Cinneadh
Ms X and Health Products Regulatory Authority
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-108970-J5S8W4
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-108970-J5S8W4
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Whether the HPRA was justified in its decision to grant partial access to an inspection report concerning a fertility clinic.
20 June 2022
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 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 HPRA received a request 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 FOI 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 1 June 2021, the HPRA notified the requestor of its decision to partially grant his request and it released five records related to two parties. On 18 June 2021, the HPRA informed the requestor that objections raised by four other parties had been resolved and it was now releasing those records in part. The HPRA informed the requestor 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.
This decision deals with the clinic’s request for a review of the HPRA’s decision. The requestor also applied for a review of the HPRA’s decision and the decision in that case will issue separately under reference number OIC-109419-C1H9W9.
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 report under sections 30, 35, 36 and 37(1) of the Act. The applicant has sought a review in relation to its decision to rely on sections 35(1)(a) and 36(1)(b) of the Act in relation to parts of the report. This review is concerned solely with whether the HPRA was justified in its decision to grant access to parts of the Inspection Report under sections 35(1)(a) or section 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 partial access to the report 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.
I am limited in the description of the Inspection Report 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 clinic’s 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 clinic’s 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 sections 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.
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 information was given to an FOI body in confidence; the information was given on the understanding that it would be treated by the FOI body as confidential; disclosure of the information would be likely to prejudice the giving to the body of further similar information from the same person or other persons; and it is important to the body that such further similar information should continue to be given to the body.
In its application to this Office, the applicant says it accepts that the outcomes of inspections carried out by government bodies should be publically accessible. It says it has not proposed redaction of the fact that certain deficiencies were identified during the inspection of its clinic. It says, however, that all scientific and technical information relating to its processes and procedures should be redacted due to the confidentiality of this information. It states that it provided information relating to its procedures and technical equipment to the HPRA in confidence and on the understanding that it would remain confidential. It says at the time of providing this information to the HPRA, there was no indication that the report prepared by the HPRA would be released with “minimal redactions” on receipt of an FOI request. The applicant states that it has maintained a relationship with the HPRA that fosters open communication and it has a history of providing additional information, which falls outside the scope of the relevant legislation. It says it will not refuse to provide information to the HPRA as required by the relevant legislation; however, the sharing of additional voluntary information may become subject to further assessment in future due to the potential release of this information into the public domain.
The HPRA states that following receipt of the FOI request it engaged in consultation with the applicant. It says the applicant provided a submission in which it proposed further redactions. The HPRA says it accepted a small number of further redactions as proposed by the applicant as comprising commercially sensitive information. It did not, however, accept the majority of further proposed redactions, as the information did not appear to meet the requirements of FOI Act in terms of applicability of exemptions and/or should be released in the public interest. The HPRA says one of the key issues for the applicant was around deficiencies found. The HPRA says it has various categories of deficiencies that may be found on inspection and the general classification of deficiency is on its website. The HPRA says it did not agree with the redaction of the classification of the deficiency or the redaction of almost the entirety of the following paragraph was warranted. It says that this information was not obtained from the applicant but is a HPRA finding. The HPRA states that information obtained from the applicant in terms of specific procedures or equipment etc. was redacted.
The HPRA has provided this Office with a copy of the Inspection Report with the redactions proposed by the applicant highlighted and a copy with its redactions highlighted. I have examined the report closely. The applicant contends that additional information should be redacted from Section 2 Inspection, Observations and Findings, Section 4 Deficiencies and Section 5 Points for Clarification/to Note. In my view, the redactions made to the report by the HPRA are not minimal. I accept that the HPRA has sought to redact information that appears proprietary, unique or refers to specific equipment and processes used by the clinic. It seems to me that the information in Sections 4 and 5, which the applicant contends should be redacted on grounds of confidentiality, consists of findings by the HPRA as opposed to information obtained from the applicant. As outlined above, the first requirement for section 35(1)(a) to apply is that the information was given to an FOI body in confidence. This requirement is not satisfied in circumstances where the information is a finding of the HPRA, as opposed to information provided by the applicant.
I find, therefore, that the HPRA was justified in granting access to the parts of the Inspection Report at issue under section 35(1)(a) of the FOI Act.
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 that could occur must be specified with a reasonable degree of clarity.
The applicant contends that all scientific and technical information relating to its processes and procedures should be redacted to protect its competitive position. It also contends that the full text of the deficiencies should not be released.
The HPRA contends that information obtained from the clinic in terms of specific procedure or equipment etc. was redacted. It states that while it may be argued that the information concerning deficiencies could reasonably be expected to result in a material financial loss to the applicant, such loss could be mitigated by providing an explanation as to the nature of inspection findings. It states, however, that the HPRA does not endorse such statements and they represent the interpretation of the position by the clinic in question
In its submissions, the HPRA acknowledges that there has been a large increase in the number of Fertility Clinics, that clinics heavily promote their cutting edge treatments and that the sector is very price sensitive with increasing competition. It seems to me that the proposed release of information from parts 4 and 5 of the report in relation to deficiencies found during the inspection could prejudice the clinic’s competitive position.
I find, therefore that this information is exempt under section 36(1)(b) of the FOI Act. In light of this finding, it is necessary to consider sections 36(2) and section 36(3) of the FOI Act in relation to this information.
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”. 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 says it operates a policy of transparency with its patients. It states that a full and accurate explanation of events is provided to patients and investigations into incidents are also communicated to the patients affected. It states that people undergoing fertility treatment often experience high levels of stress and anxiety due to the very nature of the treatment they require. It states that it has given careful consideration to whether the public interest lies in releasing the full text of the report. It states that, to a member of the public, the full text relating to deficiencies may cause unwarranted alarm due to a limited understanding of the technical and scientific aspects of these processes. It says for this reason it proposes that specific details of deficiencies should be redacted while not denying the existence of deficiencies themselves.
The HPRA states that the information in question here is the specific findings of deficiencies and their particular classification. The HPRA states that it is of the view that the public interest lies in such findings being made available to the public. The HPRA contends that the public have a strong interest is knowing that such clinics operate within the standards prescribed by law and it is important to the public, for public health reasons generally and specifically, for those who are considering utilising the services in question, that the findings of deficiencies are something that can be accessed by the public, under the provisions of the FOI Act or otherwise. As such, the HPRA considers that notwithstanding the potential application of s.36(1)(b), the public interest lies in the release of findings of deficiencies and the nature of the deficiencies in question.
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.
In relation to the harm which could be caused by disclosure, I have identified potential prejudice to the competitive position of the clinic. 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 of deficiencies and their particular classification. The HPRA has not sought to release the entire text of the deficiencies and it has redacted references to specific procedures or equipment used by the clinic where they are included in the description of a deficiency. Having regard to the findings of the Supreme Court in the judgment cited above, I am satisfied that public interest in terms of knowing that such clinics operate within the standards prescribed by law, as overseen by the HPRA, outweighs any possible prejudice to the applicant’s clinic. Accordingly, I find that section 36(3) applies to the information at issue.
In conclusion, I find that the HPRA was justified in granting partial access to the report 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 affirm the HPRA’s decision to grant partial access to the report.
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