Case number: OIC-53425-Z9M8M3

Whether the Institute was justified in refusing access to records relating to a new medical device under sections 36 or 37 of the FOI Act

 
20 September 2019
 

Background

 
The applicant is a co-inventor of a medical device in respect of which intellectual property rights were assigned to the Institute. The Institute appointed investigators to carry out an investigation into certain matters and it was found that there was no evidence to support allegations made.
 
In a request dated 26 November 2018, the applicant sought access to:
 
1. All records in relation to my Intellectual Property which was assigned to the Institute concerning the medical device;  
2. All records in relation to the preliminary investigation report into certain matters, including the terms of reference of the investigation;
3. All records in relation to the report of the investigation into certain breakthrough research; 
4. The applications to the Ethics Committee and the HPRA for the use of the device in a compassionate case; 
5. All records in relation to large animal studies carried out using the device. 
 
In a decision dated 11 March 2019, the Institute granted the applicant’s request in part. It located 196 records which fall within the scope of the applicant’s request. It granted access to 109 records. It refused access in full or in part to the remaining 87 records under sections 30, 31, 35, 36 or 37 of the Act. On 13 March 2019, the applicant requested an internal review of the decision. In its internal review decision dated 2 April 2019, the Institute affirmed its original decision. 
 
In his application to this Office dated 12 April 2019, the applicant narrowed the scope of his request to the following records:
 
1. The applications to the Ethics Committee and the HPRA for the use of the device in a compassionate case; 
2. The following records: 44, 45, 52, 53, 54, 55, 56, 58, 59, 60, 61, 62, 63 (attachments not provided), 64, 66, 67, 68, 69, 70, 73, 74, 76, 77, 80, 81, 84, 85, 90, 93, 112, 123, 124, 125, 126, 127, 128, 129, 132, 162, 166, 167 and 172.
3. The preliminary investigation into allegations made (i.e. record 196).
 
In the course of the review, the Institute released the application to the Ethics Committee and the authorisation from the HPRA for the use of the device in a compassionate case to the applicant. The Institute also released three of the attachments to record 63 to the applicant; it refused access to the remaining two attachments under section 36(1)(b) of the Act. The Institute confirmed that it no longer wished to rely on section 31(1)(a) of the Act in relation to record 132; however, it argued that this record is exempt under sections 35 and 37 of the Act. Finally, the Institute released record 162 to the applicant. 
 
This Office provided the applicant with an update in relation to the Institute’s position. The applicant confirmed that he was willing to accept its decision in relation to the ethics applications and in relation to the records refused under section 31(1)(a) of the Act (i.e. records 53, 76, 77, 90, 123, 124, 125, 126, 127, 128, 129). The applicant confirmed that he would like a formal, binding decision in relation to the remaining records to which access was refused.
 
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 submissions made to date. I have also examined the records at issue. 
 

Scope of the review

 
The scope of this review is confined to whether the Institute was justified in its decision to refuse access to records 44, 45, 52, 54, 55, 56, 58, 59, 60, 61, 62, 63 (attachments 3 and 5), 64, 66, 67, 68, 69, 70, 73, 74, 80, 81, 84, 85, 93, 112, 132, 166, 167, 172 and 196 under sections 35(1)(a)/(b) or 36(1)(b) or 37(1) of the FOI Act.
 

Preliminary Matters

 
Section 13(4) of the FOI Act provides that 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).
 
Section 18 of the Act provides for the deletion of exempt information and the granting of access to a copy of a record with such exempt information removed. This should be done where it is practicable to do so and where the copy of the record thus created would not be misleading. However, the Commissioner takes the view that neither the definition of a record nor the provisions of section 18 envisage or require the extracting of particular sentences or occasional paragraphs from records for the purpose of granting access to those particular sentences or paragraphs. Generally speaking, therefore, the Commissioner is not in favour of the cutting or "dissecting" of records to such an extent.
 
Although I am obliged to give reasons for my decision, section 25(3) requires all reasonable precautions to be taken in the course of a review to prevent disclosure of information contained in an exempt record. This means that the description which I can give of the background, the records at issue and the material that I can refer to in the analysis is limited. The release of a record under the FOI Act is considered, effectively, as release to the world at large.
 
Section 36 - Commercially Sensitive Information
As the Institute relied on section 36 of the Act in refusing access to many of the records, I will consider that exemption provision first. The Institute refused access in full or in part to records 44, 45, 52, 54, 55, 56, 58, 59, 60, 61, 62, 63 (attachments 3 and 5), 64, 66, 67, 68, 69, 70, 73, 74, 84, 85, 93 and 112 under section 36(1)(b) of the Act. 
 
