Cinneadh
Ms X and Health Products Regulatory Authority
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-133065-S7Q6Z7
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-133065-S7Q6Z7
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Whether the HPRA was justified in granting partial access to a record relating to an inspection carried out
6 June 2023
This review arises from the decision of the HPRA to part-grant access to a certain 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 to this Office for a review of that decision. This case concerns an application for review made by an affected third party (the applicant).
The HPRA received a request for access to certain inspection reports relating to nonconformities/breaches regarding the Medicinal Products (Control of Advertising) Regulations 2007. In correspondence dated 19 October 2022, the HPRA notified the applicant of the review under Section 38 of the FOI Act. It outlined its preliminary view that, on balance, the public interest would be better served by part-granting the requester the information than by refusing it. It enclosed a copy of the record, highlighting those parts it intended to redact under sections 35, 36, and 37 of the Act, and on the ground that some parts of the record are not related to the specific request. On 10 November 2022, the applicant made submissions to the HPRA. It argued that the entire record should be exempt.
On 24 November 2022, the HPRA informed the applicant of its decision to part-grant access to the records. It said that the HPRA concluded that the additional information in the records did not meet the necessary requirements of sections 35 and 36 of the FOI Act. On 8 December 2022, the applicant sought a review by this Office 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 correspondence between the applicant and the HPRA as set out above, and to the submissions made by the applicant, the HPRA and the original requester. I have also had regard to the contents of the records at issue. I have decided to conclude this review by way of a formal, binding decision.
As I have outlined above, the HPRA provided the applicant with a copy of the record with the information it intended to redact highlighted. In its submissions, the HPRA said it had erroneously redacted from the start of the relevant record the stated number of deficiencies identified during the inspection. It said its position is that such information should be released. Accordingly, I will consider this information within the scope of this review.
During the course of this review, and in the context of a related case concerning the same record, the applicant made further submissions in respect of certain information in the record which effectively comprises an argument that section 37 applies. Section 37 protects personal information. The information in question relates to an identifiable third party referenced in section 1.d.ii on page 6. However, the original requester has indicated that he is not seeking information contained in the records which relates to identifiable third parties. He has stated that he is happy for such information to be redacted by the HPRA. Accordingly, on the understanding that the HPRA will redact same, I will not consider this information within the scope of this review.
This review is concerned solely with whether the HPRA was justified in its decision to grant access to the remaining parts of the record concerned, excluding the information that the HPRA highlighted for redaction (with the exception of the stated number of deficiencies referenced above) and information relating to identifiable third parties, as referenced above.
Before I address the substantive issues arising, I wish to make a number of preliminary comments. First, it is important to note that under section 22(12)(a) of the 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 records at issue was not justified.
Second, 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 the 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.
Third, in its submissions to this Office, the applicant argued that the original FOI request is “flawed and should be rejected on procedural grounds”. It said that the request does not meet the requirements of section 12 of the FOI Act as it “does not meet the expectations of clarity and specificity set out by the [Act] and comes across as a “fishing expedition” rather than a genuine request for access to information that would serve the public interest”.
The Act provides for a right of access to records held by FOI bodies, subject to the exemptions set out in the Act. Section 12 provides that a person who wishes to exercise the right of access must make a request for access to the record sought and the request must contain sufficient particulars in relation to the information concerned to enable the record to be identified by the taking of reasonable steps. The right of access applies to all records held by FOI bodies and is not limited to records whose release would serve the public interest. Moreover, section 13(4) provides that, subject to the Act, in deciding whether to grant or refuse an FOI request, any reason that the requester gives for the request and any belief or opinion of the FOI body as to the reasons for the request shall be disregarded. Thus, while certain provisions of the Act implicitly render the motive of the requester relevant, as a general rule, the actual or perceived reasons for a request must be disregarded in deciding whether to grant or refuse an access request under the FOI Act. Furthermore, I am satisfied that the request in this case was clear and unambiguous and the HPRA had no issue in identifying the records sought. Accordingly, I do not accept that the request was flawed.
