Decision
Ms X and Health Products Regulatory Authority
From Office of the Information Commissioner (OIC)
Case number: OIC-132432-Y7L7Y5
Published on
From Office of the Information Commissioner (OIC)
Case number: OIC-132432-Y7L7Y5
Published on
Whether the HPRA was justified in its decision to grant partial access to inspection reports concerning fertility clinics
6 June 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 an FOI request on 12 August 2022, for a copy of all inspection reports carried out on fertility clinics between 25 March 2021 and 25 March 2022. Following communications between the parties, the requester agreed to narrow the scope of his request to five inspection reports where major or more serious deficiencies were identified. 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. Two of the inspection reports relate to fertility clinics operated by the applicant.
In a letter dated 28 September 2022, the HPRA notified the applicant of the request. It informed the applicant that it was considering granting partial access to the inspection reports. It provided the applicant with a copy of the reports 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 17 October 2022, the applicant made submissions to the HPRA and it provided the HPRA with copies of the inspection reports with its proposed further redactions highlighted.
On 3 November 2022, the HPRA informed the applicant of its decision to part-grant access to the reports. It explained that it had decided to make further redactions to the reports 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 of the FOI Act. On 17 November 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 requester 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 correspondence between the applicant and the HPRA as set out above, and to the submissions made by the applicant and the HPRA. I have also had regard to the contents of the record at issue and to the provisions of the FOI Act.
I have decided to conclude this review by way of a formal, binding decision.
This review is concerned solely with whether the HPRA was justified in its decision to grant access to specific parts of the reports that the applicant has contended are exempt from release under sections 35 and 36 of the FOI Act. Any parts of the reports that the HPRA decided to withhold are outside the scope of this review, as are those parts of the reports to which the applicant did not object to release.
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 to satisfy this Office that the HPRA's decision to grant partial access to the reports at issue was not justified.
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.
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 as follows on its website hpra.ie/homepage/blood-tissues-organs/inspection-process
The contents of the reports at issue are not identical, however they are broadly similar and either or both reports contain the following sections:
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.
Section 35(1)(a) – Information obtained in confidence
Section 35(1)(a) applies to a record containing information given to an FOI body in confidence. Four requirements must be satisfied for a record to be exempt under section 35(1)(a):
The applicant said it made available a number of documents in confidence to the HPRA in order for the HPRA to carry out the inspection that is the subject of the request. The applicant said where it had relied on section 35(1)(a), the documents and information meet the four-part test as required under section 35(1)(a). It said the information was given to the HPRA in confidence and is not in the public domain, it understood that the information given to the HPRA would remain confidential. It said that if the information is released, it will be more cautious in the future about the information that is handed over to the HPRA. Finally, it said it believes that it is important that there is open dialogue between it and the HPRA. The applicant said the requested redactions relate to information that was imparted to 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 clinic in confidence.
The HPRA said it accepted some of the additional redactions proposed in the applicant’s submissions and it refused others. It said the approach taken was to release information in relation to deficiencies it identified in order for the public to know that the clinic’s legislative obligations are enforced by the HPRA. It said it redacted references to specific processes, procedures or equipment used by the applicant. 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.
The record at issue consists of a report carried out by the HPRA in the context of a regulatory inspection. The applicant has proposed the redaction of certain information, including information in relation to incidents, non-conformances, change control issues and deficiencies on the basis that this information is exempt under sections 35 and 36 of the Act. I am not satisfied that partial disclosure of the record, in circumstances where the HPRA sought to redact what it understood to be confidential or 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. The main inspection provisions under S.I. No. 158 of 2006 are listed at Regulation 19 which provides as follows:
“…(3) The Irish Medicines Board (now the HPRA) may also serve a notice on a tissue establishment requiring that it furnish the IMB with such information concerning its compliance with these Regulations as shall be specified in the notice within such period as shall be specified in the notice.
(4) Any tissue establishment which receives a request for information in accordance with paragraph (3) shall provide the information requested within the period specified in the notice…”
The clinics are required to provide the HPRA with such information concerning their compliance with the 2006 Regulations as specified by the HPRA. Given the powers of the HPRA in terms of obtaining information, I am not satisfied that disclosure of the information at issue would be likely to prejudice the giving of further similar information from the same person or other persons. I find that the information at issue is not 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 commercially sensitive information.
