Case number: OIC-134995-F5R0Z8
8 March 2024
This review arises from the decision of the HPRA to part-grant access to certain records 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 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 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 the decision. This case concerns an application for review made by an affected third party company (the applicant).
The requester sought access to certain inspection reports following inspections undertaken by the HPRA as well as "any replies sent to the HPRA from each company, in which they are asked to address any deficiencies set out in the inspection reports". He specified that the request related to non-conformities or breaches with regards the Medicinal Products (Control of Advertising) Regulations 2007 (the 2007 Regulations).
When processing the request, the HPRA formed the view that the release of the records could affect the interests of third parties, specifically the pharmaceutical companies that were the subject of the inspections. The applicant in this case is one such company.
The HPRA notified the applicant of the request on 14 December 2022. It informed the applicant that it was considering granting partial access to two records relevant to the applicant, namely a letter from the HPRA detailing inspection findings and the applicant's response. It provided the applicant with a copy of the records, identifying certain information that it proposed to redact on the basis that it was exempt or outside the scope of the request. It outlined its preliminary view that, on balance, the public interest would be better served by granting access to the remainder of the records. On 4 January 2023, the applicant provided submissions to the HPRA. It said that it agreed with the proposed redactions and identified further information that it believed should be withheld.
On 20 January 2023, the HPRA informed the applicant that it had made the decision to grant partial access to the records. It said it had decided not to accept the further redactions proposed by the applicant. It said that while the information in question may comprise confidential and/or commercially sensitive information, it considered that the public interest lies in favour of release in accordance with sections 35(3) and 36(3) of the FOI Act.
On 30 January 2023, the applicant sought a review by this Office of the HPRA's decision. It said that while it did not object to the release of the documents, it wanted the company's name and address to be redacted, pursuant to section 36(1)(c) of the Act.
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 applicant, the original requester and the HPRA. I have also examined the records at issue. I have decided to conclude this review by way of a formal, binding decision.
There are two records at issue in this case. Record 1 comprises a letter dated 2 November 2018 from the HPRA to the applicant in which it outlines findings from an inspection undertaken in 2018. Record 2 comprises correspondence from the applicant in which it responds to those findings.
As I have outlined above, the applicant argued in its application for review that the company name and address should be redacted from the records as per section 36(1)(c). Subsequently during the course of the review, it said that while it has no objection to the public availability of the information [in the records], it believes it is unnecessary to reveal the company name, even indirectly. It also indicated that it considers the company identity to be confidential information and that it should be redacted. As I have also outlined above, in its decision on the request, the HPRA said it considered that the public interest favours release of the redacted records "in accordance with section 35(3) and section 36(3)" of the FOI Act.
Accordingly, this review is concerned solely with whether the HPRA was justified in its decision to grant access, under section 35(3) and/or section 36(3) of the Act, to the identity of the applicant.
Before I address the substantive issues arising, I wish to note that under section 22(12)(a) of the Act, a decision to grant a request to which section 38 applies shall be presumed to have been justified unless the person to whom the information relates shows to the satisfaction of the Commissioner that the decision was not justified. This means that the onus is on the applicant to satisfy this Office that the HPRA's decision to grant partial access to the records at issue was not justified.
It is also important to note that a review by this Office is considered to be "de novo", which means that, in this case, it is based on the circumstances and the law as they pertain at the time of the decision and is not confined to the basis upon which the FOI body reached its decision.
Relevant Background Information
In its submissions to this Office, the HPRA said that it regulates the advertising of human medicinal products in Ireland. It said 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 that it ensures compliance with the 2007 Regulations in a number of ways. It said that it performs pre-planned and random compliance reviews of advertisements and also carries out inspections at the offices of marketing authorisation holder (MAH) 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
As the applicant argued that the company identity is exempt from release under section 36(1)(c), I will commence my analysis by considering that exemption first.
Section 36(1)(c)
Section 36(1)(c) provides for the mandatory refusal of a request if the record concerned contains information whose disclosure could prejudice the conduct or outcome of contractual or other negotiations of the person to whom the information relates.
The 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 application to this Office, the applicant said it does not see the advantage nor the requirement for its identity to be revealed. It argued that the release of the company name could prejudice the conduct or outcome of contracts or future negotiations.
In its submissions, the HPRA said that in the case of deficiencies found, indications of lack of regulatory compliance may impact on contractual negotiations. However, it said it does not agree that withholding the applicant's identity is appropriate. It argued that the public interest lies in knowing specifically which organisations were found to have deficiencies on inspection.
