Cinneadh
Ms X and Health Products Regulatory Authority
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-132166-W4K2F0
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-132166-W4K2F0
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
2 June 2023
This review arises from a decision of the HPRA to grant partial access to a record 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 for a review of that decision to this Office. This case concerns an application for review made by an affected third party.
On 12 August 2022, the requester made an FOI request to the HPRA 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 the 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. One of the inspection reports relates to a fertility clinic operated by the applicant.
On 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 report. It provided the applicant with a copy of the report showing which parts it was considering releasing and which 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 28 October 2022, the applicant provided the HPRA with a copy of the report with its further proposed redactions highlighted.
On 3 November 2022, the HPRA informed the applicant of its decision to part-grant access to the report. It said it had decided to make further redactions to the report having regard to the applicant’s proposed redactions. It said it had decided that while the remaining information may comprise confidential or commercially sensitive information, it should be released in the public interest. On 9 November 2022, the applicant sought a review by this Office of the HPRA’s decision. 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 report that the applicant has contended are 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. Any parts of the report that the applicant did not object to release of are also outside the scope of this review.
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 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 record 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 on its website at: hpra.ie/homepage/blood-tissues-organs/ inspection-process The report at issue is broken down as follows
The applicant’s position is that further redactions should be made to the report on the basis of sections 35 and 36 of the FOI Act. I will address section 36 first.
Section 36(1) – Commercially Sensitive Information
Section 36(1) of the FOI Act provides a mandatory exemption for commercially sensitive information.
Sections 36(1)(a)
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. The applicant has not submitted that the report contains a trade secret. Having regard to the provisions of section 22(12)(a), I find that section 36(1)(a) does not apply.
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 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 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 that to a member of the public, the full text relating to deficiencies identified may cause unwarranted alarm due to a limited understanding of the technical and scientific aspects of these processes. It said, for this reason, it proposes not to publish the deficiencies, while not denying the existence of deficiencies themselves.
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 record 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 of 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.
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. However, 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 a low test.
The redactions sought by the applicant concern the findings of the HPRA following its inspection of the applicant’s facility. I accept that the market in which fertility clinics operate is very competitive. I also accept that the proposed release of information from parts of the report in relation to findings concerning deficiencies could prejudice the applicant’s competitive position. I find, therefore, that section 36(1)(b) applies to the applicant’s proposed redactions.
Sections 36(1)(c)
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 applicant has not submitted that the report contains information, the disclosure of which could prejudice the outcome of negotiations. Having regard to the provisions of section 22(12)(a), I find that section 36(1)(c) does not apply.
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 dis-apply section 36(1).
Sections 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.
Sections 36(3)
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 said it operates a policy of transparency and strives to uphold the duty of candour, which it owes to its patients. It said patients are fully informed of any incidents occurring within the clinic which have an impact on their embryos or gametes. It said that people undergoing fertility treatment often experience high levels of stress and anxiety due to the very nature of the treatment they require. The applicant said it has given careful consideration to whether the public interest lies in releasing the full text in relation to deficiencies, however to a member of the public the full text of the deficiencies may cause unwarranted alarm due to a limited understanding of the technical aspects of these process and for this reason it proposed not publishing the deficiencies, while not denying the existence of deficiencies themselves.
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 these deficiencies. It said 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.
The FOI Act was designed to increase openness and transparency in relation to 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 clinic in this case is a private enterprise. 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. Instead, the HPRA has 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 of the relevant legislation by the HPRA.
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 dis-apply section 36(1)(b) in this case.
Section 35(1) – 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 agrees that the outcomes of inspections carried out by government bodies are vital, however it said the publication of these reports may cause undue stress to the public while undergoing fertility treatment. The applicant said the report created by the HPRA should omit the information as seen in its proposed redactions before being released into the public domain as it contains sensitive information about incidents and quality processes in the applicant’s clinic.
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 applicant has proposed the redaction of HPRA’s findings 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. The first two requirements which must be satisfied for a record to be exempt under section 35(1)(a) are that (i) the information was given to an FOI body in confidence; (ii) the information was given on the understanding that it would be treated by the FOI body as confidential. In my view, the information that the applicant has proposed to have redacted comprises of the findings of the HPRA following the inspection process, rather than information given to the HPRA. In my view, the fact that information provided by the applicant may have been considered as part of those findings is not, of itself, sufficient for section 35(1)(a) to apply. I accept that the applicant may reasonably have considered that any commercially sensitive information disclosed during the inspection process would be treated as confidential, however I do not accept that the applicant could reasonably have understood that the findings of the HPRA would be treated as confidential, in circumstances where the HPRA sought to redact references to specific processes, procedures or equipment used by the applicant. 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.
Deirdre Gallagher, Senior Investigator