Staff performance for appraisal year 2013/14

Leonard Spencer

Dear Medicines and Healthcare products Regulatory Agency,

For the latter half of the staff appraisal year 2013/14, the MHRA adopted the new Civil Service Competency Framework. Staff were given a rating between 1 and 5 for the 'what' and the 'how' – with 1 being very good and 5 being very poor.

Please provide ratings for both the 'what' and the 'how' for all staff in grades A, E, H, S and 7 for the Communications Division in the following format (or so that it can be converted to this format with no loss of information):

Communications: Staff member 1 – grade: A, what: 4, how: 2, staff member 2 – grade: E, what: 2, how: 1, … staff member X – grade: 7, what: 4, how: 5.

Please provide the same information for the remaining eight MHRA Divisions – Devices, Operations and Finance, Human Resources, Information Management, Inspection, Enforcement and Standards, Licensing, Policy and Vigilance and Risk Management of Medicines. Please do not combine the information from the nine divisions.

The MHRA procedure and guidance applicable to the appraisal year 2013/14 provides that the final rating must be agreed between the employee and their line manager. Please provide the number of staff in each Division who have not agreed or refused to agree their rating, eg:

Communications: 1, Devices: 4, Operations and Finance: 0 … Vigilance and Risk Management of Medicines: 2.

Yours faithfully,

Leonard Spencer

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare Products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 18 working days. Further information on how we handle different
requests can be found on our website at the link below:
 
[1]http://www.mhra.gov.uk/Contactus/Custome...
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical Trials of medicines:
 
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:
 
[3]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Manufacturer’s and wholesale dealer’s licences:

[4]http://www.mhra.gov.uk/Howweregulate/Med...
 
Registration of medical devices, opticians and dental laboratories:

[5]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Reporting a side effect to a medicine:

[6]http://www.mhra.gov.uk/Safetyinformation...
 
Reporting an adverse incident involving a medical device:
 
[7]http://www.mhra.gov.uk/Safetyinformation...
 
Does my product need a licence?:

[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
Reporting a counterfeit medical product:
 
[9]http://www.mhra.gov.uk/Safetyinformation...
 
Buying medicines over the internet:
 
[10]http://www.mhra.gov.uk/Safetyinformation...
 
We’d like to thank you if you participated in our recent survey, the
result is now published on our Customer Services webpage at
[11]http://www.mhra.gov.uk/Contactus/Custome.... We are
continuously looking to make improvements to the service offered by our
Customer Services team, so if you have any feedback please don’t hesitate
to get in touch with us either on the number below or by completing the
form at the link below:
[12]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards,
 
The Customer Services Team
External Relations
Medicines and Healthcare Products Regulatory Agency
 
Please note this is an automated reply; please do not respond to this
message.
 
 
 

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 14/242
       
Dear Mr Spencer,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 9 June 2014. 
       
I confirm that your request is 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.
       
Kind Regards,

Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency
Tel: 020 3080 6000

show quoted sections

Leonard Spencer

Dear MHRA Customer Services,

I refer you to my request of 8th June 2014 - your reference FOI 14/242. By law you were required to reply promptly and by no later that 4th July 2014. You have done neither.

Please provide the information I have requested and also an explanation for the delay.

Yours sincerely,

Leonard Spencer

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare Products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 18 working days. Further information on how we handle different
requests can be found on our website at the link below:
 
[1]http://www.mhra.gov.uk/Contactus/Custome...
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical Trials of medicines:
 
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:
 
[3]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Manufacturer’s and wholesale dealer’s licences:

[4]http://www.mhra.gov.uk/Howweregulate/Med...
 
Registration of medical devices, opticians and dental laboratories:

[5]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Reporting a side effect to a medicine:

[6]http://www.mhra.gov.uk/Safetyinformation...
 
Reporting an adverse incident involving a medical device:
 
[7]http://www.mhra.gov.uk/Safetyinformation...
 
Does my product need a licence?:

[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
Reporting a counterfeit medical product:
 
[9]http://www.mhra.gov.uk/Safetyinformation...
 
Buying medicines over the internet:
 
[10]http://www.mhra.gov.uk/Safetyinformation...
 
We’d like to thank you if you participated in our recent survey, the
result is now published on our Customer Services webpage at
[11]http://www.mhra.gov.uk/Contactus/Custome.... We are
continuously looking to make improvements to the service offered by our
Customer Services team, so if you have any feedback please don’t hesitate
to get in touch with us either on the number below or by completing the
form at the link below:
[12]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards,
 
The Customer Services Team
External Relations
Medicines and Healthcare Products Regulatory Agency
 
Please note this is an automated reply; please do not respond to this
message.
 
 
 

show quoted sections

Leonard Spencer

Dear Medicines and Healthcare products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Staff performance for appraisal year 2013/14'.

By law you were required to reply promptly and by no later
than the 4th July 2014. You have done neither.

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

Yours faithfully,

Leonard Spencer

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare Products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 18 working days. Further information on how we handle different
requests can be found on our website at the link below:
 
[1]http://www.mhra.gov.uk/Contactus/Custome...
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical Trials of medicines:
 
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:
 
[3]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Manufacturer’s and wholesale dealer’s licences:

[4]http://www.mhra.gov.uk/Howweregulate/Med...
 
