Case number: OIC-132808-M2K5V9
10 May 2023
This review arises from a 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 that it was considering the release of an inspection report relevant to the applicant’s interests and that its preliminary view was that the public interest would, on balance, be better served by part-granting access to the record. 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 8 November 2022, the applicant made submissions to the HPRA. It argued that the entire record should be withheld.
On 24 November 2022, the HPRA informed the applicant of its decision to grant partial access to the record. It said that it concluded that the additional information in the record did not meet the necessary requirements of sections 35 and 36 of the FOI Act. On 30 November 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 record 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 during the review, the HPRA said it had redacted in error the number of deficiencies identified during the inspection as contained in the record. It said that 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 the review, the HPRA identified a small amount of additional information which it did not intend to release. This review is therefore concerned solely with whether the HPRA was justified in its decision to grant access to the remaining parts of the record concerned.
For the sake of clarity, the following information is outside the scope of this review:
I note that the named third party entity on page 9 is also referenced on page 6. I assume that the HPRA’s intention is to redact the name wherever it occurs in the record and as such, I will not consider that information further.
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 record at issue was not justified.
Secondly, I note that the applicant has asked that submissions made to this Office be treated as confidential. Section 22(10) of the FOI Act provides that the Commissioner shall give reasons for his decisions. Accordingly, I believe that I must make adequate reference to matters I have considered in reaching a decision, including submissions made by the parties. In doing so I am cognisant of the fact that 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. I do not believe that my description of the applicant’s submissions in this decision is in breach of that requirement, although it does mean that the extent to which I can describe the contents of the record at issue is limited.
Finally, I note that in its decision letter to the applicant, the HPRA’s stated position was that the additional information in the record did not meet the necessary requirements of sections 35 and 36 of the FOI Act. However, in its submissions to this Office, the HPRA said 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 has made submissions to this Office, in which it has addressed the public interest test in respect of both sections 35 and 36. I also note that the onus in such cases 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 expect the HPRA to ensure in future that its decision letters accurately reflect its position in respect of any exemption provisions relied upon.
The records in question
In its submissions, the HPRA said it regulates the advertising of human medicinal products in Ireland. It said its role is 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 compliance with the 2007 Regulations “ensures that advertisements for human medicinal products are accurate, not misleading and in line with approved product information”. It said it ensures compliance with the 2007 Regulations in a number of ways. It said it carries out inspections at the offices of companies that 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 applicant. The applicant’s position is that the entirety of the record is exempt under sections 35(1)(a) and 36(1)(b) and (c) of the FOI Act.
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.
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 had 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  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.  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:
While the applicant made arguments in respect of the applicability of section 35(1)(a), 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 under sections 35 and 36 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 the record contains information about the company’s marketing plans and budget breakdowns, interactions with healthcare providers and healthcare companies, brand planning, external funding and other promotional and non-promotional activities. It argued that the specifics of this information is not in the public domain. It argued that the detail in the record is extensive and is confidential and commercially sensitive.
The applicant said it ensured that its staff would engage in detail and with candour with the HPRA’s inspectors on the basis that the company and the HPRA were acting with the common goal of determining the level of compliance of the company’s activities with respect to the requirements of relevant Irish legislation pertaining to the marketing of medicinal products, and the expeditious rectification of any deficiencies that were identified. It said that in order to best achieve this, it provided a fulsome response to all queries, on the understanding that the information provided in the responses (which included commercially sensitive information) was given in confidence and on the understanding that that it would be treated as confidential by the HPRA.
The original requester argued that the inspection reports do not involve information obtained in confidence because they are part of a regulatory process where the companies are obliged to cooperate with the regulator and give candid responses to its queries. He argued that they 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.
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, which it considered to be confidential information or commercially sensitive information 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, it 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/or substances 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, and the HPRA’s conclusions and recommendations. The substantive part of the report comprises the HPRA’s findings. I do not accept that such 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, 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(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 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.
As I have referenced above, the applicant said the record contains information about the company’s marketing plans and budget breakdowns, interactions with healthcare providers and healthcare companies, brand planning, external funding and other promotional and non-promotional activities. It argued that if its current and potential competitors had access to the information in the record as a whole, they would be able to form a view as to the company’s strategy in certain areas. It said this information would provide competitors with significant information on the direction the company is headed in the future and could serve to undercut the company in the market going forward if disclosed, e.g. outlining how the company approaches its marketing strategy for certain brands.
The applicant further argued that the information could be used by competitors to target the company in relation to engagement with specific vendors and healthcare parties. It says that the information in the record includes the details and dates of conferences and events to which the applicant provided funding as well as the details of individual grants provided by the applicant, named organisations and the circumstances in which such grants were made available.
The applicant acknowledged that the information in the record dates from 2019. Nevertheless, it argued that the information is still relevant and may be used to extrapolate information for use by competitors. It referenced previous decisions of this Office where we found that, even where the information was several years old, there was an inherent competitive advantage in knowing the plans of competitors in a market where planning and regulatory frameworks can contribute to long lead in times for projects. It argued that disclosure of the record would compromise its ability to compete in the pharmaceutical industry in Ireland with other companies who are not subject to disclosure of the same information.
In its submissions, the HPRA said that information in the record relating to findings of deficiencies identified is commercially sensitive but that it considered that the information should be released in the public interest. It said 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 was redacted as the HPRA regarded such information as commercially sensitive and considered that the public interest did not weigh in favour of release. It also referenced a number of recent decisions of this Office which it said support its approach in the current case.
