Cinneadh
Ms M and Health Products Regulatory Authority
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-127873-T4V8J5
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-127873-T4V8J5
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Whether the HPRA was justified in granting partial access to records relating to an inspection carried out
18 January 2023
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.
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.
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.
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:
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;
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 section 11 of the FOI Act 2014), the public body must be in lawful possession of the record in connection with, or for the purpose of, its business or functions and must also be entitled to access the information in the record. Given that record 3 was sent to the HPRA in response to the findings of a regulatory inspection, I am satisfied that it is in lawful possession of the record for the purpose of its business or functions. I find that the letter is a record that is held by the HPRA for the purposes of the FOI Act.
On the matter of whether the entirety of record 3 is exempt under section 35(1)(a), the applicant’s position is that record 3 meets the requirements of the exemption at section 35(1)(a). It said the information was given to the HPRA in confidence and that it understood the information would remain confidential. It said that if the information was to be released, it “will be more cautious” in the future about corresponding and having an open relationship with the HPRA and will prejudice the applicant in relation to making disclosures to the HPRA.
In its submissions to this Office, the HPRA said that information that is commercially sensitive is prima facie confidential. It said the information that was agreed to be redacted was understood by the HPRA to comprise commercially sensitive information and it accepts that such information was therefore given to it in confidence on the understanding that it would not be released to the public.
Record 3 comprises the applicant’s response to inspection findings made by the HPRA, which was given in the context of a regulatory inspection. I am not satisfied that partial disclosure of the record, in circumstances where the HPRA sought to redact what it understood to be commercially sensitive information, would prejudice the giving to the HPRA of further similar information from the same person or other persons. The 2006 Regulations, referenced above, include provisions relating to inspections, the powers of inspectors and requirements in respect of cooperation and the provision of information. It seems to me that it is in the interest of clinic providers to provide responses and action plans in respect of regulatory findings. Accordingly, I am not satisfied that disclosure would prejudice the giving of similar information.
In any event, it is important to note that, in circumstances where the HPRA has not decided to release the entirety of record 3, the question of the release of the entire record is not before this Office. Instead, our review is concerned solely with whether the HPRA was justified in deciding to grant partial access to the record. The applicant’s position is that in the event of a finding by this Office that the record does, indeed, come within the scope of the Act, certain information in the record that the HPRA has decided to release is exempt under section 36. However, it identified no specific information in any of the records to which it deems section 35(1)(a) to apply. In the circumstances, having regard to the provisions of section 22(12)(a) of the Act as outlined above, I find that the applicant has not satisfactorily shown that the information at issue in the record is exempt from release under section 35(1)(a) of the Act.
Section 36(1) – commercially sensitive information
Section 36(1) of the FOI Act provides a mandatory exemption for what is generally described as commercially sensitive information. While the applicant has made submissions that sections 36(1)(a) and 36(1)(c) also apply to the information, its primary arguments concern the applicability of section 36(1)(b). I will therefore consider that section in the first instance.
Section 36(1)(b)
Section 36(1)(b) of the FOI Act provides that an FOI body shall refuse to grant a request if the disclosure of the record sought 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 the 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 that could occur must be specified with a reasonable degree of clarity.
The applicant’s position is that there is a reasonable expectation that the release of certain information contained in the records would “impact on the reputation and thus the financial and commercial growth” of the applicant as a private business. It argued that release creates the impression that the facility is not compliant with the relevant legislation and could result in distress to patients.
In its submissions to his Office, the HPRA noted that “tissue establishments are commercial establishments that are in competition with each other”. It said it considers that the issue of commercial sensitivity arises. It said it sought to exempt information from the records which appears to be proprietary, unique or which refers to specific equipment and processes used. In respect of the section 38 consultation, it said it accepted the applicant’s submissions where they appeared reasonable and in line with relevant exemptions and “agreed to many of the redactions proposed by the applicant”. In respect of the findings documented following inspection, the HPRA said release of such information may impact the competitive position of the applicant and it considers that such information is commercially sensitive. It said that the sector is “very price sensitive” and that “the suite of techniques and technological advancements in AHR technology also fuels competition”.
I note that the applicant also sought to redact the terminology used by the HPRA in describing its findings. In essence, its argument is that the release of such information could be reasonably expected to lead to certain presumptions by the reader in respect of those findings without any context regarding current practices and the impact of same. I do not accept this argument. As I have set out above, the HPRA inspection process is summarised on the HPRA website and I am satisfied that the disclosure of the terminology used in the records at issue would not, of itself, give rise to the harms set out in section 36(1)(b).
The records also contain information which I would describe as standard or procedural text including abbreviations, the scope and objective of HPRA inspections and lists of standard procedures carried out by such clinics. The applicant is seeking the redaction of this information as commercially sensitive. The HPRA’s position is that it does not meet the requirements of section 36(1)(b). Having carefully reviewed the information, I am not satisfied that the applicant has sufficiently demonstrated that the relevant harms could flow from the release of this type of information and I find that section 36(1)(b) does not apply.
On the other hand, I accept that the proposed release of details of the findings identified during the inspection and the applicant’s responses to same could prejudice its competitive position. I find that section 36(1)(b) applies to such information. As I have found that section 36(1)(b) applies, I must also consider whether section 36(2) or section 36(3) serve to disapply section 36(1).
Sections 36(1)(a) and 36(1)(c)
Section 36(1)(a) provides for the mandatory refusal of a request if the record concerned contains trade secrets of a person other than the requester concerned. This Office accepts that a trade secret is information used in the trade or business which, if disclosed to a competitor, would be liable to cause real (or significant) harm to the owner of the secret and that the owner must limit the dissemination of it or at least not encourage or permit widespread publication.
