfully,
Kenneth MacArthur
Dear Mr MacArthur
Thank you for your message. Once a request has been sent out, that case is closed on our electronic correspondence system, and anything subsequent relating to that case therefore needs to be assigned a new reference number.
I hope this is helpful.
Yours sincerely
FOI team
Dear Department of Health and Social Care,
Thank you for your response.
That makes sense. Would it be reasonable given the circumstances to expect that my message of 4 March 2022 be responded to forthwith, rather than my having to wait potentially 20 working days?
Yours faithfully,
Kenneth MacArthur
Dear Mr MacArthur
Yes, I can confirm that we will try to respond as soon as possible.
Yours sincerely
FOI team
Dear Mr MacArthur,
Please find attached the Department of Health and Social Care's response
to your recent FOI request (our ref:FOI-1397171).
Yours sincerely,
Freedom of Information Team
Department of Health and Social Care
Dear Department of Health and Social Care,
Please pass this on to the person who conducts Freedom of Information reviews.
I am writing to request an internal review of the Department of Health and Social Care's handling of my FOI request 'Communications with MHRA/CHM regarding Valneva COVID-19 vaccine'.
In my request of 14 February 2022 (which you labelled FOI-1393824), I asked the following:
"Please could you provide a copy of all communications to date between, on the one hand, ministers and selected civil servants in the Department of Health and Social Care (or their offices), and, on the other hand, the Medicines and Healthcare products Regulatory Agency (MHRA) and/or the Commission on Human Medicines (CHM) regarding the Valneva COVID-19 vaccine candidate.
"The selected civil servants mentioned above are as follows: (i) Director - Medicines & Pharmacy, (ii) Deputy Director - Medicines Regulation & Prescribing, (iii) Deputy Director - EU Exit & Medicines Supply, (iv) Deputy Director - Medicines & Pharmacy Analysis, (v) Deputy Director - Medicines Pricing & Supply, and (vi) Senior Policy Manager, MHRA Sponsorship."
My request clearly referred to four categories of people:
1) Ministers
2) Ministers' offices
3) Selected civil servants
4) Selected civil servants' offices
You responded to this request on 4 March 2022, but in this response you seemingly referred only to one of the four above-listed categories of people (namely, selected civil servants), ignoring the other three categories.
I responded on 4 March 2022 querying this, and you informed me on 15 March 2022 that you were treating my query as a new FOI request (which you labelled FOI-1397171).
You responded to this 'new' FOI request on 25 March 2022. In this response, you contended that providing the information requested would exceed the appropriate cost limit.
I have a number of questions in relation to this which I would appreciate specific and separate answers to:
a) In your original response on 4 March 2022, were you indeed referring only to "selected civil servants", ignoring ministers, the offices of ministers, and the offices of selected civil servants?
b) Do you agree that you made a mistake in that original response, given that the phrase "ministers and selected civil servants in the Department of Health and Social Care (or their offices)" clearly refers to (1) ministers, (2) ministers' offices, (3) selected civil servants, and (4) selected civil servants' offices?
c) Do you further agree that the only possible alternative interpretation of what I wrote is that ministers, selected civil servants and selected civil servants' offices should be in scope (ie, that only ministers' offices would be out of scope)?
d) In any case, if you think there was any ambiguity in my wording (in relation to whether ministers' offices were or were not in scope), why didn't you get in touch with me to seek clarification? As the ICO's guidance document on the duty to provide advice and assistance (https://ico.org.uk/media/1624140/duty-to...) states, "A public authority’s duty to provide advice and assistance is extensive and will apply to both prospective and actual applicants for information. The purpose of section 16 is to ensure that a public authority communicates with an applicant to find out what information they want and how they can obtain it."
e) Why, when the mistake was pointed out to you (even if it was made in good faith), did you not respond to my request forthwith with a corrected response, but instead insisted on treating my pointing out of the mistake as a new request?
f) You are now claiming that providing the information requested would exceed the appropriate cost limit. Can you please provide cogent evidence - again, per ICO guidance - of how you calculated this to be the case. The group of people who are in scope is relatively small, so I am struggling to understand why it would take you more than 3.5 days to search their e-mails.
g) Again, per ICO guidance and your statutory obligations to advise and assist, can you please advise on (i) how many people there are in each of the four categories of people listed above, and (ii) approximately how many individuals' e-mail you could search for a request of this nature (ie, requesting communications between those individuals and the Medicines and Healthcare products Regulatory Agency (MHRA) and/or the Commission on Human Medicines (CHM) regarding the Valneva COVID-19 vaccine candidate) while remaining within the appropriate cost limit.
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/c...
Yours faithfully,
Kenneth MacArthur
Dear Mr MacArthur.
Please find attached the internal review outcome letter in respect of the
handling of FOI-1397171.
Yours sincerely,
Mr D Stanton
This e-mail and any attachments is intended only for the attention of the
addressee(s). Its unauthorised use, disclosure, storage or copying is not
permitted. If you are not the intended recipient, please destroy all
copies and inform the sender by return e-mail. Any views expressed in this
message are not necessarily those of the Department of Health and Social
Care. Please note: Incoming and outgoing email messages are routinely
monitored for compliance with our policy on the use of electronic
communications.
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