As noted above, in this case the onus is on the applicant to satisfy this Office that the HPRA's decision to grant access to the details of its identity in the records at issue was not justified. The applicant has not identified any specific negotiations whose conduct or outcome might be prejudiced by the disclosure of its identity or how such prejudice might occur. Nevertheless, in its judgment inThe Minister for Communications, Energy and Natural Resources and the Information Commissioner & Ors[2020] IESC 57 (the eNet case), the Supreme Court described the presumption in section 22(12) of the Act as "a starting point" for a review by the Commissioner. The Commissioner's review functions are inquisitorial in nature. Thus, the applicant's failure to provide detailed submissions in support of its arguments is not the end of the matter. I have also had regard to the contents of the records at issue.
While the applicant has objected to the disclosure of its identity only, it is important to note that the disclosure of the records without the redaction of its identity would also involve the disclosure of the fact that certain specified deficiencies identified by the HPRA in relation to the investigation and management of a specified defect issue concern the applicant. However, it is also important to note that the disclosure of the records would disclose the explanation provided by the applicant for one of the deficiencies identified, the corrective action identified for the deficiencies, and the fact that the corrective action was identified and mainly completed at the time of the applicant's response.
As a general proposition, I accept that it is possible for the disclosure of certain specified deficiencies identified by the HPRA following its inspection of a pharmaceutical company to potentially prejudice the conduct or outcome of ongoing or pending negotiations of that company. However, I do not accept that such prejudice will always arise. It seems to me that much will depend on the particular facts of the case and could be influenced by a range of factors such as the seriousness of the deficiencies, the number and extent of the deficiencies, the timing of the investigation, the actions taken by the company to correct the identified deficiencies etc.
In this case, having regard to the discrete nature of the deficiencies identified by the HPRA, to the fact that the applicant identified and took action to correct those deficiencies, and to the fact that the records relate to an inspection which took place more than five years ago, I find it difficult to accept that the release of the identity of the applicant as the company that was involved could prejudice the conduct or outcome of contractual or other negotiations of the applicant, particularly in circumstances where the applicant has not identified any specific negotiations whose conduct or outcome might be prejudiced by the disclosure of its identity. Accordingly, I find that the applicant has not satisfied this Office that section 36(1)(c) applies to the identity of the applicant.
Section 36(1)(b)
When notifying the applicant of its decision, the HPRA referred to its initial letter of notification of the request and said it had indicated in that letter that it regarded the information at issue as potentially comprising confidential and/or commercially sensitive information and that it was considering releasing the information in the public interest. It did not identify any particular subsection of section 36 as applying to the records at issue. However, its submissions to this Office, it indicated that it deemed section 36(1)(b) to be of relevance. That section provides for the mandatory refusal of a request if the record concerned contains financial, commercial, scientific or technical or other information whose disclosure could reasonably be expected to result in a material financial loss or gain to the person to whom the information relates, or could prejudice the competitive position of that person in the conduct of his or her profession or business or otherwise in his or her occupation. The essence of the test in section 36(1)(b) is not the nature of the information but the nature of the harm which might be occasioned by its release.
The harm test in the first part of section 36(1)(b) is that disclosure "could reasonably be expected to result in material loss or gain". This Office takes the view that the test to be applied is not concerned with the question of probabilities or possibilities but with whether the decision maker's expectation is reasonable. The 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.
The HPRA said that in the case of deficiencies found, the release of such information may impact the competitive position of the applicant in that it may have the effect of reducing the number of persons purchasing the products of the applicant due to concerns about the level of compliance of the applicant with the relevant legislative requirements or indications of lack of regulatory compliance may impact on share price, contractual negotiations, financing arrangements and other commercial activity.
The applicant made no specific submissions as to the applicability of section 36(1)(b) in this case. In similar recent cases involving the HPRA and other pharmaceutical companies, I found that, given the low standard of proof required for the harm in the second part of section 36(1)(b) to apply, the release of details of the findings of deficiencies identified during a HPRA inspection could prejudice the competitive position of the companies concerned. In this case, although I consider it to be a closer call, I accept that the proposed release of the records with the applicant's identity included could potentially impact public confidence in the applicant's products and therefore prejudice its competitive position. However, I believe that the limited and historical nature of the findings coupled with the inclusion in the records of the corrective action identified and actioned for the deficiencies serves to significantly reduce the harm associated with disclosure of the applicant's identity. Nevertheless, I accept that the relevant harm test has been met. I find that section 36(1)(b) applies to the identity of the applicant.
Having found section 36(1)(b) to apply, I must proceed to consider whether sections 36(2) or 36(3) serve 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) arise 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 application to this Office, the applicant stated that it agrees that the public interest lies in favour of release in accordance with section 36(3). However, its position is that its name and address should be redacted. It said that it does not see the advantage or requirement for its identity to be revealed.
