Cinneadh
Mr Y and Health Products Regulatory Authority
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-127630-X5D7M8
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-127630-X5D7M8
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
3 April 2023
This review arises from the HPRA’s decision to grant partial access to an Inspection Report pursuant to an FOI 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 records 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 records 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. This case concerns an application for review made by an affected third party.
In this case, the HPRA received a request on 23 June 2022 for a copy of “all inspection reports on fertility clinics carried out from 26 March 2022 to date.” When processing the request, the HPRA formed the view that the release of the records could affect the interests of third parties, in particular clinics who were the subjects of such reports. The applicant in this case is one such clinic.
The HPRA notified the applicant of the request on 6 July 2022. It informed the applicant that it considering granting partial access to a 2022 inspection report (the report). It provided the applicant with a copy of the report showing what parts it was considering releasing and what parts it was considering redacting. It outlined its preliminary view that, on balance, the public interest would be better served by part-granting the request. On 24 July 2022, the applicant provided submissions to the HPRA in which it proposed further redactions to the report.
On 11 August 2022, the HPRA informed the applicant of its decision to part-grant access to the record. It explained that it had decided to make some further redactions to the record having regard to the applicant’s submissions. However, it said that in relation to additional redactions requested by the applicant, it had decided that the information at issue was either not exempt under section 35 or section 36.
On 26 August 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. In the course of the review, the original requestor was invited to make submissions but he did not do so.
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 by the HPRA and the applicant to date. I have also had regard to the contents of the record at issue. I have decided to conclude this review by way of a formal, binding decision. In its submissions to this Office, the applicant provided a schedule of 21 numbered redactions. In referring to the various redactions at issue, I have adopted that numbering system.
This review is concerned solely with whether the HPRA was justified in its decision to grant access to specific parts of the report that the applicant has argued to be exempt from release under sections 35 and 36 of the FOI Act. Any parts of the report that the HPRA decided to withhold are outside the scope of this review, as are those parts of the report to which the applicant did not object to release. The redactions under consideration are 1a, 1b, 1c, 2, 3, 5, 6, 7, 8, 11, 13, 18, and 19.
Before I address the substantive issues arising, I would like to make a number of preliminary comments. Firstly, 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 information in the report falling within the scope of the review is limited.
Secondly, it is important to note that under section 22(12)(a) of the FOI 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 of satisfying this Office that the HPRA's decision to grant access to the relevant parts of the report was not justified.
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 here.
The report at issue is broken down as follows:
The applicant’s position is that further redactions should be made to the record on the basis of sections 35 and 36 of the FOI Act. As the applicant cited section 36 in respect of all of the redactions, I will address this section first.
Section 36(1)(a)
Section 36(1)(a) of the Act provides for the mandatory refusal of a request where the record sought contains trade secrets of a person other than the requester. In its submissions to this Office, the applicant argued that some of the information in the report that has not been redacted relates to “trade secrets”. However, in the schedule it provided wherein it provided details of the precise exemptions claimed, it did not include any arguments that section 36(1)(a) applied. Accordingly, in accordance with the provisions of section 22(12)(a) as outlined above, I find that the applicant has not shown that any of the information at issue is exempt from release under section 36(1)(a).
Section 36(1)(b)
The applicant cited section 36(1)(b) of the Act in respect of all thirteen redactions. Section 36(1)(b) provides for the mandatory refusal of a request where the record sought 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 the section 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 nature of the harm envisaged and a basis for a claim that such harm could reasonably be expected to result from disclosure of the particular information in the record(s) at issue should be shown by an FOI body or a third party relying on this provision.
The harm test in the second part of the section is that disclosure of the information "could prejudice the competitive position" of the person in the conduct of its 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.
While I have regard to the entirety of the applicant’s submissions, I do not propose to repeat them in detail here, although I can confirm I have had full regard to them for the purposes of the review. The redactions sought by the applicant broadly concern the findings of the HPRA following its inspection of the applicant’s facility, the actions sought to address those findings, and the terminology used by the HPRA relating to its findings. In essence, the applicant’s arguments can be summarised as arguments that the release of the information at issue could be taken out of context and could create the impression that the its facility is not compliant with the relevant legislation, and that the release of the information would impact on its reputation and thus its financial and commercial growth.