Section 36(1)(c) provides for the mandatory refusal of a request if the record concerned contains information whose disclosure could prejudice the conduct or outcome of contractual or other negotiations of the person to whom the information relates. The standard of proof required to meet this exemption is relatively low in the sense that the test is not whether prejudice or harm is certain to materialise but whether it might do so. Having said that, this Office expects that a person seeking to rely on this exemption would be able to show that contractual or other negotiations were in train or were reasonably foreseen which might be affected by the disclosure and would be able to explain how exactly the disclosure could prejudice the conduct or the outcome of such negotiations.
The applicant made limited submissions in respect of the applicability of section 36(1)(a). It said that some of the information in the records which has not been redacted relates to trade secrets and that such information is not made available to the public. However, it has not specifically identified any such information in the records. Having regard to the provisions of section 22(12)(a), I find that section 36(1)(a) does not apply.
In respect of the applicability of section 36(1)(c), the applicant said that the disclosure of the information “would in our view prejudice the conduct or outcome of contractual or other negotiations”. It said that “negative inferences could be drawn that [it] is not compliant with the required legislation and is not operating at an adequate standard” and that this could prejudice current negotiations with prospective clients and service providers. In line with my findings in respect of section 36(1)(b) above, I find that section 36(1)(c) applies to the findings identified during the inspection and the applicant’s responses to same but to none of the other redacted information.
Sections 36(2) and 36(3)
Section 36(2) provides for the release of information to which section 36(1) is found to apply in certain circumstances. I am satisfied that none of the circumstances identified at section 36(2) arises in this case.
Section 36(3) provides that section 36(1) does not apply to a case in which the FOI body considers that the public interest would, on balance, be better served by granting than refusing to grant the request. 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. That section recognises the need to enhance public scrutiny and accountability of government and public affairs, particularly the activities and decision making of FOI bodies. However, in a judgment delivered on 25 September 2020 (The Minister for Communications, Energy and Natural Resources and the Information Commissioner & Ors, available on our website), the Supreme Court held that general principles of openness and transparency do not provide a sufficient basis for directing the release of otherwise exempt information in the public interest. Rather, a “sufficiently specific, cogent and fact-based reason” is required “to tip the balance in favour of disclosure”.
Moreover, while the Court stated that the public interest balancing test involves a “weighing of the respective private and public interests in the analysis of the records in issue”, it did not disturb the guidance that it previously gave in The Governors and Guardians of the Hospital for the Relief of Poor Lying-In Women v. the Information Commissioner [2011] IESC 26 ("the Rotunda Hospital case") in which it drew a distinction between private and public interests. Relevant private interests are those that are recognised by law and, in particular, through the protection afforded by the exemption provisions.
In respect of the public interest provision at subsection 35(3), the applicant said that “while the proposed redactions might be interesting to the public, it is not in the public interest for such information to be released”. It said it is a private business and relies on members of the public availing of its services. It argued that release of the information will “cause undue distress to members of the public” including patients currently undergoing treatment. It said it provides a necessary service to the public and that the release of the information could significantly damage its reputation and the services it is able to provide. It argued that release would also impact the service providers it contracts with. It said it operates a policy of transparency with its patients and “routinely discloses relevant information, guidance and advice, including risks of medical treatments and [its] practices”.
In its submissions, the HPRA said that “the major point of difference between the HPRA and the applicant is the treatment of information about its findings and the description of same”. It said it is of the view that the public interest lies in such findings being made available to the public. It said it carries out inspections to ensure that clinics offering assisted human reproduction services operate within standards prescribed by law. It said that the public has a strong interest in knowing that such clinics operate within those standards and that findings such as those at issue can be accessed. It said that this is particularly the case for those considering utilising such services. It said it does not accept the applicant’s arguments that release would cause harm to members of the public. It said it is in the interests of patients that there be “appropriate transparency around the enforcement of the statutory obligations” of such clinics.
The original requester also made submissions to this Office during the course of the review. He said that in light of the fact that such reports are compiled by a public regulator, he believes there is an overwhelming public interest in there being transparency in respect of such findings. He said this can “help better inform the public about the issues that arise in such clinics and help them make informed choices about which clinics they use”.
In relation to the harm which could be caused by disclosure, I have identified potential prejudice to the competitive position of the clinic and to its negotiations. As a general principle, I do not believe that the FOI Act was designed as a means by which the operations of private enterprises were to be opened up to scrutiny. As noted above, scientific and technical information relating to the clinic’s processes and procedures has been redacted by the HPRA. What is at issue here is information in relation to specific findings and actions proposed by the applicant in response to such findings. The HPRA has not sought to release the entirety of the records and it has redacted references to specific procedures or equipment used by the clinic.
I consider that there is a significant public interest in knowing that such clinics operate within the standards prescribed by law, in this case the 2006 Regulations which the HPRA, on behalf of the public, is required to enforce. In my view, there is a strong public interest in knowing how the HPRA carries out clinic inspections in individual cases and that the regulatory functions assigned to the HPRA achieve the purpose of the relevant legislation. There is also significant public interest in ensuring that the welfare of people undergoing fertility treatment is seen to be protected by the enforcement by the HPRA of the relevant legislation. I find that the public interest would, on balance, be better served by granting access to the information at issue. I find, therefore, that section 36(3) serves to disapply sections 36(1)(b) and 36(1)(c) in this case.
In conclusion, therefore, I find that the applicant has not satisfied this Office that the HPRA’s decision to grant partial access to the records at issue was not justified.
Having carried out a review under section 22(2) of the FOI Act, I hereby affirm the HPRA’s decision. I find that it was justified in granting partial access to the records at issue.
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.
Stephen Rafferty, Senior Investigator