As noted above, the HPRA said that it does not agree that withholding the applicant's company name is appropriate. It said that the public interest lies in knowing specifically which organisations were found to have deficiencies on inspection. It said that release of such information allows the public to know how a regulated entity's legislative obligations are enforced by the HPRA. It said the public have a strong interest in knowing that advertising activities are undertaken within the standards prescribed by law. It said that it is important for the public, "for public health reasons generally and specifically for those who use the products", that findings of deficiencies are something that can be accessed.
The HPRA's position is that the findings of a deficiency, while considered commercially sensitive and also confidential, should be released in the public interest. In its submissions, it said that details of particular Standard Operating Procedures and internal controls, staff members working in particular areas and specific product names were redacted as it regarded such information as commercially sensitive and considered that private interests overrode any public interest in release. It said that there is a public interest in the maintenance of commercial sensitivity in respect of the availability of medicines on the Irish market.
The HPRA referenced previous decisions of this Office, specifically OIC-108970, OIC-109419, OIC-127873, OIC-127630, OIC-020533 and OIC-67447. It referred to this Office's decision-making in those cases and cited reasoning in respect of the public interest. The HPRA said that its decision-making in this case is analogous to the previous reviews and that it believes that release in the public interest of the fact of a deficiency in terms of compliance with legal requirements in terms of advertising or medicinal products is the correct approach. The HPRA said that in previous decisions, this Office distinguished between releasing information on deficiencies, in order for the public to know how a regulated entity's legislative obligations are enforced by the HPRA, and refusing information specific to a company which is not in the public interest to release.
In respect of information on deficiencies, the HPRA referenced an interest in the public knowing "how a regulated entity's legislative obligations are enforced by the HPRA". It said that it is of the view that "the public interest lies in findings of a deficiency being made available to the public". It said that "the HPRA regulates certain activities relating to the advertisement of medicines and the public have a strong interest in knowing that advertising activities are undertaken within the standards prescribed by law and it is important to the public, for public health reasons generally and specifically, for those who use the products of the MAH in question, that the findings of deficiencies are something that can be accessed by the public, under the provisions of the FOI Act or otherwise". It said "the primary driver of the advertising regulations is, at its heart, the protection of public health in the public interest".
Following receipt of the HPRA's submissions and considering the content of same, the Investigator notified the applicant of the detailed submissions received. In response, the applicant maintained its position that its name should be withheld. It said that it has no objection to the public availability of the information in the records, but that it is "unnecessary to reveal the company name, even indirectly".
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".
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. 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 identifiable information about the applicant company in the context of specific deficiencies identified by the HPRA and its responses and corrective actions identified. It seems to me that by redacting certain information, the HPRA has sought to mitigate the risks of releasing information that might give rise to the harms identified in section 36(1)(b). Moreover, it seems to me that the inclusion in the records of the applicant's responses and outlined actions in respect of the HPRA findings serves to contextualise those findings, thereby significantly reducing the harm associated with the disclosure of those findings. Accordingly, having carefully examined the parts of the records that the HPRA has decided to release, my view is that the impact of disclosure on the interest underpinning the exemption is low.
I would also note that while the applicant is a private enterprise, it is one engaged in regulated activities. The disclosure of the information at issue would disclosure information relating to the applicant's compliance with the 2007 Regulations and the inspection process in respect of same. 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;
Having considered the content of the records in this case, my view is that release of the specific information in the records will serve these public interests by demonstrating the extent of the applicant's compliance with legal standards and by demonstrating the extent of the enforcement activity carried out by the HPRA following the inspection of the applicant.
In my view, the public interests identified are even stronger in circumstances where the matters involved concern public health. It seems to me that the HPRA has sought to strike a balance by deciding to release relevant information that would serve these public interests whilst simultaneously striving to protect sensitive information relating to the applicant the release of which might affect its commercial interests. As I have indicated above, a number of factors serve to mitigate any harms which could arise from disclosure of the remaining information in the relevant records. These include the historical nature of the information and the fact that the applicant's responses and actions are included in the records.
In the circumstances, I am satisfied that the public interest would, on balance, be better served by granting access to the applicant's identity. I find, therefore, that section 36(3) serves to disapply section 36(1)(b) in this case.
Section 35(1)
Section 35 of the Act provides as follows:
(1) 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.
Subsection (2) of section 35 provides that 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 subsection (2) serves to disapply subsection (1), I consider it appropriate to first examine whether it serves to disapply subsection (1) in respect of record 1, which comprises a letter created by HPRA staff in the course of the performance of their functions. 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. Accordingly, I have considered whether the release of the record would constitute a breach of an equitable duty of confidence owed to the applicant.
