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United Kingdom Information Tribunal including the National Security Appeals Panel


You are here: BAILII >> Databases >> United Kingdom Information Tribunal including the National Security Appeals Panel >> Jenkins v Information Commisioner and Dept for Environment, Food and Rural Affairs [2007] UKIT EA_2006_0067 (02 November 2007)
URL: http://www.bailii.org/uk/cases/UKIT/2007/EA_2006_0067.html
Cite as: [2007] UKIT EA_2006_0067, [2007] UKIT EA_2006_67

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Appeal Number: EA/2006/0067
Information Tribunal Appeal Number: EA/2006/0067
Information Commissioner’s Ref: FS 50075607
Heard in Chambers                                                         Decision Promulgated
On 22 October 2007                                                         2nd November 2007
Freedom of Information Act 2000 (FOIA)
Decision Reached on Consideration of the Papers Only
BEFORE
INFORMATION TRIBUNAL
DEPUTY CHAIRMAN
David Marks
And
LAY MEMBERS
David Wilkinson
Henry Fitzhugh
Between
JOHN JENKINS
Appellant
And
INFORMATION COMMISSIONER
Respondent
And
DEPARTMENT FOR ENVIRONMENT, FOOD AND RURAL AFFAIRS
Additional Party
1

Appeal Number: EA/2006/0067
Reasons for Decisions
Introduction
1. This case concerns various requests made by the Appellant to the
Veterinary Medicines Directorate (VMD), an executive agency of the
Department for Environment, Food and Rural Affairs (DEFRA) which is the
Additional Party, for detailed information regarding a product called
Rimadyl and its ingredients. The Appeal raises various issues being
principally first the applicability and scope of section 12 of the Freedom of
Information Act 2000 (FOIA) and the reliance by DEFRA on two allegedly
applicable exemptions. The first exemption is the absolute exemption
contained in section 41 of FOIA which exempts information provided to a
public authority in confidence, and the second exemption is a qualified
exemption contained in section 43 which provides that information is
exempt if its disclosure under the Act would or would be likely to prejudice
the commercial interests of the person or public authority holding it. As
will be seen below, the Tribunal has been persuaded that this Appeal
represents an opportunity to deal with a particular sub-issue which relates
to section 12. Finally, a related matter, though minor, in scope arises
about the applicability of section 16 of FOIA which obliges a public
authority to provide advice and assistance to a person making a request
where appropriate. This Appeal is being dealt with following a
consideration of the papers alone.
2

Appeal Number: EA/2006/0067
The Facts
2.        By letter dated 1 November 2004, the Appellant sent his first written
request to VMD. The letter was headed “RIMADYL: ADVERSE
REACTION”. The Appellant asked for:
“… full and frank disclosure of ALL data in your possession detailing
clinical trials and results and adverse reaction reports supplied to you as
REGULAR from the License HOLDER Pfizer in the case of RIMADYL
[carprophen]”
Some of the background to the request can be seen from the terms of the
request itself. The Appellant had a dog called Ben. Rimadyl had been
prescribed and administered to Ben which in the Appellant’s opinion
caused the dog’s death. The Tribunal has seen a veterinary expert’s draft
report dealing with the circumstances surrounding Ben’s death. It appears
that after experiencing vomiting and similar problems, the dog was
diagnosed with gastritis and then prescribed a number of drugs, including
Rimadyl, used it seems specifically to address inflammation suffered by
the dog.
The Appellant was particularly concerned that Rimadyl was being
administered in the United Kingdom without proper testing. He stated that
the drug was the subject of an ongoing litigation in the United States.
3.        VMD replied by letter dated 23 November 2004. VMD pointed out that
FOIA did not come into force until 1 January 2005. The letter went on to
say that no point would be taken against the Appellant on that account
and nothing further turns on this. The Appellant was told he would get a
substantive reply only after 1 January 2005. In the meantime however, he
was supplied with a copy of what was called an SPC, namely a Summary
of Product Characteristics for Rimadyl. Information about data supplied to
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Appeal Number: EA/2006/0067
a European data base regarding serious adverse reactions would not
however be supplied.
4.        The Appellant then made a second request dated 1 January 2005. In
effect, the Appellant amplified his first request by stating that he was
“keen” to have:
“… a full appraisal of the precise DATES, TIMES and SPECIFICS of the
Marketing Authorizations applicable to RIMADYL for use in the UK. To
this end could you outline the different kinds of information held by the
VMD which might meet the terms of this request. In addition are you able
to provide a reference, catalogue or index which gives a comprehensive
listing of information on Marketing Authorizations held by you as the UK
Licensing Authority.”
5.        Under cover of its reply of 23 November 2004, the VMD had also supplied
a so-called Traffic Light Document (TLD) which was a document entitled
“Memorandum of Understanding between the Association of the British
Pharmaceutical Industry, Medicines and Health Care Products Regulatory
Agency, National Office of Animal Health & the Veterinary Medicines
Directorate”. It reflected a general description of what information could
be disclosed or withheld after discussion with the relevant affected bodies.
It was dated September 2004 and represented an outline guide to the
foreseen operation of FOIA. The reason the document was called a TLD
was to reflect the fact that certain information could or could not be
released under the TLD depending on its importance. If the information
could not be released under FOIA, then it was red; if it could be released it
was green and if it was to be considered for release it was amber.
6.        The disclosure of this TLD prompted the Appellant to ask in his second
request for the following items, namely:
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Appeal Number: EA/2006/0067
“1 Veterinary Medicines Advisory Board Minutes where RIMADYL was
discussed and any background papers.
2      History of Licensing of RIMADYL with VMD [TLD too].
3      Pre-clinical safety data – All published literature and any non-
published data.
4      Evidence of Animal Testing Certificate Applications
- disclosure of Adverse drug reactions exhibited in clinical trials
-  disclosure of clinical trial results after the grant of Marketing
Authorization.
5      Pfizer expert Report &/or common technical document indicating
overall safety and ethicacy.
-  Any assessment reports produced by the VMD on safety and
ethicacy.
-  Any correspondence/e mails between VMD, Advisory Body and
Pfizer.
- copy of package leaflet on RIMADYL applicable at 19/7/2000.
6      Please supply a number of suspected adverse reaction reports
SAR’s with reference to RIMADYL.
- any Periodic Safety Update reports with regard to RIMADYL.
- Information on Adverse reaction reports listed by drugs’ substance
[carprophen] ascribed to any other particular products.”
7. In this second request, and prior to the passage quoted above, the
Appellant in effect asked for information in the form of correspondence
5