Section 36(1)(b)
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 substance of the test in section 36(1)(b) is not the nature of the information at issue, 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) of the FOI Act 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 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 said the information contained in its proposed redactions creates the impression that it is not compliant with the legislation referenced in the inspection reports. It said this could result in distress to its patients, specifically those who received treatment during that time and whose treatment and/or medical care is ongoing. The applicant submits that there is a reasonable expectation that the release of this information would impact on its reputation and thus the financial and commercial growth of its business.
In its submissions to this 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 where it is reasonable to assume that it is part of the clinic’s unique business model for which they have a realistic expectation will not be shared with others. It said as part of the third party consultation, where further information was identified as being commercially sensitive, it accepted the applicant’s submissions where they appeared reasonable and in line with the FOI exemptions. The HPRA submitted that if certain findings in the report comprise 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, it is important to note, at the outset, that this Office considers the possibility of the public misunderstanding information is, generally speaking, not a good cause for refusing access to the records of public bodies. The redactions sought by the applicant include standard terminology used by the HPRA that is not unique to the report at issue and the findings of the HPRA following its inspection of the applicant’s facility. 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) of the FOI Act.
The HPRA inspection process is summarised on the HPRA website and the terminology used is standard and is publicly available. As such, I find that section 36(1)(b) does not apply to the proposed redaction of standard headings or terminology used in the report. 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 concern findings of the HPRA. I accept that the disclosure of these redactions could prejudice the applicant’s competitive position. I find, therefore, that section 36(1)(b) applies to the remaining redactions regarding the HPRA’s findings.
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. In its submissions to this Office, the applicant 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.
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. In its submissions to this Office, the applicant said that negative inferences could be drawn suggesting that it is not compliant with the required legislation. It said this could prejudice current negotiations with prospective clients and service providers who may decide not to deal with the applicant.
I have already accepted that section 36(1)(b) applies to redactions which concern findings of the HPRA. I do not accept that standard headings or terminology used in the reports constitutes a trade secret of the applicant nor do I accept that the release of this type of information could prejudice the conduct or outcome of negotiations involving the applicant. I find that section 36(1)(a) and 36(1)(c) do not apply to the remaining redactions.
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
Section 36(3) The Public Interest
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”.
Furthermore, 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.
The applicant submitted that while the proposed redactions might be interesting to the public, it is not in the public interest for the proposed redactions to be released. It said release of the proposed redactions would cause undue distress to its patients including those who are still undergoing medical treatment. The applicant said it provides a necessary service to the public and if the information at issue is released, it could significantly damage its reputation and negatively impact on the services that it is able to provide. The applicant said it discusses the risks of treatment plans with patients and prospective patients. It said this information is given in context to ensure that there is a transparent delivery of the information that is understood by patients and which does not cause unnecessary harm to members of the public. The applicant submitted that the arguments made by the HPRA are not sufficiently specific, cogent and fact based to tip the balance in favour of disclosure. It stated that the level of detail in these records provides an insight into its operations as a private company beyond what would generally be available to the public.
The HPRA said that the major point of difference between the HPRA and the applicant is the treatment of information about the finding of deficiencies and the description of same. It said it is of the view that the public interest lies in findings of a deficiency being made available to the public. The HPRA said it regulates certain activities pertaining to assisted human reproduction and it carries out inspections to ensure that clinics offering such services operate within the applicable legislative framework. It said that the public have a strong interest in knowing that such clinics operate within the standards prescribed by law. It said that it is important to the public, for public health reasons generally and specifically for those utilising the clinics’ services that the findings of deficiencies are something that can be accessed by the public. 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.
It is important to note that the FOI Act was designed to increase openness and transparency in the way in which FOI bodies conduct their operations and, in general terms, it was not designed as a means by which the operation of private enterprise is opened up to scrutiny. The fertility clinics in this case are private enterprises. 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.
In my view, 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.
In conclusion, I find that the HPRA was justified in granting partial access to the reports having regard to sections 35 and 36 of the FOI Act.
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 reports 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.
Deirdre Gallagher, Senior Investigator