MHRA staff working on COVID-19 vaccines
Dear Medicines and Healthcare products Regulatory Agency (MHRA),
I am writing to make a request for information under section 1 of the Freedom of Information Act 2000.
Please can you confirm how many MHRA members of staff (permanent and temporary) are currently working, or have worked, either full-time or part-time, on:
a) The licensing of COVID-19 vaccines,
b) Pharmacovigilance for COVID-19 vaccines, and
c) Any other matter related to COVID-19 vaccines.
Please provide the numbers separately for (a), (b) and (c).
For each of (a), (b) and (c), please can you confirm (simultaneously):
1) How many members of staff fall into the category of (i) Senior Civil Servant (excluding Directors or above) and (ii) Director or above.
2) The split of staff between MHRA Divisions.
Eg, "5 members of staff are currently working, or have worked, on (a) (the licensing of COVID-19 vaccines). Of these 5 members of staff, 4 work in the 'X' Division (of which 1 is a Senior Civil Servant and none are Directors or above), and 1 works in the 'Y' Division (of which none are either Senior Civil Servants or Directors or above)."
Finally, please can you separately confirm whether MHRA is using any consulting, professional services or similar firms to support with work related to COVID-19 vaccines, and, if so, how many full-time equivalents (FTEs) from these firms are currently working, or have worked, on this topic, subdivided into matters (a), (b) and (c) listed above.
For the avoidance of doubt, the terms Senior Civil Servant and Director have the same meaning in this request as in the MHRA's most recent annual report (https://assets.publishing.service.gov.uk...).
Yours faithfully,
Kenneth MacArthur
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Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
Canary Wharf,
London
E14 4PU
gov.uk/mhra
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Our Ref: FOI 21/751
Dear Kenneth MacArthur,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 8th 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
FOI 21/751
Dear Kenneth MacArthur
Thank you for your email.
The MHRA is conducting almost real time safety surveillance of all
COVID-19 vaccines currently used in the UK. Many people across the whole
Agency contribute to the work on licensing and monitoring the safety of
COVID vaccines so it is not possible to give an exact number. In the
Division responsible for vigilance and risk management for medicines,
there are a total of 137 FTEs. The division's responsibilities include
receiving Yellow Card reports and monitoring the benefits and risks of
COVID-19 Vaccines in use.
If you disagree with how we have interpreted the Freedom of Information
Act 2000 with regards to your request, you can ask for the decision to be
reviewed. The review will be carried out by a senior member of the Agency
who was not involved with the original decision. Internal review requests
should be submitted within two months of the date you receive this
response and addressed to: [1][MHRA request email].
If you were to remain dissatisfied with the outcome of the internal
review, you would have the right to apply directly to the Information
Commissioner for a decision. Please bear in mind that the Information
Commissioner will not normally review our handling of your request unless
you have first contacted us to conduct an internal review.
The Information Commissioner can be contacted online:
[2]https://ico.org.uk/make-a-complaint/offi...
If you have a query about the information provided, please reply to this
email
Please remember to quote the reference number above in any future
communications.
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear Medicines and Healthcare products Regulatory Agency (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 'MHRA staff working on COVID-19 vaccines'.
My request was a valid request under section 8 of the Freedom of Information Act (FOIA) 2000.
The information I have requested is not exempt from disclosure - at least, you have not claimed this to be the case, and I cannot see any grounds in FOIA 2000 for it to be so.
You are therefore required under section 1 FOIA 2000 to provide the information I have requested.
You cannot avoid complying with your legal obligation to disclose simply by asserting that doing so "is not possible".
Per ICO guidance, you should "focus searches on the locations most likely to hold relevant information". Applying that to the circumstances of this request could, for example, involve focusing on the set of people with formal or otherwise clear responsibilities around the licensing of, pharmacovigilance for, or other matters related to, the COVID-19 vaccines, without worrying about, say, the person who spends most of their time working on something else, but who reviewed a document for an hour or answered a couple of questions. (And, conversely, it would not be necessary to exclude someone simply because they haven't spent 100% of their time on one of the above-mentioned topics.)
In your response, you use the term "exact number" - which was not language used in my request - as if to imply that this request can only be answered either with complete and utter precision, reflecting every detail and nuance, or it cannot be answered at all. That is unreasonable.
If this case was to end up in front of a tribunal, it seems implausible that the tribunal would agree that it is not possible to identify the people set out in my request (to be clear, I am not asking you to identify them by name, but rather to identify them solely in order to count them). A reasonable person would find it bizzarre that, with all of the attention currently on the COVID-19 pandemic, the UK's medicines regulator can't say how many of its staff are working on the COVID-19 vaccines.
If the secretary of state for health and social care, or the prime minister, posed exactly the same question as I have, would you really respond with a short "it is not possible to give an exact number"? Or would you provide a more helpful answer? I suspect you would do the latter - but please let me know in your response.
