Whether HPRA was justified in refusing access to the names of healthcare facilities using a particular supplier-™s knee implant system since 2003

5 July 2023

Background

This review concerns a request to which section 38 of the FOI Act applies. Section 38 applies to cases where, at some stage in the decision making process, the public body has formed the view that the record(s) in question qualify for exemption under one or more of the relevant exemptions in the FOI Act (i.e. sections 35, 36 and 37 - relating to information that is confidential, commercially sensitive, or personal information about third parties, respectively) but that the record(s) should be released in the public interest.

Where section 38 applies, the public body is required to notify an affected third party before making a final decision on whether or not the exemption(s), otherwise found to apply, should be overridden in the public interest. The requester, or an affected third party, on receiving notice of the final decision of the public body, may apply directly for a review of that decision to this Office.

By way of general background, HPRA-™s website says that its market compliance and surveillance function includes investigating, on the basis of risk to public and animal health, reports of suspected quality defects in both human and veterinary medicines and in their related active substances. It also co-ordinates any subsequent recall actions on the Irish market. Its risk based sampling and analysis programme is focused on monitoring matter such as the quality and safety of medicinal products both on the Irish market and produced for export.

The applicant-™s FOI request to HPRA of 25 August 2022, as subsequently narrowed on 15 September 2022, sought access to:

1. A listing of all hospitals using a particular supplier-™s specified knee implant system in Ireland since 2003, and

2. A summary listing of incident reports as submitted by the supplier to the HPRA in relation to the system concerned, and/or any records relating to a specific incident of the applicant-™s request.

HPRA formed the opinion that the request was one to which section 38 of the FOI Act applied. On 29 September 2022, HPRA invited a submission from the supplier regarding the possible release of details relevant to part 1. The supplier made a submission to HPRA on 11 October 2022.

On 4 November 2022, HPRA decided to part-grant the request. It granted access to the details sought at 2. It refused access to the details sought at part 1 under sections 36 (commercial sensitivity) and 37 (personal information) of the FOI Act.

On 19 December 2022, the applicant sought a review by this Office of HPRA-™s decision on part 1 of the request.

I have now completed my review in accordance with section 22(2) of the FOI Act and I have decided to conclude it by way of a formal, binding decision. In carrying out my review, I have

had regard to the above exchanges, to correspondence between this Office, the applicant, and the supplier, to the details at issue, and to the provisions of the FOI Act.

Scope of Review

HPRA-™s section 38 consultation with the supplier of 29 September 2022 concerned a three-column table. The table was one part of the supplier-™s response to various queries raised with it by HPRA.

Column one of the table lists private and public healthcare facilities using the knee implant system from 2015-2022. Columns two and three contain names of medical staff in those facilities, email addresses for some of those staff, and what seem to be general contact details for some of the facilities.

I have received no comment from the applicant disputing my view that the request, and this review, covers only part of the table. Neither have I received any comment on my position that the review does not extend to HPRA-™s explanation of why the table does not cover 2003-2015.

Accordingly, this review is confined to whether HPRA was justified under the FOI Act in withholding the supplier-™s list of healthcare facilities using its implant system from 2015-2022, and any general contact details for those facilities that are also listed.

Analysis and Findings

Section 36(1)(b) -  commercially sensitive information

Section 36(1)(b) of the FOI Act provides that a head shall refuse to grant an FOI request 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. 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.

The harm test in the first part of section 36(1)(b) is that disclosure "could reasonably be expected to result in material loss or gain". This Office takes the view that the test to be applied is not concerned with the question of probabilities or possibilities but with whether the decision maker's expectation is reasonable.

The harm test in the second part of section 36(1)(b) is that disclosure of the information "could prejudice the competitive position" of the person in the conduct of their business or profession. The standard of proof to be met here is considerably lower than the "could reasonably be expected" test in the first part of this exemption.  However, this Office takes the view that, in invoking "prejudice", the damage which could occur must be specified with a reasonable degree of clarity.

It is also relevant that release of records under FOI is generally understood to have the same effect as publishing them to the world at large, given that the Act places no constraints on the uses to which the information contained in those records may be put.

However, section 36(2) provides for a number of exceptions to section 36(1). Furthermore, section 36(3) provides that access to a record to which section 36(1) applies may be granted if the public interest would, on balance, be better served by granting than refusing to grant the request.

The parties-™ arguments

HPRA says that the details comprise the supplier-™s customer list and are indicative of the system-™s market share in Ireland. It says that release of these details could enable the supplier-™s competitors to target their alternative products at the supplier-™s customers, thus causing commercial harm to the supplier. 

The supplier says that the details comprise its current and active customer list, and reflect business relationships which it developed by significant investments of time and resources. It says that disclosure to the world at large could enable competitors, without doing any work of their own, to target and seek to win the business of the listed customers. It says that such an outcome could prejudice its competitive position.

The applicant does not accept that disclosure of the facilities list would negatively impact on the supplier-™s commercial position but does not explain why it holds this view.

