Mr A and Health Products Regulatory Authority [2024] IEIC 132892 (25 April 2024)

1. Background
2. Scope of Review
3. Preliminary Matters
4. Analysis and Findings

5. Submissions
6. Analysis
7. Decision
8. Right of Appeal

Whether the HPRA was justified in refusing access to certain inspection reports on the basis of sections 35(1), 36(1)(b) and 37(1) of the FOI Act

25 April 2024

Background

On 18 August 2022, the applicant submitted a four-part request to the HPRA for information and records relating to inspections carried out in connection with the Medicinal Products (Control of Advertising) Regulations 2007. Following correspondence between the parties, the applicant refined his request. On 14 October 2022, the HPRA wrote to the applicant confirming that the request had been refined to extracts from nine specified inspection reports "relating to nonconformities/breaches re Medicinal Products (Control of Advertising) Regulations 2007 between 2016 and 2021".

The HPRA notified the nine relevant third parties of the request pursuant to section 38 of the Act, wherein it outlined its preliminary view that, on balance, the public interest would be better served by releasing the records in part. 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 36, 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 HPRA provided the third parties with copies of the relevant records with its proposed redactions highlighted. Following those consultations, the HPRA decided to grant partial access to all nine reports. It provided the applicant with copies of five redacted inspection reports. The applicant sought a review by this Office of the HPRA's decision to redact information from those five reports. That application was accepted and assigned the reference number OIC-132892.

While the HPRA had also decided to grant partial access to the remaining four reports, it did not provide the applicant with redacted copies of those reports as the relevant third parties had sought a review by this Office of the HPRA's decision to release them in part. The applicant sought a review of the HPRA's decision to part-grant access to the records. That application was accepted and assigned the reference number OIC-136425. Given the overlapping issues arising, this is a composite decision covering both reviews.

During the course of the review, the nine relevant third parties were provided with an opportunity to make submissions. To date, substantive submissions have been received from three parties. A number of other third parties communicated with this Office on foot of receipt of the above notifications but no substantive submissions have been received. In addition, four third parties were notified of material matters at a later stage of the review and three provided submissions in response.

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 by the relevant parties. 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.

Scope of Review

The HPRA decided to grant partial access to the nine records at issue, redacting certain information under sections 35(1)(a), 36(1)(b) and 37(1) of the FOI Act. Redacted copies of records 1, 2, 5, 7 and 9 were released to the applicant. A redacted copy of record 6 was released after an application for review made to this Office by a relevant third party was withdrawn. Records 3, 4 and 8 were also the subject of reviews by this Office. The scope of those reviews was limited to considering whether the HPRA was justified in its decision to grant access to certain information in the records. This review concerns the decision of the HPRA to redact certain information from the records. In referring to the records at issue, I have adopted the record numbering system used by the HPRA in the schedule of records, updated on 8 March 2023, that it provided to this office during the review. The applicant also referenced this schedule in communications with this Office so I understand that he has sight of same.

The HPRA also identified and redacted from each of the records information which it deemed to fall outside the scope of the applicant's request. In its submissions, it noted the applicant's reference to the Medicinal Products (Control of Advertising) Regulations 2007 (the 2007 Regulations). It said that information contained in the inspection reports that was not related to advertising compliance, and information relating to matters such as changes to business organisation, was deemed to fall outside the scope of the request.

The applicant confirmed that the scope of his request and this review is limited to information in the relevant records pertaining to the 2007 Regulations. I have reviewed the information that the HPRA considers to fall outside the scope of the request (highlighted in red in the copies of the records provided to this Office for the purpose of the review). I am satisfied that the majority of information identified falls outside the scope of the request and I will give no further consideration to that information. However, in his submissions to this Office, the applicant referenced the redaction of certain information he assumed to refer to deficiencies identified in the relevant parts of certain reports. The HPRA's position is that the information in question is outside the scope of the request. The applicant appears to be of the opinion that the HPRA has redacted substantive findings. While I am limited in the extent to which I can describe the contents of the records, it appears that the HPRA redacted certain information from seven of the reports on the basis that it did not comprise information relating to non-conformities/breaches, notwithstanding the fact that it released similar such information in the two other reports. This is, in my view, an unduly narrow interpretation of the request. I am satisfied that the information in question, in records 1-4 and 7-9, is captured by the scope of the request.

