Cinneadh
Mr X and Health Products Regulatory Authority
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-109419-C1H9W9
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-109419-C1H9W9
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Whether the HPRA was justified in its decision to refuse access in part to inspection reports concerning fertility clinics.
21 June 2022
This review arises from the HPRA’s decision to refuse access in part to Inspection Reports 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 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.
In this case, the applicant submitted an FOI request to the HPRA on 25 March 2021, for access to reports, assessments, audits and investigations carried out into fertility clinics from 2019 to date. When processing the request, the HPRA formed the view that the release of the records would affect the interests of third parties and it engaged in a process of consultation with affected fertility clinics under section 38 of the Act. The HPRA wrote to the clinics concerned and informed them that it had formed the view that the request was one to which section 38 of the FOI Act applied and it invited submissions on the possible partial release of the relevant Inspection Reports. The fertility clinics concerned made submissions to the HPRA. On 01 June 2021, the HPRA notified the applicant of its decision to partially grant his request and it released 5 records related to two parties. On 18 June 2021, the HPRA informed the applicant that objections raised by a further four parties had been resolved and it was now releasing those records in part. The HPRA also informed the applicant that objections raised by one of the clinics had not been resolved and that clinic had applied to this Office for a review of its decision. The decision in that case will issue separately under reference number OIC-108970-J5S8W4. The applicant also applied to this Office for a review of the HPRA’s decision and this decision deals with the applicant’s request for a review of the HPRA’s decision.
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 to date, I have also examined the record at issue and had regard to the provisions of the FOI Act. I have decided to conclude this review by way of a formal, binding decision.
The HPRA has refused access to information contained in the reports under sections 30, 35, 36 and 37 of the Act. During the course of the review, the applicant confirmed that he was not interested in receiving information in relation to the identities of patients or staff working at the clinics which was redacted under section 37 of the Act. This review is concerned solely with whether the HPRA was justified in its decision to refuse access to parts of the Inspection Reports under sections 30(1)(a), 35(1)(a), or 36(1)(b) of the FOI Act.
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 records at issue was not justified.
Section 18 of the FOI Act provides for the deletion of exempt information and the granting of access to a copy of a record with such exempt information removed. This should be done where it is practicable to do so and where the copy of the record thus created would not be misleading. However, the Commissioner takes the view that neither the definition of a record nor the provisions of section 18 envisage or require the extracting of particular sentences or occasional paragraphs from records for the purpose of granting access to those particular sentences or paragraphs. Generally speaking, therefore, the Commissioner is not in favour of the cutting or "dissecting" of records to such an extent.
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.
I am limited in the description of the Inspection Reports that I can provide. I can say that Section 1 the Introduction contains information in relation to the scope and objective of the report. Section 2 the Inspection, Observations and Findings contains information in relation to the clinics premises, facilities, quality systems, controls and equipment etc. Sections 3 and 4 contain the Classification of Deficiencies and Deficiencies Identified during the Inspection and Section 5 contains points for clarification.
The HPRA states that in managing the FOI request, it has sought to exempt information that appears proprietary, unique or refers to specific equipment and processes used where it is reasonable to assume that it is part of a clinics unique business model and for which they have a realistic expectation will not be shared with others. It states that it has redacted this type of information under 35(1)(a), or 36(1)(b) of the FOI Act. The HPRA states that it has sought to release information in relation to deficiencies identified during inspection. It says it did not accept that a finding of a deficiency in and of itself was information that should be exempt as commercially sensitive or confidential information. However, the detail of the particular process, procedure or equipment used, when outlined in specific terms in a finding of a deficiency, was redacted when the information comprised commercially sensitive and confidential information.
Having regard to the nature of the information at issue, it seems to me that section 36(1)(b) is the most appropriate exemption provision to consider at the outset. Section 36(1)(b) must be applied to certain types of information whose disclosure could reasonably be expected to result in 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 which could occur must be specified with a reasonable degree of clarity.