Section 36(1)(b)
Section 36(1)(b) applies to a record containing 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 it 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. 
 
The essence of the test in section 36(1)(b) is not the nature of the information but the nature of the harm that might be occasioned by its release. The harm test in the first part of subsection (1)(b) is that disclosure of the information "could reasonably be expected to result in material financial loss or gain." The test to be applied in this regard is whether the decision maker's expectation is reasonable. The harm test in the second part of subsection (1)(b) is whether disclosure of the information "could prejudice the competitive position" of the person concerned. The standard of proof necessary to meet this test is considerably lower than the standard to meet the test of "could reasonably be expected to" in the first part of subsection 36(1)(b). However, the Commissioner takes the view that, in invoking "prejudice", the damage which could occur must be specified with a reasonable degree of clarity.
 
In his submissions to this Office, the applicant states that he believes he has a right to know what the Institute is doing with his Intellectual Property in which he has a commercial interest. He contends that his Intellectual Property was to be licensed to a “spin out” company in which he was involved. He rejects the claim of commercial sensitivity. He also says that he would not disclose any commercially sensitive information.
 
The Institute states that the applicant assigned his Intellectual Property to it as evidenced by record 43 (released to the applicant) which provides that “the Assignors have agreed with the Assignee to assign to the Assignee all their right, title, share and interest in and to the said Invention”. The Institute argues that the applicant has no rights relating to the invention whether by reason of the draft licence agreement or otherwise. It states that the draft agreement did not proceed beyond a draft document which was never entered into (it provided this Office with a copy of the draft agreement). The Institute argues that the records contain technical information about the device and that disclosure under FOI, which is disclosure to the world at large, would enable other researchers to replicate the device and develop it for their own commercial purposes. 
 
As a general principle, the Commissioner takes the view that section 36 is primarily aimed at protecting the commercial interests of parties engaged in commercial activity. As such, it is not clear that it is entirely appropriate for an FOI body, which is engaged in the provision of public services, to seek to claim exemption under section 36 to protect its financial interests. However, depending on the circumstances of the case, the Commissioner has accepted that the FOI Act does not prohibit an FOI body relying on the provisions of section 36.
 
While the applicant is a co-inventor of the device, there is no hierarchy in terms of who can access records under FOI and the applicant’s request must be treated in the same way as a request from any member of the public because with certain limited exceptions, the FOI Act does not provide for the limiting of access to records to particular individuals only. When a record is released under the FOI Act, it effectively amounts to disclosure to "the world at large" H.(E.) v. Information Commissioner [2001] IEHC 58. The FOI Act places no restrictions on the type or extent of disclosure or the subsequent use to which the record may be put. 
 
It is clear that the intellectual property rights in relation to the device were assigned to the Institute. It is also clear from the records that there was an intention that this intellectual property would be commercialised. I have no information to refute the position that the licence agreement involving the applicant did not proceed beyond a draft agreement. The records contain detailed technical information about patents, inventorship, commercialisation and spin out of the technology. Many of the records also contain detailed technical information in relation to a separate medical device. It seems to me that release of this type of information under FOI could prejudice the ability of the Institute, as the holder of the intellectual property rights in the device, to develop the device for commercial purposes and could result in material financial loss to the Institute. I find that the Institute was justified in refusing access in full or in part to the following records under section 36(1)(b) of the Act: 44, 45, 52, 54, 55, 56, 58, 59, 60, 61, 62, 63 (attachments 3 and 5), 64, 66, 67, 68, 69, 70, 73, 74, 84, 85, 93 and 112.
 
Section 36(2)
Section 36(2) provides for various exceptions to section 36(1). I am satisfied that the exceptions provided for at section 36(1)(a)-(d) are not relevant to the information which I have found to be commercially sensitive. Section 36(2)(e) provides that a head shall grant an FOI request if the disclosure of the information concerned is necessary to avoid a serious and imminent danger to the life or health of an individual or to the environment.
 
The applicant states that from what he can see looking at the partially release records, changes have been made to the patent without his knowledge or consent. He states that changes that involve detailed technical information must be shared with him in case these changes could potentially cause harm to patients. 
 
I note that the records released to the applicant during the course of the review include an application to an Ethics Committee for use of the device in a compassionate case and correspondence from the Health Products Regulatory Authority authorising use of the device in a compassionate case. While I accept that the records concern a new medical device, I am not satisfied that release of these records is necessary to avoid a serious and imminent danger to the life or health of an individual. I find that section 36(2)(e) does not apply to the information which I have found to be commercially sensitive.
 