Registration of medical devices, opticians and dental laboratories:

[5]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Reporting a side effect to a medicine:

[6]http://www.mhra.gov.uk/Safetyinformation...
 
Reporting an adverse incident involving a medical device:
 
[7]http://www.mhra.gov.uk/Safetyinformation...
 
Does my product need a licence?:

[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
Reporting a counterfeit medical product:
 
[9]http://www.mhra.gov.uk/Safetyinformation...
 
Buying medicines over the internet:
 
[10]http://www.mhra.gov.uk/Safetyinformation...
 
We’d like to thank you if you participated in our recent survey, the
result is now published on our Customer Services webpage at
[11]http://www.mhra.gov.uk/Contactus/Custome.... We are
continuously looking to make improvements to the service offered by our
Customer Services team, so if you have any feedback please don’t hesitate
to get in touch with us either on the number below or by completing the
form at the link below:
[12]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards,
 
The Customer Services Team
External Relations
Medicines and Healthcare Products Regulatory Agency
 
Please note this is an automated reply; please do not respond to this
message.
 
 
 

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Mr Spencer,
       
Thank you for your email.

Attached is the response to your FOI request.
       
Kind Regards,

Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency

Tel: 020 3080 6000

 

show quoted sections

Leonard Spencer

Dear Medicines and Healthcare products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Staff performance for appraisal year 2013/14'.

I find your response of 14 July 2014 to be wholly unacceptable.

Firstly, I am not concerned whether the information I have requested under the Freedom of Information Act has 'not been finalised yet'. Ratings were given by line managers to their staff so the information I requested exists. How the Agency intends to further process the information is irrelevant to this request. I am happy for it to be provided in its current form – there is no exemption under the Act for it not to be supplied on the basis that further processing may or may not take place.

Secondly, I cannot in general terms agree with your position that you would unlikely be able to provide the information I have requested due to its 'sensitive personal nature'. For example, should there be only one person at grade 7 in the Communications Division, then I would agree it may be possible to discover the performance rating of that person in the event the Agency either now, or in the future, disclosed the identities and grades of all its employees at the time of the performance management review. I think this unlikely. I appreciate that discretion will be necessary where there is only one person at a particular grade in a particular Division. However, if there are c.10 people at grade E in the Communications Division, it would be impossible to identify an individual based on the information I have requested. I therefore suggest that where there there is a single person at a given grade in any Division, then information be provided on an Agency wide basis, ie:

Whole Agency: Staff member 1 – grade: 7, what: 4, how: 2, staff member 2 – grade: 7, what: 2, how: 1, … staff member X – grade: 7, what: 4, how: 5.

Finally, I cannot accept that providing the number of people 'who have not agreed or refused to agree their rating' could possibly lead to the identification of a single individual. To take such a position shows a clear lack of understanding of the information requested and is an abuse of the Act.

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

Yours faithfully,

Leonard Spencer

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare Products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 18 working days. Further information on how we handle different
requests can be found on our website at the link below:
 
[1]http://www.mhra.gov.uk/Contactus/Custome...
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical Trials of medicines:
 
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:
 
[3]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Manufacturer’s and wholesale dealer’s licences:

[4]http://www.mhra.gov.uk/Howweregulate/Med...
 
Registration of medical devices, opticians and dental laboratories:

[5]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Reporting a side effect to a medicine:

[6]http://www.mhra.gov.uk/Safetyinformation...
 
Reporting an adverse incident involving a medical device:
 
[7]http://www.mhra.gov.uk/Safetyinformation...
 
Does my product need a licence?:

[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
Reporting a counterfeit medical product:
 
[9]http://www.mhra.gov.uk/Safetyinformation...
 
Buying medicines over the internet:
 
[10]http://www.mhra.gov.uk/Safetyinformation...
 
We’d like to thank you if you participated in our recent survey, the
result is now published on our Customer Services webpage at
[11]http://www.mhra.gov.uk/Contactus/Custome.... We are
continuously looking to make improvements to the service offered by our
Customer Services team, so if you have any feedback please don’t hesitate
to get in touch with us either on the number below or by completing the
form at the link below:
[12]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards,
 
The Customer Services Team
External Relations
Medicines and Healthcare Products Regulatory Agency
 
Please note this is an automated reply; please do not respond to this
message.
 
 
 

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Mr Spencer,

Please find attached the outcome of the internal review of request FOI
14/242.

Kind Regards,

Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency
Tel: 020 3080 6000

show quoted sections

Commins, Peter, Medicines and Healthcare Products Regulatory Agency

Dear Mr Spencer, further to the internal review of your request FOI 14/242
conducted on 15 August 2014, I am writing to advise you of developments
subsequent to that review.