In the Supreme Court decision in the case ofMahon 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 inCoco 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."
The information at issue in record 1 comprises findings made by the HPRA. While I accept that the disclosure of findings may, in certain cases, also involve the disclosure of information provided by a relevant party, I am not satisfied that the findings at issue in this case could be described as information communicated in circumstances which impose an obligation of confidence or trust. In the circumstances, I find that the release of the relevant parts of record 1 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.
I note, in any event, that even if I am wrong in so finding, the applicant made no submissions in respect of the applicability of section 35(1) of the Act to either record. Instead, it asserted that it considered the company identity to be confidential. Moreover, the HPRA said it considered that the public interest favours release of the redacted records "in accordance with section 35(3) and section 36(3)" of the FOI Act. Accordingly, for the sake of completeness, I have also considered whether section 35(1)(a) serves to protect the identity of the applicant as contained in the records. I am satisfied that it does not.
The HPRA's position is that "information that is commercially sensitive is prima facie confidential". It said it redacted information which it understood comprised commercially sensitive information which was therefore given to the HPRA in confidence. It said that information relating to findings of deficiencies in terms of advertising compliance, while considered commercially sensitive and also therefore confidential, was not redacted. It said that it considers such information should be released in the public interest.
In respect of the question of whether release would be likely to prejudice the giving to the FOI body of further similar information, the HPRA said that "given the powers of the HPRA in terms of obtaining information, it is arguable that this limb of the confidentiality test is difficult to demonstrate". With reference to the specific subsection in question, it said that "the FOI Act clearly foresaw eventualities whereby confidential information included information that was required to be given to the FOI body under law". It said that the exchange and collection of the relevant information is necessary for the HPRA to adequately and appropriately conduct inspections.
The HPRA also drew my attention to a European guidance document produced by the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) (available here). The guidance document relates to the release of information after the granting of a marketing authorisation. Section 3.3 of the document concerns information on inspections and states that;
"information on the outcome of inspections (e.g. compliance/non-compliance/outstanding issues to be addressed) is not regarded as confidential, however specific details e.g. information regarding facilities and equipment are considered commercially confidential".
The HPRA said that it expects that marketing authorisation holders are aware of this pan-EEA approach in terms of findings of non-compliance or deficiencies. It noted that its approach is slightly more nuanced in that it accepts that the information may be commercially sensitive but should be released in the public interest. The Investigator notified the applicant of the potential relevance of the above guidance document. In response, the applicant restated its position that identifying information is confidential.
I have considered the submissions made by the applicant, the HPRA's submissions, and the content of the records. The HPRA's position is that commercially sensitive information is "prima facie" confidential. That is not the test articulated in section 35(1)(a) of the FOI Act. Rather, the four requirements outlined above must be satisfied.
Among other things, I am not satisfied that the disclosure of the records would be likely to prejudice the giving of similar information such as was provided by the applicant to the HPRA in this case. I note that compliance with the 2007 Regulations is required and the Irish Medicines Board Act 1995 provides that contravention is an offence. I note, for example, that the 2007 Regulations require marketing authorisation holders to ensure that, in relation to an advertisement relating to a medicinal product, any decision taken by the HPRA is immediately and fully complied with, and that any advertising of medicinal products carried out conforms with the requirements of the Regulations. The HPRA may also appoint authorised officers with extensive powers of inspection and examination under the Medicine Boards Act. In such circumstances, it seems to me that it is very much in the interest of such marketing authorisation holders to provide information to the HPRA during the course of an inspection and to provide responses and action plans in respect of regulatory findings of deficiencies.
Notwithstanding the HPRA's submissions, I do not accept that release of the specific information at issue would result in the relevant prejudice, particularly in the context of the legal and regulatory requirements referenced and the powers granted to the HPRA in that regard. I note that the HPRA has redacted information from the records which it considered to be commercially sensitive and confidential. In light of that, and the regulatory framework in place, I do not accept that release could reasonably result in marketing authorisation holders withholding information and requiring the HPRA to formally engage its legal powers.
Accordingly, I am not satisfied that the disclosure of the records at issue, with the inclusion of the applicant's identity, would prejudice the giving of further similar information. This finding alone is sufficient for me to find that section 35(1)(a) does not apply.
In conclusion, therefore, I find that the HPRA was justified in its decision that the public interest would, on balance, be better served by granting access to the identity of the applicant in the records at issue.
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 the applicant's identity in the records to which it has decided to release in part.
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