Appeal Number: EA/2006/0067
files, etc pertinent to the preparation of the TLD and similar material
between VMD and the Royal College of Veterinary Surgeons (RCVS) with
regard to adverse reactions to Rimadyl. On any view, this second request
went well beyond the scope of the Appellant’s first request.
8. VMD acknowledged this second request by letter dated 7 January 2005.
The letter was signed by John O’Brien as Director of Licensing in the
VMD. A detailed provision of what was called “some of the information
you requested” was provided under cover of a VMD letter dated 28
January 2005, again signed by Mr O’Brien. The Tribunal accepts that the
VMD provided the Appellant with a significant amount of information, but
prefaced its reply by stating that it wished to extend the time limit while it
considered “the public interest test” and asking the Appellant: “to narrow
down your request to focus more clearly on the precise information you
are seeking”. The remaining contents of the letter in effect provided
information as to the following items, namely:
(1)    the fact that there was no available correspondence with Pfizer;
(2)    the presence of all marketing authorisations on the VMD’s own
website;
(3)    the date of authorisation as to Rimadyl’s Small Animal Injection;
(4)    the fact that the RCVS was not a public authority;
(5)    the dates and nature of meetings concerning the TLD;
(6)    the number of SARs in relation to Rimadyl expressed as a
percentage of sales and the nature of adverse reactions to a
predecessor drug to Rimadyl, namely Zenecarp.
Reference to SARs was a reference to suspected adverse reaction
reports.
6

Appeal Number: EA/2006/0067
9.        The Tribunal feels it is important to note that prior to its response to the
second request, Mr O’Brien had quite sensibly been taking steps to see
how much the copying charges of any matters which might be disclosed
would cost. By an email of 12 January 2005, i.e. shortly before his lengthy
reply mentioned above, he was informed, no doubt by a colleague, that to
retrieve and print off approximately 500 pages from a microfiche would
cost £750 plus VAT. As will be explained more fully below the appropriate
costs’ limit prescribed by FOIA and the appropriate Regulations puts the
figure of £600 in play as the limit, beyond which a public authority can in
general terms refuse to supply the information on the grounds of
excessive costs. The Tribunal finds that it was quite clear that by mid-
January, Mr O’Brien knew what the size of the task faced by the VMD was
likely to amount to in the light of the second request.
10.      In any event, the Appellant did thereafter attempt to “narrow down” his
previous request or requests, leading to what could be viewed as his third
request. Whether he did in reality effect any form of narrowing down is
debateable since he asked for the following under cover of an email dated
1 February 2005, namely:
(1)    so-called SPC information, not only on Zenecarp, but also on two
other drugs entitled “Norocarp” and “Carprodyl”, the same to be
provided by 28 February 2005;
(2)    the “precise date” when Zenecarp was authorised for use on dogs;
(3)    the “ACTUAL” numbers of Adverse Events reported to the VMD up to
and including what he called “it’s [sic] withdrawal from the market …”;
(4)    a response to his six points as set out in the second request; and
(5)    “access” to any appropriate catalogues and indexes held by the
VMD.
7

Appeal Number: EA/2006/0067
11.      On 4 February 2005, Mr O’Brien wrote to Pfizer asking for permission to
disclose principally safety data and safety update reports regarding SARs
as well as Animal Test Certificate (ATC) applications, clinical trial results
and sales data. This request was refused by Pfizer, reflecting the terms
and effect of the Memorandum of Understanding already referred to. In
particular, as to the sales information sought, Pfizer relied on the need to
protect its commercial sensitivity.
12.      However, by letter dated 11 February 2005, VMD did provide the
Appellant with some of the information he had requested in the second
request, namely:
(1)    a history of the licensing of Rimadyl Small Animal Injection with
reference being given, namely Vm0057/4193 as well as the history of
the licensing regarding Rimadyl tablets in two sizes, i.e. 20mg and
50mg and also with regard to Zenecarp injections and Zenecarp
tablets;
(2)    copies of the leaflet and the SPC that had applied in July 2000.
13.      However, reflecting a further separate request to Pfizer to supply any
further details, especially in relation to PSURs, i.e. Periodic Safety Update
Reports and ATCs (Animal Testing Certificates), the VMD was compelled
to send the Appellant a letter dated 28 February 2005 declining to disclose
principally pre-clinical safety data and expert reports, PSURs, ATC
applications, the results of clinical trials after the grant of a Marketing
Authorisation and sales data. The letter, again sent by Mr O’Brien went
on to add:
“Over and above all the reasons I have given which prevent us from
disclosing the information you have requested, Section 12 of the Act
allows us to refuse to answer requests for information if the cost of
complying would exceed the “appropriate limit” prescribed in the
8