In its submissions to this Office, the HPRA identified certain information in a number of the records which concerns the number of deficiencies found during the relevant inspections. It said that this information was redacted in error and should be released. As the HPRA no longer intends to redact such information, I will not consider it further as part of this review.

The applicant also confirmed that he is not seeking information contained in the records which relates to identifiable third party individuals. He stated that he is happy for such information to be excluded from the scope of the review.

Finally, as noted above, four of the third parties sought reviews by this Office. During the course of those reviews, the HPRA informed this Office that it had decided to withhold further limited information from records 3, 6 and 8. In respect of record 3, it decided to redact certain information relating to an identifiable third party in section 1.d.ii, page 6. In respect of record 6, it decided to redact the final letter in a product name which it had erroneously omitted from its redactions. In respect of record 8, it decided to redact the name of a third party entity in sections a.ii, page 6 and i, page 9 and a particular product name in section b.ii, page 7. In further submissions it said it had decided to redact certain financial percentages and figures on pages 6 and 7, information in respect of sponsorship recipients in section d.iii, page 9 and reference to a particular meeting in section h, page 9. I am satisfied that the additional information withheld from record 3 is outside the scope of this review as it relates to an identifiable individual. I will consider whether the HPRA was justified in deciding to withhold the remaining additional information from records 6 and 8 as outlined above as part of this review.

Accordingly, this review is concerned solely with whether the HPRA was justified in refusing access, under sections 35(1)(a), 36(1)(b) and 37(1) of the FOI Act, to the remaining parts of the nine records apart from the information identified above that I have excluded from the review.

Preliminary Matters

Before I address the substantive issues arising, I wish to make a number of preliminary comments. Firstly, section 22(12)(b) of the FOI Act provides that a decision to refuse to grant a request shall be presumed not to have been justified unless the head of the relevant FOI body shows to the Commissioner's satisfaction that its decision was justified. This means that the onus is on the HPRA of satisfying this Office that its decision to redact certain information from the records sought was justified.

Secondly, 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 at issue is limited.

Analysis and Findings

The records in question

In its submissions, the HPRA explained that it regulates the advertising of human medicinal products in Ireland and that its role is to ensure that advertisements for medical products are in compliance with the 2007 Regulations. It said that the 2007 Regulations set out the requirements for medicinal product advertising in Ireland and compliance ensures that advertisements are accurate, not misleading and in line with approved product information.

The HPRA said it ensures compliance with the 2007 Regulations in a number of ways. It said it performs pre-planned and random compliance reviews of advertisements and also carries out inspections at the offices of Marketing Authorisation Holder companies which advertise human medicinal products in Ireland. Information in respect of the HPRA's approach to advertising compliance is available on its website.

In its submissions, the HPRA said that its inspection process may be summarised as follows:

1. Inspection organised

2. Inspection carried out

3. Deficiencies against requirements of regulations identified

4. Report written by inspectors and sent to inspected party

5. Responses (corrective action) and timeframes submitted to HPRA and reviewed by inspectors

6. Further responses may be required or a further inspection may be required, based on the responses received

7. Close out of inspection

The records in question comprise cover letters and inspection reports relating to nine separate companies. The inspections took place between 2016 and 2020. Each of the records outlines the legislation used by the HPRA as the basis for the inspection. In each record, a variety of legislation is listed, including the 2007 Regulations. As noted above, I am satisfied that given the specificity of the applicant's request, information in the records relating to other legislative regimes and/or not related to deficiencies identified in respect of the 2007 Regulations is outside the scope of this review. The HPRA released information in the records relating to findings of deficiencies on the basis that, while commercially sensitive and confidential, the public interest weighed in favour of release.

