Cinneadh
Mr S and Health Products Regulatory Authority
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-133040-G6H1G9
Foilsithe
Teanga: Níl leagan Gaeilge den mhír seo ar fáil.
Ó Oifig an Choimisinéara Faisnéise
Cásuimhir: OIC-133040-G6H1G9
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
16 May 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 27 October 2022, the applicant made submissions to the HPRA. In its submissions, it identified further information in the records that it argued to be exempt under section 35.
On 24 November 2022, the HPRA informed the applicant of its decision to part-grant access to the records. It explained that it had decided to make some further redactions to the record in line with the submissions received from the applicant. It said that while the remaining information may comprise confidential and/or commercially sensitive information, the HPRA considered that the public interest favoured its release. 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 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.
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 initially highlighted for redaction.
Before I address the substantive issues arising, I wish to make a number of preliminary comments. 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.
In addition, although I am obliged to give reasons for my decision, section 25(3) of the FOI Act requires me to take all reasonable precautions in the course of a review to prevent disclosure of information contained in an exempt record. This means that the extent to which I can describe the contents of the record is limited.
The records in question
As noted above, I am limited in the description of the records that I can provide. However, I believe it would be useful to provide some high-level detail in respect of the records and the functions of the HPRA.
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 applicant. The applicant’s position is that the entire record in question is exempt under sections 35, 36 and 37 of the FOI Act. I would again note that the HPRA has proposed the redaction of a significant amount of information from the record on the basis that it is exempt or falls outside the scope of the original request. As such, limited information remains in scope for the purposes of this review.
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 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 [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 referenced section 35 and the confidentiality of information in its application to this Office, it made no substantive submissions in respect of the applicability of section 35. As noted above, in cases concerning section 38 of the FOI Act, 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. Nevertheless, I have considered whether the release of the record would constitute a breach of an equitable duty of confidence owed to the applicant. I have considered the arguments advanced by the applicant in its application to this Office. Such arguments centre on the impact of the partial release of information. The applicant’s position is that disclosure of the record is likely to give a “misleading and inaccurate” account of relevant events. I will consider further arguments made by the applicant in my analysis of section 36 of the FOI Act. I am not satisfied that the applicant has made any submissions or arguments of relevance to the question of whether section 35(2) applies.
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, in response, identified further information in the record which it said was “confidential in line with section 35”. In its decision, the HPRA said that it had “applied some further redactions in line with your submission”. It said that it concluded that the remaining information, relating to findings of deficiencies, may comprise confidential and/or commercially sensitive information, but that it considered that the public interest favoured its 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. I note, for example that the HPRA sought to redact individual product names and information about internal procedures 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, and the findings following inspection. 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 my view that it is entirely appropriate 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 its application to this Office, the applicant said that the record in question is exempt under section 36 because of the commercial sensitivity of its contents. While it did not specify the subsection which it considers to apply, it argued that the release of the record would damage its business and reputation and could damage its commercial interests and those of its affiliates worldwide. It said the information would be of interest to its competitors and that disclosure of the record may cause harm to its ability to successfully compete for public sector contracts due to misinterpretation of the disclosure. Accordingly, I have considered whether sections 36(1)(b) and/or 36(1)(c) apply in this case.
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 considerably lower than the "could reasonably be expected" test in the first part of this exemption. However, this Office takes the view that, in invoking "prejudice", the damage that could occur must be specified with a reasonable degree of clarity.
The applicant argued that releasing limited information from the report “otherwise heavily redacted as non-relevant to the FOI request, presents a narrative that is misleading, out of context and damaging to [its] business and reputation which in turn impacts potentially the health and welfare of patients relying on [its] medicines”. It argued that part-granting the record suggests deficiencies in its advertising which it believes will, in the public eye, attach to all of its products, presenting an “unbalanced and unfair picture” of how it conducts its business. It argued that it is disproportionate to release the information given the damage it could cause to its commercial interests and to the interests of patients relying on its medicines.