Appeal Number: EA/2006/0067
Regulations. The cost of retrieving the information you have requested
from our archives greatly exceeds the appropriate limit of £600. For
example, the cost of printing some of this information from our microfiche
would amount to approximately £750. This does not take account of staff
time in accessing both the information held on microfiche and printed
copies of the data which to date on this enquiry amounts to about 60 hours
equivalent to £1500 at £25 per hour.”
14.      Naturally, at this stage there was no breakdown of these costs. In
particular, it was not made clear to the Appellant whether the estimated
cost related to information then claimed to be exempt or to non-exempt
information or indeed to both. The Tribunal will revert to this question
below in relation to the sub-issue raised in connection with section 12.
15.      By letter dated 5 March 2005, the Appellant sought an internal review, in
effect a further request. This further request was with regard to a
substance which has not been previously mentioned and which for the
present purposes can be called simply “Cox 2”.
16.      By letter dated 25 April 2005, the VMD sent back a lengthy response
reporting on the result of the internal review. The letter stressed, perhaps
not unnaturally, that the information requested by the Appellant on
Rimadyl was “extensive”. The letter again in the Tribunal’s view, quite
properly summarised the actions taken by the VMD adding that the VMD
in the person of the author of the letter, a Mr Chris Bean, a Director of
Corporate Business was “satisfied” that the VMD had “acted in
accordance with the requirements of” FOIA. The letter referred again to
the fact that the £600 limit had been reached with regard to the cost of
“providing the information requested from our archives”. Indeed he went
on to say that the appropriate limit of £600 had been “greatly” exceeded.
Nevertheless, the VMD did provide information with regard to Cox 2 and
the Appellant was invited to clarify that request and another issue
9

Appeal Number: EA/2006/0067
regarding which the Appellant had provided a description, namely, “the EU
law dimension”.
17. On about 12 May 2005, the Appellant complained to the Commissioner.
By letter dated 28 April 2006, the VMD informed the Commissioner’s office
that the information withheld from the Appellant was “extremely
voluminous” adding:
“For example, part of the information requested by Mr Jenkins was that
supplied by the company on clinical efficacy and target species tolerance
in support of their original application for the authorisation and runs to
seven volumes, one of which totals in excess of 400 pages.”
Pausing here, it was still not clear whether this referred to material which
was the subject of exemptions which had by then been claimed under
sections 41 and 43. In Mr O’Brien’s letter of 28 February 2005, there had
been specific reference to the fact that it was withholding such materials
as the pre-clinical safety data and PSURs, etc under section 43 of FOIA.
The letter went on to claim reliance on both sections 43 and 41 of FOIA
with detailed reasons being given for their applicability. The letter ended
with further facts about the expense incurred. In the present case, the
request had been given a unique code which was AT1001. Staff kept a
record of the time spent. The total time spent in “identifying and putting
together the information covered by this request” had been recorded as
89.91 hours. In addition, the VMD had received the quotation for printing
which has been referred to and it was estimated that it would take a
member of staff approximately a further 7.5 hours to print these volumes
from the microfiche. Overall, the VMD took the view, quite properly in the
Tribunal’s view, that the “cost had already been greatly exceeded in
processing this request”. It was therefore decided that it was “not
appropriate to proceed with this”.
10

Appeal Number: EA/2006/0067
18.      It should perhaps be pointed out and added that on 23 May 2006 a
member of the Commissioner’s staff visited VMD and according to the
Decision Notice which will be dealt with below, noted “the volume of
material and VMD’s reference catalogue for Rimadyl – one of numerous
such indexes” and that “the VMD confirmed that the information stored on
microfiche could only be extracted in paper form” (see Decision Notice,
paragraph 4.3).
The Decision Notice
19.      The Commissioner’s Decision Notice is dated 31 July 2006. Overall, the
Commissioner found that DEFRA had dealt with the Appellant’s request in
accordance with Part I of FOIA but had failed to comply in a manner it
called “fully” with its obligations under section 16. The Tribunal pauses
here to note that the action required with regard to this non-compliance
was to require VMD to take no action save in respect of its then existing
offer to the Appellant to provide him with a copy of VMD’s relevant
catalogues and indexes. This was done, and therefore for present
purposes it can be taken, and the Tribunal so finds that there has been in
effect compliance with section 16 subject to the findings made below.
20.      At paragraph 4.4, the Commissioner noted that the VMD had provided a
substantial amount of documentary information but went on to point out
that the VMD was refusing to disclose the following, namely:
“37 volumes of dossiers of the pre-clinical trial information that supported
the marketing authorisation of Rimadyl; a letter from Pfizer dated 18
February 2005 which was provided in confidence, and numbers of
suspected reaction cases which, if combined with the % reaction incidents
data already given could enable commercially sensitive sales data to be
calculated.”
11

Appeal Number: EA/2006/0067
The above materials recited in the quotation were subject to reliance by
VMD on sections 41 and 43 of FOIA as well as the costs limitation
prescribed by section 12.
21.      As to sections 41 and 43, the Commissioner duly found that the public
interest in maintaining both exemptions justified the retention of the
material. With regard to the cost limit, the Commissioner recited what has
been set out above in this judgment and decided: “that the appropriate
limit has been reached in this case and the VMD are therefore justified in
refusing to do more, although by virtue of the exemption at section 12 of
the Act, beyond that which they have helpfully offered on the catalogue(s)
and index(es).”
The Grounds of Appeal
22.      The Appellant’s grounds are set out in this letter to the Tribunal dated 25
August 2006. The matters set out in the letter can be summarised as
follows, namely:
(1)    the Appellant maintained that the Commissioner appeared to have
found the Appellant’s complaint justified and on that basis should
have ordered the VMD to disclose more information to him;
(2)    the Appellant further maintained that there was an overriding public
health & safety issue raised by virtue of his request such as to justify
the release of commercially sensitive information: to that end, he
attached the report of a veterinary doctor, a James Van Buren, with
regard to the test conducted on his dog prepared or dated 24 April
2002 and already referred to above.
23.      The Tribunal respectfully adopts the observations made by the
Commissioner to his Reply with regard to the above two contentions. As
has been made clear from this judgment already, the only part of the
12