The remaining information withheld from the records and at issue in this review includes the detail of particular Standard Operating Procedures and internal controls, the number of staff working in particular areas, specific product names, certain external engagements, financial information and personal information relating to staff of third party companies. The HPRA's position is that such information is exempt from disclosure.

I propose commencing my analysis with a consideration of the application of section 36 of the FOI Act.

Section 36(1)(b) - commercially sensitive information

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.

Submissions

In its submissions, the HPRA said that while it has released information relating to deficiencies identified, it withheld information such as details of particular standard operating procedures and internal controls, staff numbers working in a given area and specific product names. It said it regards such information as commercially sensitive and that it "considered that private interests in not releasing such information over-rode any public interest in release". It said the companies in question are commercial entities that are in competition with one another in respect of market share and sales as well as interaction and advertisement with the public and healthcare professionals. It said that "a number of branded products may be on the market that are quite similar to each other -� and are in direct competition with each other" or that "certain products may have multiple indications and -� may be prescribed for the same (or similar) medical condition". It said that there may be originator and generic medicines on the market that will be in direct competition in respect of branding, marketing and cost.

The HPRA said that it redacted product names and "other information that may give an indication of market share, market strategy or marketing activities". It said that release of this information would allow competitors to tailor their competitive strategies in response and to the detriment of the owner of the relevant data. It said that if product names were not redacted, the vast majority of the surrounding text would fall to be redacted as commercially sensitive.

It said that where third parties consulted identified further information as being commercially sensitive, such submissions were accepted "where they appeared reasonable and in line with the FOI exemptions". It said that, in some cases, "the HPRA will not be fully aware of what information may cause commercial harm on release".

In his submissions to this Office, the applicant referenced the decision-making records and said that the HPRA made "no attempt to explain the link between the exemption and the records in question and provide reasons for the basis of the application of this exemption". He also referenced the age of the information in question. Two of the relevant inspection took place in 2016, three took place in 2017, three took place in 2019 and one took place in 2020. He referenced previous decisions of this Office which have held that the release of certain historic information could not be expected to give rise to the relevant harms. The applicant also made some specific observations in respect of apparent redactions, particularly the redaction of drug names and information in respect of meetings with healthcare professionals. He said he does not understand the rationale for the redactions and how such information could be considered confidential, commercially sensitive or personal.

As noted above, this Office notified the nine third parties of this review and invited submissions. Three parties responded substantively.

One of the third party companies said that it supported the decision of the HPRA to redact information from the relevant record. It said the redaction of certain information was justified and not overridden by the public interest. It said that in submissions it made to the HPRA, it proposed redactions under sections 35 and 36 of the FOI Act, in particular section 36(1)(b). It said the rationale for the proposed redactions included "protecting the identity of a 3rd party, commercial confidentiality or seeking to avoid prejudice to [the third party's] competitive position by eroding healthcare practitioners' and/or members of the public's trust in [the third party] based on historical resolved situations".

One of the third parties drew my attention to submissions it made in a separate review by this Office. That review concerned the HPRA's decision to release information contained in the relevant record on the basis that it was commercially sensitive or confidential but the public interest weighed in favour of release. In its submissions, it said that additional information included in the inspection report should be exempt from disclosure under sections 35 and 36 of the FOI Act. While not explicitly stated in the submissions, it is clear that its position extends to the information the HPRA proposed to withhold in this case.

Another third party company contacted the Office and drew my attention to the submissions it had made to the HPRA during the consultation process. In this submission, the third party suggested additional redactions that it said should be made on the grounds that the information comprises personal information and is not relevant to the request made. For the avoidance of doubt, the question of whether additional information should have been redacted in the records part-granted to the requester is outside the scope of this review.

During the course of the review, four third parties were notified of particular relevant matters and provided with an additional opportunity to make further submissions. Three responded. I have considered their submissions in full but will refer to their content only as relevant below.