 

Following the decision of the internal review to make an amended release
of the requested information, we have received further advice, which has
meant that we are applying a further exemption to your request. This
exemption is under section 36(4) of the Freedom Of Information Act 2000
(Information Prejudicial to the conduct of public affairs). As we had
previously explained, the data the agency holds is incomplete, inaccurate
(because it hasn’t be checked, moderated and verified/agreed) and Public
bodies have the right to the safe space to cleanse such data and make it
accurate before considering release. Certain uses of Section 36 of the Act
are subject to a Public Interest test, including this use. I have
considered the public interest and can see no benefit to the public of
having this information released early that would outweigh the potential
harm (such as through loss of trust or confidence) that it would cause
between managers and staff of the MHRA.

 

I realise that this is in contrast to the information given to you on 15
August, where we stated that the suitably anonymised information could be
released following your acceptance of provisional data. I apologise for
this situation, and that the exemption was not applied –at the time- in
respect of the original request. For your information, we are now in the
final phase of the process (appeals against markings) and staff have until
12 September to lodge their appeals following which we expect all appeals
to be completed by the end of October.  Following this the data should
then be finalised. You may still, of course, refer this matter to the
Information Commissioner’s Office if you are dissatisfied with the way in
which it has been handled.

 

Peter Commins

Chief Operating Officer

Medicines and Healthcare Products Regulatory Agency

 

show quoted sections

Dear Mr Commins

I refer you to your email of 29 August and write to express the deepest concern. Before I refer this matter to the Information Commissioner, I wish to make it patently clear to you the wholly untenable position in which the Agency has chosen to place itself.

The finding of the internal review was that appropriately redacted information would be released under the Freedom of Information Act 200 (the “Act”). Your email of 29 August states that this will now not take place. This is unacceptable.

You state '...I am writing to advise you of developments subsequent to that review.'. You state '...we have received further advice, which has meant that we are applying a further exemption to your request'. You then cite s.36(4) [sic] the Act. Subsection 4 has no bearing on the request so I assume you are referring to the general provisions of s.36.

I regret to inform you that in order for an exemption under s.36 to be engaged, it must be raised before the end of the internal review. See Thackeray, fn 144, para 56, endorsing the Tribunal's conclusions in McIntyre v Information Commissioner and Ministry of Defence, EA/2007/0061; and Roberts v Information Commissioner and BERR, EA/2012/0035, paras 23 and 27. See also Ryanair v Information Commissioner and Office of Fair Trading, EA/2012/0088 at para 42, in which the timing of the opinion (post review) gave rise to a 'strong objective perception that [it] was an ex post facto conclusion … that goes at the heart of eroding the concept of reasonableness'. The internal review ended on 15 August and you cited s.36 on 29 August. Therefore an exemption under s.36 is not engaged.

You state 'Certain uses of Section 36 of the Act are subject to a Public Interest test, including this use'. You state 'I have considered the public interest...'. Section 36 the Act is a prejudice-based exemption. The public interest is irrelevant. The opinion by the 'qualified person' is restricted to the issue of prejudice alone, not any balancing of competing public interests.

I regret to inform you that you have failed to apply the appropriate test. In applying a public interest test to a prejudice-based exemption, your response is not 'Wednsebury reasonable'. That is to say not within the bounds of reasonableness or range of reasonable opinions. See Thackeray, fn 144, para 53; Guardian Newspapers and Brooke v Information Commissioner and BBC, EA/2006/0011 at paras 57-9; University of Central Lancashire v Information Commissioner and Colquhuon, EA/2009/0034 at paras 56-8 (reasonable decision must be based on sound argument and evidence). Therefore the appropriate test under s.36 has not been undertaken.

You state 'I have considered the public interest...'. For the purposes of s.36, the appropriate 'qualified person' is given at s.36(5) the Act.

In the case of the purported exemption, the appropriately 'qualified person' is either the Secretary of Sate or the chief executive officer of the Medicines and Healthcare Products Regulatory Agency – Dr Ian Hudson. The role of a 'qualified person' cannot be delegated. See Brooke v Information Commissioner and BBC, EA/2006/0011 at para 26. You, Mr Commins, as mere chief operating officer, do not qualify to make make such a decision.

You state '..following your acceptance of provisional data', echoing the incorrect conclusion reached by the internal review. At no point did I accept anything. My request progressed as follows – I asked for the information – I was refused – I asked for an internal review. In order for me to have accepted anything there must have been an offer made by the Agency. The Agency made no offer. There was no offer for me to accept. I have accepted nothing. You therefore have a perverted view of what has lead to this point and that is disturbing.

Section 1(4)(b) the Act states:

'...is the information in question held at the time when the request is received, except that account may be taken of any amendment or deletion made between that time and the time when the information is to be communicated under subsection (a)(b), being an amendment or deletion that would have been made regardless of the receipt of the request.'

When I submitted my request, I required the information as it was on that date subject to s.1 of the Act. The information exists – each and every employee was given a rating between 1 and 5 for the 'what' and the 'how' by their line manager. You know you will not be destroying that information. I know you will not be destroying that information. You will merely be creating more information following further processing – what you describe to be 'because it hasn't been checked, moderated and verified/agreed.

I will be referring this matter to the Information Commissioner on 20 September. Should you chose to supply the information I requested on the 08 June, I shall refrain from doing so.

Yours sincerely

Leonard Spencer