Appeal Number: EA/2006/0067
Appellant’s complaint that the Commissioner found to be justified was in
relation to the failure to provide catalogues and indexes.
24. The second contention raised by the Appellant is in effect a contention
that though the section 43 exemption was engaged, the Commissioner
applied the public interest test required by the terms of section 43
incorrectly. This ground will be considered in more detail below. It is
sufficient to state that in his Reply, the Commissioner rejected the
argument that he had applied the section 43 exemption incorrectly adding
that nothing in Mr Van Buren’s report persuaded him to exercise the public
interest balancing test differently. In particular, the Commissioner
observed that in the inclusion data report, Mr Van Buren stated that
Rimadyl was administered to the Appellant’s dog “in an extra-label
fashion”, i.e. that it was administered notwithstanding that the information
on the label would have indicated that it was not appropriate that it be
administered to the Appellant’s dog in the light of the symptoms which the
dog exhibited. Indeed the Commissioner stressed that Mr Van Buren’s
written report stated that Rimadyl should not have been given to the
Appellant’s dog at least without a prior diagnostic test, such as a blood
sample. The Commissioner also noted that Mr Van Buren had referred in
two footnotes to his report, to two papers on adverse reactions to Rimadyl
otherwise publicly available, thus adding greater weight to the
Commissioner’s conclusion that in this case the public interest in
maintaining the section 43 exemption outweighed the public interest of
disclosure. The Commissioner concluded in his Reply by noting that the
Appellant apparently did not contest the applicability of the exemptions in
section 42, however the Tribunal is minded as indicated above, to deal
with a number of particular sub-issues that arise from the applicability of
section 12 in this case.
Subsequent events
13

Appeal Number: EA/2006/0067
25.      It is fair to add that following the Commissioner’s Reply, the Appellant
formally objected to the fact that he might otherwise have been taken to
have conceded that section 41 and section 12 did apply adducing what he
called new evidence consisting principally of a then recent newspaper
investigative article about transactions involving multi-national drug
companies, including Pfizer and the relationship with the UK Government
as well as details of a United States Legal Class Action dealing with
Rimadyl. The Commissioner has not contended that these additional
items were irrelevant to the issues in the Appeal, and the Tribunal
respectfully agrees.
26.      By letter dated 2 October 2006 and in response to the Commissioner’s
Decision Notice, the VMD disclosed the relevant indexes redacting the
names of any individuals whose names appeared in those indexes and
related materials.
The evidence
27.      The Commissioner provided written evidence predominantly as to the
steps which the Commissioner had taken to verify the VMD’s claim that
the applicable fees limit has been exceeded. This evidence is in the form
of a written statement provided by Dr Roy Wernham, one of the
Commissioner’s Complaints Resolution Officers. The Tribunal will not
spend too much time dealing with the contents of Dr Wernham’s
statement which is dated 8 February 2007 since its contents are in effect
revisited in greater detail by evidence provided by DEFRA.
28.      In essence, Dr Wernham took the view that after he visited the VMD
offices on 23 May 2006, it was confirmed to him that the VMD staff had
spent “at least 24hrs of relevant staff time” at £25 per hour. He added at
paragraph 22 that in relation to the time spent which he considered at or
during the meeting, some of the information was held on microfiche and
would need a further 7.5 hours of staff time to print it. Alternatively it
14