The HPRA added that during the consultation process, the applicant identified certain information relating to financial matters including sponsorship amounts and said that this information was already in the public domain. It said the applicant referenced the Irish Pharmaceutical Healthcare Association’s (IPHA) transfer of value process in this regard. It said the publication of such information is not within its regulatory remit but that “it appears that the financial information in the inspection reports that was not redacted and relating to sponsorship etc. was published by IPHA since 2016, is therefore in the public domain, and therefore would not be amenable to exemption under the FOI Act.”
The applicant argued that section 15(1)(d) applies to such information already in the public domain. I will consider the application of further exemptions below.
The original requester also made submissions in which he argued that the information in the record is “relatively old” and that its value as commercially sensitive information is “highly questionable”. He said he was unclear as to what specific harm could reasonably be expected to occur were the records to be released.
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 the 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 2017, 2018 and 2019. 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 four to six years ago. It does not relate to product pricing, but to specific marketing and sponsorship activities of the applicant. I also note the applicant’s submissions that information relating to payments it made to healthcare providers is “already in the public domain” through the above-referenced annual transfer of value disclosure process.
Given the passage of time since the activities referred to in the record occurred and noting the applicant’s submissions in respect of the previous publication of certain information, I am not satisfied that release of the particular information in the record 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 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 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) service 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”.
The applicant argued that the public interest is better served by refusing release of the record. It referenced the “chilling effect that disclosure would have on the dialogue generally required between regulators and regulated entities”. It said that “disclosure of such proprietary information would be, in some but not all cases, to the detriment of functional and effective regulation” which it described as “integral to the public interest”. It said it “appreciates that there is a specific public interest in ensuring regulated entities … act within the confines of the law”. However, it said the HPRA findings identified in the record have already been made public in an anonymised form during a presentation given by the HPRA. The applicant also sought to draw a distinction between the current case and a previous decision of this Office relating to the regulation of fertility clinics. It argued that the subject matters of the current record “arguably have less of an immediate impact on individuals”.
In it submissions, the HPRA said the presentation cited by the applicant included a listing of anonymised deficiencies and noted that the record in question and specific findings are not in the public domain. 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 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 the public has a strong interest in knowing that advertising activities are undertaken within the standards prescribed by law. It said it is important for public health reasons generally and specifically, and 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 argued that there is an “obvious public interest” in details concerning non-compliance being released. He said 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 the information, I have identified potential prejudice to the competitive position of the applicant and to its negotiations. 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. However, as noted above, information relating to the particular products and internal procedures has been redacted by the HPRA, as well as information which it considers outside the scope of the request. What is at issue here is information in 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 that the public interest has been sufficiently served by the prior publication of limited anonymised information relating to findings. I find that the public interest would, on balance, be better served by granting access to information in the record relating to the findings of the HPRA. I find, therefore, that section 36(3) serves to disapply section 36(1)(b) in this case.
Section 36(1)(c) – contractual negotiations
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, the applicant made limited arguments that section 36(1)(c) applies to certain information at issue. It said disclosure of the detail contained in the Record would not just benefit its competitors but would reduce its ability to secure value in negotiations with vendors. It said it is particularly concerned that the disclosure of its relationship with a particular vendor could affect the confidence of that vendor in the applicant’s capability to meet its contractual obligations. However, as I have outlined above when describing the scope of the review, the HPRA said it did not intend to release the name of the vendor in question so I do not need to give this argument any further consideration.
The applicant also argued that disclosing details of patient support groups and support provided to them could affect their confidence in engaging with the applicant. It provided limited submissions in this regard and has not identified specific contractual or other negotiations. Having considered the contents of the records, I note that only high-level references are made to patient support groups. I am not satisfied that disclosure of this information could prejudice the conduct or outcome of contractual or other negotiations
Accordingly, I find that the applicant has not satisfied this Office that section 36(1)(c) applies to any of the information in the record.
Other provisions cited
In its submissions to this Office, the applicant referenced a number of other provisions of the FOI Act which I propose dealing with briefly.
With reference to the applicability of section 15(1)(d), it said that “relevant sections of the findings from the regulatory inspection are already in the public domain”. Section 15 provides for the refusal to grant FOI requests on specified administrative grounds. Section 15(1)(d) provides for the discretionary refusal of a request where the information is already in the public domain. The HPRA said that the record in question and the specific findings of deficiencies are not in the public domain. In any event, it seems to me that it would not be appropriate for me to direct the HPRA to redact occasional sentences or pieces of text from the record on the ground that the applicant can identify such information as being in the public domain. It seems to me that it would not be readily apparent to the reader of the record that such information is publicly available. Moreover, I note that section 15(1)(d) is not mandatory and provides that an FOI body “may” refuse to grant the request in certain circumstances.
The applicant also argued that the release of a redacted copy of the record is not appropriate where the redactions would “render the released material of negligible value”. It referenced section 18 of the FOI Act in this regard. It also said that the entirety of the record, “other than salutations”, should be redacted. I have considered the applicant’s arguments in respect of confidentiality and commercial sensitivity above. Section 18(1) provides, that "if it is practicable to do so", access to an otherwise exempt record shall be granted by preparing a copy, in such form as the head of the FOI body concerned considers appropriate, of the record with the exempt information removed. Section 18(1) does not apply, however, if the copy provided for thereby would be misleading (section 18(2) refers). I am satisfied that the copy of the record for release that is in line with my findings in this case would not be misleading.
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.