Analysis

Having carefully considered the records in question, it seems to me that the HPRA has sought to redact commercial, scientific or technical information relating to the third parties in question. The HPRA has distinguished between information relating to deficiencies and regulatory findings and information relating to the commercial operations of specific third parties. The latter has been redacted, while the former, where it relates to the 2007 Regulations, has been released.

Given the relatively low bar associated with section 36(1)(b), I accept that the release of information relating to specific commercial products, internal processes and procedures and certain external engagements and service providers in the context of HPRA findings could prejudice the competitive position of the relevant third parties. I believe it is reasonable to expect that certain information could give competitors an insight into strategies or internal processes. I accept that the relevant companies operate in a competitive market and that release of the relevant information in the context of the associated HPRA findings could prejudice their competitive position. Given the nature of the pharmaceutical market and the length of time that medicines are on the market, I am not satisfied that the reports are sufficiently historical to negate the potential harms associated with the disclosure of certain information in the records. Much of the withheld information relates to deficiencies identified by the HPRA. I consider it reasonable to expect that the release of information in respect of deficiencies could negatively impact the public's perception of the relevant third parties.

The HPRA also withheld certain financial information from record 1. Information which appears to be of a similar type has been released in respect of other records. This Office queried same and the HPRA said it accepted submissions in respect of the information made by the relevant third party during the section 38 consultation process. As noted above, the HPRA said it accepted such submissions "where they appeared reasonable and in line with the FOI exemptions". Having considered the information in question, this Office sought submissions from the relevant third party in support of its position that the information in question should be exempt. In submissions received, the third party agreed to the release of the monetary amount which was transferred to a named organisation as part of a sponsorship. It said that the name of the organisation should not be released. Its position is that release could prejudice the competitive position of that organisation in the conduct of its profession or business. It said that the FOI request should centre on the findings of the HPRA in relation to the third party's adherence to regulations. It said that allowing the named organisation to be linked with the findings could prejudice them in the conduct of their affairs including attracting other sponsorship arrangements.

The financial information in question in record 1 relates to sponsorship money provided to a named organisation in 2015. As noted in the HPRA's submissions, 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 Transfers of Value process. In its submissions, the third party acknowledged that the name of the healthcare organisation and the amount of sponsorship was publically disclosed in 2016. It said that such disclosures are no longer searchable online. I have carefully considered the information and taken into account the level of detail provided, the historical nature of the information, the fact that similar information has been released in respect of other reports, and the information provided in respect of the Transfers of Value Process. I do not accept that the fact that the specific payment details may no longer be publicly available means that the disclosure of the information at this stage might give rise to the harms identified in section 36(1)(b). Indeed, such sponsorship payments are now published as a matter of course. I find that section 36(1)(b) does not serve to exempt the limited financial information in section III (1)(b) of record 1.

In addition, I am not satisfied that section 36(1)(b) serves to exempt the information in records 1-4 and 7-9 that the HPRA sought exclude on the ground that it fell outside the scope of the request and that I have found to be captured by the request. While I am constrained by section 25(3) from describing the information here, I am satisfied that its release could not possibly give rise to the harms outlined in section 36(1)(b).

I find that section 36(1)(b) applies to the remaining information withheld from the records. In light of this finding, it is necessary to consider the applicability of sections 36(2) and section 36(3) of the FOI Act.

Sections 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 its submissions, the HPRA said it believes that the release of information relating to deficiencies is in the public interest. However, it said that "in terms of purely commercial data deriving from the companies in question, a competing public interest for the HPRA is to ensure that companies are confident that key commercial data relating to their medicines can be protected and consequently they will continue to put products on the Irish market". It said that Ireland, because of its market size, "struggles to have sufficient medicines on the market". The HPRA referenced a number of decisions of this Office which it said support its decision-making in the current case.