Finally, I note that in its decision letter to the applicant, the HPRA’s stated position was that the additional information in the records was not confidential or commercially sensitive as the content of the records does not meet the necessary requirements of sections 35 and 36 of the FOI Act. However, in its submissions to this Office, the HPRA position is that information in the records relating to findings of deficiencies is commercially sensitive and confidential but that the public interest weighs in favour of release. The applicant in this case has had the opportunity to make submissions in respect of the public interest both to the HPRA and to this Office. I also note again that the onus on satisfying this Office that the decision to grant access to the record at issue was not justified lies with the applicant.
Accordingly, I am satisfied that the applicant has not been adversely affected by the differing stated positions of the HPRA. However, I would urge the HPRA to ensure that its decision letters accurately reflect its position in respect of any exemptions claimed. In any event, it is also relevant to note that a review by this Office is considered to be “de novo”, which means that in this case, it is based on the circumstances and the law as they pertain at the time of my decision and is not confined to the basis upon which the HPRA reached its decision.
The records in question
In its submissions, the HPRA said that it regulates the advertising of human medicinal products in Ireland. It said that its role it to ensure that advertisements in respect of medicinal products comply with the Medicinal Products (Control of Advertising) Regulations 2007, which set out relevant requirements. It said that compliance with the 2007 Regulations “ensures that advertisements for human medicinal products are accurate, not misleading and in line with approved product information”.
The HPRA said that it ensures compliance with the 2007 Regulations in a number of ways. It said that it carries out inspections at the offices of companies which advertise human medicinal products and investigates complaints received in relation to advertisements. Information in respect of the HPRA’s approach to advertising compliance is available on its website.
The record in question is an inspection report and cover letter relating to the third party applicant. The applicant’s position is that the record is exempt under sections 35 and 36 of the FOI Act.
Section 35 – information obtained in confidence
Section 35(1) of the Act provides as follows:
Subject to this section, a head shall refuse to grant an FOI request if –
a.) the record concerned contains information given to an FOI body, in confidence and on the understanding that it would be treated by it as confidential (including such information as aforesaid that a person was required by law, or could have been required by the body pursuant to law, to give to the body) and, in the opinion of the head, its disclosure would be likely to prejudice the giving to the body of further similar information from the same person or other persons and it is of importance to the body that such further similar information as aforesaid should continue to be given to the body, or
b) disclosure of the information concerned would constitute a breach of a duty of confidence provided for by a provision of an agreement or enactment (other than a provision specified in column (3) in Part 1 or 2 of Schedule 3 of an enactment specified in that Schedule) or otherwise by law.
(2) Subsection (1) shall not apply to a record which is prepared by a head or any other person (being a director, or member of the staff of, an FOI body or a service provider) in the course of the performance of his or her functions unless disclosure of the information concerned would constitute a breach of a duty of confidence that is provided for by an agreement or statute or otherwise by law and is owed to a person other than an FOI body or head or a director, or member of the staff of, an FOI body or of such a service provider.
As section 35(1) does not apply where the records fall within the terms of section 35(2), I deem it appropriate to consider the applicability of section 35(2) at the outset. The record at issue in this case was created by HPRA staff in the course of the performance of their functions. Accordingly, for section 35(1) to apply, release of the record must constitute a breach of a duty of confidence that is provided for by an agreement or statute or otherwise by law and is owed to a person other than an FOI body or head or a director, or member of the staff of, an FOI body or of such a service provider.
No argument has been made that the release of the record would constitute a breach of a duty of confidence that is provided for by an agreement or statute. However, a duty of confidence provided for “otherwise by law” is generally accepted to include a duty of confidence arising in equity.