Section 36(3) - the Public Interest
Section 36(3) provides that subsection (1) does not apply in relation to a case in which, in the opinion of the head concerned, the public interest would, on balance, be better served by granting than by refusing to grant the FOI request. 
 
Section 36(1) itself reflects the public interest in the protection of commercially sensitive information. The Commissioner accepts that there is a legitimate public interest in persons being able to conduct commercial transactions with public bodies without fear of suffering commercially as a result and it is this public interest which section 36(1) seeks to protect. The Act also recognises, both in its long title and its individual provisions that there is a significant public interest in government being open and accountable. The Commissioner takes the view that, in attempting to strike the balance between openness on the one hand and the need to protect commercially sensitive information on the other, it is legitimate to consider two things:
 
• the first is the positive public interest which is served by disclosure and 
• the second is the harm that might be caused by disclosure.
 
The applicant states that the development of the device was partially funded by a grant from a Government Agency and he argues that it is in the public interest that public funds are spent correctly by the public bodies that they are awarded to. The applicant also argues that it is in the public interest for the Institute to ensure that no patients are harmed and this public interest consideration supersedes the rights of the Institute as a public body to commercialise the device.  
 
The Institute argues that there is a strong public interest in FOI bodies being able to protect their commercial interests and those of other third parties, including protecting their intellectual property. It argues that it is not in the public interest to jeopardise the Institute’s ability to commercialise a device, whose IP it owns, and that the public interest in favour of release is greatly outweighed by the public interest factors against release. 
 
There is a strong public interest in openness and accountability in the use of public funds. Openness in respect of the expenditure of public funds is a significant aid in ensuring effective oversight of public expenditure, in ensuring that the public obtains value for money, and in preventing fraud, corruption and waste or misuse of public funds.
 
In this case the Institute has refused access to technical information in relation to the device itself. There is very little information in these records in relation to the expenditure of public funds in development of the device. There is a small number of references to expenditure on patent application fees; however, such information in relation to expenditure on patent fees is included in the records released to the applicant (including record 74).
 
I am not satisfied that release of technical information in relation to the device is necessary in the public interest to ensure that patients are not harmed. There are protections in place to ensure patient safety in relation to the use of new medical devices. I find that, on balance, the public interest would not be better served by the release of this information.  
 
Finally, as I have found that records 44, 45 and 64 are exempt under section 36 of the Act, it is not necessary to consider whether these records are also exempt under section 35 of the Act on the basis that they contain confidential information.
 
Section 37 - Personal Information
The Institute refused access to records 80, 81, 132, 166, 167, 172, and 196 under section 37(1) of the Act.  Section 37(1) of the FOI Act provides that, subject to the other provisions of the section, an FOI body shall refuse a request if access to the record concerned would involve the disclosure of personal information. This does not apply where the information involved relates to the requester (section 37(2)(a) refers). However, section 37(7) provides that, notwithstanding section 37(2)(a), an FOI body shall refuse to grant a request if access to the record concerned would, in addition to involving the disclosure of personal information relating to the requester, also involve the disclosure of personal information relating to an individual or individuals other than the requester. Where a record or part of a record contains personal information relating to the requester, which is closely intertwined with personal information relating to another party (or parties), and where it is not feasible to separate the personal information relating to the requester from that relating to the other party (or parties), it can be described as joint personal information and section 37(7) must be considered. 
 
Section 2 of the Act defines "personal information" as information about an identifiable individual that, either - (a) would, in the ordinary course of events, be known only to the individual or members of the family, or friends, of the individual, or (b) is held by an FOI body on the understanding that it would be treated by that body as confidential. Section 2 of Act details fourteen specific categories of information that is personal without prejudice to the generality of the foregoing definition. These categories include (iii) information relating to the employment or employment history of the individual; (v) information relating to the individual in a record falling within section 11(6)(a) (i.e. a personnel record); (xii) the name of the individual where it appears with other personal information relating to the individual or where the disclosure of the name would, or would be likely to, establish that any personal information held by the FOI body concerned relates to the individual and (xiv) the views or opinions of another person about the individual. 
 
In his submissions to this Office, the applicant states that his reason for requesting the preliminary investigation report (record 196) was to ascertain how the investigators concluded that there was no case for further investigation into the actions of a particular individual. The applicant states that he was informed by the Institute that all of the allegations were investigated. However, he states that it appears from the records released that the original email setting out the allegations was not in fact given to the investigators. The applicant questions whether a full investigation of all of the issues raised was in fact carried out. The applicant also requests access to all parts of the report that make reference to him. He states that he has a right to the personal information which the Institute holds about him and, if named in the report, he would like to see the context in which this occurred. 
 