Appeal Number: EA/2006/0067
would cost £750 to commission a service to print it and he accepted at the
time that that was not required. He also confirmed that VMD had in turn
confirmed to him that VMD was unable to retrieve the microfiche
information electronically and that this would include company summaries
of the product safety data.
29.      DEFRA and the VMD have provided written statements from Mr O’Brien.
He has provided two open witness statements and a closed witness
statement. His first witness statement is dated 26 February 2007. At
paragraph 14 and particularly at 14(5), after having confirmed that he had
earlier indicated reliance on section 43 to the Appellant, and in the course
of reciting the history of the VMD’s exchanges with the Appellant, Mr
O’Brien confirmed that at the time he wrote to the Appellant by letter dated
28 February 2005, he explained to the Appellant that the £600 limit was
being applied as “spending on these enquiries had already totalled
£1500”. This represented 60 hours of staff time. He provided a table,
found at page 181 of the bundle before the Tribunal which showed there
were 38 volumes stored in microfiche form giving a total of 4,121 pages.
Significantly however, he provided a separate schedule found at page 184
of the bundle being as he described it:
“… a table of additional documents in paper form containing information
which fell within the scope of the request by Mr Jenkins”
These were documents not held on microfiche and all of them were
contended by VMD to be subject to the section 43 exemption.
30.      It is therefore apparent that at this stage, or at least by 28 February 2005,
the VMD acting by Mr O’Brien took the view that as a result of the acts of
determining whether it held the information requested and/or locating the
information and/or retrieving it and/or extracting the information from
documents which contained the information, all of which are distinct
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Appeal Number: EA/2006/0067
activities addressed by the costs regulations, the £600 estimate was
thought to have been greatly exceeded.
31.      Mr O’Brien supplied a far more detailed picture in his second open witness
statement of 27 July 2007. The second statement was produced in effect
in response to open directions made at an oral hearing on 22 June 2007,
the terms of which need not be set out here, save to note that the Tribunal
by those directions in effect ordered that all relevant issues were to be
considered on the final determination of the Appeal.
32.      At paragraph 11, although Mr O’Brien quite properly recognises that for
the purposes of the appropriate fees Regulations, a public authority can
only take into account time spent determining whether it holds the
information requested, locating it, retrieving it or extracting it, and although
the VMD recorded how much time had been spent working on a particular
topic or project, it did not break such time down into the different types of
work done. Nonetheless, to his credit Mr O’Brien did make an attempt to
estimate, based on his memory of what occurred at the time, how much
time was spent on each of the itemised activities set out above and
apportion the time accordingly.
Retrieval of adverse reaction data                                               8.33 hours
Locating and retrieving data provided by the applicant 3.00 hours
company in support of his applications
Retrieval of licensing information                                                        11.25
hours
Reviewing data held to assess whether it fell within the            21.00
scope of the request                                                                            hours
Total:            43.58
hours
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Appeal Number: EA/2006/0067
At a charge of £25 per hour, this amounted to a £1,089.50.
33.      Mr O’Brien then confirmed that the present appeal was primarily
concerned with four categories of information, namely:
(1)    data provided when seeking a marketing authorisation from VMD
dealing with the quality, safety and efficacy of the product;
(2)    VMD database materials containing details of SARs, i.e. suspected
adverse reactions to Rimadyl and Carprofen products;
(3)     Serious Adverse Reaction Reports, i.e. SARRs; and
(4)    PSURs.
34.      He then revisited the printing costs attributable to printing off records held
on microfiche as to category (1). On revisiting the issue, he stated that far
from what was initially thought to be 900 to 1000 pages in microfiche,
there were in fact 3,004 that would need to be printed which alone would
cost £625. In addition there were 1,117 pages of information not held on
microfiche which would have cost £200 to print.
35.      As to category (2), Mr O’Brien estimated that it would take two hours to
interrogate the VMD database at a total of cost of £50, whilst category (3)
SARs information was stored in paper form comprising in this case 22 files
which would cost £550 to copy. As to category (4), the estimate in time as
to extraction and copying was six hours but in terms of cost was
subsumed in category (3).
36.      The next operation which Mr O’Brien describes is the redaction required
which he describes as “significant”. The redaction in question involved
principally the redaction of individuals’ names and addresses which he
said would inevitably arise had VMD continued to deal with the Appellant’s
request. He therefore considered that “on a very conservative estimate” it
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Appeal Number: EA/2006/0067
would take one person, one minute per page to view each of the 4,121
microfiche pages, yielding a total of 69 hours, just short of two working
weeks at a cost of £1,717. The same exercise he added would need to be
repeated for the database, as well as SARs and PSURs as they too might
also contain information on particular identities, company contact details,
etc. This led to him estimating that it would take a further 28.5 hours, i.e.
£712.50 to redact the information provided with regard to the documents
and categories (2), (3) and (4), giving a total cost of £2,429.50. On that
basis the cost of redacting alone, would have exceeded four times over
the section 12 limit of £600.
37.      At paragraph 27 of second witness statement, the total was set out as
follows:
(a)    work actually done in locating and retrieving data:
£1,089.50
(b)    work required to print information from microfiche:
£625.00
(c)    work required to copy comb-bound information:                 £200.00
(d)    work required to sort and print database:                             £50.00
(e)    work required to copy SARs and PSURs:                           £550.00
(f)     work required to redact all information:                            £2,429.00
Total:                       £4,918.50
38.      Mr O’Brien then went on to deal again, quite properly in the Tribunal’s
view with an issue that had arisen at the oral directions hearing mentioned
above. At this hearing, the Commissioner had contended that if at the
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Appeal Number: EA/2006/0067
point of applying the section 12 exemption, the VMD had information that
was “ready to be sent” or, as it was put at the hearing, ready to be put in a
brown envelope but for the application of the other exemptions relied on in
this case, the VMD could not rely on section 12 alone as a reason for
refusing to disclose the information. This came to be called the brown
envelope point and will be dealt with in further detail below.
39.      For the moment, however, it is sufficient to note that Mr O’Brien has
refuted the suggestion, that on the facts of this case the VMD did have
information that could have been put in the brown envelope. This is
because as he described it, although a good deal of information had been
identified and located, the information held on microfiche and hard copy
had not been extracted or copied at the point of which the exemption was
applied. He went on to add the following, namely:
“Similarly, the information on the database had not been sorted, printed