Analysis

I have no reason to dispute the supplier-™s assertions about the current nature of its customer list for the relevant system, or about the work involved in developing that customer base.

It could be argued that the details are to some extent already in the public domain, given that surgeons in healthcare facilities may give details of available knee replacement systems to potential or actual recipients. However, I accept that any occasional and general provision of such details does not equate to disclosure of a complete customer list to the world at large.

It could also be argued that due to the small size of the Irish market, the suppliers-™ competitors have already approached, or are likely to approach, the listed facilities. However, the list would identify exactly which facilities are using the particular system. It seems to me that such disclosure could, for instance, enable the supplier-™s competitors to target those facilities with more focussed marketing campaigns about their own alternative product offerings than might otherwise be the case.

In the circumstances, I accept that the details at issue comprise information the disclosure of which could prejudice the competitive position of the supplier in the conduct of its business. I find that section 36(1)(b) applies.

Section 36(2) - exceptions to section 36(1)

Section 36(2) provides for the release, in certain circumstances, of information to which section 36(1) applies. The applicant makes no arguments that section 36(2) is relevant. I am satisfied that none of the circumstances identified in section 36(2) arise in this case.

Section 36(3) - the public interest

Section 36(3) provides that subsection 36(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.

In relation to the public interest test contained in section 36(3), I wish to emphasise that in carrying out any review, this Office has regard to the general principles of openness and transparency set out in section 11(3) of the FOI Act. In sum, section 11(3) recognises the need to enhance public scrutiny and accountability of government and public affairs, particularly the activities and decision making of FOI bodies.

On the matter of where the public interest lies and the factors to be considered, this Office generally has regard to the comments of the Supreme Court inThe Governors and Guardians of the Hospital for the Relief of Poor Lying-In Women v. the Information Commissioner[2011] IESC 26 (the Rotunda case). It is noted that a true public interest should be distinguished from a private interest.

On the matter of the type of public interest factors that might be considered in support of the release of the information at issue, I have had regard to the findings of the Supreme Court inThe Minister for Communications, Energy and Natural Resources v The Information Commissioner & Ors[2020] IESC 5 (the eNet judgment). In her judgment, Baker J. indicated that the public interest in favour of disclosure cannot be the same public interest as that broadly stated in the Act. She said the public interest in disclosure must be something more than the general public interest in disclosure and the reason must be found from the scrutiny of the contents of the record. She said there must be a sufficiently specific, cogent and fact-based reason to tip the balance in favour of disclosure.

While the comments of the Supreme Court in both judgments cited above were made in relation to provisions of the FOI Act other than section 37, this Office considers them to be relevant to the consideration of public interest tests generally.

Arguments and analysis

The supplier says that the public interest weighs in favour of protecting its commercially sensitive information. I have explained why I accept that disclosure could cause the supplier commercial harm in the conduct of its business.

The applicant does not explain why it believes that there is a public interest in knowing which hospitals are using the supplier-™s system. The requested record lists the supplier-™s private and public sector customers. However, the FOI Act is generally concerned with the activities of public sector bodies. I do not see how, of itself, it is in the public interest to disclose the identities of the supplier-™s private sector customers. Furthermore, disclosure of the identities of the public sector clients gives only a minimal insight into the relevant arrangements and does not, for instance, reveal any information about the expenditure of public monies or the nature of the contracts entered into.

HPRA says that while there is a strong public interest in disclosing details about the outcome of a regulatory action, notwithstanding commercial harm that may arise, the public interest in this case does not weigh in favour of disclosing commercially sensitive information received from a third party. It also notes the framing of the request and says that a request for a customer list differs to, for instance, a request for a list of hospitals that HPRA may have contacted on foot of a field safety notice for a particular product.

Given that the customer details were sought and received by HPRA as part of its surveillance activities, it seems to me that their disclosure will provide a limited insight into HPRA-™s performance of such functions.

I am also aware that, subsequent to HPRA-™s decision on the request, the supplier subsequently voluntarily recalled one particular component of the system. I have therefore considered whether the public interest might weigh particularly in favour of disclosing the identity of any facilities on the list which were affected by the recall of the component concerned.

I note HPRA-™s comments on the disclosure of commercially sensitive information reflecting the outcome of a regulatory action, and on the framing of the request. It seems to me that a pre-existing customer list for a complete system does not of itself contain any information about the particular recalled component of that system, about the recall itself, or about HPRA-™s performance of its functions in relation to this matter. I have received no comment from the applicant on this issue.

Having considered this issue carefully, I am aware of no public interest factors further to which I can conclude that the public interest would, on balance, be better served by granting than refusing to grant the request for the supplier-™s customer list. I find, therefore, that section 36(3) does not apply.

Decision

Having carried out a review under section 22(2) of the FOI Act, I hereby affirm HPRA-™s decision on part 1 of the request. I find that relevant details are exempt under section 36(1)(b) of the FOI Act.

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.

Anne Lyons
Investigator