The Institute states that these records relate to an investigation into allegations made against an Institute staff member under special procedures which are akin to disciplinary procedures. It states that the investigation concluded that the allegations were unfounded and the person was cleared of the allegations. It argues that documentation in relation to the identity of the individual and its handling of the allegations contains the personal information of the individual concerned. The Institute states that, while the applicant will be aware of the identity of the individual involved, disclosure under FOI means disclosure to the world at large and there is no restriction on what a person can do with the information they obtain under FOI. It argues that it would be inappropriate for allegations of such a serious nature to be put into the public domain and that this would be seriously damaging to the reputation of the individual accused and subsequently cleared.
Records 80, 81, 132, 166, 167, 172, and 196 contain personal information in relation to a named individual including information relating to the employment of the individual; personnel records, and the views of another person about the individual. As the individual concerned is a staff member of an FOI body, paragraph I of section 2 is relevant. This paragraph excludes certain matters from the definition of "personal information", including the names of staff members of an FOI body and information relating to their office. The exclusion at (I) does not provide for the exclusion of all information relating to staff members of FOI bodies. The Commissioner takes the view that this exclusion is intended to ensure that section 37 will not be used to exempt the identity of a staff member of an FOI body in the context of the particular position held or any records created by the staff member while carrying out his or her official functions. The Commissioner takes the view that it does not exclude personnel records relating to the "competence or ability of the individual in his or her capacity as a member of staff of an FOI body".
 
The records contain allegations concerning a staff member. I do not accept that any allegations against an individual could be characterised as being for the purpose of the performance of the staff member's functions. Accordingly, the qualification on the definition of "personal information" cited above does not apply to the information withheld from these records. In a number of the records, personal information relating to that staff member is intertwined with personal information relating to the applicant. Having regard to the content of the records, in my view it is not feasible to separate the personal information of the applicant from that of the staff member concerned. I have taken account of section 18 of the FOI Act as referred to earlier in this decision. I am satisfied that extracting the occasional word or sentence is not practicable and would result in records which are misleading. I find, therefore, that records 80, 81, 132, 166, 167, 172, and 196 are exempt on the basis of section 37(1) of the Act subject to the provisions of section 37(2) and section 37(5) which I examine below.
 
Section 37(2)
There are some circumstances, provided for at section 37(2) of the FOI Act, in which the exemption at section 37(1) does not apply. I am satisfied that none of the circumstances identified at section 37(2) (a), (b), (c), (d), or (e) arise in this case. 
 
Section 37(5)
Section 37(5) of the FOI Act provides that a request that would fall to be refused under section 37(1) may still be granted where, on balance: (a) the public interest that the request should be granted outweighs the right to privacy of the individual to whom the information relates, or (b) the grant of the information would be to the benefit of the person to whom the information relates. I do not consider that the release of the information at issue would benefit the third party to whom it relates, as envisaged by section 37(5)(b) of the Act. 
 
The Public Interest
The FOI Act itself recognises the public interest in ensuring the transparency and accountability of public bodies in the performance of their functions. On the other hand, however, the language of section 37 and the Long Title to the FOI Act recognise a very strong public interest in protecting the right to privacy, which has a Constitutional dimension, as one of the un-enumerated personal rights under the Constitution. Accordingly, privacy rights will be set aside only where the public interest served by granting the request is sufficiently strong to outweigh the public interest in protecting privacy.
 
The records contain allegations concerning a staff member of the Institute. It is clear that the applicant is aware of the nature of the allegations and the identity of the staff member concerned. I accept that granting access to the records would add to the applicant’s understanding of how the Institute dealt with the allegations; however, this would result in a very significant invasion of the staff member’s privacy. I find that, in the circumstances of this case, the right to privacy of the staff member whose personal information is in the records outweighs the public interest in granting the applicant’s request. In summary, I find that records 80, 81, 132, 166, 167, 172, and 196 are exempt from release under section 37(1) of the Act and that none of the exceptions under section 37 apply.
 

Decision

 

Having carried out a review under section 22(2) of the FOI Act, I hereby affirm the Institute’s decision in this case. I find that records 44, 45, 52, 54, 55, 56, 58, 59, 60, 61, 62, 63 (attachments 3 and 5), 64, 66, 67, 68, 69, 70, 73, 74, 84, 85, 93 and 112 are exempt in full or in part under section 36(1)(b) of the Act, I find that records 80, 81, 132, 166, 167, 172, and 196 are exempt under section 37(1) of the Act and I find that the public interest in granting the request does not outweigh the public interest in refusing it and in protecting the privacy of individuals other than the applicant.
 

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