and redacted, although it could quite easily have been and it may be that,
had s.41 and 43 not applied to it as outlined above, VMD would have
exercised its discretion to send it notwithstanding that the s.12 limit had
already been exceeded. Nevertheless, this would have been an exercise
of discretion as further costs would have needed to be incurred to
interrogate the database to bring up the correct range of reports, print and
redact the records before sending them.” (see paragraph 25 of his second
witness statement).
40.      Mr O’Brien then dealt with the claimed applications of the exemptions in
section 41 and 43. He explained that apart from European Community
Authorization a Marketing Authorization, i.e. a MA is required from the
VMD before a veterinary medicinal product can be sold or supplied in the
United Kingdom. Information is required on three principal issues,
namely: quality, safety and efficacy. In addition, expert reports as to each
of these issues has to be provided with suitable labels and literature
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Appeal Number: EA/2006/0067
including a summary of product characteristics, i.e. a SPC as mentioned
above. Quite apart from the above, the VMD collects and analyses SAR
data which emanate from any source, primary sources being veterinary
surgeons. The relevant company itself provides PSURs.
41.      Mr O’Brien places particular reliance on the penal provisions of section
118 of the Medicines Act 1968. The section make it an offence to disclose
information provided for the purpose of that Act (save in respect of
disclosure under FOIA; see SI 2004 No. 3363, article 4) from which it
follows the VMD would itself be guilty of a criminal offence were it to
disclose the type of data referred to above without the applicant
company’s consent. This in turn justified VMD’s position in treating such
information supplied by such applicant as confidential.
42.      He also confirmed that in effect the traffic light document referred to above
reflected this abiding need to treat all such information provided to the
VMD as both confidential and also as commercially sensitive. The “red”
designation in practical terms meant that information relating to quality
would not be disclosed, whilst information as to safety and efficacy would
be disclosed generally only if parts of those subjects were published in
scientific journals.
43.      Finally, he pointed to the exchanges between Pfizer and the VMD which
reflected the company’s understanding that it regarded the information
requested as constituting information which fell in the “red” category. He
ended with the observation that when it considered the public interest in
maintaining the exemption against the public interest in disclosure, the
VMD considered that the “understanding” between it and the industry that
commercially sensitive information would not be disclosed had in fact
helped to maintain an open dialogue with companies that would be
damaged were disclosure to occur in this type of case. The anticipated
result was, according to him, that Pfizer and companies in general “would
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Appeal Number: EA/2006/0067
not be as open in their dealings with VMD or indeed might not provide the
necessary information for fear of public disclosure.”
44.      The Tribunal should add that its two lay members in this case did conduct
a visit to VMD’s premises so that those members could see for
themselves the extent of the documentation in issue. The Tribunal feels
that in the circumstances it can legitimately confirm the fact that the scale
of the operation conducted by Mr O’Brien and his team is more than
adequately reflected in his witness statement and his evidence generally.
The Tribunal feels that it should stress that at every stage, he and his
team were never less than extremely cooperative with any questions put
to them by the Tribunal.
45.      As for Mr O’Brien’s closed witness statement and in the light of the
evidence which forms the basis and content of his second open witness
statement and for quite understandable reasons, Mr O’Brien gave
unredacted details of the time spent in dealing with the Appellant’s
requests by particular named individual members of staff. Of necessity he
exhibited on a confidential basis and for the Tribunal’s own consideration
a sample of database material as well as sample SARs and PSURs which
show the type of material which has contributed to the overall costs
estimate which was described by him in his second open witness
statement.
The rival contentions: section 12
46.      Section 12 of FOIA provides as follows:
“(1) Section 1(1) does not oblige a public authority to comply with a
request for information if the authority estimates that the cost of
complying with the request would exceed the appropriate limit.
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Appeal Number: EA/2006/0067
(2)    Subsection (1) does not exempt the public authority from its
obligation to comply with paragraph (a) of section 1(1) unless the
estimated cost of complying with that paragraph alone would exceed
the appropriate limit.
(3)    In subsections (1) and (2) “the appropriate limit” means such amount
as may be prescribed, and different amounts may be prescribed in
relation to different cases”.
Subsection (5) provides that the Secretary of State may by regulation
make provision for the purposes of this section as to the costs to be
estimated and as to the manner in which they are to be estimated. The
relevant regulations are the Freedom of Information and Data Protection
(Appropriate Limit and Fees) Regulations 2004 (SI 2004 No 3244) (the
“Regulations”). The relevant regulations are the following, namely:
“3(2) In the case of a public authority which is listed in Part I of Schedule
1 to the 2000 Act, the appropriate limit is £600.
***
Estimating the cost of complying with a request – general
4 (1) This regulation has effect in any case in which a public authority
proposes to estimate whether the cost of complying with the
relevant request would exceed the appropriate limit.
(2) A relevant request is any request to the extent that is a request
(b) information to which sections 1(1) of the 2000 Act would,
apart from the appropriate limit to any extent apply.
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Appeal Number: EA/2006/0067
(3)    In a case in which this regulation has effect, a public authority
may, for the purpose of its estimate, take account only of the
costs it reasonably expects to incur in relation to the request in
(a)    determining whether it holds the information,
(b)    locating the information, or a document which may contain
the information,
(c)    retrieving the information, or a document which may
contain the information, and
(d)    extracting the information from a document containing it.
(4)    To the extent to which any of the costs which a public authority
takes into account are attributable to the time which persons
undertaking any of the activities mentioned in paragraph (3) on
behalf of the authority are expected to spend on those activities,
those costs are to be estimated at a rate of £25 per person per
hour.”
Estimating the cost of complying with the request – aggregation
of related requests
5 (1) In the circumstances in which this regulation applies,
where two or more requests for information to which
section 1(1) of the 2000 Act would, apart from the
appropriate limit, to any extent apply, are made to a public
authority –
(a) by one person or
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Appeal Number: EA/2006/0067
the estimated cost of complying with any of the requests is
to be taken to be the total costs which may be taken into
account by the authority, under regulation 4, of complying
with all of them.
(2) This regulation applies in circumstances in which –
(a)    the two or more requests referred to in paragraph (1)
relate, to any extent, to the same or similar
information, and
(b)    those requests are received by the public authority
within any period of sixty consecutive working days.
Maximum fee for complying with section 1(1) of the 2000 Act