The applicant also made submissions in respect of the public interest test. He said that the reports relate to non-compliance with the regulatory framework for the advertising and marketing of prescription drugs to healthcare professionals. He said there is an "obvious public interest" in details concerning such non-compliance being released. With reference to the part-granted records, he said there is a "robust public interest in learning that a specific drug was promoted in such a way that it was found to be majorly deficient by the regulator". He said that the public should be given insight into certain practices "in the marketing and promotion of drugs", particularly in circumstances where the regulator has been critical of such practices. He said there is a "strong public interest in disclosing the names of those campaigns and meetings in circumstances where the inspectors found them deficient in the rules and regulations". He also submitted that specific information in respect of funding and sponsorships should be released.

In considering where the balance of the public interest lies in this case, I have had regard to section 11(3) of the Act which provides that in performing any functions under the Act, an FOI body must have regard to, among other things, the need to achieve greater openness in the activities of FOI bodies and to promote adherence by them to the principles of transparency in government and public affairs and the need to strengthen the accountability and improve the quality of decision making of FOI bodies. However, in doing so, I have also had regard to the judgment of the Supreme Court in the eNet case referenced above. In that case, the Supreme Court found that a general principle of openness does not suffice to direct release of records in the public interest and "there must be a sufficiently specific, cogent and fact-based reason to tip the balance in favour of disclosure". It further observed that section 36(1) "recognises that 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".

Section 36(1) is an express recognition of the fact that there is a public interest in the protection of commercially sensitive information. 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. The third parties in question are private enterprises, but they are also engaged in regulated activities. The HPRA has released information in the records relating to the third parties' compliance with the 2007 Regulations and the inspection process in respect of same, including details of deficiencies found. What is at issue here is information relating to particular products, procedures and activities of the third parties.

It seems to me that Directive 2001/83/EC, to which the 2007 Regulations give effect, and the Regulations have at their heart the protection of public health. For example, Recital 2 of the Directive provides that "the essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health", while Recital 45 provides that "Advertising to the general public, even of non-prescription medicinal products, could affect public health, were it to be excessive and ill-considered. Advertising of medicinal products to the general public, where it is permitted, ought therefore to satisfy certain essential criteria which ought to be defined".

It seems to me that there is a significant public interest in:

the public 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, and
the public knowing how public bodies carry out inspections in individual cases and that the regulatory functions assigned to them achieve the purpose of the relevant regulations.

I have carefully considered the content of the records and the submissions made by the parties. I accept the applicant's argument that there is a public interest in the public having an insight into certain practices in the marketing and promotion of drugs, particularly in circumstances where the regulator has been critical of such practices. However, in my view, that public interest has been served to a large extent by the decision of the HPRA to disclose details of the deficiencies identified during the relevant inspections and the steps it required the relevant companies to take to address those deficiencies. It is important to note that the deficiencies identified relate to the advertising of the products as opposed to the products themselves. Having considered the specific contents of the records and the nature of the inspections undertaken, it seems to me that the public interest is sufficiently served by the release of information about the advertising activities of the relevant companies. I do not accept that the public interest weighs in favour of the disclosure of product names in circumstances where it is the advertising activities which form the subject of the records. While I accept that the disclosure of the identities of the specific drugs might provide even greater insight, it is important to recall 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 third parties referenced in this case are private enterprises. It seems to me that the HPRA has sought to strike a balance between enhancing its transparency and accountability in terms of how it performs its functions while seeking to protect the commercial interests of the relevant third parties from undue harm.

Having regard to the findings of the Supreme Court in the eNet judgment referenced above, I find that the public interest would not, on balance, be better served by the release of the information to which I have found section 36(1)(b) to apply. I find, therefore, that section 36(3) does not apply.

As I am satisfied that section 36(1)(b) applies to the majority of the information redacted by the HPRA, I must consider the application of section 35(1) only to the limited financial information in record 1 and the information in the records that was originally redacted as outside scope and which I have found to fall within scope.

Section 35(1) - 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.

The records at issue in this case were created by HPRA staff in the course of the performance of their functions. 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. Accordingly, for section 35(1) to apply, release of the information in question 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 IR 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 HPRA has sought to rely on section 35 in respect of the withheld information, it made no reference to section 35(2) in its submissions. Nevertheless, I have considered its arguments in support of its position that the information is exempt as relevant to the question of whether section 35(2) applies. Accordingly, I deem it appropriate to consider whether the release of the information at issue would constitute a breach of an equitable duty of confidence owed to the relevant third party.