The HPRA states that in Ireland all but one of the fertility clinics operate as commercial enterprises and there has been a large increase in the number of fertility clinics in recent years. It states that the sector is very price sensitive with increasing competition and clinics heavily promote their cutting edge treatments. According to the HPRA, there are many providers of services, equipment and consumables supplying clinics and clinics gather data about their use of different equipment and materials and correlate this to success rates with fertilisation and births. It states that the combination of evidential data gathered is considered to be unique to each clinic and is viewed by the clinics as very commercially sensitive and confidential. The HPRA states that information obtained from the clinics in terms of specific procedure/ equipment etc. was redacted on the basis of sections 36(1)(b) of the FOI Act.
The HPRA has provided this Office with copies of the Inspection Reports with its redactions highlighted. I have examined the reports closely. It seems to me, that the HPRA has sought to redact scientific and technical information relating to the clinic’s equipment and procedures from the reports. It has, for example, withheld information such as the fact that a particular clinic plans to be the first clinic to introduce a new technology, references to specific equipment and material used and details of future contract arrangements with other clinics. I accept that the release of information in relation to services, procedures and equipment etc. could prejudice the competitive position of clinics by facilitating their competitors to obtain commercial details without the cost of developing and testing these services, procedures and equipment. I also accept that this could allow competitors to deliver the same services and procedures at lower costs leading to a reduction in patients in the clinic in question. I find, therefore that section 36(1)(b) applies to the parts of the reports that the HPRA has identified as containing commercially sensitive information. In light of this finding, it is necessary to consider sections 36(2) and section 36(3) of the FOI Act.
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) 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”. Amongst other things, it found as follows:
“The public interest engaged … cannot be the general public interest in disclosure and transparency in public undertakings…
[Section 36(1)] recognises there is a public interest in the protection of commercial sensitivity and this may be normally served by the operation of the exemption itself, which provides for the refusal of an FOI request…
… the public interest engaged at this stage of the process must be something more than the general public interest in disclosure and the reason must be found from the scrutiny of the record, and the balancing of the interests of commercial sensitivity or confidentiality against the public interest in the disclosure of that content…
There must be a sufficiently specific, cogent and fact-based reason to tip the balance in favour of disclosure…
The public interest override contained in … section [36(3)] does not seem to me to be a simple restatement of the overall aim of fostering transparency.”
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.
The applicant contends that the redactions made are excessive and fail to take into account the need for transparency in the public regulation of these organisations and the public interest in such reports being released in full.
The HPRA states that the public interest does not override the application of the exemption in this case in terms of the information that was redacted i.e. scientific and technical information relating to the clinic’s equipment and procedures. It states that the private interests of the clinics should be protected in the manner afforded by the FOI Act exemption provisions.
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 (European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 (S.I. No. 158 of 2006) which the HPRA, on behalf of the public is required to enforce. In my view, there is a strong public interest in the public 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 is important to note, however, that it is the public body carrying out the inspection that is subject to the FOI Act and not the private enterprises inspected. I take the view that the 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 operations of private enterprises were to be opened up to scrutiny. The fertility clinics in this case are private enterprises.
The HPRA has taken the position that while information concerning deficiencies could reasonably be expected to result in commercial loss to the clinics, the public have a strong interest in knowing that such clinics operate within the standards prescribed by law and the public interest lies in the release of specific findings of deficiencies and their particular classification. The HPRA has released information concerning deficiencies from the reports. What is at issue here is information relating to processes, procedures and equipment used by clinics.
Having regard to the findings of the Supreme Court in the judgment cited above, I am not satisfied that the public interest in enhancing the transparency and accountability of the HPRA in terms of how it carries out its inspections would be served by the release of information in relation to the processes, procedures and equipment used by clinics. I am aware of no specific public interest factors in favour of the release of the information at issue that would lead me to conclude that the public interest would, on balance, be better served by its release. I find, therefore, that section 36(3) does not apply. As I am satisfied that section 36(1)(b) applies to the information redacted by the HPRA, it is not necessary to consider whether this information is also exempt from release on the basis of sections 30(1)(a) or 35(1)(a) of the FOI Act.
Having carried out a review under section 22(2) of the FOI Act, I hereby affirm the HPRA’s decision on the applicant’s request on the basis that section 36(1)(b) of the FOI Act applies.
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 McGoldrick, Senior Investigator