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United Kingdom Information Tribunal including the National Security Appeals Panel |
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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 |
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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
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Appeal Number: EA/2006/0067 |
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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. |
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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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4 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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”. |
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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.” |
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Appeal Number: EA/2006/0067 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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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(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 |
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(b) information to which sections
1(1) of the 2000 Act would,
apart from the appropriate limit to any extent apply. 22 |
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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 24 |
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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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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. 27 |
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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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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 31 |
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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. |
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Signed
Date: 2nd November 2007 |
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David Marks Deputy Chairman |
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