The HPRA said that following its consultation with the third party, it agreed to redact the financial information on the basis that the third party regarded the information to be confidential. It referred to submissions received by the third party and its position that the information related to sponsorship activity from 2015 and that such information is no longer publically available on the Transfers of Value website as data is only retained on the site for three years. It said that it considered that the information was no longer in the public domain and therefore confidential. The HPRA revised its position somewhat in later submissions and said that it would be sufficient to withhold the monetary amount but release detail relating to the activity and recipient. The third party also made submissions to this Office, referenced above.

In his submissions, the applicant 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.

This Office has previously drawn a distinction between information given or imparted to an FOI body and information which comprises the opinion or observation of the FOI body or its staff. The Commissioner takes the view that in so far as information consists of opinions and observations formed by members of staff of an FOI body, the opinions and observations concerned are not 'imparted' to them by anyone. However, I accept that the disclosure of findings may, in certain cases, also involve the disclosure of information provided by a relevant party. It can occasionally be difficult to separate observations formed by staff members from information provided. The former may be predicated on the latter. That said, even if information provided by a third party is contained within an opinion or observation, an equitable duty of confidence would still need to be established.

I have carefully considered the limited information at issue, which relates to financial sponsorship provided to a named organisation in 2015 and findings made by the HPRA in respect of same. I note that similar information has been released in respect of other records within the scope of this review. I am not satisfied that the "contours" of the equitable duty of confidence have been met. While I note the HPRA and third party submissions in respect of the fact that such information is no longer accessible on the Transfers of Value website, it seems to me that information of this kind is routinely published by pharmaceutical companies. In fact, the third party acknowledged that the name of the sponsorship recipient and the amount was publically disclosed in 2016. I do not accept that the information has the necessary quality of confidence about it. Nor do I accept that it was communicated in circumstances which impose an obligation of confidence or trust on the HPRA. No evidence was offered to suggest that any assurance of confidentiality was sought or given. The applicant in this case is engaged in regulated activities; the HPRA is the relevant regulatory body. In the circumstances, I find that the release of limited information in record 1 would not constitute a breach of an equitable duty of confidence owed to the third party. I find, therefore, that section 35(1) cannot apply to that information

On the matter of the information in the records that was originally redacted as outside scope and which I have found to fall within scope, that information can, in my view, reasonably be described as recording the observations of HPRA staff and is not information that was given to the HPRA by the companies concerned. I find, therefore, that section 35(1) cannot apply.

Section 37(1) - personal information

Section 37(1) of the Act provides that, subject to the other provisions of the section, an FOI body shall refuse a request if access to the record concerned would involve the disclosure of personal information. Section 2 of the Act defines "personal information" as information about an identifiable individual that, either - (a) would, in the ordinary course of events, be known only to the individual or members of the family, or friends, of the individual, or (b) is held by an FOI body on the understanding that it would be treated by that body as confidential. Section 2 of Act details fourteen specific categories of information that is personal without prejudice to the generality of the foregoing definition. These categories include (iii) information relating to the employment or employment history of the individual.

In its submissions, the HPRA identified the information which it withheld on the basis of section 37(1). It said that it redacted any information relating to a natural person who is identified or identifiable. It referred specifically to names and certain functions or positions where such information could identify an individual. It said that "the names of individuals employed at entities regulated by the HPRA and their position in the organisation is information which may not be in the public domain and therefore in the course of ordinary events would not be known to the general public". It says that such information would also be covered by section (iii) of the definition as it relates to the employment of the individual.

In his submissions to this Office, the applicant said that he assumes section 37(1) has been "applied to instances where individual staff members are named". He said he has no difficulty with this, "as long as this is the extent to which it has been used".