6 (1) Any fee to be charged under section 9 of the 2000 Act by
a public authority to whom a request for information is
made is not to exceed the maximum determined by the
public authority in accordance with this regulation.
(2) Subject to paragraph (4), the maximum fee is a sum
equivalent to the total costs the public authority
reasonably expects to incur in relation to the request
in –
(a)    informing the person making the request
whether it holds the information and
(b)    communicating the information to the person
making the request.”
47. The principal issue between the Commissioner and DEFRA is whether the
words “extracting the information from a document containing it” include
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Appeal Number: EA/2006/0067
the redaction of exempt information containing it. The Commissioner
claims that:
(1)    the actions set out in Regulation 4(3) are sequential;
(2)    extracting information is in effect the task of extracting information to
be disclosed from a document where either the whole document or a
large part of the information contained within it has been requested:
this follows from the language of Regulation 4(3)(d) itself which talks
of extracting the information “from a document containing it”;
(3)    in any event, redaction can be viewed as part of the time spent
considering whether information is exempt and as such may be
charged as a part of a fee under Regulation 6 of the Regulations: the
Tribunal pauses here to note that this was not disputed by DEFRA;
(4)    the reading suggested by the Commissioner is faithful to the scheme
of Regulation 4 as a whole, namely that on a proper reading of
Regulation 4(3)(a)-(d) on a sequential basis, the extraction will be
from a document which has been located or retrieved and therefore
for a document to “contain” information requested, there must be
other information not requested within it;
(5)    when the Regulations speak of a “relevant request” in Regulation
4(2), account should be taken of the words “to any extent”; the
Commissioner claims that these words are plainly intended to
indicate not only that Regulation 4 applies whenever a “request for
information” falling within the meaning of section 1(1) of the Act is
received, but also whenever such a request is made, section 1(1)
always applies to some extent even if, in the event, e.g. by claiming
the exemption or having the same endorsed or determined by the
Commissioner or by the Tribunal, the public authority is relieved of its
duty under section 1(1)(b) to communicate that information to the
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Appeal Number: EA/2006/0067
applicant; in other words, section 1(1) will always apply “to some
extent”.
48. Against that, DEFRA claims that:
(1)    Regulation 4(3)(d) is about what it calls getting information “out” of
whatever document is in question; in particular DEFRA claims that it
seems “unlikely” that the purpose of Regulation 4(3)(d) is only to
cover the removal of the relevant material as opposed to the
redaction or extraction of exempt material as well;
(2)    reliance can be placed on Regulation 6 as well as, incidentally,
Regulation 7 which deals with a maximum fee which applies to the
fees under Regulation 6: DEFRA claims that it is clear that
Regulations 6 and 7 show that public authorities are permitted to
charge for Regulation 4 costs plus Regulation 6 costs, and therefore
it is clear that the cost of redaction would be included under one or
the other as the overall purpose of the Regulations, particularly of
Regulation 6 and 7 to permit costs’ recovery;
(3)    the Ministry of Justice’s own guidelines in paraphrasing Regulation
4(3) add the following parenthesis after Regulation 4(3)(d), namely:
“(including editing or redacting information)” within an accompanying
footnote which reads as follows:
“This can include the first time an individual working in the authority
reads information to establish what is contained within a file or
document, although any subsequent readings, (e.g. to consider
exemptions), or if the information is passed to others to read, should
not be included.”;
(4)    as also indicated above, the wording of Regulation 4(2) with its
reference to “information to which section 1(1) of the 2000 Act would,
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Appeal Number: EA/2006/0067
apart from the appropriate limit to any extent apply” necessarily
means that if information is exempt, then it is information to which
section 1(1) does not apply and therefore if time is needed to
“extract” disclosable material from material which does not fall to be
disclosed, then that time can be counted.
49.      The Tribunal finds the Commissioner’s contentions more persuasive,
although the point is not entirely free from doubt. This is partly because of
the drafting in Regulation 4 itself, and indeed in the Regulations as a
whole which the Tribunal finds could perhaps more clearly have
expressed its intentions with regard to the issue under consideration.
However, it is perhaps understandable that in the early days of this
regime, specific attention was perhaps not afforded to the addressing of
this issue, namely whether an allowable cost can be counted in respect of
extracting exempt material.
50.      The Tribunal finds, as does the Commissioner, that proper force and effect
should be given to the language of Regulation 4(3)(d) which speaks in an
unqualified manner of extracting the information, i.e. the information which
has been requested out of a document which, of necessity, contains other
information that has not been requested. If, as the Tribunal finds, the
remaining material represents unrequested information, the act of
extraction addresses itself to requested information in the sense that
extraction refers to and forms part of the process of disclosure. On the
other hand, extracting or as it is somewhat curiously put in the Ministry of
Justice’s guidelines, “redacting” exempt information is in effect an actual
deletion as the Commissioner also contends. The Tribunal agrees with
the Commissioner that such an act of deletion, i.e. removal of what may
be thought to be exempt material, even at the stage at which the exercise
is carried out, cannot sensibly be viewed as coming within the provisions
of Regulation 4(3)(d) as it is presently drafted.
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Appeal Number: EA/2006/0067
51.      The exercise which a public authority may embark on in order to consider
whether an exemption applies and the extent to which material otherwise
disclosable may be subject to an exemption, is a separate exercise. The
Commissioner and DEFRA agree that Regulation 6 is wide enough to
encompass the charge of a fee in that respect. The Tribunal does not find
that the Ministry of Justice guidelines add anything to what is ultimately a
question of statutory interpretation: those guidelines are no more than
guidelines.
52.      The above determination is not, both the above two parties accept, directly
relevant to the facts of this case. The Tribunal confirms that given the
evidence in this case which shows that the costs incurred by DEFRA in
dealing with the request have been so large, the issue of whether the
costs of redacting the exempt information for the purpose of section 12 is,
as it was put, largely if not wholly, “academic”.
53.      The next issue concerns the so-called brown envelope point. On this
issue which has been sketched out above, the Tribunal is unwilling to do
anything other than address the facts which are, for the moment,
unchallenged. The Commissioner and DEFRA have, together, debated
whether or not, as a point of principle, there is an obligation on a public
authority in general terms to provide information requested from an
applicant, and not be able to rely on section 12 if the material has already
been identified, located, retrieved or extracted. As to the facts in this
case, both parties are agreed that in the light of the evidence provided by
Mr O’Brien in his second witness statement (see in particular paragraphs
28 and 29) to the extent that the complete contents of a microfiche tape or