The applicant further argued that disclosure of the record would be very likely to prejudice the commercial interests of the applicant and its affiliates worldwide. It argued that sharing partial sentences and disjointed paragraphs could lead to misinterpretation and result in ill-informed commentary that could damage patient confidence in its portfolio. It argued that the disclosure of findings risks “tainting” its entire product range without clarifying the context. It said that despite the lapse of time, the information in question remains commercially sensitive and would be of interest to competitors. The applicant also argued that disclosure of the record could affect patient adherence to prescribed medication, potentially impacting patient safety. Moreover, it made submissions in respect of a particular finding made by the HPRA in respect of a particular advertisement and argued that its release could taint its entire product range.
In its submissions, the HPRA said that in respect of information relating to findings of deficiencies identified, such information is commercially sensitive but that it considered that the information should be released in the public interest. 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.
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 indicated 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) certain information regarding the scope of the HPRA’s inspection, and
(iii) relevant findings and a brief conclusion.
In respect of category (i) above, the record contains limited information in respect of the activities of the applicant. The applicant has not made submissions in respect of this information, nor was it highlighted in correspondence between the applicant and the HPRA during the consultation process. I am not satisfied that release of the limited information could give rise to the harms set out 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 submissions received and 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).
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 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 application for review, the applicant argued that the disclosure of the record could jeopardise its entire product portfolio, including medicines for very serious illnesses. It said there is a “real and present concern regarding irreparable damage to trust and confidence in [the applicant] and its products within the medical … and patient communities”. It also said that when taken out of context, the release of the information could affect patient adherence to medication, unnecessarily impacting patient safety.
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, and for those who use the regulated products, that findings of deficiencies can be accessed.
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. On this point, 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 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 with 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. While I note that the scope of the original request has resulted in significant portions of the record being withheld, I do not accept that applicant’s arguments that release of the remaining information relating to findings of the HPRA would be misleading. 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 argued that the disclosure of the record may harm its ability to successfully compete for public sector contracts due to the misinterpretation of the information therein. 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. As such, I propose briefly considering the application of section 36(1)(c) to the remaining information in the record.
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.
No further submissions have been received by the applicant in respect of the reference to public sector contracts above. It seems to me that the applicant’s argument amounts to no more than a general assertion that the exemption applies. I am not satisfied that the disclosure of the record may harm the applicant’s ability to successfully compete for public sector contracts due to the misinterpretation of the information therein. For such an argument to succeed, I would have to accept that public sector bodies might, in the future, misinterpret the specific record at issue when negotiating contracts, without the applicant having an opportunity to put the record in context. I do not accept such an argument. Having considered the specific content of the record, I find that the applicant has not satisfied this Office that section 36(1)(c) applies to the information at issue.
Section 37 – personal information
In its application to this Office, the applicant argued that certain information in the record is exempt under section 37 of the FOI Act. It refers to a specific paragraph within the report which relates to an individual and said that the information therein “could, if allied to other publically available information, identify the person in question”. It said that this could have data privacy implications for the individual and that it is not in the public interest to release that information.
In the copy of the record provided to this Office, the HPRA indicated that it is withholding the above referenced paragraph. In its submission, it said that “following on from the third party consultation, some further information was accepted as being commercially sensitive and confidential and was not considered to fall for release in the public interest”. It said that such information “was highlighted in pink on the records sent to the third party”. The information in question is highlighted in pink on the document provided to this Office. I understand, therefore, that the HPRA does not intend to release this information.
Accordingly, I do not consider it necessary to assess the applicability of section 37 to the information in question. The above submissions are the only reference to personal information made by the applicant to this Office. I find that the applicant has not satisfied this Office that section 37(1) applies to any further information in the record.
Section 18 – access to parts of records
Section 2 of the Act defines “record” as including “a copy or part” of anything falling within the definition of a record. 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 note the applicant’s position that the release of limited information from the report creates a narrative which is “misleading”. Having considered the record carefully, I am not satisfied that release of a redacted version would be misleading under section 18(2). While the copy will have considerable information redacted, this is on the basis that such information is outside the scope of the request, rather than on the basis of it being exempt under the FOI Act. I do not believe that the remaining information, which includes introductory information, the basis for the inspection in question and detail in respect of findings, is misleading. I find that section 18(2) does not preclude the part-grating of 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 record 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