In submissions to this Office, the HPRA said the redactions sought may be generally characterised as descriptions of findings or references to such findings. It said some of the terminology used in the report that the applicant seeks to be redacted is standard text in inspection reports of this nature and that the definitions appear in inspection reports as explanatory text even if no such findings are made and that they also appear on the HPRA’s website. It said it had not sought to release the entire text of its findings and that references to specific procedures or equipment used by the facility are redacted and accordingly, it argued that release of the information would not constitute release of information in relation to the processes, procedures and equipment used by the applicant. It said the text proposed for release illustrates how the HPRA carries out clinic inspections in individual cases, and how the regulatory framework is applied and enforced.
The HPRA further argued that if the fact of certain defined findings arises and the type of finding comprises confidential information under section 35(1), or commercially sensitive information under section 36(1), then the public interest in such information being known to the public outweighs the private interests of the facility in question
Having considered the submissions of the parties, I would note at the outset that this Office considers that the possibility of the public misunderstanding information is, generally speaking, not a good cause for refusing access to the records of public bodies. More specifically, I am not satisfied that the release of certain terminology used in the report could, of itself, give rise to the harms identified in section 36(1)(b). As I have set out above, the HPRA inspection process is summarised on the HPRA website and the terminology used in the report is standard and is publicly available. As such, I find that section 36(1)(b) does not apply to redactions 1b or 1c. Moreover, I do not accept that section 36(1)(b) applies to redaction 1a, given that it contains no findings in respect of the applicant’s facility
On the other hand, as I have noted above, the harm test in the second part of section 36(1)(b), namely that disclosure of the information "could prejudice the competitive position" of the person in the conduct of its business or profession, is quite low. The remaining redactions sought concern findings of the HPRA and related actions sought. In essence, the applicant is seeking the redaction of any information that could disclose the general nature of the HPRA finding and/or action sought.
I note the HPRA’s submission that the sector in which the applicant operates is very price sensitive and, with increasing competition, not all clinics are commercially viable. Accordingly, I accept that the disclosure of the information the applicant wishes to be redacted could potentially affect the reputation of the applicant’s facility and as such could prejudice its competitive position. I find, therefore, that section 36(1)(b) applies to the remaining redactions.
Section 36(1)(c)
The applicant cited section 36(1)(c) in respect of all redactions apart from redactions 1b and 1c. That section provides for the mandatory refusal of a request if the record sought 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 an applicant 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.
In respect of the applicability of section 36(1)(c), the applicant made broadly similar arguments to those made in respect of the applicability of section 36(1)(b). It argued that the disclosure of the information at issue could prejudice the conduct or outcome of contractual or other negotiations on the basis that a negative inference could be drawn that suggests the applicant is not compliant with the required legislation and is not operating at an adequate standard. It said that this could prejudice current negotiations with prospective clients and service providers. However, it has not identified any specific negotiations, nor has it explained how the release of the information at issue could prejudice the conduct or outcome of such negotiations.
I have already accepted that section 36(1)(b) applies to the remaining redactions apart from redaction 1a on the basis that their disclosure could potentially affect the reputation of the applicant’s facility and as such could prejudice its competitive position. I accept that the release of findings of the HPRA could influence potential clients of the applicant in deciding whether or not to avail of its services. However, this cannot be regarded, in my view, as prejudicing the conduct or outcome of negotiations with the applicant. Neither has the applicant explained how the release of the information might prejudice the conduct or outcome of its negotiations with service providers.
In relation to redaction 1a, the applicant argued that the information it wishes to be redacted, when not read in line with recent reports both covered by the FOI request creates the impression that the applicant is not compliant with the relevant legislation, thus prejudicing current negotiations with prospective clients. Having regard to the specific information at issue, I do not accept that argument. The information does not, in my view, create the impression suggested. I find that section 36(1)(c) does not apply to redaction 1a.
Having found section 36(1)(b) to apply to a number of the redactions sought, I must go on to consider whether any of the other subsections of section 36 serve to disapply section 36(1)
Section 36(2)
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) arise in this case.
Section 36(3)
Section 36(3) provides that section 36(1) does not apply where 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”.
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 record 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.
The applicant argued that the public interest would not be better served by the release of the information at issue. It argued that the release of the information would cause undue distress to its clients, including those patients who are still undergoing medical treatment. It argued that the information should be withheld due to the particular sensitivity of the information. It also argued that it provides a necessary service to the public and that the release of the information could significantly damage its reputation and thus would have a direct correlation to the services that it is able to provide.