Bearing in mind all of the above, please can you now respond in full to my request, noting in particular how I have requested that the information be provided.
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/m...
Yours faithfully,
Kenneth MacArthur
Thank you for your email. This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible.
Please note that we may not respond if your query:
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only
Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
Canary Wharf,
London
E14 4PU
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC.
The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here.
References
Visible links
1. https://www.gov.uk/government/collection...
Internal Review of FOI 21/751
Dear Kenneth MacArthur,
Thank you for your email.
We confirm that an internal review will be carried out on FOI 21/751. We normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.
Kind Regards
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear Medicines and Healthcare products Regulatory Agency,
It is now 48 working days - or over two months - since the date of my internal review request. Under the statutory code of practice issued under section 45 of the Freedom of Information Act 2000 (paragraph 5.5), in instances where public authorities need longer than 20 working days to respond, they should "provide a reasonable target date by which they will be able to respond to the internal review".
Can you please now either provide your substantive response, or provide a reasonable target date by which you will be able to provide your substantive response?
If you do not provide either a substantive response or a reasonable target date by 31 October 2021, I will raise a case with the ICO regarding this matter.
Yours sincerely,
Kenneth MacArthur
Thank you for your email. This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible.
Please note that we may not respond if your query:
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only
Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
Canary Wharf,
London
E14 4PU
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC.
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.
________________________________________ From: Kenneth MacArthur
<[FOI #771773 email]> Sent: Tuesday, October 19,
2021 7:57:14 AM To: MHRA Customer Services Subject: Re: FOI 21/751
Internal review of Freedom of Information request - MHRA staff working on
COVID-19 vaccines Dear Medicines and Healthcare products Regulatory
Agency, It is now 48 working days - or over two months - since the date of
my internal review request. Under the statutory code of practice issued
under section 45 of the Freedom of Information Act 2000 (paragraph 5.5),
in instances where public authorities need longer than 20 working days to
respond, they should "provide a reasonable target date by which they will
be able to respond to the internal review". Can you please now either
provide your substantive response, or provide a reasonable target date by
which you will be able to provide your substantive response? If you do not
provide either a substantive response or a reasonable target date by 31
October 2021, I will raise a case with the ICO regarding this matter.
Yours sincerely, Kenneth MacArthur -----Original Message----- Internal
Review of FOI 21/751 Dear Kenneth MacArthur, Thank you for your email. We
confirm that an internal review will be carried out on FOI 21/751. We
normally aim to respond to requests for internal review within 20 working
days of receipt. However, due to high volumes of queries we are currently
receiving related to COVID-19 please be aware that responses may take
longer than usual. Kind Regards MHRA Customer Service Centre Medicines and
Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf,
London E14 4PU
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Internal Review of FOI 21/751
Dear Kenneth MacArthur,
As requested, we have conducted an Internal Review of FOI 21/751.
We confirm that we do not hold accurate data on the number of staff
working on COVID-19 vaccines at any defined interval. However, we can
provide some information in addition* to that originally issued with the
response to FOI 21/751.
Staff in the MHRA’s Licensing Division are responsible for regulatory
approval of the COVID-19 vaccines, and there are a total of 192.9 FTEs in
this department. The MHRA staff primarily working on regulatory
assessments of COVID-19 vaccines are part of the Biologicals Unit (a
sub-unit of the Licencing Division); the Biologicals unit includes 14.6
FTEs. Please also note, wider resources in the Licensing Division can be
made available to assist evaluation of COVID-19 vaccines as necessary and
if appropriate.
In addition to the above, we would like to mention the valuable
contributions from NIBSC scientists, as members of key decision-making
bodies at both European and international level, feed into the development
of national and international policies that help to ensure the safety and
efficacy of biological medicines, including COVID-19 vaccines [[1]NIBSC -
About us] and [[2]NIBSC - Independent batch release testing of COVID-19
(coronavirus) vaccines]. And, in order to provide a further context of the
breadth of expertise involved in the MHRA assessments of the COVID-19
vaccines, it is also necessary to explain that the assessments are also
reviewed and guided by the advice and expertise of the independent
Commission on Human Medicines (CHM) and Expert Working Groups, in
particular, the Vaccine B/R EWG.
* Please note that the following was provided in the original response and
is provided here in the Internal Review for completeness:
The MHRA is conducting almost real time safety surveillance of all
COVID-19 vaccines currently used in the UK. Many people across the whole
Agency contribute to the work on licensing and monitoring the safety of
COVID vaccines so it is not possible to give an exact number. In the
Division responsible for vigilance and risk management for medicines,
there are a total of 137 FTEs. The division's responsibilities include
receiving Yellow Card reports and monitoring the benefits and risks of
COVID-19 Vaccines in use.
If you remain dissatisfied, you may ask the ICO to make a decision on
whether or not we have interpreted the FOIA correctly in dealing with the
request and subsequent internal review. The ICO’s address is:
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
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