of a ring-bound book failed to be the subject of disclosure, if there were no
need for any further process of extraction or separation, then the
information could have been ready for sending to the Appellant. However,
the Tribunal is not prepared to go behind, what it regards as the plain
meaning of Mr O’Brien’s evidence, particularly at paragraph 29. Without
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Appeal Number: EA/2006/0067
the benefit of cross-examination, it finds that what Mr O’Brien was saying
was that in relation to the information held on microfiche, such information
still had to be extracted by means of a print-out or similar method. The
same applied, arguably, to the inspection of any ring-bound files. It
follows that the Tribunal is not prepared to find that, quite apart from the
operation of sections 41 and 43, Mr O’Brien necessarily stated that the
information in question had already been identified, located, retrieved
and/or extracted within the meaning of Regulation 4(3)(a)-(d) of the
Regulations and was therefore ready to be communicated to the Appellant
without additional time being spent on the exercise, no doubt in the
process of further extraction in the sense of printing the relevant material.
Sections 41 and 43
54. Section 41 is an absolute exemption since it provides as follows, namely:
“(1) Information is exempt information if –
(a)    it was obtained by the public authority from any other person
(including another public authority), and
(b)    the disclosure of the information to the public (otherwise than
under this Act) by the public authority holding it would constitute
a breach of confidence actionable by that or any other person.
(2) The duty to confirm or deny does not arise if, or to the extent that, the
confirmation or denial that would have to be given to comply with
section 1(1)(a) would (apart from this Act) constitute an actionable
breach of confident.”.
Section 41 is an absolute exemption to which the public interest test under
FOIA does not apply. However, the public interest does fall to be
considered when determining whether or not the exemption applies.
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Appeal Number: EA/2006/0067
55.      The Tribunal agrees that the four categories of information described by
Mr O’Brien at paragraph 12 of his second witness statement and as set
out above, all have the necessary hallmark of confidence. Overall, the
information in question comprised information that Pfizer considered to be
either constituting a trade secret or as information which had it been
disclosed to a third party might have caused significant harm to Pfizer.
There is no doubt that the information in question was imparted in
circumstances which imported an obligation of confidence.
56.      The Tribunal therefore respectfully agrees with both the Commissioner
and DEFRA that there is in fact little, if any, public interest in the
disclosure of all these categories of information. Nor has Mr Jenkins
himself sought to advance any arguments in relation to the application of
the exemption. The only arguable element advanced by the Appellant is
the one highlighted above, namely that the Appellant suggested that
incidents such as the regrettable one involving his dog entailed some
“overriding public health & safety concern”. No reliance can be placed on
the report of Mr Van Buren for the reasons advanced earlier. The Tribunal
therefore upholds the Commissioner’s finding that there is no overriding
public interest in this case that would provide the Defence to inaction for a
breach of confidence were any of the categories of information to be
disclosed.
57.      With regard to section 41, a small difference or emphasis has surfaced as
between the Commissioner and DEFRA. In its written submissions,
DEFRA argues that reference to “all the circumstances of the case”
otherwise found in section 2(2) of FOIA and which is necessarily required
in relation to the public interest to be considered, means that public
interest should be considered “in the round”. This Tribunal agrees with the
findings on this issue made by the Tribunal in Hogan and Oxford City
Council v Information Commissioner
(EA/2005/0026), especially at
paragraphs 59 and 60, to the effect that the focus should be upon the
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Appeal Number: EA/2006/0067
public interest expressed explicitly or implicitly in the particular exemption
in question. However, in the circumstances of this case, the Tribunal
respectfully agrees with DEFRA that any distinction between the two
positions is academic.
58.      With regard to section 43, the same provides an exemption that protects
commercial interests as follows, namely:
“(1) Information is exempt information if it constitutes a trade secret;
(2) Information is exempt information if its disclosure under this Act
would, or would be likely to, prejudice the commercial interests of any
person (including the public authority holding it).”
59.      The Tribunal has no hesitation in finding that the information withheld in
the present case is plainly information to which section 43 applies, subject
to the application of the public interest test. Again, the Appellant has not
sought to suggest that the information is not information which, were it
disclosed, would be likely to prejudice Pfizer’s commercial interests. On
the contrary, the Appellant simply claims that the issue is one of public
safety. The Tribunal upholds the Commissioner’s decision that the VMD
was entitled to rely on the exemption in section 43.
Section 16
60.      Section 16 of FOIA provides that:
“(1) It shall be the duty of a public authority to provide advice and
assistance, so far as would be reasonable to expect the authority to
do so, to persons who propose to make, or have made requests for
information to it.
(2) Any public authority which, in relation to the provision of advice or
assistance in any case, conforms with the code of practice and that
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Appeal Number: EA/2006/0067
section 45 is to be taken to comply with the duty imposed by
subsection (1) in relation to that case.”
61.      The Appellant did not refer to section 16 in his grounds of appeal, but has
done so in a short witness statement since that time. One complaint is
that the VMD failed to provide him with a copy of the index and that
constituted a failure under section 16. The Tribunal agrees with the
Commissioner that this complaint is misconceived. In addition, the
Appellant complained about the content of the information communicated
to him, in particular the so-called “reaction, current figures”. The
Commissioner, quite properly in the Tribunal’s view, contends that this
complaint goes to the form or format in which the information was
communicated to him, whereas section 16 is a section directed as it
clearly states to the information the public authority may need to consider
to clarify a request that has been made to it. The Tribunal has no
hesitation in upholding the Commissioner’s decision that VMD fulfilled its
obligations under section 16.
62.      The observations of the Appellant have prompted the Commissioner to
remind the Tribunal that there is a typographical error in the Decision
Notice. At paragraph 4.10, it is stated:
“VMD did not fully comply with section 1 of the Act in that they did not
respond to the complainant’s repeated requests for access to their
catalogues and indexes listing the information held on marketing
authorisations relating to Rimadyl.”
This is clearly a mistaken reference to section 16. The Tribunal does not
feel in the circumstances of this case that there is any practical point in
amending the Decision Notice for the sake of a simple typographical error
when any sensible reading of the paragraph in question would show what
the sense really was.
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Appeal Number: EA/2006/0067
Conclusion
63. For all the above reasons, the Tribunal dismisses this Appeal.
Signed                                                                             Date: 2nd November 2007
David Marks
Deputy Chairman
33


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