In the Supreme Court decision in the case of Mahon v Post Publications Ltd [2007] 3 I.R. 338, Fennelly J confirmed that the requirements for a successful action based on a breach of an equitable duty of confidence, at least in a commercial setting, are found in the judgment of Megarry J in Coco v. A. N. Clark (Engineers) Ltd. [1969] R.P.C. 41, at 47:
“[T]hree elements are normally required if, apart from contract, a case of breach of confidence is to succeed. First, the information itself ... must 'have the necessary quality of confidence about it'. Secondly, that information must have been imparted in circumstances importing an obligation of confidence. Thirdly, there must be an unauthorised use of that information to the detriment of the party communicating it."
Fennelly J summarised or restated the requirements of what he called “the contours” of the equitable doctrine of confidence as follows:
1. “the information must in fact be confidential or secret: it must ... ‘have the necessary quality of confidence about it’;
2. it must have been communicated by the possessor of the information in circumstances which impose an obligation of confidence or trust on the person receiving it;
3. it must be wrongfully communicated by the person receiving it or by another person who is aware of the obligation of confidence.”
While the applicant made arguments in respect of the application of section 35, it made no reference to section 35(2) in its submissions. Nevertheless, it seems to me that much of its argument in support of its position that the entirety of the record at issue is exempt is also of relevance to the question of whether section 35(2) applies. Accordingly, I deem it appropriate to consider whether the release of the record would constitute a breach of an equitable duty of confidence owed to the applicant.
In its submissions to this Office, the applicant said that the record was prepared by the HPRA based on information provided during the course of the relevant inspection. It said that such information was provided “in confidence and on the understanding that it would be treated as confidential, and for the exclusive purposes of complying with the HPRA’s statutory powers of inspection”. It said that release of the information contained in the record would raise serious concerns about the protection afforded by the HPRA to confidential company information, making it less likely that other companies will engage proactively and collaboratively in the future. It said that this could undermine the HPRA’s effectiveness in exercising its statutory functions.
The applicant said that the HPRA never indicated that such information could become public and said that, “as a rule, such inspection reports are not made public by the HPRA”. It also drew attention to the HPRA Code of Conduct (available on the HPRA website) and to references therein to the confidential nature of information provided to it and its obligations “not to disclose any information obtained while performing, or as a result of performing, any activities on behalf of the HPRA”. The applicant said that release of the information could have serious adverse consequences on the voluntary collaboration between the HPRA and the companies it regulates.
In his submissions, the original requester said the information supplied in respect of such inspections and reports is not voluntary, but is part of a regulatory process. He said that relevant entities have a duty to cooperate with the HPRA inspectors and provide candid responses to their queries. He argued that such inspection reports do not involve a voluntary process of disclosure from, for example, members of the public or a concerned employee providing information in private. He suggested that some of the information is relatively old and so its value as commercially sensitive information is highly questionable.
The requester further noted that this Office has previously made a distinction between information communicated to an FOI body, on the one hand, and information that comprises the opinion or observation of the FOI body itself. He argued that where the information consists of opinions and observations formed by members of staff of the FOI body, the opinions and observations are not imparted to them by anyone. He argued that in the present case, the HPRA inspectors prepared their reports as part of their statutory duties and that there is nothing to suggest that disclosure would constitute a breach of a duty of confidence owed to the applicant.
On the matter of the applicant’s comments concerning the HPRA’s Code of Conduct, I note that it also says that “where, exceptionally, it is proposed to release confidential information in the public interest, the HPRA ensures that appropriate consultation with relevant third parties takes place prior to the release of any such information”. I note that in its letter of 19 October 2022, wherein it notified the applicant of the request, the HPRA said it was proposing redactions to the record in respect of information it considered to be confidential or commercially sensitive and it asked the applicant to identify any personal information or other confidential or commercially sensitive information. The applicant did not do so and instead argued that the entire record should be withheld. In its decision, the HPRA said it concluded that the additional information in the record did not meet the necessary requirements of sections 35 and 36 of the FOI Act. As I have outlined above, it subsequently informed this Office of its view that the information in the record relating to findings of deficiencies is commercially sensitive and confidential but that the public interest weighs in favour of release.