In addition to the instances outlined above, in records 5, 6 and 8, the HPRA has redacted information relating to external meetings held including the location, date and/or the number of relevant healthcare professionals in attendance. The applicant specifically queried this aspect of the decision, saying that he is "at a loss to understand how any of the -� information could be considered confidential, commercially sensitive or personal". My Office queried this approach with the HPRA. In response, the HPRA said that it accepted specific submissions received by relevant third parties during the section 38 consultation process. The HPRA said that "it agreed to redact this information on the basis that the information may serve to identify third parties and should be exempt under s. 37".

Having considered the submissions received and the information at issue, this Office sought submissions from the relevant third parties in support of their position that the information in question should be exempt. Two third parties provided submissions in response. One said that due to the "small size and population of the location", the individuals attending a referenced meeting could be identified if such information was released. It proposed a "compromise" position whereby the number of attendees and the location would remain withheld but the nature of the attendees (ie. their employment post) would be disclosed. The second third party made submissions in respect of the application of section 37 but specifically referenced instances in which individuals were identified in the relevant record. It did not address the information relating to a meeting.

I have considered the submissions made and the contents of the records at issue. I would note that similar information has been released in respect of other records within the scope of this review. Having considered the level of detail provided and its historical nature, I do accept that the release of the information could reasonably be expected to result in the disclosure of personal information. I am not satisfied that section 37(1) serves to exempt information relating to meetings/events contained in the following records and sections.

Record 5, sections 1.a-g, 1.i and 1.k
Record 6, section 1.j
Record 8, section 1.h

In respect of the remaining records and information, I am satisfied that the HPRA has withheld the names and certain positions of staff members of third parties as well as information relating to certain individuals who engaged with the third parties. I note that the HPRA has not withheld the names of HPRA staff included in the records. I find that this information is exempt from release on the basis of section 37(1) of the FOI Act. Accordingly, I must go on to consider sections 37(2) and 37(5). However, I note that the applicant has stated that he has no difficulty with the HPRA's position in respect of such information. As such, I do not intend to consider subsections (2) and (5) in detail.

In short, and for the avoidance of doubt, I am satisfied that none of the circumstances outlined in section 37(2) arise in this case. Furthermore, I am not aware of any public interest in granting access to the relevant information which outweighs the right to privacy of the individuals to whom the information relates. Accordingly, I find that section 37(5)(a) does not apply and that the HPRA was justified in redacting, under section 37(1) of the FOI Act, the information to which I have found section 37(1) to apply.

Decision

Having carried out a review under section 22(2) of the FOI Act, I hereby vary the decision of the HPRA. I find that it was justified in refusing access to the majority of the withheld information on the basis of sections 36(1)(b) and 37(1) of the FOI Act.

I find that it was not justified in withholding the following information on the basis of sections 36(1)(b), 35(1) and 37(1) of the FOI Act and I direct its release:

The information in records 1-4 and 7-9, that the HPRA redacted on the ground that it fell outside the scope of the request but which I have found to come within scope, namely the information redacted from Part I of records 1, 2, 3, 7, 8 and 9 under the heading "Summary of Deficiencies" or "Inspectors' Findings and Observations" and the information redacted from Parts I and II of record 4 under the heading "Summary of Deficiencies"
The information relating to financial sponsorship in record 1, section III 1.b
The information relating to meetings/events in record 5, sections 1.a-g, 1.i and 1.k, record 6, section 1.j and record 8, section 1.h

Right of Appeal

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 by the applicant not later than eight weeks after notice of the decision was given, and by any other party not later than four weeks after notice of the decision was given.

Stephen Rafferty, Senior Investigator

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	Irish Information Commissioner's Decisions
You are here: BAILII >> Databases >> Irish Information Commissioner's Decisions >> Mr A and Health Products Regulatory Authority [2024] IEIC 132892 (25 April 2024) URL: http://www.bailii.org/ie/cases/IEIC/2024/132892.html Cite as: [2024] IEIC 132892

Irish Information Commissioner's Decisions

Mr A and Health Products Regulatory Authority