The applicant added that 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, to members of the public who avail of its services. It said this information is provided to said members of the public in the context of their medical treatment. It said it also provides its patients with the opportunity to ask questions to ensure that the information is understood and to enable its patients, or prospective patients, to make fully informed decisions about their health and any fertility treatment they may elect to undergo.
The HPRA said it has not sought to release the entire text of its findings. It said references to specific procedures or equipment used by the applicant’s facility are redacted and accordingly, it argued that release of the information at issue would not constitute release of information in relation to the processes, procedures and equipment used by the applicant. It said the information proposed for release illustrates how the HPRA carries out clinic inspections in individual cases, and how the regulatory framework is applied and enforced.
The HPRA added that it is of the view that the public interest lies in findings of a deficiency being made available to the public. It said it regulates certain activities of AHR clinics and carries out inspections to ensure that the clinics operate within the applicable legislative framework. It argued that the public have a strong interest in knowing that such clinics operate within the standards prescribed by law and that it is important to the public, for public health reasons generally and specifically, for those who are considering utilising the services in question, that its findings are something that can be accessed by the public, under the provisions of the FOI Act or otherwise.
In relation to the harm which could be caused by disclosure, I have identified potential prejudice to the competitive position of the applicant. 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. However, as I have outlined above, the HPRA has said release of the information at issue would not constitute release of information in relation to the processes, procedures and equipment used by the applicant and has, instead, sought to release information that illustrates how the HPRA carries out clinic inspections in individual cases, and how the regulatory framework is applied and enforced.
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.
It seems to me that the HPRA has sought to strike a balance in this case by withholding commercially sensitive information concerning the applicant’s processes and procedures whilst also striving to serve the relevant public interest factors in disclosure as described above. I agree with the HPRA 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 section 36(1)(b) in this case.
Section 35(1) - Information obtained in confidence
The applicant cited section 35(1)(a) of the Act in respect of redactions 3, 5, 6, 7, 8, 11, 13 and 18. Section 35(1)(a) provides for the mandatory protection of information given to an FOI body in confidence. For the exemption to apply, it is necessary to show the following:
The applicant said that the requested redactions directly relate to information that was imparted on the HPRA and does not concern an opinion or observation of the HPRA, and, in any case, the HPRA could not form an opinion or observation regarding such matters had the information not been given to the HPRA by the applicant in confidence. It said it made available a number of documents to the HPRA in confidence in order for the HPRA to carry out the inspection in question. It said that information was given in confidence and on the understanding that it would remain confidential. It said that if the information was released, it would be more cautious in the future about the information that is handed over to the HPRA. It said it will be prejudiced in regard to making disclosure to the HPRA. It added that believes that it is important that there is open dialogue between it and the HPRA.
The HPRA said it did not accept the applicant’s objections to the release of the details it had decided to release relating to its findings on the basis of confidentiality or commercial sensitivity. It said, however, that the detail of the particular process, procedure or equipment used, when outlined in specific terms in a finding, was redacted when the information comprised commercially sensitive and confidential information.
The redactions at issue relate to the HPRA’s findings. As I have outlined above, the first two requirements for section 35(1)(a) to apply are that (i) the record sought contains information given to an FOI body in confidence, and (ii) the information was given on the understanding that it would be treated as confidential. It seems to me that the information the applicant wishes to be redacted is not information that was given to the HPRA. Rather, it comprises the findings of the HPRA as a result of the inspection process carried out. The fact that information provided by the applicant may have formed the basis for those findings is not, of itself, sufficient for section 35(1)(a) to apply. Moreover, while I accept that the applicant may reasonably have considered that any commercially sensitive information disclosed during the inspection process would be treated as confidential, I do not accept that it could reasonably have understood that the HPRA findings would be treated as confidential, in circumstances where the HPRA has agreed to redact the specific details of the particular process, procedure or equipment used. I find, therefore, 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.
In conclusion, therefore, I find that the applicant has not satisfactorily shown that the decision of the HPRA to grant access to the information 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 the HPRA was justified in its decision to grant access to specific parts of the report that the applicant has argued to be exempt from release under sections 35 and 36 of the FOI Act.
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