It seems to me that the HPRA has sought to protect any information it considered to be confidential apart from the information in the record relating to deficiencies found. The implication of this must be that the HPRA does not accept that the information it proposes to release, apart from the information relating to deficiencies, is confidential. I note, for example, that the HPRA sought to redact individual product names and information in respect of internal processes throughout the record to avoid the release of commercial information not directly related to a finding of a deficiency.
The relevant parts of the record at issue that fall within the scope of this review essentially comprise a brief high-level summary of the activities of the applicant, the scope of the HPRA’s inspection, the advertising activities inspected, the findings following inspection, points to note, and the HPRA’s conclusions and recommendations. The substantive part of the report comprises the HPRA’s findings. I do not accept that the information meets the necessary requirements for an equitable duty of confidence to exist. I do not accept that the findings of the HPRA can reasonably be described as information that was communicated by the applicant. In my view, the fact that information provided by the applicant may have formed the basis for those findings is not, in and of itself, sufficient to regard the details of the findings as information that was communicated by the applicant. Even if it was, I do not accept that the information can reasonably be considered to have been given in circumstances which impose an obligation of confidence on the HPRA. It is entirely appropriate, in my view, that the HPRA would not consider itself under an obligation of confidence in respect of details of its findings following a regulatory inspection in circumstances where it has sought to protect other confidential and commercially sensitive information provided by the inspected party.
In the circumstances, I find that the release of the relevant parts of the record would not constitute a breach of an equitable duty of confidence owed to the applicant. Accordingly, I find that, pursuant to section 35(2), section 35(1) does not apply to the record at issue.
Section 36 – commercially sensitive information
In submissions to this Office, the applicant argued that certain information in the record should be exempt from disclosure under section 36 of the FOI Act. It did not specify the relevant subsection but in light of the submissions made, I will consider section 36(1)(b) in the first instance.
Section 36(1)(b)
Section 36(1)(b) of the FOI Act provides that an FOI body shall refuse to grant a request if the disclosure of the record sought 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 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 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.
In its submissions, the applicant said that the record contains details in respect of its business on the market in Ireland, including information in respect of internal policies and processes which “offer highly sensitive insights into the commercial strategies of the company”. It said that disclosure would make the information available to competitors, “potentially distorting free and fair competition”. It said that if such exchanges of information were to occur directly between the applicant and a competitor “they would likely fall foul of national and EU competition rules”.
The applicant identified specific information contained in the record which is said should be considered exempt. This includes reference to meetings and events organised by third parties and financial support provided by the applicant as well as information relating to recipients of sponsorship, grants and donations. It said that disclosure of this information would offer highly sensitive insights into the applicant’s resources, budgets and considerations taken in respect of certain decisions. It referenced the “intense competition in the pharmaceutical industry” and said that the strategic nature of the information means that disclosure is capable of seriously undermining its competitive position.
The applicant also said that the rights and expectations of confidentiality held by the recipients of financial support does not appear to have been factored into the decision of the HPRA. It said that such third parties are likely to be more reluctant to collaborate with the applicant in future, damaging its legitimate interests and undermining its reputation and competitive position.
In its submissions, the HPRA said that in respect of information relating to findings of deficiencies identified, such information is “commercially sensitive and confidential however it was considered that the public interest in release of such information was such that the information should be released”. It said that individual product names or substances were redacted throughout the record to “avoid the release of commercial information not directly related to a finding of a deficiency”. It said that details of Standard Operating Procedures (SOPs), internal controls and staffing information were redacted as the HPRA regarded such information as commercially sensitive and considered that the public interest did not weigh in favour of release.
It said that in respect of deficiencies and findings, release of such information may cause a financial loss in that it may impact public confidence in the applicant and reduce market share and sales, share price, contractual negotiations, financing arrangements and other commercial activity. The HPRA said that it considered such information to be commercially sensitive. The HPRA references a number of recent decisions of this Office which it said support its approach in the current case.
