Whether the Hospital was justified in its decision to refuse access to records concerning the use of certain medical devices in the Hospital under section 10(1)(a) of the FOI Act on the basis that the records do not exist or cannot be found after all reasonable steps to ascertain their whereabouts have been taken

Conducted in accordance with section 34(2) of the FOI Act by Elizabeth Dolan, Senior Investigator, who is authorised by the Information Commissioner to conduct this review

Background

On 26 August 2014, the applicant made an FOI request to the HSE seeking copies of agreements and clinical trial indemnity forms entered into between Beaumont Hospital and the manufacturers of four types of medical device used in the treatment of stroke. The devices in question were the (1) Stryker Merci, (2) Stryker Trevo, (3) Coviden Solitare and (4) Medtronic Solitaire. The applicant's fifth request was for copies of agreements and clinical trial indemnity forms entered into between Beaumont Hospital and the University of Calgary in respect of the Escape Trial into the treatment of stroke at the Hospital. The applicant's request was forwarded by the HSE to Beaumont Hospital.

On 2 December 2014 the Hospital decided to refuse access to all of the records requested on the basis that they contained commercially sensitive information. The applicant sought an internal review of the Hospital's original decision and on 9 January 2015, the Hospital issued an internal review decision upholding its original decision. On 25 February 2015 the applicant applied to this Office for a review of the decision of the Hospital. On 20 March 2015, the Hospital wrote to this Office stating that no documents existed in relation to the applicant's request 1 to 4 and the record requested at 5 was commercially sensitive. The Hospital however subsequently agreed to release record 5. Both the applicant and the Hospital made a number of submissions in the course of the review. At this stage, I must bring the review to a close by the issue of a formal binding decision as the applicant requires this.

In conducting this review, I have had regard to correspondence between the applicant and the Hospital, to correspondence between the Hospital and this Office, to correspondence between the applicant and this Office, and to the contents of the records at issue. Finally, I have had regard to the provisions of the FOI Act.

In the interests of clarity, I should point out that this review was carried out under the provisions of the FOI Acts 1997-2003 notwithstanding the fact that the FOI Act 2014 has now been enacted. The transitional provisions in section 55 of the 2014 Act provide that any action commenced under the 1997 Act but not completed before the commencement of the 2014 Act shall continue to be performed and shall be completed as if the 1997 Act had not been repealed.

Scope of Review

This review is concerned solely with whether the Hospital was justified in refusing access to the remaining records sought by the applicant under section 10(1)(a) of the Act, on the basis that the Hospital claimed that the records are not held by it or cannot be found after all reasonable steps to ascertain their whereabouts have been taken. The Hospital initially argued that record 5 was exempt under section 27(1)(b) of the FOI Act which protects commercially sensitive information. However, after further consideration, it released record 5 to the applicant. Therefore, this review will deal with records 1-4 only.

Preliminary Matters

At the outset I should explain that this Office's remit does not extend to commenting on the manner in which a public body performs its functions generally. Furthermore, this Office is concerned with ensuring public access to existing records in accordance with the provisions of the FOI Act. The FOI Act does not provide for a right of access to records which ought to exist.

The release of a record under the FOI Act is considered, effectively, as release to the world at large. Another matter to note is that, under section 8(4) of the FOI Act, the actual or perceived reasons for a request must generally be disregarded by the decision maker, including the Information Commissioner (except insofar as such reasons are relevant to consideration of the public interest or other provisions of the Act).

Analysis and Findings

The Hospital's position is that it cannot locate records 1-4 on the basis that they are not held by it. Accordingly, section 10(1)(a) of the FOI Act is relevant. That section provides that a public body may refuse a request where the record sought does not exist or cannot be found after all reasonable steps to ascertain its whereabouts have been taken. The Commissioner's role in a case such as this is to review the decision of the public body and to decide whether the decision than no further records exist is justified. This means that I must have regard to the evidence available to the decision maker and the reasoning used by the decision maker in arriving at his/her decision. The evidence in "search" cases consists of the steps actually taken to search for records along with miscellaneous other evidence about the record management practices of the public body on the basis of which the public body concluded that the steps taken to search for records was reasonable. The Commissioner's understanding of his role in such cases was approved by Mr Justice Quirke in the High Court case of Matthew Ryan and Kathleen Ryan and the Information Commissioner (2002 No. 18 M.C.A., available on this Office's website at www.oic.ie).

