Ms M and Health Products Regulatory Authority

• Jurisdiction: Ireland
• Judge: Stephen Rafferty Senior Investigator
• Judgment Date: 18 January 2023
• Case Outcome: The Senior Investigator affirmed the decision of the HPRA. He found that sections 35 and 36(1) did not apply to certain of the information at issue. He found that while sections 36(1)(b) and 36 (1)(c) applied to some of the information, the public interest would, on balance, be better served by granting access to that information.
• Record Number: OIC-127873-T4V8J5
• Court: Information Commission
• Respondent: Health Products Regulatory Authority

Whether the HPRA was justified in granting partial access to records relating to an inspection carried out

18 January 2023

Background

This review arises from a decision of the HPRA to part-grant access to certain records pursuant to an FOI request to which section 38 of the FOI Act applies. Section 38 applies where, at some stage in the decision making process, the FOI body has formed the view that the records at issue 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 third party personal information, respectively) but that the records should be released in the public interest. Where section 38 applies, the FOI body is required to notify an affected third party before making a final decision on whether or not the exemptions, 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 FOI body, may apply directly to this Office for a review of that decision. This case concerns an application for review made by an affected third party.

The HPRA received a request on 30 June 2022 for a copy of “any 2018 inspection reports” in respect of a named facility under Tissue Establishment Authorisation regulations. The requester also sought access to copies of any correspondence between the HPRA and the named facility arising from the inspection and its findings.

In a letter dated 13 July 2022, the HPRA notified the named facility (the applicant) of the review under section 38 of the FOI Act. It outlined its preliminary view that, on balance, the public interest would be better served by part-granting the request. It provided the applicant with copies of three redacted records it was proposing to release. On 3 August 2022, the applicant made submissions to the HPRA.

On 22 August 2022, the HPRA informed the applicant of its decision to part-grant access to the records. It explained that it had decided to make further redactions to the records having regard to the applicant’s submissions. It said it had decided that the remaining information was either not exempt under section 35 or section 36, or that it should be released in the public interest. On 5 September 2022, the applicant sought a review by this Office of the HPRA’s decision. For the avoidance of doubt, references to communications with the applicant in this decision include communication with its representatives.

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 correspondence between the applicant and the HPRA as set out above, and to the submissions made by the applicant, the HPRA and the original requester. I have also had regard to the contents of the records at issue. I have decided to conclude this review by way of a formal, binding decision.

Scope of Review

The HPRA granted partial access to the three records it identified as falling within the scope of the original request. It redacted certain information from the records under sections 35(1)(a), 36(1)(b) and 37(1) of the FOI Act.

During the course of the review, the HPRA identified a small amount of information which it no longer intends to release. In identifying that information, the HPRA used the same section numbering system as that used by the applicant in shared documentation. I have adopted this system also. Accordingly, along with the information that the HPRA decided to redact from the three records, the following information is also outside the scope of this review: page 227, section 14, page 238, section 21, page 246, section 62, and page 255, section 7. This review is therefore concerned solely with whether the HPRA was justified in its decision to grant access to the remaining parts of the records concerned.

Preliminary Matters

Before I address the substantive issues arising, I wish to make a number of preliminary comments. First, it is important to note that under section 22(12)(a) of the Act, a decision to grant a request to which section 38 applies shall be presumed to have been justified unless the person to whom the information relates shows to the satisfaction of the Commissioner that the decision was not justified. This means that the onus is on the applicant to satisfy this Office that the HPRA's decision to grant partial access to the records at issue was not justified.

Secondly, although I am obliged to give reasons for my decision, section 25(3) of the FOI Act requires me to take all reasonable precautions in the course of a review to prevent disclosure of information contained in an exempt record. This means that the extent to which I can describe the contents of the records is limited.

Finally, during the review it came to my attention that the correspondence issued to the original requester on 18 August 2022 notifying him of the HPRA’s decision did not comply with certain procedural requirements. There is a statutory requirement to set out in the decision the reasons for the refusal, details of any exemption which is being relied upon and the particulars of any matter relating to the public interest taken into consideration for the purposes of the decision. This Office alerted the HPRA to the inadequacy of the notification and a revised decision was issued to the requester on 24 November 2022.

Analysis and Findings

The records in question

As noted above, I am limited in the description of the records that I can provide. However, I believe it would be useful to provide some high-level detail in respect of the records and the functions of the HPRA.

The HPRA is the competent authority in respect of tissue and cell establishments in Ireland under EU Directive 2004/23/EC. This Directive was transposed into Irish law by the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 (the 2006 Regulations). The HPRA said its role in relation to the regulation of tissue establishments, including Assisted Human Reproduction (AHR) clinics, is to “ensure that standards of quality and safety are adhered to for the donation, procurement, testing, processing and preservation of tissues and cells”. It said clinics in the State that carry out defined processes must comply with regulatory requirements and that compliance with these requirements is verified by way of regular inspections.

The HPRA inspection process is summarised on the HPRA website as follows:

• Inspection Organised
• Inspection Carried Out
• Deficiencies against requirements of Regulations and Good Practice Identified
• Report written by Inspectors and sent to establishments/organisations/centres
• Responses (corrective actions) and timeframes submitted to HPRA and Reviewed by Inspectors
• Further Responses Required or Further Inspection Required based on Responses
• Close out of Inspection

The records in question relate to one such inspection. Record 1 is a summary report. Record 2 is an inspection report. Record 3 is a copy of the applicant’s response to the findings outlined in record 1.

The applicant’s position is that further redactions should be made to the records in question on the basis of sections 35 and 36 of the FOI Act.

Section 35(1) – information obtained in confidence

Section 35(1)(a) provides for the protection of certain information given to an FOI body in confidence. For a record to be exempt under section 35(1)(a), four requirements must be satisfied, namely that;

• the information was given to an FOI body in confidence;
• the information was given on the understanding that it would be treated by the FOI body as confidential;
• disclosure of the information would be likely to prejudice the giving to the body of further similar information from the same person or other persons; and
• it is important to the body that such further similar information should continue to be given to the body.

In its submissions to this Office, the applicant argued that the entirety of record 3 is exempt under section 35(1)(a). Indeed, it argued that the letter does not come within the remit of the FOI Act. It said the letter was sent to the HPRA by the applicant as a private company and that the letter itself is “not a record” but rather is private correspondence relating to a public record.

It appears the applicant is of the view that only records considered to be “public” records come within the scope of the Act. That is not the case. The Act provides for a right of access to all records held by FOI bodies, unless they are otherwise exempt. The Supreme Court considered the meaning of “held” for the purposes of the FOI Act 1997 in Minister for Health v Information Commissioner [2019] IESC 40. In its judgment, the Court found that for a record to be held within the meaning of section 6(1) of the Act of 1997 (the equivalent provision of...