In its submissions, the HPRA also acknowledged the submissions made by the applicant in respect of competition law. It said that such submissions “may have some validity and compliance with the law is a public interest that would override a more generalised public interest in release of commercial information, if such exists as a standalone interest without any other public interest elements attaching”.
The original requester also made submissions. He said that it is unclear as to what specific harm could reasonably be expected to occur should the record be released. He also noted that the record is several years old.
As I have outlined above, the relevant parts of the record at issue that fall within the scope of this review essentially comprise:
i. a brief high-level summary of the activities of the applicant, including advertising activities inspected,
ii. the scope of the HPRA’s inspection, and
iii. the HPRA’s findings, conclusions and recommendations following inspection.
In respect of category (i) above, the record contains information in respect of the activities of the applicant. Limited information is provided in an introductory section. The majority of this category of information is linked to the findings of the HPRA. I am not satisfied that release of the limited introductory information could give rise to the harms set out in section 36(1)(b).
The record contains information in respect of the activities of the applicant in the context of HPRA findings. Such information relates to financial activities, sponsorship, external event participation and engagement with third parties. The question at issue is whether the release of this information could reasonably give rise to the harms outlined in section 36(1)(b).
At the outset, I note that the information relates to matters arising in 2015, 2016 and 2017. This Office may have regard to the historic nature of the information contained in records in considering the effect of its disclosure and whether the harm test has been met. The information in question relates to the commercial activities of the applicant six to eight years ago. It does not relate to product pricing, but to certain marketing and sponsorship activities of the applicant.
I note that in its submission to the HPRA during the section 38 consultation process, the applicant itself stated that the “the information included in the Inspection Report is dated and is no longer relevant to serve any apparent public interest”. It said that the Irish Pharmaceutical Healthcare Association (IPHA) Code mandates that transfers of value between pharmaceutical companies and Irish healthcare professionals and organisations are published as part of the transfer of value process. The applicant said that information in the report relating to such interactions “would have been in the public domain in the past”. It made this submission in support of a position that the information should be exempt under a discretionary administrative ground (section 15(1)(d)). However, I believe these submissions are relevant to the question of harm under section 36(1)(b).
I note also the applicant’s arguments in respect of recipients of financial support, some of whom are referenced in the record. Having considered the level of detail provided in the record and the historical nature of the transactions in question, I am not satisfied that any of the harms claimed could reasonably be expected to flow from release of this information.
I note the applicant’s reference to EU and national competition law. However, limited submissions have been made in this respect. I have no specific arguments before me in respect of the implications of release in the context of such a legal regime. I note the passage of time since any competitive activities relating to the information occurred and I also note that certain information in the records relating to products and procedures has been withheld by the HPRA as confidential and commercially sensitive. As such, the applicant has not satisfied me that its reference to EU and national competition law serves to exempt any remaining information in the record.
Given the passage of time since the activities referred to in the record and noting the applicant’s submissions in respect of the previous publication of certain information, I am not satisfied that release of historical information relating to financial activities, sponsorship, external event participation and engagement with third parties could reasonably give rise to the harms outlined in section 36(1)(b).
In relation to category (ii), the applicant has not made any specific arguments as to why this category of information should be withheld. As noted above, information in respect of advertising compliance is available on the HPRA website. I am not satisfied that the disclosure of information relating to this process could reasonably give rise to the harms set out in section 36(1)(b).
In relation to category (iii), the HPRA said that it considered this category of information to be commercially sensitive. It said that in the case of deficiencies found, release of such information may cause a financial loss to a market authorisation holder (MAH) such as the applicant in that it may impact public confidence in the MAH and reduce market share and sales. It said indications of a lack of regulatory compliance may impact on share price, contractual negotiations, financing arrangements and other commercial activity. Given the low standard of proof required for the harm in the second part of section 36(1)(b) to apply, I find that the release of details of the findings of deficiencies identified during the inspection could prejudice the applicant’s competitive position. I find that section 36(1)(b) applies to the information relating to findings identified.
