Case Number: 170160

Whether the Hospital was justified in refusing access under section 36(1)(b) of the FOI Act to documents from its Ethics Committee describing why two specified clinical trials were not approved

Conducted in accordance with section 22(2) of the FOI Act by Elizabeth Dolan, Senior Investigator, who is authorised by the Information Commissioner to conduct this review

Background

In a request dated 6 January 2017, the applicant sought access, in pertinent part, to documents from the Hospital's Ethics Committee describing why two specified clinical trials were not approved. The Hospital decided to refuse access to the records concerned under section 36(1)(b) of the Act. On 6 April 2017, the applicant applied to this Office for a review of the Hospital's decision.

I have now completed my review in accordance with section 22(2) of the FOI Act. In carrying out my review, I have had regard to the contents of the records at issue and to the submissions made by the applicant. I note, on 1 June 2017, this Office invited the Hospital to make written submissions in support of its decision but that no such submissions have been received to date. I have decided to conclude this matter by way of a formal, binding decision.

Scope of the Review

The Hospital forwarded two binders of documents relating to the specified clinical trials to this Office for the purposes of the review. However, in subsequent contacts with this Office, the applicant confirmed that he was willing to confine his request to records of the Ethics Committee describing the reasons why the specified clinical trials were not approved at its meeting on 22 January 2003. The request itself was made in reference to an extract of the minutes of the meeting which had apparently previously been made available to the applicant.

The binders include letters to the respective "Principal Investigators" (i.e. the consultants who proposed the studies), both dated 23 January 2003, summarising the reasons why the Ethics Committee did not approve the proposed studies on 22 January 2003. In a telephone conversation with this Office on 31 May 2017, the Hospital clarified the letters were based on the discussions held with the consultants at the meeting. The Hospital also stated that the files forwarded to this Office are complete, i.e. that no further records relating to the proposed trials exist. Having examined the binders of documents and the extract of the minutes of the meeting that accompanied the applicant's request, I find no reason to believe that additional records of the Ethics Committee providing reasons for the relevant decisions made at its meeting on 22 January 2003 exist. Accordingly, I consider that this review is concerned solely with the question of whether the Hospital was justified in refusing access to the letters to the respective "Principal Investigators" dated 23 January 2003 summarising the reasons why the Ethics Committee did not approve the proposed trials on 22 January 2003.

Analysis and Findings

Section 22(12)(b) of the FOI Act provides that a decision to refuse to grant access to a record "shall be presumed not to have been justified unless the head concerned shows to the satisfaction of the Commissioner that the decision was justified." It should also be noted that a review by this Office under section 22 of the FOI Act is de novo in that it is based on the circumstances and the law as they apply on the date of the decision.

In this case, the Hospital's refusal of access was based on section 36(1)(b) of the FOI Act, which states that a request shall be refused if the record concerned contains "financial, commercial, scientific or technical or other information whose disclosure could reasonably be expected to result in a material financial loss or gain to the person to whom the information relates, or could prejudice the competitive position of that person in the conduct of his or her profession or business or otherwise in his or her occupation". Section 36(1) does not apply if the public interest would, on balance, be better served by granting rather than by refusing the request (section 36(3) refers)

It is well settled that the essence of the test in section 36(1)(b) is not the nature of the information, but the nature of the harm which might be occasioned by its release. In the High Court case of Westwood Club v The Information Commissioner [2014] IEHC 375, Cross J. held that it is not sufficient for a party relying on section 36(1)(b) to merely restate the provisions of the section, list the documents and say that they are commercially sensitive. In this case, no explanation whatsoever has been provided in support of the claim for refusal under section 36(1)(b). Indeed, although invited to do so, the Hospital has not even identified the relevant information (financial, commercial, scientific, or technical or other) contained in the records concerned and the identity of the person to whom the information relates. For instance, it is not clear whether the claim of commercial sensitivity has been made in relation to the Hospital itself, the consultants who proposed the studies (both of whom were named in the minutes previously made available to the applicant), or some other third party such as the pharmaceutical companies that may have been involved. The records are now over 14 years old and there is nothing to suggest that they are of any relevance to any clinical trials currently underway or under consideration. In the circumstances, and having regard to the burden of proof under section 22(12)(b), I find no basis for concluding that section 36(1)(b) applies.

Decision

Having carried out a review under section 22(2) of the FOI Act, I hereby annul the decision of the Hospital and direct the release of the records concerned.

Right of Appeal

Section 24 of the FOI Act sets out detailed provisions for an appeal to the High Court by a party to a review, or any other person affected by the decision. In summary, such an appeal, normally on a point of law, must be initiated not later than four weeks after notice of the decision was given to the person bringing the appeal.

Elizabeth Dolan
Senior Investigator