In her submissions, the applicant stated that the Hospital is a designated body under the Clinical Indemnity Scheme and that the State provides an indemnity for claims from patients whose treatment was part of a clinical trial at the Hospital. The applicant made detailed submissions as to why she believed that the Hospital should have indemnity forms in relation to medical devices used in clinical trials and why the Hospital should hold records relevant to parts 1-4 of her request. The applicant submitted that the information requested concerns the legal basis on which the named medical devices are in active deployment on public patients admitted to the Hospital. The applicant outlined details of records she obtained on foot of a request made to a hospital in Northern Ireland. The applicant submitted details arising from that separate request which, she argued, support her view that the Hospital should have records relevant to parts 1-4 of her request.

The Hospital stated that when the request was received and processed it was decided at both the initial and internal review stages that the documents, which were clearly described by the applicant at parts 1-4 of her request, contained commercially sensitive information. According to the Hospital, the reasoning behind its decision was that both the competitive and contractual position of the third parties and potentially the Hospital could have been compromised if the records were released. Apparently, the Hospital decided that it was not necessary to search for and retrieve the records. It was only when the Hospital received a request from this Office for a copy of the records that it became apparent that records 1-4 were not held by it. This is clearly very poor practice and does not comply with the FOI Act or the guidelines prepared by the Central Policy Unit of the Department of Public Expenditure and Reform in regard to decision making under the Act. The FOI Officer stated that the Hospital has decided to carry out a review of how it conducts FOI requests generally to ensure that, in future, when a request for records is received the records will be searched for, retrieved and examined before any exemption is considered or applied based on proper consideration of the relevant records. The Hospital says that it will not base future decisions on the description of the records given in the request. The Hospital also apologised for any inconvenience caused in this case.

The Hospital's FOI Officer outlined the steps taken to search for the records in this case. Following a request from this Office, she made contact in person and by telephone with the CEO's Office and the Ethics Research Office to see if they held the records. The FOI Officer also spoke to the investigator who dealt with the ESCAPE Trial in The Hospital who confirmed that in relation to the requests 1-4, no such agreements were entered into and no relevant records exist. The investigator confirmed that an agreement did exist in relation to request number 5 and he provided the FOI Officer with a copy of this agreement which has since been released to the applicant.

The position of the Hospital is that reasonable searches have been carried out to locate records 1-4, and as a result of these searches it is apparent that in relation to records 1-4, no agreements have been entered into and, therefore, none exist. This Office wrote to the Hospital on a number of occasions throughout the course of this review seeking further information in relation to the searches carried out. The applicant was provided with details of these searches by this Office's Investigator. . Therefore, while I do not propose to repeat all of those details here, I confirm that I have had regard to them for the purposes of this decision.

Having considered the submissions of both parties and the measures taken by the Hospital to locate the records sought by the applicant, I am satisfied that the Hospital has taken reasonable steps in order to locate the records at issue. I find, therefore, that the Hospital's decision to refuse the applicant's request was justified on the basis of section 10(1)(a) of the Act and I find accordingly.

Decision

Having carried out a review under section 34(2) of the Freedom of Information Act 1997, as amended, I hereby affirm the decision of the Hospital to refuse access to records 1-4 under section 10(1)(a) of the Act on the basis that the records do not exist or cannot be found.

Right of Appeal

A party to a review, or any other person affected by a decision of the Information Commissioner following a review, may appeal to the High Court on a point of law arising from the decision. Such an appeal must be initiated not later than eight weeks from the date on which notice of the decision was given to the person bringing the appeal.

Elizabeth Dolan
Senior Investigator