As I have found that section 36(1)(b) applies to certain information in the record, I must also consider whether sections 36(2) or section 36(3) serve to disapply section 36(1).
Section 36(2) and 36(3)
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”.
In its submissions, the applicant’s position is that the HPRA has not provided a clear rationale as to why it decided to part-grant access to the records. In this regard, it references the above need for a sufficiently specific, cogent and fact-based reason to tip the balance in favour of disclosure. It said that a general public interest in disclosure, “cannot by default outweigh [the applicant’s] legitimate expectations around the protection of its confidential and/or commercially sensitive information”. It references the “broad, non-descript” nature of the FOI request in support of this position. It also said that the HPRA did not consider that the information in the record concerns the applicant and third parties, rather than the HPRA itself. It said that the proposed partial disclosure is not capable of providing meaningful insight into the activities of the HPRA as an FOI body. It said the record contains “little information about the discharge of the HPRA’s duties or its use of public resources”.
The HPRA has also addressed the public interest question in its submissions. It said that “a significant 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 that it does not accept that the full report should be exempt and is of the view that the public interest lies in findings of a deficiency being made available to the public. It said that the public has a strong interest in knowing that advertising activities are undertaken within the standards prescribed by law. It said that it is important for public health reasons generally, and specifically for those who use the regulated products, that findings of deficiencies can be accessed. It said that, notwithstanding the potential application of exemption provisions, it considers that the public interest lies in the release of findings of deficiencies and the nature of the deficiencies in question.
In his submissions, the original requester said that there is an “obvious public interest” in details concerning non-compliance being released. He said that the public should be “given insight into certain practices in the marketing and promotion of drugs among healthcare professionals, especially when the regulator has been critical of such practices”.
In relation to the harm which could be caused by disclosure of information, 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. As noted above, information relating to the particular products and internal procedures has been redacted by the HPRA, as has information which it considers outside the scope of the request. What is at issue here is information relating to specific findings made by the HPRA. The HPRA has not sought to release the entirety of the record.
I consider that there is a significant public interest in knowing that entities involved in the advertising of human medicinal products operate within the standards prescribed by law, in this case the 2007 Regulations which the HPRA is required to enforce. In my view, there is a strong public interest in knowing how the HPRA carries out inspections in individual cases and that the regulatory functions assigned to the HPRA achieve the purpose of the relevant legislation. I do not accept the applicant’s argument that the record contains little information in respect of the discharge of the HPRA’s functions. Rather, I believe that the information in the record relates directly to the HPRA’s regulatory work and that undertaking inspections and making findings, particularly in respect of deficiencies, is fundamental to this work. I find that the public interest would, on balance, be better served by granting access to information in the records relating to the findings of the HPRA. I find, therefore, that section 36(3) serves to disapply section 36(1)(b).
Section 36(1)(c)
As noted above, the applicant’s submissions to this Office do not specify a particular subsection of section 36 of the FOI Act. However, in its submissions to the HPRA as part of the section 38 consultation process, it referenced section 36(1)(c) as applying to information in the records. I will consider the subsection accordingly.
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 any third parties whose identity may become public as a result of disclosure “are likely to be more reluctant to collaborate with [the applicant] in the future”.
I note the applicant’s position that information relating to interactions and monetary transfers between the applicant and healthcare professionals and organisations has been previously in the public domain through the IPHA transfer of value process. As such, I am not satisfied that the release of this information could prejudice contractual or other negotiations. Nor have substantive arguments been made in this regard.
Accordingly, I find that the applicant has not satisfied this Office that section 36(1)(c) applies to information in the record.
In conclusion, therefore, I find that the applicant has not satisfied this Office that the HPRA’s decision to grant partial access to the records 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 it was justified in its decision to grant access to specific information in the report which the applicant 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